APhA coronavirus watch: APhA responds to Senate white paper on public health preparedness

The nation’s patients would have benefited from full utilization of pharmacists in diagnostic testing, treatment, and immunization planning services at the start of the COVID-19 pandemic, APhA said in a June 26 letter to Sen. Lamar Alexander (R-TN). Alexander chairs the powerful Senate Health, Education, Labor, and Pensions (HELP) Committee. APhA submitted the letter in response to Alexander’s white paper on preparedness for future public health emergencies.

Alexander’s white paper—which summarizes past federal actions, makes recommendations, and asks questions about how lessons from the COVID-19 pandemic can inform future emergency response efforts—stresses the importance of imminently passing legislation to optimize preparedness. “In this internet age, attention spans are short. Even with an event as significant as COVID-19, memories fade and attention moves quickly to the next crisis,” the paper reads. “That makes it imperative that Congress act on needed changes this year [to] better prepare for the next pandemic.” The June 26 letter supports certain recommendations and answers questions posed in the paper.

The white paper makes five major recommendations for preparedness legislation: accelerate research and development of tests, treatments, and vaccines; expand the ability to detect, identify, model, and track emerging infectious diseases; rebuild and maintain federal and state stockpiles and improve medical supply surge capacity and distribution; improve state and local response capacity; and improve coordination of federal agencies during a public health emergency. Each recommendation includes a subset of more specific recommendations.

APhA expressed support for recommendations to

  • Engage and partner with the private sector early to develop diagnostic tests, ensure flexibility to develop and use laboratory-developed tests in a public health emergency, and ensure that the stockpile is better prepared to address diagnostic needs (1.4);
  • Ensure timely communication between health professionals, states, CDC, and the public, as appropriate, of case data and information regarding how emerging infectious diseases affect populations, including who is at higher risk for severe disease and death; this would help inform state and local response and address any potential disproportionate impact on minority populations (2.1);
  • Encourage CDC, states, and health professionals to work together to identify barriers to earlier identification of cases, including whether case definitions and testing recommendations were overly narrow for too long (2.2);
  • Ask states to establish distribution plans and procedures to better inform and communicate with health care providers that request supplies, and ensure the Strategic National Stockpile provides guidance to states, territories, and tribes on best practices to coordinate and distribute medical supplies, including procedures to request resources from the federal stockpile (3.2);
  • Require appropriate levels of personal protective equipment and ancillary medical supplies to be stockpiled and replenished, both at the federal and state level; and more frequently and consistently utilize the shelf-life extension program to extend the life of stockpiled supplies or better identify the expiration of such products and plan to use those products before expiration, among other countermeasures (3.3);
  • Establish plans in advance for how the federal government, states, and the private sector will coordinate to assess needs and distribute newly developed tests, treatments, or vaccines (3.4);
  • Ensure that the United States does not lose the gains made in telehealth (4.2); and
  • Remove red tape and allow states to use Public Health Emergency Preparedness and Hospital Preparedness Program funds to respond to a public health emergency and report back to HHS on how they were used, rather than having to wait for written approval from Washington (4.4).

In response to a question about how the federal government could have better positioned itself to facilitate testing, treatment, and vaccines during the COVID-19 crisis, APhA emphasized pharmacists’ accessibility and recommended the removal of barriers that inhibit widespread testing at pharmacies. These include unclear pathways to payment. “Under the current pathways for pharmacist testing and payment outlined by [CMS], [Medicare does not pay pharmacists] for specimens collected at the pharmacy, which are necessary for completing a COVID-19 point-of-care test, or the assessment of test results” the way physicians are. Congress should pass legislation that includes reimbursement for pharmacists’ services under Medicare Part B, otherwise known as provider status, APhA said.

To improve states’ and hospitals’ ability to maintain a reserve of supplies to ensure the Strategic National Stockpile is a backup—not the primary source of supplies—during emergencies, APhA cited temporary FDA guidance permitting both community and health-system pharmacists to compound drugs in shortage without a patient-specific prescription. The guidance applies to hospitalized patients. Making this guidance permanent would stave off drug shortages.

Other options to improve preparedness include funding and a supply chain for adequate personal protective equipment, removing certain requirements and limitations for pharmacists performing tests, and fully utilizing pharmacists in immunization efforts.

APhA and partner organization have lobbied to ensure reimbursement through Medicare Part B for pharmacists’ testing and eventual immunizing for COVID-19. HHS has already authorized pharmacists to provide testing and specified that this authority supersedes state scopes of practice. Several states have passed regulations allowing pharmacists to be reimbursed by their Medicaid programs, and more are exploring the idea.