OTC Monograph Reform Signed into Law as Part of COVID-19 Stimulus
On March 27, President Trump signed into law Congress’s phase three COVID-19 stimulus bill that includes a measure to reform the Food and Drug Administration’s (FDA) over-the-counter (OTC) drug monograph regulatory framework. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) also includes a measure allowing consumers to use flexible spending arrangements (FSAs) and health savings accounts (HSAs) to purchase OTC drugs and menstrual products. The bill’s OTC monograph reform language establishes user fees for OTC drug products, allows for 18 months of exclusivity for innovative OTC drugs and changes the way FDA responds to OTC drug safety issues. The stimulus bill also strikes language from the Internal Revenue Code that only allows prescription drugs to count as qualified medical expenses to be paid for with HSAs and FSAs. Removing that language now allows OTC drugs to again be considered qualified medical expenses.
FCC: Proposed Plan for $200 Million COVID-19 Telehealth Program
On March 30, the Federal Communications Commission’s (FCC) chairman, Ajit Pai, released a plan to use $200 million allocated by Congress for a grant program for hospitals and health system providers aiming to use telehealth in their COVID-19 response. The $200 million comes from the third coronavirus stimulus package signed into law on March 27. Providers would be able to use a streamlined application to apply for funding to fully cover their telehealth needs, from broadband connectivity to devices.
Eligible providers may be in postsecondary education programs, including teaching hospitals, community health centers, local health departments or agencies, community mental health clinics, nonprofit hospitals, rural health clinics and skilled nursing facilities. Providers that are selected would not be responsible for the costs of their telehealth projects, officials said, and would be accepted on a rolling basis until funds are exhausted or the pandemic ends. The plan still has to be adopted by the commission—find the announcement here. Keep updated on the FCC response to telehealth and COVID-19 here.
FDA Makes Exceptions to Blood Collection Processes for COVID-19, Reduces Deferral Periods
On April 2, the Food and Drug Administration (FDA) announced it would make exceptions to standard blood donation procedures and allow donation sites to follow alternative processes for releasing blood donations throughout the duration of the COVID-19 pandemic. The FDA will allow blood donor sites to follow alternative processes for releasing donations found to be unsuitable after donation, and the FDA has temporarily reduced the quarantine time for release of plasma donations by 15 days, from 60 to 45 days. The exceptions will only apply to the COVID-19 pandemic, though the FDA is considering whether it would be appropriate to extend the exceptions beyond the pandemic. Find the guidance here.
FDA Starts Program to Speed Review, Development of COVID-19 Drugs
On March 31, the Food and Drug Administration (FDA) established a program to speed reviews of COVID-19 treatments and support research on COVID-19 drugs. The Coronavirus Treatment Acceleration Program (CTAP) will provide rapid review of, and input on, drug and biologic development plans. The FDA will quickly respond to requests for investigational drug access and work with applicants and other regulatory agencies to avoid supply disruptions by transferring manufacturing to alternative sites. The FDA plans to review single patient expanded access requests within three hours. To support the program, FDA will redeploy medical and regulatory staff to COVID-19 therapy review teams, involve senior management in submission review, streamline the process for submitting inquiries and provide resources to help providers and researchers submit emergency requests for investigational products. Find more information here.
FDA Adds Chloroquine, Hydroxychloroquine to Drug Shortage List
On March 31, the Food and Drug Administration (FDA) added the anti-malaria drugs hydroxychloroquine and chloroquine to the drug shortage list. Though the FDA has not yet approved chloroquine or hydroxychloroquine for COVID-19, there has been an increased demand for the drug to treat COVID-19 patients and for use in clinical trials. The drugs are in short supply, especially for patients with rheumatoid arthritis and lupus, conditions for which hydroxychloroquine is FDA-approved to treat.
CMS: Regulatory Changes to Help U.S. Health Care System Address COVID-19 Patient Surge
On March 30, the Centers for Medicare and Medicaid Services (CMS) lifted safety rules and other regulations to give hospitals more flexibility to respond to the COVID-19 pandemic, including allowing them to move patients to makeshift off-site locations and reducing the amount of supervision required for certain nonphysicians to provide services. The new policies, in place for the duration of the public health emergency, are aimed at increasing hospital capacity and expanding the health care workforce. These changes include a waiver of federal rules that require hospitals to provide services within their own buildings. The waiver will allow hospitals to transfer some patients to locations such as hotels, dormitories and gymnasiums while still receiving hospital payments under Medicare. The new waiver will allow communities to convert unconventional sites into hospitals, without relying on the Federal Emergency Management Agency (FEMA). The policies are being implemented through a series of waivers and a wide-ranging rule here.
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.