Three consolidated False Claims Act (“FCA”) lawsuits against chiropractor Yury Gampel (“Gampel”), 15 Modern Vascular office-based labs owned primarily by Gampel located across the United States, and five Modern Vascular-affiliated companies owned by Gampel alert other chiropractic, physician and other medical providers using office-based labs send a clear warning to other health care providers and suppliers for services covered or billed to Medicare, Medicaid, TRICARE or other federal health care programs about the necessity to ensure their arrangements don’t involve illegal financial relationships or transactions.
False Claims Act Liability Arising From Participation In Or Filing Claims Involving Improper Inducements
The Justice Department suit against the defendants alleges the defendants both arose from the defendants participation in arrangements involving the offering and payment of illegal remuneration in violation of the federal Anti-Kickback Statute (“AKS”) and that the claims for benefits made to Medicare and other federal programs for care provided involving the arrangement violated the FCA.
The AKS generally prohibits any person or entity from soliciting, receiving, offering, or paying any direct or indirect prohibited remuneration as an inducement or reward for referring, recommending, ordering, or arranging for the purchase of any item or service for which payment may be made in whole or in part by a federal health care program. Parties violating the AKS commit a felony punishable with a fine of up to $100,000, imprisonment for up to 10 years or both.
In addition to any criminal liability arising under the AKS, filing claims derived or involving transactions prohibited by the AKS also can trigger liability for violation of the FCA. The FCA makes it unlawful for any person to submit, directly or indirectly, false or fraudulent claims for payment to the Government by among other things:
Knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval in violation of 31 U.S.C. § 3729(a)(1)(A) (the “presentment provision”); or
Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim in violation of 31 U.S.C. § 3729(a)(1)(B).
The FCA defines the term “knowingly” under the FCA very broadly. As defined, “knowingly” means that a person, with respect to information, (i) has actual knowledge of the information, (ii) acts in deliberate ignorance of the truth or falsity of the information, or (iii) acts in reckless disregard of the truth or falsity of the information. 31 U.S.C. § 3729(b). No proof of specific intent to defraud is required to show that a person acted knowingly under the FCA.
Violations of the FCA subject the defendant to mandatory civil penalties per FCA violation, plus three times the amount of damages that the Government sustains as a result of the defendant’s actions. 31 U.S.C. § 3729(a). Under 42 U.S.C. § 1320a-7(b)(7), health care providers submitting claims to Medicare or other federal health care programs also can face exclusion from participation in federal health care programs for FCA violations.
Health care providers filing claims for Medicare or other federal health plans can violate the FCA by knowingly presenting or causing to be presented claims for items or services that the person knew or should have known were not medically necessary, or were false or fraudulent. 42 U.S.C. §§ 1320a-7a(a)(1).
Moreover, health care providers under the Medicare statute have an affirmative duty to familiarize themselves with the statutes, regulations, and guidelines regarding coverage for the Medicare services. As a condition of program participation, Medicare regulations require providers and suppliers to certify that:
The provider or supplier meets, and will continue to meet, the requirements of the Medicare statute and regulations, 42 C.F.R. § 424.516(a)(1), including that any claims and underlying transactions made in a claim for Medicare comply with the Federal anti-kickback statute and the Stark law), and on the supplier’s compliance with all otherwise applicable conditions of participation in Medicare; and
The provider or supplier will not knowingly to present or cause to be presented a false or fraudulent claim for payment by Medicare, or to submit claims with deliberate ignorance or reckless disregard of their truth or falsity.
Additional certifications of continued compliance with these requirements also are required when claims are filed. Accordingly, since health care providers and suppliers are responsible for taking appropriate steps to familiarize themselves with the rules and regulations applicable to their claim and the transactions underlying it and certify in connection with the filing of the claim that the claim and its underlying transactions comply with the law, health care providers filing claims involving prohibited financial incentives or other transactions prohibited by law risk FCA liability.
Gampel, Modern Vascular FCA Complaint
Derived from the Justice Department’s assumption and consolidation of various qui tam lawsuits separately brought by various physicians, the United States filed its complaint in three consolidated lawsuits pending in the United States District Court for the District of Arizona under the qui tam, or whistleblower, provisions of the False Claims Act, 31 U.S.C. §§ 3729-3733 (“FCA”) which allow a private citizen to sue on behalf of the government and share in any recovery. The United States is also entitled to intervene in the lawsuits, as it did in these cases.
The resulting consolidated three consolidated Justice Department lawsuits seek to recover treble damages and civil penalties, and under common law and equitable theories of recovery from defendants for their billing of Medicare, TRICARE and other federal health care programs for claims resulting from transactions involving prohibited remuneration offered and provided in violation of the AKS under Gampel’s alleged schemes Nobility Management LLC; Modern Vascular LLC; Modern Vascular of South Florida LLC; Modern Vascular Management LLC; Modern Vascular Management – East LLC; Modern Vascular Management – West LLC; Modern Vascular Institute LLC; Modern Vascular of Mesa LLC; Modern Vascular of Glendale LLC; Modern Vascular of Sun City LLC; Modern Vascular of Tucson LLC; San Antonio Vascular Specialists Corp. dba Modern Vascular; Fort Worth Vascular Specialists Corp. dba Modern Vascular; Modern Vascular of Denver LLC; Modern Vascular – Navajo LLC; Modern Vascular of Fairfax LLC; Modern Vascular of Houston LLC; Modern Vascular of Indianapolis LLC; Modern Vascular of Southaven LLC; Modern Vascular of St. Louis LLC; and Modern Vascular of Kansas LLC.
The Justice Department complaint alleges Defendant Yury Gampel, a chiropractor, is the founder and former Chief Executive Officer (“CEO”) of a franchise of office-based labs (“OBL”) located in Arizona, New Mexico, Colorado, Texas, Indiana, Kansas, Mississippi, Missouri, Tennessee, and Virginia operating under the name Modern Vascular (collectively, the “Modern Vascular OBLs”). The Modern Vascular OBLs – each its own separate legal entity – focus on the treatment of peripheral arterial disease (“PAD”), particularly through an aggressive use of vascular intervention procedures, such as angioplasty and atherectomy. The complaint claims Gampel and the Modern Vascular defendants designed and promoted the franchises that incorporated a package of management and other services provided by various Modern Vascular defendant companies.
Defendant Nobility Management, LLC, provides management services to the Modern Vascular OBLs. Defendants Modern Vascular Management, LLC; Modern Vascular Management – East, LLC; and Modern Vascular Management – West, LLC, offer IT and management support to Modern Vascular OBLs. Defendants Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, are corporations controlled by Gampel that have various ownership interests in Modern Vascular OBLs. Through Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, and in his own capacity, Gampel is the majority owner of the Modern Vascular OBLs. (These entities that own and manage the Modern Vascular OBLs are referred to collectively below as “Modern Vascular Corporate.”)
The complaint alleges that Gampel and Modern Vascular Corporate designed and implemented a fraud scheme at Modern Vascular OBLs at the expense of patients and federal payors from at least January 1, 2018 through June 30, 2022. Among other things, the complaint charges Gampel and the Modern Vascular defendants offered physicians the opportunity to invest in Modern Vascular office-based labs to induce them to refer their Medicare and TRICARE patients to Modern Vascular for the treatment of peripheral arterial disease. More specifically, Gampel and Modern Vascular Corporate opened Modern Vascular OBLs in new markets where referring physicians and vascular surgeons had established relationships. Prior to opening an OBL in a particular location, Gampel sought out up to 20 local physicians – usually podiatrists and pain management physicians – who traditionally referred to vascular surgeons and offered each up to a two percent ownership interest in the OBL in order to induce the physicians to refer to the OBL. Gampel and Modern Vascular Corporate selected these particular physicians (hereinafter “physician investors”) to offer ownership investment because Gampel and Modern Vascular Corporate identified them as potential high-referral sources. Once they invested in an OBL, Gampel and Modern Vascular Corporate further required the physician-investors to make referrals to Modern Vascular OBLs as a condition for remaining as a physician-investor. The complaint also alleges that Gampel pressured vascular surgeons and interventional radiologists employed at the Modern Vascular office-based labs to increase the number of invasive surgical procedures performed by tracking procedures and setting aggressive weekly and monthly goals for such procedures. In particular, Gampel and Modern Vascular Corporate provided remuneration to physician investors in Modern Vascular OBLs to induce those investors to refer patients to the Modern Vascular OBL.
The Justice Department charges that using this scheme, Defendants between January 1, 2018 and June 30, 2022 submitted, and caused to be submitted, tens of millions of dollars in false or fraudulent claims to Medicare, TRICARE and other federal health care programs by offering and providing illegal remuneration to health care providers to induce referrals to the Modern Vascular OBLs in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b. To induce referrals, Gampel and Modern Vascular Corporate provided remuneration to physician-investors in the form of equity ownership interests in an OBL, which also included distributions, the prospect of future distributions, and/or the prospect of a cash-out of the equity ownership amounts when the Modern Vascular OBLs were sold. During the relevant time period, the Justice Department also claims Modern Vascular OBLs received over $50 million from Medicare Part B alone for claims submitted for patients referred by physician-investors in violation of the FCA.
Warning To Other Heath Care Providers & Suppliers
In announcing its filing of the Gambrel FCA lawsuit, the Justice Department warned other federal health program providers and suppliers and their business partners, investors, employees and agents from violating the AKS, FCA or both in the provision of or billing of health care services or supplies. “As part of our mission to protect the American people, the FBI remains committed to safeguarding patients who rely on our healthcare systems,” said Deputy Assistant Director Aaron Tapp of the FBI’s Criminal Investigative Division. “The FBI and our law enforcement partners will continue to investigate those who abuse our healthcare systems, place patients at risk, and waste taxpayer dollars.”
This warning, along with the ever-lengthening list of federal criminal and civil prosecutions, convictions and settlements by the Justice Department, the Department of Health & Human Services Office of Inspector General and other agencies provide a strong warning to health care providers, suppliers and others involved in creating or administering transactions and other arrangements for the delivery and billing for health are to be billed to Medicare, Medicaid, TRICARE and other health care arrangements covered by the AKS, the FCA or other federal or state health care fraud laws to take well documented care to ensure the care delivery arrangement does not involve transactions prohibited under the AKS or other federal or state health care fraud transactions and the care billed qualifies for reimbursement before submitting the claim. Parties who know or suspect that they may have participated in an arrangement prohibited under these laws or submitted prohibited claims should contact experienced legal counsel within the scope of attorney-client privilege for assistance in reviewing those concerns and exploring options for correction or mitigation.
For More Information
If your organization would like to learn more about the concerns discussed in this update or seeks assistance auditing, updating, administering or defending its human resources, compensation, benefits, corporate ethics and compliance practices, or other performance related concerns, contact management attorney and consultant Cynthia Marcotte Stamer.
An attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization, Ms. Stamer is recognized for work helping organizations management people, operations and risk as a Fellow in the American College of Employee Benefit Counsel, a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Labor and Employment Law and Health Care Law; a “Best Lawyers” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law.”
For 35 years, Ms. Stamer’s work has focused on advising and assisting businesses and business leaders with these and other employment and other staffing, employee benefit, compensation, risk, performance and compliance management and other operational solutions and concerns. Her experience includes helping management both manage performance and manage legal risk and compliance. While helping businesses define and manage the conduct and performance of their employees, contractors and vendors, she also assists employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, leave, and other labor and employment laws, advises and defends businesses against labor and employment, employee benefit, compensation, fraud and other regulatory compliance and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor, Department of Justice, SEC, Federal Trade Commission, HUD, HHS, DOD, Departments of Insurance, and other federal and state regulators. Ms. Stamer also speaks, coaches management and publishes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see hereor contact Ms. Stamer directly.
Other Helpful Resources & Information
If you found this article of interest, you also may be interested in reviewing other Breaking News, articles and other resources available including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. If you do not wish to receive these updates in the future, unsubscribe by updating your profile here.
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.
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.
Health care providers, health plans and insurers and other stakeholders concerned about the Department of Health and Human Services Office of the National Coordinator for Healthcare Information (“ONC”) electronic clinical quality measures (“eCQMs”) have the opportunity to review and comment on draft changes to the eCQM specifications and supporting resources under consideration by ONC as part of ONC’s 2022 Change Review Process (CRP) for the ONC Project Tracking System. Interested stakeholders must monitor the posting of issues and act quickly to share their feedback, however, as stakeholders have only two weeks to comment after a ONC posts a new proposed eCQm change.
eCQMs As Measure of Health Care Quality
Electronic clinical quality measures or “eCQMs” are tools that ONC develops with stakeholder input to help Medicare and Medicaid measure and track the quality of health care services that eligible hospitals and critical access hospitals (CAHs) provide, as generated by a provider’s electronic health record (EHR). CMS Measuring and reporting eCQMs helps to ensure that our health care system is delivering effective, safe, efficient, patient-centered, equitable, and timely care. CMS’ eCQMs measure many aspects of patient care, including:
Patient and Family Engagement
Patient Safety
Care Coordination
Population/Public Health
Efficient Use of Healthcare Resources
Clinical Process/Effectiveness
To successfully participate in the Medicare and Medicaid Promoting Interoperability Programs, the Centers for Medicare and Medicaid Services (“CMS”) requires eligible providers, eligible hospitals, critical access hospitals and dual-eligible hospitals electronically to report on eCQMs determined by CMS that require the use of data from the provider’s certified electronic health record (“EHR”) technology (CEHRT) or other health information technology systems to measure and report quality measures in a standardized manner. For calendar year (CY) 2022, Medicare Promoting Interoperability Program participants arerequired to report on three self-selected eCQMs and the Safe Use of Opioids – Concurrent PrescribingeCQM from the set of nine available for at least three self-selected quarters of CY 2022 data. To report eCQMs successfully, health care providers must use an EHR and adhere to the requirements identified by the CMS quality program. Failing to meet these eCQM reporting requirements can prevent the provider from meeting meaningful use requirements and trigger reductions in reimbursements for care.
Health care quality, credentialing, accreditation, and other provider, health plan and other organizations also use the eCQMs data alone or with other quality measures and tools to set standards and assess and enforce quality goals and performances.
As the proposed changes on a relevant eCQM could materially impact the reporting responsibilities of the reporting providers, the quality and meaning of a proposed data measure, or both, impacted stakeholders should monitor the system for possible changes impacting the eCQMs used or applicable to their organizations and its activities and if appropriate, comment promptly.
2022 eCQMs Updates
Each year, CMS makes updates to the eCQMs approved for CMS programs to reflect changes in:
Evidence-based Medicine
Code Sets
Measure Logic
Conducted annually as part of OCN’s eCQM Issue Tracker project, the CRP provides eCQM users the opportunity to review and comment on draft changes to the eCQM specifications and supporting resources under consideration by the measure stewards. The goal of the CRP is for eCQM implementers to comment on the potential impact of draft changes to eCQMs so CMS and measure stewards can make improvements to meet CMS’s intent of minimizing provider and vendor burden in the collection, capture, calculation, and reporting of eCQMs.
Stakeholders with an account on the ONC Project Tracking System can monitor, review and comment on proposed eCQM changes through the eCQM Issue Tracker project during the two week period following the date the issue is posted in the eCQM Issue Tracker. To participate in the CRP, users must have an ONC Project Tracking System account. New users can create an account via the ONC Project Tracking System website.
The following table reflects the eCQM issues open on the eCQM Issue Tracker as of September 14, 2022 and their scheduled comment closing dates
Issues Open for Public Comment As of 9/14/2022
CMS eCQM Identifier and Measure Title
CRP Issue Title
Issue Number and Link
Issue Type
Goal of Review
Public Comment Open Date
Public Comment Close Date
Multiple measures
Incorporate ‘Diagnosis’ datatype to capture Hospice Care
CMS128: Anti-depressant Medication Management; CMS136: Follow-Up Care for Children Prescribed ADHD Medication (ADD); CMS156: Use of High-Risk Medications in Older Adults
Update Cumulative Medication Duration function to calculate maximum daily frequency
eCQM Issue Tracker Open Issues As Of September 14, 2022
As proposed eCQM changes are posted for public comment as CRP issues. ONC informs eCQM accountholders of the proposed change or eCQM issue by posting for review in the ONC Project Tracking System. Accountholders only have two weeks after ONC posts a proposed eCQM to comment on the posted issue. Stakeholders interested in commenting on a particular issue must submit their comment in accordance with the directions within this two week period.
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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
Physicians and other health care prescribers must remain hyper vigilant when prescribing, documenting, billing and managing opiate and other pain management prescriptions and patients. That’s the clear message sent by the ever-growing wave of federal prosecutions and convictions like the March 2, 2022 federal conviction of Tennessee physician Mark Murphy and his wife, Jennifer Murphy and his wife for unlawfully distributing opioids, providing unnecessary services and defrauding insurers from their now-shuttered North Alabama Pain Services clinics (“NAPS”) and March 1, 2022 sentencing of former physician Patrick Titus to 20 years in prison for his conviction of unlawful distribution of opioid drug outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice.
Tennessee Doctor & Wife Convicted of Pain Management Related Unlawful Opioid Distribution, Health Care Fraud & Other Criminal Charges
The March 2 federal jury conviction of Dr. and Ms. Murphy stemmed from their ownership and operation of their now-defunct pain management clinics resulted from evidence gathered through a joint investigation by the Federal Bureau of Investigation, the Department of Health & Human Services Office of Inspector General, the Internal Revenue Service, and the Drug Enforcement Agency.
During the resulting jury trial, federal prosecutors presented evidence that during the five-year period leading up to the clinic closing its Alabama locations in 2017, Dr. Murphy and Ms. Murphy, who was the office manager, caused over $50 million in fraudulent or unnecessary medical services to be charged to Medicare, TRICARE, Blue Cross Blue Shield of Alabama and others. Evidence at trial showed that NAPS provided pre-signed prescriptions to thousands of patients a month, including prescriptions written outside the usual course of professional practice without a legitimate medical purpose. Federal prosecutors also introduced evidence that the Murphys also solicited and received unlawful payments for referring fraudulent or unnecessary services to patients.
Based on the evidence, the jury found both Dr. and Ms. Murphy guilty on numerous criminal charges including:
Conspiracy to unlawfully distribute and unlawful distribution of controlled substances;
Conspiracy to commit and commission of health care fraud;
Conspiracy to defraud the United States; and
Receiving illegal kickbacks in violation of the Anti-Kickback Statute.
Ms. Murphy also was convicted of tax-related charges for underreporting clinic income.
Currently scheduled for sentencing in June, the Murphys each face a maximum of 20 years in prison for the drug charges and a maximum of 10 years in prison for the health care fraud charges. Both defendants also face a maximum of five years in prison for charges stemming from violations of the Anti-Kickback Statute, and Ms. Murphy faces up to three years in prison for the tax charges.
Former Delaware Doctor Sentenced to 20 Years in Prison for Unlawful Opioid Distribution
The Murphy’s jury conviction came one day after the sentencing of former to 20 years in prison for his July 2021 federal jury conviction on 13 counts of unlawfully distributing and dispensing controlled substances and one count of maintaining a drug-involved premises.
Federal prosecutors presented evidence in court documents and trial that Dr. Titus unlawfully distributed or dispensed opioid drugs including fentanyl, morphine, methadone, OxyContin and oxycodone outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice. The Justice Department charged Dr. Titus frequently prescribed these dangerous controlled substances in high dosages, sometimes in combination with each other or in other dangerous combinations, mostly in exchange for cash. Evidence at trial showed he distributed over 1 million opioid pills without providing any meaningful medical care and to patients he knew were suffering from substance use disorder and/or who demonstrated clear signs that the prescribed drugs were being abused, diverted or sold on the street.
Health Care Fraud Task Force Targeting Opioid Distribution, Billing, & Related Misconduct
Both the Murphy and Titus prosecutions and convictions are two of a growing series of convictions resulted from investigations into opioid and other pain management prescribing conducted as part of efforts targeting physicians and other health care providers involved in prohibited the federal Health Care Fraud Strike Force Program. See e.g., Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme.
The Federal agencies made a point of warning to other physicians not to overprescribe, bill or engage in other prohibited dealings involving opioids or other controlled substances when announcing the Titus sentencing.
“As we continue the fight against the opioid crisis, this case serves as an important reminder that health care professionals have a duty to prescribe medication responsibly to ensure the well-being of individuals under their care. Failing to do so can endanger patients and undermines critical, ongoing public health measures,” said Special Agent in Charge Maureen Dixon of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG will continue to work with our law enforcement partners to hold bad actors accountable.”
“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’ care for their own profit.”
“DEA-registered medical practitioners have an important role in our communities to treat patients compassionately and responsibly,” said DEA Administrator Anne Milgram. “Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable.”
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.
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.
The U.S. Department of Justice along with the Minnesota and New York Attorneys General (collectively “Justice Department”) are suing to stop UnitedHealth Group Incorporated (“United”) from acquiring Change Healthcare Inc. (“Change”) on February 24, 2022 in an announced $13 billion transaction as prohibited by antitrust laws. The suit is the latest in a series of Justice Department suits that seek to prevent continued consolidation of the health industry giants following decades of industry consolidation.
United, headquartered in Minnetonka, Minnesota, is an integrated health care enterprise that includes, among other subsidiaries, UnitedHealthcare, the largest health insurer in the United States; Optum Health, a large network of health care providers located throughout the country; OptumRx, a large pharmacy benefit manager; and OptumInsight, a health care technology business. United’s revenues were $288 billion in 2021.
Change Healthcare Inc. headquartered in Nashville, Tennessee, is a leading independent health care technology company providing health care analytics, software, services and data to health care providers, health insurers and other software and services firms in the health care industry. Today, Change markets itself as a partner to a wide variety of other health care ecosystem organizations including United’s major health insurance competitors as providing vital software and services need for innovation and problem solving. These services include electronic data interchange (EDI) clearinghouse services, which transmit claims and payment information between insurers and providers, and first-pass claims editing solutions, which review claims under the health insurer’s policies and relevant treatment protocols. Change’s revenues were $3.4 billion in 2021.
In the civil antitrust complaint filed in the U.S. District Court for the District of Columbia on February 24, 2022, the Justice Department charges United’s acquisition of this neutral player would allow United to tilt the playing field in its favor, harming current competition and allowing United to control and distort the course of innovation in this industry for the foreseeable future.
Among other things, the Justice Department alleges allowing United to eliminate a significant independent and innovative competitor firm by acquiring Change will undermine competition in the commercial health insurance market, stifle innovation in the employer health insurance markets and suppress competition in the market for a vital technology used by health insurers to process health insurance claims and reduce health care costs by giving United control of a critical data highway through which about half of all Americans’ health insurance claims pass each year.
As alleged in the complaint, the proposed transaction would give United, a massive company that owns the largest health insurer in the United States, access to a vast amount of its rival health insurers’ competitively sensitive information. Post-acquisition, United would be able to use its rivals’ information to gain an unfair advantage and harm competition in health insurance markets. The Justice Department also claims the proposed transaction would eliminate United’s only major rival for first-pass claims editing technology — a critical product used to efficiently process health insurance claims and save health insurers billions of dollars each year — and give United a monopoly share in the market.
A Justice Department press release about the lawsuit quotes Principal Deputy Assistant Attorney General Doha Mekki of the Justice Department’s Antitrust Division as saying, “Unless the deal is blocked, United stands to see and potentially use its health insurance rivals’ competitively sensitive information for its own business purposes and control these competitors’ access to innovations in vital health care technology. The department’s lawsuit makes clear that we will not hesitate to challenge transactions that harm competition by placing so much control of data and innovation in the hands of a single firm.”
The suit is the latest in a series of civil antitrust lawsuits challenging proposed mergers or acquisitions of between health insurance industry giants as anticompetitive in recent years. Stay tuned for more details.
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.
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.
CMS recently updated its Nursing Home Resource Centerwith new pieces of informational guidance on visitation and vaccines in response to the recent surge in Omicron cases.
Visitation
As of January 6, CMS updated the Nursing Home Visitation FAQs (PDF) to give additional guidance about visitation during the Omicron surge and also created an infographic (PDF) to graphically represent how to safely conduct visits to nursing homes during this time of spiking COVID cases around the country. Nursing home providers, patients, caregivers, and CMS partners can use these 2 new resources to stay informed about CMS’ latest thinking for keeping nursing homes safe in the current COVID climate.
CMS also continues to urge long-term care settings, like nursing homes, assisted living, residential care communities, group homes, and senior housing, to ensure residents and staff get COVID-19 vaccine primary series and booster shots.
Vaccination
while long-term care and other Medicare and Medicaid participating healthcare providers continue to await the Supreme Court’s decision on the enforceability and validity of the Biden administration vaccine mandate for program participation, CMS continues to urge long-term care providers to coordinate access to COVID-19 vaccines, either in the local community or on-site using the newest CDC resources.
As a reminder, through enforcement discretion, CMS allows Medicare-enrolled immunizers, including but not limited to pharmacies working with the U.S., to bill directly and get direct reimbursement from the Medicare program for vaccinating Medicare skilled nursing facility residents. See, Medicare billing and payment information.
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.
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.
Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.
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, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of a multitude of health industry and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
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.
Federal health care fraud prosecution continues to thrive despite the ongoing COVID-19 health care emergency.
Recently announced prosecutions and other enforcement actions include Fraud & Abuse, False Claims Act and other health care fraud prosecutions commonly pursued by the Justice Department in recent decades as well as a host of new prosecutions of abuses of Covid-19 relief programs. Examples include:
These and other actions send a clear message to health care and life science organizations to continue vigorous health care fraud compliance and risk management activities as well as stay vigilant for signs of new audit and enforcement activities.
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.
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.
Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.
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, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of a multitude of health industry and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
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.
Learn more about recent changes to the Center for Medicare & Medicaid Services (“CMS”) Quality Measurement and Value-Based Incentives Group (“QMVIG”) quality initiatives during its upcoming Bi-Monthly Forum on Tuesday, September 28 from 1:30 – 2:30 p.m. ET.
During this webinar, CMS says attendees will learn about and have opportunities to ask CMS questions about quality reporting programs and initiatives that directly impact their organizations.
CMS says forum will include updates on the following topics:
Medicare Promoting Interoperability Program
Electronic Clinical Quality Improvement (eCQI) Resource Center
Clinical Quality Language Libraries
Annual Change Review Process
Quality Payment Program (QPP)
Alternative Payment Models (APMs) and the APM Performance Pathway
CMS requires persons desiring to participate to register using the filling link and information:
If you have questions regarding registration, want to receive future communications regarding the forum, email CMS at CMSQualityTeam@ketchum.com.
More Information
Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
More Information
Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
This article is republished by permission of the author, Cynthia Marcotte Stamer. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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.
All Medicare and Medicaid certified health care facilities, and a broad range of other employers must prepare to meet impending new federal COVID-19 vaccine mandates announced by the Biden-Harris Administration today.
According to today’s announcements all healthcare facilities participating in Medicare or Medicaid or employing 100 or more employees will be required to ensure all staff are vaccinated against COVID-19.
The Biden-Harris Administration says the new health industry COVID-19 vaccine mandates will be implemented through emergency regulations to be issued in October.
According to today’s announcement, the Centers for Medicare & Medicaid Service (“CMS”) in collaboration with the Centers for Disease Control (“CDC”) is developing an Interim Final Rule with Comment Period that will be issued in October that will extend vaccine mandates originally announced last month for all Medicare and Medicaid participating nursing home workers to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. See CMS/CDC Mandating COVID Vaccination For All Nursing Home Staff.
The announcement of the vaccine mandates for healthcare workers coincides with the Biden-Harris Administration’s announcement of sweeping new vaccine mandates for all government workers, government contractors and employers employing more than 100 employees.
The two mandates will force most health care facilities to impose mask mandates for all staff in order to meet the requirement all staff be vaccinated.
CMS and CDC say the decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19. They claim the action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities.
According to the CDC, nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant.
In it’s announcement of the impending vaccination requirements, CDC urged health care facilities to prepare now to meet the new mandate in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements.
CDC also urged any health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately and facilities to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.
While legal challenges to the mandate requirements are likely, most facilities that have not already adopted vaccine mandates are expected to adopt these mandates rather than risk losing eligibility for Medicare and Medicaid reimbursement and other sanctions.
Beyondprogram disqualification and attendant financial pressures, announcement of the new vaccine mandates adds vaccination to the list of safety safeguards that healthcare facilities as employers can expect to be required to enforce as part of the occupational safety rules of the Occupational Safety and Health Administration (”OSHA”).
OSHA already is sanctioning employers for violating COVID-19 related OSHA requirements. For instance, OSHA nailed Lakewood Resource and Referral Center Inc., dba Center for Education Medicine and Dentistry (CHEMED) with heavy fines for allegedly violating applicable COVID-19 safety guidelines in January, 2021.
In a July 23, 2021 citation letter, OSH proposes to fine CHEMED $273,064.00 for willfully violating OSHA by not providing a medical evaluation to determine each employee’s ability to use a N95 respirator, before the employee was fit tested or required to use the respirator in the workplace to protect against SARS-CoV-2 virus while testing suspected COVID-19 individuals.
In addition to the proposed fine, the citation also orders CHEMED to take a series of corrective actions and to post notices in the workplace informing workers of the violation.
Along with the CHEMED citation, OSH also cited a staffing agency contracted to provide nursing staffing to CHEMED, Homecare Therapies for also failing to conduct medical evaluations and fit tests. It received two violations and a proposed fine of $13,653.
In the face of these potential consequences, most covered health care facilities and other employers impacted by the mandate are likely to implement mandates unless and until these requirements are struct down by the courts or withdrawn.
Assuming the Administration follows appropriate procedures to adopt the rules, most legal commentators do not expect the legal challenges opposing the mandate orders to be successful in the courts particularly after the Supreme Court refused to overturn or hear arguments for overturning a unanimous decision of a three-judge panel of the United States Court of Appeals for the Seventh Circuit in Klassen v. Trustees of Indiana University that refused to enjoin a vaccine mandate imposed by Indiana University as a condition of student or staff in person participation in classes or other activities.
While most healthcare and other covered businesses are not expected to challenge the rules, compliance us likely to trigger backlash from some unvaccinated workers strongly opposed to becoming vaccinated. Employers may find that some employees will resign their employment or take other tactics to avoid becoming vaccinated. Even those who elect to become vaccinated to retain their employment are likely to express opposition and dissatisfaction that could create liability exposures for the employers if it becomes a basis for retaliation claim.
Employers in Texas and certain other states that have adopted rules restricting or prohibiting vaccine, mask or other mandates also may face challenges based on the state rules.
In light of these and other uncertainties and challenges, Healthcare and Other or Employers generally should seek legal advice and assistance from legal counsel experienced with the relevant health care, labor and employment, privacy and other concerns.
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 Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
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.
The Occupational Safety and Health Administration (“OSHA”) has issued two citations against AMA Health Holdings LLC, for violating an OSHA emergency COVID standard published in June at its Seaside Guest Services transitional housing facility. Like OSHA’s July 23rd $273,064.00 citation of Lakewood Resource and Referral Center Inc. (“CHEMED”), the AMA Holdings citations and proposed penalties illustrate the risks health industry and other employers face for failing to comply with COVID-19 safety protocols.
The AMA Holdings citationsstem from acomplaint-driven OSHA investigation at the Seaside Guest Services’ residential housing facility in Trenton, New Jersey where 11 employees and 28 residents tested positive for the coronavirus by late March found numerous violations.
The residential facility provides transitional housing for people attending area behavioral-health programs and those who have completed some level of addiction treatment.
In June OSHA issued an emergency temporary standard to protect healthcare workers from contracting coronavirus. In March, OSHA launched a national emphasis program focusing enforcement efforts on companies that put the largest number of workers at serious risk of contracting the coronavirus. The program also prioritizes employers who retaliate against workers for complaints about unsafe or unhealthy conditions, or for exercising other rights protected by federal law.
According to OSHA, its investigation of a complaint revealed that while Seaside Guest Services’ continuity of operations plan required that residents with coronavirus be isolated and workers notified, neither happened. Additionally, OSHA inspectors determined the facility provided protective masks to its employees, but did not enforce their use. Seaside also failed to enforce social distancing despite posting signs in its four housing units.
OSHA cited the facility’s operator, AMA Health Holdings LLC, with two citations for failing to develop and implement effective measures to mitigate the spread of the virus and not recording each work-related illness. The agency proposed $10,923 in penalties.
AMA Health Holdings LLC has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
The AMA Holdings OSHA actions demonstrate OSHA’s commitment to investigate complaints of violations is its COVID emergency standards and fine employers that violate them.
The citations against AMA Health Holdings follow OSHA’s earlier citation of CHEMED for retaliating against employees for questioning the adequacy of COVID safety at the dental practice where they worked.
In the face of these enforcement actions, all employers should take care to ensure their ability to demonstrate and defend their operation’s compliance with all applicable emergency COVID safety standards and other safety requirements here.
As illustrated by the recently issued Centers for Disease Control (“CDC”) nursing home vaccination mandate announced last week, OSHA requirements evolve are likely to evolve rapidly in response to changing CDC guidance. Consequently, employers should remain vigilant for changing requirements and respond accordingly.
Additionally, employers should keep in mind that improperly handled employee questions or statements of concern about the adequacy of workplace COVID -19 safeguards could create retaliation or whistleblower risks. Accordingly, employers should use care to investigate and respond carefully to these concerns.
More Information
Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.
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.
The Centers for Medicare and Medicaid Services (CMS) is encouraging QHP issuers and Exchange administrators to review their 2021 Quality Rating System (QRS) preview reports, QRS proof sheets, and QHP Enrollee Survey Quality Improvement Reports on the CMS Marketplace Quality Initiative (MQI) website by September 3.
CMS created the QRS to help consumers, their families, and caregivers compare and more easily investigate quality. The 2021 QRS quality ratings and QHP Enrollee Survey results are available for preview from August 23rd at 9am ET through September 3rd at 5pm ET.
QHP issuers and Exchange administrators may review the QRS preview reports, QRS proof sheets, and QHP Enrollee Survey Quality Improvement Reports for their respective reporting units in CMS’ Health Insurance Oversight System Marketplace Quality Module (HIOS-MQM).
Access to HIOS-MQM is required to preview the QRS rating information. See the HIOS-MQM Quick Reference Guide for details about registering and accessing the HIOS-MQM.
Inquiries regarding the preview results should be submitted to the CMS help desk, CMS_FEPS@cms.gov, by September 3, 2021.
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 Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.
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.
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 Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.
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.
The Centers for Disease Control and Prevention (CDC) is exempting unaccompanied noncitizen children (UC) from the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on October 13, 2020 (October Order).
The Order published here in today’s Federal Register, took effect on July 16.
In the Order CDC finds “appropriate infrastructure in place to protect the children, caregivers, and local communities from elevated risk of COVID–19 transmission as a result of the introduction of UCs, and U.S. healthcare resources are not significantly impacted by providing UC necessary care. CDC adopted these findings despite its simultaneous alerts to schools and the public generally about the need for tighter protocols to protect children given rising infection rates among children and teens. See here. The Order highlights the challenges the Biden Administration immigration policy creates for CDC COVID containment.
CDC believes the COVID–19-related public health concerns associated with UC introduction can be adequately addressed without the UC being subject to the October Order, thereby permitting the government to better address the humanitarian challenges for these children.
Based on these findings, CDC is fully excepting UC from the October Order, and the Notice regarding the temporary exception of UC published February 17, 2021 is hereby superseded.
More Information
If you are interested in a more detailed description of this or other developments discussed in this article, see here.
If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.
About the Author
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 health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
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.
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:
Responding to the July 2, announcement by IT software management company Kaseya VSA an that a supply-chain ransomware attack leveraged a vulnerability in the Kaseya RMM Tool against multiple managed service providers (MSPs) and their customers, the Office of Civil Rights (“OCR”) is urging health care providers, health plans, health care clearinghouses and their managed service providers (“MSPs”) and other business associates to follow guidance from the Cybersecurity and Infrastructure Security Agency (CISA) and Federal Bureau of Investigation (“FBI”) for customers affected by the Kaseya VSA Supply-Chain ransomware attack.
CISA and FBI also recommend affected MSPs and other parties
Contact Kaseya at support@kaseya.com with the subject “Compromise Detection Tool Request” to obtain and run Kaseya’s Compromise Detection Tool available to Kaseya VSA customers. The tool is designed to help MSPs assess the status of their systems and their customers’ systems.
Enable and enforce multi-factor authentication (MFA) on every single account that is under the control of the organization, and—to the maximum extent possible—enable and enforce MFA for customer-facing services.
Implement allow listing to limit communication with remote monitoring and management (RMM) capabilities to known IP address pairs, and/or
Place administrative interfaces of RMM behind a virtual private network (VPN) or a firewall on a dedicated administrative network.
CISA and FBI recommend affected MSP customers ensure backups are up to date and stored in an easily retrievable location that is air-gapped from the organizational network;
CISA and FBI also recommend MSP customers affected by this attack take immediate action to implement the following cybersecurity best practices. Note: These actions are especially important for MSP customer who do not currently have their RMM service running due to the Kaseya attack.For guidance specific to this incident from the cybersecurity community, see Cado Security’s GitHub page,Resources for DFIR Professionals Responding to the REvil Ransomware Kaseya Supply Chain Attack.Note: Due to the urgency to share this information, CISA and FBI have not yet validated this content.
If you are interested in a more detailed information about this or other developments discussed in this article, see here.
If you would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.
About the Author
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 health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
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.
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:
Newly sworn in President Joe Biden chose to make an executive order outlining the core principles for his Administration’s policy for fighting COVID-19 the first signed in his new administration.
The American people deserve an urgent, robust, and professional response to the growing public health and economic crisis caused by the coronavirus (COVID-19) outbreak. President Biden believes that the federal government must act swiftly and aggressively to help protect and support our families, small businesses, first responders, and caregivers essential to help us face this challenge, those who are most vulnerable to health and economic impacts, and our broader communities – not to blame others or bail out corporations.
The Biden-Harris administration will always:
Listen to science Ensure public health decisions are informed by public health professionals Promote trust, transparency, common purpose, and accountability in our government President Biden and Vice President Harris have a seven-point plan to beat COVID-19.
Ensure all Americans have access to regular, reliable, and free testing.
Double the number of drive-through testing sites. Invest in next-generation testing, including at home tests and instant tests, so we can scale up our testing capacity by orders of magnitude. Stand up a Pandemic Testing Board like Roosevelt’s War Production Board. It’s how we produced tanks, planes, uniforms, and supplies in record time, and it’s how we will produce and distribute tens of millions of tests. Establish a U.S. Public Health Jobs Corps to mobilize at least 100,000 Americans across the country with support from trusted local organizations in communities most at risk to perform culturally competent approaches to contact tracing and protecting at-risk populations. Fix personal protective equipment (PPE) problems for good.
President Biden is taking responsibility and giving states, cities, tribes, and territories the critical supplies they need.
Fully use the Defense Production Act to ramp up production of masks, face shields, and other PPE so that the national supply of personal protective equipment exceeds demand and our stores and stockpiles — especially in hard-hit areas that serve disproportionately vulnerable populations — are fully replenished. Build immediately toward a future, flexible American-sourced and manufactured capability to ensure we are not dependent on other countries in a crisis. Provide clear, consistent, evidence-based guidance for how communities should navigate the pandemic – and the resources for schools, small businesses, and families to make it through.
Social distancing is not a light switch. It is a dial. President Biden will direct the CDC to provide specific evidence-based guidance for how to turn the dial up or down relative to the level of risk and degree of viral spread in a community, including when to open or close certain businesses, bars, restaurants, and other spaces; when to open or close schools, and what steps they need to take to make classrooms and facilities safe; appropriate restrictions on size of gatherings; when to issue stay-at-home restrictions. Establish a renewable fund for state and local governments to help prevent budget shortfalls, which may cause states to face steep cuts to teachers and first responders. Call on Congress to pass an emergency package to ensure schools have the additional resources they need to adapt effectively to COVID-19. Provide a “restart package” that helps small businesses cover the costs of operating safely, including things like plexiglass and PPE. “THIS ISN’T ABOUT POLITICS. IT’S ABOUT SAVING LIVES.”
PRESIDENT BIDEN, SEPTEMBER 16, 2020 Plan for the effective, equitable distribution of treatments and vaccines — because development isn’t enough if they aren’t effectively distributed.
Invest $25 billion in a vaccine manufacturing and distribution plan that will guarantee it gets to every American, cost-free. Ensure that politics plays no role in determining the safety and efficacy of any vaccine. The following 3 principles will guide the Biden-Harris administration: Put scientists in charge of all decisions on safety and efficacy; publicly release clinical data for any vaccine the FDA approves; and authorize career staff to write a written report for public review and permit them to appear before Congress and speak publicly uncensored. Ensure everyone — not just the wealthy and well-connected — in America receives the protection and care they deserve, and consumers are not price gouged as new drugs and therapies come to market. Protect older Americans and others at high risk.
President Biden understands that older Americans and others at high-risk are most vulnerable to COVID-19.
Establish a COVID-19 Racial and Ethnic Disparities Task Force, as proposed by Vice President Harris, to provide recommendations and oversight on disparities in the public health and economic response. At the end of this health crisis, it will transition to a permanent Infectious Disease Racial Disparities Task Force. Create the Nationwide Pandemic Dashboard that Americans can check in real-time to help them gauge whether local transmission is actively occurring in their zip codes. This information is critical to helping all individuals, but especially older Americans and others at high risk, understand what level of precaution to take. Rebuild and expand defenses to predict, prevent, and mitigate pandemic threats, including those coming from China.
Immediately restore the White House National Security Council Directorate for Global Health Security and Biodefense, originally established by the Obama-Biden administration. Immediately restore our relationship with the World Health Organization, which — while not perfect — is essential to coordinating a global response during a pandemic. Re-launch and strengthen U.S. Agency for International Development’s pathogen-tracking program called PREDICT. Expand the number of CDC’s deployed disease detectives so we have eyes and ears on the ground, including rebuilding the office in Beijing. Implement mask mandates nationwide by working with governors and mayors and by asking the American people to do what they do best: step up in a time of crisis.
Experts agree that tens of thousands of lives can be saved if Americans wear masks. President Biden will continue to call on:
Every American to wear a mask when they are around people outside their household. Every Governor to make that mandatory in their state. Local authorities to also make it mandatory to buttress their state orders. Once we succeed in getting beyond this pandemic, we must ensure that the millions of Americans who suffer long-term side effects from COVID don’t face higher premiums or denial of health insurance because of this new pre-existing condition. The Biden-Harris Administration will work to ensure that the protections for those with pre-existing conditions that were won with Obamacare are protected. And, they will work to lower health care costs and expand access to quality, affordable health care through a Medicare-like public option.
As the new Administration and Congress get down to work, health industry organizations as well as all other U.S. organizations and communities, their leaders, and individual employees and citizens should carefully follow, and share their input to the Administration, members of Congress, and other federal, state and local officials on the actions and proposals taken to implement this and other policy that impact their interests. The need for careful attention and scrutiny is particularly important for health, managed care and insurance and management organizations as President Biden made clear throughout his campaign his intent to pursue legislative and regulatory reforms that would reverse actions of the previous administration as well as implement addition reforms to expand coverage and regulation of health care, workforce and other critical policies.
More Information
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.
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 nationally recognized for her work and thought leadership on health and other health and employee benefit issues.
An attorney board certified in labor and employment law by the Texas Board of Legal Specialization and Fellow in the American College of Employee Benefit Counsel, Ms. Stamer has worked as an on demand, special project, consulting, general counsel or other basis with health care providers, health insurers, employer and other management organizations, health and other employee benefit plans, their sponsors, insurers, administrators, providers and others and others has published and spoken extensively on these concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor and advocate for employer and other plan sponsors, fiduciaries, administrators, insurers, technology and other service providers, managed care organizations, direct primary care and other health care providers and others on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
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 or contact Ms. Stamer via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
OCR Says “No” To Allocating Respirators & Other Scarce COVID-19 Care Based On Pre-Existing Medical Conditions
This week’s Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) announcement of that the Pennsylvania Department of Health (PDH) has agreed to using a list of preexisting health care conditions to decide patient priority for access to respirators and other scarce resources during the COVID-19 health care emergency flags potential civil rights discrimination violations by the multitude of other State, local, tribal, and territorial public health policymakers, healthcare systems leadership, and other public emergency decision-makers and other public or private HHS funds recipients (collectively “COVID responders”) whose pandemic emergency response plans call for the use pre-existing health conditions or other civil rights act protected status of patients to ration scarce medical resources like ventilators or other scarce resources.
Coupled with other recent guidance warning COVID responders against discrimination and to provide all legally required accommodations for individuals with pre-existing conditions or disorders constituting disabilities, English as a second language, religion, age or other protected status under Section 504 of the Rehabilitation Act of 1973 (“Section 504”), Title II of the Americans with Disabilities Act (the “ADA”), Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) and other federal civil rights laws, health care providers, public health authorities and other COVID-19 responders should act immediately to review and take any action needed to correct civil rights law deficiencies in their own COVID-19 emergency policies or operations.
PDH Enforcement Shows Agencies’ Serious About COVID-19 Civil Rights Enforcement
OCR’s April 28, 2020, OCR announcement of PDH’s agreement to revise its Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines (CSC Guidelines) to revolve an April 3, 2020 civil rights complaint that PDH’s COVID-19 pandemic response plan illegally discriminated against patients with disabilities by denying or lowing the care priority of patients with certain listed preexisting health conditions shows that OCR and other federal agencies are carrying through on promises to take quick enforcement action against COVID-19 responders that violate federal discrimination and other civil rights laws when dealing with the COVID-19 public health emergency in the March 14, 2020 Crisis Standards of Care and Civil Rights Laws guidance (“CSC Guidelines”) and in OCR’s March 28, 2020 Civil Rights, HIPAA, and the Coronavirus Disease 2019 Bulletin (the “Bulletin”).
The CSC Guidelines jointly issued by the Health Care Resilience Taskforce (composed of HHS, FEMA, and the Army Corps of Engineers) warned public health, health care providers and other pandemic decisionmakers against adopting or applying policies in for managing ventilators or other constricted resources during the COVID-19 or other emergencies that negatively impact vulnerable populations (e.g., older adults and persons with disabilities). After reminding state, local, tribal, and territorial policymakers, healthcare systems leadership, and other decision-makers that civil rights laws are not suspended or waived in times of disaster, the CSC Guidelines cautioned “Federal civil rights laws and regulations apply, and have not been suspended, during the COVID19 national health emergency. Federal fund recipients must comply with those requirements.”
OCR reaffirmed the CSC Guidelines warnings in its March 28, 2020 Bulletin reminding health care providers and other HHS fund recipients the laudable goal of providing care quickly and efficiently during the COVID-19 health care emergency still must comply with federal civil rights prohibitions against disability discrimination in HHS funded programs under Section 1557, Section 504, and other civil rights laws, stating:
“persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities or age. Decisions by covered entities concerning whether an individual is a candidate for treatment should be based on an individualized assessment of the patient based on the best available objective medical evidence.”
The PDH disability discrimination investigation and resolution announced April 28th resulted from OCR’s investigation of a civil rights complaint filed less than a week after OCR released the Bulletin by Disability Rights Pennsylvania and other disability rights groups. Like many other regional and facility pandemic response plans, the CSC Guidelines listed specific impairments or disabilities that would lead to greater deprioritization of patients for care during a pandemic emergency. The April 3 complaint against PDH charged that Pennsylvania’s CSC Guidelines violated Section 504, Title II, and Section 1557 by unlawfully authorizing the denial of treatment to individuals with disabilities when prioritizing access to critical care and ventilators. The complaint also alleged that the guidelines did not require an individualized assessment, but instead used “preexisting conditions that are disabilities” to determine a priority score.
OCR PDH COVID-19 Civil Rights Investigation & Settlement
Consistent with the warning provided in the Bulletin, OCR moved with rare speed to investigate the complaint and notify PDH of its civil rights concerns. To resolve potential OCR civil rights charges, OCR announced April 28, 2020 that PDH agreed to accept technical assistance from OCR and make the following revisions to its CDC guidelines:
Remove criteria that automatically deprioritized persons on the basis of particular disabilities,
Require individualized assessments based on the best available, relevant, and objective medical evidence to support triaging decisions, and
Ensure at no one is denied care based on stereotypes, assessments of quality of life, or judgments about a person’s “worth” based on the presence or absence of disabilities.
Based on these “responsive actions and the revisions” to its guidelines in response to OCR’s concern, the OCR announcement states that OCR is closing its complaint investigation as satisfactorily resolved without a finding of liability while noting that this does not preclude future OCR enforcement in cases of potential discriminatory implementation of Pennsylvania’s policies by any covered health care provider.
Other Public Health, Health Care & Other COVID Responders Should Confirm COVID-19 Civil Rights Response Compliance
The PDH announcement provides a strong warning to health care providers, public health authorities and other COVID-19 responders to act quickly to evaluate and make any necessary adjustments to redress any questionable disability or other civil rights concerns in their own COVID-19 or other emergency response plans or practices.
The PDH announcement clearly alerts other health care providers and COVID-19 responders that OCR does not plan to slacken civil rights discrimination investigation or enforcement against health care providers or others because of the COVID-19 health care emergency. Rather, the PDH investigaiton and resolution make clear that COVID-19 responders need to use particular care take the well-documented steps necessary to ensure they can defend their ongoing compliance with disability discrimination and other federal civil rights laws throughout the COVID-19 health care emergency.
In this respect, OCR’s PDH announcement makes a point of clearly warning other public health, health care providers and other recipients of HHS funding across the nation against using preexisting conditions or other prohibited stereotypes or classifications of patients without individual assessments to triage and prioritize access to care or other resources for purposes of their COVID-19 or other pandemic planning or response. To emphasize the importance of continued compliance with these civil rights laws, the Bulletin quotes OCR Director Roger Severino, as stating: “Triage decisions must be based on objective and individualized evidence, not discriminatory assumptions about the prognoses of persons with disabilities” and “we must ensure that triage decisions are free from discrimination both in their creation and their application, and we will remain vigilant in achieving that goal.”
These warnings and OCR’s quick enforcement action make clear that OCR’s commitment to hold health care providers, state and local public health, and other COVID-19 responders accountable for ensuring their COVID-19 pandemic plans and operations don’t impermissibly discriminate against individuals with or needing accommodations for disabilities, limited English skills, religious beliefs, age or other status protected by HHS’ civil rights rules. Meanwhile, OCR’s reported willingness to accept PHD’s prompt corrective action without imposing financial sanctions also signals the probable willingness of OCR to show similar leniency to other health care providers or COVID-19 responders that for acting promptly to self-identify and redress potentially questionable past COVID-19 restricted resource allocation practices in response to the PDH announcement and other COVID-19 civil rights compliance guidance.
Given the often multimillion dollar penalties and other heavy sanctions that OCR already regularly imposes against a long and ever-growing list of state and other health care, child care, elder care, insurance and other entities for violating its civil rights nondiscrimination and accommodation requirements and the often significant judgements awarded to private litigant victims, state and local public health, health care providers and other COVID providers generally will want to review and tighten as advisable their existing practices to reduce the risk of being incuring penalties or judgments, being sanctioned, excluded or a combination of these consequences for violation of these nondiscrimination and other civil rights requirements by among other things:
Auditing the adequacy of their pandemic response and other plans, policies, practices and actions for allocating scarce resources and care during the COVID-19 health emergency and in other scarce resource situations;
Developing a strategy and procedures for receiving, investigating and responding with appropriate documentation to complaints or other indicators of potential civil rights violations or risks;
Taking prompt, documented action to reform and strengthen civil rights policies, practices and controls, training, investigations and other compliance and risk management;
Explore potential strategies, if any, to mitigate potential liability exposure to OCR or private litigant investigations or enforcement from past, ongoing or future policies or actions; and
Other actions to maintain and demonstrate their organization-wide culture of compliance with applicable civil rights laws.
Since organization and their leaders likely will be required to uncover and discuss legally and politically sensitive information in the course of these activities, public health, health care and other COVID responders are encouraged to consider engaging qualified legal counsel with relevant experience to advise and guide them in conducting, maintaining and using attorney-client privilege and other procedures to safeguard sensitive analysis, discussions and work product from avoidable discovery and other processes to promote the legal effectiveness and defensibility of their actions.
More Information & Resources
We hope this update is helpful. If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. In addition to this update, the author of this article also is extensively published and frequent speaker on pandemic and other infectious disease, and other health industry crisis preparedness and response, and many other regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is widely recognized for her pragmatic, leading edge work, scholarship and thought leadership on domestic and international, public and private sector health care and managed care, workforce and performance, safety, legal and operational compliance and risk management, crisis preparedness and response, and other essential legal and operational concerns.
Her experience includes extensive work domestically and internationally with hospitals, health care systems, clinics, skilled nursing and other long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; accreditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thought leadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations . For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides consulting, publications and other information, education, coaching, training, tools and other resources on leadership, governance, health care, human resources, employee benefits, insurance, public policy and regulatory affairs, data security and privacy and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Healthcare providers, the Centers for Disease Control and Prevention (“CDC”) can get continuing education credit for completing free heath care provider training available online on “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” originally presented by CDC live on April 16, 2020.
In addition to providing training about proper classification of COVID-19 related deaths on death certificates, health care providers participating in the call may qualify for continuing education credit.
About CDC’s 4/16 COVID-19 Death Reporting Training
The training covers updated rules on completing death certificates for patients believed to have died when infected with COVID-19 published April 2. Monitoring the emergence of Coronavirus Disease 2019 (COVID-19) and guiding public health response requires accurate and timely mortality data. As death certificates are one of the few sources of health-related data that are comparable for small geographic areas and are available over a long time period in the United States, mortality data from the National Vital Statistics System (NVSS) derived from information reported on death certificates to monitor deaths due to COVID-19 versus other causes of death.
During this COCA Call, the following presenters from the CDC provide an overview of the importance of mortality data, discuss the NCHS publication and the guidance it provides to clinicians who may need to certify a death involving COVID-19, and present a summary of COVID-19 surveillance through the NVSS.
Robert N. Anderson, PhD, Chief, Mortality Statistics Branch, National Center for Health Statistics;
Margaret Warner, PhD, Injury Epidemiologist, National Center for Health Statistics;
Lee Anne Flagg, PhD, Statistician (Health), National Center for Health Statistics; and
Farida Ahmad, MPH, Mortality Surveillance Lead, National Center for Health Statistics.
An advance copy of the program Slides is currently available on the CDC website and CDC plans to post a transcript of the program following the presentation.
Continuing Education Credit
Health care providers participating in today’s training may be able to qualify for continuing education credit. CDC says that health care providers wishing to receive continuing education for participation should complete the online between May 19, 2020, and May 19, 2022, and use course code WD2922. The access code is COCA041620. Continuing education certificates can be printed immediately upon completion of your online evaluation. A cumulative transcript of all CDC/ATSDR CEs obtained through the CDC Training & Continuing Education Online System will be maintained for each user.
Interested providers and others can learn mre at this CDC Clinician Outreach and Communication Activity (COCA) here.
More Information
We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is most widely recognized for her career long pragmatic, leading edge work, scholarship and thought leadership domestic and international, public and private sector health care and managed care, workforce and employee benefits, insurance and financial services, their technology, data, and other service providers and advisors, and governments domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; creditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers, and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thoughtleadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations . For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
Working or interested in working on the development and testing of data sharing functionalities to support clinical care, research, and improved health care outcomes? Listen in tomorrow (April 15, 2020) at 1:30 p.m. Eastern, 12:30 p.m. Central time to an informational briefing about newly announced funding opportunities issued by the Office of the National Coordinator for Health Information Technology under its Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT) whose specific aims address one of the following areas:
Advancing Registry Infrastructure for a Modern API-based Health IT Ecosystem
Cutting Edge Health IT Tools for Scaling Research
Integrating Health Care and Human Services Data to Support Improved Outcomes
Under the 21st Century Cures Act, Congress gave ONC authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:
The development and use of upgraded health IT capabilities;
Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
Improvement of the health IT end user experience, including by reducing administrative burden.
The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act and to increase nationwide interoperability of health information and reduce clinician burden.
ONC’s resulting emphasis on health data interoperability raises new business and compliance planning opportunities and challenges for health care providers, health insurers and other payers, health data and information technology (IT) providers and others. The new funding opportunities are intended to produce new capabilities for achieving these objectives.
We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, 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:
All Health Care Providers & Business Associates Reminded To Conduct Documented Risk Assessments In Response To COVID-19 Operational Changes
The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS). The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.
While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis. Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief. While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems. Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency. See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released; OCR Grants HIPAA Telemedicine Relief During COVID-19 Crisis.
April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities
According to Director Roger Severino, the limited enforcement relief in the Notice is intended “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.” Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency. The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.
The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS. According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing. Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS. Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,
While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:
Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
Using secure technology at a CBTS to record and transmit electronic PHI.
Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.
While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.
Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief
Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief, the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance. In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements. To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events. Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.
More Information
We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, 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:
Skilled nursing and other long term care facilities commonly known as “nursing homes” (“LTC facilities”),[i] rehabilitation, assisted living, retirement and other facilities and communities caring for elderly, disabled, aged or other infirm patients or residents should use recently released tools to confirm the adequacy of and update their current COVID-19 and other infectious disease prevention and control and other key policies and practices with the latest Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) requirements and guidelines in light of recently announced changes to CMS nursing home inspection policies (the “Targeted Inspection Policy”)[iii] that target nursing homes with COVID-19 outbreaks or death for likely inspection announced March 23, 2020 including all existing requirements including new “recommendations” on nursing homes on COVID-19 preparedness and response announced April 2, 2020 (the “April Recommendations”).[iii]
Prompted by the continuing explosive growth in COVID-19 infection and deaths among nursing home residents and widespread deficiencies found during recent inspections at the Kirkland, Washington Life Care Center nursing homes (the “Kirkland Facilities”) made notorious by the death of 23 people and other nursing homes with COVID-19 inspections, the Targeted Inspection Policy and April Recommendations supplement and give more teeth to the CMS Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (the “3/3 Directive”)[iv] previously released by CMS released in conjunction with President Trump’s Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (“COVID Emergency Declaration”) in response to concerns raised by reports of 19 COVID-19 related deaths at the Kirkland Facilities[v] on March 13, 2020.
Despite CMS and CDC’s efforts to reign in nursing home based COVID-19 infections and deaths by ordering nursing homes in the Nursing Home Directive to limit outside visitors and take other precautions outlined in the Nursing Home Directive and release of other guidance and tools, nursing home based COVID-19 infections and deaths have continued to soar since March 13, 2020.[vi] Meanwhile, onsite audits at the Kirkland Facilities and other facilities during March uncovered concerning deficiencies in the compliance at the Kirkland Facilities and many other nursing homes across the nation, as well as the need to address other weaknesses in current CMS and CDC practices and guidelines that the agencies determined were perpetuating practices that left nursing home residents exposed to COVID-19.
The new Targeted Inspection Policy and April Recommendations attempt to address these compliance and other concerns by updating, clarifying and supplementing previously established requirements and guidance, providing new tools for nursing homes and their inspectors to use to assess nursing home compliance with the latest standards and stepping up inspections and enforcement of nursing homes that experience COVID-19 outbreaks.[vii]
April Recommendations Send Warnings, Share New Tools
To this end, the just announced April Recommendations urge nursing homes to move quickly to clean up their practices by:
Urging nursing homes to immediately ensure that they are complying with all CMS and CDC guidance related to COVID-19 and other infection control and other requirements;
Urging nursing homes immediately to implement symptom screening for all staff, residents, and visitors – including temperature checks; [viii]
Urging nursing homes to ensure all staff are using appropriate PPE when interacting with patients and residents, to the extent PPE is available and per CDC guidance on conservation of PPE;
Confirming the availability of Medicare coverage of Medicare enrolled residents performed by laboratories and that facilities can allow laboratory personnel into facilities to perform the tests;
Urging State and local leaders to consider the needs of long term care facilities with respect to supplies of PPE and COVID-19 tests as nursing homes are a critical part of the healthcare system, and because of the ease of spread in long term care facilities and the severity of illness that occurs in residents with COVID-19,
Recommending facilities use separate staffing teams for residents to the best of their ability to avoid transmission within nursing homes in response to evidence that using staff shared between multiple facilities helped to fuel the COVID-19 outbreak in the Kirkland Facilities;
Consistent previously published guidance and resources on the CDC Isolation Sites and Alternative Care Sites webpage,[ix] urging nursing homes to work with State and local leaders to designate separate facilities or units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and individuals with unknown COVID-19 status; and
Encouraging facilities to use new targeted survey assessment tools adopted by CMS to guide inspections under the Targeted Inspection Program to self-assess and make appropriate adjustments to tighten their facility compliance with applicable requirements and guidelines promptly.
While characterized as “recommendations,” the reaffirmation in the April Recommendations that CMS intends to continue to follow the new Targeted Inspection Policy announced March 23, 2020 sends a strong message to all nursing homes that CMS does not view compliance with the recommendations as optional.
Under the Targeted Inspection Policy, CMS intends to conduct targeted inspections giving prioritization for Immediate Jeopardy investigations over recertification surveys for Clinical Laboratory Improvement Amendment (CLIA) laboratories.
According to CMS’ announcement regarding the Targeted Inspection Policy, only the following types of federal inspections will be prioritized and conducted over the next few weeks:
Complaint inspections: State survey agencies will continue to conduct inspections related to complaints and facility-reported incidents that are triaged at the Immediate Jeopardy level. Inspectors will use a streamlined Infection Control review tool, regardless of the Immediate Jeopardy allegation.
Targeted Infection Control inspections: Federal and state inspectors will conduct targeted infection control inspections of providers identified through CMS collaboration with the Centers for Disease Control and Prevention (CDC). These inspectors will use a streamlined targeted review checklist to minimize the impact on provider activities, while ensuring providers are implementing actions to protect health and safety. This will consist of both onsite and offsite inspections.
Self-Assessments: The Infection Control checklist referenced above will also be shared with providers and suppliers, to allow for self-assessment of their Infection Control plans. This may be the best solution in some cases when there is a lack of personal protective equipment or state surveyors available.
During this time frame, CMS has indicated it will not conduct the following inspections:
Standard inspections for nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices; and
Revisit inspections not associated with Immediate Jeopardy.
In addition to redefining the priorities and scope for conducting inspections in the new Targeted Inspection Policy, CMS also refocused the inspection process that surveyors are expected to use when conducting inspections under the Targeted Inspection Policy which includes existing components of CMS’s infection control inspection process updated to include the latest CDC and CMS guidance. Under the Targeted Inspection Policy CMS and state inspectors will be guided by a newly developed and updated targeted assessment tool in assessing if certain facilities are prepared to meet CMS’s expectations for preventing the spread of COVID-19. When gaps are identified, CMS warns that facilities will be required to take corrective actions to close the gaps.
Facilities are well advised to follow the recommendation of CMS to use the new surveyor tools to self-assess their own ability to prevent the spread of COVID-19 in accordance with applicable CMS requirements both to mitigate potential exposures to CMS sanctions and because CMS also is encouraging residents and families to be proactive about nursing home safety by among other things asking facility staff how the facility performed on its self-assessment. Facilities and their leaders at all times should keep in mind the significant risks that they are likely to incur if significant deficiencies are found from an inspection. While the March 23, 2020 announcement of the Targeted Inspection Policy states that CMS is not seeking to be punitive, but rather to respond to urgent issues while proactively ensuring providers are compliant with federal health and safety standards. Accordingly, CMS has indicated that CMS intends to exercise enforcement discretion, unless Immediate Jeopardy situations arise. Given the conclusions announced regarding Immediate Jeopardy findings found from the inspection at the Kirkland Facility, however, nursing homes are well advised to assume that the occurrence of COVID-19 related deaths or infections at their facilities might create a significant risk of Immediate Jeopardy findings with regard to their facilities which could result in significant sanctions.
CMS and other agencies continue to tailor their response to the COVID-19 outbreak. In addition to verifying and maintaining their compliance with current COVID-19 and other CMS, CDC and state and local requirements and guidelines, nursing homes and their leaders also should continue to monitor emerging developments and guidance from CMS, CDC, the Federal Emergency Management Agency (“FEMA”) and their state and local regulatory bodies.
[i] Nursing homes (also known as “skilled nursing facilities” under the Medicare program and “nursing facilities” under Medicaid; or “long-term care facilities”).
[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.
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.
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:
The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS). The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.
While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis. Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief. While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems. Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency. See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released; OCR Grants HIPAA Telemedicine Relief During COVID-19 Crisis.
April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities
According to Director Roger Severino, the limited enforcement relief in the Notice is intended “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.” Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency. The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.
The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS. According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing. Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS. Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,
While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:
Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
Using secure technology at a CBTS to record and transmit electronic PHI.
Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.
While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.
Today, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released two comprehensive toolkits on telehealth:
The Telehealth Toolkit for General Practitioners available here;
The End-Stage Renal Disease Providers Toolkit available here.
The Toolkits’ release follows up on last week’s Centers for Medicare & Medicare Services (“CMS”) loosening of requirements for Medicare coverage of telehealth services and privacy and data security requirements so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.
COVID-19 Emergency TeleHealth Waivers & Rules
Under this temporary new waiver, Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence starting March 6, 2020. The waiver applies to a range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to their patients.
New TeleHealth Toolkits
Each of the telehealth toolkits released today contains electronic links to reliable sources of information on telehealth and telemedicine, which will reduce the amount of time providers spend searching for answers and increase their time with patients. HHS intends these links to help providers choose learn about the general concept of telehealth, choose telemedicine vendors, initiate a telemedicine program, monitor patients remotely, and develop documentation tools. Additionally, the information contained within each toolkit also outlines temporary virtual services that could be used to treat patients during this specific period of time.
The HHS COVID-19 emergency teleheath waivers follow up on the HHS Office for Civil Rights (OCR) March 20, 2020 Notification of Enforcement Discretion on Telehealth Remote Communications (the “Notice”) announcing temporary, limited scope enforcement relief from some, but not all of the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules for health care providers using “non-public facing” communication technologies to provide telemedicine services during the COVID-19 health care emergency
Intended to allow health care providers greater latitude under HIPAA to communicate with patients and provide telehealth services through remote communications technologies during the COVID-19 national emergency, the Notice allows covered health care providers wishing to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency the option to any availabe “non-public facing” remote communication product to communicate with patients if the platform by verifying the platform is HIPAA compliant and securing the necessary business associate agreement (“BAA”) with the communication provider.
Specifically the Notice announces OCR is exercising its enforcement discretion not to impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using non-public facing audio or video communication products during the COVID-19 nationwide public health emergency in accordance with the requirements set forth in the Notice. The non-enforcement policy applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19. During the COVID-19 emergency, this relief for non-public facing remote communications allows a health care providers the flexibility when it determines appropriate in his or her professional judgement to request to examine a patient using a video chat application connecting the provider’s or patient’s phone or desktop computer in order to assess a greater number of patients while limiting the risk of infection of other persons who would be exposed from an in-person consultation.
The relief does not apply to “public facing” remote communications however, Facebook Live, Twitch, TikTok, and similar video communication applications are considered “public facing.” The OCR bulletin states health care providers should not use any of these or other public facing remote communications to provide telehealth services under the Bulletin.
The Notice also alerts health care providers providing telemedicine services under the Notice need to ensure they have in place appropriate business associate agreements {“BAAs”) with each technology vendors used to conduct these communications and that the vendor is otherwise HIPAA compliant. The Notice lists the following as some vendors that have represented to OCR that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA include:
Skype for Business
Updox
VSee
Zoom for Healthcare
me
Google G Suite Hangouts Meet
Providers should note that the Notice also states that OCR does not endorse, recommend or certify any of these vendors or the adequacy of their BAAs. Consequently, providers intending to use any of thes platforms should conduct their own documented due diligence to confirm that the necessary HIPAA requirements are met. Providers also should keep in mind that the OCR Notice does not modify any otherwise applicable federal or state law, contractual or ethical requirements that may apply to their use of these telemedicine platforms. As many provider’s HIPAA notices may have included statements inconsistent with the use of these technologies, the provider should consider providing notification of the change of its practices that includes disclosures about potentially lower privacy protections. Because the relief is limited in scope and duration, providers relying on the relief also will need to closely monitor developments and adjust practices as necessary when the emergency waivers expire or are modified.
Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief
Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief, the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance. In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements. To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events. Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.
More Information & Resources
We hope this update is helpful. If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. To learn more about Ms. Stamer, her services, experience, publications or involvements; to review or request other developments, publications, resources and tools; or to register for future updates, see www.cynthiastamer.com, see www.cynthiastamer.com; connect on LinkedIn or Facebook; or contact us via e-mail or via telephone at (214) 452 -8297
About The Author
Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is widely recognized for her pragmatic, leading edge work, scholarship and thought leadership on domestic and international, public and private sector health care and managed care, workforce and performance, safety, legal and operational compliance and risk management, crisis preparedness and response, and other essential legal and operational concerns.
Her experience includes extensive work domestically and internationally with hospitals, health care systems, clinics, skilled nursing and other long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; accreditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thought leadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations.
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.
Reducing health care providers burdens from using electronic health records (“EHRs”) and promoting the better uses of electronic medical data in medical research are the focus of two new health information technology (“health IT”) policy documents released this week by the Department of Health & Human Services (“HHS”) Office of the National Coordinator for Health Information Technology (“ONC”). Health care providers, health researchers, health plans, health care clearinghouses and other health data collectors or users, as well as health IT providers and other interested persons will want to evaluate carefully these new ONC releases for insights about policy and other efforts ONC is promoting to shape the use of health IT and data.
Reducing Health IT and EHR Burdens On Providers
On February 21, 2020, ONC moved forward on its efforts to implement “a comprehensive strategy to reduce the regulatory and administrative burden related to the use of health IT, including EHRs” by publishing its “Strategy on Reducing Regulatory and Administrative Burdens Relating to the Use of Health IT and EHRs” (the “EHR Report”) targets burdens tied to regulatory and administrative requirements that HHS can directly impact through the rulemaking process. A collaborative effort between ONC and the Centers for Medicare & Medicaid Services (CMS), the report’s strategies was developed in response to a Congressional mandate in the 21st Century Cures Act, which directed HHS to develop a plan of action to reduce regulatory and administrative burden relating to the use of health IT and EHRs and finalizes the draft version of this strategy ONC released in November 2018. Based on stakeholder input, the final HER Report outlines three overarching goals designed to reduce clinician burden:
Reduce the effort and time required to record health information in EHRs for clinicians;
Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations; and
Improve the functionality and ease of use of EHRs.
ONC says reducing unnecessary regulatory burden will alleviate time spent on administrative tasks. For example, during listening sessions with clinicians, we heard criticism that the documentation guidelines for Evaluation and Management (E/M) visits were a source of EHR-related burden and overly complicated. They told us these requirements result in “pajama time,” where physicians spend hours after clinic sessions and on weekends entering data to satisfy billing and quality reporting requirements. Poor usability features within EHRs can further exacerbate this issue, as clinicians find it difficult to navigate long records within the EHR interface. Based on this feedback, the report covers four key areas:
Clinical documentation
Health IT usability (or ease of use of health IT tools and systems)
Federal health IT and EHR reporting requirements
Public health reporting (including coordination with prescription drug reporting programs and electronic prescribing of controlled substances).
In addition to responding to the direction included in the EHR Report, health care and health IT providers also will want to continue to monitor and communicate with ONC. While moving forward on the implementation of the objectives identified in the EHR Report, ONC says it plans to continue to reach out and engage the clinician community and other key stakeholder communities and to monitor emerging and ongoing burdens related to the use of EHRs, such as burdens related to EHR inbox management and other efforts to enable further automation in health care, with a focus on prior authorization, quality reporting, and other aspects of our current system that can reduce time spent using health IT.
Leveraging Health IT For Research
On February 24, 2020, ONC followed up by releasing its National Health IT Priorities for Research: A Policy and Development Agenda. The Agenda articulates its latest vision of a health information technology infrastructure that supports alignment between the clinical and research ecosystems in research.
The Agenda identifies two overarching goals along with nine associated priority areas ONC believes stakeholders can take to achieve the respective visions more quickly and effectively:
The Agenda is the latest in a series of priorities, agendas and other initiatives adopted by ONC since its establishment in furtherance of its legislative mandate under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009 to improve the health and well-being of individuals and communities through the use of technology and health information.
Health care providers, plans, technology vendors and providers and other stakeholders impacted by ONC and other electronic medical record or health IT systems should take into account the likely implications of these and other ONC pronouncements on their programs and practices when planning and updating them.
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.
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 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 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.
The $65,000 payment and corrective action plan commitments West Georgia Ambulance, Inc. (“West Georgia”) is making to settle Department of Health & Human Services Office for Civil Rights (“OCR”) charges it recurrently violated the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule sends a warning to all oher HIPAA-covered health care providers, health plans, health care clearighouses and their business associates (“covered entities”)maintain and be prepared to defend their own HIPAA compliance under a Resolution Agreement and Corrective Action Plan (“Resolution Agreement”) OCR announced on December 30, 2019.
The Resolution Agreement resolves charges resulting from an OCR investigation initiated in response to a HIPAA breach report the Georgia based ambulance company filed in 2013 in which the company, which provides emergency and non-emergency ambulance services in Carroll County, Georgia, disclosed the loss of an unencrypted laptop containing the protected health information (PHI) of 500 individuals. The breach occurred when an unencrypted laptop fell off the back bumper of an ambulance. The laptop was not recovered. West Georgia reported that exactly 500 individuals were affected by the breach.
In the course of its investigation of the breach report, OCR’s investigation uncovered long-standing noncompliance with the HIPAA Rules, including failures to conduct a risk analysis, provide a security awareness and training program, and implement HIPAA Security Rule policies and procedures. Specifically, the Resolution Agreement states that West Georgia:
Did not conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. See 45 C.F.R. § 164.308(a)(1)(ii)(A);
Failed to have a HIPAA security training program, and failed to provide security training to its employees. See 45 C.F.R. § 164.308(a)(5);
Failed to implement Security Rule policies or procedures. See 45 C.F.R. § 164.316; and
Despite OCR’s investigation and technical assistance, “did not take meaningful steps to address their systemic failures.”
To resolve its exposure to the substantially higher civil monetary penalties that OCR could impose for violations of this nature, West Georgia agreed to pay a $65,000 resolution payment to OCR and implement and comply with a corrective action plan that in addition to requiring West Georgia to correct the compliance deficiencies, also subjects West Georgia to two years of OCR monitoring and oversight.
The Resolution Agreement and corrective action plan carry a number of important messages for other health care providers and other Covered Entities. First, the OCR enforcement action against West Georgia coming at the end of yet another heavy HIPAA enforcement year by OCR reminds Covered Entities that OCR is serious about HIPAA enforcement on the heels of its 2018 HIPAA record setting collection of $28.7 million in civil monetary penalties and resolution payments including the single largest individual HIPAA settlement in history of $16 million with Anthem, Inc. See OCR Concludes 2018 with All-Time Record Year for HIPAA Enforcement. While not topping this record, OCR during 2019 now has collected civil monetary penalties and resolution payments totaling more than $15 million from HIPAA Covered Entities and their business associates including:
Second, the Resolution Agreement and various other smaller settlements during the year show HIPAA compliance and enforcement is a concern for smaller provideres and other covered entities, not juswt the huge ones. While the $65,000 settlement payment required by the Resolution Agreement is substantially smaller than the amounts of the civil monetary penalties and many of resolution payments OCR collected in its other 2019 enforcement actions, the West Georgia and other 2019 enforcement actions demonstrate the teeth behind the warning in the OCR Press Release announcing the West Georgia Resolution Agreement from OCR Director Roger Severino that“All providers, large and small, need to take their HIPAA obligations seriously.” With OCR promises to keep up its vigorous investigation and enforcement of the HIPAA requirements, every Covered Entity and business associate should take the necessary steps to verify and maintain their HIPAA compliance and to be prepared to defend their compliance under the Privacy, Security, Breach Notification and HIPAA access and other individual rights mandates of HIPAA.
Third, OCR’s statement in the Resolution Agreement about the failure by West Georgia to meaningfully act to correct compliance deficiencies and cooperate in other corrective action during the period following the breach report highlights the importance for covered entities involved in a breach or other dealings with OCR on a potential compliance concern to behave appropriately to express and exhibit the necessary concern OCR expects regarding the compliance issue to position themselves to request and receive the clemency OCR is empowered under HIPAA to extend when deciding the sanctions for any noncompliance.
Of course meeting the requirements of HIPAA is not the only concern that covered entities should consider as they review and tightened their HIPAA and other privacy and data security procedures. Health care providers and other covered entities also should keep in mind their other obligations to protect patient and other confidential information under other federal laws, the requirements of which also are ever-evolving. For instance, on January 1, 2020 Texas providers like other Texas businesses will become subject to a shortened deadline for providing notice of data breaches under a new law enacted by the Texas Legislature in its last session. Arrangements should be designed to fulfill all of these requirements as well as any ethical or contractual.
Covered entities also should keep in mind that violations of HIPAA can have implications well beyond HIPAA.ramifications beyond HIPAA itself. For instance, heath care providers can face disqualification from federal program participation, licensing and ethics discipline and other professional consequences. Health plans and their fiduciaries also may face Department of Labor and other fiduciary claims, while insurers can face licensing and other regulatory consequences.
For More Information
We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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 the Department of Health & Human Services Office of Civil Rights, 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 has extensive legal, operational, and public policy experience advising and representing health care, health care and other entities about HIPAA and other privacy, data security, confidentiality and other matters.
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, public and private primary, secondary, and other educational institutions, 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 recurrently worked extensively with public school districts and public and private primary and secondary schools, colleges and universities, academic medical, and other educational institutions, insured and self-insured health plans; domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; 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, employers; and federal and state legislative, regulatory, investigatory and enforcement bodies and agencies on health care, education, and other data privacy, security, use, protection and disclosure; disability and other educational rights; workforce, and a host of other risk management and compliance concerns.
Ms. Stamer is most widely recognized for her decades-long 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.
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.
Nonprofit health organizations must develop anti-retaliation policies for doctors and submit biennial reports to the Texas Medical Board in response to aHouse Bill 1532mandate that takes effect January 1, 2020.
Passed by the Texas Legislature on September 1, 2019, the Bill also amends the Medical Practice Act to require the Texas Medical Board to accept and process complaints against a certified nonprofit health organization in the same manner it would handle complaints against a health professional.
For More Information
We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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, public and private primary, secondary, and other educational institutions, 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 recurrently worked extensively with public school districts and public and private primary and secondary schools, colleges and universities, academic medical, and other educational institutions, insured and self-insured health plans; domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; 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, employers; and federal and state legislative, regulatory, investigatory and enforcement bodies and agencies on health care, education, and other data privacy, security, use, protection and disclosure; disability and other educational rights; workforce, and a host of other risk management and compliance concerns.
Ms. Stamer is most widely recognized for her decades-long 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.
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.
The Department of Justice today sued the nation’s largest long term care pharmacy provider, Omnicare, and its parent company, CVS Healthcare Corporation seeking seeks damages and civil penalties under the False Claims Act for fraudulently billing federal healthcare programs for hundreds of thousands of non-controlled prescription drugs DOJ says Omnicare illegally dispensed to elderly and disabled individuals in assisted living facilities, group homes, independent living communities, and other non-skilled residential long-term care facilities (“LTC facilities”).
In the civil health care fraud complaint the DOJ filed a New York Federal District Court, the Omnicare illegally dispensed and billed the federal government and patients for antipsychotics, anticonvulsants, and antidepressants to elderly and disabled residents in LTC facilities without proper prescriptions. DOJ’s lawsuit alleges that instead of obtaining new prescriptions from patients’ doctors after the old ones had expired or run out of refills, Omnicare just assigned a new number to the old prescription and kept on dispensing drugs for months, and sometimes years, after the prescriptions expired. DOJ’s complaint alleges that Omnicare internally referred to these renumbered expired prescriptions as “rollover” prescriptions. The DOJ complaint also charges that Omnicare also submitted, or caused to be submitted false claims for payment for medications dispensed based on invalid prescriptions it internally referred to as “rollover” prescriptions” to Medicare, Medicaid, and TRICARE in violation of the False Claims Act.
Omnicare is the country’s largest provider of pharmacy services to LTC facilities. It currently operates approximately 160 pharmacies in 47 states across the United States, which dispense tens of millions of prescription drugs to LTC facilities that serve elderly and disabled individuals. CVS acquired Omnicare in May 2015, and shortly thereafter assumed an active role in overseeing Omnicare’s operations, including pharmacy dispensing practices and systems.
According to the DOJ complaint failed today, from 2010 until 2018, Omnicare and CVS allowed Omnicare pharmacies to dispense non-controlled prescription drugs to tens of thousands of elderly and disabled individuals living in LTC facilities based on prescriptions that had expired, were out of refills, or were otherwise invalid. Omnicare repeatedly disregarded prescription refill limitations and expiration dates that required doctor visits to reevaluate whether the drug should be renewed. Instead of requesting new prescriptions when old ones expired, Omnicare allowed prescriptions to “roll over.” At Omnicare, “rolling over” a prescription meant that when a prescription expired, Omnicare’s computer systems would assign the old prescription a new number and the pharmacy would continue to dispense the drug indefinitely without the need for a prescription renewal. Depending on the computer system used, Omnicare also sometimes assigned a fake number of authorized refills to a prescription – usually 99 allowable refills for Medicare patients – to allow for continuous refilling. DOJ claims that Omnicare pharmacies “rolled over” prescriptions for elderly and disabled individuals living in more than 3,000 residential long-term care facilities, including assisted living facilities operated by the largest long-term care providers in the country, such as Brookdale Senior Living, Atria Senior Living, Sunrise Senior Living Services, and Five Star Senior Living. DOJ also claims Omnicare managers exerted pressure on overwhelmed pharmacy staff to fill prescriptions quickly so that Omnicare could submit claims and collect payments.
According to the DOJ, Senior management at Omnicare and CVS knew of the practices. The DOJ complaint charges among other things that the Omnicare’s Compliance Department succinctly acknowledged the problem in an internal April 2015 email in which one Regional Compliance Officer stated: “An issue that I am running into more and more in multiple states concerns the ability of our systems to allow prescriptions to continue to roll after a year to a new prescription number without any documentation or pharmacist intervention.” A compliance officer then forwarded the email to the head of Omnicare’s Third Party Audit group, who responded that she had a “potential solution (programmed last year) but no one is rolling it out now.”
DOJ says Omnicare’s practice of illegally dispensing drugs to elderly and disabled individuals living in LTC facilities exposed these vulnerable individuals to a significant risk of harm. In contrast to traditional skilled nursing homes, where residents have access to 24-hour medical care supervised by doctors, assisted living and other non-skilled residential facilities offer more limited medical care, or none at all. In particular, these LTC facilities generally do not have doctors on staff to oversee and monitor residents’ drug therapy.
Many of the prescription drugs dispensed by Omnicare without valid prescriptions treat serious, chronic conditions, such as dementia, depression, and heart disease. They include antipsychotics, anticonvulsants, cardiovascular medications, anti-depressants, and other drugs that can have dangerous side effects and need to be closely monitored by doctors, particularly when taken in combination with other drugs by elderly patients. By repeatedly dispensing potent drugs without current and valid prescriptions, Omnicare jeopardized the health and safety of tens of thousands of individuals who continued to take the same drugs for months, and sometimes years, without consulting their doctors to determine whether the medications were still clinically appropriate.
A large percentage of the long-term care residents served by Omnicare are beneficiaries of federal healthcare programs. By dispensing drugs without valid prescriptions, Omnicare presented, or caused to be presented, hundreds of thousands of false claims to Medicare, Medicaid, and TRICARE. These claims were ineligible for payment. In addition, Omnicare knowingly transmitted false information to these federal healthcare programs that made it appear that drug dispensations were supported by current, valid prescriptions from physicians when in fact they were not.
The DOJ lawsuit resulted from the DOJ’s intervention in whistleblower lawsuits filed by former employees.
In today’s announcement of the lawsuit, Manhattan U.S. Attorney Geoffrey S. Berman said: “As alleged, Omnicare put at risk the health of tens of thousands of elderly and disabled individuals living in assisted living and other residential long-term care facilities by dispensing drugs for months, and sometimes years, without obtaining current, valid prescriptions from doctors. A pharmacy’s fundamental obligation is to ensure that drugs are dispensed only under the supervision of treating doctors who monitor patients’ drug therapies. Omnicare blatantly ignored this obligation in favor of pushing drugs out the door as quickly as possible to make more money. This Office will continue to hold accountable those who put at risk people’s health and safety just to turn a profit.”
Meanwhile, HHS-OIG Special Agent in Charge Scott J. Lampert said: “Failing to consult doctors as to whether prescriptions should be refilled places patients’ health and medical care at serious risk. These automatic rollover refills could have significant consequences for vulnerable people in long term-care facilities. We will continue working with law enforcement partners to protect people depending on these taxpayer-funded government health programs.”
More information is expected to be forthcoming.
For More Information
We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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 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-long 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 fraud, substandard quality, safety, unprofessional conduct, 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, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.
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.
The $1.6 million civil monetary penalty (“CMP”) assessed against the Texas Health and Human Services Commission (“TX HHSC”) for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules between 2013 and 2017 committed by a predecessor agency, the Department of Aging and Disability Services (“DADS”) illustrates the critical need for all HIPAA covered entities and business associates to confirm the adequacy of their enterprise wide security assessment, oversight, and other HIPAA Privacy and Security compliance and risk management including documentation of the reassessment and updating of these materials and assessments in connection with any update or change in software, systems or other system and security relevant developments.
OCR imposed the CMPs against TX HHSC for violations of HIPAA OCR found DADS committed from 2015 to 2017, before it was reorganized into TX HHSC in September 2017. Like most other large HIPAA CMPs and settlements paid to avoid CMPs, a review of the TX HSSC CMP events makes clear that the large penalty resulted mostly because of inadequate assessment and oversight of security, rather than the actual breach itself that prompted the investigation leading to the CMP assessment.
Before its merger into TX HHSC, DADS was the Texas agency primarily responsible for providing and administering the state’s long-term care services for aging and intellectually and physically disabled people. TX HHSC now administers and provides the services previously provided by DADS as part of its broader operation of state supported living centers; provision of mental health and substance use services; regulation of child care and nursing facilities; and administration of hundreds of other programs for people needing supplemental nutrition benefits, Medicaid and certain other assistance including those previously provided by DADS.
DADS Breaches & Violations
The $1.6 million CMPs assessment against TX HHSC resulted after OCR investigated a 2015 breach report made by DADS. On June 11, 2015, DADS submitted a Breach Notification Report (“Report”) notifying OCR that on April 21, 2015 names, addresses, social security numbers, treatment information and other electronic protected health information (“ePHI”) of 6,617 individuals was viewable over the internet when a software coding flaw allowed prohibited access to ePHI with access credentials when DADS moved an internal application from a private, secure server to a public server. OCR’s investigation determined that, in addition to that impermissible disclosure, DADS violated the HIPAA Security Rule by failing to conduct an enterprise-wide risk analysis and implement access and audit controls on Community Living Assistance and Support Services and Deaf Blind with Multiple Disabilities (“CLASS/DBMD”) program information systems and applications intended to collect and report information about “Utilization Management and Review” activities to the Centers for Medicare & Medicaid Services (“CMS”) for the CLASS/DBMD waiver programs.. The CMS waiver programs required DADS to collect and report to CMS applicant and enrollee community and institutional service choice, Level of Care, Plan of Care, waiver provider choice and other waiver program performance data for CLASS and DBMD as part of a required evidentiary report on all §1915(c) waiver programs. The CLASS/DBMD application glitch compromised the ePHI by allowing an undetermined number of unauthorized users to view the ePHI without verifying user credentials. TX HHSC learned of the breach from an unauthorized user who accessed ePHI in the application without being required to input user credentials. Because of inadequate audit controls, DADS was unable to determine how many unauthorized persons accessed individuals’ ePHI.
OCR initiated a compliance review of DADS on June 23, 2015 in response to the breach notification. As HIPAA Security Rule at 45 C.F.R. ·§ 164.312(a)(l) requires a covered entity to implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs properly granted access rights under HIPAA Security Rule § 164.308(a)(4), OCR found that by placing the CLASS/DBMD application on their public server without requiring users to provide access credentials, TX HHSC violated HIPAA by failing to implement access controls on all of its systems and applications throughout its enterprise in violation of 45 C.F.R. § 164.312(a)(l).
The HIPAA Security Rule at 45 C.F.R. § 164.312(b) requires a covered entity to implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI. In the course of its investigation, OCR requested in its June 23, 2015 Data Request that DADS provide a copy of its current HIPAA administrative and technical policies and procedures. As DADS provided no evidence that the application was capable of auditing user access after it was moved to the unsecure public server as required by 45 C.F.R. § 164.312(b) with its response, OCR also concluded from its investigation that TX HHSC failed to implement audit controls to all of its systems and applications, like the application involved in the breach, as required by 45 C.F.R. § 164.312(b).
Beyond these violations, OCR also found that DADS also violated the HIPAA Security Rule by failing to conduct the required accurate and thorough enterprise wised risk analysis required by the HIPAA Security Rule. In this respect, the HIPAA Security Rule at 45 C.F.R. § 164.308(a)(1)(ii)(A) requires a covered entity to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI it holds. In its August 31, 2015 response to OCR’s Data Request dated July 23, 2015, DADS acknowledged that, while it had performed ”risk assessment activities” on individual applications and servers, it never performed an “agency-wide” security risk analysis. On July 28, 2017, OCR received the documentation that DADS represented to be the documentation of its risk analysis. After reviewing this evidence, OCR additionally found DADS violated the HIPAA Security Rule by failing to conduct an enterprise-wide risk analysis and implement access and audit controls.
Calculation & Assessment CMPs Totaling $1.6 Million
On May 23, 2018, OCR issued a Letter of Opportunity and informed TX HHSC that OCR’s investigation indicated that TX HHSC failed to comply with the Privacy and Security Rules, which remained unresolved despite OCR’s attempts to do so. The letter stated that pursuant to 45 C.F.R. § 160.312(a)(3), OCR was informing TX HHSC of the preliminary indications of non-compliance and providing TX HHSC with an opportunity to submit written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 45 C.F.R. § 160.410 for OCR’s consideration in making a CMP determination under 45 C.F.R. § 160.404. The letter identified each area of noncompliance. It also stated that TX HHSC also could submit written evidence to support a waiver of a CMP for the indicated areas of non-compliance.
Although the designated representative for TX HHSC as DADS successor received the Letter of Opportunity on May 24, 2018, . TX HHSC did not provide any written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 4S C.F.R. § 160.410 for OCR’s consideration in making the CMP determination or submit any written evidence to support a waiver of a CMP for the indicated areas of non-compliance. Accordingly, after securing the requisite approval from the Justice Department, OCR issued a Notice of Proposed Determination of Civil Monetary Penalties (“Proposed CMP”) on July 29, 2019.
As explained by the Proposed CMP, as amended by the HITECH Act, Section 13410, 42 U.S.C. § 1320d-5(a)(3), HIPAA authorizes OCR as the designated representative of the Secretary of HHS to impose CMPs against a covered entity for post-February 18, 2009 HIPAA Privacy or Security Rule violations. These current CMP provisions provide the following rules for the assessment of CMPs for such violations:
A minimum of$100 for each violation where the covered entity or business associate did not know and, by exercising reasonable diligence, would not have known that the covered entity or business associate violated such provision, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $25,000.
A minimum of$1,000 for each violation due to reasonable cause and not to willful neglect, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $100,000. Reasonable cause means an act or omission in which a covered. entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.
A minimum of $10,000 for each violation due to willful neglect and corrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $250,000.
A minimum of$50,000 for each violation due to willful neglect and uncorrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $1,500,000.
By law, OCR adjusts the CMP ranges and calendar year cap for each penalty tier for inflation. The adjusted amounts are applicable only to CMPs whose violations occurred after November 2, 2015.
The Proposed CMP included notice of the CMPs OCR intended to impose CMPs totaling $1.6 million for the violations. Characterizing each of the violations as due to reasonable cause and not willful neglect, the Proposed CMP Notice made note that OCR was authorized by statute to assess penalties of up to $50,000 per day for each day of the identified violations due for reasonable cause, rather than willful neglect, but authorized OCR to adjust the penalties in light of aggravating and mitigating factors. The Proposed CMP stated that in arriving at the lesser daily penalty amount, OCR considered as mitigating factors that:
The violations did not result in any known physical, financial, or reputational harm to any individuals nor did it hinder any individual’s ability to obtain health care; and
TX HHSC immediately removed the application once it received a report that unauthorized users could access the ePHI of individual beneficiaries.
However, OCR also took note that it viewed DADS failure to act promptly to remediate the breach and to keep a commitment made to OCR in August, 2015 timely to conduct and complete the agency wide risk analysis by August 31, 2016 as an aggravating factor. Considering these factors, the Proposed CMP notified TX HHSC that OCR intended to assess a daily penalty amount of$1,000 per day ($1,141 after November 2, 2015) per violation capped at $100,000 per calendar year per violation. Applying these amounts, the CMP notified TX HHSC that OCR intended to impose CMPs totaling $1.6 million, as follows:
Impermissible disclosures in violation of 45 C.F.R. § 164.502(a), a $100,000 CMP
Inadequate access controls in violation of 45 C.F .R. § 164.312(a)(l), a $500,000 CMP
Inadequate audit controls in violation of 45 C.F.R. § 164.312(b), a $500,000 CMP
Failure to perform required enterprise wide risk analysis in violation of 45 C.F.R. § 164.308(a)(l)(ii)(a), a $500,000.
After TX HHSC , as successor to DADS, did not file a request for hearing before an administrative law judge within the 90 days, OCR imposed the $1.6 million CMP in dated October 25, 2019 made public on November 7, 2019.
Lessons For Other Health Care Providers, Health Plans, Clearinghouses & Business Associates
The latest in a growing series of multimillion dollar CMPs and Resolution Payments assessed and collected by OCR, the TX HHSC CMP illustrates the critical necessity for all covered entities and business both to take appropriate, well-documented action to prevent, timely discover and redress, and report ePHI breaches and otherwise comply with the otherwise applicable requirements of the HIPAA Privacy, Security and Breach Notification Rules including the conduct and continuous maintenance of appropriate enterprise wide security assessments, audits, and oversight. With OCR promising to continue its enforcement, all covered entities and business associates should verify the existence and adequacy of their existing enterprise wide risk assessments and safeguards and procedures for monitoring, investigating potential security risks and other breaches and other HIPAA compliance oversight. Beyond these compliance efforts, the TX HHSC and other CMP actions also drive home the strong advisability for covered entities or business associates that experience a known or potential breach or other violation promptly to investigate and mitigate potential breaches and other violations. As part of these efforts, covered entities and business associates should seek assistance in conducting their assessments as well as responding to any preexisting and emergent breach or other compliance concerns within the scope of attorney-client privilege from qualified legal counsel with the necessary knowledge and experience of HIPAA and other federal and state laws, regulations and administrative and judicial decisions that define and shape their exposure. In the event of a breach or other compliance concern, timely guidance and representation by legal counsel with both experience of these requirements and with dealing with OCR and other agencies may help mitigate exposures by expediting timely and appropriate response.
For More Information
We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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 GroupMs. 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 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-long 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, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.
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.
Jackson Health System (JHS) has paid a heavy price for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules between 2013 and 2016.
The $2,154,000 civil monetary penalty the Miami, Florida-based nonprofit academic medical system paid to the Department of Health & Human Services Office for Civil Rights (OCR) to settle OCR charges it violated the HIPAA Security & Breach Notifications= Rules makes clear the urgent need for other health care providers, health plans, healthcare clearinghouses and their business associates to verify the adequacy of their organizations with HIPAA’s privacy, security and breach notification rules currently and on an ongoing basis.
The $2.1 million plus payment was required to satisfy a civil monetary penalty assessment OCR imposed in a Notice of Proposed Determination and Notice of Final Determination made public by OCR on October 23, 2019 in response to findings from a series of investigations of HIPAA breach and compliance concerns raised between 2013 and 2016 raised by various HIPAA-mandated breach reports and media reports that raised concerns about improper access disclosure and use of patient PHI between 2013 and 2016. When JHS did not challenge the findings or determination became final. OCR reports JHS has paid the specified $2.154,000 civil monetary penalties.
JHS HIPAA Violations Found By OCR
JHS operates six major hospitals, a network of urgent care centers, multiple primary care and specialty care centers, long-term care nursing facilities, and corrections health services clinics, provides health services to approximately 650,000 patients annually, and employs about 12,000 individuals. The OCR investigation stemmed from a series of breach and media reports spanning several years and revealed a host of long standing violations of long-standing HIPAA requirements and a failure to accurately disclose or correct those or other violations of a nature that likely continue to exist in many health care systems and other covered entities.
On August 22, 2013, JHS submitted a breach report to OCR stating that its Health Information Management Department lost paper records containing the protected health information (PHI) of 756 patients in January 2013. JHS’s internal investigation determined that an additional three boxes of patient records also were lost in December 2012; however, JHS did not report the additional loss or the increased number of individuals affected to 1,436, until June 7, 2016.
In July 2015, OCR initiated an investigation following a media report that disclosed the PHI of a JHS patient. A reporter had shared a photograph of a JHS operating room screen containing the patient’s medical information on social media. JHS subsequently determined that two employees had accessed this patient’s electronic medical record without a job-related purpose.
On February 19, 2016, JHS submitted a breach report to OCR reporting that an employee had been selling patient PHI. The employee had accessed inappropriately over 24,000 patients’ records since 2011.
According to OCR Director Roger Severino, “OCR’s investigation revealed a HIPAA compliance program that had been in disarray for a number of years. …This hospital system’s compliance program failed to detect and stop an employee who stole and sold thousands of patient records; lost patient files without notifying OCR as required by law; and failed to properly secure PHI that was leaked to the media.”
These and other findings led to the OCR determination in the Notice of Proposed Determination and Notice of Final Determination that JHS failed to provide timely and accurate breach notification to the Secretary of HHS, conduct enterprise-wide risk analyses, manage identified risks to a reasonable and appropriate level, regularly review information system activity records, and restrict authorization of its workforce members’ access to patient ePHI to the minimum necessary to accomplish their job duties. OCR assessed the $2.1 million civil monetary penalty based on these determinations.
Lessons For Other Health Providers & HIPAA Covered Entities Likely Similarly Exposed
The JHS civil monetary penalty is the latest in a growing series of OCR enforcement and regulatory actions that drive home the perils HIPAA-covered health care, health plan, healthcare clearinghouse and business associates risk by failing to responsibly and effectively manage their HIPAA compliance. A review of the available JHS record reveals that like all too many HIPAA-covered entities, JHS never adequately implemented appropriate measures to operationally comply with many of the original HIPAA requirements and perpetuated those deficiencies despite the series of breaches. Sadly, many other health care systems and other HIPAA-covered entities are subject to the same practices. Failing to address these compliance issues makes these non-compliant entities susceptible to the same type of enforcement and other liabilities that JHS now has experienced.
OCR enforcement data documents a steady rise in OCR investigation and enforcement activity. OCR set all-time records for HIPAA Enforcement in 2018. Heavy enforcement activity has continued in 2019. Before its October 23, 2019 announcement of the JHS civil monetary penalties, OCR already had announced:
Its first HIPAA right of access resolution agreement against a health care provider for violating HIPAA’s right of access rules on September 9, 2019 as part of its recently announced HIPAA access rule enforcement initiative;
The collection of a $3 million resolution payment collected from a Tennessee diagnostic medical imaging services company to settle HIPAA civil monetary penalty exposures arising from a breach that exposed the protected health information of more than 300,000 patients; and
A multitude of other audits and enforcement activities resolved through corrective action without collection of any resolution payment or civil monetary penalties.
Given these and other previously announced enforcement initiatives and actions, all HIPAA covered entities and their business associates are urged to maintain hyper-vigilance about their own HIPAA compliance with long standing as well as emerging HIPAA requirements taking into account old, recent, and emerging guidance and enforcement activities of OCR. Given the almost certain discovery or discussion of known or uncovered compliance concerns and other sensitive information, covered entities are cautioned that these activities generally should be undertaken under the guidance of an experienced attorney within the scope of attorney client privilege.
For More Information
We hope this update is helpful. For more information about this or other labor and employment 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 and join discussions about these and other human resources, health and other employee benefit and patient empowerment concerns by participating and contributing to the discussions in our Solutions Law Press Health Care Risk Management & Operations Group and registering for updates on our Solutions Law Press Website.
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 primary focus of this work, Ms. Stamer has worked extensively with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers, health industry advocacy and other service providers and groups and other health industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
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, the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is noted for her decades-long 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, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 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 here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.
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.
December 10, 2019 is the deadline for charitable and other tax-exempt organizations to comment on proposed regulations the Internal Revenue Service (“IRS”) intends to use to implement clarify the reporting requirements generally applicable to tax-exempt organizations as they apply to returns filed after September 6, 2019.
The proposed regulations officially published by the IRS in the September 10, 2019 Federal Register implement changes in response to various statutory amendments and certain grants of reporting relief announced by the Treasury Department and the IRS in prior guidance to help many tax-exempt organizations generally find the reporting requirements in one place. Among other provisions, the proposed regulations incorporate the existing exception from having to file an annual return for certain organizations that normally have gross receipts of $50,000 or less, which is found in Revenue Procedure 2011-15.
In addition, the proposed regulations also reissue relief for certain tax-exempt entities from requirements to report contributor names and addresses on annual returns filed by certain tax-exempt organizations. Originally announced last year in Revenue Procedure 2018-38, the relief was invalidated by a district court ruling that the Treasury Department and the IRS failed to follow required notice and comment procedures. Under the proposed regulations, filing requirements for Section 501(c)(3) organizations and Section 527 political organizations remain unchanged, and all organizations are required to keep the contributor information and make it available to the IRS upon request.
Additionally, the IRS issued Notice 2019-47 (PDF) providing penalty relief for certain exempt organizations that, consistent with the 2018 guidance from the IRS, do not report the names and addresses of contributors on annual returns for tax years ending on or after December 31, 2018, but on or before July 30, 2019.
Need more information or help evaluating or responding to this or developments? Contact the author licensed attorney experienced in FDA and other health care and other regulatory affairs matters.
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 including extensive experience advising and representing health care systems and providers about sexual abuse, assault, harassment, discrimination and other personal and professional misconduct policies, training and other prevention and investigation, peer review and other discipline, mitigation and charges defense, as well extensively published and conducted workshops on “Sex, Drugs & Rock ‘N Role: Preventing and Addressing Personal Misconduct In Healthcare,” “What To Do When Your Employee’s Life Becomes Your Business,” and other educational training and publications for health industry clients and others on these concerns.
In these and other legal, management, governmental affairs work and speaking and publications, Ms. Stamer When working with these and other clients, Ms. Stamer merges a talent for creative problem solving with her detailed legal and operational knowledge and experience to help her clients develop and use legally defensible, pragmatic, client-centric law, performance and risk management tools and processes to manage people, performance, quality, compliance, risk and other operational needs on a real-time, “on demand” basis as well as outsourced general, operations, regulatory affairs or other special counsel capacity on an interim, special project, or ongoing basis. Her clients have included domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients.
Her 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, discipline and defend 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, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 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 a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting 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 here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Health care providers should review and tighten their policies and practices for conducting therapies or other procedures on children and other procedures on any patient involving the exposure of the breasts, genitalia or rectum where a patient is fully or partially disrobed as well as sexual assault, abuse and harassment policies and procedures in light of a resolution agreement between the Board of Trustees of Michigan State University (“MSU”) d/b/a Michigan State University and MSU HealthTeam (“MSU HealthTeam”) and MSU Health Care, Inc. (“MSU Health Care”) announced by the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) arising from a civil rights compliance review OCR initiated after federal and state criminal investigations found that an osteopathic physician Larry Nassar sexually abused gymnasts and others while employed as an associate professor by MSU.
OCR opened a compliance review of MSU to determine if its doctors’ offices and clinics violated Title IX of the Education Amendments of 1972 (“Title IX”) and Section 1557 of the Patient Protection and Affordable Care Act (“Section 1557”) after federal and state criminal investigations found Nassar sexually abused hundreds of women and girls under his care over decades while an associate professor at MSU.
Considered alone or in conjunction with the growing awareness and concern fueled by the #me too movement, widespread publicity about the sexual misconduct of Nassar alleged Bill Cosby, billionaire Jeffrey Einstein, who died in prison while awaiting trial last Saturday and others, and OCR’s reaffirmation of its commitment to vigorously enforce civil rights laws in connection with its May 24, 2019 proposal of changes to its Section 1557 implementing regulations, the Resolution Agreement sends a strong signal to health care organizations and individual physician and other health care providers of the advisability of proactively preventing and managing their exposure to potential sexual abuse, assault and harassment complaints brought by patients, caregivers, employees and others.
The OCR investigation that led to the Resolution Agreement arose from a compliance review OCR started after Nassar was sentenced to 40 to 125 years in prison on February 5, 2018, after entering a guilty plea to seven counts of felony criminal sexual conduct in the first degree in Eaton County, Michigan. He also has been convicted to various other federal and state sexual offenses. Additionally, the former dean of MSU’s College of Osteopathic Medicine, William Strampel, was convicted of felony misconduct stemming from a charge that he used his public office to sexually harass students and a separate charge of willfully neglecting to monitor Nassar after an earlier investigation.
Title IX and Section 1557 are two of a multitude of federal laws prohibiting sex discrimination enforced by OCR, Title IX prohibits discrimination on the basis of sex in federally assisted education programs or activities while Section 1557 prohibits discrimination on the basis of sex, race, color, national origin, age and disability in certain health programs or activities.
The Resolution Agreement resolves potential additional enforcement action by OCR against MSU arising from the investigation commenced in response to the Nassar convictions as well as enforcement actions OCR had initiated against the MSU Entities for failing to comply with an earlier OCR resolution agreement.
In return for OCR’s agreement to close its investigation, the Resolution Agreement requires the MSU Entities to implement specific procedures for conducting examinations and procedures involving children as well as procedures and therapies conduct on patients of any age and gender s where the patient is disrobed, in full or in part, and there is exposure of the breasts, genitalia or rectum (“sensitive examinations”) as well as strengthen its other policies, notices and practices impacting the prevention, investigation and redress of sexual abuse, sexual assault, sexual harassment and other sex discrimination against patients, staff, employees and others.
Notably, to help safeguard patients from future sexual assault or abuse, the Resolution Agreement requires the MSU Entities to adopt, communicate to patients and staff and enforce specific policies patient privacy, chaperones and informed consent and patient privacy including
Requiring that staff always follow Universal Precautions with conducting “sensitive examinations,” which the Resolution Agreement defines as “procedures or therapies where the Patient is disrobed, in full or in part, and there is exposure of the breasts, genitalia or rectum);
Require that staff provide the patient with: an explanation of the required examination, procedure or therapy before beginning the procedure and secure informed consent from the patient or if the patient lacks decision making capacity, the consent of the patient’s guardian before conducting any sensitive examination;
Always honor the Patient’s request to have a parent, relative or friend present as a support person present during any sensitive examination;
Requiring a chaperone for all sensitive examinations;
For sensitive examinations of patients of 10 years of age or greater that the chaperone be an authorized member of the health care team and in other cases allow patients and/or their parent or other support person, as well as providers to request a chaperone at any time;
Require that physical examinations of an infant, toddler or child always be performed in the presence of a patient or guardian unless the parent or guardian or, if the parent is unavailable or in situations involving suspected abuse, mental health or other instances where the parental presence would interfere with the examination, another member of the health care team;
Require the use of a chaperone for sensitive examinations be documented in the patient record or where a patient declines or refuses a chaperone for an examination where one is required, require that the provider document the offer and its declination in the record and have the patient or guardian sign a waiver;
Always honor a patient’s request to have a chaperone present even when the patient also has a support person present when conducting a sensitive examination; and
Allow the patient’s wishes and comfort to determine the sex of the chaperone and accommodate, to the extent practicable, a patient’s request for a same sex chaperone
Moreover, the Resolution Agreement also dictates that the MSU Entities ensure that staff always provide patients undergoing sensitive examinations with an appropriate gown, privacy for undressing and dressing, and sensitive draping to maximize physical privacy.
In addition to these specified required procedures for the actual conduct of sensitive medical examinations, the Resolution Agreement also requires that the MSU Entities significantly strengthen their policies, notifications, procedures, and training regarding sexual assault, sexual abuse, sexual harassment and sex discrimination including to:
Revise their existing non-discrimination notices and sexual misconduct policies to clarify Title IX’s and Section 1557’s prohibitions against sex discrimination, including sex discrimination, sexual harassment, sexual abuse and sexual assault, against men and women;
In the revised non-discrimination notices and sexual misconduct policies clearly communicate that patient, staff or individuals who believe they are victims of sexual harassment, abuse, assault or other sexual harassment are “encouraged” to report their concerns to the designated MSU Entities’ Title IX and Section 1557 compliance team, the MSU police and OCR and explains the procedures for making those reports;
Conspicuously post and distribute the revised nondiscrimination and sexual misconduct policy notices which clearly communicate the clarified non-discrimination and sexual harassment policies;
Improve their processes for notifying students, staff, patients and others about reporting and for investigating and resolving Title IX and Section 1557 complaints (including for MSU-students, non-MSU-student patients, faculty and staff) including specific requirements concerning reporting to and coordination between MSU Entities’ compliance staff and law enforcement;
Designate a responsible official to coordinate the acceptance, investigation and resolution of Title IX and Section 1557 complaints;
Conduct all-staff training, planning and coordination between MSU Entities’ compliance and investigation teams and law enforcement, and provide bi-annual reports to OCR during the three year term of the agreement;
Require that all grievances or complaints alleging sexual assault, sexual abuse, sexual harassment or other sex discrimination filed by any patient, staff or other individual related to the MSU Health Team, be reviewed and investigated by, or under the supervision of, a dedicated independent health care investigator approved by OCR, who MSU may only terminate for cause with OCR’s consent.
While neither exhaustive nor binding on any other health care providers, the conditions (CR imposed against MSU under the Resolution Agreement are concrete steps other health care organizations and providers, academic institutions and other organizations and individuals at risk of claims directly or vicariously should consider using as part of their efforts to prevent and defend themselves against potential exposures to sexual misconduct charges.
With the #metoo movement and other widespread media coverage of the Nassar, Jeffery Epstein, Bill Cosby and other sex scandals fueling growing awareness and discussion about sexual abuse, assault and harassment, physicians and other individual health care providers as well as the health care systems, clinics and other health industry organizations, educational institutions and businesses generally face heightened risks of accusations by patients, caregivers, employees, and others of sexual misconduct. Whether founded in fact, hypersensitivity, or independent agenda, recent history proves the potentially financially costly civil judgments or settlements, as well as career if not freedom ending consequences health care providers and institutions if unable to defend these claims. In addition to the criminal sentences imposed upon Nassar and, for instance, MSU previous entered into a civil settlement with more than 300 alleged victims of 332 women and girls who alleged they were Nassar sexual assault victims. See MSU reaches $500M settlement with Nassar victims. This huge civil liability and the fact that MSU accepteed it rather than risk a potential jury verdict reflects the significance of the this liability risk.
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 including extensive experience advising and representing health care systems and providers about sexual abuse, assault, harassment, discrimination and other personal and professional misconduct policies, training and other prevention and investigation, peer review and other discipline, mitigation and charges defense, as well extensively published and conducted workshops on “Sex, Drugs & Rock ‘N Role: Preventing and Addressing Personal Misconduct In Healthcare,” “What To Do When Your Employee’s Life Becomes Your Business,” and other educational training and publications for health industry clients and others on these concerns.
In these and other legal, management, governmental affairs work and speaking and publications, Ms. Stamer When working with these and other clients, Ms. Stamer merges a talent for creative problem solving with her detailed legal and operational knowledge and experience to help her clients develop and use legally defensible, pragmatic, client-centric law, performance and risk management tools and processes to manage people, performance, quality, compliance, risk and other operational needs on a real-time, “on demand” basis as well as outsourced general, operations, regulatory affairs or other special counsel capacity on an interim, special project, or ongoing basis. Her clients have included domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients.
Her 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, discipline and defend 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, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 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 a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting 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 here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources 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.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
Physicians, pharmacists and pharmacies, prescription benefit management companies and other health industry participants should begin preparing for new questions and other responsibilities likely to arise from the Department of, Health and Human Services(“HHS”) Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency Final Rule (the “Rule”) announced on Wednesday, May 8 and scheduled for official publication in the May 10, 2019 Federal Register.
Under the Rule, the Centers for Medicare & Medicaid Services (“CMS”) will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy. Basically this means the required price information will be added to the disclosures pharmaceutical manufacturers provide during their television advertisements.
Part of President Trump’s American Patients First blueprint, the 102 page Rule seeks to increase transparency for patients and bring down overall drug costs both for patients and for the Medicare and Medicaid programs with the prices updated quarterly.
According to CMS, the 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy. CMS believes patients should know what a drug costs as they discuss their options with their doctor.
While pharmaceutical drug manufactures generally must obtain approval from the FDA Office of Prescription Drug Promotion (ODPD) for advertising, OPDP does not review price information in prescription drug advertisements. Consequently, HHS says ODPD will not require a manufacturer that simply adds price information to a direct-to-consumer advertisement as required by § 403.1202 of the Rule unless the price information explicitly or implicitly incorporates safety or efficacy information about the drug, or makes express or implied claims about the safety or efficacy of the drug.
In addition to the Rule, HHS continues to review a number of other rules and proposals it hopes to further advance the American Patients First blueprint initiative to improve drug price transparency and inform consumer decision making by fixing opaque systems, changing incentives that drive costs or other undesirable behaviors by pharmaceutical companies, prescription benefit management (“PBM”) companies, health insurers and plans, providers and patients.
While physicians and other health care providers, health plans and their employer sponsors and other health industry organizations have urged greater transparency and other reforms to impact skyrocketing pharmaceutical costs and other concerns, health care providers and health plans need to prepare for a wave of new questions from patients and their caregivers that the new information on pricing likely will fuel and the resulting scrutiny of their own activities and processes relation to the selection of prescription drugs. Physicians and other health care providers should anticipate that more patients and caregivers will question provider prescription of higher cost drugs and ask providers to justify their choices. Providers not only should be prepared to explain their own choices and also to chart their advice to help defend potential challenges. Meanwhile hospitals and other health care entities, health plans, health insurers, PBMs and other health industry players using internal pharmaceutical cost management programs also can anticipate those practices also will come under added scrutiny. In anticipating this added scrutiny, health and health plan players should resist the temptation of assuming that the availability of the additional price information will facilitate discussions with patients or their caregivers about prescription drugs, their selection and comparability for treatment choices and other related concerns. Rather, health care providers and plans alike should anticipate that the added discussions the new price transparency rules are intended to fuel will result in more questioning and require greater care in responding to and justifying their recommendations to patients and plan members. Prayers and providers alike need to anticipate these demands and make the necessary arrangements to prepare for these discussions, by budgeting and setting aside the required time, preparing defensible explanations for the recommendations, and creating the necessary documentation to defend these activities.
If you have questions or would like more information about the new Rule or other developments impacting your health plan design or administration, please contact the author directly. You also are invited to stay abreast of these and other health care developments by participating in our Solutions Law Press, Inc. Linkedin SLP Health Care Risk Management & Operations Group or COPE: Coalition On Patient Empowerment Group or Project COPE: Coalition on Patient Empowerment Facebook Page.
About the Author
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.
Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.
Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.
Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with operational compliance and risk management; strategic planning; product and services development and innovation; workforce and operations management: crisis preparedness and response; public and regulatory affairs and host of other concerns.
As part of this work, Ms. Stamer continuously advises clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. She helps clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.
Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not
Posted by Cynthia Marcotte Stamer