APhA Advocacy Issues
APhA’s provider status efforts seek to recognize pharmacists as integral members of the health care team and provide patients with access to and coverage for our quality patient care services.
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.
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 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. 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. 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.
Tours of your pharmacy or practice site provide one of the most effective methods of communication between you and your federal legislators. Visiting a pharmacy or practice site gives legislators a valuable opportunity to develop a good sense of the role pharmacists play in the community and on the health care team.
Site visits such as these are particularly useful for introducing legislators to a large number of constituents and voters, and most legislators and their staff want to know as many of their constituents as possible. Showing how pharmacists help patients in a real world setting also helps humanize the issues for legislators.
Below are some tips on how to schedule and conduct a visit with your Member of Congress at your local pharmacy or practice site.
APhA Statements (2018-2019)
Centers for Medicare & Medicaid Services
- Joint Pharmacy Comments to CMS on Scope of Practice
- 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
- CMS Scope of Practice - Member Template
- 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
Food and Drug Administration
- Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
- 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
- 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)
Drug Enforcement Administration:
- 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)
Congress / Executive Office
- 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)