Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan Premiums, 15240-15245 [2014-06031]
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methylethyl)-1-(1H-1,2,4-triazol-1ylmethyl)cyclopentanol) in or on
vegetable, legume, group 6 at 0.01 ppm.
EPA is revising the tolerance expression
for ipconazole to clarify that metabolites
and degradates are covered by the
tolerances and to specify how
compliance with the tolerances is to be
measured. The existing tolerances for
pea and bean, dried shelled, except
soybean, subgroup 6C at 0.01 ppm and
soybean, seed at 0.01 ppm will be
removed from paragraph (a) of § 180.646
as these tolerances are encompassed
within vegetable, legume, group 6.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
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government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
§ 180.646 Ipconazole; tolerances for
residues.
VII. Congressional Review Act
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 12, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.646:
a. Revise the introductory text in
paragraph (a).
■ b. Remove ‘‘Pea and bean, dried
shelled, except soybean, subgroup 6C’’,
and ‘‘Soybean, seed’’ from the table in
paragraph (a).
■ c. Add alphabetically ‘‘Vegetable,
legume, group 6’’ to the table in
paragraph (a).
The amendments read as follows:
■
■
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(a) General. Tolerances are
established for residues of ipconazole,
including its metabolites and
degradates, in or on the commodities
listed in the table below. Compliance
with the tolerance levels specified
below is to be determined by measuring
only ipconazole (2-[(4chlorophenyl)methyl]-5-(1methylethyl)-1-(1H-1,2,4-triazol-1ylmethyl)cyclopentanol) in or on the
commodity.
Parts per
million
Commodity
*
*
*
Vegetable, legume, group 6
*
*
*
*
*
*
0.01
*
[FR Doc. 2014–06059 Filed 3–18–14; 8:45 am]
BILLING CODE 6560–50–P
45 CFR Part 156
[CMS–9943–IFC]
RIN 0938–AS28
Patient Protection and Affordable Care
Act; Third Party Payment of Qualified
Health Plan Premiums
Centers for Medicare and
Medicaid Services, Department of
Health and Human Services (HHS).
ACTION: Interim final rule with comment
period.
AGENCY:
This interim final rule
requires issuers of qualified health plans
(QHPs), including stand-alone dental
plans (SADPs), to accept premium and
cost-sharing payments made on behalf
of enrollees by the Ryan White HIV/
AIDS Program, other Federal and State
government programs that provide
premium and cost sharing support for
specific individuals, and Indian tribes,
tribal organizations, and urban Indian
organizations.
SUMMARY:
Effective Date: This interim final
rule is effective on March 14, 2014.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
May 13, 2014.
ADDRESSES: In commenting, please refer
to file code CMS–9943–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission. You may submit
DATES:
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Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Rules and Regulations
comments in one of four ways (please
choose only one of the ways listed).
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–9943–IFC, P.O. Box 8016,
Baltimore, MD 21244–8016. Please
allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–9943–IFC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses prior to the close of
the comment period:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201. (Because access
to the interior of the Hubert H.
Humphrey Building is not readily
available to persons without federal
government identification, commenters
are encouraged to leave their comments
in the CMS drop slots located in the
main lobby of the building. A stamp-in
clock is available for persons wishing to
retain a proof of filing by stamping in
and retaining an extra copy of the
comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your comments
to the Baltimore address, call telephone
number (410) 786–7195 in advance to
schedule your arrival with one of our
staff members. Comments erroneously
mailed to the addresses indicated as
appropriate for hand or courier delivery
may be delayed and received after the
comment period. For information on
viewing public comments, see the
beginning of the SUPPLEMENTARY
INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Leigha Basini, (301) 492–4380 for
questions related to this rule.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
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received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://regulations.gov.
Follow the search instructions on that
Web site to view public comments.
Comments received timely also will be
available for public inspection as they
are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
The Patient Protection and Affordable
Care Act (Pub. L. 111–148) was enacted
on March 23, 2010. The Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152), which amended and
revised several provisions of the Patient
Protection and Affordable Care Act, was
enacted on March 30, 2010. In this final
rule, we refer to the two statutes
collectively as the ‘‘Affordable Care
Act.’’
As of October 1, 2013, for coverage
that started as early as January 1, 2014,
qualified individuals and qualified
employers have been able to enroll in
QHPs and SADPs—private health and
dental insurance that has been certified
as meeting certain standards—through
competitive Marketplaces called
‘‘Exchanges’’ or ‘‘health insurance
Marketplaces.’’ The word ‘‘Exchanges’’
refers to both State Exchanges, also
called State-based Exchanges (SBEs),
and Federally-facilitated Exchanges
(FFEs). In this final rule, when we refer
to ‘‘FFEs,’’ we are also referring to State
Partnership Exchanges. CMS has
implemented Affordable Care Act
provisions through regulations codified
in title 45 of the Code of Federal
Regulations (CFR), and, unless
otherwise indicated, all regulatory
references herein are to that title.
In the individual market Exchanges,
premium and cost-sharing payment
arrangements are generally managed
directly between QHP and SADP issuers
and enrollees. For those QHP enrollees
eligible for advance payments of the
premium tax credit and cost-sharing
reductions, the federal government
makes applicable payments to QHP
issuers.
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CMS has issued ‘‘Frequently Asked
Questions’’ or ‘‘FAQs’’ with respect to
premium and cost-sharing payments
made by third parties on behalf of QHP
enrollees. In a FAQ issued on November
4, 2013 (the November FAQ),1 CMS
encouraged QHP issuers not to accept
third-party payments from hospitals,
other healthcare providers, and other
commercial entities due to concerns that
such practices could skew the insurance
risk pool and create an unlevel field in
the Exchanges.
On February 7, 2014, CMS issued
additional FAQs (the February FAQs)
clarifying that the November FAQ was
not intended to discourage QHP issuers
from accepting third party premium and
cost-sharing payments made by Indian
tribes, tribal organizations, and urban
Indian organizations, as well as by state
and federal government programs (such
as the Ryan White HIV/AIDS Program).2
CMS affirmatively encouraged QHP
issuers to accept such payments given
that federal or state law or policy
specifically envisions third party
payment of premium and cost-sharing
amounts by these entities.
Specifically, the Ryan White HIV/
AIDS Program plays a critical role in
ensuring that people living with HIV in
the United States have access to lifesaving antiretroviral medications,
serving over 550,000 people living with
HIV annually. Medication access is
provided through both payment for
medication and payment of insurance
premiums and cost-sharing when such
assistance is cost effective for the Ryan
White HIV/AIDS Program. The Ryan
White HIV/AIDS Program has been
authorized to provide insurance
assistance for low-income people living
with HIV since 1990 under section 2615
of the Public Health Service Act, as
added by the Ryan White
Comprehensive AIDS Resources
Emergency (CARE) Act (Pub. L. 101–
381, title II, § 201, Aug. 18, 1990).
Section 2616(f) of the Public Health
Service Act provides authority for states
to use AIDS Drug Assistance Program
grant funds to purchase or maintain
health insurance or plans when the
coverage includes the relevant
therapeutics and the cost of such
coverage does not exceed the costs of
otherwise providing them directly. This
provision was added in 2000 as
subsection (e) by the Ryan White CARE
Act Amendments of 2000 (Pub. L. 106–
1 https://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/third-party-qa-11-042013.pdf.
2 https://www.cms.gov/CCIIO/Resources/FactSheets-and-FAQs/Downloads/third-partypayments-of-premiums-for-qualified-health-plansin-the-marketplaces-2-7-14.pdf.
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345, § 204(b)) and was subsequently
renumbered to (f) in 2006. Through
Policy Notices 99–01, 7–05, and most
recently 13–04, 13–05 and 13–06, the
Health Resources and Services
Administration HIV/AIDS Bureau has
provided guidance to grantees
reiterating that the funds awarded under
the Parts A, B, and C of the Ryan White
HIV/AIDS Program may be used to
support a health insurance premium
and costs-sharing assistance program as
a core medical service for eligible lowincome people living with HIV when it
is cost-effective for the program. Ryan
White HIV/AIDS Program funds are
payer-of-last-resort funds and may be
used for public or private health
insurance premiums, as well as costsharing (for example, deductibles,
copayments, and coinsurance). In fiscal
year 2013, the Ryan White HIV/AIDS
Program AIDS Drug Assistance Program
paid $397,245,305 in premium
assistance to issuers on behalf of
program beneficiaries. As of June 2013,
the Ryan White HIV/AIDS Program
AIDS Drug Assistance Program provided
premium assistance for 52,568 people
living with HIV. These premium
assistance expenditures were paid
directly to issuers.
In addition, section 1312 of the
Affordable Care Act, section 402 of the
Indian Health Care Improvement Act,
and 45 CFR 155.240(b) provides that
Exchanges may permit Indian tribes,
tribal organizations, and urban Indian
organizations to pay aggregated QHP
premiums on behalf of qualified
individuals, subject to terms and
conditions determined by the Exchange.
In the past, a number of tribes have
provided premium assistance to tribal
members eligible to enroll in the
Medicare Part D program. These
arrangements have resulted in an
increase in the number of tribal
members enrolled in Medicare Part D.
Building from that experience, these
same arrangements are being replicated
by tribes and tribal organizations in
providing premium assistance to
qualified individuals for QHPs in the
Exchanges. Under these arrangements
tribes aggregate premium payments to
issuers and reduce their administrative
costs.
II. Provisions of the Interim Final Rule
We have become aware that, despite
related policy clarifications, some QHP
issuers continue to reject payments of
premium and cost sharing by the Ryan
White HIV/AIDS Program. In particular,
this QHP issuer practice is causing
access problems for persons who rely on
the Ryan White HIV/AIDS Program for
assistance. Accordingly, we are
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promulgating a new requirement at
§ 156.1250 that QHP and SADPs must
accept third party premium and cost
sharing payments from the Ryan White
HIV/AIDS Program.
To ensure that individuals reliant on
programs similar to the Ryan White
HIV/AIDS Program are not being
adversely affected by QHPs’ and SADPs’
refusal to accept third party premium
and cost-sharing payments, we are
including within the new requirement
that QHPs and SADPs must accept third
party premium and cost-sharing
payments from the following other
entities in addition to the Ryan White
HIV/AIDS Program: Indian tribes, tribal
organizations, and urban Indian
organizations; and state and federal
government programs. This standard
applies to all individual market QHPs
and SADPs, regardless of whether they
are offered through an FFE, an SBE, or
outside of the Exchanges.
Our new standard does not prevent
QHPs and SADPs from having
contractual prohibitions on accepting
payments of premium and cost sharing
from third party payers other than those
specified in this interim final regulation.
In particular, as stated in our November
FAQ, we remain concerned that third
party payments of premium and cost
sharing provided by hospitals, other
healthcare providers, and other
commercial entities could skew the
insurance risk pool and create an
unlevel competitive field in the
insurance market. We continue to
discourage such third party payments of
premiums and cost sharing, and we
encourage QHPs and SADPs to reject
these payments.
We are also amending § 156.805 to
ensure that new § 156.1250 can be
enforced. Enforcement of FFE issuer
standards and requirements is governed
by § 156.800 through § 156.810. In the
August 30, 2013 Program Integrity Rule
(78 FR 54070, 54143), we established
the bases for HHS to impose civil money
penalties (CMPs) against QHP issuers
for violations of certain standards
applicable to issuers offering QHPs in
the FFEs. In § 156.805(a), we set forth
the grounds for imposing CMPs. Since
the publication of that final rule, we
noted that certain paragraphs under
these sections should be clarified and,
in some instances, technical corrections
are necessary, to properly reflect when
these enforcement remedies will apply.
These clarifications and corrections are
specifically necessary to reflect that
these enforcement remedies will apply
to violations of § 156.1250. For example,
under paragraph (1), the word
‘‘including’’ was inadvertently omitted
from the phrase ‘‘misconduct in the
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Federally-facilitated Exchange or
substantial non-compliance with the
Exchange standards applicable to
issuers offering QHPs in the Federallyfacilitated Exchange [including] under
subparts C through G of part 153 of this
subchapter.’’ This same phrase also
inadvertently referenced specific
subparts within part 153, including
subparts C and D, which contain
standards and requirements for States in
relation to the reinsurance and risk
adjustment programs. We are therefore
amending paragraph (1) so that it
correctly provides that § 156.805 targets
violations of issuer standards and
requirements of part 153 that are
applicable to issuers. We are also
making changes to clarify that
substantial non-compliance with any
Exchange standard or requirement
applicable to issuers in the FFE is
grounds for imposing CMPs and that
reference to specific subparts of part 153
was not intended to be limit the types
of QHP standards and requirements for
which enforcement under this section
would be available. We are further
amending paragraph (1) to add an
explicit reference to part 156, to clarify
that substantial non-compliance with
the Exchange standards applicable to
issuers offering QHPs in the FFEs under
part 156, including new § 156.1250, may
be a basis for the imposition of CMPs
under § 156.805.
Accordingly, failure to comply with
the requirement to accept third party
payments in accordance with § 156.1250
could constitute a violation of
§ 156.805(a)(1) as ‘‘substantial noncompliance with [an] Exchange
standard[].’’ Depending upon the
circumstances, a QHP or SADP issuer’s
failure to comply with § 156.1250 could
also fall under § 156.805(a)(4) as a
‘‘practice that would reasonably be
expected to have the effect of denying
or discouraging enrollment into a QHP
offered by the issuer (except as
permitted by this part) by qualified
individuals whose medical condition or
history indicates the potential for a
future need for significant medical
services or items.’’ Under § 156.805(c),
an issuer offering a QHP or SADP
through an FFE may be subject to a
maximum penalty of $100 per day, per
each individual who is adversely
affected by the QHP or SADP issuer’s
non-compliance.
Issuers offering QHPs or SADPs
through an SBE or outside of the
Exchanges would be subject to any
penalties that the SBE or the state has
established to address issuer noncompliance with general QHP and
SADP standards and requirements
under part 156, Subpart M, in addition
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to any other SBE-specific or statespecific enforcement.
Qualified individuals in states with
an FFE or SPE who are affected by a
QHP’s or SADP’s violation of this new
requirement, either because they are
unable to effectuate coverage because an
issuer will not accept the third party
premium payments which the
individual needs to be able to make a
complete payment of the premium
within the open enrollment time frame,
or because they lose coverage due to the
issuer’s refusal to accept the required
third-party premium or cost-sharing
payments from entities described in 45
CFR 156.1250, may be eligible for an
FFE special enrollment period (SEP) in
accordance with § 155.420(d)(9) and a
certificate of exemption under
§ 155.605(g)(1)(iii). CMS will issue
additional guidance in the near future
clarifying the specific criteria for
obtaining the SEP or hardship
exemption. We also encourage all SBEs
to grant an SEP and certificate of
exemption under these circumstances.
We continue to consider making
additional regulatory changes to QHP
and SADP issuer responsibilities to
ensure that QHPs and SADPs accept
third party premium and cost-sharing
payments from the Ryan White HIV/
AIDS Program, other state and federal
government programs that support
premium and cost sharing, and Indian
tribes, tribal organizations, and urban
Indian organizations.
III. Waiver of Proposed Rulemaking
and Waiver of Delay in Effective Date
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule before publishing a
final rule that responds to comments
and sets forth final regulations that
generally take effect at least thirty days
later. This procedure can be waived,
however, if an agency finds good cause
that a notice-and-comment procedure is
impracticable, unnecessary, or contrary
to the public interest and incorporates a
statement of the finding and its reasons
in the rule issued. CMS for good cause,
under 5 U.S.C. 553(b)(B), finds that the
notice-and-comment requirements of
the Administrative Procedure Act (APA)
would be impracticable and contrary to
the public interest given that a delay in
coverage for people who rely on one of
the third parties noted in the regulation
to pay their premiums could result in
worsening medical conditions. Further,
there is risk that one or more issuers
may discontinue the existing QHP
coverage of HIV/AIDS patients who are
dependent on the Ryan White HIV/AIDS
Program for premium assistance in the
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near future. Based on these same
concerns, we find for good cause, under
5 U.S.C. 553(b)(B), that the notice-andcomment requirements of the APA
would be impracticable and contrary to
the public interest with respect the
clarification and correction of our
enforcement authority at § 156.805(a).
For the reasons outlined above, the
public interest requires that new
§ 156.1250 be immediately enforced.
Additionally, section 553(d) of the
APA (5 U.S.C. 553(d)) ordinarily
requires that a final rule be effective not
less than 30 days from the date of their
publication in the Federal Register.
This 30-day delay in effective date can
be waived, however, if otherwise
provided by an agency for good cause
found and published with the rule. For
the reasons set forth below, we also find
good cause to waive the 30-day delay in
effective date as unnecessary,
impracticable and contrary to the public
interest.
In this case, given the short timeframe
under which this change must be
implemented, delaying the
promulgation and effectiveness of this
rule would mean that some people who
are eligible to enroll in a QHP but rely
on the Ryan White HIV/AIDs Program,
tribes and tribal organizations, or other
state or federal programs to contribute to
the cost of the premium, either in whole
or in part, would not be able to
effectuate their coverage. It could also
mean that the third parties noted in the
regulation would not be able to assist
people who are already enrolled but do
not have the funds to continue to pay
their premiums, which could lead to
coverage terminations for failure to pay
premiums. Both of these scenarios could
result in people’s medical conditions
worsening and an increase in
uncompensated care. We consider this
policy to be a benefit to consumers.
Recent studies have demonstrated that
individuals with HIV on antiretroviral
medications who achieve viral load
suppression are less likely to transmit
HIV to others.3 Ensuring access to care
and treatment services support the
achievement of viral suppression, and,
therefore, has a significant public health
impact on HIV incidence as well.
The full scope of this issue and the
need for § 156.1250 was not known
until after open enrollment began on
October 1, 2013. We assumed that
3 Myron S. Cohen, Marybeth McCauley, and
Theresa R. Gamble, HIV treatment as prevention
and HPTN 052, Current Opinion in HIV and AIDS,
Volume 7(2), p. 99–105 (March 2012); William
Miller, Kimberly Powers, M. Kumi Smith, Myron S
Cohen, Community viral load as a measure for
assessment of HIV treatment as prevention, Lancet
Infect Dis 13:459–64 (2013).
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issuers of QHPs and SADPs would
continue to accept these payments as
these issuers had done prior to the
availability of coverage through the
Exchanges, and thus the impact of such
third party payments was built into
their baselines.4 Indeed, we expect that
the vast majority of issuers already have
been accepting these payments with this
understanding. Similarly, with respect
to the clarification of and correction to
our enforcement authority at
§ 156.1280(a), waiver of the 30-daydelay in effective date is necessary to
enable CMS to take immediate
enforcement action as necessary against
those issuers who continue to refuse to
accept the referenced third party
payments. As described above, these
actions could interfere with the ability
of at-risk individuals to effectuate or
maintain coverage.
Given the unusual circumstances and
for the reasons outlined above, CMS
finds good cause under the APA, 5
U.S.C. 553(b)(B) and (d)(3), to waive
notice-and-comment rulemaking and to
waive the delay in effective date and
proceed directly with the issuance of a
final rule with an immediate effective
date.
IV. Collection of Information
Requirements
This rule does not impose new or
alter existing information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
V. Regulatory Impact Analysis
We have examined the impact of this
final rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993) and
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
4 For this reason, we do not believe that the new
requirement in § 156.1250 will have a material
effect on the risk pools of QHP and SADP issuers.
Further, starting in 2014, the risk adjustment,
transitional reinsurance, and risk corridor programs
offer new protection to issuers in the individual
market against adverse selection.
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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
(RIA) must be prepared for major rules
with economically significant effects
($100 million or more in any 1 year). It
is CMS’s belief that this final rule does
not reach this economic threshold and
thus is not considered a major rule.
This rule requires individual market
QHPs and SADPs to accept premium
payments made by certain third parties.
The rule would also require individual
market QHPs and SADPs to accept costsharing payments made by these third
parties. We do not believe these actions
would impose any significant new costs
on issuers because we assume that the
vast majority of issuers already accept
such payments.
A. Regulatory Flexibility Act
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) (RFA) requires
agencies to prepare an initial regulatory
flexibility analysis to describe the
impact of the rule on small entities,
unless the head of the agency can certify
that the rule would not have a
significant economic impact on a
substantial number of small entities.
Agencies must analyze options for
regulatory relief for small businesses if
a rule has a significant impact on a
substantial number of small entities.
The RFA generally defines a ‘‘small
entity’’ as—(1) a proprietary firm
meeting the size standards of the Small
Business Administration (SBA); (2) a
not-for-profit organization that is not
dominant in its field; or (3) a small
government jurisdiction with a
population of less than 50,000. States
and individuals are not included in the
definition of ‘‘small entity.’’ CMS uses
as its measure of significant economic
impact on a substantial number of small
entities a change in revenues of more
than 3 percent. For the purposes of the
regulatory flexibility analysis, we expect
issuers offering individual market QHPs
and SADPs operating in an FFE, an SBE
or outside of the exchange to be affected
by this proposed rule.
As discussed in Health Insurance
Issuers Implementing Medical Loss
Ratio (MLR) Requirements under the
Patient Protection and Affordable Care
Act; Interim Final Rule,5 few, if any,
issuers are small enough to fall below
the size thresholds for small business
5 Health Insurance Issuers Implementing Medical
Loss Ratio (MLR) Requirements under the Patient
Protection and Affordable Care Act; Interim Final
Rule, 75 Federal Register 74864, 74918–20
(December 1, 2010) (codified at 45 CFR Part 158).
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15:37 Mar 18, 2014
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established by the SBA. In that rule, we
used a data set created from 2009 NAIC
Health and Life Blank annual financial
statement data to develop an updated
estimate of the number of small entities
that offer comprehensive major medical
coverage in the individual and group
markets. For purposes of that analysis,
CMS used total Accident and Health
earned premiums as a proxy for annual
receipts. We estimated that there are 28
small entities with less than $7 million
in accident and health earned premiums
offering individual or group
comprehensive major medical
coverage.6 However, this estimate may
overstate the actual number of small
health insurance issuers offering such
coverage, since it does not include
receipts from these companies’ other
lines of business.
Therefore, we are not preparing an
analysis for the RFA because we have
determined, and the Secretary certifies,
that this final rule will not have a
significant economic impact on a
substantial number of small entities.
B. Unfunded Mandates
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated
costs and benefits and take certain other
actions before issuing a proposed rule
(and subsequent final rule) that includes
any federal mandate that may result in
expenditures in any one year by a state,
local, or tribal governments, in the
aggregate, or by the private sector, of
$100 million in 1995 dollars, updated
annually for inflation. In 2014, that
threshold is approximately $141
million. UMRA does not address the
total cost of a rule. Rather, it focuses on
certain categories of costs, mainly those
‘‘federal mandate’’ costs resulting from:
(1) Imposing enforceable duties on
State, local, or tribal governments, or on
the private sector; or (2) increasing the
stringency of conditions in, or
decreasing the funding of, state, local, or
tribal governments under entitlement
programs.
This final rule requires QHPs and
SADPs to accept premiums paid by
certain third parties. Many issuers
currently have systems in place to
accept premium payments as part of the
normal course of business, including
payments made by people other than
6 According to SBA size standards, entities with
average annual receipts of $7 million or less would
be considered small entities for North American
Industry Classification System (NAICS) Code
524114 (Direct Health and Medical Insurance
Carriers). For more information, see ‘‘Table of Size
Standards Matched to North American Industry
Classification System Codes,’’ effective March 26,
2012, U.S. Small Business Administration, available
at https://www.sba.gov.
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Fmt 4700
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the insured. For example, the Ryan
White HIV/AIDS Program AIDS Drug
Assistance Program provided
$397,245,000 in premium assistance to
issuers on behalf of Ryan White HIV/
AIDS Program participants during fiscal
year 2013. In June 2013, the Ryan White
HIV/AIDS Program AIDS Drug
Assistance Program provided premium
assistance for 52,568 people living with
HIV. These premium assistance
expenditures were paid directly to
issuers. Accordingly, this rule generally
should not impose any significant new
administrative costs on issuers. CMS
has concluded that this rule does not
place any mandates on state, local, or
tribal governments or the private sector
that exceed the threshold for 2014.
C. Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
costs on state and local governments,
preempts state law, or otherwise has
federalism implications. This rule does
not impose any costs on state or local
governments not otherwise imposed by
already-finalized provisions of the
regulations implementing the
Affordable Care Act.
In compliance with the requirement
of Executive Order 13132 that agencies
examine closely any policies that may
have federalism implications or limit
the policy-making discretion of the
states, CMS has engaged in efforts to
consult with and work cooperatively
with affected states, including
participating in conference calls with
and attending conferences of the NAIC,
and consulting with State insurance
officials on an individual basis. We
believe that this rule does not impose
substantial direct costs on state and
local governments, preempt state law, or
otherwise have federalism implications.
We are amending the operational
requirements for QHPs and SADPs.
Under the requirements set forth in
section 8(a) of Executive Order 13132,
and by the signatures affixed to this
regulation, the Department of Health
and Human Services certifies that CMS
has complied with the requirements of
Executive Order 13132 for the attached
proposed regulation in a meaningful
and timely manner.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
D. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801, et seq., as added by the
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Small Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. We will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register.
List of Subjects in 45 CFR Part 156
Administrative appeals,
Administrative practice and procedure,
Administration and calculation of
advance payments of premium tax
credit, Advertising, Advisory
Committees, Brokers, Conflict of
interest, Consumer protection, Costsharing reductions, Grant programshealth, Grants administration, Health
care, Health insurance, Health
maintenance organization (HMO),
Health records, Hospitals, American
Indian/Alaska Natives, 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,
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:
standards and requirements applicable
to issuers offering QHPs in the
Federally-facilitated Exchange,
including but not limited to issuer
standards and requirements under parts
153 and 156 of this subchapter;
*
*
*
*
*
3. Section 156.1250 is added to read
as follows:
■
§ 156.1250 Acceptance of certain third
party payments.
Issuers offering individual market
QHPs, including stand-alone dental
plans, must accept premium and costsharing payments from the following
third-party entities on behalf of plan
enrollees:
(a) Ryan White HIV/AIDS Program
under title XXVI of the Public Health
Service Act;
(b) Indian tribes, tribal organizations
or urban Indian organizations; and
(c) State and Federal Government
programs.
Dated: March 11, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: March 12, 2014.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2014–06031 Filed 3–14–14; 4:15 pm]
BILLING CODE 4150–01–P
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
15245
For access to the docket to
read background documents, including
those referenced in this document, or to
read comments received, go to https://
www.regulations.gov at any time and
insert ‘‘FMCSA–2012–0156’’ in the
‘‘Keyword’’ box, and then click
‘‘Search.’’ The docket is also available
by going to the ground floor, Room
W12–140, DOT Building, 1200 New
Jersey Avenue SE., Washington, DC,
between 9 a.m. and 5 p.m., e.t., Monday
through Friday, except Federal holidays.
ADDRESSES:
Mr.
Gary Siekmann, Office of Enforcement,
Federal Motor Carrier Safety
Administration, 1200 New Jersey
Avenue SE., Washington, DC 20590–
0001, by telephone at (202) 493–0442 or
via email at Garry.Siekmann@dot.gov.
Office hours are from 9 a.m. to 5 p.m.
e.t., Monday through Friday, except
Federal holidays. If you have questions
on viewing material in the docket,
contact Docket Operations (202) 366–
9826.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Executive Summary
Purpose and Summary of the Major
Provisions
This rule clarifies the applicability
and improves the enforceability of the
safety regulations by redefining GCWR.
This revised definition provides a
uniform means for motor carriers,
drivers, and enforcement officials to
determine whether a driver operating a
combination vehicle is subject to the
commercial driver’s license (CDL)
requirements (49 CFR Part 383) or the
general safety requirements (49 CFR Part
390). This rule also responds to a
petition filed by the Commercial
Vehicle Safety Alliance (CVSA) on
February 14, 2008, seeking changes in
the definition of ‘‘gross combination
weight rating.’’
PART 156—HEALTH INSURANCE
ISSUER STANDARDS UNDER THE
AFFORDABLE CARE ACT, INCLUDING
STANDARDS RELATED TO
EXCHANGES
49 CFR Parts 383 and 390
■
1. The authority citation for part 156
continues to read as follows:
Gross Combination Weight Rating;
Definition
Authority: Title I of the Affordable Care
Act, sections 1301–1304, 1311–1313, 1321–
1322, 1324, 1334, 1342–1343, 1401–1402,
Pub. L. 111–148, 124 Stat. 119 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).
AGENCY:
Benefits and Costs
FMCSA amends the Federal
Motor Carrier Safety Regulations
(FMCSRs) by revising the definition of
‘‘gross combination weight rating’’ (or
GCWR) to clarify the applicability of the
Agency’s safety regulations for singleunit trucks (vehicles other than truck
tractors) when they are towing trailers,
and the GCWR information is not
included on the vehicle manufacturer’s
certification label.
DATES: The final rule is effective April
18, 2014.
This action only clarifies the
definition of GCWR to eliminate
confusion surrounding the language of
the previous definition and longstanding enforcement practices. The
rule provides clear criteria for
determining the applicability of the
FMCSRs when the GCWR is the
deciding factor. Costs, if any, will be
borne by motor carriers and drivers who
had previously concluded, based on the
wording of the GCWR definition, that
their operations were not subject to
certain safety regulations, but now will
comply with the applicable rules.
2. Section 156.805 is amended by
revising paragraph (a)(1) to read as
follows:
wreier-aviles on DSK5TPTVN1PROD with RULES
■
§ 156.805 Bases and process for imposing
civil money penalties in Federally-facilitated
Exchanges.
(a) * * *
(1) Misconduct in the Federallyfacilitated Exchange or substantial noncompliance with the Exchange
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[Docket No. FMCSA–2012–0156]
RIN 2126–AB70; Formerly RIN 2126–AB53
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Final rule.
SUMMARY:
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Agencies
[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Rules and Regulations]
[Pages 15240-15245]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06031]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 156
[CMS-9943-IFC]
RIN 0938-AS28
Patient Protection and Affordable Care Act; Third Party Payment
of Qualified Health Plan Premiums
AGENCY: Centers for Medicare and Medicaid Services, Department of
Health and Human Services (HHS).
ACTION: Interim final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This interim final rule requires issuers of qualified health
plans (QHPs), including stand-alone dental plans (SADPs), to accept
premium and cost-sharing payments made on behalf of enrollees by the
Ryan White HIV/AIDS Program, other Federal and State government
programs that provide premium and cost sharing support for specific
individuals, and Indian tribes, tribal organizations, and urban Indian
organizations.
DATES: Effective Date: This interim final rule is effective on March
14, 2014.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on May 13, 2014.
ADDRESSES: In commenting, please refer to file code CMS-9943-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. You may submit
[[Page 15241]]
comments in one of four ways (please choose only one of the ways
listed).
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-9943-IFC, P.O. Box 8016,
Baltimore, MD 21244-8016. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-9943-IFC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201. (Because access to the interior of the Hubert H. Humphrey
Building is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your
comments to the Baltimore address, call telephone number (410) 786-7195
in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate
for hand or courier delivery may be delayed and received after the
comment period. For information on viewing public comments, see the
beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Leigha Basini, (301) 492-4380 for
questions related to this rule.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: https://regulations.gov. Follow the search instructions on
that Web site to view public comments. Comments received timely also
will be available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, at the
headquarters of the Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view
public comments, phone 1-800-743-3951.
I. Background
The Patient Protection and Affordable Care Act (Pub. L. 111-148)
was enacted on March 23, 2010. The Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised
several provisions of the Patient Protection and Affordable Care Act,
was enacted on March 30, 2010. In this final rule, we refer to the two
statutes collectively as the ``Affordable Care Act.''
As of October 1, 2013, for coverage that started as early as
January 1, 2014, qualified individuals and qualified employers have
been able to enroll in QHPs and SADPs--private health and dental
insurance that has been certified as meeting certain standards--through
competitive Marketplaces called ``Exchanges'' or ``health insurance
Marketplaces.'' The word ``Exchanges'' refers to both State Exchanges,
also called State-based Exchanges (SBEs), and Federally-facilitated
Exchanges (FFEs). In this final rule, when we refer to ``FFEs,'' we are
also referring to State Partnership Exchanges. CMS has implemented
Affordable Care Act provisions through regulations codified in title 45
of the Code of Federal Regulations (CFR), and, unless otherwise
indicated, all regulatory references herein are to that title.
In the individual market Exchanges, premium and cost-sharing
payment arrangements are generally managed directly between QHP and
SADP issuers and enrollees. For those QHP enrollees eligible for
advance payments of the premium tax credit and cost-sharing reductions,
the federal government makes applicable payments to QHP issuers.
CMS has issued ``Frequently Asked Questions'' or ``FAQs'' with
respect to premium and cost-sharing payments made by third parties on
behalf of QHP enrollees. In a FAQ issued on November 4, 2013 (the
November FAQ),\1\ CMS encouraged QHP issuers not to accept third-party
payments from hospitals, other healthcare providers, and other
commercial entities due to concerns that such practices could skew the
insurance risk pool and create an unlevel field in the Exchanges.
---------------------------------------------------------------------------
\1\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/third-party-qa-11-04-2013.pdf.
---------------------------------------------------------------------------
On February 7, 2014, CMS issued additional FAQs (the February FAQs)
clarifying that the November FAQ was not intended to discourage QHP
issuers from accepting third party premium and cost-sharing payments
made by Indian tribes, tribal organizations, and urban Indian
organizations, as well as by state and federal government programs
(such as the Ryan White HIV/AIDS Program).\2\ CMS affirmatively
encouraged QHP issuers to accept such payments given that federal or
state law or policy specifically envisions third party payment of
premium and cost-sharing amounts by these entities.
---------------------------------------------------------------------------
\2\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/third-party-payments-of-premiums-for-qualified-health-plans-in-the-marketplaces-2-7-14.pdf.
---------------------------------------------------------------------------
Specifically, the Ryan White HIV/AIDS Program plays a critical role
in ensuring that people living with HIV in the United States have
access to life-saving antiretroviral medications, serving over 550,000
people living with HIV annually. Medication access is provided through
both payment for medication and payment of insurance premiums and cost-
sharing when such assistance is cost effective for the Ryan White HIV/
AIDS Program. The Ryan White HIV/AIDS Program has been authorized to
provide insurance assistance for low-income people living with HIV
since 1990 under section 2615 of the Public Health Service Act, as
added by the Ryan White Comprehensive AIDS Resources Emergency (CARE)
Act (Pub. L. 101-381, title II, Sec. 201, Aug. 18, 1990). Section
2616(f) of the Public Health Service Act provides authority for states
to use AIDS Drug Assistance Program grant funds to purchase or maintain
health insurance or plans when the coverage includes the relevant
therapeutics and the cost of such coverage does not exceed the costs of
otherwise providing them directly. This provision was added in 2000 as
subsection (e) by the Ryan White CARE Act Amendments of 2000 (Pub. L.
106-
[[Page 15242]]
345, Sec. 204(b)) and was subsequently renumbered to (f) in 2006.
Through Policy Notices 99-01, 7-05, and most recently 13-04, 13-05 and
13-06, the Health Resources and Services Administration HIV/AIDS Bureau
has provided guidance to grantees reiterating that the funds awarded
under the Parts A, B, and C of the Ryan White HIV/AIDS Program may be
used to support a health insurance premium and costs-sharing assistance
program as a core medical service for eligible low-income people living
with HIV when it is cost-effective for the program. Ryan White HIV/AIDS
Program funds are payer-of-last-resort funds and may be used for public
or private health insurance premiums, as well as cost-sharing (for
example, deductibles, copayments, and coinsurance). In fiscal year
2013, the Ryan White HIV/AIDS Program AIDS Drug Assistance Program paid
$397,245,305 in premium assistance to issuers on behalf of program
beneficiaries. As of June 2013, the Ryan White HIV/AIDS Program AIDS
Drug Assistance Program provided premium assistance for 52,568 people
living with HIV. These premium assistance expenditures were paid
directly to issuers.
In addition, section 1312 of the Affordable Care Act, section 402
of the Indian Health Care Improvement Act, and 45 CFR 155.240(b)
provides that Exchanges may permit Indian tribes, tribal organizations,
and urban Indian organizations to pay aggregated QHP premiums on behalf
of qualified individuals, subject to terms and conditions determined by
the Exchange. In the past, a number of tribes have provided premium
assistance to tribal members eligible to enroll in the Medicare Part D
program. These arrangements have resulted in an increase in the number
of tribal members enrolled in Medicare Part D. Building from that
experience, these same arrangements are being replicated by tribes and
tribal organizations in providing premium assistance to qualified
individuals for QHPs in the Exchanges. Under these arrangements tribes
aggregate premium payments to issuers and reduce their administrative
costs.
II. Provisions of the Interim Final Rule
We have become aware that, despite related policy clarifications,
some QHP issuers continue to reject payments of premium and cost
sharing by the Ryan White HIV/AIDS Program. In particular, this QHP
issuer practice is causing access problems for persons who rely on the
Ryan White HIV/AIDS Program for assistance. Accordingly, we are
promulgating a new requirement at Sec. 156.1250 that QHP and SADPs
must accept third party premium and cost sharing payments from the Ryan
White HIV/AIDS Program.
To ensure that individuals reliant on programs similar to the Ryan
White HIV/AIDS Program are not being adversely affected by QHPs' and
SADPs' refusal to accept third party premium and cost-sharing payments,
we are including within the new requirement that QHPs and SADPs must
accept third party premium and cost-sharing payments from the following
other entities in addition to the Ryan White HIV/AIDS Program: Indian
tribes, tribal organizations, and urban Indian organizations; and state
and federal government programs. This standard applies to all
individual market QHPs and SADPs, regardless of whether they are
offered through an FFE, an SBE, or outside of the Exchanges.
Our new standard does not prevent QHPs and SADPs from having
contractual prohibitions on accepting payments of premium and cost
sharing from third party payers other than those specified in this
interim final regulation. In particular, as stated in our November FAQ,
we remain concerned that third party payments of premium and cost
sharing provided by hospitals, other healthcare providers, and other
commercial entities could skew the insurance risk pool and create an
unlevel competitive field in the insurance market. We continue to
discourage such third party payments of premiums and cost sharing, and
we encourage QHPs and SADPs to reject these payments.
We are also amending Sec. 156.805 to ensure that new Sec.
156.1250 can be enforced. Enforcement of FFE issuer standards and
requirements is governed by Sec. 156.800 through Sec. 156.810. In the
August 30, 2013 Program Integrity Rule (78 FR 54070, 54143), we
established the bases for HHS to impose civil money penalties (CMPs)
against QHP issuers for violations of certain standards applicable to
issuers offering QHPs in the FFEs. In Sec. 156.805(a), we set forth
the grounds for imposing CMPs. Since the publication of that final
rule, we noted that certain paragraphs under these sections should be
clarified and, in some instances, technical corrections are necessary,
to properly reflect when these enforcement remedies will apply. These
clarifications and corrections are specifically necessary to reflect
that these enforcement remedies will apply to violations of Sec.
156.1250. For example, under paragraph (1), the word ``including'' was
inadvertently omitted from the phrase ``misconduct in the Federally-
facilitated Exchange or substantial non-compliance with the Exchange
standards applicable to issuers offering QHPs in the Federally-
facilitated Exchange [including] under subparts C through G of part 153
of this subchapter.'' This same phrase also inadvertently referenced
specific subparts within part 153, including subparts C and D, which
contain standards and requirements for States in relation to the
reinsurance and risk adjustment programs. We are therefore amending
paragraph (1) so that it correctly provides that Sec. 156.805 targets
violations of issuer standards and requirements of part 153 that are
applicable to issuers. We are also making changes to clarify that
substantial non-compliance with any Exchange standard or requirement
applicable to issuers in the FFE is grounds for imposing CMPs and that
reference to specific subparts of part 153 was not intended to be limit
the types of QHP standards and requirements for which enforcement under
this section would be available. We are further amending paragraph (1)
to add an explicit reference to part 156, to clarify that substantial
non-compliance with the Exchange standards applicable to issuers
offering QHPs in the FFEs under part 156, including new Sec. 156.1250,
may be a basis for the imposition of CMPs under Sec. 156.805.
Accordingly, failure to comply with the requirement to accept third
party payments in accordance with Sec. 156.1250 could constitute a
violation of Sec. 156.805(a)(1) as ``substantial non-compliance with
[an] Exchange standard[].'' Depending upon the circumstances, a QHP or
SADP issuer's failure to comply with Sec. 156.1250 could also fall
under Sec. 156.805(a)(4) as a ``practice that would reasonably be
expected to have the effect of denying or discouraging enrollment into
a QHP offered by the issuer (except as permitted by this part) by
qualified individuals whose medical condition or history indicates the
potential for a future need for significant medical services or
items.'' Under Sec. 156.805(c), an issuer offering a QHP or SADP
through an FFE may be subject to a maximum penalty of $100 per day, per
each individual who is adversely affected by the QHP or SADP issuer's
non-compliance.
Issuers offering QHPs or SADPs through an SBE or outside of the
Exchanges would be subject to any penalties that the SBE or the state
has established to address issuer non-compliance with general QHP and
SADP standards and requirements under part 156, Subpart M, in addition
[[Page 15243]]
to any other SBE-specific or state-specific enforcement.
Qualified individuals in states with an FFE or SPE who are affected
by a QHP's or SADP's violation of this new requirement, either because
they are unable to effectuate coverage because an issuer will not
accept the third party premium payments which the individual needs to
be able to make a complete payment of the premium within the open
enrollment time frame, or because they lose coverage due to the
issuer's refusal to accept the required third-party premium or cost-
sharing payments from entities described in 45 CFR 156.1250, may be
eligible for an FFE special enrollment period (SEP) in accordance with
Sec. 155.420(d)(9) and a certificate of exemption under Sec.
155.605(g)(1)(iii). CMS will issue additional guidance in the near
future clarifying the specific criteria for obtaining the SEP or
hardship exemption. We also encourage all SBEs to grant an SEP and
certificate of exemption under these circumstances.
We continue to consider making additional regulatory changes to QHP
and SADP issuer responsibilities to ensure that QHPs and SADPs accept
third party premium and cost-sharing payments from the Ryan White HIV/
AIDS Program, other state and federal government programs that support
premium and cost sharing, and Indian tribes, tribal organizations, and
urban Indian organizations.
III. Waiver of Proposed Rulemaking and Waiver of Delay in Effective
Date
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule before
publishing a final rule that responds to comments and sets forth final
regulations that generally take effect at least thirty days later. This
procedure can be waived, however, if an agency finds good cause that a
notice-and-comment procedure is impracticable, unnecessary, or contrary
to the public interest and incorporates a statement of the finding and
its reasons in the rule issued. CMS for good cause, under 5 U.S.C.
553(b)(B), finds that the notice-and-comment requirements of the
Administrative Procedure Act (APA) would be impracticable and contrary
to the public interest given that a delay in coverage for people who
rely on one of the third parties noted in the regulation to pay their
premiums could result in worsening medical conditions. Further, there
is risk that one or more issuers may discontinue the existing QHP
coverage of HIV/AIDS patients who are dependent on the Ryan White HIV/
AIDS Program for premium assistance in the near future. Based on these
same concerns, we find for good cause, under 5 U.S.C. 553(b)(B), that
the notice-and-comment requirements of the APA would be impracticable
and contrary to the public interest with respect the clarification and
correction of our enforcement authority at Sec. 156.805(a). For the
reasons outlined above, the public interest requires that new Sec.
156.1250 be immediately enforced.
Additionally, section 553(d) of the APA (5 U.S.C. 553(d))
ordinarily requires that a final rule be effective not less than 30
days from the date of their publication in the Federal Register. This
30-day delay in effective date can be waived, however, if otherwise
provided by an agency for good cause found and published with the rule.
For the reasons set forth below, we also find good cause to waive the
30-day delay in effective date as unnecessary, impracticable and
contrary to the public interest.
In this case, given the short timeframe under which this change
must be implemented, delaying the promulgation and effectiveness of
this rule would mean that some people who are eligible to enroll in a
QHP but rely on the Ryan White HIV/AIDs Program, tribes and tribal
organizations, or other state or federal programs to contribute to the
cost of the premium, either in whole or in part, would not be able to
effectuate their coverage. It could also mean that the third parties
noted in the regulation would not be able to assist people who are
already enrolled but do not have the funds to continue to pay their
premiums, which could lead to coverage terminations for failure to pay
premiums. Both of these scenarios could result in people's medical
conditions worsening and an increase in uncompensated care. We consider
this policy to be a benefit to consumers. Recent studies have
demonstrated that individuals with HIV on antiretroviral medications
who achieve viral load suppression are less likely to transmit HIV to
others.\3\ Ensuring access to care and treatment services support the
achievement of viral suppression, and, therefore, has a significant
public health impact on HIV incidence as well.
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\3\ Myron S. Cohen, Marybeth McCauley, and Theresa R. Gamble,
HIV treatment as prevention and HPTN 052, Current Opinion in HIV and
AIDS, Volume 7(2), p. 99-105 (March 2012); William Miller, Kimberly
Powers, M. Kumi Smith, Myron S Cohen, Community viral load as a
measure for assessment of HIV treatment as prevention, Lancet Infect
Dis 13:459-64 (2013).
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The full scope of this issue and the need for Sec. 156.1250 was
not known until after open enrollment began on October 1, 2013. We
assumed that issuers of QHPs and SADPs would continue to accept these
payments as these issuers had done prior to the availability of
coverage through the Exchanges, and thus the impact of such third party
payments was built into their baselines.\4\ Indeed, we expect that the
vast majority of issuers already have been accepting these payments
with this understanding. Similarly, with respect to the clarification
of and correction to our enforcement authority at Sec. 156.1280(a),
waiver of the 30-day-delay in effective date is necessary to enable CMS
to take immediate enforcement action as necessary against those issuers
who continue to refuse to accept the referenced third party payments.
As described above, these actions could interfere with the ability of
at-risk individuals to effectuate or maintain coverage.
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\4\ For this reason, we do not believe that the new requirement
in Sec. 156.1250 will have a material effect on the risk pools of
QHP and SADP issuers. Further, starting in 2014, the risk
adjustment, transitional reinsurance, and risk corridor programs
offer new protection to issuers in the individual market against
adverse selection.
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Given the unusual circumstances and for the reasons outlined above,
CMS finds good cause under the APA, 5 U.S.C. 553(b)(B) and (d)(3), to
waive notice-and-comment rulemaking and to waive the delay in effective
date and proceed directly with the issuance of a final rule with an
immediate effective date.
IV. Collection of Information Requirements
This rule does not impose new or alter existing information
collection and recordkeeping requirements. Consequently, it need not be
reviewed by the Office of Management and Budget under the authority of
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
V. Regulatory Impact Analysis
We have examined the impact of this final rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993) and Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 202 of the Unfunded
Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive
Order 13132 on Federalism (August 4, 1999), and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is
[[Page 15244]]
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 (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). It is CMS's
belief that this final rule does not reach this economic threshold and
thus is not considered a major rule.
This rule requires individual market QHPs and SADPs to accept
premium payments made by certain third parties. The rule would also
require individual market QHPs and SADPs to accept cost-sharing
payments made by these third parties. We do not believe these actions
would impose any significant new costs on issuers because we assume
that the vast majority of issuers already accept such payments.
A. Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA)
requires agencies to prepare an initial regulatory flexibility analysis
to describe the impact of the rule on small entities, unless the head
of the agency can certify that the rule would not have a significant
economic impact on a substantial number of small entities. Agencies
must analyze options for regulatory relief for small businesses if a
rule has a significant impact on a substantial number of small
entities. The RFA generally defines a ``small entity'' as--(1) a
proprietary firm meeting the size standards of the Small Business
Administration (SBA); (2) a not-for-profit organization that is not
dominant in its field; or (3) a small government jurisdiction with a
population of less than 50,000. States and individuals are not included
in the definition of ``small entity.'' CMS uses as its measure of
significant economic impact on a substantial number of small entities a
change in revenues of more than 3 percent. For the purposes of the
regulatory flexibility analysis, we expect issuers offering individual
market QHPs and SADPs operating in an FFE, an SBE or outside of the
exchange to be affected by this proposed rule.
As discussed in Health Insurance Issuers Implementing Medical Loss
Ratio (MLR) Requirements under the Patient Protection and Affordable
Care Act; Interim Final Rule,\5\ few, if any, issuers are small enough
to fall below the size thresholds for small business established by the
SBA. In that rule, we used a data set created from 2009 NAIC Health and
Life Blank annual financial statement data to develop an updated
estimate of the number of small entities that offer comprehensive major
medical coverage in the individual and group markets. For purposes of
that analysis, CMS used total Accident and Health earned premiums as a
proxy for annual receipts. We estimated that there are 28 small
entities with less than $7 million in accident and health earned
premiums offering individual or group comprehensive major medical
coverage.\6\ However, this estimate may overstate the actual number of
small health insurance issuers offering such coverage, since it does
not include receipts from these companies' other lines of business.
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\5\ Health Insurance Issuers Implementing Medical Loss Ratio
(MLR) Requirements under the Patient Protection and Affordable Care
Act; Interim Final Rule, 75 Federal Register 74864, 74918-20
(December 1, 2010) (codified at 45 CFR Part 158).
\6\ According to SBA size standards, entities with average
annual receipts of $7 million or less would be considered small
entities for North American Industry Classification System (NAICS)
Code 524114 (Direct Health and Medical Insurance Carriers). For more
information, see ``Table of Size Standards Matched to North American
Industry Classification System Codes,'' effective March 26, 2012,
U.S. Small Business Administration, available at https://www.sba.gov.
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Therefore, we are not preparing an analysis for the RFA because we
have determined, and the Secretary certifies, that this final rule will
not have a significant economic impact on a substantial number of small
entities.
B. Unfunded Mandates
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits and take
certain other actions before issuing a proposed rule (and subsequent
final rule) that includes any federal mandate that may result in
expenditures in any one year by a state, local, or tribal governments,
in the aggregate, or by the private sector, of $100 million in 1995
dollars, updated annually for inflation. In 2014, that threshold is
approximately $141 million. UMRA does not address the total cost of a
rule. Rather, it focuses on certain categories of costs, mainly those
``federal mandate'' costs resulting from: (1) Imposing enforceable
duties on State, local, or tribal governments, or on the private
sector; or (2) increasing the stringency of conditions in, or
decreasing the funding of, state, local, or tribal governments under
entitlement programs.
This final rule requires QHPs and SADPs to accept premiums paid by
certain third parties. Many issuers currently have systems in place to
accept premium payments as part of the normal course of business,
including payments made by people other than the insured. For example,
the Ryan White HIV/AIDS Program AIDS Drug Assistance Program provided
$397,245,000 in premium assistance to issuers on behalf of Ryan White
HIV/AIDS Program participants during fiscal year 2013. In June 2013,
the Ryan White HIV/AIDS Program AIDS Drug Assistance Program provided
premium assistance for 52,568 people living with HIV. These premium
assistance expenditures were paid directly to issuers. Accordingly,
this rule generally should not impose any significant new
administrative costs on issuers. CMS has concluded that this rule does
not place any mandates on state, local, or tribal governments or the
private sector that exceed the threshold for 2014.
C. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct costs on state and local
governments, preempts state law, or otherwise has federalism
implications. This rule does not impose any costs on state or local
governments not otherwise imposed by already-finalized provisions of
the regulations implementing the Affordable Care Act.
In compliance with the requirement of Executive Order 13132 that
agencies examine closely any policies that may have federalism
implications or limit the policy-making discretion of the states, CMS
has engaged in efforts to consult with and work cooperatively with
affected states, including participating in conference calls with and
attending conferences of the NAIC, and consulting with State insurance
officials on an individual basis. We believe that this rule does not
impose substantial direct costs on state and local governments, preempt
state law, or otherwise have federalism implications. We are amending
the operational requirements for QHPs and SADPs. Under the requirements
set forth in section 8(a) of Executive Order 13132, and by the
signatures affixed to this regulation, the Department of Health and
Human Services certifies that CMS has complied with the requirements of
Executive Order 13132 for the attached proposed regulation in a
meaningful and timely manner.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
D. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the
[[Page 15245]]
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. We will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.
List of Subjects in 45 CFR Part 156
Administrative appeals, Administrative practice and procedure,
Administration and calculation of advance payments of premium tax
credit, Advertising, Advisory Committees, 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, American
Indian/Alaska Natives, 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, 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 continues to read as follows:
Authority: Title I of the Affordable Care Act, sections 1301-
1304, 1311-1313, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, Pub.
L. 111-148, 124 Stat. 119 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 156.805 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 156.805 Bases and process for imposing civil money penalties in
Federally-facilitated Exchanges.
(a) * * *
(1) Misconduct in the Federally-facilitated Exchange or substantial
non-compliance with the Exchange standards and requirements applicable
to issuers offering QHPs in the Federally-facilitated Exchange,
including but not limited to issuer standards and requirements under
parts 153 and 156 of this subchapter;
* * * * *
0
3. Section 156.1250 is added to read as follows:
Sec. 156.1250 Acceptance of certain third party payments.
Issuers offering individual market QHPs, including stand-alone
dental plans, must accept premium and cost-sharing payments from the
following third-party entities on behalf of plan enrollees:
(a) Ryan White HIV/AIDS Program under title XXVI of the Public
Health Service Act;
(b) Indian tribes, tribal organizations or urban Indian
organizations; and
(c) State and Federal Government programs.
Dated: March 11, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Approved: March 12, 2014.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2014-06031 Filed 3-14-14; 4:15 pm]
BILLING CODE 4150-01-P