WASHINGTON — Just hours before the implementation of mandatory DMEPOS accreditation, the already chaotic situation exploded Wednesday with actions on the part of CMS, the Center for Regulatory Effectiveness and even Congress itself that threw into question the deadline, onsite surveys and indeed, the whole program.
Based on "an avalanche" of posts on its Web site that took issue with the accreditation program and said it would force thousands of providers to close, the CRE announced it was launching an investigation of the program.
"We are getting a lot of comments from [durable medical equipment] suppliers, and I think they are accurate that this accreditation business is going to put them out of business," said Jim Tozzi, former administrator of regulatory affairs for the Office of Management and Budget who now heads the CRE.
The CRE site is rife with posts — both signed and anonymous — that detail issues with the accreditation program.
Wrote one provider: "I am in a rural community and need another 30 days to complete accreditation. I am strapped due to my small size and few employees, not to mention financial obligations. The flu virus cut my staff in half this month, which has put us off schedule. I will have to close if there is any cash flow decrease. I have a 13-year-old business and over 2,000 customers. They will have no local provider and will suffer the most!"
Other providers said they were still waiting for onsite surveys months after completing all the preparation for accreditation.
"Inspectors are overloaded and unable to inspect everyone," wrote one provider. "Medicare is dropping provider numbers of everyone who does not make it by Oct. 1st. Thousands of jobs and small businesses are at stake. Not to mention the Medicare patients being cared for. Please help us if you can. A three-month deadline extension could save thousands of jobs."
A Texas provider said she had applied for accreditation in January and still has not received a final decision. "We will not have it in time to bill Medicare this next month," she wrote. "We have lots of capped oxygen customers who no one will take because they will not get paid. What are these people to do without their oxygen? We desperately need an extension so we can continue to serve our patients."
Steve Winter, director of We the People Patient Rights Group, noted that "not one Medicare patient was ever notified about this potential disaster in October."
Winter, who fought and won the right for Medicare catheter patients to receive more frequent sterile catheters, said his battle will have been for naught if patients cannot get their supplies because their provider did not make the accreditation deadline.
"There are going to be patients who won't get their products," he told HomeCare.
"Bottom line," he wrote on his CRE post, "if any patient does not get a catheter in October because of this mess, we are instructing the patients to go to the ER … CMS will have to extend the deadline or promise to honor any retroactive claim or they will be liable for the disruption of patients' health care. If a patient has to reuse a urinary catheter and gets infected, everybody loses."
Numerous posts also took issue with accrediting bodies, detailing poor customer service that included no acknowledgement an application had been received and no decision letter for months, and workers ill-equipped to perform onsite surveys.
All of this, Tozzi said, indicated an investigation was in order.
"We don't initiate an investigation lightly," he said. "We have to have a lot of people — and people who are affected by [an issue]. The gravity of the public comments on this convinced us to do it." Even the comments that were anonymous carried some weight, he said, noting that no provider would want to incur the wrath of an accrediting body or a government agency.
Tozzi said he has already had numerous conversations with CMS officials about the accreditation program "and the CMS view appears to be, 'We told them three years ago [accreditation was coming].'"
He said he is putting together a group of former government regulators, such as a former investigator for the Inspector General's office, to look into the issue. The investigation will start shortly, but Tozzi said he has no idea when it will conclude.
"It won't be in time to get these people reinstated right away," he said about those providers that are not accredited in time. "It will be in ample time before competitive bidding [implementation on Jan. 1, 2011]."
CRE practices transparent investigations, he added, and information on the on-going investigation will be available on the CRE site. He said CMS will get a copy of the final report (which will also be posted) and it will likely go to the Office of Inspector General, the General Accounting Office and the Office of Management and Budget. The White House also monitors the site, he said.
CMS and Congress
The CRE posts also included several about an accrediting organization that had been granting accreditation without onsite surveys, an issue that has been rumored throughout the industry for some weeks and which CMS is now looking into, according to an agency spokesman.
Accreditation standards require unannounced, onsite visits before accreditation can be granted; however, providers, consultants and accrediting bodies themselves have been outraged that one accreditor had allegedly been allowed to accredit providers without doing the site surveys, thus short-circuiting the process for its clients.
"We're hearing the same concerns that you are," the CMS spokesperson told HomeCare. "We have immediately started looking into it. We are taking every complaint very seriously. I don't have anything to report — we just started hearing the concerns. We need to dig into it."
It's too early to tell what CMS might find, he said, but if the agency does uncover any wrongdoing, "we would be aggressive in our actions."
Reprieve for Pharmacists?
Meanwhile, even as stakeholders peppered their CRE posts with pleas for an extension of the accreditation deadline, pharmacists won a victory in the House of Representatives Wednesday afternoon when, in a unanimous voice vote, the House passed a bill that extended the accreditation deadline for pharmacies to Dec. 31, 2009. Reps. Zack Spence, D-Ohio, and Lee Terry, R-Neb., introduced the bill on Tuesday; late Wednesday night, a spokesman for the National Community Pharmacists Association said NCPA was still holding out hope for a companion bill to pass in the Senate that could be sent on to the president for his signature.
Barring that, said Kevin Schweers, vice president, public affairs, for NCPA, the organization hopes that CMS will get the message and voluntarily extend the deadline for pharmacies. Schweers said 50 members of Congress sent a letter late Tuesday to Acting CMS Administrator Charlene Frizzera noting their concerns about accreditation and also the $50,000 surety bond requirement that is to be implemented Friday (Oct. 2).
Saying that the two mandates "present significant financial obligations" and could cause pharmacies to drop out of the Medicare program, thus causing access problems for beneficiaries, the legislators asked CMS to delay both deadlines.
"Congress has already begun to address these requirements in health reform legislation," the legislators pointed out, citing H.R. 3200 (the House health care reform bill), which would "conditionally exempt pharmacies from the surety bond requirements while also waiving accreditation requirements for certain products."
The letter added, "The Senate Finance Committee has also indicated an interest in altering these regulations."
While passage of the House bill brought pharmacies and others a glimmer of hope, it also brought up a question.
"The other side of the coin is that if they extend the pharmacies, how can they not extend DMEPOS providers?" asked Sandra Canally, president of The Compliance Team, one of CMS 10 deemed accrediting organizations. She pointed out that the House vote was a good thing from the standpoint of thousands of pharmacies and their beneficiaries. But the beneficiaries of those DMEPOS providers who could not get accredited in time will also have access issues, she said.
The CMS spokesperson, however, while acknowledging the House vote, said he did not foresee a delay of the deadline for DMEPOS providers.
Confusion Reigns
Yet even in the last days before the Sept. 30 deadline, providers remained frustrated and confused about a variety of issues, a fact that did not escape CMS. The agency released a new version of MLN Matters SE0925 that was "revised to include and emphasize important information regarding voluntary and non-voluntary enrollments/terminations," the agency said. Among other things, the revision encourages companies that are no longer Medicare providers to alert their patients as soon as possible.
But the article was too late for some. For the last week, numbers of providers, many of whom have been waiting to learn of their accreditation status, have reportedly been trying to withdraw their Medicare billing numbers voluntarily effective Oct. 1 because they feared they would not be accredited in time.
Accreditors, who said they continued to work around the clock to get as many providers through the process as possible, said they had also advised some providers that they wouldn't make the deadline and they should voluntarily withdraw from Medicare until their accreditation had been secured.
"We had quite a few providers that signed up in September," Canally said. Some were prepared, their onsite surveys were completed and they made the deadline, she said. Others weren't ready and were encouraged to withdraw voluntarily from the Medicare program.
Under CMS rules, unaccredited providers who did not submit a voluntary termination of their Medicare billing number risk termination by the National Supplier Clearinghouse and will then not be able to reenroll for at least a year. Those who voluntarily withdrew their numbers can apply to reenroll once they are accredited, the agency has said.
However, Waterloo, Iowa-based service group VGM reported that some providers filed to withdraw their numbers only to discover that their accreditor had approved their accreditation status. The NSC, however, had already processed their voluntary withdrawal request and they had been terminated. VGM officials took the issue to CMS and were later told by the NSC that those providers who did receive accreditation by Oct. 1 could withdraw their termination request by submitting the appropriate sections of an updated CMS-855S form.
While it is too early to gauge the fallout from the accreditation program in terms of beneficiary access and the number of providers that dropped or were dropped from the program, it claimed at least one casualty on Wednesday, according to the Accredited Medical Equipment Providers of America.
"All Florida Medical Supply in Delray Beach [Fla.] is still listed as accredited through July 31, 2010, with the Accreditation Commission for Health Care (ACHC), but they recently closed their doors, leaving a staff of nine unemployed, and resigned from the Medicare program," reported AMEPA President Rob Brant. "This coming Monday, Oct. 5th, the former AMEPA member will have their remaining assets sold in an absolute auction to pay back creditors."
"'I spoke to the owners a few months ago about their potential closing,' said Jack Marquez, vice president of AMEPA and co-bidder in the first Round 1 with All Florida Medical Supply in the All Florida Network.
"We bid together in a network … in 2007," Marquez added. "Most of the members of the network were located in Miami-Dade County, and All Florida Medical had a 12-year history of providing quality service and products to cover Palm Beach County. Their client base was almost 100 percent Medicare, and with the 36-month cap in oxygen, 9.5 percent reduction in reimbursement, increased ongoing documentation requirements and mandatory surety bond, it is understandable why they and so many other companies are going out of business."
