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 six fundamental areas now dominating the legislative and regulatory landscape:
PBMs process prescription drug claims for PDPs, including Medicare and Medicaid plans, employer- sponsored plans, and plans in the individual market. PBMs typically generate income from drug manufacturers through complex payment mechanisms – generally known as “rebates.” PBMs also extract various administrative fees and charges from pharmacies, which generally are buried in lengthy contractual language.
In some cases, these contracts actually prevent the pharmacy or pharmacist from informing consumers that it would be less expensive to pay for a prescription entirely out-of-pocket instead of going through the PBM and paying a co-pay or deductible.
In most Long-Term Care Pharmacy (LTCP) agreements, pharmacies must pay a fee per prescription. LTCPs appear to be the only providers of any type ultimately paid by Medicare or Medicaid which must pay a fee to third party intermediaries simply to get paid. This is but one example of rapacious post point-of-sale fees and claw backs PBMs impose on LTCPs.
With greater demand from consumers, Congress and regulators about the need for more competition and pricing transparency in our increasingly complex, tumultuous pharmaceutical marketplace, PBMs are increasingly viewed as unaccountable, opaque middlemen.
The time has come for a thorough congressional investigation into PBM pricing and other predatory practices, particularly as they impact LTCPs and their patients. SCPC seeks to work with lawmakers on a constructive, bipartisan basis to bring about more transparency and restrict anti-competitive behavior by the de facto oligopolies that have come to dominate the LTC pharmacy sector, as well as the entire pharmaceutical marketplace.
- Download the SCPC PBM Issue Brief
- Read recent media coverage on PBM practices and government action
- View CMS report on PBM rebates
- Download Avalere Health report on MAC pricing
- Download The Economic Costs of Pharmacy Benefit Managers: A Review of the Literature
- Improving Transparency and Accuracy in Medicare Part D Drug Spending Act
- Prescription Drug Transparency Act
- Creating Transparency to Have Drug Rebates Unlocked Act
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.