The CMS proposal establishes a new kind of rural hospital while, in the meantime, the FDA will now allow pharmacies to administer antiviral therapy.
Dr. Ronald Hirsch recently wrote an excellent summary for RACmonitor on the new rural provider type that the Centers for Medicare & Medicaid Services (CMS) has proposed, called the Rural Emergency Hospital (REH). Also last week, in what some see as another benefit for rural health, the Food and Drug Administration (FDA) added pharmacists to the list of providers who are allowed to prescribe antiviral therapy to treat COVID.
The FDA’s announcement is part of the Covid Test and Treat program that President Biden announced in his State of the Union Address early in the year. The Test and Treat program is intended for consumers who test positive for COVID at certain pharmacies could then immediately be administered the antiviral therapy by an on-site provider, on the spot and at no cost. Originally, the pharmacy’s on-site provider had to be a nurse practitioner or physician assistant, but those kinds of professionals are not available at many pharmacies.
As my colleague Cate Brantley reported in March on this broadcast, the American Medical Association (AMA) expressed concern about the Test and Treat program precisely because it allowed a provider without an established patient-doctor relationship to prescribe the pills. According to the AMA, Paxlovid, one of the antivirals to be prescribed, has over six pages of drug interactions that would require patients to modify or even stop other prescriptions they are taking. The AMA said it was therefore important that patients with COVID work with actual physicians on treatment options. The Test and Treat option, the AMA said, was extremely risky.
Despite concern by the AMA, the FDA has gone further than its original Emergency Use Authorization (EUA) for the Test and Treat program. Under the FDA’s update of the authorization last week, the types of providers that can prescribe the antiviral therapy now include pharmacists. Thousands of additional pharmacies will now be able to participate in the program, and many of those will be in rural areas and in places that serve some of the hardest hit populations and populations without insurance.
To AMA’s concern, the policy is also likely to accelerate a growing trend in which the types of providers that can prescribe and treat certain health conditions is being broadened, and pharmacies are being given more and more authority to treat patients. The FDA did set some limits, however, in its updated authorization. The agency said that patients should bring their health records and a list of all the medications they are taking, so that pharmacists can screen for drugs that would have negative interactions with the antivirals.
Speaking of precedence, and switching to the judiciary, last week the Supreme Court declined to take up a legal challenge that was brought against New York’s vaccine mandate on healthcare workers. Last August, New York required all healthcare employees to get vaccinated. The mandate provided an exemption for health reasons, but no exemption based on religion. Several workers sued, claiming the mandate infringed on religious freedom. By refusing to hear the case, the Supreme court has, in essence, rejected the claim that the vaccine mandate violates First Amendment provisions.
Programming Note: Listen to Matthew Albright’s live reporting of healthcare legislation every Monday on Monitor Mondays, sponsored by Zelis.
Recently, I attended the American Health Lawyers Association (AHLA) annual conference in San Francisco. Attorneys must attend a certain number of continuing legal education (CLE)
In 2019 Medicare released the following statement: “It appears that hospitals in a limited number of states have used urban-to-rural hospital reclassifications to inappropriately influence
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