11110 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Notices 

12 In particular, the written request for 

confidential treatment that accompanies the 

comment must include the factual and legal basis 

for the request, and must identify the specific 

portions of the comment to be withheld from the 

public record. See FTC Rule 4.9(c), 16 CFR 4.9(c). 

information. In addition, do not include 

any ‘‘[t]rade secret or any commercial or 

financial information which is . . . 

privileged or confidential’’ as provided 

in Section 6(f) of the FTC Act 15 U.S.C. 

46(f), and FTC Rule 4.10(a)(2), 16 CFR 

4.10(a)(2). In particular, do not include 

competitively sensitive information 

such as costs, sales statistics, 

inventories, formulas, patterns devices, 

manufacturing processes, or customer 

names. 

If you want the Commission to give 

your comment confidential treatment, 

you must file it in paper form, with a 

request for confidential treatment, and 

you have to follow the procedure 

explained in FTC Rule 4.9(c).12 Your 

comment will be kept confidential only 

if the FTC General Counsel grants your 

request in accordance with the law and 

the public interest. 

Postal mail addressed to the 

Commission is subject to delay due to 

heightened security screening. As a 

result, we encourage you to submit your 

comments online. To make sure that the 

Commission considers your online 

comment, you must file it at https://

ftcpublic.commentworks.com/ftc/

rbprulepra, by following the 

instructions on the web-based form. If 

this Notice appears at http://

www.regulations.gov/#!home, you also 

may file a comment through that Web 

site. 

If you file your comment on paper, 

write ‘‘RBP Rule, PRA Comment, 

P145403,’’ on your comment and on the 

envelope, and mail or deliver it to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Room H–113 (Annex J), 600 

Pennsylvania Avenue NW., Washington, 

DC 20580. If possible, submit your 

paper comment to the Commission by 

courier or overnight service. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before April 28, 2014. You can find 

more information, including routine 

uses permitted by the Privacy Act, in 

the Commission’s privacy policy, at 

http://www.ftc.gov/ftc/privacy.htm. 

David C. Shonka, 

Principal Deputy General Counsel. 

[FR Doc. 2014–04235 Filed 2–26–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notice of Opportunity for Hearing on 

Compliance of Florida State Plan 

Provisions Concerning Payment for 

Outpatient Hospital Services With Title 

XIX (Medicaid) of the Social Security 

Act 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of Opportunity for a 

Hearing; Compliance of Florida 

Medicaid State Plan Outpatient Hospital 

Benefit. 

SUMMARY: This notice announces the 

opportunity for an administrative 

hearing to be held by April 28, 2014 at 

the CMS Atlanta Regional Office, 61 

Forsyth Street SW., Suite 4T20, Atlanta, 

GA 30303–8909, to consider whether 

Florida provisions concerning payments 

for outpatient hospital services comply 

with the requirements of the Social 

Security Act as discussed in the [date of 

publication] letter sent to the state and 

published herein. 

Closing Date: Requests to participate 

in the hearing as a party must be 

received by the presiding officer by 

March 31, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin R. Cohen, Hearing Officer, 

Centers for Medicare & Medicaid 

Services, 2520 Lord Baltimore Drive, 

Suite L, Baltimore, MD 21244, (301) 

869–3169. 

SUPPLEMENTARY INFORMATION: This 

notice announces the opportunity for an 

administrative hearing concerning the 

finding of the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) that the state of Florida 

is not operating their outpatient hospital 

services in compliance with their 

approved state plan, or in compliance 

with the provisions of the Social 

Security Act (the Act), and the proposed 

withholding of Federal reimbursement 

of a portion of Florida’s administrative 

dollars proportionate to outpatient 

hospital services. In particular, CMS has 

found that Florida has continued to 

implement a limit on the number of 

times a Medicaid beneficiary may visit 

an emergency department, even though 

CMS disapproved an amendment to add 

this limit to the Florida state plan. 

Consequently, Federal payments for a 

portion of the Federal funding of 

administrative costs will be withheld, 

subject for the opportunity for a hearing 

described below. This notice is being 

provided pursuant to the requirements 

of section 1904 of the Act, as 

implemented at 42 CFR 430.35 and 42 

CFR 430, Subpart D. 

Under section 1902(a)(10)(A) of the 

Act, a state plan must provide for 

making medical assistance available to 

eligible individuals, including for most 

eligible individuals the medical 

assistance specified in section 

1905(a)(2) of the Act. This provision 

includes in the definition of medical 

assistance ‘‘outpatient hospital 

services.’’ Section 1902(a)(17) of the Act 

requires the state plan to include 

reasonable standards for determining 

the extent of medical assistance, and 

under section 1902(a)(19) of the Act, the 

state plan must assure that eligibility for 

care and services are provided in the 

best interest of the recipients. As the 

implementing regulations at 42 CFR 

440.230(b) require, a state plan must 

‘‘specify the amount, duration, and 

scope of each service that it provides,’’ 

and ‘‘each service must be sufficient in 

amount, duration, and scope to 

reasonably achieve its purpose.’’ While 

states may place ‘‘appropriate limits on 

a service based on such criteria as 

medical necessity or utilization control 

procedures’’ under CFR 440.230(d), 42 

CFR 440.230(c) specifies that a state 

may not arbitrarily deny or reduce the 

amount, duration, or scope of required 

services, including physicians’ services, 

solely because of the diagnosis, type of 

illness, or condition. 

The proposed limitation on certain 

outpatient hospital services appeared to 

be based on the diagnosis, illness, or 

condition because it is limited to 

outpatient services furnished at a 

hospital emergency room, which are 

designed to address acute and 

immediate conditions. Thus, the 

limitation appeared to violate the 

requirements of 42 CFR 440.230(c). 

Even if that were not the case, the state 

did not demonstrate that the limitation 

is consistent with provision of a 

sufficient amount, duration, and scope 

to reasonably achieve the purpose of the 

benefit, which in this case would be 

providing reasonable coverage that 

meets the needs of most beneficiaries 

who need the outpatient hospital 

services, consistent with 42 CFR 

440.230(b). 

In disapproving SPA 12–015, CMS 

staff suggested to the state some 

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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Notices 11111 

alternate methods to address 

inappropriate utilization of hospital 

emergency rooms, including the 

development of payment rates for 

hospital emergency rooms that are lower 

if the individual does not require care 

for an acute and immediate condition, 

or the use of the alternative cost sharing 

authority available to states under 

section 1916(d) of the Act, permitting 

higher beneficiary cost sharing for 

elective non-emergency use of the 

emergency room. CMS offered to work 

with the state on these options and 

technical assistance. 

The state requested reconsideration of 

the denial of the state plan amendment. 

During the course of the 

reconsideration proceedings, CMS 

became aware of Florida’s continued 

implementation of the limitation on 

emergency department visits. 

The notice to Florida containing the 

details concerning the compliance issue, 

the proposed withholding, opportunity 

for a hearing, and possibility of 

postponing and ultimately avoiding 

withholding by coming into 

compliance, reads as follows: 

Justin M. Senior 

Deputy Secretary for Medicaid 

Florida Agency for Health Care 

Administration 

2727 Mahan Drive, MS #8 

Tallahassee, Florida 32308 

Dear Mr. Senior: 

This letter provides notice that the 

Centers for Medicare & Medicaid 

Services (CMS) has found that Florida is 

not providing all Medicaid beneficiaries 

with outpatient hospital benefits 

required under title XIX of the Social 

Security Act (the Act) and that until this 

deficiency is corrected (by making 

outpatient hospital services available to 

all beneficiaries entitled to such 

services), a portion of the Federal 

funding of the administrative costs 

associated with the operation of the 

Florida Medicaid program will be 

withheld, subject to the opportunity for 

Florida to request a hearing on this 

finding. The details of the finding, 

proposed withholding, opportunity for a 

hearing, and possibility of postponing 

and ultimately avoiding withholding by 

coming into compliance, are described 

in detail below. 

Specifically, CMS has found that 

Florida is not providing beneficiaries 

with medical assistance for outpatient 

hospital services in accordance with the 

approved Florida State Plan, specifically 

by imposing numeric limits (six visits 

annually) on coverage of outpatient 

hospital visits furnished in hospital 

emergency departments. The approved 

state plan does not contain any numeric 

limitation on coverage of outpatient 

hospital services or services of a 

hospital emergency department. It is our 

understanding that Florida is 

nevertheless imposing a numeric 

limitation on such coverage. 

This issue is related to the 

disapproval of a proposed state plan 

amendment that would have placed 

numeric limitations on outpatient 

hospital visits furnished in a hospital 

emergency department. Florida 

submitted the proposed amendment to 

the coverage provisions of the Medicaid 

state plan on September 14, 2012, to 

impose a limit of 6 visits per year to 

emergency departments. The proposed 

state plan amendment would have been 

effective on August 1, 2012. CMS 

disapproved the amendment on 

December 13, 2012, indicating that the 

limitation on outpatient services was 

not consistent with the requirements of 

section 1902 of the Social Security Act 

and implementing regulations because 

the limitation: 1) would not be 

consistent with the mandatory nature of 

the outpatient hospital services benefit 

under section 1902(a)(10)(A); 2) would 

not be a reasonable standard consistent 

with section 1902(a)(17) of the Act 

because it would arbitrarily deny 

coverage of outpatient hospital services, 

a mandatory benefit, based on the 

(emergency) condition of the patient; 

and 3) would not be consistent with the 

best interests of beneficiaries as required 

by section 1902(a)(19). 

In disapproving the amendment, CMS 

suggested to the state some alternate 

methods to address inappropriate 

utilization of hospital emergency rooms, 

including the development of payment 

rates for hospital emergency rooms that 

are lower if the individual does not 

require care for an acute and immediate 

condition, or the use of the alternative 

cost sharing authority available to states 

under section 1916(d) of the Act, 

permitting higher beneficiary cost 

sharing for elective non-emergency use 

of the emergency room. CMS offered to 

work with the state on these options and 

technical assistance. 

Florida requested reconsideration of 

the CMS disapproval of the amendment 

in February 2013. In the CMS response, 

CMS noted that the disapproval was 

also supported because the proposed 

coverage limitations has an exception to 

the limitation on emergency room visits 

for ‘‘aliens’’ that would violate the 

‘‘comparability’’ requirements of 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. 

During the course of the 

reconsideration process, CMS learned 

that Florida had implemented the six 

visit limit on hospital emergency 

department visits and was still applying 

the limit after the proposed amendment 

was disapproved. This means that 

Florida is not operating its program in 

accordance with the approved state 

plan. It should also be mentioned that 

Florida’s submission of its quarterly 

expenditure reports through the CMS– 

64, includes a certification that the state 

is operating under the authority of its 

approved Medicaid state plan. 

In light of our obligation to ensure 

that beneficiaries receive services to 

which they are entitled under the 

approved state plan, I am taking this 

compliance action to withhold a portion 

of the Federal Financial Participation 

(FFP) in state expenditures for 

administrative costs necessary to 

administer the Florida Medicaid 

program, subject to the opportunity for 

a hearing described below, until such 

time as I am satisfied that the state is 

complying with the Federal 

requirements described above. The 

withholding will initially be 10 percent 

of the Federal share of the state’s 

quarterly claim for administrative 

expenditures allocable to outpatient 

hospital services, using an allocation 

method based on the proportion of total 

State Medicaid expenditures that were 

for outpatient hospital expenditures, as 

reported on Form CMS–64. The 

withholding percentage will increase by 

5 percentage points (i.e. 15%, 20%, etc.) 

for every quarter in which the state 

remains out of compliance, up to a 

maximum withholding percentage of 

100 percent (of administrative 

expenditures allocable to outpatient 

hospital services). The withholding will 

end when Florida implements a 

corrective action plan to bring its 

Medicaid program into compliance with 

Federal requirements. 

The state has 30 days from the date of 

this letter to request a hearing. As 

specified in the accompanying Federal 

Register notice, we are providing an 

opportunity for an administrative 

hearing to ensure that you have an 

opportunity for a hearing prior to this 

determination becoming final. However, 

it is up to the state whether to go 

forward with this hearing. If a request 

for a hearing is timely submitted, the 

hearing will be convened by the Hearing 

Officer designated below no later than 

60 days after the date of the Federal 

Register notice, or a later date by 

agreement of the parties and the Hearing 

Officer, at the CMS Regional Office in 

Atlanta, Georgia, in accordance with the 

procedures set forth in Federal 

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11112 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Notices 

regulations at 42 CFR Part 430, Subpart 

D. The overall issue in any such appeal 

will be whether the Florida outpatient 

hospital benefit is consistent with 

Federal requirements. Any request for 

such a hearing should sent to the 

designated Hearing Officer. The Hearing 

Officer also should be notified if you 

request a hearing but cannot meet the 

timeframe expressed in this notice. Your 

Hearing Officer is: 

Benjamin R. Cohen, Hearing Officer 

Centers for Medicare & Medicaid 

Services 

2520 Lord Baltimore Drive, Suite L 

Baltimore, MD 21244 

If the state requests a hearing but 

nevertheless plans to come into 

compliance with the approved state 

plan, please submit within 30 days of 

the date of this letter an explanation of 

how the state plans to come into 

compliance with Federal requirements 

and the timeframe for doing so. If that 

explanation is satisfactory, we may 

consider postponing the timing of the 

scheduled hearing (which would also 

delay the imposition of the withholding 

of funds). Our goal is to ensure 

compliance. We are available to provide 

further information or assistance on the 

steps necessary to bring the state into 

compliance with its approved state 

plan. 

Should you not request a hearing 

within 30 days, a notice of withholding 

will be sent to you and the withholding 

of Federal funds will begin as described 

above. 

If you have any questions or wish to 

discuss this determination further, 

please contact: 

Jackie Glaze 

Associate Regional Administrator 

Division of Medicaid and Children’s 

Health Operations 

CMS Atlanta Regional Office 

61 Forsyth Street SW., Suite 4T20 

Atlanta, GA 30303–8909 

Sincerely, 

Marilynn Tavenner, 

Administrator. 

(Catalog of Federal Domestic Assistance 

Program No. 13.714, Medicaid Assistance 

Program.) 

Dated: February 20, 2014. 

Marilynn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–04290 Filed 2–26–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0717] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Evaluation of the Food and Drug 

Administration’s General Market Youth 

Tobacco Prevention Campaign 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Evaluation of the Food and Drug 

Administration’s General Market Youth 

Tobacco Prevention Campaign’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

February 7, 2014; the Agency submitted 

a proposed collection of information 

entitled ‘‘Evaluation of the Food and 

Drug Administration’s General Market 

Youth Tobacco Prevention Campaign’’ 

to OMB for review and clearance under 

44 U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0753. The 

approval expires on October 31, 2016. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: February 21, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–04271 Filed 2–26–14; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0110] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Prescription Drug 

Advertisements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements, including 

third party disclosure, contained in 

FDA’s current regulations on 

prescription drug advertisements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 28, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane., Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

mstockstill on DSK4VPTVN1PROD with NOTICES