[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Proposed Rules]
[Pages 74097-74102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26282]



[[Page 74097]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 156

[CMS-9898-NC]
RIN 0938-AV14


Request for Information; Essential Health Benefits

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Request for information.

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SUMMARY: This request for information (RFI) solicits public comment on 
issues related to the Essential Health Benefits (EHB) under the Patient 
Protection and Affordable Care Act (the Affordable Care Act or ACA). 
CMS is issuing this RFI to gather input from the public regarding a 
variety of topics related to the coverage of benefits in health plans 
subject to the EHB requirements of the ACA. These topics include: the 
description of the EHB, the scope of benefits covered in typical 
employer plans, the review of EHB, coverage of prescription drugs, and 
substitution of EHB.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below by January 31, 2023.

ADDRESSES: In commenting, refer to file code CMS-9898-NC.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY:

    Centers for Medicare & Medicaid Services, Department of Health 
and Human Services, Attention: CMS-9898-NC, P.O. Box 8016, 
Baltimore, MD 21244-8016.

    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY:

    Centers for Medicare & Medicaid Services, Department of Health 
and Human Services, Attention: CMS-9898-NC, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.

    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Leigha Basini, (301) 492-4380, or Rebecca Bucchieri, (301) 492-
4341, for general information.
    Ken Buerger, (410) 786-1190.
    Nathan Caulk, (667) 290-9975.
    Nicole Levesque, (667) 290-9974.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

I. Background

    Section 1301(a)(1)(B) of the Affordable Care Act \1\ requires all 
issuers of qualified health plans (QHPs) to cover the ``Essential 
Health Benefits (EHB) package'' described in section 1302(a) of the 
ACA, which includes coverage of the services described in section 
1302(b) of the ACA. Section 2707(a) of the Public Health Service Act 
(PHS Act) extends the requirement to cover the ``EHB package'' to non-
grandfathered individual and small group health insurance coverage 
(hereinafter, such plans are referred to as plans subject to EHB 
requirements), irrespective of whether such coverage is offered through 
an Exchange.
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    \1\ The Patient Protection and Affordable Care Act (Pub. L. 111-
148) was enacted on March 23, 2010. The Healthcare and Education 
Reconciliation Act of 2010 (Pub. L. 111-152), which amended and 
revised several provisions of the Patient Protection and Affordable 
Care Act, was enacted on March 30, 2010. In this request for 
information, the two statutes are referred to collectively as the 
``Patient Protection and Affordable Care Act,'' ``Affordable Care 
Act'' or ``ACA''.
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    Section 1302 of the ACA provides for the establishment of this 
``EHB package'' to include coverage of the EHB (as defined by the 
Secretary), cost-sharing limits, and actuarial value (AV) requirements. 
Section 1302(b) of the ACA directs the Secretary, in defining the EHB, 
to ensure that they are equal in scope to the benefits provided under a 
typical employer plan, and that they include at least the following 10 
general categories and the items and services covered within the 
categories: ambulatory patient services; emergency services; 
hospitalization; maternity and newborn care; mental health and 
substance use disorder services, including behavioral health treatment; 
prescription drugs; rehabilitative and habilitative services and 
devices; laboratory services; preventive and wellness services and 
chronic disease management; and pediatric services, including oral and 
vision care.
    On December 16, 2011, HHS released a bulletin \2\ that outlined an 
intended regulatory approach for defining EHB, including a benchmark-
based framework. We established requirements relating to EHBs in the 
Standards Related to Essential Health Benefits, Actuarial Value, and 
Accreditation Final Rule, which was published in the February 25, 2013 
Federal Register (78 FR 12833) (EHB Rule). As implemented in the EHB 
Rule, for a non-grandfathered individual or small group market health 
plan to provide the ``EHB package,'' the health plan must, among other 
things, provide the benefits in accordance with the State's EHB-
benchmark plan, as described at 45 CFR 156.115. A State's EHB-benchmark 
plan serves as a reference plan for the benefits considered as EHB in 
the State. Section 156.115(a) states that the provision of EHB means 
that a health plan, among other things, provides benefits that are 
substantially equal to the State's EHB-benchmark plan including: 
covered benefits; limitations on coverage including coverage of benefit 
amount, duration, and scope; and prescription drug benefits that meet 
the requirements of Sec.  156.122.\3\
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    \2\ The HHS EHB bulletin is available on the CMS website at 
https://www.cms.gov/CCIIO/Resources/Files/Downloads/essential_health_benefits_bulletin.pdf.
    \3\ An issuer of a plan offering EHB may substitute benefits for 
those provided in the EHB-benchmark plan pursuant to Sec.  
156.115(b).
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    For plan years 2014 through 2016, each State's EHB-benchmark plan 
was based on one of the health plans identified at Sec.  156.100 that 
was available in the State in 2012, with any missing benefit categories 
supplemented as specified under Sec.  156.110.\4\ For plan

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years 2017, 2018, and 2019, each State's EHB-benchmark plan was based 
on one of the health plans identified at Sec.  156.100 that was 
available in the State in 2014, with any missing benefit categories 
supplemented as specified under Sec.  156.110.
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    \4\ As specified by Sec.  156.100(c), for plan years beginning 
prior to January 1, 2020, if a State did not make an EHB-benchmark 
selection using the process described in the section, the State's 
EHB-benchmark defaulted to the largest plan by enrollment in the 
largest product by enrollment in the State's small group market.
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    The 2019 Payment Notice final rule, which appeared in the April 17, 
2018 Federal Register (83 FR 16930), added Sec.  156.111 to provide 
States with additional options from which to select an EHB-benchmark 
plan for plan years 2020 and beyond. In that final rule, we stated that 
we believe States should have additional choices with respect to 
benefits and affordable coverage, and we added Sec.  156.111 to provide 
additional flexibility for States to select new EHB-benchmark plans 
starting with the 2020 plan year.\5\ To date, CMS has approved changes 
to 7 State EHB-benchmark plans under Sec.  156.111.\6\ For each plan 
year, States that opt not to exercise this flexibility use the same 
EHB-benchmark plan from the previous plan year. The current EHB-
benchmark plans are available on the CMS website at https://www.cms.gov/CCIIO/Resources/Data-Resources/ehb.
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    \5\ Under Sec.  156.111(a), a State may change its EHB-benchmark 
plan by: (1) selecting the EHB-benchmark plan that another State 
used for the 2017 plan year; (2) replacing one or more EHB 
categories of benefits in its EHB-benchmark plan used for the 2017 
plan year with the same category or categories of benefits from 
another State's EHB-benchmark plan used for the 2017 plan year; or 
(3) otherwise selecting a set of benefits that would become the 
State's EHB-benchmark plan.
    \6\ Illinois (2020), South Dakota (2021), Michigan (2022), New 
Mexico (2022), Oregon (2022), Colorado (2023), and Vermont (2024).
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II. Solicitation of Public Comments

    CMS requests comments from all interested parties to gain a better 
understanding of the coverage of benefits in health plans with respect 
to the following specific areas:

Benefit Descriptions in EHB-Benchmark Plan Documents

    The EHB-benchmark plan approach was designed to ``allow States to 
build on coverage that is already widely available, minimize market 
disruption, and provide consumers with familiar products. This should 
heighten consumer understanding of plan options and may facilitate 
consumers' abilities to make choices that better suit their needs.'' 
\7\ We believe that this approach was largely successful in these 
regards. At the same time, we are mindful of concerns that this 
approach creates a patchwork of coverage of EHB, such that any 
particular benefit may have disparate coverage nationwide across all 51 
EHB-benchmark plans.
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    \7\ 78 FR 12833, 12860 (February 25, 2013).
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    We are also mindful that the EHB-benchmark plan documents can 
describe the covered benefits differently, which may create ambiguity 
in defining the EHB in a particular State. For example, one State's 
EHB-benchmark plan may specifically mention coverage of ground, water, 
and air ambulance, while another State's EHB-benchmark plan may simply 
cover ``medically necessary transportation'' without distinguishing 
whether such coverage includes ground, water, or air ambulance. As 
another example, one EHB-benchmark plan may cover ``Diagnostic 
radiology services and Imaging studies,'' while another EHB-benchmark 
plan has a more detailed description of covered radiological and 
imaging benefits: ``Benefits are also available for advanced imaging 
services, which include but are not limited to: CT scan, CTA scan, 
Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA), 
Magnetic resonance spectroscopy (MRS), Nuclear Cardiology, PET scans, 
PET/CT Fusion scans, QTC Bone Densitometry, Diagnostic CT 
Colonography.'' Accordingly, some State EHB-benchmark plan documents 
are well over 100 pages and include these more detailed descriptions of 
covered benefits and limitations, while other EHB-benchmark plans are 
only a few dozen pages with shorter, more generalized descriptions of 
covered benefits and limitations.
    The difference in how the benefits are described in the EHB-
benchmark plans is not particularly surprising. These plan documents 
were written by different authors at different times, serving different 
segments of the population with different health needs, and subjected 
to different Federal or State requirements. We understand that the 
authors of the plan documents used as the EHB-benchmark plans may not 
have anticipated that the language used in that plan document would be 
used to define the EHB for a State indefinitely. Even now, with States 
able to change their EHB-benchmark plan by selecting a set of benefits 
to become the State's EHB-benchmark plan under Sec.  156.111(a)(3), we 
believe it may be unreasonable to expect a State to exhaustively 
describe all covered benefits and limitations in their EHB-benchmark 
plan document.
    Based on our experience and review of the EHB-benchmark plan 
documents, it is apparent that the more descriptive an EHB-benchmark 
plan document is, the greater the certainty is that a specific benefit 
is considered to be an EHB in the State. As a result, it is difficult 
for States, CMS, and other interested parties to reliably compare the 
EHB-benchmark plan document from one State to another. This inhibits 
State and Federal ability to gauge the overall generosity of plans 
subject to EHB requirements, which makes it more difficult for States 
to consider changes to their EHB-benchmark plans under Sec.  
156.111(a)(1) and (2).\8\ It also makes it more difficult for CMS to 
fulfill its statutory obligation at section 1302(b)(4)(G) and (H) of 
the ACA to periodically review and update the EHB to address gaps in 
coverage or changes in evidence basis.
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    \8\ In addition, it inhibits the ability of self-insured plans 
to gauge the overall scope of items and services included in EHB-
benchmark plans for purposes of selecting a definition of EHB to 
comply with the requirement to limit enrollee cost sharing to the 
annual limitation on cost sharing and the prohibition of lifetime or 
annual limits. See 45 CFR 147.126(c) and ACA Implementation FAQ 18 
at https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs18.
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    To be clear, we do not necessarily believe that this ambiguity in 
the covered benefits and limitations in the EHB-benchmark plans has 
resulted in overt consumer harm. For example, based on our discussions 
with States and a lack of consumer complaints about exclusions or 
claims denials, plans subject to EHB requirements do not appear to be 
excluding services that are generally understood to be covered, 
regardless of their specific inclusion in the relevant EHB-benchmark 
plan document. Accordingly, we believe that the States have generally 
proven to be effective enforcers of the EHB requirement in ensuring 
that benefits are still treated as EHB in instances where the EHB-
benchmark plan language is ambiguous or lacking in detail.\9\ We seek 
public comment on this understanding, including to what extent States 
may require additional guidance on how to ensure that plans are 
interpreting the EHB-benchmark plan documents in a manner that provides 
EHB coverage to consumers, consistent with applicable requirements.
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    \9\ CMS has the responsibility to directly enforce the relevant 
Public Health Service Act provisions with respect to health 
insurance issuers in the group and individual markets in Missouri, 
Oklahoma, Texas, and Wyoming.
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Typical Employer Plans

    Section 1302(b)(2)(A) of the ACA requires the scope of the EHB to 
be equal to the scope of benefits provided under a ``typical employer 
plan.'' To implement section 1302(b) of the ACA and the typical 
employer plan standard, CMS defined EHB based on a

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benchmark plan approach at Sec.  156.100(a). States were required to 
select from one of 10 base-benchmark plans, including the largest 
health plan by enrollment in any of the three largest small group 
insurance products by enrollment, any of the largest three State 
employee health benefit plan options by enrollment and generally 
available to State employees in the State involved, any of the largest 
three national Federal Employees Health Benefits (FEHB) Program plan 
options by aggregate enrollment that are offered to all FEHB-eligible 
Federal employees, or the coverage plan with the largest insured 
commercial non-Medicaid enrollment offered by a health maintenance 
organization operating in the State.
    In the 2019 Payment Notice, we finalized options at Sec.  156.111 
to provide States with greater flexibility to select new EHB-benchmark 
plans beginning with the 2020 plan year, if they so choose. A State's 
EHB-benchmark plan must still provide a scope of benefits equal to the 
scope of benefits provided under a typical employer plan.\10\ For plan 
year 2020 and after, Sec.  156.111(b)(2) defines a typical employer 
plan as either (1) one of the selecting State's 10 base-benchmark plan 
options established at Sec.  156.100 from which the State was able to 
select for the 2017 plan year; or (2) the largest health insurance plan 
by enrollment in any of the five largest large group health insurance 
products by enrollment in the selecting State, provided that the plan 
meets the requirements in Sec.  156.111(b)(2)(i)(B)(1) through (4).
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    \10\ Or greater than the scope of benefits provided under a 
typical employer plan to the extent any supplementation is required 
to provide coverage within each EHB category at Sec.  156.110(a).
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    We seek comment on changes in the scope of benefits offered by 
employer plans since plan year 2014. In particular, we are interested 
in comments that discuss the relative generosity of the current typical 
employer plans described at Sec.  156.100(a)(1) through (4) and Sec.  
156.111(b)(2)(i)(B), and whether they are reflective of the scope of 
benefits provided under employer plans offered in more recent plan 
years, or whether employer plans offered since plan year 2014 are more 
or less generous. We seek comment on whether there are other employer 
plans commonly sold in States that are not reflected in the current 
typical employer plans described at Sec.  156.100(a)(1) through (4) and 
Sec.  156.111(b)(2)(i)(B). We invite our State partners to elaborate on 
whether changes in State markets since 2014 may warrant changes to the 
current definition of a ``typical employer plan.''

Review of EHB

    Section 1302(b)(4)(G)(i) through (iv) of the ACA require CMS to 
periodically review the EHB to determine: (1) whether enrollees are 
facing any difficulty accessing needed services for reasons of coverage 
or cost; (2) whether EHB need to be modified or updated to account for 
changes in medical evidence or scientific advancement; (3) information 
on how EHB will be modified to address any such gaps in access or 
changes in the evidence base; and (4) the potential of additional or 
expanded benefits to increase costs and the interactions between the 
addition or expansion of benefits and reductions in existing benefits 
to meet actuarial limitations. In furtherance of this statutory 
obligation, we seek comment on each of these topics.
Barriers of Accessing Services Due to Coverage or Cost
    First, we seek comment on whether and to what extent consumers 
enrolled in plans that provide EHB are facing any difficulty accessing 
needed services due to coverage or cost. Specifically:
     Are there significant barriers for consumers to access 
mental health and substance use disorder services, including behavioral 
health services that are EHB? To what extent has the utilization of 
telehealth impacted access to the behavioral health services that are 
EHB, particularly during the COVID-19 pandemic? How could telehealth 
utilization better address potential gaps in consumer access to EHB for 
behavioral health services or other health care services?
     What other strategies have plans implemented to broaden 
access to telehealth services?
     What efforts have plans found effective in controlling 
costs of EHB? To what extent do plans that provide EHB see increased 
utilization and higher costs if those efforts are not implemented? What 
strategies have consumers and providers seen plans implement to reduce 
utilization and costs, such as use of prior authorization, step 
therapy, etc.? Are these strategies to reduce utilization and costs 
applied broadly or are they targeted to a specific area? What, if any, 
geographic differences have been found in the strategies plans use to 
reduce utilization and costs within a State? How are these tools 
effective or ineffective? To what extent do these tools curb or 
complicate access to medically necessary care?
Changes in Medical Evidence and Scientific Advancement
    Second, we seek comment on whether and to what extent the EHB need 
to be modified or updated to account for changes in medical evidence 
and scientific advancement. We expect that there have been significant 
changes in medical evidence and scientific advancement for certain 
benefits since 2014. For example, after the original EHB-benchmark 
plans had been selected, silver diamine fluoride, which is an 
inexpensive treatment that can stop dental caries and is particularly 
useful for pediatric populations, became available in the U.S.\11\ 
Another example of a change in medical evidence is the increased 
understanding of and reliance on doula services as a cost-effective way 
to improve maternal and newborn health outcomes.\12\ To that end:
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    \11\ Crystal YO, Niederman R. Evidence-Based Dentistry Update on 
Silver Diamine Fluoride. Dent Clin North Am. 2019 Jan;63(1):45-68. 
doi: 10.1016/j.cden.2018.08.011. PMID: 30447792; PMCID: PMC6500430. 
Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500430/.
    \12\ Greiner KS (et al.). The Cost-Effectiveness of Professional 
Doula Care for a Woman's First Two Births: A Decision Analysis 
Model. Journal of Midwifery & Women's Health. Available at https://onlinelibrary.wiley.com/doi/full/10.1111/jmwh.12972.
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     What changes in medical evidence and scientific 
advancement have occurred since 2014 that are not reflected in the 
current EHB-benchmark plans? Are there benefits widely covered as EHB 
that are not supported by current medical evidence?
     Are there other barriers to incorporating changes in 
medical evidence and scientific advancement into the EHB? How can the 
EHB better track with changes in medical evidence and scientific 
advancement? What steps should be taken to address EHB that are not 
supported by current medical evidence?
    We are also interested in how changes in medical evidence or 
scientific advancement generally could inform CMS' health equity and 
nondiscrimination efforts with regards to EHB. For example, there may 
be lack of coverage for treatment informed by scientific advancements 
in certain areas of health care resulting in a disproportionate impact 
on consumers, or there may be new medical evidence indicating certain 
consumers are encountering specific barriers in accessing certain EHB. 
To that end:
     How might the EHB adapt to more quickly address pressing 
public health issues such as public health emergencies (including the 
opioid and overdose epidemic) and maternal

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mortality rates (particularly among underserved populations)? For 
example, what are the barriers for third-parties such as family members 
or caregivers to obtain naloxone?
     How should the EHB advance health equity by taking into 
consideration economic, social, racial, or ethnic factors that are 
relevant to health care access (for example, access to appropriate 
language services)?
     In what ways could EHB better address health conditions 
that disproportionately affect underserved populations or large parts 
of the American population?
     For example, how could EHB address nutrition-related 
health conditions for the American population? How has the medical 
evidence regarding nutrition-related health conditions changed since 
2014? How can EHB better improve nutrition-related health outcomes for 
the populations that are most likely to benefit from coverage of 
nutrition-related care, such as people with diabetes?
     What strategies are issuers and plan sponsors using to 
improve nutritional-related health outcomes for enrollees, and what 
strategies could they implement? To what extent have issuers and plan 
sponsors designed their own strategies as compared to relying on 
existing models (for example, the evidence-based National Diabetes 
Prevention Program \13\)?
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    \13\ National Diabetes Prevention Program. Available at https://www.cdc.gov/diabetes/prevention/index.html.
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     How have scientific advancements and new delivery 
mechanisms impacted the content of nutrition-related care, provider 
delivery, access to care, and how plan sponsors and issuers manage it?
Addressing Gaps in Coverage
    Third, we seek comment on how the EHB could be modified to address 
any gaps in coverage or scope of benefits. Specifically:
     Are there examples of benefits that are essential to 
maintaining health, including behavioral health, that are 
insufficiently covered as EHB but that are routinely covered by other 
specific health plans or programs, such as employer-sponsored plans, 
Medicare, and Medicaid? To what extent does the EHB cover screening, 
consultative, and treatment modalities that supports the integration of 
both mental health and substance use disorder services into primary 
care?
     Many State base-benchmark plan documents do not include 
specific coverage for habilitative services. To comply with section 
1302(b)(1)(G) of the ACA, these States supplement the base-benchmark 
plans with habilitative services pursuant to Sec.  156.110(f) by 
determining which services in that category will be covered as EHB.\14\ 
In our experience, State supplementation of habilitative services is 
inconsistent. We are interested in comments on which habilitative 
services are currently covered as EHB, and whether further definition 
is needed in general to clarify the covered benefits. We also seek 
comment on whether EHB-benchmark plans' current coverage and limits 
regarding habilitative services, which were primarily based on coverage 
for rehabilitative purposes, are sufficient and in line with current 
clinical guidelines for treatment of developmental disabilities.
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    \14\ 45 CFR 156.110(f) states: ``If the base-benchmark plan does 
not include coverage for habilitative services, the State may 
determine which services are included in that category.''
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     Is there sufficient coverage as EHB of emergency 
behavioral health services, including mobile crisis care and 
stabilization services? To what extent is there sufficient coverage as 
EHB for other levels of care, such as for crisis prevention and care 
coordination for behavioral health services? To what extent do plans 
that provide EHB include peer and recovery support for behavioral 
health services?
     Aside from the required preventive services for 
children,\15\ and the identification in section 1302(b)(1)(J) of the 
ACA for ``[p]ediatric services, including oral and vision care'' as one 
of the 10 categories of EHB, the EHB-benchmark plans largely do not 
differentiate between benefits for adults and benefits for children. 
Are there differences between adult and pediatric benefits and those 
populations' needs such that further delineation of pediatric benefits 
is warranted? How does the scope of health benefits for children 
compare between employer-sponsored group health plans and States' 
separate Children's Health Insurance Program plans?
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    \15\ See generally 45 CFR 147.130(a)(1).
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     To what extent could EHB better address any gaps in 
coverage for those with chronic and lifelong conditions?
     How can CMS balance State flexibility (as States are 
generally the primary enforcers of EHB) with the statutory requirement 
to ensure sufficient coverage for a diverse population, including those 
living in rural areas who may have limited provider types available?
     What other strategies could be implemented to modify EHB 
to address gaps in coverage or changes in the evidence base?
Actuarial and Cost-Sharing Limitations
    Lastly, we recognize that any efforts to revise the EHB to change 
the benefits covered as EHB have the potential to impact costs and the 
ability of plans to meet the actuarial and cost-sharing limitations 
under section 1302 of the ACA. We invite comments that address the 
ability of plans subject to EHB requirements to conform benefit designs 
to these requirements.

Coverage of Prescription Drugs as EHB

    As finalized in the EHB Rule, plans subject to EHB requirements 
must comply with Sec.  156.122(a)(1) to cover at least the same number 
of prescription drugs in every United States Pharmacopeia (USP) 
category and class as covered by the State's EHB-benchmark plan, or one 
drug in every category and class, whichever is greater. We also stated 
that plans could exceed the minimum number of drugs required to be 
covered and that additional drugs would still be considered EHB. In 
that final rule,\16\ we chose to use the USP Model Guidelines Version 
5.0 (USP Guidelines) to classify the drugs required to be covered as 
EHB under Sec.  156.122(a)(1). In so doing, we noted that ``[w]hile 
there was concern among commenters on the use of USP as the system, 
there was no universal system identified as a potential alternative. We 
chose the current version USP Model Guidelines (version 5) because it 
is publicly available and many pharmacy benefit managers are familiar 
with it. We believe the USP model best fits the needs for the years 
2014 and 2015 during the transitional EHB policy.'' \17\ CMS and the 
USP developed the USP Guidelines in 2004 to implement the Medicare Part 
D Prescription Drug Program.\18\ Section 1860D-2(e) of the Social 
Security Act (the Act) defines a ``covered part D drug'' for purposes 
of the Medicare Part D program, and the statutory definition excludes 
certain drugs,\19\ such as drugs for anorexia, weight loss, or weight 
gain.\20\

[[Page 74101]]

Consequently, the USP Guidelines do not include categories and classes 
to classify these excluded drugs; as a result, these drugs are not 
required to be covered as EHB under Sec.  156.122(a)(1). However, 
certain types of weight management drugs may still be covered in a 
health plan as EHB but under a different drug category (for example, 
weight management drugs classified and covered under the category for 
central nervous system drugs). Additionally, nothing prevents plans 
from voluntarily covering these drugs as EHB. However, the variation in 
classification for these drugs leads to potential coverage gaps for 
consumers.
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    \16\ 78 FR at 12846.
    \17\ 78 FR at 12845-12846.
    \18\ USP Medicare Model Guidelines. Available at https://www.usp.org/health-quality-safety/usp-medicare-model-guidelines.
    \19\ See section 1860D-2(e)(2) of the Act.
    \20\ See section 1927(d)(2) of the Act. List of Drugs Subject to 
Restriction include drugs used for anorexia, weight loss, weight 
gain, fertility, cosmetic purposes or hair growth, symptomatic 
relief of cough and colds, smoking cessation, prescription vitamins 
and mineral products, nonprescription drugs, certain covered 
outpatient drugs, barbiturates, benzodiazepines, and drugs for the 
treatment of sexual or erectile disfunction.
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    In the 2016 Payment Notice,\21\ we solicited comments regarding 
whether to replace the USP Guidelines with a standard based on the 
American Hospital Formulary Service (AHFS) or another drug 
classification system. CMS ultimately decided to retain the USP 
Guidelines classification system because ``[i]ssuers have already 
developed 2 years of formularies based on it, States have already 
developed systems to review those formularies, and interested parties 
are familiar with the system. Thus, while AHFS had the benefit of being 
updated more frequently and incorporating a broader set of classes and 
subclasses, commenters did not uniformly support its use because of 
several issues, including a lack of transparency, the need to 
supplement certain classes when compared with USP, and the complexity 
of the AHFS system.'' \22\
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    \21\ 2016 Final Payment Notice: Patient Protection and 
Affordable Care Act; HHS Notice of Benefit and Payment Parameters 
for 2016, 80 FR 10750, 10813 (February 27, 2015). Available at 
https://www.govinfo.gov/content/pkg/FR-2015-02-27/pdf/2015-03751.pdf.
    \22\ Id.
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    In 2017, the USP developed a second drug classification system, the 
USP Drug Classification (DC), an independent drug classification system 
``developed in response to input from interested parties that it would 
be helpful to have a classification system beyond the Medicare Model 
Guidelines (MMG) to assist with formulary support outside of Medicare 
Part D.'' \23\ We note that USP DC system has many features that may be 
beneficial to consumers and meet evolving public health challenges. The 
USP DC system provides examples of common U.S. outpatient drugs and is 
updated annually.
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    \23\ USP Drug Classification. Available at https://www.usp.org/health-quality-safety/usp-drug-classification-system.
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    We recognize the potential challenges of switching drug 
classification systems for EHB. We reviewed public comments for the 
proposed 2016 Payment Notice related to the AHFS system and recognize 
the concerns of lack of transparency or the need to supplement certain 
classes when compared with USP Guidelines, and the complexity of the 
AHFS system. However, we note that other drug classification systems, 
such as USP DC or others, may provide greater benefit for consumers. In 
addition, we note that switching to the USP DC system may not be as 
disruptive as switching to AHFS due to the unique features of the USP 
DC system such as applicability and readiness of the system. We seek 
public comment to confirm or further expand on our understanding of the 
risks and benefits of replacing the current USP Guidelines with a 
different drug classification system.
    We seek comment on whether CMS should consider using an alternative 
prescription drug classification standard for defining the EHB 
prescription drug category, such as the USP DC or others, in the 
future.

Substitution of EHB

    In the EHB Rule, we added Sec.  156.115(b) so that health plans may 
substitute benefits for those provided in the EHB-benchmark plan, 
provided that the substitution is actuarially equivalent and the 
benefit is not a prescription drug benefit. We added this flexibility 
``to provide greater choice to consumers, and promote plan innovation 
through coverage and design options.'' \24\ In the 2019 Payment Notice, 
we modified paragraph (b)(1)(ii) to allow States to permit issuers to 
substitute benefits within the same EHB category and between EHB 
categories, as long as the substituted benefit is actuarially 
equivalent to the benefit being replaced and is not a prescription drug 
benefit.\25\ In the 2023 Payment Notice,\26\ we amended Sec.  
156.115(b)(2) to withdraw the flexibility for health plans to 
substitute benefits between different EHB categories in response to 
public comments that the practice could lead to adverse selection and 
discrimination by allowing health plans to remove benefits needed by 
people with significant health needs and substitute them with benefits 
meant to attract healthier enrollees.
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    \24\ 78 FR 12833, 12844 (February 25, 2013).
    \25\ 83 FR 16930, 16930 (April 17, 2018).
    \26\ 87 FR 27208 (May 6, 2022).
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    Ever since we implemented the ability for the substitution of EHB, 
we have received substantial feedback urging CMS to remove the ability 
for health plans to substitute EHB because of concerns that the 
practice could lead to discrimination or negative health outcomes. 
Others have expressed concerns that allowing such substitution makes it 
difficult for regulators to ensure that plans are actually covering the 
EHB and that substitution could be confusing for consumers. However, we 
have also received feedback that the option of substitution may allow 
plans flexibility in benefit design to address changing public health 
concerns and cover innovations in health care as EHB.
    To date, CMS has not received any information that any health plan 
has ever substituted an EHB using this flexibility. While States are 
not required to notify CMS when health plans substitute benefits under 
Sec.  156.115(b), any health plan seeking certification as a QHP on a 
Federally-facilitated Exchange (FFE) may indicate, at its option, 
whether a particular benefit is substituted in its QHP application. 
CMS, as operator of the FFEs, has not received any QHP application that 
indicates that any QHP issuer on an FFE has substituted a benefit in 
this manner. We seek comment regarding the extent to which health plans 
have ever substituted EHB under Sec.  156.115.
    To the extent the substitution of EHB is not widely used by health 
plans, we seek comment on how we might revisit our rules regarding the 
substitution of EHB in future rulemaking so that consumers have access 
to health plans that can better address changing public health concerns 
or innovation in health care. Alternatively, we seek comment regarding 
whether health plans should not be permitted to substitute EHB within 
the same EHB category.

III. Collection of Information Requirements

    Please note, this is a RFI only. In accordance with the 
implementing regulations of the Paperwork Reduction Act of 1995 (PRA), 
specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt 
from the PRA. Facts or opinions submitted in response to general 
solicitations of comments from the public, published in the Federal 
Register or other publications, regardless of the form or format 
thereof, provided that no person is required to supply specific 
information pertaining to the commenter, other than that necessary for 
self-identification, as a condition of the agency's full consideration, 
are not generally considered information collections and therefore not 
subject to the PRA.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a Request for Proposal (RFP), applications, 
proposal abstracts, or quotations. This RFI does

[[Page 74102]]

not commit the U.S. Government to contract for any supplies or services 
or make a grant award. Further, CMS is not seeking proposals through 
this RFI and will not accept unsolicited proposals. Responders are 
advised that the U.S. Government will not pay for any information or 
administrative costs incurred in response to this RFI; all costs 
associated with responding to this RFI will be solely at the interested 
party's expense. CMS notes that not responding to this RFI does not 
preclude participation in any future procurement, if conducted. It is 
the responsibility of the potential responders to monitor this RFI 
announcement for additional information pertaining to this request. In 
addition, CMS will not respond to questions about the policy issues 
raised in this RFI.
    CMS will actively consider all input as we develop future 
regulatory proposals or future subregulatory policy guidance. CMS may 
or may not choose to contact individual responders. These 
communications would be for the sole purpose of clarifying Statements 
in the responders' written responses. Contractor support personnel may 
be used to review responses to this RFI. Responses to this notice are 
not offers and cannot be accepted by the U.S. Government to form a 
binding contract or issue a grant. Information obtained as a result of 
this RFI may be used by the U.S. Government for program planning on a 
non-attribution basis. Responders should not include any information 
that might be considered proprietary or confidential. This RFI should 
not be construed as a commitment or authorization to incur cost for 
which reimbursement would be required or sought. All submissions become 
U.S. Government property and will not be returned. In addition, CMS may 
publicly post the public comments received, or a summary of those 
public comments.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on November 14, 2022.

    Dated: November 29, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-26282 Filed 11-30-22; 4:15 pm]
BILLING CODE 4120-01-P