Accreditation Deadline Brings Action, Anxiety

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.”