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:
- Track and Trace Requirements Go Into Effect Friday (November 24, 2020)
- 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)
APhA Statements (2019-2021)
Centers for Medicare & Medicaid Services
- Joint Pharmacy Letter Opposing Weakening Statutory Patient Protections under the Part D Payment Modernization Model (February 2021)
- APhA Comments: Medicaid Program; Patient Protection and Affordable Care Act; Reducing Provider and Patient Burden by Improving Prior Authorization Processes, Proposed Rule (January 2021)
- APhA Comments: Fourth Interim Final Rule with Request for Comments (IFC) on Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (January 2021)
- APhA Comments: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards, Proposed Rule (December 2020)
- Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part II and 2022 Draft Call Letter (November 2020)
- Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments, and Patient Protection and Affordable Care Act: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (November 2020)
- Medicare Program: CY 2021 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies (October 2020) (Advocacy Summary)
- Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (July 2020) (Advocacy Summary)
- Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency, Interim Final Rule with Comment Period (June 2020)
- Joint Comments on CMS Office of Minority Health - Request for Information Regarding Maternal and Infant Health Care in Rural Communities
- Proposed Rule Policy and Technical Changes for Part D for Calendar Years 2021 and 2022 (March 2020)
- Advance Notice of Methodological Changes for Calendar Year (CY) 2021 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2021 Draft Call Letter (March 2020)
- Joint Pharmacy Comments to CMS on Scope of Practice (January 2020)
- Transparency in Coverage (January 2020)
- CMS Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements (December 2019)
- CMS Scope of Practice - Member Template (January 2020)
- Request for Information for the Development of a CMS Action Plan to Prevent Opioid Addiction and Enhance Access to Medication-Assisted Treatment (October 2019)
- CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements (September 2019)
- Request for Information; Reducing Administrative Burden to Put Patients Over Paperwork (August 2019)
- Advance Notice of Methodological Changes for Calendar Year (CY) 2020 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2020 Draft Call Letter (March 2019)
- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020 (February 2019)
- Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses (January 2019)
- CMS Scope of Practice – Request for Feedback (January 2020)
Food and Drug Administration
- APhA Comments to FDA on Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate Release Opioid Analgesics (February 2021)
- Comments to FDA on REMS Assessment Summary for Web Posting (January 2021)
- Urgent Request for Exercise of Enforcement Discretion for Certain Dispenser and Wholesale Distributor Requirements Under the Drug Supply Chain Security Act (October 2020)
- Request for Exercise of Enforcement Discretion for Certain Dispenser Requirements
Under the Drug Supply Chain Security Act - Comments for Making Improvements to the Orange Book
- Comments on Generic Drug User Fee Amendments (GDUFA) III (August 2020)
- FDA Public Meeting on the Reauthorization of the Prescription
Drug User Fee Act (PDUFA) (July 2020) - FDA Virtual FDA Listening Session on Drug Compounding (June 2020)
- Joint Letter to OMB on FDA Information Collection on Final MOU (June 2020)
- Joint Letter to FDA to Exercise of Enforcement Discretion for Certain Dispenser Requirements Under the Drug Supply Chain Security Act (May 2020)
- Letter to FDA Regarding Compounding Products in Shortage or Anticipated to be in Shortage During National Emergency (March 2020)
- Joint Pharmacy Comments on Policy for Temporary Compounding of Alcohol-Based Hand Sanitizer (March 2020)
- Joint Pharmacy Comments on Importation Proposed Rule (March 2020)
- APhA Comments: Importation of Prescription Drugs Proposed Rule (March 2020)
- Draft Importation Guidance (Februrary 2020)
- Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products (January 2020)
- Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comment (August 2019)
- Draft Memorandum of Understanding Addressing Certain Distributors of Compounded Drug Products Between the [insert state] Board of Pharmacy and the U.S. Food and Drug Administration (July 2019)
- Scientific Data and Information about Products Containing Cannabis or Cannabis-derived Compounds; Public Hearing; Request for Comments (July 2019)
- Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability (May 2019)
- Risk Evaluation and Mitigation Strategies Assessment: Planning and Reporting; Draft Guidance (April 2019)
Department of Health and Human Services
- APhA and NASPA Joint Comments to HRSA on Delaying the Effective Date of Revisions to the Vaccine Injury Table (February 2021)
- Joint Letter Urges HHS to Allow Retired Pharmacists and Pharmacy Technicians to Serve as COVID-19 Vaccinators (February 2021)
- APhA and NASPA Joint Comments to HRSA on Revisions to the Vaccine Injury Table (January 2021) (Advocacy Summary)
- APhA Comments: Regulatory Relief to Support Economic Recovery; Request for Information (RFI) (December 2020)
- APhA Comments: Request for Information (RFI) on Effective and Innovative Approaches/Best Practices in Health Care in Response to the COVID-19 Pandemic (December 2020)
- APhA Comments: Request for Information (RFI) on Redundant, Overlapping, or Inconsistent Regulations (December 2020)
- APhA Comments: HHS Draft Vaccines National Strategic Plan 2021–2025 (December 2020)
- Advocacy Summary: HHS Releases Drug Pricing Announcements, Fails to Address Harmful DIR Fees (November 2020)
- Joint Pharmacy Statement RE: RE: Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act
- Joint Pharmacy Response Statement on HHS Action on Childhood Vaccines (August 2020)
- Executive Order on Regulatory Relief to Support Economic Recovery (August 2020)
- Request for Information (RFI): Inviting Input on NIDA’s Strategic Plan for 2021-2025 (August 2020)
- Joint Pharmacy Response to Include DIR Fee Reform in Executive Order Rebate Rule (July 2020)
- Joint Pharmacy Request for Authorization for Licensed Pharmacists to Order and Administer COVID-19 Vaccines under the PREP Act (June 2020) (Advocacy Summary)
- CDC Management of Acute and Chronic Pain: Request for Comment (June 2020)
- Joint Pharmacy Letter to Admiral Giroir (May 2020)
- APhA Recommendations to the President's Coronavirus Task Force (March 2020)
- Confidentiality of Substance Use Disorder Patient Records (October 2019)
- Implementation of Executive Order 13890: Protecting and Improving Medicare for Our Nation’s Seniors (October 2019)
- Nondiscrimination in Health and Health Education Programs or Activities (August 2019)
- Letter to Secretary Azar Regarding State Importation Plans (June 2019)
- Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager (PBM) Service Fees (April 2019)
- Draft Report: Pain Management Best Practices Inter-Agency Task Force (April 2019)
Federal Trade Commission
- Draft Vertical Merger Guidelines (February 2020)
- Joint Comments Draft Vertical Merger Guidelines (February 2020)
Drug Enforcement Administration:
- APhA Comments to DEA on Partial Filling of Prescriptions for Schedule II Controlled Substances (February 2021)
- Comments to DEA on Suspicious Orders of Controlled Substances (January 2021)
- Comments to DEA on SUPPORT Act – Dispensing and Administering MAT (January 2021)
- Letter to DEA on Reporting of Theft or Significant Loss of Controlled Substances Proposed Rule (September 2020)
- Letter to DEA on Signature Requirement for OTC Pseudoephedrine Products (April 2020)
- Comments on Electronic Prescriptions for Controlled Substances, Interim Final Rule (June 2020)
- Joint Association Letter to DEA on the Pharmacist's Manual (September 2019)
- Joint Letter to DEA About Partial Filling of Schedule II Prescriptions (August 2019)
- New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (April 2019)
Department of Labor:
- Letter to OSHA Requesting Clarification of the Level of Protection for Pharmacists and Pharmacy Staff (April 2020)
Office of Personnel Management
- APhA Comments: OPM Request for Information (RFI) on Improving the Value of Prescription Drug Benefits (March 2021)
States
- Support Letter for Implementation of Ohio Provider Status Law (July 2020) (Webpage)
- Joint Letter to Pennsylvania Request Laboratory Requirement Waiver: COVID-19 Testing by Pharmacists (May 2020)
- HHS Letter to States to Waive Restrictions on Scope of Practice During Coronavirus (March 2020)
- HHS Guidance to States to Waive Restrictions on Scope of Practice During Coronavirus (March 2020)
- West Virginia Provider Status Legislation (February 2020)
- Joint Letter West Virginia Provider Status Legislation (February 2020)
- Joint Final West Virginia Provider Status Support Letter (February 2020)
- Joint Letter New Mexico Provider Status Legislation (February 2020)
Congress / Executive Office
- APhA Statement for the Record on Energy and Commerce Health Subcommittee Hearing on the Future of Telehealth (March 2021)
- Joint Pharmacy Request to Appoint a Pharmacist to the COVID-19 Health Equity Task Force (February 2021)
- Joint Letter to President Biden to Address Compounding Issues (January 2021)
- Joint Letter to President Biden on Maintaining Vaccine and Supply Chain Resiliency (January 2021)
- Joint PSPC Coalition Letter to Congressional Leaders (December 2020)
- Joint Letter to Biden Transition Team with Public Health Recommendations and Meeting Request (December 2020)
- APhA Letter to Biden Transition COVID-19 Advisory Board (November 2020)
- Letter to Congressional Leadership on Ways to Maximize the Use of Pharmacists to
Prevent, Treat, Test and Respond to Coronavirus (July 2020) - Comments on Senate HELP White Paper on Preparing for the Next Pandemic (June 2020)
- Chart on Provisions Impacting Pharmacists in Senate-Passed Coronavirus Legislation (April 2020)
- Joint Pharmacy Letter to Congress to Include DIR Fix in Coronavirus Legislation (March 2020)
- Joint Pharmacy Letter to House to Include Provider Status in Coronavirus Legislation (March 2020)
- Joint Pharmacy Letter to Senate to Include Provide Status in Coronavirus Legislation (March 2020)
- Letter to House and Senate Leadership on Coronavirus (March 2020)
- Cures 2.0 (December 2019)
- DIR Coalition Statement on Grassley Wyden S 2543 (December 2019)
- Letter from Representative Care and Representative Guthrie to Secretary Azar: Including Pharmacists in the Implementation of Executive Order (EO) 13890: Protecting and Improving Medicare for our Nation's Seniors (November 2019)
- The Mitigating Emergency Drug Shortages (MEDS) Act (November 2019)
- Substance Use Disorder Treatment Request for Information (November 2019)
- APhA Statement on Mainstreaming Addiction Treatment Act of 2019 (H.R. 2482 / S. 2074) (October 2019)
- APhA Statement for the Record to U.S. House Energy and Commerce Committee on DIR Fee Reform (September 2019)
- Press Release: Senate Finance Committee Wages Bipartisan Effort Across Branches of Government to Relieve Patients and Pharmacies from Pharmacy DIR Fees (September 2019)
- Related: Senate Finance Committee Letter to Secretary Azar on DIR Fee Reform (September 2019)
- Press Release: Pharmacy Urges Decisive Action to Close DIR Fee Loophole, Appreciates Senate Finance Committee's Initial Bipartisan Movement on Issue (July 2019)
- Comments to Senate Aging Committee on Falls Prevention (June 2019)
- House and Senate Members Send Letter to President Trump About DIR Fees (June 2019)
- Joint Senate Letter to President Trump on DIR Fees (June 2019)
- Joint House Letter to President Trump on DIR Fees (June 2019)
- Letter to President Trump Regarding Pharmacy DIR Fees (June 2019) (Press Release available here)
- U.S. Senate Health, Education, Labor and Pensions (HELP) Committee Discussion Draft Legislation – “Lower Health Care Costs Act” (June 2019)
- Statement for the Record: U.S. Senate Committee on Finance, Drug Pricing in America: A Prescription for Change, Part III (April 2019)
- Letter to Chairman Alexander: Recommendations to Help Address America's Rising Health Care Costs (March 2019)
- Joint Statement: American and Canadian pharmacist associations warn that drug importation policies could put patients at risk (February 2019)
- Letter to Chairman Alexander, Ranking Member Murray and Members of the Senate Committee on Health, Education, Labor and Pensions, "Access to Care: Health Centers and Providers in Underserved Communities" (January 2019)
National Academies of Sciences, Engineering, and Medicine
- Joint Comments on the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (HTML)