48974 Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: September 17, 2009. 

Joe Ellis, 

Director, OPERA, OER, National Institutes of 

Health. 

[FR Doc. E9–23078 Filed 9–24–09; 8:45 am] 

BILLING CODE 4140–10–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0449] 

Enforcement of General Tobacco 

Standard Special Rule for Cigarettes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Family Smoking Prevention and 

Tobacco Control Act (FSPTCA), 

establishes a tobacco standard special 

rule for cigarettes. This special rule for 

cigarettes prohibits a cigarette or any of 

its component parts (including the 

tobacco, filter, or paper) from 

containing, as a constituent (including a 

smoke constituent) or additive, an 

artificial or natural flavor (other than 

tobacco or menthol) or an herb or spice, 

including strawberry, grape, orange, 

clove, cinnamon, pineapple, vanilla, 

coconut, licorice, cocoa, chocolate, 

cherry, or coffee, that is a characterizing 

flavor of the tobacco product or tobacco 

smoke. The Food and Drug 

Administration (FDA) is providing this 

notice to remind regulated industry that 

as of the effective date identified in the 

FSPTCA, cigarettes that contain certain 

characterizing flavors are considered 

adulterated under the act. FDA is also 

providing in this notice contact 

information to which individuals who 

observe violative products after the 

effective date of the tobacco standard 

special rule may report their 

observations to FDA. 

DATES: Effective September 22, 2009. 

ADDRESSES: To report tobacco products 

that fail to comply with section 

907(a)(1)(A) of the act after September 

22, 2009, please contact the Center for 

Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373 or http://www.fda.gov/flavored

tobacco. 

FOR FURTHER INFORMATION CONTACT: 

Michele Mital, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373, Michele.Mital@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Smoking 

is the leading preventable cause of death 

in the United States. An important way 

to reduce the death and disease caused 

by smoking is to prevent children and 

adolescents from starting to smoke. 

Congress has stated that flavors make 

cigarettes more appealing to youth and 

often result in exposure to additional 

carcinogens and other toxic 

constituents. The removal from the 

market of cigarettes that contain certain 

characterizing flavors is an important 

step in FDA’s efforts to reduce the 

burden of illness and death caused by 

tobacco products. 

The FSPTCA provides FDA with 

regulatory authority over the 

manufacture, marketing, and 

distribution of tobacco products. 

Specifically, section 907(a)(1)(A) of the 

act, as amended by the FSPTCA, 

establishes a tobacco product standard 

special rule for cigarettes that states in 

part: ‘‘* * * a cigarette or any of its 

component parts (including the tobacco, 

filter, or paper) shall not contain, as a 

constituent (including a smoke 

constituent) or additive, an artificial or 

natural flavor (other than tobacco or 

menthol) or an herb or spice, including 

strawberry, grape, orange, clove, 

cinnamon, pineapple, vanilla, coconut, 

licorice, cocoa, chocolate, cherry, or 

coffee, that is a characterizing flavor of 

the tobacco product or tobacco smoke.’’ 

This standard applies to all tobacco 

products that meet the definition of a 

‘‘cigarette’’ in section 900(3) of the act, 

as amended, even if they are not labeled 

as ‘‘cigarettes’’ or are labeled as cigars or 

as some other product. 

As of the September 22, 2009, 

effective date, cigarettes and their 

component parts that fail to comply 

with the special rule established under 

section 907 of the act, as amended, are 

deemed adulterated under section 902 

of the act, as amended. Under the act, 

adulterated products sold or held for 

sale in the United States may be subject 

to seizure under section 304 of the act 

(21 U.S.C. 334). In addition, 

manufacturers, distributors, and 

retailers may be subject to injunction 

actions, civil money penalties, and/or 

criminal prosecution for violating the 

requirements of the act (sections 301, 

302, and 303 of the act (21 U.S.C. 331, 

332, and 333, respectively)). FDA 

intends to use the full range of 

enforcement tools within the agency’s 

authority to ensure compliance with the 

new requirement. 

FDA encourages individuals who 

observe violative products after 

September 22, 2009, to report their 

observations to FDA. This collection of 

information was approved under OMB 

control number 0910–0647 and expires 

on March 31, 2010. Individuals may 

report products in violation of this 

standard to FDA through the contact 

information provided in the ADDRESSES

section of this document. 

Dated: September 21, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23144 Filed 9–22–09; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2487–FN] 

Medicare and Medicaid Programs; 

Application by the American 

Osteopathic Association for Continued 

Deeming Authority for Ambulatory 

Surgical Centers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the American 

Osteopathic Association (AOA) for 

continued recognition as a national 

accreditation program for ambulatory 

surgical centers (ASCs) seeking to 

participate in the Medicare or Medicaid 

programs. 

DATES: Effective Date: This final notice 

is effective on October 23, 2009 through 

October 23, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in an ambulatory surgical 

center (ASC) provided certain 

requirements are met. Sections 

1832(a)(2)(F)(i) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as an 

ASC. Under this authority, the 

minimum requirements that an ASC 

must meet to participate in Medicare are 

set forth in regulations at 42 CFR part 

416, which determine the basis and 

scope of ASC covered services, and the 

conditions for Medicare payment for 

facility services. Regulations concerning 

provider agreements are at 42 CFR part 

489 and those pertaining to activities 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 48975 

relating to the survey and certification 

of facilities are at 42 CFR part 488. 

Generally, to enter into an agreement, 

an ASC must first be certified by a State 

survey agency as complying with 

conditions or requirements set forth in 

part 416 of our regulations. Then, the 

ASC is subject to regular surveys by a 

State survey agency to determine 

whether it continues to meet those 

requirements. There is an alternative, 

however, to surveys by State agencies. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization that 

all applicable Medicare conditions are 

met or exceeded, we may ‘‘deem’’ those 

provider entities as having met the 

requirements. Accreditation by an 

accreditation organization is voluntary 

and is not required for Medicare 

participation. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, a 

provider entity accredited by the 

national accrediting body’s approved 

program may be deemed to meet the 

Medicare conditions. A national 

accreditation organization applying for 

approval of deeming authority under 

part 488, subpart A, must provide us 

with reasonable assurance that the 

accreditation organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning re-approval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accreditation organizations to reapply 

for continued approval of deeming 

authority every 6 years, or sooner as we 

determine. 

II. Deeming Applications Approval 

Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of deeming applications 

is conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of an application 

to complete our survey activities and 

application review process. Within 60 

days of receiving a completed 

application, we must publish a notice in 

the Federal Register that identifies the 

national accreditation body making the 

request, describes the request, and 

provides no less that a 30-day public 

comment period. At the end of the 210- 

day period, we must publish an 

approval or denial of the application. 

III. Provisions of the Proposed Notice 

On May 26, 2009, we published a 

proposed notice (74 FR 24857) 

announcing the American Osteopathic 

Association’s (AOA) request for reapproval as a deeming organization for 

ASCs. In the proposed notice, we 

detailed our evaluation criteria. Under 

section 1865(a)(2) of the Act and our 

regulations at § 488.4 (Application and 

reapplication procedures for 

accreditation organizations), we 

conducted a review of the AOA 

application in accordance with the 

criteria specified by our regulation, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

AOA’s—(1) Corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and (5) survey review and decisionmaking process for accreditation; 

• A comparison of AOA’s ASC 

accreditation standards to our current 

Medicare ASC conditions for coverage; 

and 

• A documentation review of AOA’s 

survey processes to: 

Æ Determine the composition of the 

survey team, surveyor qualifications, 

and the ability of AOA to provide 

continuing surveyor training; 

Æ Compare AOA’s processes to those 

of State survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

Æ Evaluate AOA’s procedures for 

monitoring providers or suppliers found 

to be out of compliance with AOA’s 

program requirements. The monitoring 

procedures are used only when AOA 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d); 

Æ Assess AOA’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner; 

Æ Establish AOA’s ability to provide 

us with electronic data and reports 

necessary for effective validation and 

assessment of AOA’s survey process; 

Æ Determine the adequacy of staff and 

other resources; 

Æ Review AOA’s ability to provide 

adequate funding for performing 

required surveys; 

Æ Confirm AOA’s policies with 

respect to whether surveys are 

announced or unannounced; and 

Æ Obtain AOA’s agreement to provide 

us with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require, including corrective 

action plans. 

In accordance with section 

1865(a)(3)(A) of the Act, the May 26, 

2009 proposed notice (74 FR 24857) also 

solicited public comments regarding 

whether AOA’s requirements met or 

exceeded the Medicare conditions for 

coverage (CfC) for ASCs. We received no 

public comments in response to our 

proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between AOA’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared the AOA’s ASCs 

accreditation requirements and survey 

process with the Medicare CfCs and 

survey process as outlined in the State 

Operations Manual (SOM). Our review 

and evaluation of the AOA’s deeming 

application, which were conducted as 

described in section III of this final 

notice, yielded the following: 

• AOA modified its policies related to 

the accreditation effective date in 

accordance with the requirements at 

§ 489.13; 

• AOA modified its policies regarding 

timeframes for sending and receiving a 

plan of correction (PoC) in accordance 

with section 2728 of the SOM; 

• AOA revised its policies to include 

timeframes for investigation of 

complaints in accordance with the 

requirements at section 5075.9 of the 

SOM; 

• AOA developed and implemented 

internal monitoring procedures to 

ensure its surveyors are trained and 

qualified to meet the requirements at 

§ 488.4(a)(4); 

• AOA developed an action plan to 

ensure that deemed status survey files 

are complete, accurate, and consistent 

with the requirements at § 488.6(a); 

• AOA developed and conducted 

surveyor training on the documentation 

of deficiencies to ensure that all cited 

deficiencies contain a regulatory 

reference, a clear and detailed 

description of the deficient practice, and 

relevant finding; 

• AOA developed a policy to ensure 

that facilities with condition level noncompliance on a recertification survey 

submit an acceptable PoC, and receive 

a follow-up onsite focused survey, in 

order to meet the requirements at 

§ 488.20(b) and § 488.28(a); 

• AOA revised its policies and 

developed an internal tracking tool to 


jlentini on DSKJ8SOYB1PROD with NOTICES
48976 Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 

ensure that facilities with condition 

level non-compliance on an initial 

survey receive an onsite follow-up full 

survey, in order to meet the 

requirements at section 2005A2 of the 

SOM; 

• AOA developed and incorporated 

measures to improve the accuracy and 

consistency of data submissions to CMS 

in order to meet the requirements at 

§ 488.4(b); 

• AOA revised its policies on 

blackout dates to meet the requirements 

at 2700A of the SOM; 

• AOA revised its accreditation 

decision letters to ensure that they are 

accurate and contain all the required 

elements for our Regional Office to 

render a decision regarding the deemed 

status of an accredited ASC; 

• AOA revised and updated its 

surveyor team handbook to include 

references to its ASC deeming program; 

• AOA extended its onsite survey 

time allotted for review of the CfCs from 

1 day to 2 days in order to meet the 

requirements at § 488.26; and 

• AOA removed all references to 

mandatory consultative services from its 

policies to avoid potential conflict of 

interest issue. 

To verify AOA’s continued 

compliance with the provisions of this 

final notice, we will conduct a followup corporate onsite visit within 1 year 

of the date of publication of this notice. 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that the 

AOA’s requirements for ASCs meet or 

exceed our requirements. Therefore, we 

approve AOA as a national accreditation 

organization for ASCs that request 

participation in the Medicare program, 

effective October 23, 2009 through 

October 23, 2013. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 10, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–22956 Filed 9–24–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4141–N] 

Medicare Program; Medicare Appeals; 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

annual adjustment in the amount in 

controversy (AIC) threshold amounts for 

Administrative Law Judge (ALJ) 

hearings and judicial review under the 

Medicare appeals process. The 

adjustment to the AIC threshold 

amounts will be effective for requests 

for ALJ hearings and judicial review 

filed on or after January 1, 2010. The 

2010 AIC threshold amounts are $130 

for ALJ hearings and $1,260 for judicial 

review. 

DATES: Effective Date: This notice is 

effective on January 1, 2010. 

FOR FURTHER INFORMATION CONTACT: Liz 

Hosna, (410) 786–4993. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1869(b)(1)(E) of the Social 

Security Act (the Act), as amended by 

section 521 of the Medicare, Medicaid, 

and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA), 

established AIC threshold amounts for 

ALJ hearing requests and judicial review 

at $100 and $1000, respectively, for 

Medicare Part A and Part B appeals. 

Section 940 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003, amended 

section 1869(b)(1)(E) of the Act to 

require the AIC threshold amounts for 

ALJ hearings and judicial review to be 

adjusted annually. The AIC threshold 

amounts are to be adjusted, as of 

January 2005, by the percentage increase 

in the medical care component of the 

consumer price index for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. Section 

940(b)(2) of the MMA provided 

conforming amendments to apply the 

AIC adjustment requirement to 

Medicare Part C (Medicare Advantage 

‘‘MA’’) appeals and certain health 

maintenance organization and 

competitive health plan appeals. Health 

care prepayment plans are also subject 

to MA appeals rules, including the AIC 

adjustment requirement. Section 101 of 

the MMA provides for the application of 

the AIC adjustment requirement to 

Medicare Part D appeals. 

A. Medicare Part A and Part B Appeals 

The statutory formula for the annual 

adjustment to the AIC threshold 

amounts for ALJ hearings and judicial 

review of Medicare Part A and Part B 

appeals, set forth at section 

1869(b)(1)(E) of the Act, is included in 

the applicable implementing 

regulations, 42 CFR part 405, subpart I, 

at § 405.1006(b). The regulations require 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) to publish changes to the AIC 

threshold amounts in the Federal 

Register (§ 405.1006(b)(2)). In order to 

be entitled to a hearing before an ALJ, 

a party to a proceeding must meet the 

AIC requirements at § 405.1006(b). 

Similarly, a party must meet the AIC 

requirements at § 405.1006(c) at the time 

judicial review is requested for the court 

to have jurisdiction over the appeal 

(§ 405.1136(a)). 

B. Medicare Part C (Medicare 

Advantage) Appeals 

Section 940(b)(2) of the MMA applies 

the AIC adjustment requirement to Part 

C (MA) appeals by amending section 

1852(g)(5) of the Act. The implementing 

regulations for Medicare Part C appeals 

are found at 42 CFR part 422, subpart 

M. Specifically, § 422.600 and § 422.612 

discuss the AIC threshold amounts for 

ALJ hearings and judicial review. 

Section 422.600 grants any party to 

the reconsideration, except the MA 

organization, who is dissatisfied with 

the reconsideration determination, a 

right to an ALJ hearing as long as the 

amount remaining in controversy after 

reconsideration meets the threshold 

requirement established annually by the 

Secretary. Section 422.612 states that 

any party, including the MA 

organization, may request judicial 

review if, in part, the amount in 

controversy meets the threshold 

requirement established annually by the 

Secretary. 


jlentini on DSKJ8SOYB1PROD with NOTICES