27400 Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices 

specifically required the Secretary to 

establish and implement programs 

under which competitive bidding areas 

are established throughout the United 

States for contract award purposes for 

the furnishing of certain competitively 

priced items and services for which 

payment is made under Medicare Part 

B. This program is commonly known as 

the ‘‘Medicare DMEPOS Competitive 

Bidding Program.’’ 

CMS conducted its first round of 

bidding for the Medicare DMEPOS 

Competitive Bidding Program in 2007 

with the help of its contractor, the 

Competitive Bidding Implementation 

Contractor. CMS published a Request 

for Bids instructions and accompanying 

forms for suppliers to submit their bids 

to participate in the program. During 

this first round of bidding, DMEPOS 

suppliers from across the U.S. submitted 

bids identifying the MSA(s) to service 

and the competitively bid item(s) they 

wished to furnish to Medicare 

beneficiaries. CMS evaluated these bids 

and contracted with those suppliers that 

met all program requirements. The first 

round of bidding was successfully 

implemented on July 1, 2008. 

On July 15, 2008, however, Congress 

delayed this program in section 154 of 

the Medicare Improvements for Patients 

and Providers Act of 2008 (MIPPA). 

MIPPA mandated certain changes to the 

competitive bidding program which 

included, but are not limited to: a delay 

of Rounds 1 (competition began in 2009) 

and 2 of the program (competition began 

in 2011 in 70 specific MSAs); the 

exclusion of Puerto Rico and negative 

pressure wound therapy from Round 1 

and group 3 complex rehabilitative 

power wheelchairs from all rounds of 

competition; a process for providing 

feedback to suppliers regarding missing 

financial documentation; and a 

requirement for contract suppliers to 

disclose to CMS information regarding 

subcontracting relationships. Section 

154 of the MIPPA specified that the 

competition for national mail order 

items and services may be phased in 

after 2010 and established a rule 

requiring that a bidder demonstrate that 

its bid covers 50 percent (or higher) of 

the types of diabetic testing strips, based 

on volume (the ‘‘50 percent rule’’) for 

national mail order competitions. As 

required by MIPPA, CMS conducted the 

competition for the Round 1 Rebid in 

2009. The Round 1 Rebid contracts and 

prices became effective on January 1, 

2011. 

The Affordable Care Act, enacted on 

March 23, 2010, expanded the Round 2 

competition by adding an additional 21 

MSAs, bringing the total MSAs for 

Round 2 to 91. The competition for 

Round 2 began in December 2011. CMS 

also began a competition for National 

Mail Order of Diabetic Testing Supplies 

at the same time as Round 2. The Round 

2 and National Mail-Order contracts and 

prices have a target implementation date 

of July 1, 2013. 

The MMA requires the Secretary to recompete contracts not less often than 

once every 3 years. Most Round 1 Rebid 

contracts will expire on December 31, 

2013. (Round 1 Rebid contracts for mailorder diabetic testing supplies ended on 

December 31, 2012.) Consequently, we 

are currently in the process of recompeting the competitive bidding 

contracts in the Round 1 Rebid areas. 

The most recent approval for this 

information collection request (ICR) was 

issued by OMB on October 10, 2012. 

Since then, CMS has decided to 

sequentially update the paperwork 

burden necessary to administer the 

program as it expands nationally and 

cycles through multiple rounds of 

competition. Specifically, we are now 

seeking to update our burden estimates 

for certain contract maintenance forms 

for Round 2 and the national mail-order 

competitions. These include Form C 

and the Contract Supplier’s Disclosure 

of Subcontractors form. We are also 

requesting approval of two additional 

forms: the Change of Ownership 

(CHOW) Purchaser Form and the CHOW 

Contract Supplier Notification Form, 

which will be utilized in all rounds of 

competition. Finally, we are retaining 

without change Forms A, B, and D and 

their associated burden under this ICR. 

We note that the information collection 

for Forms A and B is already complete. 

We intend to continue use of the forms 

in future rounds of competition. 

Form Number: CMS–10169 (OCN: 

0938–1016). Frequency: Occasionally. 

Affected Public: Private Sector (business 

or other for-profits) and Individuals or 

households. Number of Respondents: 

19,035. Total Annual Responses: 

19,035. Total Annual Hours: 9,311. (For 

policy questions regarding this 

collection contact Michael Keane at 

410–786–4495. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on June 10, 2013. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer. Fax Number: (202) 395– 

6974. Email: 

OIRA_submission@omb.eop.gov. 

Dated: May 6, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group,Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–11033 Filed 5–9–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–R–70, CMS–R– 

72, CMS–R–247, CMS–10287, CMS–R–43, 

CMS–855(POH), CMS–2552–10, and CMS– 

10062] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Reinstatement with a change of 

a previously approved collection; Title 

of Information Collection: Information 

Collection Requirements in HSQ–110, 

Acquisition, Protection and Disclosure 

of Peer review Organization Information 

and Supporting Regulations in 42 CFR, 

Sections 480.104, 480.105, 480.116, and 

480.134; Use: The Peer Review 

Improvement Act of 1982 authorizes 

quality improvement organizations 

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Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices 27401 

(QIOs), formally known as peer review 

organizations (PROs), to acquire 

information necessary to fulfill their 

duties and functions and places limits 

on disclosure of the information. The 

QIOs are required to provide notices to 

the affected parties when disclosing 

information about them. These 

requirements serve to protect the rights 

of the affected parties. The information 

provided in these notices is used by the 

patients, practitioners and providers to: 

obtain access to the data maintained and 

collected on them by the QIOs; add 

additional data or make changes to 

existing QIO data; and reflect in the 

QIO’s record the reasons for the QIO’s 

disagreeing with an individual’s or 

provider’s request for amendment.: 

Form Number: CMS–R–70 (OCN: 0938– 

0426); Frequency: Reporting—On 

occasion; Affected Public: Business or 

other for-profits; Number of 

Respondents: 400; Total Annual 

Responses: 21,200; Total Annual Hours: 

42,400. (For policy questions regarding 

this collection contact Coles Mercier at 

410–786–2112. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Information Collection Requirements in 

42 CFR 478.18, 478.34, 478.36, 478.42, 

QIO Reconsiderations and Appeals; Use: 

In the event that a beneficiary, provider, 

physician, or other practitioner does not 

agree with the initial determination of a 

Quality Improvement Organization 

(QIO) or a QIO subcontractor, it is 

within that party’s rights to request 

reconsideration. The information 

collection requirements at 42 CFR 

478.18, 478.34, 478.36, and 478.42, 

contain procedures for QIOs to use in 

reconsideration of initial 

determinations. The information 

requirements contained in these 

regulations are imposed on QIOs to 

provide information to parties 

requesting the reconsideration. These 

parties will use the information as 

guidelines for appeal rights in instances 

where issues are actively being 

disputed. Form Number: CMS–R–72 

(OCN: 0938–0443); Frequency: 

Reporting—On occasion; Affected 

Public: Individuals or Households and 

Business or other for-profit institutions; 

Number of Respondents: 2,590; Total 

Annual Responses: 5,228; Total Annual 

Hours: 2,822. (For policy questions 

regarding this collection contact Coles 

Mercier at 410–786–2112. For all other 

issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Reinstatement with a change of 

a previously approved collection; Title 

of Information Collection: Expanded 

Coverage for Diabetes Outpatient SelfManagement Training Services and 

Supporting Regulations Contained in 42 

CFR 410.141, 410.142, 410.143, 410.144, 

410.145, 410.146, 414.63; Use: 

According to the National Health and 

Nutrition Examination Survey 

(NHANES), as many as 18.7 percent of 

Americans over age 65 are at risk for 

developing diabetes. The goals in the 

management of diabetes are to achieve 

normal metabolic control and reduce 

the risk of micro- and macro-vascular 

complications. Numerous epidemiologic 

and interventional studies point to the 

necessity of maintaining good glycemic 

control to reduce the risk of the 

complications of diabetes. Despite this 

knowledge, diabetes remains the leading 

cause of blindness, lower extremity 

amputations and kidney disease 

requiring dialysis. Diabetes and its 

complications are primary or secondary 

factors in an estimated 9 percent of 

hospitalizations (Aubert, RE, et al., 

Diabetes-related hospitalizations and 

hospital utilization. In: Diabetes in 

America. 2nd ed. National Institutes of 

Health, National Institute of Diabetes 

and Digestive and Kidney Disease, NIH, 

Pub. No 95–1468–1995: 553–570). 

Overall, beneficiaries with diabetes are 

hospitalized 1.5 times more often than 

beneficiaries without diabetes. HCFA– 

3002–F ‘‘Expanded Coverage for 

Outpatient Diabetes Self-Management 

Training and Diabetes Outcome 

Measurements’’, provided for uniform 

coverage of diabetes outpatient selfmanagement training services. These 

services include educational and 

training services furnished to a 

beneficiary with diabetes by an entity 

approved to furnish the services. The 

physician or qualified non-physician 

practitioner treating the beneficiary’s 

diabetes would certify that these 

services are needed as part of a 

comprehensive plan of care. This rule 

established the quality standards that an 

entity would be required to meet in 

order to participate in furnishing 

diabetes outpatient self-management 

training services. It set forth payment 

amounts that have been established in 

consultation with appropriate diabetes 

organizations. It implements section 

4105 of the Balanced Budget Act of 

1997. Form Number: CMS–R–247 (OCN: 

0938–0818); Frequency: Recordkeeping 

and Reporting—Occasionally; Affected 

Public: Business or other for-profit 

institutions; Number of Respondents: 

5327; Total Annual Responses: 63,924; 

Total Annual Hours: 197,542. (For 

policy questions regarding this 

collection contact Kristin Shifflett at 

410–786–4133. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Quality of Care Complaint Form; Use: In 

accordance with Section 1154(a)(14) of 

the Social Security Act, Quality 

Improvement Organizations (QIOs) are 

required to conduct appropriate reviews 

of all written complaints submitted by 

beneficiaries concerning the quality of 

care received. The Medicare Quality of 

Care Complaint Form will be used by 

Medicare beneficiaries to submit quality 

of care complaints. This form will 

establish a standard form for all 

beneficiaries to utilize and ensure 

pertinent information is obtained by 

QIOs to effectively process these 

complaints. Form Number: CMS–10287 

(OCN: 0938–1102); Frequency: 

Reporting—Occasionally; Affected 

Public: Individuals or Households; 

Number of Respondents: 3,500; Total 

Annual Responses: 3,500; Total Annual 

Hours: 583. (For policy questions 

regarding this collection contact Coles 

Mercier at 410–786–2112. For all other 

issues call 410–786–1326.) 

5. Type of Information Collection 

Request: Reinstatement with change of a 

currently approved collection; Title of 

Information Collection: Conditions of 

Participation for Portable X-ray 

Suppliers and Supporting Regulations 

in 42 CFR Sections 486.104, 486.106, 

486.110; Use: The requirements 

contained in this information collection 

request are classified as conditions of 

participation or conditions for coverage. 

These conditions are based on a 

provision specified in law relating to 

diagnostic X-ray tests ‘‘furnished in a 

place of residence used as the patient’s 

home,’’ and are designed to ensure that 

each supplier has a properly trained 

staff to provide the appropriate type and 

level of care, as well as, a safe physical 

environment for patients. CMS uses 

these conditions to certify suppliers of 

portable X-ray services wishing to 

participate in the Medicare program. 

This is standard medical practice and is 

necessary in order to help to ensure the 

well-being, safety and quality 

professional medical treatment 

accountability for each patient. Form 

Number: CMS–R–43 (OCN: 0938–0338); 

Frequency: Yearly; Affected Public: 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 578; Total Annual 

Responses: 578; Total Annual Hours: 

948. (For policy questions regarding this 

collections contact Alesia Hovatter at 

410–786–6861. For all other issues call 

410–786–1326.) 

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27402 Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices 

6. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Annual Report 

of Physician-Owned Hospital 

Ownership and/or Investment Interest; 

Use: Section 6001 of the Affordable Care 

Act (ACA) requires Medicare hospitals 

to report whether they have any 

physician owners including 

immediately family members of the 

physician. 

Currently the CMS 855A captures 

basic ownership/managerial information 

on providers. The CMS 855A was 

revised in July 2011 and a specific 

attachment designed to capture 

physician-owned hospital ownership 

and investment interest data was added 

to the form. The attachment is being 

removed from the CMS 855A 

application because the annual 

reporting requirement for physicianowned hospitals is not required for 

Medicare enrollment processing. This 

physician-owned hospital data 

collection is mandated to be reported on 

an annual basis. Additionally, the ACA 

prohibits the expansion of current 

physician-owned hospitals and banned 

the establishment of new ones making 

the CMS 855A the improper method to 

collect this required annual report. 

CMS is requesting the physicianowned hospital ownership information, 

investment information or both, 

previously collected in Attachment 1 of 

the CMS 855A enrollment application to 

become a stand-alone form with a 

unique OMB number for the following 

reasons: 

• The physician-owned data 

collection has a small targeted audience 

of approximately 140 physician-owned 

hospitals nationwide. 

• The physician-owned data 

collection is required annually, as noted 

above. 

• The data required under section 

6001 is more specific than the data 

currently collected on the CMS–855A 

provider enrollment application. 

• The data is not required for 

Medicare provider enrollment purposes. 

Form Number: CMS–855 (POH)(OCN: 

0938-New); Frequency: Reporting— 

Yearly; Affected Public: Private Sector— 

Business or other for-profits and not-forprofit institutions; Number of 

Respondents: 140; Total Annual 

Responses: 140; Total Annual Hours: 

140. (For policy questions regarding this 

collection contact Kim McPhillips at 

410–786–5374. For all other issues call 

410–786–1326.) 

7. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Hospital and 

Health Care Complexes and Supporting 

Regulations in 42 CFR 413.20 and 

413.24; Use: Medicare Part A 

institutional providers must provide 

adequate cost data to receive Medicare 

reimbursement (42 CFR 413.24(a)). 

Providers must submit the cost data to 

their Medicare Fiscal Intermediary (FI)/ 

Medicare Administrative Contractor 

(MAC) through the Medicare cost report 

(MCR). We are submitting a revision of 

the Hospital and Hospital Health Care 

Complex Cost Report, Form CMS–2552– 

10. Form CMS 2552–10 is used by 

hospitals participating in the Medicare 

program to report the health care costs 

to determine the amount of 

reimbursable costs for services rendered 

to Medicare beneficiaries. The revisions 

were caused by legislative requirements 

in the Patient Protection and Affordable 

Care Act of 2010 and the Temporary 

Payroll Tax Cut Continuation Act of 

2011. Form Number: CMS–2552–10 

(OCN: 0938–0050); Frequency: 

Reporting—Yearly; Affected Public: 

Private Sector—Business or other forprofits and not-for-profit institutions; 

Number of Respondents: 6,171; Total 

Annual Responses: 6,171; Total Annual 

Hours: 4,153,083. (For policy questions 

regarding this collection contact Nadia 

Massuda at 410–786–5834. For all other 

issues call 410–786–1326.) 

8. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection. Title of 

Information Collection: Collection of 

Diagnostic Data from Medicare 

Advantage Organizations for Risk 

Adjusted Payments. Use: CMS will use 

the data to make risk adjusted payment 

under Parts C. MA and MA–PD plans 

will use the data to develop their Parts 

C bids. As required by law, CMS also 

annually publishes the risk adjustment 

factors for plans and other interested 

entities in the Advance Notice of 

Methodological Changes for MA 

Payment Rates (every February) and the 

Announcement of Medicare Advantage 

Payment Rates (every April). Lastly, 

CMS issues monthly reports to each 

individual plan that contains the CMS– 

HCC and RxHCC models’ output and the 

risk scores and reimbursements for each 

beneficiary that is enrolled in their plan. 

Form Number: CMS–10062 (OMB 0938– 

0838). Frequency: Quarterly. Affected 

Public: Private Sector (business or other 

for-profit and not-for-profit institutions). 

Number of Respondents: 766. Total 

Annual Responses: 830,000. Total 

Annual Hours: 40,650. (For policy 

questions regarding this collection 

contact Michael Massimini at 410–786– 

1566. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by July 9, 2013: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: May 6, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–11035 Filed 5–9–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1181] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medicated Feed 

Mill License Application; Extension 

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. 

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