Comment Letter on CMS Medicare & Medicaid Conditions of Participation for LTC Facilities Proposed Rule

The Senior Care Pharmacy Coalition (“SCPC”) appreciates the opportunity to address the Center for Medicare and Medicaid Services (“CMS”) “Medicare and Medicaid Conditions of Participation for Long Term Care Facilities” Proposed Rule, 80 Fed. Reg. 42168 (July 16, 2015) (the “Proposed Rule”1). The SCPC is the national association representing independent long term care (“LTC”) pharmacies. Our member pharmacies provide care and services to patients in long term care facilities in more than 40 states who occupy approximately 400,000 beds across the country. The SCPC advocates for public policies that protect patients, improve the quality of healthcare across a shifting care continuum, and strengthen the economic viability of independent LTC pharmacies and their ability to serve medically compromised seniors.

LTC pharmacies — sometimes called “closed-door” or “institutional” pharmacies — are a distinct subset within the pharmacy community. Skilled nursing facilities (“SNFs”) and nursing facilities (“NFs”) typically contract with a LTC pharmacy to prepare and dispense prescription drugs for individual patients, and to provide an array of consulting pharmacy and care planning services required by Medicare, Medicaid, state licensure laws, and professional standards. As CMS is aware, its regulations define “long term care pharmacy,” 42 C.F.R. § 423.100 (”Definitions”), and both statute and regulation require that LTC facilities “provide routine and emergency drugs and biologicals to [their] residents, or obtain them under an agreement described in [42 C.F.R. § 483.75(h)].” See 42 U.S.C. §§ 1395i-3(a) and 1396r(a)(4) (“Provision of Services and Activities”); 42 C.F.R. § 483.60 (Pharmacy Services). The cross-referenced regulations require a facility to be “administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident,” and expressly authorizes the engagement of outside professional resources, if that is effective and efficient. See 42 C.F.R. § 483.75(h) (“Use of Outside Resources”).

If a facility does not employ a qualified professional person to furnish a specific service to be provided by the facility, the facility must “have that service furnished to residents by a person or agency outside the facility and under an arrangement [that, among other things ensures] services that meet professional standards and principles [and t]he timeliness of the services.”. 42 C.F.R. § 483.75. It typically is most effective and efficient for SNFs and NFs to contract for pharmacy services with pharmacies such as SCPC’s members, rather than having to maintain individual pharmacies and product stocks at each location.

In addition to the statute and regulations, the industry is informed by sub-regulatory guidance, primarily the State Operations Manual, and specifically Appendix PP, Section F425 and F428.2 We understand that CMS is interested in supplementing and enhancing this guidance, elevating elements of the guidance into regulation, and adding other regulatory requirements to LTC facilities directly related to LTC pharmacy management and services. It is those proposals upon which the SCPC offers comments.

Click here to see the full comment letter.