69488 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

determinations of ITL situations; and 

surveyor documentation that includes a 

detailed deficiency statement that 

clearly supports the determination of 

manner and degree of non-compliance 

and the appropriate level of citation. 

• Section 488.8(a)(2)(iv), to 

strengthen surveyor documentation to 

include sufficient detail to support the 

determination of the manner and degree 

of non-compliance and the appropriate 

level of deficiency citation. 

• Section 489.13, related to the 

effective date of accreditation for 

facilities undergoing a survey for 

purposes of its initial participation in 

Medicare; to ensure the effective date of 

accreditation when deficiencies have 

been identified, and to ensure it is 

consistent with CMS regulatory 

requirements. 

• To ensure comparability with the 

survey process requirements at 

§ 488.26(d), TJC must have— 

++ Updated its accreditation process 

policies to clarify that all surveys for 

TJC’s Medicare ASC accreditation 

program are conducted unannounced. 

++ Updated its accreditation process 

policies to ensure all required follow-up 

surveys for its Medicare ASC 

accreditation program meet the 

Medicare requirements. 

++ Revised its accreditation process 

policies to clarify that the appropriate 

level of citation be made when an 

Immediate Threat to Health or Safety is 

identified. 

++ Clarified its survey policies in the 

surveyor activity guide (SAG) to address 

how ‘‘Special Issue Resolution’’ is 

handled during surveys lasting only 1 

day. 

++ Updated its ASC accreditation 

process policies to clearly demonstrate 

that the policies are related to ASCs and 

not hospitals. 

• Section 488.28(a), to include all 

documented observations of noncompliance and all internal, 

uncompleted Plans for Improvement 

(PFI) listed in the accredited ASC’s 

‘‘Statement of Condition (SOC) to 

correct Life Safety Code Deficiencies’’ 

into the survey report. In addition, TJC 

will provide CMS with rationale for 

each standard for which TJC has 

determined will not require a citation of 

non-compliance when a single 

observation has been made. 

• Complied with section 1861(e)(9)(C) 

of the Act, to require that waiver and 

equivalency requests submitted by 

accredited organizations for Life Safety 

Code deficiencies that would result in 

unreasonable hardship for such a 

facility to resolve and would not 

jeopardize patient health or safety, be 

reviewed by TJC, and forwarded to CMS 

for approval, as appropriate. 

• To demonstrate comparability with 

minimum eligibility requirements for 

Initial surveys, increased the minimum 

number of patients/volume of services 

from three patients served with one 

active at the time of survey, to ten 

patients served, with one active at the 

time of survey. 

• To comply with TJS’s own policies, 

TJS must— 

++ Ensure its surveyors complete the 

ASC Infection Control Worksheet on 

every survey. 

++ Ensure its surveyors observe at 

least one surgery during every survey. 

++ Ensure that the minimum number 

of medical records have been reviewed 

on every survey. 

++ Ensure that findings noted on the 

Infection Control Worksheet are 

integrated into the survey report 

findings. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we approve TJC as a national 

accreditation organization for ASCs that 

request participation in the Medicare 

program, effective December 20, 2014 

through December 20, 2020. 

To verify TJC’s continued compliance 

with the provisions of this final notice, 

we will conduct a follow-up corporate 

on-site visit and survey observation 

within 18 months of the date of 

publication of this final notice. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

Dated: November 5, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–27577 Filed 11–20–14; 8:45 am] 

BILLING CODE 4120–01–P 

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. 

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 NonEmergent 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-coveragedatabase/details/nca-decision-memo.

aspx?NCAId=37&bc=AiAAAAAAA

gAAAA%3d%3d&. In addition, some of 

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Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69489 

1Office of Inspector General, Hyperbaric Oxygen 

Therapy, Its Use and Appropriateness, October 

2000. 

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: 

• $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 

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69490 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

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 nonaffirmative 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 nonaffirmative 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1464–N] 

Medicare Program; Town Hall Meeting 

on FY 2016 Applications for New 

Medical Services and Technology AddOn Payments 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

Town Hall meeting in accordance with 

section 1886(d)(5)(K)(viii) of the Social 

Security Act (the Act) to discuss fiscal 

year (FY) 2016 applications for add-on 

payments for new medical services and 

technologies under the hospital 

inpatient prospective payment systems 

(IPPS). Interested parties are invited to 

this meeting to present their comments, 

recommendations, and data regarding 

whether the FY 2016 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criterion. 

DATES: Meeting Date: The Town Hall 

Meeting announced in this notice will 

be held on Tuesday, February 3, 2015. 

The Town Hall Meeting will begin at 

9:00 a.m. Eastern Standard Time (e.s.t.) 

and check-in will begin at 8:30 a.m. 

e.s.t. 

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