Group Hopes Lawmakers Will Define ‘LTC Pharmacy’ By End Of Next Congress

DATE: September 13, 2016

Published by Inside Health Policy

A long term care pharmacy coalition is calling on Congress to legislatively define the term “LTC pharmacy” in an effort to harmonize what it says are conflicting CMS, FDA and Environmental Protection Agency regulations. The group hopes lawmakers will act by the end of the next Congress and says language in the CMS Medicare Part D Manual could be a starting point for a statutory definition.

“Federal regulation today contains a widely divergent set of actual and proposed definitions of LTC pharmacy,” wrote King & Spalding in a brief on behalf of the Senior Care Pharmacy Coalition. “In several important instances, the definitions conflict with each other, and create the proverbial ‘Hobson’s choice’ for pharmacies to comply with CMS regulations, FDA regulations, or EPA regulations. Particularly if several of the pending regulatory and subregulatory proposals are finalized as proposed, it will be impossible for LTC pharmacies to meet some of the different requirements without violating others.”

The coalition is having “very positive” conversations to educate members of Congress about the issues faced by LTC pharmacies, but legislation has not yet been crafted, SCPC President & CEO Alan Rosenbloom told Inside Health Policy. The coalition hopes to have an agreed-upon proposed statutory definition of LTC pharmacies before the end of the calendar year and to have legislation passed by the end of the next Congress.

SCPC penned a letter in July with the American Society of Consultant Pharmacies and the American Health Care Association/National Center for Assisted Living asking FDA carve out LTC pharmacies from the agency’s February draft compounding guidance on repackaging, arguing inclusion of the pharmacies would directly conflict with CMS regulations.

“FDA’s recent draft Repackaging Guidance — and the focus of SCPC’s current effort to modify it — is overly broad in scope because the FDA lacks a commonly accepted, federally endorsed manner in which to identify and address LTC pharmacy,” SCPC wrote in a Sept. 6 press release.

The FDA guidance requires drugs to be “repackaged and distributed” only after the receipt of a valid prescription for an identified patient or a written order in a patient’s chart in a health care setting. The groups complain that including LTC pharmacies in the guidance would threaten existing business practices that ensure their compliance with CMS requirements, including preventing them from producing prepackaged kits of emergency medicines, known as e-kits. This would conflict with federal Medicare and Medicaid Requirements of Participation, which require LTC facilities to provide access to e-kits, according to the groups.

While FDA has not responded to the groups’ July letter, the coalition hopes a statutory definition would provide FDA the basis for an exception. A statutory definition of LTC pharmacies would give FDA a clear demarcation to allow the agency to exempt LTC pharmacies from the February guidance, Rosenbloom told IHP.

SCPC also takes issue with EPA’s 2015 proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” that uses a definition of “health care facility” to define the scope of the legislation, which lumps LTC pharmacies and assisted living facilities together with hospitals and ambulatory surgical centers, among other larger facilities.

“[T]he proposed EPA definition also includes within its scope assisted living facilities (ALFs), which will pose a significant (if not impossible) operational challenge to LTC pharmacy due both the absence of any other federal definition of what constitutes an ALF and how any pharmacy, much less LTC pharmacy, can exert control over medications sold to ALF residents,” states the LTC pharmacy brief. “The EPA’s broad over-regulation is an unfortunate example of misuse of the term LTC pharmacy without a clear understanding of defines an LTC pharmacy.”

Currently, the “sole federal regulatory definition” for LTC pharmacies is in Medicare Part D regulations, according to the brief. The regulations define a long term care pharmacy as “a pharmacy owned by or under contract with a long-term care facility to provide prescription drugs to the faculty’s residents.”

The brief also holds up the CMS Part D Manual as providing a more comprehensive description of LTC pharmacies.

“Although the regulatory definition is somewhat circular and does not include any definitional characteristics of a LTC pharmacy other than being in a contractual relationship with a nursing home, the Part D manual provides extensive guidance regarding the minimum performance and service criteria for long-term care pharmacies,” states the brief.

The brief argues that the Part D manual definition could serve as a starting point for regulators to build on.

“The most comprehensive and most accurate federal definition of LTC pharmacy is found in the CMS Part D Manual, which memorializes (perhaps in somewhat outdated terms) the scope and practice of LTC pharmacy in a manner that ensures quality patient care today and into the future,” the brief states. “The Part D Manual provisions could serve as the starting point for the development of a federal statutory definition of the term.”

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