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.
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 requirments, and overview of components of the law most relevant to pharmacists.
Centers for Medicare & Medicaid Services
Food and Drug Administration
Substance Abuse and Mental Health Services Administration
Centers for Disease Control and Prevention
Department of Labor