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.
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.’…
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
I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests
On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris administration will be requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so people with private health coverage can get them for free starting January 15, 2022. This new coverage requirement means that most consumers with private health insurance will be able to purchase an at-home COVID-19 test (online or at a pharmacy) and it will either be paid for directly by their health plan or the consumer can submit a claim for reimbursement.
Starting January 15, 2022, insurance companies and health plans will be required to cover eight (8) free over-the-counter at-home tests per covered individual per month, and there will be no limit on the number of tests that are covered if they are ordered or administered by a health care provider following an individualized clinical assessment.
As part of the new requirement, the administration is incentivizing insurers and group health plans to create programs that allow people to get the over-the-counter tests directly through preferred pharmacies, retailers, or other entities with no out-of-pocket costs. Retailers and other entities providing access to consumers for over-the-counter testing should be aware of the requirements. Even if plans and insurers make tests available through preferred pharmacies or retailers, such plans and insurers are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or, if less, the cost of the test)…
Continue Reading New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices
To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending licensure reciprocity for certain out-of-state providers to provide services (in person or via telemedicine) to patients in Massachusetts. Order 2021-13 extends prior DPH orders which authorized issuance of temporary licenses for certain health care providers and renewal or reactivation of certain temporary licenses.
Continue Reading Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests