With the release of the White House’s next phase National COVID-19 Preparedness Plan and looming deadlines to fund the federal government, including replenishing aid for pandemic relief, it has been an eventful month on Capitol Hill for the health care industry.
In the most recent iteration of President Joseph R. Biden’s pandemic preparedness plan, the White House aims to take full advantage of newly authorized oral coronavirus disease 2019 (COVID-19) treatments by launching a “Test to Treat” program, which would allow pharmacy-based clinics, community health centers, long-term care facilities, and United States Department of Veterans Affairs facilities to test patients for COVID-19 and immediately prescribe oral antiviral medications for those who test positive. With the challenges the Administration has faced in recent months ensuring adequate testing capacity across the country, President Biden’s “Test to Treat” program would address a significant bottleneck in timely treatments and ensure that patients are able to reap the full benefits of these next-generation therapies.
However, some critics argue that the impact and reach of the program will be limited, as a one-stop “Test to Treat” service (ie, the patient receives testing and treatment in the same visit) will only be possible at pharmacies with a licensed health care provider on staff because Food and Drug Administration has not authorized pharmacists to prescribe these COVID-19 antivirals.
That may soon change, as efforts are underway to expand the services pharmacists are able to provide. A bipartisan bill, the Equitable Community Access to Pharmacist Services Act (H.R. 7213), released in the House in late March, would increase access for patients to pharmacist care services and reimburse pharmacists for the transition of care services covered under Medicare Part B, such as tests and treatment regimens for streptococcus pharyngitis and COVID-19. Several states already permit pharmacists to provide these services, but H.R. 7213 would help ensure that these services are covered across the country and where they are needed most, such as in rural and underserved communities.
Aside from limitations on the pharmacies capable of providing “Test to Treat” services, Biden’s new program also faces funding challenges. After weeks of back-and-forth negotiations, on March 15, 2022, President Biden signed into law a $1.5 trillion omnibus spending bill, averting a government shutdown and providing funding for the federal government through September 30, 2022. However, to overcome partisan differences, House Democrats stripped billions for future pandemic aid, including funding that would cover the domestic distribution of COVID-19 vaccines, therapeutics, diagnostics, services, and supplies. Congress has promised to take up separate legislation in the coming weeks, but until additional funding is approved, the “Test to Treat” program will likely remain on hold, as may soon be the case for COVID-19 testing and treatment for the uninsured.
Despite bipartisan differences in future COVID-19 funding relief, Congress does seem to agree that the benefits of Medicare coverage for telehealth services are worth exploring post-pandemic. Included in the omnibus bill are several provisions extending flexibilities in Medicare coverage for telehealth services. And although these flexibilities are set to expire five months after the conclusion of the public health emergency (PHE), which is set to end on April 16, 2022, these extensions set the stage for a continuation of coverage for telehealth services in the future. Notably, remote prescribing of controlled substances under the Ryan Haight Online Pharmacy Consumer Protection Act was not addressed in this omnibus bill, as Congress expects Drug Enforcement Administration to address it. Continuation of the following flexibilities, however, has been approved.
- Flexibility in originating site: Prior to the pandemic, Medicare beneficiaries were restricted in where they could be physically located (ie, their originating site) when receiving telehealth services. However, in response to the pandemic, those requirements were loosened, allowing patients to receive many telehealth services from any geographic area, even in the comfort of their homes.
- Eligible practitioners and sites: In response to restrictions on in-person interactions during the pandemic, Medicare introduced coverage for telehealth services provided by physical therapists, occupational therapists, speech-language pathologists, and audiologists. Coverage of these services will continue. Additionally, the 1,400 federally qualified health centers and 4,300 rural health clinics can continue offering telehealth services post-PHE, including mental health visits.
- In-person requirement for mental health: Prior to the pandemic, providers offering telehealth-based mental health services were required to hold one in-person meeting with any new patient, but that requirement has been delayed.
As federal coverage of COVID-19 testing and treatment comes to a halt and we draw closer to the April 16 expiration of the PHE, Congress will no doubt feel the pressure to act. An extension of the PHE looks likely and extended coverage for telehealth services post-pandemic is all but ensured, but it remains to be seen what changes to the Biden Administration’s current pandemic preparedness plan and funding proposal will be needed to garner bipartisan support.