ASHP's Office of Government Relations continues to work to ensure that the voice of hospital and health-system pharmacists is represented throughout all levels of government. Together with our members, we made significant progress in 2019 on our advocacy priorities. Below is an update of our successes and a preview of what we will be working on in 2020.
ASHP continues to advocate on behalf of PGY-1 residency funding and has had productive discussions with the Centers for Medicare & Medicaid Services (CMS) regarding the funding disallowances for several programs. We are working with CMS to resolve this issue and provide guidance to our members on how they can avoid compliance challenges that would jeopardize funding. You can join the over 1,000 members who have already helped us raise awareness of the importance of funding pharmacy residencies.
During our Annual Legislative Day in September, and throughout 2019, ASHP and its members advocated for bills aimed at curbing high prescription drug costs, including the CREATES Act, which prohibit manufacturers from using safety requirements to prevent generic competitors from accessing samples of brand name products. ASHP's efforts paid off with the inclusion of the CREATES Act in the 2019 end-of-year budget deal, which was signed into law on December 20, 2019 and is expected to improve access to generic drugs while also saving the government about $4 billion dollars.
In 2019, we also lobbied to reform Direct and Indirect Remuneration (DIR) Fees imposed by PBMs. ASHP is pleased to see bipartisan legislation in the Senate that addresses DIR fees. The bill requires PBMs include any price concessions at the point of sale for Medicare Part D drugs. We are advocating for this language to be included in a final drug pricing bill.
Addressing drug shortages was one of our top advocacy areas in 2019 and we are pleased that Congress has turned to us for advice as they develop shortage legislation. The Senate has introduced the Mitigating Emergency Drug Shortages (MEDS) Act. The bill incorporates many of ASHP's policy proposals to address shortages including:
- Requirement to disclose the cause and expected duration of shortages;
- Disclosure of manufacturing sites and use of contract manufacturers;
- Contingency plans for manufacturing disruptions; and
- Assessment of national security risks associated with drug shortages.
We are working closely with the House of Representatives and expect to see a similar bill introduced early this year. FDA's Drug Shortages Taskforce also published an ASHP-supported proposal to reduce supply disruptions from manufacturing quality challenges. The proposal calls for making manufacturing quality metrics available to inform pharmacy purchasing.
Provider Status and Scope of Practice
Several state legislatures made progress expanding pharmacists' scopes of practice in 2019. We are actively working with state societies to continue that progress and secure reimbursement for those services.
We are starting 2020 by working with other state and national pharmacy organizations to ask CMS to eliminate barriers to pharmacists practicing at the top of their licenses. In particular, we are highlighting pharmacists' role in patient care and asking for CMS to align Medicare supervision and payment rules with the most robust pharmacist state scopes of practice.