Despite months of public and private efforts to make vaccines widely accessible, about 40 percent of adults in the United States are not yet fully vaccinated. As coronavirus cases surge, overwhelming hospitals in some parts of the country, colleges and universities, private employers, and states and cities are imposing vaccine mandates for employees, students, and customers. With new evidence suggesting that the delta variant is more transmissible than prior strains and that a majority of the remaining unvaccinated are unlikely to seek out vaccination, the United States urgently needs to use all available tools to increase vaccination rates and avoid continued surges, along with their health and economic impacts. The Medicare and Medicaid Conditions of Participation and Conditions for Coverage are untapped levers the federal government can use to support this effort.
To date, more than 500,000 health care workers have contracted the coronavirus and 1,673 have died from COVID-19. Unvaccinated health care workers put patients at high risk, given that their jobs require close interaction with unvaccinated patients and others who are immunocompromised and at higher risk for complications. Yet by the end of May, 1 in 4 hospital workers still had not been vaccinated at all.
Congregate settings, such as long-term care (LTC) facilities, are particularly susceptible to the spread of infectious disease. In December 2020, the Advisory Committee on Immunization Practices (ACIP) recommended that health care workers and LTC facility residents be prioritized for the COVID-19 vaccination to protect those at the highest risk of severe illness and death. Yet according to an analysis of 300 LTC facilities published by the Centers for Disease Control and Prevention (CDC), only 46 percent of aides and 57 percent of nurses—providers who have the most patient contact—had been fully vaccinated by the beginning of April, with 1 in 3 aides declining the vaccine. Partial vaccination of staff provides insufficient protection: COVID-19 outbreaks have occurred through spread among unvaccinated workers even in LTC facilities with high vaccination rates among residents. As of March 2021, residents and staff of LTC facilities accounted for almost one-third of COVID-19-related deaths in the United States.
According to one public health expert, “vaccinating workers in nursing homes is a national emergency.” In addition, a CDC presentation obtained in late July by The Washington Post asked its audience to “consider vaccine mandates for HCP [health care personnel] to protect vulnerable populations”; it did not, however, propose any mechanism for expanding mandates.
Medicare Conditions of Participation and Conditions for Coverage should be updated to increase COVID-19 vaccination rates
As the largest payers of health care in the United States, the Centers for Medicare and Medicaid Services (CMS) have a variety of regulatory policy tools that can support COVID-19 vaccine administration. One of the most powerful tools the Biden administration has at its disposal is the Conditions of Participation (CoPs) and Conditions for Coverage (CfCs), the federal health and safety standards that health care organizations must meet in order to participate and receive funding from the Medicare and Medicaid programs. Under Section 1861(e) of the Social Security Act, the secretary of the U.S. Department of Health and Human Services has the authority to adopt proposed CoPs that are found to be “necessary in the interest of the health and safety of the individuals who are furnished services in hospitals.” Other health care providers must similarly meet health and safety standards.
Although, typically, CMS must go through notice-and-comment rulemaking to modify Conditions of Participation and Conditions for Coverage, the agency may waive this process and instead adopt changes through interim final rules when it finds there is “good cause,” meaning that notice-and-comment rulemaking is “impracticable, unnecessary, or contrary to the public interest.” CMS has already waived notice-and-comment rulemaking when amending these health and safety standards in response to the COVID-19 pandemic.
For example, in August 2020, CMS added new universal hospital COVID-19 data reporting requirements and critical access hospital CoPs to support virus tracking, prevent spread, and protect the health and safety of patients. CMS invoked a good-cause exception to notice-and-comment rulemaking as well as the typical 30-day delay in a rule’s effective date, stating that “time is of the essence in controlling the spread of COVID-19” and that “universal resident and staff testing will assist public health officials in detecting outbreaks and saving lives.”
More recently, in May 2021, CMS issued an interim final rule establishing new requirements for educating LTC residents and staff about COVID-19 vaccines and for offering the vaccine. Again, CMS explained that these changes were “critically important” given the ongoing pandemic, as it would be “impracticable and contrary to the public interest for [CMS] to undertake normal notice and comment rulemaking procedures” under these circumstances. Moreover, the agency explained it could not “afford sizable delay in effectuating this [change]” due to the ongoing crisis.
CMS should now update these standards to mandate that health care and LTC staff and contractors, as well as health care providers with hospital privileges, are vaccinated against COVID-19; the emergence of the delta variant, stalling vaccination rates, and the threat to patient safety posed by unvaccinated health care workers have created the need for action beyond staff education and vaccine access. It is in the public interest to increase vaccination rates without delay, and mandatory vaccinations for health care workers are of critical importance in protecting patients’ health and safety. Providers would have eight weeks from the effective date of the rule to ensure compliance, allowing the time needed for full vaccination. CMS should also evaluate whether it can impose civil monetary penalties, set to increase over time, for noncompliant organizations.
A policy with nationwide reach is crucial
Importantly, CoPs and CfCs are national in scope, making them a powerful tool to effectuate change when there is local or regional reluctance. For instance, in 1965, federal officials required hospitals to desegregate to be eligible for Medicare reimbursement, leading more than 1,000 hospitals to integrate their medical staffs and hospital floors in less than four months.
Vaccination rates vary significantly from region to region and from state to state. In areas with low vaccination rates, employers—including health care and LTC employers—may be less likely to adopt mandates on their own. State and local officials who have been resistant to public health measures such as masking are unlikely ever to adopt vaccine requirements for all workers in health care, as California has done, or for all nursing home staff, as Massachusetts has done. Some states even have passed laws to limit employer-mandated vaccination. Yet patients, facility residents, and health care workers in all communities deserve the protection afforded by vaccination.
A consistent, national policy is necessary to overcome employers’ perceived financial disincentive to mandate vaccination. While hospitals and other health care employers are well aware of the risks of transmission, the concept of a self-imposed vaccine mandate presents them with a conundrum: In a tight labor market, they fear imposing new restrictions will cause them to lose workers to competing institutions at a time when they are already short-staffed. However, a federal rule requiring full vaccination in virtually all health care jobs would level the playing field, ensuring that no individual facility is disadvantaged by mandating employee vaccination.
Conclusion: The time is right for CMS to act
The movement to ensure that all health care workers are fully vaccinated is gaining momentum. More than 50 health care professional societies and organizations have urged all health care employers to require their employees to be vaccinated against COVID-19 to protect the safety of patients, residents, and communities. Meanwhile, dozens of medical centers and hospital systems, including the U.S. Department of Veterans Affairs, are requiring their workers to get vaccinated. While this movement is encouraging, it is unlikely that all health care and LTC facilities will independently adopt worker vaccination mandates without federal policy intervention.
Making COVID-19 vaccination mandatory for providers participating in Medicare and Medicaid would protect vulnerable patients, set a positive example for other employers, and contribute to the national effort to contain the virus.
Jill Rosenthal is the director of Public Health Policy at the Center for American Progress. Emily Gee is the senior economist for Health Policy at the Center. Maura Calsyn is the vice president and coordinator for Health Policy at the Center.
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