BALTIMORE--During an Open Door Forum on Wednesday, CMS' Sandra Bastinelli once again issued a warning to HME providers: Get on the ball to get accredited--or get left behind.
Those hoping to bid in round two of competitive bidding need to contact an accrediting body and get the process in motion, she said.
"They are not besieged with new applications, which is not a good sign," Bastinelli said of the accrediting agencies. "You don't need to wait for any deadline announcement [to get the ball rolling]."
And with round two fast approaching, accreditation experts are also encouraging providers not to wait.
"Since they released the drop-dead date, we definitely have seen an increase [in providers applying for accreditation]. That's across the board. And they're coming in from across the country," said Sandra Canally, president of The Compliance Team, one of CMS' 10 approved accrediting bodies. "But that being said, [the volume of applications] is nowhere near where it needs to be now that the 70 MSAs have been announced."
Providers who continue to wait, according to Canally, run the risk of long lead times that could translate into missing CMS' deadline for round two bidders, or even its mandatory accreditation deadline for all providers in September 2009. Canally estimates that nearly 100,000 providers will need to be accredited, and if they all wait until the last minute, "it'll be like trying to put 50 pounds of flour in a 10-pound bag."
But some are holding out hopes for the next few months.
Consultant Mary Ellen Conway, president of Capital Healthcare Group of Bethesda, Md., said CMS may be speaking too soon. "It takes a provider four to six months to become accredited. So if it takes them four to six months, I don't know why [CMS] thinks a month [after the drop-dead date was announced] there would be this deluge. It takes two or three months for those applications to get processed. I expect to see the deluge this spring."
Tom Cesar, president of the Accreditation Commission for Health Care, agreed, and said ACHC has seen a measurable increase since the deadline announcement. According to Cesar, January was the largest selling month for the organization's manuals--more than 100 were sold--and last month also saw 47 companies apply for accreditation. Thus far in February, Cesar said ACHC has already sold more than 70 manuals.
But despite the upswing, Cesar also said the time for action is now. "The industry has known that CMS has not backed off on this requirement. The final date is September 2009, but you have to plan for it. Allow at least six months for the process. Then, hopefully, there won't be a backlog at the end of the year."
Adding to the crunch, CMS has posted proposed revisions to its accreditation quality standards, which are currently under a 30-day public comment period. "We are not opening all the standards up," Bastinelli said at the Open Door. "We are only taking public comments on those that are underlined [in the document]."
While experts said most of the changes will not have an overwhelming impact, there are a few that merit attention.
"Probably the areas that have been hit the hardest in increases are the areas of orthotics and prosthetics and diabetic shoes. There are truly some detailed items [in the quality standards] that anyone doing those products needs to pay attention to," advised Canally.
Specifically, the proposed change both Canally and Conway find most perplexing states that a supplier shall "verify, authenticate and document" that products are not "adulterated, counterfeit, suspected of being counterfeit, and have not been obtained by fraud or deceit."
"You must verify that you're getting something from an FDA-approved place that hasn't been tampered with in any way. I don't know how you do that for medical equipment," Conway said. "I don't really know what [CMS'] expectation is there."
Canally said she is also unsure about this revision.
"Unless [providers] are dealing with some less-than-reputable manufacturer or wholesaler, that would be the only thing I would question," she said, noting, "these are interesting add-ons."
Canally said industry response will be vital in shaping the outcome of the revisions. "I encourage people to [comment]. That's how we got results before," she said. "Everybody needs to look at this and see how it affects their business."
The deadline to submit comments is March 18, 2008.
View a PDF of the proposed revisions to CMS' accreditation quality standards.
View guidelines on how to submit comments, which
will be accepted only electronically or by mail.