[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Proposed Rules]
[Pages 70160-70162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28876]


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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.

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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

[[Page 70161]]

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\
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    \1\ The 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.
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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

[[Page 70162]]

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:
    <bullet> Development, maintenance, distribution, and update of 
``decision support'' protocols;
    <bullet> Adjudication of external review cases, using established 
protocols;
    <bullet> Timely and accurate disposition of all external review 
cases;
    <bullet> Collection, consolidation, storage, maintenance, and 
transmission of information regarding the receipt and disposition of 
external review cases for the Federal external review process;
    <bullet> 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;
    <bullet> Participation and coordination with other entities 
(including other IROs) involved in the Federal external review process 
for quality improvement purposes;
    <bullet> Communication of external review decisions to claimants 
and other parties involved in the case;
    <bullet> Case management and documentation, which may include 
document imaging to produce a complete electronic case file; and
    <bullet> 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