The Centers for Medicare & Medicaid Services (CMS) has issued its promised emergency regulation requiring staff working at healthcare facilities be vaccinated for COVID-19 as a condition of participation in Medicare and Medicaid.
According to an announcement from the agency, healthcare facilities must have a policy in place that ensures all eligible staff have received the first dose of a two-dose COVID-19 vaccine series or a one-dose COVID-19 shot "prior to providing any care, treatment or other services" by Dec. 5. Eligible employees will then need to be fully vaccinated by Jan. 4, 2022.
“Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combatting the pandemic and the constantly evolving challenges we’re seeing,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “Today’s action addresses the risk of unvaccinated health care staff to patient safety and provides stability and uniformity across the nation’s health care system to strengthen the health of people and the providers who care for them.”
CMS said its new regulation requires healthcare facilities to develop a process for exemptions based on medical conditions or religious grounds in accordance with federal law. The full interim rule is 214 pages long and is scheduled to be published in the federal register Nov. 5.
The agency said these requirements will apply to roughly 76,000 providers and cover more than 17 million healthcare workers across the U.S.
It plans to ensure compliance with the COVID-19 vaccination requirements through a survey and enforcement process. Surveyors who determine a provider or supplier does not meet the requirements will be cited as noncompliant be given a grace period to become compliant “before additional actions occur,” the agency said.
“CMS’ goal is to bring healthcare providers into compliance. However, the agency will not hesitate to use its full enforcement authority to protect the health and safety of patients,” the agency wrote in its announcement.
CMS said in the announcement that it has already seen an “encouraging” 9% uptick in nursing home staff vaccination rates since announcing over the summer that staff in those facilities would be required to be vaccinated. The agency also referenced a report from the White House published in early October that found 40% of all U.S. hospitals had already implemented a workforce vaccination requirement and that those requirements led to relatively few staff resignations.
“Vaccines are a crucial scientific tool in preserving and restoring efficient operations across the nation’s healthcare system while protecting individuals,” CMS wrote. “This new requirement presents an opportunity to continue driving down COVID-19 infections, stabilize the nation’s health care system, and ensure safety for anyone seeking care.”
According to the announcement from the agency, the new employee vaccination requirement will apply to: ambulatory surgical centers, hospices, programs of all-inclusive care for the elderly, hospitals, long-term care facilities, psychiatric residential treatment facilities, intermediate care facilities for individuals with intellectual disabilities, home health agencies, comprehensive outpatient rehabilitation facilities, critical access hospitals, clinics (rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services), community mental health centers, home infusion therapy suppliers, rural health clinics/federally qualified health centers and end-stage renal disease facilities.
The emergency regulation received conditional applause from the American Health Care Association and National Center for Assisted Living (AHCA/NCAL), which said it supports the intent of the policy but is concerned that its execution could exacerbate an ongoing workforce shortage.
"A hard deadline with no resources for providers or glide path for unvaccinated workers is likely to push too many out the door and ultimately, threaten residents’ access to long term care," AHCA/NCAL CEO and President Mark Parkinson said in a statement.
“Even a small percentage of staff members leaving their jobs due to this mandate would have a disastrous impact on vulnerable seniors who need around-the-clock care. Across the country, access to long term care is becoming strained as providers have no choice but to limit admissions or even close their doors due to workforce shortages. We hope to continue working with the administration to make the federal vaccine mandate successful while supporting our residents and caregivers," he said.
Bruce Siegel, M.D., President and CEO of America's Essential Hospitals, said in a statement that his group appreciates the multi-phase approach to compliance outlined by CMS. He also requested that the agency promptly release interpretive guidance to support providers as they move to meet the new requirements.
In a statement, American Hospital Association President and CEO Rick Pollack said his organization appreciates the extra clarity that came with the new rule. Notably, by specifying that hospitals only need comply with the CMS rule and not the others COVID-19 vaccination requirements released by the administration, the agency has removed "unnecessary complexity" for hospitals as they work to implement their vaccination policies, he said.
CMS' release coincides with another emergency temporary standard from the U.S. Occupational Safety and Health Administration requiring employers with 100 or more employees to enforce a mandatory COVID-19 vaccination or regular testing policy.
The administration’s push for COVID-19 vaccination within healthcare and without has faced opposition from political opponents and those who do not believe the government should be requiring the shots.
The past couple of months have seen right-leaning states governors and legislators push out their own regulations forbidding organizations from mandating vaccination across their staff as a condition of employment. Although legal experts say that most of those laws and orders will be trumped by the federal requirements, the conflicting guidance has many hospitals trapped in noncompliance until a clear answer comes from the courts.