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Policy Priorities

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:

Fix FDA Repackaging Draft Guidance
Current FDA guidelines – developed without necessary LTC Pharmacy community input – would prohibit essential patient safety care practices. Unless proactively addressed, the draft guidance would: Limit the ability of LTC Pharmacies to prepackage pharmaceutical products – including drugs that remain in the pharmacy – without receipt of a patient-specific prescription/chart order; Prevent any dispatch of prepackaged/repackaged pharmaceuticals, packaged and sent from the pharmacy, in advance of receiving patient-specific prescriptions or chart orders; Impede pharmacy practices in a manner that would negatively impact nursing home compliance with safety requirements.

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 To allow LTC pharmacies to continue meeting the needs of nursing home residents in a timely manner, SCPC believes the Draft Guidance must be revised before it becomes final to continue FDA’s practice of allowing current LTC pharmacy-repackaging practices that meet state law requirements.

Resources:

Click here to see all news related to the FDA repackaging draft guidance.

Medicare Part D Lock-In
In an effort to reduce substance abuse among Medicare Part D beneficiaries, Congress is considering several proposals to allow Prescription Drug Plans (PDPs) to require Medicare beneficiaries who are prescribed drugs designated as “frequently-abused” to obtain some or all of their prescription medications from one or a very limited network of pharmacies. One proposal also locks these beneficiaries into one prescribing physician for at least some of their medications.We strongly support the laudable goal of reducing substance abuse. However, SCPC believes that applying the “lock in” provision to Part D beneficiaries who reside in long-term care (LTC) facilities is unnecessary, and could threaten these patients’ access to needed medications.

Resources

Click here to see all news related to the Medicare Part D lock-in provision.

Maximum Allowable Cost (MAC) Pricing
Independent LTC pharmacies and patients under their care require adequate protection against Medicare Part D pricing policies and other questionable practices that are secretive, opaque, and afford no recourse to address behaviors that inappropriately shift Medicare dollars from providers to intermediaries – like Pharmacy Benefit Managers (PBMs) — in ways that undermine their ability to provide the key consultative services Medicare rules demand.

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.

Resources:

Click here to see all news related to Maximum Allowable Cost (MAC) pricing.

Drug Enforcement Agency (DEA) Relationships
Curbing the potential abuse of controlled substances along with their proper disposal in an environmentally appropriate manner has and always will be a priority of the LTC pharmacy community. SCPC seeks to work with the DEA, CMS and Congress in a collaborative, positive manner to strike the right balance between meeting the stringent enforcement needs that protect our citizens and communities on the one hand, and protecting the needs and care of patients, on the other.

Click here to see all news related to Drug Enforcement Agency (DEA) Relationships.

Protecting 2016 Daily Dispensing Fee (DDF) Rule Implementation
In February, 2015, CMS finalized a long-awaited rule prohibiting the use of prorated or daily dispensing fees (DDF) by Medicare Part D prescription drug plans – a seminal, long fought victory for SCPC and the LTC pharmacy sector. By prohibiting the use of DDFs and incentivizing more efficient drug dispensing techniques, CMS has now ensured that LTC pharmacies will receive the professional fee that appropriately recognizes all of the unique activities related to filling a LTC prescription, and the value of those services to quality care — regardless of the quantity of medication dispensed. Moving forward, SCPC will remain vigilant in assuring that the final regulation goes into effect, unfettered, in January 2016.

Click here to see all news related to the Daily Dispensing Fee (DDF) Rule.

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