Biden Administration Inherits Slew of Medicare Regulatory Changes

Nearly all Medicare providers have been impacted by at least one COVID-19 pandemic-related regulatory change, the Commonwealth Fund reports.

Under the Trump administration, there were 244 Medicare regulatory changes that impacted clinicians, hospitals, and other healthcare providers during the COVID-19 pandemic, according to the Commonwealth Fund’s new report based on data from Health Management Associates.

The regulatory changes were made between July 25, 2020, and January 8, 2021, to support healthcare providers responding to COVID-19 and its impact on care delivery at the time.

Of the changes, hospitals (67), post-acute care providers (62), and clinicians (48) were the most impacted.

The most common themes among the over 200 Medicare regulatory changes also included payment systems and quality programs (58), conditions of participation (55), provider capacity and workforce (38), and benefits and care management (33).

Notably, there were 19 pandemic-related regulatory changes associated with telehealth in Medicare through Jan. 8, 2021, the Commonwealth Fund found.

Another well-known theme among regulatory changes at the time – alternate care sites – only corresponded to 12 changes even though, like telehealth changes, the regulations were leveraged by many providers during the pandemic.

Nearly all the pandemic-related regulatory changes were enacted beyond the established notice-and-comment rulemaking process to ensure speedy implementation.

However, the majority (86 percent) of these regulatory changes, including popular telehealth and alternate care site changes, are temporary and slated to expire with the HHS-declared public health emergency or even sooner depending on the change.

In fact, just 14 of all the pandemic-related changes permanently altered Medicare regulations, while 211 were temporary, 12 non-enforcement actions, five varied, and two were terminated.

The only temporary pandemic-related regulatory changes terminated were associated with the mandatory submission of skilled nursing facility staffing information and the return of contract-level audits for Medicare Advantage plans, Part D plans, and other managed care organizations.

The Trump administration had indicated that it planned to make some of the pandemic-related regulatory changes permanent and had the opportunity to revisit changes through regular rulemaking, the Commonwealth Fund stated.

Under President Trump, CMS did move more telehealth services to the Medicare-approved telehealth services list and permitted non-physician practitioners to supervise diagnostic tests to the extent authorized by stated law and licensure.

But the recent inauguration of President Joe Biden on Jan. 20, 2021, makes the Medicare regulatory landscape the responsibility of a new administration that has also inherited the response efforts for the ongoing pandemic.

“The Biden administration has inherited this slate of temporary COVID-related Medicare regulatory changes and will have to decide whether and how to extend these policies given the state of the pandemic and its impact on health care providers,” the Commonwealth Fund said in the report.

Additionally, the new administration will also lean on regulatory and subregulatory changes to “reflect the administration’s COVID and Medicare policies,” the organization stated.

The Commonwealth Fund has previously stated that it may be necessary to allow some temporary waivers, which represented 147 of the pandemic-related regulatory changes, to expire if data shows that the potential for patient or program harm outweighs the potential benefits of the waiver. For example, if the risk associated with delaying safety inspections is greater than the benefit of minimizing the number of people in the healthcare facility to reduce the risk of infection.

However, provider industry groups have been pushing for many of the temporary regulatory changes to become part of the permanent Medicare regulatory landscape, especially when the changes relate to telehealth.

The American College of Physicians (ACP), for example, has recommended that CMS maintain payment parity between telehealth and in-person visits even after HHS lifts the public health emergency and that the agency permanently extend the policy waiving geographical and originating-site restrictions.

“ACP supports CMS’ efforts to make things easier for America’s frontline physicians in the wake of the COVID-19 public health crisis,” Ryan Mire, MD, FACP, chair of ACP’s Medical Practice and Quality Committee, said at the time. “However, more needs to be done to ensure that our physician practices are able to weather the crisis.”

Statute limits CMS from making many of the pandemic-related regulatory changes permanent, the Commonwealth Fund explained, meaning Biden would need to go to Congress to extend changes after the public health emergency.

“It is possible that Congress will consider legislation that addresses at least some of the temporary changes — to modify, extend, or terminate them,” the Commonwealth Fund stated.

Congress has already acted on 28 items, including extending or delaying CMS Innovation Center demonstrations and expanding the scope of practice for some non-physician practitioners, through COVID-19 legislation, the organization added.

With Democrats recently taking the Senate, as well as the House, during the 2020 election, Biden does have a better chance at pushing through legislation acting on pandemic-related regulatory changes.

The administration, however, has not laid out its plans for permanent changes to the Medicare regulatory landscape except for broader policy wishes, such as a Medicare-like public option.