WASHINGTON — Calling Medicare's accreditation requirement "unnecessary and unfair," Reps. Marion Berry, D-Ark., and Jerry Moran, R-Kan., introduced a bill on Wednesday that would exempt pharmacists.

The bill comes just days before CMS' advised Jan. 31 accreditation sign-up deadline. Applying by that date, the agency has said, will ensure providers get through the process in time to meet the agency's mandatory Sept. 30 deadline, by which all DMEPOS providers must be accredited in order to bill Medicare.

CMS has exempted some "eligible professionals," including physicians, from the requirement. In addition, "other persons," including orthotists, prosthetists, opticians and audiologists, are also exempt. The proposed legislation would add pharmacists to the list.

In announcing the bill (H.R. 616), Berry pointed out that community pharmacists "are the only licensed medical professionals that must meet new CMS accreditation requirements as suppliers of DMEPOS."

"In rural areas … community pharmacists are often the only medical professionals available who can supply this vital equipment to patients," he said. "The current law threatens the ability of patients to get the supplies and care they must have to stay healthy. This bill will ensure Medicare patients have access to the supplies they need while also helping community pharmacies keep their doors open."

Pharmacy groups, including the American Pharmacists Association, Food Marketing Institute, National Association of Chain Drug Stores, National Community Pharmacists Association and the National Alliance of State Pharmacy Associations, applauded the bill.

"Not only are there significant costs associated with the accreditation process that can create huge financial barriers for pharmacies and pharmacists that are already state-licensed, more importantly, the process poses a threat to patients' access to DME supplies and counseling from their pharmacist," according to a release from the groups.

But accreditation stakeholders were not as enthusiastic about the bill.

"It's mixed good and bad from this perspective," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy in Mount Prospect, Ill., which accredits pharmacies. "We didn't really believe this rule was needed for pharmacists or pharmacies to begin with. We thought it was a bit of overkill because they are already licensed.

"Now that we are accrediting," he continued, "we have seen some benefits from accreditation, and we have been able to detect a bit of fraud that wouldn't have been detected if accreditation hadn't been in place."

He said while some independent pharmacies have complained that the accreditation price tag is too high, others have said the process has helped them do business better. Indeed, he said, accreditation — and NABP has accredited about 10,000 pharmacies, "every major chain except Wal-mart," Catizone said — has helped raise pharmacies to higher standards.

"Hopefully, the right thing to do is to keep accreditation in place and if it is not working, then get rid of it in a few years," he said.

Sandra Canally, president of accrediting body The Compliance Team, Spring House, Pa., said she does not support exempting pharmacies — or anyone else.

"To exempt these folks is not a good decision," said Canally, noting her company has already accredited hundreds of pharmacies. "The whole point of the Medicare Modernization Act [which mandated accreditation] was not only to prevent fraud and abuse but to elevate standards of care. How can you raise standards of care when one provider can get away from any standards and the other is held accountable to the nth degree?"

Mary Ellen Conway, president of Capital Healthcare Group, Bethesda, Md., not only questioned the wisdom of exempting pharmacists but also the timing of the bill. "I think it is a shame at this point to give [pharmacists] false hope," Conway said. "Even if this passes, it won't be anytime soon."

If pharmacists wait to see what happens, she noted, that could put them in a risky position. "This is another potential distraction that people look for, and it may not come to fruition," she said. "And then on Nov. 1 they are in trouble because all their Oct. 1 claims have been denied [since they are not accredited]."

Catizone agreed that pharmacies could be practicing risky business if they wait on the outcome of H.R. 616.

"We know people are going to sit on the fence and say, 'We'll wait and see what happens,'" he said, but "once they miss that [Jan. 31] application deadline, accrediting agencies won't be able to get to them because they will have all those other pharmacies."

Even if pharmacies that wait to apply find an accreditor to take them on, they — or any other providers who wait — could run into trouble, Canally said. While her company does not, some accreditors require providers to be ready for an inspection at the time they submit their applications. And by Sept. 30, every provider who wants to continue billing Medicare must ensure their businesses are up to CMS standards, which can take time — and that will be in short supply for those who wait, she continued. If an accreditor finds any problems on the accreditation survey, for example, that could mean further delay.

"God forbid they don't make it through the first time and we give them a corrective action plan and 60 days or so to complete it," Canally said. "If they wait until the final hour, they better be bloody perfect because otherwise they are going to lose their billing number."

View a list of CMS' 10 approved accreditation organizations.