APhA Advocacy Issues

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. To learn more about the COVID-19 policy landscape and how you can be an advocate for the profession during this time, visit our COVID-19 Advocacy Opportunities page. 

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’s 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.  

Provider Status Backgrounder (PDF)

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.

Eliminating PBM direct and indirect remuneration (DIR) fees

APhA opposes retroactive DIR fees and supports initiatives to prohibit the imposition of 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.

DIR Fees Backgrounder (PDF)

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 

APhA supports efforts to protect the integrity of our Nation’s drug supply. The Drug Supply Chain and 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. For informational purposes, APhA has developed checklists of current and future requirements and an overview of components of the law most relevant to pharmacists.  Also, FDA offers a free 45-minute continuing education course for pharmacists to help explain DSCSA requirements and has a pharmacist-specific page regarding DSCSA. Learn more:

APhA Statements (2019-2021) 

Centers for Medicare & Medicaid Services

Food and Drug Administration 

Department of Health and Human Services 

Federal Trade Commission

Drug Enforcement Administration: 

Department of Labor: 

Office of Personnel Management

States

Congress / Executive Office  

National Academies of Sciences, Engineering, and Medicine

 

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