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[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69488-69490]
From the Federal Register Online via the Government Printing 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 
HBOPA@cms.hhs.gov.

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
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