[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Proposed Rules]
[Pages 81544-81547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32612]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
Request for Information Regarding Value-Based Insurance Design in
Connection With Preventive Care Benefits
AGENCIES: Internal Revenue Service, Department of the Treasury;
Employee Benefits Security Administration, Department of Labor; Office
of Consumer Information and Insurance Oversight, Department of Health
and Human Services.
ACTION: Request for information.
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SUMMARY: This document contains a request for information on how group
health plans and health insurance issuers can employ value-based
insurance design in the coverage of recommended preventive services.
DATES: Comments are due on or before February 28, 2011.
ADDRESSES: Written comments may be submitted to any of the addresses
specified below. Any comment that is submitted to any Department will
be shared with the other Departments. Please do not submit duplicates.
All comments will be made available to the public. Warning: Do not
include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that
you do not want publicly disclosed. All comments may be posted on the
Internet and can be retrieved by most Internet search engines. Comments
may be submitted anonymously.
Department of Labor. Comments to the Department of Labor,
identified by VBID, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected].
Mail or Hand Delivery: Office of Health Plan Standards and
Compliance Assistance, Employee Benefits Security Administration, Room
N-5653, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210, Attention: VBID.
Comments received by the Department of Labor will be posted without
change to http://www.regulations.gov and http://www.dol.gov/ebsa, and
available for public inspection at the Public Disclosure Room, N-1513,
Employee Benefits Security Administration, 200 Constitution Avenue,
NW., Washington, DC 20210.
Department of Health and Human Services. In commenting, please
refer to file code HHS-OS-2010-002. 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 the instructions under
the ``More Search Options'' tab.
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: HHS-OS-
2010-002, 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.
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: HHS-OS-2010-002, Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201.
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 the following address: Office of Consumer Information and
Insurance Oversight, Department of Health and Human Services,
Attention: HHS-OS-2010-002, 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
[[Page 81545]]
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.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately
three 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. EST. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Internal Revenue Service. Comments to the IRS, identified by REG-
120391-10 VBID, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: CC:PA:LPD:PR (REG-120391-10 VBID), Room 5205,
Internal Revenue Service, P.O. Box 7604, Ben Franklin Station,
Washington, DC 20044.
Hand or courier delivery: Monday through Friday between
the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-120391-10 VBID),
Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue,
NW., Washington DC 20224.
All submissions to the IRS will be open to public inspection and
copying in Room 1621, 1111 Constitution Avenue, NW., Washington, DC
from 9 a.m. to 4 p.m.
FOR FURTHER INFORMATION CONTACT: Amy Turner or Beth Baum, Employee
Benefits Security Administration, Department of Labor, at (202) 693-
8335; Karen Levin, Internal Revenue Service, Department of the
Treasury, at (202) 622-6080; Lisa Campbell, Office of Consumer
Information and Insurance Oversight, Department of Health and Human
Services, at (301) 492-4100.
Customer Service Information: Individuals interested in obtaining
information from the Department of Labor concerning employment-based
health coverage laws may call the EBSA Toll-Free Hotline at 1-866-444-
EBSA (3272) or visit the Department of Labor's Web site (http://www.dol.gov/ebsa). In addition, information from HHS on private health
insurance for consumers can be found on the Centers for Medicare &
Medicaid Services (CMS) Web site (http://www.cms.hhs.gov/HealthInsReformforConsume/01_Overview.asp) and the Office of Consumer
Information & Insurance Oversight (OCIIO) Web site (http://www.hhs.gov/OCIIO).
SUPPLEMENTARY INFORMATION:
I. Background
Section 1001 of the Patient Protection and Affordable Care Act (the
Affordable Care Act) added a new section 2713 to the Public Health
Service Act (the PHS Act), relating to preventive care. The Affordable
Care Act also added a new section 715(a)(1) to the Employee Retirement
Income Security (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 2713) into ERISA and the
Code, making section 2713 applicable to group health plans and health
insurance coverage in connection with group health plans. The
Departments of the Treasury, Labor, and Health and Human Services (the
Departments) published interim final regulations implementing the
provisions of PHS Act section 2713 on July 19, 2010, at 75 FR 41726.
Section 2713 of the PHS Act and the Departments' implementing
regulations apply to group health plans and health insurance issuers
offering group or individual health insurance coverage that is not
grandfathered.\1\ These provisions require such plans and issuers to
provide coverage for recommended preventive services, without imposing
cost-sharing requirements.\2\ The complete list of items and services
that are required to be covered under these interim final regulations
can be found at http://www.HealthCare.gov/center/regulations/prevention.html.
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\1\ For information on whether a particular group health plan or
health insurance coverage is a grandfathered plan, see Affordable
Care Act section 1251 and the Departments' implementing regulations
at 75 FR 34538 (as amended by 75 FR 70114).
\2\ In general, the recommended preventive services are: (1)
Evidence-based items or services that have in effect a rating of A
or B in the current recommendations of the United States Preventive
Services Task Force (Task Force) with respect to the individual
involved; (2) immunizations for routine use in children,
adolescents, and adults that have in effect a recommendation from
the Advisory Committee on Immunization Practices of the Centers for
Disease Control and Prevention with respect to the individual
involved; (3) with respect to infants, children, and adolescents,
evidence-informed preventive care and screenings provided for in the
comprehensive guidelines supported by the Health Resources and
Services Administration (HRSA); and (4) with respect to women,
evidence-informed preventive care and screening provided for in
comprehensive guidelines supported by HRSA (not otherwise addressed
by the recommendations of the Task Force).
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The interim final regulations clarify that, with respect to a plan
or health insurance coverage that has a network of providers, a plan or
issuer is not required to provide coverage for recommended preventive
services delivered by an out-of-network provider. Such a plan or issuer
may also impose cost-sharing requirements for recommended preventive
services delivered by an out-of-network provider.
The interim final regulations also provide that if a recommendation
or guideline for a recommended preventive service does not specify the
frequency, method, treatment, or setting for the provision of that
service, the plan or issuer may use reasonable medical management
techniques to determine any coverage limitations. The use of reasonable
medical management techniques allows plans and issuers to adapt these
recommendations and guidelines for coverage of specific items and
services where cost sharing must be waived. Thus, a plan or issuer may
rely on established techniques and the relevant evidence base to
determine the frequency, method, treatment, or setting for which a
recommended preventive service will be available without cost-sharing
requirements to the extent not specified in a recommendation or
guideline.
The preamble to the interim final regulations also invited comments
on value-based insurance designs (VBID). In general, VBID includes the
provision of information and incentives for consumers that promote
access to and use of higher value providers, treatments, and services.
The preamble stated:
The Departments recognize the important role that value-based
insurance design can play in promoting the use of appropriate
preventive services. These interim final regulations, for example,
permit plans and issuers to implement designs that seek to foster
better quality and efficiency by allowing cost-sharing for
recommended preventive services delivered on an out-of-network basis
while eliminating cost-sharing for recommended preventive health
services delivered on an in-network basis. The Departments are
developing additional guidelines regarding the utilization of value-
based insurance designs by group health plans and health insurance
issuers with respect to preventive benefits. The Departments are
seeking comments related to the development of such guidelines for
value-based insurance designs that promote consumer choice of
providers or services that offer the best value and quality, while
ensuring access to critical, evidence-based preventive services.
In response to the solicitation of comments, the Departments
received about 25 comment letters regarding VBID. Many commenters cited
the importance of using VBID to help control rising health care costs
and promote better health care outcomes. A number of other commenters
raised
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concerns about VBID becoming a barrier to access to services. Some also
questioned how value would be assessed and whether that assessment
would include measures such as quality and effectiveness, not solely
measures of cost.
The Departments remain interested in promoting high-value,
clinically effective, evidence-based preventive care. (Outside the
context of preventive care, the coverage requirements and cost-sharing
prohibition of PHS Act section 2713 are not applicable.) The
Departments are issuing the fifth in a series of Affordable Care Act
Implementation Frequently Asked Questions (FAQs), which identifies
certain health plan design elements that are considered to comply with
PHS Act section 2713. To inform future guidance, this RFI solicits
additional information on specific examples and best practices of VBID
for recommended preventive services, as well as data used to support
and inform VBID benefit design, measurement, and evaluation in the
context of recommended preventive services.
II. Solicitation of Comments
A. Comments Regarding Regulatory Guidance
This RFI requests comments generally on VBID in the context of
recommended preventive services, as well as specifically on the
following questions:
1. What specific plan design tools do plans and issuers currently
use to incentivize patient behavior, and which tools are perceived as
most effective (for example, specific network design features, targeted
cost-sharing mechanisms)? How is effective defined?
2. Do these tools apply to all types of benefits for preventive
care, or are they targeted towards specific types of conditions (for
example, diabetes) or preventive services treatments (for example,
colonoscopies, scans)?
3. What considerations do plans and issuers give to what
constitutes a high-value or low-value treatment setting, provider, or
delivery mechanism? What is the threshold of acceptable value? What
factors impact how this threshold varies between services? What data
are used? How is quality measured as part of this analysis? What time
frame is used for assessing value? Are the data readily available from
public sources, or are they internal and/or considered proprietary?
4. What data do plans and issuers use to determine appropriate
incentive models and/or amounts in steering patients towards high-value
and/or away from low-value mechanisms for delivery of a given
recommended preventive service?
5. How often do plans and issuers re-evaluate data and plan design
features? What is the process for re-evaluation? Specifically:
a. How is the impact of VBID on patient utilization monitored?
b. How is the impact of VBID on patient out-of-pocket costs
monitored?
c. How is the impact of VBID on health plan costs monitored?
d. What factors are considered in evaluating effectiveness (for
example, cost, quality, utilization)?
6. Are there particular instances in which a plan or issuer has
decided not to adopt or continue a particular VBID method? If so, what
factors did they consider in reaching that decision?
7. What are the criteria for adopting VBID for new or additional
preventive care benefits or treatments?
8. Do plans or issuers currently implement VBIDs that have
different cost-sharing requirements for the same service based on
population characteristics (for example, high vs. low risk populations
based on evidence)?
9. What would be the data requirements and other administrative
costs associated with implementing VBIDs based on population
characteristics across a wide range of preventive services?
10. What mechanisms and/or safety valves, if any, do plans and
issuers put in place or what data are used to ensure that patients with
particular co-morbidities or special circumstances, such as risk
factors or the accessibility of services, receive the medically
appropriate level of care? For example, to the extent a low-cost
alternative treatment is reasonable for some or the majority of
patients, what happens to the minority of patients for whom a higher-
cost service may be the only medically appropriate one?
11. What other factors, such as ensuring adequate access to
preventive services, are considered as part of a plan or issuer's VBID
strategy?
12. How are consumers informed about VBID features in their health
coverage?
13. How are prescribing physicians/other network providers informed
of VBID features and/or encouraged to steer patients to value based
services and settings?
14. What consumer protections, if any, need to be in place to
ensure adequate access to preventive care without cost sharing, as
required under PHS Act section 2713?
B. Comments Regarding Economic Analysis, Paperwork Reduction Act, and
Regulatory Flexibility Act
Executive Order 12866 (EO 12866) requires an assessment of the
anticipated costs and benefits of a significant rulemaking action and
the alternatives considered, using the guidance provided by the Office
of Management and Budget. These costs and benefits are not limited to
the Federal government, but pertain to the affected public as a whole.
Under Executive Order 12866, a determination must be made whether
implementation of this rule will be economically significant. A rule
that has an annual effect on the economy of $100 million or more is
considered economically significant.
In addition, the Regulatory Flexibility Act (RFA) may require the
preparation of an analysis of the impact on small entities of proposed
rules and regulatory alternatives. An analysis under the Regulatory
Flexibility Act must generally include, among other things, an estimate
of the number of small entities subject to the regulations (for this
purpose, plans, employers, and issuers and, in some contexts small
governmental entities), the expense of the reporting, recordkeeping,
and other compliance requirements (including the expense of using
professional expertise), and a description of any significant
regulatory alternatives considered that would accomplish the stated
objectives of the statute and minimize the impact on small entities.
For this purpose, the Departments consider a small entity to be an
employee benefit plan with fewer than 100 participants.
The Paperwork Reduction Act (PRA) requires an estimate of how many
respondents will be required to comply with any ``collection of
information'' requirements contained in regulations and how much time
and cost will be incurred as a result. A collection of information
includes recordkeeping, reporting to governmental agencies, and third-
party disclosures.
The Departments are requesting comments that may contribute to the
analyses that will be performed under these requirements, both
generally and with respect to the following specific areas:
1. What costs and benefits are associated with expanded use of VBID
methods? How do costs and benefits vary among different types of
preventive screenings, lifestyle interventions, medications,
immunizations, and diagnostic tests?
2. What policies, procedures, practices and disclosures of group
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health plans and health insurance issuers would be impacted by expanded
use of VBID methods? What direct or indirect costs and benefits would
result? Which stakeholders will be impacted by such benefits and costs?
3. What impact would expanded use of VBID methods have on small
employers or small plans? Are there unique costs or benefits for small
plans? What special considerations, if any, should the Departments take
into account for small employers or small plans?
Signed at Washington, DC on December 20, 2010.
Nancy J. Marks,
Division Counsel/Associate Chief Counsel, Tax Exempt and Government
Entities, Internal Revenue Service, Department of the Treasury.
Signed at Washington, DC on December 21, 2010.
George H. Bostick
Benefits Tax Counsel, Department of the Treasury.
Signed at Washington, DC on December 16, 2010.
Phyllis C. Borzi
Assistant Secretary, Employee Benefits Security Administration, U.S.
Department of Labor.
Dated: December 21, 2010.
Jay Angoff
Director, Office of Consumer Information and Insurance Oversight.
[FR Doc. 2010-32612 Filed 12-27-10; 8:45 am]
BILLING CODE 4830-01-P; 4510-29-P; 4120-01-P