70160 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules 

Department of Labor and the 

Department of Health and Human 

Services (the joint rulemaking). The text 

of those temporary regulations also 

serves as the text of these proposed 

regulations. The preamble to the 

temporary regulations explains the 

temporary regulations and these 

proposed regulations. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking is not a 

significant regulatory action as defined 

in Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

has also been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 

to this proposed regulation. It is hereby 

certified that the collection of 

information contained in this notice of 

proposed rulemaking will not have a 

significant impact on a substantial 

number of small entities. Accordingly, a 

regulatory flexibility analysis is not 

required. 

The amendment to the temporary 

regulations adds a new third-party 

disclosure requirement so that it also 

applies to a group health plan that is 

changing health insurance coverage. 

The group health plan must provide to 

a succeeding or new health insurance 

issuer (and the succeeding or new 

health insurance issuer must require) 

documentation of plan terms (including 

benefits, cost sharing, employer 

contributions, and annual limits) under 

the prior health insurance coverage 

sufficient to make a determination 

whether a change described in 

§ 54.9815–1251T(g)(1) has occurred. The 

hour and cost burden associated with 

this requirement is de minimis, because 

group health plans can satisfy the 

requirement by providing a copy of the 

policy or summary plan description to 

the succeeding or new health insurance 

issuer. This is not a significant burden 

for any plan and thus will not have a 

significant impact on a substantial 

number of small entities. 

For further information and for 

analyses relating to the joint 

rulemaking, see the preamble to the 

joint rulemaking. Pursuant to section 

7805(f) of the Internal Revenue Code, 

this regulation has been submitted to 

the Chief Counsel for Advocacy of the 

Small Business Administration for 

comment on its impact on small 

business. 

Comments and Requests for a Public 

Hearing 

Before these proposed regulations are 

adopted as final regulations, 

consideration will be given to any 

written comments (a signed original and 

eight (8) copies) or electronic comments 

that are submitted timely to the IRS. 

Comments are specifically requested on 

this amendment to the proposed 

regulations, including the prospective 

effective date of the rule and how that 

affects plans with different plan years. 

All comments will be available for 

public inspection and copying. A public 

hearing may be scheduled if requested 

in writing by a person that timely 

submits written comments. If a public 

hearing is scheduled, notice of the date, 

time, and place for the hearing will be 

published in the Federal Register. 

Drafting Information 

The principal author of these 

proposed regulations is Karen Levin, 

Office of the Division Counsel/Associate 

Chief Counsel (Tax Exempt and 

Government Entities), IRS. The 

proposed regulations, as well as the 

temporary regulations, have been 

developed in coordination with 

personnel from the U.S. Department of 

Labor and the U.S. Department of 

Health and Human Services. 

List of Subjects in 26 CFR Part 54 

Excise taxes, Health care, Health 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

Proposed Amendments to the 

Regulations 

Accordingly, 26 CFR part 54 is 

proposed to be amended as follows: 

PART 54—PENSION EXCISE TAXES 

Paragraph 1. The authority citation 

for part 54 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

Par. 2. Section 54.9815–1251 as 

published on June 17, 2010, at 75 FR 

34571, is amended by revising 

paragraphs (a)(1), (a)(3)(ii), (f), and (g)(4) 

Example 9 to read as follows: 

§ 54.9815–1251 Preservation of right to 

maintain existing coverage. 

(a) * * * (1) [The text of proposed 

§ 54.9815–1251(a)(1) is the same as the 

text of § 54.9815–1251T(a)(1) published 

elsewhere in this issue of the Federal 

Register]. 

* * * * * 

(3) * * * 

(ii) [The text of proposed § 54.9815– 

1251(a)(3)(ii) is the same as the text of 

§ 54.9815–1251T(a)(3)(ii) published 

elsewhere in this issue of the Federal 

Register]. 

* * * * * 

(f) [The text of proposed § 54.9815– 

1251(f) is the same as the text of 

§ 54.9815–1251T(f) published elsewhere 

in this issue of the Federal Register]. 

(g) * * * 

(4) * * * 

Example 9. [The text of proposed 

§ 54.9815–1251(g)(4) Example 9 is the 

same as the text of § 54.9815– 

1251T(g)(4) Example 9 published 

elsewhere in this issue of the Federal 

Register]. 

Steven T. Miller, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. 2010–28866 Filed 11–15–10; 4:15 pm] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 147 

[Docket No. OCIIO–9986–NC] 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

Affordable Care Act; Federal External 

Review Process; Request for 

Information 

AGENCY: Office of Consumer Information 

and Insurance Oversight, Department of 

Health and Human Services; Employee 

Benefits Security Administration, 

Department of Labor. 

ACTION: Notice; request for information. 

SUMMARY: This notice is a request for 

information (RFI) to gain market 

analysis information in advance of one 

or more future Requests for Proposals 

(RFP). On July 23, 2010, the 

Departments of Health and Human 

Services, Labor, and the Treasury 

published interim final regulations 

regarding, among other things, 

procedures for external review of health 

plan denials. The regulations include a 

provision for a Federal external review 

process in instances where there is no 

applicable State process. This RFI 

solicits information that will enable the 

Departments of Health and Human 

Services (HHS) and Labor (DOL) to 

conduct a market analysis and assist the 

Departments in planning and 

developing the Federal external review 

process. HHS and/or DOL may contract 

for services required to fulfill the 

statutory and regulatory requirements of 

the Federal external review process 

established under section 2719 of the 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules 70161 

1The Departments’ interim final regulations 

provide for a transition period for States until July 

1, 2011 during which time HHS will work with 

States to assist them in making any necessary 

changes so that the State process provides, at a 

minimum, the consumer protections under the 

NAIC Uniform Model Act. 

Public Health Service Act, as amended 

by the Affordable Care Act, and its 

implementing regulations. 

DATES: Submit written or electronic 

comments by December 8, 2010. 

We note that responses to this notice 

are not offers and cannot be accepted by 

the Government to form a binding 

contract or issue a grant. The purpose of 

this RFI is to inform the RFP, not to 

gather public comments on the interim 

final rules for internal claims and 

appeals and external review processes 

under the Affordable Care Act; those 

comments are being collected and 

evaluated on a separate track. 

Information obtained as a result of this 

RFI may be used by the government for 

program planning and development on 

a non-attribution basis. Do not include 

any information that might be 

considered proprietary or confidential. 

ADDRESSES: In commenting, please refer 

to file code OCIIO–9986–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): 

1. Electronically. You may submit 

electronic comments on this regulation 

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

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Office of Consumer Information and 

Insurance Oversight, Department of 

Health and Human Services, Attention: 

OCIIO–9986–NC, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: 

Office of Consumer Information and 

Insurance Oversight, Department of 

Health and Human Services, Attention: 

OCIIO–9986–NC, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

Office of Consumer Information and 

Insurance Oversight, Department of 

Health and Human Services, Attention: 

OCIIO–9986–NC, 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 OCIIO 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.) 

Comments mailed to the address 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Linda G. Greenberg, Department of 

Health and Human Services, Office of 

Consumer Information and Insurance 

Oversight at (301) 492–4225 or Amy 

Turner, Department of Labor, Employee 

Benefits Security Administration at 

(202) 693–8335. 

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 electronic 

comments received before the close of 

the comment period on the following 

public Web site as soon as possible after 

they have been received at: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will be 

available for public inspection as they 

are received, generally beginning 

approximately 3 weeks after publication 

of a document, at Room 445–G, 

Department of Health and Human 

Services, Hubert H. Humphrey Building, 

200 Independence Avenue, SW., 

Washington, DC 20201, Monday 

through Friday of each week from 

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

appointment to view public comments, 

call 1–800–743–3951. 

I. Background 

Section 1001 of the Patient Protection 

and Affordable Care Act (the Affordable 

Care Act), Public Law 111–148, added a 

new section 2719 to the Public Health 

Service Act (the PHS Act). The 

Affordable Care Act also added a new 

section 715(a)(1) to the Employee 

Retirement Income Security Act (ERISA) 

and section 9815(a)(1) to the Internal 

Revenue Code (the Code) incorporating 

the provisions of part A of title XXVII 

of the PHS Act (including PHS Act 

section 2719) into ERISA and the Code 

and making them applicable to group 

health plans and health insurance 

coverage in connection with group 

health plans. The Departments of Health 

and Human Services, Labor, and the 

Treasury (the Departments) published 

interim final regulations implementing 

the provisions of PHS Act section 2719 

on July 23, 2010, at 75 FR 43330. 

Section 2719(b)(1) of the PHS Act and 

the Departments’ regulations provide 

that, if a State external review process 

that applies to and is binding on a 

health insurance issuer includes, at a 

minimum, the consumer protections set 

forth in the Uniform External Review 

Model Act issued by the National 

Association of Insurance Commissioners 

(‘‘NAIC Uniform Model Act’’), then the 

issuer is not required to comply with 

the Federal external review process. 

State law may provide similar 

protection for group health plans that 

are not subject to ERISA preemption, 

such as nonfederal governmental plans. 

The Departments, through guidance, are 

authorized to establish an external 

review process that is similar to a State 

external review process that meets the 

standards set forth in the interim final 

regulations for group health plans and 

health insurance coverage if a State has 

not established such a process.1

II. Questions 

This RFI requests comments on 

operational issues associated with 

implementation of a Federal external 

review process for health coverage in 

States that do not have an applicable 

external review process that meets the 

minimum Federal standards. HHS and 

DOL plan to ensure consistent and 

uniform processes for external review 

by independent review organizations 

(IROs) within relevant geographic areas 

and throughout the nation. The 

Department of HHS and/or Labor may 

enter into one or more contractual 

relationships to implement the external 

review process and reserve the right to 

award one contract or several contracts 

depending on the workload and 

decisions on how to divide the 

workload of the Federal external review 

process, as necessary. 

In particular, HHS and/or DOL may 

contract for services required to fulfill 

the statutory and regulatory 


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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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