December 16, 2019

Pharmaceuticals Rule Applicability to Long-Term Care Facilities Clarified

In EPA’s hazardous waste pharmaceuticals rule, long-term care facilities (LTCFs) with >20 beds that generate above very small quantity generator (VSQG) thresholds are subject to Part 266, Subpart P. [§266.504] In RO 14917, EPA weighs in on whether an intermediate care facility for individuals with intellectual disabilities (ICF) would meet the definition of an LTCF.

ICFs are regulated by the Centers for Medicare and Medicaid Services (CMS) under 42 CFR Part 440. While there are similarities between ICFs and LTCFs regarding licensing and institutional long-term care, the overall mission of the two entities is quite different. An LTCF includes “hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities.” [§266.500] On the other hand, RO 14917 notes that ICFs provide “[active treatment], a continuous, aggressive, and consistent implementation of a program of specialized and generic training, treatment, and health or related services, directed toward helping the enrollee function with as much self-determination and independence as possible.”

ICFs promote functional status and independence, including vocational and other activities outside of the residence, which contrasts with the goal of an LTCF to provide onsite physical and mental health services. Therefore, EPA concludes that ICFs more closely resemble group homes or assisted living facilities, which are not considered LTCFs, than nursing facilities, which are considered LTCFs. ICFs are thus not subject to Part 266, Subpart P. Rather, hazardous wastes generated at these facilities are considered household hazardous waste, excluded by §261.4(b)(1). Despite this, EPA encourages environmentally sound disposal of all ICF-generated wastes, including pharmaceuticals.

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