[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69488-69490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27578]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-6064-N]
Medicare Program; Prior Authorization of Non-Emergent Hyperbaric
Oxygen (HBO) Therapy
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces a 3-year Medicare Prior Authorization
model for non-emergent hyperbaric oxygen therapy services in the states
of Illinois, Michigan, and New Jersey where there have been high
incidences of improper payments for these services.
DATES: The model will begin on March 1, 2015 in Michigan, New Jersey,
and Illinois.
FOR FURTHER INFORMATION CONTACT: Jennifer McMullen, (410) 786-7635.
Questions regarding the Medicare Prior Authorization Model for Non-
Emergent Hyperbaric Oxygen (HBO) Therapy should be sent to
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Hyperbaric Oxygen (HBO) therapy is a modality used for treatment of
wounds in which the entire body is exposed to oxygen under increased
atmospheric pressure. HBO therapy is covered as adjunctive therapy only
after there have been no measurable signs of healing during at least 30
consecutive days of treatment with standard wound therapy, and must be
used in addition to standard wound care. Wounds must be evaluated at
least every 30 days during administration of HBO therapy. Continued
treatment with HBO therapy is not covered if measurable signs of
healing have not been demonstrated within any 30-day period of
treatment.
Medicare issued a National Coverage Determination (NCD) for HBO
therapy in 2002, which lists clinical conditions for which HBO therapy
is medically necessary and clinical conditions for which HBO therapy is
not medically necessary, and therefore; not covered by Medicare. The
NCD can be found in the Medicare National Coverage Determinations
Manual (CMS Pub. No. 100-03), Chapter 1, Part 1, Section 20.29, and in
the NCD database at http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=37&bc=AiAAAAAAAgAAAA%3d%3d&. In
addition, some of
[[Page 69489]]
the Medicare Administrative Contractors (MACs) have Local Coverage
Determinations (LCDs) that expand on the NCD.
In 2000, a report by the HHS Office of Inspector General \1\ on
hyperbaric oxygen therapy found the following:
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\1\ Office of Inspector General, Hyperbaric Oxygen Therapy, Its
Use and Appropriateness, October 2000.
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$14.2 million (of $49.9 million in allowed charges for
outpatient hospital departments and physicians) was paid in error,
either for beneficiaries who received treatments for non-covered
conditions or when documentation did not adequately support HBO.
An additional $4.9 million was paid for treatments deemed
to be excessive.
Lack of testing and treatment monitoring raised quality of
care concerns.
Data from CMS' Chronic Condition Warehouse were used to determine
state rankings based on average number of sessions per beneficiary.
States were then ranked by expenditures. Illinois, Michigan, and New
Jersey were selected as the initial states for the model because they
ranked in the top three for average number of sessions per beneficiary.
Section 1115A of the Social Security Act (the Act) authorizes the
Secretary to test innovative payment and service delivery models to
reduce program expenditures, while preserving or enhancing the quality
of care furnished to Medicare, Medicaid, and Children's Health
Insurance Program beneficiaries.
Section 1115A(d)(1) of the Act authorizes the Secretary to waive
such requirements of Titles XI and XVIII and of sections 1902(a)(1),
1902(a)(13), and 1903(m)(2)(A)(iii) of the Act as may be necessary
solely for purposes of carrying out section 1115A of the Act with
respect to testing models described in section 1115A(b) of the Act. For
this model, consistent with this standard, we will waive such
provisions of sections 1834(a)(15) and 1869(h) of the Act that limit
our ability to conduct prior authorization. We have determined that the
implementation of this model does not require the waiver of any fraud
and abuse law, including sections 1128A, 1128B, and 1877 of the Act.
Thus, providers and suppliers affected by this model must comply with
all applicable fraud and abuse laws. While these provisions are
specific to durable medical equipment (DME) and physician services, we
will waive any portion of these sections as well as any portion of 42
CFR 410.20(d) of the regulations, which implements section 1869(h) of
the Act, that could be construed to limit our ability to conduct prior
authorization.
II. Provisions of the Notice
We plan to implement a 3-year Medicare Prior Authorization process
for non-emergent HBO therapy rendered in 3 states (Illinois, Michigan,
and New Jersey). These states were selected as the initial states for
the model because of their high utilization and improper payment rates
for this service. The model will begin in Michigan, New Jersey, and
Illinois on March 1, 2015.
We plan to test whether prior authorization helps reduce
expenditures, while maintaining or improving quality of care, using a
model that would establish a prior authorization process for non-
emergent HBO therapy to reduce utilization of services that do not
comply with Medicare policy.
We plan to use this prior authorization process to ensure that all
relevant clinical or medical documentation requirements are met before
services are rendered to beneficiaries and before claims are submitted
for payment. This prior authorization process will further ensure that
payment complies with Medicare documentation, coverage, payment, and
coding rules.
The use of prior authorization will not create new clinical
documentation requirements. Instead, it will require the same
information that is already required to support Medicare payment, just
earlier in the process. Prior authorization allows facilities to
address issues with claims prior to rendering services.
The prior authorization process under this model will be available
for the following code for Medicare payment: C1300--Hyperbaric oxygen
under pressure, full body chamber, per 30 minute interval.
Prior authorization is only needed for the facility payment part of
the HBO therapy service. However, if a facility does not have prior
authorization, or has a non-affirmed prior authorization, the
associated physician claims with the following code will be subject to
medical review: 99183--Physician attendance and supervision of
hyperbaric oxygen, per session.
Of the 15 covered clinical conditions listed in the NCD, the
following 6 will be available for prior authorization:
Preparation and preservation of compromised skin grafts
(not for primary management of wounds).
Chronic refractory osteomyelitis, unresponsive to
conventional medical and surgical management.
Osteoradionecrosis as an adjunct to conventional
treatment.
Soft tissue radionecrosis as an adjunct to conventional
treatment.
Actinomycrosis, only as an adjunct to conventional therapy
when the disease process is refractory to antibiotics and surgical
treatment.
Diabetic wounds of the lower extremities in patients who
meet the following three criteria:
++ Patient has Type I or Type II diabetes and a lower extremity
wound that is due to diabetes.
++ Patient has a wound classified as Wagner grade III or higher.
++ Patient has failed an adequate course of wound therapy as
defined in the NCD.
A provisional affirmative prior authorization decision, justified
by the beneficiary's condition, may affirm up to 36 treatments in a 12-
month period. A provisional affirmation is a preliminary finding that a
future claim submitted to Medicare for the service likely meets
Medicare's coverage, coding, and payment requirements. A provisional
affirmative decision can be for all or part of the requested number of
treatments. If additional treatments are needed, a subsequent prior
authorization request must be submitted.
Prior to the start of the model, we will conduct (and thereafter
will continue to conduct) outreach and education to facilities that
provide HBO therapy, as well as to beneficiaries, through such methods
as Open Door Forums, frequently asked questions (FAQs) on our Web site,
other Web site postings, and educational materials issued by the
Medicare Administrative Contractors (MACs). Additional information
about the implementation of the prior authorization model is available
on the CMS Web site at http://go.cms.gov/PAHBO.
Under this model prior authorization process, the facility or
beneficiary will be encouraged to submit to the MAC a request for prior
authorization along with all relevant documentation to support Medicare
coverage of the HBO therapy. In order to be affirmed, the request for
prior authorization must meet all applicable rules and policies, and
any NCD and Local Coverage Determination (LCD) requirements for HBO
therapy.
After receipt of all relevant documentation, the MACs will make
every effort to conduct a review and postmark the notification of their
decision on a prior authorization request within 10 business days for
an initial submission. Notification will be provided to the submitter
of the prior
[[Page 69490]]
authorization request (and, upon request, to the beneficiary if he or
she was not the original submitter). If a subsequent prior
authorization request is submitted after a non-affirmative decision on
an initial prior authorization request, the MACs will make every effort
to conduct a review and postmark the notification of their decision on
the request within 20 business days.
A facility or beneficiary may request an expedited review when the
standard timeframe for making a prior authorization decision could
jeopardize the life or health of the beneficiary. If the MAC agrees
that the standard review timeframe would put the beneficiary at risk,
the MAC will make reasonable efforts to communicate a decision within 2
business days of receipt of all applicable, Medicare-required
documentation. As this model is for a non-emergent service only, we
expect requests for expedited reviews to be extremely rare.
The following describes examples of various prior authorization
scenarios:
Scenario 1: When a facility or beneficiary submits a prior
authorization request to the MAC with appropriate documentation and all
relevant Medicare coverage and documentation requirements are met for
the HBO therapy, the MAC will send a provisional affirmative prior
authorization decision to the submitter (and, upon request, to the
beneficiary if he or she was not the original submitter). When the
claim is submitted to the MAC, it is linked to the prior authorization
via the claims processing system and the claim is paid so long as all
Medicare coding, billing, and coverage requirements are met. However,
after submission, the claim could be denied for technical reasons, such
as the claim being a duplicate claim or being for a date of service
after a beneficiary's death.
Scenario 2: When a facility or beneficiary submits a prior
authorization request but all relevant Medicare coverage requirements
are not met, the MAC will send a non-affirmative prior authorization
decision to the submitter (and, upon request, to the beneficiary if he
or she was not the original submitter), advising them that Medicare
will not pay for the service. The facility or beneficiary may then
resubmit the request with documentation showing that Medicare
requirements have been met. Alternatively, a facility could render the
service, and submit a claim with a non-affirmative prior authorization
tracking number, at which point the MAC would deny the claim. The
facility or the beneficiary would then have the Medicare denial for
secondary insurance purposes and would have the opportunity to submit
an appeal of the claim denial if they believe Medicare coverage was
denied inappropriately.
Scenario 3: When a facility or beneficiary submits a prior
authorization request with incomplete documentation, a detailed
decision letter will be sent to the submitter (and, upon request, to
the beneficiary if he or she was not the original submitter) with an
explanation of what information is missing. The facility or beneficiary
can rectify the situation and resubmit the prior authorization request
with appropriate documentation.
Scenario 4: When a facility renders a service that is
subject to the prior authorization process to a beneficiary, and
submits the claim to the MAC for payment without requesting a prior
authorization, the claim will be stopped for prepayment review and
documentation will be requested.
++ If the claim is determined to be not medically necessary or to
be insufficiently documented, the claim will be denied, and all current
policies and procedures regarding liability for payment will apply. The
facility and/or beneficiary can appeal the claim denial if they believe
the denial was inappropriate.
++ If the claim is determined to be payable, it will be paid.
Under the model, we will work to limit any adverse impact on
beneficiaries and to educate beneficiaries about the process. If a
prior authorization request is not affirmed, and the claim is still
submitted by the facility, the claim will be denied in full, but
beneficiaries will continue to have all applicable administrative
appeal rights.
Only one prior authorization request per beneficiary per designated
time period can be provisionally affirmed. If the initial facility
cannot complete the total number of HBO treatments (for example, the
initial facility closes or the beneficiary moves out of the area), the
initial request is cancelled. In this situation, a subsequent prior
authorization request may be submitted for the same beneficiary and
must include the required documentation in the submission. If multiple
facilities are providing HBO treatments to the beneficiary during the
same or overlapping time period, the prior authorization decision will
only cover the facility indicated in the provisionally affirmed prior
authorization request. Any facility submitting claims for which no
prior authorization request is recorded will be subject to 100 percent
pre-payment medical review of those claims.
Additional information is available on the CMS Web site at http://go.cms.gov/PAHBO.
III. Collection of Information Requirements
Section 1115A(d)(3) of the Act, as added by section 3021 of the
Affordable Care Act, states that chapter 35 of title 44, United States
Code (the Paperwork Reduction Act of 1995), shall not apply to the
testing and evaluation of models or expansion of such models under this
section. Consequently, this document need not be reviewed by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 35).
Authority: Section 1115A of the Social Security Act.
Dated: October 8, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-27578 Filed 11-20-14; 8:45 am]
BILLING CODE 4120-01-P