ATLANTA--CMS' decision not to include enteral nutrition under the grandfather clause of its final rule governing national competitive bidding--and the absence of a transition period for enteral nutrition recipients--could put patients at risk, according to HME stakeholders.

"I think there most definitely could be problems," said Georgie Blackburn, vice president, government relations and legislative affairs, for Tarentum, Pa.-based Blackburn's Medical and treasurer of the American Association for Homecare. "If indeed the patient cannot elect to stay with the current provider ... then right away there has to be some significant management of the patient's care. I don't know how that would take place."

Many providers had thought that the grandfather provision applied to enteral nutrition, one of the 10 product categories included in the competitive bidding project. Under that provision, providers who do not win competitive bidding contracts can, if beneficiaries elect to stay with them, maintain their current patients.

But during a recent conference call, CMS officials informed listeners that enteral nutrition was not among the grandfathered products. "We do not believe we have authority to allow grandfathering for other DMEPOS, such as glucose testing supplies and enteral nutrition, equipment and supplies," the final rule states.

In response to a listener's follow-up question, the agency also said it was not providing a transition time for enteral nutrition beneficiaries.

"There is not a plan for transition, but there will be enough suppliers within that area for the beneficiaries to receive their treatment plans," a CMS official said.

That was small comfort to providers, who pointed out that enteral nutrition, which is the sole source of nutrition for those receiving it under Medicare, requires oversight and frequent attention.

"There is a lot of detail ... Sometimes there are issues with transitioning patients from one formula to another," noted Lynn Giglione, RN, BSN, general manager of Chartwell Pennsylvania, an infusion company in Pittsburgh that has about 750 enteral nutrition patients on its rolls.

"There are formulas that are very similar, but there are specialty formulas, too," Giglione continued. "A provider might not have it on their shelf and would have to get it in. If you're talking a lot of patients, that could take some time ... If you are talking about transitioning hundreds of patients, that would be monumental."

Giglione also said that patients transitioning to new providers might get different pumps, which would necessitate training on how to handle those pumps.

And then there is the quality-of-care issue. Giglione's company, like many others, offers a clinical component. "We have two dietitians on staff and we clinically monitor the patients from the day they come on," she said. "Patients are on teams so they deal with the same person day in and day out."

It would likely be confusing and overwhelming for patients, most of whom are elderly, to adapt to a completely different company and perhaps one without that clinical component, she said.

Alan Parver, a health care attorney with Powell Goldstein LLP in Atlanta, also pointed out that "enteral nutrition is the one area subject to competitive bidding where the majority of patients reside in nursing homes, not in homes."

That translates into a mix of standards, he said, because nursing homes and home care suppliers must adhere to different criteria, and the needs of the patients are different.

"When they are put into the same mix, there could be some serious issues that arise as this goes forward. There might be situations where nursing home suppliers will find themselves doing home care and home care suppliers may end up treating nursing home patients," he said. "It's a different model, a different business ... It may force nursing homes to lose suppliers they have had a long-term relationship with, that they have been comfortable with."

Parver, like other stakeholders, questioned the wisdom of including enteral nutrition in competitive bidding.

Katherine Werner, vice president of professional affairs for the National Home Infusion Association, said NHIA objected to its inclusion in the project early on.

"We didn't feel that enteral therapy was a good candidate for competitive bidding because there was such a care component over and above the equipment," she said.

Werner added that paraenteral nutrition had been removed from the Polk County, Fla., competitive bidding demonstration "and it was our understanding that it was removed from the project because of questions about care of patients," she said. That same quality-of-care issue could arise with enteral nutrition, she said.

For now, the sector is in an uncomfortable wait-and-see mode. Bid contracts are expected to be awarded in December, with implementation scheduled for April 2008.