Published in The Hill
When it comes to the “alphabet soup” of federal agencies, one’s eyes can glaze over in confusion and uncertainty about what they do, why they do it, and how average citizens benefit from their federally-funded oversight. These regulatory bodies frequently work together to help ensure Americans are properly cared for and protected.
But what happens when they cannot effectively work together, or at all when the definition of smaller sub-sectors of major industries is undefined, unclear or ambiguous?
Such is the case with America’s growing long-term care (LTC) pharmacy sector — accountable for frail, elderly seniors’ compliance with complex prescription regimes, and, among other responsibilities, ensuring they are professionally reviewed within skilled nursing and assisted living facilities for accuracy to prevent deadly adverse drug interactions.
Differing, conflicting regulations from federal agencies with jurisdiction over LTC pharmacies can threaten seniors’ care during their progression across multiple settings — disrupting the clinical and consultative services and care coordination necessary to improve outcomes, reduce errors, sustain quality improvements, reduce waste and control costs.
Yet, despite LTC pharmacies’ growing importance along the care continuum — and dramatic difference from more familiar retail pharmacies — their definition and specific role in patient care is viewed very differently by three key agencies with which they interact: The Centers for Medicare and Medicaid Services (CMS), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA).
While CMS provides the most comprehensive definition of LTC pharmacies — 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 and vague in their definitional interpretations.
In a previous 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. Any Interpretation whereby LTC pharmacies caring for seniors is equated to veterinarians caring for animals is simply too broad, and unworkable.
The Senior Care Pharmacy Coalition (SCPC) believes federal regulatory agencies, and Congress itself, must not only appreciate and formally recognize the importance of LTC pharmacies’ many key clinical services — and adopt a common definition of LTC pharmacy in promulgating and coordinating regulations and sub-regulatory guidance.
Congress placing in statute Medicare’s administrative criteria formally defining LTC pharmacies would finally allow the broad range of activist federal agencies seeking to regulate them to set requirements based on the distinct characteristics of each type of provider — rather than lumping retail and LTC pharmacies together, or, more egregiously, lumping LTC pharmacies with veterinary clinics.
On behalf of current and future seniors across the nation who now or will in the future benefit from the consultative and clinical services only LTC pharmacies can provide as this key sub-sector continues to grow, we strongly urge Congress to pass a federal statutory LTC pharmacy definition into law as expeditiously as possible.
Alan Rosenbloom is the president and CEO of the Senior Care Pharmacy Coalition.