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

The New York State Department of Health (DOH) recently released a “Dear Administrator Letter” (DAL) DHCSB 22-02 for Licensed Home Care Services Agencies (LCHSAs).  The DAL addresses guidance and procedures for LCHAs as they relate to certain administrative licensure amendments.  Such amendments include changing the service, county of operation, sites, address of agency or operator, the corporate name or assumed name (d/b/a), or closing a site. Continue Reading New York State Department of Health Releases Administrative Guidance for LCHSAs’ Licensure Amendments

Effective February 3, 2022, the Massachusetts Board of Registration in Medicine (BoRM), which oversees physician licensure and the practice of medicine, updated its “Policy on Telemedicine in the Commonwealth” (Policy) to provide more guidance for licensed physicians on utilization of telemedicine in practice. BoRM initially issued this Policy in 2020 in connection with the onset of COVID-19 and the significant corresponding expansion of telemedicine and other telehealth care delivery models for patients and providers. Continue Reading Massachusetts Updates State Telemedicine Guidance for Physicians

On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking regulations enacted under the 21st Century Cures Act (Cures Act). As a reminder, in accordance with the Cures Act’s prohibition on certain information blocking practices, in 2020 ONC issued a pair of rules (available here and here) to implement information blocking regulations (now found at 45 CFR Part 171).  Due to COVID-related delays, ONC ultimately set a compliance date for such regulations of April 5, 2021. ONC is now sharing preliminary data on the information blocking claims received for the first time. Continue Reading ONC Information Blocking Data Show Majority of Claims Against Health Care Providers

A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the Administrative Procedure Act (APA) when it issued a May 17, 2021 letter to AstraZeneca to enforce the use of contract pharmacies under the 340B statute (“Enforcement Letter”).  In its decision, AstraZeneca v. Becerra, No. 1:21-cv-00027 (D. Del.) (Feb. 16, 2022), the federal district court for the District of Delaware vacated and set aside HRSA’s Enforcement Letter, and remanded the matter to HRSA for further consideration. The Court stated that it will further solicit the parties’ views on the impact of the Court’s conclusions to assess if and how the case should proceed, in terms of affording relief under AstraZeneca’s complaint.

Continue Reading Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

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

On February 14, 2022, the Office of Inspector General (OIG) issued Advisory Opinion No. 22-03 (Advisory Opinion) regarding a home health agency’s (Requestor) proposal to pay nurse aide certification tuition costs on behalf of new employees hired to work as certified nurse aides (Proposed Arrangement). The OIG concluded that the Proposed Arrangement would not generate prohibited remuneration under the federal anti-kickback statute (AKS) or the beneficiary inducements civil monetary penalties (CMP). Continue Reading OIG Issues Favorable Advisory Opinion Regarding Home Health Agency’s Proposal to Pay Tuition Costs for New Employees

On February 9, 2022, the United States Department of Justice (DOJ) announced a $3.8 million settlement with Catholic Medical Center (CMC) of Manchester, New Hampshire. This settlement resolves allegations that CMC violated the False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). The allegations were originally brought in a qui tam lawsuit filed by a physician who is a former employee of CMC. Continue Reading DOJ Announces $3.8 Million Settlement to Resolve Allegations of False Claims Act and Anti-Kickback Statute Violations

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