APhA Advocacy Issues

Provider Status

APhA’s provider status efforts seek to recognize pharmacists as integral members of the health care team and provide consumers with access to and coverage for our quality patient care services. Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 109) was re-introduced 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 a checklist and overview of components of the law most relevant to pharmacists.

APhA Statements 

Centers for Medicare & Medicaid Services 

• 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
• “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
• 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
• Medicare Program; Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models; Final Rule
• Proposed Rule: Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies
• Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process; Proposed Rule
• Request for Public Comment on the Proposed Enhanced MTM Model Encounter Data Structure and Pilot Monitoring Measures
• Medicare Program; Part B Drug Payment Model; Proposed Rule
• Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Proposed Rule
• Medicare & Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule
• Medicare Program: Merit-Based Incentive Payment System and Alternative Payment Model Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
• Medicare Program: Listening Session Regarding the Implementation of Certain Medicare Part D Provisions in the Comprehensive Addiction and Recovery Act
• Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018

Food and Drug Administration 

• Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments
• Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access
• Data and Methods for Evaluating the Impact of Opioids Formulations with Properties Designed to Deter Abuse in the Postmarket Setting
• Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward
• Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids
• Statement to FDA Listening Session on Hospital Compounding
• Statement to FDA Listening Session on Radiopharmaceuticals 
• Statement to FDA Listening Session on Drug Compounding 
• Prescription Drug Importation
• Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities, Draft Guidance
• Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities
• Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments
• Medical Product Communications That Are Consistent With the FDA Required Labeling – Questions and Answers 
• Dispenser-to-dispenser transfers under the DSCSA
• Patient and Medical Professional Perspectives on the Return of Genetic Test Results; Public Workshop; Request for Comments
• Proposed Pilot Project(s) Under the Drug Supply Chain Security Act
• Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information
• Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee
• Labeling for Biosimilar Products
• Prescription Requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry
• Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
• Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
• Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for Comments
• Insanitary Conditions at Compounding Facilities, Guidance for Industry
• FDA Public Meeting: Over-The-Counter Monograph User Fees 

Substance Abuse and Mental Health Services Administration

• Confidentiality of Substance Use Disorder Patient Records
• Medication Assisted Treatment for Opioid Use Disorders

Centers for Disease Control and Prevention

• Draft CDC Opioid Prescribing Guideline for Chronic Pain

Department of Labor

• Defining and Delimiting the Exemption for Executive, Administrative, Professional, Outside Sales and Computer Employees; Propoed Rule
• Preventing Workplace Violence in Health Care and Social Assistance Settings 

Congress

• Medicare Red Tape Relief Project 
• APhA Letter to Senate on Better Care Reconciliation Act of 2017
• Prescription Drug Monitoring Act of 2017
• Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017
• Draft of the Diagnostic Accuracy and Innovation Act
• Importation of Non-FDA Approved Prescription Drugs (March 2017); Joint APhA and NACDS Letter Re: Importation of Non-FDA Approved Prescription Drugs (May 2017); Joint APhA and NACDS Letter Re: Prescription Drug Importation Legislation (August 2017) 
• Budgeting for Opioid Addiction Treatment Act 
• Letters in support of the Improving Transparency and Accuracy in Medicare Part D Spending Act (S.3308 / H.R. 5951)
• Chronic Care Working Group Policy Options Document
• The Recovery Enhancement for Addiction Treatment Act (H.R.2536) and the Opioid Addiction Treatment Modernization Act (H.R.2872)
• Lali's Law
• The Price of Solvaldi and Its Impact on the U.S. Health Care System
• Title VI of Comprehensive Addiction and Recovery Act (CARA) of 2015
• Reducing Unused Medications Act of 2016
• Notice of Proposed Rulemaking; Defining and Delimiting the Exemption for Executive, Administrative, Professional, Outside Sales and Computer Employees
• Comprehensive Addiction and Recovery Act (CARA) of 2016 - Conference Letter
• Section 11, Biological Product Innovation in the FDA and NIH Workforce Authorities Modernization Act

State Boards of Pharmacy  

• Letter regarding USP <800>

Health Care Reform

• Medicare Red Tape Relief Project 
• Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices to Empower Patients
• Prescription Drug Importation
• APhA Advocates for Health Care Reform that Includes Improving Patients' Access to Care through Pharmacists' Services