Medical Malpractice |

New CMS LTC Staffing Requirements Likely To Increase Workforce Competition, Costs Industry-Wide

May 12, 2024

Nursing homes and other health care facilities competing for staffing with these facilities should begin preparing to cope with expected wage costs and other pressures expected to result from new staffing and other changes to staffing requirements for Meficare and Medicaid participating long-term care favorites released by the Department of Health and Human Services Centers for Medicare & Medicaid Services (“”CMS”) on April 22, 2024.

The Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting final rule (“Final Rule”) will require long-term care facilities participating in federal programs such as Medicare and Medicaid are to have a licensed registered nurse (“RN”) on site at all times and to meet minimum nurse staffing (“TNS”) requirements imposed under the Final Rule. The Final Rule also will face enhanced facility assessment requirements under the Final Rule.

The mandates of the Final Rule and resulting increases in compensation and competition will impact both participating LTCs and other health care providers competing for staffing.

Total Nurse Staffing

CMS says its new minimum nurse staffing standards “will set a national and broadly applicable baseline that will significantly reduce the risk of unsafe and low-quality care for residents across all LTC facilities.”

Subject to certain limited temporary exceptions, the TNS requirements for long-term care (“LTC”) facilities aim to significantly reduce the risk of residents receiving unsafe and low-quality care within LTC facilities by specifying required minimum nurse staffing.

The Final Rule generally will require LTC facilities to meet a total nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care. LTCs may use any combination of registered nurse (“RN”), licensed practical nurse (“LPN”), licensed vocational nurse (“LBN”), or nurse aide) to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard.

In addition, the Final Rule will require LTCs to have at least one RN on site 24 hours a day, 7 days a week to provide skilled nursing care.

Some “limited temporary exceptions” may apply to all the requirements for qualifying LTCs in areas with workforce shortages that meet other criteria. While an estimated 25% of nursing homes would be eligible for exceptions, these are “limited, temporary exceptions,” LTC must be in a workforce shortage area and report the amount of their income spent on wage and other information to prove their “good faith” efforts to hire by paying competitive wages.”

While these are minimum staffing standards, CMS expects LTC facilities to use the updated and newly strengthened facility assessment to determine whether their staffing needs to be set above these minimums, based on resident acuity and individual care needs. CMS is committed to continued examination of staffing thresholds, including work to review quality and safety data resulting from initial implementation of these finalized policies, as well as robust public engagement.

Additionally, to increase transparency related to compensation for workers, CMS will also require states to collect and report on the percent of Medicaid payments that are spent on compensation for direct care workers, and support staff, delivering care in nursing facilities and intermediate care facilities, for individuals with intellectual disabilities.

CMS Tightening LTC Assessments

LTC facilities are already required to conduct, document, and review, annually and as necessary, a facility-wide assessment to determine what resources are necessary to care for residents competently during both day-to-day operations and emergencies. ensure that facilities are utilizing the assessment as intended by making thoughtful, person-centered staffing plans, and decisions focused on meeting resident needs, including staffing at levels above the finalized minimums as indicated by resident acuity, the Final Rule raises the assessment requirements as follows:

Facilities must use evidence-based methods when care planning for their residents, including consideration for those residents with behavioral health needs.
Facilities must use the facility assessment to assess the specific needs of each resident in the facility and to adjust as necessary based on any significant changes in the resident population.
Facilities must include the input of the nursing home leadership, including but not limited to, a member of the governing body and the medical director; management, including but not limited to, an administrator and the director of nursing; and direct care staff, including but not limited to, RNs, LPNs/LVNs, and NAs, and representatives of direct care staff as applicable. The LTC facility must also solicit and consider input received from residents, resident representatives, and family members.
Facilities are required to develop a staffing plan to maximize recruitment and retention of staff consistent with what was described in the President’s April Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers.

Temporary Limited Exceptions

LTC facilities may qualify for a temporary hardship exemption from the minimum nurse staffing HPRD standards and the 24/7 RN requirement only if they meet the following criterion for geographic staffing unavailability, financial commitment to staffing, and good faith efforts to hire:

The facility is located in an area where the supply of RN, NA, or total nurse staff is not sufficient to meet area needs as evidenced by the applicable provider-to-population ratio for nursing workforce (RN, NA, or combined licensed nurse and nurse aide), which is a minimum of 20% below the national average, as calculated by CMS using data from the U.S. Bureau of Labor Statistics and the U.S. Census Bureau.
- The facility may receive an exemption from the total nurse staffing requirement of 3.48 HPRD if the combined licensed nurse and nurse aide to population ratio in its area is a minimum of 20% below the national average.
- The facility may receive an exemption from the 0.55 RN HPRD requirement, and an exemption of eight hours a day from the RN on-site 24 hours per day for seven days a week requirement, if the RN to population ratio in its area is a minimum of 20% below the national average.
- The facility may receive an exemption from the 2.45 NA HPRD requirement if the NA to population ratio in its area is a minimum of 20% below the national average.

Eligible LTC facilities that meet the criteria will receive a temporary hardship exemption by completing the following:

The facility provides documentation of good faith efforts to hire and retain staff, such as through job postings, the number and duration of vacancies, job offers made, and competitive wage offerings.
The facility provides documentation of the facility’s financial commitment to staffing, including the amount the facility expends on nurse staffing relative to revenue.

Before being considered, the LTC facility must be surveyed for compliance with the LTC participation requirements. CMS will coordinate with state survey agencies to determine if the facility meets the criteria for a hardship exemption noted above.

Facilities granted an exemption will be required to: 1) post a notice of its exemption status in a prominent and publicly viewable location in each resident facility; 2) provide notice of its exemption status, and the degree to which it is not in compliance with the HPRD requirements, to each current and prospective resident; and 3) send a copy of the notice to a representative of the Office of the State Long-Term Care Ombudsman.

CMS will indicate if a facility has obtained an exemption on the Medicare.gov Care Comparewebsite.

Facilities are not eligible for an exemption if any one of the following is true:

They have failed to submit their data to the Payroll Based Journal System.
They have been identified as a special focus facility (SFF).
They have been identified within the preceding 12 months as having: widespread, or a pattern of, insufficient staffing that resulted in actual harm to a resident; or an incident of insufficient staffing that caused or is likely to cause serious harm or death to a resident.

Facilities that meet the hardship exemption criteria are eligible from the time at which the exemption is granted until the next standard recertification survey, unless the facility meets any of the above-mentioned criteria for not being eligible for the exemption during that time. The hardship exemption may be extended on each standard recertification survey, after the initial period, if the facility continues to meet the exemption criteria.

Implementation Deadlines

The Final Rule has staggered implementation timeframe for its minimum nurse staffing standards and 24/7 RN requirement based on geographic location as well as possible exemptions for qualifying facilities for some parts of these requirements based on workforce unavailability and other factors.

CMS is implementing the minimum nurse staffing requirements to occur in three phases over a three-year period for all non-rural facilities. The following deadlines apply for non-rural facilities:

Phase 1 — Within 90 days of the final rule publication, facilities must meet the facility assessment requirements.
Phase 2 — Within two years of the final rule publication, facilities must meet the 3.48 HPRD total nurse staffing requirement and the 24/7 RN requirement.
Phase 3 — Within three years of the final rule publication, facilities must meet the 0.55 RN and 2.45 NA HPRD requirements.

The Final Rule sets later deadlines for rural facilities in acknowledgment of the unique challenges that rural LTC facilities may face in staffing as follows:

Phase 1 — Within 90 days of the final rule publication, facilities must meet the facility assessment requirements.
Phase 2 — Within three years of the final rule publication, facilities must meet the 3.48 HPRD total nurse staffing requirement and the 24/7 RN requirement.
Phase 3 — Within five years of the final rule publication, facilities must meet the 0.55 RN and 2.45 NA HPRD requirements.

Qualification as a rural facility is determined by the Office of Management and Budget.

CMS Nursing Home Staffing Campaign

CMS continues efforts to encourage the availability to increase the number of nurses in nursing homes. As part of these efforts, CMS plans to promote awareness of the many career pathways in the nursing field that are available to help recruit all types of individuals, from NAs to LPNs/LVNs and RNs. It also plans to offer financial incentives like tuition assistance for nurses to work in the nursing home environment in qualifying facilities or state oversight roles and to make it easier for individuals to become nurse aides by streamlining the process for enrolling in training programs and finding placement in a nursing home.

Additionally, CMS plans to partner with states to bolster nurse recruitment.

CMS says more announcements are expected later this year and it anticipates beginning distribution of financial incentives in 2025.

Begin Preparing Now

All nursing homes and other health care facilities competing for staffing should begin preparing for these changes immediately. Obviously, LTC is participating in Medicare, Medicaid or other covered programs will face the most immediate and direct impact from these rules. Facility should begin documented efforts to meet the staffing requirements and where applicable, evidence and other materials needed to prepare for required surveys and to establish, other criteria necessary to qualify for exemption if needed.

It is not just the facilities directly covered by the rules that the new staffing requirements will impact.

While the new requirements technically apply only to LTCs participating in Medicare, Medicaid or other CMS regulated programs, their applicability likely will impact non-participating programs as well. the new minimum requirements will affect standards of care for negligence and other purposes.

Likewise, increases in compensation and other terms and conditions of employment at covered facilities will affect other types of providers. Non-participating nursing homes, home health, hospice, rehabilitation, hospitals, rehabilitation, facilities, assisted living facilities and other providers should expect greater scrutiny of their staffing and greater pressure to pay better wages and improve other work conditions and benefits in response to greater competition for workers.

Facilities that have used noncompetition agreements or other restraints on post employment eligibility to work are cautioned that these types of restraints could run afoul of the federal trade commissions new Non-Competition Clause Final Rule slated to take affect in September, 2024 if the current judicial stay against it is lifted by that time.

Likewise, long-term care another healthcare employers planning to increase wages, or other terms of employment are cautioned to use care to comply with any applicable duties to bargain or other requirements if subject to union organization or contracts.

Given the complicated maze of employment, benefits, and healthcare regulations that facilities working to deal with these new requirements must negotiate, healthcare providers working with these and other recruitment rules are encouraged to consult with qualified legal counsel with experience in both the healthcare and employment issues involved.

For Additional Information

We hope this update is helpful. Solutions Law Press, Inc. invites you to receive future updates by registering on here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

If you need have questions or need assistance with this or other cybersecurity, health, benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, to inquire about arranging for compliance audit or training, or need legal representation on other matters, contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

About the Author

Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of workforce, risk management, compliance, regulatory and government affairs and other work with health care, employee benefit, managed care and other insurance, education, workforce and other performance and data dependent organizations, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with government and private health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services, education and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications, her experience includes extensive involvement throughout her career advising and representing health care and life sciences and other clients about preventing, investigating and defending HHS CMS, OIG, CIICO, OCR; , DOL WHD, EEOC, EBSA, OSHA; DOJ, OFCCP; NLRB; DOE; ICE; state attorney general licensing, Department of Health, Aging, Disability, Insurance, and other federal and state, JCHO and other accreditation and quality, peer review, employment and other workforce, contract and other investigations, audits, and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state laws.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Laws Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here.

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Posted by Cynthia Marcotte Stamer

Banner Health Pays $1.25 Million To Settle Cybersecurity Breach Impacting Nearly 3 Million Individuals

February 3, 2023

Phoenix-based nonprofit health system Banner Health and its affiliates (“Banner Health”) paid $1.25 million and agreed to take corrective actions to resolve its exposure to potentially much greater Health Insurance Portability and Accountability Act (HIPAA) Security Rule civil monetary penalty exposure for a 2016 cyber hacking breach that compromised the personal health information of 2.81 million consumers. OCR used its February 2 announcement of the Banner Health settlement to warn health care providers, health plans, health care clearinghouses (“covered entities”) and business associates covered by HIPAA to guard their own systems containing protected health information against breach by cyber hacking.

Banner Health Settlement

Banner Health is one of the largest non-profit health systems in the country, with over 50,000 employees and operating in six states. Banner Health is the largest employer in Arizona and one of the largest in northern Colorado.

In November 2016, OCR initiated an investigation of Banner Health following the receipt of a breach report stating that a threat actor had gained unauthorized access to electronic protected health information, potentially affecting millions. The hacker accessed protected health information that included patient names, physician names, dates of birth, addresses, Social Security numbers, clinical details, dates of service, claims information, lab results, medications, diagnoses and conditions, and health insurance information.

OCR’s investigation found evidence of long-term, pervasive noncompliance with the HIPAA Security Rule across Banner Health’s organization, a serious concern given the size of this covered entity. Organizations must be proactive in their efforts to regularly monitor system activity for hacking incidents and have measures in place to sufficiently safeguard patient information from risk across their entire network.

The potential violations OCR identified specifically included:

A lack of an analysis to determine risks and vulnerabilities of electronic protected health information across the organization;
Insufficient monitoring of its health information systems’ activity to protect against a cyber-attack;
Failure to implement an authentication process to safeguard its electronic protected health information; and
Failure to have security measures in place to protect electronic protected health information from unauthorized access when it was being transmitted electronically.

Under the Resolution Agreement and Corrective Action Plan negotiated to resolve these potential violations, Banner Health paid $1,250,000 to OCR. Banner Health also agreed to implement a corrective action plan, which identifies steps Banner Health will take to resolve these potential violations of the HIPAA Security Rule and protect the security of electronic patient health information that will be monitored for two years by OCR to ensure compliance with the HIPAA Security Rule. Under the corrective action plan, Banner has agreed to take the following steps:

Conduct an accurate and thorough risk analysis to determine risks and vulnerabilities to electronic patient/system data across the organization
Develop and implement a risk management plan to address identified risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI
Develop, implement, and distribute policies and procedures for a risk analysis and risk management plan, the regular review of activity within their information systems, an authentication process to provide safeguards to data and records, and security measures to protect electronic protected health information from unauthorized access when it is being transmitted electronically, and
Report to HHS within thirty (30) days when workforce members fail to comply with the HIPAA Security Rule.

OCR Warns Other HIPAA-Covered Entities

In the health care sector, hacking is now the greatest threat to the privacy and security of protected health information. OCR’s announcement of the settlement reports 74 percent (74%) of the breaches reported to OCR in 2021 involved hacking/IT incidents.

The announcement also notes OCR offers an array of resources to help health care organizations bolster their cybersecurity posture and comply with the HIPAA Rules,

The settlement and OCR’s announcement warn other covered entities and business associates to use these and other necessary resources to protect their systems with protected health information from cyber hacking and other breaches.

In conjunction with reminding other covered entities of these resources, the settlement announcement quotes OCR Director Melanie Fontes Rainer as a warning, “Hackers continue to threaten the privacy and security of patient information held by health care organizations, including our nation’s hospitals, … It is imperative that hospitals and other covered entities and business associates be vigilant in taking robust steps to protect their systems, data, and records, and this begins with understanding their risks, and taking action to prevent, respond to and combat such cyber-attacks. … Cyber security is on all of us, and we must take steps to protect our health care systems from these attacks.”

OCR’s enforcement record confirms these are not idyl threats. Breaches of the Security or Breach Notification Rules often result in significant civil monetary penalty assessments or negotiated settlements to mitigate civil liability exposures arising out of such breaches. See e.g., Clinical Laboratory Pays $25,000 To Settle Potential HIPAA Security Rule Violations (May 25, 2021); Health Insurer Pays $5.1 Million to Settle Data Breach Affecting Over 9.3 Million People (January 15, 2021); Aetna Pays $1,000,000 to Settle Three HIPAA Breaches(October 28, 2020); Health Insurer Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People (September 25, 2020); HIPAA Business Associate Pays $2.3 Million to Settle Breach Affecting Protected Health Information of Over 6 million Individual – (September 23, 2020); Lifespan Pays $1,040,000 to OCR to Settle Unencrypted Stolen Laptop Breach (July 27, 2020); Small Health Care Provider Fails to Implement Multiple HIPAA Security Rule Requirements (July 23, 2020).

Alerts issued by OCR regarding heightened security risks in recent months and a growing tide of highly publicized breaches send a strong warning to other covered entities and their business associates to reconfirm the adequacy of their own HIPAA privacy, security, breach notification and other procedures and protections by among other things:

Reviewing and monitoring on a documented, ongoing basis the adequacy and susceptibilities of existing practices, policies, safeguards of their own organizations, as well as their business associates and their vendors within the scope of attorney-client privilege taking into consideration data available from OCR, data regarding known or potential susceptibilities within their own operations as well as in the media, and other developments to determine if additional steps are necessary or advisable.
Updating policies, privacy and other notices, practices, procedures, training and other practices as needed to promote compliance and defensibility.
Renegotiating and enhancing service provider agreements to detail the specific compliance, audit, oversight and reporting rights, workforce and vendor credentialing and access control, indemnification, insurance, cooperation and other rights and responsibilities of all entities and individuals that use, access or disclose, or provide systems, software or other services or tools that could impact on security; to clarify the respective rights, procedures and responsibilities of each party in regards to compliance audits, investigation, breach reporting, and mitigation; and other relevant matters.
Verifying and tightening technological and other tracking, documentation and safeguards and controls to the use, access and disclosure of protected health information and systems.
Conducting well-documented training as necessary to ensure that members of the workforce of each covered entity and business associate understand and are prepared to comply with the expanded requirements of HIPAA, understand their responsibilities and appropriate procedures for reporting and investigating potential breaches or other compliance concerns, and understand as well as are prepared to follow appropriate procedures for reporting and responding to suspected
violations or other indicia of potential security concerns.
Tracking and reviewing on a systemized, well-documented basis actual and near-miss security threats to evaluate, document decision-making and make timely adjustments to policies, practices, training, safeguards and other compliance components as necessary to identify and resolve risks.
Establishing and providing well-documented monitoring of compliance that includes board-level oversight and reporting at least quarterly and sooner in response to potential threat indicators.
Establishing and providing well-documented timely investigation and redress of reported
violations or other compliance concerns.
Establishing contingency plans for responding in the event of a breach.
Establishing a well-documented process for monitoring and updating policies, practices and other efforts in response to changes in risks, practices and requirements.
Preparing and maintaining a well-documented record of compliance, risk, investigation and other security activities.
Pursuing other appropriate strategies to enhance the covered entity’s ability to demonstrate its compliance commitment both on paper and in operation.

Because of susceptibilities in systems, software and other vendors of business associates, suppliers and other third parties, covered entities and their business associates should use care to assess and manage business associate and other vendor-associated risks and compliance as well as tighten business associate and other service agreements to promote the improved cooperation, coordination, management and oversight required to comply with the new breach notification and other HIPAA requirements by specifically mapping out these details.

Beyond these HIPAA exposures, breaches and other HIPAA noncompliance carries other liability risks. Leaders of covered entities or their business associates also are cautioned that while HIPAA itself does not generally create any private right of action for victims of breach under HIPAA, breaches may create substantial liability for their organizations or increasingly, organizational leaders. For instance, the Department of Health & Human Services has warned health care providers participating in Medicare or other federal programs and Medicare Advantage health plans that HIPAA compliance is a program term of participation.

Health care providers and health insurers can face liability under state data privacy and breach, negligence or other statutory or common laws. In addition, physicians and other licensed parties may face professional discipline or other professional liability for breaches violating statutory or ethical standards.

Health plans also face a myriad of other exposures from failing to use appropriate cyber safeguards. Plan fiduciaries of employment-based health plans covered by the Employee Retirement Income Security Act (“ERISA”) risk liability under ERISA’s fiduciary responsibility rules. The Department of Labor Employee Benefit Security Administration (“EBSA”) now audits the adequacy of the cybersecurity and other HIPAA compliance of health plans and their third-party administrators and other business associates as part of EBSA’s oversight and enforcement of ERISA. Department of Labor Assistant Secretary for EBSA Lisa Gomez confirmed audit and enforcement of cybersecurity obligations is a key priority in EBSA’s current work plan in her February 4, 2023 comments to the American Bar Association.

Meanwhile, the Securities and Exchange Commission has indicated that it plans to pursue enforcement against leaders of public health care or other public companies that fail to use appropriate care to ensure their organizations comply with privacy and data security obligations.

Furthermore, appropriate cyber security practices also may be advisable elements for organizations to include in their Federal Sentencing Guideline Compliance Programs to mitigate potential organization liability risks under federal electronic crime and related laws.

In the face of these risks and warnings, all covered entities and their business associates should reassess and confirm the adequacy of their and their business associates’ cyber security defenses and breach response preparations.

More Information

We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

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Posted by Cynthia Marcotte Stamer

CDC Eases Opiate Prescription Guidelines

November 3, 2022

The Centers for Disease Control released updated opiate prescription guidance today, loosening restrictions on prescription of the pain management narcotics under certain conditions.

Ironically the new guidance loosening opiate prescription guidelines comes on the heels of the announcement yesterday of sellements of opiate litigation against CVS and Walgreens brought by multiple states’ seeking to recover states’ costs arising from citizens ‘ addicted to opiates.

CDC’s revised opiate guidance is intended to give providers more flexibility to prescribe under various situations in response to criticism that the original more narrow guidelines harmed patients legitimately needing the pain management treatment.

Guideline changes are likely to implicate prescribing practices as well as some prescription drug coverages, as well as electronic recordkeeping and prescribing systems.

Slay tuned for more details about the new guidelines and other health care and life sciences relevant developments.

More Information

We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.

Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.

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NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.

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Posted by Cynthia Marcotte Stamer

6 Texas Physicians Face Federal Health Care Fraud Charges For Alleged Improper Kickbacks & Lab Testing Claims

May 29, 2022

The Department of Justice sent another strong warning to physicians and other health care provides not to violate the False Claims Act by making improper patient referrals in violation of the Anti-Kickback Statute and the Stark Law, billing federal health care programs for medically unnecessary laboratory testing or other services or both when charged six Texas physicians with federal health care fraud this week. The prosecution of the physicians for laboratory tests arranged and billed through management services organizations also reminds physicians and other providers that reliance upon management services or other third-party service providers generally does not protect a physician participating in prohibited laboratory or other testing, durable medical equipment, facility, physical therapy or other health care billing or referral arrangements from liability.

Charges Against Texas Physicians

This week, the Justice Department added the following six physicians as defendants to criminal charges filed in a False Claims Act complaint filed in January 2022 against former True Health Diagnostics LLC (THD) CEO Christopher Grottenthaler, former Boston Heart Diagnostics Corporation (BHD) CEO Susan Hertzberg, former LRH CEO Jeffrey Madison, and others:

Doyce Cartrett, Jr., M.D., of Silsbee, Texas, allegedly received over $320,000 from LRH and two management services organizations or “MSOs,” Ascend MSO of TX LLC (Ascend) and Eridanus MG LLC (Eridanus), in return for his referrals.
Elizabeth Seymour, M.D., of Corinth, Texas, allegedly received over $280,000 from two MSOs, Ascend and Eridanus, in return for her referrals.
Emanuel Paul “E.P.” Descant, II, M.D., of Spring, Texas, allegedly received over $125,000 from two MSOs, North Houston MSO and Tomball Medical Management Inc., in return for his referrals.
Frederick Brown, M.D., of Missouri City, Texas, allegedly received over $190,000 from two MSOs, Ascend and Indus MG LLC (Indus), in return for his referrals.
Heriberto Salinas, M.D., of Cleburne, Texas, allegedly received over $75,000 from two MSOs, Ascend and Herculis MG LLC (Herculis), in return for his referrals.
Hong Davis, M.D., of Lewisville, Texas, allegedly received over $70,000 from two MSOs, Ascend and Herculis, in return for her referrals.

The complaint in United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.) charges that small Texas hospitals including Rockdale Hospital dba Little River Healthcare (LRH), THD, BHD, the six physicians and others conspired to pay physicians to induce referrals to the hospitals for laboratory testing performed by THD or BHD. The charges stem from allegations made under the qui tam or whistleblower provisions of the False Claims Act by STF LLC by Felice Gersh, M.D. and Chris Riedel. The United States intervened in the qui tam action in December 2021.

The complaint alleges the charged hospitals paid a portion of their laboratory profits to recruiters, who in turn kicked back those funds to the referring physicians through MSOs allegedly set up by the recruiters to make payments to referring physicians. The Justice Department charges the alleged kickbacks were disguised as investment returns but actually were based on, and offered in exchange for, the physicians’ referrals. The complaint alleges that laboratory tests resulting from this referral scheme were billed to various federal health care programs, and that the claims not only were tainted by improper inducements but, in many cases, also involved tests that were not reasonable and necessary.

The Justice Department reports that before adding charges against the six physicians to the complaint this week, the Justice Department recovered more than $31 million relating to conduct involving BHD, THD and LRH, including False Claims Act settlements with 29 physicians, two health care executives and a laboratory company.

Health Care Fraud Liability Under False Claims Act, Anti-Kickback Statute, Stark Law

The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally-funded programs. The Stark Law forbids a hospital or laboratory from billing Medicare for certain services referred by physicians that have a financial relationship with the hospital or laboratory. The Anti-Kickback Statute and the Stark Law seek to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients.

The False Claims Act prohibits health care providers from billing federal health care programs for services resulting from referrals prohibited by the Anti-Kickback Statute or the Stark law.

Under the False Claims Act, a private party can file an action on behalf of the United States and receive a portion of the recovery. The False Claims Act also allows the Justice Department to intervene in such lawsuits and add claims and defendants, as happened in this litigation. The qui tam case is captioned United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.). If a defendant is found liable for violating the act, the United States may recover three times the amount of its losses plus applicable penalties.

The United States’ pursuit of this lawsuit illustrates the government’s emphasis on combating health care fraud generally with a special emphasis on physicians. For instance, U.S. Attorney Brit Featherston is quoted as saying, “Schemes that funnel health care referrals do not work without the participation of physicians. … They are not merely passive players in these elaborate schemes, but an integral part, without which the scheme could not exist. Our office is committed to rooting out health care fraud by pursuing all players involved the scheme, from the laboratories and their leaders to the marketers and the physicians who make it all possible. Naming these physicians in the complaint is evidence of that commitment.”

Given this clear warning, physicians and other prescribers, as well as recruiting, billing and management services organizations, laboratories and others involved in recruiting and marketing, providing or billing for laboratory or other services to double check the appropriateness of their referral and other practices keeping in mind that the Anti-Kickback Statute and Stark Law prohibitions against direct and indirect compensation can reach to a wide range of subtle value and benefits in addition to the obvious payment of cash or gifts delivered in a multitude of ways. The prosecution of these physicians for referrals made and compensation delivered under management services contracts also clearly warns physicians and other providers against expecting their reliance upon billing, management services or other staff or management service providers to shield them from liability if an improper referral or payment happens.

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About the Author

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.

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Posted by Cynthia Marcotte Stamer

Federal Convictions Of Physicians Highlight Need For Care In Opiate & Other Pain Management Prescribing & Billing

March 4, 2022

Physicians and other health care prescribers must remain hyper vigilant when prescribing, documenting, billing and managing opiate and other pain management prescriptions and patients. That’s the clear message sent by the ever-growing wave of federal prosecutions and convictions like the March 2, 2022 federal conviction of Tennessee physician Mark Murphy and his wife, Jennifer Murphy and his wife for unlawfully distributing opioids, providing unnecessary services and defrauding insurers from their now-shuttered North Alabama Pain Services clinics (“NAPS”) and March 1, 2022 sentencing of former physician Patrick Titus to 20 years in prison for his conviction of unlawful distribution of opioid drug outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice.

Tennessee Doctor & Wife Convicted of Pain Management Related Unlawful Opioid Distribution, Health Care Fraud & Other Criminal Charges

The March 2 federal jury conviction of Dr. and Ms. Murphy stemmed from their ownership and operation of their now-defunct pain management clinics resulted from evidence gathered through a joint investigation by the Federal Bureau of Investigation, the Department of Health & Human Services Office of Inspector General, the Internal Revenue Service, and the Drug Enforcement Agency.

During the resulting jury trial, federal prosecutors presented evidence that during the five-year period leading up to the clinic closing its Alabama locations in 2017, Dr. Murphy and Ms. Murphy, who was the office manager, caused over $50 million in fraudulent or unnecessary medical services to be charged to Medicare, TRICARE, Blue Cross Blue Shield of Alabama and others. Evidence at trial showed that NAPS provided pre-signed prescriptions to thousands of patients a month, including prescriptions written outside the usual course of professional practice without a legitimate medical purpose. Federal prosecutors also introduced evidence that the Murphys also solicited and received unlawful payments for referring fraudulent or unnecessary services to patients.

Based on the evidence, the jury found both Dr. and Ms. Murphy guilty on numerous criminal charges including:

Conspiracy to unlawfully distribute and unlawful distribution of controlled substances;
Conspiracy to commit and commission of health care fraud;
Conspiracy to defraud the United States; and
Receiving illegal kickbacks in violation of the Anti-Kickback Statute.

Ms. Murphy also was convicted of tax-related charges for underreporting clinic income.

Currently scheduled for sentencing in June, the Murphys each face a maximum of 20 years in prison for the drug charges and a maximum of 10 years in prison for the health care fraud charges. Both defendants also face a maximum of five years in prison for charges stemming from violations of the Anti-Kickback Statute, and Ms. Murphy faces up to three years in prison for the tax charges.

Former Delaware Doctor Sentenced to 20 Years in Prison for Unlawful Opioid Distribution

The Murphy’s jury conviction came one day after the sentencing of former to 20 years in prison for his July 2021 federal jury conviction on 13 counts of unlawfully distributing and dispensing controlled substances and one count of maintaining a drug-involved premises.

Federal prosecutors presented evidence in court documents and trial that Dr. Titus unlawfully distributed or dispensed opioid drugs including fentanyl, morphine, methadone, OxyContin and oxycodone outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice. The Justice Department charged Dr. Titus frequently prescribed these dangerous controlled substances in high dosages, sometimes in combination with each other or in other dangerous combinations, mostly in exchange for cash. Evidence at trial showed he distributed over 1 million opioid pills without providing any meaningful medical care and to patients he knew were suffering from substance use disorder and/or who demonstrated clear signs that the prescribed drugs were being abused, diverted or sold on the street.

Health Care Fraud Task Force Targeting Opioid Distribution, Billing, & Related Misconduct

Both the Murphy and Titus prosecutions and convictions are two of a growing series of convictions resulted from investigations into opioid and other pain management prescribing conducted as part of efforts targeting physicians and other health care providers involved in prohibited the federal Health Care Fraud Strike Force Program. See e.g., Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme.

The Federal agencies made a point of warning to other physicians not to overprescribe, bill or engage in other prohibited dealings involving opioids or other controlled substances when announcing the Titus sentencing.

“As we continue the fight against the opioid crisis, this case serves as an important reminder that health care professionals have a duty to prescribe medication responsibly to ensure the well-being of individuals under their care. Failing to do so can endanger patients and undermines critical, ongoing public health measures,” said Special Agent in Charge Maureen Dixon of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG will continue to work with our law enforcement partners to hold bad actors accountable.”

“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’ care for their own profit.”

“DEA-registered medical practitioners have an important role in our communities to treat patients compassionately and responsibly,” said DEA Administrator Anne Milgram. “Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable.”

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About the Author

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.

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Posted by Cynthia Marcotte Stamer

Comment Now On CMS Electronic Clinical Quality Measures Review Process

September 9, 2021

Now is the time health care providers and others users can give the Centers for Medicare & Medicaid Services (CMS) feedback on its electronic clinical quality measures (eCQMs) using CMS’ 2021 Change Review Process (CRP).

Many physician and other healthcare providers complain misdirected or unrealistic eCQMS unfairly make them choose between quality care and reimbursement Aziz readings impact level of reimbursement Medicare and Medicaid provide to providers under Medicare‘s quality reporting and reimbursement system. Because of the impact on reimbursement and the claim of quality assurance, these readings also often have consequences well beyond reimbursement. In fact they can be used to trigger fraud and other quality investigations by government payers, private payers and facilities using these measures in their compliance and efficiency.

The goal of the CRP is for eCQM implementers to comment on the potential impact of draft changes to eCQMs so CMS and measure stewards can make improvements to meet CMS’s intent of minimizing provider and vendor burden in the collection, capture, calculation, and reporting.

The CRP provides eCQM users the opportunity to review and comment on draft changes to the eCQM specifications and supporting resources under consideration by the measure steward.

This latest installment of the CRP for eligible professional/eligible clinician and eligible hospital/critical access hospital issues will be conducted using the web-based public comment tools on the Office of the National Coordinator for Health Information Technology (ONC) Project Tracking System eCQM Issue Tracker during fall 2021.

A reminder that an ONC Project Tracking System account is required to post a question or comment. New users can create an account via the ONC Project Tracking System website.

CRP updates regarding issues available for public comment will be posted on the ONC Project Tracking System eCQM Issue Trackersummary page.

To subscribe to weekly CRP digest emails containing updates on CRP activities, please email CRP@mathematica-mpr.com.

To find out more about eCQMs, visit the Electronic Clinical Quality Improvement (eCQI) Resource Center. To report questions and comments regarding eCQMs, visit the eCQM Issue Tracker. To submit technical questions and issues related to the development and implementation of the Clinical Quality Language (CQL) standard, visit the CQL Issue Tracker.

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This article is republished by permission of the author, Cynthia Marcotte Stamer. To review the original work, see here.

Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.

For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.

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Posted by Cynthia Marcotte Stamer

COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released

March 24, 2020

The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS). The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.

While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis. Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief. While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems. Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency. See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released; OCR Grants HIPAA Telemedic ine Relief During COVID-19 Crisis.

April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities

According to Director Roger Severino, the limited enforcement relief in the Notice is intended “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.” Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency. The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.

The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS. According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing. Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS. Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,

While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:

Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
Using secure technology at a CBTS to record and transmit electronic PHI.
Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.

While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.

Today, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released two comprehensive toolkits on telehealth:

The Telehealth Toolkit for General Practitioners available here;
The End-Stage Renal Disease Providers Toolkit available here .

The Toolkits’ release follows up on last week’s Centers for Medicare & Medicare Services (“CMS”) loosening of requirements for Medicare coverage of telehealth services and privacy and data security requirements so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.

COVID-19 Emergency TeleHealth Waivers & Rules

Under this temporary new waiver, Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence starting March 6, 2020. The waiver applies to a range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to their patients.

New TeleHealth Toolkits

Each of the telehealth toolkits released today contains electronic links to reliable sources of information on telehealth and telemedicine, which will reduce the amount of time providers spend searching for answers and increase their time with patients. HHS intends these links to help providers choose learn about the general concept of telehealth, choose telemedicine vendors, initiate a telemedicine program, monitor patients remotely, and develop documentation tools. Additionally, the information contained within each toolkit also outlines temporary virtual services that could be used to treat patients during this specific period of time.

COVID-19 Temporary Limited Scope HIPAA Privacy Telehealth Relief

The HHS COVID-19 emergency teleheath waivers follow up on the HHS Office for Civil Rights (OCR) March 20, 2020 Notification of Enforcement Discretion on Telehealth Remote Communications (the “Notice”) announcing temporary, limited scope enforcement relief from some, but not all of the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules for health care providers using “non-public facing” communication technologies to provide telemedicine services during the COVID-19 health care emergency

Intended to allow health care providers greater latitude under HIPAA to communicate with patients and provide telehealth services through remote communications technologies during the COVID-19 national emergency, the Notice allows covered health care providers wishing to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency the option to any availabe “non-public facing” remote communication product to communicate with patients if the platform by verifying the platform is HIPAA compliant and securing the necessary business associate agreement (“BAA”) with the communication provider.

Specifically the Notice announces OCR is exercising its enforcement discretion not to impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using non-public facing audio or video communication products during the COVID-19 nationwide public health emergency in accordance with the requirements set forth in the Notice. The non-enforcement policy applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19. During the COVID-19 emergency, this relief for non-public facing remote communications allows a health care providers the flexibility when it determines appropriate in his or her professional judgement to request to examine a patient using a video chat application connecting the provider’s or patient’s phone or desktop computer in order to assess a greater number of patients while limiting the risk of infection of other persons who would be exposed from an in-person consultation.

The relief does not apply to “public facing” remote communications however, Facebook Live, Twitch, TikTok, and similar video communication applications are considered “public facing.” The OCR bulletin states health care providers should not use any of these or other public facing remote communications to provide telehealth services under the Bulletin.

The Notice also alerts health care providers providing telemedicine services under the Notice need to ensure they have in place appropriate business associate agreements {“BAAs”) with each technology vendors used to conduct these communications and that the vendor is otherwise HIPAA compliant. The Notice lists the following as some vendors that have represented to OCR that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA include:

Skype for Business
Updox
VSee
Zoom for Healthcare
me
Google G Suite Hangouts Meet

Providers should note that the Notice also states that OCR does not endorse, recommend or certify any of these vendors or the adequacy of their BAAs. Consequently, providers intending to use any of thes platforms should conduct their own documented due diligence to confirm that the necessary HIPAA requirements are met. Providers also should keep in mind that the OCR Notice does not modify any otherwise applicable federal or state law, contractual or ethical requirements that may apply to their use of these telemedicine platforms. As many provider’s HIPAA notices may have included statements inconsistent with the use of these technologies, the provider should consider providing notification of the change of its practices that includes disclosures about potentially lower privacy protections. Because the relief is limited in scope and duration, providers relying on the relief also will need to closely monitor developments and adjust practices as necessary when the emergency waivers expire or are modified.

Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief

Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief, the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance. In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements. To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events. Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.

More Information & Resources

We hope this update is helpful. If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. To learn more about Ms. Stamer, her services, experience, publications or involvements; to review or request other developments, publications, resources and tools; or to register for future updates, see www.cynthiastamer.com, see www.cynthiastamer.com; connect on LinkedIn or Facebook; or contact us via e-mail or via telephone at (214) 452 -8297

About The Author

Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is widely recognized for her pragmatic, leading edge work, scholarship and thought leadership on domestic and international, public and private sector health care and managed care, workforce and performance, safety, legal and operational compliance and risk management, crisis preparedness and response, and other essential legal and operational concerns.

Her experience includes extensive work domestically and internationally with hospitals, health care systems, clinics, skilled nursing and other long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; accreditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thought leadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations.

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Posted by Cynthia Marcotte Stamer

Health IT Provider Pays $100K To OCR For Breach After No HIPAA Risk Assessment

May 24, 2019

The $100,000 payment Medical Informatics Engineering, Inc. (MIE) has agreed to pay under a just-announced HIPAA Resolution Agreement and Corrective Action Plan (“MIE Agreement”) with an Indiana health care information technology provider sends a clear warning to health care providers, health plans and insurers, health care clearinghouses (“covered entities””) and their business associate service providers (“business associates”)(collectively (“HIPAA entities”)to ensure they can prove they properly conduct and update documented security risk assessments verifying their systems adequately meet the medical data privacy security requirements of the Health Insurance Portability and Accountability Act (“HIPAA”) or be prepared to pay when a breach happens.

Coming less than a month after the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (“HHS”) announced its collection of a $3 million settlement payment from a radiology provider that also allowed hackers to breach its electronic protected health information (ePHI) by failing to conduct and respond to HIPAA-required risk assessments, OCR’s announcement late yesterday of the MIE Agreement makes clear that HIPAA entities need to tighten their HIPAA risk assessment, documentation and other compliance practices.

The latest in a lengthening list of OCR enforcement actions identifying as a key violation the failure to maintain up to date risk assessments, the MIE Agreement between OCR and the Indiana based provider of software and electronic medical record services to healthcare providers resulted from an OCR investigation of MIE’s July 23, 2015 breach report that hackers had used a compromised user ID and password to access the electronic protected health information (ePHI) of approximately 3.5 million people. OCR’s investigation revealed that MIE did not conduct a comprehensive risk analysis prior to the breach. To avoid potential prosecution by OCR for the breach, MIE agrees in the MIE Agreement to pay $100,000 to OCR, as well as to conduct a complete enterprise wide HIPAA risk assessment, to periodically update that risk assessment in accordance with the HIPAA rules and take other corrective actions to avoid potential prosecution by OCR for alleged violations of HIPAA’s Privacy and Security Rules.

Coming less than a month after OCR’s collection of a $3 million HIPAA resolution penalty from medical imaging provider Touchstone Medical Imaging where failure to conduct regular risk assessments was also identified as a violation, OCR’s announcement of the MIE Agreement sends a clear warning to other HIPAA covered entities and business associates not to make the same mistake. “Entities entrusted with medical records must be on guard against hackers,” said OCR Director Roger Severino. “The failure to identify potential risks and vulnerabilities to ePHI opens the door to breaches and violates HIPAA.”

While the HIPAA Security Rules always have included and OCR’s high dollar enforcement actions consistently demonstrate the need to meet their obligation to conduct documented comprehensive enterprise risk assessments and to update those assessments on an ongoing basis in response to changes in systems, software, participants or other events creating the potential for threats to the security of ePHI and the systems that include them, most HIPAA entities fail to adequate appreciate the scope of this responsibility or the steps OCR expects them to take to fulfill this expectation. Meanwhile, litigation and enforcement records resulting from heath care and other data breaches under the Fair and Accurate Credit Transactions Act and other federal and state privacy and data security rules also show the value and need for excellent, well-documented risk assessment and mitigation response to mitigate breach and other exposures.

While clearly necessary and valuable establishing appropriate requirements and processes for ensuring the conduct and documentation of these required assessments, managing the compliance and risks resulting from their findings, documenting this analysis and other actions needed while also balancing other operational, legal, and financial challenges is complex and challenging. The legally, operationally and politically sensitive discussions require both management of compliance and risks arising from the administration of these responsibilities themselves and the dealing with vendors, patients, other providers and payers and the community make it highly advisable that management of HIPAA Entities involve experienced legal counsel throughout the process to utilize legal advice and attorney-client privilege and other evidentiary tools to help safeguard sensitive discussions in the course of this process and manage other risks.

If have questions or need more information about the risk assessment or other HIPAA requirements or other health care regulatory developments or their implications on your organization, contact the author. You also are invited to stay abreast of these and other health care developments by participating in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group or COPE: Coalition On Patient Empowerment Group or Project COPE: Coalition on Patient Empowerment Facebook Page.

About the Author

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

As a key part of this work, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, her involvement in assisting clients with HIPAA and other privacy and data security concerns pre-dates the enactment of HIPAA and arises from her career-long health and managed care and insurance industry work.

Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health facilities and systems; physicians, physician practices, and other health care providers; medical staff, and other provider organizations; managed care organizations, insurers, self-insured health plans and other payers; health care and insurance accreditation, peer review and quality committees and organizations; billing, utilization management, management services, electronic medical record and other health information technology (IT) organizations; group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management providers and organizations; health and insurance industry consultants, investors; technology, billing and reimbursement and other services and product vendors and developers; products and solutions consultants and developers; investors;; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with operational compliance and risk management; strategic planning; product and services development and innovation; workforce and operations management: crisis preparedness and response; public and regulatory affairs and host of other concerns.

Ms. Stamer also helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer also continuously works with a diverse array of clients to monitor, shape and respond to federal and state legislative, regulatory, enforcement and other public policy and regulatory affairs concerns. This work involves a steady diet of involvement with Congress, federal regulators and state legislative, regulatory and enforcement bodies dealing with cutting edge health and insurance legislation, regulation and enforcement throughout her 30 year career.

Author of leading works on a multitude of these and other concerns, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, and Board Certified by the Texas Board of Legal Specialization in Labor and Employment Law, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or experience publications, speaking, public advocacy or other involvements, see here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including:

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

New Pharma Transparency Rules Mean More Work For Providers

May 9, 2019

Physicians, pharmacists and pharmacies, prescription benefit management companies and other health industry participants should begin preparing for new questions and other responsibilities likely to arise from the Department of, Health and Human Services(“HHS”) Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency Final Rule (the “Rule”) announced on Wednesday, May 8 and scheduled for official publication in the May 10, 2019 Federal Register.

Under the Rule, the Centers for Medicare & Medicaid Services (“CMS”) will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy. Basically this means the required price information will be added to the disclosures pharmaceutical manufacturers provide during their television advertisements.

Part of President Trump’s American Patients First blueprint, the 102 page Rule seeks to increase transparency for patients and bring down overall drug costs both for patients and for the Medicare and Medicaid programs with the prices updated quarterly.

According to CMS, the 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy. CMS believes patients should know what a drug costs as they discuss their options with their doctor.

While pharmaceutical drug manufactures generally must obtain approval from the FDA Office of Prescription Drug Promotion (ODPD) for advertising, OPDP does not review price information in prescription drug advertisements. Consequently, HHS says ODPD will not require a manufacturer that simply adds price information to a direct-to-consumer advertisement as required by § 403.1202 of the Rule unless the price information explicitly or implicitly incorporates safety or efficacy information about the drug, or makes express or implied claims about the safety or efficacy of the drug.

In addition to the Rule, HHS continues to review a number of other rules and proposals it hopes to further advance the American Patients First blueprint initiative to improve drug price transparency and inform consumer decision making by fixing opaque systems, changing incentives that drive costs or other undesirable behaviors by pharmaceutical companies, prescription benefit management (“PBM”) companies, health insurers and plans, providers and patients.

While physicians and other health care providers, health plans and their employer sponsors and other health industry organizations have urged greater transparency and other reforms to impact skyrocketing pharmaceutical costs and other concerns, health care providers and health plans need to prepare for a wave of new questions from patients and their caregivers that the new information on pricing likely will fuel and the resulting scrutiny of their own activities and processes relation to the selection of prescription drugs. Physicians and other health care providers should anticipate that more patients and caregivers will question provider prescription of higher cost drugs and ask providers to justify their choices. Providers not only should be prepared to explain their own choices and also to chart their advice to help defend potential challenges. Meanwhile hospitals and other health care entities, health plans, health insurers, PBMs and other health industry players using internal pharmaceutical cost management programs also can anticipate those practices also will come under added scrutiny. In anticipating this added scrutiny, health and health plan players should resist the temptation of assuming that the availability of the additional price information will facilitate discussions with patients or their caregivers about prescription drugs, their selection and comparability for treatment choices and other related concerns. Rather, health care providers and plans alike should anticipate that the added discussions the new price transparency rules are intended to fuel will result in more questioning and require greater care in responding to and justifying their recommendations to patients and plan members. Prayers and providers alike need to anticipate these demands and make the necessary arrangements to prepare for these discussions, by budgeting and setting aside the required time, preparing defensible explanations for the recommendations, and creating the necessary documentation to defend these activities.

If you have questions or would like more information about the new Rule or other developments impacting your health plan design or administration, please contact the author directly. You also are invited to stay abreast of these and other health care developments by participating in our Solutions Law Press, Inc. Linkedin SLP Health Care Risk Management & Operations Group or COPE: Coalition On Patient Empowerment Group or Project COPE: Coalition on Patient Empowerment Facebook Page.

About the Author

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with operational compliance and risk management; strategic planning; product and services development and innovation; workforce and operations management: crisis preparedness and response; public and regulatory affairs and host of other concerns.

As part of this work, Ms. Stamer continuously advises clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. She helps clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

As part of this work, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

For more information about Ms. Stamer or experience publications, speaking, public advocacy or other involvements, see here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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Posted by Cynthia Marcotte Stamer

2/11/19 Deadline To Comment On Reducing HIPAA Regulatory Burden

December 13, 2018

February 12, 2019 is the deadline for health care providers, health plans, health care clearinghouses, their business associates, health care consumers, employer and other plan sponsors and fiduciaries, and other concerned persons to provide input on reducing the regulatory burdens of the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security and Breach Notification Rules in response to the December 12, 2018 invitation of the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR).

OCR issued the invitation for public comment in a December 12, 2019 Request for Information (RFI). The RIF seeks input from the public on how OCR’s HIPAA Privacy and other Rules could be modified to further the HHS Secretary’s goal of promoting coordinated, value-based healthcare. This RFI is a part of the Regulatory Sprint to Coordinated Care, an initiative led by HHS Deputy Secretary Eric Hargan.

HHS developed the HIPAA Rules to protect individuals’ health information privacy and security interests, while permitting information sharing needed for important purposes. However, in recent years, OCR has heard calls to revisit aspects of the Rules that may limit or discourage information sharing needed for coordinated care or to facilitate the transformation to value-based health care. The RFI requests information on any provisions of the HIPAA Rules that may present obstacles to these goals without meaningfully contributing to the privacy and security of protected health information (PHI) and/or patients’ ability to exercise their rights with respect to their PHI.

OCR’s December 12, 2018 press release concerning the RFI indicates that OCR is looking for candid feedback about how the existing HIPAA regulations are working in the real world and how OCR can improve them to improve quality of care and eliminate undue burdens on covered entities while maintaining robust privacy and security protections for individuals’ health information.

In addition to requesting broad input on the HIPAA Rules, the RFI also seeks comments on specific areas of the HIPAA Privacy Rule, including:

Encouraging information-sharing for treatment and care coordination
Facilitating parental involvement in care
Addressing the opioid crisis and serious mental illness
Accounting for disclosures of PHI for treatment, payment, and health care operations as required by the HITECH Act
Changing the current requirement for certain providers to make a good faith effort to obtain an acknowledgment of receipt of the Notice of Privacy Practices

Public comments on the RFI are due by February 11, 2019.

The RFI follows up on OCR’s announcement of another series of high dollar resolution agreements against covered entities and business associates for alleged breaches of HIPAA’s Privacy or Security Rules, as well as publication of various new guidance intended to help patients, their families, covered entities, business associates and others understand when HIPAA restricts or allows the release of protected health information by covered entities and business associates in mass shooting or other disaster situations, when dealing with patients with substance abuse or mental health conditions and in various other scenarios. Covered entities, their business associates as well as employer and other health plan sponsors, fiduciaries and others involved with protected health information transactions and disclosures should review this new guidance and evaluate its implications on their actions and practices in addition to sharing input with OCR about opportunities to improve existing HIPAA Rules.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of managed care and other health industry, health and other benefit and insurance, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has been continuously involved the design, regulation, administration and defense of managed care and other health care and health benefit arrangements, contracts, systems, and processes throughout her career. In addition to her extensive provider and payer contracting work, Ms. Stamer also is recognized for her knowledge, experience and leadership on health benefit, health care, health, financial and other information technology, data and related process and systems development, policy and operations throughout her career, and scribe of the ABA JCEB annual Office of Civil Rights agency meeting, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include employers and other workforce management organizations; employer, union, association, government and other insured and self-insured health and other employee benefit plan sponsors, benefit plans, fiduciaries, administrators, and other plan vendors; managed care organizations, insurers, self-insured health plans and other payers and their management; public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long-term care, rehabilitation and other health care providers and facilities; medical staff, health care accreditation, peer review and quality committees and organizations; managed care organizations, insurers, third-party administrative services organizations and other payer organizations; billing, utilization management, management services organizations; group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; claims, billing and other health care and insurance technology and data service organizations; other health, employee benefit, insurance and financial services product and solutions consultants, developers and vendors; and other health, employee benefit, insurance, technology, government and other management clients.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career. Her public policy and regulatory affairs experience encompasses advising and representing domestic and multinational private sector health, insurance, employee benefit, employer, staffing and other outsourced service providers, and other clients in dealings with Congress, state legislatures, and federal, state and local regulators and government entities, as well as providing advice and input to U.S. and foreign government leaders on these and other policy concerns.

Beyond her public policy and regulatory affairs involvement, Ms. Stamer also has extensive experience helping these and other clients to design, implement, document, administer and defend workforce, employee benefit, insurance and risk management, health and safety, and other programs, products and solutions, and practices; establish and administer compliance and risk management policies; comply with requirements, investigate and respond to government; accreditation and quality organizations; private litigation and other federal and state health care industry investigations and enforcement actions; evaluate and influence legislative and regulatory reforms and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns. Ms. Stamer’s experience in these matters includes supporting these organizations and their leaders on both a real-time, “on demand” basis with crisis preparedness, intervention and response as well as consulting and representing clients on ongoing compliance and risk management; plan and program design; vendor and employee credentialing, selection, contracting, performance management and other dealings; strategic planning; policy, program, product and services development and innovation; mergers, acquisitions, and change management; workforce and operations management, and other opportunities and challenges arising in the course of their operations.

As a key part of this work, Ms. Stamer throughout her career regularly has worked with health care providers and payers, employer and other health benefit plan sponsors and vendors, health industry, insurers, health IT, life sciences and other health and insurance industry clients design, document and enforce managed care and other contracts, benefit plans and insurance arrangements, practices, policies, systems and solutions; manage regulatory, contractual and other legal and operational compliance; vendors, supplier, and patient and member relations and requirements; deal with Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA, state insurance law and other private payer rules and requirements; contracting; licensing; terms of participation; medical billing, reimbursement, claims administration and coordination, and other provider-payer relations; reporting and disclosure, government investigations and enforcement, privacy and data security; and other compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; HIPAA administrative simplification, meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA, HEDIS and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.

Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending plan sponsors, administrators, insurance and managed care organizations, health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and employer and association group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions. Scribe for the ABA JCEB annual agency meeting with HHS OCR, she also has worked extensively on health and health benefit coding, billing and claims, meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical, workforce, consumer financial and other data confidentiality and privacy, federal and state data security, data breach and mitigation, and other information privacy and data security concerns.

Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long-term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about contracting, credentialing and quality assurance, compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Author of works on Payer and Provider Contracting and many other managed care concerns, Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; an ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here such as:

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

Allergy Practice $125,000 Settlement Reminds Health Care Providers, Other HIPAA Entities Of Press-Related HIPAA Risk

November 27, 2018

Physician practices and other health care providers, health plans and insurers, health care clearinghouses (“Covered Entities”) and their business associates should learn from the costly schooling the Allergy Associates of Hartford, P.C. (“Allergy Associates”) is paying to settle charges that its physician violated the Privacy Rules of the Health Insurance Portability and Accountability Act (“HIPAA”) by commenting to a reporter on a patient complaint under a Resolution Agreement and Corrective Action Plan (“Resolution Agreement”) announced by the Department of Health & Human Services (HHS) Office of Civil Rights (“OCR”) yesterday (November 26, 2018). The latest in a series of OCR HIPAA settlements arising from health care providers improperly discussing or disclosing protected health information (PHI) with the press or other media, the Resolution Agreement reminds health care providers and other HIPAA-Covered Entities and their business associates not to discuss or disclose PHI with the media or others without first obtaining a HIPAA compliant authorization even to respond to accusations made by the patient or others.

Allergy Associates HIPAA Complaint Charge & Resolution

On November 26, 2018, OCR announced that Allergy Associates, a three doctor health care practice that specializes in treating individuals with allergies at four locations across Connecticut, has agreed to pay OCR $125,000 and take corrective action under the Resolution Agreement to resolve charges that the comments a physician made to a reporter on a patient dispute with the practice in 2015 violated HIPAA.

According to OCR, the disclosure of patient information that prompted OCR’s HIPAA charges resulted from a physician associated with the practice commenting to a local television station reporter doing on a story about a disabled patient’s complaint to the station that Allergy Associates turned her away from a scheduled appointment because of her use of a service animal. After the patient contacted the television statement to complain about being turned away by the practice when accompanied by her service animal, the Resolution Agreement indicates that the station contacted the doctor for comment about the dispute between the Allergy Associates’ doctor and the patient. Although OCR reports its investigation revealed that Allergy Associates’ Privacy Officer instructed the doctor to either not respond to the media or respond with “no comment,” the doctor nevertheless accepted the television station reporter’s invitation to comment and discussed the dispute with the reporter.

The physician’s comments to the reporter were brought to the attention of OCR when OCR received a copy of an October 6, 2015, HHS civil rights complaint filed on behalf of the patient with the Department of Justice, Connecticut, U.S. Attorney’s Office (DOJ) by the Connecticut Office of Protection and Advocacy for Persons with Disabilities (OPA). In response to this complaint, OCR initiated a joint investigation with DOJ into the civil rights allegations against Allergy Associates. The complaint also alleged that Allergy Associates impermissibly disclosed the patient’s PHI in violation of HIPAA.

OCR found the physician’s discussion of the patient’s complaint without first obtaining a HIPAA-complaint authorization from the patient both violated HIPAA and demonstrated a reckless disregard for the patient’s HIPAA privacy rights. Additionally, Resolution Agreement also states that OCR’s investigation revealed that Allergy Associates did not take any disciplinary or other corrective action against the doctor after learning of his impermissible disclosure to the media.

To resolve the HIPAA charges, Allergy Associates agrees in the Resolution Agreement and Corrective Action Plan to pay $125,000 as well as to undertake a corrective action plan that includes two years of monitoring their compliance with the HIPAA Rules.

Other Providers Also Paid High Price To OCR For Sharing PHI With Media

Of course, OCR enforcement action against and Resolution Agreement with Allergy Associates is just one of several reported OCR actions against health care providers for improperly disclosing or allowing the press or other media access to PHI without patient authorization.

For instance, a Resolution Agreement announced by OCR on June 14, 2013 required Shasta Regional Medical Center (SRMC) to pay OCR $275,000 and implement a series of corrective actions for using and disclosing to the media PHI of a patient while trying to perform public relations damage control against accusations reported in the media that SRMC had engaged in fraud or other misconduct when dealing with the patient. That Resolution Agreement resulted from OCR investigating a January 4, 2012 Los Angeles Times article report that two SRMC senior leaders had met with media to discuss medical services provided to a patient. OCR’s investigation indicated that SRMC failed to safeguard the patient’s PHI from impermissible disclosure by intentionally disclosing PHI to multiple media outlets on at least three separate occasions, without a valid written authorization. OCR’s review also revealed senior management at SRMC impermissibly shared details about the patient’s medical condition, diagnosis and treatment in an email to the entire workforce. Further, SRMC failed to sanction its workforce members for impermissibly disclosing the patient’s records pursuant to its internal sanctions policy.

The sanctions were even greater in the May 10, 2017 Resolution Agreement and Corrective Action Plan OCR announced with the largest not-for-profit health system in Southeast Texas, Memorial Hermann Health System (MHHS) for issuing a press release with the name and other PHI about a patient arrested and charged with presenting an allegedly fraudulent identification card to MHHS office staff to fraudulently obtain care without first obtaining a HIPAA-compliant authorization from the patient. MHHS paid OCR a $2.4 million resolution payment to resolve HIPAA charges OCR brought against MHHS as well as agreed to implement a detailed corrective action plan. See $2.4M HIPAA Settlement Warns Providers About Media Disclosures Of PHI.

The costs of resolution have been even higher when OCR has addressed disclosures to media made by health care providers or other Covered Entities that allowed their desire for media publicity and coverage of their organizations ahead of patient privacy. For instance, OCR collected a $2.2 million resolution payment from New York Presbyterian Hospital (NYP) for allowing unauthorized filming and photographing of patients in its facility by a television film crew and other staff filming for the television program “NY Med” in the hospital. See $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use.

Furthermore, earlier this year OCR collected a total of $999,0000 from Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH)(collectively, the “Hospitals”) for putting publicity before patient privacy by allowing ABC News documentary film crews to film patients and access other patient information for a news documentary without obtaining prior patient authorization under three settlement agreements with the Hospitals announced by OCR in September, 2018. The payments were made under three separate settlement agreements between OCR and each respective Hospital made public by OCR in connection with the September 20, 2018 announcement stemming from the Hospital’s allowing ABC film crews to film in patient treatment and other areas for the ABC medical documentary “Save My Life: Boston Trauma” series. See $999K Price Hospitals Pay To Settle HIPAA Privacy Charges From Allowing ABC To Film Patients Without Authorization.

OCR’s concern about and intolerance for improper disclosures of PHI to the media by health care providers and other Covered Entities is further demonstrated by OCR’s publication of its 2016 Frequently Asked Question (Media FAQ) addressing Covered Entities’ responsibilities when dealing with the media coincident with OCR’s announcement of its Resolution Agreement with NYP in 2016. The Allergy Associates’ Resolution Agreement further reinforces OCR’s continuing commitment to hold health care providers and other Covered Entities and their business associates accountable for complying with HIPAA when dealing with the press and other media. In the fact of this commitment, health care providers and other Covered Entities must take the necessary steps to implement the appropriate policies, training and controls to ensure that they and their staff and representatives comply with these directives when dealing with press and other media.

Resolution Agreement Also Highlights Need For Sensitivity When Dealing With Disabled Patients With Service Animals

Beyond the HIPAA charges and settlement discussed in the Resolution Agreement, health care providers and other Covered Entities also should heed the factual circumstances that prompted the television interview of the Allergy Associates’ physician that prompted the OCR HIPAA enforcement action as a precautionary warning to ensure that their policies, procedures and staff training for dealing with disabled patients supported by service animals are defensible legally and in the court of public opinion.

The Allergy Associates Resolution Agreement states that OCR’s HIPAA investigation was conducted in response to and in tandem with a Department of Justice (“Justice Department”) Office of Civil Rights investigation of a complaint that Allergy Associates violated the patient’s civil rights by improperly refusing to allow the patient’s service animal to accompany the patient during the patient’s appointment. The patient’s complaint about the practice that the television reporter asked for and obtained the comments from the Allergy Associates’ physician that OCR found violated HIPAA related to Allergy Associates refusing to allow the patient to be accompanied by her service animal during her appointment with Allergy Associates.

While research as of the date of the publication of this article did not uncover any published record of any Justice Department prosecution or settlement or other official notification concerning the Justice Department civil rights investigation against Allergy Associates, the Justice Department Office of Civil Rights as well as the HHS OCR Civil Rights Division have in the past pursued enforcement action against health care providers and others for improperly restricting or denying access to care or facilities by disabled persons based on their accompaniment by service animals.

Title III of the Americans With Disabilities Act (“ADA”) generally prohibits places of public accommodations, including the professional office of a health care provider, from discriminating against any individual on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation, by any person who owns, leases (or leases to), or operates a place of public accommodation, including health care services. 42 U.S.C. § 12182(a); 28 C.F.R. § 36.201. The ADA also requires that such entities make reasonable modifications in policies, practices, or procedures to permit the use of service animals by people with disabilities. 42 U.S.C. § 12182(b)(2)(A)(ii); 28 C.F.R. § 36.302(c). Health care providers also generally are prohibited from discriminating against and required to provide accommodation to individuals with disabilities under the Rehabilitation Act and the Medicare statutes.

The Justice Department, HHS and courts have interpreted these disability prohibition and accommodation laws as making it illegal for a health care provider or its agent to fail to make reasonable accommodations for a person with a service animal unless the health care provider proves (1) the accommodations would fundamentally alter the nature of the facility or service it provides; or (2) based upon an individual assessment, the hospital determines that the service animal poses a substantial and direct threat to health or safety which cannot be mitigated by reasonable accommodations. See, e.g., Tamara v. El Comino Hospital, 964 F.Supp.2d 1077 (N.D.Ca. 2013).

While other types of discriminatory actions by health care providers found to be in violation of these rules often trigger substantial damage awards, administrative penalties, disqualification or restriction of Medicare and other federal program participation for violation of Conditions of Participation, to date the reported agency and judicial enforcement actions brought against health care providers for improperly refusing to allow service animals to accompany patients when accessing facilities or receiving care generally have ordered injunctive or other corrective action but have not imposed substantial damage or administrative penalties upon the culpable provider. Health care providers should avoid the temptation to underestimate the potential seriousness or liability that their organization is likely to incur based on the current lack of substantial financial damage awards or administrative sanctions, however. The 11th Circuit’s ruling in Sheely v. MRI Radiology Network, P.A., 505 F.3d 1173 (11^th Cir. 2007), that noneconomic compensatory damages were available as a remedy for the emotional distressed caused by the violation under the Rehabilitation Act and that the voluntary correction of its policies during the pendency of the litigation did not render moot Sheely’s claim for monetary relief clearly opens the door for a jury to award substantial damages against a health care provider when the jury perceives the circumstances warrant. Furthermore, health care providers need to keep in mind the typically financial and operational burdens of defending litigation or a Justice Department or HHS OCR Civil Rights investigation and costs of implementation and compliance with administrative or injunctive orders to take corrective action as well as the negative public relations attend these types of complaints, their investigation and resolution. Moreover, health care providers participating in Medicare, Medicaid or other federal health care programs also need to take into account the possibility that an alleged violation of these nondiscrimination rules also can serve as a basis for investigation of compliance with applicable Conditions of Participation for program participation and reimbursement. Considering these risks, physician and other health care providers should heed the reminder of their obligations to offer and provide proper accommodation to allow appropriate access to disabled individuals with disabilities requiring service animal support and take steps to review and update their policies, practices and staff training to minimize the risk of potential charges of violation of these requirements.

Health Care Providers, Other Covered Entities Encouraged To Act To Manage HIPAA & Disability Accommodation Risks

The Allergy Associates and other HIPAA Resolution Agreements arising from improper sharing of PHI with the press or other media make clear the need for health care providers and other Covered Entities to exercise great care when dealing with the press and other media.

Clearly, health care providers and other Covered Entities should heed the warning by conducting a risk assessment of their organization’s susceptibility to potential improper disclosures to media or others and reviewing and implementing necessary written policies, procedures and training to prevent the improper disclosure of patient PHI to media or others unless the Covered Entity either secures prior HIPAA-compliant authorization from the patient or can prove the disclosure falls squarely under an exception to the Privacy Rule’s prohibition against disclosure of PHI without authorization except as allowed by the Privacy Rule.

Based on experiences reported in the Allergy Associates and other Resolution Agreements and OCR guidance concerning media disclosures, Covered Entities also generally will want to ensure that their policies, procedures and training extend to all potential sources of communications that could involve patient information and make clear that the Privacy Rule restrictions must be followed even if the circumstances involve allegations of misconduct, special performance by healthcare providers or others that it would benefit the organization or certain individuals to have known to the public, or other circumstances likely to be of interest to the media or other parties.

As part of this process, health care providers and other Covered Entities should ensure they look outside the four corners of their Privacy Policies to ensure that appropriate management, supervision, training and direction is provided to address media, practice transition, workforce communication and other policies and practices that may be covered by pre-existing or other policies of other departments or operational elements not typically under the direct oversight and management of the Privacy Officer such as media relations. Media relations, physician and patients affairs, outside legal counsel, media relations, marketing and other internal and external departments and consultants dealing with the media, the public or other inquiries or disputes should carefully include and coordinate with the privacy officer both to ensure appropriate policies and procedures are followed and proper documentation created and retained to show authorization, account, or meet other requirements.

In conducting this analysis and risk assessment, it also is important that Covered Entities include, but also look beyond the four corners of their Privacy Policies to ensure that their review and risk assessment identifies and assesses and addresses compliance risks on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer.

For this reason, Covered Entities also generally will not only to adopt and implement specific policies, processes and training in these other departments to prohibit and prevent inappropriate disclosures of PHI in the course of those departments operations. As part of these processes, Covered Entities generally will want to implement a pre-established process for reviewing media or other communications for potential PHI content which includes a requirement for prior review of any proposed public relations and other internal or external communications containing patient PHI or other information by the privacy officer, legal counsel or another suitably qualified party.

Because of the high risk that the preparation or review of media or other public communications reports will involve the use and disclosure of PHI, Covered Entities also generally should verify that all outside media or public relations, legal, or other outside service providers participating in the investigation, response or preparation or review of communications to the media or others both are covered by signed business associate agreements that fulfill the Privacy Rule and other requirements of HIPAA as well as possess detailed knowledge and understanding of the Privacy and Security Rules suitable to participate in and help safeguard the Covered Entity against violations of these and other Privacy Rules. See e.g., Latest HIPAA Resolution Agreement Drives Home Importance Of Maintaining Current, Signed Business Associate Agreements.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of managed care and other health industry, health and other benefit and insurance, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has been continuously involved the design, regulation, administration and defense of managed care and other health care and health benefit arrangements, contracts, systems, and processes throughout her career. In addition to her extensive provider and payer contracting work, Ms. Stamer also is recognized for her knowledge, experience and leadership on health benefit, health care, health, financial and other information technology, data and related process and systems development, policy and operations throughout her career, and scribe of the ABA JCEB annual Office of Civil Rights agency meeting, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include employers and other workforce management organizations; employer, union, association, government and other insured and self-insured health and other employee benefit plan sponsors, benefit plans, fiduciaries, administrators, and other plan vendors; managed care organizations, insurers, self-insured health plans and other payers and their management; public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long-term care, rehabilitation and other health care providers and facilities; medical staff, health care accreditation, peer review and quality committees and organizations; managed care organizations, insurers, third-party administrative services organizations and other payer organizations; billing, utilization management, management services organizations; group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; claims, billing and other health care and insurance technology and data service organizations; other health, employee benefit, insurance and financial services product and solutions consultants, developers and vendors; and other health, employee benefit, insurance, technology, government and other management clients.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career. Her public policy and regulatory affairs experience encompasses advising and representing domestic and multinational private sector health, insurance, employee benefit, employer, staffing and other outsourced service providers, and other clients in dealings with Congress, state legislatures, and federal, state and local regulators and government entities, as well as providing advice and input to U.S. and foreign government leaders on these and other policy concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here such as:

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Apply for 2019 CDC Externships in Public Health Law By 1/31/19

November 21, 2018

Now is the time to apply for selection to participate in the Center for Disease Control (CDC) Public Health Law Program (PHLP).

The PHLP offers externships in public health law, tribal public health law, and public health administration and communications. The externships consist of 9–14 weeks of professional work experience with PHLP in Atlanta, Georgia. With rolling start and completion dates during the academic year, unpaid externships must qualify for academic credit as authorized by law and public health schools. Applications for summer 2019 positions are due by January 31, 2019.

About the Author

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

For more information about Ms. Stamer or experience publications, speaking, public advocacy or other involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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Posted by Cynthia Marcotte Stamer

Trump Signs Sweeping Opiate Prescription & Treatment Reform Bill Into Law

October 24, 2018

Today (October 24, 2018), President Trump signed into law bill he and Congress hope will combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

The bipartisan law takes aim at the U.S. Opiate Addiction Epidemic by combining over 70 bills from the House and Senate to combat the opioid crisis, including:

H.R. 5773, Preventing Addiction for Susceptible Seniors (PASS) Act, which ombines several member bills that aim to prevent opioid overuse by increasing program integrity efforts and resources for beneficiaries to help ensure that they are properly adhering to their prescribed pain medications.

H.R. 5775, Providing Reliable Options for Patients and Educational Resources (PROPER) Act, which combines several member bills that aim to increase educational resources for Medicare beneficiaries. These resources ensure beneficiaries are aware of the adverse effects of prolonged opioid use and their coverage options for the treatment of pain. The PROPER ACT also eliminates pain-related questions from required patient satisfaction surveys in hospitals.

H.R. 5774, Combating Opioid Abuse for Care in Hospitals (COACH) Act, which combines several member bills that aim to educate providers and beneficiaries to reduce opioid use, and promotes the development and adoption of quality measure related to opioid use and opioid use disorder treatments.

H.R. 6110, Dr. Todd Graham Pain Management, Treatment, and Recovery Act, which combines several member bills that aim to eliminate Medicare payment incentives to prescribe opioids instead of non-opioid pain management treatments and expand access to non-opioid alternatives and substance use disorder treatment, including in underserved and rural areas.

H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act, which examines incentives under Medicare hospital payments for prescribing of opioids relative to non-opioid alternatives and the ability to track and monitor opioid use through Medicare claims.

H.R. 5676, Stop Excessive Narcotics in our Retirement (SENIOR) Communities Protection Act, which extends the authority of Medicare Prescription Drug Plans to suspend payments pending an investigation of a credible allegation of fraud against the provider or supplier in the same manner already available under Medicare fee-for-service today.

H.R. 5788, Synthetics Trafficking and Overdose Prevention Act of 2018 (STOP Act of 2018), which requires the United States Postal Service to obtain advance electronic data on international mail shipments, which will allow U.S. Customs and Border Protection to target high-risk shipments – including those containing synthetic opioids – for inspection and seizure at the border.

The above bills included measures from many of the following pieces of legislation:

H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries.

H.R 4841, Standardizing Electronic Prior Authorization for Safe Prescribing.

H.R. 5676, Stop Excessive Narcotics in our Retirement (SENIOR) Communities Protection Act.

H.R.5684, Protecting Seniors from Opioid Abuse Act.

H.R. 5699, Hospital Opioid Solutions Toolkit (HOST) Act.

H.R . T 5686, Medicare Clear Health Options in Care for Enrollees (CHOICE) Act.

H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act.

H.R. 5716, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors (COMPASS) Act.

H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act.

H.R. 5718, Perioperative Reduction of Opioids (PRO) Act.

H.R. 5714, Education for Disposal of Unused (EDU) Opioids Act.

H.R. 5719, Reduce Overprescribing Opioids in Treatment (ROOT) Act.

H.R. 5725, Benefit Evaluation of Safe Treatment (BEST) Act.

H.R. 5722, Dr. Todd Graham Pain Management Improvement Act of 2018.

H.R. 5779, Promoting Quality of Care in Pain Management Act.

H.R. 5777, Centralized Opioid Guidance (COG) Act of 2018.

H.R. 5790, A bill to amend title XI of the Social Security Act to provide for clinical psychologist services models to be tested by the Center for Medicare and Medicaid Innovation, and for other purposes.

H.R. 5769, Expanding Access to Treatment Act of 2018.

H.R. 5080, A bill based on the Comprehensive Opioid Management and Bundled Addiction Treatment (COMBAT) Act of 2018.

H.R. 5778, Promoting Outpatient Access to Non-Opioid Treatments Act.

The sweeping legislation will significantly impact the responsibilities of providers prescribing opiates as well as impact the legal and illegal access of patients to these medications, treatment for opiate dependency, and reimbursement for opiate and other related care.

About the Author

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

For more information about Ms. Stamer or experience publications, speaking, public advocacy or other involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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Posted by Cynthia Marcotte Stamer

Congress Set To Pass Opiate Addition Crisis Bill

September 26, 2018

Legislation targeting opiate addition crisis in the United States is heading to President Trump for signature.

Yesterday (September 25, 2018), House and Senate leaders reached an agreement on the reconciliation of differences in versions of legislation passed in the House and Senate targeting opiate and other drug addition crisis.

The Opiate Crisis

Opiate addition increasingly is recognized as one of the leading and most costly social and financial challenges in the U.S.

The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is considered a serious national crisis that affects public health as well as social and economic welfare.

according to the National Institutes of Health (NIH), more than 115 people in the United States die after overdosing on opioids every day.

The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

Concern about the addiction crisis prompted President Trump to make addressing the opiate epidemic a key Administration priority and reform efforts generally enjoy widespread bipartisan support with Congress.

The Bill

In June, the House passed H.R. 6, the SUPPORT for Patients and Communities Act by a vote of 396-14. On September 17th, the Senate passed the Opioid Crisis Response Act of 2018 by a vote of 99-1.

The bipartisan, bicameral agreement allows the final legislation negotiated through the reconciliation process, the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” more commonly referred to as the ‘‘SUPPORT for Patients and Communities Act’’ to move swiftly through both chambers of congress and to the president’s desk.

Among other things, the Bill:

Expands opiate addition treatment coverage, requires added utilization management and oversight for coverage of opiate prescriptions and makes other changes to opiate-related Medicare and federal rules, including adding requirements for automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries and suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud,
Requiring expanded coverage and Clains reporting about by healthcare payers including requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program,

Modifies provisions regarding electronic prescriptions and post-surgical pain management,
Requires prescription drug plan sponsors to establish drug management programs for at-risk beneficiaries,
Establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids,
Increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver),
Clarifies FDA regulation of non-addictive pain products.
Requires the FDA to develop and implement guidelines for opiate prescribing and new safety-enhancing packaging,
Targets illegal distribution with new notification, nondistribution, and controlled substances recall rules, expanding controls on illegal importation, and strengthening FDA and CBP coordination and capacity
Creating or expanding a plethora of social, treatment, oversight and other programs and services.

Read the full text of the legislation here. For more information about the Bill or its effects, contact the author.

About the Author

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

For more information about Ms. Stamer or experience publications, speaking, public advocacy or other involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

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Posted by Cynthia Marcotte Stamer

Stamer Speaks, Moderates On Medical Cyber Security At LA Medical Privacy Summit

May 12, 2017

Solutions Law Press, Inc. editor and attorney Cynthia Marcotte Stamer will speak and moderate two key panel programs on health care privacy and data security scheduled at the Healthcare Privacy & Security Form hosted on May 19, 2017 by the Information Security Systems Association of Los Angeles County (ISSA-LA) as a component of its 9th Annual ISSA-LA Information Security Summit. The presentations of Ms. Stamer and others at the conference are particularly timely coming on the heels of the May 12 Cyber alerts to U.S. health industry and other businesses about the urgent need to defend against the spread of an epidemic international malware threat targeting U.S. healthcare and other businesses. See Health Care, Health Plan & Other Health IT Systems Warned of E-Mail Cyber Attack; Urgent WannaCry Ransomware Cyber Warning Issued; Alert: Guard Health E-Mail, Other IT Against WannaCry Malware Attack.

The Medical Privacy & Security Summit is part of the 9th Annual ISSA-LA Information Security Summit scheduled for May 18-19, 2017 at the Universal City Hilton in Los Angeles. Recognized as a premier information security education and networking event, the Summit is expected to bring together 1000 or more health industry and other IT and InfoSec executives, leaders, analysts, and practitioners to learn from the experts, exchange ideas with their peers, and enjoy conversations with the community.

The Healthcare Privacy & Security Forum offered for the 5^th year as a component of the annual Summit on May 19 specifically focuses on leading challenges, issues and opportunities confronted by health industry privacy and security professionals and their organizations. Ms. Stamer has served on the steering committee, moderator and popular faculty member for the 2017 Forum for the 5^th consecutive year. During the 2017 Forum, she will moderate and speak on two panels:

“Finding & Negotiating The Mine Fields: CISO, CIO & Privacy Officer’s Playbook for Promoting Compliance & Security Without Getting Fired,” a luncheon interactive panel discussion with the audience exploring the challenging mission CISOs, CIOs and Privacy Officers face to ensure their healthcare, financial and other critical information, data and systems continue to support the patient care and operating functions of their organizations, while at the same time defending these systems, operations and their sensitive, but mission critical data against malicious or innocent misappropriation, use, access or destruction; and
The closing panel on “What Initiatives Are on the Horizon in Healthcare, and How Can We Secure Them?”, which will explore likely future emerging privacy and security threats and technologies, regulatory challenges and enforcement, and other trends that Privacy and Security professionals are likely to face and tips and strategies for preparing to leverage these likely new opportunities and manage new challenges.

Register or get the full schedule of programs and other events scheduled at the Healthcare Privacy & Security Forum specifically along with the overall Information Security Summit here.

About Ms. Stamer

Cynthia Marcotte Stamer is a Martindale-Hubble “AV-Preeminent (Top 1%) rated practicing attorney and management consultant, health industry public policy advocate, widely published author and lecturer, recognized for her nearly 30 years’ of work on health industry and other privacy and data security and other health care, health benefit, health policy and regulatory affairs and other health industry legal and operational as a LexisNexis® Martindale-Hubbell® “LEGAL LEADER™ and “Top Rated Lawyer,” in Health Care Law and Labor and Employment Law; a D Magazine “Best Lawyers In Dallas” in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law,” a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel.

Scribe for ABA JCEB annual agency meeting with OCR for many years, Ms. Stamer is well-known for her extensive work and leadership throughout her career on HIPAA, FACTA, PCI, IRC and other tax, Social Security, GLB, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns. Ms. Stamer has worked extensively throughout her career with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks, insurers and other financial institutions, and others on trade secret confidentiality, privacy, data security and other risk management and compliance including design, establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, drafting and negotiation of business associate, chain of custody, confidentiality, and other contracting; risk assessments, audits and other risk prevention and mitigation; investigation, reporting, mitigation and resolution of known or suspected breaches, violations or other incidents; and defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others; reporting known or suspected violations; commenting or obtaining other clarification of guidance and other regulatory affairs, training and enforcement, and a host of other related concerns.

Her clients include public and private health care providers, health insurers, health plans, employers, payroll, staffing, recruitment, insurance and financial services, health and other technology and other vendors, and others.

Author of a multitude of highly-regarded works and training programs on HIPAA and other data security, privacy and use published by BNA, the ABA and other premier legal industry publishers In addition to representing and advising these organizations, she also speaks extensively and conducts training on health care and other privacy and data security and many other matters Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

Beyond these involvements, Ms. Stamer also is active in the leadership of a broad range of other professional and civic organizations. Through these and other involvements, she helps develop and build solutions, build consensus, garner funding and other resources, manage compliance and other operations, and take other actions to identify promote tangible improvements in health care and other policy and operational areas.

For additional information about Ms. Stamer, see here or contact Ms. Stamer directly by e-mail here or by telephone at (469) 767-8872. ©2017 Cynthia Marcotte Stamer. Limited, non-exclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

$2.4M HIPAA Settlement Warns Providers About Media Disclosures Of PHI

May 11, 2017

Healthcare providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) can’t disclose the name or other protected health care information about a patient in press releases or other announcements without prior authorization from the patient. That’s the clear lesson Covered Entities should learn from the $2.4 million payment to the U.S. Department of Health and Human Services (HHS) that the largest not-for-profit health system in Southeast Texas, Memorial Hermann Health System (MHHS) is paying to settle charges it violated the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule by issuing a press release with the name and other protected health information (PHI) about a patient without the patient’s prior HIPAA-compliant authorization under a Resolution Agreement and Corrective Action Plan (Resolution Agreement) announced May 10, 2017 by HHS Office of Civil Rights (OCR).

The Resolution Agreement resolves OCR charges the operator of 13 hospitals, eight Cancer Centers, three Heart & Vascular Institutes, and 27 sports medicine and rehabilitation centers violated the Privacy Rule that resulted from an OCR compliance review of MHHS triggered by multiple media reports suggesting that MHHS improperly disclosed the name and other details about a patient arrested and charged with presenting an allegedly fraudulent identification card to office staff at an MHHS’s clinic after MHHS clinic staff alerted law enforcement of suspicions the patient was presenting false identification to the clinic. According to OCR, after law enforcement investigated and arrested the patient, MHHS published a press release concerning the incident in which MHHS senior management approved the impermissible disclosure of the patient’s PHI by adding the patient’s name in the title of the press release without securing prior authorization of the patient.

While OCR concluded the report to law enforcement allowable under the Privacy Rule, OCR found MHHS violated the Privacy Rule by issuing the press release disclosing the patient’s name and other PHI without authorization from the patient and also by failing to timely document the sanctioning of its workforce members for impermissibly disclosing the patient’s information.

To resolve and avoid the potential Civil Monetary Penalties that HIPAA could authorize OCR to impose for the alleged Privacy Rule violation, MHHS agrees in the Resolution Agreement to pay OCR a $2.4 million monetary settlement and implement a corrective action plan that obligates MHHS to update and train its workforce on its policies and procedures on safeguarding PHI from impermissible uses and disclosures including specific instructions and procedures to:

Address (a) Uses and disclosures for which an authorization is required, including to the media, to public officials, and on the internet; (b) Disclosures for law enforcement purposes; and (c) Uses and disclosures for health oversight activities;
Identify MHHS personnel or representatives whom workforce members, agents, or business associates may contact in the event of any inquiry or concern regarding compliance with HIPAA in relation to these activities;
Internal reporting procedures requiring all workforce members to report to the designated person or office at the earliest possible time any potential violations of the Privacy, Security or Breach Notification Rules or of MHHS’ privacy and security policies and procedures and MHHS promptly to investigate and address all received reports in a timely manner; and
Application and documentation of appropriate sanctions (which may include retraining or other instructive corrective action, depending on the circumstances) against members of MHHS’ workforce, including senior level management, who fail to comply with the Privacy, Security or Breach Notification Rules or MHHS’ privacy and security policies and procedures, including a description of the sanctions; a timeframe in which MHHS will apply and document sanctions for violations of the HIPAA Rules or of MHHS’ privacy, security or breach policies or procedures; the manner in which MHHS will document the sanctions; and where MHHS will store or retain such documentation (e.g., personnel file).

The corrective action plan in the Resolution Agreement also requires all MHHS facilities to attest to their understanding of permissible uses and disclosures of PHI, including disclosures to the media and others.

Covered entities should keep in mind the MHHS Resolution Agreement is the latest in a series of OCR enforcement actions and resolution agreements highlighting the need for Covered Entities to adopt and use appropriate policies and procedures to prevent wrongful disclosures of PHI to the media or public. For instance, in June, 2013, OCR required Shasta Regional Medical Center (SRMC) to pay a $275,000 settlement payment and implement a comprehensive corrective action plan to resolve OCR charges stemming from SRMC’s disclosure of PHI about a patient to members of the media and its workforce in an effort to respond to accusations the patient made that SRMC engaged in fraud and other misconduct. See HIPAA Sanctions Triggered From Covered Entity Statements To Media, Workforce. In contrast, the $2.2 million resolution agreement that OCR required New York Presbyterian Hospital for improperly allowing a film crew to film hospital patients in violation of HIPAA was almost 10 times greater than the SRMC penalty and was accompanied by OCR’s publication OCR of specific additional guidance warning Covered Entities against improper disclosures to the media. See $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use.

Following on the heels of this previous guidance and prior enforcement actions warning Covered Entities against wrongful disclosure to the media, the MHHS Resolution Agreement sends a strong message to Covered Entities that they should expect little sympathy if their organizations improperly share PHI with the media. OCR’s announcement of the MHHS Resolution Agreement, for instance quotes OCR Director Roger Severino with stating that “Senior management should have known that disclosing a patient’s name on the title of a press release was a clear HIPAA Privacy violation that would induce a swift OCR response.” The announcement goes on to quote Director Severino further as stating, “This case reminds us that organizations can readily cooperate with law enforcement without violating HIPAA, but that they must nevertheless continue to protect patient privacy when making statements to the public and elsewhere.”

Risk Assess & Control Media Relations & Other Communications For PHI Disclosures Enterprisewide

Covered entities should heed the warning by conducting a risk assessment of their organization’s susceptibility to potential improper disclosures to media or others and reviewing and implementing necessary written policies, procedures and training to prevent the improper disclosure of patient PHI to media or others unless the Covered Entity either secures prior HIPAA-compliant authorization from the patient or can prove the disclosure falls squarely under an exception to the Privacy Rule’s prohibition against disclosure of PHI without authorization except as allowed by the Privacy Rule.

Taking these and other needed steps to evaluate, and strengthen and enforce as needed, risk assessments, policies, procedures, and training to prevent wrongful use, access or disclosure of PHI to the media or others is particularly critical in light of the ongoing tightening of expectations, and rising enforcement and sanctions for HIPAA violations since Congress amended HIPAA in 2009. See OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.

Based on experiences reported in the MHHS and other similar resolution agreements, Covered Entities also generally will want to ensure that their policies, procedures and training extend to all potential sources of communications that could involve patient information and make clear that the Privacy Rule restrictions must be followed even if the circumstances involve allegations of misconduct, special performance by healthcare providers or others that it would benefit the organization or certain individuals to have known to the public, or other circumstances likely to be of interest to the media or other parties.
As part of this process, covered entities should ensure they look outside the four corners of their Privacy Policies to ensure that appropriate training and clarification is provided to address media, practice transition, workforce communication and other policies and practices that may be covered by pre-existing or other policies of other departments or operational elements not typically under the direct oversight and management of the Privacy Officer such as media relations. Media relations, physician and patients affairs, outside legal counsel, media relations, marketing and other internal and external departments and consultants dealing with the media, the public or other inquiries or disputes should carefully include and coordinate with the privacy officer both to ensure appropriate policies and procedures are followed and proper documentation created and retained to show authorization, account, or meet other requirements.

In conducting this analysis and risk assessment, it will be important that Covered Entities include, but also look beyond the four corners of their Privacy Policies to ensure that their review and risk assessment identifies and assesses and addresses compliance risks on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer.

For this reason, Covered Entities also generally will not only to adopt and implement specific policies, processes and training in these other departments to prohibit and prevent inappropriate disclosures of PHI in the course of those departments operations. It also may be advisable to pre-established processes for reviewing media or other communications for potential PHI content and require prior review of any proposed public relations and other internal or external communications containing patient PHI or other information by the privacy officer, legal counsel or another suitably qualified party.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

A core focus of this work includes work to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; dealings with JCHO and other accreditation and quality organizations; investigation and defense of private litigation and other federal and state health care industry investigations and enforcement; insurance or other liability management and allocation; process and product development; managed care, physician and other staffing, business associate and other contracting; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.
Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other data security, privacy and breach laws.

In connection with this work, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.

Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.
In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

The American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health plans, health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other “nonpar,” insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; an ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional organizations.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.

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Posted by Cynthia Marcotte Stamer

6/26 Deadline To Comment On Proposed Medicare SNF (Nursing Home) Rule Changes

May 10, 2017

June 26, 2017 is the deadline to submit comments to the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) on changes to Medicare’s Skilled Nursing Facility (nursing home) reimbursement, quality reporting and various other proposed by CMS in the Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Proposal To Correct the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020 (Proposed Rule) published May 4^th. With the U.S. aging population making SNF expenditures both a significant Medicare cost driver and a major care concern for American families and communities, SNF and other health care providers, payers, community leaders, caregivers and other concerned stakeholders should act promptly to review the proposed changes and timely submit feedback in response to the Proposed Rule.

Among other things, the Proposed Rule as currently proposed would revise Medicare reimbursement and terms of participation rules for SNFs to:

Update the Skilled Nursing Facility (SNF) prospective payment rates and other background information for Fiscal Year (FY) 2018 in response to §§ 1888(e)(4)(E) and (H) of the Social Security Act (the Act);
Update the requirements for the Skilled Nursing Facility Quality Reporting Program (SNF QRP) and additional proposals for the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP);
Clarify requirements related to survey team composition and investigation of complaints under 42 C.F.R §§ 488.30, 488.301, 488.314, and 488.308;
Add a proposal related to the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP); and
Solicits comments about potential changes to the recently finalized Requirements for Long-Term Care Facilities that CMS intends to reduce regulatory burdens as well as potential CMMI models and other demonstration projects that would reduce cost and increase quality of care for SNF, or more generally Post-Acute Care patients.

The Proposed Rule regulatory burden reduction proposals primarily focus on three areas also invites input about other areas of burden reduction and cost changes that could be accomplished by revising current SNF requirements for Medicare participation:

The Grievance and Abuse/Neglect Reporting Processes
Quality Assurance and Performance Improvement (QAPI)
Discharge Notices

SNF and other healthcare providers, payers, accreditation and oversight, payers, caregivers and others concerned about SNF care and reimbursement for patients in SNFs should carefully evaluate these proposals and share their input on the proposals and other opportunities to improve the Medicare SNF quality and reimbursement rules as soon as possible.

About The Author

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

Throughout her career, she has helped health industry clients manage workforce, medical staff, vendors and suppliers, medical billing, reimbursement, claims and other provider-payer relations, business partners, and their recruitment, performance, discipline, compliance, safety, compensation, benefits, and training ;board, medical staff and other governance; compliance and internal controls; strategic planning, process and quality improvement; change management; assess, deter, investigate and address staffing, quality, compliance and other performance; meaningful use, EMR, HIPAA and other data security and breach and other health IT and data; crisis preparedness and response; internal, government and third-party reporting, audits, investigations and enforcement; government affairs and public policy; and other compliance and risk management, government and regulatory affairs and operations concerns.

Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other laws.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on health care, disability, aging, workforce, retirement and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

$2.4M+ St. Joseph Health HIPAA Settlement Teaching Lesson For Other HIPAA-Covered Entities & Business Associates

October 25, 2016

St. Joseph Health (SJH) has agreed to pay a $2.4 million plus settlement payment, conduct an enterprise-wide risk analysis and implement and administer a comprehensive correction plan under a Resolution Agreement and Corrective Action Plan (SJH Settlement) reached with the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) to settle OCR charges that SJH violated the Privacy & Security Rules of the Health Insurance Portability & Accountability Act (HIPAA) by allowing files containing electronic protected health information (ePHI) of 31,800 individuals that SJH created for its participation in the Medicare meaningful use program to be publicly accessible on the internet from February 1, 2011, until February 13, 2012. The SJH Settlement announced here by OCR on October 18, 2016 demonstrates the mounting HIPAA enforcement exposures that HIPAA-covered health care providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) risk when a breach of ePHI or other prohibited use, access, destruction or disclosure of ePHI or other personal health information (PHI) results from the failure of the Covered Entity or its business associates to properly protect or secure it in accordance with HIPAA. A review of the SJH Settlement drives home the point that Covered Entities should not assume that meaningful use or other electronic recordkeeping systems containing ePHI are properly secured in accordance with HIPAA.

SJH Investigation & Charges Resulting In $2.4 Million+ Settlement

A nonprofit integrated Catholic health care delivery system sponsored by the St. Joseph Health Ministry, who through its 24,000 employees and 6,000 physicians provides a range of health care services to more than 137,000 inpatients and 3.6 million outpatients each year at SHS’ 4 acute care hospitals, home health agencies, hospice care, outpatient services, skilled nursing facilities, community clinics and physician organizations located throughout California and in parts of Texas and New Mexico.

OCR’s charges against SJH arose out of OCR’s investigation into a 2012 breach notification report SJS filed with OCR. On February 14, 2012, SJH reported to OCR that files containing electronic protected health information (ePHI) of 31,800 individuals from five of the SJH hospitals-St. Jude Medical Center, Mission Hospital, Queen of the Valley Medical Center, Santa Rosa Memorial Hospital, and Petaluma Valley Hospital that SJH created for its participation in the meaningful use program were publicly accessible on the internet from February 1, 2011, until February 13, 2012, via Google and possibly other internet search engines.

SJH’s report to OCR indicated that this public access resulted from a configuration within its network server in which PDF files containing following patient information were uploaded: patient names; BMI; blood pressure; lab results; smoking status; diagnoses lists; medication allergies; advance directive status and demographic information (language, ethnicity, race, sex, and birth date). The server SJH purchased to store the files included a file sharing application whose default settings allowed anyone with an internet connection to access them. Upon implementation of this server and the file sharing application, SJH did not examine or modify it. As a result, the public had unrestricted access to PDF files containing the ePHI of 31,800 individuals, including patient names, health statuses, diagnoses, and demographic information from February 14, 2012 until SJH blocked external access to the ePHI when it shut down the application February 13, 2012.

OCR’s investigation indicated the following potential violations of the HIPAA Rules:

From February 1, 2011 to February 13, 2012, SJH potentially disclosed the PHI of 31,800 individuals;
Evidence indicated that SJH failed to conduct an evaluation in response to the environmental and operational changes presented by implementation of a new server for its meaningful use project, thereby compromising the security of ePHI;
Although SJH hired a number of contractors to assess the risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by SJH, evidence indicated that this was conducted in a patchwork fashion and did not result in an enterprise-wide risk analysis, as required by the HIPAA Security Rule.

SJH Settlement Agreement Highlights

Under the settlement agreement with SJH that OCR announced on October 18, 2016, SJH must pay a $2,140,500 settlement payment and adopt a comprehensive corrective action plan which among other things, requires SJH to conduct an enterprise-wide risk analysis, develop and implement a risk management plan, revise its policies and procedures, and train its staff on these policies and procedures. SJH’s Chief Executive Officer, Annette M. Walker, is named in the Corrective Action Plan as the SJH authorized representative and contact person responsible for overseeing the CAP implementation.

Among other things, the Corrective Action Plan specifically requires that SJH:

Within 240 days, conduct an enterprise-wide analysis and provide a report to OCR which includes a complete inventory of all electronic equipment, data systems, and applications that contain or store ePHI, and prepare and deliver to OCR for review an enterprise-wide risk analysis that identifies all security risks and vulnerabilities that incorporates all electronic equipment, data systems, and applications controlled, administered, or owned by SJH, its workforce members, and affiliated staff that contains, stores, transmits, or receives electronic protected health information (ePHJ);
Revise this risk analysis plan as directed by OCR based on its review of the presented risk analysis;
Develop and implement to the satisfaction of OCR an organization-wide risk management plan to address and mitigate any security risks and vulnerabilities identified in the risk analysis;
Distribute the risk management plan as finally approved by OCR to to workforce members involved with implementation of the plan within 30 days of OCR approval;
Revise to OCR’s satisfaction, adopt and implement within 30 days of OCR’s approval compliant HIPAA policies and procedures;
Prepare for review of OCR training materials and once approved by OCR, provide initial training to required workforce members, and obtain certification of completion of that training from each required workforce member within 60 days of OCR’s approval of the training and thereafter at least annually as long as the Corrective Action Plan remains in force;
Promptly conduct a documented investigation of any information indicating a potential workforce member violation of the new HIPAA policies in the manner required by OCR and if the investigation confirms a violation (Reportable Event), notify OCR of the relevant facts, findings, corrective actions and sanctions imposed against the violating workforce member in the manner required by the Corrective Action Plan;
Submit annual report to OCR signed and attested to by an SJH officer, which contains the information and attestations of compliance with the requirements of the Corrective Action Plan in accordance with the Corrective Action Plan;
Retain for inspection and copying and provide to OCR upon request all documents and records relating to compliance with this Corrective Action Plan for six (6) years from the Effective Date of the SJH Settlement Agreement.

Take Away For Other Covered Entities & Business Associates

To help safeguard their own organizations against potential sanctions from OCR and other HIPAA enforcement risks, Covered Entities and their business associates should ensure that their organization possesses a well-documented current enterprise-wide risk assessment, as well as has in place and is administering as necessary to maintain the currency and adequacy of its risk assessment strong practices for conducting documented evaluations of their own HIPAA security, policies, practices, audits and investigations and other procedures necessary to comply with HIPAA, taking into account recent OCR guidance, its initiation of its Phase II audit program, the insights offered by the SJH and other OCR’s ever growing list of enforcement actions and compliance tools, as well as changes in systems, documentation, software, equipment or other occurrences within the operations of the Covered Entity or business associate’s operations that could impact the currency and adequacy of its risk assessment or otherwise raise compliance risks..

In this respect, Covered Entities and business associates are encouraged to take special note of the advisability of specifically reviewing and updating their HIPAA policies, practices, business associate agreements, training, oversight and documentation to in response to OCR’s;

A series of recent OCR Resolution Agreements emphasizing the need for Covered Entities and their Business Associates to verify that have in place, and review and update as necessary business associate agreements e.g .HIPAA Settlement Illustrates The Importance Of Reviewing And Updating, As Necessary, Business Associate Agreements (September 23, 2016); Business Associate’s Failure to Safeguard Nursing Home Residents’ PHI Leads to $650,000 HIPAA Settlement (June 29, 2016)
Clarification of Permissible Fees for HIPAA Right of Access – Flat Rate Option Up to $6.50 is Not a Cap on All Fees for Copies of PHI (May 23, 2016)
Guidance On HIPAA & Cloud Computing released October 6, 2016, which provides guidance for Covered Entities and business associates about contracting and other procedures that HIPAA-regulated Covered Entities and their business associates should implement when contracting for and using Cloud Computing Services;
Joint Guidance published October 21, 2016 by the Federal Trade Commission and OCR reminding Covered Entities and their business associates of the need to ensure that in addition to fulfilling the technical content requirements of HIPAA, their HIPAA authorizations, privacy practices notices and other HIPAA notices and communications are written and presented in plan language, include required specific terms and descriptions and in a manner that does not mislead individuals about their rights or about what is happening with their PHI. Furthermore, where Covered Entities and their business associates contemplate that businesses associates may request that individuals sign HIPAA authorizations, Covered Entities and their business associates should the Covered Entity and business associate have in place a current, signed HIPAA-compliant business associate agreement that that expressly authorizes the business associate to request the HIPAA authorization in light of statements in the Joint Guidance indicating that OCR views the Privacy Rules as prohibiting a business associate from asking a consumer to sign a HIPAA authorization unless its business associate contract expressly permits the business associate to do so; and
Other OCR enforcement actions, tools and guidance. See, e.g. All Covered Entities Should Learn Lessons From Mississippi Medical Center’s $2.75 Million HIPAA Resolution Agreement; Providers, Health Plans Should Confirm Copy Charges Comply With New OCR HIPAA Guidance; $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use; Addressing Gaps in Cybersecurity: OCR Releases Crosswalk Between HIPAA Security Rule and NIST Cybersecurity Framework; HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework.

As breaches of PHI and other violations of HIPAA also frequently give rise to responsibilities or risks under a broad range of other federal and state laws medical and financial privacy and data security, Medicare and other terms of federal program participation, medical credentialing, licensure and ethics, insurance and Employee Retirement Income Security Act fiduciary responsibilities in the case of health plans, contractual, tort and other exposures, Covered Entities and their business associates also generally are best served to take into account these other responsibilities and exposures in conjunction with the design and administration of their HIPAA compliance and risk management policies and practices.

Covered Entities and their business associates also should seek advice from legal counsel regarding the adequacy of their compliance, investigatory, training, management oversight, training, reporting, documentation, document retention and other processes and procedures that could reduce risks of HIPAA violations and position the organization to effectively and more efficiently respond to a potential breach, audit, investigation or enforcement action and mitigate the costs and potential liability exposures that increasingly attends these events. In addition, given the typically high financial, operational and legal costs typically incurred to conduct investigations, report and redress breaches, and respond to OCR audits or investigations, much less make any payments and implement any corrective actions required to settle OCR changes, most Covered Entities and their business associations will want to consider the advisability and adequacy of insurance and other sources of funding or indemnification for the often substantial costs that often attend a HIPAA breach, audit or enforcement event. Since HIPAA violations under certain circumstances also can give rise to felony criminal liability, boards of directors and other leaders of Covered Entities and business associates also will want to ensure that their HIPAA compliance policies and practices also are incorporated and monitored by management as part of their organization’s overall Federal Sentencing Guideline Compliance programs and practices.

About The Author

Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely recognized for her extensive work and pragmatic thought leadership, experience, publications and training on HIPAA and other privacy, medical records and data and other health care and health plan concerns.

Recognized as “LEGAL LEADER™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble and as among the “Best Lawyers In Dallas” in employee benefits by D Magazine; Ms. Stamer has more than 28 years of extensive proven, pragmatic knowledge and experience representing and advising health industry clients and others on operational, regulatory and other compliance, risk management, product and process development, public policy and other key concerns.

As a core component of her work as the Managing Shareholder of Cynthia Marcotte Stamer, PC, Ms. Stamer has worked extensively throughout her career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance with HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.

Beyond her extensive involvement advising and representing clients on privacy and data security concerns and other health industry matters, Ms. Stamer also has served for several years as a scrivener for the ABA JCEB’s meeting with OCR, the Chair of the Southern California ISSA Health Care Privacy & Security Summit, and an editorial advisory board member, author, program chair or steering committee member, and faculties for a multitude of other programs and publications regarding privacy, data security, technology and other compliance, risk management and operational concerns in the health care, health and other insurance, employee benefits and human resources, retail, financial services and other arenas.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clientson the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com or contact Ms. Stamer via email here or via telephone to (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources at http://www.solutionslawpress.com such as:

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North Memorial Hit With $3.9M HIPAA Fine For HIPAA Violations

March 25, 2016

Just one day after the announcement of a $1,555,000 settlement with North Memorial Health Care of Minnesota under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules, the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) announced March 17, 2016 that Feinstein Institute for Medical Research has agreed to pay $3.9 million and will undertake a substantial corrective action plan to settle charges of HIPAA violations and bring its operations into compliance. The two settlements drive home again the substantial liability that health care providers, health plans, health care clearinghouses and their business associates risk for violating HIPAA. Register for March 30, 2016 Solutions Law Press, Inc. briefing to learn the latest about this and other new regulatory and enforcement guidance impacting the HIPAA compliance obligations and risks of health care providers, health plans, health care clearinghouses and their business associates. 3/30 Webex Shares Latest On Security, Patient Access & Other HIPAA Developments.

Feinstein Settlement

Feinstein is a biomedical research institute that is organized as a New York not-for-profit corporation and is sponsored by Northwell Health, Inc., formerly known as North Shore Long Island Jewish Health System, a large health system headquartered in Manhasset, New York that is comprised of twenty one hospitals and over 450 patient facilities and physician practices.

OCR’s investigation began after Feinstein filed a breach report indicating that on September 2, 2012, a laptop computer containing the electronic protected health information (ePHI) of approximately 13,000 patients and research participants was stolen from an employee’s car. The ePHI stored in the laptop included the names of research participants, dates of birth, addresses, social security numbers, diagnoses, laboratory results, medications, and medical information relating to potential participation in a research study.

OCR’s investigation discovered that Feinstein’s security management process was limited in scope, incomplete, and insufficient to address potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by the entity. Further, Feinstein lacked policies and procedures for authorizing access to ePHI by its workforce members, failed to implement safeguards to restrict access to unauthorized users, and lacked policies and procedures to govern the receipt and removal of laptops that contained ePHI into and out of its facilities. For electronic equipment procured outside of Feinstein’s standard acquisition process, Feinstein failed to implement proper mechanisms for safeguarding ePHI as required by the Security Rule.

“Research institutions subject to HIPAA must be held to the same compliance standards as all other HIPAA-covered entities,” said OCR Director Jocelyn Samuels. “For individuals to trust in the research process and for patients to trust in those institutions, they must have some assurance that their information is kept private and secure.”

The resolution agreement and corrective action plan may be found here.

The Feinstein settlement announcement follows yesterday’s announcement of a $1.5 million plus settlement with North Memorial to resolve HIPAA charges that it failed to implement a business associate agreement with a major contractor and failed to institute an organization-wide risk analysis to address the risks and vulnerabilities to its patient information. North Memorial is a comprehensive, not-for-profit health care system in Minnesota that serves the Twin Cities and surrounding communities. The settlement highlights the importance for healthcare providers, health plans, healthcare clearinghouses and their business associates to comply with HIPAA’s business associate agreement and other HIPAA organizational, risk assessment, privacy and security, and other requirements.

OCR’s announcement emphasizes the importance of meeting these requirements. “Two major cornerstones of the HIPAA Rules were overlooked by this entity,” said Jocelyn Samuels, Director of the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). “Organizations must have in place compliant business associate agreements as well as an accurate and thorough risk analysis that addresses their enterprise-wide IT infrastructure.”

The settlement comes from charges filed after OCR initiated its investigation of North Memorial following receipt of a breach report on September 27, 2011, which indicated that an unencrypted, password-protected laptop was stolen from a business associate’s workforce member’s locked vehicle, impacting the electronic protected health information (ePHI) of 9,497 individuals.

OCR’s investigation indicated that North Memorial failed to have in place a business associate agreement, as required under the HIPAA Privacy and Security Rules, so that its business associate could perform certain payment and health care operations activities on its behalf. North Memorial gave its business associate, Accretive, access to North Memorial’s hospital database, which stored the ePHI of 289,904 patients. Accretive also received access to non-electronic protected health information as it performed services on-site at North Memorial.

The investigation further determined that North Memorial failed to complete a risk analysis to address all of the potential risks and vulnerabilities to the ePHI that it maintained, accessed, or transmitted across its entire IT infrastructure — including but not limited to all applications, software, databases, servers, workstations, mobile devices and electronic media, network administration and security devices, and associated business processes.

In addition to the $1,550,000 payment, North Memorial is required to develop an organization-wide risk analysis and risk management plan, as required under the Security Rule. North Memorial will also train appropriate workforce members on all policies and procedures newly developed or revised pursuant to this corrective action plan.

The Resolution Agreement and Corrective Action Plan can be found here.

Settlement Latest Reminder To Manage HIPAA Risks

Following up on OCR’s imposition of its second-ever HIPAA Civil Monetary Penalty (CMP) and the latest in an ever-growing list of settlements by Covered Entities under HIPAA, the North Memorial settlement is another example of the substantial liability that Covered Entities face for violating HIPAA. To avoid these liabilities, Covered Entities must constantly be diligent to comply with the latest guidance of OCR concerning their obligations under HIPAA. As OCR continues to issue additional guidance as well as supplement this guidance through information shared in settlement agreements like the North Memorial settlement, even if Covered Entities reviewed their practices in the last 12-months, most will want to update this review in response to new OCR guidance and enforcement actions, including new guidance on obligations to provide plan members or other subjects of protected health information with access to or copies of their records and other guidance, as well as the ever expanding list of enforcement actions by OCR.

Since the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) amended HIPAA, Covered Entities face growing responsibilities and liability for maintaining the security of ePHI. In response to HITECH, OCR continues to use a carrot and stick approach to encouraging and enforcing compliance. As demonstrated by OCR’s imposition of the second-ever HIPAA Civil Monetary Penalty (CMP) of $239,000 against Lincare and the ever-growing list of Resolution Agreements OCR announces with other Covered Entities, OCR continues to step up enforcement against Covered Entities that breach the Privacy and Security Rules. See OCR’s 2nd-Ever HIPAA CMP Nails Lincare For $239,000.

On the other hand, OCR also continues to encourage voluntary compliance by Covered Entities by sharing guidance and tools to aid Covered Entities to understand fulfill their HIPAA responsibilities such as the HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework (Crosswalk) unveiled by OCR on February 24, 2016.The crosswalk that maps the HIPAA Security Rule to the standards of the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity (the Cybersecurity Framework) as well as mappings to certain other commonly used security frameworks.

While stating that the HIPAA Security Rule does not require use of the NIST Cybersecurity Framework, OCR says it hopes the Crosswalk will provide “a helpful roadmap” for HIPAA Covered Entities and their business associates to understand the overlap between the NIST Cybersecurity Framework, the HIPAA Security Rule, and other security frameworks that can help Covered Entities safeguard health data in a time of increasing risks and help them to identify potential gaps in their programs. At the same time, OCR’s announcement of its release of the Crosswalk also cautions users that “use of the Framework does not guarantee HIPAA compliance.” Rather, OCR says “the crosswalk provides an informative tool for entities to use to help them more comprehensively manage security risks in their environments.

With a USA Today report attributing more than 40 percent of data breaches to the healthcare industry over the last three years 91 percent of all health organizations having reporting breaches over the last two years, OCR has made clear that it intends to zealously investigate and enforce the Security Rules against Covered Entities that violate the Security Rules against Covered Entities that fail to take suitable steps to safeguard the security of PHI as required by the HIPAA Security Rule. To meet these requirements, the HIPAA Security Rule requires that Covered Entities conduct and be prepared to product documentation of their audit and other efforts to comply with the Security Rule Most Covered Entities will want to consider including an assessment of the adequacy of their existing practices under the Crosswalk and other requirements disclosed by OCR in these assessments to help position the Covered Entity to defend or mitigate HIPAA CMP and other liabilities in the event of a HIPAA breach or audit.

Latest Guidance Clarifies Patient Rights To Access PHI & Allowable Charges

In addition to maintaining adequate security, HIPAA also requires Covered Entities to provide individuals with the right to access and receive a copy of their health information from their providers, hospitals, and health insurance plans in accordance with the HIPAA Privacy Rule. In response to recurrent difficulties experienced by individuals in exercising these rights, OCR recently published supplemental guidance to clarify and promote better understanding and compliance with these rules by Covered Entities.

OCR started this process in January, 2015 by releasing a comprehensive fact sheet (Access fact sheet) and the first in a series of topical frequently asked questions (FAQs) addressing patients’ right to access their medical records, which set forth requirements providers must follow in sharing medical records with patients, including that they must do so in a timely manner and in a format that works for the patient.

Earlier this month, OCR followed up by publishing on March 1, 2016 a second set of FAQs addresses additional issues, including the fees individuals may be charged for copies of their health information and the right of individuals to have their health information sent directly to a third party if they so choose.

Covered entities and their business associates should move quickly to review and update their business associate agreements and other practices to comply with this new guidance as well as watch for further guidance and enforcement about these practices from OCR.

Other Key HIPAA Regulatory & Enforcement Changes Raise Responsibilities & Risks

OCR’s new guidance on access to PHI follows a host of other regulatory and enforcement activities. While the particulars of each of these new actions and guidance vary, all send a very clear message: OCR expects Covered Entities and their business associates to comply with HIPAA and is offering tools and other guidance to aid them in that process.. In the event of a breach or audit, Covered Entities and their business associates need to be prepared to demonstrate their efforts to comply. Those that cannot show adequate compliance efforts should be prepared for potentially substantial CMP or Resolution Agreement payments and other sanctions.

Register For 3/30 Webex Briefing

Solutions Law Press, Inc.™ invites to catch up on the latest guidance on the Covered Entities’ responsibility under HIPAA to provide access to patients to PHI by registering here to participate in the “HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments” Webex briefing by attorney Cynthia Marcotte Stamer that Solutions Law Press, Inc.™ will host beginning at Noon Central Time on Wednesday, March 30, 2016. Get additional information or register here.

About The Author

Recognized as “LEGAL LEADER™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble and as among the “Best Lawyers In Dallas” in employee benefits 2015 by D Magazine; Ms. Stamer has more than 28 years of extensive proven, pragmatic knowledge and experience representing and advising health industry clients and others on operational, regulatory and other compliance, risk management, product and process development, public policy and other key concerns.

As a core component of her work as the Managing Shareholder of Cynthia Marcotte Stamer, PC, the Co-Managing Member of Stamer Chadwick Soefje PLLC, Ms. Stamer has worked extensively throughout her nearly 30 year career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance with HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.

Beyond her extensive involvement advising and defending clients on these matters, Ms. Stamer also has served for several years as the scrivener for the ABA JCEB’s meeting with OCR for many years. She returns as Chair of the Southern California ISSA Health Care Privacy & Security Summit for the third year in 2016, as well as speaks and serves on the steering committee of a multitude of other programs.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE; Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Counsel, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clientson the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com or the Stamer│Chadwick │Soefje PLLC or contact Ms. Stamer via email to here or via telephone to (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources at http://www.solutionslawpress.com such as:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here. ©2016 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved.

Leave a Comment » | Academic medicine, ASC, Childrens Health Insurance Program, Consumer Driven Health Care, data breach, data security, Disease Management, Doctor, drug treatment, E-Prescribing, Electronic Health Records, Electronic Medical Records, Employer, Employment law, FACTA, Federal Health Center, Federal Sentencing Guidelines, Genetic Information, GINA, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Labor Law, Laws, managed care, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Mental Health, Mental Heatlh, OCR, Outpatient, Patient Empowerment, Pharmacy, Physician, Physician Licensing, Prescription Drugs, Privacy, Psychiatric, Reproductive Rights, Rural Health Care, substance abuse treatment, Technology, Telemarketing, Telemedicine, Union, Veterans Health, Wellness | Tagged: breech, Data Breech, HIPAA, Medical Confidentiality, Medical Privacy, North Memorial, OCR, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

North Memorial Health Care Pays $1.5M Plus HIPAA Settlement For Business Associate Agreement Deficiencies

March 16, 2016

North Memorial Health Care of Minnesota has agreed to pay $1,550,000 to settle charges that it potentially violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules by failing to implement a business associate agreement with a major contractor and failing to institute an organization-wide risk analysis to address the risks and vulnerabilities to its patient information. North Memorial is a comprehensive, not-for-profit health care system in Minnesota that serves the Twin Cities and surrounding communities. The settlement highlights the importance for healthcare providers, health plans, healthcare clearinghouses and their business associates to comply with HIPAA’s business associate agreement and other HIPAA organizational, risk assessment, privacy and security, and other requirements.

The Resolution Agreement and Corrective Action Plan can be found on the HHS website at: http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/north-memorial-health-care/index.html.

Settlement Latest Reminder To Manage HIPAA Risks

Latest Guidance Clarifies Patient Rights To Access PHI & Allowable Charges

Other Key HIPAA Regulatory & Enforcement Changes Raise Responsibilities & Risks

Register For 3/30 Webex Briefing

About The Author

Recognized as “LEGAL LEADER™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble and as among the “Best Lawyers In Dallas” in employee benefits 2015 by D Magazine; Ms. Stamer has more than 28 years of extensive proven, pragmatic knowledge and experience representing and advising health industry clients and others on operational, regulatory and other compliance, risk management, product and process development, public policy and other key concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE; Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Counsel, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clientson the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com or the Stamer│Chadwick │Soefje PLLC or contact Ms. Stamer via email to here or via telephone to (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources at http://www.solutionslawpress.com such as:

Leave a Comment » | Academic medicine, Corporate Compliance, data breach, data security, Disease Management, DME, Doctor, E-Prescribing, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Federal Health Center, Genetic Information, Health Care, Health Care Provider, Health Care Quality, Health IT, Health Plan, HIPAA, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, Hospital, hospitals, Inpatient Rehabilitation Facility, managed care, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Health, OCR, Outpatient, Pandemic, Patient Empowerment, Pharmacy, Physician, Privacy, Psychiatric, Rural Health Care, Technology, Telemarketing, Telemedicine | Tagged: business associate, covered entity, Health Care, Health Plan, HIPAA, Hospital, Medical Privacy, North Memorial, OCR, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

Health Care Providers, Provide ACO, Reimbursement Reform Input To HHS

March 2, 2015

Physicians, nurses, hospitals and other health care providers, patients and others concerned about health care reimbursement and other health care reforms in the United States should sign up and participate in the new Health Care Payment Learning and Action Network (“Network”) the Department of Health and Human Services (HHS) is creating to help shape ongoing reform of the US health care delivery system to promote better care, smarter spending, and healthier people through the expansion of new health care payment models and other reforms. HHS is inviting private payers, employers, providers, patients, states, consumer groups, consumers, and other partners within the health care community to register here to participate in the Network activities including kickoff event scheduled for Wednesday, March 25, 2015.

HHS hopes cooperation through the Network will help the entire U.S. health care system match and exceed the following HHS goals for Medicare:

Tying 30 percent of payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements by the end of 2016, and
Tying 50 percent of payments to alternative payment models by the end of 2018. The Network will also support the broader goal of tying the vast majority of payments in the health care system to quality or value.

As HHS moves forward to promote ACOs and other reforms, it is particularly important that providers and patients provide feedback and input about the goals and ideas HHS is promoting as solutions for “improving” health care. While HHS often touts consolidation of care into ACOs and other reimbursement strategies using government generated standards of quality as the best means of improving quality and cost-effectiveness, many patients, providers and others worry that HHS ACO and other reimbursement reforms as presently implemented or contemplated by HHS cut costs at the expense of patients by denying reimbursement or other access for effective care options based on cost or ignore other patient needs in the name of cost savings. Active, consistent participation in these and other opportunities for input is critical for those concerned about these and other issues to question and shape the goals, assumptions and actions HHS, Congress and others take to change the U.S. health care system.

HHS says most Network meetings will occur virtually by teleconference or webinar. In-person meetings will occur in the Washington D.C. area. HHS plans to hold the first live streaming of the kickoff event on Wednesday, March 25, 2015. HHS will share details through e-mails to those registered online to participate in the network. Individuals and organizations concerned about ACO and other HHS-lead health care reforms are urged to register and participate in the Network as one of the ways to help monitor and shape health care reform as lead by HHS.

About Project COPE: The Coalition On Patient Empowerment & Coalition on Responsible Health Policy

Do you have feedback or other experiences to share about medical debit, ACA or other health care challenges? Have ideas for helping improve our system, helping Americans cope with these and other health care challenges or other health care matters? Know other helpful resources or experiences that you are willing to share? Are you concerned about health care coverage or other health care and disability issues or policy concerns? Join the discussion and share your input by joining Project COPE: Coalition for Patient Empowerment here.

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these needs is the purpose of

The Coalition and its Project COPE are founded and operate based on the belief that health care reform and policy must be patient focused, patient centric and patient empowering. The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans. The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch. Americans can best improve health care by not waiting for someone else to step up: Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can. Building health care neighborhoods filled with good neighbors throughout the community is the key.

The outcome of this latest health care reform push is only a small part of a continuing process. Whether or not the Affordable Care Act makes financing care better or worse, the same challenges exist. The real meaning of the enacted reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye. Americans individually and collectively clearly should monitor and continue to provide input through this critical time to help shape constructive rather than obstructive policy. Regardless of how the policy ultimately evolves, however, Americans, American businesses, and American communities still will need to roll up their sleeves and work to deal with the realities of dealing with ill, aging and disabled people and their families. While the reimbursement and coverage map will change and new government mandates will confine providers, payers and patients, the practical needs and challenges of patients and families will be the same and confusion about the new configuration will create new challenges as patients, providers and payers work through the changes.

We also encourage you and others to help develop real meaningful improvements by joining Project COPE: Coalition for Patient Empowerment here by sharing ideas, tools and other solutions and other resources. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.

Examples of some of these recent health care related publications include:

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Border Health, Centers For Disease Control, Conditions of Participation, Consumer Driven Health Care, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, FDA, Federal Health Center, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Policy, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, OIG, Outcomes Data, Patient Empowerment, Pharmacy, Physician, Prospective Payment, Public Policy, Rural Health Care, Stark, Telemedicine | Permalink
Posted by Cynthia Marcotte Stamer

Use New State Ebola Protocol Table In Ebola Prevention & Management Planning

January 10, 2015

Health care providers, public health, school, and other community organizations, employers and other business leaders and others concerned about continuing Ebola and other pandemic prevention and containment should check out the new table of State Ebola Protocols Table compiled by the Centers for Disease Control (CDC) to help law and policy makers prepare for and respond to Ebola-related situations As part of continuing Federal efforts to make up for lost time on helping U.S. health care providers and communities prepare to prevent and respond to Ebola outbreak risks since the death of Liberian Ebola patient Thomas Eric Duncan at a in Dallas hospital last year alerted Americans to the risks and need for tighter preparations.

While the Dallas hospital that treated Mr. Duncan paid a settlement to his family and faced other widespread criticism and negative publicity, it then has become clear that misinformation provided by the patient, the original presentation of the patient with flu-like symptoms, the Obama Administration’s reluctance to adopt policies or communications that might interfere with its pro-immigration political agenda, the CDC’s failure to maintain and communicate the most current health care information to health care providers and communities, the CDC’s academic rather than operational emphasis, EMTALA mandates that forced the hospital to triage the patient, Medicaid and other insurance payment protocols that would have as medically unnecessary screening tests in the absence of more clear risk factors, federal licensing restrictions on the use of testing and a host of other limits and deficiencies in the Federal government’s preparations and response to Ebola and other communication risks, left Texas Health Resources and other U.S. health care providers, as well as U.S schools, public service agencies, employers and others at a great disadvantage in their efforts to deal with the outbreak. After denying the seriousness of Ebola risk concerns for several weeks, the diagnosis with Ebola of health care providers that treated Mr. Duncan and subsequent death and diagnosis resulted in the CDC and other federal and state agencies stepping up their Ebola preparation and guidelines. In keeping with this ongoing commitment, CDC says the CDC now will continue to update the State guidelines table as states continue to modify their Ebola response protocols.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related developments or other risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Centers For Disease Control, Childrens Health Insurance Program, Disability Discrimination, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, FDA, Health Care, Health Care Fraud, Health Care Provider, Health Care Quality, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Medical Licensure, Medical Malpractice, OIG, Pandemic, Patient Empowerment, Pharmacy, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, Health Plans, HEAT, HIPAA, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Unpatched and Unsupported Software Triggers Latest HIPAA Security Breach Resolution Agreement

December 11, 2014

Health care providers, health plans, health care clearinghouses (covered entities) and their business associates need to watch for and protect protected health information (PHI) against security exposures from unpatched or unsupported software and other weaknesses in their data security protections as part of their compliance obligations under the Security Rules of the Health Insurance Portability & Accountability Act (HIPAA).

The need to monitor and address data security threats associated with unpatched or unsupported software is demonstrated by the December 9, 2014 announcement by the U.S. Department of Health & Human Services (HHS) Office of Civil Rights (OCR) that Anchorage Community Mental Health Services (ACMHS) will pay $150,000 and adopt a corrective action plan to correct deficiencies in its HIPAA compliance program resulting from unpatched and unsupported software.

OCR opened an investigation against the five-facility, nonprofit provider of behavioral health care services to children, adults, and families in Anchorage, Alaska after receiving notification from ACMHS of a breach of unsecured electronic protected health information (ePHI) affecting 2,743 individuals due to malware compromising the security of its information technology resources.

According to the OCR announcement of the ACMHS Resolution Agreement with OCR, OCR’s investigation revealed that ACMHS had adopted sample Security Rule policies and procedures in 2005, but failed to follow these procedures. Moreover, OCR found that the reported security incident directly resulted of ACMHS failing to identify and address basic risks, such as not regularly updating their IT resources with available patches and running outdated, unsupported software.

“Successful HIPAA compliance requires a common sense approach to assessing and addressing the risks to ePHI on a regular basis,” said OCR Director Jocelyn Samuels. “This includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.”

In an effort to promote awareness of the need to assess and monitor the security of ePHI by covered entities and business associates, OCR continues to encourage covered entities and business associates to conduct regular documented evaluations of the adequacy of their ePHI safeguards and systems. To aid in this process, OCR and the Office of the National Coordinator for Health Information Technology have created a Security Rule Risk Assessment Tool available here to assist organizations that handle PHI in conducting a regular review of the administrative, physical and technical safeguards they have in place to protect the security of the information. Since OCR points to the Tool as a resource, covered entities and business associates should anticipate that their failure to identify and address any deficiencies in the areas identified by the tools as a potentially serious compliance issue. As a result, covered entities and business associates likely will want to take steps to ensure that their records include documented review of the adequacy of the security safeguards identified in the Tool. At the same time, covered entities and their business associates should not assume that the Tool adequately covers all potential HIPAA Security Rule exposures. OCR has made clear in this and other Resolution Agreements that HIPAA’s Security Rule requires ongoing monitoring and assessment of the adequacy of security in response to changes in software or system, emerging threats and other developments.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Centers For Disease Control, Childrens Health Insurance Program, Disability Discrimination, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, FDA, Health Care, Health Care Fraud, Health Care Provider, Health Care Quality, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Medical Licensure, Medical Malpractice, OIG, Pandemic, Patient Empowerment, Pharmacy, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, Health Plans, HEAT, HIPAA, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Congress Sends Bill To Fast Track FDA Ebola Treatment Review & HHS Declaration Gives Ebola Treatment Manufacturers Special Immunity

December 11, 2014

As part of Washington’s late response to the Ebola outbreak crisis, the House and Senate in the past week have passed legislation that if signed by the President as expected will add Ebola and other filoviruses to the list of diseases eligible for fast track review by the Food and Drug Administration (FDA) under the FDA Priority Review Voucher Program (Program).

The FDA Program awards vouchers to sponsors of human drug applications that are approved to prevent or treat designated tropical diseases. A voucher entitles the holder to have a future human drug application acted upon by the FDA within six months.

The House on December 3, 2014 and the Senate on December 10, 2014 respectively passed the “FDA Priority Review Voucher Program Act,” (S.B. 2917/H.B. 5729) (the “Bill”) that will amend the Federal Food, Drug, and Cosmetic Act to add Ebola and other filoviruses to the list of diseases covered by the Program. The Bill also seeks to expedite FDA approval of Ebola and other designated disease treatments by:

Changing the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).
Allowing priority review vouchers to be transferred between sponsors of human drug applications any number of times.
Reducing from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.

Congress sent the Bill to the President just one day after Department of Health & Human Services (HHS) Secretary Sylvia M. Burwell today announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act HHS says it hopes will “facilitate the development and availability of experimental Ebola vaccines in hopes of helping combat the current epidemic in West Africa and help prevent future outbreaks there.”

Fighting the disease in Africa has been the primary focus of the Obama Administration’s Ebola response. The December 9, 2014 HHS declaration provides immunity under United States law against legal claims related to the manufacturing, testing, development, distribution, and administration of three vaccines for Ebola virus disease. It does not, generally, provide immunity for a claim brought in a court outside the United States.

For many years, the U.S. has encouraged vaccine development by managing liability and compensation, starting with the National Childhood Vaccine Injury Act of 1986. The PREP Act was designed to facilitate the development of medical countermeasures to respond to urgent public health needs, including the development of critical vaccines like those to prevent the spread of Ebola. This U.S. declaration under the PREP act is part of a global dialogue to address these issues in the U.S., and other countries where the vaccine is being developed, manufactured and potentially used.

“My strong hope in issuing this PREP Act declaration in the United States is that other nations will also enact appropriate liability protection and compensation legislation,” said Secretary Burwell. “As a global community, we must ensure that legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine, an essential strategy in our global response to the Ebola epidemic in West Africa.”

HHS hopes the PREP Act declaration will strengthen the incentive to conduct research and spur development, manufacturing, and the potential use of the vaccines in large scale vaccination campaigns in West Africa. The PREP Act declaration provides legal protection under U.S. law for three vaccine candidates:

the GlaxoSmithKline’s Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine known as ChAd3-EBO-Z;
the BPSC1001 vaccine, known as rVSV-ZEBOV-GP, made by BioProtection Services Corporation, a subsidiary of Newlink Genetics; and
the Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen Corporation, subsidiary of Johnson & Johnson/Bavarian Nordic.

Similar PREP Act declarations have been issued, revised or renewed 14 times since the Act was signed in 2005. Past declarations have covered vaccines used in H5N1 pandemic influenza clinical trials in 2008, products related to the H1N1 influenza pandemic in 2009, and the development and manufacturing of antitoxins to treat botulism in 2008. For more information about the PREP Act, see here .

The Bill and the HHS PREP Act declaration are the latest efforts to provide what many health care providers see as a long overdue response to the Ebola outbreak in the wake of the diagnosis and subsequent death of an Ebola patient in Dallas lead to his death and the infection of nurses involved in his treatment, and a small number of other Ebola victims in the United States raised national awareness and concern.

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Former Center Texas Medical Center CFO Faces 5 Years After Guilty Plea To EHR Incentive Fraud Reminder To Manage Incentive Compliance

November 18, 2014

The prosecution and resulting November 12, 2014 guilty plea of former Shelby Regional Medical Center Chief Financial Officer Joe White to making false statements when applying for electronic health record (EHR) incentives highlights another growing fraud exposure risk that health care organizations and their leaders need to manage arising from applications or other claims made in seeking EHR or other incentives or grants.

White presently faces sentencing to up to five years in prison after pleading guilty to making a false statement in an application for EHR incentives he signed on behalf of Center, Texas-based Shelby Regional Medical Center. White plead guilty to the charge before U.S. Magistrate Judge John D. Love on November 12, 2014.

The charges against White stemmed from an application he made on behalf of the medical center for EHR incentives. According to information presented by the U.S. Department of Justice in court, White was the Chief Financial Officer for the medical center owned and operated by Dr. Taqriq Mahmood. White oversaw the implementation of EHRs for the hospital and was responsible for attesting to the meaningful use of electronic health records in order to qualify to receive incentive payments under Medicare’s Electronic Health Record (EHR) Incentive Program.　 The Justice Department charged that on November 20, 2012, White knowingly made a false statement to Medicare falsely representing that the hospital was a meaningful user of electronic health records, when the hospital did not meet the meaningful use requirements.　 As a result, the medical center received $785,655.00 in EHR incentives from Medicare.　 A federal grand jury indicted White on February 6, 2014. He faces up to five years in prison when sentenced. The sentencing date is not set yet.
White’s prosecution and guilty plea is one of several actions that highlight the growing exposure that health care organizations and their leaders face to criminal and civil prosecution for fraud or other misconduct in seeking or collecting federal incentives or grants.

Federal and state officials responsible for administering the massive influx of grants and incentives to health care providers and others authorized under the Patient Protection and Affordable Care Act, the Stimulus Bill and other legislation now are auditing and investigating fraud or other compliance concerns and acting aggressively to prosecute organizations and individuals criminally, civilly or both for fraudulent or other abuse of the rules. The White criminal conviction, for instance, follows the October, 2014 civil complaint and simultaneous settlement of theFalse Claims Act civil suit, US ex rel. v. Columbia U. and ICAP complaint-in-intervention and its resolution through the simultaneously filed US ex rel. v. Columbia U. and ICAP stipulation and order (“Settlement”) involving the Trustees Of Columbia University In The City Of New York (“Columbia University”), and ICAP (formerly known as the International Center For Aids Care And Treatment Programs) (collectively, “Columbia”). In that suit, federal officials charged Columbia University with improperly defrauding the federal government in violation of the False Claims Act in federal grants that Columbia University obtained to fund ICAP’s AIDS- and HIV-related work. The United States’ Complaint-in-Intervention (the “Complaint”) alleged that Columbia University, as the grant administrator on behalf of ICAP, received millions of dollars in federal grants and, pursuant to the rules applicable to such grants, was required for nearly 200 of ICAP’s employees located in New York City to use a suitable means of verifying that the employees had actually performed the work charged to a particular grant. The Complaint alleges that Columbia was well aware that this was not being done, yet continued wrongly to charge many federal grants for work that was not devoted to the projects they funded. According to the Justice Department, Colombia failed to ensure that these reports were created or verified by the more than 200 individuals for which grant monies were sought. Instead, Columbia’s Finance Department provided information for these reports even though the employees of that department had limited or no knowledge of which grants the individuals actually worked on. In addition, the lawsuit charged that the effort reports were certified as correct by the principal investigators on the grants without using suitable means to verify the accuracy of the reports. Instead of taking the appropriate steps to determine whether the reports were accurate, the principal investigators would certify large batches of the reports, without making any inquiry into whether the allocation of work among the grants was accurate. Moreover, ICAP’s management was well aware of the inaccuracies of the effort reporting system. According to the complaint, these omissions resulted in Columbia charging grants for work that was not performed on the project being funded by that grant. For instance, an ICAP Finance Analyst stated that he spent approximately 15-20% of his time on MCAP in fiscal year 2010, but his effort report falsely listed his MCAP effort, and related salary charges, as 85%. Likewise, in fiscal year 2010, an ICAP Subcontracts Manager’s effort report listed her effort as 100% MCAP, but the Subcontracts Manager actually worked on three other grants, in addition to MCAP, that year. The time submitted for many other employees was similarly mischarged. The complaint also charged that ICAP also charged federal grants for time spent on activities that are not chargeable to any federal grants, such as competitive grant proposal writing. For example, an ICAP Grants Manager spent a significant amount of her time writing competitive grant proposals, but her effort report showed that all of her time was charged to grants, with as much as 92% of her time charged to MCAP in some years.

In the Settlement, Columbia admitted failing to use a suitable means of verifying whether the salary and wage charges that ICAP applied to specific federal grants were based on an employee’s actual effort for that grant. Columbia also admitted that as a result, certain effort reports contained inaccurate information, and for a number of years ICAP mischarged certain federal grants for work that was not allocable to those agreements. Columbia also agreed to pay $9,020,073 to resolve the Government’s claims.

The White criminal prosecution and conviction and the Colombia civil prosecution and settlement are two of a growing list of reminders to health care, educational and other organizations receiving Department of Health & Human Services or other federal grants or incentives as a critical reminder to review and tighten as necessary their federal grant and other incentive program compliance and documentation to ensure that it can withstand an audit or other scrutiny by federal officials.

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Posted by Cynthia Marcotte Stamer

Preparing Privacy Compliance For Emergencies-Ebola Crisis Prompts HHS OCR To Share Guidance On HIPAA Privacy in Emergency Situations

November 11, 2014

The recent US Ebola scare provided an important reminder to health care providers, health insurers and health plans, health care clearinghouses, employers and others of the importance of understanding and preparing to deal with health care privacy and other challenges arising from epidemics and other emergencies. In response to the recent Ebola and other contagious disease outbreaks and just as U.S. health care and other business leaders are working to prepare for the biggest contagious disease time of the year, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is reminding health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates that the privacy rules of the Health Insurance Portability & Accountability Act (HIPAA) requiring Covered Entities and their business associates to limit the use, access and disclosure of patient’s protected health information (PHI) continue to apply during emergency situations and help them understand when HIPAA allows them to share PHI in emergency situations in a new notice titled “HIPAA Privacy in Emergency Situations” (Guidance) published November 10, 2014. A business associate of a covered entity (including a business associate that is a subcontractor) also must continue to comply with HIPAA and may only make disclosures permitted by the Privacy Rule on behalf of a Covered Entity or another business associate to the extent authorized by its business associate agreement and consistent with HIPAA’s requirements.

Sharing Patient Information

The Guidance begins by reminding Covered Entities and their business associates that HIPAA’s Privacy Rule continues to apply in emergency situations and requires Covered Entities protect and prohibits their use, access or disclosure of patient’s protected health information except as allowed by HIPAA unless the patient authorizes the Covered Entity to disclose the PHI in accordance with HIPAA’s requirements for authorization set forth in 45 CFR 164.508.

The Guidance then goes on to discuss the following circumstances that the HIPAA Privacy Rule might allow Covered Entities to share PHI without getting patient authorization, subject to the reminder that in many cases, HIPAA will require that the Covered Entity limit the disclosure to the minimum necessary disclosure necessary for the allowable purpose and require other conditions to be fulfilled:

Treatment.

Under the Privacy Rule, covered entities may disclose, without a patient’s authorization, protected health information about the patient as necessary to treat the patient or to treat a different patient. Treatment includes the coordination or management of health care and related services by one or more health care providers and others, consultation between providers, and the referral of patients for treatment. See 45 CFR §§ 164.502(a)(1)(ii), 164.506(c), and the definition of “treatment” at 164.501.

Public Health Activities.

The HIPAA Privacy Rule recognizes the legitimate need for public health authorities and others responsible for ensuring public health and safety to have access to protected health information that is necessary to carry out their public health mission. Therefore, the Privacy Rule permits covered entities to disclose needed protected health information without individual authorization:

To Or At The Direction Of A Public Health Authority.

The HIPAA Privacy Rule allows Covered Entities to share protected health information with Public Health Authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury or disability like the Centers for Disease Control and Prevention (CDC) or a state or local health department. This would include, for example, the reporting of disease or injury; reporting vital events, such as births or deaths; and conducting public health surveillance, investigations, or interventions. A “public health authority” is an agency or authority of the United States government, a State, a territory, a political subdivision of a State or territory, or Indian tribe that is responsible for public health matters as part of its official mandate, as well as a person or entity acting under a grant of authority from, or under a contract with, a public health agency. See 45 CFR §§ 164.501 and 164.512(b)(1)(i). For example, a covered entity may disclose to the CDC protected health information on an ongoing basis as needed to report all prior and prospective cases of patients exposed to or suspected or confirmed to have Ebola virus disease.

The HIPAA Privacy Rule also allows Covered Entities to share information at the direction of a public health authority:

To a foreign government agency that is acting in collaboration with the public health authority. See 45 CFR 164.512(b)(1)(i); and
To persons at risk of contracting or spreading a disease or condition if other law, such as state law, authorizes the covered entity to notify such persons as necessary to prevent or control the spread of the disease or otherwise to carry out public health interventions or investigations. See 45 CFR 164.512(b)(1)(iv)

Disclosures to Family, Friends, and Others Involved in an Individual’s Care and for Notification.

The HIPAA Privacy Rule allows a Covered Entity to share protected health information:

With a patient’s family members, relatives, friends, or other persons identified by the patient as involved in the patient’s care;
About a patient as necessary to identify, locate, and notify family members, guardians, or anyone else responsible for the patient’s care, of the patient’s location, general condition, or death including where necessary to notify family members and others, the police, the press, or the public at large. See 45 CFR 164.510(b).

The Guidance reminds Covered Entities, however, that the Privacy Rule requires the Covered Entity to get verbal permission from individuals or otherwise be able to reasonably infer that the patient does not object, when possible. If the individual is incapacitated or not available, the Guidance states Covered Entities may share information for these purposes if, in their professional judgment, doing so is in the patient’s best interest.

The Guidance also confirms that Covered Entities may share protected health information with disaster relief organizations authorized by law or by their charters to assist in disaster relief efforts like the American Red Cross for the purpose of coordinating the notification of family members or other persons involved in the patient’s care, of the patient’s location, general condition, or death. It is unnecessary to obtain a patient’s permission to share the information in this situation if doing so would interfere with the organization’s ability to respond to the emergency.

Imminent Danger

The Guidance also states that Covered Entities that are health care providers may share patient information with anyone as necessary to prevent or lessen a serious and imminent threat to the health and safety of a person or the public – consistent with applicable law (such as state statutes, regulations, or case law) and the provider’s standards of ethical conduct. See 45 CFR 164.512(j).

Disclosures to the Media & Others Not Involved in the Care of the Patient/Notification

The Guidance also reminds Covered Entities of the importance of closely adhering to HIPAA’s rules when responding to information requests from the medial or others not involved in the care of a patient. The Guidance states that when the media or other other party not involved un the patient’s care asks the Covered Entity for information about a particular patient by name, a hospital or other health care facility may release limited facility directory information to acknowledge an individual is a patient at the facility and provide basic information about the patient’s condition in general terms (e.g., critical or stable, deceased, or treated and released) if the patient has not objected to or restricted the release of such information or, if the patient is incapacitated, if the disclosure is believed to be in the best interest of the patient and is consistent with any prior expressed preferences of the patient. See 45 CFR 164.510(a). In general, except in the limited circumstances authorized in the HIPAA Privacy Rule, affirmative reporting to the media or the public at large about an identifiable patient, or the disclosure to the public or media of specific information about treatment of an identifiable patient, such as specific tests, test results or details of a patient’s illness, may not be done without the patient’s written authorization (or the written authorization of a personal representative who is a person legally authorized to make health care decisions for the patient).

Minimum Necessary Restriction Requirement

The Guidance cautions Covered Entities and their business associates that for most disclosures, a Covered Entity generally must make reasonable efforts to limit the information disclosed to that which is the “minimum necessary” to accomplish the purpose. However, this minimum necessary requirement does not apply to disclosures to health care providers for treatment purposes.

Covered Entities may rely on representations from a public health authority or other public official that the requested information is the minimum necessary when making disclosures in response to request from those parties. For example, a covered entity may rely on representations from the CDC that the protected health information requested by the CDC about all patients exposed to or suspected or confirmed to have Ebola virus disease is the minimum necessary for the public health purpose.

Required Internal Restrictions On Use, Access & Disclosure

Internally, covered entities should continue to apply their role-based access policies to limit access to protected health information to only those workforce members who need it to carry out their duties. See 45 CFR §§ 164.502(b), 164.514(d).

Safeguarding Patient Information

Beyond limiting the use, access and disclosure of PHI, the Guidance also reminds Covered Entities and their business associates that even in emergency situations, HIPAA continues to require them to implement reasonable safeguards to protect patient information against intentional or unintentional impermissible uses and disclosures as well as to apply the administrative, physical, and technical safeguards of the HIPAA Security Rule to electronic PHI.

Limited Waiver

Although HHS has yet to take steps to trigger a limited waiver, the Guidance also reminds Covered Entities and their business associates that HHS has the power to do so, the effect of a limited waiver and the circumstances under which HHS could elect to apply a limited waiver to waive sanctions against a hospital for certain specific types of HIPAA violations while the waiver is in effect.

As the Guidance notes, the HIPAA Privacy Rule is not suspended during a public health or other emergency. Rather, the limited waiver rules only operates to permit the Secretary of HHS to waive certain provisions of the Privacy Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act. The limited waiver only applies when the President declares an emergency or disaster and HHS declares a public health emergency. When and if these requirements are met, HHS may waive sanctions and penalties against a Covered Entity that is a hospital for failing to comply with the following HIPAA Privacy Rule provisions:

The requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
The requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
The requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
The patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
The patient’s right to request confidential communications. See 45 CFR 164.522(b).

If the Secretary issues such a waiver, Covered Entities and their business associates should keep in mind the waiver only applies to the list violations and only applies:

For so long as the waiver remains in effect;
In the emergency area and for the emergency period identified in the public health emergency declaration
To hospitals that have instituted a disaster protocol; and
For up to 72 hours from the time the hospital implements its disaster protocol.

When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.

Not Necessarily Just About HIPAA

HIPAA is not necessarily the only law that Covered Entities, business associates or others need to consider when deciding what to disclose during an emergency or otherwise. The HIPAA Privacy Rule applies to disclosures made by and Covered Entities, business associates employees, volunteers, and other members of a Covered Entity’s or Business Associate’s workforce. The Privacy Rule does not apply to disclosures made by entities or other persons who are not Covered Entities.

Beyond HIPAA, Covered Entities, their business associates or members of their workforce, employers, and other organizations also need to consider whether other federal or state laws, ethical rules, contracts or policies may restrict use or disclosure, safeguard, or take other steps to protect PHI or other information. For instance, other federal laws, state law, professional ethical rules, contracts, facility policies or procedures, or other restrictions often apply to health care provides, insurers, brokers, employers or others. Employers, health care organizations, insurers and others also need to be concerned about potential discrimination, common law and statutory privacy, retaliation, defamation and other exposures.

Prepare For Compliance Now

The recent experiences of various health care organizations intimately involved in caring for the Ebola patients highlights the importance of anticipating, preparing and conducting training, and having your workforce practice to prepare to deal with the special challenges of dealing with HIPAA and other legal responsibilities in advance of emergency events. When preparing for these events, Covered Entities and business associates need to take into account the need to comply operationally as well as to document and retain records of compliance. They should both should anticipate and prepare to respond to both typical inquiries as well as those from the media, public and others. They also should consider how various types of emergencies could create new privacy or security risks. For instance, in certain emergency situations, recordkeeping or other systems could be disrupted, impacting the ability retain and subsequently produce required documentation. Furthermore, Covered Entities also should prepare to manage the patient and public relations aspects of these events including adverse impressions that often arise when the media or others are disappointed at being denied information because of compliance obligations, from breaches or perceived breaches, or other similar events.

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Posted by Cynthia Marcotte Stamer

IRS Issues Ebola-Related Tax Relief

October 29, 2014

The Internal Revenue Service (IRS) has published the following tax rule relief under the Internal Revenue Code (Code)

Notice 2014-65 designates the Ebola virus outbreak occurring in the West African countries of Guinea, Liberia, and Sierra Leone as a qualified disaster for purposes of section 139 of the Code. As a result of the designation of the EVD outbreak as a qualified disaster for purposes of § 139, payments of qualified disaster relief to assist victims affected by the EVD outbreak in the three countries (Guinea, Liberia, and Sierra Leone) are excludable from the recipients’ gross income.

Notice 2014-68 provides guidance on the treatment of leave-based donation programs to aid victims of the Ebola virus outbreak occurring in the West African countries of Guinea, Liberia, and Sierra Leone for income and employment tax purposes where an employer allows employees to elect to forgo vacation, sick, or personal leave in exchange for cash payments an employer makes to organizations described in § 170(c) of the Code for the relief of victims of the EVD outbreak in Guinea, Liberia, and Sierra Leone. This notice provides guidance on the treatment of these payments for income and employment tax purposes.

Notice 2014-65 and Notice 2014-68 will be published in Internal Revenue Bulletin 2014-47 on Nov. 17.

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Parkview Hospital To Pay $800K To Settle HIPAA Charges After Retiring Physician Blows The Whistle

Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement

Health Care & Other HIPAA Covered Entities Should Review New Reports As Part of HIPAA Risk Management Efforts

CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule

Medicare Fraud Strike Force Nails 90 Individuals For Almost $260 Million In False Billing Including 16 Doctors

Encrypt Mobile Devices & Clean Up Management Documentation Key HIPAA Compliance Messages In New HIPAA Settlements

Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years

Latest OCR Resolution Agreement Hits Public Health Department, Shows Needs To Stay Up-To-Date

Euless Healthcare Corporation Owner, Associates Face Conspiracy And Health Care Fraud Charges For Alleged Submission Of $700,000+ In Fraudulent Health Care Claims

Former Manager 9th Employee Sentenced For Involvement In Maxim Medicare False Claims Action

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Posted by Cynthia Marcotte Stamer

Columbia to Pay $9 Million Plus To Settle DOJ/HHS False Claims Charges For Submitting Inaccurate Cost Reports and Mischarging Federal Grants

October 29, 2014

The US ex rel. v. Columbia U. and ICAP complaint-in-intervention civil False Claims Act lawsuit (lawsuit) and its resolution through the simultaneously filed US ex rel. v. Columbia U. and ICAP stipulation and order (“Settlement”) entered against the Trustees Of Columbia University In The City Of New York (“Columbia University”), and ICAP (formerly known as the International Center For Aids Care And Treatment Programs) (collectively, “Columbia”) that U.S. Department of Justice (DOJ) announced October 28, 2014 reminds health care, education and other organizations receiving federal grant monies that their False Claims Act and other compliance programs must provide for appropriate management and recordkeeping of any federal grant programs participated in by their organizations. The lawsuit and settlement highlight the importance for health care, education and other organizations receiving or managing federal grants to establish appropriate controls to ensure that they can demonstrate the requisite compliance with grant requirements and other terms and conditions.

The settlement resolves a civil lawsuit jointly brought and simultaneously settled by DOJ and the Department of Health & Human Service against Colombia that charged Columbia with submitting false claims in connection with federal grants that Columbia University obtained to fund ICAP’s AIDS- and HIV-related work. The United States’ Complaint-in-Intervention (the “Complaint”) alleged that Columbia University, as the grant administrator on behalf of ICAP, received millions of dollars in federal grants and, pursuant to the rules applicable to such grants, was required for nearly 200 of ICAP’s employees located in New York City to use a suitable means of verifying that the employees had actually performed the work charged to a particular grant. The Complaint alleges that Columbia was well aware that this was not being done, yet continued wrongly to charge many federal grants for work that was not devoted to the projects they funded. The lawsuit seeks damages and penalties under the False Claims Act.

According to DOJ, the Colombia lawsuit and Settlement arose from Columbia’s participation in the President’s Emergency Plan for AIDS Relief (“PEPFAR program”), a global HIV/AIDS program, targeting billions of dollars in new funding for prevention, treatment, and care services in the most affected countries of the world. Columbia received $125 million in PEPFAR funding through the Multi-Country Columbia Antiretroviral Program (“MCAP”) grant, and over the years obtained over 75 grants and many millions more from the federal government for HIV- and AIDs-related work performed by ICAP.

The grant rules among other things, required that grantees track the work performed by the recipient’s employees and, with limited exceptions, charge grants only for work actually performed as a part of that grant. Columbia claimed to accomplish this by producing effort reports for ICAP’s New York City-based employees purportedly detailing the employees’ distribution of work across federal, state, and private grants, as well as Columbia-sponsored projects. These reports were used to determine how much a given grant was charged for work performed by individual employees.

For nearly 200 individuals, however, DOJ and the Justice Department charged Colombia failed to ensure that these reports were created or verified by the individuals to whom they applied. Instead, Columbia’s Finance Department provided information for these reports even though the employees of that department had limited or no knowledge of which grants the individuals actually worked on. In addition, the lawsuit charged that the effort reports were certified as correct by the principal investigators on the grants without using suitable means to verify the accuracy of the reports. Instead of taking the appropriate steps to determine whether the reports were accurate, the principal investigators would certify large batches of the reports, without making any inquiry into whether the allocation of work among the grants was accurate. Moreover, ICAP’s management was well aware of the inaccuracies of the effort reporting system.

According to the complaint, these omissions resulted in Columbia charging grants for work that was not performed on the project being funded by that grant. For instance, an ICAP Finance Analyst stated that he spent approximately 15-20% of his time on MCAP in fiscal year 2010, but his effort report falsely listed his MCAP effort, and related salary charges, as 85%. Likewise, in fiscal year 2010, an ICAP Subcontracts Manager’s effort report listed her effort as 100% MCAP, but the Subcontracts Manager actually worked on three other grants, in addition to MCAP, that year. The time submitted for many other employees was similarly mischarged.

The complaint also charged that ICAP also charged federal grants for time spent on activities that are not chargeable to any federal grants, such as competitive grant proposal writing. For example, an ICAP Grants Manager spent a significant amount of her time writing competitive grant proposals, but her effort report showed that all of her time was charged to grants, with as much as 92% of her time charged to MCAP in some years.

Health care, educational and other organizations receiving HHS or other federal grants should heed the lawsuit and settlement as a reminder to review and tighten as necessary their federal grant program compliance and documentation to ensure that it can withstand an audit or other scrutiny by federal officials.

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Posted by Cynthia Marcotte Stamer

OIG Warns Pharma Manufacturers to Prevent Copayment Coupon Use for Part D Drug Purchases

September 19, 2014

Pharmaceutical manufacturers risk sanctions unless they take appropriate steps to ensure that their copayment coupons intended to reduce patient out-of-pocket costs for purchase for specific brand name drugs do not induce improperly the purchase drugs paid for by Medicare Part D or other Federal health care programs items or services.

The warning from the Department of Health & Human Services Office of Inspector General (OIG) appears in OEI-05-12-00540 Study Results and accompanying Special Advisory Bulletin published warns pharmaceutical manufacturers they may be liable under the anti-kickback statute if they offer coupons to induce the purchase of drugs paid for by Federal health care programs, including Medicare Part D.

Pharmaceutical manufacturers often offer copayment coupons to reduce or eliminate the cost of patients’ out of pocket copayments for specific brand name drugs.

The anti-kickback statute prohibits the knowing and willful offer or payment of remuneration to a person to induce the purchase of any item or service for which payment may be made by a Federal health care program.

According to OIG, the use of coupons by Medicare beneficiaries could impose significant costs on the Part D program because many coupons encourage beneficiaries to choose more expensive brand name drugs over less expensive alternative drugs.

OIG’s warning comes in conjunction with its announcement of findings an OIG study about the safeguards pharmaceutical manufacturers employ to prevent their copayment coupons from being used for drugs paid for by Part D and to identify vulnerabilities in those safeguards which OIG reports revealed that pharmaceutical manufacturers’ current safeguards may not prevent all copayment coupons from being used for drugs paid for by Part D.

According to the OIG, all surveyed manufacturers provide notices directed to beneficiaries and pharmacists that coupons may not be used in Federal health care programs. Most surveyed manufacturers use pharmacy claims edits to prevent coupons from being processed for drugs covered by Part D. Despite these actions, OIG reports most of these edits may not prevent all coupons from being processed for Part D covered drugs. Finally, Part D plans and other entities cannot identify coupons within pharmacy claims.

In light of these findings, OIG’s Special Advisory Bulletin affirms that pharmaceutical manufacturers should act to ensure that their copayment coupons do not induce the purchase of Federal health care programs items or services, including drugs paid for by Medicare Part D. The guidance makes clear that OIG does not view the current practices of many manufacturers as sufficient controls.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Posted by Cynthia Marcotte Stamer

Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement

June 26, 2014

Former employee turned whistleblower Donald Gale will receive $17.24 million of the $124.24 million that the U.S.’ largest provider of pharmaceuticals and pharmacy services to nursing homes, Omnicare, Inc. has agreed to pay to settle charges that Omnicare violated the Anti-Kickback Statute by offering improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to provide pharmaceuticals and pharmacy services to their residents. The settlement announced June 25, 2014 by the Department of Justice (DOJ) highlights the growing risks that health care organizations using aggressive marketing incentive programs face to whistleblower, Department of Justice and other investigations.

According to DOJ, the Omnicare settlement resolves allegations that “Omnicare provided improper discounts in return for the opportunity to provide medication to Medicare and Medicaid beneficiaries” in violation of the Anti-Kickback Statute. The settlement resolves allegations initially brought by two whistleblowers that Omnicare submitted false claims by entering into below-cost contracts to supply prescription medication and other pharmaceutical drugs to skilled nursing facilities and their resident patients to induce the facilities to select Omnicare as their pharmacy provider. The facilities were participating providers under agreements with Medicare and Medicaid. In addition to the facilities’ own claims for reimbursement from Medicare for short-term rehabilitation treatment rendered to patients, Omnicare submitted additional claims for reimbursement to Medicare and Medicaid for drugs Omnicare supplied.

The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally funded programs as a means of helping to ensure that the selection of health care providers and suppliers is not compromised by improper financial incentives and is instead based on the best interests of the patient. This settlement illustrates both the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative and the critical role that current or former employees or other whistleblowers often play in the successful investigation and prosecution of these cases.

The HEAT initiative announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius makes heavy use of whistleblowers to uncover potential violations and then uses the False Claims Act and other expanded investigatory and enforcement tools granted by Congress to nail providers.

In conducting its war against health care fraud, Federal officials credited new tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) with aiding their health care fraud investigation and enforcement efforts. Legal reforms and new resources granted under the Affordable Care Act and various other legal changes have beefed up the fraud detection and fighting powers of Federal health care fraud investigators and prosecutors. Examples of these new tools include:

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coordination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet. Since January 2009, the Justice Department has recovered a total of more than $19.5 billion through False Claims Act cases, with more than $13.9 billion of that amount recovered in cases involving fraud against federal health care programs. In announcing the settlement, Justice Department officials sent strong warnings to other health care providers and suppliers about the dangers of providing or accepting improper discounts or other improper incentives as part of their business marketing strategies. “Health care providers who seek to profit from providing illegal financial benefits will be held accountable,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Schemes such as this one undermine the health care system and take advantage of elderly nursing home residents.” Meanwhile, Steven M. Dettelbach, United States Attorney for the Northern District of Ohio, said “Nursing homes should select their pharmacy provider based on the best quality, service and cost to the residents, not based on improper discounts to the nursing facility.”

Any quick look at the DOJ’s enforcement record shows its acting on these promises. For instance, in addition to the Omnicare settlement, DOJ also announced on June 25 the guilty plea of a physician and the sentencing on an ambulance company owner on health care fraud charges. See Huntersville Physician Pleads Guilty To Health Care Fraud and Tax Fraud and Agrees To Pay $6.2 Million to Settle Civil Fraud Claims; Ambulance Company Co-Owner Sentenced To 13 1/2 Years for Health Care Fraud Scheme.

Health Care Providers Must Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Posted by Cynthia Marcotte Stamer

CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule

May 28, 2014

July 28, 2014 is the deadline for concerned persons to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule requiring prior authorization for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The proposed rule available for review at http://www.gpo.gov/fdsys/pkg/FR-2014-05-28/pdf/2014-12245.pdf would establish a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization and would add a contractor’s decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.

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If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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1 Comment | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Medicare Fraud Strike Force Nails 90 Individuals For Almost $260 Million In False Billing Including 16 Doctors

May 13, 2014

27 Medical Professionals Charged with Health Care Fraud

A nationwide takedown by Medicare Fraud Strike Force operations in six cities today (May 13, 2014) resulted in charges against 90 individuals, including 27 doctors, nurses and other medical professionals, for alleged participation in Medicare fraud schemes involving approximately $260 million in false billings, according to U.S. Attorney General Eric Holder and Department of Health and Human Services (HHS) Secretary Kathleen Sebelius. The announcement reminds U.S. health care providers that the Obama Administration continues to target health care providers in its campaign against health care fraud.

The seventh coordinated national Medicare fraud takedown by the Medicare Fraud Strike Force operations team of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), Federal officials filed charges that accuse the defendants of various health care fraud-related crimes, including conspiracy to commit health care fraud, violations of the anti-kickback statutes and money laundering. The charges are based on a variety of alleged fraud schemes involving various medical treatments and services, including home health care, mental health services, psychotherapy, physical and occupational therapy, durable medical equipment and pharmacy fraud.

Among the defendants charged were 27 medical professionals, including 16 doctors, who Federal officials charge included doctors billing for services that were never rendered, supply companies providing motorized wheelchairs that were never needed, and recruiters paying kickbacks to get Medicare billing numbers of patients. According to court documents, the defendants allegedly participated in schemes to submit claims to Medicare for treatments that were medically unnecessary and often never provided. In many cases, court documents allege that patient recruiters, Medicare beneficiaries and other co-conspirators were paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could then submit fraudulent bills to Medicare for services that were medically unnecessary or never performed. Collectively, the doctors, nurses, licensed medical professionals, health care company owners and others charged are accused of conspiring to submit approximately $260 million in fraudulent billings.

In Miami, a total of 50 defendants were charged today and yesterday for their alleged participation in various fraud schemes involving approximately $65.5 million in false billings for home health care and mental health services, and pharmacy fraud. In one case, two defendants were charged in connection with a $23 million pharmacy kickback and laundering scheme. Court documents allege that the defendants solicited kickbacks from a pharmacy owner for Medicare beneficiary information, which was used to bill for drugs that were never dispensed. The kickbacks were concealed as bi-weekly payments under a sham services contract and were laundered through shell entities owned by the defendants.

Eleven individuals were charged by the Houston Medicare Strike Force. Five Houston-area physicians were charged with conspiring to bill Medicare for medically unnecessary home health services. According to court documents, the defendant doctors were paid by two co-conspirators to sign off on home health care services that were not necessary and often never provided.

Eight defendants were charged in Los Angeles for their roles in schemes to defraud Medicare of approximately $32 million. In one case, a doctor was charged for causing almost $24 million in losses to Medicare through his own fraudulent billing and referrals for durable medical equipment, including over 1,000 expensive power wheelchairs, and home health services that were not medically necessary and often not provided.

In Detroit, seven defendants were charged for their roles in fraud schemes involving approximately $30 million in false claims for medically unnecessary services, including home health services, psychotherapy and infusion therapy. In one case, four individuals, including a doctor, were charged in a sophisticated $28 million fraud scheme, where the physician billed for expensive tests, physical therapy and injections that were not necessary and not provided. Court documents allege that when the physician’s billings raised red flags, he was put on payment review by Medicare. He was allegedly able to continue his scheme and evade detection by continuing to bill using the billing information of other Medicare providers, sometimes without their knowledge.

In Tampa, Florida, seven individuals were charged in a variety of schemes, ranging from fraudulent physical therapy billings to a scheme involving millions of dollars in physician services and tests that never occurred. In one case, five individuals were charged for their alleged roles in a $12 million health care fraud and money laundering scheme that involved billing Medicare using names of beneficiaries from Miami-Dade County for services purportedly provided in Tampa area clinics, 280 miles away. The defendants then allegedly laundered the proceeds through a number of transactions involving several shell entities.

In Brooklyn, New York, the Strike Force announced an indictment against Syed Imran Ahmed, M.D., in connection with his alleged $85 million scheme involving billings for surgeries that never occurred; Dr. Ahmed had been arrested last month and charged by complaint. Dr. Ahmed has charged with health care fraud and making false statements. In addition, the Brooklyn Strike Force charged six other individuals, including a physician and two billers who allegedly concocted a $14.4 million scheme in which they recruited elderly Medicare beneficiaries and billed Medicare for medically unnecessary vitamin infusions, diagnostic tests and physical and occupational therapy supposedly provided to these patients.

The cases announced today are being prosecuted and investigated by Medicare Fraud Strike Force teams comprised of attorneys from the Fraud Section of the Justice Department’s Criminal Division and from the U.S. Attorney’s Offices for the Southern District of Florida, the Eastern District of Michigan, the Eastern District of New York, the Southern District of Texas, the Central District of California, the Middle District of Louisiana, the Northern District of Illinois and the Middle District of Florida; and agents from the FBI, HHS-OIG and state Medicaid Fraud Control Units.

The HEAT Strike Force is a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The joint Department of Justice and HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Almost 400 law enforcement agents from the FBI, HHS-OIG, multiple Medicaid Fraud Control Units and other federal, state and local law enforcement agencies participated in today’s takedown.

Since their inception in March 2007, Strike Force operations in nine locations have charged almost 1,900 defendants who collectively have falsely billed the Medicare program for almost $6 billion. Overall, since its inception, the Department of Justice’s Medicare Fraud Strike Force has charged nearly 1,900 individuals involved in approximately $6 billion of fraud. We are committed to using every tool at our disposal to prevent, deter, and prosecute health care fraud. In addition, CMS, working in conjunction with HHS-OIG, has suspended enrollments of high-risk providers in five Strike force locations and has removed over 17,000 providers from the Medicare program since 2011.

“Medicare is a sacred compact with our nation’s seniors, and to protect it, we must remain aggressive in combating fraud,” said Attorney General Holder. “This nationwide Medicare Strike Force takedown represents another important step forward in our ongoing fight to safeguard taxpayer resources and to ensure the integrity of essential health care programs. Department of Justice will not tolerate these activities. And we will continue working alongside the Department of Health and Human Services – as well as federal, state, and local partners – to use every appropriate tool and available resource to find, stop, and punish those who seek to take advantage of their fellow citizens.”

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coordination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

“The Affordable Care Act has given us additional tools to preserve Medicare and protect the tens of millions of Americans who rely on it each day,” said Secretary Sebelius. “By expanding our authority to suspend Medicare payments and reimbursements when fraud is suspected, the law allows us to better preserve the system and save taxpayer dollars. Today we’re sending a strong, clear message to anyone seeking to defraud Medicare: You will get caught and you will pay the price. We will protect a sacred trust and an earned guarantee.”

The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to demonstrate the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Latest OCR Resolution Agreement Hits Public Health Department, Shows Needs To Stay Up-To-Date

March 16, 2014

Health Department HIPAA Violations Cost County $250,000, Requires Sweeping HIPAA Reforms

Hear Update On Resolution Agreement & Other New HIPAA Developments At 3/18 North Texas Healthcare Professionals Association Meeting –

RSVP here by Noon on March 17, 2014

Skagit County, Washington will pay a $215,000 monetary settlement and work closely with the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) to correct deficiencies in its HIPAA compliance program to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules by the Skagit County Public Health Department (Health Department) under a Resolution Agreement announced by OCR on March 7, 2014. The Resolution Agreement makes clear the need for health care providers, health plans, health care clearinghouses and their business associates to update and maintain their policies and practices in compliance with the constantly evolving OCR guidance and resolution agreements, as well as to timely investigate and report breaches. Interested persons are invited to hear a briefing on a series of new developments including this latest Resolution Agreement at the March 18, 2014 North Texas Healthcare Professionals Association Meeting.

OCR investigated the Health Department after receiving a breach report that unknown parties accessed money receipts with electronic protected health information (ePHI) of seven individuals after the ePHI had been inadvertently moved to a publicly accessible server maintained by the County.

OCR reports its investigation revealed a broader exposure of protected health information involved in the incident, which included the ePHI of 1,581 individuals. Many of the accessible files involved sensitive information, including protected health information about the testing and treatment of infectious diseases.

OCR’s investigation further uncovered general and widespread non-compliance by Skagit County with the HIPAA Privacy, Security, and Breach Notification Rules.

Specifically, the Resolution Agreement between OCR and the Health Department states that OCR found the following conduct occurred (“Covered Conduct”).

From approximately September 14, 2011 until September 28, 2011, Skagit County disclosed the ePHI of 1,581 individuals in violation of the Privacy Rule by providing access to ePHI on its public web server;
From November 28, 2011 until present, Skagit County failed to provide notification as required by the Breach Notification Rule to all of the individuals for whom it knew or should have known that the privacy or security of the individual’s ePHI had been compromised as a result of the breach incident;
From April 20, 2005 until present, Skagit County failed to implement sufficient policies and procedures to prevent, detect, contain, and correct security violations;
From April 20, 2005 until June 1, 2012, Skagit County failed to implement and maintain in written or electronic form policies and procedures reasonably designed to ensure compliance with the Security Rule; and
From April 20, 2005 until present, Skagit County failed to provide security awareness and training to all workforce members, including its Information Security staff members, as necessary and appropriate for the workforce members to carry out their functions within Skagit County.

To resolve OCR’s allegations of these breaches, Skagit County agrees under the Resolution Agreement to pay HHS $215,000.00 and to ensure that the Health Department implements a series of corrective actions. Among other things, the Resolution Agreement requires that the Health Department:

Provide substitute Breach Notification to individuals not previously notified of the breach of their ePHI in accordance with the Resolution Agreement
Revise to the satisfaction of OCR and adopt revised accounting for disclosure, hybrid entity designations, policies on safeguarding PHI, including its sample business associate agreements;
Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI) held by the covered health care components of Skagit County as identified in its hybrid entity documentation approved by HHS and implement security measures sufficient to reduce the risks and vulnerabilities identified in the risk analysis to a reasonable and appropriate level.
Create and revise, as necessary, written policies and procedures for its covered health care components to comply with the Federal standards that govern the privacy, security, and breach notification of individually identifiable health information;
Comply with strict workforce training requirements;
Notify and OCR of the occurrence of some reported breaches, its investigation and corrective actions;
Provide a summary of the reported events and the status of any corrective and preventative action relating to all such Reportable Events; and
Provide OCR with an attestation signed by an officer of Skagit County attesting that he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.

In addition to bringing its policies and practices up to date with OCR regulations in effect at the time of the breach that resulted in the Resolution Agreement, the Health Department also will have to update its polic9ies and practices to meet changes to OCR’s HIPAA rules that have taken effect since the breach under the revised rules published by OCR in its Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Final Rule) OCR published January 25, 2013 as well as a series of recently issued OCR rules such as the following:

With OCR stepping up both audits and enforcement and penalties for violations higher than ever since the HITECH Act amended HIPAA, Covered Entities and business associates should act quickly to review and update their policies, practices and training to implement any adjustments needed to maintain compliance and manage other risks under these ever-evolving HIPAA standards.

Covered Entities & Business Associates Should Review & Tighten Practices in Response To Resolution Agreement & Other New Guidance

Other covered entities and their business associates should carefully evaluate and tighten their existing practices in response to the Resolution Agreement and other recent guidance. In the past, OCR officials have stated it expects that other health care providers, health plans, health care clearinghouses and their business associates will review resolution agreements like this one along with other emerging OCR guidance and update their practices as necessary to address concerns within their own organization that might be similar to those reflected in the applicable resolution agreement. The Resolution Agreement documents this expectation by specifically incorporating this requirement as part of its terms.

When conducting these efforts, Covered Entities and business associates not only carefully watch for and react promptly to new OCR guidance and enforcement actions, but also document their commitment and ongoing compliance and risk management activities to help support their ability to show their organization maintains the necessary “culture of compliance” commitment needed to mitigate risks in the event of a breach or other HIPAA violation and take well-documented, reasonable steps to encourage their business associates to do the same. When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent.

Hear Stamer’s Update On Resolution Agreement & Other New HIPAA Developments At 3/18 North Texas Healthcare Professionals Association Meeting

Scribe for the American Bar Association Annual Agency Meeting with OCR for the fourth year, attorney Cynthia Marcotte Stamer will overview these and other HIPAA developments when she presents “Tutoring On OCR’s Latest HIPAA Homework” at the North Texas Healthcare Professionals Association Study Group Luncheon on Tuesday, March 18, 2014 from 11:30 p.m. to 1:00 p.m. at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706. A complimentary luncheon will be served to guests to who register in advance. There is no charge to particulate but space is limited. RSVP here by Noon on March 17, 2014.

For More Information Or Assistance

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, GINA, Health Care, Health Care Provider, Health IT, HIPAA, HITECH Act, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: Business Associates, Compliance, controlled substance, Covered Entities, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, HIPAA, licensure, Medicaid, Medical Board, Medical Privacy, pain management, pharmacist, pharmacy, PHI, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

NLRB Helps Union Force Another Health Care Employer To Recognize & Bargain With Union

March 13, 2014

Hospitals, skilled nursing and other health care organizations need to be concerned about union organizing of their employees in light of the growing success of unions with the aid of the pro-union support and agenda of the National Labor Relations Board (NLRB) under the Obama Administration’s leadership. The Administration’s goal of telling health care providers what to do extends well beyond Medicare and Medicaid into their workforce and terms and conditions of employment.

On February 21, 2014, for instance, the Obama Administration helped the Service Employees International Union (the Union) force Holy Cross Youth and Family Services, Inc., d/b/a Kairos Healthcare (the Employer), a provider of drug and alcohol rehabilitation services, to recognize and bargain with the over terms and conditions of employees with the Union by securing a court order forcing the employer to recognize and bargain with the Union.

Ruling in a lawsuit filed by the NLRB against the Employer on February 21, a federal court judge for the Eastern District of Michigan ordered upheld the allegations made in August 23, 2013 by the National Labor Relations Board (NLRB) Detroit, Michigan Regional Office that the Employer violated the National Labor Relations Act when it withdrew recognition from Local 517M, made unilateral changes to employees’ terms and conditions of employment without affording the Union an opportunity to bargain over those changes, and failed to provide relevant information to the Union to help in its bargaining with the Employer on behalf of the employees.

The Regional Office sought, and the Board authorized, seeking interim injunctive relief to return the parties to the bargaining table pending final resolution of the matter, to require the Employer to provide the Union with the information it requested and, upon request, to rescind the unilateral changes made to employees’ terms and conditions of employment.

On February 21, 2014, the District upheld the Regional Office’s action. It ruled that an interim injunction was appropriate to prevent loss of Union support, to keep the employees’ right to bargain with their Employer through their chosen bargaining representative, and to provide the Union with the information it needs to evaluate and make bargaining proposals while the administrative case is pending before the Board.

The case is one of a growing number of actions where the NLRB has used is powers to help Unions force health care and other employers to yield to union demands. See e.g., Specialty Healthcare and Rehabilitation of Mobile, Board Case No. 15-CA-68248 (reported at 357 NLRB No. 174) (6^th Cir. decided August 15, 2013 under the name Kindred Nursing Centers East, LLC f/k/a Specialty Healthcare and Rehabilitation of Mobile v. NLRB).

These decisions should remind health care and other employers of the highly union-friendly bent of the NLRB under the current administration, as well as the hazards of mishandling efforts to defend against union organizing and other protected activities under the NLRA. Beyond the obligation to recognize and bargain with properly certified collective bargaining unions, the NLRB and other federal labor laws also grant employees a host of other protections. Among these are recently affirmed rights-even for a worker not represented by a union – to insist another employee be present when participating in disciplinary and certain other meetings with management, rules limit the ability of employers to prohibit or restrict employees requiring employees to keep confidential and not discuss among each other salary, wages or other terms of compensation or employment terms and conditions, and others. The Obama Administration has made known its desire to expand these rights further and has carried out an aggressive legislative, regulatory and enforcement campaign in pursuit of this goal since taking office. For this reason, health care or other organizations should seek the advice and assistance of qualified legal counsel experienced with labor management relations matters to review policies for compliance, to prepare and administer anti-organizing activities, and to evaluate and respond to union organizing or bargaining activities.

For More Information Or Assistance

If you need assistance responding to health industry staffing and workforce, regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD, and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Board Certified in Labor and Employment Law, Ms. Stamer’s experience includes continuous involvement in advising and representing health care organizations about employment, labor-management, peer review and staffing and other workforce management and compensation concerns. Ms. Stamer also continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

1 Comment | Corporate Compliance, Doctor, Employment law, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Labor Law, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, collective bargaining, Employment, Health Care, HHS, HIPAA Privacy, Hospital, labor law, labor-management, NLRA, NLRB, nursing home, Security, Union, Union Organizing | Permalink
Posted by Cynthia Marcotte Stamer

OCR Assigns More HIPAA Compliance Work To Health Care Providers

March 5, 2014

Think your health care organization or health plan has health care privacy covered? Think again.

A series of supplemental guidance issued by the Department of Health & Human Services Office of Civil Rights (OCR) in recent weeks is giving health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates even more to do in reviewing and updating their policies, practices and training for handing protected health information (PHI) beyond bringing their policies and practices into line with OCR’s restatement and update to the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Final Rule) OCR published January 25, 2013.

Covered Entities generally have been required to comply with most requirements the Omnibus Final Rule’s restated regulations restating OCR’s regulations implementing the Health Insurance Portability & Accountability Act (HIPAA) Privacy, Security and Breach Notification Rules to reflect HIPAA amendments enacted by the Health Information Technology for Economic and Clinical Health (HITECH) Act since the Omnibus Final Rule took effect on March 26, 2013 and to have updated business associate agreements in place since September 23, 2013. Meanwhile, the Omnibus Final Rule generally has required business associates have updated business associate agreements in place and otherwise to have come into compliance with all of the applicable requirements of the Omnibus Final Rule since September 23, 2013. Although these deadlines are long past, many Covered Entities and business associates have yet to complete the policy, process and training updates required to comply with the modifications implemented in the Omnibus Final Rule.

Even if a Covered Entity or business associate completed the updates required to comply with the Omnibus Final Rule, however, recent supplemental guidance published by OCR means that most organizations now have even more work to do on HIPAA compliance. This includes the following supplemental guidance concerning its interpretation and enforcement of HIPAA against Covered Entities and business associates published by OCR since January 1, 2014 alone:

Beyond this 2014 guidance, Covered Entities and their business associates also should look at enforcement actions and data as well as other guidance OCR issued during 2013 after publishing the Omnibus Final Rule such as:

When conducting these efforts, Covered Entities and business associates not only carefully watch for and react promptly to new OCR guidance and enforcement actions, but also document their commitment and ongoing compliance and risk management activities to help support their ability to demonstrate their organization maintains the necessary “culture of compliance” commitment needed to mitigate risks in the event of a breach or other HIPAA violation and take well-documented, reasonable steps to encourage their business associates to do the same. When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent.

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If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Federal Health Care Fraud Enforcement Recouped Record $4.3 Billion in FY 2013

March 4, 2014

Health care providers got another reminder last week of their ever-growing exposure to federal health care fraud detection and enforcement efforts. The joint federal health care fraud enforcement efforts of the Departments of Justice (DOJ) and Health and Human Services (HHS) set new records for recoveries in Fiscal Year (FY) 2013, according to the newly released annual Health Care Fraud and Abuse (HCFAC) Program Report (the “Fraud Report”).

Record Breaking Fraud Recoveries In FY 2013 Highlight Health Care Fraud Enforcement Risk

According to the Fraud Report, the government’s health care fraud prevention and enforcement efforts recovered a record-breaking $4.3 billion in taxpayer dollars in Fiscal Year (FY) 2013, up from $4.2 billion in FY 2012, from individuals and companies who attempted to defraud federal health programs serving seniors or who sought payments from taxpayers to which they were not entitled.　 Over the last five years, the Fraud Report says administration’s enforcement efforts have recovered $19.2 billion, up from $9.4 billion over the prior five-year period.　 Since the inception of the program in1997, the HCFAC Program has returned more than $25.9 billion to the Medicare Trust Funds and treasury.

These reported recoveries show the commitment and growing success of federal health care fraud detection, investigation and enforcement efforts targeting providers and others in health care. This is the fifth consecutive year that the program has increased recoveries over the past year, climbing from $2 billion in FY 2008 to over $4 billion every year since FY 2011.

Recoveries Show Providers Big & Growing

The DOJ and HHS credit the success of these efforts largely to the joint Health Care Fraud Prevention and Enforcement Action Team (HEAT) program DOJ and HHS created in 2009 to target health care fraud and reforms passed as part of the Patient Protection and Affordable Care Act (ACA) that aid government investigation and enforcement efforts.

DOJ and HHS have used HEAT and expanded powers in ACA to strengthen and grow their join fraud detection and enforcement efforts. ACA reforms have strengthened these efforts by giving the agencies new tools.

Among other things, ACA empowered HHS to:

Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.

These tools make it easier for HHS to detect and prevent potential questionable activities, as well as aid DOJ and HHS in investigating and prosecuting suspected fraud or other misconduct. The agencies tout their use of these tools along with their heightened enforcement and coordination for the growing success of their health care fraud detection and prosecution efforts.

“With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder.　 “Thanks to initiatives like HEAT, our work to combat fraud has never been more cooperative or more effective.　 And our unprecedented commitment to holding criminals accountable, and securing remarkable results for American taxpayers, is paying dividends.”

“These impressive recoveries for the American taxpayer are just one aspect of the comprehensive anti-fraud strategy we have implemented since the passage of the Affordable Care Act,” said HHS Secretary Sebelius.　 “We’ve cracked down on tens of thousands health care providers suspected of Medicare fraud. New enrollment screening techniques are proving effective in preventing high risk providers from getting into the system, and the new computer analytics system that detects and stops fraudulent billing before money ever goes out the door is accomplishing positive results – all of which are adding to savings for the Medicare Trust Fund.”

Federal officials also give credit to new new authorities given to them by the Affordable Care Act that help HHS and the Centers for Medicare & Medicaid Services (CMS) to detect and target heatlh care fraud.

In FY 2013, CMS announced the first use of its temporary moratoria authority granted by the Affordable Care Act.　 The action stopped enrollment of new home health or ambulance enrollments in three fraud hot spots around the country, allowing CMS and its law enforcement partners to remove bad actors from the program while blocking provider entry or re-entry into these already over-supplied markets.

The Justice Department and HHS have improved their coordination through HEAT and are currently operating Medicare Fraud Strike Force teams in nine areas across the country. The strike force teams use advanced data analysis techniques to identify high-billing levels in health care fraud hot spots so that interagency teams can target emerging or migrating schemes as well as chronic fraud by criminals masquerading as health care providers or suppliers. The Justice Department’s enforcement of the civil False Claims Act and the Federal Food, Drug and Cosmetic Act has produced similar record-breaking results.　 These combined efforts coordinated under HEAT have expanded local partnerships and helped educate Medicare beneficiaries about how to protect themselves against fraud.

In Fiscal Year 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (46). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.

In FY 2013, the Justice Department opened 1,013 new criminal health care fraud investigations involving 1,910 potential defendants, and a total of 718 defendants were convicted of health care fraud-related crimes during the year.　 The department also opened 1,083 new civil health care fraud investigations.

The strike force coordinated a takedown in May 2013 that resulted in charges by eight strike force cities against 89 individuals, including doctors, nurses and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $223 million in false billings. As a part of the May 2013 takedown, HHS also suspended or took other administrative action against 18 providers using authority under the health care law to suspend payments until an investigation is complete.

In FY 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (48). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.

In March 2011, CMS began an ambitious project to revalidate all 1.5 million Medicare enrolled providers and suppliers under the Affordable Care Act screening requirements. As of September 2013, more than 535,000 providers were subject to the new screening requirements and over 225,000 lost the ability to bill Medicare due to the Affordable Care Act requirements and other proactive initiatives.　 Since the Affordable Care Act, CMS has also revoked 14,663 providers and suppliers’ ability to bill the Medicare program. These providers were removed from the program because they had felony convictions, were not operational at the address CMS had on file, or were not in compliance with CMS rules.

HHS and the Justice Department are leading historic efforts with the private sector to bring innovation to the fight against health care fraud. In addition to real-time data and information exchanges with the private sector, CMS’ Program Integrity Command Center worked with the HHS Office of the Inspector General and the FBI to conduct 93 missions to detect, investigate, and reduce improper payments in FY 2013.

From May 2013 through August 2013, CMS led an outreach and education campaign targeted to specific communities where Medicare fraud is more prevalent.　 This multimedia campaign included national television, radio, and print outreach and resulted in an increased awareness of how to detect and report Medicare fraud.

These and other activities make it more important than ever that hospitals, physicians and other health care providers participating in Medicare, Medicaid or other federal health care programs tighten their compliance and risk management practices and processes to manage their exposures.

Providers Urged To Act To Manage Risks

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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CMS Publishes Tools To Help Providers Understand E-Health Administrative Simplification Tools & Processes

March 4, 2014

The Centers for Medicare & Medicaid Services (CMS) is offering training resources to help providers learn about the electronic administrative simplification tools available through the CMS eHealth programs implemented as part of the Health Insurance Portability & Accountability Act (HIPAA) Administrative Simplification rules.

CMS recently launched eHealth University, a new education portal designed to give providers information vital for understanding, implementing, and successfully participating in a range of . The curriculum offers resources organized by level, from beginner to advanced, in a variety of formats, including　fact sheets, guides, videos, checklists, webinar recordings, and more.

As part of eHealth University, CMS is offering tools and resources to help providers understand Administrative Simplification initiatives such as claims and eligibility operating rules, electronic funds transfer and remittance advice operating rules and standards, and the health plan identifier. These resources include:

What Administrative Simplification Does For You – This fact sheet explains the basics behind how Administrative Simplification will help improve health care efficiency and lower costs.
Introduction to Administrative Simplification – This guide gives an overview of Administrative Simplification initiatives and their purposes.
Introduction to Administrative Simplification: Operating Rules – A short video with information on Administrative Simplification operating rules.

Once providers or others have an understanding of the basics of Administrative Simplification through these beginner-level resources, the user can use the intermediate and advanced resources also available on the eHealth University website.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients on how to establish, administer and defend workforce, staffing, management, compliance and risk management policies and practices; prevent, conduct and investigate, and respond to employment, staffing, peer review and other quality, compliance and enforcement concerns; and to respond to OSHA and other Department of Labor, IRS, Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Posted by Cynthia Marcotte Stamer

OSHA Hospital Tool Signals OSHA Enforcement Risk

January 20, 2014

Health industry employers brace for heightened worker health and safety exposures. The U.S. Department of Labor’s Occupational Safety and Health Administration (OHSA) is getting serious about health care worker safety.

On January 15, 2014, OSHA launched a new educational Web-based OSHA Hospital Resource with extensive materials it intends to help hospitals prevent worker injuries, assess workplace safety needs, enhance safe patient handling programs, and implement safety and health management systems. The materials include fact books, self-assessments and best practice guides.

In announcing the new resource, OSHA noted that hospital workers face serious hazards, including: lifting and moving patients, workplace violence, slips and falls, exposure to chemicals and hazardous drugs, exposures to infectious diseases and needlesticks.

According to OSHA, U.S. hospitals recorded 250,000 work-related injuries and illnesses, almost 60,000 of which caused employees to miss work in 2012. Nationwide, workers’ compensation losses result in a total annual expense of $2 billion for hospitals.

According to OSHA, the website’s materials on safe patient handling are designed to address the most common type of injuries hospital workers face, and hospitals can use these resources to protect their workers, improve patient safety and reduce costs.

While presented as helpful tools for industry employers, health care employers should not overlook the potential legal exposures risked by failing to properly manage employee health and safety risks.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. Viewed from this perspective, health industry employers generally will want to use the tool within the scope of attorney-client privilege to evaluate their potential risks and exposures in the event of a workplace injury or death, OSHA audit or both, and take appropriate steps to mitigate those risks promptly.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients on how to establish, administer and defend workforce, staffing, management, compliance and risk management policies and practices; prevent, conduct and investigate, and respond to employment, staffing, peer review and other quality, compliance and enforcement concerns; and to respond to OSHA and other Department of Labor, IRS, Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Health Insurance Provider Fee Reporting Rules Published

January 20, 2014

Notice 2013-76 provides guidance on the health insurance providers fee related to (1) the time and manner for submitting Form 8963, “Report of Health Insurance Provider Information,” (2) the time and manner for notifying covered entities of their preliminary fee calculation, (3) the time and manner for submitting a corrected Form 8963 for the error correction process, and (4) the time for notifying covered entities of their final fee calculation. The Notice was published in the Internal Revenue Bulletin on December 16, 2013.

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If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Posted by Cynthia Marcotte Stamer

HHS “Safer Guides” Tool For Safe EHR Implementation Published

January 20, 2014

The Office of the National Coordinator for Health Information Technology (ONC) recently published guidance intended to help health care providers safely use electronic health record (EHR) technology. The Safety Assurance Factors for EHR Resilience (SAFER) Guides published here January 15, 2014 as part of the U.S. Department of Health and Human Services’ (HHS’) Health IT Patient Safety Action and Surveillance Plan are intended to serve as a tool health care providers can use to help identify and mitigate potential hazards of EHR technology.
According to HHS, HHS does not intend for the SAFER Guides to replace or revise the requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules, the Centers for Medicare & Medicaid Services EHR Incentive Program (Meaningful Use) Rules or other federal rules. Rather, HHS intends for health care providers to use the Guides to start a process that identifies electronic health record (EHR) EHR-related safety concerns and encourages mitigation of the high-priority risks of the EHR.
HHS has published each SAFER Guide in an interactive PDF format designed to help guide providers in self-assessing and documenting their assessments in the following areas associated with EHR implementation:

High Priority Practices;
Organizational Responsibilities;
Patient Identification;
Computerized Physician Order Entry with Decision Support;
Test Results Review and Follow-Up;
Clinician Communication;
Contingency Planning;
System Interfaces; and
System Configuration

A checklist of recommended practices in each SAFER Guide may help providers show and assess EHR safety practices adopted at their organization.

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If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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2/28/14 Deadline To Submit Quality Data for 2013 PQRS-Medicare EHR Incentive Pilot

January 17, 2014

February 28, 2014 is the deadline for any eligible professional participating or wishes to participate in the 2013 PQRS-Medicare EHR Incentive Pilot to submit its quality data. Eligible providers wishing to participate in the pilot must submit 12 months of CQM data by February 28, 2014 at 11:59 pm ET. The system is currently open to accept this data so eligible professionals wishing to participate should complete the collection and submission of this data as soon as possible.

Steps to Successfully Participate
To successfully participate in the pilot, you must do the following by February 28, 2014:

Register for an IACS account (for EHR submission only)
Indicate intent to report CQMs using pilot in EHR Registration & Attestation System
Generate required reporting files
Test data submission
Submit quality data

Eligible professionals that cannot submit their CQM data for 12 months electronically through PQRS must return to the EHR Attestation System and deselect the electronic reporting option. Please note: if a provider does not submit its 2013 quality data or deselect the electronic reporting option in the EHR Attestation System, CMS says the provider will not receive an EHR incentive payment.

For More Information
For further guidance on the 2013 PQRS-Medicare EHR Incentive Pilot, eligible providers should read the Participation Guide and Quick-Reference Guide.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Posted by Cynthia Marcotte Stamer

Final CMS Rule To Expand Medicaid Support For Community & Home-Based Care

January 12, 2014

New Rule Expands Medicaid Coverage For Community Living For Disabled Aging Adults

Caregivers and service providers caring the Medicaid-eligible aging or disabled individuals will want to check out the new final rule on Home and Community-Based Services published by the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) on Friday, January 10. See Final Rule: Home and Community-Based Services (“Final Rule”).

HHS views the Final Rule as supporting its Community Living Initiative, which seeks to expand and improve community services in order to allow aging and disabled people to live, work, and participate in the greater community. The Initiative reflects the growing community support for helping aging and disabled individuals to avoid institutionalization and instead “age in place” by offering broader care options, developing community services that extend options for disabled and aging persons to live independently, and other actions that support the ability of individuals to live safely within community rather than institutional settings. In announcing the Final Rule, HHS Secretary Kathleen Sebelius. “Today’s announcement will help ensure that all people participating in Medicaid home and community-based services programs have full access to the benefits of community living.”

The Final Rule expands the conditions under which Medicaid provides coverage for home and community-based services as an alternative to institutional care for older.. adults covered by Medicaid. Among other things, the Final Rule defines home and community-based settings and implements new flexibility authorized by the Patient Protection and Affordable Care Act (ACA) that gives states additional options as part of their State Plan Option to expand home and community-based services and to target services to specific populations under the provisions of Section 1915(i) on home and community-based services. It also amends the 1915(c) home and community-based services waiver program to add new person-centered planning requirements, allow states to combine multiple target populations in one waiver, and streamlines waiver administration. The final rule also includes a transitional period for states to adjust their programs to meet the new home and community-based services settings requirements. CMS says technical assistance will also be available for states.

Service providers and community agencies caring for Medicaid-eligible populations will want to check out these new rules for insights on helping the aging and disabled covered by Medicaid and their families to adapt care plans in response to the new options that the Final Rule may afford.

For more information about Home and Community-Based Services available under Medicaid, see here. For information about the HHS Community Living Initiative, see here. For additional resources, persons interested in these and other aging in place trends and resources may want to contact the author of this update, Cynthia Marcotte Stamer, who regularly speaks and writes on these concerns.

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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Posted by Cynthia Marcotte Stamer

Abbott Labs, Sisters of Charity Paying More Than $9M In Two Anti-Kickback Settlements

January 2, 2014

The Justice Department’s recovery of more than $9 million in two physician kickback settlements during the last week of December, 2013 sends another strong warning to health care providers and physicians of the risks of structuring physician compensation or other arrangements that run afoul of the federal Anti-kickback Statute, STARK Law or False Claims Act Health care providers and physicians or others who may be receiving or seeking compensation or other benefits prohibited by these and other federal or state health care fraud laws should seek advice and assistance from experienced qualified legal counsel to structure or review any proposed or existing transactions that could create these risks.

The two settlements both stem from alleged payments of kickbacks to physicians to induce referrals in contravention of federal health care fraud laws.

On December 31, 2013, DOJ announced that Butte, Montana based St. James Healthcare (St. James) and its Denver-based parent company, Sisters of Charity of Leavenworth Health System (Sisters of Charity), have agreed to pay $3.85 million to resolve allegations that they violated the Anti-Kickback Statute, the Stark Law and the False Claims Act by improperly providing financial benefits to physicians and physician groups that made referrals to the hospital. Colorado Health Care Organization and One of Its Montana Hospitals to Pay $3.85 Million for Allegedly Providing Financial Benefits to Referring Physicians and Physician Groups.

The St. James settlement announcement follows DOJ’s December 27, 2013 announcement that pharmaceutical giant Abbot Laboratories has agreed to pay the United States $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products. U.S. Department of Justice. Abbott Laboratories Pays U.S. $5.475 Million to Settle Claims That Company Paid Kickbacks to Physicians.

St. James/Sisters of Charity Settlement

The settlement with St. James and Sisters of Charity resolves DOJ charges that they provided various improper financial incentives to physicians and physician groups involved in a joint venture with St. James to own and run a medical office building on the St. James campus. These incentives included a payment to the joint venture that increased the share values for the physicians and physician groups in the joint venture and resulted in below fair market value lease rates for the physicians renting space in the medical office building. Additional incentives provided by St. James and Sisters of Charity included below fair market value lease rates for the land upon which the medical office building was constructed and other below fair market value arrangements related to shared facilities, use and maintenance. These issues were disclosed by St. James and Sisters of Charity to the government. To resolve their liability, St. James and the Sisters of Charity will pay $3.85 millions to the U.S. Government.

In announcing the settlement, U.S. Attorney for the District of Montana Michael W. Cotter cautioned other heath care providers to review their own transactions and to take the rules seriously, stating. “We are encouraged that hospitals like St. James Healthcare are taking these issues seriously by reviewing their operations and making disclosures to the government where necessary.”

Abbott Laboratories Settlement

The Abbott Laboratories settlement requires it to pay the U.S. $5.475 million to resolve allegations that Abbott Laboratories knowingly paid prominent physicians for teaching assignments, speaking engagements and conferences with the expectation that these physicians would arrange for the hospitals with which they were affiliated to purchase Abbott’s carotid, biliary and peripheral vascular products in violation of the Anti-Kickback Act and caused the submission of false claims to Medicare for the procedures using these Abbott products .

The settlement resolves allegations originally brought in a lawsuit filed by Steven Peters and Douglas Gray, former Abbott employees, under the qui tam provision of the False Claims Act. See United States ex rel. Peters et al. v. Abbott Laboratories, Inc., Civil Action No. 3:09-CV-430 (E.D. Tenn.). The False Claims Act allows whistleblowers to file suit on behalf of the United States for false claims and share in any recovery Whistleblower claims are a major tool in the enforcement efforts and success of the DOJ in its campaign to find and prosecute health care fraud. As part of the Abbott Laboratory’s settlement, the two whistleblowers will receive a total payment of more than $1 million.

Settlements Reflect Heightened Enforcement Risks For Health Care Providers Participating In Kickback Arrangements

Health care providers offering or providing illegal or otherwise aggressive inducements to physicians or others for referrals of health care services covered by Medicare, Medicaid or other federal health care programs should heed the settlements as a warning. The two settlements illustrate the growing emphasis on the investigation and enforcement of Anti-Kickback, STARK and False Claims Act laws against health care providers by the DOJ and Department of Health & Human Services (HHS). The Anti-Kickback Statute prohibits the provision of remuneration with the intent to induce referrals of government health care program business unless the transaction falls within one of the safe harbors or otherwise qualifies as exempt from the prohibition. The Stark Law restricts financial relationships that hospitals or other designated health care providers may enter into with physicians who refer patients to them unless the arrangement meets the criteria to qualify as exempt from the prohibition. When either of these two prohibitions is violated, billing for services for care rendered creates additional fraud law exposures. Federal law prohibits payment by federal health care programs of medical claims that result from arrangements that violate the Anti-Kickback Statute or the Stark Law. The settlements announced this week both stemmed from civil prosecutions by the Justice Department. However, violations of these health care fraud laws also may result in criminal prosecutions.

DOJ, HHS and other federal and state agencies acting through the Medicare Fraud Strike Force activities conducted as part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), federal RAC audits and other actions hunting for, and increasingly finding an prosecuting health care providers and others who participate in transactions that violate these and other federal health care fraud laws as part of efforts to control health care costs and expenditures. HEAT is a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The joint Department of Justice-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Since its announcement, the Strike Force has used the combined resources of agents from the FBI, HHS-Office of Inspector General (HHS-OIG), multiple Medicaid Fraud Control Units, and other state and local law enforcement agencies to investigate and prosecute a rising number of organizations and individuals throughout the industry for alleged violations of Federal health care fraud prohibitions.

The effectiveness of these Federal efforts to deter, find and prosecute false claims and other perceived abuses of Federal health care law has been significantly strengthened since Congress passed the Patient Protection & Affordable Care Act (Affordable Care Act). Among other things, ACA empowered HHS to:

Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.

In its Abbott Laboratories settlement announcement, DOJ touted the HEAT efforts with resulting in the recovery of a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.

Act To Manage Risks

For More Information Or Assistance

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

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CMS Releases New Eligible Professionals Guide On Stage 2 EHR Incentive Program

September 18, 2013

CMS just released An Eligible Professional’s Guide to Stage 2 of the EHR Incentive Programs, which provides a comprehensive overview of Stage 2 of the EHR Incentive Programs for eligible professionals. The guide outlines criteria for Stage 2 meaningful use, 2014 clinical quality measure reporting, and 2014 EHR certification including Chapters on;

What is Stage 2 of the EHR Incentive Programs?
What are the requirements under Stage 2 of Meaningful Use?
How will clinical quality measures (CQMs) change?
Resources

The guide can be found on the Educational Resources page of the EHR website.

Health care providers and their vendors and advisors using these resources also are reminded to ensure that their business associate agreements, privacy practices notices and other privacy and data security processes, policies, and procedures are updated to comply with changes to the Privacy, Security, Breach Notification and other requirements he for the protection and handling of personal health information including electronic personal health information of the Health Insurance Portability & Accountability Act (HIPAA) as amended by the HITECH Act. The Final Omnibus Regulations published by the Office of Civil Rights (OCR) generally took effect earlier this year except that the regulations set next Monday, September 23, 2013 as the deadline for updating business associate agreements and the effective date for the extension of most HIPAA requirements to business associates. As demonstrated by recent enforcement actions by OCR, Health care providers and other covered entities, their business associates and advisors continuously reconfirm that their systems and arrangements continue to comply with these requirements as they make updates.

For More Information Or Assistance

If you need assistance responding to EHR, HIPAA or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information on this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, EHR, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

OCR Shares Model Privacy Notices 1 Week Before Deadline For Updated Business Associate Agreements

September 16, 2013

A week before the September 23, 2013 deadline for all health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates to have updated their business associate agreements to comply with the Final Omnibus HIPAA Rule, the Department of Health & Human Services Office of the National Coordinator for Health Information Technology (ONC) and the Office for Civil Rights (OCR) today (September 16, 2013) released Model Notices of Privacy Practices (Notices) for health care providers and health plans to use to communicate with their patients and plan members. With penalties and enforcement continuing to rise, Covered Entities and their business associates should take appropriate steps to review and update their privacy and breach notification policies and procedures, privacy officer appointments, notices of privacy practices, business associate agreements and other HIPAA compliance and risk management documentation, practices, procedures and coverage, breach notification and other HIPAA compliance and risk management practice.

Model HIPAA Notices

Developed collaboratively by ONC and OCR the Notices available here designed in the following three different styles are designed for users to customize to fit their specific needs and practices:

A notice in the form of a booklet;
A layered notice with a summary of the information on the first page and full content on the following pages; and
A notice with the design elements of the booklet, but that is formatted for full-page presentation.

Use of these model Notices is optional. While the agencies designed the Notices to let Covered Entities to use these models by entering some of their own information into the model, such as contact information, and then printing for distribution and posting on their websites, Covered Entities should consult with legal counsel to determine the suitability of the Notices generally for their entity’s use and any customization, if any, that may be recommended or required to a Notice if the Covered Entity decides rely upon a model Notice to prepare its Notice of Privacy Practices. To facilitate any tailoring, the agencies provided a text-only version for Covered Entities wishing only wish to use the content with or without tailoring.

September 23 Business Associate Agreement Update Deadline

September 23, 2013 also is the final deadline established in the Final Omnibus HIPAA Rule for Covered Entities and their business associations to update the business associate agreements required by HIPAA to reflect application of the breach notification, business associate, and many of HIPAA’s requirements to directly cover business associates and other aspects of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009. While HHS published a Sample Business Associate Agreement last June to aid Covered Entities and their business associates with understanding the business associate agreement requirements as impacted by the Omnibus Final HIPAA Rule, it also made clear that Covered Entities and their business associates should tailor their business associate agreements to fit their specific circumstances and relationships. OCR National Office and regional officials speaking about their findings about past business associate agreement compliance have indicated that their audit and enforcement activities show widespread compliance issues among Covered Entities and business associates with the original business associate agreements. OCR clearly expects Covered Entities and their business associates to address and resolve these compliance issues going forward.

Covered Entities and their business associates are increasingly at peril if caught violating HIPAA’s Privacy, Security or Breach Notification rules. With the HITECH Act Breach Notification rules now requiring Covered Entities to self-disclose breaches, OCR becomes aware of breaches much more easily. Coupled with the HITECH Act’s increase in sanctions for HIPAA violations, Covered Entities and, beginning September 23, 2013, their business associates face rising risks for violating HIPAA. See, e.g. HHS Settles with Health Plan in Photocopier Breach Case; WellPoint Settles HIPAA Security Case for $1,700,000; Shasta Regional Medical Center Settles HIPAA Security Case for $275,000; Idaho State University Settles HIPAA Security Case for $400,000; and HHS announces first HIPAA breach settlement involving less than 500 patients.

In response to the updated Final Regulations and these expanding HIPAA enforcement and exposures, all Covered Entities should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses; and other developments to decide if additional steps are necessary or advisable. In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to decide if tightening their policies, practices, documentation or training is necessary or advisable.

For More Information Or Assistance

If you need assistance responding to HIPAA or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information on this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

CMS To Host Provider Webinar To Celebrate National Health IT Week

September 13, 2013

In celebration of the third annual National Health IT Week is September 16-20, the Centers for Medicare & Medicaid Services (CMS) will host several webinars and launching new eHealth tools and resources that it intends to help providers participate in eHealth programs. These programs may be of interest to providers as well as payers who are interested in what providers are doing to use eHealth tools.

Details of Webinar

The eHealth Provider Webinar will be held on Thursday, September 19^th from 12:00 p.m. to 1:30 p.m. ET. CMS plans to present an overview of the eHealth programs and its eHealth initiative—an initiative that aligns health IT and electronic standards programs on:

Administrative Simplification
eRx Incentive Program
ICD-10
Quality Measurement

A portion of the webinar will also be dedicated to Q&A.

Registration Information

Space is limited. Register now to secure your spot for the eHealth Provider Webinar. Once registration is complete, you will receive a follow-up email with step-by-step instructions on how to log-in to the webinar. Listserv messages are sent prior to each webinar session with registration information.

If you’d like to view past webinars, the PowerPoint presentations and recordings can now be accessed on the Resources page of the eHealth website. For more information about CMS’ eHealth Initiatives, visit the CMS eHealth website for the latest news and updates on CMS’ eHealth initiatives.

For More Information Or Assistance

If you need assistance responding to this invitation or with other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Ms. Stamer also has extensive other public policy and regulatory experience with HHS and other U.S. federal and state agencies as well as internationally. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Disability Discrimination, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, Federal Health Center, Genetic Information, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, HIPAA, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OCR, OIG, Outcomes Data, Outpatient, Pandemic, Patient Empowerment, Patient Protection and Affordable Care Act, Peer Review, Physician, Physician Licensing, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Real Estate, Rehabilitation Act, Reimbursement, Reproductive Rights, Rural Health Care, Stark, Substance Abuse, Swine Flu, Technology, Telemedicine, Veterans Health, Veterans Health Care | Tagged: Breach Notification, CMS, eHealth, Health IT, HHS, HIPAA Privacy, Hospital, Physicians, Providers, Security | Permalink
Posted by Cynthia Marcotte Stamer

Tell HHS What You Think-Comment On HHS Strategic Plan Now!

September 9, 2013

Health care providers, health plans, employers and others concerned about the regulatory and enforcement activities of the Department of Health & Human Services (HHS) can make their concerns known by speaking up now. Share your input on the draft HHS strategic plan that will guide HHS’ regulatory and enforcement agenda for the next 4 years.

Every 4 years, HHS updates its strategic plan, which describes its work to address complex, multifaceted, and ever-evolving health and human service issues, including:

Health Care
Research and Innovation
Prevention and Wellness

HHS is inviting public input on the draft HHS Strategic Plan for FY 2014-2018. The comment period is open until October 15, 2013. Individuals or organizations wishing to respond to this invitation can read the HHS Strategic Plan FY 2014-2018 (Draft) and submit your comments several ways including:

Submit your comments online here
Via Email to: strategicplanning@hhs.gov
Via Fax: (202) 690-8252
U.S. Mail (not recommended as security screening results in significant delay.

For More Information Or Assistance

If you need assistance responding to this invitation for comment or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Ms. Stamer also has extensive other public policy and regulatory experience with HHS and other U.S. federal and state agencies as well as internationally. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Disability Discrimination, Disease Management, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, Employment, Evidence Based Medicine, Federal Health Center, Genetic Information, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Qulity, Health Care Reform, Health Insurance Exchange, Health Plan, Health Plans, Health Policy, HIPAA, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OCR, OIG, Outcomes Data, Outpatient, Pandemic, Patient Empowerment, Patient Protection and Affordable Care Act, Peer Review, Physician, Physician Licensing, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Real Estate, Rehabilitation Act, Reimbursement, Reproductive Rights, Rural Health Care, Stark, Substance Abuse, Swine Flu, Technology, Telemedicine, Veterans Health, Veterans Health Care | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

Stamer Speaks On Managing Physician Conduct At 9/17 NTHCPA Meeting

August 21, 2013

The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals faced with these and other challenges to join us on Tuesday, September 17, 2013 from 11:30 a.m. to 1:30 p.m. for our Study Group Luncheon featuring attorney Cynthia Marcotte Stamer speaking on “Sex Drugs & Rock ‘N Role: Managing Physician Conduct in Health Care.”Interested persons can RSVP here by Noon on September 16, 2013 to attend this meeting free of charge.

About the Program

Whether false claims and other aggressive billing, referral or treatment practices, chemical dependency or other impairment, medical staff or other rule breaking, harassing or other disruptive conduct or a host of other personal behavioral or performance concerns, preventing and addressing personal misconduct and other risky behaviors by physicians on the staff or team of a hospital, medical practice personal misconduct often present major legal, quality, financial, political and operational challenges and risks for health care compliance, medical staff, risk management and other leaders. Alternatively, properly directed physicians can significantly help the operation and performance of health care organizations in many critical ways.

While physician involvement remains an operational necessity for most hospitals, group practices and other health care organizations, these and other health care organizations and other members of their team often face significant legal, financial, reputational and operational risks when a physician becomes impaired by chemical dependency, mental illness, stress, personal tragedy or other personal impairment; is disruptive; or engages in sexual or other harassment of staff or patients, billing, treatment, referral, anticompetitive or other illegal conduct, medical board or facility rule violations, or other acts of personal or professional misconduct. While these behaviors often create major risks for health care organizations and others, successful redress of these or other physician performance or misconduct concerns often depends upon the ability to successfully negotiate a complex minefield of due process and other procedural, legal, political, operational and other challenges.

Ms. Stamer will use lead participants in a workshop examining these challenges and discussion of strategies to help health care organizations and their compliance officers can use to help their organization prevent, investigate and redress these and other physician performance and misconduct concerns while managing HCQIA and other peer review, licensing board, contractual, defamation and other legal, professional and operational traps that often arise out of physician discipline or other corrective actions. On the other hand, well-motivated and properly focused physicians play a key role in leading quality, financial, compliance and other improvements in health care organizations and practices.

Registration & Meeting Details

The meeting scheduled from 11:30 a.m. to 1:30 p.m. on September 17, 2013 at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706 will feature a complimentary luncheon for those who timely R.S.V.P. Networking and lunch service will begin at 11:30 a.m.. Our program will begin at Noon. There is no charge to participate in the meeting. However space is limited and available only on a first come, first serve basis. To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on September 16, 2013. Walk in guests will be accommodated on a space-available basis only.

About The Speaker, Cynthia Marcotte Stamer, J.D.

Attorney, author and health care change leader Cynthia Marcotte Stamer, J.D. is nationally and internationally recognized for her more than 25 years of health policy and legal work, process improvement and reengineering, publications and programs, and advocacy. Ms. Stamer works extensively with public and private health care organizations, managed care and health insurance organizations, governments and community leaders and others health industry compliance, risk management, quality, staffing, workforce, patient, quality and performance management, operations, governance, compensation, reimbursement and financing, regulatory and public policy, process improvement and reengineering and other health industry legal and operational concerns.

Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Vice-President of the North Texas Health Care Compliance Professionals Association, past Board Compliance Chair of the National Kidney Foundation of North Texas, Past President of Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, combines her health industry operations compliance, and risk management experience with an in-depth knowledge of federal and state healthcare, workforce, governance, internal controls, enforcement and other operational issues to help health industry clients to support legal and operational risk and performance management. Her experience includes advising public and private health care systems, hospitals, managed care organizations and physician management organizations, physicians and physician practice groups, skilled nursing, home health, rehabilitation, pharmacy, and other health industry clients domestically and internationally on a wide range of matters including physician and other staffing, credentialing and peer review, gainsharing and other performance management, compliance, enforcement, and a wide range of other matters. Her experience includes extensive work with health care systems, hospitals, physicians and physician organizations, medical staffs, peer review, credentialing and quality committees, ACOs, managed care organizations, and others on physician credentialing, peer review and discipline, quality improvement, performance management, compensation, leadership development, and other matters.

A widely recognized health industry thought leader, advocate, author and speaker, Ms. Stamer’s insights are sought out by health care and other business, government and community leaders, and quoted in HealthLeaders, Managed Care Executive, the Wall Street Journal and many other national popular, business and industry publications. She also conducts continuing board, medical education, workforce and other health industry compliance and risk management training for many organizations on a wide range of topics. She also regularly represents health care organizations and other health industry clients before peer review and other disciplinary bodies, federal and state regulators, investigators, Congress and state legislatures, licensing and credentialing and other governmental and regulatory authorities. To learn more or contact Ms. Stamer, see www.CynthiaStamer.com.

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles. The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

Would you or someone you know like to join the NTHCPA, get notice of upcoming meetings or events and network on relevant professional developments with other health care professionals? Stay on top of information about upcoming meetings and share and dialogue with other NTHCPA members about health care compliance challenges and developments by participating in our meetings and events, joining our North Texas Health Care Compliance Professionals Association LinkedIn Group and checking out the NTHCPA News here. To be added to our invitation list, we also encourage interested persons to make sure we have your current contact information by registering to receive health care updates here or sending your current contact information including name, title, company, preferred mailing address, e-mail, and telephone number to Vice-President Cynthia Marcotte Stamer here.

Thanks To Solutions Law Press, Inc. ™

The NTHCPA thanks Solutions Law Press, Inc.™ and its Coalition for Responsible Health Policy and Project COPE: the Coalition on Patient Empowerment, for its generous underwriting support of the September 17, 2013 luncheon. Solutions Law Press, Inc.™ publishes the Solutions Law Press Health Care Update and other resources, as well as provides health care risk management, compliance and risk management and other operational consulting, briefings, training, policy, event management, recruiting and other resources and services on health care, human resources, employee benefits, compensation, data security and privacy, insurance, and other key compliance, risk management, internal controls and other key operational concerns.

About Project COPE: The Coalition On Patient Empowerment & Its Coalition on Responsible Health Policy

The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans. The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch. Americans can best improve health care by not waiting for someone else to step up: Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can. Building health care neighborhoods filled with good neighbors throughout the community is the key. Project COPE: The Coalition On Patient Empowerment brings together people, organizations, and resources to promote awareness and collaboration, share ideas, tools and other solutions and other resources to help promote patient empowerment, heath care access, health care quality and health and health coverage operations in meaningful, tangible ways. Its focus is little and big actions that help patients, providers, communities and others deal with or work within the health care system in the real world. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

To review or receive the Health Care Update, learn or get involved with the Coalition on Responsible Health Policy or its PROJECT COPE: The Coalition on Patient Empowerment, or participate in discussions in a Solutions Law Press, Inc.™ LinkedIn Group or for other information about Solutions Law Press, Inc™ resources and services, see www.SolutionsLawPress.com.

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Posted by Cynthia Marcotte Stamer

Court Upholds NLRB Certification of CNAs As Bargaining Union Based On NLRB Modified Community Of Interest Test

August 21, 2013

Hospitals, skilled nursing and other health care organizations facing or concerned about union organizing or their nursing or other staffs employees should consider an apparent change in National Labor Relations Board (NLRB) certification policy upheld when the Sixth Circuit ruling upheld the NLRB’s certification of a bargaining unit consisting exclusively of certified nursing assistants (CNAs) at Specialty Healthcare and Rehabilitation of Mobile (Specialty) nursing home and enforced the Board’s order finding that Specialty’s refusal to bargain with the certified unit violated Section 8(a)(5) and (1) of the National Labor Relations Act (NLRA).

Specialty Healthcare and Rehabilitation of Mobile, Board Case No. 15-CA-68248 (reported at 357 NLRB No. 174) (6^th Cir. decided August 15, 2013 under the name Kindred Nursing Centers East, LLC f/k/a Specialty Healthcare and Rehabilitation of Mobile v. NLRB), arose after the union had petitioned to represent a unit of 53 full-time and part-time CNAs, Specialty claimed that the smallest appropriate unit must include 86 other service and maintenance employees.　 The NLRB Regional Director found the unit appropriate and conducted the election, which the union won.　 The NLRB granted review, asked the parties and public for their views on eight questions on community of interest unit determinations in the non-acute care healthcare industry, and ultimately issued a decision upholding the unit determination and the union’s election victory.

In its decision, the Board overruled Park Manor Care Center, 305 NLRB 872 (1991), which applied a “pragmatic or empirical community of interests approach” to determining unit appropriateness in nursing homes.　 Instead, the Board ruled that it would apply the traditional test to evaluate appropriateness, which examines whether a proposed unit is readily identifiable and shares a community of interest distinct from other employees.　 Then, the Board explained, if “a party contends that a petitioned-for unit containing employees readily identifiable as a group who share a community of interest is nevertheless inappropriate because it does not contain additional employees, the burden is on the party so contending to show that the excluded employees share an overwhelming community of interest with the included employees.”　 Because the CNA-only unit was readily identifiable and shared a distinct community of interest, and because Specialty failed to show that the excluded service and maintenance employees shared an overwhelming community of interest with the CNAs, the Board certified the unit and the union’s victory.　 Specialty refused to bargain, and this technical NLRA Section 8(a)(5) proceeding followed.

The Sixth Circuit affirmed the Board’s order and its clarification of the community-of-interest test.　 First, rejecting Specialty’s argument that the Board did not merely embrace the traditional community-of-interest test but instead improperly created an entirely new framework, the court held that the Board permissibly “adopted a community-of-interest test based on some of the Board’s prior precedents, and . . . did explain its reasons for doing so.”　 In so holding, the court explicitly recognized the ambiguity in the Act’s command that bargaining units must be “appropriate,” and observed that the Board merely granted Judge Posner’s “wish that the Board would give [the traditional community-of-interest test] ‘a precise meaning.’” Slip op. at 13 (quoting Cont’l Web Press v. NLRB, 742 F.2d 1087, 1090 (7th Cir. 1984)).

Next, the court concluded that the Board acted within its discretion in requiring a party claiming that the smallest appropriate unit must include additional employees to show that the excluded employees share an “overwhelming community of interest” with the proposed unit.　 Indeed, the court explained that “[t]he Board has used the overwhelming-community-of-interest standard before, so its adoption [here] is not new.”　 After citing numerous cases, including the D.C. Circuit’s Blue Man Vegas LLC v. NLRB, 529 F.3d 417 (D.C. Cir. 2008), the court agreed that the Board merely clarified existing law, overruled any inconsistent precedent, appropriately placed the burden of proving overwhelming community of interest on the employer (who typically possesses the information to make that case), and explained its reasons for doing all of the above.

Turning to Specialty’s third defense, the court concluded that the Board’s test did not run afoul of Section 9(c)(5), which prohibits the Board from finding “the extent to which the employees have organized . . . controlling” in making unit determinations.　 To the contrary, the court noted that the Board first engaged in an independent community of interest determination to find out whether the proposed CNA-only unit was appropriate “aside from the fact that the union had organized it.”　 Further, “[a]s long as the Board applies the overwhelming community of interest standard only after the proposed unit has been shown to be prima facie appropriate, the Board does not run afoul of the statutory injunction that the extent of the union’s organization not be given controlling weight.”　 Slip op. at 19 (internal quotations omitted and emphasis in original).

Finally, the court held that “the Board did not abuse its discretion in adopting a generally applicable rule through adjudication instead of rule making because NLRB v. Bell Aerospace Co. Div. of Textron, Inc., 416 U.S. 267, 294 (1974), holds both that ‘the Board is not precluded from announcing new principles in an adjudicative proceeding and that the choice between rule making and adjudication lies in the first instance within the Board’s discretion.’”

The Court’s opinion is available here.

The Speciality ruling reminds health care and other employers of the highly union-friendly bent of the NLRB under the current administration, as well as the hazards of mishandling efforts to defend against union organizing and other protected activities under the NLRA. Beyond the obligation to recognize and bargain with properly certified collective bargaining unions, the NLRB and other federal labor laws also grant employees a host of other protections. Among these are recently affirmed rights-even for a worker not represented by a union – to insist another employee be present when participating in disciplinary and certain other meetings with management, rules limit the ability of employers to prohibit or restrict employees requiring employees to keep confidential and not discuss among each other salary, wages or other terms of compensation or employment terms and conditions, and others. For this reason, health care or other organizations should seek the advice and assistance of qualified legal counsel experienced with labor management relations matters to review policies for compliance, to prepare and administer anti-organizing activities, and to evaluate and respond to union organizing or bargaining activities.

For More Information Or Assistance

If you need assistance responding to HIPAA or other health industry regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters. She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD, and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Board Certified in Labor and Employment Law, Ms. Stamer’s experience includes continuous involvement in advising and representing health care organizations about employment, labor-management, peer review and staffing and other workforce management and compensation concerns. Ms. Stamer also continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, collective bargaining, Employment, Health Care, HHS, HIPAA Privacy, Hospital, labor-management, NLRB, nursing home, Security, Union Organizing | Permalink
Posted by Cynthia Marcotte Stamer

$1.2M HIPAA Settlement Results From Improper Copier Disposal

August 15, 2013

Be careful when repurposing or disposing of copiers and other equipment and media that may contain protected health information. That’s the message the Office of Civil Rights is sending health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates in its August 14, 2013 announcement of a $1.2 million plus settlement agreement with Affinity Health Plan, Inc. (Affinity) under the Health Insurance Portability & Accountability Act Privacy and Security Rules.

According to OCR, the non-profit New York area managed care plan Affinity will pay $1,215,780 and take other corrective actions to settle alleged HIPAA violations under the Affinity Resolution Agreement and CAP (Affinity Settlement). The settlement comes as the September 24, 2013 deadline for health plans, health care providers, health care clearinghouses (Covered Entities) and their business associates to update the written business associate agreements that HIPAA requires exist before business associates can be allowed to create, use, access or disclose personally identifiable health care information protected by HIPAA (PHI) to carry out HIPAA-covered functions on behalf of a Covered Entity to comply with changes to HIPAA’s implementing regulations adopted by OCR earlier this year. Health plans and other Covered Entities should take timely action to confirm that their existing procedures appropriate safeguards to protect PHI when using or disposing of copiers or other equipment or media as well as to implement business associate or other policy, procedures or training updates required to comply with the updated HIPAA rules.

HIPAA Updates Require Breach Notification, Tightened Other HIPAA Requirements

HIPAA generally requires that Covered Entities (and after September 24, 2013, their business associates) safeguard and restrict the use, access or disclosure of PHI as required by HIPAA. The HITECH Act amended these requirements to tighten certain of these requirements and restrictions, to expand the sanctions for violation of these requirements, to require Covered Entities and their business associates to provide notification of breaches of unsecured PHI to individuals whose information was breached, OCR and in some cases, the media, and made certain other changes to the original requirements of HIPAA. Earlier this year, OCR amended and restated its original Privacy and Security Rules here (2013 Final Rule) to comply with changes in the regulations resulting from these HITECH Act amendments beginning last March, but set the deadline for updating business associate agreements to meet these updated requirements at September 23, 2013.

The 2013 Final Rule and other OCR guidance makes clear that OCR expects Covered Entities and their business associates appropriately to safeguard PHI stored in computers, hard drives, and other digital media until it is properly disposed in accordance with the updated standards required by HIPAA as implemented under the 2013 Final Rule. HITECH Breach Notification Rule requires HIPAA-covered entities to notify HHS of a breach of unsecured protected health information, including breaches resulting from failure to properly secure PHI stored in digital format until it has been destroyed in accordance with the standards established by the 2013 Final Rule. OCR previously has sanctioned other Covered Entities for failed to properly destroy or safeguard PHI stored in digital format on computer or other equipment before abandoning or disposing of that equipment. The Affinity Settlement reaffirms OCR’s concern that Covered Entities meet these disposal requirements when replacing or abandoning equipment containing electronic PHI.

Affinity Settlement Highlights

According to the August 14, 2013 OCR announcement of the settlement, the settlement resulted from an investigation initiated after Affinity filed a breach report with OCR on April 15, 2010, as required by the Health Information Technology for Economic and Clinical Health Act (HITECH Act.)

In its breach report, Affinity indicated that it was informed by a representative of CBS Evening News that, as part of an investigatory report, CBS had purchased a photocopier previously leased by Affinity. CBS informed Affinity that the copier that Affinity had used contained confidential medical information on the hard drive.

Affinity estimated in its breach report that up to 344,579 individuals may have been affected by this breach. OCR’s investigation indicated that Affinity impermissibly disclosed the protected health information of these affected individuals when it returned multiple photocopiers to leasing agents without erasing the data contained on the copier hard drives. In addition, OCR reports its investigation revealed that Affinity failed to incorporate the electronic protected health information (ePHI) stored on photocopier hard drives in its analysis of risks and vulnerabilities as required by the Security Rule, and failed to implement policies and procedures when returning the photocopiers to its leasing agents.

In addition to the $1,215,780 payment, the Affinity Settlement includes a corrective action plan requiring Affinity to use its best efforts to retrieve all hard drives that were contained on photocopiers previously leased by the plan that remain in the possession of the leasing agent, and to take certain measures to safeguard all ePHI.

Learn From Affinity Lesson On Proper Disposal Procedures

Like prior OCR settlements stemming from inadequate security for PHI when transitioning equipment, media or facilities, the Affinity Settlement sends another reminder to Covered Entities and their business associates again of the importance of using appropriate procedures to protect or dispose of PHI when replacing or redeploying equipment or media that may contain PHI.

“This settlement illustrates an important reminder about equipment designed to retain electronic information: Make sure that all personal information is wiped from hardware before it’s recycled, thrown away or sent back to a leasing agent,” said OCR Director Leon Rodriguez. “HIPAA covered entities are required to undertake a careful risk analysis to understand the threats and vulnerabilities to individuals’ data, and have appropriate safeguards in place to protect this information.”

OCR has published guidance concerning HIPAA’s requirements for the proper safeguarding and disposal of media and equipment in the 2013 Final Rule and other guidance. Concerning the proper disposition of copiers that may have PHI stored on their hard drives or in other digital formal, OCR in the Affinity Settlement recommended that Covered Entities and their associates also review the Federal Trade Commission’s Guidance On Safeguarding Sensitive Data Stored In The Hard Drives Of Digital Copiers and the National Institute of Standards and Technology has issued Guidance On Assessing The Security Of Multipurpose Office Machines. Covered Entities and their business associates should use this and other guidance to ensure that they can demonstrate that appropriate practices and procedures have been used to when disposing of or repurposing copies or other equipment that may contain electronic PHI.

HIPAA Regulation Updates Require Other Updates Beyond Disposal Procedures

In addition to addressing the concerns that lead to the Affinity Settlement, Covered Entities and their business associates also should verify that their practices, policies, privacy notices, business associate agreements, and training also are updated to comply with updates to the updated 2013 Final Rule adopted by OCR earlier this year here.

Since passage of the HITECH Act, OCR officials have warned Covered Entities to expect an omnibus restatement of its original regulations. While OCR had issued certain regulations implementing some of the HITECH Act changes, it waited to publish certain regulations necessary to implement other HITECH Act changes until it could complete a more comprehensive restatement of its previously published HIPAA regulations to reflect both the HITECH Act amendments and other refinements to its HIPAA Rules. The 2013 Regulations published today fulfill that promise by restating OCR’s HIPAA Regulations to reflect the HITECH Act Amendments and other changes and clarifications to OCR’s interpretation and enforcement of HIPAA.

For More Information Or Assistance

About Solutions Law Press

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

Leave a Comment » | Corporate Compliance, Doctor, Durable Medical Equipment, Genetic Information, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Licensing, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, OCR, OIG, Physician, Physician Licensing, Rehabilitation Act, Reimbursement, Substance Abuse | Tagged: Breach Notification, HHS, HIPAA Privacy, Hospital, Security | Permalink
Posted by Cynthia Marcotte Stamer

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