In Urging Congress to Adopt Statutory Long-Term Care (LTC) Pharmacy Definition, Analysis Finds Specific Legislation “Unlikely to Have Significant Budgetary Effects”

DATE: May 31, 2018

Washington, DC — In focusing attention on the significant value-added services provided by long-term care (LTC) pharmacies and the resulting clinical benefits accrued by over two million seniors receiving post-acute and LTC services, the Senior Care Pharmacy Coalition (SCPC) today released a new analysis of the likely budgetary consequences of a legislative proposal to convert Medicare’s current sub-regulatory guidance into statutory language. The analysis by Lieberman Consulting, and funded by SCPC, finds the proposal “is unlikely to have significant budgetary effects; directionally, its effects, if any, are likely to lower federal costs.”

A statutory LTC pharmacy definition has been a longstanding, organizational objective of SCPC since its 2014 inception, and the group issued a policy brief in 2016 warning how differing, conflicting regulations from federal agencies with jurisdiction over LTC pharmacies can threaten seniors’ care during their progression across multiple settings. Additionally, the lack of clarity can disrupt the clinical and consultative services and care coordination necessary to improve outcomes, reduce errors, sustain quality improvements, reduce waste and control costs.

“In promoting the benefits 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 post-acute, geriatric and chronic care populations across settings – the time had come to assess the budgetary impact of doing so,” said Alan G. Rosenbloom, President and CEO of SCPC. “Now we have done so — and the legislation is expected to have no scoring impact. Passing a federal statutory definition into law would be a LTC pharmacy sector milestone in assuring seniors and other LTC patients benefit from the consultative clinical services, medication management and specialized packaging only LTC pharmacies provide.”

Rosenbloom said continuing to educate Congress and federal regulatory authorities about the urgent need for consistent, updated and streamlined oversight is a top 2018 SCPC public policy priority.

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 retail and other pharmacies), the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) are far less concise in their definitional interpretation. For example, in a prior 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.

The new analysis points out only 2 percent (1,403) of the approximately 62,000 retail pharmacies in the United States meet the 10 Medicare criteria that administratively define long-term care (LTC) pharmacies and the associated services needed to serve nursing home residents. However, regulations issued by FDA and EPA frequently apply to all pharmacies — apparently because federal statute fails to differentiate and separately define LTC pharmacies.

Rosenbloom noted a proposed 2015 FDA guidance, for example, would have prevented LTC pharmacies from supplying emergency medications to LTC facilities, which would have threatened patient care and risked the lives of the country’s most vulnerable seniors.  “It took two years of intensive advocacy to persuade FDA to exercise discretion to avoid such unintended consequences, an outcome that would have been easy with a cross-cutting statutory definition,” he said.

The SCPC leader said putting in statute Medicare’s administrative criteria defining LTC pharmacies would permit federal agencies to set requirements based on the distinct characteristics of each type of provider, rather than lumping retail and LTC pharmacies together. “It is SCPC’s view that the broad range of activist federal agencies seeking to regulate LTC pharmacies implores Congress to adopt a clear, statutory definition that explicitly identifies the unique and specific service offerings that LTC pharmacies provide,” Rosenbloom concluded.

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 The Senior Care Pharmacy Coalition (SCPC) is the only national organization exclusively representing the interests of LTC pharmacies. Its members operate in all 50 states and serve 750,000 patients daily in skilled nursing and assisted living facilities across the country. Visit seniorcarepharmacies.org  to learn more.