Newer, more stringent USP 800 regulations on cleanrooms are a couple of years off, thanks to a postponement of implementation, but they’re still a worry for independent oncology practices, whose in-house pharmacy staff may sit up nights wondering about the stability of their drug revenues.The newer regulations, set to debut in 2018, could require separate cleanrooms and storage, an appointed supervisor, special garb, and annual competency training. Like many other tasks and requirements at oncology practices, these things are not subsidized by payment from the Centers for Medicare & Medicaid Services or any other plan. “I spend thousands of dollars a year to have my cleanrooms and hoods certified and maintained,” says Steve D’Amato, executive director of New England Cancer Specialists, in Scarborough, Maine. “That’s an unreimbursed service, but it’s the cost of doing business.”New England Cancer Specialists is the last independent oncology practice in Maine, and the challenges of drug procurement and dispensing are among their chief concerns. The Northeastern practice has four locations in Maine and a satellite facility in New Hampshire. Like all independents, they must grapple with increasingly aggressive policies among payers, pharmacy benefit managers, and pharma companies. Competition from specialty pharma is ever-present.For the New England group as well as for Florida Cancer Specialists (FCS), the nation’s largest independent oncology practice, the battlefield strategy is the value mantra: the constant broadcast of the message to payers and pharma that independents can deliver lower cost and greater efficiency in handling and dispensing of drugs.“What I tell payers is, ‘Look, you’re trying to extract savings out of small, community oncology practices and all you’re doing is driving them into the arms of hospital systems, where you’re going to get charged three times as much when they go into that site of care,’” says Ray Bailey, RPh, the pharmacy director for FCS. “That’s the most compelling argument to the payers. You need to work with and partner with community oncology, because that’s your most cost-effective site of care. And I think they’re understanding that, or at least my experience with payers is they’re understanding that.”

Continue Reading on OncLive.com