15434 Federal Register / Vol. 75, No. 59 / Monday, March 29, 2009 / Notices 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Member of Research Community .................................................................................... 325 1 20/60 108

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–6903 Filed 3–26–10; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10108, CMS– 

367, CMS–10302, CMS–10179, CMS–R–234 

and CMS–2540] 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid 

Managed Care Regulations for 42 CFR 

438.6, 438.8, 438.10, 438.12, 438.50, 

438.56, 438.102, 438.114, 438.202, 

438.204, 438.206, 438.207, 438.240, 

438.242, 438.402, 438.404, 438.406, 

438.408, 438.410, 438.414, 438.416, 

438.604, 437.710, 438.722, 438.724, and 

438.810; Use: These information 

collection requirements implement 

regulations that allow States greater 

flexibility to implement mandatory 

managed care program, implement new 

beneficiary protections, and eliminate 

certain requirements viewed by State 

agencies as impediments to the growth 

of managed care programs. Information 

collected includes information about 

managed care programs, grievances and 

appeals, enrollment broker contracts, 

and managed care organizational 

capacity to provide health care services. 

Form Number: CMS–10108 (OMB#: 

0938–0920); Frequency: Reporting: 

Occasionally; Affected Public: State, 

Local, or Tribal Government; Number of 

Respondents: 39,114,558; Total Annual 

Responses: 4,640,344; Total Annual 

Hours: 3,930,093.5. (For policy 

questions regarding this collection 

contact Angela Garner at 410–786–7062. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Program Monthly and Quarterly Drug 

Reporting Format; Use: Section 1927 of 

the Social Security Act requires drug 

manufacturers to enter into and have in 

effect a rebate agreement with the 

federal government for States to receive 

funding for drugs dispensed to 

Medicaid beneficiaries. The Deficit 

Reduction Act (DRA) of 2005 modified 

section 1927 to require additional 

reporting requirements beyond the 

quarterly data currently collected. CMS 

Form 367 identifies the data fields that 

manufacturers must submit to CMS on 

both a monthly and quarterly basis. 

Form Number: CMS–367 (OMB#: 0938– 

0578); Frequency: Monthly and 

Quarterly; Affected Public: Private 

Sector: Business or other for-profits; 

Number of Respondents: 580; Total 

Annual Responses: 9,280; Total Annual 

Hours: 137,344. (For policy questions 

regarding this collection contact 

Samone Angel at 410–786–1123. For all 

other issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Collection 

Requirements for Compendia for 

Determination of Medically-accepted 

Indications for Off-label Uses of Drugs 

and Biologicals in an Anti-cancer 

Chemotherapeutic Regimen Use: 

Congress enacted the Medicare 

Improvement of Patients and Providers 

Act (MIPPA). Section 182(b) of MIPPA 

amended section 1861(t)(2)(B) of the 

Social Security Act (42 U.S.C. 

1395x(t)(2)(B)) by adding at the end the 

following new sentence: ‘On and after 

January 1, 2010, no compendia may be 

included on the list of compendia under 

this subparagraph unless the compendia 

has a publicly transparent process for 

evaluating therapies and for identifying 

potential conflicts of interest.’ We 

believe that the implementation of this 

statutory provision that compendia have 

a ‘‘publicly transparent process for 

evaluating therapies and for identifying 

potential conflicts of interests’’ is best 

accomplished by amending 42 CFR 

414.930 to include the MIPPA 

requirements and by defining the key 

components of publicly transparent 

processes for evaluating therapies and 

for identifying potential conflicts of 

interests. 

All currently listed compendia will be 

required to comply with these 

provisions, as of January 1, 2010, to 

remain on the list of recognized 

compendia. In addition, any 

compendium that is the subject of a 

future request for inclusion on the list 

of recognized compendia will be 

required to comply with these 

provisions. No compendium can be on 

the list if it does not fully meet the 

standard described in section 

1861(t)(2)(B) of the Act, as revised by 

section 182(b) of the MIPPA. Form 

Number: CMS–10302 (OMB #: 0938– 

1078); Frequency: Reporting, 

Recordkeeping and Third-party 

disclosure; Affected Public: Business 

and other for-profits and Not-for-profit 

institutions; Number of Respondents: 

845; Total Annual Responses: 900; Total 

Annual Hours: 5,135. (For policy 

questions regarding this collection 

contact Brijet Burton at 410–786–7364. 

For all other issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Requests by 

Hospitals for an Alternative Cost-toCharge Ratio. Use: Section 1886(d)(5)(A) 

of the Act provides for additional 

Medicare payments to Inpatient 

Prospective Payment System (IPPS) 

hospitals for cases that incur 

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Federal Register / Vol. 75, No. 59 / Monday, March 29, 2009 / Notices 15435 

extraordinarily high costs. To qualify for 

outlier payments, a case must have costs 

above a predetermined threshold 

amount (a dollar amount by which the 

estimated cost of a case must exceed the 

Medicare payment). Hospital-specific 

cost-to-charge ratios are applied to the 

covered charges for a case to determine 

the estimated cost of the case. In 

general, additional outlier payments for 

eligible cases are made based on a 

marginal cost factor of 80 percent, i.e. a 

fixed percentage of the costs. Therefore, 

if the estimated cost of the case exceeds 

the Medicare payment for that discharge 

plus the outlier threshold, generally 

Medicare will pay the hospital 80 

percent of the excess amount. The 

outlier threshold is updated annually at 

the beginning of the Federal Fiscal Year. 

Form Number: CMS–10179 (OMB #: 

0938–1020); Frequency: Occasionally; 

Affected Public: Private Sector and 

Business or other for-profits, Not-forprofit institutions; Number of 

Respondents: 18; Total Annual 

Responses: 18 Total Annual Hours: 144. 

(For policy questions regarding this 

collection contact Michael Treitel at 

410–786–4552. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Subpart 

D—Private Contracts and Supporting 

Regulations contained in 42 CFR 

405.410, 405.430, 405.435, 405.440, 

405.445, and 405.455. Use: Section 4507 

of Balancing Budget Act (BBA) 1997 

amended section 1802 of the Social 

Security Act to permit certain 

physicians and practitioners to opt-out 

of Medicare and to provide through 

private contracts services that would 

otherwise be covered by Medicare. 

Under such contracts the mandatory 

claims submission and limiting charge 

rules of section 1848(g) of the Act would 

not apply. Subpart D and the 

Supporting Regulations contained in 42 

CFR 405.410, 405.430, 405.435, 405.440, 

405.445, and 405.455, counters the 

effect of certain provisions of Medicare 

law that, absent section 4507 of BBA 

1997, preclude physicians and 

practitioners from contracting privately 

with Medicare beneficiaries to pay 

without regard to Medicare limits. Form 

Number: CMS–R–234 (OMB#: 0938– 

0730); Frequency: Biennially; Affected 

Public: Private Sector and Business or 

other for-profits; Number of 

Respondents: 26,820; Total Annual 

Responses: 26,820; Total Annual Hours: 

7,197. (For policy questions regarding 

this collection contact Fred Grabau at 

410–786–0206. For all other issues call 

410–786–1326.) 

6. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Skilled Nursing 

Facility and Skilled Nursing Facility 

Health Care Complex Cost Report. Use: 

Providers of services participating in the 

Medicare program are required under 

sections 1815(a), 1833(e) and 

1861(v)(1)(A) of the Social Security Act 

(42 USC 1395g) to submit annual 

information to achieve settlement of 

costs for health care services rendered to 

Medicare beneficiaries. Form Number: 

CMS–2540 (OMB#: 0938–0463); 

Frequency: Yearly; Affected Public: 

Private Sector; Number of Respondents: 

15,071; Total Annual Responses: 

15,071; Total Annual Hours: 2,953,916 

(For policy questions regarding this 

collection contact Edwin Gill Sr. at 410– 

786–4525. 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 

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 May 28, 2010: 

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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: March 19, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–7027 Filed 3–26–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10292, CMS– 

718–721 and CMS–685] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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), Department of Health 

and Human Services, 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 function; 

(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: New Collection; Title of 

Information Collection: State Medicaid 

HIT Plan and Templates for 

Implementation of Section 4201 of 

ARRA; Form Number: CMS–10292 

(OMB#: 0938–NEW); Use: This 

information is being requested in order 

that States can submit documentation to 

CMS for review and approval in order 

that States can implement the Medicaid 

program and draw down Federal 

financial participation. The American 

Reinvestment and Recovery Act of 2009 

(ARRA) provides States with the 

flexibility to request funds to develop a 

health information technology vision 

and road to get to the ultimate goal of 

meaningful use of certified electronic 

health records technology. We will be 

sending State Medicaid Directors letters 

and templates for the State Medicaid Hit 

Plan (SMHP), the Planning Advance 

Planning Document (PAPD) and the 

Implementation Advance Planning 

Document (IAPD) to States in an effort 

to request these changes if they so 

choose to make the process as simple as 

possible. Frequency: Yearly, once and/ 

or occasionally; Affected Public: State, 

Tribal and Local governments; Number 

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