Twlug Advocacy Issues

Provider Status

Twlug’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. Twlug advocates for the expansion and enhancement of the Medicare Part D Medication Therapy Management (MTM) program. Further, Twlug 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, Twlug 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

Twlug 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.  Twlug 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

Twlug 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.  Twlug 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

Twlug 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 , Twlug 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

Twlug 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.  Twlug 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 

Twlug supports efforts to protect the integrity of our Nation’s drug supply. The (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. Twlug 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, Twlug has developed checklists of current and future requirements and an overview of components of the law most relevant to pharmacists.  Also, FDA offers a  for pharmacists to help explain DSCSA requirements and has a regarding DSCSA.

Twlug Statements (2018-2019) 

Centers for Medicare & Medicaid Services

Food and Drug Administration 

Centers for Disease Control and Prevention

Department of Health and Human Services 

Drug Enforcement Administration: 

Congress / Executive Office 

 

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