Preserving, protecting and defending the health and safety interests of our increasingly diverse patient population — and bolstering the economic viability of independent LTC pharmacies serving their growing needs — are the foundational pillars of SCPC’s federal legislative and regulatory agenda. Moreover, fostering a strong and dynamic independent LTC pharmacy sector is integral to improving patient outcomes and optimizing Medicare savings, today and in the future. Operating in today’s volatile, unpredictable legislative and regulatory environment requires flexibility, foresight and tactical agility. These four overarching principles will guide us:
- Clinical efficacy, and achieving optimal patient outcomes
- Pricing transparency and marketplace equity
- Regulatory efficiency, effectiveness and fairness
- Policy solutions that anticipate and act upon future trends related to our long term and post-acute care patient populations
To address both the threats and opportunities currently facing LTC pharmacies and their patients, the SCPC will focus on five fundamental areas now dominating the legislative and regulatory landscape:
The FDA currently permits LTC pharmacy repackaging practices in compliance with state pharmacy law. To allow LTC pharmacies to continue meeting the needs of nursing home residents in a timely manner, SCPC believes the Draft Guidance must be revised before it becomes final to continue FDA’s practice of allowing current LTC pharmacy-repackaging practices that meet state law requirements.
- FDA Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (Feb. 2015)
- SCPC statement on the FDA repackaging draft guidance (May 20, 2015)
- SCPC comment letter on the FDA repackaging draft guidance (May 20, 2015)
- SCPC issue brief: FDA Repackaging Guidance Must Account For Long Term Care Pharmacy
Click here to see all news related to the FDA repackaging draft guidance.
- SCPC statement: SCPC Applauds Unanimous House Panel Passage of 21st Century Cures Bill Recognizing Unique Challenges Facing Long Term Care (LTC) Pharmacy Patients, Providers (May 21, 2015)
- SCPC statement submitted for the legislative hearing on the 21st Century Cures draft legislation (April 30, 2015)
- House Energy & Commerce Committee statement: The 21st Century Cures Act UNANIMOUSLY APPROVED (May 21, 2015)
Click here to see all news related to the Medicare Part D lock-in provision.
SCPC believes new research from Avalere Health clearly demonstrates that PBMs’ MAC pricing methodology for generic drugs leads to arbitrary and capricious reimbursement, warranting greater congressional scrutiny.
These PBM pricing policies and practices threaten quality patient care and negatively affect taxpayers, as they eventually add unnecessary costs to the Medicare program. Ultimately, SCPC believes MAC pricing is not market pricing and contrary to the fundamental principles of Medicare Part D. We will build on the progress we made in 2015 focusing public attention on this issue, and move aggressively in 2016 to sustain our case in the public policy arena.
- Pharmacy Benefit Managers (PBMs) – Unaccountable Drug Industry Middlemen
- Avalere Health Report: MAC Pricing Analysis (November 17, 2015)
- SCPC statement: New Avalere Health Study Reveals Substantial Variation in PDP/PBM Reimbursements for Most Commonly Prescribed Drugs in Long Term Care Settings (November 17, 2015)
Click here to see all news related to Maximum Allowable Cost (MAC) pricing.
Click here to see all news related to Drug Enforcement Agency (DEA) Relationships.
Click here to see all news related to the Daily Dispensing Fee (DDF) Rule.