On January 25, 2022, the US Occupational Safety and Health Administration (OSHA) announced that it would withdraw its controversial “vax-or-test” Emergency Temporary Standard (ETS), which required large employers to impose vaccination or testing requirements upon their employees. The withdrawal will be effective as soon as the announcement is published in the Federal Register, which is scheduled to occur on January 26, 2022.
Throughout the latest COVID-19 wave, some healthcare employers have relaxed safety measures to bring COVID-positive employees back to work. According to this Corporate Counsel article, these decisions may signal a new direction in how businesses deal with safety measures as they navigate a competitive labor market and demand. McDermott’s Abigail M. Kagan noted many healthcare facilities are doing their best to balance employee safety with workplace strain.
“If a patient hears that their nurse has tested positive that morning, the patient may be uncomfortable,” Kagan noted. “ … On the other hand, if it’s the difference between having no nurse, or having a nurse that medical authorities in the (United States) seem to believe is not going to be contagious anymore, that’s something that employers have to think about.”
Healthcare and life sciences lawyers will likely have plenty of work in 2022 thanks to pending legislative and regulatory actions throughout the healthcare, health insurance, and drug and device industries.
According to this Law360 article, surprise billing, abortion and drug pricing are some of the major issues facing lawmakers and regulators in the year ahead. McDermott Partner Michael Ryan noted that changes to the Medical Device User Fee Amendments (MDUFA) also could be in order.
On January 13, 2022, the Supreme Court of the United States released two emergency opinions that change the landscape of the three federal vaccine rules. In summary:
In response to a directive from the White House, based on provisions of the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act that eliminated cost sharing for COVID-19 diagnostic testing, three federal government departments—the US Department of Health and Human Services (HHS), the US Department of Labor (Labor) and the US Department of the Treasury (Treasury)—issued guidance in the form of frequently asked questions (FAQs) that states group health plans and insurers must also cover over-the-counter (OTC) COVID-19 diagnostic testing. This guidance is effective beginning January 15, 2022.
In addition, the Health Resources and Services Administration (HRSA) updated the Affordable Care Act’s (ACA) comprehensive preventive care and screening guidelines for women and children to cover additional services and supplies without a copay or deductible, effective 2023.
COVID-19 AT-HOME TESTING COVERAGE
On January 10, 2022, HHS, Labor and the Treasury together issued FAQs that elaborated on prior guidance and indicated that group health plans and insurers are required to cover OTC COVID-19 diagnostic tests without cost sharing. Because of the recent spike in COVID-19 cases resulting from the rapid spread of the Omicron variant, the guidance will continue for the duration of the public emergency.
Most consumers with private health coverage will be able to buy OTC COVID-19 tests and either have the cost covered upfront or be reimbursed later by submitting a claim to their health plan. The new requirement only applies to “diagnostic” OTC COVID-19 testing. It does not include the treatment of COVID-19 or testing that is for employment purposes.
The guidance provides that health plans and insurers must cover at least eight OTC COVID-19 diagnostic tests per covered individual per a 30-day period. Insurers will be able to set up networks of preferred suppliers to provide OTC COVID-19 tests directly to participants without upfront costs. Insurers must still reimburse OTC COVID-19 tests purchased outside the direct coverage program, however, the reimbursable amount is limited to $12 per test if the health plan also provides tests through its preferred pharmacy network and through a direct-to-consumer shipping program without upfront costs.
Besides the risk of increasing the average cost of OTC COVID-19 tests, the new initiative raises concerns over fraud and abuse. For health plans and insurers to protect themselves, the FAQs provide several examples of permissible activities to prevent fraud and abuse, like requiring proof of purchase or an attestation that the test was purchased for proper purposes (i.e., is being used by the covered individual, is not being reimbursed by another source, is not being resold and is not for employment purposes).
HRSA UPDATES ACA PREVENTIVE HEALTHCARE GUIDELINES
On January 11, 2022, HRSA announced that it updated the preventive health and screening guidelines for women, infants, children and adolescents. Under the ACA, certain group health plans and insurers must provide coverage with no out-of-pocket costs for preventive health services within these HRSA-endorsed comprehensive guidelines.
HRSA accepted the updates recommended by the Women’s Preventative [...]
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In hopes that the COVID-19 public health emergency (PHE) will soon end, Congress and the administration are evaluating the telehealth expansions and flexibilities put in place to respond to the PHE. As a result, the future for telehealth stakeholders remains uncertain. This article outlines various changes in Medicare telehealth reimbursement policy in effect during the PHE and identifies what actions would be required to make these changes permanent.
On November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the Provider Self-Disclosure Protocol last updated by OIG in 2013. The changes are mostly procedural in nature and update the SDP based on legislative adjustments to penalty amounts.
The courts continue to move the vaccine mandate goalposts on employers as dozens of legal challenges work their way through the courts. The latest developments are major game changers for employers. As of today, the US Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) vaccine-or-test rule is enforceable nationwide, and the US Centers for Medicare & Medicaid Services (CMS) Interim Final Rule (IFR) mandating vaccination, subject to exemptions, is enforceable in 25 states.
A flurry of litigation in federal district and appellate courts has led to an even split between states in which the COVID-19 vaccine mandate issued by the US Centers for Medicare and Medicaid Services (CMS) may be implemented and states in which such implementation has been prevented. Additional appeals are expected shortly; however, the practical effect of these decisions on enforcement of the CMS mandate remains uncertain.
On December 13, 2021, the Commissioner of the New York City Department of Health and Mental Hygiene (DOHMH), Dr. Dave A. Chokshi, published an order (the Order) requiring private employers to impose COVID-19 vaccine mandates upon all in-person employees within New York City, with limited exceptions, as of December 27, 2021. DOHMH provided a series of FAQs and additional guidance on December 15, 2021. The Order follows Mayor Bill de Blasio’s December 6, 2021, announcement of this impending mandate.
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