Policy Roundup
Rachel Balick
Life moves fast. Here’s a roundup of a few of the most important policy developments to help you keep up.
Are we prepared for the next pandemic?
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. Read the letter at https://apha.us/APhA_HELP_letter.
Recommendations
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. Read the white paper at https://apha.us/NextPandemic.
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 the U.S. Department of Health and Human Services (HHS) on how they were used, rather than having to wait for written approval from Washington (4.4).
Feedback
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. 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.
WHO withdrawal prompts pharmacy response
Frontline pharmacists who are caring for patients rely heavily on the World Health Organization (WHO), said APhA and the International Pharmaceutical Federation (FIP) in a July 8, 2020, statement. The statement—which can be found at https://apha.us/WHOstatement—urges the United States to reconsider its withdrawal from the global health organization.
WHO is an offshoot of the United Nations focused on international public health. Established in 1948, WHO advocates for universal health care, monitors public health risks, coordinates responses to health emergencies, and promotes human health and well-being. It provides technical assistance to countries, sets international health standards and guidelines, and collects data on global health issues. During the pandemic, its work around health emergencies—preparing for emergencies by identifying, mitigating, and managing risks; preventing emergencies and supporting development of tools necessary during outbreaks; and detecting and responding to acute health emergencies—is especially crucial.
“It’s important now, more than ever, that communities and health professionals across the globe work together to continue to understand and mitigate the spread of coronavirus,” APhA Executive Vice President and CEO Scott J. Knoer, MS, PharmD, FASHP, said in the July 8 statement. “Not having the United States influence and support WHO could be detrimental to the health of patients around the world during this immediate crisis, and as we prepare for future pandemics.”
On May 29, 2020, President Donald Trump announced that the United States would stop funding and leave WHO, citing accusations it helped China conceal COVID-19 during the virus’s early stages. Critics of the move say the decision will weaken public health efforts around the world. The withdrawal will not take effect until July 6, 2021. Trump’s Democratic challenger, former Vice President Joe Biden, released a statement saying that if elected, he will reverse the decision.
Pharmacists have a long history of working with WHO. “FIP has been in official relations with the WHO since 1948 and has made considerable strides in our partnership to expand the roles of pharmacists and pharmaceutical scientists in improving global well-being and health and safe access to medicines,” Catherine Duggan, PhD, FRPharmS, FIP chief executive officer, said in the statement. “The experiences and support of the U.S. government and practitioners have significantly shaped the work and collaboration opportunities emanating from the WHO, especially during COVID-19.”
“We strongly urge the U.S. government to reconsider its withdrawal from the WHO and support collaborative efforts in the global fight against COVID-19. We applaud the work and dedication of individual practitioners, organizations, communities and governments worldwide in their efforts to mitigate, contain and prevent the spread of COVID-19,” the APhA/FIP statement concludes.
Oral arguments in PBM case set for October 6
After a pandemic-related delay, the U.S. Supreme Court announced that oral arguments in Rutledge v Pharmaceutical Care Management Association (PCMA) will be heard on October 6, 2020. Rulings typically come several months after oral arguments. At press time, it was still unknown whether arguments would be held in person or virtually.
The case was filed by Arkansas Attorney General (AG) Leslie Rutledge. PCMA is the professional association that represents PBMs.
“This case is one of the most impactful health care cases at the Supreme Court in a decade. That’s why the U.S. Solicitor General encouraged the Court to take this case,” AG Rutledge told Pharmacy Today. “The case will give clarity that would allow states to implement their PBM regulations or put some in place. This is to protect the American consumer—to protect patients—and make sure that they have access to quality health care and that they are able to continue to use their own pharmacist of choice.”
APhA, along with the National Community Pharmacists Association, the Arkansas Pharmacists Association, and the National Alliance of State Pharmacy Associations, filed an amicus curiae brief in the case. Pharmacy associations from almost every state and the District of Columbia signed on to the brief, which supports states’ right to regulate PBMs.
Access the brief at https://apha.us/AmicusBrief. To review the entire case docket, visit https://apha.us/RutledgeDocket.