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

February 3, 2023

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

Banner Health Settlement

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

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

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

The potential violations OCR identified specifically included:

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

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

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

OCR Warns Other HIPAA-Covered Entities

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More Information

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

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

About the Author

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

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

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

About Solutions Law Press, Inc.™

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:

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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

FTC-HHS Seek To Help Mobile Health App Developers Assess When Certain Federal Rules Apply

December 8, 2022

Developers of mobile applications for healthcare and fitness must identify and negotiate a diverse array of federal and state laws, regulations and rulings when designing and deploying their apps.

Since figuring out which federal rules apply often proves challenging, the Federal Trade Commission (FTC) in conjunction with the HHS Office for Civil Rights (OCR), the HHS Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA) maintain and have just updated the Mobile Health App Interactive Tool intended to help developers of health-related mobile apps understand when and federal laws and regulations might apply.

While not covering all relevant legal risks, the guidance tool does highlight certain key regulatory concerns by asking developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance tool points the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Children’s Online Privacy Protection Act (COPPA), the Health Insurance Portability and Accountability Act (HIPAA), the Federal Food, Drug and Cosmetics Act (FD&C Act), and the 21st Century Cures Act and ONC Information Blocking Regulations.

Using the tool can help to clarify the potential applicability of these rules to a proposed app and help focus the developer on issues to consider regarding these laws as they design in administer their apps. Running through the tool also could help reduce legal fees and other consulting anniversary costs by helping developers of these apps gather helpful information and be more prepared to participate in informed manner when working with the legal team on their compliance. Additionally documented use of the tool could prove helpful in the event of a compliance audit or investigation by capturing evidence helpful to establish a culture of compliance or mitigate other potential liability concerns.

Of course app developers using these tools need to keep in mind that they are not legal advice or a substitute for legal advice. The tools only are intended to provide guidance regarding the potential likely application of the rules covered by the tool. They do not cover broad range of other federal and state Laws, regulations, rulings, and contractual commitments that also can impact the use and design of these apps and their defensibility and a broad range of circumstances. Moreover developers also should keep in mind that the use of the tools and their discussion may uncover existing or past compliance concerns, which might best be conducted within the protection of attorney-client privilege. Consequently, developers and users should consult and closely worked with experienced, qualified legal counsel to address these and other legal risks and compliance.

For Help With Comments, Investigations Or Other Needs

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 here or contact Ms. Stamer directly.

Other Helpful Resources & Information

If you found this article of interest, you also may be interested in reviewing other Breaking News, articles and other resources available including:

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

OCR Dental Practices Settlements Warn Providers To Honor HIPAA Access Rights

September 20, 2022

Today’s U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announcement of resolution agreements with three separate dental practices warns all health care providers, health plans and health care clearinghouses of the importance of complying with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule’s patient right of access and other federal and state mandates about providing patients and health plan members access to their records.

The following three resolution agreements OCR announced September 20, 2022 underscore the importance and necessity of compliance with the right of access and other HIPAA requirements:

Chicago-based Family Dental Care, P.C. (“FDC”), paid $30,000.00 to resolve potential OCR charges aiding from OCR’s investigation located in Chicago, Illinois. OCR received a complaint on August 8, 2020, alleging that FDC failed to provide a former patient with timely access to her complete medical records. The former patient requested her entire medical records in May 2020, but received only portions. The former patient filed a complaint with OCR, and during OCR’s investigation, FDC provided her with the remainder of her records in October 2020. Thus, FDC did not provide a complete copy of the records until more than five months after the request was made. OCR’s investigation determined that FDC’s failure to provide timely access to the requested medical records was a potential violation of the HIPAA right of access provision. FDC agreed to pay $30,000 and implement a corrective action plan.

Georgia based dental and orthodontics provider Great Expressions Dental Center of Georgia, P.C. (“GEDC-GA”) paid $80,000 to resolve concerns arising from OCR’s investigation of a November 2020 complaint alleging that GEDC-GA would not provide an individual with copies of her medical records because she would not pay GEDC-GA’s $170 copying fee. The individual first requested her records in November 2019, but did not receive them until February 2021, over a year later. OCR’s investigation determined that GEDC-GA’s failure to provide timely access to the requested medical records, and its practice of assessing copying fees that were not reasonable and cost-based, were potential violations of the HIPAA right of access provision. GEDC-GA agreed to pay $80,000 and implement a corrective action plan.

Las Vegas, Nevada dental practice B. Steven L. Hardy, D.D.S., LTD, doing business as Paradise Family Dental (“Paradise”) paid $25,000 to resolve potential violations uncovered after OCR investigated an October 26, 2020 complaint alleging that Paradise had failed to provide a mother with copies of her and her minor child’s protected health information. The mother submitted multiple record requests between April 11, 2020, and December 4, 2020, but Paradise did not send the records until December 31, 2020, more than eight months after her initial request. OCR’s investigation determined that Paradise’s failure to provide timely access to the requested medical records was a potential violation of the HIPAA right of access provision. Paradise agreed to pay $25,000 and implement a corrective action plan.

The three newly announced resolution agreements bring to 41 the number of resolution agreements OCR has announced since announcing its program targeting access right violations. OCR call Rosov call Riedel access violations are the most common of all reported HIPAA violations.

OCR made clear its announcements of these resolution agreements to “send an important message to dental practices of all sizes that are covered by the HIPAA Rules to ensure they are following the law,” said OCR Director Melanie Fontes Rainer. “Patients have a fundamental right under HIPAA to receive their requested medical records, in most cases, within 30 days. I hope that these actions send the message of compliance so that patients do not have to file a complaint with OCR to have their medical records requests fulfilled.”

Health care providers as well as health plans should heed thus strong warning by ensuring their compliance with the HIPAA right of access as well as other applicable rules about providing patient and plan members copies of records or other data. for healthcare providers, you can please but are not limited to State medical records, ethics, and other rules and regulations. Or health plan, the HIPAA Records access rules are in addition to the Employee Retirement Invome Security Act mandates to provide plan records when requested.

If circumstances come to light that indicate a breach of the access or any other HIPAA standards, 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, all HIPAA-covered entities and their leaders always must keep in mind that their responsibilities and potential liability for mishandling protected health information 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

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

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

About the Author

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

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

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

About Solutions Law Press, Inc.™

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

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.

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Posted by Cynthia Marcotte Stamer

Year-End $3 Million HIPAA Settlement Pushes 2018 OCR HIPAA Recoveries Over $28 Million; Act Promptly To Strengthen Compliance & Share Ideas For Simplification

February 7, 2019

Health care providers, health plans, health care clearinghouse and their business associates (“Covered Entities”) should reconfirm the adequacy of their organization’s Health Insurance Portability and Accountability Act (“HIPAA”) compliance in light the U.S Department of Health and Human Services Office of Civil Rights (“OCR”) February 7, 2019 announcement that OCR reached a 2018 year-end $3 Million Resolution Agreement with California-based Cottage Health that pushed OCR’s already record-setting 2018 enforcement HIPAA recoveries to more than $28.7 million in a year already distinguished by OCR’s record-setting $16 million resolution payment collection from Anthem.

Along with acting to ensure their own organization’s ability to defend their HIPAA compliance, Covered Entities and their leaders also should take advantage of the opportunity to provide input to OCR on opportunities for simplifying and improving OCR’s HIPAA regulations and enforcement by submitting relevant comments by February 12, 2019 in response to a Request for Information published by OCR in December that invites public input.

Learn more de

2018 Cottage Health Resolution Agreement

According to OCR’s February 7, 2019 announcement, Cottage Health agreed in OCR’s final settlement of 2017 to pay OCR $3 million and to adopt a substantial corrective action plan to settle charges of HIPAA violations resulting from OCR’s investigations into two HIPAA Breach notifications Cottage Health filed regarding breaches of unsecured electronic protected health information (ePHI) affecting over 62,500 individuals.

A December 2, 2013 breach notification that the removal of electronic security protections by a Cottage Health contractor rendered ePHI such as patient names, addresses, dates of birth, diagnoses/conditions, lab results and other treatment information of 33,349 individuals on a Cottage Health server accessible for download without a username or password from the internet to anyone outside Cottage Health. In an update to its original report filed on July 2, 2014, Cottage Health increased the number of individuals affected by this breach to 50,917. OCR’s investigation determined that security configuration settings of the Windows operating system permitted access to files containing ePHI without requiring a username and password. As a result, patient names, addresses, dates of birth, diagnoses, conditions, lab results and other treatment information were available to anyone with access to Cottage Health’s server.
A December 1, 2015, that the misconfiguration of a server following an IT response to a troubleshooting ticket, exposed unsecured ePHI including patient names, addresses, dates of birth, social security numbers, diagnoses, conditions, and other treatment information of 11,608 individuals over the internet.

Based upon its investigation into the two breach reports, OCR concluded Cottage Health violated HIPAA by failing to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the ePHI; failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level; failed to perform periodic technical and non-technical evaluations in response to environmental or operational changes affecting the security of ePHI; and failed to obtain a written business associate agreement with a contractor that maintained ePHI on its behalf.

To resolve its exposure to potentially must greater civil monetary sanctions that OCR might seek for such potential violations under HIPAA’s civil monetary sanction rules, Cottage Health entered into December, 2018 Resolution Agreement to pay the $3 million settlement and undertake what OCR characterizes as “a robust corrective action plan to comply with the HIPAA Rules.” Among other things, the corrective action plan requires Cottage Health to:

Conduct an enterprise-wide risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by Cottage Health (“Risk Analysis”) that OCR views as satisfactory to meet the requirements of 45 CFR 164.308(a)(1)(ii)(A);
Develop and implement a risk management plan to address and mitigate any security risks and vulnerabilities identified in the Risk Analysis acceptable to OCR;
Implement a process for regularly evaluating environmental and operational changes that affect the security of Cottage Health’s ePHI;
Develop, maintain, and revise, as necessary, written policies and procedures to comply with the Federal standards that govern the privacy and security of individually identifiable health information under 45 C.F.R. Part 160 and Subparts A, C, and E of Part 164 (the “Privacy Rule” and “Security Rule”).
Distribute to and conduct training on the HIPAA policies and procedures from all existing and new members of the Cottage Health workforce with access to PHI. Additionally, Cottage Health require all workforce members that have access to PHI to certify their receipt of, understanding and commitment to comply with the HIPAA Policies before allowing access to PHI and must deny access to PHI to any workforce member that has not provided the required certification.
Submit to ongoing notification and reporting requirements to keep OCR informed about its compliance efforts.

2018 Record Setting HIPAA Enforcement Year

The final Resolution Agreement negotiated by OCR in 2018, the $3 million Cottage Health Resolution Agreement signed on December 11, 2018 added to an already record-setting year of HIPAA enforcement recoveries by OCR. In addition to recovering the single largest individual HIPAA settlement in history of $16 million with Anthem, Inc. OCR’s recovery of the following HIPAA settlements and fines totaling nearly $28.7 million surpassed its previous 2016 record of $23.5 million by 22 percent.

Date	Name	Amount
Jan. 2018	Filefax, Inc (settlement)	$ 100,000
Jan. 2018	Fresenius Medical Care North America (settlement)	$ 3,500,000
June 2018	MD Anderson (judgment)	$ 4,348,000
Aug. 2018	Boston Medical Center (settlement)	$ 100,000
Sep. 2018	Brigham and Women’s Hospital (settlement)	$ 384,000
Sep. 2018	Massachusetts General Hospital (settlement)	$ 515,000
Sep. 2018	Advanced Care Hospitalists (settlement)	$ 500,000
Oct. 2018	Allergy Associates of Hartford (settlement)	$ 125,000
Oct. 2018	Anthem, Inc (settlement)	$ 16,000,000
Nov. 2018	Pagosa Springs (settlement)	$ 111,400
Dec. 2018	Cottage Health (settlement)	$ 3,000,000
Total (settlements and judgment)		$ 28,683,400

Aside from the previously discussed Cottage Health Resolution Agreement OCR announced on February 7, 2019, these OCR 2018 enforcement recoveries included:

FileFax Resolution Agreement. In January 2018, OCR settled for $100,000 with Filefax, Inc., a medical records maintenance, storage, and delivery services provider. OCR’s investigation found that Filefax impermissibly disclosed protected health information (PHI) by leaving the PHI in an unlocked truck in the Filefax parking lot, or by granting permission to an unauthorized person to remove the PHI from Filefax, and leaving the PHI unsecured outside the Filefax facility.
Fresenius Medical Care North America Resolution Agreement. In January 2018, OCR also settled for $3.5 million with Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure. FMCNA filed five breach reports for separate incidents occurring between February 23, 2012 and July 18, 2012, implicating the electronic protected health information (ePHI) of five FMCNA owned covered entities. OCR’s investigation revealed that FMCNA failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. Additional potential violations included failure to implement policies and procedures and failure to implement a mechanism to encrypt and decrypt ePHI, when it was reasonable and appropriate to do so under the circumstances.
MD Anderson ALJ Ruling. In June 2018, an HHS Administrative Law Judge ruled in favor of OCR and required The University of Texas MD Anderson Cancer Center (MD Anderson), a Texas cancer center, to pay $4.3 million in civil money penalties for HIPAA violations. OCR investigated MD Anderson following three separate data breach reports in 2012 and 2013 involving the theft of an unencrypted laptop from the residence of an MD Anderson employee and the loss of two unencrypted universal serial bus (USB) thumb drives containing the unencrypted ePHI of over 33,500 individuals. OCR’s investigation found that MD Anderson had written encryption policies going back to 2006 and that MD Anderson’s own risk analyses had found that the lack of device-level encryption posed a high risk to the security of ePHI. Despite the encryption policies and high risk findings, MD Anderson did not begin to adopt an enterprise-wide solution to encrypt ePHI until 2011, and even then it failed to encrypt its inventory of electronic devices containing ePHI between March 24, 2011 and January 25, 2013. This matter is under appeal with the HHS Departmental Appeals Board.
MMC/BWH/MGH Resolution Agreements. In September 2018, OCR announced that it has reached separate settlements totaling $999,000, with Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH) for compromising the privacy of patients’ PHI by inviting film crews on premises to film an ABC television network documentary series, without first obtaining authorization from patients.
ACH Resolution Agreement. In September 2018, OCR also settled with Advanced Care Hospitalists (ACH), a contractor physician group, for $500,000. ACH filed a breach report confirming that ACH patient information was viewable on a medical billing services’ website. OCR’s investigation revealed that ACH never had a business associate agreement with the individual providing medical billing services to ACH, and failed to adopt any policy requiring business associate agreements until April 2014. Although ACH had been in operation since 2005, it had not conducted a risk analysis or implemented security measures or any other written HIPAA policies or procedures before 2014.
Allergy Associates Resolution Agreement. In October 2018, OCR settled with Allergy Associates, a health care practice that specializes in treating individuals with allergies, for $125,000. In February 2015, a patient of Allergy Associates contacted a local television station to speak about a dispute that had occurred between the patient and an Allergy Associates’ doctor. OCR’s investigation found that the reporter subsequently contacted the doctor for comment and the doctor impermissibly disclosed the patient’s PHI to the reporter.
Anthem Resolution Agreement. In October 2018, Anthem, Inc. also paid $16 million to OCR and agreed to take substantial corrective action to settle potential violations of the HIPAA Rules after a series of cyberattacks led to the largest U.S. health data breach in history. Anthem filed a breach report after discovering cyber-attackers had gained access to their IT system via an undetected continuous and targeted cyberattack for the apparent purpose of extracting data, otherwise known as an advanced persistent threat attack. After filing their breach report, Anthem discovered cyber-attackers had infiltrated their system through spear phishing emails sent to an Anthem subsidiary after at least one employee responded to the malicious email and opened the door to further attacks. OCR’s investigation revealed that between December 2, 2014 and January 27, 2015, the cyber-attackers stole the ePHI of almost 79 million individuals, including names, social security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information.
Pegosa Springs Medical Center. In November 2018, Pagosa Springs Medical Center (PSMC), a critical access hospital, paid $111,400 to OCR to resolve potential violations concerning a former PSMC employee that continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ ePHI, after separation of employment. OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a business associate agreement in place.

These 2018 Resolution Agreements reaffirm the growing risks that Covered Entities and their business associates run by failing to take adequate steps to prevent and respond to breaches of ePHI and otherwise to maintain their compliance with HIPAA. Covered entities and business associates and their leaders should recognize and respond to these growing risks by reevaluating and strengthening their HIPAA compliance and risk management efforts to minimize the likelihood of violations and enhance their ability to mitigate potential liability that can result from breaches of HIPAA by responding efficiently and effectively.

Other Regulatory & Enforcement Developments

In addition to reaffirming their ongoing compliance with the longstanding requirements of HIPAA and other related federal and state laws, Covered Entities also should use care to carefully monitor and respond to new regulatory and other developments that might create new responsibilities or new opportunities to simplify their HIPAA compliance. In this respect, Covered Entities should take note of the 2018 and ongoing efforts by OCR to develop and publish new rules and other guidance intended to help health care providers and other Covered Entities, patients and caregivers and others understand their rights and responsibilities when dealing with protected health information in relation to patients afflicted with substance abuse and mental illness. Undertaken as part of the Trump Administration’s broader effort to combat opiate and other substance abuse within the United States, OCR in October published a package of guidance on How HIPAA Allows Doctors To Respond To The Opioid Crisis. Covered Entities and others concerned with the management of patients afflicted with substance abuse and mental illness should evaluate this guidance to understand and tailor their practices to respond to OCR’s perspectives of how HIPAA impacts the use, access and disclosure of protected health information as part of these efforts.

Covered Entities and others concerned about HIPAA compliance and interpretation also should carefully monitor and provide appropriate and timely input on developing HIPAA guidance that could impact their operations. In this regard, Covered Entities with ideas about opportunities for improving existing HIPAA guidance are encouraged to submit comments to OCR by February 12, 2019 in response to its Request for Information on improving care coordination and reducing the regulatory burdens of the HIPAA Rules published on December 12, 2018. In that RFI, OCR invites input from the public on how the HIPAA Privacy Rule, could be modified to:

Encourage information-sharing for treatment and care coordination;
Facilitate parental involvement in care;
Address the opioid crisis and serious mental illness;
Account for disclosures of PHI for treatment, payment, and health care operations as required by the HITECH Act;
Change the current requirement for certain providers to make a good faith effort to obtain an acknowledgment of receipt of the Notice of Privacy Practices; and/or
Otherwise simplify or improve the existing HIPAA rules.

As a part of these efforts, Covered Entities and other concerned parties also should anticipate that OCR will be focusing heavily in the upcoming year on the potential HIPAA privacy and security implications of efforts by its sister agency, the Office of the National Coordinator for Health Information Technology (“ONC”), to promote greater interoperability of electronic medical records discussed in ONC’s recent 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.

These priorities seek to increase nationwide interoperability of health information and reduce clinician burden. The Report says increases in the adoption of health IT means most Americans receiving health care services now have their health data recorded electronically. However, this information is not always accessible across systems and by all end users—such as patients, health care providers, and payers—in the market in productive ways. While the Report states ONC intends to move forward to promote efforts to help ensure that electronic health information can be shared safely and securely where appropriate to improve the health and care of all Americans, these activities inherently will raise many HIPAA concerns and challenges. Covered Entities and others concerned with these activities will want to carefully monitor the concurrent activities of OCR and ONC as these efforts progress, both to help tailor their planning and compliance efforts to respond to the anticipated demand for greater interoperability as required by ONC and to help shape these rules by providing timely input as appropriate in response to these developments.

About the Author

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

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has been continuously involved the design, regulation, administration and defense of managed care and other health and employee benefit, health care, human resources and other staffing and workforce arrangements, contracts, systems, and processes. As a continuous component of this work, Ms. Stamer has worked closely with these and other clients on the design, development, administration, defense, and breach and data recovery of health care, workforce, insurance and financial services, trade secret and other information technology, data and related process and systems development, policy and operations throughout her career.

Scribe of the ABA JCEB annual Office of Civil Rights agency meeting, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues.

Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long-term care, rehabilitation and other health care providers and facilities; medical staff, health care accreditation, peer review and quality committees and organizations; employers and other workforce management organizations; employer, union, association, government and other insured and self-insured health and other employee benefit plan sponsors, benefit plans, fiduciaries, administrators, and other plan vendors; managed care organizations, insurers, self-insured health plans and other payers and their management; managed care organizations, insurers, third-party administrative services organizations and other payer organizations; billing, utilization management, management services organizations; group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; claims, billing and other health care and insurance technology and data service organizations; other health, employee benefit, insurance and financial services product and solutions consultants, developers and vendors; and other health, employee benefit, insurance, technology, government and other management clients.

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

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

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

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

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

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

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

About Solutions Law Press, Inc.™

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

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Posted by Cynthia Marcotte Stamer

ONC Report Signals New Interoperability Demands Coming

January 8, 2019

Interoperability will be a key priority for the Office of the National Coordinator for Health Information Technology (“ONC”) going forward.

That’s the message in the just released 2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (“Report”).

The plan to promote interoperability raises new business and compliance planning opportunities for health care providers, health insurers and other payers, health data and information technology (IT) providers and others.

The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act.

Under the 21st Century Cures Act, Congress gave HHS 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.

These priorities seek to increase nationwide interoperability of health information and reduce clinician burden..

Current Status

The Report says increases in the adoption of health IT means most Americans receiving health care services now have their health data recorded electronically. However, this information is not always accessible across systems and by all end users—such as patients, health care providers, and payers—in the market in productive ways. For example:

Despite the individual right to access health information about themselves established by the HIPAA Privacy Rule, patients often lack access to their own health information, which hinders their ability to manage their health and shop for medical care at lower prices;

Health care providers often lack access to patient data at the point of care, particularly when multiple health care providers maintain different pieces of data, own different systems, or use health IT solutions purchased from different developers; and

Payers often lack access to clinical data on groups of covered individuals to assess the value of services provided to their customers.

The Report says these limitations create several problems, including:

Patients should be able to easily and securely access their medical data through their smartphones. Currently, patients electronically access their health information through patient portals that prevent them from easily pulling from multiple sources or health care providers. Patient access to their electronic health information also requires repeated use of logins and manual data updates.

For health care providers and payers, interoperable access and exchange of health records is focused on accessing one record at a time.
Payers cannot effectively represent their members if they lack computational visibility into which health care providers offer the highest quality care at the lowest cost. Without the capability to access multiple records across a population of patients, health care providers and payers will not benefit from the value of using modern computing solutions—such as machine learning and artificial intelligence—to inform care decisions and identify trends.
Payers and employer group health plans which purchase health care have little information on health outcomes. Often, health care providers and payers negotiate contracts based on the health care provider’s reputation rather than on the quality of care that health care provider offers to patients. Health care providers should instead compete based on the entire scope of the quality and value of care they provide, not on how exclusively they can craft their networks. Outcome data will allow payers to apply machine learning and artificial intelligence to have better insight into the value of the care they purchase.

Current Barriers

According to the Report, HHS heard from stakeholders over the past year that barriers to interoperable access to health information remain, including technical, financial, trust, and business practice barriers. These barriers impede the movement of health information to where it is needed across the care continuum. In addition, burden arising from quality reporting, documentation, administrative, and billing requirements that prescribe how health IT systems are designed also hamper the innovative usability of health IT.

Current and Upcoming Actions

The Report states HHS has many efforts to help ensure that electronic health information can be shared safely and securely where appropriate to improve the health and care of all Americans.

ONC also reports Federal agencies, states, and industry have taken steps to address technical, trust, and financial challenges to interoperable health information access, exchange, and use for patients, health care providers, and payers (including insurers). HHS aims to build on these successes through the ONC Health IT Certification Program, HHS rulemaking, health IT innovation projects, and health IT coordination.

In accordance with the Cures Act, HHS is actively leading and coordinating a number of key programs and projects. These include continued work to deter and penalize poor business practices and that HHS conducted multiple outreach efforts to engage the clinical community and health IT stakeholders to better understand these barriers, challenges, and health care provider burden.

Recommendations

The Report makes the following overarching recommendations for future actions HHS plans to support through its policies and that the health IT community as a whole can take to accelerate progress:

Focus on improving interoperability and upgrading technical capabilities of health IT, so patients can securely access, aggregate, and move their health information using their smartphones (or other devices) and health care providers can easily send, receive, and analyze patient data.

Increase transparency in data sharing practices and strengthen technical capabilities of health IT so payers can access population-level clinical data to promote economic transparency and operational efficiency to lower the cost of care and administrative costs.

Prioritize improving health IT and reducing documentation burden, time inefficiencies, and hassle for health care providers, so they can focus on their patients rather than their computers.

The Report also says interoperable access underpins HHS’s efforts to pursue a health care system where data are available when and where needed.

ONC intends to particularly focus on promoting open APIs. Open APIs are technology that allow one software program to access the services provided by another software program and can improve access and exchange of health information. ONC says APIs can:

Support patients’ ability to have more access to information electronically through, for example, smartphones and mobile applications. HHS applauds the emergence of patient-facing applications that allow patients to access, aggregate, and act on their health information; and

Allow payers to receive necessary and appropriate information on a group of members without having to access one record at a time.
Increase institutional accountability, support value- based care models, and lead to competitive medical care pricing that benefits patients.

The Report claims patients, health care providers, and payers with appropriate access to health information can use modern computing solutions to generate value from the data. Improved interoperability can strengthen market competition, result in greater quality, safety, and value for the healthcare system, and enable patients, health care providers, and payers to experience the benefits of health IT.

Prepare For Enhanced Operability Requirements

ONC’s plan to achieve greater interoperability presents 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. Among other things, participants in the healthcare system and their suppliers will need to prepare to comply with new expectations and mandates for interoperability. Meeting these demands will require financial expenditures as well as present technological challenges.The increased availability and access to electronica medical records and information resulting from these changes also a can be expected to drive new challenges and demands. Among other things, businesses relying on control of health information or records to influence or control patience, reimbursement, or other business value need to reevaluate and adjust their business models accordingly.

Improve accessibility and interoperability also is likely to create new expectations and demands by patients, payers, other providers and perhaps most significantly for providers and payers, regulators. Participants in the system will need to understand these applications and prepare to both defend their business performance as well as their compliance taking into account these new demands.

Amid all of this, of course, providers, pears, and their business associates can anticipate continued if not enhanced demands for enhanced data security and privacy protections and accompanying enforcement of these standards.

As ONC move forward on its plans to enhance interoperability, all concerned stakeholders will want to monitor developments and provide thoughtful and timely input. The time to get started is now. ONC and it’s sister agency, the Office of Civil Rights currently are inviting public comments about how to achieve these and other health IT and privacy improvements. Those interested in providing input should make sure their comments are submitted by the applicable deadlines next month.

Read the full Report here and share your input by the specified deadlines.

About the Author

Ms. Stamer’s clients include employers and other workforce management organizations; employer, union, association, government and other insured and self-insured health and other employee benefit plan sponsors, benefit plans, fiduciaries, administrators, and other plan vendors; managed care organizations, insurers, self-insured health plans and other payers and their management; public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long-term care, rehabilitation and other health care providers and facilities; medical staff, health care accreditation, peer review and quality committees and organizations; managed care organizations, insurers, third-party administrative services organizations and other payer organizations; billing, utilization management, management services organizations; group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; claims, billing and other health care and insurance technology and data service organizations; other health, employee benefit, insurance and financial services product and solutions consultants, developers and vendors; and other health, employee benefit, insurance, technology, government and other management clients.

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

About Solutions Law Press, Inc.™

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

RAISE Act Immigration Visa, Visa Holder Public Benefit Limits Create Potential Health Industry Concerns

August 3, 2017

Immigration law changes proposed in the newly revised version of the Reforming American Immigration for a Strong Economy Act (RAISE Act) reintroduced yesterday (August 2, 2017) seek significant changes in the foreign workers granted United States (U.S.) work visas and the public benefit eligibility of work and other visa holders in the U.S. that could have significant impacts on health care providers and other health industry organizations.

Backed by President Trump, Senate Co-Sponsor Tom Cotton said the the RAISE Act seeks to refocus U.S. legal immigration system to promote two main goals:

Helping American workers get a decent pay raise and have a higher standard of living; and
Helping promote economic growth to make America more competitive in the world.

The promote these Goals, the RAISE Act would overhaul the procedures that the U.S. uses to pick foreign immigrants granted certain U.S. work and other visas as well as reform rules and limits for granting work, refugee and family member visas and limit their eligibility for public benefits.

The centerpiece of the RAISE Act’s proposed reform is replacement of the current U.S. permanent employment visa and lottery visa programs with a new “merit based” selection process that would rely upon a “skills-based points system” created under the Act to determine the foreign workers eligible to receive work visas. As proposed under RAISE Act, the U.S. would issue a maximum of 140,000 employment-based visas annually. The U.S. Citizenship and Immigration Service would select the applicants invited to file full application and undergo security vetting twice a year from a pool of potential immigrants based on their point score ranking under the new skills-based point system. The new skills-based points system would prioritize workers for visa eligibility based applicants’ relative scores determined based on the English language ability, education, age and other “predictors of immigrant success and economic contribution” listed in the RAISE Act. For more details, see here.

Beyond replacing the current employment visa and lottery visa programs, the RAISE Act also would impose new limits on the number of visas granted, tighten the eligibility rules and requirements for granting visas to noncitizen family members of U.S. citizens and legal residents and foreign workers and refugees and exclude holders of these visas from eligibility for government benefits.

In addition to reforming the visa selection process, the RAISE Act also includes reforms intended to protect U.S. taxpayers against the cost of providing public benefits for visa holders. The REACH Act provides that immigrant households arriving through the skills-based points system are not eligible for federal means tested benefits for a period of 5 years. It also generally would restrict public benefit eligibility for immigrants in the U.S. on family or parent visas and require among other things, that adult citizens and legal residents sponsoring a newly created parental visa must provide health insurance coverage at no cost to the parent and other required support. Section 6 conditions naturalization on the sponsors of an immigrant fulfilling their obligation to reimburse the federal government for benefits used by the immigrant, as required under current law.

The RAISE Act’s proposed modifications to the work and other visa eligibility and selection process and imposition of restrictions on public benefit eligibility of visa holders are likely to have multiple implications for health care providers and other health industry organizations. Beyond potential implications on the recruitment and availability foreign workers to fulfill various positions, the proposed reforms are likely to change the mix and characteristics of foreign workers eligible to obtain visas to work in the United States, the predictability and timing of the selection of workers, foreign workers’ compensation, employer-provided and government provided benefit needs and and expectation, and other recruitment, compensation and other requirements and expectations of foreign workers and their families.

Meanwhile, the proposed limits on public benefits for visa holders contained in the RAISE Act also are likely to impact the availability, reliability, predictability and source of payment for health care or other services health care and other agencies provide to immigrant populations and raise questions about how the proposed public benefit reforms will interact with emergency assessment and treatment mandates like the Emergency Medical Treatment and Labor Act (EMTALA), federal and state English as a Second Language and other nondiscrimination and cultural diversity requirements that commonly trigger special responsibilities or risks relative to treatment or other interactions involving immigrants in the U.S.

Furthermore, it also remains to be seen how consideration under the skills-based points system of applicants’ English language skills, education, age and other criteria will impact English-only prohibitions, employment discrimination and affirmative action, and other “linguistic and cultural diversity” laws and practices that have gained traction over the past decade, U.S. employers will want to carefully evaluate the likely implications of these and other potential workforce implications on their recruitment, hiring and workforce practices, provide any relevant input concerning potential concerns to Congress and monitor the progress of these proposed reforms as President Trump and its sponsors push for the RAISE Act’s enactment.

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 health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

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

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

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Posted by Cynthia Marcotte Stamer

Use Free Cyber Security Awareness Month Resources To Boost HIPAA & Other Cyber Security Training & Skills

October 25, 2015

Halloween’s annual celebration of spooks and goblins peak is a perfect time to promote awareness and help American businesses and citizens build their skills to guard against the real and growing menace of identity thieves and other cybercriminals by getting involved with the 12^th annual National Cyber Security Awareness Month (NCSAM) in October, begin preparing to participate in the next annual “Data Privacy Day” on January 28, 2016 and joining in other activities highlighted through NCSAM and Data Privacy Day to help deter Cybercrime and identity theft threats. Even if your organization or family choose not to participate in any official or public way, checking out and using the many free resources provides an invaluable, free opportunity to raise your defenses against this rising menace.

Health care providers and organizations, health plans, and their business associates face special legal and ethical mandates to safeguard “protected health information” and other sensitive patient information under the Privacy & Security Rules of the Health Insurance Portability & Accountability Act (HIPAA), state health care, insurance, medical ethics and licensure, identity theft and other laws. Most health care organizations and providers are sensitive to the need to comply with these requirements as a result of the stiff civil and criminal sanctions associated with violation of these medical privacy and data security requirements and notoriety surrounding stiff sanctions imposed as part of their enforcement, effective operationalization and maintenance of compliance with these rules remains a continuous challenge and only covers a small part of any health care organization’s legal responsibilities and risks. Health care organizations not only must manage their health care specific obligations, but also a host of other concerns like those that apply to other organizations. Getting workforce members, vendors, patients and others to understand and practice good Cyber Security in all aspects of their personal and private lives is key to effective management of all of these risks and responsibilities.

With virtually every American business and citizen now connected to and using the Internet to conduct key personal and business transactions and the constant drive by government and business to digitize regular business transactions, no one agency, business or individual alone can truly know where and who has their sensitive data, much less reliably can defend this data against the identity and other theft and other cybercriminals lurking in the digital world’s virtual streets waiting to strike, then disappear in “Jack The Ripper” style into the darkness of the Internet. That’s why every American and American business in general – and health industry organizations and providers particularly – should take time to participate and urge others to Get Involved in the 12^th Annual NCSAM activities this month and use the supportive resources offered through that involvement throughout the year.

Celebrated annually in October, NCSAM was created to provide resources to help Americans stay safer and more secure online through public-private collaboration between the U.S. Department of Homeland Security and industry led by the National Cyber Security Alliance (NCSA). NCSAM and its associated activities outreach to consumers, small and medium-sized businesses, corporations, educational institutions and young people across the nation. NCSAM 2015 particularly focuses on the consumer and his/her needs regarding cybersecurity and safety continuing the overall message of STOP. THINK. CONNECT. Campaign founded in 2010 and its capstone concepts: “Keep a Clean Machine,” “Protect Your Personal Information,” “Connect with Care,” “Be Web Wise” and “Be a Good Online Citizen.” NCSAM seeks to remind Americans to incorporate “STOP. THINK. CONNECT.” into their online routines and offers resources to help individuals understand and put these principles into practice into their online routine at the home, the office and elsewhere.

Designed to be accessible and understandable by consumers, many business and government organizations may want to support and promote their Cyber Security employee and customer training and awareness efforts by participating annually in NCSAM in October, signing up your organization to Data Privacy Day Champion and/or participating in Data Privacy Day on January 28, 2016, or otherwise using and sharing tips, tools and other resources in the Privacy Library such as:

General Privacy & Cyber Security Awareness

Be A Good Citizen On Line
Protect All Devices
Practice Good Online Safety Habits With These Tips & Advice
Spam & Phishing
Hacked Accounts
Check Your Privacy Settings
Privacy Tips for Teens – A video with STOP. THINK. CONNECT. tips to help teens be privacy-savvy and manage their online reputation.
“Perceptions of Privacy Online and in the Digitally Connected World,” a summary of the results of a 2013-2014 data privacy study conducted by the National Cyber Security Alliance’s Privacy Messaging Development Committee.
Data is Permanent Too – STOP.THINK. is this TMI? A short video created by the Intel Corporation.
Why Privacy Matters – The first in the series of explainers from Zero Knowledge Privacy Foundation.
The Fine Print of Privacy – The second in the series of explainers from Zero Knowledge Privacy Foundation.
“The Right to Fail in Citizenville,” a blog by David Hoffman, Director of Security Policy and Global Privacy Officer, Intel (March, 2013).
The Privacy Engineer’s Manifesto: Getting from Policy to Code to QA to Value, an e-book by McAfee’s Michelle Finneran Dennedy, Jonathan Fox, and Thomas R. Finneran.

Keep a Clean Machine/Cookies & Behavioral Tracking

Malware & Botnets
A video about cookies and why they matter created by the Wall Street Journal.
Information about the Network Advertising Initiative (NAI) offering opt-out of online behavior advertising and provides factual information about online behavioral advertising, privacy, cookies.

Health Privacy

What is HIPAA and Why Should You Care? A Patient’s Guide to HIPAA (Health Insurance Portability and Accountability Act)
Medical Records Privacy from Privacy Rights Clearinghouse
Understanding Health Information Privacy by the U.S. Department of Health and Human Services

Identity Theft Prevention & Clean Up

Links to resources at fraud.org about how to spot a scam, file a complaint and learn about scams.
“ID Theft & Account Fraud – Prevention & Cleanup” a helpful resource provided by Consumer Action offered in numerous languages.
Fighting Back Against Identity Theft and other information for consumers on how to deter, detect and defend against identity theft
IRS resources about how to report phishing.

Mobile App Privacy & Security

“Your Apps Are Watching You,” an investigative report from the Wall Street Journal found popular iPhone and Android apps are collecting and transmitting information without users’ awareness or consent.
Net Safety Tips On The Go app for Android phones app provides quick, practical, friendly advice one tip at a time.
Tips to help protect your privacy when using a mobile device provided by the National Cyber Security Alliance.
Microsoft’s “Location & Privacy: Where are we headed?” and “What Does Your Online Reputation Say About You?”
Protect your personal information while using public Wi-Fi with this video.
10 travel tips for protecting your privacy from PUBLIC WiFi.
Online Services – Banking, Dating & General Guidelines
Don’t Upload Financial Data to Questionable Sources video created by the Intel Corporation
The Perils and Pitfalls of Online Dating: How to Protect Yourself from the Privacy Rights Clearinghouse.
The Google Privacy Channel on YouTube offers a number of short informative videos on privacy issues including: interest-based advertising; use of privacy settings in Google Latitude; advertising privacy; and how to protect your privacy on Google Chrome.

Student & Educational Privacy & Security

I want to each online safety for Grades K-2, Grades 3-5 Middle and High School Higher Education and CSave Volunteer Lesson Plans & Materials
The Protecting Privacy in Connected Learning toolkit is an in-depth, step-by-step guide to navigating the Family Education Rights and Privacy Act (FERPA), the Children’s Online Privacy Protection Act (COPPA) and related privacy issues.
Securing Your Home Network
The Family Educational Rights and Privacy Act, or FERPA, is the main federal law that deals with education privacy, but there are a host of other laws, best practices, and guidelines that are essential to understanding education privacy. FERPA|SHERPA aims to provide service providers, parents, school officials, and policymakers with easy access to those materials to help guide responsible uses of student’s data.
General guidance for parents provided by the department of education Family Educational Rights and Privacy Act (FERPA)
Student Privacy 101: FERPA for parents and students – Ever have questions about your rights regarding education records? This short video highlights the key points of the family education rights and privacy act (FERPA).

Other Resources

About the Author

Cynthia Marcotte Stamer is a practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C., a member of Stamer│Chadwick │Soefje PLLC, author, pubic speaker, management policy advocate and industry thought leader with more than years’ experience helping business and government organizations and their leaders manage. Ms. Stamer’s legal and management consulting work throughout her 28 plus year career has focused on helping organizations and their management understand and use the law and process to manage people, process, compliance, operations and risk including significant work in the prevention, investigation and remediation of data breach and other Cybercrime events.

Scribe responsible for leading the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) annual agency meeting with the Department of Health & Human Services Office of Civil Rights,Scribe responsible for leading the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) annual agency meeting with the Department of Health & Human Services Cynthia Marcotte Stamer’s practice has focused on advising and representing government and private technology, security, health care providers, health plans, health, schools and other educational organizations, insurance, banking and financial services, retail, employer and other organizations about privacy and data security compliance and risk management, breach and other investigations and enforcement, workforce and performance management and other risk management, compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

With data and technology use, protection and management imbedded in virtually every aspect of her client’s operations, data and other confidential information and systems use, protection, breach or other abuse investigation and response, enforcement and liability mitigation and defense and other Cybercrime and Cyber Security challenges are a continuous component of Ms. Stamer’s management work. Ms. Stamer helps public and private, domestic and international businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup workforce, data breach and Cybercrime, and other legal and operational crises large and small that arise in the course of operations. Ms. Stamer regularly helps clients design, administer and defend HIPAA, FACTA, data breach, identity theft and other risk management, compliance and other privacy, data security, confidential information and other data security, technology and management policies and practices affecting their operations. She also helps clients prevent, investigate and mitigate HIPAA, FACTA, PHI and other data breach hacking, identity theft, data breach, data loss or destruction, theft of trade secrets or other sensitive data, spoofing, industrial espionage, insider and other parties misuse of data or technology and other cybercrime and technology use concerns. Best-known for her extensive work helping health care, insurance and other highly regulated entities manage both general employment and management concerns and their highly complicated, industry specific corporate compliance, internal controls and risk management requirements, Ms. Stamer’s clients and experience also includes a broad range of other businesses. Her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes. Common engagements include internal and external privacy and data security compliance, risk management, investigation and remediation, workforce hiring, management, training, performance management, compliance and administration, discipline and termination, and other aspects of workforce management including employment and outsourced services contracting and enforcement, sentencing guidelines and other compliance plan, policy and program development, administration, and defense, performance management, wage and hour and other compensation and benefits, reengineering and other change management, internal controls, compliance and risk management, communications and training, worker classification, tax and payroll, investigations, crisis preparedness and response, government relations, safety, government contracting and audits, litigation and other enforcement, and other legal and operational compliance, risk management, disaster preparedness and response, and liability defense and mitigation concerns arising out of organization’s operations.

Cindy also is widely recognized for her regulatory and public policy advocacy, publications, and public speaking on privacy and other compliance, risk management concerns. Among others, she is the author of “Privacy & Securities Standards-A Brief Nutshell,” “Privacy Invasions of Medical Care-An Emerging Perspective,” the E-Health Business and Transactional Law Chapter on Other Liability-Tort and Regulatory;” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA;” “Personal Identity Management Legal Demands and Technology Solutions;” “Tailoring A Records Management Plan And Process To Meet Your Legal And Operational Needs;” “Brokers & Insurers Identity Theft and Privacy Perils;” “HR’s Role In Personal Identity Theft & Cyber Crime Prevention;” “Protecting & Using Patient Data In Disease Management Opportunities, Liabilities And Prescriptions;” “Why Your Business Needs A Cybercrime Prevention and Compliance Program;” “Leveraging Your Enterprise Digital Identity Management Investments and Breaking though the Identity Management Buzz;” “When Your Employee’s Private Life Becomes Your Business;” “Healthcare Breaches: How to Respond” and hundreds of other works. Her insights on privacy, data security, and other matters have appeared in The Wall Street Journal, Business Insurance, the Dallas Morning News, Spencer Publications, and a host of other publications. She speaks and has conducted privacy training 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.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer works with businesses and government organizations and their management, employee benefit plans, schools, financial institutions, retail, hospitality, and other organizations deal with all aspects of these and other operations performance and compliance management. She supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Ms. Stamer also is active in the leadership of a broad range of other professional and civic organizations. For instance, Ms. Stamer serves on the steering committee and as a faculty member of the Southern California ISSA-HIMMS Annual Security Summit and Chaired its 2015 3rd Annual Health Care Privacy Summit. Ms. Stamer presently serves on an American Bar Association (ABA) Joint Committee on Employee Benefits Council representative; Vice President of the North Texas Healthcare Compliance Professionals Association; Immediate Past Chair of the ABA RPTE Employee Benefits & Other Compensation Committee, its current Welfare Benefit Plans Committee Co-Chair, on its Substantive Groups & Committee and its incoming Defined Contribution Plan Committee Chair and Practice Management Vice Chair; Past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and a current member of its Healthcare Coordinating Council; current Vice Chair of the ABA TIPS Employee Benefit Committee; the former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division; on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. She also previously served as a founding Board Member and President of the Alliance for Healthcare Excellence, as a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association. For additional information about Ms. Stamer, see here, or the Stamer Chadwick Soefje PLLC website here. To contact Ms. Stamer, e-mail her at here or telephone (469) 767-8872.

About Solutions Law Press, Inc.™

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

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Posted by Cynthia Marcotte Stamer

CMS To Host Provider Webinar To Celebrate National Health IT Week

September 13, 2013

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

Details of Webinar

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

Administrative Simplification
eRx Incentive Program
ICD-10
Quality Measurement

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

Registration Information

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

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

For More Information Or Assistance

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

About Solutions Law Press

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

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

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Posted by Cynthia Marcotte Stamer

ONC Touts Research On Health IT Benefits In Health Affairs Article

March 20, 2011

Researchers from the Office of the National Coordinator for Health Information Technology (ONC) and other Department of Health & Human Services (HHS) leaders are touting new studies they say show the benefits of investing in health information technology (health IT).

Under the Health Information Technology for Economic and Clinical Health Act (HITECH), part of the American Recovery and Reinvestment Act of 2009, as much as $27 billion Medicare and Medicaid incentive payments will be available to eligible professionals, eligible hospitals, and critical access hospitals when they adopt certified EHR technology and successfully demonstrate “meaningful use” of the technology in ways that improve quality, safety, and effectiveness of patient-centered care.

On March 8, 2011, ONC researches reported results of a comprehensive review of recent studies it says show the effects of health IT on key aspects of health care on the ONC website and in Health Affairs.

According to Donald Berwick, M.D., administrator of the Centers for Medicare & Medicaid Services, the study supports the investments that the HITECH Act makes in health IT. “These new findings are very significant in helping to confirm that our Nation has made the right choice in moving aggressively toward adoption of health information technology,” said Dr. Berwick. “These new findings are very significant in helping to confirm that our Nation has made the right choice in moving aggressively toward adoption of health information technology.”

The review included articles published from July 2007 up to February 2010, following up on earlier reviews of articles from 1995 to 2004 and from 2004 to 2007. This latest review initially surveyed more than 4,000 peer-reviewed articles, of which 154 were found qualified for the parameters of the study, a number similar to the previous efforts. In addition to quality and efficiency of care, the authors categorized additional outcomes including access to care, preventive care, care process, patient safety, and provider or patient satisfaction.

According to the authors, a current review of 154 peer-reviewed studies from July 2007 to February 2010 found:

More than 92 percent reached positive overall conclusions on the effects of health IT;
30 percent found mixed but predominantly positive results; and
Ten articles were found to have negative or mixed-negative results.

ONC reports that the review also reflected a new balance of evidence between HIT “leader” organizations and other entities, especially smaller medical practices. In previous years, much evidence has come from the “leaders.” The current review shows increased evidence of benefits for others as well.

Examples of positive results highlighted by ONC in its reports include:

One study found that at three New York City dialysis centers, patient mortality decreased by as much as 48 percent while nurse staffing decreased by 25 percent in the three years following implementation of electronic health records (EHRs).
In an inpatient study, a clinical decision support tool designed to decrease unnecessary red blood cell transfusions reduced both transfusions and costs, with no increase in patient length-of-stay or mortality.
Another study addressing HIT in 41 Texas hospitals found that hospitals with more advanced HIT had fewer complications, lower mortality and lower costs than hospitals with less advanced HIT.

ONC researchers report that negative findings in the study were most often associated with provider or staff satisfaction related to difficulties in the process of transitioning from paper-based to electronic-based records and care. The researchers conclude these findings “highlight the need for studies that document the challenging aspects of implementing HIT more specifically and how these challenges might be addressed,” such as through strong leadership or staff participation when adopting and implementing HIT.

Reflecting on the findings, Surgeon General Regina Benjamin, M.D., said, “My own personal experience in switching my practice from paper to EHRs showed that the change requires some initial effort; however, it did not interrupt work flow in the clinic. The results are better care for patients and new opportunities for the physician and staff to improve quality outcomes.” Dr. Benjamin switched to EHRs in her Gulf Coast Alabama family practice after two hurricanes and a fire destroyed the clinic’s paper records.

At the Agency for Healthcare Research and Quality, where research into health informatics has been supported since 1968, agency Director Carolyn Clancy, M.D., called attention to the importance of rapid information feedback and current evidence as the Nation pursues HIT implementation. “As we have known, and this new review of the available literature shows, HIT holds tremendous potential to improve health care quality. It is important that we continue to use experience from the field and scientific evidence to guide our efforts to improve the quality and safety of health care for all Americans.”

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others.. 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. You can get more information about her health industry 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 please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

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Posted by Cynthia Marcotte Stamer

Health Providers, Plans Make Recommendations To ONC Working Group On Governance Mechanisms By 11/3

October 26, 2010

The Office of the National Coordinator for Health Information Technology (ONC) Governance Workgroup (Workgroup) is developing recommendations on governance mechanisms for the nationwide health information network.

The Workgroup identified overarching objectives, key principles, and core functions for governance in its Preliminary Report and Recommendations on the Scope of Governance presented to the Health Information Technology (HIT) Policy Committee on October 20^th. The Workgroup is now preparing final recommendations on how governance functions should be implemented and by whom.

As a first step, the Workgroup would like to identify:

Existing mechanisms that might be appropriate, with or without modifications, and with or without some added coordination; and
Whether and what new mechanisms are needed.

The Workgroup would like public input on these issues and has created a table listing the core functions and questions to frame the input.

Submit your comments here by November 3, 2010.

For More Information or Assistance

If you need assistance evaluating or responding to this development of other health care technology and process, compliance, risk management, transactional, operational, reimbursement, enforcement or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. She continuously advises health industry clients about the use of technology, process and other mechanisms to promote compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational needs. As part of this experience, she has worked extensively with health care providers, payers, health care technology and consulting and other health industry clients on the design and use of health information systems, technology, privacy and other related. A popular lecturer and widely published author on health industry concerns, Ms. Stamer also publishes and speaks extensively on health care privacy, technology, and other health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. To review some of her many publications and presentations, or for additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

OIG Shares Key Insights On When Owners, Officers & Managers Face OIG Program Exclusion Based On Health Care Entity Misconduct

HHS to Host Regional 11/18 Meeting in LA as Part of HITECH Act Psychotherapy Notes &Testing Data Study

CMS Delegated Lead Responsibility For Development of New Affordable Care Act-Required Medicare Self-Referral Disclosure Protocol

HHS announces Rules Implementing Tools Added By Affordable Care Act to Prevent Federal Health Program Fraud

Monday 9/13 Deadline To Comment Proposed HITECH Act HIPAA Privacy Rules; 9/14 Meeting Studies Proposed Changes

DMEPOS Suppliers Face 9/27 Deadline To Meet Tightened Medicare Standards Initial EHR Certification Bodies Named

HHS Announces Adjustments to Federal Medical Assistance Percentage (FMAP) Rates

CMS Publishes Corrections To Proposed 2011 Physician Fee Schedule Rules

Medicare Changing How It Pays For Outpatient Dialysis

Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As OCR Moves To Tighten Privacy Rules

HHS Invites Input On Medicaid Changes To Promote Children’s Health Quality

CMS Adopts ESRD Facility Prospective Payment System & Proposes New Quality Incentive Program

CMS Rule Clarifies When Outpatient Services Subject to 3-Day Rule & Finalizes FY 2011 Inpatient Payment Rates

New Affordable Care Act Mandated High Risk Pre-Existing Condition Insurance Pool Program Regulations Set Program Rules, Prohibit Plan Dumping of High Risk Members

CMS Proposes Changes To Civil Monetary Penalty Rules For Nursing Homes

For More Information

We hope that this information is useful to you. You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here. To unsubscribe, e-mail here.

Leave a Comment » | Affordable Care Act, ARRA, Electronic Health Records, Health Care, Health IT, Health Policy, Patient Protection and Affordable Care Act, Privacy, Public Policy, Technology | Tagged: ARRA, Corporate Governance, Governance, health information network, Health IT, HIPAA, internal controls, ONC | Permalink
Posted by Cynthia Marcotte Stamer

CMS & ONC To Co-Host 7/22 ONC Certification & Medicare/Medicaid EHR Incentive Program Audio Training

July 20, 2010

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) will co-host an Audio Training on the Final Rules for ONC Certification and Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs on July 22, 2010 from 2:00-3:30 pm EST.

During the training, the Agencies plan to discuss:

Benefits of HIT
Summary of the final rules
ONC temporary certification process
ONC initial set of standards and implementation specifications
Medicare and Medicaid EHR Incentives Programs including the initial definition of meaningful Use

To join the audio training, dial 1-877-251-0301 and enter the Conference ID pass code: 87841621

Materials will be made available prior to the training at the following web address here.

For more information about CMS EMR incentives, see here.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers, health plans and insurers, and other health and insurance industry clients with HIPAA, EMR and other privacy and data security, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. Ms. Stamer also regularly conducts training on these and other health industry technology, compliance, management and operations matters. You can get more information about her health industry 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 please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about health industry and other related concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here. To unsubscribe, e-mail here.

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Posted by Cynthia Marcotte Stamer

DEA/DOJ Release Interim Final E-Prescribing Rules

March 25, 2010

Health care providers wishing to electronically prescribe controlled substance should begin reviewing and updating their practices and technology to comply with requirements of the Interim Final Regulations scheduled for publication in the Federal Register on March 31, 2010. Read details at http://wp.me/ptOGJ-94

An advance copy of the new Interim Final Regulation with Request for Comments released March 24, 2010 by the Drug Enforcement Administration (DEA) and Department of Justice on Electronic Prescribing of Controlled Substance on is posted for review here.

Concurrent with publication of the Interim Final Rule, the DEA is inviting comment on DEA is seeking additional comments on the following issues: identity proofing, access control, authentication, biometric subsystems and testing of those subsystems, internal audit trails for electronic prescription applications, and third-party auditors and certification organizations.

About The Author

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@solutionslawyer.net or (469) 767-8872.

Nationally and internationally recognized for more than 22 years of work with health industry technology, privacy and data security, regulatory compliance, reimbursement, workforce and staffing, licensure and accreditation, and other quality, risk management, operations and public policy matters organizations, publications, workshops and presentations and leadership Cynthia Marcotte Stamer has worked extensively with physicians, health systems, specialty and other pharmacy, telemedicine and other health technology, and other health industry clients on a diverse range of operational, product and process development, regulatory, licensure, public policy and risk management protections relating to e-prescribing, telemedicine, interoperable and other electronic health and medicine arrangements and other health care internal controls, process and privacy and technology matters. The publisher of the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update, Ms. Stamer also is a popular speaker and author of these and other health industry topics. She regularly publishes, speaks and conducts training for health industry and other organizations, the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, various medical society and other professional organizations, the Medical Group Management Association, and many other organizations. Her many publications and programs include“Changing Regulations Will Ease Way for E-Prescribing, But Physicians Shouldn’t Jump the Gun,” “Telemedicine, E-Prescribing & Electronic Health Records: Opportunities & Exposures,” “Telemedicine & E-Prescribing: Evolving Ethical, Licensing & Reimbursement Rules & Realities,” the “Tort & Other Liability” Chapter of the ABA Health Law Section/BNA E-Health & Technology Treatise, “Protecting & Using Patient Data in Disease Management Opportunities, Liabilities and Prescriptions,” Chapter 1: Privacy.” The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks (AHLA 2005) (Contributing Author), “Cybercrime and Identity Theft: Health Information Security beyond HIPAA,” “Privacy & Securities Standards-A Brief Nutshell” and numerous other programs and publications on telemedicine and e-prescribing, HIPAA and other privacy and data security, and other related internal controls and operational matters. Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others. You can review other highlights of Ms. Stamer’s health care experience here, and employment experience here. Her insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More Information

We hope that this information is useful to you. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here. To unsubscribe, e-mail here.

Leave a Comment » | Centers For Disease Control, Controlled Substances, Corporate Compliance, DEA, Doctor, E-Prescribing, Electronic Health Records, Electronic Medical Records, false claims act, FDA, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, HIPAA, HITECH Act, Hospital, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Pharmacy, Physician, Physician Licensing, Prescription Drugs, Privacy, Reimbursement, Telemedicine | Tagged: Controlled Substances, DEA, E-Prescribing, Health IT, Health Technology, HIPAA, HITECH Act, Meaningful Use, Telemedicine | Permalink
Posted by Cynthia Marcotte Stamer

House Could Vote On Health Care Reform As Early As Sunday

March 19, 2010

By Cynthia Marcotte Stamer

The stage now appears to be set for the House of Representatives to vote as early as Sunday on the latest version of health care reform backed by President Obama, Speaker Nancy Pelosi and other key Congressional Democrats, the Reconciliation Act of 2010 (H.R. 4872). The impending deadline means that health industry providers and other Americans concerned about the potential outcome of the impending vote need to act quickly if they wish to attempt to influence the decision. For tips about sharing your input with Congress effectively, see Getting Your Health Care Reform Message Heard By Key Congressional Leaders.

Developments Today Start Clock Running For Vote

On Thursday, March 18, 2010, two key developments set the stage for a vote on H.R. 4871 as early as Sunday:

The House Rules Committee posted the text of H.R. 4872 on its website; and
The Congressional Budget Office (CBO) delivered its scoring of H.R 4872 to House Speaker Nancy Pelosi.

The delivery of CBO scoring started the clock running on the 72 hour mandatory period between the release of the CBO scoring and any final vote on the bill. This means the House could vote on H.R. 4872 as early as Sunday, March 21.

If passed by the House, H.R. 4872 would make sweeping changes to the U.S. health care system impacting virtually every American patient, health care provider, employer and taxpayer. To learn the facts about these proposed changes, read the full text of H.R. 4872 here.

According to the CBO, H.R. 4872 will cost $940 billion over 10 years to extend coverage to 32 million uninsured people. To learn more specifics about these cost and other determinations, review the CBO scoring here.

This Is Only The Beginning: Stay Involved

The outcome of this latest health care reform push is only a small part of a continuing process. Whether or not the President’s proposal or some other version of health care reform passes this week, Congress already has and will continue to consider other legislation impacting health care reform. This reality is demonstrated by Congressional actions recently taken on the COBRA premium subsidy extension, Medical reimbursement for physicians, continuing federal efforts to develop and implement federal health care quality and technology standards, and other legislative, regulatory and enforcement actions taken while public attention has been focused largely only on the broader health care reform debate.

Upcoming mid-term elections will significantly impact the nature and scope of these upcoming efforts. Perhaps even more significantly, the enactment of legislation is only a beginning point. The real meaning of these or other health care reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye. Monitoring and staying active in these ongoing processes provides a critical opportunity to continue to monitor your issues and provide input to shape how they are addressed.

Individuals concerned about these and other health care reform proposals and concerns are invited to stay involved in the discussion by sharing their input with Congress, regulators. Concerned individuals also are invited to stay involved in the discussion by joining the Coalition for Responsible Health Care Reform Group on Linkedin and registering to receive these updates here. The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. You can get more information about her health industry experience here.

Help Monitoring & Responding To Developments

If you need assistance evaluating or formulating comments on the proposed reforms contained in the House Bill or on other health industry matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com or 214.270.2402.

From her extensive involvement with federal and state legislative and regulatory licensing, telemedicine, managed care, privacy and other health, pension and other reforms in the U.S. to her involvement as a lead advisor to the Government of Bolivia on its pension privatization legislation, Ms. Stamer’s experience includes significant experience working with clients domestically on key health care and other public policy matters. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Chairman of the Board of Richardson Development Center for Children and past Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer couples her policy experience with her extensive experience working with health industry clients on regulatory, staffing, reimbursement, risk management and compliance and other operational matters. She has more than 22 years experience advising health industry clients about these and other matters. A popular lecturer and widely published author on health industry matters, Ms. Stamer advises hospitals and other health industry clients about responding to and using these and other quality measures and other related concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters.

Leave a Comment » | Anti-KickBack, ASC, Childrens Health Insurance Program, Consumer Driven Health Care, Durable Medical Equipment, Electronic Health Records, Employment, Evidence Based Medicine, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Plans, Hospital, Indian Health, Medical Malpractice, Medicare, Physician, Prescription Drugs, Public Policy, Reimbursement, Stark, Tax, Veterans Health, Veterans Health Care | Tagged: H.R. 4872, Health Care Fraud, Health Care Provider, Health Care Reform, Health insurer, Health IT, Health Plans, Payer, Physician, Provider, Reconciliation Act of 2010 | Permalink
Posted by Cynthia Marcotte Stamer

HIT Committee To Meet October 14 In Washington, D.C.

September 29, 2009

The next meeting of the HIT Standards Committee of the Office of the National Coordinator for Health Information Technology (ONC) will be held on October 14, 2009, from 9 a.m. to 3 p.m./Eastern Time at the Omni Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Interested members of the public are invited to attend.

Created under the American Recovery and Reinvestment Act of 2009 (ARRA), the HIT Standards Committee is charged with making recommendations to the Office of National Coordinator for Health Information Technology (ONC) on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee. Even as Congress debates further reforms, the activities of the HIT Committee and other components of the ONC are key actors in the continuing efforts of the Obama Administration to promote health care efficiency by reengineering health care technology.

During a previous meeting on August 20, 2009, the HIT Committee finalized certain recommendations concerning meaningful use of electronic medical records, clinical quality, and privacy and security of protected health information, which are available for review here.

According to the ONC announcement regarding the upcoming meeting in today’s (September 29, 2009) Federal Register available here, the Committee plans during the meeting to:

Discuss reports from its Clinical Operations, Clinical Quality, and Privacy and Security Workgroups
Take testimony from invited experts in the field of security as it relates to health information technology

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 6, 2009. Oral comments from the public will be scheduled between approximately 2:30 p.m. to 3 p.m. Time allotted for each presentation may be limited. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public hearing session, ONC will take written comments after the meeting until close of business.

ONC hopes to make background material available to the public at least two (2) business days prior to the meeting. However, if ONC is unable to post the background material on its Web site before the meeting, it will make that material publicly available at the location of the advisory committee meeting, and post the background material on ONC’s web site after the meeting here.

The designated person to contact for additional information is Jonathan Ishee, Office of the National Coordinator, HHS, 200 Independence Ave, SW., Room 729-G, Washington, DC 20201, 202-205-8493, Fax: 202-690-6079, e-mail: jonathan.ishee@hhs.gov.

If you need assistance preparing or presenting comments to the HIT Standards Committee or with monitoring or responding to other health care IT, privacy and data security, regulatory, operational, public policy or other health care concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Chair and Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Updates available online by clicking on the applicable article title below:

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here, registering to receive updates in blog form here or e-mailing this information to support@solutionslawyer.net.

Leave a Comment » | ARRA, Doctor, Electronic Health Records, Electronic Medical Records, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Outcomes Data, Physician, Technology | Tagged: ARRA, Health Care, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, Health Insurance, Health IT, Health Plans, Health Policy, Health Technology, HHS, HIPAA, Hospital, Identity Theft, Medicare, Medicare Part B, PBMs, Privacy, Public Policy, Reimbursement, Technology | Permalink
Posted by Cynthia Marcotte Stamer

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

Banner Health Settlement

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ONC Report Signals New Interoperability Demands Coming

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RAISE Act Immigration Visa, Visa Holder Public Benefit Limits Create Potential Health Industry Concerns

Use Free Cyber Security Awareness Month Resources To Boost HIPAA & Other Cyber Security Training & Skills

CMS To Host Provider Webinar To Celebrate National Health IT Week

ONC Touts Research On Health IT Benefits In Health Affairs Article

Health Providers, Plans Make Recommendations To ONC Working Group On Governance Mechanisms By 11/3

CMS & ONC To Co-Host 7/22 ONC Certification & Medicare/Medicaid EHR Incentive Program Audio Training

DEA/DOJ Release Interim Final E-Prescribing Rules

House Could Vote On Health Care Reform As Early As Sunday

HIT Committee To Meet October 14 In Washington, D.C.

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