70162 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules 

requirements of the Federal external 

review process established under 

section 2719 of the PHS Act and its 

implementing regulations. In such a 

case, the contractor would be 

responsible for conducting standard and 

expedited reviews of all adverse benefit 

determinations and final internal 

adverse benefit determinations that are 

eligible for external review as defined 

by the regulations. Reviews would be 

conducted in an accurate, efficient, 

timely, and consistent manner. In 

conjunction with completing these 

reviews, the contractor may be tasked 

with the following functions and 

responsibilities to support the 

permanent Federal external appeals 

process: 

• Development, maintenance, 

distribution, and update of ‘‘decision 

support’’ protocols; 

• Adjudication of external review 

cases, using established protocols; 

• Timely and accurate disposition of 

all external review cases; 

• Collection, consolidation, storage, 

maintenance, and transmission of 

information regarding the receipt and 

disposition of external review cases for 

the Federal external review process; 

• Performance of statistical and data 

analyses of external review cases to 

include trend analyses, and compliance 

with HHS data and reporting 

requirements including ad-hoc analyses 

for reports and inquiries from HHS, 

Congress, and other entities, and for 

purposes of continuous quality 

improvement; 

• Participation and coordination with 

other entities (including other IROs) 

involved in the Federal external review 

process for quality improvement 

purposes; 

• Communication of external review 

decisions to claimants and other parties 

involved in the case; 

• Case management and 

documentation, which may include 

document imaging to produce a 

complete electronic case file; and 

• Training all critical and qualified 

staff on all aspects of the external 

review process. 

Accordingly, the Departments of HHS 

and Labor are seeking to engage 

formally, in a transparent and 

participatory manner, with the public 

on best practices and standards 

currently used by IROs. Specific 

questions are set forth below. Comments 

are invited from all stakeholders on 

these issues. 

Qualified Organizations and Staff 

(1) What accreditation standards 

currently apply to IROs? 

(2) What credentialing standards do 

IROs require for medical and legal 

reviewers? Is credentialing required or 

voluntary? 

(3) What procedures are currently 

used by IROs to assure that reviewers do 

not have conflicts of interest with 

disputing parties? 

(4) What are IROs’ current capacity for 

performing reviews? Does staffing and 

the time necessary for performing a 

review differ based on the type of claim 

(e.g., medical necessity, experimental/ 

investigational treatment, coverage 

issues, etc.)? 

Infrastructure 

(5) Please describe the type of data 

collection systems that IROs currently 

use to conduct analyses, reporting, and 

tracking of appeals and grievances. 

(6) Are the current data systems 

available in a secure, 508-compliant, 

web-based interactive structure? 

(7) What telecommunication systems 

and consumer technical support 

systems do IROs currently maintain for 

consumers (e.g., Web sites, 24-hour 

hotlines, helpdesk, and/or translation 

services for non-English speakers)? 

(8) What is a reasonable amount of 

time for a contractor to become fully 

operational (have all systems in place to 

conduct external reviews) after the date 

of a contract award? What resources 

would be necessary? 

(9) What considerations must be taken 

into account to smoothly transition from 

the current Federal interim external 

review process to a possible new 

permanent Federal external review 

process? 

(10) Do IROs currently operate 

nationally or in limited geographic 

areas? Would IROs that currently serve 

local areas be able to expand their 

service areas to possibly include other 

geographic areas such as other States? 

Are there any State and/or local 

licensing requirements? 

(11) Are there any special 

considerations HHS and/or DOL should 

be aware of in considering a specialized 

contract for urgent care appeals or for 

experimental and investigational 

treatments? Would such an approach 

have an impact on coordination? 

(12) Please describe the difference in 

standard operating procedures and 

resources (time, cost, personnel) for 

appeals that involve only medical 

necessity and those that involve both 

medical necessity and coverage 

questions. 

Data Collection 

(13) What data are currently collected 

by IROs for tracking appeals and 

conducting analyses? 

(14) What steps are taken to ensure 

confidentiality and security protections 

of patient information? 

Evaluation 

(15) Do IROs (or subcontractors) 

currently conduct evaluations of their 

operations? Do such evaluations include 

an assessment of how easy it is for 

consumers to access and use the 

external review process in a timely 

manner? Do evaluations result in quality 

improvement initiatives? If so, what are 

some examples of quality improvement 

initiatives undertaken by IROs? 

(16) What specific requirements 

should be applied to IROs to evaluate 

progress toward performance goals? 

What performance goals are the most 

appropriate? 

Signed at Washington, DC, November 10, 

2010. 

Elizabeth Fowler, 

Director of Policy, Office of Consumer 

Information and Insurance Oversight. 

Department of Health and Human Services. 

Signed at Washington, DC, November 9, 

2010. 

Phyllis C. Borzi, 

Assistant Secretary, Employee Benefits 

Security Administration Department of Labor. 

[FR Doc. 2010–28876 Filed 11–12–10; 11:15 am] 

BILLING CODE 4150–29– 4150–65–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 3 

RIN 2900–AN83 

Presumptive Service Connection for 

Diseases Associated With Persian Gulf 

War Service: Functional 

Gastrointestinal Disorders 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) is amending its 

adjudication regulations concerning 

presumptive service connection for 

medically unexplained chronic 

multisymptom illnesses associated with 

service in the Southwest Asia theater of 

operations for which there is no record 

during service. This amendment is 

necessary to implement a decision of 

the Secretary of Veterans Affairs that 

there is a positive association between 

service in Southwest Asia during certain 

periods and the subsequent 

development of functional 

gastrointestinal disorders (FGIDs), and 

to clarify that FGIDs fall within the 

scope of the existing presumption of 

service connection for medically 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules 70163 

unexplained chronic multisymptom 

illnesses. The intended effect of this 

amendment is to clarify the 

presumption of service connection for 

these illnesses based on service in the 

Southwest Asia theater of operations 

during the Persian Gulf War. 

DATES: Comments must be received by 

VA on or before December 17, 2010. 

ADDRESSES: Written comments may be 

submitted through http:// 

www.Regulations.gov; by mail or handdelivery to Director, Regulations 

Management (02REG), Department of 

Veterans Affairs, 810 Vermont Ave., 

NW., Room 1068, Washington, DC 

20420; or by fax to (202) 273–9026. 

(This is not a toll free number.) 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AN83—Presumptive Service Connection 

for Diseases Associated With Persian 

Gulf War Service: Functional 

Gastrointestinal Disorders (FGIDs).’’ 

Copies of comments received will be 

available for public inspection in the 

Office of Regulation Policy and 

Management, Room 1063B, between the 

hours of 8 a.m. and 4:30 p.m., Monday 

through Friday (except holidays). Please 

call (202) 461–4902 for an appointment. 

(This is not a toll free number.) In 

addition, during the comment period, 

comments may be viewed online 

through the Federal Docket Management 

System at http://www.Regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Gerald Johnson, Regulations Staff 

(211D), Compensation and Pension 

Service, Veterans Benefits 

Administration, Department of Veterans 

Affairs, 810 Vermont Avenue, NW., 

Washington, DC 20420, (202) 461- 9727 

(This is not a toll-free number.) 

SUPPLEMENTARY INFORMATION: The 

Secretary of Veterans Affairs has 

determined that the available scientific 

and medical evidence presented in the 

National Academy of Sciences (NAS) 

April 2010 report, titled Gulf War and 

Health, Volume 8: Update on the Health 

Effects of Serving in the Gulf War is 

sufficient to warrant a presumption of 

service connection for FGIDs in 

individuals deployed to the Southwest 

Asia theater of operations during the 

Persian Gulf War. Pursuant to that 

determination, this document proposes 

to clarify that the Department of 

Veterans Affairs (VA) adjudication 

regulations (38 CFR Part 3), specifically 

38 CFR 3.317, would include FGIDs as 

medically unexplained chronic 

multisymptom illnesses subject to 

presumptive service connection. FGIDs 

include, but are not limited to, such 

conditions as irritable bowel syndrome 

(IBS) and functional dyspepsia. 

National Academy of Sciences (NAS) 

Reports 

FGIDs, Including, But Not Limited to, 

Irritable Bowel Syndrome (IBS) and 

Functional Dyspepsia 

The NAS issued its report titled Gulf 

War and Health, Volume 8: Update on 

Health Effects of Serving in the Gulf 

War, on April 9, 2010. The NAS was 

asked to review, evaluate, and 

summarize the literature to determine if 

any of the health outcomes noted in its 

2006 report, titled Gulf War and Health, 

Volume 4: Health Effects of Serving in 

the Gulf War, appear at higher incidence 

or prevalence levels in Gulf Wardeployed veterans. The NAS sought to 

characterize and weigh the strengths 

and limitations of the available 

evidence. The NAS Update committee 

reviewed over 1000 relevant studies and 

focused on over 400 relevant references, 

including the studies reviewed in the 

Volume 4 report. The NAS determined 

that there is sufficient evidence of an 

association between deployment to the 

Gulf War and FGIDs, including, but not 

limited to, IBS and functional 

dyspepsia. The committee also noted 

that there is inadequate evidence of an 

association between deployment to the 

Gulf War and structural gastrointestinal 

(GI) disease. 

FGIDs, such as IBS or functional 

dyspepsia, are syndromes characterized 

by recurrent or prolonged GI symptoms 

that occur together. They are 

distinguished from structural or 

‘‘organic’’ GI disorders in that they 

generally are not associated with 

detectable anatomical abnormalities. 

The severity of FGIDs ranges from 

occasional mild episodes to more 

persistent and disabling symptoms. 

According to the NAS report, there have 

been numerous reports of GI 

disturbances in Gulf War veterans and 

the symptoms have continued to be 

persistent in the years since that war. 

All studies examined by NAS favored a 

greater prevalence of various GI 

symptoms and primary functional GI 

disorders, including IBS and dyspepsia. 

In NAS’s opinion, there also was 

compelling emerging evidence of 

exposure during deployment to enteric 

pathogens leading to the development of 

post-infectious IBS. 

The overall pattern of symptoms 

found in the primary and secondary 

studies NAS reviewed confirms an 

association between deployment to the 

Gulf War and functional GI symptoms, 

including abdominal pain, diarrhea, 

nausea, and vomiting. The NAS 

recommended that further studies be 

conducted to determine the role of prior 

acute gastroenteritis among deployed 

servicemembers in the development of 

FGIDs. 

Detailed information on the 

committee’s findings may be found at: 

http://www.iom.edu/Reports/2010/GulfWar-and-Health-Volume-8–HealthEffects-of-Serving-in-the-Gulf-War.aspx. 

The report findings are organized by 

category and can be found under the 

heading, ‘‘Table of Contents.’’ 

Statutory Provisions 

Pursuant to 38 U.S.C. 1118, VA must 

establish a presumption of service 

connection for each illness shown by 

sound scientific and medical evidence 

to have a positive association with 

exposure to a biological, chemical, or 

other toxic agent, environmental or 

wartime hazard, or preventive medicine 

or vaccine known or presumed to be 

associated with service in the Armed 

Forces in the Southwest Asia theater of 

operations during the Persian Gulf War. 

Because the recent NAS report was 

primarily a review of the prevalence of 

illnesses among Gulf War veterans, it 

generally did not state conclusions as to 

whether the illnesses are associated 

with the types of exposures referenced 

in § 1118. The NAS noted that there was 

significant emerging evidence that 

FGIDs may be associated with exposure 

to enteric pathogens during Gulf War 

deployments and recommended further 

study of that issue. However, NAS did 

not state a conclusion concerning the 

strength of the evidence of an 

association between FGIDs and 

exposure to enteric pathogens. VA has 

determined that resolution of that 

question is not necessary for purposes of 

this rule, because FGIDs are within the 

scope of the existing presumption of 

service connection for medically 

unexplained chronic multisymptom 

illnesses. 

Section 1117 of title 38, United States 

Code, provides a presumption of service 

connection for ‘‘qualifying chronic 

disability’’ in veterans who served in the 

Southwest Asia theater of operations 

during the Persian Gulf War. The statute 

defines the term ‘‘qualifying chronic 

disability’’ to include ‘‘[a] medically 

unexplained chronic multisymptom 

illness (such as chronic fatigue 

syndrome, fibromyalgia, and irritable 

bowel syndrome) that is defined by a 

cluster of signs or symptoms.’’ 38 U.S.C. 

1117(a)(2)(B). The plain language of the 

statute makes clear that it applies to all 

medically unexplained chronic 

multisymptom illnesses including, but 

not limited to, the three conditions 

parenthetically listed as examples. VA 

recently amended its regulation at 38 

CFR 3.317 to clarify that the 


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70164 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules 

presumption is not limited to the three 

listed examples. See 75 FR 61995. 

FGIDs are medically unexplained 

chronic multisymptom illnesses within 

the meaning of the statute and 

regulation. These disorders are defined 

by clusters of signs and symptoms 

affecting GI functions. Further, FGIDs 

are ‘‘medically unexplained’’ because 

they are, by definition, disorders that 

cannot be attributed to observable 

structural or organic changes and the 

causes of the disorders are generally not 

known. Irritable Bowel Syndrome, 

which is a form of FGID, is expressly 

identified in the current statute and 

regulation as a medically unexplained 

chronic multisymptom illness. Because 

other FGIDs, such as functional 

dyspepsia and functional vomiting, also 

are medically unexplained chronic 

multisymptom illnesses, the current 

statute and regulation, as recently 

amended, provide a presumption of 

service connection for FGIDs in veterans 

who served in the Southwest Asia 

theater of operations during the Persian 

Gulf War. In view of the findings in the 

recent NAS report identifying FGIDs as 

prevalent and persistent illnesses among 

Gulf War Veterans, VA has determined 

that its regulations should be revised to 

expressly identify FGIDs as a type of 

medically unexplained chronic 

multisymptom illness within the scope 

of the existing presumption. 

Regulatory Amendments 

We propose to amend 38 CFR 3.317 

to incorporate the more specific 

language regarding FGIDs. We propose 

to: Revise § 3.317(a)(2)(i)(B)(3) by 

removing ‘‘Irritable Bowel Syndrome’’ 

and replacing it with ‘‘Functional 

gastrointestinal disorders, including, but 

not limited to, irritable bowel syndrome 

and functional dyspepsia (excluding 

structural gastrointestinal diseases)’’; 

and add a Note with the definition of 

functional gastrointestinal disorders. 

The intended effect of this change is to 

clarify that FGIDs are medically 

unexplained chronic multisymptom 

illnesses and are thus within the scope 

of the presumption of service 

connection for such illnesses. 

Other Illnesses 

This proposed rule does not reflect 

determinations concerning any illnesses 

other than those discussed in this 

proposal. The Secretary’s 

determinations concerning other 

illnesses discussed in the NAS report 

will be addressed in other documents 

published in the Federal Register. 

Paperwork Reduction Act 

This document contains no provisions 

constituting a collection of information 

under the Paperwork Reduction Act (44 

U.S.C. 3501–3521). 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities as they are 

defined in the Regulatory Flexibility 

Act, 5 U.S.C. 601–612. This rule would 

not affect any small entities. Only VA 

beneficiaries could be directly affected. 

Therefore, pursuant to 5 U.S.C. 605(b), 

this rule is exempt from the initial and 

final regulatory flexibility analysis 

requirements of §§ 603 and 604. 

Executive Order 12866 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Executive Order classifies a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB), as any regulatory action that is 

likely to result in a rule that may: (1) 

Have an annual effect on the economy 

of $100 million or more or adversely 

affect in a material way the economy, a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

or tribal governments or communities; 

(2) create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

The economic, interagency, 

budgetary, legal, and policy 

implications of this proposed rule have 

been examined and it has been 

determined not to be a significant 

regulatory action under the Executive 

Order because it would not result in a 

rule that may materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

year. This rule would have no such 

effect on State, local, and tribal 

governments, or on the private sector. 

Catalog of Federal Domestic Assistance 

Numbers and Titles 

The Catalog of Federal Domestic 

Assistance program numbers and titles 

for this proposed rule are 64.109, 

Veterans Compensation for ServiceConnected Disability, and 64.110, 

Veterans Dependency and Indemnity 

Compensation for Service-Connected 

Death. 

Comment Period 

Although under the rulemaking 

guidelines in Executive Order 12866 VA 

ordinarily provides a 60-day comment 

period, the Secretary has determined 

that there is good cause to limit the 

public comment period on this 

proposed rule to 30 days. The current 

proposed rule does not create a new 

presumption of service connection. 

Consistent with 38 U.S.C. 1117, it 

clarifies that functional gastrointestinal 

disorders fall within the scope of the 

existing presumption of service 

connection for medically unexplained 

chronic multisymptom illnesses. 

Because this rule merely clarifies VA’s 

interpretation of the existing statute and 

regulation, a public comment period is 

not required under the Administrative 

Procedures Act. However, because this 

clarifying rule relates to VA’s response 

to a report referred to in 38 U.S.C. 1118, 

VA has determined that it is appropriate 

to provide for public comment as 

provided in that statute. A 30-day notice 

and comment period will enable the 

rapid issuance of final regulations 

providing the public and VA 

adjudicators with clear guidance 

regarding the interpretation of the 

existing statute and regulation as they 

pertain to FGIDs. This will ensure that 

Veterans suffering from FGID will 

receive a fair determination of benefit 

eligibility, and will promote rapid 

action on affected benefits claims. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. John 

R. Gingrich, Chief of Staff, Department 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules 70165 

of Veterans Affairs, approved this 

document on October 18, 2010, for 

publication. 

List of Subjects in 38 CFR Part 3 

Administrative practice and 

procedure, Claims, Disability benefits, 

Health care, Veterans, Vietnam. 

Dated: November 9, 2010. 

Robert C. McFetridge, 

Director, Regulations Policy and 

Management, Department of Veterans Affairs. 

■ For the reasons set out in the 

preamble, VA proposes to amend 38 

CFR part 3 as follows: 

PART 3—ADJUDICATION 

Subpart A—Pension, Compensation, 

and Dependency and Indemnity 

Compensation 

1. The authority citation for part 3, 

subpart A continues to read as follows: 

Authority: 38 U.S.C. 501(a), unless 

otherwise noted. 

2. Amend § 3.317 by revising 

paragraph (a)(2)(i)(B)(3) to read as 

follows: 

§ 3.317 Compensation for certain 

disabilities due to undiagnosed illnesses. 

(a) * * * 

(2) * * * 

(i) * * * 

(B) * * * 

(3) Functional gastrointestinal 

disorders, including, but not limited to, 

irritable bowel syndrome and functional 

dyspepsia (excluding structural 

gastrointestinal diseases); or Note to 

paragraph (a)(2)(i)(B)(3): Functional 

gastrointestinal disorders are a group of 

conditions characterized by chronic or 

recurrent symptoms that were present 

for at least 6 months prior to diagnosis 

and have been currently active for 3 

months, that are unexplained by any 

structural, endoscopic, laboratory, or 

other objective signs of disease or injury 

and that may be related to any part of 

the gastrointestinal tract. Common 

symptoms include abdominal pain, 

substernal burning or pain, nausea, 

vomiting, altered bowel habits 

(including diarrhea, constipation), 

indigestion, bloating, postprandial 

fullness, and painful or difficult 

swallowing. Specific functional 

gastrointestinal disorders include, but 

are not limited to, irritable bowel 

syndrome, functional dyspepsia, 

functional vomiting, functional 

constipation, functional bloating, 

functional abdominal pain syndrome, 

and functional dysphagia. 

[FR Doc. 2010–28707 Filed 11–16–10; 8:45 am] 

BILLING CODE 8320–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Chapter IV 

[CMS–1345–NC] 

Medicare Program; Request for 

Information Regarding Accountable 

Care Organizations and the Medicare 

Shared Saving Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This document is a request for 

comments regarding certain aspects of 

the policies and standards that will 

apply to accountable care organizations 

(ACOs) participating in the Medicare 

program under section 3021 or 3022 of 

the Affordable Care Act. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

December 3, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1345–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

• Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

‘‘Submit a comment’’ instructions. 

• By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1345–NC, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

• By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–1345–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

• By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to one of 

the following addresses prior to the 

close of the comment period: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–7195 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Carey, (410) 786–4560 or 

Thomas.Carey@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 

8:30 a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

The Affordable Care Act seeks to 

improve the quality of health care 

services and to lower health care costs 

by encouraging providers to create 

integrated health care delivery systems. 

These integrated systems will test new 

reimbursement methods intended to 


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