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 SNFs Face Stricter Regs on Disposing of Hazardous Waste Pharmaceuticals

Legal experts say by mid-August skilled nursing facilities (SNFs) will have to address some major changes to how they dispose of hazardous waste pharmaceuticals after the Environmental Protection Agency (EPA) issued its final rule this past December that, among other things, bans the disposal of drugs down a drain or via a flushed toilet.

Jennifer Hilliard, an attorney in the health care practice of the law firm Arnall Golden Gregory tells Provider that the exact date for implementation of the new EPA management standards for hazardous waste materials awaits the rule’s publication in the Federal Register.

Delayed by the more than month-long government shutdown, the rule’s publication is likely to come this week, starting a six-month clock for when SNFs have to become experts on hazardous waste disposal, she says.

Hilliard notes, however, that most states have their own hazardous waste regulations in place, as authorized by EPA, so even though the new EPA rule is a federal rule, states will have to approve most of the provisions.

“But, one provision that will be effective as soon as the law goes into effect in August is the prohibition in putting hazardous waste pharmaceuticals down a drain. A facility cannot flush them down a drain anymore,” she says.

One possible way forward, away from the drain option that she says nobody thinks is a good idea, is to follow FDA recommendations that drugs be mixed with unpalatable materials, such as crushing them into kitty litter or coffee grounds.

In addition to how to react to the rule, advocates for SNFs say one major concern is the time frame question. Holly Harmon, associate vice president, quality and clinical affairs, American Health Care Association, says the short implementation window of six months is troubling.

Beyond the question of preparation time for such a major change, she says one good thing about the rule is that assisted living communities are not covered by the changes. “That is a positive, we are pleased to see that,” Harmon says.

But for SNFs, EPA has put one more issue on their already crowded plates in terms of regulations. “While we do not yet know what the impact on operations will be, it can be a bit overwhelming given that the third phase of RoP [Requirements of Participation] takes effect in November, among other regulatory issues,” she says.

Then there is the cost. Although she has no knowledge of a cost estimate on facilities for meeting the new rules, attorney Hilliard assumes there will be upfront costs of some variety, notably on training staff, drafting policies and procedures for pharmaceutical and nonpharmaceutical waste, and how to handle the waste, likely through contracting with disposal companies.

“All of this is brand new because historically nursing facilities were treated as households for purposes of hazardous waste regulations,” she says. However, later EPA became concerned about it, “since in their eyes, nursing homes are more like hospitals than individual homes,” she says.

EPA changes have not been an overnight event, with Hilliard saying that a previous attempt came back in 2008 before being revived again in 2015.

“Frankly, I thought that this regulation was kind of buried at EPA and would not see the light of day, but sure enough in December the EPA administrator signed off on it and only because of shutdown has it not yet been published in the Federal Register,” she says.

 
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