Congress Urged to Adopt Clear, Statutory Definition of Long Term Care (LTC) Pharmacies

DATE: September 6, 2016

New Senior Care Pharmacy Coalition (SCPC) Policy Brief Details How Confusing Federal Regulatory Overlap Threatens Seniors’ Health, Jeopardizes LTC Pharmacy Clinical Benefits in Rapidly Evolving Care Delivery System

Washington, DC – In pointing out the significant value-added services provided by long term care (LTC) pharmacies and the resulting clinical benefits accrued by over 1.4 million seniors receiving post-acute and long term care services  in an increasingly diverse array of care settings, the Senior Care Pharmacy Coalition (SCPC) today released a new Policy Brief warning how differing, conflicting regulations from federal agencies with jurisdiction over LTC pharmacies can threaten seniors’ care during their progression across multiple settings, and disrupt the clinical and consultative services and care coordination necessary to improve clinical outcomes, reduce errors, sustain quality improvements, reduce waste and  control costs.

The new policy brief, entitled, “An Overdue Need: The Federal Definition of Long Term Care Pharmacy,” explains the need for and “benefit of a statutory, legislative definition of ‘long term care pharmacy’ that will compel consistency across the relevant regulatory agencies and better enable LTC pharmacies to follow geriatric and chronic care populations across settings.” Michael Bronfein, an SCPC founder and Chairman of the Board, said, “Passing a federal statutory definition into law would be an important first step in assuring elderly patients benefit from the many clinical benefits of LTC pharmacy involvement and oversight.”

Alan G. Rosenbloom, President and CEO of SCPC, said educating Congress and regulatory authorities about the urgent need for consistent, updated and streamlined oversight is a major SCPC public policy priority, and that this Policy Brief will be followed later this year by offering for consideration a specific, new federal definition of LTC pharmacy.

Explains the Policy Brief in broad context: “The specialized services and clinical oversight only LTC pharmacies provide necessarily will be required beyond the historic boundaries of a nursing home’s walls. This patient population takes an average of eight prescription medications each day and takes 11 to 13 prescription medications each month. Ever greater coordination of care – particularly during care transitions – is essential to avoiding unnecessary care and treatment, and the risk of adverse medical and prescription medication events.  Greater care management across settings and during care transitions increasingly will be crucial to controlling health care costs as well.”

LTC Pharmacies Significantly Different from Retail Pharmacies

Unlike retail pharmacies, which sell a variety of products beyond prescription drugs and other medications — LTC pharmacies serve residents in institutions like nursing homes and assisted living facilities, as well as LTC patients in more residential environments.  They generally are not open to the public in a manner similar to retail pharmacies, nor do they offer merchandise other than prescription medications. LTC pharmacies provide cost-effective, efficient solutions for facilities to assure that patients receive appropriate and timely prescription medications. In addition to dispensing prescription medications, the LTC pharmacy staff must be actively involved in clinical and related consultative services and provide technological resources directly related to improved outcomes and reduced waste to patients in skilled nursing centers and other settings.

Further, legal and regulatory requirements imposed on LTC pharmacies are very stringent – including detailed requirements on packaging and labeling medications to reduce potential medication errors.  LTC pharmacies play an essential part in avoiding adverse medical reactions, improving clinical outcomes and ultimately minimizing unnecessary complications and rehospitalizations.  In fact, the job of the LTC pharmacies and the pharmacists they employ continue after a drug is dispensed.   “LTC pharmacies remain an integral part of a patient’s care team, and federal regulatory agencies must appreciate the importance of these clinical services and adopt a common definition of LTC pharmacy in promulgating and coordinating regulations and sub-regulatory guidance,” added Rosenbloom.

CMS, EPA, FDA Differ Regarding Interpretation of LTC Pharmacy

While the Centers for Medicare & Medicaid Services (CMS) provides the most comprehensive definition of LTC pharmacies under its Medicare Part D Manual and Medicare and Medicaid Requirements of Participation concerning the provision of pharmacy services in nursing homes (most clearly outlining the role and responsibility of LTC pharmacies and how they differ from other pharmacies), the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) are far less concise in their definitional interpretation. For example, in its 2015 Proposed Rule for “Management Standards for Hazardous Waste Pharmaceuticals,” the EPA broadly defines “healthcare facility” to include – among others besides LTC pharmacies – hospitals, optical and dental providers, chiropractors and even veterinary clinics.

In addition, the 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. At issue is not just regulatory certainty for pharmacies, but the quality of medication therapy that those pharmacies are able to provide to LTC residents.  Drug utilization review, specialized medication packaging, 24/7/365 pharmacist availability, emergency delivery, and onsite emergency medications are crucial to resident care, and have been standard LTC pharmacy practice for decades. Yet, in the absence of a definition that makes this clear, the FDA Guidance as drafted puts patient care at risk by imposing requirements on LTC pharmacies directly conflicting with CMS requirements.

“The range of activist federal agencies seeking to regulate LTC pharmacies today demands that Congress adopt a clear, statutory definition that explicitly identifies the unique and specific service offerings that LTC pharmacies provide,” Rosenbloom concluded.  “Beyond a statutory definition, Congress must also address the emerging LTC pharmacy market, and the different ways LTC pharmacies will operate in a future value-based care model. Only by doing so can federal laws appropriately – and consistently – apply to the practice of LTC pharmacy, particularly in the face of a growing need for LTC services in our rapidly evolving health care delivery system.”

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The SCPC is the national association for independent LTC pharmacies. Our member pharmacies provide care and services to patients in LTC facilities in more than 40 states occupying approximately 400,000 beds across the country. Learn more at seniorcarepharmacies.org.