COVID-19

Subscribe to COVID-19

The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.

Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:…

Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023.  On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a Report entitled, “Labs With Questionably High Billing for Additional Tests Alongside COVID-19 Tests Warrant Further Scrutiny” (Report).  The Report discusses why the study pertaining to the billing of additional tests alongside COVID-19 testing was conducted, how it was conducted, and what the key takeaways of the study are.  This was followed by OIG’s issuance in mid-December of a Data Brief reviewing Medicare Part B spending on lab tests entitled, “Medicare Part B Spending on Lab Tests Increased in 2021, Driven by Higher Volume of COVID-19 Tests, Genetic Tests and Chemistry Tests” (Data Brief). …

Continue Reading OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests

Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in response to the COVID-19 public health emergency CMS previously enacted extensive temporary COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. However, the Centers for Medicare and Medicaid Services (CMS) have now determined that various regulatory requirements must be restored in order to protect the health and safety of residents in long-term care facilities.…

Continue Reading NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities

OSHA has partially reopened the rulemaking record and scheduled an informal public hearing to seek comments on several topics relating to the development of a final standard to protect healthcare and healthcare support service workers from workplace exposure to COVID-19. In June of last year, OSHA issued an Emergency Temporary Standard (ETS) to protect workers in healthcare settings from occupational exposure to the virus. This ETS also served as a proposed rule and focused on healthcare workers most likely to have contact with people infected with the virus.
Continue Reading OSHA Taking Comments on Proposed Permanent Healthcare COVID-19 Standard

The federal Office of Inspector General (OIG) recently published a report (OIG Report) as part of a series of analyses of the expansion and utilization of telehealth in response to the COVID-19 public health emergency.  In its report, the OIG concludes that telehealth was “critical for providing services to Medicare beneficiaries during the first year of the pandemic” and that the utilization of telehealth “demonstrates the long-term potential of telehealth to increase access to health care for beneficiaries.” The OIG’s conclusions are notable because they come at a time when policymakers and health care stakeholders are determining whether and how to make permanent certain expansions of telehealth for patients nationwide.
…
Continue Reading OIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19

On March 8, 2022, OSHA released an enforcement memorandum detailing a new initiative involving a short-term increase in highly focused inspections directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients. The goal of this initiative is to ensure continued mitigation to control the spread of COVID-19 and future variants of the SARS-CoV-2 virus and protect the health and safety of healthcare workers who are at heightened risk for contracting the virus. This short-term initiative is a supplement to OSHA’s targeted enforcement under the COVID-19 National Emphasis Program (NEP), focusing on follow-up and monitoring inspections of hospitals and skilled nursing care facilities previously inspected or investigated by OSHA. It is also coming as yet-to-be released proposed permanent OSHA regulations to protect health-care workers from COVID-19 are under review at the White House’s Office of Information and Regulatory Affairs, which is typically one of the last steps before regulations are enacted.
…
Continue Reading OSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care Facilities

In a February 14, 2022, press release, The Joint Commission (Joint Commission) announced that it began surveying affected facilities for compliance with the Centers for Medicare and Medicaid Services (CMS) interim final rule entitled “Omnibus COVID-19 Health Care Staff Vaccination,” published on November 5, 2021, with guidance following on December 28, 2021 (see our previous analysis here and here). Among other things, the rule required eligible staff in affected facilities to be vaccinated against COVID-19. Joint Commission surveying began on January 27, 2022, in states that did not challenge CMS’s interim final rule, and the Joint Commission will begin surveying the remaining states (except Texas) on February 14, 2022. It is not clear when surveys will begin in Texas, as the deadlines for compliance with the interim final rule differ from the other 49 states.
Continue Reading The Joint Commission Announces COVID-19 Vaccine Surveys Have Begun

The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:

Full Approval of the Moderna COVID-19 Vaccine for 18+

On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020.  This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’…

Continue Reading COVID-19 Vaccine Update – February 2022

In a per curiam decision issued January 13, 2022, the U.S. Supreme Court upheld the federal health care worker vaccine mandate rule, finding that the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services was authorized by law to issue the rule.  See our previous analyses of the rule and subsequent litigation here and here for more background information on the stakes of this case.
Continue Reading U.S. Supreme Court Upholds Health Care Worker Vaccine Mandate