AHA Sends Letter to CMS Commenting on Healthcare Worker Interim Final Rule

On Jan. 4, the American Hospital Association (AHA) sent a letter to the Centers for Medicare & Medicaid Services (CMS) commenting on the Interim Final Rule (IFR) requiring vaccination of healthcare personnel.

The letter begins by AHA expressing its appreciation for the opportunity to comment on CMS’ IFR. “The AHA repeatedly has urged the vaccination of all healthcare workers, and supports hospitals and health systems that chose to implement vaccination requirements,” the letter continues. “Prior to CMS’ publication of the IFR, a number of hospitals and health systems implemented vaccination requirements for their staff with decisions made on an organization-by-organization basis. Now, with the IFR’s publication, CMS has made the decision to implement a national mandate for healthcare facilities to vaccinate their personnel. That decision now places the responsibility on CMS to ensure the policy’s stated goal—the vaccination of all healthcare staff for their safety and the safety of the patients they treat—is met through a thoughtful, transparent, consistent and meaningful compliance process that appropriately balances maintaining access to care with the decision to use enforcement action.”

Additionally, the letter states AHA’s appreciation that CMS released its Dec. 28 interpretive guidance for the IFR with updated FAQs. AHA explains that its members rely on this guidance to ensure they are implementing the right processes in the correct manner to meet regulatory expectations. The letter also states that AHA Is pleased that the interpretive guidance announced pushing back the two implementation dates for compliance with the IFR. Organizations will now have until Jan. 27, 2022 to establish practices mandating COVID-19 vaccinations for healthcare workers and until Feb. 28 to have workers complete primary vaccination series. Furthermore, the AHA writes that it is pleased that CMS indicated it will exercise enforcement discretion for hospitals and other healthcare delivery organizations to ensure they comply with the mandate.

“Finally, we want to acknowledge the current legal challenges to the IFR. As of Dec. 31, there is a temporary injunction to the rule in 25 states, with a decision by the U.S. Supreme Court on the injunction expected within the month,” the letter adds. “This puts hospitals and health systems in a difficult position, as some healthcare workers will be required to become vaccinated and others will not, based on where their employer is located.”

The letter then lays out several comments including:

• Further clarification of interpretive guidance – AHA writes that the language of the IFR and interpretive guidance creates parameters for CMS’ vaccination requirements, but its members have more questions, and they are urging CMS to provide hospitals and health systems the opportunity to submit questions and receive quick feedback to stay in compliance with the rule.
• Recognizing processes already in place – AHA urges CMS to consider grandfathering already-established hospital and health system processes that are on par with the agency’s vaccination objectives.
• Providing time to come into compliance – AHA urges CMS to develop a “balanced and thoughtful approach” to enforcing its determinations now and in the future, citing staffing issues that won’t be quickly resolved and that moving forward to aggressively could create disruptions in patient care.
• Flexibility in the event of vaccine supply shortages – The U.S. has been fortunate since May 2021 that there has been adequate supplies of COVID-19 vaccines for individuals who want them. Yet, it is possible that disruptions to manufacturing or distribution could cause shortages in vaccine supply.
• The use of an interim final rule – AHA writes that CMS implemented the mandate by means of a condition of participation (CoP), stated in an IFR. AHA explains that this action caused CMS not to benefit from input prior to implementation from Congress and those most affected by the rule—such as rural providers. AHA continues by saying that assuring the integrity of CoPs is important in the hospital field to set a standard and since this carries a potential penalty of exclusion from Medicare and Medicaid programs due to lack of compliance. For these reasons, AHA says, CMS should establish CoPs through an IFR only under “extraordinary circumstances” and even under such circumstances the agency should talk with congressional leaders and stakeholders through “other, less formal means.”