Proposed Rule2021-13138
Request for Information Regarding Reporting on Pharmacy Benefits and Prescription Drug Costs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 23, 2021
Issuing agencies
Personnel Management OfficeTreasury DepartmentInternal Revenue ServiceLabor DepartmentEmployee Benefits Security AdministrationHealth and Human Services Department
Abstract
This document is a request for information on issues related to certain reporting requirements under section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage. The Departments of Health and Human Services, Labor, and the Treasury (the Departments) are issuing this request for information to gather input from the public regarding implementation considerations for the data collection required under section 204 of Title II of Division BB of the CAA, and the associated impact on group health plans and health insurance issuers. As part of this request for information, the Office of Personnel Management (OPM) is also seeking input from the public regarding implementation considerations for the data collection required under section 204 of Title II of Division BB of the CAA as it pertains to Federal Employees Health Benefits (FEHB) carriers (whether or not they are also health insurance issuers). The Departments and OPM also seek input on specific data elements, including the level of detail that is feasible to report for entities subject to the data collection requirements and the associated burdens and potential compliance costs. Public comments will inform the Departments' and OPM's implementation of section 204 through rulemaking and the establishment of processes to receive the required information.
Full Text
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<title>Federal Register, Volume 86 Issue 118 (Wednesday, June 23, 2021)</title>
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[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Proposed Rules]
[Pages 32813-32817]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13138]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 /
Proposed Rules
[[Page 32813]]
OFFICE OF PERSONNEL MANAGEMENT
5 CFR Part 890
RIN 3206-AO27
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
RIN 1545-BQ10
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AC07
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 149
[CMS-9905-NC]
RIN 0938-AU66
Request for Information Regarding Reporting on Pharmacy Benefits
and Prescription Drug Costs
AGENCY: Office of Personnel Management; Internal Revenue Service,
Department of the Treasury; Employee Benefits Security Administration,
Department of Labor; Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
ACTION: Request for information.
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SUMMARY: This document is a request for information on issues related
to certain reporting requirements under section 204 of Title II of
Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are
applicable to group health plans and health insurance issuers offering
group or individual health insurance coverage. The Departments of
Health and Human Services, Labor, and the Treasury (the Departments)
are issuing this request for information to gather input from the
public regarding implementation considerations for the data collection
required under section 204 of Title II of Division BB of the CAA, and
the associated impact on group health plans and health insurance
issuers. As part of this request for information, the Office of
Personnel Management (OPM) is also seeking input from the public
regarding implementation considerations for the data collection
required under section 204 of Title II of Division BB of the CAA as it
pertains to Federal Employees Health Benefits (FEHB) carriers (whether
or not they are also health insurance issuers). The Departments and OPM
also seek input on specific data elements, including the level of
detail that is feasible to report for entities subject to the data
collection requirements and the associated burdens and potential
compliance costs. Public comments will inform the Departments' and
OPM's implementation of section 204 through rulemaking and the
establishment of processes to receive the required information.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on July 23, 2021.
ADDRESSES: Written comments may be submitted to the addresses specified
below. Any comment that is submitted will be shared among the
Departments and OPM. Please do not submit duplicates.
Comments will be publicly posted on <a href="http://Regulations.gov">Regulations.gov</a>. Warning: Do
not include any personally identifiable information (such as name,
address, or other contact information) or confidential business
information that you do not want publicly disclosed. Comments may be
submitted anonymously.
In commenting, refer to file code CMS-9905-NC. Because of staff and
resource limitations, we cannot accept comments by facsimile (FAX)
transmission.
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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY:
Office of Health Plan Standards and Compliance Assistance, Employee
Benefits Security Administration, US Department of Labor, Attention:
Request for Information Regarding Reporting on Pharmacy Benefits and
Prescription Drug Costs, 200 Constitution Avenue NW, Room N-5653,
Washington, DC 20210.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY:
Office of Health Plan Standards and Compliance Assistance, Employee
Benefits Security Administration, US Department of Labor, Attention:
Request for Information Regarding Reporting on Pharmacy Benefits and
Prescription Drug Costs, 200 Constitution Avenue NW, Room N-5653,
Washington, DC 20210.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Rina Shah, Office of Personnel
Management, at (202) 606-0004.
Christopher J. Dellana, Internal Revenue Service, Department of the
Treasury, at (202) 317-5500.
Matthew Litton, Employee Benefits Security Administration,
Department of Labor, at (202) 693-8335.
Christina Whitefield, Centers for Medicare & Medicaid Services,
Department of Health and Human Services, at (301) 492-4172.
Customer Service Information:
Individuals interested in obtaining information from the Department
of Labor (DOL) concerning employment-based health coverage laws may
call the Employee Benefits Security Administration (EBSA) Toll-Free
Hotline at 1-866-444-EBSA (3272) or visit the DOL's website
(<a href="http://www.dol.gov/agencies/ebsa">www.dol.gov/agencies/ebsa</a>). In addition, information from the
Department of Health and Human Services (HHS) on private health
insurance coverage and non-Federal governmental group health plans can
be found on the Centers for Medicare & Medicaid Services (CMS) website
(<a href="http://www.cms.gov/cciio">www.cms.gov/cciio</a>), and information on health care reform can be found
at <a href="http://www.HealthCare.gov">www.HealthCare.gov</a>.
[[Page 32814]]
Information from OPM on Federal Employees Health Benefits (FEHB) plans
can be found on the OPM website (<a href="http://www.opm.gov/healthcare-insurance">www.opm.gov/healthcare-insurance</a>).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: 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. Comments received before the
close of the comment period are posted on the following website as soon
as possible after they have been received: <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. Follow the search instructions on that website to
view public comments.
I. Background
A. Purpose
In recent years, there has been a broad effort toward promoting
greater price transparency in health care as a means to promote
competition and bring down overall costs. Section 204 of Title II of
Division BB of the CAA added parallel provisions at section 2799A-10 of
the Public Health Service Act (PHS Act), section 725 of the Employee
Retirement Income Security Act of 1974 (ERISA), and section 9825 of the
Internal Revenue Code (Code). These provisions include certain
reporting requirements for group health plans (plans) and health
insurance issuers offering group or individual health insurance
coverage (issuers). The reporting requirements primarily relate to
prescription drug expenditures, requiring that plans and issuers submit
the relevant information to the Departments. The provisions also
require the Departments to issue biannual public reports on
prescription drug reimbursements under group health plans and
individual health insurance coverage, prescription drug pricing trends,
and the impact of prescription drug costs on premium rates, aggregated
in such a way so that no drug or plan specific information will be made
public.
Title I of Division BB also amended 5 U.S.C. 8902(p) to include
specified provisions of the CAA into FEHB carrier contracts. Although
section 204 is not enumerated as a specified provision in section
8902(p), FEHB carrier compliance with the Departments' collection
pursuant to this section helps accomplish the CAA's intended purpose of
achieving national health data transparency and lower costs. Therefore,
references to ``plans'' for purposes of this request for information
include FEHB health benefits plans.
The Departments and OPM are requesting input from the public
regarding implementation of the data collection, the data elements to
be collected, and the associated impact on plans and issuers. Public
input will inform the Departments' and OPM's implementation through
rulemaking and establishment of processes to receive the information
that must be reported. Using the information obtained through this data
collection, the Departments and OPM intend to analyze trends in overall
spending on prescription drugs and other health care services by plans
and issuers and to publish the analysis in the required reports in a
format that the Departments and OPM intend to enable plans and issuers
to ultimately negotiate fairer rates and lower costs for participants,
beneficiaries, and enrollees.
B. Reporting Requirements
By December 27, 2021, and not later than June 1 of each year
thereafter, plans and issuers must submit to the Departments certain
information with respect to the health plan or coverage for the
previous plan year. This includes general information on the plan or
coverage, such as the beginning and end dates of the plan year, the
number of participants, beneficiaries, or enrollees, as applicable, and
each state in which the plan or coverage is offered. Plans and issuers
must also report the 50 most frequently dispensed brand prescription
drugs, and the total number of paid claims for each such drug; the 50
most costly prescription drugs by total annual spending, and the annual
amount spent by the plan or coverage for each such drug; and the 50
prescription drugs with the greatest increase in plan expenditures over
the plan year preceding the plan year that is the subject of the
report, and, for each such drug, the change in amounts expended by the
plan or coverage in each such plan year. Additionally, plans and
issuers must report total spending by the plan or coverage broken down
by the type of health care services; spending on prescription drugs by
the plan or coverage as well as by participants, beneficiaries, and
enrollees, as applicable; and the average monthly premiums paid by
participants, beneficiaries, and enrollees and paid by employers on
behalf of participants, beneficiaries, and enrollees, as applicable.
Plans and issuers must report rebates, fees, and any other remuneration
paid by drug manufacturers to the plan or coverage or its
administrators or service providers, including the amount paid with
respect to each therapeutic class of drugs and for each of the 25 drugs
that yielded the highest amount of rebates and other remuneration under
the plan or coverage from drug manufacturers during the plan year.
Finally, plans and issuers must report any reduction in premiums and
out-of-pocket costs associated with these rebates, fees, or other
remuneration.
C. Public Report and Privacy Protections
Not later than 18 months after the date on which plans and issuers
must first submit the information described in section B and biannually
thereafter, the Departments and OPM will publish on the internet
reports on prescription drug reimbursements under group health plans
and group and individual health insurance coverage, prescription drug
pricing trends, and the role of prescription drug costs in contributing
to premium increases or decreases under such plans or coverage,
aggregated so that no drug or plan specific information is made public.
Furthermore, these reports will not include any confidential or trade
secret information submitted pursuant to the reporting requirements of
PHS Act section 2799A-10, ERISA section 725, and Code section 9825.
II. Solicitation of Comments
The Departments and OPM request comments from all interested
stakeholders to gain a better understanding of the issues related to
compliance with this provision, including reporting on premiums,
enrollment, pharmacy drug benefits, and prescription drug costs, and to
estimate the impact of any potential rules, both generally and with
respect to the following specific areas:
A. General Implementation Concerns
1. What, if any, challenges do plans and issuers anticipate facing
in meeting the statutory reporting obligations? For example, do plans
or issuers currently have access to all the information they are
required to report under PHS Act section 2799-10, ERISA section 725,
and Code section 9825? If not, which statutory data elements are not
readily accessible to plans and issuers, and how could plans and
issuers obtain the information necessary to comply with the reporting
requirements? Are there ways in which the Departments and OPM could
structure the reporting requirements to facilitate compliance?
2. Are FEHB carriers (including those that are also issuers) able
to report data separately for each FEHB plan?
3. After the Departments and OPM finalize rulemaking and publish
the reporting format and instructions, how much time will plans and
issuers need to prepare their data and submit it to the
[[Page 32815]]
Departments and OPM? What data sources are readily available and which
data may take longer to compile? Are there operational, formatting, or
technical considerations that the Departments and OPM should be aware
of that may impact plans' and issuers' abilities to meet the statutory
deadline for reporting?
4. Are there different considerations regarding data reporting by
health insurance issuers versus group health plans that would affect
their ability to comply with the statutory reporting obligations? Among
group health plans, are there different considerations for reporting by
fully-insured versus self-insured plans, or for insured plans with
small group versus large group coverage? Are there different
considerations for reporting FEHB carrier data versus other plans and
issuers? Are there different considerations for reporting of premiums,
spending, and other data by partially-insured group health plans, such
as those that utilize minimum premium, stop-loss, or similar coverage?
Are there special considerations the Departments should take into
account for multiemployer plans, or that OPM should take into account
for policies offered by FEHB carriers that are not issuers?
5. What data reporting tools and systems should the Departments and
OPM consider when deciding on the format of the data collection? What
are the operational advantages and disadvantages of various reporting
formats, such as Excel spreadsheets, fillable PDF forms, or flat files?
How can the Departments and OPM reduce the need for manual data entry?
What are the ways in which the Departments and OPM could implement the
reporting requirements to facilitate compatibility with the systems
most commonly used by plans and issuers?
6. Are there state laws with similar reporting requirements that
could serve as models for implementing the requirements under PHS Act
section 2799A-10, ERISA section 725, and Code section 9825? If so, in
what ways are these state laws directly comparable to PHS Act section
2799A-10, ERISA section 725, and Code section 9825, and what should the
Departments and OPM consider when deviating from the state
requirements?
B. Definitions
1. What considerations should the Departments and OPM take into
account in defining ``rebates, fees, and any other remuneration''?
Should bona fide service fees--for example, administrative fees, data
sharing fees, formulary placement fees, credits, and market share
incentives--be included in this definition? Are there additional fees
that the Departments and OPM should include in this definition? How
should manufacturer copay assistance programs and coupon cards be
accounted for? How should copay accumulator programs be accounted for?
2. What considerations should the Departments and OPM take into
account in defining the term ``pharmacy''? Are there different
considerations for retail pharmacies versus mail order or specialty
pharmacies? Are there different considerations for prescription drugs
dispensed in an inpatient, outpatient, office, home, or other setting?
3. What considerations should the Departments and OPM take into
account in defining the term ``prescription drug''? Should prescription
drugs be identified by National Drug Codes (NDCs)? Are there other
prescription drug classification systems that should be considered,
such as the first nine digits of the NDC, the RxNorm Concept Unique
Identifier (RxCUI), or the United States Pharmacopeia Drug
Classification (USP-DC)? How does the choice of prescription drug
classification influence plan and issuer operational costs?
4. Should there be different definitions of ``prescription drug''
for different elements of the PHS Act section 2799A-10, ERISA section
725, and Code section 9825 data collection, such as the 9-digit NDC for
identifying the 25 drugs with the highest rebates and the RxCUI for
identifying the 50 most costly drugs? What classification systems do
plans and issuers currently use for internal needs and compliance with
reporting requirements other than those under PHS Act section 2799A-10,
ERISA section 725, and Code section 9825?
5. What considerations should the Departments and OPM take into
account in defining the term ``therapeutic class''? How do plans and
issuers currently classify prescription drugs by therapeutic class?
Does the classification method rely on proprietary software, and how
would the choice of therapeutic classification method influence plan
and issuer operational costs?
6. What considerations should the Departments and OPM take into
account in defining ``health care services''? It is preferable to
define the term as a service or bundle of services necessary to treat
an illness (for example, by Diagnosis-Related Group code)? Or would it
be preferable to disaggregate by particular services (for example, by
Current Procedure Technology code)? In what ways could this definition
help reduce burdens or increase the utility of data reporting?
C. Entities That Must Report
1. Are there special considerations for certain types or sizes of
group health plans, such as individual coverage health reimbursement
arrangements and other account-based plans, that make it challenging or
not feasible for these plans to satisfy the reporting requirements?
What are those specific challenges? If exemptions are provided for
certain plans, how might that affect the value of the required public
analysis?
2. Should the Departments expect that self-insured and partially-
insured group health plans will contract with third-party
administrators or other service providers to submit the required data
on their behalf? Is there any relevant information or data that may be
helpful in determining how widespread this approach may be?
3. Are there ways for issuers and plan service providers to submit
data on behalf of multiple plans and coverage options, consistent with
the statutory requirements? What benefit would there be to issuers and
plan service providers having the ability to submit aggregated data as
opposed to reporting information separately for each group health plan,
to the extent consistent with the statutory requirements? What
considerations exist with respect to issuers that participate in the
FEHB Program submitting FEHB-specific data separately as opposed to
including FEHB data in their general book of business?
4. What role, if any, will Pharmacy Benefits Managers (PBMs) play
in furnishing necessary information to plans and issuers, or to the
Departments or OPM? If permitted, would plans and issuers rely on PBMs
to help satisfy their reporting obligations, such as by retaining PBMs
to conduct some or all of the reporting? Could PBMs obtain all the
information required to be reported, including general information on
the plan or coverage, such as the number of participants,
beneficiaries, and enrollees; each state in which the plan or coverage
is offered; monthly premiums paid by employers and by participants,
beneficiaries, and enrollees; total spending on health care services
broken down by type; and the impact on premiums of prescription drug
rebates, fees, and any other remuneration paid by drug manufacturers to
the plan or coverage or its administrators or service providers? If
not, would allowing separate
[[Page 32816]]
reporting forms, modules, or data collection systems for PBMs and
issuers and plan administrators to report such information be
administratively and operationally feasible? How would separate
reporting forms change the costs or burdens associated with compliance?
D. Information Required To Be Reported
1. What considerations are important for plans and issuers in
determining the 50 brand prescription drugs that are most frequently
dispensed by pharmacies for claims paid by the plan or coverage, and
the total number of paid claims for each drug? Should the determination
be based on the number of claims, the number of days' supply, or
something else? Should the unique number of participants,
beneficiaries, or enrollees that received a prescription be taken into
account, and, if so, how?
2. What considerations are important for plans and issuers in
determining the 50 prescription drugs with the greatest increase in
plan expenditures? Should the increase be measured based on the
absolute increase in dollars; percentage increase in price; the
increase relative to another measure, such as overall spending by the
plan or issuer; or something else? What factors should the Departments
and OPM consider in selecting an approach? If the Departments and OPM
define the increase in proportion to the change in overall spending,
should the increase be measured in comparison to total spending or only
to spending on prescription drugs?
3. If the top prescription drugs are identified by RxCUI (or any
classification other than NDC), is it feasible for plans and issuers to
report the required information separately by NDC for each NDC
associated with the given RxCUI?
4. Which data elements can be directly tied to a specific
prescription drug or class of prescription drugs, and which data
elements must be allocated among prescription drugs or prescription
drug classes? If an amount must be allocated, what allocation method(s)
are preferable, and why?
5. What considerations are important for plans and issuers in
determining the 25 drugs that yielded the highest amount of rebates and
other remuneration from drug manufacturers during the plan year? Should
rebates and other remuneration be measured by total dollar amount?
Should rebates and other remuneration be measured in comparison to
another measure, such as total spending on a drug or a unit price? If a
price measure is used, which price measure should be used and why?
6. PHS Act section 2799A-10, ERISA section 725, and Code section
9825 require plans and issuers to report total spending on health care
services separately for hospital costs, health care provider and
clinical service costs (for primary care and specialty care
separately), prescription drug costs, and other medical costs,
including wellness services. Which cost elements should be included in
each category? Should the Departments and OPM collect prescription drug
spending information separately based on the setting of care?
7. Should the Departments collect information separately by market,
state, or employer size? If so, are there data elements that must be
allocated among the categories? What allocation methods should be used?
Are there differences in the capacities of different size entities to
comply with the Departments' and OPM's reporting requirements, or in
the costs and burdens of compliance?
8. What considerations are important for plans and issuers in
measuring the impact of drug manufacturer rebates on premiums and out-
of-pocket costs? What quantitative or qualitative analyses might plans
and issuers perform? What analyses do plans and issuers currently
perform?
9. Should the Departments and OPM collect information on rebates,
fees, and any other remuneration at the total level or broken out by
relevant subcategories? For example, in the PBM Transparency for
Qualified Health Plans (QHPs) data collection,\1\ PBMs will report
information for retained rebates, rebates expected but not yet
received, PBM incentive payments, price concessions for administrative
services from manufacturers, all other price concessions from
manufacturers, amounts received and paid to pharmacies, and spread
amounts for retail and mail order pharmacies. Should the Departments
use the same or similar subcategories for the reporting requirements
under PHS Act section 2799A-10, ERISA section 725, and Code section
9825?
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\1\ Section 1150A of the Social Security Act, and its
implementing regulations at 45 CFR 156.295 and 45 CFR part 184,
require issuers of QHPs or their PBMs to report certain prescription
drug information to HHS.
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10. Are there types of payments that flow from plans, issuers, or
PBMs directly to drug manufacturers? If so, how should these payments
be treated? Should they be netted against rebates and other price
concessions that are received from drug manufacturers?
11. Are there types of rebates and price concessions that are
passed directly to the participant, beneficiary, or enrollee? If so,
how should they be treated? Should they be included or acknowledged in
this data collection?
E. Coordination With Other Reporting Requirements
1. Are there opportunities to remove other reporting requirements
applicable to plans and issuers or to leverage or combine those
requirements with the reporting requirements under PHS Act section
2799A-10, ERISA section 725, and Code section 9825 to reduce
administrative burdens or costs associated with complying with the new
requirements? For example, the Departments are aware that there may be
some overlap between the data subject to collection under PHS Act
section 2799A-10, ERISA section 725, and Code section 9825 and the data
subject to collection in the PBM Transparency for QHPs data
collection,\2\ which requires issuers of QHPs or their PBMs to report
prescription drug information to HHS.
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\2\ Id.
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F. Public Report and Privacy Protections
1. In what ways can the Departments and OPM facilitate use of the
reports by a variety of interested parties, such as government
entities, academics, industry entities, and consumers and their
advocates?
2. Should OPM issue a public report specifically for FEHB carriers?
3. Would the Departments' and OPM's reports have greater value and
utility if data were collected on a calendar year basis, by plan or
policy years, or by some combination, to the extent consistent with the
statutory requirements? If data were to be collected by plan or policy
year, are there any considerations the Departments and OPM should take
into account when determining the plan or policy year effective dates
for reporting periods? For example, what is the last plan or policy
year end date that should be included in data submitted by June 1 of
each year?
4. Are there any examples of similar reports published by state
agencies? If so, what are any strengths or limitations of the reports
published by the state agencies that would be relevant to the
Departments and OPM? In what ways should the Departments and OPM
consider adapting or differentiating the process under PHS Act section
2799A-10, ERISA section 725, and Code section 9825 from any similar
state reporting processes?
5. Should the public report include a comparative analysis of
prescription drug costs for plans and issuers, relative
[[Page 32817]]
to costs under Medicare or in other countries?
G. Regulatory Impact Analysis
1. What benefits, costs, and other impacts do plans, issuers, or
other stakeholders anticipate from the reporting requirements of PHS
Act section 2799A-10, ERISA section 725, and Code section 9825?
2. Are there benefits to academics or other researchers? How will
consumers benefit?
3. What data, research, or other information is available to help
quantify the benefits, costs, and other impacts of the reporting
requirements? Are there existing data, research, or reporting analogues
that could be extrapolated from to predict market impacts?
4. What actions could the Departments and OPM take to minimize the
compliance costs of the reporting requirements?
5. Operationally, which types of employees will be necessary to
ensure compliance with the reporting requirements? Will staff
specialized in medical billing coding be needed for the purpose of
reporting?
6. Will new or additional technology be needed for the collection,
maintenance, or storage of the data to be reported?
7. Will there be coordination costs or benefits from simultaneously
complying with state regulations that require the reporting of medical
services costs or prescription drug costs?
8. Would greater alignment with other Federal reporting
requirements reduce associated compliance costs, and if so, how?
III. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping, or third-party disclosure
requirements under the Paperwork Reduction Act of 1995 (PRA). However,
Section II of this document does contain a general solicitation of
comments in the form of a request for information. In accordance with
the implementing regulations of the 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. Consequently, there is no need for review by the Office of
Management and Budget under the authority of the PRA.
Signed at Washington DC.
Laurie Bodenheimer,
Associate Director, Healthcare and Insurance, Office of Personnel
Management.
Signed at Washington DC.
Rachel D. Levy,
Associate Chief Counsel (Employee Benefits, Exempt Organizations, and
Employment Taxes), Internal Revenue Service, Department of the
Treasury. Signed at Washington DC.
Carol A. Weiser,
Benefits Tax Counsel, Department of the Treasury.
Signed at Washington DC.
Ali Khawar,
Acting Assistant Secretary, Employee Benefits Security Administration,
Department of Labor.
Signed at Washington DC.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-13138 Filed 6-21-21; 8:45 am]
BILLING CODE 4510-29-P; 6523-63-P; 4120-01-P; 4830-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.