Talking Points
APhA staff
Have a chance to talk to a policymaker but not sure how to express pharmacy’s needs? This guide outlines APhA’s positions on the most important matters facing pharmacy. Personalize them with your own stories or patients’ stories to enhance their impact.
Drug pricing
APhA strongly supports patient access to affordable and cost-effective medications. Drug costs are more complicated than just the price of medication. Medication management and patient education are important parts of managing costs and getting the most value out of pharmaceuticals, especially as medications become more expensive and complex. The costliest drugs are those not taken or not taken correctly.
As such, APhA supports a “transparent pricing” framework that provides clarity about medication costs to providers—including pharmacists—and patients.
Utilizing pharmacists. APhA recommends that the U.S. Department of Health and Human Services and Congress consider mechanisms to better utilize pharmacist services to optimize medication use. Without pharmacist involvement, medication value cannot be accurately assessed; and the costs associated with adverse events or misuse will be shifted to other segments of the health care system. Drug-pricing policies should be adopted that incorporate pharmacists’ services to increase the value of medication regimens and consider drug costs in the context of a patient’s comprehensive care.
Eliminating direct and indirect remuneration (DIR) fees. APhA opposes retroactive DIR fees and supports initiatives to prohibit such fees on pharmacies. Beneficiaries’ point-of-sale (POS) prices or copays at the pharmacy counter can be based on the contracted price before DIR fees are assessed. Because PBMs extract DIR fees weeks or months after prescriptions are filled, Medicare beneficiaries do not save any money from drug-price concessions—and, although they may not know it at time of dispensing because fees are clawed back retroactively, pharmacies are forced to dispense products below their actual cost. CMS has cited numerous studies that suggest higher cost sharing by patients impedes access to necessary medications, which leads to poorer health outcomes and higher overall health care costs for both patients and Medicare.
Pharmacy DIR fee reform is needed immediately to bring down beneficiary out-of-pocket costs and avoid further losses to pharmacies, including closures that reduce patient access to care. APhA supports regulatory and legislative efforts to
End post-POS price concessions, such as retroactive pharmacy DIR fees, to ensure consistency throughout the Part D benefit.
Establish standardized and achievable pharmacy quality measures for CMS to provide incentive payments to pharmacies.
Protecting the U.S. supply chain from non–FDA-approved drugs. APhA has raised concerns with importation policies that would allow importation of non–FDA approved drugs to address high drug prices. APhA supports strategies to lower Americans’ costs by providing FDA-approved drugs through a secure and dependable supply chain that includes their pharmacist and is consistent with the Drug Quality & Security Act (DQSA).
Provider status
APhA pursues avenues to recognizing pharmacists as integral members of the health care team. This includes access to and coverage of pharmacist-provided patient-care services under Medicare Part B. Medicare Part B does not currently cover such services.
Other improvements to Medicare
As scientific innovation leads to medications that are exponentially more complex, APhA believes that pharmacists, as the medication experts, need to be key players on patient health care teams. APhA advocates for expansion and enhancement of the Medicare Part D medication therapy management (MTM) program.
APhA supports requiring Part D plans and PBMs to contract with any pharmacy willing to accept the PBM’s contractual terms and conditions for network participation (i.e., the “any willing pharmacy” requirement) to increase patient access and choice. In addition, APhA will continue to advocate for increased transparency in Part D plans, including efforts to provide beneficiaries with up-to-date information about actual access standards and cost-sharing information.
Prescription drug misuse and treatment
APhA supports legislative, regulatory, and private sector efforts that address prescription drug misuse and treatment. Efforts to curb prescription drug misuse must balance the need for patient access to medications for legitimate medical purposes—including medications used in medication-assisted treatment—with the need to prevent diversion and risks to patients.
Pharmacists’ knowledge, accessibility, and expertise puts them in a unique position to help combat the opioid epidemic. APhA believes prescription drug misuse that leads to substance use disorder should be addressed using a multipronged approach: medication-assisted treatment, abuse-deterrent formulations, access to treatment, integrated prescription drug monitoring programs, prescribing guidelines, and access to prescription drug take-back receptacles and programs.
Compounding
APhA urges policymakers to defer to existing state laws on traditional compounding, including laws related to “office-use,” and has asked FDA to clarify that its guidance is not designed to infringe on the practice of pharmacy as historically regulated by the states.
APhA also remains concerned that arbitrary limitations on the out-of-state distribution of compounded drug products may limit patient access to medically necessary medications.
Track and trace
APhA supports efforts to protect the integrity of our nation’s drug supply. The Drug Supply Chain and Security Act of 2013 (DSCSA)—also known as track and trace—outlines three phases to construct an electronic, interoperable system that identifies and traces certain prescription drugs down to the package level as they move through the supply chain. Learn more about DSCSA at https://apha.us/DSCSA.
APhA will continue to monitor FDA’s track-and-trace implementation efforts and advocate for pharmacists’ interests, especially as FDA begins developing pilot programs that may seek participation from pharmacists.
For informational purposes, APhA has developed checklists of current and future requirements and an overview of components of the law most relevant to pharmacists. Access them at https://apha.us/TandTOverview, https://apha.us/CurrentRequirements, and https://apha.us/FutureRequirements, respectively.
FDA offers a free 45-minute continuing education course for pharmacists to help explain DSCSA requirements. Access the course at https://apha.us/FDAcourse. FDA also has a pharmacist-specific page about DSCSA. View the page at https://apha.us/DSCSApharmacists.
Biologics and biosimilars
APhA strongly supports the development of biologics and biosimilars. In addition, APhA supports the implementation of state biosimilar substitution practices that mirror substitution practices for small-molecule drugs, unless science dictates otherwise.
APhA advocates against either unique names, suffixes, or both reference biologics and biosimilars. Unique names and suffixes create a distinction that could contribute to confusion about biosimilar interchangeability.
Health information technology
APhA is involved with standards development organizations aiming to establish standards that are aligned with the needs and interests of pharmacists who will use the technology. Through the Pharmacy Health Information Technology Collaborative, APhA works with other pharmacy stakeholders to address pharmacist services’ billing and documentation codes, communication standards, pharmacist electronic health records, and documentation codes and values sets for use in the national electronic health information exchanges for pharmacy.
Learn more about the Pharmacy Health Information Technology Collaborative at http://pharmacyhit.org.