CMS Issues Guidance on its COVID Vaccine Mandate

Last week, the Centers for Medicare and Medicaid Services (CMS) issued guidance related to the interim final rule, which (according to CMS) provides important information on implementation, as well as guidelines to assess and maintain compliance with the COVID-19 vaccination requirements for health care workers at facilities participating in the Medicare and Medicaid programs.

Status of OSHA’s Health Care Worker ETS

The Occupational Safety and Health Administration (OSHA) announced that it intends to continue to work to issue a final standard to protect health care workers from COVID-19 related hazards as it also considers broader infectious diseases rulemaking. OSHA adopted an emergency temporary standard (ETS) for health care workers on June 21, 2021. The rule required social distancing protocols, proper patient screening, paid time off for vaccination, and encouraging employees to get the vaccine. This ETS would remain in effect until superseded by a permanent standard within six months of the ETS’ promulgation. Because OSHA anticipates that a final rule cannot be completed within the six-month timeframe, the agency has withdrawn the non-recordkeeping portions of the ETS while the reporting provisions remain in effect. The agency strongly encourages all health care employers to continue to implement the ETS’s requirements to protect employees from the continuing dangers of COVID-19 and specifically the delta and omicron variants. OSHA also stressed that continued adherence to the terms of the health care ETS is the simplest way to remain in compliance with OSHA’s general duty clause and its general standards, including the Personal Protective Equipment (PPE) and Respiratory Protection Standards.

FDA Authorizes Two New COVID-19 Treatments

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Pfizer’s PAXLOVIDTM for the treatment of mild-to-moderate coronavirus disease in adults and pediatric patients. The prescription treatment is for patients 12 years of age and older weighing at least 40 kilograms with positive results of direct SARS- CoV-2 testing, and who are at high risk for progression to severe COVID-19. It should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom offset. Pfizer stated that it is ready to start delivery of the treatment immediately, and that it plans to file a New Drug Application (NDA) with the FDA in 2022 for potential full regulatory approval. Merck & Co.’s COVID-19 pill molnupiravir has also been authorized by the agency for emergency use as a treatment for mild-to-moderate coronavirus disease in certain adults aged 18 and older who are at high-risk for progression to severe COVID-19. It is not recommended for use during pregnancy or for the pre-exposure or post- exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19. The federal government has purchased 10 million courses of PAXLOVIDTM and 3 million courses of molnupiravir. The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) will oversee the fair and equitable allocation of each drug to state and territorial health departments.

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions (HELP) Committee vote on Dr. Robert Califf ’s nomination to be Commissioner of Food and Drugs; 10:00 a.m.; January 5

Recently Introduced Health Legislation

S.3437 — A bill to extend certain COVID-19 bankruptcy relief provisions through March 27, 2022. Sponsor: Sen. Durbin, Richard J. [D-IL]; Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Voice Vote.

S.3434 — A bill to commission a study relating to the manufacturing programs of the Department of Commerce, and for other purposes. Sponsor: Sen. Peters, Gary C. [D-MI]; Committees: Senate - Commerce, Science, and Transportation

S.3431 — A bill to support programs and services under the Older Americans Act of 1965 through innovation and modernization, and for other purposes. Sponsor: Sen. Kelly, Mark [D-AZ]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.6332 — To direct the Secretary of Veterans Affairs to improve long-term care provided to veterans by the Department of Veterans Affairs, and for other purposes; Sponsor: Rep. Kilmer, Derek [D-WA-6]; Committees: House - Veterans’ Affairs

H.R.6333 — To prohibit the use of Federal funds to establish, maintain, or support any national database identifying individuals as having received or not received any vaccine; Sponsor: Rep. Lesko, Debbie [R-AZ-8]; Committees: House - Energy and Commerce

H.R.6339 — To amend the Internal Revenue Code of 1986 to extend the health coverage tax credit; Sponsor: Rep. Turner, Michael R. [R-OH-10]; Committees: House - Ways and Means

H.R.6344 —To amend the Internal Revenue Code of 1986 to expand refundability and increase simplification of the research credit for certain small businesses; Sponsor: Rep. Neguse, Joe [D-CO-2]; Committees: House - Ways and Means

H.R.6342 —To increase funding for cancer research by the National Institutes of Health to be more in proportion to the mortality rates of cancer; Sponsor: Rep. Fitzpatrick, Brian K. [R-PA-1]; Committees: House – Appropriations. The press release and bill text can be found here.

H.Res.859 — Providing for consideration of the joint resolution (H.J. Res 65), Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to “COVID-19 Vaccination and Testing; Emergency Temporary Standard”; Sponsor: Rep. Keller, Fred [R-PA-12]; Committees: House – Rules

H.R. 6352 – A bill to amend the Federal Food, Drug, and Cosmetic Act to provide a process to lock and suspend domain names used to facilitate the online sale of drugs illegally, and for other purposes. Sponsor: Rep. David McKinley [R-WV]; Committees: House - Energy and Commerce

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