APhA Advocacy Issues
Provider status
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. The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 109) was reintroduced in the House and Senate in January 2017. The legislation will provide some of our most vulnerable citizens access to health care through pharmacist-provided 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 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 abuse should be addressed using multipronged 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 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.
APhA Statements (2017-2018)
Centers for Medicare & Medicaid Services
- Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (March 2018)
- Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (March 2018)
- Medicare Program; Contract Year (CY) 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Proposed Rule (January 2018)
- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019 (November 2017)
- Centers for Medicare & Medicaid Services: Innovation Center New Direction, Request for Information (November 2017)
- HHS Draft Strategic Plan FY 2018 - 2022 Sections (October 2017)
- Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices To Empower Patients (July 2017)
- “2017 Transformation Ideas” in the Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and Final Call Letter (April 2017)
- Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (March 2017)
- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program; Proposed Rule (September 2017)
- Medicare Program; CY 2018 Updates to the Quality Payment Program (August 2017)
Food and Drug Administration
- Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (April 2018)
- Opioid Policy Steering Committee: Prescribing Intervention-Exploring a Strategy for Implementation; Public Hearing; Request for Comments (March 2018)
- Packaging, Storage, and Disposal Options to Enhance Opioid Safety-Exploring the Path Forward (March 2018)
- December 5-6 Public Meeting: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (February 2018)
- Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance for Industry (January 2017)
- Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments (December 2017)
- Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements (December 2017)
- Format and Content of a REMS Document Guidance for Industry (December 2017)
- Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements; Establishment of a Public Docket; Request for Information and Comments (November 2017)
- Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry (October 2017)
- Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (September 2017)
- Data and Methods for Evaluating the Impact of Opioids Formulations with Properties Designed to Deter Abuse in the Postmarket Setting (September 2017)
- Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy; Draft Guidance for Industry (September 2017)
- Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments (September 2017)
- Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward (July 2017)
- Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids (July 2017)
- FDA Compounding Listening Session: Hospital Organizations Statement (June 2017)
- FDA Compounding Listening Session: Radiopharmaceutical Organizations (June 2017)
- Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (April 2017)
- Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments (April 2017)
- Medical Product Communications That Are Consistent With the FDA Required Labeling – Questions and Answers (April 2017)
- Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities, Draft Guidance (February 2017)
Substance Abuse and Mental Health Services Administration
Department of Labor
Federal Trade Commission
- Federal Trade Commission Workshop on “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics” (December 2017)
Department of Health and Human Services
- Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, Proposed Rule (March 2018)
- Pharmacist Provision of Medication-Assisted Treatment for Opioid Use Disorders (February 2018)
- Promoting Healthcare Choice and Competition Across the United States; Request for Information (January 2018)
Congress
- U.S. House Energy and Commerce Committee, Request to Include H.R. 592 in Opioid-related Legislation (April 2018)
- Letter to Sens. Collins and McCaskill, Patient Right to Know Drug Prices Act (March 2018)
- Letter to Sens. Stabenow and Collins, Know the Lowest Price Act (March 2018)
- U.S. House Committee on Ways and Means and the Committee’s Subcommittee on Health Request for Feedback Regarding Response to the Opioid Epidemic (March 2018)
- Letter to Sen. Ernst, Access to Increased Drug Disposal Act (March 2018)
- U.S. Senate Finance Committee, Response to the Opioid Epidemic, Letter to Sens. Hatch and Wyden (February 2018)
- U.S. House Energy and Commerce Committee, Subcommittee on Health, "Examining Implementation of the Compounding Quality Act", Statement for the Record (January 2018)
- U.S. House Energy and Commerce Committee, Subcommittee on Health, "Examining the Drug Supply Chain", Statement for the Record (December 2017)
- U.S. Senate Health, Education, Labor, and Pensions, "The Cost of Prescription Drugs: How the Drug Delivery System Affects what Patient Pay, Part II", Questions for the Record (October 2017)
- U.S. House Energy & Commerce Committee, "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives", Statement for the Record (October 2017)
- U.S. Senate, Prescription Drug Importation Legislation, Letter (October 207)
- U.S. House Ways and Means Committee, "Medicare Red Tape Relief Project" (August 2017)
- U.S. House Energy and Commerce Committee, Subcommittee on Health, "Examining Bipartisan Legislation to Improve the Medicare Program (July 2017)
- Letter to Leader McConnell, Leader Schumer, Assistant Leader Cornyn and Assistant Leader Durbin, Better Care Reconciliation Act of 2017 (June 2017)
- Letter to Sens. Klobuchar, Portman, Manchin, and King, Prescription Drug Monitoring Act of 2017 (June 2017)
- Letter to Sen. Schatz, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017 (April 2017)
- Letter to Reps. Bucshon and DeGette, Draft of the Diagnostic Accuracy and Innovation Act (DAIA) (April 2017)
- Letter to Sen. Manchin, Budgeting for Opioid Addiction Treatment (April 2017)
- Letter to Reps. Burgess and DeGette, and Sens. Crapo and Cardin, Prevention Health Savings Act (April 2017)