No M.D.? Then No Home Sleep Testing

ATLANTA–In an unexpected move last week, the four regional DME
MACs issued a revised Local Coverage Determination for CPAP policy
prohibiting HME providers from conducting home sleep tests.

According to the LCD, “No aspect of a HST including but
not limited to delivery and/or pickup of the device, may be
performed by a DME supplier. This prohibition does not extend to
the results of studies conducted by hospitals certified to do such
tests.”

The new LCD caught the HME industry off guard, particularly
following CMS’ National Coverage Determination on coverage of CPAP
therapy for obstructive sleep apnea–issued March 13–which opened
the door for HST. (See
HomeCare Monday, March 17.)

But according to Patrick Clevidence, vice president of
respiratory services, Medical Service Company, Cleveland, “In
clear and precise language, the LCDs eliminated HME involvement in
home sleep testing, and they further stated that only sleep
physicians may be involved in the tests.”

Under the new regulation, primary care physicians, internal
medicine physicians and even cardio-thoracic physicians may be
unable to perform the tests.

The guidelines require all sleep tests to be interpreted by a
physician who is:

–A diplomat of the American Board of Sleep Medicine (ABSM); –A
diplomat in Sleep Medicine by a member board of the American Board
of Medical Specialties (ABMS); or –An active staff member of a
sleep center or laboratory accredited by the American Academy of
Sleep Medicine (AASM) or The Joint Commission.

“This eliminates involvement by primary care physicians,
cardiologists and other physicians,” Clevidence explained,
adding that while those physicians and others can prescribe the
tests, “these same physicians must defer to a sleep physician
and their staff to perform the tests and interpret the
results.”

Clevidence continued, “There is no doubt that many in the
HME community are disappointed with this ruling, especially in
light of the recent Medicare cuts and the pain of the competitive
bid process. Many HMEs looked at this as a new revenue opportunity
and a way to increase their sleep business. Now it is clear that
this will not happen.”

However, Clevidence noted, he feels this is a sound decision
that will maintain the integrity and quality of sleep testing with
those specialists who know it best and can make the best
therapeutic plan of care for their patients.

Reaction from other HME stakeholders was mixed.

“The whole point of the National Coverage Determination
was to provide easier and earlier access to care for these patients
who were entering the health care system 10 years too late and
driving up huge bills because of the present comorbidities due to
having their sleep apnea untreated. Now, they are again putting a
barrier to treatment,” said Kelly Riley, director of the
National Respiratory Network for The MED Group, Lubbock, Texas.

Carol Laumer, executive director of Rice Home Medical in
Willmar, Minn., also believes providers should be able to perform
the tests. “This will be difficult for them and will be a
blow to their financial bottom line. I see CMS following the rule
they have used with home oxygen but in a more stringent
manner,” she said. “The technology is there, and if we
can provide infusion medications and can do ventilators in the
home, I believe we can do home sleep studies and that they can be
accurate,” she said.

According to Todd Cressler, CEO of Harrisburg, Pa.-based
CressCare Medical, “The result will be that home testing will move
a little slower, but all the labs will eventually offer it to be
competitive. Forward-thinking physicians will get on board with
this and realize that home testing will get people on therapy that
would normally not go into a sleep lab to get their
[polysomography].”

Cressler sees the situation as an opportunity for HME providers
to partner with sleep labs. “For the labs that are doing
their own DME, they will not be able to do that with home testing,
so that is an opportunity for us.”

Clevidence also said he is a proponent of partnering with sleep
labs to help improve patient compliance and outcomes. “This
decision will help foster that between the sleep labs and the HME
companies. There are so many ways an HME can help a sleep lab grow
their business and, thus, increase their own business. This kind of
creative thinking results in a victory for both businesses but,
most importantly, the patient is the biggest winner of all,”
he said.

The revised LCD also changes the name of the policy to
“Positive Airway Pressure (PAP) Devices for the Treatment of
Obstructive Sleep Apnea.”

According to the LCD, “The change reflects the addition of
coverage criteria for respiratory assist devices (E0470 and E0471)
when used to treat OSA. With the addition of these coverage
criteria to the PAP policy, provisions related to the use of codes
E0470 and E0471 for OSA were removed from the Respiratory Assist
Device (RAD) policy. A revision of the RAD policy reflecting this
change will be published in the near future.”

While Riley said most of the policy is “good
medicine,” she is concerned about some aspects of the LCD,
especially language that states providers are “encouraged to
educate physicians.”

“This is the most frustrating part, because providers are
put in the position to tell physicians how to practice medicine.
This is never well-received, and it is not appropriate or
practical,” she said. Some in the sleep sector said the issue
of fraud may have played a role in the decision on the LCD.

Existing regulations restrict only suppliers from performing the
sleep diagnostic test, but in the July 7 Federal Register,
CMS issued a proposed rule that would prohibit CPAP reimbursement
if a supplier “or its affiliate” performs the test.
According to the proposed rule:

We are proposing to revise the durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS) supplier enrollment
safeguards … to protect the Medicare program and its
beneficiaries from fraudulent or abusive practices that may be
related to CPAP devices. We are proposing to add new definitions
… to define ‘‘sleep test’’ and
‘‘CPAP device’’ and to add a new paragraph
… which would establish a specific payment prohibition that
would not allow the supplier to receive Medicare payment for a CPAP
device if that supplier, or its affiliate, is directly or
indirectly the provider of the sleep test used to diagnose a
beneficiary with OSA

CMS said the agency believes that “the interests of
beneficiaries and the Medicare program can be harmed if the
provider of a diagnostic test has a vested interest in the outcome
of the test itself.”

Laumer is not surprised. “It does seem as if they try to
find ways to trip up HME providers and pay less for medical
equipment. It is time [CMS] starts sharing the responsibility for
fraud,” she said.

The comment period for the proposed rule is open until Aug. 29.
To submit electronic comments, go to
www.regulations.gov/search/index.jsp and enter CMS-1403-P in
the “Comment or Submission” bar.

To read the full text of the new LCD,
click here.