Enteral Nutrition Sector Raises Concerns about Patient Care under NCB

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.