Home Sleep Testing Gets the Nod

BALTIMORE–As expected for months, on Thursday, CMS issued its
final decision memo on home sleep testing.

The agency’s reconsideration of the national coverage
determination for CPAP therapy now allows for home testing for
obstructive sleep apnea with type II, III and IV devices (those
measuring at least three channels), as well as for polysomnography
in a sleep lab.

But the new NCD also initially limits coverage of CPAP to a
12-week period for beneficiaries.

Some patients with OSA do not continue with CPAP treatment or do
not improve on treatment. Thus, CMS said it is limiting initial
coverage of CPAP for OSA to 12 weeks to determine if the
beneficiary will respond to the treatment. Long-term CPAP will be
covered for those beneficiaries who continue and respond to
treatment, the agency said.

While there were some surprises, industry stakeholders said they
view the new coverage policy as mostly positive.

“It is a great first step in bringing needed clinical
diagnostic procedures to the home setting and ensuring to those in
rural and outlying areas access to the medical care they
require,” said Tom Pontzius, president of Waterloo,
Iowa-based VGM’s Nationwide Respiratory. “However, the
inclusion of type IV devices is still a surprise as well as the
requirement that initially limits CPAP therapy to 12
weeks.”

Marcia Nusgart, executive director of the Coalition of
Respiratory Care Manufacturers in Bethesda, Md., said the group is
pleased with CMS’ decision since it will open up the potential for
more people to be tested.

“The goal is to get more people tested and treated,”
she said, “given the data that of the 20 million to 40
million people with obstructive sleep apnea, there have been
approximately 6 million who have been tested after 20
years.”

Nusgart said the NCD will “have a very positive impact on
the HME industry” in helping providers “put new
programs in place aligned with the needs of physicians, sleep
clinicians and patients.” However, she continued, many of the
“details for implementation will need to be addressed by the
Medicare contractors.”

According to Pontzius, “The yet to be announced [local
coverage determinations] will be the proof in the pudding on
whether or not this NCD is good for patients and the industry. It
will certainly provide opportunities for HME providers to diversify
their businesses, but the scope of that impact is yet to be
determined until the LCDs are released … There may be
requirements and protocols that could affect the involvement of HME
providers in a negative manner.”

Kristin Mastin, director of marketing for DeVilbiss Healthcare,
Somerset, Pa., noted the decision does raise “some important
questions.

“Regarding the 12-week CPAP trial, what constitutes an
improvement in the condition, and how is adherence defined?”
Mastin asked. “We are curious what the home testing
reimbursement fee will be as well as who will be able to administer
the tests. Also, there was no mention of how CPAP units will be
titrated in the home. It seems reasonable that auto-adjust units
would be used to titrate; however, these units are still reimbursed
at standard CPAP rates, and there was no indication in this
decision that the rate will be increased.”

Mastin said DeVilbiss was pleased to see an emphasis on
education and the evaluation of patient aptitude to administer the
test at home, adding this will be critical to ensuring validity of
the test data.

“Our revised policy provides more options for Medicare
beneficiaries and their treating physicians,” stated Kerry
Weems, CMS’ acting administrator, in a release. “At the
same time, we remain vigilant to ensure that Medicare payments for
these services do not create incentives for inappropriate
use.”

CMS will continue to monitor the use of the CPAP home testing
services, the statement said, “examining the potential for
fraud and abuse as well as making recommendations to implement
appropriate safeguards to mitigate potential risk.”

Neither Nusgart nor Pontzius believe the new policy will result
in fraudulent behavior.

“The issue of potential fraud will probably be addressed
in policies developed by the Medicare contractors,” Nusgart
pointed out.

“I don’t think that fraud will be a huge issue as
there are a number of checks and balances that have been put in
place. But with anything, there will be a few that will try to game
the system and possibly make it through the system,” Pontzius
said.

Pontzius also had this advice:

“Physicians are involved in the process at all levels of
care and, as a provider, I would be certain that there is an
understanding of the information that physicians would like to see
and how many parameters they would like measured. Although all
devices that have been classified as type II, III or IV are
acceptable means of providing diagnostic testing, it doesn’t
mean the physicians will be on board from a clinical
standpoint.”

The coverage decision also removed the requirement that the test
must produce results from a minimum two hours of continuous
recorded sleep time, stating the “effect of this change is to
permit coverage of CPAP in those beneficiaries whose OSA was
paradoxically too severe to permit successful completion of the
test under the previous NCD without removing coverage for
beneficiaries who would have met the requirements of the previous
NCD.”

Other elements of the decision include the following:

–The elimination of the distinct requirements that an
individual have moderate-to-severe OSA and that surgery is a likely
alternative.
–Coverage for CPAP therapy for other conditions, such as
narcolepsy and nocturnal seizures, is not indicated by this
NCD.
–The initiation of home sleep testing or evaluation of the test
results without a prior order from the beneficiary’s treating
physician will not be covered.
–If a home sleep test does not appear to be appropriate for the
patient or the result of a HST is insufficient, CMS believes the
treating physician will order a polysomnogram.
–CMS chose not to make a specific determination regarding whether
independent diagnostic testing facilities can provide HSTs.
–CMS does not believe PSG is the true “gold standard”
for diagnosing OSA.
–CMS commented on oximetry, stating “it cannot be confident
that this diagnostic modality accurately identifies those patients
with OSA who will respond clinically to CPAP and excludes those who
will not.”

According to Mastin, the NCD marks “the dawn of a new day
in the sleep industry.

“I think we will all learn through this process and,
hopefully, be able to provide more therapeutic benefits to patients
who desperately need it,” she said. “Home testing is
certainly more comfortable for the patient and, based on this, one
would assume that the market will grow.”

View the decision memo in full.