When it comes to the “alphabet soup” of three- and four-letter federal agencies, one’s eyes can glaze over in confusion about what they do, why they do it and how average citizens benefit from their federally funded oversight. In the realm of health policy and our rapidly aging population, these regulatory bodies are frequently required to work together to help ensure seniors are properly cared for and protected.
But what happens when they cannot effectively work together, or at all? And what are the implications when sub-sectors of major industries within the vast U.S. economy are statutorily undefined, unclear and ambiguous due to a federal failure to modernize a 20th-century regulatory framework no longer meeting seniors’ 21st-century care needs?
Both scenarios are on display when it comes to regulatory governance of America’s growing long-term care pharmacy sector. LTC pharmacies provide life-saving medication management and other value-added clinical benefits to the more than 1.3 million frail, elderly seniors in LTC facilities — and to many more residing in an increasingly varied array of settings, extending from institutions to homes. And unlike retail, mail order and other pharmacy types, LTC pharmacies, significantly, remain an integral part of patients’ ongoing care team as they progress across multiple settings.
Seniors benefitting from LTC pharmacy clinical oversight, most of whom are Medicare and Medicaid beneficiaries, require prescription medications to treat chronic conditions and maintain general health. The typical nursing home patient, for example, requires 8-10 prescription medications a day and averages 11-13 per month. As America’s population continues to age, a growing number of seniors will require the specialized services only LTC pharmacies provide — especially the effective medication management protocols that keep patients safe as they move across care settings.
Yet, despite the tangible, unique and frequently life-saving, value-added services provided by LTC pharmacies, there illogically exists no statutory LTC pharmacy definition under federal law. Rather, there exists a patchwork of vague, inconsistent regulatory and sub-regulatory provisions impacting LTC pharmacies across multiple federal agencies — primarily the Centers for Medicare and Medicaid Services, the Food and Drug Administration and the Environmental Protection Agency.
The net result is regulatory chaos and jurisdictional confusion. This places seniors’ care at risk by disrupting the clinical, consultative and care coordination necessary to improve outcomes, reduce errors, sustain quality improvements, reduce waste and control health costs.
Examples of regulatory confusion abound:
— In 2019, the FDA proposed a requirement mandating manufacturers package opioids in blister packs of five, 10 or 15 tablets. This requirement conflicts directly with CMS guidance concerning packaging of medications for patients in LTC facilities. The FDA has yet to issue final guidance.
— In 2015, under the Obama administration, the EPA proposed new regulations concerning the disposal of hazardous pharmaceutical waste that would have established its own definition of LTC facilities and pharmacies — creating significant conflicts with CMS guidelines and requirements. In 2019, under the Trump administration, the EPA issued final regulations substantially different from the original proposal.
— In 2015, the FDA proposed revised repackaging guidance that would have prevented LTC pharmacies from providing emergency medications to LTC facilities — in direct conflict with CMS Medicare and Medicaid obligations. This was not corrected in final guidance issued in 2017, although the FDA has chosen not to enforce the requirement in LTC settings — at least for now, though it is subject to change. This is irresponsible, dangerous and unacceptable.
The simple, commonsense solution to this confusing morass of muddled regulatory overlap is to finally pass into law a statutory federal LTC pharmacy definition. Congress placing in statute and formally defining LTC pharmacies would allow the broad range of federal agencies seeking to regulate them to establish requirements based on the distinct characteristics of each provider type — rather than lumping LTC, retail, mail order and other pharmacies together.
This will not only make regulatory jurisdiction more clear-cut and defined but also help ensure elderly seniors’ safety and care across the care continuum is the 21st-century, bipartisan health policy priority it deserves to be. On behalf of current and future seniors across the nation who now or will in the future benefit from the consultative and clinical services that only LTC pharmacies can provide as this key pharmacy sub-sector continues to grow, we urge Congress to expeditiously pass a federal LTC pharmacy definition into law.
Alan G. Rosenbloom is president and CEO of the Senior Care Pharmacy Coalition.
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