83_FR_62729 83 FR 62496 - Patient Protection and Affordable Care Act; Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee Adjustment

83 FR 62496 - Patient Protection and Affordable Care Act; Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee Adjustment

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 233 (December 4, 2018)

Page Range62496-62498
FR Document2018-26332

The U.S. Department of Health and Human Services (HHS) is issuing this final rule to eliminate references to internal Executive Branch procedures provided for under Office of Management and Budget (OMB) circular A-25R in connection with an adjustment to the Federally- facilitated Exchange (FFE) user fee. HHS is amending these regulations because it has determined that an exception to OMB circular A-25R is not required to effectuate the FFE user fee adjustment. Thus, this final rule removes the language that refers to an exception under OMB circular A-25R as an aspect of reducing a participating issuer's FFE user fee obligation. This rule does not affect the ability of an issuer to obtain an applicable reduction in FFE user fee obligations, amend the calculation of the FFE user fee credit provided to a participating issuer, change the application of the monthly user fee adjustment, or alter any of the other standards that participating issuers must meet to qualify for the user fee adjustment.

Federal Register, Volume 83 Issue 233 (Tuesday, December 4, 2018)
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62496-62498]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 156

[CMS-9917-F]
RIN 0938-AT93


Patient Protection and Affordable Care Act; Elimination of 
Internal Agency Process for Implementation of the Federally-Facilitated 
User Fee Adjustment

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

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Health and Human Services (HHS) is 
issuing this final rule to eliminate references to internal Executive 
Branch procedures provided for under Office of Management and Budget 
(OMB) circular A-25R in connection with an adjustment to the Federally-
facilitated Exchange (FFE) user fee. HHS is amending these regulations 
because it has determined that an exception to OMB circular A-25R is 
not required to effectuate the FFE user fee adjustment. Thus, this 
final rule removes the language that refers to an exception under OMB 
circular A-25R as an aspect of reducing a participating issuer's FFE 
user fee obligation. This rule does not affect the ability of an issuer 
to obtain an applicable reduction in FFE user fee obligations, amend 
the calculation of the FFE user fee credit provided to a participating 
issuer, change the application of the monthly user fee adjustment, or 
alter any of the other standards that participating issuers must meet 
to qualify for the user fee adjustment.

DATES: These regulations are effective on January 3, 2019.

FOR FURTHER INFORMATION CONTACT: Jaya Ghildiyal, (301) 492-5149, or 
Adrianne Patterson, (410) 786-0686.

SUPPLEMENTARY INFORMATION:

I. Background

A. Determination To Issue a Final Rule

    The U.S. Department of Health and Human Services (HHS) is 
publishing this final rule without previously publishing a proposed 
rule because HHS has determined that the rule qualifies for exemption 
from notice-and-comment rulemaking under section 553 of the 
Administrative Procedures Act (Pub. L. 79-404, enacted June 11, 1946) 
(APA), both because it is a ``matter relating to agency management'' 
under section 553(a)(2) \1\ and a ``rule of agency organization, 
procedure or practice'' under section 553(b)(3)(A). This rule 
eliminates an unnecessary reference to an internal inter-agency 
process, but makes no changes to the policy or operational processes 
set forth for participating FFE issuers or third parties subject to 45 
CFR 156.50(d), and will have no effect on these entities or the other 
individuals and entities that were subjects of the July 2, 2013 final 
rule ``Coverage of Certain Preventive Services Under the Affordable 
Care Act'' (78 FR 39870), namely eligible organizations, self-insured 
plans of eligible organizations, and participants and beneficiaries of 
those plans.
---------------------------------------------------------------------------

    \1\ Although HHS's predecessor agency, the U.S. Department of 
Health, Education, and Welfare (HEW), waived the APA's exemption to 
the requirement for notice and comment rulemaking for ``public 
property, loans, grants, benefits, or contracts'' in section 
553(a)(2), see ``Public Participation in Rule Making,'' 36 FR 2532 
(Feb. 5, 1971), HEW did not waive the exemption in section 553(a)(2) 
for ``matter[s] relating to agency management or personnel.''
---------------------------------------------------------------------------

B. Legislative and Regulatory Overview

    The Patient Protection and Affordable Care Act (Pub. L. 111-148, 
enacted March 23, 2010) and the Health Care and Education 
Reconciliation Act of 2010 (Pub. L. 111-152, enacted March 30, 2010) 
are collectively referred to as ``PPACA'' in this final rule. Section 
1321(a) of the PPACA provides broad authority for the Secretary to 
establish standards and regulations to implement the statutory 
requirements related to Exchanges, qualified health plans (QHPs), and 
other components of title I of the PPACA. When operating an FFE under 
section 1321(c)(1) of the PPACA, HHS has the authority under sections 
1321(c)(1) and 1311(d)(5)(A) of the PPACA to collect and spend user 
fees. OMB Circular A-25 Revised (OMB Circular A-25R) establishes 
federal

[[Page 62497]]

policy regarding user fees and specifies that a user charge will be 
assessed against each identifiable recipient for special benefits 
derived from federal activities beyond those received by the general 
public.
    Section 2713(a)(4) of the Public Health Service Act, as added by 
the PPACA and incorporated into the Employee Retirement Income Security 
Act of 1974 and the Internal Revenue Code, requires that non-
grandfathered group health plans and health insurance issuers offering 
non-grandfathered group or individual health insurance coverage provide 
certain women's preventive health services as a benefit without cost 
sharing, as provided for in comprehensive guidelines supported by the 
Health Resources and Services Administration. On July 2, 2013, the 
final rule ``Coverage of Certain Preventive Services Under the 
Affordable Care Act'' (78 FR 39870) published by HHS, the Department of 
the Treasury, and the Department of Labor, set forth regulations 
allowing eligible organizations to receive an accommodation relating to 
coverage of contraceptive services, so that they are not required to 
provide, arrange, or pay for these services. Those regulations at 45 
CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A were 
amended, but largely left in place, by interim final rules with 
requests for comments published in the Federal Register on October 13, 
2017, Religious Exemptions and Accommodations for Coverage of Certain 
Preventive Services Under the Affordable Care Act (82 FR 47792) and 
Moral Exemptions and Accommodations for Coverage of Certain Preventive 
Services Under the Affordable Care Act (82 FR 47838) and final rules 
published in the Federal Register on November 15, 2018,with an 
effective date of January 14, 2019, Religious Exemptions and 
Accommodations for Coverage of Certain Preventive Services Under the 
Affordable Care Act (83 FR 57536) and Moral Exemptions and 
Accommodations for Coverage of Certain Preventive Services Under the 
Affordable Care Act (83 FR 57592). The 2013 final regulation also set 
forth processes and standards at Sec.  156.50(c) and (d) to take into 
account the payments for the contraceptive services that are provided 
for participants and beneficiaries in self-insured plans of eligible 
organizations under the accommodation described in that final rule 
through an adjustment in the FFE user fee payable by an issuer 
participating in an FFE, at no cost to plan participants or 
beneficiaries, eligible organizations, third party administrators, or 
issuers.

II. Provisions of the Final Regulations

    This final rule amends the regulations for adjustments of FFE user 
fees set forth at Sec.  156.50, as established in the final rule 
published in the July 2, 2013 Federal Register. HHS is amending Sec.  
156.50(d)(3), to remove the current language providing that an 
authorizing exception under OMB Circular No. A-25R must be in effect in 
order for HHS to provide a participating issuer a reduction in its 
obligation to pay the FFE user fee. HHS will calculate the user fee 
reduction as the sum of the total dollar amount of the payments for 
contraceptive services submitted by applicable third party 
administrators, as described in paragraph (d)(2)(iii)(D), and an 
allowance, specified by HHS, for administrative costs and margin.
    HHS is also amending Sec.  156.50(d)(4) to remove a corresponding 
requirement that an authorizing exception under OMB Circular No. A-25R 
be in effect. If the amount of the reduction under Sec.  156.50(d)(3) 
is greater than the amount of the obligation to pay the FFE user fee in 
a particular month, the participating issuer will be provided a credit 
in succeeding months in the amount of the excess.
    HHS has determined that an exception to OMB Circular No. A-25R is 
not required to be in effect to effectuate the FFE user fee adjustment 
for participating issuers. HHS has implemented an adjustment to FFE 
user fee collections for each benefit year beginning with the 2014 
benefit year, and the adjustment has accounted for less than 2 percent 
of total FFE user fee collections for each benefit year. Therefore, HHS 
continues to believe that the adjustment to FFE user fee collections 
will not materially undermine FFE operations. HHS believes that the 
reduced user fee collections resulting from the adjustment will not 
necessitate an exception to OMB Circular No. A-25R. Subject to HHS's 
standing financial management procedures, HHS will continue to monitor 
user fee collections and expenditures to ensure compliance under OMB 
Circular No. A-25R going forward. Additionally, HHS notes that it has 
not raised the FFE user fee finalized in the annual notice of benefit 
and payment parameters to offset the FFE user fee adjustments for any 
applicable benefit year. HHS estimates that payments for contraceptive 
services will continue to represent only a small portion of total FFE 
user fees in future benefit years, and it does not anticipate that it 
will need to increase the FFE user fee rate to offset the FFE user fee 
adjustment available to participating issuers.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501, et seq.).

IV. Regulatory Impact Analysis

    HHS has examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, 
enacted September 19, 1980) (RFA), section 1102(b) of the Social 
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4, enacted March 22, 1995), Executive Order 13132 on 
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 
804(2)), and Executive Order 13771 on Reducing Regulation and 
Controlling Regulatory Costs. 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 one year).
    This final rule is not ``economically significant'' within the 
meaning of section 3(f)(1) of Executive Order 12866 because it is 
unlikely to have an annual effect of $100 million in any single year. 
In addition, for the reasons noted in this final rule, HHS does not 
believe that this final rule is a major rule under the Congressional 
Review Act.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. This rule would not have a significant impact on 
small businesses.
    In addition, section 1102(b) of the Act requires HHS to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
rule would not have a significant impact on small rural hospitals 
because the amendments

[[Page 62498]]

contained in this final rule do not pertain to hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by state, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $100 million in 1995 dollars, updated annually for 
inflation. In 2018, that threshold is approximately $150 million. HHS 
anticipates this rule would not impact state governments or the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has federalism 
implications. HHS does not anticipate this rule would impose direct 
requirement costs on state or local governments, preempt state law, or 
otherwise have federalism implications.

List of Subjects in 45 CFR Part 156

    Administrative appeals, Administrative practice and procedure, 
Advertising, Advisory Committees, American Indian/Alaska Natives, 
Brokers, Conflict of interest, Consumer protection, Cost-sharing 
reductions, Grant programs-health, Grants administration, Health care, 
Health insurance, Health maintenance organization (HMO), Health 
records, Hospitals, Individuals with disabilities, Loan programs-
health, Organization and functions (Government agencies), Medicaid, 
Payment and collections reports, Public assistance programs, Reporting 
and recordkeeping requirements, State and local governments, Sunshine 
Act, Taxes, Technical assistance, Women, and Youth.
    For the reasons set forth in the preamble, the Department of Health 
and Human Services amends 45 CFR part 156 as set forth below:

PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE 
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES

0
1. The authority citation for part 156 is revised to read as follows:

    Authority: 42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 
18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 
U.S.C. 9701.


0
2. Section 156.50 is amended by revising paragraphs (d)(3) and (4) to 
read as follows:


Sec.  156.50  Financial support.

* * * * *
    (d) * * * * *
    (3) If the requirements set forth in paragraph (d)(2) of this 
section are met, the participating issuer will be provided a reduction 
in its obligation to pay the Federally-facilitated Exchange user fee 
specified in paragraph (c) of this section equal in value to the sum of 
the following:
    (i) The total dollar amount of the payments for contraceptive 
services submitted by the applicable third-party administrators, as 
described in paragraph (d)(2)(iii)(D) of this section; and
    (ii) An allowance for administrative costs and margin. The 
allowance will be no less than 10 percent of the total dollar amount of 
the payments for contraceptive services specified in paragraph 
(d)(3)(i) of this section. HHS will specify the allowance for a 
particular calendar year in the annual HHS notice of benefit and 
payment parameters.
    (4) If the amount of the adjustment under paragraph (d)(3) of this 
section is greater than the amount of the participating issuer's 
obligation to pay the Federally-facilitated Exchange user fee in a 
particular month, the participating issuer will be provided a credit in 
succeeding months in the amount of the excess.
* * * * *

    Dated: November 16, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: November 20, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-26332 Filed 11-30-18; 4:15 pm]
 BILLING CODE 4120-01-P



     62496               Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations

                                                                                                                                                                                 Date certain
                                                                       Community        Effective date authorization/cancellation of sale of     Current effective            Federal assistance
                         State and location                               No.                      flood insurance in community                     map date                  no longer available
                                                                                                                                                                                   in SFHAS

          Monument, Town of, El Paso County ................                080064   June 10, 1975, Emerg; December 18, 1986, Reg;             ......do ...................       Do.
                                                                                       December 7, 2018, Susp.
          Palmer Lake, Town of, El Paso County .............                080065   August 16, 1973, Emerg; July 3, 1978, Reg; De-            ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
                          Region X
     Oregon:
         Bandon, City of, Coos County ............................          410043   October 11, 1974, Emerg; August 15, 1984, Reg;            ......do ...................       Do.
                                                                                       December 7, 2018, Susp.
          Coos Bay, City of, Coos County ........................           410044   August 23, 1974, Emerg; August 1, 1984, Reg; De-          ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
          Coos County, Unincorporated Areas .................               410042   July 7, 1975, Emerg; November 15, 1984, Reg; De-          ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
          Coquille, City of, Coos County ...........................        410045   April 29, 1975, Emerg; September 28, 1984, Reg;           ......do ...................       Do.
                                                                                       December 7, 2018, Susp.
          Lakeside, City of, Coos County ..........................         410278   June 2, 1975, Emerg; August 1, 1984, Reg; De-             ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
          Myrtle Point, City of, Coos County .....................          410047   January 30, 1975, Emerg; July 16, 1984, Reg; De-          ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
          North Bend, City of, Coos County ......................           410048   June 4, 1975, Emerg; August 1, 1984, Reg; De-             ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
          Powers, City of, Coos County ............................         410049   August 6, 1975, Emerg; June 30, 1976, Reg; De-            ......do ...................       Do.
                                                                                       cember 7, 2018, Susp.
       * ......do = Ditto.
       Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.


       Dated: November 16, 2018.                                       language that refers to an exception                       organization, procedure or practice’’
     Eric Letvin,                                                      under OMB circular A–25R as an aspect                      under section 553(b)(3)(A). This rule
     Deputy Assistant Administrator for                                of reducing a participating issuer’s FFE                   eliminates an unnecessary reference to
     Mitigation, Federal Insurance and Mitigation                      user fee obligation. This rule does not                    an internal inter-agency process, but
     Administration—FEMA Resilience,                                   affect the ability of an issuer to obtain                  makes no changes to the policy or
     Department of Homeland Security, Federal                          an applicable reduction in FFE user fee                    operational processes set forth for
     Emergency Management Agency.                                      obligations, amend the calculation of                      participating FFE issuers or third parties
     [FR Doc. 2018–26132 Filed 12–3–18; 8:45 am]                       the FFE user fee credit provided to a                      subject to 45 CFR 156.50(d), and will
     BILLING CODE 9110–12–P                                            participating issuer, change the                           have no effect on these entities or the
                                                                       application of the monthly user fee                        other individuals and entities that were
                                                                       adjustment, or alter any of the other                      subjects of the July 2, 2013 final rule
     DEPARTMENT OF HEALTH AND                                          standards that participating issuers must                  ‘‘Coverage of Certain Preventive
     HUMAN SERVICES                                                    meet to qualify for the user fee                           Services Under the Affordable Care Act’’
                                                                       adjustment.                                                (78 FR 39870), namely eligible
     45 CFR Part 156                                                                                                              organizations, self-insured plans of
                                                                       DATES: These regulations are effective
     [CMS–9917–F]                                                      on January 3, 2019.                                        eligible organizations, and participants
                                                                                                                                  and beneficiaries of those plans.
     RIN 0938–AT93                                                     FOR FURTHER INFORMATION CONTACT: Jaya
                                                                       Ghildiyal, (301) 492–5149, or Adrianne                     B. Legislative and Regulatory Overview
     Patient Protection and Affordable Care                            Patterson, (410) 786–0686.
     Act; Elimination of Internal Agency                                                                                             The Patient Protection and Affordable
                                                                       SUPPLEMENTARY INFORMATION:                                 Care Act (Pub. L. 111–148, enacted
     Process for Implementation of the
     Federally-Facilitated User Fee                                    I. Background                                              March 23, 2010) and the Health Care
     Adjustment                                                                                                                   and Education Reconciliation Act of
                                                                       A. Determination To Issue a Final Rule                     2010 (Pub. L. 111–152, enacted March
     AGENCY:  Centers for Medicare &                                     The U.S. Department of Health and                        30, 2010) are collectively referred to as
     Medicaid Services (CMS), Department                               Human Services (HHS) is publishing                         ‘‘PPACA’’ in this final rule. Section
     of Health and Human Services (HHS).                               this final rule without previously                         1321(a) of the PPACA provides broad
     ACTION: Final rule.                                               publishing a proposed rule because                         authority for the Secretary to establish
                                                                       HHS has determined that the rule                           standards and regulations to implement
     SUMMARY:   The U.S. Department of                                 qualifies for exemption from notice-and-                   the statutory requirements related to
     Health and Human Services (HHS) is                                comment rulemaking under section 553                       Exchanges, qualified health plans
     issuing this final rule to eliminate                              of the Administrative Procedures Act                       (QHPs), and other components of title I
     references to internal Executive Branch                           (Pub. L. 79–404, enacted June 11, 1946)                    of the PPACA. When operating an FFE
     procedures provided for under Office of                           (APA), both because it is a ‘‘matter                       under section 1321(c)(1) of the PPACA,
     Management and Budget (OMB) circular                              relating to agency management’’ under                      HHS has the authority under sections
     A–25R in connection with an                                       section 553(a)(2) 1 and a ‘‘rule of agency                 1321(c)(1) and 1311(d)(5)(A) of the
     adjustment to the Federally-facilitated                                                                                      PPACA to collect and spend user fees.
     Exchange (FFE) user fee. HHS is                                      1 Although HHS’s predecessor agency, the U.S.
                                                                                                                                  OMB Circular A–25 Revised (OMB
     amending these regulations because it                             Department of Health, Education, and Welfare               Circular A–25R) establishes federal
     has determined that an exception to                               (HEW), waived the APA’s exemption to the
                                                                       requirement for notice and comment rulemaking for
     OMB circular A–25R is not required to                             ‘‘public property, loans, grants, benefits, or             1971), HEW did not waive the exemption in section
     effectuate the FFE user fee adjustment.                           contracts’’ in section 553(a)(2), see ‘‘Public             553(a)(2) for ‘‘matter[s] relating to agency
     Thus, this final rule removes the                                 Participation in Rule Making,’’ 36 FR 2532 (Feb. 5,        management or personnel.’’



VerDate Sep<11>2014      16:14 Dec 03, 2018       Jkt 247001     PO 00000   Frm 00048    Fmt 4700    Sfmt 4700   E:\FR\FM\04DER1.SGM       04DER1


                      Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations                                        62497

     policy regarding user fees and specifies                eligible organizations, third party                   fee rate to offset the FFE user fee
     that a user charge will be assessed                     administrators, or issuers.                           adjustment available to participating
     against each identifiable recipient for                                                                       issuers.
                                                             II. Provisions of the Final Regulations
     special benefits derived from federal
                                                                This final rule amends the regulations             III. Collection of Information
     activities beyond those received by the
                                                             for adjustments of FFE user fees set                  Requirements
     general public.
        Section 2713(a)(4) of the Public                     forth at § 156.50, as established in the                This document does not impose
     Health Service Act, as added by the                     final rule published in the July 2, 2013              information collection requirements,
                                                             Federal Register. HHS is amending                     that is, reporting, recordkeeping, or
     PPACA and incorporated into the
                                                             § 156.50(d)(3), to remove the current                 third-party disclosure requirements.
     Employee Retirement Income Security
                                                             language providing that an authorizing                Consequently, there is no need for
     Act of 1974 and the Internal Revenue
                                                             exception under OMB Circular No. A–                   review by the Office of Management and
     Code, requires that non-grandfathered
                                                             25R must be in effect in order for HHS                Budget under the authority of the
     group health plans and health insurance
                                                             to provide a participating issuer a                   Paperwork Reduction Act of 1995 (44
     issuers offering non-grandfathered
                                                             reduction in its obligation to pay the                U.S.C. 3501, et seq.).
     group or individual health insurance
                                                             FFE user fee. HHS will calculate the
     coverage provide certain women’s                                                                              IV. Regulatory Impact Analysis
                                                             user fee reduction as the sum of the total
     preventive health services as a benefit
                                                             dollar amount of the payments for                        HHS has examined the impact of this
     without cost sharing, as provided for in                contraceptive services submitted by
     comprehensive guidelines supported by                                                                         rule as required by Executive Order
                                                             applicable third party administrators, as             12866 on Regulatory Planning and
     the Health Resources and Services                       described in paragraph (d)(2)(iii)(D), and
     Administration. On July 2, 2013, the                                                                          Review (September 30, 1993), Executive
                                                             an allowance, specified by HHS, for                   Order 13563 on Improving Regulation
     final rule ‘‘Coverage of Certain                        administrative costs and margin.
     Preventive Services Under the                                                                                 and Regulatory Review (January 18,
                                                                HHS is also amending § 156.50(d)(4)                2011), the Regulatory Flexibility Act
     Affordable Care Act’’ (78 FR 39870)                     to remove a corresponding requirement
     published by HHS, the Department of                                                                           (Pub. L. 96–354, enacted September 19,
                                                             that an authorizing exception under                   1980) (RFA), section 1102(b) of the
     the Treasury, and the Department of                     OMB Circular No. A–25R be in effect. If
     Labor, set forth regulations allowing                                                                         Social Security Act, section 202 of the
                                                             the amount of the reduction under
     eligible organizations to receive an                                                                          Unfunded Mandates Reform Act of 1995
                                                             § 156.50(d)(3) is greater than the amount
     accommodation relating to coverage of                                                                         (Pub. L. 104–4, enacted March 22,
                                                             of the obligation to pay the FFE user fee
     contraceptive services, so that they are                                                                      1995), Executive Order 13132 on
                                                             in a particular month, the participating
     not required to provide, arrange, or pay                                                                      Federalism (August 4, 1999), the
                                                             issuer will be provided a credit in
     for these services. Those regulations at                                                                      Congressional Review Act (5 U.S.C.
                                                             succeeding months in the amount of the
     45 CFR 147.131, 26 CFR 54.9815–                                                                               804(2)), and Executive Order 13771 on
                                                             excess.
     2713A, and 29 CFR 2590.715–2713A                           HHS has determined that an                         Reducing Regulation and Controlling
     were amended, but largely left in place,                exception to OMB Circular No. A–25R                   Regulatory Costs. Executive Orders
     by interim final rules with requests for                is not required to be in effect to                    12866 and 13563 direct agencies to
     comments published in the Federal                       effectuate the FFE user fee adjustment                assess all costs and benefits of available
     Register on October 13, 2017, Religious                 for participating issuers. HHS has                    regulatory alternatives and, if regulation
     Exemptions and Accommodations for                       implemented an adjustment to FFE user                 is necessary, to select regulatory
     Coverage of Certain Preventive Services                 fee collections for each benefit year                 approaches that maximize net benefits
     Under the Affordable Care Act (82 FR                    beginning with the 2014 benefit year,                 (including potential economic,
     47792) and Moral Exemptions and                         and the adjustment has accounted for                  environmental, public health and safety
     Accommodations for Coverage of                          less than 2 percent of total FFE user fee             effects, distributive impacts, and
     Certain Preventive Services Under the                   collections for each benefit year.                    equity). A regulatory impact analysis
     Affordable Care Act (82 FR 47838) and                   Therefore, HHS continues to believe                   must be prepared for major rules with
     final rules published in the Federal                    that the adjustment to FFE user fee                   economically significant effects ($100
     Register on November 15, 2018,with an                   collections will not materially                       million or more in any one year).
     effective date of January 14, 2019,                     undermine FFE operations. HHS                            This final rule is not ‘‘economically
     Religious Exemptions and                                believes that the reduced user fee                    significant’’ within the meaning of
     Accommodations for Coverage of                          collections resulting from the                        section 3(f)(1) of Executive Order 12866
     Certain Preventive Services Under the                   adjustment will not necessitate an                    because it is unlikely to have an annual
     Affordable Care Act (83 FR 57536) and                   exception to OMB Circular No. A–25R.                  effect of $100 million in any single year.
     Moral Exemptions and                                    Subject to HHS’s standing financial                   In addition, for the reasons noted in this
     Accommodations for Coverage of                          management procedures, HHS will                       final rule, HHS does not believe that
     Certain Preventive Services Under the                   continue to monitor user fee collections              this final rule is a major rule under the
     Affordable Care Act (83 FR 57592). The                  and expenditures to ensure compliance                 Congressional Review Act.
     2013 final regulation also set forth                    under OMB Circular No. A–25R going                       The RFA requires agencies to analyze
     processes and standards at § 156.50(c)                  forward. Additionally, HHS notes that it              options for regulatory relief of small
     and (d) to take into account the                        has not raised the FFE user fee finalized             businesses. This rule would not have a
     payments for the contraceptive services                 in the annual notice of benefit and                   significant impact on small businesses.
     that are provided for participants and                  payment parameters to offset the FFE                     In addition, section 1102(b) of the Act
     beneficiaries in self-insured plans of                  user fee adjustments for any applicable               requires HHS to prepare a regulatory
     eligible organizations under the                        benefit year. HHS estimates that                      impact analysis if a rule may have a
     accommodation described in that final                   payments for contraceptive services will              significant impact on the operations of
     rule through an adjustment in the FFE                   continue to represent only a small                    a substantial number of small rural
     user fee payable by an issuer                           portion of total FFE user fees in future              hospitals. This rule would not have a
     participating in an FFE, at no cost to                  benefit years, and it does not anticipate             significant impact on small rural
     plan participants or beneficiaries,                     that it will need to increase the FFE user            hospitals because the amendments


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     62498            Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations

     contained in this final rule do not                     § 156.50    Financial support.                        ACTION:   Final rule.
     pertain to hospitals.                                   *       *     *    *     *
       Section 202 of the Unfunded                              (d) * * * * *                                      SUMMARY:  DoD is issuing a final rule
     Mandates Reform Act of 1995 also                           (3) If the requirements set forth in               amending the Defense Federal
     requires that agencies assess anticipated               paragraph (d)(2) of this section are met,             Acquisition Regulation Supplement
     costs and benefits before issuing any                   the participating issuer will be provided             (DFARS) to implement a section of the
     rule that may result in expenditure in                  a reduction in its obligation to pay the              National Defense Authorization Act for
     any 1 year by state, local, or tribal                   Federally-facilitated Exchange user fee               Fiscal Year 2018 that repeals the Fiscal
     governments, in the aggregate, or by the                specified in paragraph (c) of this section            Year 2015 restrictions on the source of
     private sector, of $100 million in 1995                 equal in value to the sum of the                      photovoltaic devices in contracts
     dollars, updated annually for inflation.                following:                                            awarded by DoD that result in DoD
     In 2018, that threshold is approximately                   (i) The total dollar amount of the                 ownership of photovoltaic devices by
     $150 million. HHS anticipates this rule                 payments for contraceptive services                   means other than DoD purchase of the
     would not impact state governments or                   submitted by the applicable third-party               photovoltaic devices as end products.
     the private sector.                                     administrators, as described in                       DATES: Effective December 5, 2018.
       Executive Order 13132 establishes                     paragraph (d)(2)(iii)(D) of this section;             FOR FURTHER INFORMATION CONTACT: Ms.
     certain requirements that an agency                     and                                                   Amy G. Williams, telephone 571–372–
     must meet when it issues a proposed                        (ii) An allowance for administrative               6106.
     rule (and subsequent final rule) that                   costs and margin. The allowance will be
     imposes substantial direct requirement                                                                        SUPPLEMENTARY INFORMATION:
                                                             no less than 10 percent of the total
     costs on state and local governments,                   dollar amount of the payments for                     I. Background
     preempts state law, or otherwise has                    contraceptive services specified in
     federalism implications. HHS does not                                                                            DoD published a proposed rule in the
                                                             paragraph (d)(3)(i) of this section. HHS              Federal Register at 83 FR 42822 on
     anticipate this rule would impose direct                will specify the allowance for a
     requirement costs on state or local                                                                           August 24, 2018, to implement section
                                                             particular calendar year in the annual                813(b) of the National Defense
     governments, preempt state law, or                      HHS notice of benefit and payment
     otherwise have federalism implications.                                                                       Authorization Act (NDAA) for Fiscal
                                                             parameters.                                           Year (FY) 2018 (Pub. L. 115–91). Section
     List of Subjects in 45 CFR Part 156                        (4) If the amount of the adjustment                813(b) repeals section 858 of the NDAA
       Administrative appeals,                               under paragraph (d)(3) of this section is             for FY 2015 (Pub. L. 113–291), but does
     Administrative practice and procedure,                  greater than the amount of the                        not repeal section 846 of the NDAA for
     Advertising, Advisory Committees,                       participating issuer’s obligation to pay              FY 2011 (Pub. L. 111–383), with regard
     American Indian/Alaska Natives,                         the Federally-facilitated Exchange user               to sources of photovoltaic devises
     Brokers, Conflict of interest, Consumer                 fee in a particular month, the                        purchased by contractors that become
     protection, Cost-sharing reductions,                    participating issuer will be provided a               property of DoD. There were no public
     Grant programs-health, Grants                           credit in succeeding months in the                    comments submitted in response to the
     administration, Health care, Health                     amount of the excess.                                 proposed rule. There are no changes
     insurance, Health maintenance                           *       *     *    *     *                            from the proposed rule in the final rule.
     organization (HMO), Health records,                       Dated: November 16, 2018.
     Hospitals, Individuals with disabilities,                                                                     II. Applicability to Contracts at or
                                                             Seema Verma,                                          Below the Simplified Acquisition
     Loan programs-health, Organization and                  Administrator, Centers for Medicare &
     functions (Government agencies),                                                                              Threshold and for Commercial Items,
                                                             Medicaid Services.                                    Including Commercially Available Off-
     Medicaid, Payment and collections                         Dated: November 20, 2018.
     reports, Public assistance programs,                                                                          the-Shelf Items
                                                             Alex M. Azar II,
     Reporting and recordkeeping                                                                                      This rule does not affect the
     requirements, State and local                           Secretary, Department of Health and Human             applicability of DFARS clause 252.225–
                                                             Services.
     governments, Sunshine Act, Taxes,                                                                             7017, Photovoltaic Devices, and DFARS
                                                             [FR Doc. 2018–26332 Filed 11–30–18; 4:15 pm]
     Technical assistance, Women, and                                                                              provision 252.225–7018, Photovoltaic
     Youth.                                                  BILLING CODE 4120–01–P                                Devices—Certification. A determination
       For the reasons set forth in the                                                                            was signed by the Director, Defense
     preamble, the Department of Health and                                                                        Procurement and Acquisition Policy, on
     Human Services amends 45 CFR part                       DEPARTMENT OF DEFENSE                                 October 13, 2011, to not apply the
     156 as set forth below:                                                                                       requirements of section 846 of the
                                                             Defense Acquisition Regulations                       NDAA for FY 2011 to contracts at or
     PART 156—HEALTH INSURANCE                               System                                                below the simplified acquisition
     ISSUER STANDARDS UNDER THE                                                                                    threshold, but to apply the rule to
     AFFORDABLE CARE ACT, INCLUDING                          48 CFR Parts 212, 225, and 252                        contracts for the acquisition of
     STANDARDS RELATED TO                                    [Docket DARS–2018–0028]                               commercial items, including
     EXCHANGES                                                                                                     commercially available off-the-shelf
                                                             RIN 0750–AJ71
                                                                                                                   items.
     ■  1. The authority citation for part 156
     is revised to read as follows:                          Defense Federal Acquisition                           III. Executive Orders 12866 and 13563
       Authority: 42 U.S.C. 18021–18024, 18031–
                                                             Regulation Supplement: Sunset of
                                                             Provision Relating to the Procurement                    Executive Orders (E.O.s) 12866 and
     18032, 18041–18042, 18044, 18054, 18061,                                                                      13563 direct agencies to assess all costs
     18063, 18071, 18082, 26 U.S.C. 36B, and 31              of Certain Goods (DFARS Case 2018–
                                                             D007)                                                 and benefits of available regulatory
     U.S.C. 9701.
                                                                                                                   alternatives and, if regulation is
     ■ 2. Section 156.50 is amended by                       AGENCY: Defense Acquisition                           necessary, to select regulatory
     revising paragraphs (d)(3) and (4) to                   Regulations System, Department of                     approaches that maximize net benefits
     read as follows:                                        Defense (DoD).                                        (including potential economic,


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Document Created: 2018-12-04 00:42:27
Document Modified: 2018-12-04 00:42:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThese regulations are effective on January 3, 2019.
ContactJaya Ghildiyal, (301) 492-5149, or Adrianne Patterson, (410) 786-0686.
FR Citation83 FR 62496 
RIN Number0938-AT93
CFR AssociatedAdministrative Appeals; Administrative Practice and Procedure; Advertising; Advisory Committees; American Indian/Alaska Natives; Brokers; Conflict of Interest; Consumer Protection; Cost-Sharing Reductions; Grant Programs-Health; Grants Administration; Health Care; Health Insurance; Health Maintenance Organization (Hmo); Health Records; Hospitals; Individuals with Disabilities; Loan Programs-Health; Organization and Functions (Government Agencies); Medicaid; Payment and Collections Reports; Public Assistance Programs; Reporting and Recordkeeping Requirements; State and Local Governments; Sunshine Act; Taxes; Technical Assistance; Women and Youth

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