Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices 16507 

the Act, and implementing regulations 

at 42 CFR 440.230(b), which CMS has 

interpreted to mean that the state 

provides reasonable coverage of the 

benefit that meets the needs of most 

beneficiaries who need the outpatient 

hospital services. While the state 

provided information on emergency 

room services, it did not provide 

information on outpatient hospital 

services. 

Section 1116 of the Act and Federal 

regulations at 42 CFR part 430, establish 

Department procedures that provide an 

administrative hearing for 

reconsideration of a disapproval of a 

state plan or plan amendment. CMS is 

required to publish a copy of the notice 

to a State Medicaid agency that informs 

the agency of the time and place of the 

hearing, and the issues to be considered. 

If we subsequently notify the agency of 

additional issues that will be considered 

at the hearing, we will also publish that 

notice. 

Any individual or group that wants to 

participate in the hearing as a party 

must petition the presiding officer 

within 15 days after publication of this 

notice, in accordance with the 

requirements contained at 42 CFR 

430.76(b)(2). Any interested person or 

organization that wants to participate as 

amicus curiae must petition the 

presiding officer before the hearing 

begins in accordance with the 

requirements contained at 42 CFR 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The notice to Florida announcing an 

administrative hearing to reconsider the 

disapproval of its SPA reads as follows: 

Stuart F. Williams, Esq., General 

Counsel, Agency for Health Care 

Administration, Office of the General 

Counsel, 2727 Mahan Drive, Building 

3, MS #3, Tallahassee, FL 323008 

Dear Mr. Williams: 

I am responding to your request for 

reconsideration of the decision to 

disapprove the Florida State Plan 

Amendment (SPA) 12–015 which was 

submitted on September 14, 2012, and 

disapproved on December 13, 2012. The 

SPAs reflects a Florida state law that 

would limit outpatient hospital 

emergency room visits to six per fiscal 

year for non-pregnant adults, 21 years of 

age and older, effective August 1, 2012. 

I disapproved Florida SPA 12–015 

because it appeared to impose a 

limitation on outpatient hospital 

services that was based on the 

individual’s diagnosis, illness, or 

condition and because the state failed to 

demonstrate that the limitation is 

consistent with the provision of a 

sufficient amount, duration and scope to 

reasonably achieve the purpose of the 

benefit. At issue in this appeal are the 

following issues, which are more 

detailed than set out in the disapproval 

letter: 

• Whether the exceptions to the 

proposed general service limitations on 

outpatient hospital services violate 

comparability requirements under 

section 1902(a)(10)(B) of the Act and 

implementing regulations at 42 CFR 

440.230(c) because they provide that 

some individuals described in section 

1902(a)(10)(A) of the Act, who have 

particular diagnoses or conditions, will 

receive benefits that individuals with 

other diagnoses and conditions will not 

receive. 

• Whether the imposition of a limit 

specifically on emergency outpatient 

hospital visits would violate those 

comparability requirements because the 

limitation would be imposed only on 

outpatient hospital visits that are 

warranted to address acute and 

immediate conditions, which means 

that the limitation is based on the 

diagnosis or condition. 

• Whether the exception to the 

limitation on emergency room visits for 

‘‘aliens’’ would violate section 

1902(a)(10)(B) of the Act because it 

would provide that aliens would receive 

a greater amount, duration and scope of 

emergency outpatient hospital benefits 

than other individuals described in 

section 1902(a)(10)(A) of the Act. 

• Whether the state has demonstrated 

that the resulting outpatient hospital 

benefits are of a sufficient amount, 

duration and scope to reasonably 

achieve the purpose of the benefit, 

consistent with the requirements of 

sections 1902(a)(10)(A) and 1905(a)(2) of 

the Act, and implementing regulations 

at 42 CFR 440.230(b), which CMS has 

interpreted to mean that the state 

provides reasonable coverage of the 

benefit that meets the needs of most 

beneficiaries who need the outpatient 

hospital services. While the state 

provided information on emergency 

room services, it did not provide 

information on outpatient hospital 

services. 

I am scheduling a hearing on your 

request for reconsideration to be held on 

April 30, 2013, at the CMS Atlanta 

Regional Office, Atlanta Federal Center, 

3rdh Floor, 61 Forsyth Street, SW., Suite 

3B52, Atlanta, Georgia 30303–8909, to 

reconsider CMS’ decision to disapprove 

Florida SPA 12–015. 

If this date is not acceptable, I would 

be glad to set another date that is 

mutually agreeable to the parties. The 

hearing will be governed by the 

procedures prescribed by Federal 

regulations at 42 CFR Part 430. 

I am designating Mr. Benjamin Cohen 

as the presiding officer. If these 

arrangements present any problems, 

please contact the Mr. Cohen at (410) 

786–3169. In order to facilitate any 

communication that may be necessary 

between the parties prior to the hearing, 

please notify the presiding officer to 

indicate acceptability of the scheduled 

hearing date and provide names of the 

individuals who will represent the state 

at the hearing. 

Sincerely, 

Marilyn Tavenner 

Acting Administrator 

Section 1116 of the Social Security Act 

(42 U.S.C. section 1316; 42 CFR section 

430.18) 

(Catalog of Federal Domestic Assistance 

program No. 13.714, Medicaid Assistance 

Program.) 

Dated: March 8, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–05978 Filed 3–14–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–64, CMS– 

10295, CMS–10302 and CMS–10185] 

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. 


srobinson on DSK4SPTVN1PROD with NOTICES
16508 Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Quarterly 

Medicaid Statement of Expenditures for 

the Medical Assistance Program. Use: 

Form CMS–64 has been used since 

January 1980 by Medicaid state agencies 

to report their actual program benefit 

costs and administrative expenses. CMS 

uses this information to compute the 

federal financial participation for the 

state’s Medicaid program costs. Certain 

schedules of the CMS–64 form are used 

by states to report budget, expenditure 

and related statistical information 

required for implementation of the 

Medicaid portion of the State Children’s 

Health Insurance Programs, Title XXI of 

the Social Security Act, established by 

the Balanced Budget Act of 1997. Form 

Number: CMS–64 (OCN: 0938–0067). 

Frequency: Quarterly. Affected Public: 

State, Local, or Tribal Governments. 

Number of Respondents: 56. Total 

Annual Responses: 224. Total Annual 

Hours: 16,464. (For policy questions 

regarding this collection contact 

Abraham John at 410–786–4518. For all 

other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Reporting 

Requirements for States Under 

Transitional Medical Assistance (TMA) 

Provisions. Use: The HHS Secretary is 

required to submit annual reports to 

Congress with information collected 

from states in accordance with section 

5004(d) of the American Recovery and 

Reinvestment Act of 2009. Medicaid 

agencies in 50 states complete the 

reports while CMS reviews the 

information to determine if each state 

has met all of the reporting 

requirements specified under section 

5004(d). We are revising this package to 

remove the requirement to report the 

Medicaid Federal Medical Assistance 

Percentage since it no longer needs to be 

collected from states. Form Number: 

CMS–10295 (OCN: 0938–1073). 

Frequency: Quarterly. Affected Public: 

State, Local, or Tribal Governments. 

Number of Respondents: 50. Total 

Annual Responses: 200. Total Annual 

Hours: 400. (For policy questions 

regarding this collection contact Rhonda 

Simms at 410–786–1200. 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: 

Section 182(b) of the Medicare 

Improvement of Patients and Providers 

Act (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 (OCN: 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 Coachman at 410–786– 

7364. For all other issues call 410–786– 

1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements; Use: Title I, 

Part 423, § 423.514 describes CMS’ 

regulatory authority to establish 

reporting requirements for Part D 

sponsors. It is noted that each Part D 

plan sponsor must have an effective 

procedure to develop, compile, 

evaluate, and report to CMS, to its 

enrollees, and to the general public, at 

the times and in the manner that CMS 

requires, statistics in the following 

areas: the cost of its operations; the 

patterns of utilization of its services; the 

availability, accessibility, and 

acceptability of its services; information 

demonstrating that the Part D plan 

sponsor has a fiscally sound operation; 

and other matters that CMS may require. 

CMS has identified the appropriate data 

needed to effectively monitor plan 

performance. Changes to the currently 

approved data collection instrument 

reflect new executive orders, legislation, 

as well as recent changes to Agency 

policy and guidance. Form Number: 

CMS–10185 (OCN: 0938–0992); 

Frequency: Reporting, Recordkeeping 

and Third-party disclosure; Affected 

Public: Business and other for-profits; 

Number of Respondents: 690; Total 

Annual Responses: 8,067; Total Annual 

Hours: 12,658. (For policy questions 

regarding this collection contact Latoyia 

Grant at 410–786–5434. 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 May 14, 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 ____, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: March 12, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–06038 Filed 3–14–13; 8:45 am] 

BILLING CODE 4120–01–P 


srobinson on DSK4SPTVN1PROD with NOTICES