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

September 15, 2022

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More Information

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

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

About the Author

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

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

Ms. Stamer’s work throughout her 35 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. In the course of this work, she has worked extensively on workforce and medical staff credentialing, management, investigation, peer review and discipline, and reporting and remediation of criminal or other activity to regulatory officials.

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

About Solutions Law Press, Inc.™

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

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and 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. 

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. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™


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

September 2, 2022

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

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

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

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

More Information

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 following and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

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

A Fellow in the American College of Employee Benefit Counsel, 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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and 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. 

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. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™


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

August 23, 2022

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More Information

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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

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

A Fellow in the American College of Employee Benefit Counsel, 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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and 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. 

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. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™


Protect Remote Desktop Protocols From Malware Threat

July 1, 2022

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

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

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

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

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

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

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

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

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

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

More Information

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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

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

A Fellow in the American College of Employee Benefit Counsel, 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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and 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. 

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. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™


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

May 29, 2022

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

Charges Against Texas Physicians

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

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

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

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

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

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

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

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

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

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

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

More Information

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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.  

About the Author

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

A Fellow in the American College of Employee Benefit Counsel, 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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and 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. 

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. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™


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

May 2, 2022

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

Cummings Supreme Court Ruling

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

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

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

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

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

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

Liability Risks Remain Substantial Despite Cummings Ruling

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

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

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

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

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

For Additional Information Or Assistance

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

Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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

About Solutions Law Press, Inc.™

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

Important Information About This Communication

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and 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.

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. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™


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

September 9, 2021

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More Information

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

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

About the Author

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

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

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

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

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member,  past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.

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

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.

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


CMS/CDC Mandating COVID Vaccination For All Nursing Home Staff

August 18, 2021

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

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

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

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

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

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

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

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

More Information

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

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

About the Author

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

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

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.

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


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

August 3, 2021

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

December 21, 2020

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

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

Individual Access Rights Expanded

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

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

Encouraging Care Coordination and Case Management Activities

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

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

Required Updates To Notices of Privacy Practices

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

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

Disclosures to Family Members and Other Caretakers in Certain Situations

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

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

Clarification Regarding Disclosures to TRS Providers

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

Act Now

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

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

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 health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.


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

October 16, 2020

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

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

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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years legal and operational management work, coaching, public policy and regulatory affairs leadership and advocacy, training and public speaking and publications. As a significant part of her work, Ms. Stamer has worked extensively domestically and internationally on an demand, special project and ongoing basis with health industry, health plan and insurance and other business, government and community organizations and their leaders, spoken and published extensively on HIPAA and other privacy and data security concerns, as well as other health care and health benefits;  human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress;  and many other management concerns.

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Board Certified in Labor and Employment Law By the Texas Board of Legal Specialization, Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, and the ABA RPTE Employee Benefits & Other Compensation Group and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive experience advising, representing, defending and training health care providers, health plans and insurers, employers, community organizations and others about HIPAA and other privacy concerns and has published and spoken extensively on these concerns.

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

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Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and shares insights and thought leadership through her extensive publications and public speaking. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.  ©2020 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.


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

April 3, 2020

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

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

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

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

April Recommendations Send Warnings, Share New Tools

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

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

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

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

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

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

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

  • Standard inspections for nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices; and
  • Revisit inspections not associated with Immediate Jeopardy.

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

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

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

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

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

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

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

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

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

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

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

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

More Information

We hope this update is helpful. In addition to this update, the author also has prepared a more comprehensive discussion of these concerns scheduled for publication by the American Bar Association Health Publication in April, 2020.  To request access for a prepublication unofficial manuscript of that upcoming publication or of more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

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

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. ©2020 Cynthia Marcotte Stamer.  Limited non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.


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