On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published regulations establishing the first-ever federal vaccination requirements for health care personnel. Based on its authority to set health and safety standards for patients, CMS requires healthcare providers participating in its Medicare and/or Medicaid programs to ensure that their staff is fully vaccinated against COVID-19. The new rule applies to personnel who provide care, treatment or other services to caregivers or patients, including contractors and volunteers.
CMS says it now requires health personnel to be vaccinated, because the past attempts to simply encourage vaccination”inadequateto protect patient health and safety. CMS cites data showing that the number of COVID-19 cases in nursing homes has risen sharply with the emergence of the Delta variant. The vaccination rate for nursing home staff is nearly 73% nationwide as of October 2021, with significant variations by region. CMS concluded that standard federal requirements for all types of providers are necessary because the existing “patchwork” of state and employer requirements was not sufficient to contain the pandemic in the health care sector. CMS notes that the vaccines are safe and highly effective in preventing serious illness and death, and unvaccinated staff can put a strain on the health care system by transmitting COVID-19 to patients and missing work as they recover from COVID-19. 19 or going into quarantine after exposure .
The new rule applies to Medicare and Medicaid providers directly regulated by CMS and therefore does not reach all Medicaid providers, such as certain home and community-based services (HCBS) providers. The rule applies to nursing homes, hospitals, outpatient rehabilitation centers, federally qualified health centers, rural health centers, and home health care agencies, among other types of providers. Residents and staff of other HCBS providers, such as group homes, assisted living facilities and day rehabilitation programs, are at increased risk of serious illness or death from COVID-19, similar to nursing homes. But because states (and not CMS) license and regulate these providers, CMS has not obligated them to abide by the new rule. States or individual providers may adopt employee vaccination mandates, and providers may be subject to other regulations, such as the Occupational Safety and Health Administration’s requirements for large employers (which have been suspended by the courts) or state or local requirements.
The new rule raises many important issues to keep an eye on:
- Will providers get enough lead time to implement the new rule? Staff must have received their first vaccine dose by December 6, 2021 and be fully vaccinated by January 4, 2022, or have been granted a waiver (based on disability or genuine religious belief) or temporary deferral (based on clinical guidelines from the CDC). Decisions on whether or not to grant exemptions are taken by providers. The rule does not require staff to receive booster shots, although providers must track employees who have received a booster recommended by the CDC. Providers also need to take “additional precautions” to limit the transmission of COVID-19 and develop emergency plans to deal with personnel who are not fully vaccinated.
- How will the new rule affect healthcare staffing levels? An October 2021 KFF tracking poll found that 1 in 5 adults continue to say they will definitely not get the COVID-19 vaccine or will only do so when necessary. When asked what they would do if their employers demanded the COVID-19 vaccine without an option for regular testing, 72% of unvaccinated workers (9% of all adults) say they would leave their jobs. The same poll found that only 5% of unvaccinated adults said they left their jobs because an employer forced them to get vaccinated. CMS recognizes that some employees may leave their jobs because they do not want to receive the vaccine. It remains to be seen whether the new rule will exacerbate existing staff shortages or whether these effects could vary by region. CMS cites examples of vaccine mandates passed by health systems in Texas and Detroit and a long-term care parent company with 250 facilities, as well as the New York state health worker mandate, all of which resulted in high compliance rates and few employee layoffs.
- Will the efforts to monitor and enforce the new rule be sufficient? CMS says provider compliance with the new rule will be part of the existing oversight process by which state or federal inspectors review all Medicare and Medicaid program requirements. CMS foresees that inspectors will review facilities policies and records and conduct staff interviews to verify vaccination status. CMS will provide guidance on supervision and penalties for non-compliance, including civil fines, denial of payment for new admissions to a long-term care facility, or termination of Medicare and/or Medicaid programs.
- How long will the new rule be in effect? CMS will determine whether to make the new rule permanent based on public comments (expected January 4, 2022) and the future course of the pandemic. The new rule is not tied to the duration of the COVID-19 public health emergency (PHE), and CMS expects it to “remain relevant for some time after” the end of the PHE. Medicare interim final rules expire after three years unless they are final. In the short term, the new rule has already been challenged in a lawsuit filed by 10 attorneys general of the Missouri federal court, which could delay or prevent implementation of the rule.