Affordable Care Act; Federal External Review Process; Request for Information, 70160-70162 [2010-28876]
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<![CDATA[
70160
Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules
erowe on DSK5CLS3C1PROD with PROPOSALS-1
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
VerDate Mar<15>2010
15:18 Nov 16, 2010
Jkt 223001
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
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§ 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
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.
AGENCY:
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
SUMMARY:
E:\FR\FM\17NOP1.SGM
17NOP1
erowe on DSK5CLS3C1PROD with PROPOSALS-1
Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Proposed Rules
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 https://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
VerDate Mar<15>2010
15:18 Nov 16, 2010
Jkt 223001
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: https://
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
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70161
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
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.
E:\FR\FM\17NOP1.SGM
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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?
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15:18 Nov 16, 2010
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(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?
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Fmt 4702
Sfmt 4702
(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
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
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
SUMMARY:
E:\FR\FM\17NOP1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Proposed Rules]
[Pages 70160-70162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28876]
=======================================================================
-----------------------------------------------------------------------
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
[[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 https://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: https://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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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:
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
