As the nation and the world contended with the emergence and spread of COVID-19 this spring, policymakers in Washington responded with unprecedented speed by enacting and implementing multiple sweeping laws and regulations to combat the virus. From major cash assistance for businesses and individuals to sweeping healthcare reforms, the COVID-19 public health emergency drove policies impacting every facet of American life. Not surprisingly, pharmacists have proven to be key to helping ensure safe and timely access to medications, tests, and other products and services during the pandemic. This article provides an overview of the initial federal COVID-19 relief packages and highlights just some of the major policy changes that have impacted the practice of pharmacy during the COVID-19 pandemic thus far.
Three Phases of Pandemic Relief Laws in March
In March alone, Congress passed, and the President signed into law, three major relief bills to fund public health activities, ensure access to health care, support businesses, and send relief to individuals.
Phase 1: The first law, the Coronavirus Preparedness and Response Supplemental Appropriations Act, signed into law on March 6, focused primarily on public health prevention and response. The act deployed $8.3 billion in emergency funding for federal agencies to respond to the outbreak, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Small Business Administration, and the State Department. The law also provided funds for the Public Health and Social Services Emergency Fund at the Department of Health and Human Services (HHS) to support the healthcare workforce and made changes to Medicare policy allowing for more reimbursement of telehealth.
Phase 2: With the second law, legislators turned their attention from immediate public health response to worker and family protections during the public health emergency. The Families First Coronavirus Response Act, signed into law on March 18, mandated and funded paid sick leave and emergency leave for employees of certain companies. The act also infused money into federal agencies for federal safety programs such as food assistance and unemployment benefits. It also required and subsidized paid sick leave and emergency leave for employees as well as free COVID-19 testing.
Phase 3: By the end of the month, it was clear to Congress and the administration the public health emergency had evolved into an economic crisis. In response, the third law, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, was enacted on March 27 and allocated an unprecedented $2.2 trillion in relief funding. The act appropriated more funding intended to support workers, business, and the health care system. It created the Paycheck Protection Program, through which small businesses could benefit from $349 billion in forgivable loans; authorized direct payments to individuals; appropriated $100 billion in relief funding for health care providers; and funded payments to distressed industries among other policies and forms of relief funding.
Top 10 COVID-19 Federal Actions and Policies Impacting Pharmacy
With new authority from Congress and the emergency declarations, federal agencies like HHS have moved to loosen regulations and provide guidance to providers in the field. Through guidance documents, new regulations, and the enacted laws, many policies in Washington have directly impacted pharmacists and the practice of pharmacy during the COVID-19 public health emergency.
- COVID-19 Tests and Pharmacist Protections: HHS authorized licensed pharmacists to order and administer COVID-19 tests approved by the Food and Drug Administration (FDA). This policy allows pharmacists to qualify as “covered persons” under the Public Readiness and Emergency Preparedness Act, affording them immunity to claims for losses caused by, arising out of, and relating to or resulting from the administration or use of the FDA-approved COVID-19 tests.
- Remote Prescribing of Controlled Substances: The Drug Enforcement Administration loosened remote prescribing restrictions during the public health emergency, enabling providers to prescribe controlled substances using telemedicine.
- Protecting Pharmacists from Exposure: The CDC issued guidance on how pharmacists can take precautions to minimize risk of exposure to themselves and their patients.
- Encouraging Practice Across State Lines: HHS Secretary Azar wrote to all governors asking them to work with other states to allow for licensed or certified health professionals to practice across state lines.
- Part D and Out-of-Network Pharmacies: Centers for Medicare and Medicaid Services issued guidance directing Medicare Part D to reimburse enrollees for prescriptions obtained from out-of-network pharmacies if access to network pharmacies is disrupted.
- Compounding for Hospitalized Patients: The FDA announced the agency will not take action against compounding facilities that make a medicine that is a copy of an approved drug, use bulk ingredients not on an approved list, or fail to meet good manufacturing requirements for stability testing during the public health emergency as long as the drug is in shortage and certain criteria are met.
- Compounding Hand Sanitizer: The FDA also updated guidance to allow for and provide support for temporary compounding of alcohol-based hand sanitizer by pharmacists during the pandemic.
- 90-Day Prescription Supply: The CARES Act requires that Medicare Part D plans provide a 90-day supply of prescription medication when requested by the patient during the public health emergency. Due within 180 days of the legislation’s enactment, the guidance should address compliance with existing HIPAA regulations, including any policies that may come into effect due to the national emergency.
- HIPAA Guidance: The CARES Act directs HHS to issue guidance on the sharing of patients’ protected health information during the COVID-19 public health emergency. Due within 180 days of the legislation’s enactment, the guidance should address compliance with existing HIPAA regulations, including any policies that may come into effect due to the national emergency.
- Drug Shortages: The CARES act enacted several new policies to help avert future drug shortages. The law directs FDA to prioritize and expedite reviewing generic applications for drugs in shortage. The act also expands manufacturers’ reporting requirements around shortages and mandates the inclusion of certain medical supplies and drugs in the nation’s Strategic National Stockpile.
The top 10 policy changes described above are temporary policies in place during the pandemic. In addition, the CARES Act permanently made the first meaningful reform to the FDA’s treatment of over-the-counter (OTC) drugs in nearly 50 years. Now, the FDA may designate or approve changes to OTC monographs administratively, rather than going through full notice and comment rulemaking. Under this new, faster administrative process, decisions rest with agency scientists, which is more in line with the current procedure for prescription drug label updates. This new process should make it much easier for the FDA to revise OTC monographs to reflect the latest science and respond to safety issues. To support this new OTC drug review, the law established a new OTC user free program at the FDA.
Congress also reversed a policy from the Affordable Care Act which required individuals to obtain a prescription to use Health Savings Accounts and Health Reimbursement Accounts to purchase OTC drugs. Now patients can use these accounts for OTC drugs, medical supplies, and menstrual products.
Practice of Pharmacy and the Continued Federal Response to COVID-19
Congress and the administration acted swiftly in March of 2020 by providing funding and implementing policies to mitigate the COVID pandemic, attempting to allow health care providers to address the crisis in creative ways, without regulatory barriers. The fight against the pandemic is not over, and continued involvement from the federal government will be required both to address the pandemic and to adjust policies to the “new normal” as we emerge from it.
NABP will continue to be flexible and responsive to boards of pharmacy needs by engaging with Congress and the administration in the months to come. Meanwhile, pharmacists will continue to be on the frontlines of this pandemic providing both COVID-19-related and other health services, including if and when a vaccine is approved. As boards of pharmacy and pharmacists respond to the urgent health needs during and after the public health emergency, it will be critical that federal policies enhance and do not impede their work.