[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62496-62498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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.
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    \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.''
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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