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Sibley Hospital & Johns Hopkins Health System Pay $5 Million To Settle Stark Violations

April 19, 2023

Sibley Hospital (“Sibley”) and its parent company, Johns Hopkins Health System (“Johns Hopkins”) will pay the United States $5 million to resolve Physician Self-Referral Law, (commonly known as the “Stark Law”) allegations arising from claims that Sibley submitted to the Medicare Program, the Justice Department announced today.

The Stark Law prohibits a hospital from billing Medicare for certain services referred by physicians with whom the hospital has a financial relationship, unless that relationship satisfies one of the law’s statutory or regulatory exceptions. It is intended to ensure that medical decision-making is not influenced by improper financial incentives and instead is based on the best interests of the patient.

The new settlement resolves allegations that, from 2008 through 2011, Sibley violated the Stark Law by billing Medicare for services referred by ten cardiologists to whom Sibley was paying compensation that exceeded the fair market value of the services provided. These allegations arose out of conduct that Sibley and Johns Hopkins self-disclosed to the United States.

“Improper financial arrangements between hospitals and physicians can influence the type and amount of health care that is provided,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department is committed to holding accountable those who violate prohibitions designed to protect the integrity of physician decision-making.”

The high dollar settlement reminds other health care providers to ensure their own relationships with other health care providers comply with Stark, anti-kickback and other federal and state health care fraud laws.

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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.™

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 such as:

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

NOTICE: These statements and materials are for general informational and educational 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 circumstances 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 make 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 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. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to 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

4/21 Deadline For Comments On Proposed HIPAA Administrative Simplification Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification To Referral Certification and Authorization Transaction Standard

April 19, 2023

April 21 is the deadline to comment on the Centers for Medicare & Medicaid Services (CMS) National Standards Group (NSG) proposed rule that, if finalized, would adopt standards for “health care attachments” transactions, a standard for electronic signatures to be used in conjunction with health care attachments transactions, and a modification to the standard for the referral certification and authorization transaction (X12 278) published last December.

The April 21, 2023 deadline reflects a 30-day extension from the original deadline date of March 21, 2023. Comments must be received no later than 5 p.m. on April 21.

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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.™

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$400K EEOC Settlement Warns Health Care Organizations Against Pregnancy Discrimination

April 12, 2023

Nursing home and rehabilitation operator Symphony Deerbrook, LLC’s $400,000 payment and other relief to settle a pregnancy discrimination lawsuit brought by the U.S. Equal Employment Opportunity Commission (EEOC) warns other health industry and other employers about the risk of imposing special pregnancy notice, doctors, release and testing requirements on pregnant employees.

In its lawsuit, the EEOC charged that Symphony implemented a policy requiring employees to inform the company of any pregnancy and to obtain a note from their doctor releasing them to work without restrictions. The EEOC also alleged that Symphony denied employees with pregnancy-related restrictions reasonable accommodations and terminated them though other employees with similar restrictions were provided accommodations.

The EEOC charged these actions violatesd the Pregnancy Discrimination Act of Title VII, 42 U.S.C. 2000e(K) and 2000e-(2)(a)(1) and the Americans with Disabilities Act, 42 U.S.C. § 12112(d)(3)(C)(4)(a).

The Pregnancy Act prohibits employers from discrimination on the basis of pregnancy and requires that employers treat pregnant employees the same as other employees who are similar in their ability or inability to work.

The ADA which prohibits employee medical examinations that are not job related or consistent with business necessity.

The consent decree settling the suit requires Symphony to pay $400,000, which will be distributed among 11 affected employees. The two-and-a-half-year decree enjoins Symphony from discrimination on the basis of pregnancy in the future, including denying pregnant workers job modifications available to other similar employees and requiring pregnant employees to obtain doctor’s notes stating that they can work without restriction.

In 2021, Symphony sold the facility to Pearl of Joliet, who agreed for purposes of settlement to provide anti-discrimination training to all its employees at the facility, to post a notice about the resolution of the law lawsuit, and to report to EEOC certain types of information during the decree’s term. The EEOC has not alleged that Pearl engaged in any discrimination.

Suits and settlements like Symphony’s send a clear warning against discrimination based on pregnancy by health care providers and other employers. Healthcare and other organizations concerned about the safety of pregnant women working in particular positions should ask experienced legal counsel for assistance in managing the occupational health and safety risks, if any for pregnant or other employees without running afoul of discrimination prohibitions.

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

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 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

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.™

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 such as:

Medical Professionals, Medical Businesses Owners and Others Criminally Charged In $490 Million Plus COVID-19 Related False Billings Takedown

Sibley Hospital & Johns Hopkins Health System Pay $5 Million To Settle Stark Violations

HHS Inspector General Comments Signal MorrContinuAggressive Ahghinued Aggresdiv

4/21 Deadline For Comments On Proposed HIPAA Administrative Simplification Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification To Referral Certification and Authorization Transaction Standard

Pharmaceutical Distributor Danco’s $765,000 False Claims Act Settlement Shows Importance Of Customs Marking and Duty Rules

$400K EEOC Settlement Warns Health Care Organizations Against Pregnancy Discrimination

2 Pharmacy FCA Convictions WarnAgainst Billing Or Undelivered Drugs Or Care

“Rock Doc” Opioid Conviction Reaffirms DOJ Prioritization & Frequent Success of Illegal Opioid Distribution Enforcement

Health Care Provider Pays $4 Million For Making Prohibited Donations Toward County Medicaid Funding

OIG Asks Cigna MA Plans To Refund $6 Million, Clean Up Plan Processes After Poor Audit Results

FY 2022 Medicaid Fraud Conviction Increase, Other Data Shows Continued Robustness of Federal Medicaid Enforcement

Health Care Providers Should Verify Compliance, Audit Risks In Preparation For End of COVID Flexibilities

Prepare To Handle Justice Department Marijuana Pardon Certificates From Applicant

Sentencings & Charges Of Clinic Operators For Defrauding Health Plans Highlight Risks Of Involvement In Schemes To File Fraudulent Health Benefit Claims

Former Missouri Lawmaker Sentenced On COVID & Stem Cell Fraud, Illegally Distributing Prescription Drugs & False Statements

Ensure Health Care & Other Compliance Practices Updated For New DOJ Voluntary Disclosure Policy

F-1 Visa Guidance Could Impact Health Industry Work Eligibility Of Some Foreign Students

DOJ Withdraws Health Care Antitrust Policy & Enforcement Statements

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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 your profile here.

NOTICE: These statements and materials are for general informational and educational 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 circumstances 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 make 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 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. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to 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.

©2023 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

FY 2022 Medicaid Fraud Conviction Increase, Other Data Shows Continued Robustness of Federal Medicaid Enforcement

March 10, 2023

Department of Health & Human Services Office of Inspector General (“OIG”) data showing a rise in Medicaid criminal convictions arising from fraud and patient abuse or neglect investigations and prosecutions during the 2022 fiscal year (“FY”) confirms the continued robustness of its Medicaid Fraud Control Units (MFCUs).

According to the just-released Medicaid Fraud Control Units Fiscal Year 2022 Annual Report convictions both for fraud and for patient abuse or neglect increased since FY 2020. In FY 2022, MFCUs achieved:

1,327 criminal convictions, an increase over the previous 2 years, but resulted in criminal recoveries of only $416 million; and
553 civil settlements and judgments resulting in civil recoveries of $641 million.

A Statistical Chart included in the Report provides a breakdown by state of the civil and criminal convictions and recoveries by nature of the offense.

While the Report reveals that civil and criminal recoveries from Medicaid criminal and civil enforcement dropped in FY 2022, the increase in convictions and other data sends a clear warning to health care providers and others that Medicaid fraud investigation and enforcement remains a key priority of the OIG and federal prosecutors.

Criminal Convictions

Total convictions resulting from MFCU cases continued to increase from the FY 2020 level but remained lower than in FY 2019. In FY 2022, MFCU cases resulted in 946 convictions for fraud and 381 convictions for patient abuse or neglect.
Exhibit 2 shows the total number of convictions during FYs 2018 through 2022. Although the proportion of patient abuse or neglect convictions to fraud convictions was similar to that in previous years, the total number of patient abuse or neglect
convictions also continued to increase from the FY 2020 level.

As in previous years, significantly more convictions for fraud involved Personal Care Services (PCS) attendants than any other provider type with fraud convictions of PCS attendants, accounting for 44 percent of the fraud convictions.

MFCU convictions related to the fraudulent billing of Medicaid, fraudulent activities of Medicaid providers involving drugs diverted from legal and medically necessary uses, regardless of whether Medicaid itself was billed and other “drug diversion” cases continued to increase from the FY 2020 level. Associated criminal recoveries from drug diversion cases totaled $18 million in FY 2022. Two States, Pennsylvania and Kentucky, accounted for 79 percent of the total convictions.

In FY 2022, convictions of nurse’s aides and of nurses or physician assistants accounted for 39 percent of the total 381 convictions for patient abuse or neglect.

Criminal and Civil Recoveries

While convictions rose, criminal recoveries decreased from $857 million in FY 2021 to $416 million in FY 2022. The Report attributes the drop in atypically large criminal recovery amounts realized in FY 2021 that resulted primarily from cases prosecuted by MFCUs in Virginia and Texas that produced a combined $714 million in criminal recoveries, 83 percent of the total reported criminal recoveries in FY 2021.

The Report points out that a single Texas criminal prosecution also significantly contributed to the total criminal recoveries in FY 2022. According to the Report, $82 million of the FY 2022 criminal recoveries resulted from the prosecution and conviction of the former head of Novus and Optimum Health Services, Bradley J. Harris and other defendants by the U.S. Attorney’s Office for the Northern District of Texas for defrauding the Medicare and Medicaid programs by among other actions:

Billing Medicare and Medicaid for hospice services that were (1) not provided, (2) not directed by a medical professional, and (3) provided to patients not eligible for hospice care; and
Using blank, pre-signed controlled substance prescriptions to distribute drugs without
physician input.

Recoveries from civil settlements and judgments also decreased in FY 2022, as did the total number of civil settlements and judgments associated with pharmaceutical manufacturers. In FY 2022, $395 million (62 percent) of the $641 million in civil recoveries derived from nonglobal cases. The remaining $246 million derived from global cases.

Appendixes to the report include a list of “beneficial” practices implemented by the MFCUs to prevent and discover these and other Medicaid abuses in various regions. Reviewing the granular statistics and these findings set forth in the Report provide valuable insights for health care providers, their leaders and advisors about these and other enforcement priorities and practices.

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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.™

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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

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.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Cyber crime, data breach, data security, DME, Doctor, Employer, ERISA, Federal Sentencing Guidelines, Health Care Finance, Health Care Provider, Health Insurance, Health IT, Health Plan, Health Plans, HHS, HIPAA, HIPAA Cyber Crime, HITECH Act, home health, Hospice, Hospital, hospitals, Licensing, Meaningful Use, Medicaid, Medicaid Advantage, Medical Licensure, Medical Malpractice, Medical Privacy, Medical Records, Medicare, Medicare Advantage, OCR, Peer Review, Physician Licensing, retaliation, Technology, Telemedicine, Whistleblower | Tagged: ARRA, Breach Notification, CMS, Compliance, Corporate Compliance, Data Breach, Data Security, Doctor, DOJ, EHR, Electronic Health Records, Employer, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Compliance, Health Care Fraud, Health Care Provider, Health Care Reimbursement, Health Insurance, Health IT, Health Plan, Health Plans, HHS, HIPAA, HIPAA Privacy, HITECH Act, Hospital, Hospitals, licensure, Medicaid, Medical Privacy, Medicare, OCR, Office of Civil Rights, OIG, PHI, Physician, Physicians, Privacy, Protected Health Information | Permalink
Posted by Cynthia Marcotte Stamer

Chiropractor, Modern Vascular Office-Based Labs and Modern Vascular Corporate Entities Face False Claims Act Prosecution

December 19, 2022

Three consolidated False Claims Act (“FCA”) lawsuits against chiropractor Yury Gampel (“Gampel”), 15 Modern Vascular office-based labs owned primarily by Gampel located across the United States, and five Modern Vascular-affiliated companies owned by Gampel alert other chiropractic, physician and other medical providers using office-based labs send a clear warning to other health care providers and suppliers for services covered or billed to Medicare, Medicaid, TRICARE or other federal health care programs about the necessity to ensure their arrangements don’t involve illegal financial relationships or transactions.

False Claims Act Liability Arising From Participation In Or Filing Claims Involving Improper Inducements

The Justice Department suit against the defendants alleges the defendants both arose from the defendants participation in arrangements involving the offering and payment of illegal remuneration in violation of the federal Anti-Kickback Statute (“AKS”) and that the claims for benefits made to Medicare and other federal programs for care provided involving the arrangement violated the FCA.

The AKS generally prohibits any person or entity from soliciting, receiving, offering, or paying any direct or indirect prohibited remuneration as an inducement or reward for referring, recommending, ordering, or arranging for the purchase of any item or service for which payment may be made in whole or in part by a federal health care program. Parties violating the AKS commit a felony punishable with a fine of up to $100,000, imprisonment for up to 10 years or both.

In addition to any criminal liability arising under the AKS, filing claims derived or involving transactions prohibited by the AKS also can trigger liability for violation of the FCA. The FCA makes it unlawful for any person to submit, directly or indirectly, false or fraudulent claims for payment to the Government by among other things:

Knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval in violation of 31 U.S.C. § 3729(a)(1)(A) (the “presentment provision”); or
Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim in violation of 31 U.S.C. § 3729(a)(1)(B).

The FCA defines the term “knowingly” under the FCA very broadly. As defined, “knowingly” means that a person, with respect to information, (i) has actual knowledge of the information, (ii) acts in deliberate ignorance of the truth or falsity of the information, or (iii) acts in reckless disregard of the truth or falsity of the information. 31 U.S.C. § 3729(b). No proof of specific intent to defraud is required to show that a person acted knowingly under the FCA.

Violations of the FCA subject the defendant to mandatory civil penalties per FCA violation, plus three times the amount of damages that the Government sustains as a result of the defendant’s actions. 31 U.S.C. § 3729(a). Under 42 U.S.C. § 1320a-7(b)(7), health care providers submitting claims to Medicare or other federal health care programs also can face exclusion from participation in federal health care programs for FCA violations.

Health care providers filing claims for Medicare or other federal health plans can violate the FCA by knowingly presenting or causing to be presented claims for items or services that the person knew or should have known were not medically necessary, or were false or fraudulent. 42 U.S.C. §§ 1320a-7a(a)(1).

Moreover, health care providers under the Medicare statute have an affirmative duty to familiarize themselves with the statutes, regulations, and guidelines regarding coverage for the Medicare services. As a condition of program participation, Medicare regulations require providers and suppliers to certify that:

The provider or supplier meets, and will continue to meet, the requirements of the Medicare statute and regulations, 42 C.F.R. § 424.516(a)(1), including that any claims and underlying transactions made in a claim for Medicare comply with the Federal anti-kickback statute and the Stark law), and on the supplier’s compliance with all otherwise applicable conditions of participation in Medicare; and
The provider or supplier will not knowingly to present or cause to be presented a false or fraudulent claim for payment by Medicare, or to submit claims with deliberate ignorance or reckless disregard of their truth or falsity.

Additional certifications of continued compliance with these requirements also are required when claims are filed. Accordingly, since health care providers and suppliers are responsible for taking appropriate steps to familiarize themselves with the rules and regulations applicable to their claim and the transactions underlying it and certify in connection with the filing of the claim that the claim and its underlying transactions comply with the law, health care providers filing claims involving prohibited financial incentives or other transactions prohibited by law risk FCA liability.

Gampel, Modern Vascular FCA Complaint

Derived from the Justice Department’s assumption and consolidation of various qui tam lawsuits separately brought by various physicians, the United States filed its complaint in three consolidated lawsuits pending in the United States District Court for the District of Arizona under the qui tam, or whistleblower, provisions of the False Claims Act, 31 U.S.C. §§ 3729-3733 (“FCA”) which allow a private citizen to sue on behalf of the government and share in any recovery. The United States is also entitled to intervene in the lawsuits, as it did in these cases.

The resulting consolidated three consolidated Justice Department lawsuits seek to recover treble damages and civil penalties, and under common law and equitable theories of recovery from defendants for their billing of Medicare, TRICARE and other federal health care programs for claims resulting from transactions involving prohibited remuneration offered and provided in violation of the AKS under Gampel’s alleged schemes Nobility Management LLC; Modern Vascular LLC; Modern Vascular of South Florida LLC; Modern Vascular Management LLC; Modern Vascular Management – East LLC; Modern Vascular Management – West LLC; Modern Vascular Institute LLC; Modern Vascular of Mesa LLC; Modern Vascular of Glendale LLC; Modern Vascular of Sun City LLC; Modern Vascular of Tucson LLC; San Antonio Vascular Specialists Corp. dba Modern Vascular; Fort Worth Vascular Specialists Corp. dba Modern Vascular; Modern Vascular of Denver LLC; Modern Vascular – Navajo LLC; Modern Vascular of Fairfax LLC; Modern Vascular of Houston LLC; Modern Vascular of Indianapolis LLC; Modern Vascular of Southaven LLC; Modern Vascular of St. Louis LLC; and Modern Vascular of Kansas LLC.

The Justice Department complaint alleges Defendant Yury Gampel, a chiropractor, is the founder and former Chief Executive Officer (“CEO”) of a franchise of office-based labs (“OBL”) located in Arizona, New Mexico, Colorado, Texas, Indiana, Kansas, Mississippi, Missouri, Tennessee, and Virginia operating under the name Modern Vascular (collectively, the “Modern Vascular OBLs”). The Modern Vascular OBLs – each its own separate legal entity – focus on the treatment of peripheral arterial disease (“PAD”), particularly through an aggressive use of vascular intervention procedures, such as angioplasty and atherectomy. The complaint claims Gampel and the Modern Vascular defendants designed and promoted the franchises that incorporated a package of management and other services provided by various Modern Vascular defendant companies.

Defendant Nobility Management, LLC, provides management services to the Modern Vascular OBLs. Defendants Modern Vascular Management, LLC; Modern Vascular Management – East, LLC; and Modern Vascular Management – West, LLC, offer
IT and management support to Modern Vascular OBLs. Defendants Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, are corporations controlled by Gampel that have various ownership interests in Modern Vascular OBLs. Through Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, and in his own capacity, Gampel is the majority owner of the Modern Vascular OBLs. (These entities that own and manage the Modern Vascular OBLs are referred to collectively below as “Modern Vascular Corporate.”)

The complaint alleges that Gampel and Modern Vascular Corporate designed and implemented a fraud scheme at Modern Vascular OBLs at the expense of patients and federal payors from at least January 1, 2018 through June 30, 2022. Among other things, the complaint charges Gampel and the Modern Vascular defendants offered physicians the opportunity to invest in Modern Vascular office-based labs to induce them to refer their Medicare and TRICARE patients to Modern Vascular for the treatment of peripheral arterial disease. More specifically, Gampel and Modern Vascular Corporate opened Modern Vascular OBLs in new markets where referring physicians and vascular surgeons had established relationships. Prior to opening an OBL in a particular location, Gampel sought out up to 20 local physicians – usually podiatrists and pain management physicians – who traditionally referred to vascular surgeons and offered each up to a two percent ownership interest in the OBL in order to induce the physicians to refer to the OBL. Gampel and Modern Vascular Corporate selected these particular physicians (hereinafter “physician investors”) to offer ownership investment because Gampel and Modern Vascular Corporate identified them as potential high-referral sources. Once they invested in an OBL, Gampel and Modern Vascular Corporate further required the physician-investors to make referrals to Modern Vascular OBLs as a condition for remaining as a physician-investor. The complaint also alleges that Gampel pressured vascular surgeons and interventional radiologists employed at the Modern Vascular office-based labs to increase the number of invasive surgical procedures performed by tracking procedures and setting aggressive weekly and monthly goals for such procedures. In particular, Gampel and Modern Vascular Corporate provided remuneration to physician investors in Modern Vascular OBLs to induce those investors to refer patients to the Modern Vascular OBL.

The Justice Department charges that using this scheme, Defendants between January 1, 2018 and June 30, 2022 submitted, and caused to be submitted, tens of millions of dollars in false or fraudulent claims to Medicare, TRICARE and other federal health care programs by offering and providing illegal remuneration to health care providers to induce referrals to the Modern Vascular OBLs in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b. To induce referrals, Gampel and Modern Vascular Corporate provided remuneration to physician-investors in the form of equity ownership interests in an OBL, which also included distributions, the prospect of future distributions, and/or the prospect of a cash-out of the equity ownership amounts when
the Modern Vascular OBLs were sold. During the relevant time period, the Justice Department also claims Modern Vascular
OBLs received over $50 million from Medicare Part B alone for claims submitted for patients referred by physician-investors in violation of the FCA.

Warning To Other Heath Care Providers & Suppliers

In announcing its filing of the Gambrel FCA lawsuit, the Justice Department warned other federal health program providers and suppliers and their business partners, investors, employees and agents from violating the AKS, FCA or both in the provision of or billing of health care services or supplies. “As part of our mission to protect the American people, the FBI remains committed to safeguarding patients who rely on our healthcare systems,” said Deputy Assistant Director Aaron Tapp of the FBI’s Criminal Investigative Division. “The FBI and our law enforcement partners will continue to investigate those who abuse our healthcare systems, place patients at risk, and waste taxpayer dollars.”

This warning, along with the ever-lengthening list of federal criminal and civil prosecutions, convictions and settlements by the Justice Department, the Department of Health & Human Services Office of Inspector General and other agencies provide a strong warning to health care providers, suppliers and others involved in creating or administering transactions and other arrangements for the delivery and billing for health are to be billed to Medicare, Medicaid, TRICARE and other health care arrangements covered by the AKS, the FCA or other federal or state health care fraud laws to take well documented care to ensure the care delivery arrangement does not involve transactions prohibited under the AKS or other federal or state health care fraud transactions and the care billed qualifies for reimbursement before submitting the claim. Parties who know or suspect that they may have participated in an arrangement prohibited under these laws or submitted prohibited claims should contact experienced legal counsel within the scope of attorney-client privilege for assistance in reviewing those concerns and exploring options for correction or mitigation.

For More Information

If your organization would like to learn more about the concerns discussed in this update or seeks assistance auditing, updating, administering or defending its human resources, compensation, benefits, corporate ethics and compliance practices, or other performance related concerns, contact management attorney and consultant Cynthia Marcotte Stamer.

An attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization, Ms. Stamer is recognized for work helping organizations management people, operations and risk as a Fellow in the American College of Employee Benefit Counsel, a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Labor and Employment Law and Health Care Law; a “Best Lawyers” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law.”

For 35 years, Ms. Stamer’s work has focused on advising and assisting businesses and business leaders with these and other employment and other staffing, employee benefit, compensation, risk, performance and compliance management and other operational solutions and concerns. Her experience includes helping management both manage performance and manage legal risk and compliance. While helping businesses define and manage the conduct and performance of their employees, contractors and vendors, she also assists employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, leave, and other labor and employment laws, advises and defends businesses against labor and employment, employee benefit, compensation, fraud and other regulatory compliance and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor, Department of Justice, SEC, Federal Trade Commission, HUD, HHS, DOD, Departments of Insurance, and other federal and state regulators. Ms. Stamer also speaks, coaches management and publishes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see hereor contact Ms. Stamer directly.

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NOTICE: Terms. These materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice, a substitute for legal advice, an offer or commitment to provide legal advice or an admission. The information and statements in these materials may not address all relevant issues or apply to any situation or circumstances. The author reserves the right to qualify or retract any of these statements at any time. and does not necessarily address all relevant issues. Because the law evolves and in ways that subsequent developments could impact the currency and completeness of this discussion. The author disclaims and has 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 are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at any time. 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. 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. ©2022 Cynthia Marcotte Stamer. Nonexclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

Criminal IV Tampering Charges Against Anesthesiologist Highlight Exposures Providers And Their Facilities Can Face From Team Members Retaliatory or Other Misdeeds

September 15, 2022

The arrest and criminal charges against Dallas anesthesiologist Raynaldo Rivera Ortiz Jr. (“Dr. Ortiz”) announced September 15, 2022 highlight the advisability of health care facilities and providers to use care to use appropriate monitoring and other safeguards to protect patients and other critical operations against potential retaliatory misconduct during professional peer review or other investigation or discipline of health care professionals or other members of their workforces.

Dr. Ortiz was arrested in Plano, Texas on Wednesday, September 14, 2022 and is scheduled to make his initial court appearance on Friday, September 16, 2022 on federal felony criminal charges that he caused the death of a patient and surgical emergencies of other patients by intentionally tampering with a consumer product and intentional drug alteration.

According to the by Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, and U.S. Attorney for the Northern District of Texas Chad E. Meacham, Dr. Ortiz was arrested and charged via criminal complaint with tampering with a consumer product causing death and intentional drug adulteration.

According the criminal complaint, on June 21, 2022, a 55-year-old female coworker of Dr. Ortiz, experienced a medical emergency and died immediately after treating herself for dehydration using an IV bag of saline taken from a Baylor Scott & White operated surgical center. An autopsy report revealed that she died from a lethal dose of bupivacaine, a nerve blocking agent that is rarely abused but is often used during the administration of anesthesia.

Two months later, on August 24, 2022, an 18-year-old male patient experienced a cardiac emergency during a routine sinus surgery. The teen was intubated and transferred to a local ICU. Chemical analysis of the fluid from a saline bag used during his surgery revealed the presence of bupivacaine, epinephrine (a stimulant), and lidocaine, drugs that could have caused the patient’s sudden symptoms.

According to the complaint, surgical center personnel concluded that the incidents involving both patients suggested a pattern of intentional adulteration of IV bags used at the surgical center.

The surgical center personnel also identified 10 additional unexpected cardiac emergencies that occurred during otherwise unremarkable surgeries between May and August 2022, which the criminal complaint alleges is an exceptionally high rate of complications over such a short period of time. According to the criminal complaint, medical personnel in each of those additional 10 cases only were able to stabilize the patient through use of emergency measures. Most of the incidents occurred during longer surgeries that used more than one IV bag, including one or more bags retrieved mid-surgery from a stainless steel bag warmer.

Surveillance video from the center’s operating room hallway allegedly also shows Dr. Ortiz placing IV bags into the stainless-steel bag warmer shortly before other doctors’ patients experienced cardiac emergencies. The complaint alleges that in one instance captured in the surveillance video, agents observed Dr. Ortiz walk quickly from an operating room to the bag warmer, place a single IV bag inside, visually scan the empty hallway, and quickly walk away. Just over an hour later, according to the complaint, a 56-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure. The complaint also states that in another instance, agents observed Dr. Ortiz exit his operating room carrying an IV bag concealed in what appeared to be a paper folder, swap the bag with another bag from the warmer, and walk away. Roughly half an hour later, a 54-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure.

According to the complaint, none of the cardiac incidents occurred during Dr. Ortiz’s surgeries, and that the series of emergencies began just two days after Dr. Oritz was notified of a disciplinary inquiry stemming from an incident during which he allegedly “deviated from the standard of care” during an anesthesia procedure when a patient experienced a medical emergency. The complaint alleges that all of the incidents occurred around the time Dr. Ortiz performed services at the facility, and no incidents occurred while Dr. Ortiz was on vacation.

The complaint further alleges that Dr. Ortiz, who had a history of disciplinary actions against him, expressed concern to other physicians over the disciplinary action at the facility and complained the center was trying to “crucify” him. A nurse who worked on one of Dr. Ortiz’s surgeries allegedly told law enforcement that Dr. Ortiz refused to use an IV bag she retrieved from the warmer, physically waving the bag off.

“Our complaint alleges this defendant surreptitiously injected heart-stopping drugs into patient IV bags, decimating the Hippocratic oath,” said U.S. Attorney Chad E. Meacham in the Department of Justice announcement of the charges. The criminal charges stemmed from these findings.

The Justice Department announcement reminds readers that a criminal complaint is merely an allegation of criminal conduct, not evidence. Dr. Ortiz is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law. If convicted, however, Dr. Ortiz faces a maximum penalty of life in prison.

Both Dr. Ortiz and the surgical facility are exposed to potential liability as a result of the alleged charges. Aside from the pending criminal charges, Dr. Ortiz also almost certainly could face potential peer review and licensing board disciplinary investigation, as well as civil lawsuits.

In addition to these liability exposures for Dr. Ortiz, the surgical facility and other providers also could face civil or potentially even criminal liability.

It seems almost inevitable that the facility and potentially some other providers might be drawn into civil lawsuits brought by affected patients and their families allegedly injured or place at risk by the alleged actions by Dr. Ortiz, as well as licensing and/or accreditation investigation arising from the alleged events.

Because Dr. Ortez’s alleged Actions constitute federal felonies, the Federal Sentencing Guidelines sentencing and organizational liability rules apply. The Sentencing Guidelines will apply to determine the sentence imposed if Dr. Ortez ultimately is convicted. In addition, the Sentencing Guidelines organizational liability provisions also raise a risk of criminal charges against the facility or other parties with knowledge or other imputed responsibility. Under the organizational guidelines, organizations can have imputedliability for the criminal acts committed by the members of their workforce. However whether criminal charges will be pursued against the organization and the level of culpability and resulting liability is determined based upon both whether the organization took appropriate steps to prevent the misconduct before it happened and the extent to which the organization acted promptly in its investigation and redress of the conduct. The apparent actions of the surgical center and its leader ship to investigate, report, and cooperate in the investigation with federal officials are likely to mitigate if not resolve their criminal exposure.

Organizations and their leaders should treat the charges against Dr. Ortiz as a reminder, at minimum carefully to credential and monitor team members including doctors or other non-employer actors working in or with their facilities, to establish appropriate safeguards to prevent and identify quickly mistakes or intentional conduct, to monitor and enforce those safeguards, and to take appropriate prompt action to investigate concerns and redress and if necessary report misconduct with the advice of counsel.

When dealing with position performance and discipline concerns, facilities typically must carefully negotiate applicable contractual and workforce issues as well as the procedural and due process requirements of applicable medical staff bylaws and federal and state peer review and discipline statutes and regulations and medical staff discipline rules.

When a medical staff member protected by peer review or other procedural safeguards commits behaviors that raise a material and continuing threat to the health and safety of patients or the public, summary suspension may be necessary. When considering or taking an action to summarily suspend a healthcare provider, however, facilities and their medical staff leaders should document both the grounds for the patient safety concerns and need for immediate action and scrupulously follow the summary suspension procedures.

Along with seeking to prevent and mitigate these legal risks, Facilities and other providers also need to consider white reporting obligations they may bear under applicable statutes, regulations and contracts.

While managing these legal risks, facilities and other involved parties also need to anticipate media and public concern about the occurrences. Facilities and their leaders should anticipate and be prepared to work in conjunction with qualified legal counsel and experienced qualified public relations experts to decide when, what, and how to communicate with the public in the media about these types of events to avoid is there a bold minefield of traps created by privacy laws, evidentiary and other legal risk management concerns, and the management of relationships with other members of the medical staff and workforce, business partners, insurance, and the public.

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 35 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. In the course of this work, she has worked extensively on workforce and medical staff credentialing, management, investigation, peer review and discipline, and reporting and remediation of criminal or other activity to regulatory officials.

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.

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

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.

Leave a Comment » | Academic medicine, Ambulatory care, Anethesiology, Conditions of Participation, Corporate Compliance, Credentialing, Doctor, Employer, Employment law, FDA, Federal Sentencing Guidelines, Fiduciary Responsibility, Health Care, Health Care Provider, Health Care Quality, Home Health, home health, Hospice, Hospital, hospitals, nursing home, OIG, Physician, Physician Licensing, physician licensure, Prescription Drugs, quality repoting, retaliation, Skilled Nursing Facility, Whistleblower | Tagged: ortiz | Permalink
Posted by Cynthia Marcotte Stamer

Learn About DOJ Federal Antitrust Health Industry Market Competition Enforcement & Latest On $2.67 Billion BCBS Class Action Antitrust Settlement In 9/8 JCEB Webex

September 2, 2022

As qualifying individuals and companies that purchased or received health insurance await instructions on how to claim their share of the $2.67 billion In re: Blue Cross Blue Shield Antitrust Litigation private federal class action civil antitrust lawsuit settlement (“Settlement”) finally approved August 9, 2022 against the Blue Cross Blue Shield Association (“BCBSA”) and other settling individual Blue Cross Plans, employers and other plan sponsors, health care systems and providers, health insurers, pharmacy benefit managers, brokerages, and other health and health insurance market participants need to keep in mind that the private antitrust judgements are not their only exposure under federal antitrust laws. Health insurance and health industry market participants that engage in anticompetitive conduct or business transactions also risk investigation and prosecution under federal antitrust laws by the U.S. Department of Justice, the Federal Trade Commission and state regulators or attorneys general.

Market participants and others with health or health insurance industry market competitiveness concerns or interests should register and attend the September 8, 2022 Justice Department Health Industry Antitrust Enforcement Update to learn about key federal antitrust statutes regulating or prohibiting anticompetitive conduct and business transactions and hear how the Department of Justice uses these laws to promote market competition in the health care and health insurance marketplaces.

Hosted by the American Bar Association Joint Committee on Employee Benefits, the webinar will feature a discussion by U.S. Department of Justice Civil Division Healthcare and Consumer Products Section Antitrust Attorney Natalie Melada of basic federal antitrust rules and principles the Justice Department relies upon to safeguard market competitiveness and discusses selected Justice Department antitrust litigation and other compliance and enforcement initiatives the Department of Justice has undertaken to protect competition in the healthcare industry. Attorney and Solutions Law Press, Inc. editor and author Cynthia Marcotte Stamer also will provide an update on the In re: Blue Cross Blue Shield Antitrust Litigation and resulting $2.67 billion settlement approved August 9.

For more details and to register for the program, see here.

More Information

Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and following 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

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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Posted by Cynthia Marcotte Stamer

HIPAA Covered Entity Nailed With $300,000+ HIPAA Settlement For Improper PHI Disposal

August 23, 2022

A Massachusetts dermatology practice’s Health Insurance Portability & Accountability Act (“HIPAA”) $300,000 plus settlement with the Department of Health & Human Services Office for Civil Rights (OCR) reminds health care providers, health plans, health care clearinghouses and their business associates (“Covered Entities”) to use proper practices and safeguards when disposing of protected health information (“PHI”).

Following up on other OCR enforcement involving improper protection and disposal of paper and electronic PHI, the settlement with New England Dermatology P.C., d/b/a New England Dermatology and Laser Center (“NDELC”) OCR announced today (August 23, 2022) resolves charges that NDELC violated the HIPAA Privacy Rules when it placed specimen containers with patient identifying PHI in its parking lot garbage bin.

OCR interprets HIPAA as requiring Covered Entities to appropriate steps to ensure that safeguards are in place when disposing of patient information to keep it from being accessible by the public. ”Improper disposal of protected health information creates an unnecessary risk to patient privacy,” said Acting OCR Director Melanie Fontes Rainer.

On May 11, 2021, NEDLC filed a breach report with OCR that reported empty specimen containers with the PHI on labels were placed in a garbage bin in their parking lot. The containers’ labels included patient names and dates of birth, dates of sample collection, and name of the provider who took the specimen. On March 31, 2021, a third-party security guard found one specimen container bearing a label containing patient names, dates of birth, dates of sample collection, and name of the provider who took the specimen. During the investigation, NEDLC stated that from February 4, 2011 until March 31, 2021, it regularly discarded specimen containers with an attached label that contained PHI as regular waste, bagged and placed in an exterior dumpster accessible via the parking lot, without alteration to the PHI containing label.

OCR’s New England Regional Office found the practice of disposing of specimen containers with their labels containing PHI violated the HIPAA Privacy Rule including the impermissible use and disclosure of PHI and failure to maintain appropriate safeguards to protect the privacy of PHI.

Under the NEDLC Resolution Agreement negotiated to settle the alleged violations, NEDLC paid $300,640 to OCR and agreed to implement a “robust” corrective action plan that includes two years of OCR monitoring. Among other things, the corrective action plan requires NEDLC to:

Within 60 days, develop, maintain, and revise, as needed and present for OCR review its written policies and procedures to comply with the physical safeguard and disposal of PHI created, received or maintained by or on behalf of NEDLC and all other HIPAA Privacy, Security and Breach Notification and training protocols to ensure workforce member compliance with these policies; and sanctions for workforce members violating these requirements;
Implement the updated policies and procedures within 30 days of receipt of HHS approval;
Distribute the policies to existing members of its workforce within 30 days of receipt of HHS approval of the policies and subsequently to new members of the workforce within 30 days of their beginning of service and obtain a signed written or electronic initial compliance certification from all members of the workforce and relevant business associates stating that the workforce members have read, understand, and shall abide by such policies and procedures;
Assess, update, and revise, as necessary, the policies and procedures at least annually or as needed, provide the revised policies and procedures to HHS for review and approval, and redistribute to and obtained new compliance certifications from workforce members and business associates within 30 days of HHS approval;
If it receives information during the Compliance Term that a workforce member or business associate may have failed to comply with its policies and procedures for safeguarding PHI, promptly investigate and it the investigation finds a violation, notify HHS within 30 days of the violation and corrective action taken;
Comply with specified breach investigation and notification requirements;
Provide reports certified by a designated leader of the organization its implementation of the corrective action plan, annually and upon the occurrence of certain other events during the two-year monitoring period.

The NEDLC Resolution Agreement is not the first time OCR has nailed a Covered Entity for improper disposal of PHI. In 2015 Cornell Prescription Pharmacy paid OCR $125,000 and implemented a correction action plan to correct alleged HIPAA violations after an OCR investigation of a local news report confirmed unsecured paper documents containing PHI of more than 1600 patients were disposed of in an unlocked, open container on Cornell’s premises. The documents were not shredded and contained identifiable information regarding specific patients. See Cornell Prescription Pharmacy Resolution Agreement. See also $800,000 HIPAA Settlement in Medical Records Dumping Case.

To reduce their own exposure to potential HIPAA liability arising from improper disposal of PHI, covered entities should evaluate the adequacy of the PHI handling, security and disposal policies, procedures, training and compliance for potential weaknesses and take appropriate, timely documented corrective action to tighten their compliance with OCR’s regulations, OCR’s Frequently Asked Questions About the Disposal and other OCR enforcement actions and guidance on PHI disposal.

Since these evaluations could uncover past or ongoing compliance concerns, Covered Entities and business associates should consider engaging legal counsel experienced with HIPAA compliance to advise and aid the Covered Entity to structure, conduct, evaluate findings and determine and implement any corrective actions that the review reveals as required or advisable within the scope of attorney client privilege.

Effective protection and disposal of PHI requires that Covered Entities recognize and keep track of all PHI in the various phases of its lifecycle in the organization including when it is being disposed or or migrating through various systems. Sanctions for disposal of specimen bottles containing PHI labels should raise the need for awareness of disposal practices for other patient labeled items including identification bracelets, medication containers and labels, meal trays and the plethora of other items containing patient specific information. PHI disposal issues also can arise out of the disposal of files, storage containers, computers, copiers or other devices. For instance, under the Affinity Health Plan, Inc. Resolution Agreement, Affinity Health paid OCR $1,215,780 to settle potential HIPAA Civil Monetary Sanctions after OCR found it exposed the PHI of up to 344,579 individuals by returning photocopiers to a leasing agent without erasing the data contained on the copier hard drives.

Because HIPAA obligations continue even when a Covered Entity or business associate goes out of business, Covered Entities also need to take appropriate steps to provide for ongoing management, protection and disposal of PHI when they or a business associate ceases business. Thus, in the FileFax Resolution Agreement, for instance the receiver appointed to liquidate the assets of Filefax, Inc. agreed to pay $ 100,000 out of the receivership estate to OCR to settle potential HIPAA violations after Filefax shut its doors during the course of OCR’s investigation into alleged HIPAA violations.

Covered Entities must understand that these responsibilities generally cannot be met merely through adoption of a standard set of policies and procedures from a third-party. The HIPAA Privacy Rule requires all Covered Entities to prepare and document risk assessments and develop and enforce appropriate privacy and security policies and procedures. Security and disposal practices and procedures are among the elements of HIPAA compliance that OCR expects Covered Entities to address in the documented risk assessments the regulations require Covered Entities to prepare and maintain. See $750,000 HIPAA Settlement Underscores the Need for Organization Wide Risk Analysis. As with other HIPAA compliance responsibilities, OCR regulations require that Covered Entities include their documented assessment and decision-making about the adequacy and reasonableness of their PHI protection and destruction practices under HIPAA as part of their overall HIPAA risk assessment plan and practices.

While OCR guidance provides some examples of several practices that a Covered Entity might use that could or could not meet the destruction standards, these examples are not safe harbors. The regulations and guidance expect Covered Entities to conduct a documented review and assessment “of their own circumstances to determine what steps are reasonable to safeguard PHI through disposal and develop and implement policies and procedures to carry out those steps.” OCR guidance directs that Covered Entities should assess potential risks to patient privacy, as well as consider such issues as the form, type, and amount of PHI to be disposed. Covered entities are responsible for conducting and documenting their analysis as well as their adoption, implementation and enforcement of the resulting policies and procedures.

If circumstances come to light that indicate a breach of the standards in the course of the disposal compliance assessment or otherwise, Covered Entities also promptly should work with legal counsel timely to investigate, determine and provide any required notifications or other corrective action and document their actions to meet applicable HIPAA and other legal obligations and mitigate liability.

Of course, Covered Entities and their leaders always must keep in mind that their responsibilities and potential liability for mishandling PHI could extend well beyond HIPAA. In addition to the civil monetary penalties HIPAA authorizes, mishandling the collection, protection or disposal of PHI or other sensitive data also can trigger other legal exposures. For instance, as HIPAA compliance is part of the Conditions of Participation that Medicare participating Covered Entities and Medicare Advantage Plans must meet to qualify for program participation, noncompliance could trigger program exclusion, False Claims Act or related exposures. Deficiencies in security or destruction of credit card, banking or other PHI that also qualifies as personal financial information could trigger exposure under Federal Trade Commission, state identity theft and privacy or other laws. Public companies and their leaders also may need to evaluate if deficiencies in their security or destruction protocols trigger investor disclosure obligations under Securities and Exchange Commission rules or other federal or state laws. Considering these and other exposures, documented, compliance and defensibility of PHI and other sensitive information use, protection, disclosure and destruction should rank high among the priorities of all Covered Entities and their leaders.

More Information

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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Leave a Comment » | Academic medicine, Anethesiology, ASC, Childrens Health Insurance Program, Conditions of Participation, Cyber crime, data breach, Direct Primary Care, Durable Medical Equipment, E-Prescribing, Electronic Medical Records, Employee Benefits, Health Apps, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Insurance, Health Insurance Exchange, Health IT, Health Plan, Health Plans, healthcare, HHS, HIPAA, HIPAA Cyber Crime, HITECH Act, Home Health, home health, Hospice, Hospital, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, managed care, Medical Licensure, Medical Records, Medicare, Mental Health, Mental Heatlh, nursing home, occupational health, OCR, Outpatient, participating provider, Pharmaceudical, Pharmacy, Physician, Physician Licensing, physician licensure, Prescription Drugs, Privacy, Psychiatric, public health, Reproductive Rights, Rural Health Care, Self-Insured Group health Plans, Skilled Nursing Facility, substance abuse treatment | Tagged: Abortion, dobbs, Health Care, HIPAA, Physician, Protected Health Information, Reproductive Rights | Permalink
Posted by Cynthia Marcotte Stamer

Protect Remote Desktop Protocols From Malware Threat

July 1, 2022

As Americans prepare to celebrate the July 4th holiday, CISA, the Federal Bureau of Investigation (FBI), the Department of the Treasury (Treasury), and the Financial Crimes Enforcement Network (FinCEN) are warning of a cyber threat for Remote Desktop users. Health care, health plan, healthcare clearing houses, their business associates and other security sensitive organizations using remote access technology should perform and document their risk assessment and any corrective actions taken as part of their continuing Health Insurance Portability and Accountability Act (“HIPAA”), Fair and Accurate Credit Transactioms Act (FACTA”), government contracting, securities law, and other data security compliance.

The joint Cybersecurity Advisory (CSA), #StopRansomware: MedusaLocker, published July 1 alerts of the risk of MedusaLocker ransomware. MedusaLocker actors target vulnerabilities in Remote Desktop Protocol (RDP) to access victims’ networks.

CISA, FBI, Treasury and FinCEN are encouraging network defenders to examine their current cybersecurity posture and apply the recommended mitigations in this joint CSA, which include:

Prioritize remediating known exploited vulnerabilities.
Train users to recognize and report phishing attempts.
Enable and enforce multifactor authentication.

When assessing Remote Desktop protocol risks, covered entities, business associates and other security concerned organizations also should examine their exposures to other vulnerabilities.

A key resource for monitoring some of these vulnerabilities is the CISA Known Exploited Vulnerabilities Catalog, which lists exposures based on evidence of active exploitation. These types of vulnerabilities are a frequent attack vector for malicious cyber actors and pose significant risk federal enterprises. CISA strongly urges all organizations to reduce their exposure to cyberattacks by prioritizing timely remediation of Catalog vulnerabilities as part of their vulnerability management practice. CISA will continue to add vulnerabilities to the Catalog that meet the specified criteria.

The Department of Health & Human Services Office of Civil Rights (‘“OCR”) guidance and enforcement makes clear covered entities and business associates must monitor and take appropriate actions to update their security in response to emerging cyber security threats.

Along with monitoring and responding to this and other security threats, covered entities also should add reviewing and updating their HI-AA practices in response to new guidance OCR issued this week in response to the Supreme Court Dobbs vs. Jackson Women’s Health Organization abortion ruling. The HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care guidance generally addresses when the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule restricts or allows individuals’ private medical information (known as “protected health information” or “PHI”) relating to abortion and other sexual and reproductive health care. For more details, see here.

Beyond HIPAA, malware and other data or system security breaches and susceptibilities can create liability risks under tax, securities, government contracting, FACTA and a wide range of federal and state laws. For instance, with cybersecurity threats and compliance concerns growing, the SEC is prioritizing cybersecurity regulation, investigation and enforcement against public companies and other market participants for lack cybersecurity governance, safeguards or disclosures. See e.g., SEC Office of Compliance Inspections and Examinations Cybersecurity and Resiliency Observations. Along announcing its commitment to hold market involved and impacting regulated entities accountable for failing to maintain and enforce appropriate internal and external controls to prevent, detect and redress cybersecurity threats, including appropriate board governance and risk management, access rights and controls, data loss prevention, mobile security, incident response and resiliency, vendor management, training and awareness, investor disclosures and other practices.

Healthcare providers and other covered entities, their business associates and others with data security responsibilities or sensitivities should respond promptly and carefully document their risk analysis and response in response to these emerging concerns.

More Information

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

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.

More Information

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

SCOTUS: Emotional Injury Damages Not Recoverable In Patient’s Private Rehab Act and ACA Disability Discrimination Lawsuit But Other Significant Liability Risks Remain

May 2, 2022

Today’s Supreme Court ruling that emotional distress damages are not recoverable in a private action to enforce the disability discrimination and accommodation requirements of either the Rehabilitation Act of 1973 (“Rehab Act”) or the Patient Protection and Affordable Care Act (“ACA”) prevents health care and other businesses subject to these requirements against the risk of large emotional injury awards in private actions for discrimination based on these laws. However, health care providers and other organizations subject to these requirements should use care to maintain compliance to avoid large actual damage awards to plaintiffs bringing private lawsuits, program exclusion, penalties or other governmental sanctions or both.

Cummings Supreme Court Ruling

The May 1, 2022 United States Supreme Court ruling in Cummings v. Premier Rehab Keller authored by Supreme Court Justice John Roberts resulted from a suit that sought emotional distress damages brought by filed by a deaf and legally blind woman, Jane Cummings against Premier Rehab Keller after it denied her request that it provide an American Sign Language interpreter at her physical therapy sessions. Premier Rehab told Cummings the therapist could communicate with her through other means, Claiming Premier Rehab’s failure to provide an ASL interpreter constituted discrimination on the basis of disability in violation of the Rehab Act and Section 1557 of the ACA, Cummings sued Premier Rehab seeking various damages and other relief, including emotional distress damages.

The Supreme Court took notice that Premier Rehab was subject to these laws because its receipt of Medicare and Medicaid payments qualified as federal financial assistance triggering their applicability.

The Supreme Court affirmed the previous District Court and Fifth Circuit Court of Appeals’ rulings that emotional distress damages are not recoverable in a private action to enforce either the Rehab Act or the ACA.

The Supreme Court Majority based its decision on its finding that the Rehab Act and Act both are spending statutes that condition their offer of federal funding on a promise by the recipient not to discriminate creating what amounts essentially to a contract between the Government and the recipient of funds. Following previously established Supreme Court precedent for “private spending clause actions,” the Court ruled the emotional distress or other remedy is not available unless “the funding recipient is on notice that by accepting federal funding, it exposes itself to liability of that nature.”

To decide whether emotional distress damages are available under the Spending Clause statutes in this case, the Court therefore asked if a prospective funding recipient deciding whether to accept
federal funds would have had “clear notice” regarding that liability. Because the two statutes are silent on the availability of emotional injury damages, the Supreme Court followed prior precedent by looking to whether the emotional damages sought by Cummings were the type of damages traditionally available in suits for breach of contract so as to put Premier Rehab and other defendants on notice of their exposure to such damages from actions under the Rehab Act or ACA. While acknowledging some exceptional circumstances where punitive damages may be recovered where “the conduct constituting the breach is also a tort for which punitive damages are recoverable,” the Court found such damages “are generally not available for breach of contract.” Concluding that the recognized exception to the general rule was insufficient to give funding recipients the requisite notice that they could face such damages. the Supreme Court ruled that funding recipients under the Rehab Act and the ACA “have not, merely by accepting funds, implicitly consented to liability for punitive damages.”

To read the full Majority opinion and related consenting and dissenting opinions, see here.

Liability Risks Remain Substantial Despite Cummings Ruling

While the Supreme Court’s ruling means private litigants cannot recover emotional injury damages in discrimination actions brought to enforce the Rehabilitation Act or the ACA, health industry and other organizations remain subject to other substantial liability risks for improper discrimination in violation of those laws. Beyond recoveries for actual damages, attorneys’ fees and costs recoverable by private litigants, covered organizations also can face substantial civil monetary penalties, program disqualification, in some instances even False Claims Act liability for billing in violation of program conditions of participation and other risks. As federal agencies continue to make enforcement of these sanctions a priority, organization covered by either of these laws should use care to maintain appropriate compliance and risk management to ensure their ability to defend against any potential charges.

For instance, HHS recently reaffirmed its continued commitment and prioritization of protecting disabled individuals against disability discrimination by its publication of its February 4, 2022 FAQs for Healthcare Providers during the COVID-19 Public Health Emergency: Federal Civil Rights Protections for Individuals with Disabilities under Section 504 and Section 1557. Published to remind health care providers of their obligations under law and provide examples of applicability, HHS clarifies in that guidance that federal civil rights laws apply to health care providers, including those administering COVID-19 testing, medical supplies, and medication. These rules also apply to entities providing hospitalization, long-term care, intensive treatments, and critical care, such as oxygen therapy and mechanical ventilators. HHS also confirm that federal civil rights laws apply to state Crisis Standard of Care plans, procedures, and related standards for triaging scarce resources that hospitals are required to follow. HHS Issues New Guidance for Health Care Providers on Civil Rights Protections for People with Disabilities. See also New Guidance to Boost Accessibility and Equity in COVID-19 Vaccine Programs (December 22, 2021); HHS Takes Action to Prevent Discrimination and Strengthen Civil Rights (November 18, 2021); HHS and DOJ Issue Guidance on “Long COVID” and Disability Rights Under the ADA, Section 504, and Section 1557 (July 26, 2021); OCR Provides Technical Assistance to the State of Arizona to Ensure Crisis Standards of Care Protect Against Age and Disability Discrimination (May 25, 2021); HHS Announces Prohibition on Sex Discrimination Includes Discrimination on the Basis of Sexual Orientation and Gender Identity (May 10, 2021); New Legal Guidance and Resources to Ensure — and Expand — Access to COVID-19 Vaccines for People with Disabilities and Older Adults (April 13, 2021).

HHS’ guidance announcements all include a warning like the one from OCR Director Lisa J. Pino in the February 4, 2022 announcment that “OCR will continue our robust enforcement of federal civil rights laws that protect people with disabilities from discrimination, including when Crisis Standards of Care are in effect.”

The current and historical enforcement record of HHS demonstrates the teeth behind this commitment. OCR has a long and continuing history of extracting substantial settlements or civil monetary penalties from health care or other organizations receiving Medicare, Medicaid or other federal funds administered by HSS for engaging in conduct OCR finds inconsistent with the ACA or Rehabilitation Act discrimination requirements. See, e.g., Settlement Agreement Reached with Rhode Island Department of Children, Youth and Families to Address Discrimination Against Parents with Disabilities (March 30, 2022); Massachusetts Healthcare Provider Resolves Allegations of Discriminatory Practices Regarding Patients Needing Opioid Use Disorder Treatment (December 22, 2021); HHS Office for Civil Rights and U.S. Attorney’s Office for the District of Massachusetts Settle Disability Discrimination Case with Baystate Medical Center (November 17, 2021); HHS Office for Civil Rights and U.S. Attorney’s Office Settle Disability Discrimination Case with Backus Hospital (October 5, 2021); Rhode Island, Massachusetts Healthcare Provider Resolves Allegations of Discriminatory Practices Regarding Patients Needing Opioid Use Disorder Treatment (August 9, 2021).

These OCR guidance and enforcement actions and similar activities by other federal agencies send a strong message that OCR and other federal agencies will continue and expand their zealous investigation and enforcement of disability and other violations by health care providers and other public and private organizations covered by the Rehabilitation Act, the ACA or other federal discrimination and civil rights laws. Health care providers and others regulated by these federal discrimination laws should consider auditing the adequacy of existing practices, reaffirming their own and their business partners’ compliance, retraining workforce and taking other appropriate steps to help prevent illegal discrimination within their organization and to position their organization to respond and defend against potential discrimination investigations or charges.

For Additional Information Or Assistance

If you need have questions or need assistance with health, health or other insurance, employee benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help. Longtime scribe for the American Bar Association Joint Committee on Employee Benefits agency meeting with OCR and author of leading publications on HIPAA and other privacy and data security concerns, Ms. Stamer regularly assists clients and provides input to Congress, OCR and other agencies, publishes and speaks extensively on medical and other privacy and cybersecurity, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. 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.

Her publications and insights 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. Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications. She also is a highly-sought out speaker on privacy and data security who serves on the planning faculty and speaks for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters, e-mail Ms. Stamer or call (214) 452-8297.

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.

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Posted by Cynthia Marcotte Stamer

CMS Updates COVID-19 Guidance For Visiting Nursing Homes & LTC Facility Vaccination During Omicron Surge

January 13, 2022

CMS recently updated its Nursing Home Resource Centerwith new pieces of informational guidance on visitation and vaccines in response to the recent surge in Omicron cases.

Visitation

As of January 6, CMS updated the Nursing Home Visitation FAQs (PDF) to give additional guidance about visitation during the Omicron surge and also created an infographic (PDF) to graphically represent how to safely conduct visits to nursing homes during this time of spiking COVID cases around the country. Nursing home providers, patients, caregivers, and CMS partners can use these 2 new resources to stay informed about CMS’ latest thinking for keeping nursing homes safe in the current COVID climate.

CMS also continues to urge long-term care settings, like nursing homes, assisted living, residential care communities, group homes, and senior housing, to ensure residents and staff get COVID-19 vaccine primary series and booster shots.

Vaccination

while long-term care and other Medicare and Medicaid participating healthcare providers continue to await the Supreme Court’s decision on the enforceability and validity of the Biden administration vaccine mandate for program participation, CMS continues to urge long-term care providers to coordinate access to COVID-19 vaccines, either in the local community or on-site using the newest CDC resources.

As a reminder, through enforcement discretion, CMS allows Medicare-enrolled immunizers, including but not limited to pharmacies working with the U.S., to bill directly and get direct reimbursement from the Medicare program for vaccinating Medicare skilled nursing facility residents. See, Medicare billing and payment information.

Long-term care another healthcare providers also need to continue to ensure that they meet all other contagious disease and related requirements for participation in these federal programs as well as our meeting and managing their occupational health and safety, occupational injury, sick and disability leave, employee benefit, accommodation and anti retaliation mandates. See, e.g. SCOTUS To Hear Oral Arguments on OSHA COVID-19 Vaccination Rule Enforceability On January 7; COVID-19 Vaccination Rule Injunctions Leave Employers With Significant Liability Challenges Even As OSHA Extends Comment Period on OSHA COVID-19 Vaccine ETS

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About the Author

Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.

As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

This involvement encompasses helping health care systems and organizations, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers 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, EHR, 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; 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. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; 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 actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.

Author of a multitude of health industry and other highly regarded publications and presentations, 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 and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, 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, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.

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

Justice Department COVID & Other Health Care Fraud Enforcement Thriving Despite Pandemic Emergency

November 23, 2021

Federal health care fraud prosecution continues to thrive despite the ongoing COVID-19 health care emergency.

Recently announced prosecutions and other enforcement actions include Fraud & Abuse, False Claims Act and other health care fraud prosecutions commonly pursued by the Justice Department in recent decades as well as a host of new prosecutions of abuses of Covid-19 relief programs. Examples include:

These and other actions send a clear message to health care and life science organizations to continue vigorous health care fraud compliance and risk management activities as well as stay vigilant for signs of new audit and enforcement activities.

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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

CMS Hosts Virtual Forum On Quality Initiative Updates

September 16, 2021

Learn more about recent changes to the Center for Medicare & Medicaid Services (“CMS”) Quality Measurement and Value-Based Incentives Group (“QMVIG”) quality initiatives during its upcoming Bi-Monthly Forum on Tuesday, September 28 from 1:30 – 2:30 p.m. ET.

During this webinar, CMS says attendees will learn about and have opportunities to ask CMS questions about quality reporting programs and initiatives that directly impact their organizations.

CMS says forum will include updates on the following topics:

Medicare Promoting Interoperability Program
Electronic Clinical Quality Improvement (eCQI) Resource Center
Clinical Quality Language Libraries
Annual Change Review Process
Quality Payment Program (QPP)
Alternative Payment Models (APMs) and the APM Performance Pathway

CMS requires persons desiring to participate to register using the filling link and information:

Registration URL: https://register.gotowebinar.com/register/744915146676315659
Webinar ID: 556-206-925

If you have questions regarding registration, want to receive future communications regarding the forum, email CMS at CMSQualityTeam@ketchum.com.

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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.

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This article is republished by permission of the author, Cynthia Marcotte Stamer. 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.

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Posted by Cynthia Marcotte Stamer

Biden-Harris Administration to Expand Vaccination Requirements for Health Care and Many Other Employers

September 9, 2021

All Medicare and Medicaid certified health care facilities, and a broad range of other employers must prepare to meet impending new federal COVID-19 vaccine mandates announced by the Biden-Harris Administration today.

According to today’s announcements all healthcare facilities participating in Medicare or Medicaid or employing 100 or more employees will be required to ensure all staff are vaccinated against COVID-19.

The Biden-Harris Administration says the new health industry COVID-19 vaccine mandates will be implemented through emergency regulations to be issued in October.

According to today’s announcement, the Centers for Medicare & Medicaid Service (“CMS”) in collaboration with the Centers for Disease Control (“CDC”) is developing an Interim Final Rule with Comment Period that will be issued in October that will extend vaccine mandates originally announced last month for all Medicare and Medicaid participating nursing home workers to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. See CMS/CDC Mandating COVID Vaccination For All Nursing Home Staff.

The announcement of the vaccine mandates for healthcare workers coincides with the Biden-Harris Administration’s announcement of sweeping new vaccine mandates for all government workers, government contractors and employers employing more than 100 employees.

The two mandates will force most health care facilities to impose mask mandates for all staff in order to meet the requirement all staff be vaccinated.

CMS and CDC say the decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19. They claim the action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities.

According to the CDC, nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant.

In it’s announcement of the impending vaccination requirements, CDC urged health care facilities to prepare now to meet the new mandate in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements.

CDC also urged any health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately and facilities to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.

While legal challenges to the mandate requirements are likely, most facilities that have not already adopted vaccine mandates are expected to adopt these mandates rather than risk losing eligibility for Medicare and Medicaid reimbursement and other sanctions.

Beyondprogram disqualification and attendant financial pressures, announcement of the new vaccine mandates adds vaccination to the list of safety safeguards that healthcare facilities as employers can expect to be required to enforce as part of the occupational safety rules of the Occupational Safety and Health Administration (”OSHA”).

OSHA already is sanctioning employers for violating COVID-19 related OSHA requirements. For instance, OSHA nailed Lakewood Resource and Referral Center Inc., dba Center for Education Medicine and Dentistry (CHEMED) with heavy fines for allegedly violating applicable COVID-19 safety guidelines in January, 2021.

In a July 23, 2021 citation letter, OSH proposes to fine CHEMED $273,064.00 for willfully violating OSHA by not providing a medical evaluation to determine each employee’s ability to use a N95 respirator, before the employee was fit tested or required to use the respirator in the workplace to protect against SARS-CoV-2 virus while testing suspected COVID-19 individuals.

In addition to the proposed fine, the citation also orders CHEMED to take a series of corrective actions and to post notices in the workplace informing workers of the violation.

Along with the CHEMED citation, OSH also cited a staffing agency contracted to provide nursing staffing to CHEMED, Homecare Therapies for also failing to conduct medical evaluations and fit tests. It received two violations and a proposed fine of $13,653.

In the face of these potential consequences, most covered health care facilities and other employers impacted by the mandate are likely to implement mandates unless and until these requirements are struct down by the courts or withdrawn.

Assuming the Administration follows appropriate procedures to adopt the rules, most legal commentators do not expect the legal challenges opposing the mandate orders to be successful in the courts particularly after the Supreme Court refused to overturn or hear arguments for overturning a unanimous decision of a three-judge panel of the United States Court of Appeals for the Seventh Circuit in Klassen v. Trustees of Indiana University that refused to enjoin a vaccine mandate imposed by Indiana University as a condition of student or staff in person participation in classes or other activities.

While most healthcare and other covered businesses are not expected to challenge the rules, compliance us likely to trigger backlash from some unvaccinated workers strongly opposed to becoming vaccinated. Employers may find that some employees will resign their employment or take other tactics to avoid becoming vaccinated. Even those who elect to become vaccinated to retain their employment are likely to express opposition and dissatisfaction that could create liability exposures for the employers if it becomes a basis for retaliation claim.

Employers in Texas and certain other states that have adopted rules restricting or prohibiting vaccine, mask or other mandates also may face challenges based on the state rules.

In light of these and other uncertainties and challenges, Healthcare and Other or Employers generally should seek legal advice and assistance from legal counsel experienced with the relevant health care, labor and employment, privacy and other concerns.

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

About the Author

Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.

Ms. Stamer has extensive experience advising, representing, defending, and training domestic and international public and private business, charitable, community and governmental organizations and their leaders, employers, employee benefit plans, their fiduciaries and service providers, insurers, and others has published and spoken extensively on these concerns. As part of these involvements, she has worked, published and spoken extensively on these and other human resources, employee benefits, compensation, worker classification and other workforce and other services; insurance; health care; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other performance, risk management, compliance, public policy and regulatory affairs, and other operational concerns.

A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, 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, 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 many others.

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

CMS/CDC Mandating COVID Vaccination For All Nursing Home Staff

August 18, 2021

The Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC), announced today plans to mandate COVID-19 vaccination for all Medicare and Medicaid-participating nursing home staff.

The joint announcement released today states the agencies are developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare and Medicaid-participating nursing homes.

The agencies view the new requirement as a key component of protecting the health and safety of nursing home residents and staff.

Today’s action is in keeping with CMS’s authority to establish requirements to ensure the health and safety of individuals receiving care from all providers and suppliers participating in the Medicare and Medicaid programs. About 62% of nursing home staff are currently vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%. The emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States with the lowest staff vaccination rates.

In May, the Agency issued new regulations that require Long-Term Care (LTC) facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to educate residents, clients, and staff about COVID-19 vaccination and, when available, offer a COVID-19 vaccine to these individuals. These regulations also mandate that LTC facilities report weekly COVID-19 vaccination data for residents and staff to the CDC’s National Healthcare Safety Network (NHSN).

Today’s announcement states the agencies will continue to analyze vaccination data for residents and staff from the CDC’s National Healthcare Safety Network (NHSN) data as an additional method of compliance monitoring and in keeping with current practice, as well as deploy the Quality Improvement Organizations (QIOs)—operated under the Medicare Quality Improvement Program—to educate and engage nursing homes with low rates of vaccinations.

Meanwhile, the announcement strongly encourages nursing home residents and staff members to get vaccinated as the Agency undergoes the necessary steps in the rule-making process over the course of the next several weeks. CMS expects nursing home operators to act in the best interest of residents and their staff by complying with these new rules, which the Agency expects to issue in September.

According to today’s announcement, CMS also expects nursing home operators to use all available resources to support employees in getting vaccinated, including employee education and vaccination clinics, as they work to meet this staff vaccination requirement.

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

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Leave a Comment » | Academic medicine, Centers For Disease Control, Conditions of Participation, Covid, Doctor, Employer, Employment, Employment law, Federal Health Center, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, health care reimbursement, Health Policy, healthcare, HHS, Hospice, Hospital, hospitals, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, long-term care, Medicaid, Medicaid Advantage, Medicare, Medicare Advantage, Mental Health, nursing home, OSHA, Physician, Public Policy, quality reporting, Reimbursement, Skilled Nursing Facility, substance abuse treatment, Whistleblower | Tagged: Health Care, Hospital, Covid, Long-term care, Medicare, nursing home, Physician, vaccination | Permalink
Posted by Cynthia Marcotte Stamer

California Medical Privacy Rules Eased. New 7/1/2021 rules allow greater flexibility on disclosures of breach and give agency more fine flexibility. https://www.cdph.ca.gov/Programs/OLS/CDPH%20Document%20Library/DPH-11-009-Final-Reg-Text-ADA.pdf?TSPD_101_R0=087ed344cfab2000e6180d5b948228963ad32da0f65608ac719d6195a6f27133d24ce863d99f043c0837b3f91e1430004ffeef0033a9cb5c891c837f86137a340f296f3e726ff679e108e054e92eb347c0a393522a8d745468b6d859b3ba0e76

August 3, 2021

California Medical Privacy Rules Eased. New 7/1/2021 rules allow greater flexibility on disclosures of breach and give agency more fine flexibility. https://www.cdph.ca.gov/Programs/OLS/CDPH%20Document%20Library/DPH-11-009-Final-Reg-Text-ADA.pdf?TSPD_101_R0=087ed344cfab2000e6180d5b948228963ad32da0f65608ac719d6195a6f27133d24ce863d99f043c0837b3f91e1430004ffeef0033a9cb5c891c837f86137a340f296f3e726ff679e108e054e92eb347c0a393522a8d745468b6d859b3ba0e76

Leave a Comment » | Academic medicine, ambulance, Corporate Compliance, Cyber crime, data breach, data security, Doctor, Electronic Health Records, Electronic Medical Records, Emergency Care, Employer, Genetic Information, GINA, Health Care, Health Care Provider, Health IT, Health Plan, Health Plans, healthcare, HIPAA, HIPAA Cyber Crime, Hospice, Hospital, hospitals, Life Sciences, managed care, Medical Privacy, Medical Records, NIST, nursing home, occupational health, OCR, ONC, Pharmacy, Physician, Physician Licensing, Privacy | Tagged: California, Data Breach, Health Care, Medical Privacy, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

CDC Exempts Unaccompanied Migrant Children From Quarantine Requirements.

July 22, 2021

The Centers for Disease Control and Prevention (CDC) is exempting unaccompanied noncitizen children (UC) from the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on October 13, 2020 (October Order).

The Order published here in today’s Federal Register, took effect on July 16.

In the Order CDC finds “appropriate infrastructure in place to protect the children, caregivers, and local communities from elevated risk of COVID–19 transmission as a result of the introduction of UCs, and U.S. healthcare resources are not significantly impacted by providing UC necessary care. CDC adopted these findings despite its simultaneous alerts to schools and the public generally about the need for tighter protocols to protect children given rising infection rates among children and teens. See here. The Order highlights the challenges the Biden Administration immigration policy creates for CDC COVID containment.

CDC believes the COVID–19-related public health concerns associated with UC introduction can be adequately addressed without the UC being subject to the October Order, thereby permitting the government to better address the humanitarian challenges for these children.

Based on these findings, CDC is fully excepting UC from the October Order, and the Notice regarding the temporary exception of UC published February 17, 2021 is hereby superseded.

More Information

If you are interested in a more detailed description of this or other developments discussed in this article, see here.

If you 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 or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.

About the Author

Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.

A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

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 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 your profile here. ©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

OCR Guidance Urges Cyber Security Response To Kaseya VSA Supply-Chain Ransomware Attack

July 8, 2021

Responding to the July 2, announcement by IT software management company Kaseya VSA an that a supply-chain ransomware attack leveraged a vulnerability in the Kaseya RMM Tool against multiple managed service providers (MSPs) and their customers, the Office of Civil Rights (“OCR”) is urging health care providers, health plans, health care clearinghouses and their managed service providers (“MSPs”) and other business associates to follow guidance from the Cybersecurity and Infrastructure Security Agency (CISA) and Federal Bureau of Investigation (“FBI”) for customers affected by the Kaseya VSA Supply-Chain ransomware attack.

Organizations that used or used service providers that used these tools should review and take appropriate action in response to the guidance from the U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the Federal Bureau of Investigation (FBI); and the Kaseya advisory.

CISA and FBI also recommend affected MSPs and other parties

Contact Kaseya at support@kaseya.com with the subject “Compromise Detection Tool Request” to obtain and run Kaseya’s Compromise Detection Tool available to Kaseya VSA customers. The tool is designed to help MSPs assess the status of their systems and their customers’ systems.
Enable and enforce multi-factor authentication (MFA) on every single account that is under the control of the organization, and—to the maximum extent possible—enable and enforce MFA for customer-facing services.
Implement allow listing to limit communication with remote monitoring and management (RMM) capabilities to known IP address pairs, and/or
Place administrative interfaces of RMM behind a virtual private network (VPN) or a firewall on a dedicated administrative network.

CISA and FBI recommend affected MSP customers ensure backups are up to date and stored in an easily retrievable location that is air-gapped from the organizational network;

CISA and FBI also recommend MSP customers affected by this attack take immediate action to implement the following cybersecurity best practices. Note: These actions are especially important for MSP customer who do not currently have their RMM service running due to the Kaseya attack.For guidance specific to this incident from the cybersecurity community, see Cado Security’s GitHub page,Resources for DFIR Professionals Responding to the REvil Ransomware Kaseya Supply Chain Attack.Note: Due to the urgency to share this information, CISA and FBI have not yet validated this content.

For advice from the cybersecurity community on securing against MSP ransomware attacks, see Gavin Stone’s article, How secure is your RMM, and what can you do to better secure it?.

For general incident response guidance, CISA encourages users and administrators to see Joint Cybersecurity Advisory AA20-245A: Technical Approaches to Uncovering and Remediating Malicious Activity.

More Information

If you are interested in a more detailed information about this or other developments discussed in this article, see here.

About the Author

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 such as:

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Posted by Cynthia Marcotte Stamer

CMS Updates COVID-19 Accelerated and Advance Payments FAQs

July 8, 2021

Providers that received COVID-19 accelerated and advance payments should read the Centers for Medicare and Medicaid Services (“CMS”) updated FAQs (PDF) about repayment of COVID-19 accelerated and advance payments to learn how recoupment works and how it affects the provider’s Medicare claims payment amounts.

The new FAQ updates the Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021 (PDF) guidance.

For more information and to follow future updates, see the COVID-19 Accelerated and Advance Payments webpage or contact the author of this update.

More Information

If you are interested in a more detailed description of this or other developments discussed in this article, see here.

About the Author

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 such as:

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Posted by Cynthia Marcotte Stamer

Health Care Employers Should Brace For Increased Workforce Costs & Risks Under American Rescue Plan Act Of 2021 Minimum Wage Amendments

March 2, 2021

Health care organizations should brace for sharp increases in their wage and other workforce costs and risks if Senate Democrats succeed as expected in their plan to pass as early as this week the American Rescue Plan Act of 2021 (the “Act”) passed by the House of Representatives on Friday, February 24, 2021.

The Act’s amendments to the minimum wage rates and other provisions of the Fair Labor Standards Act of 1938 (“FLSA”) upon enactment immediately increase the federal minimum wage for non-exempt employees by $2.25 per hour and subsequently will continue to annually increase the federal minimum wage. The Act also phases out current rules allowing employers to pay tipped employees, new employees under age 20 and handicapped employees less than the regular minimum wage over the next five years. Furthermore, the reach and exposure resulting from these amendments are heightened further by the Biden-Harris Administration’s move to return to the proemployee Obama-era worker classification, joint-employer and other FLSA interpretation and enforcement policies and practices abandoned during the Trump Administration.

Senate Majority Leaders Chuck Schumer has announced plans to schedule a vote in the Senate on the Act the first week in March. With Congressional Democrats currently holding the majority of seats in the Senate by a narrow margin, the Act stands an excellent chance of enactment when put to the vote.

Given their heavy reliance on nonexempt employees and contract staffing, these changes obviously will hit health care and other workforce dependent industries hard.

Consequently, U.S. businesses should prepare to deal with these impending requirements. In response to these developments, most U.S. businesses should both prepare to implement anticipated changes in the federal minimum wage for their recognized employees as well assess their likely exposure to added costs and liabilities arising from workers rendering services to their businesses directly or indirectly as independent contractors, through subcontractor relationships or in other capacities that the business dues not view as an employment relationship.

Act’s Federal Minimum Wage Amendments

Introduced and promoted by House Democrats as their latest COVID-19 relief package, Section 2101 of the Act amends the FLSA to immediately increase the federal minimum wage for all employees as well as phases out special FLSA minimum wage rates for tipped employees, new employees under 20 years of age and handicapped workers covered by Labor Department FLSA certificates.

Aside from the direct impact of these increases to the base minimum wage, the significance and cost of these increases for U.S. businesses will be further heightened by the Biden-Harris Administration’s plan to reimplement Obama-era FLSA worker classification rules that treat as employees workers providing services under contract labor relationships historically characterized as independent contractor, subcontractor and other non-employee capacities as well as narrow other requirements for treating workers as exempt from the FLSA minimum wage and overtime requirements as well as step up enforcement of FLSA rules.

Regulatory & Enforcement Changes Heighten Health Industry Risks

Health industry leaders and organizations assessing their costs and exposures from the Act’s amendments to the FLSA should take into account the likely impact of the implications of the Biden-Harris Administration’s policies expanding the scope of the FLSA and other federal laws through revisions and enforcement of rules for characterizing workers as employees rather than independent contractors and enforcing expansive joint employer liability rules as well as other announced or expected Biden-Harris Administration proworker regulatory and enforcement changes expected to expand the potential reach and cost of the Act’s increases to federal minimum wage rates.

Even before the Biden-Harris Administration took office, health care industry employers were the subject of heightened attention and enforcement by WHD. Consistent with this high attention to health industry compliance and oversight, WHD already has sanctioned several health industry employers since the first of the year. See, e.g., Ohio Health Care Service Provider For Individuals With Developmental Disabilities Pays $92K In Overtime Back Wages To 61 Employees (February 5, 2021)(Failure to pay overtime.); Modesto Residential Care Facilities To Pay Employees $135K In Back Wages After US Department Of Labor Finds Minimum Wage, Overtime Violations (February 5, 2021) (Owner of eight residential care facilities in Modesto will pay $135,092 in back wages to 56 employees and $27,872 in civil penalties); U.S. Labor Department Recovers $35,492 in Overtime Back Wages For 12 Employees of Pittsburgh Area Ambulance Service (January 4, 2021) (Jefferson Hills Area Ambulance Association – a private ambulance service operating as Southeast Regional EMS in Clairton and Elizabeth, Pennsylvania paid $35,492 in back wages to 12 first responder employees for FLSA overtime violations); U.S. Department Of Labor Recovers $81,399 In Back Wages For 45 Employees Of Columbus, Ohio, Nursing Home (December 30, 2020) (Chelsea Health Care LLC paid $81,399 in back wages to 45 employees for FLSA overtime violations).

These historical exposures have been heighted as the COVID-19 crisis has taxed the staffing resources of many health care organizations and forced others to implement remote work and other COVID-19 driven adjustments disrupting typical staffing, timekeeping and other resources.

Amid these continuing challenges, policy and enforcement challenges by the Biden-Harris Administration are raising health industry exposures. Shortly after the Biden-Harris Administration took over in January, the WHD ended a Trump Administration Payroll Audit Independent Determination Program that offered noncompliance employers a pathway to voluntary compliance. See US Department Of Labor Ends Program That Allowed Employers To Self-Report Federal Minimum Wage And Overtime Violations.

Since taking office, the Biden-Harris Administration also has made clear it plans to review and challenge workers as exempt from the FLSA minimum wage and overtime rules based upon independent contractor or other characterizations of workers rendering services critical to operations as non-employees. In furtherance of these goals, the Biden-Harris Administration’s January 20, 2021 Memorandum on Regulatory Freeze Pending Review suspended the implementation of the Trump Administration led Labor Department’s Final Rule: Independent Contractor Status under the Fair Labor Standards Act slated to take effect on March 8, 2021, which sought to reinstitute and clarify historical policies for distinguishing employee versus independent contractor relationships and for determining the existence of joint employer status for purposes of the FLSA established by judicial precedent prior to the Obama Administration.

Subsequently, the Biden-Harris Administration led Department of Labor Wage and Hour Division (“WHD”) also has acted aggressively to reimplement and enforce Obama Administration-era standards and practices for distinguishing employees from independent contractors. Among other things, it has withdrawn Trump Ear WHD opinions which applied the more expansive view of independent contractor status contemplated by the now suspended Trump Administration-issued Final Regulations as compared to the more narrow standards applied for administration and enforcement during the Obama Administration.

Proactively Manage Compliance & Risks

Given these signals, health care and other organizations should prepare to defend against WHD and private plaintiffs efforts to use the Biden-Harris Administration’s more employee friendly interpretation and enforcement policies to attack employer characterizations of workers as contractors relied upon by the employing organization to justify nonpayment of minimum wage and overtime to those workers.

In making these preparations, health care organizations should scrutinize and tighten both their own wage and hour practices as well as their contracts, recordkeeping and retention and compliance auditing of any staffing, contract labor, subcontractors and other third-party service providers to reduce potential liability. Advance planning and efforts for work provided by contractors or other third parties is particularly critical as FLSA liabilities arising from misclassification of workers as independent contractors or joint employer liability claims can be both hard to defend and expensive because the organization charged often lacks sufficient management oversight, involvement or records to launch an effective defense. The Biden-Harris Administration has made clear that it plans to move quickly to reinstitute the regulatory and enforcement practices used during the Obama Administration to aggressively challenge employers’ characterization of workers as exempt from the FLSA’s minimum wage and overtime rules as independent contractors. Health care and other organizations receiving services from contractors or other third parties often can reduce reclassification or joint employer exposures by strengthening contractual, data reporting and collection, processes and other practices.

More Information

If you are interested in a more detailed description of the Act’s FLSA provisions and other developments discussed in this article, see here. The FLSA reforms are only one of a number of provisions of the Act impacting employers and their employee benefit plans.

About the Author

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 such as:

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Posted by Cynthia Marcotte Stamer

Biden-Harris Plan To Beat COVID-19 Includes Plan To Expand Medicare, Other Health Care Plans

January 21, 2021

Newly sworn in President Joe Biden chose to make an executive order outlining the core principles for his Administration’s policy for fighting COVID-19 the first signed in his new administration.

The text of the COVID-19: The Biden-Harris plan to beat COVID-19 reads as follows:

The American people deserve an urgent, robust, and professional response to the growing public health and economic crisis caused by the coronavirus (COVID-19) outbreak. President Biden believes that the federal government must act swiftly and aggressively to help protect and support our families, small businesses, first responders, and caregivers essential to help us face this challenge, those who are most vulnerable to health and economic impacts, and our broader communities – not to blame others or bail out corporations.

The Biden-Harris administration will always:

Listen to science
Ensure public health decisions are informed by public health professionals
Promote trust, transparency, common purpose, and accountability in our government
President Biden and Vice President Harris have a seven-point plan to beat COVID-19.

Ensure all Americans have access to regular, reliable, and free testing.

Double the number of drive-through testing sites.
Invest in next-generation testing, including at home tests and instant tests, so we can scale up our testing capacity by orders of magnitude.
Stand up a Pandemic Testing Board like Roosevelt’s War Production Board. It’s how we produced tanks, planes, uniforms, and supplies in record time, and it’s how we will produce and distribute tens of millions of tests.
Establish a U.S. Public Health Jobs Corps to mobilize at least 100,000 Americans across the country with support from trusted local organizations in communities most at risk to perform culturally competent approaches to contact tracing and protecting at-risk populations.
Fix personal protective equipment (PPE) problems for good.

President Biden is taking responsibility and giving states, cities, tribes, and territories the critical supplies they need.

Fully use the Defense Production Act to ramp up production of masks, face shields, and other PPE so that the national supply of personal protective equipment exceeds demand and our stores and stockpiles — especially in hard-hit areas that serve disproportionately vulnerable populations — are fully replenished.
Build immediately toward a future, flexible American-sourced and manufactured capability to ensure we are not dependent on other countries in a crisis.
Provide clear, consistent, evidence-based guidance for how communities should navigate the pandemic – and the resources for schools, small businesses, and families to make it through.

Social distancing is not a light switch. It is a dial. President Biden will direct the CDC to provide specific evidence-based guidance for how to turn the dial up or down relative to the level of risk and degree of viral spread in a community, including when to open or close certain businesses, bars, restaurants, and other spaces; when to open or close schools, and what steps they need to take to make classrooms and facilities safe; appropriate restrictions on size of gatherings; when to issue stay-at-home restrictions.
Establish a renewable fund for state and local governments to help prevent budget shortfalls, which may cause states to face steep cuts to teachers and first responders.
Call on Congress to pass an emergency package to ensure schools have the additional resources they need to adapt effectively to COVID-19.
Provide a “restart package” that helps small businesses cover the costs of operating safely, including things like plexiglass and PPE.
“THIS ISN’T ABOUT POLITICS. IT’S ABOUT SAVING LIVES.”

PRESIDENT BIDEN, SEPTEMBER 16, 2020
Plan for the effective, equitable distribution of treatments and vaccines — because development isn’t enough if they aren’t effectively distributed.

Invest $25 billion in a vaccine manufacturing and distribution plan that will guarantee it gets to every American, cost-free.
Ensure that politics plays no role in determining the safety and efficacy of any vaccine. The following 3 principles will guide the Biden-Harris administration: Put scientists in charge of all decisions on safety and efficacy; publicly release clinical data for any vaccine the FDA approves; and authorize career staff to write a written report for public review and permit them to appear before Congress and speak publicly uncensored.
Ensure everyone — not just the wealthy and well-connected — in America receives the protection and care they deserve, and consumers are not price gouged as new drugs and therapies come to market.
Protect older Americans and others at high risk.

President Biden understands that older Americans and others at high-risk are most vulnerable to COVID-19.

Establish a COVID-19 Racial and Ethnic Disparities Task Force, as proposed by Vice President Harris, to provide recommendations and oversight on disparities in the public health and economic response. At the end of this health crisis, it will transition to a permanent Infectious Disease Racial Disparities Task Force.
Create the Nationwide Pandemic Dashboard that Americans can check in real-time to help them gauge whether local transmission is actively occurring in their zip codes. This information is critical to helping all individuals, but especially older Americans and others at high risk, understand what level of precaution to take.
Rebuild and expand defenses to predict, prevent, and mitigate pandemic threats, including those coming from China.

Immediately restore the White House National Security Council Directorate for Global Health Security and Biodefense, originally established by the Obama-Biden administration.
Immediately restore our relationship with the World Health Organization, which — while not perfect — is essential to coordinating a global response during a pandemic.
Re-launch and strengthen U.S. Agency for International Development’s pathogen-tracking program called PREDICT.
Expand the number of CDC’s deployed disease detectives so we have eyes and ears on the ground, including rebuilding the office in Beijing.
Implement mask mandates nationwide by working with governors and mayors and by asking the American people to do what they do best: step up in a time of crisis.

Experts agree that tens of thousands of lives can be saved if Americans wear masks. President Biden will continue to call on:

Every American to wear a mask when they are around people outside their household.
Every Governor to make that mandatory in their state.
Local authorities to also make it mandatory to buttress their state orders.
Once we succeed in getting beyond this pandemic, we must ensure that the millions of Americans who suffer long-term side effects from COVID don’t face higher premiums or denial of health insurance because of this new pre-existing condition. The Biden-Harris Administration will work to ensure that the protections for those with pre-existing conditions that were won with Obamacare are protected. And, they will work to lower health care costs and expand access to quality, affordable health care through a Medicare-like public option.

As the new Administration and Congress get down to work, health industry organizations as well as all other U.S. organizations and communities, their leaders, and individual employees and citizens should carefully follow, and share their input to the Administration, members of Congress, and other federal, state and local officials on the actions and proposals taken to implement this and other policy that impact their interests. The need for careful attention and scrutiny is particularly important for health, managed care and insurance and management organizations as President Biden made clear throughout his campaign his intent to pursue legislative and regulatory reforms that would reverse actions of the previous administration as well as implement addition reforms to expand coverage and regulation of health care, workforce and other critical policies.

More Information

About the Author

An attorney board certified in labor and employment law by the Texas Board of Legal Specialization and Fellow in the American College of Employee Benefit Counsel, Ms. Stamer has worked as an on demand, special project, consulting, general counsel or other basis with health care providers, health insurers, employer and other management organizations, health and other employee benefit plans, their sponsors, insurers, administrators, providers and others and others has published and spoken extensively on these concerns.

A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor and advocate for employer and other plan sponsors, fiduciaries, administrators, insurers, technology and other service providers, managed care organizations, direct primary care and other health care providers and others on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com or contact Ms. Stamer 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 such as:

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Posted by Cynthia Marcotte Stamer

Comment & Begin Preparation For Compliance With Proposed HIPAA Privacy Rule Changes

December 21, 2020

Health care providers, health plans and health insurers, health care clearinghouses (“Covered Entities”) and their business associates should budget and begin compliance plans, even as they comment on proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule announced by the Department of Health & Human Services Office of Civil Rights (“OCR”) in its December 10, 2020 Notice of Proposed Rulemaking (“Proposed Rule). While the official Federal Register publication date has yet to be announced, OCR already is accepting comments pending the official publication. To assure consideration, comments must be received by OCR no later than 60 days from that official Federal Register publication date.

More than 300 pages in length, the proposed HIPAA Privacy Rule changes include changes OCR intends to strengthen individuals’ rights to access their own electronic and other health information; improve information sharing for care coordination and case management for individuals; facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhance flexibilities for disclosures in the Opioid and COVID-19 public health emergencies or other emergency or threatening circumstances; and reduce administrative burdens on HIPAA covered health care providers and health plans. Highlights of some of the more significant proposed changes that the Proposed Rule will make if adopted as proposed include:

Individual Access Rights Expanded

The Proposed Rule includes a number of changes that if adopted as proposed, will increase significantly the burdens upon Covered Entities of complying with the individual access requirements of the Privacy Rule. Among other things, these include the following:

Responding To Access Requests. The Proposed Rule calls for:
Reducing the maximum period that Covered Entities have to respond to requests to “as soon as practicable,” but in no case later than 15 calendar days after receipt of the request” instead of current 30 calendar days;
Clarifying the current requirement for Covered Entities to provide PHI in the form and format requested by the individual if “readily producible” in that form and format by providing that “readily producible” includes secure, standards-based APIs using applications chosen by the individuals, such as a “personal health application” and protect individual’s rights to take notes, videos, and photographs, or use other personal resources to view or capture PHI in person;
Requiring Covered Entities to allow individuals access to inspect or obtain copies of their own PHI Free of charge when inspecting in person or accessing PHI on the internet, but continue to permit certain fees for labor, supplies, and postage for certain other means of access in accordance with Privacy Rules parameters. In acquiescence to the District Court’s January, 2020 holding that the prohibition against Covered Entities charging for third party copies in the current regulations exceeded its statutory authority in Ciox Health, LLC v. Azar, however the Proposed Rule would allow Covered Entities to charge limited fees to an individual directing transmission of an electronic copy of PHI to a third party under specified circumstances. The Proposed Rule also would require Covered Entities to provide advance notice of estimated fee schedules on their websites (if they have one) for common types of requests for copies of PHI and, upon request, provide individualized estimates of fees for copies and an itemized list of actual costs for requests for copies.
Right to Direct Copies to Third Parties. The Proposed Rule will require Covered Entities to transmit electronic PHI in an electronic health record to another Covered Entity as part of the individual’s access right. In addition, also in response to the Coix Health, LLC ruling, the Proposed Rule will limit the current right of an individual to direct a copy of PHI to a third party to an electronic copy and will specify that third party direction request need not be in writing as long as it is “clear, conspicuous, and specific.”
Verification. The Proposed Rule also would prohibit a Covered Entity from imposing “unreasonable” identity verification measures on an individual, including notarization of requests, requiring the individual to provide proof of identity in person when remove verification would be practicable, or requiring the individual to complete a full HIPAA authorization form for an access request.

Encouraging Care Coordination and Case Management Activities

The Proposed Rule also would make a number of changes that OCR believes will remove the barriers created in the current Privacy Rule to Covered Entities, whether a health care provider or health plan, engaging in individual-level care coordination and case management activities. Some of the key elements of these changes include the following:

Clarification of Rules For Individual-Level Care Coordination. The Proposed Rule would revise existing rules regarding sharing of information for individual-level care coordination to apply to Covered Entities involved in such coordination activities, whether or not the participating Covered Entity is participating in the actual care or treatment of the individual by:
- Revising the definition of “health care operations” in the current version of the Privacy Rule to clarify that the Privacy Rule allows sharing of PHI for individual-level care coordination among Covered Entities whether or not the participating Covered Entity is one involved in treatment or non-treatment involved Covered Entities such as health plans;
- Revises the current minimum necessary restriction on the disclosure of PHI for purposes of individual-level care coordination to treat all Covered Entities engaging in individual-based care coordination and case management activities the same, regardless of whether performing the activities under the “treatment” or “health care operations” functions as defined by HIPAA. Currently non-treatment involved Covered Entities participating in care coordination and case management can only receive and share the minimum necessary PHI as their lack of involvement in treatment disqualifies them for reliance upon the treatment exception to the Privacy Rule’s general requirement to limit disclosures to the minimum necessary.
- The Proposed Rule also would allow Covered Entities to disclose PHI to community-based organizations, home and community-based services (HCBS) providers, social services agencies, and other similar third parties providing health-related services for individual-level care coordination and case management without obtaining a valid authorization from the individual.

Required Updates To Notices of Privacy Practices

The Proposed Rule also would change the Privacy Rule Notice of Privacy Practices (“NPP”) requirements in a manner that would require most Covered Entities to update their NPPs and associated privacy policies. In the Proposed Rule, OCR proposes:

Replacing the requirement that certain Covered Entities that have a direct treatment relationship with an individual obtain, and retain copies of, written acknowledgements from that individual confirming their receipt of the NPP with a right for the individual to discuss the NPP with a designee of the Covered Entity.
- Modification of the required NPP content to include an additional description and instruction as to how individuals can exercise their access rights and a new, more detailed and instructive, required header meeting new specifications about the information the NPP provides to individuals with respect to their rights, how to exercise them, and the availability of the Covered Entity’s designated contact person.

Disclosures to Family Members and Other Caretakers in Certain Situations

Continuing a trend that OCR has followed over the past several years in its other guidance, the Proposed Rule also would modify the Privacy Rule under specified conditions to facilitate if not encourage health care providers more broadly to disclose PHI to family members or other caretakers of individuals with substance use disorders (SUD) or serious mental illness (SMI) and in emergency situations with less concern about exposing themselves to liability under HIPAA. The key elements of these changes are accomplished as follows:

The Proposed Rule would replace the current language that allows Covered Entities to make certain uses and disclosures of PHI based on their “exercise of professional judgment” with language allowing disclosure based on a Covered Entity’s “good faith belief” that the use or disclosure is in the best interests of the individual and add a presumption of good faith by the health care provider for this purpose.
- The Proposed Rule would enable Covered Entities to disclose PHI to avert a threat to the health or safety of a person or the public when a harm is “serious and reasonably foreseeable,” instead of the current stricter requirement that the Covered Entity see a “serious and imminent” threat to health or safety.

Clarification Regarding Disclosures to TRS Providers

The Proposed Rule also would amend the current Privacy Rules to remove telephone relay service providers (“TRS providers”) from the definition of “business associates” and expressly to allow disclosures to TRS communications assistants for persons who are deaf, hard of hearing, deaf-blind, or who have a speech disability.

Act Now

HIPAA Covered Entities, business associates and other concerned or impacted persons immediately should begin evaluating the Proposed Rule as soon as possible. As the current comment will end 60 days after the impending publication of the Proposed Rule in the Federal Register, concerned persons desiring a change to any provision of the Proposed Rule should prepare and submit appropriate comments to OCR in a timely fashion within the comment period. In addition, all Covered Entities and their business associates should review the rule in preparation for its provisions taking effect with a particular eye toward understanding the actions necessary to comply with the modified rules and to budget the financial and operational resources likely to be required to accomplish that compliance.

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About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, 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. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers 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; 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. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; 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 actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.

Author of leading works on HIPAA and a multitude of other 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 and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, 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, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. 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 such as:

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Posted by Cynthia Marcotte Stamer

CMS Relief Allows Pharmacies, Other Medicare Immunizers To Bill For LTC Patient Immunizations

October 16, 2020

The Centers for Medicare & Medicaid Services (CMS) announced today it will allow Medicare-enrolled pharmacies and other immunizers to bill directly and receive direct reimbursement from the Medicare program for vaccinating skilled nursing facility residents under its COVID-19 discretionary enforcement. See CMS Special Edition 10/16/2020).

Typically, skilled nursing facilities are required to include and bill for the immunizations under Medicare rules but CMS is waiving this requirement temporarily as part of its effort to get residents immunized. CMS, the Centers for Disease Control, the Federal Drug Administration and other health care leaders view immunization against the flu a critical component of their effort to protect elderly nursing home patients against another surge of COVID-19 outbreaks this Fall.

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About the Author

REPORT THIS AD

Board Certified in Labor and Employment Law By the Texas Board of Legal Specialization, Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, and the ABA RPTE Employee Benefits & Other Compensation Group and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, 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, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive experience advising, representing, defending and training health care providers, health plans and insurers, employers, community organizations and others about HIPAA and other privacy concerns and has published and spoken extensively on these concerns.

Her involvement with HIPAA and other privacy and data concerns has taken place as part of her more than 30 years involvement working with with public and private health industry, health insurance and other employers and organizations of all sizes, employee benefit plans, insurance and financial services, health industry and a broad range of public and private domestic and international business, community and government organizations and leaders on pandemic and other health and safety, workforce and performance preparedness, risks and change management, disaster preparedness and response and other operational and tactical concerns throughout her adult life. A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on crisis preparedness and response, privacy and data security, workforce, health care and other policy and enforcement, as well as regularly advises and defends organizations about the design, administration and defense of their organizations workforce, employee benefit and compensation, safety, discipline and other management practices and actions.

REPORT THIS AD

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and shares insights and thought leadership through her extensive publications and public speaking. 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 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 your profile here. ©2020 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.

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Posted by Cynthia Marcotte Stamer

Pennsylvania OCR Settlement Warns Others Against Disability Or Other Civil Rights Discrimination In COVID-19 Resource Allocation & Other Response

April 30, 2020

OCR Says “No” To Allocating Respirators & Other Scarce COVID-19 Care Based On Pre-Existing Medical Conditions

This week’s Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) announcement of that the Pennsylvania Department of Health (PDH) has agreed to using a list of preexisting health care conditions to decide patient priority for access to respirators and other scarce resources during the COVID-19 health care emergency flags potential civil rights discrimination violations by the multitude of other State, local, tribal, and territorial public health policymakers, healthcare systems leadership, and other public emergency decision-makers and other public or private HHS funds recipients (collectively “COVID responders”) whose pandemic emergency response plans call for the use pre-existing health conditions or other civil rights act protected status of patients to ration scarce medical resources like ventilators or other scarce resources.

Coupled with other recent guidance warning COVID responders against discrimination and to provide all legally required accommodations for individuals with pre-existing conditions or disorders constituting disabilities, English as a second language, religion, age or other protected status under Section 504 of the Rehabilitation Act of 1973 (“Section 504”), Title II of the Americans with Disabilities Act (the “ADA”), Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) and other federal civil rights laws, health care providers, public health authorities and other COVID-19 responders should act immediately to review and take any action needed to correct civil rights law deficiencies in their own COVID-19 emergency policies or operations.

PDH Enforcement Shows Agencies’ Serious About COVID-19 Civil Rights Enforcement

OCR’s April 28, 2020, OCR announcement of PDH’s agreement to revise its Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines (CSC Guidelines) to revolve an April 3, 2020 civil rights complaint that PDH’s COVID-19 pandemic response plan illegally discriminated against patients with disabilities by denying or lowing the care priority of patients with certain listed preexisting health conditions shows that OCR and other federal agencies are carrying through on promises to take quick enforcement action against COVID-19 responders that violate federal discrimination and other civil rights laws when dealing with the COVID-19 public health emergency in the March 14, 2020 Crisis Standards of Care and Civil Rights Laws guidance (“CSC Guidelines”) and in OCR’s March 28, 2020 Civil Rights, HIPAA, and the Coronavirus Disease 2019 Bulletin (the “Bulletin”).

The CSC Guidelines jointly issued by the Health Care Resilience Taskforce (composed of HHS, FEMA, and the Army Corps of Engineers) warned public health, health care providers and other pandemic decisionmakers against adopting or applying policies in for managing ventilators or other constricted resources during the COVID-19 or other emergencies that negatively impact vulnerable populations (e.g., older adults and persons with disabilities). After reminding state, local, tribal, and territorial policymakers, healthcare systems leadership, and other decision-makers that civil rights laws are not suspended or waived in times of disaster, the CSC Guidelines cautioned “Federal civil rights laws and regulations apply, and have not been suspended, during the COVID19 national health emergency. Federal fund recipients must comply with those requirements.”

OCR reaffirmed the CSC Guidelines warnings in its March 28, 2020 Bulletin reminding health care providers and other HHS fund recipients the laudable goal of providing care quickly and efficiently during the COVID-19 health care emergency still must comply with federal civil rights prohibitions against disability discrimination in HHS funded programs under Section 1557, Section 504, and other civil rights laws, stating:

“persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities or age. Decisions by covered entities concerning whether an individual is a candidate for treatment should be based on an individualized assessment of the patient based on the best available objective medical evidence.”

The PDH disability discrimination investigation and resolution announced April 28^th resulted from OCR’s investigation of a civil rights complaint filed less than a week after OCR released the Bulletin by Disability Rights Pennsylvania and other disability rights groups. Like many other regional and facility pandemic response plans, the CSC Guidelines listed specific impairments or disabilities that would lead to greater deprioritization of patients for care during a pandemic emergency. The April 3 complaint against PDH charged that Pennsylvania’s CSC Guidelines violated Section 504, Title II, and Section 1557 by unlawfully authorizing the denial of treatment to individuals with disabilities when prioritizing access to critical care and ventilators. The complaint also alleged that the guidelines did not require an individualized assessment, but instead used “preexisting conditions that are disabilities” to determine a priority score.

OCR PDH COVID-19 Civil Rights Investigation & Settlement

Consistent with the warning provided in the Bulletin, OCR moved with rare speed to investigate the complaint and notify PDH of its civil rights concerns. To resolve potential OCR civil rights charges, OCR announced April 28, 2020 that PDH agreed to accept technical assistance from OCR and make the following revisions to its CDC guidelines:

Remove criteria that automatically deprioritized persons on the basis of particular disabilities,
Require individualized assessments based on the best available, relevant, and objective medical evidence to support triaging decisions, and
Ensure at no one is denied care based on stereotypes, assessments of quality of life, or judgments about a person’s “worth” based on the presence or absence of disabilities.

Based on these “responsive actions and the revisions” to its guidelines in response to OCR’s concern, the OCR announcement states that OCR is closing its complaint investigation as satisfactorily resolved without a finding of liability while noting that this does not preclude future OCR enforcement in cases of potential discriminatory implementation of Pennsylvania’s policies by any covered health care provider.

Other Public Health, Health Care & Other COVID Responders Should Confirm COVID-19 Civil Rights Response Compliance

The PDH announcement provides a strong warning to health care providers, public health authorities and other COVID-19 responders to act quickly to evaluate and make any necessary adjustments to redress any questionable disability or other civil rights concerns in their own COVID-19 or other emergency response plans or practices.

Even before the COVID-19 health care emergency, disability and other civil rights law enforcment already was a high priority for OCR and other federal agencies. See e.g., Civil Rights Settlement Highlights Health Industry Discrimination Risks As OCR Prepares To Broaden Requirements; OCR’s Proposed Sex & Other Discrimination Rules Spell Headaches & New Risks For Health Care Providers, Insurers & Others; Check Defensibility Of Policies & Practices Given New HHS/DOJ Joint Disability Law Technical Assistance; Important Lessons For Health Care Providers From Michigan State Settlement Of OCR Larry Nassar Sexual Abuse Investigation; Cognitive Disability Exclusion from Heart Transplant List Placement Prohibited.

The PDH announcement clearly alerts other health care providers and COVID-19 responders that OCR does not plan to slacken civil rights discrimination investigation or enforcement against health care providers or others because of the COVID-19 health care emergency. Rather, the PDH investigaiton and resolution make clear that COVID-19 responders need to use particular care take the well-documented steps necessary to ensure they can defend their ongoing compliance with disability discrimination and other federal civil rights laws throughout the COVID-19 health care emergency.

In this respect, OCR’s PDH announcement makes a point of clearly warning other public health, health care providers and other recipients of HHS funding across the nation against using preexisting conditions or other prohibited stereotypes or classifications of patients without individual assessments to triage and prioritize access to care or other resources for purposes of their COVID-19 or other pandemic planning or response. To emphasize the importance of continued compliance with these civil rights laws, the Bulletin quotes OCR Director Roger Severino, as stating: “Triage decisions must be based on objective and individualized evidence, not discriminatory assumptions about the prognoses of persons with disabilities” and “we must ensure that triage decisions are free from discrimination both in their creation and their application, and we will remain vigilant in achieving that goal.”

These warnings and OCR’s quick enforcement action make clear that OCR’s commitment to hold health care providers, state and local public health, and other COVID-19 responders accountable for ensuring their COVID-19 pandemic plans and operations don’t impermissibly discriminate against individuals with or needing accommodations for disabilities, limited English skills, religious beliefs, age or other status protected by HHS’ civil rights rules. Meanwhile, OCR’s reported willingness to accept PHD’s prompt corrective action without imposing financial sanctions also signals the probable willingness of OCR to show similar leniency to other health care providers or COVID-19 responders that for acting promptly to self-identify and redress potentially questionable past COVID-19 restricted resource allocation practices in response to the PDH announcement and other COVID-19 civil rights compliance guidance.

Given the often multimillion dollar penalties and other heavy sanctions that OCR already regularly imposes against a long and ever-growing list of state and other health care, child care, elder care, insurance and other entities for violating its civil rights nondiscrimination and accommodation requirements and the often significant judgements awarded to private litigant victims, state and local public health, health care providers and other COVID providers generally will want to review and tighten as advisable their existing practices to reduce the risk of being incuring penalties or judgments, being sanctioned, excluded or a combination of these consequences for violation of these nondiscrimination and other civil rights requirements by among other things:

Auditing the adequacy of their pandemic response and other plans, policies, practices and actions for allocating scarce resources and care during the COVID-19 health emergency and in other scarce resource situations;
Developing a strategy and procedures for receiving, investigating and responding with appropriate documentation to complaints or other indicators of potential civil rights violations or risks;
Taking prompt, documented action to reform and strengthen civil rights policies, practices and controls, training, investigations and other compliance and risk management;
Explore potential strategies, if any, to mitigate potential liability exposure to OCR or private litigant investigations or enforcement from past, ongoing or future policies or actions; and
Other actions to maintain and demonstrate their organization-wide culture of compliance with applicable civil rights laws.

Since organization and their leaders likely will be required to uncover and discuss legally and politically sensitive information in the course of these activities, public health, health care and other COVID responders are encouraged to consider engaging qualified legal counsel with relevant experience to advise and guide them in conducting, maintaining and using attorney-client privilege and other procedures to safeguard sensitive analysis, discussions and work product from avoidable discovery and other processes to promote the legal effectiveness and defensibility of their actions.

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. In addition to this update, the author of this article also is extensively published and frequent speaker on pandemic and other infectious disease, and other health industry crisis preparedness and response, and many other regulatory compliance, risk management and operations, public policy and other concerns. 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. also 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

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.

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 . 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 consulting, publications and other information, education, coaching, training, tools and other resources on leadership, governance, health care, human resources, employee benefits, insurance, public policy and regulatory affairs, data security and privacy 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 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 your profile here. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive license to republish granted to SOlSolutions Law Press, Inc.™ All other rights reserved.

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Posted by Cynthia Marcotte Stamer

CME Credit Offered For Providers Completing Online Replay Of 4/16 CDC Training On Certifying COVID-19 Deaths

April 16, 2020

Healthcare providers, the Centers for Disease Control and Prevention (“CDC”) can get continuing education credit for completing free heath care provider training available online on “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” originally presented by CDC live on April 16, 2020.

In addition to providing training about proper classification of COVID-19 related deaths on death certificates, health care providers participating in the call may qualify for continuing education credit.

About CDC’s 4/16 COVID-19 Death Reporting Training

The training covers updated rules on completing death certificates for patients believed to have died when infected with COVID-19 published April 2. Monitoring the emergence of Coronavirus Disease 2019 (COVID-19) and guiding public health response requires accurate and timely mortality data. As death certificates are one of the few sources of health-related data that are comparable for small geographic areas and are available over a long time period in the United States, mortality data from the National Vital Statistics System (NVSS) derived from information reported on death certificates to monitor deaths due to COVID-19 versus other causes of death.

During this COCA Call, the following presenters from the CDC provide an overview of the importance of mortality data, discuss the NCHS publication and the guidance it provides to clinicians who may need to certify a death involving COVID-19, and present a summary of COVID-19 surveillance through the NVSS.

Robert N. Anderson, PhD, Chief, Mortality Statistics Branch, National Center for Health Statistics;
Margaret Warner, PhD, Injury Epidemiologist, National Center for Health Statistics;
Lee Anne Flagg, PhD, Statistician (Health), National Center for Health Statistics; and
Farida Ahmad, MPH, Mortality Surveillance Lead, National Center for Health Statistics.

An advance copy of the program Slides is currently available on the CDC website and CDC plans to post a transcript of the program following the presentation.

Continuing Education Credit

Health care providers participating in today’s training may be able to qualify for continuing education credit. CDC says that health care providers wishing to receive continuing education for participation should complete the online between May 19, 2020, and May 19, 2022, and use course code WD2922. The access code is COCA041620. Continuing education certificates can be printed immediately upon completion of your online evaluation. A cumulative transcript of all CDC/ATSDR CEs obtained through the CDC Training & Continuing Education Online System will be maintained for each user.

Interested providers and others can learn mre at this CDC Clinician Outreach and Communication Activity (COCA) here.

More Information

We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. 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

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 most widely recognized for her career long pragmatic, leading edge work, scholarship and thought leadership domestic and international, public and private sector health care and managed care, workforce and employee benefits, insurance and financial services, their technology, data, and other service providers and advisors, and governments 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. As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; creditation, 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 thoughtleadership 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 . 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 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 your profile here. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.

Leave a Comment » | Academic medicine, ASC, Border Health, Childrens Health Insurance Program, COVID-19, data breach, data security, Direct Primary Care, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Health Care, Health Care Provider, Health Care Quality, Health Insurance, Health IT, Health Plan, Health Plans, Health Policy, healthcare, HIPAA, Home Health, home health, Hospital, Indian Health, medical devices, Medical Licensure, Medical Privacy, Medical Records, Mental Health, occupational health, Pandemic, Privacy, public health, Uncategorized, Veterans Health Administration | Tagged: cme, Complaince, COVID-19, Data Security, Health Care, HIPAA, Labs, medical, Pandemic, pharmacy, Privacy, Risk Management | Permalink
Posted by Cynthia Marcotte Stamer

4/15 ONC Briefing Covers New Health IT Funding Opportunities

April 14, 2020

Working or interested in working on the development and testing of data sharing functionalities to support clinical care, research, and improved health care outcomes? Listen in tomorrow (April 15, 2020) at 1:30 p.m. Eastern, 12:30 p.m. Central time to an informational briefing about newly announced funding opportunities issued by the Office of the National Coordinator for Health Information Technology under its Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT) whose specific aims address one of the following areas:

Advancing Registry Infrastructure for a Modern API-based Health IT Ecosystem
Cutting Edge Health IT Tools for Scaling Research
Integrating Health Care and Human Services Data to Support Improved Outcomes

The new funding opportunities are part of efforts to promote the interoperability of heath care data to enhance health care quality and affordability that continues to be a top ONC priority since ONC released its 2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (“Report”).

Under the 21st Century Cures Act, Congress gave ONC authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:

The development and use of upgraded health IT capabilities;
Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
Improvement of the health IT end user experience, including by reducing administrative burden.

The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act and to increase nationwide interoperability of health information and reduce clinician burden.

ONC’s resulting emphasis on health data interoperability raises new business and compliance planning opportunities and challenges for health care providers, health insurers and other payers, health data and information technology (IT) providers and others. The new funding opportunities are intended to produce new capabilities for achieving these objectives.

For more information, visit LEAP in Health IT.

More Information

About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health 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. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers 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, EHR, 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; 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. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; 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 actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.

Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, 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 and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, 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, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. 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 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 your profile here. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.

Leave a Comment » | Academic medicine, ASC, Border Health, Childrens Health Insurance Program, COVID-19, data breach, data security, Direct Primary Care, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Health Care, Health Care Provider, Health Care Quality, Health Insurance, Health IT, Health Plan, Health Plans, Health Policy, healthcare, HIPAA, Home Health, home health, Hospital, Indian Health, medical devices, Medical Licensure, Medical Privacy, Medical Records, Mental Health, occupational health, Pandemic, Privacy, public health, Uncategorized, Veterans Health Administration | Tagged: Complaince, COVID-19, Data Security, Health Care, HIPAA, Labs, medical, Pandemic, pharmacy, Privacy, Risk Management | Permalink
Posted by Cynthia Marcotte Stamer

OCR Adds HIPAA Privacy Rule Enforcement Relief For Community-Based COVID-19 Testing Sites; Updated HIPAA Risk Assessments Advisable For COVID-19 Impacted Operational Changes

April 9, 2020

All Health Care Providers & Business Associates Reminded To Conduct Documented Risk Assessments In Response To COVID-19 Operational Changes

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.

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

About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health 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. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

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 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 your profile here. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.

Leave a Comment » | Academic medicine, ASC, Border Health, Childrens Health Insurance Program, COVID-19, data breach, data security, Direct Primary Care, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Federal Health Center, Health Care, Health Care Provider, Health Care Quality, Health Insurance, Health IT, Health Plan, Health Plans, Health Policy, healthcare, HIPAA, Home Health, home health, Hospital, Indian Health, medical devices, Medical Licensure, Medical Privacy, Medical Records, Mental Health, occupational health, Pandemic, Privacy, public health, Uncategorized, Veterans Health Administration | Tagged: Complaince, COVID-19, Data Security, Health Care, HIPAA, Labs, medical, Pandemic, pharmacy, Privacy, Risk Management | Permalink
Posted by Cynthia Marcotte Stamer

CMS Steps Up Nursing Home Inspections & Tightens Inspections In Response To Continuing COVID-19 Outbreaks & Deaths

April 3, 2020

Skilled nursing and other long term care facilities commonly known as “nursing homes” (“LTC facilities”),[i] rehabilitation, assisted living, retirement and other facilities and communities caring for elderly, disabled, aged or other infirm patients or residents should use recently released tools to confirm the adequacy of and update their current COVID-19 and other infectious disease prevention and control and other key policies and practices with the latest Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) requirements and guidelines in light of recently announced changes to CMS nursing home inspection policies (the “Targeted Inspection Policy”)[iii] that target nursing homes with COVID-19 outbreaks or death for likely inspection announced March 23, 2020 including all existing requirements including new “recommendations” on nursing homes on COVID-19 preparedness and response announced April 2, 2020 (the “April Recommendations”).[iii]

Prompted by the continuing explosive growth in COVID-19 infection and deaths among nursing home residents and widespread deficiencies found during recent inspections at the Kirkland, Washington Life Care Center nursing homes (the “Kirkland Facilities”) made notorious by the death of 23 people and other nursing homes with COVID-19 inspections, the Targeted Inspection Policy and April Recommendations supplement and give more teeth to the CMS Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (the “3/3 Directive”)[iv] previously released by CMS released in conjunction with President Trump’s Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (“COVID Emergency Declaration”) in response to concerns raised by reports of 19 COVID-19 related deaths at the Kirkland Facilities[v] on March 13, 2020.

Despite CMS and CDC’s efforts to reign in nursing home based COVID-19 infections and deaths by ordering nursing homes in the Nursing Home Directive to limit outside visitors and take other precautions outlined in the Nursing Home Directive and release of other guidance and tools, nursing home based COVID-19 infections and deaths have continued to soar since March 13, 2020.[vi] Meanwhile, onsite audits at the Kirkland Facilities and other facilities during March uncovered concerning deficiencies in the compliance at the Kirkland Facilities and many other nursing homes across the nation, as well as the need to address other weaknesses in current CMS and CDC practices and guidelines that the agencies determined were perpetuating practices that left nursing home residents exposed to COVID-19.

The new Targeted Inspection Policy and April Recommendations attempt to address these compliance and other concerns by updating, clarifying and supplementing previously established requirements and guidance, providing new tools for nursing homes and their inspectors to use to assess nursing home compliance with the latest standards and stepping up inspections and enforcement of nursing homes that experience COVID-19 outbreaks.[vii]

April Recommendations Send Warnings, Share New Tools

To this end, the just announced April Recommendations urge nursing homes to move quickly to clean up their practices by:

Urging nursing homes to immediately ensure that they are complying with all CMS and CDC guidance related to COVID-19 and other infection control and other requirements;
Urging nursing homes immediately to implement symptom screening for all staff, residents, and visitors – including temperature checks; [viii]
Urging nursing homes to ensure all staff are using appropriate PPE when interacting with patients and residents, to the extent PPE is available and per CDC guidance on conservation of PPE;
Confirming the availability of Medicare coverage of Medicare enrolled residents performed by laboratories and that facilities can allow laboratory personnel into facilities to perform the tests;
Urging State and local leaders to consider the needs of long term care facilities with respect to supplies of PPE and COVID-19 tests as nursing homes are a critical part of the healthcare system, and because of the ease of spread in long term care facilities and the severity of illness that occurs in residents with COVID-19,
Recommending facilities use separate staffing teams for residents to the best of their ability to avoid transmission within nursing homes in response to evidence that using staff shared between multiple facilities helped to fuel the COVID-19 outbreak in the Kirkland Facilities;
Consistent previously published guidance and resources on the CDC Isolation Sites and Alternative Care Sites webpage,[ix] urging nursing homes to work with State and local leaders to designate separate facilities or units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and individuals with unknown COVID-19 status; and
Encouraging facilities to use new targeted survey assessment tools adopted by CMS to guide inspections under the Targeted Inspection Program to self-assess and make appropriate adjustments to tighten their facility compliance with applicable requirements and guidelines promptly.

While characterized as “recommendations,” the reaffirmation in the April Recommendations that CMS intends to continue to follow the new Targeted Inspection Policy announced March 23, 2020 sends a strong message to all nursing homes that CMS does not view compliance with the recommendations as optional.

Under the Targeted Inspection Policy, CMS intends to conduct targeted inspections giving prioritization for Immediate Jeopardy investigations over recertification surveys for Clinical Laboratory Improvement Amendment (CLIA) laboratories.

According to CMS’ announcement regarding the Targeted Inspection Policy, only the following types of federal inspections will be prioritized and conducted over the next few weeks:

Complaint inspections: State survey agencies will continue to conduct inspections related to complaints and facility-reported incidents that are triaged at the Immediate Jeopardy level. Inspectors will use a streamlined Infection Control review tool, regardless of the Immediate Jeopardy allegation.
Targeted Infection Control inspections: Federal and state inspectors will conduct targeted infection control inspections of providers identified through CMS collaboration with the Centers for Disease Control and Prevention (CDC). These inspectors will use a streamlined targeted review checklist to minimize the impact on provider activities, while ensuring providers are implementing actions to protect health and safety. This will consist of both onsite and offsite inspections.
Self-Assessments: The Infection Control checklist referenced above will also be shared with providers and suppliers, to allow for self-assessment of their Infection Control plans. This may be the best solution in some cases when there is a lack of personal protective equipment or state surveyors available.

During this time frame, CMS has indicated it will not conduct the following inspections:

Standard inspections for nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices; and

Revisit inspections not associated with Immediate Jeopardy.

In addition to redefining the priorities and scope for conducting inspections in the new Targeted Inspection Policy, CMS also refocused the inspection process that surveyors are expected to use when conducting inspections under the Targeted Inspection Policy which includes existing components of CMS’s infection control inspection process updated to include the latest CDC and CMS guidance. Under the Targeted Inspection Policy CMS and state inspectors will be guided by a newly developed and updated targeted assessment tool in assessing if certain facilities are prepared to meet CMS’s expectations for preventing the spread of COVID-19. When gaps are identified, CMS warns that facilities will be required to take corrective actions to close the gaps.

Facilities are well advised to follow the recommendation of CMS to use the new surveyor tools to self-assess their own ability to prevent the spread of COVID-19 in accordance with applicable CMS requirements both to mitigate potential exposures to CMS sanctions and because CMS also is encouraging residents and families to be proactive about nursing home safety by among other things asking facility staff how the facility performed on its self-assessment. Facilities and their leaders at all times should keep in mind the significant risks that they are likely to incur if significant deficiencies are found from an inspection. While the March 23, 2020 announcement of the Targeted Inspection Policy states that CMS is not seeking to be punitive, but rather to respond to urgent issues while proactively ensuring providers are compliant with federal health and safety standards. Accordingly, CMS has indicated that CMS intends to exercise enforcement discretion, unless Immediate Jeopardy situations arise. Given the conclusions announced regarding Immediate Jeopardy findings found from the inspection at the Kirkland Facility, however, nursing homes are well advised to assume that the occurrence of COVID-19 related deaths or infections at their facilities might create a significant risk of Immediate Jeopardy findings with regard to their facilities which could result in significant sanctions.

CMS and other agencies continue to tailor their response to the COVID-19 outbreak. In addition to verifying and maintaining their compliance with current COVID-19 and other CMS, CDC and state and local requirements and guidelines, nursing homes and their leaders also should continue to monitor emerging developments and guidance from CMS, CDC, the Federal Emergency Management Agency (“FEMA”) and their state and local regulatory bodies.

[i] Nursing homes (also known as “skilled nursing facilities” under the Medicare program and “nursing facilities” under Medicaid; or “long-term care facilities”).

[ii] Press release Trump Administration Issues Key Recommendations to Nursing Homes, State and Local Governments, CMS (2020), https://www.cms.gov/newsroom/press-releases/trump-administration-issues-key-recommendations-nursing-homes-state-and-local-governments (last visited Apr 2, 2020).

[iii] Fact sheet Kirkland, Washington Update and Survey Prioritization Fact Sheet, CMS (2020), https://www.cms.gov/newsroom/fact-sheets/kirkland-washington-update-and-survey-prioritization-fact-sheet (last visited Mar 31, 2020).

[iv] Guidance For Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes, DEPARTMENT OF HEALTH & HUMAN SERVICES (2020), https://www.cms.gov/files/document/3-13-2020-nursing-home-guidance-covid-19.pdf (last visited Mar 30, 2020).

[iv] Nursing home with the biggest cluster of covid-19 deaths to date in the U.S. thought it was facing an influenza outbreak, a spokesman says, https://www.msn.com/en-us/news/us/nursing-home-with-the-biggest-cluster-of-covid-19-deaths-to-date-in-the-us-thought-it-was-facing-an-influenza-outbreak-a-spokesman-says/ar-BB11fvgj (last visited Mar 30, 2020).

[vi] See e.g., Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED), CMS (2020), https://www.cms.gov/files/document/qso-20-14-nh-revised.pdf (last visited Apr 2, 2020).

[vii] In the initial wave of surveys during the week of March 30, CMS reports finding 36 percent of facilities inspected in recent days did not follow proper hand washing guidelines and 25 percent failed to demonstrate proper use of personal protective equipment (PPE) required by longstanding federal regulations. Press release Trump Administration Issues Key Recommendations to Nursing Homes, State and Local Governments, CMS (2020), https://www.cms.gov/newsroom/press-releases/trump-administration-issues-key-recommendations-nursing-homes-state-and-local-governments (last visited Apr 3, 2020).

[viii] Facilities that have not already done so should consult with experienced legal counsel for assistance about the advisability of providing or posting notifications and/or securing consents to these screening procedures, advisable or recommended procedures regarding the collection, use, or disclosure of screenings or their results, or other safeguards to manage relevant privacy or other legal rights or risks.

[ix] See Alternate Care Sites and Isolation Sites (March 25, 2020) https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/alternative-care-sites.html. Also see Topic Collection: Alternate Care Sites (including shelter medical care) https://asprtracie.hhs.gov/technical-resources/48/alternate-care-sites-including-shelter-medical-care/47.

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We hope this update is helpful. In addition to this update, the author also has prepared a more comprehensive discussion of these concerns scheduled for publication by the American Bar Association Health Publication in April, 2020. To request access for a prepublication unofficial manuscript of that upcoming publication or of 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.

About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health 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. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

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 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 your profile here. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.

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

March 24, 2020

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

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.

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

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

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Gastroenterology Practices Pays $100K For HIPAA Noncompliance

March 3, 2020

The $100,000 settlement payment the medical practice of Steven A. Porter, M.D., has agreed to pay $100,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services to settle a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule Serves as a warning to other physicians and healthcare providers that they too could pay big bucks for failing to comply with HIPAA. The resolution agreement and corrective action plan may be found here.

Dr. Porter’s medical practice provides gastroenterological services to over 3,000 patients per year in Ogden, Utah.

OCR began investigating Dr. Porter’s medical practice after it filed a breach report with OCR related to a dispute with a business associate. OCR’s investigation determined that Dr. Porter had never conducted a risk analysis at the time of the breach report, and despite significant technical assistance throughout the investigation, had failed to complete an accurate and thorough risk analysis after the breach and failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level.

Many physician and other small healthcare providers underestimate their responsibilities or their exposure for noncompliance. Many have never conducted the necessary risk analysis or initially adopted the requisite policies and procedures to comply. Furthermore, practices relying upon outsourced management or compliance services for their HIPAA compliance need to ensure that they have appropriate business associates agreements with those and all other service providers. While OCR typically takes into account efforts to obtain services as evidence of a culture of compliance, when breaches happen in the practice or at the business associate, A physician or other healthcare provider can expect OCR to investigate their compliance and potentially their culpability for the breach. physicians and other healthcare providers also should not assume that their engagement of a service HIPAA to comply with or provide HIPAA compliant services equates to making that service provider accountable for the quality in adequacy of the services.Typically service providers and consultants limit their liability contractually and otherwise when providing these services, often do not have adequate compliance themselves, or both. Licensing agreements and other services contracts typically include various provisions excusing or limiting the service provider from liability for deficiencies in compliance resulting from inadequacies in their procedures, operational noncompliance or both. In some instances, business associates may include provisions in their business associate agreement or other related agreements that actually obligate the healthcare provider to defend and indemnify the service provider for breaches and other liabilities arising out of HIPAA noncompliance. Since the cost of investigating and defending an alleged complaint can be very expensive even if no penalties are sought by OCR, most physicians and other healthcare providers should explore the availability of insurance coverage to help protect against these expenses.

“All health care providers, large and small, need to take their HIPAA obligations seriously,” said OCR Director Roger Severino. “The failure to implement basic HIPAA requirements, such as an accurate and thorough risk analysis and risk management plan, continues to be an unacceptable and disturbing trend within the health care industry.”

In addition to the monetary settlement, Dr. Porter will undertake a corrective action plan that includes two years of monitoring.

Physicians and other healthcare providers need to keep in mind that OCR penalties are not the only risk of HIPAA violations. Noncompliance with these requirements also commonly gives rise to licensing board, peer review, and other professional, employment or contractual consequences as well as negative publicity.

The resolution agreement demonstrates OCR requires physicians shouldn’t expect OCR to look the other way when they violate HIPAA. Given the potential professional and monetary liability risk that result from complaints and violations, physicians and other healthcare Should consult with qualified legal counsel for assistance with assessing the adequacy of their current clients within the scope of attorney-client privilege. Additionally, in the event of a complaint or threaten complaint, physicians and other healthcare providers should take appropriate steps to conduct a documentary investigation. As discussions and activities conducted in association with such investigations can involve sensitive communications and information, it also is advisable to consult with legal counsel at the beginning of an issue to determine whether the investigation or other activities should be conducted within the scope of attorney-client privilege so as to minimize exposure of sensitive communications as admissions or another discoverable evidence for administrative or litigation proceedings.

More Information

About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health 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. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

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 such as:

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ONC Adds Reducing Provider EHR Burdens & Promoting Electronic Health Data Use In Research To Health IT Priorities

February 25, 2020

Reducing health care providers burdens from using electronic health records (“EHRs”) and promoting the better uses of electronic medical data in medical research are the focus of two new health information technology (“health IT”) policy documents released this week by the Department of Health & Human Services (“HHS”) Office of the National Coordinator for Health Information Technology (“ONC”). Health care providers, health researchers, health plans, health care clearinghouses and other health data collectors or users, as well as health IT providers and other interested persons will want to evaluate carefully these new ONC releases for insights about policy and other efforts ONC is promoting to shape the use of health IT and data.

Reducing Health IT and EHR Burdens On Providers

On February 21, 2020, ONC moved forward on its efforts to implement “a comprehensive strategy to reduce the regulatory and administrative burden related to the use of health IT, including EHRs” by publishing its “Strategy on Reducing Regulatory and Administrative Burdens Relating to the Use of Health IT and EHRs” (the “EHR Report”) targets burdens tied to regulatory and administrative requirements that HHS can directly impact through the rulemaking process. A collaborative effort between ONC and the Centers for Medicare & Medicaid Services (CMS), the report’s strategies was developed in response to a Congressional mandate in the 21^st Century Cures Act, which directed HHS to develop a plan of action to reduce regulatory and administrative burden relating to the use of health IT and EHRs and finalizes the draft version of this strategy ONC released in November 2018. Based on stakeholder input, the final HER Report outlines three overarching goals designed to reduce clinician burden:

Reduce the effort and time required to record health information in EHRs for clinicians;
Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations; and
Improve the functionality and ease of use of EHRs.

ONC says reducing unnecessary regulatory burden will alleviate time spent on administrative tasks. For example, during listening sessions with clinicians, we heard criticism that the documentation guidelines for Evaluation and Management (E/M) visits were a source of EHR-related burden and overly complicated. They told us these requirements result in “pajama time,” where physicians spend hours after clinic sessions and on weekends entering data to satisfy billing and quality reporting requirements. Poor usability features within EHRs can further exacerbate this issue, as clinicians find it difficult to navigate long records within the EHR interface. Based on this feedback, the report covers four key areas:

Clinical documentation
Health IT usability (or ease of use of health IT tools and systems)
Federal health IT and EHR reporting requirements
Public health reporting (including coordination with prescription drug reporting programs and electronic prescribing of controlled substances).

In addition to responding to the direction included in the EHR Report, health care and health IT providers also will want to continue to monitor and communicate with ONC. While moving forward on the implementation of the objectives identified in the EHR Report, ONC says it plans to continue to reach out and engage the clinician community and other key stakeholder communities and to monitor emerging and ongoing burdens related to the use of EHRs, such as burdens related to EHR inbox management and other efforts to enable further automation in health care, with a focus on prior authorization, quality reporting, and other aspects of our current system that can reduce time spent using health IT.

Leveraging Health IT For Research

On February 24, 2020, ONC followed up by releasing its National Health IT Priorities for Research: A Policy and Development Agenda. The Agenda articulates its latest vision of a health information technology infrastructure that supports alignment between the clinical and research ecosystems in research.

The Agenda identifies two overarching goals along with nine associated priority areas ONC believes stakeholders can take to achieve the respective visions more quickly and effectively:

Read the Agenda here.

More Information

The Agenda is the latest in a series of priorities, agendas and other initiatives adopted by ONC since its establishment in furtherance of its legislative mandate under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009 to improve the health and well-being of individuals and communities through the use of technology and health information.

Health care providers, plans, technology vendors and providers and other stakeholders impacted by ONC and other electronic medical record or health IT systems should take into account the likely implications of these and other ONC pronouncements on their programs and practices when planning and updating them.

About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health 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. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, 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.

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 such as:

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