Assisted living communities can breathe a sigh of relief now that Environmental Protection Agency Acting Administrator Andrew Wheeler has signed the agency’s final rule regarding the disposal of hazardous waste pharmaceuticals.

Unlike the proposed rule, which was published in September 2015, the 491-page final rule, signed Dec. 11, does not include assisted living communities among the types of long-term care facilities that must comply with the terms.

The proposed rule, among other stipulations, called for the prohibition of long-term care and other healthcare facilities from disposing down the toilet or drain those pharmaceuticals considered to be hazardous waste, and it also defined how facilities should dispose of such drugs. An issue for assisted living operators and those whose continuing care retirement communities contain an assisted living component, however, was that assisted living was included in the definition of long-term care facility, despite the fact that assisted living residents often directly purchase and manage their own medications in their own units, and multiple pharmacies could be involved with any given community’s residents.

Advocacy efforts had much to do with the favorable final rule. Argentum had submitted comments on the proposed rule in December 2015 individually and as part of a separate letter that included several organizations, among them the American Health Care Association / National Center for Assisted Living and LeadingAge. The EPA originally had expected to issue the final rule in 2016 and then later said publication would occur in 2017.

Assisted living communities and CCRCs, the groups told the EPA in 2015, do not have the infrastructure nor the procedures in place to collect hazardous waste pharmaceuticals and would incur “significant expenses” to comply with the rule, without remuneration. Compliance would be complicated further by the fact that assisted living communities are regulated at the state level, and requirements vary from state to state, the organizations said at the time.

Listening to comments from providers and organizations representing providers, the EPA chose in its final rule to define long-term care facility as the Centers for Medicare & Medicaid Services and the Drug Enforcement Agency do and therefore not include group homes, independent living communities, assisted living facilities, and the independent living and assisted living portions of CCRCs.

“The primary change we have made to the proposed definition relates to assisted living facilities,” states a pre-publication copy of the final rule, which has not been published in the Federal Register due to the partial shutdown of the federal government.

“[C]ommenters argued, and EPA agrees, that assisted living facilities differ from [long-term care facilities] in at least two ways,” the rule states. “First, some assisted living facilities do not provide medication management. In some cases, assisted living facilities are actually prohibited from managing medications. Second, many assisted living facilities do not have on-site nursing or other medical staff. EPA believes it is easier for implementation of this rule, to make a determination about assisted living facilities as a category, rather than on the basis of whether they provide medication management of have on-site medical staff.”

Argentum, NCAL and LeadingAge representatives said they were pleased that the federal agency listened to their concerns.

“If, as it appears, assisted living communities have been exempt from these requirements, we believe that is the right course of action,” Argentum COO Maribeth Bersani told McKnight’s Senior Living. “Argentum supports the safe, proper and effective disposal of all hazardous waste, including pharmaceuticals. However, the draft rule was crafted in such a way that assisted living communities likely would be in perpetual noncompliance due to resident privacy concerns, and the burden of coordinating with multiple pharmacies used by myriad residents for disposal needs.”

An NCAL spokeswoman said: “NCAL is pleased to see our comments with other key stakeholders were acknowledged and accepted by the EPA in regard to excluding assisted living communities from this rule. It only makes sense given that assisted living is regulated by the states, and residents are often the ones in charge of their medications. We support the agency’s recommendation that communities develop voluntary pharmaceutical collection programs as a best practice.”

A LeadingAge spokeswoman said: “We are pleased that the EPA has revised its approach and removed assisted living from its definition. As we noted in earlier comments, assisted living and continuing care retirement communities are individuals’ homes, and staff members do not have authority to mandate that individuals turn over or dispose of their medications.”

Voluntary collection programs recommended

The EPA cautioned in the final rule, however, that assisted living communities still are responsible for the proper disposal of hazardous waste outside of residential areas. And some states may have more stringent requirements regarding assisted living communities and the disposal of hazardous waste in residential areas, the agency noted.

“[T]he agency recommends that assisted living facilities, group homes, independent living communities, and the independent and assisted living portions of continuing care retirement communities develop voluntary pharmaceutical collection programs for both hazardous and non-hazardous waste pharmaceuticals as a best management practice, as allowed by DEA regulations, to ensure proper management, avoid flushing, and minimize the potential for accidental poisonings, misuse or abuse,” the EPA said. The agency recommends that residents of assisted living facilities follow the guidelines developed by the U.S. Office of National Drug Control Policy, the Food and Drug Administration and the EPA for the disposal of unwanted household pharmaceuticals.

Hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing portions of CCRCs still must comply with the EPA’s final rule regarding the disposal of hazardous waste pharmaceuticals. The rule will be effective six months from when it is published in the Federal Register.

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