Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices 46439 

1http://www.cms.gov/Research-Statistics-Dataand-Systems/Monitoring-Programs/CERT/ 

Downloads/CERT_Nov_2010_Appendix_-final.pdf 

Supplemental Appendix, Table B2. 

individual patients in Table 1 of the IJC 

paper and their inappropriate impact on 

the antibody values reported in Table II 

of the IJC paper were reported in detail 

by Respondent to the Managing Editor 

in IJC in email communications dated 

September 24 and 29, 2008. 

Dr. Ravindranath has entered into a 

Voluntary Settlement Agreement and 

has voluntarily agreed for a period of 

three (3) years, beginning on July 2, 

2012: 

(1) To have any PHS-supported 

research supervised; Respondent agreed 

that prior to the submission of an 

application for PHS support for a 

research project on which the 

Respondent’s participation is proposed 

and prior to Respondent’s participation 

in any capacity on PHS-supported 

research, Respondent shall ensure that a 

plan for supervision of Respondent’s 

duties is submitted to ORI for approval; 

the supervision plan must be designed 

to ensure the scientific integrity of 

Respondent’s research contribution; 

Respondent agreed that he shall not 

participate in any PHS-supported 

research until such a supervision plan is 

submitted to and approved by ORI; 

Respondent agreed to maintain 

responsibility for compliance with the 

agreed upon supervision plan; 

(2) That any institution employing 

him shall submit, in conjunction with 

each application for PHS funds, or 

report, manuscript, or abstract involving 

PHS- supported research in which 

Respondent is involved, a certification 

to ORI that the data provided by 

Respondent are based on actual 

experiments or are otherwise 

legitimately derived, that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract, and that 

the text in such submissions is his own 

or properly cites the source of copied 

language and ideas; and 

(3) To exclude himself voluntarily 

from serving in any advisory capacity to 

PHS including, but not limited to, 

service on any PHS advisory committee, 

board, and/or peer review committee, or 

as a consultant. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

John Dahlberg, 

Director, Division of Investigative Oversight, 

Office of Research Integrity. 

[FR Doc. 2012–18990 Filed 8–2–12; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the Baker Brothers Site in Toledo, 

Ohio, To Be Included in the Special 

Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: NIOSH gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees from the 

Bakers Brothers site in Toledo, Ohio, to 

be included in the Special Exposure 

Cohort under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. The initial 

proposed definition for the class being 

evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Baker Brothers. 

Location: Toledo, Ohio. 

Job Titles and/or Job Duties: All 

employees who worked in any area. 

Period of Employment: June 1, 1943 to 

December 31, 1996. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2012–19047 Filed 8–2–12; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6042–N] 

Medicare Program; Prior Authorization 

for Power Mobility Device (PMD) 

Demonstration 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 3- 

year Medicare Prior Authorization for 

Power Mobility Device (PMD) 

Demonstration for certain PMD codes in 

seven states where there have been high 

incidences of fraudulent claims and 

improper payments 

DATES: This demonstration begins on 

September 1, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Schwartz, 410–786–4197. 

Questions regarding the Medicare 

Prior Authorization for PMD 

Demonstration should be sent to 

pademo@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Power Mobility Devices have had 

historically high incidents of fraud and 

improper payments. PMD suppliers also 

continue to be subject to significant law 

enforcement investigation. 

The Health Care Fraud Prevention 

and Enforcement Action Team (HEAT) 

Task Force was launched in May 2009 

and is co-chaired by the Deputy 

Secretary of HHS and the Deputy 

Attorney General of DOJ. Medicare 

Fraud Strike Force teams are a key 

component of HEAT, since their 

inception and based on data driven 

investigations, prosecutors have filed 

more than 600 cases charging more than 

1,150 defendants who collectively billed 

the Medicare program more than $2.9 

billion in fraudulent claims. DME is a 

primary focus of investigation for these 

strike forces. 

The Comprehensive Error Rate 

Testing (CERT) Program noted in a 2010 

Report 1 that 92.6 percent of claims for 

motorized wheelchairs did not meet 

Medicare coverage requirements. 

Although we recognize that many 

improper payments are not the result of 

willful fraud, this error rate represents 

over $822 million dollars in estimated 

improper payments. 

II. Legislative Authority 

Section 402(a)(1)(J) of the Social 

Security Amendments of 1967, 42 

U.S.C. 1395b–1(a)(1)(J), authorizes the 

Secretary to conduct demonstrations 

designed to develop or demonstrate 

improved methods for the investigation 

and prosecution of fraud in the 

provision of care or services provided 

under the Medicare program. We plan to 

conduct a demonstration that 

implements a prior authorization 

process for power mobility devices 

(PMDs), an area with historically high 

levels of fraud and improper payments, 

to develop improved methods for the 

investigation and prosecution of fraud 


TKELLEY on DSK3SPTVN1PROD with NOTICES
46440 Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices 

in order to protect the Medicare Trust 

Fund from fraudulent actions and the 

resulting improper payments. We are 

conducting this 3-year demonstration in 

California, Florida, Illinois, Michigan, 

New York, North Carolina, and Texas. 

The beneficiary’s address as reported to 

the Social Security Administration 

(SSA) will determine participation in 

the demonstration. 

We believe this demonstration will 

provide the agency with valuable data 

through which the agency, working with 

its partners, can develop new avenues 

for combating the submission of 

fraudulent claims to the Medicare 

program for PMDs. We will share data 

developed from this demonstration 

within the agency, with our contractors, 

and with our law enforcement partners 

for further analysis and investigation. 

We believe that data evidencing changes 

in physician ordering and supplier 

billing practices that coincide with this 

demonstration could provide 

investigators and law enforcement with 

important information for determining 

how and where to focus their 

investigations concerning fraud in the 

provision of PMDs. For instance, results 

from this demonstration could 

potentially indicate collaboration 

between ordering physicians and 

suppliers in submitting fraudulent 

claims for PMDs. This data could assist 

investigators and law enforcement in 

targeting their investigations in this 

area. Additionally, changes in billing 

practices that result from this 

demonstration could provide specific 

leads for investigators and law 

enforcement personnel. For instance, 

where a supplier that frequently 

submitted claims prior to the 

demonstration stops submitting claims 

during the demonstration, law 

enforcement may determine it prudent 

to investigate that supplier. 

Data we will analyze will include the 

following: 

• Suppliers who no longer bill or 

have a significant decrease in billing. 

• Physicians/treating practitioners 

with a high volume of submissions. 

• Codes that show a dramatic 

increase in use. 

• Codes that show a dramatic 

decrease in use. 

The demonstration will likely have a 

secondary benefit to help identify and 

reduce improper payments. We 

recognize that many improper payments 

are not the result of willful fraud. 

Information shared with law 

enforcement will be limited to data on 

those providers and suppliers who are 

potentially submitting fraudulent claims 

and other information that we believe 

will assist with the investigation and 

prosecution of fraud. 

Section 402(b) of the Social Security 

Amendments of 1967 authorizes the 

Secretary to waive requirements in Title 

XVIII that relate to reimbursement and 

payment in order to carry out the 

demonstrations authorized under 

section 402(a). In accordance with 

section 402(b), the Secretary waives 

certain requirements of sections 1834(a), 

1834(j)(4) and 1879 of the Social 

Security Act to the extent necessary to 

implement this demonstration, 

including, but not limited to, certain 

payment and reimbursement regulations 

set forth at 42 CFR part 414, Subpart D 

and 42 CFR Part 411, Subpart K. 

III. Provisions of the Notice 

This demonstration will implement a 

prior authorization process for PMDs in 

seven states where historically there has 

been extensive evidence of fraud and 

improper payments (CA, FL, IL, MI, NY, 

NC, and TX). 

The prior authorization process under 

this demonstration is available for the 

following codes for Medicare payment: 

• Group 1 Power Operated Vehicles 

(K0800 through K0802 and K0812). 

• All standard power wheelchairs 

(K0813 through K0829). 

• All Group 2 complex rehabilitative 

power wheelchairs (K0835 through 

K0843). 

• All Group 3 complex rehabilitative 

power wheelchairs without power 

options (K0848 through K0855). 

• Pediatric power wheelchairs (K0890 

and K0891). 

• Miscellaneous power wheelchairs 

(K0898). 

Prior to the start of the demonstration, 

we have conducted and will continue to 

conduct outreach and education 

including webinars, in-state meetings 

and other education sessions. 

Additional information about the 

implementation of the prior 

authorization demonstration is available 

on the CMS Web site (go.cms.gov/ 

PAdemo). In addition, suppliers who 

have recently furnished and 

practitioners who have recently ordered 

a PMD for a beneficiary residing in a 

demonstration state will be notified via 

certified letters about the demonstration 

prior to the start date of the 

demonstration. 

Under this demonstration, a 

physician, treating practitioner, or 

supplier will be encouraged to submit to 

their Durable Medical Equipment (DME) 

Medicare Administrative Contractor 

(MAC) a request for prior authorization 

and all relevant documentation to 

support Medicare coverage of the PMD 

item along with the written order for the 

covered item. The physician, treating 

practitioner or supplier who submits the 

request on behalf of the physician or 

treating practitioner, is referred to as the 

‘‘submitter.’’ In order to be affirmed, the 

request for prior authorization must 

meet all applicable rules, policies, and 

National Coverage Determination 

(NCD)/Local Coverage Determination 

(LCD) requirements for PMD claims. 

LCD requirements mandating 

physician/treating practitioner 

origination, such as the seven-element 

order, face-to-face encounter 

documentation and whatever other 

clinical documentation is necessary, 

must be completed by the physician/ 

treating practitioner regardless of which 

entity is functioning as the submitter. 

The supplier will still complete the 

detailed product description regardless 

of which entity is functioning as the 

submitter. 

After receipt of all relevant 

documentation, CMS or its agents will 

make every effort to conduct a review 

and postmark the notification of their 

decision with the prior authorization 

number within 10 business days. 

Notification is provided to the 

physician/treating practitioner, 

supplier, and the Medicare beneficiary 

for the initial submission. If a 

subsequent prior authorization request 

is submitted after a nonaffirmative 

decision on a prior authorization 

request, then CMS or its agents will 

make every effort to conduct a review 

and postmark the notification of 

decision with the prior authorization 

number within 20 business days. These 

timeframes will become part of the 

contractors’ performance metrics. 

There will also be a mechanism in 

place to request an expedited review in 

emergency situations where a 

practitioner indicates clearly, with 

supporting rationale that the standard 

(routine) timeframe for a Prior 

Authorization Decision (10 days) could 

seriously jeopardize the beneficiary’s 

life or health. In these cases, the 

contractor will conduct an expedited 

review. The expedited request must be 

accompanied by the required supporting 

documentation for this request to be 

considered complete thus commencing 

the 48 hours for review. Inappropriate 

expedited requests may be downgraded 

to standard requests. After conducting 

an expedited review, CMS or its agents 

will communicate a decision for the 

prior authorization request to the 

submitter within 48 hours of the 

complete submission. 

The following explains the various 

prior authorization scenarios: 

• Scenario 1: When a submitter sends 

a prior authorization request to the DME 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices 46441 

MAC with appropriate documentation 

and all relevant Medicare coverage and 

documentation requirements are met for 

the PMD, then the DME MAC sends an 

affirmative prior authorization decision 

to the physician or treating practitioner, 

supplier, and Medicare beneficiary. 

When the claim is submitted to the DME 

MAC by the supplier, it is linked to the 

Prior Authorization via the claims 

processing system and so long as all 

applicable requirements in the 

applicable NCD/LCD are met, the claim 

is paid. 

• Scenario 2: When a submitter sends 

a prior authorization request but all 

relevant Medicare coverage 

requirements are not met for the PMD, 

then the DME MAC sends a 

nonaffirmative prior authorization 

decision to the physician or treating 

practitioner, supplier, and Medicare 

beneficiary advising them that Medicare 

will not pay for the item. A supplier can 

deliver the PMD, and submit a claim 

with a non-affirmative prior 

authorization decision, at which point 

the DME MAC would deny the claim. 

The supplier and/or the beneficiary 

would then have the Medicare denial 

for secondary insurance purposes and 

would have full appeal rights. 

If an applicable PMD claim is 

submitted without a prior authorization 

decision it will be stopped and 

documentation will be requested to 

conduct medical review. After the first 

3 months of the demonstration, we will 

assess a payment reduction for claims 

that, after review, are deemed payable, 

but did not first receive a prior 

authorization decision. As evidence of 

compliance, the supplier must submit 

the prior authorization number on the 

claim in order to avoid a 25 percent 

payment reduction. The 25 percent 

payment reduction is non-transferrable 

to the beneficiary and not subject to 

appeal. In the case of capped rental 

items, the payment reduction will be 

applied to all claims in the series. 

The 25-percent reduction in the 

Medicare payment is for each payable 

base claim not preceded by a prior 

authorization request except in 

competitive bidding areas. If a 

competitive bid contract supplier 

submits a payable claim for a 

beneficiary with a permanent residence 

in a competitive bidding area, that is 

included in the supplier’s contract, 

without first receiving a prior 

authorization decision, that competitive 

bid supplier would receive the 

applicable single payment amount 

under the competitive bid program, and 

would not be subject to the 25-percent 

reduction. These suppliers must still 

adhere to all other requirements of the 

demonstration. 

• Scenario 3: When a submitter sends 

a prior authorization request where 

documentation is incomplete, the prior 

authorization request is sent back to the 

submitter with an explanation about 

what information is missing. The 

submitter can rectify the situation and 

resubmit the prior authorization request. 

The physician or treating practitioner, 

supplier, and Medicare beneficiary are 

also notified. 

• Scenario 4: When the DME supplier 

fails to receive a prior authorization 

decision, but nonetheless delivers the 

item to the beneficiary and submits the 

claim to the DME MAC for payment, the 

PMD claim will be reviewed under 

normal medical review processing 

timeframes. 

++ If the claim is determined to be not 

medically necessary or insufficiently 

documented, the claim will be denied. 

The supplier and/or beneficiary can 

appeal the claim denial. If the claim, 

after review, is deemed not payable then 

all current beneficiary/supplier liability 

policies and procedures as well as 

appeal rights remain in effect. 

++ If the claim is determined to be 

payable, it will be paid. However, 3 

months after the start of the 

demonstration, a 25-percent reduction 

in the Medicare Payment will be 

applied for failure to receive a prior 

authorization decision before the 

submission of a claim. This payment 

reduction will not be applied for 

competitive bidding program contract 

suppliers submitting claims for 

beneficiaries who maintain a permanent 

residence in a Competitive Bidding Area 

in their contracts according to the 

Common Working File (CWF)); these 

contract suppliers will continue to 

receive the applicable single payment 

amount under their contracts. The 25- 

percent payment reduction is nontransferrable to the beneficiary for the 

claims that are deemed payable. This 

payment reduction will begin 3 months 

after the start of the demonstration and 

is not subject to appeal. In the case of 

capped rental items the payment 

reduction will be applied to all claims 

in the series. After a claim is submitted 

and processed, appeal rights are 

available as they normally are. 

Under the demonstration, we will 

work to limit the impact on 

beneficiaries. We will educate 

beneficiaries as part of this protection. 

If the prior authorization request is not 

affirmed, and the claim is still 

submitted by the supplier, the claim 

will be denied in full, but beneficiaries 

will continue to have all normal appeal 

rights as well as the option of signing an 

Advance Beneficiary Notice in order to 

receive and be liable for payment for a 

denied PMD. 

Additional information is available on 

the CMS Web site at go.cms.gov/ 

PAdemo. 

IV. Collection of Information 

Requirements 

We announced and solicited 

comments for the information collection 

requirements associated with the 

Medicare Prior Authorization for Power 

Mobility Device (PMD) Demonstration 

for certain PMD codes in 60-day and 30- 

day Federal Register notices that 

published on February 7, 2012 (77 FR 

6124) and May 29, 2012 (77 FR 31616), 

respectively. The information collection 

requirements are approved under OMB 

control number 0938–1169. 

Authority: Section 402(a)(1)(J) of the 

Social Security Amendments of 1967. 

Dated: July 30, 2012 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–19014 Filed 8–1–12; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0386] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco 

Product Establishments and Listing of 

Ingredients in Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

4, 2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 


TKELLEY on DSK3SPTVN1PROD with NOTICES