Quality standards could spell doom for small HMEs

WASHINGTON - CMS outlined its draft quality standards in 104 pages, but the HME industry can sum up the document in one word: prescriptive. Everyone from healthcare attorneys to the accrediting organizations themselves (See related story on this page) are calling the standards, especially the financial management and product specific service requirements, too specific. “What struck me was that a lot of it is very procedural, in that you have to do X every time you deliver a hospital bed,” said healthcare attorney Asela Cuervo. “Accreditation is more of an outcomes based kind of process, where you're always trying to assess what you're doing and building what you find into the next round of what you do.” Ann Berriman, another healthcare attorney, took it up a notch, saying, “How can the government tell people how to run their businesses? If I want to run my business on the back of an envelope, they can't tell me I can't do it that way.” All providers will have to meet the standards eventually, starting off with the providers in the 10 metropolitan statistical areas where CMS will kick off national competitive bidding in 2007. The standards, released for comment in late September, are divided into two groups: business quality standards and product specific service requirements for 14 categories, including oxygen. The biggest bone the industry has to pick is with the financial management requirements that ask providers to do everything from keeping balance sheets on hand to notifying CMS and accrediting organizations of “potential adverse financial operations.” No one's quite sure, but the requirements may even ask providers to audit their financial statements. Simon Margolis, vice president for clinical and professional development for National Seating and Mobility, said “there's a lot of financial information that they're asking for that I'm not sure they have the right to ask for.” NSM is currently seeking accreditation, and it hasn't been asked to submit those kind of financials, Margolis said. The prescriptive nature of the standards also comes into play in the product specific service requirements, which are written in a way that makes all providers out to be repair shops, said Cara Bachenheimer, vice president of government relations for Invacare. “They're talking about checking the nuts and bolts, and checking for tears in upholstery,” she said. “When you're selling new products, suppliers shouldn't have to go through that kind of exercise if they're buying from quality manufacturers.” Bachenheimer said she's worried that all of this specificity - the standards also require compliance plans, which to date, have been voluntary - will misplace CMS's focus. “It's going to be more of a documentation game than a providing quality services game,” she said. Smaller providers fear it might be the end of the game, at least for them. They question whether they have the muscle and money to meet the draft quality standards. “I don't have an issue competing with the nationals in national competitive bidding,” said Mark Zelezen, president of Hess Healthcare Services in Bethlehem, Pa., an eight-employee HME. “What I'm interested in seeing is whether the standards will standard us out.” CMS is accepting comments on the standards until Nov. 28. The agency, along with contractor Abt Associates, plan to release final standards in April. At that time, CMS will determine what accrediting organizations will enforce the standards. That timeline leaves providers, at least those in the 10 MSAs, with little wiggle room, and accrediting organizations are recommending they begin gearing up to meet the standards now, even before the final standards are published.