BALTIMORE--Last week CMS whittled more than 100 pages of proposed requirements down to 14 in its final version of Medicare supplier quality standards.

"We're under considerable shock," said Accreditation Commission for Health Care President Tom Cesar. He noted that a staff member in his office, puzzled by the brevity of the final version, asked, "Is that all there is?"

As mandated by the Medicare Modernization Act, all DMEPOS suppliers will have to meet the quality standards and become accredited in order to do business with Medicare. Accreditation will be required first for those in the 10 yet-to-be-named cities where DME competitive bidding will begin in 2007, then eventually will expand to include all Part B suppliers.

After the proposed standards draft was released in September (see HomeCare Monday, Sept. 26, 2005), CMS said it received more than 5,600 comments, including many complaints that the standards were too prescriptive. Based on those comments, the agency said, "we have made significant revisions to reduce [the] burden on small suppliers and ensure quality services for Medicare beneficiaries."

In one of the most drastic cutbacks to the final document, issued Aug. 14, the agency cut the number of product-specific standards that had been proposed in its draft from 15 to three. Initially covering stringent requirements in areas ranging from beds and support surfaces to diabetic supplies and commodes, the final document includes product-specific standards only for respiratory equipment, wheelchairs and custom-fabricated orthotics and prosthetics.

According to CMS, other changes in the final version include:

  • eliminating unnecessary specificity and redundant information;
  • modifying overly prescriptive requirements to focus on providing reliable quality service to beneficiaries; and
  • clarifying requirements for performance management to allow suppliers flexibility in determining indicators related to their products and services.

For example, a proposed requirement for a provider to be open for 40 hours a week was replaced with a requirement to maintain posted business hours. A requirement for a toll-free number to assist beneficiaries was eliminated. A section on beneficiary services now requires that suppliers respond to consumer complaints in five days; a proposed requirement that oxygen providers respond to a patient call within an hour has been dropped. And what was a draft section on information management has dwindled to three lines on HIPAA compliance.

Under the new standards, providers will have to abide by a performance management standard that requires measurement of beneficiary satisfaction. And although they still will have to implement financial management practices that ensure accurate accounting, they won't have to bring in an independent party to conduct financial audits, an issue that had disturbed some providers, as set out in the draft standards.

Reaction from industry experts was mixed.

"By issuing the 14-page document, CMS did listen to the industry and accreditors who took issue with the initial draft," said Bob Floro, senior associate director, home care accreditation, for the Joint Commission on Accreditation of Healthcare Organizations. "This will really have a positive impact on the industry."

The American Association for Homecare also applauded the final standards. "We are pleased to see the standards have been considerably streamlined since the initial draft," said AAHomecare Chairman Tom Ryan. "It is critical for the home care community to continue to foster collaboration with CMS in this process."

However, others say that CMS went too far and has oversimplified the standards.

ACHC's Cesar said that while the first draft was "overkill," there's "not enough meat" in the final version. "They've gone from something extreme to mediocrity," he said. "What they have released in our minds does not meet the intent of traditional health care accreditation. If the intent was to raise the bar, to upgrade quality and professionalize the industry, those 14 pages aren't going to do that."

Accreditation consultant Mary Ellen Conway, president of Capital Healthcare Group, Bethesda, Md., said there are a number of gaps in the scaled-down standards. "The standards are a lot less prescriptive and severe than in the proposed guidance," she said. "But they leave so much open for interpretation; we need more clarification."

According to Conway, there are also important elements missing from the final version. Some parts of the draft section on human resource management, which specified criminal background checks and health screenings for workers, were left out. Safety precautions and infection control are other areas that aren't included. "It's completely inappropriate to have accreditation for a health care company and not address infection control," she said.

Both Cesar and Floro said the HME provider standards presently required by their accrediting organizations are more stringent than CMS' new requirements. They said they are awaiting further clarification from CMS on whether they would be required to use only the agency's new standards for accreditation, or whether they would be able to incorporate CMS' standards into their current accreditation programs.

If only CMS' standards are used, it could speed up the time it takes to accredit providers, Cesar said. What normally takes six to nine months could be reduced to four to six weeks, he said.

CMS' next step is to name accrediting bodies to apply the quality standards. The agency published a notice in Wednesday's Federal Register inviting accreditation organizations to apply for "deeming authority" as approved accreditors. Applications must be received by Oct. 2.

To view the final quality standards, visit www.cms.hhs.gov/CompetitiveAcqforDMEPOS/04_New_Quality_Standards.asp.

CMS said that a document responding to the comments it received on the draft standards also will be posted on its Web site.