According to the White House, the end of the COVID-19 national emergency and public health emergency (PHE) declarations is now barely two months away, as they are scheduled to end on May 11, 2023. These declarations provided the federal government with flexibility to waive or modify certain regulatory requirements applicable to the healthcare industry. Once the declarations end, so will the vast majority of these flexibilities and waivers. Accordingly, a relatively short and closing window remains for the healthcare industry – including but not limited to health plans, hospitals, home health agencies, clinics, and entities that offer telehealth services – to prepare their operational, administrative, and clinical teams for the reinstatement of previously waived requirements.Continue Reading Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

On September 21, 2022, the Select Subcommittee on the Coronavirus Crisis held public hearings and issued a report assessing the performance of large, for-profit nursing home chains during the early phase of the Coronavirus pandemic. The Subcommittee’s ongoing investigation began in June 2020, and focused on five for-profit nursing home chains that collectively operated over 850 skilled nursing facilities, each of which had significant outbreaks across their facilities. The Subcommittee’s key findings paint an extremely negative picture of for-profit facilities, and include the following allegations:Continue Reading U.S. Congressional Committee Takes Aim at For-Profit Nursing Homes

On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.
Continue Reading U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate

On January 13, 2022, the United States Supreme Court granted emergency relief to the petitions of numerous states, businesses, and non-governmental organizations by staying the implementation and enforcement of the federal Occupational Safety and Health Administration’s (“OSHA”) COVID-19 Emergency Temporary Standard (“ETS”).  Under the original ETS, private employers with 100 or more employees were required to implement a mandatory vaccination or weekly testing/face covering policy, which constituted a drastic change in policy for many employers and contradicted many state requirements.  Although the U.S. Court of Appeals for the Sixth Circuit has yet to ultimately decide on the merits whether the ETS can stand, the stay by the Supreme Court indicates how the Court may ultimately view the ETS and OSHA’s authority to require vaccinations and weekly testing.  Nonetheless, the ETS is not dead yet, so employers should continue to monitor the appeal process and OSHA’s response to the stay.
Continue Reading U.S. Supreme Court Stays Implementation of OSHA’s COVID-19 ETS Requiring Vaccination or Weekly Testing Policy

On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. As first announced by President Biden on December 2, 2021, the Biden Administration explained that health plans and health insurance issuers (meaning the commercial insurance market) would be required to reimburse individuals who purchase OTC COVID-19 tests during the public health emergency. The Administration directed the Tri-Agencies to issue guidance by January 15, 2022 detailing how to effectuate this expanded coverage of COVID-19 diagnostic testing. Yesterday, the Tri-Agencies published FAQ 51 which requires health plans and health insurance issuers to cover no less than 8 tests per 30-day period per individual beneficiary beginning January 15, 2022.
Continue Reading Tri-Agencies Release Guidance on Coverage of OTC COVID-19 Tests

On December 17, 2021, in a “Friday Night Surprise” the Sixth Circuit Court of Appeals lifted the Stay on the Federal Occupational Safety and Health Administration’s COVID-19 Emergency Temporary Standard (ETS).  This seminal ETS applies to employers with 100 or more employees and requires that employees be either (1) vaccinated; or (2) weekly tested and fully masked if unvaccinated.  While it is anticipated that the Supreme Court will ultimately decide whether the ETS stands, OSHA has already stated that they will begin enforcement of the ETS in January 2022.  Specifically, OSHA will enforce all requirements except testing for unvaccinated employees beginning January 10, 2022, and enforcement related to testing will begin February 9, 2022.
Continue Reading OSHA Emergency Temporary Standard Survival Guide

On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement of the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule  published on November 4, 2021, which requires staff working in Medicare or Medicaid certified providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) to have the shots necessary to be fully vaccinated against COVID-19 by January 4, 2022, and receive their first shot prior to December 6, 2021 (the “Rule”).
Continue Reading CMS Suspends Vaccine Mandate Enforcement for Healthcare Workers

“The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.”[1]

On September 30, 2021, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance (the “Guidance”) entitled, “HIPAA, COVID-19 Vaccination, and the Workplace,” regarding the applicability of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule (“Privacy Rule”) to disclosures and requests for information regarding COVID-19 vaccination status. In a frequently-asked-questions format, the Guidance sets forth a series of workplace-related scenarios involving the confidentiality of an employee’s vaccination status, an employer’s ability to obtain vaccination information from its employees, and the confidentiality of such information.Continue Reading HIPAA and COVID-19 Vaccination Status: The Office of Civil Rights Issues Workplace Guidance

On July 30, 2021, the Special Inspector General for Pandemic Recovery (“SIGPR”), Brian D. Miller, submitted his quarterly report to Congress.  SIGPR was created as an independent watchdog of the Department of the Treasury under the CARES Act.  It is tasked with investigating fraud and abuse of federal stimulus funds in response to COVID-19, and works in collaboration with law enforcement and U.S. Attorney’s Offices throughout the country.  These investigative efforts have resulted in civil and criminal enforcement actions against recipients of federal funding throughout the country, and such enforcement action investigations are sure to continue.  The quarterly report showed that the federal government has been active in investigating fraud and abuse related to stimulus funds, and its call for additional funding signals an increase in future enforcement against recipients of federal stimulus funds.
Continue Reading The Special Inspector General for Pandemic Recovery Calls For Increased Funding and Expanded Jurisdiction In Its Quarterly Report To Congress