Dear Administrator Verma:
The Senior Care Pharmacy Coalition appreciates the opportunity to comment on the Part D provisions of the Draft Call Letter titled, “Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 Draft Call Letter.” The Draft Call Letter includes several proposals affecting beneficiary access to medications under the program and the ability of long-term care (LTC) pharmacies to dispense those medications and provide related consultative services. We appreciate the opportunity to share our comments with the agency to improve and refine the proposed changes for the 2019 Plan Year.
SCPC is the only Washington-based organization exclusively representing the interests of LTC pharmacies. SCPC represents 75% of all independent LTC pharmacies and our members serve about 700,000 residents daily in skilled nursing and assisted living facilities across the country. As such, we have a unique perspective into the proposed rule from the LTC pharmacy perspective, which we share below.
I. Over-the-Counter (OTC) Drugs and Supplements: Proposed Policy Changes.
In response to requests from some PDPs, CMS has proposed that PDPs be allowed to substitute OTCs and supplements for prescription medications. While the Draft Call Letter does not state explicitly the basis for this proposal, it appears to be a cost control measure.
While we certainly appreciate that some drugs may be available in both prescription and OTC formulations and at equivalent strengths, we believe that CMS should undertake more detailed analysis, and seek stakeholder input without the time constraints inherent in the annual Call Letter development process, before finalizing this proposal. We therefore urge CMS to remove or otherwise modify this proposal in the Final Call Letter.
There are four reasons for our recommendation. First, supplements and drugs – either prescription or OTC – are not legally or therapeutically equivalent. CMS should not equate the two or allow PDPs to substitute supplements for drugs. Second, CMS should not allow PDPs to substitute either OTCs or supplements for prescription drugs as defined in the Social Security Act because this would allow PDPs to increase patient out-of-pocket costs, threaten patient care (in the case of supplements) and inappropriately shift legitimate Part D administrative and financial obligations to other payment programs (including Medicare Parts A and C and Medicaid) and to providers. Third, if CMS proceeds with the proposal, beneficiaries in LTC facilities and settings should be exempt because the relationships among plans, intermediaries, pharmacies, providers and patients differ substantially in LTC and community or retail environments. Finally, if CMS does not exempt beneficiaries in LTC facilities and settings, the agency should clearly instruct PDPs that, when they substitute OTCs or supplements for prescription drugs, the PDPs must reasonably reimburse LTC pharmacies for the costs of acquiring and dispensing OTCs and supplements consistent with the Medicare and Medicaid Requirements of Participation applicable to LTC facilities and the Part D Manual provisions detailing the requirements LTC pharmacies must meet to be eligible for Part D network participation.