Reproductive Health Care
APhA recognizes the incredibly impactful and far-reaching consequences of the Supreme Court’s decision in Dobbs v Jackson, which overturned Roe v Wade. This decision has implications on the complete span of reproductive health services, as it leaves abortion regulation to individual states and creates a new landscape for health care providers to navigate. In the wake of this decision, APhA continues to call for clarity for patients and pharmacists and affirms the vital role of the pharmacist's professional judgment in ensuring safe and effective use of medications.
COVID-19 Advocacy
APhA's COVID-19 advocacy efforts focus on maintaining the flexibilities and authorities extended to pharmacists by the federal government, while continuing to advocate for changes that will allow pharmacists to utilize their full expertise to care for patients. The federal government is looking at ways to improve access to care by being more flexible about certain requirements and expanding scope of practice through new authorities during the COVID-19 public health emergency. Our current areas of focus include immunizations, testing, payment, compounding, telehealth, and future pandemic planning.
COVID-19 Test to Treat Access
APhA’s analysis of COVID-19 Test to Treat locations, as of May 6, 2022, demonstrates that underserved and vulnerable communities do not have equitable access to care in the current program.
As hospitalization rates and deaths from COVID-19 persist, the need to quickly connect high-risk patients who test positive for COVID-19 to lifesaving treatments remains essential.
Provider Status
Pharmacists and pharmacists’ patient care services are not included in key sections of the Social Security Act (SSA), which determines eligibility for health care programs such as Medicare Part B. In the case of Medicare Part B, the omission of pharmacists as listed providers limits Medicare beneficiaries’ access to pharmacists’ services in the outpatient setting. Pharmacists have demonstrated their value while playing a crucial role in COVID-19 pandemic response by being available and accessible as front-line health care professionals. APhA encourages Congress to pass legislation that recognizes pharmacists as providers in Medicare Part B and as integral members of the health care team to provide patients with access to and coverage for our quality patient care services.
Pharmacist and Pharmacy Payment Reform
The pharmacy reimbursement and drug pricing scheme in the U.S. has grown out of control, with misaligned incentives that neither benefit the patient nor lead to better health outcomes. These misalignments are causing pharmacies across the country to shut their doors, leaving patients without access to their local pharmacies. APhA supports transparency and accountability in reimbursement and pricing and is thus concentrating policy efforts to 1) support pharmacists’ ability to focus on patient care and to be appropriately paid for these services and 2) reform pharmacy payment and PBMs’ actions and activities that are disrupting the pharmacy ecosystem. Recent advocacy and legal action led to CMS issuing a final rule that eliminates harmful retroactive direct and indirect remuneration (DIR) fees.
Other Improvements to Medicare
As scientific innovation leads to medications that are exponentially more complex, we believe that pharmacists, as the medication experts, need to be key players on patient health teams. APhA advocates for the expansion and enhancement of the Medicare Part D Medication Therapy Management (MTM) program. Further, APhA supports CMS’s efforts to increase patient access and choice by requiring Part D plans and pharmacy benefit managers (PBMs) to contract with any pharmacy willing to accept the PBM’s contractual terms and conditions for network participation (i.e. “any willing pharmacy” requirement). In addition, APhA will continue to advocate for increased transparency regarding 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 Abuse
APhA supports legislative, regulatory, and private sector efforts that address prescription drug abuse, misuse, and treatment. We acknowledge that any effort must balance the need for patient/consumer access to medications for legitimate medical purposes with the need to prevent diversion and abuse. Pharmacists’ knowledge, accessibility, and expertise, puts them in a unique position to help combat this epidemic. APhA believes prescription drug misuse and abuse that leads to substance use disorder should be addressed using multi-pronged approach that includes medication-assisted treatment, abuse-deterrent formulations, access to treatment, integrated prescription drug monitoring programs, guidelines, and access to prescription drug take-back receptacles and programs.
Biologics and Biosimilars
APhA strongly supports the development of biologics and biosimilars as well as state biosimilar substitution practices that mirror those for small-molecule drugs unless science dictates otherwise. APhA has advocated against unique names and/or suffixes for reference biologics and biosimilars for reasons including such distinction could contribute to confusion regarding biosimilar interchangeability.
Health Information Technology
APhA has continued our involvement with standards development organizations to ensure standards are aligned with the needs and interests of pharmacists who will be using 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.
Compounding
APhA urges policymakers to defer to existing state laws related to 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 adversely impact patient access to medically-necessary medications.
Track and Trace (DSCSA)
APhA supports efforts to protect the integrity of our Nation’s drug supply. The Drug Supply Chain Security Act of 2013 (DSCSA) outlines a stepwise approach 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. APhA will continue to advocate for pharmacists’ interests as requirements are established.
- APhA comments to FDA on Request for Information and Comment on Implementing Interoperable Systems and Processes for DSCSA Enhanced Drug Distribution Security Requirements (February 2024)
- APhA NCPA DSCSA Small Business Dispenser Assessment Comment Letter FINAL (September 2023)
- APhA Joint Letter to FDA to Request for Phased Implementation of the Upcoming DSCSA Requirements (July 2023)
- Dispensers: What you should know about DSCSA (November 2021 APhA powerpoint)
- DSCSA Resources for Dispensers – a compilation of DSCSA resources including checklists, CPE courses, FAQs, podcasts, presentations, publications, and webinars
- Pharmacies Must Comply With Certain Track and Trace Requirements, FDA Says (December 1, 2020, in Pharmacy Today)
- Locked on Pharmacy Podcast: Track and Trace: Pharmacists New Responsibilities to Combat Counterfeit Drugs (January 7, 2021)
- Q&As on dispenser requirements, Pharmaceutical Distribution Security Alliance (October 2020)
- FDA offers a free 45-minute continuing education course for pharmacists to help explain DSCSA requirements and has a pharmacist-specific page regarding DSCSA