Patient Protection and Affordable Care Act; Establishment of the Multi-State Plan Program for the Affordable Insurance Exchanges, 9649-9665 [2015-03421]
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Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations
OFFICE OF PERSONNEL
MANAGEMENT
45 CFR Part 800
RIN 3206–AN12
Patient Protection and Affordable Care
Act; Establishment of the Multi-State
Plan Program for the Affordable
Insurance Exchanges
Office of Personnel
Management.
ACTION: Final rule.
AGENCY:
Abbreviations
The U.S. Office of Personnel
Management (OPM) is issuing a final
rule implementing modifications to the
Multi-State Plan (MSP) Program based
on the experience of the Program to
date. OPM established the MSP Program
pursuant to the Affordable Care Act.
This rule clarifies the approach used to
enforce the applicable standards of the
Affordable Care Act with respect to
health insurance issuers that contract
with OPM to offer MSP options; amends
MSP standards related to coverage area,
benefits, and certain contracting
provisions under section 1334 of the
Affordable Care Act; and makes nonsubstantive technical changes.
DATES: Effective March 26, 2015.
FOR FURTHER INFORMATION CONTACT:
Cameron Stokes by telephone at (202)
606–2128, by FAX at (202) 606–4430, or
by email at mspp@opm.gov.
SUPPLEMENTARY INFORMATION: The
Patient Protection and Affordable Care
Act (Pub. L. 111–148), as amended by
the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152), together known as the Affordable
Care Act, provides for the establishment
of Affordable Insurance Exchanges, or
‘‘Exchanges’’ (also called Health
Insurance Marketplaces, or
‘‘Marketplaces’’), where individuals and
small businesses can purchase qualified
coverage. The Exchanges provide
competitive marketplaces for
individuals and small employers to
compare available private health
insurance options based on price,
quality, and other factors. The
Exchanges enhance competition in the
health insurance market, improve
choice of affordable health insurance,
and give individuals and small
businesses purchasing power
comparable to that of large businesses.
The Multi-State Plan (MSP) Program
was created pursuant to section 1334 of
the Affordable Care Act to increase
competition by offering high-quality
health insurance coverage sold in
multiple States on the Exchanges. The
U.S. Office of Personnel Management
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SUMMARY:
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(OPM) is issuing this final rule to
modify the standards set forth for the
MSP Program under 45 CFR Part 800
that was published as a final rule on
March 11, 2013 (78 FR 15560). This rule
clarifies OPM’s intent in administering
the Program, as well as makes regulatory
changes in order to expand issuer
participation and offerings in the
Program to meet the goal of increasing
competition.
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EHB—Essential Health Benefits
FEHB Program—Federal Employees Health
Benefits Program
HHS—U.S. Department of Health and Human
Services
MSP—Multi-State Plan
NAIC—National Association of Insurance
Commissioners
OPM—U.S. Office of Personnel Management
PHS Act—Public Health Service Act
QHP—Qualified Health Plan
SHOP—Small Business Health Options
Program
Section 1334 of the Affordable Care
Act created the Multi-State Plan (MSP)
Program to foster competition in the
health insurance markets on the
Exchanges (also called Health Insurance
Exchanges or Marketplaces) based on
price, quality, and benefit delivery. The
Affordable Care Act directs the U.S.
Office of Personnel Management (OPM)
to contract with private health
insurance issuers to offer at least two
MSP options on each of the Exchanges
in the States and the District of
Columbia.1 The law allows MSP issuers
to phase in coverage.2
In the 2014 plan year, OPM
contracted with one group of issuers to
offer more than 150 MSP options in 31
States, including the District of
Columbia. Approximately 371,000
individuals enrolled in an MSP option
in 2014. For plan year 2015, OPM
entered into contract with a second
group of issuers, and MSP coverage
expanded to 36 States. The Program
currently offers more than 200 MSP
options through the Exchanges to
further competition and expand choices
available to individuals, families, and
small businesses.
This rule builds on the MSP Program
final rule published March 11, 2013.3
1 Multi-State Plan option or MSP option means a
discrete pairing of a package of benefits with
particular cost sharing (which does not include
premium rates or premium rate quotes) that is
offered under a contract with OPM.
2 Multi-State Plan issuer or MSP issuer means a
health insurance issuer or group of issuers that has
a contract with OPM to offer MSP options pursuant
to section 1334 of the Affordable Care Act.
3 Patient Protection and Affordable Care Act;
Establishment of the Multi-State Plan Program for
the Affordable Insurance Exchanges, 78 FR 15560
(Mar. 11, 2013).
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9649
Changes to the regulations include
clarifications to the process by which
OPM administers the MSP Program,
pursuant to section 1334 of the
Affordable Care Act, and revisions to
the standards and requirements
applicable to MSP options and MSP
issuers.
Summary of Comments
OPM published a proposed rule on
November 24, 2014 (79 FR 69802), to
modify standards related to the
implementation of the MSP Program at
part 800 of title 45, Code of Federal
Regulations. The comment period for
the proposed rule closed December 24,
2014. OPM received 43 comments from
a broad range of stakeholders, including
States, health insurance issuers, health
care provider associations,
pharmaceutical companies, and
consumer groups.
While most of the comments were
related to the proposed modifications
addressed in the rule, a small number of
the comments were on areas of the
regulations for which we did not
propose changes or request comment.
A summary of the comments we
received follows, along with our
responses and changes to the proposed
regulations in light of the comments. In
addition, we are making some minor
technical and editorial changes to the
proposed regulations to correct errors
and improve clarity and readability.
Comments submitted on sections of the
regulations that we did not propose to
change are outside the scope of this
rulemaking and are not addressed here.
Length of the Comment Period
Comments: Some commenters
contended that the 30-day comment
period did not provide sufficient time to
provide feedback.
Response: OPM values the
participation of a broad array of diverse
stakeholders. In addition to the
proposed rule, we continue to seek
input and guidance from numerous
stakeholders, including the National
Association of Insurance Commissioners
(NAIC), States, tribal governments,
consumer advocates, health insurance
issuers, labor organizations, health care
provider associations, and trade groups.
Responses to Comments on the
Proposed Regulations
Subpart A—General Provisions and
Definitions
Definitions (§ 800.20)
We sought comments on two
proposed definitions for the MSP
Program. Specifically, we proposed to
add the definition for ‘‘Multi-State Plan
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option,’’ which may also be referred to
as ‘‘MSP option.’’ We also proposed to
remove the definition of ‘‘Multi-State
Plan’’ because the term ‘‘Multi-State
Plan option’’ is more precise and avoids
the confusion of the varying definitions
of the word ‘‘plan’’ in the context of
health insurance. We also proposed to
add a definition for ‘‘State-level issuer’’
as a health insurance issuer designated
by the MSP issuer to offer an MSP
option or MSP options. OPM invited
comments on the proposed changes to
the definitions under 45 CFR 800.20 as
well as any comments on the current
definition for ‘‘group of issuers.’’ OPM
received no comments on the definition
of ‘‘State-level issuer,’’ and we will
adopt the definition as proposed.
Comments: OPM received comments
that were generally supportive of adding
the proposed definition of ‘‘MSP
option.’’ One of these commenters asked
that we replace ‘‘package of benefits’’
with the term ‘‘product’’ as it is defined
in 45 CFR 144.103. We did not receive
comments on removing the definition
‘‘Multi-State Plan.’’
Response: OPM will finalize the
definition of ‘‘MSP option’’ as proposed
and will remove ‘‘Multi-State Plan.’’
The definition of ‘‘MSP option’’ will
ensure consistency within the MSP
Program and avoid confusion with
definitions from programs outside of
OPM.
Comments: Commenters responded to
our call for feedback on the definition
of ‘‘Group of Issuers’’ in § 800.20. The
commenters were generally opposed to
expanding ‘‘Group of Issuers’’ to include
alternative structures and requested
further clarification from OPM. Some
commenters were supportive of
interpreting the definition of ‘‘Group of
Issuers’’ to attract additional issuers to
the MSP Program.
Response: OPM did not propose any
changes to the ‘‘group of issuers’’
definition, and we appreciate the
comments received. It was OPM’s
intention in the proposed rule to clarify
that a group of issuers may come
together in the MSP Program either by
common control and ownership or by
using a nationally licensed service
mark. OPM recognizes there are a
number of ways to organize using a
nationally licensed service mark, and
looks forward to working with current
and potential MSP issuers who decide
to come together under either one of
these two options in the MSP Program.
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Subpart B—Multi-State Plan Issuer
Requirements
Phased Expansion, etc. (§ 800.104)
Section 1334(e) of the Affordable Care
Act provides for OPM to allow issuers
to phase in their participation in the
MSP Program. Under § 800.104(a), OPM
requested comment on how we may
expand participation in the Program to
meet the goal of increasing competition
while balancing consumers’ needs.
Specifically, we asked for comment on
the timeframes and other appropriate
parameters within which an MSP issuer
could reasonably expand participation
in the Program. We did not propose any
changes to the regulatory text for
§ 800.104(a). In clarifying the status of
the Program and how we are
implementing the standards set under
§ 800.104, we proposed to delete the
standard for an MSP issuer to submit a
plan to become statewide in
§ 800.104(b), and add a requirement that
the MSP issuer service area for MSP
coverage shall be greater than or equal
to any service area proposed by the
issuer for QHP coverage. Under
§ 800.104(c), we solicited comment on
when MSP issuers should be required to
participate on a Small Business Health
Options Program (SHOP). Based on the
comments received, the changes to
§ 800.104(b) will be accepted as
proposed.
Comments: Some commenters
commended OPM for clarifying
§ 800.104(a) of the rule and promoting
increased flexibility on standards for
coverage areas and geographic
requirements, as it will attract issuers to
the Program and promote competition.
Other commenters urged OPM to
encourage new and existing MSP issuers
to offer plans that are national in scope
and coverage.
Response: Through our continued
engagement with current and potential
MSP issuers, OPM has heard significant
concerns about the challenges of rapidly
expanding MSP coverage both within
and across State lines. OPM agrees that
increased flexibility around the
schedule to expand to each Exchange in
every State will help the MSP Program
meet its goal of increasing competition
while balancing consumers’ needs for
coverage. OPM intends to ensure that
MSP coverage is available as
expansively and as soon as practicable.
We work closely with current and
potential MSP issuers to address any
operational challenges they may face in
order to expand MSP coverage
nationally or establish reciprocity.
Comments: Some commenters
expressed that any potential MSP
issuers should be held to the same
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standards as an MSP issuer who
participated in the Program during the
first year of operations. These
commenters requested OPM set
minimum threshold standards for
participation, such as timeframes for
expanding coverage and minimum
standards for coverage areas.
Response: Since the first year of
operations for the MSP Program, OPM
consistently has applied the same
standards to all current and potential
MSP issuers, and we will continue to do
so going forward. We are not making
any changes to the text at this time.
Comment: Commenters disagreed
with OPM’s interpretation of 1334(b)
and (e) stating that neither of the MSP
issuers currently under contract with
OPM meets the statutory requirements
to participate in the Program.
Response: We respectfully disagree
with the commenter. Section 1334 sets
forth standards to guide the exercise of
OPM’s contracting authority, noting that
section 1334(b)(1) contemplates offering
coverage in every State and the District
of Columbia, and outlines a framework
within which participation in the MSP
Program is a feasible and attractive
business activity. Such standards
include the provisions under
subsections (b) and (e) on offering
coverage in every State.
Comments: Many commenters
supported OPM’s proposal to delete the
standard for an MSP issuer to submit a
plan to become statewide and instead
negotiate directly with MSP issuers to
expand coverage based on business
factors and consumers’ needs.
Commenters suggested that requiring a
specific plan to become statewide may
discourage participation in the Program,
and flexibility on meeting geographic
coverage standards would encourage
competition. These commenters also
commended OPM on efforts to evaluate
MSP issuers’ proposed service areas to
ensure they are established without
discrimination. Other commenters
opposed the proposal and sought
additional standards.
Response: OPM is committed to
statewide coverage, but is sensitive to
requirements that may discourage
participation in the Program or does not
serve the goal of promoting competition
on the Exchanges. OPM will assess
consumers’ needs for coverage,
including ensuring that MSP issuers’
proposed service areas have been
established without regard to racial,
ethnic, language, or health status-related
factors listed in section 2705(a) of the
PHS Act, or other factors that exclude
specific high-utilizing, high-cost, or
medically underserved populations.
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Comments: Commenters opposed the
proposed change to the regulatory text
to delete a plan for reaching statewide
MSP coverage, stating that OPM should
establish minimum thresholds for
expected MSP coverage areas within a
State. The commenter suggested OPM
set a standard to require coverage as
broadly as the area in which the issuer
is licensed to sell coverage in a State,
equal to any coverage offered as a
Qualified Health Plan (QHP), or
alternatively, a percent of population or
geographic area. Similarly, other
commenters recommended OPM require
coverage of 75% of the State’s counties
or other geographic area.
Response: OPM is committed to a goal
of statewide coverage in the MSP
Program, and intends to continue
working with current and potential MSP
issuers to develop productive and
ambitious approaches to achieving
statewide coverage. OPM believes that
our standard for an MSP issuer who
offers both MSP options and QHPs to
provide an MSP service area that is
equal to or greater than the issuer’s QHP
service area is adequate and reasonable
to ensure broad MSP coverage. We
appreciate the specific examples of
other minimum MSP standards for
coverage areas. At this time, we will
finalize § 800.104(b) as proposed
maintaining the standard of an MSP
coverage area to be equal to or greater
than the coverage area proposed by the
same issuer for their QHP service area.
Some commenters recommended
OPM continue to implement SHOP
participation standards consistent with
standards set by U.S. Department of
Health and Human Services (HHS) for a
Federally-facilitated SHOP or, where
applicable, standards set by State-based
Exchanges for SHOP participation
requirements that apply to QHP issuers.
Other comments suggested that the MSP
Program is not mature enough to require
MSP issuers to participate in a SHOP at
this time.
Response: In light of these comments,
OPM intends to continue its flexibility
in SHOP participation for MSP issuers
in § 800.104(c). MSP issuers must meet
the same standards for SHOP
participation set for QHP issuers,
including the requirements of 45 CFR
156.200(g) and any standards for issuers
participating on a State-based SHOP. An
MSP issuer may meet the requirements
of 45 CFR 156.200(g)(3) if a State-level
issuer or any other issuer in the same
issuer group affiliated with an MSP
issuer provides coverage on a Federallyfacilitated SHOP. We discussed this
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policy in-depth in the March 2013 final
rule.4
Benefits (§ 800.105)
In § 800.105(b), OPM proposed a
change that would allow an MSP issuer
to make essential health benefits (EHB)benchmark selections on a State-byState basis. The issuer would also be
able to offer two or more MSP options
in each State. For example, one option
could use the State-selected EHBbenchmark, and one could use the
OPM-selected EHB-benchmark. OPM
proposed this change to allow for more
flexibility to attract issuers to the MSP
Program with the expectation of
expanding competition on the
Exchanges. This flexibility could
facilitate coalition building across
issuers in different States, so that issuers
can work together toward MSP options
that meet the MSP Program standards.
In § 800.105(c)(3), OPM proposed to
clarify the policy on formularies with an
OPM-selected EHB-benchmark plan.
Under the proposed rule, OPM would
allow the MSP issuer to manage
formularies around the needs of actual
or anticipated enrollees. As part of this
proposal, OPM pointed to the current
practice in the Federal Employees
Health Benefits (FEHB) Program of
negotiating formularies and also
considered the option of substituting the
formulary from the State-selected EHBbenchmark plan. OPM noted that, even
with this change, OPM would still
ensure compliance with any HHS
standards related to drug formularies for
QHPs and assurance that the
formularies are not discriminatory. OPM
also noted that this would allow MSP
issuers to propose plans built around
the needs of enrollees, subject to
approval by OPM.
In the renumbered § 800.105(c)(4),
OPM proposed a change to apply a
Federal definition of habilitative
services and devices, should HHS
choose to define the term. In response
to comments, in this final rule OPM will
revert back to the term we used in our
final rule published March 2013,
‘‘habilitative services and devices,’’ to
ensure consistency with the recently
published HHS Notice of Benefit and
Payment Parameters for 2016.5
In § 800.105(d), OPM did not propose
any change to the regulation. However,
the preamble noted that OPM also plans
to review an MSP issuer’s package of
benefits for discriminatory benefit
design and intends to work closely with
States and HHS to identify and
4 March 11, 2013 Federal Register (78 FR 15560,
15565).
5 45 CFR 156.115(a)(5).
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9651
investigate any potentially
discriminatory or otherwise
noncompliant benefit designs in MSP
options.
In § 800.105(e), OPM proposed to
change ‘‘assume’’ to ‘‘defray’’ to align
with the language in section 1334(c)(2)
of the Affordable Care Act.
Comments: We received comments on
the proposed changes to § 800.105(b),
which describes the EHB-benchmark
policy, from a broad range of
stakeholders. Some comments opposing
the change cited consumer confusion
while others raised concerns about an
unlevel playing field between MSP
issuers and QHP issuers or
administrative efficiency. In contrast,
other commenters supported the
proposed changes, and highlighted the
opportunity to increase competition in
the MSP Program as well as additional
choices for consumers. Commenters also
highlighted that the change would allow
issuers the flexibility needed to fulfill
the goals of the Affordable Care Act.
Response: While we understand the
concerns about adverse selection and
consumer confusion, we have not seen
nor are we aware of any compelling
evidence that multiple EHB-benchmarks
would cause these issues.
With the opportunity to use
substitutions as well as expand benefits
beyond the EHB-benchmark or EHB
categories, there is already variation
among plans available to consumers.
Additionally, under the framework
that applied in the first two years of the
Program, we were already reviewing
MSP options using each State’s EHBbenchmark. Even if the OPM-selected
EHB-benchmark plan was not used in
every State, there may be some
administrative efficiency gained in the
overlap.
We note that these changes only allow
an MSP issuer to propose these types of
packages. OPM still retains the authority
to approve the package of benefits in
§ 800.105(d). OPM will scrutinize all
proposals for evidence of discriminatory
benefit designs and other issues of
noncompliance. Keeping potential
issues in mind, we are finalizing the
changes as proposed in order to increase
opportunities for competition in the
MSP Program and create the potential
for more choices for consumers.
Comments: We also received
comments that focused on the need to
maintain benefit standards and
protections under any approach. These
comments highlighted potential issues
or vulnerabilities in need of consumer
protection and identified key strategies
for addressing them.
Response: We appreciate the feedback
provided by these stakeholders and will
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take this information under
consideration as it relates to our review
process. We are not making any further
changes to § 800.105(b), but may use the
comments to inform MSP Program
operations or in drafting Program
guidance in the future.
Comments: We received comments on
the proposed changes to § 800.105(c)(3)
to the formulary requirements with an
OPM-selected EHB-benchmark plan
from a variety of stakeholders.
Commenters were generally supportive,
interpreting the changes as OPM
prioritizing the review of formularies
proposed by MSP issuers.
Other commenters raised concerns
about consumer confusion and potential
misalignment of medical and drug
benefits
Response: We appreciate the broad
support from commenters on our
proposal as well as their
acknowledgement that OPM is
prioritizing formulary review. While we
understand concerns about the changes
to the formulary requirements,
including negotiating a formulary or
using the formulary from the Stateselected EHB-benchmark plan, we do
not have any compelling evidence that
this would cause consumer confusion or
gaps in coverage between medical and
drug benefits. OPM intends to use any
tools, including the USP category and
class count framework, created by HHS
to analyze the formulary and inform our
negotiations or evaluation of the
formulary from the State-selected EHBbenchmark plan. Additionally, we
intend to use our discretion in approval
of a package of benefits and during any
negotiations to identify and remedy
gaps between medical and drug benefits.
We appreciate the concerns that were
raised, but believe we can use the
review process to mitigate them,
offering more flexibility and consumer
choice.
Comments: Commenters asked to
ensure that proposed formularies meet
the requirements of section 2713 of the
PHS Act and are compliant with other
applicable standards. Other commenters
that was supportive of the change asked
for a similar change to be applied to
State-selected EHB-benchmark plans.
Response: OPM has already identified
in § 800.102 the requirement to comply
with part A of title XXVII of the PHS
Act and has also identified in
§ 800.105(d) that OPM approval of a
proposed package of benefits, including
the formulary, will include a review
against standards set by HHS and OPM.
For example, this would include the
USP category and class count
framework and the use of a pharmacy
and therapeutics committee for
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formulary development as it applies to
QHP issuers. Based on the comments we
received and our analysis, we are
finalizing § 800.105(c)(3) with no
changes.
Comments: We received comments on
the proposed changes to apply a Federal
definition of habilitative services from a
variety of stakeholders. Some
commenters supported the change.
Others recommended OPM modify and
expand the definition proposed by HHS
and requested OPM address habilitative
devices or make provisions for specific
types of services or devices.
Commenters also asked for illustrative
lists of habilitative services. Finally, the
comments requested that the Federal
definition be treated as a Federal floor.
Response: OPM is deferring to HHS
on the substance and role of the Federal
definition. In keeping with the HHS
Notice of Benefit and Payment
Parameters for 2016, we are now using
the term ‘‘habilitative services and
devices’’ in order to remain consistent
and address the concerns raised by
several commenters. We defer to HHS in
determining the standards applicable
under its definition of habilitative
services and devices. It is not OPM’s
intention to allow the MSP issuer to
choose between State and Federal
definitions if both exist for a given State.
In the finalized version of
§ 800.105(c)(4), OPM is taking the
opportunity to add clarity to the
paragraph in explaining when a State
definition of habilitative services and
devices applies and when a Federal
definition applies. In the final
§ 800.105(c)(4), the Federal definition is
set as the floor, consistent with the HHS
Notice of Benefit and Payment
Parameters for 2016. The State retains
the flexibility to apply standards or a
definition that does not conflict with the
Federal definition. Finally, we continue
to reserve authority for OPM to define
habilitative services and devices for an
OPM-selected EHB-benchmark plan
absent a State or Federal definition.
Comments: We received comments on
the issue of non-discrimination and
OPM’s review of MSP options as it
relates to § 800.105(d). Commenters
generally supported the proposal and
asked for OPM to identify examples of
discriminatory benefit designs, and one
asked OPM to set specific standards for
review in the regulation.
Response: OPM identified the
requirement to comply with Federal law
in § 800.102 and also identified related
HHS standards against which MSP
issuers and MSP options will be
evaluated in § 800.105(d). At this time,
we believe we have the authority
necessary to apply and modify
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standards for non-discrimination,
updating and adapting our review as we
continue to learn about discriminatory
benefit designs. In practice, we will
align our review for non-discriminatory
benefit designs with HHS.
We did not receive any comments on
the proposed change to § 800.105(e).
Therefore, we are adopting the proposed
§ 800.105(e) as final.
In § 800.105(c)(1), we are removing
the reference to (c)(4) and replacing it
with a reference to (c)(5) in
§ 800.105(c)(1) to correct an internal
cross reference.
Assessments and User Fees (§ 800.108)
OPM has authority to collect MSP
Program user fees, and continues to
preserve its discretion to collect an MSP
Program user fee. In the proposed rule,
we clarified that OPM may begin
collecting the fee as early as plan year
2015. OPM intends to use the MSP
assessment or user fee to fund OPM’s
functions for administration of the
Program, including but not limited to
entering into contracts with, certifying,
recertifying, decertifying, overseeing
MSP options and MSP issuers for that
plan year, and audits and investigations
performed by OPM’s Office of Inspector
General related to the MSP Program. In
the Federally-facilitated Exchanges,
OPM is coordinating with HHS
regarding the collection of user fees, so
that issuers would not be affected
operationally. We proposed to revise the
regulatory text to allow for flexibility in
the process for collecting MSP Program
assessments or user fees. We also
solicited comments on the process for
collecting user fees in the State-based
Exchanges and the general use of any
fees collected by OPM.
Comments: Some commenters were
opposed to the imposition of user fees
in State-based Exchanges citing
operational challenges in collecting fees.
Response: We have considered the
comments received and agree that
operational complexities for collecting
any user fee from MSP issuers on Statebased Exchanges exist. We will not be
collecting or imposing user fees on MSP
issuers operating on State-based
Exchanges in plan year 2016. Therefore,
the changes to § 800.108 will be
accepted as proposed.
Network Adequacy (§ 800.109)
In § 800.109(b), OPM proposed to
codify the requirement that MSP issuers
must comply with any additional
provider directory standards that may
be set by HHS.
Comments: Commenters generally
supported the proposed change, noting
that incorporating HHS standards for
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provider directories would improve the
quality of information consumers
receive. Some commenters suggested
OPM defer to State requirements where
they exist.
Response: It has been OPM’s intention
that an MSP issuer comply with
appropriate Federal, and where
applicable, State requirements for
provider directories. OPM did not
intend for the proposed changes to
§ 800.109(b) to alter that framework.
After further consideration of the
proposed change to subsection (b), we
decided that the proposed language is
unnecessary. We are, therefore,
removing the proposed addition to
subsection (b) from the regulatory text.
Again, we intend for MSP issuers to
comply with any additional regulations
promulgated by HHS for QHP issuers,
and where applicable, State
requirements for provider directories.
Accreditation (§ 800.111)
In the proposed rule, we proposed to
revise the reference to the specific
section in the Code of Federal
Regulations to 45 CFR 156.275(a)(1) to
be more precise. We received no
comments on this proposed change, and
are finalizing the text as proposed.
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Level Playing Field (§ 800.115)
In § 800.115, we proposed to revise
the regulatory text to clarify that all
areas listed under section 1324(b) of the
Affordable Care Act are subject to
§ 800.114. In addition, we made a
technical correction to § 800.115(l) to
change a reference to 45 CFR part 162
to 45 CFR part 164. We received no
comments on these changes and are
finalizing as proposed.
Subpart D—Application and
Contracting Procedures
In subpart D of 45 CFR part 800, OPM
set forth procedures for processing and
evaluating applications from issuers
seeking participation in the MSP
Program. Subpart D also establishes
processes pertaining to executing
contracts to offer MSP coverage. In
particular, this subpart includes
sections that address an application
process, review of applications, MSP
Program contracting, term of a contract,
contract renewal process, and
nonrenewal. OPM did not receive any
comments pertaining to this subpart,
except for § 800.301. We are finalizing
Subpart D as proposed.
Application Process (§ 800.301)
In § 800.301, OPM proposed a
technical correction that it would
consider annual applications from
health insurance issuers to participate
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in the MSP Program. We also specified
that an existing MSP issuer could
submit a renewal application to OPM
annually. This correction is intended to
clarify the distinction between new and
renewal applications.
Comment: Commenters recommended
that renewal applicants should be
required to complete a full (not
streamlined) application.
Response: Renewal applications
require comprehensive and detailed
responses to adequately inform OPM
about whether to renew its contract with
the issuer. OPM has, and will continue
to use its experience in the FEHB
Program to inform and guide its
contracting process with MSP issuers to
the extent such experience is applicable
to the individual and small group
markets within which the MSP Program
operates. We are finalizing our proposal.
Subpart E—Compliance
In subpart E of 45 CFR part 800, OPM
set forth standards and requirements
with which MSP issuers must comply.
This subpart also contains a nonexhaustive list of actions OPM may
utilize in instances of non-compliance
and the process by which OPM may
reconsider any compliance actions we
decide to take. In particular, this subpart
includes sections regarding contract
performance, contract quality assurance,
fraud and abuse, compliance actions,
and reconsideration of compliance
actions. OPM did not receive any
comments pertaining to this subpart,
except for § 800.404. We are finalizing
Subpart E as proposed.
Compliance Actions (§ 800.404)
In § 800.404(a)(4), OPM proposed to
clarify that we may initiate a
compliance action against an MSP
issuer for violations of applicable law or
the terms of its contract pursuant to
OPM’s authority under §§ 800.102 and
800.114. In § 800.404(b)(2), OPM
clarified that compliance actions may
include withdrawal of certification of an
MSP option or options. We also added
nonrenewal of participation as a
compliance action in order to be
consistent with the new paragraph
under § 800.306(a)(2). In § 800.404(d),
OPM clarified that requirements
pertaining to notices to enrollees are
triggered when one of the following
occurs: The MSP Program contract is
terminated, OPM withdraws
certification of an MSP option, or if a
State-level issuer’s participation is not
renewed.
Comment: Commenters suggested that
OPM should establish a Federal
standard to ensure a seamless transition
for enrollees when a plan is terminated
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9653
or an enrollee is transferred to another
issuer and enrolled in a new plan.
Response: To the extent that the MSP
issuer is providing health insurance
coverage in a Federally-facilitated
Exchange, Federal requirements
regarding notice to enrollees must be
followed. MSP coverage offered in a
State-based Exchange must meet the
requirements of that specific State or
Exchange to the extent there is no
conflict with Federal law. This
delineation is consistent with the
approach for applicable requirements
across the MSP Program. Therefore, we
are adopting this section as final, with
no changes.
Subpart G—Miscellaneous
In subpart G of 45 CFR part 800, OPM
set forth requirements pertaining to
coverage and disclosure of non-excepted
abortion services and data-sharing with
State entities.
Consumer Choice With Respect to
Certain Services (§ 800.602)
We proposed adding a new paragraph
(c) to § 800.602 that would require an
MSP issuer to provide notice of
coverage or exclusion of non-excepted
abortion services in an MSP option.
Under our proposal, an MSP issuer must
disclose to consumers prior to
enrollment the exclusion of nonexcepted abortion services in a State
where coverage of such abortion
services is permitted by State law. We
also proposed that if an MSP issuer
provides an MSP option that covers
non-excepted abortion services, in
addition to an MSP option that excludes
coverage, notice of coverage would also
need to be provided to consumers prior
to enrollment. Finally, OPM reserved
the authority to review and approve
these MSP notices and materials. OPM
requested comments on the form and
manner of these disclosures.
Comments: In general, commenters
supported the proposed notice
requirements. However, commenters
expressed concern that consumers
would receive notice that an MSP
option excludes coverage of nonexcepted abortion services only if the
MSP option is offered in a State that
permits coverage of non-excepted
abortion services. Commenters argued
that consumers may not know if their
State permits coverage of non-excepted
abortion services.
Response: We agree that it is in the
best interests of consumers for an MSP
issuer to provide notice if an MSP
option excludes non-excepted abortion
services from coverage in every State,
not just the States that would permit
coverage of such services. We have
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amended the regulatory text to reflect
this change.
Comments: Commenters also
generally supported our proposal that
an MSP issuer who offers an MSP
option with coverage of non-excepted
abortion services must provide notice of
coverage of such services to consumers.
We proposed that MSP issuers must
provide this notice of coverage in a
manner consistent with 45 CFR
147.200(a)(3) to meet the requirements
of 45 CFR 156.280(f). Commenters
offered a variety of suggestions on the
form and manner of notices of coverage
of non-excepted abortion services.
Response: We believe adding the
disclosure and notice requirements will
assist consumers in making informed
decisions about their coverage options.
Consumers should have accurate
information on an MSP option’s covered
benefits, exclusions, and limitations.
Therefore, we are finalizing this section
as proposed, with changes to improve
readability and clarity.
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Disclosure of Information (§ 800.603)
OPM proposed this new section to
clarify that OPM may use its discretion
and authority to disclose information to
State entities, including State
Departments of Insurance and
Exchanges, in order to keep such
entities informed about the MSP
Program and its issuers.
Comments: Commenters expressed
concern that the language in the new
section gives OPM but not States
discretion to withhold information.
Others supported the language in the
new section, indicating that it will assist
States in being better primary regulators.
Response: This section has been
added to the rule to make it easier for
States to obtain information from OPM
on the MSP Program. This provision
does not address disclosure of
information from States to OPM, and
therefore, this provision does not dictate
information that a State may or may not
withhold from OPM. We are finalizing
this section as proposed.
Executive Orders 13563 and 12866;
Regulatory Review
OPM has examined the impact of this
proposed rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993) and
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011). Executive Orders
12866 and 13563 direct agencies to
assess all costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
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environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year adjusted
for inflation). Section 3(f) of Executive
Order 12866 defines a ‘‘significant
regulatory action’’ as an action that is
likely to result in a rule that may:
(1) Have an annual effect on the
economy of $100 million or more in any
one year or adversely affect in a material
way a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal government or
communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency;
(3) Materially alter the budgetary
impacts of entitlement grants, user fees,
or loan programs, or the rights and
obligations of recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in Executive Order 12866.
OPM will continue to generally
operate the MSP Program as it
previously had in plan year 2014. The
regulatory changes in this final rule are
for purposes of policy clarification, and
any changes will have minimal impact
on the administration of the Program.
Administrative costs of the rule are
generated both within OPM and by
issuers offering MSP options. The costs
that MSP issuers may incur are the same
as those of QHPs, and as stated in 45
CFR part 156, will include:
Accreditation, network adequacy
standards, and quality reporting. The
costs associated with MSP certification
offset the costs that issuers would face
were they to be certified by the State, or
HHS on behalf of the State, to offer
QHPs through the Exchange. For the
2014 plan year, there are approximately
371,000 consumers enrolled in MSP
options and with an estimated average
monthly premium of $350, premiums
collected by MSP issuers for consumers
enrolled in MSP options are
approximately $1.4 billion this year.
While the overall regulation and
Program have a significant economic
impact, this final rule provides for no
substantial changes to the Program and
is not economically significant.
We received one comment suggesting
that the proposed rule could potentially
have an economic impact of $100
million or more per year. The
commenter recommended OPM perform
a full regulatory impact analysis.
Based on the analysis presented in
our proposed rule and acknowledged
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above, the economic impact of this rule
is not expected to exceed the $100
million threshold.
Paperwork Reduction Act
The Paperwork Reduction Act of
1995 6 requires that the U.S. Office of
Management and Budget (OMB)
approve all collections of information
by a Federal agency from the public
before they can be implemented.
Respondents are not required to respond
to any collection of information unless
it displays a current valid OMB control
number. OPM is not requiring any
additional collections from MSP issuers
or applicants seeking to become MSP
issuers in this final rule. OPM continues
to expect fewer than ten responsible
entities to respond to all of the
collections noted above. For that reason
alone, the existing collections are
exempt from the Paperwork Reduction
Act.7
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) 8
requires agencies to prepare an initial
regulatory flexibility analysis to
describe the impact of a rule on small
entities, unless the head of the agency
can certify that the rule would not have
a significant economic impact on a
substantial number of small entities.
The RFA generally defines a ‘‘small
entity’’ as—(1) A proprietary firm
meeting the size standards of the Small
Business Administration (SBA); (2) a
not-for-profit organization that is not
dominant in its field; or (3) a small
government jurisdiction with a
population of less than 50,000. States
and individuals are not included in the
definition of ‘‘small entity.’’
The RFA requires agencies to analyze
options for regulatory relief of small
businesses, if a proposed rule has a
significant impact on a substantial
number of small entities. For purposes
of the RFA, small entities include small
businesses, small non-profit
organizations, and small government
jurisdictions. Small businesses are those
with sizes below thresholds established
by the SBA. With respect to most health
insurers, the SBA size standard is $38.5
million in annual receipts.9 Issuers
6 44
U.S.C. chapter 35; see 5 CFR part 1320.
U.S.C. 3502(3)(A)(i).
8 5 U.S.C. 601 et seq.
9 According to the SBA size standards, entities
with average annual receipts of $38.5 million or less
would be considered small entities for North
American Industry Classification System (NAICS)
Code 524114 (Direct Health and Medical Insurance
Carriers) (for more information, see ‘‘Table of Size
Standards Matched To North American Industry
Classification System Codes,’’ effective July 14,
2014, U.S. Small Business Administration, available
at https://www.sba.gov).
7 44
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could possibly be classified in 621491
(HMO Medical Centers) and, if this is
the case, the SBA size standard would
be $32.5 million or less.
OPM does not think that small
businesses with annual receipts less
than $38.5 million would likely have
sufficient economies of scale to become
MSP issuers or be part of a group of
MSP issuers. Similarly, while the
Director must enter into an MSP
Program contract with at least one nonprofit entity, OPM does not think that
small non-profit organizations would
likely have sufficient economies of scale
to become MSP issuers or be part of a
group of MSP issuers. OPM does not
think that this final rule would have a
significant economic impact on a
substantial number of small businesses
with annual receipts less than $38.5
million, because there are only a few
health insurance issuers that could be
considered small businesses. Moreover,
while the Director must enter into an
MSP contract with at least one nonprofit entity, OPM does not think that
this final rule would have a significant
economic impact on a substantial
number of small non-profit
organizations, because few health
insurance issuers are small non-profit
organizations.
OPM incorporates by reference
previous analysis by HHS, which
provides some insight into the number
of health insurance issuers that could be
small entities. Based on HHS data from
Medical Loss Ratio (MLR) annual report
submissions for the 2013 MLR reporting
year, approximately 141 out of 500
issuers of health insurance coverage
nationwide had total premium revenues
of $38.5 million or less.10 HHS estimates
this data may overstate the actual
number of small health insurance
companies, since 77 percent of these
small companies belong to larger
holding groups, and many if not all of
these small companies are likely to have
non-health lines of business that would
result in their revenues exceeding $38.5
million. OPM concurs with this HHS
analysis, and, thus, does not think that
this final rule would have a significant
economic impact on a substantial
number of small entities.
Based on the foregoing, OPM is not
preparing an analysis for the RFA
because OPM has determined, and the
Director certifies, that this final rule
would not have a significant economic
impact on a substantial number of small
entities.
10 79
FR 70747.
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Unfunded Mandates
Section 202 of the Unfunded
Mandates Reform Act of 1995
(UMRA) 11 requires that agencies assess
anticipated costs and benefits, and take
certain other actions before issuing a
final rule that includes any Federal
mandate that may result in expenditures
in any one year by a State, local, or
tribal governments, in the aggregate, or
by the private sector, of $100 million in
1995 dollars, updated annually for
inflation. In 2015, that threshold is
approximately $154 million. UMRA
does not address the total cost of a rule.
Rather, it focuses on certain categories
of costs, mainly those ‘‘Federal
mandate’’ costs resulting from: (1)
Imposing enforceable duties on State,
local, or tribal governments, or on the
private sector; or (2) increasing the
stringency of conditions in, or
decreasing the funding of, State, local,
or tribal governments under entitlement
programs.
This final rule does not place any
Federal mandates on State, local, or
Tribal governments, or on the private
sector. This final rule would modify the
MSP Program, a voluntary Federal
program that provides health insurance
issuers the opportunity to contract with
OPM to offer MSP options on the
Exchanges. Section 3 of UMRA excludes
from the definition of ‘‘Federal
mandate’’ duties that arise from
participation in a voluntary Federal
program. Accordingly, no analysis
under UMRA is required.
Federalism
Executive Order 13132 outlines
fundamental principles of federalism,
and requires the adherence to specific
criteria by Federal agencies in the
process of their formulation and
implementation of policies that have
‘‘substantial direct effects’’ on the
States, the relationship between the
national government and States, or on
the distribution of power and
responsibilities among the various
levels of government. Federal agencies
promulgating regulations that have
these federalism implications must
consult with State and local officials,
and describe the extent of their
consultation and the nature of the
concerns of State and local officials in
the preamble to the regulation.
This final rule has federalism
implications because it has direct effects
on the States, the relationship between
the national government and States, or
on the distribution of power and
responsibilities among various levels of
11 Public
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9655
government. However, these sections of
the regulation were not modified.
In compliance with the requirement
of Executive Order 13132 that agencies
examine closely any policies that may
have federalism implications or limit
the policy making discretion of the
States, OPM has engaged in efforts to
consult with and work cooperatively
with affected State and local officials,
including attending meetings of the
NAIC and consulting with State
insurance officials on an individual
basis. It is expected OPM will continue
to act in a similar fashion in enforcing
the Affordable Care Act requirements.
Throughout the process of
administering the MSP Program and
developing this final regulation, OPM
has attempted to balance the States’
interests in regulating health insurance
issuers, and the statutory requirement to
provide two MSP options in all
Exchanges in the each States and the
District of Columbia. By doing so, it is
OPM’s view that it has complied with
the requirements of Executive Order
13132.
Pursuant to the requirements set forth
in section 8(a) of Executive Order
13132, and by the signature affixed to
this final regulation, OPM certifies that
it has complied with the requirements
of Executive Order 13132 for the
attached regulation in a meaningful and
timely manner.
Congressional Review Act
This final rule is subject to the
Congressional Review Act provisions of
the Small Business Regulatory
Enforcement Fairness Act of 1996 (5
U.S.C. 801 et seq.), which specifies that
before a rule can take effect, the Federal
agency promulgating the rule must
submit to each House of Congress and
to the Comptroller General a report
containing a copy of the rule along with
other specified information. In
accordance with this requirement, OPM
has transmitted this rule to Congress
and the Comptroller General for review.
List of Subjects in 5 CFR Part 800
Administrative practice and
procedure, Health care, Health
insurance, Reporting and recordkeeping
requirements.
Office of Personnel Management.
Katherine Archuleta,
Director.
Accordingly, the U.S. Office of
Personnel Management is republishing
part 800 to title 45, Code of Federal
Regulations, as follows:
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PART 800—MULTI-STATE PLAN
PROGRAM
Subpart A—General Provisions and
Definitions
Sec.
800.10
800.20
Basis and scope.
Definitions.
Subpart B—Multi-State Plan Program Issuer
Requirements
800.101 General requirements.
800.102 Compliance with Federal law.
800.103 Authority to contract with issuers.
800.104 Phased expansion, etc.
800.105 Benefits.
800.106 Cost-sharing limits, advance
payments of premium tax credits, and
cost-sharing reductions.
800.107 Levels of coverage.
800.108 Assessments and user fees.
800.109 Network adequacy.
800.110 Service area.
800.111 Accreditation requirement.
800.112 Reporting requirements.
800.113 Benefit plan material or
information.
800.114 Compliance with applicable State
law.
800.115 Level playing field.
800.116 Process for dispute resolution.
Subpart C—Premiums Rating Factors,
Medical Loss Ratios, and Risk Adjustment
800.201 General requirements.
800.202 Rating factors.
800.203 Medical loss ratio.
800.204 Reinsurance, risk corridors, and
risk adjustment.
Subpart D—Application and Contracting
Procedures
800.301
800.302
800.303
800.304
800.305
800.306
Application process.
Review of applications.
MSP Program contracting.
Term of the contract.
Contract renewal process.
Nonrenewal.
Subpart E—Compliance
800.401 Contract performance.
800.402 Contract quality assurance.
800.403 Fraud and abuse.
800.404 Compliance actions.
800.405 Reconsideration of compliance
actions.
Subpart F—Appeals by Enrollees of Denials
of Claims for Payment or Service
800.501 General requirements.
800.502 MSP issuer internal claims and
appeals.
800.503 External review.
800.504 Judicial review.
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Subpart G—Miscellaneous
800.601 Reservation of authority.
800.602 Consumer choice with respect to
certain services.
800.603 Disclosure of information.
Authority: Sec. 1334 of Pub. L. 111–148,
124 Stat. 119; Pub. L. 111–152, 124 Stat. 1029
(42 U.S.C. 18054).
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plans (QHPs) and MSP options available
to qualified individuals and qualified
employers. Unless otherwise identified,
§ 800.10 Basis and scope.
this term refers to State Exchanges,
(a) Basis. This part is based on the
regional Exchanges, subsidiary
following sections of title I of the
Exchanges, and a Federally-facilitated
Affordable Care Act:
Exchange.
(1) 1001. Amendments to the Public
Federal Employees Health Benefits
Health Service Act.
Program or FEHB Program means the
(2) 1302. Essential Health Benefits
health benefits program administered by
Requirements.
the United States Office of Personnel
(3) 1311. Affordable Choices of Health Management pursuant to chapter 89 of
Benefit Plans.
title 5, United States Code.
(4) 1324. Level Playing Field.
Group of issuers means:
(5) 1334. Multi-State Plans.
(1) A group of health insurance
(6) 1341. Transitional Reinsurance
issuers that are affiliated either by
Program for Individual Market in Each
common ownership and control or by
State.
common use of a nationally licensed
(7) 1342. Establishment of Risk
service mark (as defined in this section);
Corridors for Plans in Individual and
or
Small Group Markets.
(2) An affiliation of health insurance
(8) 1343. Risk Adjustment.
issuers and an entity that is not an
(b) Scope. This part establishes
issuer but that owns a nationally
standards for health insurance issuers to licensed service mark (as defined in this
contract with the United States Office of section).
Health insurance coverage means
Personnel Management (OPM) to offer
benefits consisting of medical care
Multi-State Plan (MSP) options to
(provided directly, through insurance or
provide health insurance coverage on
reimbursement, or otherwise) under any
Exchanges for each State. It also
hospital or medical service policy or
establishes standards for appeal of a
certificate, hospital or medical service
decision by OPM affecting the issuer’s
plan contract, or health maintenance
participation in the MSP Program and
organization contract offered by a health
standards for an enrollee in an MSP
insurance issuer. Health insurance
option to appeal denials of payment or
coverage includes group health
services by an MSP issuer.
insurance coverage, individual health
§ 800.20 Definitions.
insurance coverage, and short-term,
For purposes of this part:
limited duration insurance.
Actuarial value (AV) has the meaning
Health insurance issuer or issuer
given that term in 45 CFR 156.20.
means an insurance company, insurance
Affordable Care Act means the Patient service, or insurance organization
Protection and Affordable Care Act
(including a health maintenance
(Pub. L. 111–148), as amended by the
organization) that is required to be
Health Care and Education
licensed to engage in the business of
Reconciliation Act of 2010 (Pub. L. 111– insurance in a State and that is subject
152).
to State law that regulates insurance
Applicant means an issuer or group of (within the meaning of section 514(b)(2)
issuers that has submitted an
of the Employee Retirement Income
application to OPM to be considered for Security Act (ERISA)). This term does
participation in the Multi-State Plan
not include a group health plan as
Program.
defined in 45 CFR 146.145(a).
Benefit plan material or information
HHS means the United States
means explanations or descriptions,
Department of Health and Human
whether printed or electronic, that
Services.
describe a health insurance issuer’s
Level of coverage means one of four
products. The term does not include a
standardized actuarial values of plan
policy or contract for health insurance
coverage as defined by section
coverage.
1302(d)(1) of the Affordable Care Act.
Cost sharing has the meaning given
Licensure means the authorization
that term in 45 CFR 155.20.
obtained from the appropriate State
Director means the Director of the
official or regulatory authority to offer
United States Office of Personnel
health insurance coverage in the State.
Multi-State Plan Program issuer or
Management.
EHB-benchmark plan has the meaning MSP issuer means a health insurance
issuer or group of issuers (as defined in
given that term in 45 CFR 156.20.
this section) that has a contract with
Exchange means a governmental
OPM to offer health plans pursuant to
agency or non-profit entity that meets
section 1334 of the Affordable Care Act
the applicable requirements of 45 CFR
and meets the requirements of this part.
part 155 and makes qualified health
Subpart A—General Provisions and
Definitions
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Multi-State Plan option or MSP option
means a discrete pairing of a package of
benefits with particular cost sharing
(which does not include premium rates
or premium rate quotes) that is offered
pursuant to a contract with OPM
pursuant to section 1334 of the
Affordable Care Act and meets the
requirements of 45 CFR part 800.
Multi-State Plan Program or MSP
Program means the program
administered by OPM pursuant to
section 1334 of the Affordable Care Act.
Nationally licensed service mark
means a word, name, symbol, or device,
or any combination thereof, that an
issuer or group of issuers uses
consistently nationwide to identify
itself.
Non-profit entity means:
(1) An organization that is
incorporated under State law as a nonprofit entity and licensed under State
law as a health insurance issuer; or
(2) A group of health insurance
issuers licensed under State law, a
substantial portion of which are
incorporated under State law as nonprofit entities.
OPM means the United States Office
of Personnel Management.
Percentage of total allowed cost of
benefits has the meaning given that term
in 45 CFR 156.20.
Plan year means a consecutive 12month period during which a health
plan provides coverage for health
benefits. A plan year may be a calendar
year or otherwise.
Prompt payment means a requirement
imposed on a health insurance issuer to
pay a provider or enrollee for a claimed
benefit or service within a defined time
period, including the penalty or
consequence imposed on the issuer for
failure to meet the requirement.
Qualified Health Plan or QHP means
a health plan that has in effect a
certification that it meets the standards
described in subpart C of 45 CFR part
156 issued or recognized by each
Exchange through which such plan is
offered pursuant to the process
described in subpart K of 45 CFR part
155.
Rating means the process, including
rating factors, numbers, formulas,
methodologies, and actuarial
assumptions, used to set premiums for
a health plan.
Secretary means the Secretary of the
Department of Health and Human
Services.
SHOP means a Small Business Health
Options Program operated by an
Exchange through which a qualified
employer can provide its employees and
their dependents with access to one or
more qualified health plans (QHPs).
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Silver plan variation has the meaning
given that term in 45 CFR 156.400.
Small employer means, in connection
with a group health plan with respect to
a calendar year and a plan year, an
employer who employed an average of
at least one but not more than 100
employees on business days during the
preceding calendar year and who
employs at least one employee on the
first day of the plan year. In the case of
plan years beginning before January 1,
2016, a State may elect to define small
employer by substituting ‘‘50
employees’’ for ‘‘100 employees.’’
Standard plan has the meaning given
that term in 45 CFR 156.400.
State Insurance Commissioner means
the commissioner or other chief
insurance regulatory official of a State.
State means each of the 50 States or
the District of Columbia.
State-level issuer means a health
insurance issuer designated by the
Multi-State Plan (MSP) issuer to offer an
MSP option or MSP options. The Statelevel issuer may offer health insurance
coverage through an MSP option in all
or part of one or more States.
Subpart B—Multi-State Plan Program
Issuer Requirements
§ 800.101
General requirements.
An MSP issuer must:
(a) Licensed. Be licensed as a health
insurance issuer in each State where it
offers health insurance coverage;
(b) Contract with OPM. Have a
contract with OPM pursuant to this part;
(c) Required levels of coverage. Offer
levels of coverage as required by
§ 800.107 of this part;
(d) Eligibility and enrollment. MSP
options and MSP issuers must meet the
same requirements for eligibility,
enrollment, and termination of coverage
as those that apply to QHPs and QHP
issuers pursuant to 45 CFR part 155,
subparts D, E, and H, and 45 CFR
156.250, 156.260, 156.265, 156.270, and
156.285;
(e) Applicable to each MSP issuer.
Ensure that each of its MSP options
meets the requirements of this part;
(f) Compliance. Comply with all
standards set forth in this part;
(g) OPM direction and other legal
requirements. Timely comply with OPM
instructions and directions and with
other applicable law; and
(h) Other requirements. Meet such
other requirements as determined
appropriate by OPM, in consultation
with HHS, pursuant to section
1334(b)(4) of the Affordable Care Act.
(i) Non-discrimination. MSP options
and MSP issuers must comply with
applicable Federal and State non-
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discrimination laws, including the
standards set forth in 45 CFR 156.125
and 156.200(e).
§ 800.102
Compliance with Federal law.
(a) Public Health Service Act. As a
condition of participation in the MSP
Program, an MSP issuer must comply
with applicable provisions of part A of
title XXVII of the PHS Act. Compliance
shall be determined by the Director.
(b) Affordable Care Act. As a
condition of participation in the MSP
Program, an MSP issuer must comply
with applicable provisions of title I of
the Affordable Care Act. Compliance
shall be determined by the Director.
§ 800.103
issuers.
Authority to contract with
(a) General. OPM may enter into
contracts with health insurance issuers
to offer at least two MSP options on
Exchanges and SHOPs in each State,
without regard to any statutes that
would otherwise require competitive
bidding.
(b) Non-profit entity. In entering into
contracts with health insurance issuers
to offer MSP options, OPM will enter
into a contract with at least one nonprofit entity as defined in § 800.20 of
this part.
(c) Group of issuers. Any contract to
offer MSP options may be with a group
of issuers as defined in § 800.20 of this
part.
(d) Individual and group coverage.
The contracts will provide for
individual health insurance coverage
and for group health insurance coverage
for small employers.
§ 800.104
Phased expansion, etc.
(a) Phase-in. OPM may enter into a
contract with a health insurance issuer
to offer MSP options if the health
insurance issuer agrees that:
(1) With respect to the first year for
which the health insurance issuer offers
MSP options, the health insurance
issuer will offer MSP options in at least
60 percent of the States;
(2) With respect to the second such
year, the health insurance issuer will
offer the MSP options in at least 70
percent of the States;
(3) With respect to the third such
year, the health insurance issuer will
offer the MSP options in at least 85
percent of the States; and
(4) With respect to each subsequent
year, the health insurance issuer will
offer the MSP options in all States.
(b) Partial coverage within a State. (1)
OPM may enter into a contract with an
MSP issuer even if the MSP issuer’s
MSP options for a State cover fewer
than all the service areas specified for
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that State pursuant to § 800.110 of this
part.
(2) If an issuer offers both an MSP
option and QHP on the same Exchange,
an MSP issuer must offer MSP coverage
in a service area or areas that is equal
to the greater of:
(i) The QHP service area defined by
the issuer or,
(ii) The service area specified for that
State pursuant to § 800.110 of this part
covered by the issuer’s QHP.
(c) Participation in SHOPs. (1) An
MSP issuer’s participation in a
Federally-facilitated SHOP must be
consistent with the requirements for
QHP issuers specified in 45 CFR
156.200(g).
(2) An MSP issuer must comply with
State standards governing participation
in a State-based SHOP, consistent with
§ 800.114. For these State-based SHOP
standards, OPM retains discretion to
allow an MSP issuer to phase-in SHOP
participation in States pursuant to
section 1334(e) of the Affordable Care
Act.
(d) Licensed where offered. OPM may
enter into a contract with an MSP issuer
who is not licensed in every State,
provided that the issuer is licensed in
every State where it offers MSP coverage
through any Exchanges in that State and
demonstrates to OPM that it is making
a good faith effort to become licensed in
every State consistent with the
timeframe in paragraph (a) of this
section.
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§ 800.105
Benefits.
(a) Package of benefits. (1) An MSP
issuer must offer a package of benefits
that includes the essential health
benefits (EHB) described in section 1302
of the Affordable Care Act for each MSP
option within a State.
(2) The package of benefits referred to
in paragraph (a)(1) of this section must
comply with section 1302 of the
Affordable Care Act, as well as any
applicable standards set by OPM and
any applicable standards set by HHS.
(b) Package of benefits options. (1) An
MSP issuer must offer at least one
uniform package of benefits in each
State that is substantially equal to:
(i) The EHB-benchmark plan in each
State in which it operates; or
(ii) Any EHB-benchmark plan selected
by OPM under paragraph (c) of this
section.
(2) An issuer applying to participate
in the MSP Program may select either or
both of the package of benefits options
described in paragraph (b)(1) of this
section in its application. In each State,
the issuer may choose one EHBbenchmark for each product it offers.
(3) An MSP issuer must comply with
any State standards relating to
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substitution of benchmark benefits or
standard benefit designs.
(c) OPM selection of benchmark
plans. (1) The OPM-selected EHBbenchmark plans are the three largest
Federal Employees Health Benefits
(FEHB) Program plan options, as
identified by HHS pursuant to section
1302(b) of the Affordable Care Act, and
as supplemented pursuant to paragraphs
(c)(2) through (5) of this section.
(2) Any EHB-benchmark plan selected
by OPM under paragraph (c)(1) lacking
coverage of pediatric oral services or
pediatric vision services must be
supplemented by the addition of the
entire category of benefits from the
largest Federal Employee Dental and
Vision Insurance Program (FEDVIP)
dental or vision plan options,
respectively, pursuant to 45 CFR
156.110(b) and section 1302(b) of the
Affordable Care Act.
(3) In all States where an MSP issuer
uses the OPM-selected EHB-benchmark
plan, the MSP issuer may manage
formularies around the needs of
anticipated or actual users, subject to
approval by OPM.
(4) An MSP issuer must follow the
definition of habilitative services and
devices as follows:
(i) An MSP issuer must follow the
Federal definitions where HHS
specifically defines habilitative services
and devices if the State does not define
the term, if the State defines the term in
a conflicting way, or if the State
definition is less stringent than the
Federal definition.
(ii) An MSP issuer must follow State
definitions where the State specifically
defines the habilitative services and
devices category pursuant to 45 CFR
156.110(f) and the State definition is not
in conflict with the Federal definition or
goes above the standards set in the
Federal definition.
(iii) In the case of any State that does
not define this category and absent a
clearly applicable Federal definition, if
any OPM-selected EHB-benchmark plan
lacks coverage of habilitative services
and devices, OPM may determine what
habilitative services and devices are to
be included in that EHB-benchmark
plan.
(5) Any EHB-benchmark plan selected
by OPM under paragraph (c)(1) of this
section must include, for each State, any
State-required benefits enacted before
December 31, 2011, that are included in
the State’s EHB-benchmark plan as
described in paragraph (b)(1)(i) of this
section, or specific to the market in
which the plan is offered.
(d) OPM approval. An MSP issuer’s
package of benefits, including its
formulary, must be submitted for
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approval by OPM, which will review a
package of benefits proposed by an MSP
issuer and determine if it is
substantially equal to an EHBbenchmark plan described in paragraph
(b)(1) of this section, pursuant to
standards set forth by OPM and any
applicable standards set forth by HHS,
including 45 CFR 156.115, 156.122, and
156.125.
(e) State payments for additional
State-required benefits. If a State
requires that benefits in addition to the
benchmark package be offered to MSP
enrollees in that State, then pursuant to
section 1334(c)(2) of the Affordable Care
Act, the State must defray the cost of
such additional benefits by making
payments either to the enrollee or to the
MSP issuer on behalf of the enrollee.
§ 800.106 Cost-sharing limits, advance
payments of premium tax credits, and costsharing reductions.
(a) Cost-sharing limits. For each MSP
option it offers, an MSP issuer must
ensure that the cost-sharing provisions
of the MSP option comply with section
1302(c) of the Affordable Care Act, as
well as any applicable standards set by
OPM or HHS.
(b) Advance payments of premium tax
credits and cost-sharing reductions. For
each MSP option it offers, an MSP
issuer must ensure that an eligible
individual receives the benefit of
advance payments of premium tax
credits under section 36B of the Internal
Revenue Code and the cost-sharing
reductions under section 1402 of the
Affordable Care Act. An MSP issuer
must also comply with any applicable
standards set by OPM or HHS.
§ 800.107
Levels of coverage.
(a) Silver and gold levels of coverage
required. An MSP issuer must offer at
least one MSP option at the silver level
of coverage and at least one MSP option
at the gold level of coverage on each
Exchange in which the issuer is certified
to offer an MSP option pursuant to a
contract with OPM.
(b) Bronze or platinum metal levels of
coverage permitted. Pursuant to a
contract with OPM, an MSP issuer may
offer one or more MSP options at the
bronze level of coverage or the platinum
level of coverage, or both, on any
Exchange or SHOP in any State.
(c) Child-only plans. For each level of
coverage, the MSP issuer must offer a
child-only MSP option at the same level
of coverage as any health insurance
coverage offered to individuals who, as
of the beginning of the plan year, have
not attained the age of 21.
(d) Plan variations for the reduction
or elimination of cost-sharing. An MSP
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issuer must comply with section 1402 of
the Affordable Care Act, as well as any
applicable standards set by OPM or
HHS.
(e) OPM approval. An MSP issuer
must submit the levels of coverage plans
and plan variations to OPM for review
and approval by OPM.
§ 800.108
Assessments and user fees.
(a) Discretion to charge assessment
and user fees. Beginning in plan year
2015, OPM may require an MSP issuer
to pay an assessment or user fee as a
condition of participating in the MSP
Program.
(b) Determination of amount. The
amount of the assessment or user fee
charged by OPM for a plan year is the
amount determined necessary by OPM
to meet the costs of OPM’s functions
under the Affordable Care Act for a plan
year, including but not limited to such
functions as entering into contracts
with, certifying, recertifying,
decertifying, and overseeing MSP
options and MSP issuers for that plan
year. The amount of the assessment or
user fee charged by OPM will be offset
against the assessment or user fee
amount required by any State-based
Exchange or federally-facilitated
Exchange such that the total of all
assessments and user fees paid by the
MSP issuer for the year for the MSP
option shall be no greater than nor less
than the amount of the assessment or
user fee paid by QHP issuers in that
State-based Exchange or federallyfacilitated Exchange for that year.
(c) Process for collecting MSP
assessment or user fees. OPM may
require an MSP issuer to make payment
of the MSP Program assessment or user
fee amount directly to OPM, or may
establish other mechanisms for the
collection process.
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§ 800.109
Network adequacy.
(a) General requirement. An MSP
issuer must ensure that the provider
network of each of its MSP options, as
available to all enrollees, meets the
following standards:
(1) Maintains a network that is
sufficient in number and types of
providers to assure that all services will
be accessible without unreasonable
delay;
(2) Is consistent with the network
adequacy provisions of section 2702(c)
of the Public Health Service Act; and
(3) Includes essential community
providers in compliance with 45 CFR
156.235.
(b) Provider directory. An MSP issuer
must make its provider directory for an
MSP option available to the Exchange
for publication online pursuant to
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guidance from the Exchange and to
potential enrollees in hard copy, upon
request. In the provider directory, an
MSP issuer must identify providers that
are not accepting new patients.
(c) OPM guidance. OPM will issue
guidance containing the criteria and
standards that it will use to determine
the adequacy of a provider network.
§ 800.110
Service area.
An MSP issuer must offer an MSP
option within one or more service areas
in a State defined by each Exchange
pursuant to 45 CFR 155.1055. If an
Exchange permits issuers to define their
service areas, an MSP issuer must obtain
OPM’s approval for its proposed service
areas. Pursuant to § 800.104 of this part,
OPM may enter into a contract with an
MSP issuer even if the MSP issuer’s
MSP options for a State cover fewer
than all the service areas specified for
that State. MSP options will follow the
same standards for service areas for
QHPs pursuant to 45 CFR 155.1055.
§ 800.111
Accreditation requirement.
(a) General requirement. An MSP
issuer must be or become accredited
consistent with the requirements for
QHP issuers specified in section 1311 of
the Affordable Care Act and 45 CFR
156.275(a)(1).
(b) Release of survey. An MSP issuer
must authorize the accrediting entity
that accredits the MSP issuer to release
to OPM and to the Exchange a copy of
its most recent accreditation survey,
together with any survey-related
information that OPM or an Exchange
may require, such as corrective action
plans and summaries of findings.
(c) Timeframe for accreditation. An
MSP issuer that is not accredited as of
the date that it enters into a contract
with OPM must become accredited
within the timeframe established by
OPM as authorized by 45 CFR 155.1045.
§ 800.112
Reporting requirements.
(a) OPM specification of reporting
requirements. OPM will specify the data
and information that must be reported
by an MSP issuer, including data
permitted or required by the Affordable
Care Act and such other data as OPM
may determine necessary for the
oversight and administration of the MSP
Program. OPM will also specify the
form, manner, processes, and frequency
for the reporting of data and
information. The Director may require
that MSP issuers submit claims payment
and enrollment data to facilitate OPM’s
oversight and administration of the MSP
Program in a manner similar to the
FEHB Program.
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9659
(b) Quality and quality improvement
standards. An MSP issuer must comply
with any standards required by OPM for
reporting quality and quality
improvement activities, including but
not limited to implementation of a
quality improvement strategy,
disclosure of quality measures to
enrollees and prospective enrollees,
reporting of pediatric quality measures,
and implementation of rating and
enrollee satisfaction surveys, which will
be similar to standards under section
1311(c)(1)(E), (H), and (I), (c)(3), and
(c)(4) of the Affordable Care Act.
§ 800.113 Benefit plan material or
information.
(a) Compliance with Federal and State
law. An MSP issuer must comply with
Federal and State laws relating to
benefit plan material or information,
including the provisions of this section
and guidance issued by OPM specifying
its standards, process, and timeline for
approval of benefit plan material or
information.
(b) General standards for MSP
applications and notices. An MSP
issuer must provide all applications and
notices to enrollees in accordance with
the standards described in 45 CFR
155.205(c). OPM may establish
additional standards to meet the needs
of MSP enrollees.
(1) Accuracy. An MSP issuer is
responsible for the accuracy of its
benefit plan material or information.
(2) Truthful, not misleading, no
material omissions, and plain language.
All benefit plan material or information
must be:
(i) Truthful, not misleading, and
without material omissions; and
(ii) Written in plain language, as
defined in section 1311(e)(3)(B) of the
Affordable Care Act.
(3) Uniform explanation of coverage
documents and standardized
definitions. An MSP issuer must comply
with the provisions of section 2715 of
the PHS Act and regulations issued to
implement that section.
(4) OPM review and approval of
benefit plan material or information.
OPM may request an MSP issuer to
submit to OPM benefit plan material or
information, as defined in § 800.20.
OPM reserves the right to review and
approve benefit plan material or
information to ensure that an MSP
issuer complies with Federal and State
laws, and the standards prescribed by
OPM with respect to benefit plan
material or information.
(5) Statement on certification by OPM.
An MSP issuer may include a statement
in its benefit plan material or
information that:
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(i) OPM has certified the MSP option
as eligible to be offered on the
Exchange; and
(ii) OPM monitors the MSP option for
compliance with all applicable law.
§ 800.114 Compliance with applicable
State law.
(a) Compliance with State law. An
MSP issuer must, with respect to each
of its MSP options, generally comply
with State law pursuant to section
1334(b)(2) of the Affordable Care Act.
However, the MSP options and MSP
issuers are not subject to State laws that:
(1) Are inconsistent with section 1334
of the Affordable Care Act or this part;
(2) Prevent the application of a
requirement of part A of title XXVII of
the PHS Act; or
(3) Prevent the application of a
requirement of title I of the Affordable
Care Act.
(b) Determination of inconsistency.
After consultation with the State and
HHS, OPM reserves the right to
determine, in its judgment, as
effectuated through an MSP Program
contract, these regulations, or OPM
guidance, whether the standards set
forth in paragraph (a) of this section are
satisfied with respect to particular State
laws.
tkelley on DSK3SPTVN1PROD with RULES
§ 800.115
Level playing field.
An MSP issuer must, with respect to
each of its MSP options, meet the
following requirements in order to
ensure a level playing field, subject to
§ 800.114:
(a) Guaranteed renewal. Guarantee
that an enrollee can renew enrollment
in an MSP option in compliance with
sections 2703 and 2742 of the PHS Act;
(b) Rating. In proposing premiums for
OPM approval, use only the rating
factors permitted under section 2701 of
the PHS Act and State law;
(c) Preexisting conditions. Not impose
any preexisting condition exclusion and
comply with section 2704 of the PHS
Act;
(d) Non-discrimination. Comply with
section 2705 of the PHS Act;
(e) Quality improvement and
reporting. Comply with all Federal and
State quality improvement and
reporting requirements. Quality
improvement and reporting means
quality improvement as defined in
section 1311(h) of the Affordable Care
Act and quality improvement plans or
strategies required under State law, and
quality reporting as defined in section
2717 of the PHS Act and section 1311(g)
of the Affordable Care Act. Quality
improvement also includes activities
such as, but not limited to,
implementation of a quality
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improvement strategy, disclosure of
quality measures to enrollees and
prospective enrollees, and reporting of
pediatric quality measures, which will
be similar to standards under section
1311(c)(1)(E), (H), and (I) of the
Affordable Care Act;
(f) Fraud and abuse. Comply with all
Federal and State fraud and abuse laws;
(g) Licensure. Be licensed in every
State in which it offers an MSP option;
(h) Solvency and financial
requirements. Comply with the solvency
standards set by each State in which it
offers an MSP option;
(i) Market conduct. Comply with the
market conduct standards of each State
in which it offers an MSP option;
(j) Prompt payment. Comply with
applicable State law in negotiating the
terms of payment in contracts with its
providers and in making payments to
claimants and providers;
(k) Appeals and grievances. Comply
with Federal standards under section
2719 of the PHS Act for appeals and
grievances relating to adverse benefit
determinations, as described in subpart
F of this part;
(l) Privacy and confidentiality.
Comply with all Federal and State
privacy and security laws and
requirements, including any standards
required by OPM in guidance or
contract, which will be similar to the
standards contained in 45 CFR part 164
and applicable State law; and
(m) Benefit plan material or
information. Comply with Federal and
State law, including § 800.113 of this
part.
§ 800.116
Process for dispute resolution.
(a) Determinations about applicability
of State law under section 1334(b)(2) of
the Affordable Care Act. In the event of
a dispute about the applicability to an
MSP option or MSP issuer of a State
law, the State may request that OPM
reconsider a determination that an MSP
option or MSP issuer is not subject to
such State law.
(b) Required demonstration. A State
making a request under paragraph (a) of
this section must demonstrate that the
State law at issue:
(1) Is not inconsistent with section
1334 of the Affordable Care Act or this
part;
(2) Does not prevent the application of
a requirement of part A of title XXVII of
the PHS Act; and
(3) Does not prevent the application of
a requirement of title I of the Affordable
Care Act.
(c) Request for review. The request
must be in writing and include contact
information, including the name,
telephone number, email address, and
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mailing address of the person or persons
whom OPM may contact regarding the
request for review. The request must be
in such form, contain such information,
and be submitted in such manner and
within such timeframe as OPM may
prescribe.
(1) The requester may submit to OPM
any relevant information to support its
request.
(2) OPM may obtain additional
information relevant to the request from
any source as it may, in its judgment,
deem necessary. OPM will provide the
requester with a copy of any additional
information it obtains and provide an
opportunity for the requester to respond
(including by submission of additional
information or explanation).
(3) OPM will issue a written decision
within 60 calendar days after receiving
the written request, or after the due date
for a response under paragraph (c)(2) of
this section, whichever is later, unless a
different timeframe is agreed upon.
(4) OPM’s written decision will
constitute final agency action that is
subject to review under the
Administrative Procedure Act in the
appropriate U.S. district court. Such
review is limited to the record that was
before OPM when OPM made its
decision.
Subpart C—Premiums, Rating Factors,
Medical Loss Ratios, and Risk
Adjustment
§ 800.201
General requirements.
(a) Premium negotiation. OPM will
negotiate annually with an MSP issuer,
on a State by State basis, the premiums
for each MSP option offered by that
issuer in that State. Such negotiations
may include negotiations about the costsharing provisions of an MSP option.
(b) Duration. Premiums will remain in
effect for the plan year.
(c) Guidance on rate development.
OPM will issue guidance addressing
methods for the development of
premiums for the MSP Program. That
guidance will follow State rating
standards generally applicable in a
State, to the greatest extent practicable.
(d) Calculation of actuarial value. An
MSP issuer must calculate actuarial
value in the same manner as QHP
issuers under section 1302(d) of the
Affordable Care Act, as well as any
applicable standards set by OPM or
HHS.
(e) OPM rate review process. An MSP
issuer must participate in the rate
review process established by OPM to
negotiate rates for MSP options. The rate
review process established by OPM will
be similar to the process established by
HHS pursuant to section 2794 of the
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PHS Act and disclosure and review
standards established under 45 CFR part
154.
(f) State effective rate review. With
respect to its MSP options, an MSP
issuer is subject to a State’s rate review
process, including a State’s Effective
Rate Review Program established by
HHS pursuant to section 2794 of the
PHS Act and 45 CFR part 154. In the
event HHS is reviewing rates for a State
pursuant to section 2794 of the PHS Act,
HHS will defer to OPM’s judgment
regarding the MSP options’ proposed
rate increase. If a State withholds
approval of an MSP option and OPM
determines, in its discretion, that the
State’s action would prevent OPM from
administrating the MSP Program, OPM
retains authority to make the final
decision to approve rates for
participation in the MSP Program,
notwithstanding the absence of State
approval.
(g) Single risk pool. An MSP issuer
must consider all enrollees in an MSP
option to be in the same risk pool as all
enrollees in all other health plans in the
individual market or the small group
market, respectively, in compliance
with section 1312(c) of the Affordable
Care Act, 45 CFR 156.80, and any
applicable Federal or State laws and
regulations implementing that section.
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§ 800.202
Rating factors.
(a) Permissible rating factors. In
proposing premiums for each MSP
option, an MSP issuer must use only the
rating factors permitted under section
2701 of the PHS Act.
(b) Application of variations based on
age or tobacco use. Rating variations
permitted under section 2701 of the
PHS Act must be applied by an MSP
issuer based on the portion of the
premium attributable to each family
member covered under the coverage in
accordance with any applicable Federal
or State laws and regulations
implementing section 2701(a) of the
PHS Act.
(c) Age rating. For age rating, an MSP
issuer must use the ratio established by
the State in which the MSP option is
offered, if it is less than 3:1.
(1) Age bands. An MSP issuer must
use the uniform age bands established
under HHS regulations implementing
section 2701(a) of the PHS Act.
(2) Age curves. An MSP issuer must
use the age curves established under
HHS regulations implementing section
2701(a) of the PHS Act, or age curves
established by a State pursuant to HHS
regulations.
(d) Rating areas. An MSP issuer must
use the rating areas appropriate to the
State in which the MSP option is offered
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and established under HHS regulations
implementing section 2701(a) of the
PHS Act.
(e) Tobacco rating. An MSP issuer
must apply tobacco use as a rating factor
in accordance with any applicable
Federal or State laws and regulations
implementing section 2701(a) of the
PHS Act.
(f) Wellness programs. An MSP issuer
must comply with any applicable
Federal or State laws and regulations
implementing section 2705 of the PHS
Act.
§ 800.203
Medical loss ratio.
(a) Required medical loss ratio. An
MSP issuer must attain:
(1) The medical loss ratio (MLR)
required under section 2718 of the PHS
Act and regulations promulgated by
HHS; and
(2) Any MSP-specific MLR that OPM
may set in the best interests of MSP
enrollees or that is necessary to be
consistent with a State’s requirements
with respect to MLR.
(b) Consequences of not attaining
required medical loss ratio. If an MSP
issuer fails to attain an MLR set forth in
paragraph (a) of this section, OPM may
take any appropriate action, including
but not limited to intermediate
sanctions, such as suspension of
marketing, decertifying an MSP option
in one or more States, or terminating an
MSP issuer’s contract pursuant to
§ 800.404 of this part.
§ 800.204 Reinsurance, risk corridors, and
risk adjustment.
(a) Transitional reinsurance program.
An MSP issuer must comply with
section 1341 of the Affordable Care Act,
45 CFR part 153, and any applicable
Federal or State regulations under
section 1341 that set forth requirements
to implement the transitional
reinsurance program for the individual
market.
(b) Temporary risk corridors program.
An MSP issuer must comply with
section 1342 of the Affordable Care Act,
45 CFR part 153, and any applicable
Federal regulations under section 1342
that set forth requirements to implement
the risk corridor program.
(c) Risk adjustment program. An MSP
issuer must comply with section 1343 of
the Affordable Care Act, 45 CFR part
153, and any applicable Federal or State
regulations under section 1343 that set
forth requirements to implement the
risk adjustment program.
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9661
Subpart D—Application and
Contracting Procedures
§ 800.301
Application process.
(a) Acceptance of applications.
Without regard to 41 U.S.C. 6101(b)–(d),
or any other statute requiring
competitive bidding, OPM may consider
annual applications from health
insurance issuers, including groups of
health insurance issuers as defined in
§ 800.20, to participate in the MSP
Program. If OPM determines that it is
not beneficial for the MSP Program to
consider new issuer applications for an
upcoming year, OPM will issue a notice
to that effect. Each existing MSP issuer
may complete a renewal application
annually.
(b) Form and manner of applications.
An applicant must submit to OPM, in
the form and manner and in accordance
with the timeline specified by OPM, the
information requested by OPM for
determining whether an applicant meets
the requirements of this part.
§ 800.302
Review of applications.
(a) Determinations. OPM will
determine if an applicant meets the
requirements of this part. If OPM
determines that an applicant meets the
requirements of this part, OPM may
accept the applicant to enter into
contract negotiations with OPM to
participate in the MSP Program.
(b) Requests for additional
information. OPM may request
additional information from an
applicant before making a decision
about whether to enter into contract
negotiations with that applicant to
participate in the MSP Program.
(c) Declination of application. If, after
reviewing an application to participate
in the MSP Program, OPM declines to
enter into contract negotiations with the
applicant, OPM will inform the
applicant in writing of the reasons for
that decision.
(d) Discretion. The decision whether
to enter into contract negotiations with
a health insurance issuer who has
applied to participate in the MSP
Program is committed to OPM’s
discretion.
(e) Impact on future applications.
OPM’s declination of an application to
participate in the MSP Program will not
preclude the applicant from submitting
an application for a subsequent year to
participate in the MSP Program.
§ 800.303
MSP Program contracting.
(a) Participation in MSP Program. To
become an MSP issuer, the applicant
and the Director or the Director’s
designee must sign a contract that meets
the requirements of this part.
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(b) Standard contract. OPM will
establish a standard contract for the
MSP Program.
(c) Premiums. OPM and the applicant
will negotiate the premiums for an MSP
option for each plan year in accordance
with the provisions of subpart C of this
part.
(d) Package of benefits. OPM must
approve the applicant’s package of
benefits for its MSP option.
(e) Additional terms and conditions.
OPM may elect to negotiate with an
applicant such additional terms,
conditions, and requirements that:
(1) Are in the interests of MSP
enrollees; or
(2) OPM determines to be appropriate.
(f) Certification to offer health
insurance coverage.
(1) For each plan year, an MSP
Program contract will specify MSP
options that OPM has certified, the
specific package(s) of benefits
authorized to be offered on each
Exchange, and the premiums to be
charged for each package of benefits on
each Exchange.
(2) An MSP issuer may not offer an
MSP option on an Exchange unless its
MSP Program contract with OPM
includes a certification authorizing the
MSP issuer to offer the MSP option on
that Exchange in accordance with
paragraph (f)(1) of this section.
§ 800.304
Term of the contract.
(a) Term of a contract. The term of the
contract will be specified in the MSP
Program contract and must be for a
period of at least the 12 consecutive
months defined as the plan year.
(b) Plan year. The plan year is a
consecutive 12-month period during
which an MSP option provides coverage
for health benefits. A plan year may be
a calendar year or otherwise.
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§ 800.305
Contract renewal process.
(a) Renewal. To continue participating
in the MSP Program, an MSP issuer
must provide to OPM, in the form and
manner and in accordance with the
timeline prescribed by OPM, the
information requested by OPM for
determining whether the MSP issuer
continues to meet the requirements of
this part.
(b) OPM decision. Subject to
paragraph (c) of this section, OPM will
renew the MSP Program contract of an
MSP issuer who timely submits the
information described in paragraph (a).
(c) OPM discretion not to renew. OPM
may decline to renew the contract of an
MSP issuer if:
(1) OPM and the MSP issuer fail to
agree on premiums and benefits for an
MSP option for the subsequent plan
year;
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(2) The MSP issuer has engaged in
conduct described in § 800.404(a) of this
part; or
(3) OPM determines that the MSP
issuer will be unable to comply with a
material provision of section 1334 of the
Affordable Care Act or this part.
(d) Failure to agree on premiums and
benefits. Except as otherwise provided
in this part, if an MSP issuer has
complied with paragraph (a) of this
section and OPM and the MSP issuer
fail to agree on premiums and benefits
for an MSP option on one or more
Exchanges for the subsequent plan year
by the date required by OPM, either
party may provide notice of nonrenewal
pursuant to § 800.306 of this part, or
OPM may in its discretion withdraw the
certification of that MSP option on the
Exchange or Exchanges for that plan
year. In addition, if OPM and the MSP
issuer fail to agree on benefits and
premiums for an MSP option on one or
more Exchanges by the date set by OPM
and in the event of no action (no notice
of nonrenewal or renewal) by either
party, the MSP Program contract will be
renewed and the existing premiums and
benefits for that MSP option on that
Exchange or Exchanges will remain in
effect for the subsequent plan year.
§ 800.306
Nonrenewal.
(a) Nonrenewal. Nonrenewal may
pertain to the MSP issuer or the Statelevel issuer. The circumstances under
which nonrenewal may occur are:
(1) Nonrenewal of contract. As used
in this subpart and subpart E of this
part, ‘‘nonrenewal of contract’’ means a
decision by either OPM or an MSP
issuer not to renew an MSP Program
contract.
(2) Nonrenewal of participation. As
used in this subpart and subpart E of
this part, ‘‘nonrenewal of participation’’
means a decision by OPM, an MSP
issuer, or a State-level issuer not to
renew a State-level issuer’s participation
in a MSP Program contract.
(b) Notice required. Either OPM or an
MSP issuer may decline to renew an
MSP Program contract by providing a
written notice of nonrenewal to the
other party.
(c) MSP issuer responsibilities. The
MSP issuer’s written notice of
nonrenewal must be made in
accordance with its MSP Program
contract with OPM. The MSP issuer also
must comply with any requirements
regarding the termination of a plan that
are applicable to a QHP offered on an
Exchange on which the MSP option was
offered, including a requirement to
provide advance written notice of
termination to enrollees. MSP issuers
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shall provide written notice to enrollees
in accordance with § 800.404(d).
Subpart E—Compliance
§ 800.401
Contract performance.
(a) General. An MSP issuer must
perform an MSP Program contract with
OPM in accordance with the
requirements of section 1334 of the
Affordable Care Act and this part. The
MSP issuer must continue to meet such
requirements while under an MSP
Program contract with OPM.
(b) Specific requirements for issuers.
In addition to the requirements
described in paragraph (a) of this
section, each MSP issuer must:
(1) Have, in the judgment of OPM, the
financial resources to carry out its
obligations under the MSP Program;
(2) Keep such reasonable financial
and statistical records, and furnish to
OPM such reasonable financial and
statistical reports with respect to the
MSP option or the MSP issuer, as may
be requested by OPM;
(3) Permit representatives of OPM
(including the OPM Office of Inspector
General), the U.S. Government
Accountability Office, and any other
applicable Federal Government auditing
entities to audit and examine its records
and accounts that pertain, directly or
indirectly, to the MSP option at such
reasonable times and places as may be
designated by OPM or the U.S.
Government Accountability Office;
(4) Timely submit to OPM a properly
completed and signed novation or
change-of-name agreement in
accordance with subpart 42.12 of 48
CFR part 42;
(5) Perform the MSP Program contract
in accordance with prudent business
practices, as described in paragraph (c)
of this section; and
(6) Not perform the MSP Program
contract in accordance with poor
business practices, as described in
paragraph (d) of this section.
(c) Prudent business practices. OPM
will consider an MSP issuer’s specific
circumstances and facts in using its
discretion to determine compliance
with paragraph (b)(5) of this section. For
purposes of paragraph (b)(5) of this
section, prudent business practices
include, but are not limited to, the
following:
(1) Timely compliance with OPM
instructions and directives;
(2) Legal and ethical business and
health care practices;
(3) Compliance with the terms of the
MSP Program contract, regulations, and
statutes;
(4) Timely and accurate adjudication
of claims or rendering of medical
services;
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(5) Operating a system for accounting
for costs incurred under the MSP
Program contract, which includes
segregating and pricing MSP option
medical utilization and allocating
indirect and administrative costs in a
reasonable and equitable manner;
(6) Maintaining accurate accounting
reports of costs incurred in the
administration of the MSP Program
contract;
(7) Applying performance standards
for assuring contract quality as outlined
at § 800.402; and
(8) Establishing and maintaining a
system of internal controls that provides
reasonable assurance that:
(i) The provision and payments of
benefits and other expenses comply
with legal, regulatory, and contractual
guidelines;
(ii) MSP funds, property, and other
assets are safeguarded against waste,
loss, unauthorized use, or
misappropriation; and
(iii) Data is accurately and fairly
disclosed in all reports required by
OPM.
(d) Poor business practices. OPM will
consider an MSP issuer’s specific
circumstances and facts in using its
discretion to determine compliance
with paragraph (b)(6) of this section. For
purposes of paragraph (b)(6) of this
section, poor business practices include,
but are not limited to, the following:
(1) Using fraudulent or unethical
business or health care practices or
otherwise displaying a lack of business
integrity or honesty;
(2) Repeatedly or knowingly
providing false or misleading
information in the rate setting process;
(3) Failing to comply with OPM
instructions and directives;
(4) Having an accounting system that
is incapable of separately accounting for
costs incurred under the contract and/
or that lacks the internal controls
necessary to fulfill the terms of the
contract;
(5) Failing to ensure that the MSP
issuer properly pays or denies claims,
or, if applicable, provides medical
services that are inconsistent with
standards of good medical practice; and
(6) Entering into contracts or
employment agreements with providers,
provider groups, or health care workers
that include provisions or financial
incentives that directly or indirectly
create an inducement to limit or restrict
communication about medically
necessary services to any individual
covered under the MSP Program.
Financial incentives are defined as
bonuses, withholds, commissions, profit
sharing or other similar adjustments to
basic compensation (e.g., service fee,
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capitation, salary) which have the effect
of limiting or reducing communication
about appropriate medically necessary
services.
(e) Performance escrow account. OPM
may require MSP issuers to pay an
assessment into an escrow account to
ensure contract compliance and benefit
MSP enrollees.
§ 800.402
Contract quality assurance.
(a) General. This section prescribes
general policies and procedures to
ensure that services acquired under
MSP Program contracts conform to the
contract’s quality requirements.
(b) Internal controls. OPM may
periodically evaluate the contractor’s
system of internal controls under the
quality assurance program required by
the contract and will acknowledge in
writing if the system is inconsistent
with the requirements set forth in the
contract. OPM’s reviews do not
diminish the contractor’s obligation to
implement and maintain an effective
and efficient system to apply the
internal controls.
(c) Performance standards. (1) OPM
will issue specific performance
standards for MSP Program contracts
and will inform MSP issuers of the
applicable performance standards prior
to negotiations for the contract year.
OPM may benchmark its standards
against standards generally accepted in
the insurance industry. OPM may
authorize nationally recognized
standards to be used to fulfill this
requirement.
(2) MSP issuers must comply with the
performance standards issued pursuant
to this section.
§ 800.403
Fraud and abuse.
(a) Program required. An MSP issuer
must conduct a program to assess its
vulnerability to fraud and abuse as well
as to address such vulnerabilities.
(b) Fraud detection system. An MSP
issuer must operate a system designed
to detect and eliminate fraud and abuse
by employees and subcontractors of the
MSP issuer, by providers furnishing
goods or services to MSP enrollees, and
by MSP enrollees.
(c) Submission of information. An
MSP issuer must provide to OPM such
information or assistance as may be
necessary for the agency to carry out the
duties and responsibilities, including
those of the Office of Inspector General
as specified in sections 4 and 6 of the
Inspector General Act of 1978 (5 U.S.C.
App.). An MSP issuer must provide any
requested information in the form,
manner, and timeline prescribed by
OPM.
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§ 800.404
9663
Compliance actions.
(a) Causes for OPM compliance
actions. The following constitute cause
for OPM to impose a compliance action
described in paragraph (b) of this
section against an MSP issuer:
(1) Failure by the MSP issuer to meet
the requirements set forth in
§ 800.401(a) and (b);
(2) An MSP issuer’s sustained failure
to perform the MSP Program contract in
accordance with prudent business
practices, as described in § 800.401(c);
(3) A pattern of poor conduct or
evidence of poor business practices
such as those described in § 800.401(d);
or
(4) Such other violations of law or
regulation as OPM may determine,
including pursuant to its authority
under §§ 800.102 and 800.114.
(b) Compliance actions. (1) OPM may
impose a compliance action against an
MSP issuer at any time during the
contract term if it determines that the
MSP issuer is not in compliance with
applicable law, this part, or the terms of
its contract with OPM.
(2) Compliance actions may include,
but are not limited to:
(i) Establishment and implementation
of a corrective action plan;
(ii) Imposition of intermediate
sanctions, such as suspension of
marketing;
(iii) Performance incentives;
(iv) Reduction of service area or areas;
(v) Withdrawal of the certification of
the MSP option or options offered on
one or more Exchanges;
(vi) Nonrenewal of participation
(vii) Nonrenewal of contract; and
(viii) Withdrawal of approval or
termination of the MSP Program
contract.
(c) Notice of compliance action. (1)
OPM must notify an MSP issuer in
writing of a compliance action under
this section. Such notice must indicate
the specific compliance action
undertaken and the reason for the
compliance action.
(2) For compliance actions listed in
§ 800.404(b)(2)(v) through (viii), such
notice must include a statement that the
MSP issuer is entitled to request a
reconsideration of OPM’s determination
to impose a compliance action pursuant
to § 800.405.
(3) Upon imposition of a compliance
action listed in paragraphs (b)(2)(iv)
through (vii) of this section, OPM must
notify the State Insurance
Commissioner(s) and Exchange officials
in the State or States in which the
compliance action is effective.
(d) Notice to enrollees. If the contract
is terminated, if OPM withdraws
certification of an MSP option, or if a
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State-level issuer’s participation in the
MSP Program contract is not renewed,
as described in §§ 800.306 and
800.404(b)(2), or in any situation in
which an MSP option is no longer
available to enrollees, the MSP issuer
must comply with any State or
Exchange requirements regarding
discontinuing a particular type of
coverage that are applicable to a QHP
offered on the Exchange on which the
MSP option was offered, including a
requirement to provide advance written
notice before the coverage will be
discontinued. If a State or Exchange
does not have requirements about
advance notice to enrollees, the MSP
issuer must inform current MSP
enrollees in writing of the
discontinuance of the MSP option no
later than 90 days prior to discontinuing
the MSP option, unless OPM determines
that there is good cause for less than 90
days’ notice.
(e) Definition. As used in this subpart,
‘‘termination’’ means a decision by OPM
to cancel an MSP Program contract prior
to the end of its contract term. The term
includes OPM’s withdrawal of approval
of an MSP Program contract.
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§ 800.405
actions.
Reconsideration of compliance
(a) Right to request reconsideration.
An MSP issuer may request that OPM
reconsider a determination to impose
one of the following compliance actions:
(1) Withdrawal of the certification of
the MSP option or options offered on
one or more Exchanges;
(2) Nonrenewal of participation
(3) Nonrenewal of contract; or
(4) Termination of the MSP Program
contract.
(b) Request for reconsideration and/or
hearing. (1) An MSP issuer with a right
to request reconsideration specified in
paragraph (a) of this section may request
a hearing in which OPM will reconsider
its determination to impose a
compliance action.
(2) A request under this section must
be in writing and contain contact
information, including the name,
telephone number, email address, and
mailing address of the person or persons
whom OPM may contact regarding a
request for a hearing with respect to the
reconsideration. The request must be in
such form, contain such information,
and be submitted in such manner as
OPM may prescribe.
(3) The request must be received by
OPM within 15 calendar days after the
date of the MSP issuer’s receipt of the
notice of compliance action. The MSP
issuer may request that OPM’s
reconsideration allow a representative
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of the MSP issuer to appear personally
before OPM.
(4) A request under this section must
include a detailed statement of the
reasons that the MSP issuer disagrees
with OPM’s imposition of the
compliance action, and may include any
additional information that will assist
OPM in rendering a final decision under
this section.
(5) OPM may obtain additional
information relevant to the request from
any source as it may, in its judgment,
deem necessary. OPM will provide the
MSP issuer with a copy of any
additional information it obtains and
provide an opportunity for the MSP
issuer to respond (including by
submitting additional information or
explanation).
(6) OPM’s reconsideration and
hearing, if requested, may be conducted
by the Director or a representative
designated by the Director who did not
participate in the initial decision that is
the subject of the request for review.
(c) Notice of final decision. OPM will
notify the MSP issuer, in writing, of
OPM’s final decision on the MSP
issuer’s request for reconsideration and
the specific reasons for that final
decision. OPM’s written decision will
constitute final agency action that is
subject to review under the
Administrative Procedure Act in the
appropriate U.S. district court. Such
review is limited to the record that was
before OPM when it made its decision.
Subpart F—Appeals by Enrollees of
Denials of Claims for Payment or
Service
§ 800.501
General requirements.
(a) Definitions. For purposes of this
subpart:
(1) Adverse benefit determination has
the meaning given that term in 45 CFR
147.136(a)(2)(i).
(2) Claim means a request for:
(i) Payment of a health-related bill; or
(ii) Provision of a health-related
service or supply.
(b) Applicability. This subpart applies
to enrollees and to other individuals or
entities who are acting on behalf of an
enrollee and who have the enrollee’s
specific written consent to pursue a
remedy of an adverse benefit
determination.
§ 800.502
appeals.
MSP issuer internal claims and
(a) Processes. MSP issuers must
comply with the internal claims and
appeals processes applicable to group
health plans and health insurance
issuers under 45 CFR 147.136(b).
(b) Timeframes and notice of
determination. An MSP issuer must
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provide written notice to an enrollee of
its determination on a claim brought
under paragraph (a) of this section
according to the timeframes and
notification rules under 45 CFR
147.136(b) and (e), including the
timeframes for urgent claims. If the MSP
issuer denies a claim (or a portion of the
claim), the enrollee may appeal the
adverse benefit determination to the
MSP issuer in accordance with 45 CFR
147.136(b).
§ 800.503
External review.
(a) External review by OPM. OPM will
conduct external review of adverse
benefit determinations using a process
similar to OPM review of disputed
claims under 5 CFR 890.105(e), subject
to the standards and timeframes set
forth in 45 CFR 147.136(d).
(b) Notice. Notices to MSP enrollees
regarding external review under
paragraph (a) of this section must
comply with 45 CFR 147.136(e), and are
subject to review and approval by OPM.
(c) Issuer obligation. An MSP issuer
must pay a claim or provide a healthrelated service or supply pursuant to
OPM’s final decision or the final
decision of an independent review
organization without delay, regardless
of whether the plan or issuer intends to
seek judicial review of the external
review decision and unless or until
there is a judicial decision otherwise.
§ 800.504
Judicial review.
(a) OPM’s written decision under the
external review process established
under § 800.503(a) of this part will
constitute final agency action that is
subject to review under the
Administrative Procedure Act in the
appropriate U.S. district court. A
decision made by an independent
review organization under the process
established under § 800.503(a) is not
within OPM’s discretion and therefore
is not final agency action.
(b) Judicial review under paragraph
(a) of this section is limited to the record
that was before OPM when OPM made
its decision.
Subpart G—Miscellaneous
§ 800.601
Reservation of authority.
OPM reserves the right to implement
and supplement these regulations with
written operational guidelines.
§ 800.602 Consumer choice with respect
to certain services.
(a) Assured availability of varied
coverage. Consistent with § 800.104 of
this part, OPM will ensure that at least
one of the MSP issuers on each
Exchange in each State offers at least
one MSP option that does not provide
E:\FR\FM\24FER1.SGM
24FER1
Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations
coverage of services described in section
1303(b)(1)(B)(i) of the Affordable Care
Act.
(b) State opt-out. An MSP issuer may
not offer abortion coverage in any State
where such coverage of abortion
services is prohibited by State law.
(c) Notice to Enrollees—(1) Notice of
exclusion. The MSP issuer must provide
notice to consumers prior to enrollment
that non-excepted abortion services are
not a covered benefit in the form,
manner, and timeline prescribed by
OPM.
(2) Notice of coverage. If an MSP
issuer chooses to offer an MSP option
that covers non-excepted abortion
services, in addition to an MSP option
that does not cover non-excepted
abortion services, the MSP issuer must
provide notice to consumers prior to
enrollment that non-excepted abortion
services are a covered benefit. An MSP
issuer must provide notice in a manner
consistent with 45 CFR 147.200(a)(3), to
meet the requirements of 45 CFR
156.280(f). OPM may provide guidance
on the form, manner, and timeline for
this notice.
(3) OPM review and approval of
notices. OPM may require an MSP
issuer to submit to OPM such notices.
OPM reserves the right to review and
approve these consumer notices to
ensure that an MSP issuer complies
with Federal and State laws, and the
standards prescribed by OPM with
respect to § 800.602.
tkelley on DSK3SPTVN1PROD with RULES
§ 800.603
Disclosure of information
(a) Disclosure to certain entities. OPM
may provide information relating to the
activities of MSP issuers or State-level
issuers to a State Insurance
Commissioner or Director of a Statebased Exchange.
(b) Conditions of when to disclose.
OPM shall only make a disclosure
described in this section to the extent
that such disclosure is:
(1) Necessary or appropriate to permit
OPM’s Director, a State Insurance
Commissioner, or Director of a Statebased Exchange to administer and
enforce laws applicable to an MSP
issuer or State-level issuer over which it
has jurisdiction, or
(2) Otherwise in the best interests of
enrollees or potential enrollees in MSP
options.
(c) Confidentiality of information.
OPM will take appropriate steps to
cause the recipient of this information
to preserve the information as
confidential.
[FR Doc. 2015–03421 Filed 2–20–15; 8:45 am]
BILLING CODE 6325–63–P
VerDate Sep<11>2014
16:15 Feb 23, 2015
Jkt 235001
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 101206604–1758–02]
RIN 0648–XD731
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Coastal
Migratory Pelagic Resources of the
Gulf of Mexico and South Atlantic;
2015 Commercial Run-Around Gillnet
Closure
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS implements an
accountability measure (AM) through
this temporary rule for commercial
harvest of king mackerel in the Florida
west coast southern subzone of the
eastern zone of the Gulf of Mexico (Gulf)
exclusive economic zone (EEZ) using
run-around gillnet gear. NMFS has
determined that the commercial annual
catch limit (ACL; commercial quota) for
king mackerel using run-around gillnet
gear in the Florida west coast southern
subzone of the Gulf EEZ will be reached
on February 20, 2015. Therefore, NMFS
closes the Florida west coast southern
subzone to commercial king mackerel
fishing using run-around gillnet gear in
the Gulf EEZ. This closure is necessary
to protect the Gulf king mackerel
resource.
SUMMARY:
The closure is effective 12:01
p.m., eastern standard time, February
20, 2015, until 6 a.m., eastern standard
time, January 19, 2016.
FOR FURTHER INFORMATION CONTACT:
Susan Gerhart, NMFS Southeast
Regional Office, telephone: 727–824–
5305, email: susan.gerhart@noaa.gov.
SUPPLEMENTARY INFORMATION: The
fishery for coastal migratory pelagic fish
(king mackerel, Spanish mackerel, and
cobia) is managed under the Fishery
Management Plan for the Coastal
Migratory Pelagic Resources of the Gulf
of Mexico and South Atlantic (FMP).
The FMP was prepared by the Gulf of
Mexico and South Atlantic Fishery
Management Councils and is
implemented by NMFS under the
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act (Magnuson-Stevens Act) by
regulations at 50 CFR part 622.
Gulf migratory group king mackerel’s
Florida west coast subzone of the Gulf
DATES:
PO 00000
Frm 00075
Fmt 4700
Sfmt 4700
9665
eastern zone is divided into northern
and southern subzones, each with
separate commercial quotas. From
November 1 through March 31, the
southern subzone encompasses an area
of the EEZ south of a line extending due
west of the Lee and Collier County, FL,
boundary on the Florida west coast, and
south of a line extending due east of the
Monroe and Miami-Dade County, FL,
boundary on the Florida east coast,
which includes the EEZ off Collier and
Monroe Counties, FL. From April 1
through October 31, the southern
subzone is reduced to the EEZ off
Collier County, and the EEZ off Monroe
County becomes part of the Atlantic
migratory group area (50 CFR
622.384(b)(1)(i)(C)).
On January 30, 2012 (76 FR 82058,
December 29, 2011), NMFS
implemented a commercial quota for the
Gulf migratory group king mackerel in
the Florida west coast southern subzone
of 551,448 lb (250,133 kg) for vessels
using run-around gillnet gear (50 CFR
622.384(b)(1)(i)(B)(1)), for the current
fishing year, July 1, 2014, through June
30, 2015.
Regulations at 50 CFR 622.8(b) require
NMFS to close any segment of the king
mackerel commercial sector when its
quota has been reached, or is projected
to be reached, by filing a notification
with the Office of the Federal Register.
NMFS has determined that the
commercial quota of 551,448 lb (250,133
kg) for Gulf group king mackerel for
vessels using run-around gillnet gear in
the Florida west coast southern subzone
will be reached on February 20, 2015.
Accordingly, commercial fishing using
such gear in the Florida west coast
southern subzone is closed at 12:01
p.m., eastern standard time, February
20, 2015, until 6 a.m., eastern standard
time, January 19, 2016, the beginning of
the next fishing season, i.e., the day after
the 2016 Martin Luther King, Jr. Federal
holiday. Accordingly, the operator of a
vessel that has been issued a Federal
commercial permit to harvest Gulf
migratory group king mackerel using
run-around gillnet gear in the Florida
west coast southern subzone must have
landed ashore and bartered, traded, or
sold such king mackerel prior to 12:01
p.m., eastern standard time, February
20, 2015.
Persons aboard a vessel for which a
commercial permit for king mackerel
has been issued, except persons who
also possess a king mackerel gillnet
permit, may fish for or retain Gulf group
king mackerel harvested using hookand-line gear in the Florida west coast
southern subzone unless the
commercial quota for hook-and-line gear
has been met and the hook-and-line
E:\FR\FM\24FER1.SGM
24FER1
Agencies
[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Rules and Regulations]
[Pages 9649-9665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03421]
[[Page 9649]]
=======================================================================
-----------------------------------------------------------------------
OFFICE OF PERSONNEL MANAGEMENT
45 CFR Part 800
RIN 3206-AN12
Patient Protection and Affordable Care Act; Establishment of the
Multi-State Plan Program for the Affordable Insurance Exchanges
AGENCY: Office of Personnel Management.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Office of Personnel Management (OPM) is issuing a
final rule implementing modifications to the Multi-State Plan (MSP)
Program based on the experience of the Program to date. OPM established
the MSP Program pursuant to the Affordable Care Act. This rule
clarifies the approach used to enforce the applicable standards of the
Affordable Care Act with respect to health insurance issuers that
contract with OPM to offer MSP options; amends MSP standards related to
coverage area, benefits, and certain contracting provisions under
section 1334 of the Affordable Care Act; and makes non-substantive
technical changes.
DATES: Effective March 26, 2015.
FOR FURTHER INFORMATION CONTACT: Cameron Stokes by telephone at (202)
606-2128, by FAX at (202) 606-4430, or by email at mspp@opm.gov.
SUPPLEMENTARY INFORMATION: The Patient Protection and Affordable Care
Act (Pub. L. 111-148), as amended by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111- 152), together known as the
Affordable Care Act, provides for the establishment of Affordable
Insurance Exchanges, or ``Exchanges'' (also called Health Insurance
Marketplaces, or ``Marketplaces''), where individuals and small
businesses can purchase qualified coverage. The Exchanges provide
competitive marketplaces for individuals and small employers to compare
available private health insurance options based on price, quality, and
other factors. The Exchanges enhance competition in the health
insurance market, improve choice of affordable health insurance, and
give individuals and small businesses purchasing power comparable to
that of large businesses. The Multi-State Plan (MSP) Program was
created pursuant to section 1334 of the Affordable Care Act to increase
competition by offering high-quality health insurance coverage sold in
multiple States on the Exchanges. The U.S. Office of Personnel
Management (OPM) is issuing this final rule to modify the standards set
forth for the MSP Program under 45 CFR Part 800 that was published as a
final rule on March 11, 2013 (78 FR 15560). This rule clarifies OPM's
intent in administering the Program, as well as makes regulatory
changes in order to expand issuer participation and offerings in the
Program to meet the goal of increasing competition.
Abbreviations
EHB--Essential Health Benefits
FEHB Program--Federal Employees Health Benefits Program
HHS--U.S. Department of Health and Human Services
MSP--Multi-State Plan
NAIC--National Association of Insurance Commissioners
OPM--U.S. Office of Personnel Management
PHS Act--Public Health Service Act
QHP--Qualified Health Plan
SHOP--Small Business Health Options Program
Section 1334 of the Affordable Care Act created the Multi-State
Plan (MSP) Program to foster competition in the health insurance
markets on the Exchanges (also called Health Insurance Exchanges or
Marketplaces) based on price, quality, and benefit delivery. The
Affordable Care Act directs the U.S. Office of Personnel Management
(OPM) to contract with private health insurance issuers to offer at
least two MSP options on each of the Exchanges in the States and the
District of Columbia.\1\ The law allows MSP issuers to phase in
coverage.\2\
---------------------------------------------------------------------------
\1\ Multi-State Plan option or MSP option means a discrete
pairing of a package of benefits with particular cost sharing (which
does not include premium rates or premium rate quotes) that is
offered under a contract with OPM.
\2\ Multi-State Plan issuer or MSP issuer means a health
insurance issuer or group of issuers that has a contract with OPM to
offer MSP options pursuant to section 1334 of the Affordable Care
Act.
---------------------------------------------------------------------------
In the 2014 plan year, OPM contracted with one group of issuers to
offer more than 150 MSP options in 31 States, including the District of
Columbia. Approximately 371,000 individuals enrolled in an MSP option
in 2014. For plan year 2015, OPM entered into contract with a second
group of issuers, and MSP coverage expanded to 36 States. The Program
currently offers more than 200 MSP options through the Exchanges to
further competition and expand choices available to individuals,
families, and small businesses.
This rule builds on the MSP Program final rule published March 11,
2013.\3\ Changes to the regulations include clarifications to the
process by which OPM administers the MSP Program, pursuant to section
1334 of the Affordable Care Act, and revisions to the standards and
requirements applicable to MSP options and MSP issuers.
---------------------------------------------------------------------------
\3\ Patient Protection and Affordable Care Act; Establishment of
the Multi-State Plan Program for the Affordable Insurance Exchanges,
78 FR 15560 (Mar. 11, 2013).
---------------------------------------------------------------------------
Summary of Comments
OPM published a proposed rule on November 24, 2014 (79 FR 69802),
to modify standards related to the implementation of the MSP Program at
part 800 of title 45, Code of Federal Regulations. The comment period
for the proposed rule closed December 24, 2014. OPM received 43
comments from a broad range of stakeholders, including States, health
insurance issuers, health care provider associations, pharmaceutical
companies, and consumer groups.
While most of the comments were related to the proposed
modifications addressed in the rule, a small number of the comments
were on areas of the regulations for which we did not propose changes
or request comment.
A summary of the comments we received follows, along with our
responses and changes to the proposed regulations in light of the
comments. In addition, we are making some minor technical and editorial
changes to the proposed regulations to correct errors and improve
clarity and readability. Comments submitted on sections of the
regulations that we did not propose to change are outside the scope of
this rulemaking and are not addressed here.
Length of the Comment Period
Comments: Some commenters contended that the 30-day comment period
did not provide sufficient time to provide feedback.
Response: OPM values the participation of a broad array of diverse
stakeholders. In addition to the proposed rule, we continue to seek
input and guidance from numerous stakeholders, including the National
Association of Insurance Commissioners (NAIC), States, tribal
governments, consumer advocates, health insurance issuers, labor
organizations, health care provider associations, and trade groups.
Responses to Comments on the Proposed Regulations
Subpart A--General Provisions and Definitions
Definitions (Sec. 800.20)
We sought comments on two proposed definitions for the MSP Program.
Specifically, we proposed to add the definition for ``Multi-State Plan
[[Page 9650]]
option,'' which may also be referred to as ``MSP option.'' We also
proposed to remove the definition of ``Multi-State Plan'' because the
term ``Multi-State Plan option'' is more precise and avoids the
confusion of the varying definitions of the word ``plan'' in the
context of health insurance. We also proposed to add a definition for
``State-level issuer'' as a health insurance issuer designated by the
MSP issuer to offer an MSP option or MSP options. OPM invited comments
on the proposed changes to the definitions under 45 CFR 800.20 as well
as any comments on the current definition for ``group of issuers.'' OPM
received no comments on the definition of ``State-level issuer,'' and
we will adopt the definition as proposed.
Comments: OPM received comments that were generally supportive of
adding the proposed definition of ``MSP option.'' One of these
commenters asked that we replace ``package of benefits'' with the term
``product'' as it is defined in 45 CFR 144.103. We did not receive
comments on removing the definition ``Multi-State Plan.''
Response: OPM will finalize the definition of ``MSP option'' as
proposed and will remove ``Multi-State Plan.'' The definition of ``MSP
option'' will ensure consistency within the MSP Program and avoid
confusion with definitions from programs outside of OPM.
Comments: Commenters responded to our call for feedback on the
definition of ``Group of Issuers'' in Sec. 800.20. The commenters were
generally opposed to expanding ``Group of Issuers'' to include
alternative structures and requested further clarification from OPM.
Some commenters were supportive of interpreting the definition of
``Group of Issuers'' to attract additional issuers to the MSP Program.
Response: OPM did not propose any changes to the ``group of
issuers'' definition, and we appreciate the comments received. It was
OPM's intention in the proposed rule to clarify that a group of issuers
may come together in the MSP Program either by common control and
ownership or by using a nationally licensed service mark. OPM
recognizes there are a number of ways to organize using a nationally
licensed service mark, and looks forward to working with current and
potential MSP issuers who decide to come together under either one of
these two options in the MSP Program.
Subpart B--Multi-State Plan Issuer Requirements
Phased Expansion, etc. (Sec. 800.104)
Section 1334(e) of the Affordable Care Act provides for OPM to
allow issuers to phase in their participation in the MSP Program. Under
Sec. 800.104(a), OPM requested comment on how we may expand
participation in the Program to meet the goal of increasing competition
while balancing consumers' needs. Specifically, we asked for comment on
the timeframes and other appropriate parameters within which an MSP
issuer could reasonably expand participation in the Program. We did not
propose any changes to the regulatory text for Sec. 800.104(a). In
clarifying the status of the Program and how we are implementing the
standards set under Sec. 800.104, we proposed to delete the standard
for an MSP issuer to submit a plan to become statewide in Sec.
800.104(b), and add a requirement that the MSP issuer service area for
MSP coverage shall be greater than or equal to any service area
proposed by the issuer for QHP coverage. Under Sec. 800.104(c), we
solicited comment on when MSP issuers should be required to participate
on a Small Business Health Options Program (SHOP). Based on the
comments received, the changes to Sec. 800.104(b) will be accepted as
proposed.
Comments: Some commenters commended OPM for clarifying Sec.
800.104(a) of the rule and promoting increased flexibility on standards
for coverage areas and geographic requirements, as it will attract
issuers to the Program and promote competition. Other commenters urged
OPM to encourage new and existing MSP issuers to offer plans that are
national in scope and coverage.
Response: Through our continued engagement with current and
potential MSP issuers, OPM has heard significant concerns about the
challenges of rapidly expanding MSP coverage both within and across
State lines. OPM agrees that increased flexibility around the schedule
to expand to each Exchange in every State will help the MSP Program
meet its goal of increasing competition while balancing consumers'
needs for coverage. OPM intends to ensure that MSP coverage is
available as expansively and as soon as practicable. We work closely
with current and potential MSP issuers to address any operational
challenges they may face in order to expand MSP coverage nationally or
establish reciprocity.
Comments: Some commenters expressed that any potential MSP issuers
should be held to the same standards as an MSP issuer who participated
in the Program during the first year of operations. These commenters
requested OPM set minimum threshold standards for participation, such
as timeframes for expanding coverage and minimum standards for coverage
areas.
Response: Since the first year of operations for the MSP Program,
OPM consistently has applied the same standards to all current and
potential MSP issuers, and we will continue to do so going forward. We
are not making any changes to the text at this time.
Comment: Commenters disagreed with OPM's interpretation of 1334(b)
and (e) stating that neither of the MSP issuers currently under
contract with OPM meets the statutory requirements to participate in
the Program.
Response: We respectfully disagree with the commenter. Section 1334
sets forth standards to guide the exercise of OPM's contracting
authority, noting that section 1334(b)(1) contemplates offering
coverage in every State and the District of Columbia, and outlines a
framework within which participation in the MSP Program is a feasible
and attractive business activity. Such standards include the provisions
under subsections (b) and (e) on offering coverage in every State.
Comments: Many commenters supported OPM's proposal to delete the
standard for an MSP issuer to submit a plan to become statewide and
instead negotiate directly with MSP issuers to expand coverage based on
business factors and consumers' needs. Commenters suggested that
requiring a specific plan to become statewide may discourage
participation in the Program, and flexibility on meeting geographic
coverage standards would encourage competition. These commenters also
commended OPM on efforts to evaluate MSP issuers' proposed service
areas to ensure they are established without discrimination. Other
commenters opposed the proposal and sought additional standards.
Response: OPM is committed to statewide coverage, but is sensitive
to requirements that may discourage participation in the Program or
does not serve the goal of promoting competition on the Exchanges. OPM
will assess consumers' needs for coverage, including ensuring that MSP
issuers' proposed service areas have been established without regard to
racial, ethnic, language, or health status-related factors listed in
section 2705(a) of the PHS Act, or other factors that exclude specific
high-utilizing, high-cost, or medically underserved populations.
[[Page 9651]]
Comments: Commenters opposed the proposed change to the regulatory
text to delete a plan for reaching statewide MSP coverage, stating that
OPM should establish minimum thresholds for expected MSP coverage areas
within a State. The commenter suggested OPM set a standard to require
coverage as broadly as the area in which the issuer is licensed to sell
coverage in a State, equal to any coverage offered as a Qualified
Health Plan (QHP), or alternatively, a percent of population or
geographic area. Similarly, other commenters recommended OPM require
coverage of 75% of the State's counties or other geographic area.
Response: OPM is committed to a goal of statewide coverage in the
MSP Program, and intends to continue working with current and potential
MSP issuers to develop productive and ambitious approaches to achieving
statewide coverage. OPM believes that our standard for an MSP issuer
who offers both MSP options and QHPs to provide an MSP service area
that is equal to or greater than the issuer's QHP service area is
adequate and reasonable to ensure broad MSP coverage. We appreciate the
specific examples of other minimum MSP standards for coverage areas. At
this time, we will finalize Sec. 800.104(b) as proposed maintaining
the standard of an MSP coverage area to be equal to or greater than the
coverage area proposed by the same issuer for their QHP service area.
Some commenters recommended OPM continue to implement SHOP
participation standards consistent with standards set by U.S.
Department of Health and Human Services (HHS) for a Federally-
facilitated SHOP or, where applicable, standards set by State-based
Exchanges for SHOP participation requirements that apply to QHP
issuers. Other comments suggested that the MSP Program is not mature
enough to require MSP issuers to participate in a SHOP at this time.
Response: In light of these comments, OPM intends to continue its
flexibility in SHOP participation for MSP issuers in Sec. 800.104(c).
MSP issuers must meet the same standards for SHOP participation set for
QHP issuers, including the requirements of 45 CFR 156.200(g) and any
standards for issuers participating on a State-based SHOP. An MSP
issuer may meet the requirements of 45 CFR 156.200(g)(3) if a State-
level issuer or any other issuer in the same issuer group affiliated
with an MSP issuer provides coverage on a Federally-facilitated SHOP.
We discussed this policy in-depth in the March 2013 final rule.\4\
---------------------------------------------------------------------------
\4\ March 11, 2013 Federal Register (78 FR 15560, 15565).
---------------------------------------------------------------------------
Benefits (Sec. 800.105)
In Sec. 800.105(b), OPM proposed a change that would allow an MSP
issuer to make essential health benefits (EHB)-benchmark selections on
a State-by-State basis. The issuer would also be able to offer two or
more MSP options in each State. For example, one option could use the
State-selected EHB-benchmark, and one could use the OPM-selected EHB-
benchmark. OPM proposed this change to allow for more flexibility to
attract issuers to the MSP Program with the expectation of expanding
competition on the Exchanges. This flexibility could facilitate
coalition building across issuers in different States, so that issuers
can work together toward MSP options that meet the MSP Program
standards.
In Sec. 800.105(c)(3), OPM proposed to clarify the policy on
formularies with an OPM-selected EHB-benchmark plan. Under the proposed
rule, OPM would allow the MSP issuer to manage formularies around the
needs of actual or anticipated enrollees. As part of this proposal, OPM
pointed to the current practice in the Federal Employees Health
Benefits (FEHB) Program of negotiating formularies and also considered
the option of substituting the formulary from the State-selected EHB-
benchmark plan. OPM noted that, even with this change, OPM would still
ensure compliance with any HHS standards related to drug formularies
for QHPs and assurance that the formularies are not discriminatory. OPM
also noted that this would allow MSP issuers to propose plans built
around the needs of enrollees, subject to approval by OPM.
In the renumbered Sec. 800.105(c)(4), OPM proposed a change to
apply a Federal definition of habilitative services and devices, should
HHS choose to define the term. In response to comments, in this final
rule OPM will revert back to the term we used in our final rule
published March 2013, ``habilitative services and devices,'' to ensure
consistency with the recently published HHS Notice of Benefit and
Payment Parameters for 2016.\5\
---------------------------------------------------------------------------
\5\ 45 CFR 156.115(a)(5).
---------------------------------------------------------------------------
In Sec. 800.105(d), OPM did not propose any change to the
regulation. However, the preamble noted that OPM also plans to review
an MSP issuer's package of benefits for discriminatory benefit design
and intends to work closely with States and HHS to identify and
investigate any potentially discriminatory or otherwise noncompliant
benefit designs in MSP options.
In Sec. 800.105(e), OPM proposed to change ``assume'' to
``defray'' to align with the language in section 1334(c)(2) of the
Affordable Care Act.
Comments: We received comments on the proposed changes to Sec.
800.105(b), which describes the EHB-benchmark policy, from a broad
range of stakeholders. Some comments opposing the change cited consumer
confusion while others raised concerns about an unlevel playing field
between MSP issuers and QHP issuers or administrative efficiency. In
contrast, other commenters supported the proposed changes, and
highlighted the opportunity to increase competition in the MSP Program
as well as additional choices for consumers. Commenters also
highlighted that the change would allow issuers the flexibility needed
to fulfill the goals of the Affordable Care Act.
Response: While we understand the concerns about adverse selection
and consumer confusion, we have not seen nor are we aware of any
compelling evidence that multiple EHB-benchmarks would cause these
issues.
With the opportunity to use substitutions as well as expand
benefits beyond the EHB-benchmark or EHB categories, there is already
variation among plans available to consumers.
Additionally, under the framework that applied in the first two
years of the Program, we were already reviewing MSP options using each
State's EHB-benchmark. Even if the OPM-selected EHB-benchmark plan was
not used in every State, there may be some administrative efficiency
gained in the overlap.
We note that these changes only allow an MSP issuer to propose
these types of packages. OPM still retains the authority to approve the
package of benefits in Sec. 800.105(d). OPM will scrutinize all
proposals for evidence of discriminatory benefit designs and other
issues of noncompliance. Keeping potential issues in mind, we are
finalizing the changes as proposed in order to increase opportunities
for competition in the MSP Program and create the potential for more
choices for consumers.
Comments: We also received comments that focused on the need to
maintain benefit standards and protections under any approach. These
comments highlighted potential issues or vulnerabilities in need of
consumer protection and identified key strategies for addressing them.
Response: We appreciate the feedback provided by these stakeholders
and will
[[Page 9652]]
take this information under consideration as it relates to our review
process. We are not making any further changes to Sec. 800.105(b), but
may use the comments to inform MSP Program operations or in drafting
Program guidance in the future.
Comments: We received comments on the proposed changes to Sec.
800.105(c)(3) to the formulary requirements with an OPM-selected EHB-
benchmark plan from a variety of stakeholders. Commenters were
generally supportive, interpreting the changes as OPM prioritizing the
review of formularies proposed by MSP issuers.
Other commenters raised concerns about consumer confusion and
potential misalignment of medical and drug benefits
Response: We appreciate the broad support from commenters on our
proposal as well as their acknowledgement that OPM is prioritizing
formulary review. While we understand concerns about the changes to the
formulary requirements, including negotiating a formulary or using the
formulary from the State-selected EHB-benchmark plan, we do not have
any compelling evidence that this would cause consumer confusion or
gaps in coverage between medical and drug benefits. OPM intends to use
any tools, including the USP category and class count framework,
created by HHS to analyze the formulary and inform our negotiations or
evaluation of the formulary from the State-selected EHB-benchmark plan.
Additionally, we intend to use our discretion in approval of a package
of benefits and during any negotiations to identify and remedy gaps
between medical and drug benefits. We appreciate the concerns that were
raised, but believe we can use the review process to mitigate them,
offering more flexibility and consumer choice.
Comments: Commenters asked to ensure that proposed formularies meet
the requirements of section 2713 of the PHS Act and are compliant with
other applicable standards. Other commenters that was supportive of the
change asked for a similar change to be applied to State-selected EHB-
benchmark plans.
Response: OPM has already identified in Sec. 800.102 the
requirement to comply with part A of title XXVII of the PHS Act and has
also identified in Sec. 800.105(d) that OPM approval of a proposed
package of benefits, including the formulary, will include a review
against standards set by HHS and OPM. For example, this would include
the USP category and class count framework and the use of a pharmacy
and therapeutics committee for formulary development as it applies to
QHP issuers. Based on the comments we received and our analysis, we are
finalizing Sec. 800.105(c)(3) with no changes.
Comments: We received comments on the proposed changes to apply a
Federal definition of habilitative services from a variety of
stakeholders. Some commenters supported the change. Others recommended
OPM modify and expand the definition proposed by HHS and requested OPM
address habilitative devices or make provisions for specific types of
services or devices. Commenters also asked for illustrative lists of
habilitative services. Finally, the comments requested that the Federal
definition be treated as a Federal floor.
Response: OPM is deferring to HHS on the substance and role of the
Federal definition. In keeping with the HHS Notice of Benefit and
Payment Parameters for 2016, we are now using the term ``habilitative
services and devices'' in order to remain consistent and address the
concerns raised by several commenters. We defer to HHS in determining
the standards applicable under its definition of habilitative services
and devices. It is not OPM's intention to allow the MSP issuer to
choose between State and Federal definitions if both exist for a given
State. In the finalized version of Sec. 800.105(c)(4), OPM is taking
the opportunity to add clarity to the paragraph in explaining when a
State definition of habilitative services and devices applies and when
a Federal definition applies. In the final Sec. 800.105(c)(4), the
Federal definition is set as the floor, consistent with the HHS Notice
of Benefit and Payment Parameters for 2016. The State retains the
flexibility to apply standards or a definition that does not conflict
with the Federal definition. Finally, we continue to reserve authority
for OPM to define habilitative services and devices for an OPM-selected
EHB-benchmark plan absent a State or Federal definition.
Comments: We received comments on the issue of non-discrimination
and OPM's review of MSP options as it relates to Sec. 800.105(d).
Commenters generally supported the proposal and asked for OPM to
identify examples of discriminatory benefit designs, and one asked OPM
to set specific standards for review in the regulation.
Response: OPM identified the requirement to comply with Federal law
in Sec. 800.102 and also identified related HHS standards against
which MSP issuers and MSP options will be evaluated in Sec.
800.105(d). At this time, we believe we have the authority necessary to
apply and modify standards for non-discrimination, updating and
adapting our review as we continue to learn about discriminatory
benefit designs. In practice, we will align our review for non-
discriminatory benefit designs with HHS.
We did not receive any comments on the proposed change to Sec.
800.105(e). Therefore, we are adopting the proposed Sec. 800.105(e) as
final.
In Sec. 800.105(c)(1), we are removing the reference to (c)(4) and
replacing it with a reference to (c)(5) in Sec. 800.105(c)(1) to
correct an internal cross reference.
Assessments and User Fees (Sec. 800.108)
OPM has authority to collect MSP Program user fees, and continues
to preserve its discretion to collect an MSP Program user fee. In the
proposed rule, we clarified that OPM may begin collecting the fee as
early as plan year 2015. OPM intends to use the MSP assessment or user
fee to fund OPM's functions for administration of the Program,
including but not limited to entering into contracts with, certifying,
recertifying, decertifying, overseeing MSP options and MSP issuers for
that plan year, and audits and investigations performed by OPM's Office
of Inspector General related to the MSP Program. In the Federally-
facilitated Exchanges, OPM is coordinating with HHS regarding the
collection of user fees, so that issuers would not be affected
operationally. We proposed to revise the regulatory text to allow for
flexibility in the process for collecting MSP Program assessments or
user fees. We also solicited comments on the process for collecting
user fees in the State-based Exchanges and the general use of any fees
collected by OPM.
Comments: Some commenters were opposed to the imposition of user
fees in State-based Exchanges citing operational challenges in
collecting fees.
Response: We have considered the comments received and agree that
operational complexities for collecting any user fee from MSP issuers
on State-based Exchanges exist. We will not be collecting or imposing
user fees on MSP issuers operating on State-based Exchanges in plan
year 2016. Therefore, the changes to Sec. 800.108 will be accepted as
proposed.
Network Adequacy (Sec. 800.109)
In Sec. 800.109(b), OPM proposed to codify the requirement that
MSP issuers must comply with any additional provider directory
standards that may be set by HHS.
Comments: Commenters generally supported the proposed change,
noting that incorporating HHS standards for
[[Page 9653]]
provider directories would improve the quality of information consumers
receive. Some commenters suggested OPM defer to State requirements
where they exist.
Response: It has been OPM's intention that an MSP issuer comply
with appropriate Federal, and where applicable, State requirements for
provider directories. OPM did not intend for the proposed changes to
Sec. 800.109(b) to alter that framework. After further consideration
of the proposed change to subsection (b), we decided that the proposed
language is unnecessary. We are, therefore, removing the proposed
addition to subsection (b) from the regulatory text. Again, we intend
for MSP issuers to comply with any additional regulations promulgated
by HHS for QHP issuers, and where applicable, State requirements for
provider directories.
Accreditation (Sec. 800.111)
In the proposed rule, we proposed to revise the reference to the
specific section in the Code of Federal Regulations to 45 CFR
156.275(a)(1) to be more precise. We received no comments on this
proposed change, and are finalizing the text as proposed.
Level Playing Field (Sec. 800.115)
In Sec. 800.115, we proposed to revise the regulatory text to
clarify that all areas listed under section 1324(b) of the Affordable
Care Act are subject to Sec. 800.114. In addition, we made a technical
correction to Sec. 800.115(l) to change a reference to 45 CFR part 162
to 45 CFR part 164. We received no comments on these changes and are
finalizing as proposed.
Subpart D--Application and Contracting Procedures
In subpart D of 45 CFR part 800, OPM set forth procedures for
processing and evaluating applications from issuers seeking
participation in the MSP Program. Subpart D also establishes processes
pertaining to executing contracts to offer MSP coverage. In particular,
this subpart includes sections that address an application process,
review of applications, MSP Program contracting, term of a contract,
contract renewal process, and nonrenewal. OPM did not receive any
comments pertaining to this subpart, except for Sec. 800.301. We are
finalizing Subpart D as proposed.
Application Process (Sec. 800.301)
In Sec. 800.301, OPM proposed a technical correction that it would
consider annual applications from health insurance issuers to
participate in the MSP Program. We also specified that an existing MSP
issuer could submit a renewal application to OPM annually. This
correction is intended to clarify the distinction between new and
renewal applications.
Comment: Commenters recommended that renewal applicants should be
required to complete a full (not streamlined) application.
Response: Renewal applications require comprehensive and detailed
responses to adequately inform OPM about whether to renew its contract
with the issuer. OPM has, and will continue to use its experience in
the FEHB Program to inform and guide its contracting process with MSP
issuers to the extent such experience is applicable to the individual
and small group markets within which the MSP Program operates. We are
finalizing our proposal.
Subpart E--Compliance
In subpart E of 45 CFR part 800, OPM set forth standards and
requirements with which MSP issuers must comply. This subpart also
contains a non-exhaustive list of actions OPM may utilize in instances
of non-compliance and the process by which OPM may reconsider any
compliance actions we decide to take. In particular, this subpart
includes sections regarding contract performance, contract quality
assurance, fraud and abuse, compliance actions, and reconsideration of
compliance actions. OPM did not receive any comments pertaining to this
subpart, except for Sec. 800.404. We are finalizing Subpart E as
proposed.
Compliance Actions (Sec. 800.404)
In Sec. 800.404(a)(4), OPM proposed to clarify that we may
initiate a compliance action against an MSP issuer for violations of
applicable law or the terms of its contract pursuant to OPM's authority
under Sec. Sec. 800.102 and 800.114. In Sec. 800.404(b)(2), OPM
clarified that compliance actions may include withdrawal of
certification of an MSP option or options. We also added nonrenewal of
participation as a compliance action in order to be consistent with the
new paragraph under Sec. 800.306(a)(2). In Sec. 800.404(d), OPM
clarified that requirements pertaining to notices to enrollees are
triggered when one of the following occurs: The MSP Program contract is
terminated, OPM withdraws certification of an MSP option, or if a
State-level issuer's participation is not renewed.
Comment: Commenters suggested that OPM should establish a Federal
standard to ensure a seamless transition for enrollees when a plan is
terminated or an enrollee is transferred to another issuer and enrolled
in a new plan.
Response: To the extent that the MSP issuer is providing health
insurance coverage in a Federally-facilitated Exchange, Federal
requirements regarding notice to enrollees must be followed. MSP
coverage offered in a State-based Exchange must meet the requirements
of that specific State or Exchange to the extent there is no conflict
with Federal law. This delineation is consistent with the approach for
applicable requirements across the MSP Program. Therefore, we are
adopting this section as final, with no changes.
Subpart G--Miscellaneous
In subpart G of 45 CFR part 800, OPM set forth requirements
pertaining to coverage and disclosure of non-excepted abortion services
and data-sharing with State entities.
Consumer Choice With Respect to Certain Services (Sec. 800.602)
We proposed adding a new paragraph (c) to Sec. 800.602 that would
require an MSP issuer to provide notice of coverage or exclusion of
non-excepted abortion services in an MSP option. Under our proposal, an
MSP issuer must disclose to consumers prior to enrollment the exclusion
of non-excepted abortion services in a State where coverage of such
abortion services is permitted by State law. We also proposed that if
an MSP issuer provides an MSP option that covers non-excepted abortion
services, in addition to an MSP option that excludes coverage, notice
of coverage would also need to be provided to consumers prior to
enrollment. Finally, OPM reserved the authority to review and approve
these MSP notices and materials. OPM requested comments on the form and
manner of these disclosures.
Comments: In general, commenters supported the proposed notice
requirements. However, commenters expressed concern that consumers
would receive notice that an MSP option excludes coverage of non-
excepted abortion services only if the MSP option is offered in a State
that permits coverage of non-excepted abortion services. Commenters
argued that consumers may not know if their State permits coverage of
non-excepted abortion services.
Response: We agree that it is in the best interests of consumers
for an MSP issuer to provide notice if an MSP option excludes non-
excepted abortion services from coverage in every State, not just the
States that would permit coverage of such services. We have
[[Page 9654]]
amended the regulatory text to reflect this change.
Comments: Commenters also generally supported our proposal that an
MSP issuer who offers an MSP option with coverage of non-excepted
abortion services must provide notice of coverage of such services to
consumers. We proposed that MSP issuers must provide this notice of
coverage in a manner consistent with 45 CFR 147.200(a)(3) to meet the
requirements of 45 CFR 156.280(f). Commenters offered a variety of
suggestions on the form and manner of notices of coverage of non-
excepted abortion services.
Response: We believe adding the disclosure and notice requirements
will assist consumers in making informed decisions about their coverage
options. Consumers should have accurate information on an MSP option's
covered benefits, exclusions, and limitations. Therefore, we are
finalizing this section as proposed, with changes to improve
readability and clarity.
Disclosure of Information (Sec. 800.603)
OPM proposed this new section to clarify that OPM may use its
discretion and authority to disclose information to State entities,
including State Departments of Insurance and Exchanges, in order to
keep such entities informed about the MSP Program and its issuers.
Comments: Commenters expressed concern that the language in the new
section gives OPM but not States discretion to withhold information.
Others supported the language in the new section, indicating that it
will assist States in being better primary regulators.
Response: This section has been added to the rule to make it easier
for States to obtain information from OPM on the MSP Program. This
provision does not address disclosure of information from States to
OPM, and therefore, this provision does not dictate information that a
State may or may not withhold from OPM. We are finalizing this section
as proposed.
Executive Orders 13563 and 12866; Regulatory Review
OPM has examined the impact of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993) and Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011). Executive Orders 12866 and 13563 direct
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). A regulatory impact analysis must be prepared for major
rules with economically significant effects ($100 million or more in
any 1 year adjusted for inflation). Section 3(f) of Executive Order
12866 defines a ``significant regulatory action'' as an action that is
likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more in
any one year or adversely affect in a material way a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal government or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
Executive Order 12866.
OPM will continue to generally operate the MSP Program as it
previously had in plan year 2014. The regulatory changes in this final
rule are for purposes of policy clarification, and any changes will
have minimal impact on the administration of the Program.
Administrative costs of the rule are generated both within OPM and by
issuers offering MSP options. The costs that MSP issuers may incur are
the same as those of QHPs, and as stated in 45 CFR part 156, will
include: Accreditation, network adequacy standards, and quality
reporting. The costs associated with MSP certification offset the costs
that issuers would face were they to be certified by the State, or HHS
on behalf of the State, to offer QHPs through the Exchange. For the
2014 plan year, there are approximately 371,000 consumers enrolled in
MSP options and with an estimated average monthly premium of $350,
premiums collected by MSP issuers for consumers enrolled in MSP options
are approximately $1.4 billion this year. While the overall regulation
and Program have a significant economic impact, this final rule
provides for no substantial changes to the Program and is not
economically significant.
We received one comment suggesting that the proposed rule could
potentially have an economic impact of $100 million or more per year.
The commenter recommended OPM perform a full regulatory impact
analysis.
Based on the analysis presented in our proposed rule and
acknowledged above, the economic impact of this rule is not expected to
exceed the $100 million threshold.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 \6\ requires that the U.S.
Office of Management and Budget (OMB) approve all collections of
information by a Federal agency from the public before they can be
implemented. Respondents are not required to respond to any collection
of information unless it displays a current valid OMB control number.
OPM is not requiring any additional collections from MSP issuers or
applicants seeking to become MSP issuers in this final rule. OPM
continues to expect fewer than ten responsible entities to respond to
all of the collections noted above. For that reason alone, the existing
collections are exempt from the Paperwork Reduction Act.\7\
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\6\ 44 U.S.C. chapter 35; see 5 CFR part 1320.
\7\ 44 U.S.C. 3502(3)(A)(i).
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Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) \8\ requires agencies to
prepare an initial regulatory flexibility analysis to describe the
impact of a rule on small entities, unless the head of the agency can
certify that the rule would not have a significant economic impact on a
substantial number of small entities. The RFA generally defines a
``small entity'' as--(1) A proprietary firm meeting the size standards
of the Small Business Administration (SBA); (2) a not-for-profit
organization that is not dominant in its field; or (3) a small
government jurisdiction with a population of less than 50,000. States
and individuals are not included in the definition of ``small entity.''
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\8\ 5 U.S.C. 601 et seq.
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The RFA requires agencies to analyze options for regulatory relief
of small businesses, if a proposed rule has a significant impact on a
substantial number of small entities. For purposes of the RFA, small
entities include small businesses, small non-profit organizations, and
small government jurisdictions. Small businesses are those with sizes
below thresholds established by the SBA. With respect to most health
insurers, the SBA size standard is $38.5 million in annual receipts.\9\
Issuers
[[Page 9655]]
could possibly be classified in 621491 (HMO Medical Centers) and, if
this is the case, the SBA size standard would be $32.5 million or less.
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\9\ According to the SBA size standards, entities with average
annual receipts of $38.5 million or less would be considered small
entities for North American Industry Classification System (NAICS)
Code 524114 (Direct Health and Medical Insurance Carriers) (for more
information, see ``Table of Size Standards Matched To North American
Industry Classification System Codes,'' effective July 14, 2014,
U.S. Small Business Administration, available at https://www.sba.gov).
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OPM does not think that small businesses with annual receipts less
than $38.5 million would likely have sufficient economies of scale to
become MSP issuers or be part of a group of MSP issuers. Similarly,
while the Director must enter into an MSP Program contract with at
least one non-profit entity, OPM does not think that small non-profit
organizations would likely have sufficient economies of scale to become
MSP issuers or be part of a group of MSP issuers. OPM does not think
that this final rule would have a significant economic impact on a
substantial number of small businesses with annual receipts less than
$38.5 million, because there are only a few health insurance issuers
that could be considered small businesses. Moreover, while the Director
must enter into an MSP contract with at least one non-profit entity,
OPM does not think that this final rule would have a significant
economic impact on a substantial number of small non-profit
organizations, because few health insurance issuers are small non-
profit organizations.
OPM incorporates by reference previous analysis by HHS, which
provides some insight into the number of health insurance issuers that
could be small entities. Based on HHS data from Medical Loss Ratio
(MLR) annual report submissions for the 2013 MLR reporting year,
approximately 141 out of 500 issuers of health insurance coverage
nationwide had total premium revenues of $38.5 million or less.\10\ HHS
estimates this data may overstate the actual number of small health
insurance companies, since 77 percent of these small companies belong
to larger holding groups, and many if not all of these small companies
are likely to have non-health lines of business that would result in
their revenues exceeding $38.5 million. OPM concurs with this HHS
analysis, and, thus, does not think that this final rule would have a
significant economic impact on a substantial number of small entities.
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\10\ 79 FR 70747.
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Based on the foregoing, OPM is not preparing an analysis for the
RFA because OPM has determined, and the Director certifies, that this
final rule would not have a significant economic impact on a
substantial number of small entities.
Unfunded Mandates
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) \11\
requires that agencies assess anticipated costs and benefits, and take
certain other actions before issuing a final rule that includes any
Federal mandate that may result in expenditures in any one year by a
State, local, or tribal governments, in the aggregate, or by the
private sector, of $100 million in 1995 dollars, updated annually for
inflation. In 2015, that threshold is approximately $154 million. UMRA
does not address the total cost of a rule. Rather, it focuses on
certain categories of costs, mainly those ``Federal mandate'' costs
resulting from: (1) Imposing enforceable duties on State, local, or
tribal governments, or on the private sector; or (2) increasing the
stringency of conditions in, or decreasing the funding of, State,
local, or tribal governments under entitlement programs.
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\11\ Public Law 104-4.
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This final rule does not place any Federal mandates on State,
local, or Tribal governments, or on the private sector. This final rule
would modify the MSP Program, a voluntary Federal program that provides
health insurance issuers the opportunity to contract with OPM to offer
MSP options on the Exchanges. Section 3 of UMRA excludes from the
definition of ``Federal mandate'' duties that arise from participation
in a voluntary Federal program. Accordingly, no analysis under UMRA is
required.
Federalism
Executive Order 13132 outlines fundamental principles of
federalism, and requires the adherence to specific criteria by Federal
agencies in the process of their formulation and implementation of
policies that have ``substantial direct effects'' on the States, the
relationship between the national government and States, or on the
distribution of power and responsibilities among the various levels of
government. Federal agencies promulgating regulations that have these
federalism implications must consult with State and local officials,
and describe the extent of their consultation and the nature of the
concerns of State and local officials in the preamble to the
regulation.
This final rule has federalism implications because it has direct
effects on the States, the relationship between the national government
and States, or on the distribution of power and responsibilities among
various levels of government. However, these sections of the regulation
were not modified.
In compliance with the requirement of Executive Order 13132 that
agencies examine closely any policies that may have federalism
implications or limit the policy making discretion of the States, OPM
has engaged in efforts to consult with and work cooperatively with
affected State and local officials, including attending meetings of the
NAIC and consulting with State insurance officials on an individual
basis. It is expected OPM will continue to act in a similar fashion in
enforcing the Affordable Care Act requirements. Throughout the process
of administering the MSP Program and developing this final regulation,
OPM has attempted to balance the States' interests in regulating health
insurance issuers, and the statutory requirement to provide two MSP
options in all Exchanges in the each States and the District of
Columbia. By doing so, it is OPM's view that it has complied with the
requirements of Executive Order 13132.
Pursuant to the requirements set forth in section 8(a) of Executive
Order 13132, and by the signature affixed to this final regulation, OPM
certifies that it has complied with the requirements of Executive Order
13132 for the attached regulation in a meaningful and timely manner.
Congressional Review Act
This final rule is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.), which specifies that before a rule can
take effect, the Federal agency promulgating the rule must submit to
each House of Congress and to the Comptroller General a report
containing a copy of the rule along with other specified information.
In accordance with this requirement, OPM has transmitted this rule to
Congress and the Comptroller General for review.
List of Subjects in 5 CFR Part 800
Administrative practice and procedure, Health care, Health
insurance, Reporting and recordkeeping requirements.
Office of Personnel Management.
Katherine Archuleta,
Director.
Accordingly, the U.S. Office of Personnel Management is
republishing part 800 to title 45, Code of Federal Regulations, as
follows:
[[Page 9656]]
PART 800--MULTI-STATE PLAN PROGRAM
Subpart A--General Provisions and Definitions
Sec.
800.10 Basis and scope.
800.20 Definitions.
Subpart B--Multi-State Plan Program Issuer Requirements
800.101 General requirements.
800.102 Compliance with Federal law.
800.103 Authority to contract with issuers.
800.104 Phased expansion, etc.
800.105 Benefits.
800.106 Cost-sharing limits, advance payments of premium tax
credits, and cost-sharing reductions.
800.107 Levels of coverage.
800.108 Assessments and user fees.
800.109 Network adequacy.
800.110 Service area.
800.111 Accreditation requirement.
800.112 Reporting requirements.
800.113 Benefit plan material or information.
800.114 Compliance with applicable State law.
800.115 Level playing field.
800.116 Process for dispute resolution.
Subpart C--Premiums Rating Factors, Medical Loss Ratios, and Risk
Adjustment
800.201 General requirements.
800.202 Rating factors.
800.203 Medical loss ratio.
800.204 Reinsurance, risk corridors, and risk adjustment.
Subpart D--Application and Contracting Procedures
800.301 Application process.
800.302 Review of applications.
800.303 MSP Program contracting.
800.304 Term of the contract.
800.305 Contract renewal process.
800.306 Nonrenewal.
Subpart E--Compliance
800.401 Contract performance.
800.402 Contract quality assurance.
800.403 Fraud and abuse.
800.404 Compliance actions.
800.405 Reconsideration of compliance actions.
Subpart F--Appeals by Enrollees of Denials of Claims for Payment or
Service
800.501 General requirements.
800.502 MSP issuer internal claims and appeals.
800.503 External review.
800.504 Judicial review.
Subpart G--Miscellaneous
800.601 Reservation of authority.
800.602 Consumer choice with respect to certain services.
800.603 Disclosure of information.
Authority: Sec. 1334 of Pub. L. 111-148, 124 Stat. 119; Pub. L.
111-152, 124 Stat. 1029 (42 U.S.C. 18054).
Subpart A--General Provisions and Definitions
Sec. 800.10 Basis and scope.
(a) Basis. This part is based on the following sections of title I
of the Affordable Care Act:
(1) 1001. Amendments to the Public Health Service Act.
(2) 1302. Essential Health Benefits Requirements.
(3) 1311. Affordable Choices of Health Benefit Plans.
(4) 1324. Level Playing Field.
(5) 1334. Multi-State Plans.
(6) 1341. Transitional Reinsurance Program for Individual Market in
Each State.
(7) 1342. Establishment of Risk Corridors for Plans in Individual
and Small Group Markets.
(8) 1343. Risk Adjustment.
(b) Scope. This part establishes standards for health insurance
issuers to contract with the United States Office of Personnel
Management (OPM) to offer Multi-State Plan (MSP) options to provide
health insurance coverage on Exchanges for each State. It also
establishes standards for appeal of a decision by OPM affecting the
issuer's participation in the MSP Program and standards for an enrollee
in an MSP option to appeal denials of payment or services by an MSP
issuer.
Sec. 800.20 Definitions.
For purposes of this part:
Actuarial value (AV) has the meaning given that term in 45 CFR
156.20.
Affordable Care Act means the Patient Protection and Affordable
Care Act (Pub. L. 111-148), as amended by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152).
Applicant means an issuer or group of issuers that has submitted an
application to OPM to be considered for participation in the Multi-
State Plan Program.
Benefit plan material or information means explanations or
descriptions, whether printed or electronic, that describe a health
insurance issuer's products. The term does not include a policy or
contract for health insurance coverage.
Cost sharing has the meaning given that term in 45 CFR 155.20.
Director means the Director of the United States Office of
Personnel Management.
EHB-benchmark plan has the meaning given that term in 45 CFR
156.20.
Exchange means a governmental agency or non-profit entity that
meets the applicable requirements of 45 CFR part 155 and makes
qualified health plans (QHPs) and MSP options available to qualified
individuals and qualified employers. Unless otherwise identified, this
term refers to State Exchanges, regional Exchanges, subsidiary
Exchanges, and a Federally-facilitated Exchange.
Federal Employees Health Benefits Program or FEHB Program means the
health benefits program administered by the United States Office of
Personnel Management pursuant to chapter 89 of title 5, United States
Code.
Group of issuers means:
(1) A group of health insurance issuers that are affiliated either
by common ownership and control or by common use of a nationally
licensed service mark (as defined in this section); or
(2) An affiliation of health insurance issuers and an entity that
is not an issuer but that owns a nationally licensed service mark (as
defined in this section).
Health insurance coverage means benefits consisting of medical care
(provided directly, through insurance or reimbursement, or otherwise)
under any hospital or medical service policy or certificate, hospital
or medical service plan contract, or health maintenance organization
contract offered by a health insurance issuer. Health insurance
coverage includes group health insurance coverage, individual health
insurance coverage, and short-term, limited duration insurance.
Health insurance issuer or issuer means an insurance company,
insurance service, or insurance organization (including a health
maintenance organization) that is required to be licensed to engage in
the business of insurance in a State and that is subject to State law
that regulates insurance (within the meaning of section 514(b)(2) of
the Employee Retirement Income Security Act (ERISA)). This term does
not include a group health plan as defined in 45 CFR 146.145(a).
HHS means the United States Department of Health and Human
Services.
Level of coverage means one of four standardized actuarial values
of plan coverage as defined by section 1302(d)(1) of the Affordable
Care Act.
Licensure means the authorization obtained from the appropriate
State official or regulatory authority to offer health insurance
coverage in the State.
Multi-State Plan Program issuer or MSP issuer means a health
insurance issuer or group of issuers (as defined in this section) that
has a contract with OPM to offer health plans pursuant to section 1334
of the Affordable Care Act and meets the requirements of this part.
[[Page 9657]]
Multi-State Plan option or MSP option means a discrete pairing of a
package of benefits with particular cost sharing (which does not
include premium rates or premium rate quotes) that is offered pursuant
to a contract with OPM pursuant to section 1334 of the Affordable Care
Act and meets the requirements of 45 CFR part 800.
Multi-State Plan Program or MSP Program means the program
administered by OPM pursuant to section 1334 of the Affordable Care
Act.
Nationally licensed service mark means a word, name, symbol, or
device, or any combination thereof, that an issuer or group of issuers
uses consistently nationwide to identify itself.
Non-profit entity means:
(1) An organization that is incorporated under State law as a non-
profit entity and licensed under State law as a health insurance
issuer; or
(2) A group of health insurance issuers licensed under State law, a
substantial portion of which are incorporated under State law as non-
profit entities.
OPM means the United States Office of Personnel Management.
Percentage of total allowed cost of benefits has the meaning given
that term in 45 CFR 156.20.
Plan year means a consecutive 12-month period during which a health
plan provides coverage for health benefits. A plan year may be a
calendar year or otherwise.
Prompt payment means a requirement imposed on a health insurance
issuer to pay a provider or enrollee for a claimed benefit or service
within a defined time period, including the penalty or consequence
imposed on the issuer for failure to meet the requirement.
Qualified Health Plan or QHP means a health plan that has in effect
a certification that it meets the standards described in subpart C of
45 CFR part 156 issued or recognized by each Exchange through which
such plan is offered pursuant to the process described in subpart K of
45 CFR part 155.
Rating means the process, including rating factors, numbers,
formulas, methodologies, and actuarial assumptions, used to set
premiums for a health plan.
Secretary means the Secretary of the Department of Health and Human
Services.
SHOP means a Small Business Health Options Program operated by an
Exchange through which a qualified employer can provide its employees
and their dependents with access to one or more qualified health plans
(QHPs).
Silver plan variation has the meaning given that term in 45 CFR
156.400.
Small employer means, in connection with a group health plan with
respect to a calendar year and a plan year, an employer who employed an
average of at least one but not more than 100 employees on business
days during the preceding calendar year and who employs at least one
employee on the first day of the plan year. In the case of plan years
beginning before January 1, 2016, a State may elect to define small
employer by substituting ``50 employees'' for ``100 employees.''
Standard plan has the meaning given that term in 45 CFR 156.400.
State Insurance Commissioner means the commissioner or other chief
insurance regulatory official of a State.
State means each of the 50 States or the District of Columbia.
State-level issuer means a health insurance issuer designated by
the Multi-State Plan (MSP) issuer to offer an MSP option or MSP
options. The State-level issuer may offer health insurance coverage
through an MSP option in all or part of one or more States.
Subpart B--Multi-State Plan Program Issuer Requirements
Sec. 800.101 General requirements.
An MSP issuer must:
(a) Licensed. Be licensed as a health insurance issuer in each
State where it offers health insurance coverage;
(b) Contract with OPM. Have a contract with OPM pursuant to this
part;
(c) Required levels of coverage. Offer levels of coverage as
required by Sec. 800.107 of this part;
(d) Eligibility and enrollment. MSP options and MSP issuers must
meet the same requirements for eligibility, enrollment, and termination
of coverage as those that apply to QHPs and QHP issuers pursuant to 45
CFR part 155, subparts D, E, and H, and 45 CFR 156.250, 156.260,
156.265, 156.270, and 156.285;
(e) Applicable to each MSP issuer. Ensure that each of its MSP
options meets the requirements of this part;
(f) Compliance. Comply with all standards set forth in this part;
(g) OPM direction and other legal requirements. Timely comply with
OPM instructions and directions and with other applicable law; and
(h) Other requirements. Meet such other requirements as determined
appropriate by OPM, in consultation with HHS, pursuant to section
1334(b)(4) of the Affordable Care Act.
(i) Non-discrimination. MSP options and MSP issuers must comply
with applicable Federal and State non-discrimination laws, including
the standards set forth in 45 CFR 156.125 and 156.200(e).
Sec. 800.102 Compliance with Federal law.
(a) Public Health Service Act. As a condition of participation in
the MSP Program, an MSP issuer must comply with applicable provisions
of part A of title XXVII of the PHS Act. Compliance shall be determined
by the Director.
(b) Affordable Care Act. As a condition of participation in the MSP
Program, an MSP issuer must comply with applicable provisions of title
I of the Affordable Care Act. Compliance shall be determined by the
Director.
Sec. 800.103 Authority to contract with issuers.
(a) General. OPM may enter into contracts with health insurance
issuers to offer at least two MSP options on Exchanges and SHOPs in
each State, without regard to any statutes that would otherwise require
competitive bidding.
(b) Non-profit entity. In entering into contracts with health
insurance issuers to offer MSP options, OPM will enter into a contract
with at least one non-profit entity as defined in Sec. 800.20 of this
part.
(c) Group of issuers. Any contract to offer MSP options may be with
a group of issuers as defined in Sec. 800.20 of this part.
(d) Individual and group coverage. The contracts will provide for
individual health insurance coverage and for group health insurance
coverage for small employers.
Sec. 800.104 Phased expansion, etc.
(a) Phase-in. OPM may enter into a contract with a health insurance
issuer to offer MSP options if the health insurance issuer agrees that:
(1) With respect to the first year for which the health insurance
issuer offers MSP options, the health insurance issuer will offer MSP
options in at least 60 percent of the States;
(2) With respect to the second such year, the health insurance
issuer will offer the MSP options in at least 70 percent of the States;
(3) With respect to the third such year, the health insurance
issuer will offer the MSP options in at least 85 percent of the States;
and
(4) With respect to each subsequent year, the health insurance
issuer will offer the MSP options in all States.
(b) Partial coverage within a State. (1) OPM may enter into a
contract with an MSP issuer even if the MSP issuer's MSP options for a
State cover fewer than all the service areas specified for
[[Page 9658]]
that State pursuant to Sec. 800.110 of this part.
(2) If an issuer offers both an MSP option and QHP on the same
Exchange, an MSP issuer must offer MSP coverage in a service area or
areas that is equal to the greater of:
(i) The QHP service area defined by the issuer or,
(ii) The service area specified for that State pursuant to Sec.
800.110 of this part covered by the issuer's QHP.
(c) Participation in SHOPs. (1) An MSP issuer's participation in a
Federally-facilitated SHOP must be consistent with the requirements for
QHP issuers specified in 45 CFR 156.200(g).
(2) An MSP issuer must comply with State standards governing
participation in a State-based SHOP, consistent with Sec. 800.114. For
these State-based SHOP standards, OPM retains discretion to allow an
MSP issuer to phase-in SHOP participation in States pursuant to section
1334(e) of the Affordable Care Act.
(d) Licensed where offered. OPM may enter into a contract with an
MSP issuer who is not licensed in every State, provided that the issuer
is licensed in every State where it offers MSP coverage through any
Exchanges in that State and demonstrates to OPM that it is making a
good faith effort to become licensed in every State consistent with the
timeframe in paragraph (a) of this section.
Sec. 800.105 Benefits.
(a) Package of benefits. (1) An MSP issuer must offer a package of
benefits that includes the essential health benefits (EHB) described in
section 1302 of the Affordable Care Act for each MSP option within a
State.
(2) The package of benefits referred to in paragraph (a)(1) of this
section must comply with section 1302 of the Affordable Care Act, as
well as any applicable standards set by OPM and any applicable
standards set by HHS.
(b) Package of benefits options. (1) An MSP issuer must offer at
least one uniform package of benefits in each State that is
substantially equal to:
(i) The EHB-benchmark plan in each State in which it operates; or
(ii) Any EHB-benchmark plan selected by OPM under paragraph (c) of
this section.
(2) An issuer applying to participate in the MSP Program may select
either or both of the package of benefits options described in
paragraph (b)(1) of this section in its application. In each State, the
issuer may choose one EHB-benchmark for each product it offers.
(3) An MSP issuer must comply with any State standards relating to
substitution of benchmark benefits or standard benefit designs.
(c) OPM selection of benchmark plans. (1) The OPM-selected EHB-
benchmark plans are the three largest Federal Employees Health Benefits
(FEHB) Program plan options, as identified by HHS pursuant to section
1302(b) of the Affordable Care Act, and as supplemented pursuant to
paragraphs (c)(2) through (5) of this section.
(2) Any EHB-benchmark plan selected by OPM under paragraph (c)(1)
lacking coverage of pediatric oral services or pediatric vision
services must be supplemented by the addition of the entire category of
benefits from the largest Federal Employee Dental and Vision Insurance
Program (FEDVIP) dental or vision plan options, respectively, pursuant
to 45 CFR 156.110(b) and section 1302(b) of the Affordable Care Act.
(3) In all States where an MSP issuer uses the OPM-selected EHB-
benchmark plan, the MSP issuer may manage formularies around the needs
of anticipated or actual users, subject to approval by OPM.
(4) An MSP issuer must follow the definition of habilitative
services and devices as follows:
(i) An MSP issuer must follow the Federal definitions where HHS
specifically defines habilitative services and devices if the State
does not define the term, if the State defines the term in a
conflicting way, or if the State definition is less stringent than the
Federal definition.
(ii) An MSP issuer must follow State definitions where the State
specifically defines the habilitative services and devices category
pursuant to 45 CFR 156.110(f) and the State definition is not in
conflict with the Federal definition or goes above the standards set in
the Federal definition.
(iii) In the case of any State that does not define this category
and absent a clearly applicable Federal definition, if any OPM-selected
EHB-benchmark plan lacks coverage of habilitative services and devices,
OPM may determine what habilitative services and devices are to be
included in that EHB-benchmark plan.
(5) Any EHB-benchmark plan selected by OPM under paragraph (c)(1)
of this section must include, for each State, any State-required
benefits enacted before December 31, 2011, that are included in the
State's EHB-benchmark plan as described in paragraph (b)(1)(i) of this
section, or specific to the market in which the plan is offered.
(d) OPM approval. An MSP issuer's package of benefits, including
its formulary, must be submitted for approval by OPM, which will review
a package of benefits proposed by an MSP issuer and determine if it is
substantially equal to an EHB-benchmark plan described in paragraph
(b)(1) of this section, pursuant to standards set forth by OPM and any
applicable standards set forth by HHS, including 45 CFR 156.115,
156.122, and 156.125.
(e) State payments for additional State-required benefits. If a
State requires that benefits in addition to the benchmark package be
offered to MSP enrollees in that State, then pursuant to section
1334(c)(2) of the Affordable Care Act, the State must defray the cost
of such additional benefits by making payments either to the enrollee
or to the MSP issuer on behalf of the enrollee.
Sec. 800.106 Cost-sharing limits, advance payments of premium tax
credits, and cost-sharing reductions.
(a) Cost-sharing limits. For each MSP option it offers, an MSP
issuer must ensure that the cost-sharing provisions of the MSP option
comply with section 1302(c) of the Affordable Care Act, as well as any
applicable standards set by OPM or HHS.
(b) Advance payments of premium tax credits and cost-sharing
reductions. For each MSP option it offers, an MSP issuer must ensure
that an eligible individual receives the benefit of advance payments of
premium tax credits under section 36B of the Internal Revenue Code and
the cost-sharing reductions under section 1402 of the Affordable Care
Act. An MSP issuer must also comply with any applicable standards set
by OPM or HHS.
Sec. 800.107 Levels of coverage.
(a) Silver and gold levels of coverage required. An MSP issuer must
offer at least one MSP option at the silver level of coverage and at
least one MSP option at the gold level of coverage on each Exchange in
which the issuer is certified to offer an MSP option pursuant to a
contract with OPM.
(b) Bronze or platinum metal levels of coverage permitted. Pursuant
to a contract with OPM, an MSP issuer may offer one or more MSP options
at the bronze level of coverage or the platinum level of coverage, or
both, on any Exchange or SHOP in any State.
(c) Child-only plans. For each level of coverage, the MSP issuer
must offer a child-only MSP option at the same level of coverage as any
health insurance coverage offered to individuals who, as of the
beginning of the plan year, have not attained the age of 21.
(d) Plan variations for the reduction or elimination of cost-
sharing. An MSP
[[Page 9659]]
issuer must comply with section 1402 of the Affordable Care Act, as
well as any applicable standards set by OPM or HHS.
(e) OPM approval. An MSP issuer must submit the levels of coverage
plans and plan variations to OPM for review and approval by OPM.
Sec. 800.108 Assessments and user fees.
(a) Discretion to charge assessment and user fees. Beginning in
plan year 2015, OPM may require an MSP issuer to pay an assessment or
user fee as a condition of participating in the MSP Program.
(b) Determination of amount. The amount of the assessment or user
fee charged by OPM for a plan year is the amount determined necessary
by OPM to meet the costs of OPM's functions under the Affordable Care
Act for a plan year, including but not limited to such functions as
entering into contracts with, certifying, recertifying, decertifying,
and overseeing MSP options and MSP issuers for that plan year. The
amount of the assessment or user fee charged by OPM will be offset
against the assessment or user fee amount required by any State-based
Exchange or federally-facilitated Exchange such that the total of all
assessments and user fees paid by the MSP issuer for the year for the
MSP option shall be no greater than nor less than the amount of the
assessment or user fee paid by QHP issuers in that State-based Exchange
or federally-facilitated Exchange for that year.
(c) Process for collecting MSP assessment or user fees. OPM may
require an MSP issuer to make payment of the MSP Program assessment or
user fee amount directly to OPM, or may establish other mechanisms for
the collection process.
Sec. 800.109 Network adequacy.
(a) General requirement. An MSP issuer must ensure that the
provider network of each of its MSP options, as available to all
enrollees, meets the following standards:
(1) Maintains a network that is sufficient in number and types of
providers to assure that all services will be accessible without
unreasonable delay;
(2) Is consistent with the network adequacy provisions of section
2702(c) of the Public Health Service Act; and
(3) Includes essential community providers in compliance with 45
CFR 156.235.
(b) Provider directory. An MSP issuer must make its provider
directory for an MSP option available to the Exchange for publication
online pursuant to guidance from the Exchange and to potential
enrollees in hard copy, upon request. In the provider directory, an MSP
issuer must identify providers that are not accepting new patients.
(c) OPM guidance. OPM will issue guidance containing the criteria
and standards that it will use to determine the adequacy of a provider
network.
Sec. 800.110 Service area.
An MSP issuer must offer an MSP option within one or more service
areas in a State defined by each Exchange pursuant to 45 CFR 155.1055.
If an Exchange permits issuers to define their service areas, an MSP
issuer must obtain OPM's approval for its proposed service areas.
Pursuant to Sec. 800.104 of this part, OPM may enter into a contract
with an MSP issuer even if the MSP issuer's MSP options for a State
cover fewer than all the service areas specified for that State. MSP
options will follow the same standards for service areas for QHPs
pursuant to 45 CFR 155.1055.
Sec. 800.111 Accreditation requirement.
(a) General requirement. An MSP issuer must be or become accredited
consistent with the requirements for QHP issuers specified in section
1311 of the Affordable Care Act and 45 CFR 156.275(a)(1).
(b) Release of survey. An MSP issuer must authorize the accrediting
entity that accredits the MSP issuer to release to OPM and to the
Exchange a copy of its most recent accreditation survey, together with
any survey-related information that OPM or an Exchange may require,
such as corrective action plans and summaries of findings.
(c) Timeframe for accreditation. An MSP issuer that is not
accredited as of the date that it enters into a contract with OPM must
become accredited within the timeframe established by OPM as authorized
by 45 CFR 155.1045.
Sec. 800.112 Reporting requirements.
(a) OPM specification of reporting requirements. OPM will specify
the data and information that must be reported by an MSP issuer,
including data permitted or required by the Affordable Care Act and
such other data as OPM may determine necessary for the oversight and
administration of the MSP Program. OPM will also specify the form,
manner, processes, and frequency for the reporting of data and
information. The Director may require that MSP issuers submit claims
payment and enrollment data to facilitate OPM's oversight and
administration of the MSP Program in a manner similar to the FEHB
Program.
(b) Quality and quality improvement standards. An MSP issuer must
comply with any standards required by OPM for reporting quality and
quality improvement activities, including but not limited to
implementation of a quality improvement strategy, disclosure of quality
measures to enrollees and prospective enrollees, reporting of pediatric
quality measures, and implementation of rating and enrollee
satisfaction surveys, which will be similar to standards under section
1311(c)(1)(E), (H), and (I), (c)(3), and (c)(4) of the Affordable Care
Act.
Sec. 800.113 Benefit plan material or information.
(a) Compliance with Federal and State law. An MSP issuer must
comply with Federal and State laws relating to benefit plan material or
information, including the provisions of this section and guidance
issued by OPM specifying its standards, process, and timeline for
approval of benefit plan material or information.
(b) General standards for MSP applications and notices. An MSP
issuer must provide all applications and notices to enrollees in
accordance with the standards described in 45 CFR 155.205(c). OPM may
establish additional standards to meet the needs of MSP enrollees.
(1) Accuracy. An MSP issuer is responsible for the accuracy of its
benefit plan material or information.
(2) Truthful, not misleading, no material omissions, and plain
language. All benefit plan material or information must be:
(i) Truthful, not misleading, and without material omissions; and
(ii) Written in plain language, as defined in section 1311(e)(3)(B)
of the Affordable Care Act.
(3) Uniform explanation of coverage documents and standardized
definitions. An MSP issuer must comply with the provisions of section
2715 of the PHS Act and regulations issued to implement that section.
(4) OPM review and approval of benefit plan material or
information. OPM may request an MSP issuer to submit to OPM benefit
plan material or information, as defined in Sec. 800.20. OPM reserves
the right to review and approve benefit plan material or information to
ensure that an MSP issuer complies with Federal and State laws, and the
standards prescribed by OPM with respect to benefit plan material or
information.
(5) Statement on certification by OPM. An MSP issuer may include a
statement in its benefit plan material or information that:
[[Page 9660]]
(i) OPM has certified the MSP option as eligible to be offered on
the Exchange; and
(ii) OPM monitors the MSP option for compliance with all applicable
law.
Sec. 800.114 Compliance with applicable State law.
(a) Compliance with State law. An MSP issuer must, with respect to
each of its MSP options, generally comply with State law pursuant to
section 1334(b)(2) of the Affordable Care Act. However, the MSP options
and MSP issuers are not subject to State laws that:
(1) Are inconsistent with section 1334 of the Affordable Care Act
or this part;
(2) Prevent the application of a requirement of part A of title
XXVII of the PHS Act; or
(3) Prevent the application of a requirement of title I of the
Affordable Care Act.
(b) Determination of inconsistency. After consultation with the
State and HHS, OPM reserves the right to determine, in its judgment, as
effectuated through an MSP Program contract, these regulations, or OPM
guidance, whether the standards set forth in paragraph (a) of this
section are satisfied with respect to particular State laws.
Sec. 800.115 Level playing field.
An MSP issuer must, with respect to each of its MSP options, meet
the following requirements in order to ensure a level playing field,
subject to Sec. 800.114:
(a) Guaranteed renewal. Guarantee that an enrollee can renew
enrollment in an MSP option in compliance with sections 2703 and 2742
of the PHS Act;
(b) Rating. In proposing premiums for OPM approval, use only the
rating factors permitted under section 2701 of the PHS Act and State
law;
(c) Preexisting conditions. Not impose any preexisting condition
exclusion and comply with section 2704 of the PHS Act;
(d) Non-discrimination. Comply with section 2705 of the PHS Act;
(e) Quality improvement and reporting. Comply with all Federal and
State quality improvement and reporting requirements. Quality
improvement and reporting means quality improvement as defined in
section 1311(h) of the Affordable Care Act and quality improvement
plans or strategies required under State law, and quality reporting as
defined in section 2717 of the PHS Act and section 1311(g) of the
Affordable Care Act. Quality improvement also includes activities such
as, but not limited to, implementation of a quality improvement
strategy, disclosure of quality measures to enrollees and prospective
enrollees, and reporting of pediatric quality measures, which will be
similar to standards under section 1311(c)(1)(E), (H), and (I) of the
Affordable Care Act;
(f) Fraud and abuse. Comply with all Federal and State fraud and
abuse laws;
(g) Licensure. Be licensed in every State in which it offers an MSP
option;
(h) Solvency and financial requirements. Comply with the solvency
standards set by each State in which it offers an MSP option;
(i) Market conduct. Comply with the market conduct standards of
each State in which it offers an MSP option;
(j) Prompt payment. Comply with applicable State law in negotiating
the terms of payment in contracts with its providers and in making
payments to claimants and providers;
(k) Appeals and grievances. Comply with Federal standards under
section 2719 of the PHS Act for appeals and grievances relating to
adverse benefit determinations, as described in subpart F of this part;
(l) Privacy and confidentiality. Comply with all Federal and State
privacy and security laws and requirements, including any standards
required by OPM in guidance or contract, which will be similar to the
standards contained in 45 CFR part 164 and applicable State law; and
(m) Benefit plan material or information. Comply with Federal and
State law, including Sec. 800.113 of this part.
Sec. 800.116 Process for dispute resolution.
(a) Determinations about applicability of State law under section
1334(b)(2) of the Affordable Care Act. In the event of a dispute about
the applicability to an MSP option or MSP issuer of a State law, the
State may request that OPM reconsider a determination that an MSP
option or MSP issuer is not subject to such State law.
(b) Required demonstration. A State making a request under
paragraph (a) of this section must demonstrate that the State law at
issue:
(1) Is not inconsistent with section 1334 of the Affordable Care
Act or this part;
(2) Does not prevent the application of a requirement of part A of
title XXVII of the PHS Act; and
(3) Does not prevent the application of a requirement of title I of
the Affordable Care Act.
(c) Request for review. The request must be in writing and include
contact information, including the name, telephone number, email
address, and mailing address of the person or persons whom OPM may
contact regarding the request for review. The request must be in such
form, contain such information, and be submitted in such manner and
within such timeframe as OPM may prescribe.
(1) The requester may submit to OPM any relevant information to
support its request.
(2) OPM may obtain additional information relevant to the request
from any source as it may, in its judgment, deem necessary. OPM will
provide the requester with a copy of any additional information it
obtains and provide an opportunity for the requester to respond
(including by submission of additional information or explanation).
(3) OPM will issue a written decision within 60 calendar days after
receiving the written request, or after the due date for a response
under paragraph (c)(2) of this section, whichever is later, unless a
different timeframe is agreed upon.
(4) OPM's written decision will constitute final agency action that
is subject to review under the Administrative Procedure Act in the
appropriate U.S. district court. Such review is limited to the record
that was before OPM when OPM made its decision.
Subpart C--Premiums, Rating Factors, Medical Loss Ratios, and Risk
Adjustment
Sec. 800.201 General requirements.
(a) Premium negotiation. OPM will negotiate annually with an MSP
issuer, on a State by State basis, the premiums for each MSP option
offered by that issuer in that State. Such negotiations may include
negotiations about the cost-sharing provisions of an MSP option.
(b) Duration. Premiums will remain in effect for the plan year.
(c) Guidance on rate development. OPM will issue guidance
addressing methods for the development of premiums for the MSP Program.
That guidance will follow State rating standards generally applicable
in a State, to the greatest extent practicable.
(d) Calculation of actuarial value. An MSP issuer must calculate
actuarial value in the same manner as QHP issuers under section 1302(d)
of the Affordable Care Act, as well as any applicable standards set by
OPM or HHS.
(e) OPM rate review process. An MSP issuer must participate in the
rate review process established by OPM to negotiate rates for MSP
options. The rate review process established by OPM will be similar to
the process established by HHS pursuant to section 2794 of the
[[Page 9661]]
PHS Act and disclosure and review standards established under 45 CFR
part 154.
(f) State effective rate review. With respect to its MSP options,
an MSP issuer is subject to a State's rate review process, including a
State's Effective Rate Review Program established by HHS pursuant to
section 2794 of the PHS Act and 45 CFR part 154. In the event HHS is
reviewing rates for a State pursuant to section 2794 of the PHS Act,
HHS will defer to OPM's judgment regarding the MSP options' proposed
rate increase. If a State withholds approval of an MSP option and OPM
determines, in its discretion, that the State's action would prevent
OPM from administrating the MSP Program, OPM retains authority to make
the final decision to approve rates for participation in the MSP
Program, notwithstanding the absence of State approval.
(g) Single risk pool. An MSP issuer must consider all enrollees in
an MSP option to be in the same risk pool as all enrollees in all other
health plans in the individual market or the small group market,
respectively, in compliance with section 1312(c) of the Affordable Care
Act, 45 CFR 156.80, and any applicable Federal or State laws and
regulations implementing that section.
Sec. 800.202 Rating factors.
(a) Permissible rating factors. In proposing premiums for each MSP
option, an MSP issuer must use only the rating factors permitted under
section 2701 of the PHS Act.
(b) Application of variations based on age or tobacco use. Rating
variations permitted under section 2701 of the PHS Act must be applied
by an MSP issuer based on the portion of the premium attributable to
each family member covered under the coverage in accordance with any
applicable Federal or State laws and regulations implementing section
2701(a) of the PHS Act.
(c) Age rating. For age rating, an MSP issuer must use the ratio
established by the State in which the MSP option is offered, if it is
less than 3:1.
(1) Age bands. An MSP issuer must use the uniform age bands
established under HHS regulations implementing section 2701(a) of the
PHS Act.
(2) Age curves. An MSP issuer must use the age curves established
under HHS regulations implementing section 2701(a) of the PHS Act, or
age curves established by a State pursuant to HHS regulations.
(d) Rating areas. An MSP issuer must use the rating areas
appropriate to the State in which the MSP option is offered and
established under HHS regulations implementing section 2701(a) of the
PHS Act.
(e) Tobacco rating. An MSP issuer must apply tobacco use as a
rating factor in accordance with any applicable Federal or State laws
and regulations implementing section 2701(a) of the PHS Act.
(f) Wellness programs. An MSP issuer must comply with any
applicable Federal or State laws and regulations implementing section
2705 of the PHS Act.
Sec. 800.203 Medical loss ratio.
(a) Required medical loss ratio. An MSP issuer must attain:
(1) The medical loss ratio (MLR) required under section 2718 of the
PHS Act and regulations promulgated by HHS; and
(2) Any MSP-specific MLR that OPM may set in the best interests of
MSP enrollees or that is necessary to be consistent with a State's
requirements with respect to MLR.
(b) Consequences of not attaining required medical loss ratio. If
an MSP issuer fails to attain an MLR set forth in paragraph (a) of this
section, OPM may take any appropriate action, including but not limited
to intermediate sanctions, such as suspension of marketing,
decertifying an MSP option in one or more States, or terminating an MSP
issuer's contract pursuant to Sec. 800.404 of this part.
Sec. 800.204 Reinsurance, risk corridors, and risk adjustment.
(a) Transitional reinsurance program. An MSP issuer must comply
with section 1341 of the Affordable Care Act, 45 CFR part 153, and any
applicable Federal or State regulations under section 1341 that set
forth requirements to implement the transitional reinsurance program
for the individual market.
(b) Temporary risk corridors program. An MSP issuer must comply
with section 1342 of the Affordable Care Act, 45 CFR part 153, and any
applicable Federal regulations under section 1342 that set forth
requirements to implement the risk corridor program.
(c) Risk adjustment program. An MSP issuer must comply with section
1343 of the Affordable Care Act, 45 CFR part 153, and any applicable
Federal or State regulations under section 1343 that set forth
requirements to implement the risk adjustment program.
Subpart D--Application and Contracting Procedures
Sec. 800.301 Application process.
(a) Acceptance of applications. Without regard to 41 U.S.C.
6101(b)-(d), or any other statute requiring competitive bidding, OPM
may consider annual applications from health insurance issuers,
including groups of health insurance issuers as defined in Sec.
800.20, to participate in the MSP Program. If OPM determines that it is
not beneficial for the MSP Program to consider new issuer applications
for an upcoming year, OPM will issue a notice to that effect. Each
existing MSP issuer may complete a renewal application annually.
(b) Form and manner of applications. An applicant must submit to
OPM, in the form and manner and in accordance with the timeline
specified by OPM, the information requested by OPM for determining
whether an applicant meets the requirements of this part.
Sec. 800.302 Review of applications.
(a) Determinations. OPM will determine if an applicant meets the
requirements of this part. If OPM determines that an applicant meets
the requirements of this part, OPM may accept the applicant to enter
into contract negotiations with OPM to participate in the MSP Program.
(b) Requests for additional information. OPM may request additional
information from an applicant before making a decision about whether to
enter into contract negotiations with that applicant to participate in
the MSP Program.
(c) Declination of application. If, after reviewing an application
to participate in the MSP Program, OPM declines to enter into contract
negotiations with the applicant, OPM will inform the applicant in
writing of the reasons for that decision.
(d) Discretion. The decision whether to enter into contract
negotiations with a health insurance issuer who has applied to
participate in the MSP Program is committed to OPM's discretion.
(e) Impact on future applications. OPM's declination of an
application to participate in the MSP Program will not preclude the
applicant from submitting an application for a subsequent year to
participate in the MSP Program.
Sec. 800.303 MSP Program contracting.
(a) Participation in MSP Program. To become an MSP issuer, the
applicant and the Director or the Director's designee must sign a
contract that meets the requirements of this part.
[[Page 9662]]
(b) Standard contract. OPM will establish a standard contract for
the MSP Program.
(c) Premiums. OPM and the applicant will negotiate the premiums for
an MSP option for each plan year in accordance with the provisions of
subpart C of this part.
(d) Package of benefits. OPM must approve the applicant's package
of benefits for its MSP option.
(e) Additional terms and conditions. OPM may elect to negotiate
with an applicant such additional terms, conditions, and requirements
that:
(1) Are in the interests of MSP enrollees; or
(2) OPM determines to be appropriate.
(f) Certification to offer health insurance coverage.
(1) For each plan year, an MSP Program contract will specify MSP
options that OPM has certified, the specific package(s) of benefits
authorized to be offered on each Exchange, and the premiums to be
charged for each package of benefits on each Exchange.
(2) An MSP issuer may not offer an MSP option on an Exchange unless
its MSP Program contract with OPM includes a certification authorizing
the MSP issuer to offer the MSP option on that Exchange in accordance
with paragraph (f)(1) of this section.
Sec. 800.304 Term of the contract.
(a) Term of a contract. The term of the contract will be specified
in the MSP Program contract and must be for a period of at least the 12
consecutive months defined as the plan year.
(b) Plan year. The plan year is a consecutive 12-month period
during which an MSP option provides coverage for health benefits. A
plan year may be a calendar year or otherwise.
Sec. 800.305 Contract renewal process.
(a) Renewal. To continue participating in the MSP Program, an MSP
issuer must provide to OPM, in the form and manner and in accordance
with the timeline prescribed by OPM, the information requested by OPM
for determining whether the MSP issuer continues to meet the
requirements of this part.
(b) OPM decision. Subject to paragraph (c) of this section, OPM
will renew the MSP Program contract of an MSP issuer who timely submits
the information described in paragraph (a).
(c) OPM discretion not to renew. OPM may decline to renew the
contract of an MSP issuer if:
(1) OPM and the MSP issuer fail to agree on premiums and benefits
for an MSP option for the subsequent plan year;
(2) The MSP issuer has engaged in conduct described in Sec.
800.404(a) of this part; or
(3) OPM determines that the MSP issuer will be unable to comply
with a material provision of section 1334 of the Affordable Care Act or
this part.
(d) Failure to agree on premiums and benefits. Except as otherwise
provided in this part, if an MSP issuer has complied with paragraph (a)
of this section and OPM and the MSP issuer fail to agree on premiums
and benefits for an MSP option on one or more Exchanges for the
subsequent plan year by the date required by OPM, either party may
provide notice of nonrenewal pursuant to Sec. 800.306 of this part, or
OPM may in its discretion withdraw the certification of that MSP option
on the Exchange or Exchanges for that plan year. In addition, if OPM
and the MSP issuer fail to agree on benefits and premiums for an MSP
option on one or more Exchanges by the date set by OPM and in the event
of no action (no notice of nonrenewal or renewal) by either party, the
MSP Program contract will be renewed and the existing premiums and
benefits for that MSP option on that Exchange or Exchanges will remain
in effect for the subsequent plan year.
Sec. 800.306 Nonrenewal.
(a) Nonrenewal. Nonrenewal may pertain to the MSP issuer or the
State-level issuer. The circumstances under which nonrenewal may occur
are:
(1) Nonrenewal of contract. As used in this subpart and subpart E
of this part, ``nonrenewal of contract'' means a decision by either OPM
or an MSP issuer not to renew an MSP Program contract.
(2) Nonrenewal of participation. As used in this subpart and
subpart E of this part, ``nonrenewal of participation'' means a
decision by OPM, an MSP issuer, or a State-level issuer not to renew a
State-level issuer's participation in a MSP Program contract.
(b) Notice required. Either OPM or an MSP issuer may decline to
renew an MSP Program contract by providing a written notice of
nonrenewal to the other party.
(c) MSP issuer responsibilities. The MSP issuer's written notice of
nonrenewal must be made in accordance with its MSP Program contract
with OPM. The MSP issuer also must comply with any requirements
regarding the termination of a plan that are applicable to a QHP
offered on an Exchange on which the MSP option was offered, including a
requirement to provide advance written notice of termination to
enrollees. MSP issuers shall provide written notice to enrollees in
accordance with Sec. 800.404(d).
Subpart E--Compliance
Sec. 800.401 Contract performance.
(a) General. An MSP issuer must perform an MSP Program contract
with OPM in accordance with the requirements of section 1334 of the
Affordable Care Act and this part. The MSP issuer must continue to meet
such requirements while under an MSP Program contract with OPM.
(b) Specific requirements for issuers. In addition to the
requirements described in paragraph (a) of this section, each MSP
issuer must:
(1) Have, in the judgment of OPM, the financial resources to carry
out its obligations under the MSP Program;
(2) Keep such reasonable financial and statistical records, and
furnish to OPM such reasonable financial and statistical reports with
respect to the MSP option or the MSP issuer, as may be requested by
OPM;
(3) Permit representatives of OPM (including the OPM Office of
Inspector General), the U.S. Government Accountability Office, and any
other applicable Federal Government auditing entities to audit and
examine its records and accounts that pertain, directly or indirectly,
to the MSP option at such reasonable times and places as may be
designated by OPM or the U.S. Government Accountability Office;
(4) Timely submit to OPM a properly completed and signed novation
or change-of-name agreement in accordance with subpart 42.12 of 48 CFR
part 42;
(5) Perform the MSP Program contract in accordance with prudent
business practices, as described in paragraph (c) of this section; and
(6) Not perform the MSP Program contract in accordance with poor
business practices, as described in paragraph (d) of this section.
(c) Prudent business practices. OPM will consider an MSP issuer's
specific circumstances and facts in using its discretion to determine
compliance with paragraph (b)(5) of this section. For purposes of
paragraph (b)(5) of this section, prudent business practices include,
but are not limited to, the following:
(1) Timely compliance with OPM instructions and directives;
(2) Legal and ethical business and health care practices;
(3) Compliance with the terms of the MSP Program contract,
regulations, and statutes;
(4) Timely and accurate adjudication of claims or rendering of
medical services;
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(5) Operating a system for accounting for costs incurred under the
MSP Program contract, which includes segregating and pricing MSP option
medical utilization and allocating indirect and administrative costs in
a reasonable and equitable manner;
(6) Maintaining accurate accounting reports of costs incurred in
the administration of the MSP Program contract;
(7) Applying performance standards for assuring contract quality as
outlined at Sec. 800.402; and
(8) Establishing and maintaining a system of internal controls that
provides reasonable assurance that:
(i) The provision and payments of benefits and other expenses
comply with legal, regulatory, and contractual guidelines;
(ii) MSP funds, property, and other assets are safeguarded against
waste, loss, unauthorized use, or misappropriation; and
(iii) Data is accurately and fairly disclosed in all reports
required by OPM.
(d) Poor business practices. OPM will consider an MSP issuer's
specific circumstances and facts in using its discretion to determine
compliance with paragraph (b)(6) of this section. For purposes of
paragraph (b)(6) of this section, poor business practices include, but
are not limited to, the following:
(1) Using fraudulent or unethical business or health care practices
or otherwise displaying a lack of business integrity or honesty;
(2) Repeatedly or knowingly providing false or misleading
information in the rate setting process;
(3) Failing to comply with OPM instructions and directives;
(4) Having an accounting system that is incapable of separately
accounting for costs incurred under the contract and/or that lacks the
internal controls necessary to fulfill the terms of the contract;
(5) Failing to ensure that the MSP issuer properly pays or denies
claims, or, if applicable, provides medical services that are
inconsistent with standards of good medical practice; and
(6) Entering into contracts or employment agreements with
providers, provider groups, or health care workers that include
provisions or financial incentives that directly or indirectly create
an inducement to limit or restrict communication about medically
necessary services to any individual covered under the MSP Program.
Financial incentives are defined as bonuses, withholds, commissions,
profit sharing or other similar adjustments to basic compensation
(e.g., service fee, capitation, salary) which have the effect of
limiting or reducing communication about appropriate medically
necessary services.
(e) Performance escrow account. OPM may require MSP issuers to pay
an assessment into an escrow account to ensure contract compliance and
benefit MSP enrollees.
Sec. 800.402 Contract quality assurance.
(a) General. This section prescribes general policies and
procedures to ensure that services acquired under MSP Program contracts
conform to the contract's quality requirements.
(b) Internal controls. OPM may periodically evaluate the
contractor's system of internal controls under the quality assurance
program required by the contract and will acknowledge in writing if the
system is inconsistent with the requirements set forth in the contract.
OPM's reviews do not diminish the contractor's obligation to implement
and maintain an effective and efficient system to apply the internal
controls.
(c) Performance standards. (1) OPM will issue specific performance
standards for MSP Program contracts and will inform MSP issuers of the
applicable performance standards prior to negotiations for the contract
year. OPM may benchmark its standards against standards generally
accepted in the insurance industry. OPM may authorize nationally
recognized standards to be used to fulfill this requirement.
(2) MSP issuers must comply with the performance standards issued
pursuant to this section.
Sec. 800.403 Fraud and abuse.
(a) Program required. An MSP issuer must conduct a program to
assess its vulnerability to fraud and abuse as well as to address such
vulnerabilities.
(b) Fraud detection system. An MSP issuer must operate a system
designed to detect and eliminate fraud and abuse by employees and
subcontractors of the MSP issuer, by providers furnishing goods or
services to MSP enrollees, and by MSP enrollees.
(c) Submission of information. An MSP issuer must provide to OPM
such information or assistance as may be necessary for the agency to
carry out the duties and responsibilities, including those of the
Office of Inspector General as specified in sections 4 and 6 of the
Inspector General Act of 1978 (5 U.S.C. App.). An MSP issuer must
provide any requested information in the form, manner, and timeline
prescribed by OPM.
Sec. 800.404 Compliance actions.
(a) Causes for OPM compliance actions. The following constitute
cause for OPM to impose a compliance action described in paragraph (b)
of this section against an MSP issuer:
(1) Failure by the MSP issuer to meet the requirements set forth in
Sec. 800.401(a) and (b);
(2) An MSP issuer's sustained failure to perform the MSP Program
contract in accordance with prudent business practices, as described in
Sec. 800.401(c);
(3) A pattern of poor conduct or evidence of poor business
practices such as those described in Sec. 800.401(d); or
(4) Such other violations of law or regulation as OPM may
determine, including pursuant to its authority under Sec. Sec. 800.102
and 800.114.
(b) Compliance actions. (1) OPM may impose a compliance action
against an MSP issuer at any time during the contract term if it
determines that the MSP issuer is not in compliance with applicable
law, this part, or the terms of its contract with OPM.
(2) Compliance actions may include, but are not limited to:
(i) Establishment and implementation of a corrective action plan;
(ii) Imposition of intermediate sanctions, such as suspension of
marketing;
(iii) Performance incentives;
(iv) Reduction of service area or areas;
(v) Withdrawal of the certification of the MSP option or options
offered on one or more Exchanges;
(vi) Nonrenewal of participation
(vii) Nonrenewal of contract; and
(viii) Withdrawal of approval or termination of the MSP Program
contract.
(c) Notice of compliance action. (1) OPM must notify an MSP issuer
in writing of a compliance action under this section. Such notice must
indicate the specific compliance action undertaken and the reason for
the compliance action.
(2) For compliance actions listed in Sec. 800.404(b)(2)(v) through
(viii), such notice must include a statement that the MSP issuer is
entitled to request a reconsideration of OPM's determination to impose
a compliance action pursuant to Sec. 800.405.
(3) Upon imposition of a compliance action listed in paragraphs
(b)(2)(iv) through (vii) of this section, OPM must notify the State
Insurance Commissioner(s) and Exchange officials in the State or States
in which the compliance action is effective.
(d) Notice to enrollees. If the contract is terminated, if OPM
withdraws certification of an MSP option, or if a
[[Page 9664]]
State-level issuer's participation in the MSP Program contract is not
renewed, as described in Sec. Sec. 800.306 and 800.404(b)(2), or in
any situation in which an MSP option is no longer available to
enrollees, the MSP issuer must comply with any State or Exchange
requirements regarding discontinuing a particular type of coverage that
are applicable to a QHP offered on the Exchange on which the MSP option
was offered, including a requirement to provide advance written notice
before the coverage will be discontinued. If a State or Exchange does
not have requirements about advance notice to enrollees, the MSP issuer
must inform current MSP enrollees in writing of the discontinuance of
the MSP option no later than 90 days prior to discontinuing the MSP
option, unless OPM determines that there is good cause for less than 90
days' notice.
(e) Definition. As used in this subpart, ``termination'' means a
decision by OPM to cancel an MSP Program contract prior to the end of
its contract term. The term includes OPM's withdrawal of approval of an
MSP Program contract.
Sec. 800.405 Reconsideration of compliance actions.
(a) Right to request reconsideration. An MSP issuer may request
that OPM reconsider a determination to impose one of the following
compliance actions:
(1) Withdrawal of the certification of the MSP option or options
offered on one or more Exchanges;
(2) Nonrenewal of participation
(3) Nonrenewal of contract; or
(4) Termination of the MSP Program contract.
(b) Request for reconsideration and/or hearing. (1) An MSP issuer
with a right to request reconsideration specified in paragraph (a) of
this section may request a hearing in which OPM will reconsider its
determination to impose a compliance action.
(2) A request under this section must be in writing and contain
contact information, including the name, telephone number, email
address, and mailing address of the person or persons whom OPM may
contact regarding a request for a hearing with respect to the
reconsideration. The request must be in such form, contain such
information, and be submitted in such manner as OPM may prescribe.
(3) The request must be received by OPM within 15 calendar days
after the date of the MSP issuer's receipt of the notice of compliance
action. The MSP issuer may request that OPM's reconsideration allow a
representative of the MSP issuer to appear personally before OPM.
(4) A request under this section must include a detailed statement
of the reasons that the MSP issuer disagrees with OPM's imposition of
the compliance action, and may include any additional information that
will assist OPM in rendering a final decision under this section.
(5) OPM may obtain additional information relevant to the request
from any source as it may, in its judgment, deem necessary. OPM will
provide the MSP issuer with a copy of any additional information it
obtains and provide an opportunity for the MSP issuer to respond
(including by submitting additional information or explanation).
(6) OPM's reconsideration and hearing, if requested, may be
conducted by the Director or a representative designated by the
Director who did not participate in the initial decision that is the
subject of the request for review.
(c) Notice of final decision. OPM will notify the MSP issuer, in
writing, of OPM's final decision on the MSP issuer's request for
reconsideration and the specific reasons for that final decision. OPM's
written decision will constitute final agency action that is subject to
review under the Administrative Procedure Act in the appropriate U.S.
district court. Such review is limited to the record that was before
OPM when it made its decision.
Subpart F--Appeals by Enrollees of Denials of Claims for Payment or
Service
Sec. 800.501 General requirements.
(a) Definitions. For purposes of this subpart:
(1) Adverse benefit determination has the meaning given that term
in 45 CFR 147.136(a)(2)(i).
(2) Claim means a request for:
(i) Payment of a health-related bill; or
(ii) Provision of a health-related service or supply.
(b) Applicability. This subpart applies to enrollees and to other
individuals or entities who are acting on behalf of an enrollee and who
have the enrollee's specific written consent to pursue a remedy of an
adverse benefit determination.
Sec. 800.502 MSP issuer internal claims and appeals.
(a) Processes. MSP issuers must comply with the internal claims and
appeals processes applicable to group health plans and health insurance
issuers under 45 CFR 147.136(b).
(b) Timeframes and notice of determination. An MSP issuer must
provide written notice to an enrollee of its determination on a claim
brought under paragraph (a) of this section according to the timeframes
and notification rules under 45 CFR 147.136(b) and (e), including the
timeframes for urgent claims. If the MSP issuer denies a claim (or a
portion of the claim), the enrollee may appeal the adverse benefit
determination to the MSP issuer in accordance with 45 CFR 147.136(b).
Sec. 800.503 External review.
(a) External review by OPM. OPM will conduct external review of
adverse benefit determinations using a process similar to OPM review of
disputed claims under 5 CFR 890.105(e), subject to the standards and
timeframes set forth in 45 CFR 147.136(d).
(b) Notice. Notices to MSP enrollees regarding external review
under paragraph (a) of this section must comply with 45 CFR 147.136(e),
and are subject to review and approval by OPM.
(c) Issuer obligation. An MSP issuer must pay a claim or provide a
health-related service or supply pursuant to OPM's final decision or
the final decision of an independent review organization without delay,
regardless of whether the plan or issuer intends to seek judicial
review of the external review decision and unless or until there is a
judicial decision otherwise.
Sec. 800.504 Judicial review.
(a) OPM's written decision under the external review process
established under Sec. 800.503(a) of this part will constitute final
agency action that is subject to review under the Administrative
Procedure Act in the appropriate U.S. district court. A decision made
by an independent review organization under the process established
under Sec. 800.503(a) is not within OPM's discretion and therefore is
not final agency action.
(b) Judicial review under paragraph (a) of this section is limited
to the record that was before OPM when OPM made its decision.
Subpart G--Miscellaneous
Sec. 800.601 Reservation of authority.
OPM reserves the right to implement and supplement these
regulations with written operational guidelines.
Sec. 800.602 Consumer choice with respect to certain services.
(a) Assured availability of varied coverage. Consistent with Sec.
800.104 of this part, OPM will ensure that at least one of the MSP
issuers on each Exchange in each State offers at least one MSP option
that does not provide
[[Page 9665]]
coverage of services described in section 1303(b)(1)(B)(i) of the
Affordable Care Act.
(b) State opt-out. An MSP issuer may not offer abortion coverage in
any State where such coverage of abortion services is prohibited by
State law.
(c) Notice to Enrollees--(1) Notice of exclusion. The MSP issuer
must provide notice to consumers prior to enrollment that non-excepted
abortion services are not a covered benefit in the form, manner, and
timeline prescribed by OPM.
(2) Notice of coverage. If an MSP issuer chooses to offer an MSP
option that covers non-excepted abortion services, in addition to an
MSP option that does not cover non-excepted abortion services, the MSP
issuer must provide notice to consumers prior to enrollment that non-
excepted abortion services are a covered benefit. An MSP issuer must
provide notice in a manner consistent with 45 CFR 147.200(a)(3), to
meet the requirements of 45 CFR 156.280(f). OPM may provide guidance on
the form, manner, and timeline for this notice.
(3) OPM review and approval of notices. OPM may require an MSP
issuer to submit to OPM such notices. OPM reserves the right to review
and approve these consumer notices to ensure that an MSP issuer
complies with Federal and State laws, and the standards prescribed by
OPM with respect to Sec. 800.602.
Sec. 800.603 Disclosure of information
(a) Disclosure to certain entities. OPM may provide information
relating to the activities of MSP issuers or State-level issuers to a
State Insurance Commissioner or Director of a State-based Exchange.
(b) Conditions of when to disclose. OPM shall only make a
disclosure described in this section to the extent that such disclosure
is:
(1) Necessary or appropriate to permit OPM's Director, a State
Insurance Commissioner, or Director of a State-based Exchange to
administer and enforce laws applicable to an MSP issuer or State-level
issuer over which it has jurisdiction, or
(2) Otherwise in the best interests of enrollees or potential
enrollees in MSP options.
(c) Confidentiality of information. OPM will take appropriate steps
to cause the recipient of this information to preserve the information
as confidential.
[FR Doc. 2015-03421 Filed 2-20-15; 8:45 am]
BILLING CODE 6325-63-P