83 FR 19431 - Clarification of Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act

DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 86 (May 3, 2018)

Page Range		19431-19436
FR Document		2018-09369
On November 18, 2015, the Departments of Labor, Health and Human Services, and the Treasury (the Departments) published a final rule in the Federal Register titled ``Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act'' (the November 2015 final rule), regarding, in part, the coverage of emergency services by non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage, including the requirement that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage limit cost-sharing for out-of-network emergency services and, as part of that rule, pay at least a minimum amount for out-of-network emergency services. The American College of Emergency Physicians (ACEP) filed a complaint in the United States District Court for the District of Columbia, which on August 31, 2017 granted in part and denied in part without prejudice ACEP's motion for summary judgment and remanded the case to the Departments to respond to the public comments from ACEP and others. In response, the Departments are issuing this notice of clarification to provide a more thorough explanation of the Departments' decision not to adopt recommendations made by ACEP and certain other commenters in the November 2015 final rule.
Federal Register, Volume 83 Issue 86 (Thursday, May 3, 2018)
[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Rules and Regulations]
[Pages 19431-19436]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09369]


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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 54

[TD 9744]
RIN 1545-BJ45, 1545-BJ50, 1545-BJ62, 1545-BJ57

DEPARTMENT OF LABOR

Employee Benefits Security Administration

29 CFR Part 2590

RIN 1210-AB72

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Parts 144, 146, and 147

[CMS-9993-N]
RIN 0938-AS56


Clarification of Final Rules for Grandfathered Plans, Preexisting 
Condition Exclusions, Lifetime and Annual Limits, Rescissions, 
Dependent Coverage, Appeals, and Patient Protections Under the 
Affordable Care Act

AGENCY: Internal Revenue Service, Department of the Treasury; Employee 
Benefits Security Administration, Department of Labor; and Centers for 
Medicare & Medicaid Services, Department of Health and Human Services.

ACTION: Final rule; clarification.

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SUMMARY: On November 18, 2015, the Departments of Labor, Health and 
Human Services, and the Treasury (the Departments) published a final 
rule in the Federal Register titled ``Final Rules for Grandfathered 
Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, 
Rescissions, Dependent Coverage, Appeals, and Patient Protections Under 
the Affordable Care Act'' (the November 2015 final rule), regarding, in 
part, the coverage of emergency services by non-grandfathered group 
health plans and health insurance issuers offering non-grandfathered 
group or individual health insurance coverage, including the 
requirement that non-grandfathered group health plans and health 
insurance issuers offering non-grandfathered group or individual health 
insurance coverage limit cost-sharing for out-of-network emergency 
services and, as part of that rule, pay at least a minimum amount for 
out-of-network emergency services. The American College of

[[Page 19432]]

Emergency Physicians (ACEP) filed a complaint in the United States 
District Court for the District of Columbia, which on August 31, 2017 
granted in part and denied in part without prejudice ACEP's motion for 
summary judgment and remanded the case to the Departments to respond to 
the public comments from ACEP and others. In response, the Departments 
are issuing this notice of clarification to provide a more thorough 
explanation of the Departments' decision not to adopt recommendations 
made by ACEP and certain other commenters in the November 2015 final 
rule.

DATES: This clarification is applicable beginning May 3, 2018.

FOR FURTHER INFORMATION CONTACT: Amber Rivers, Employee Benefits 
Security Administration, Department of Labor, at (202) 693-8335; Dara 
R. Alderman, Internal Revenue Service, Department of the Treasury, at 
(202) 317-5500; and Katherine Carver, Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, at (410) 786-1565.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Rulemaking at Issue

i. Statutory 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) was enacted on March 30, 
2010. These statutes are collectively referred to as ``PPACA'' in this 
document. The PPACA reorganized, amended, and added to the provisions 
of part A of title XXVII of the Public Health Service Act (PHS Act). 
PPACA also added section 715 to the Employee Retirement Income Security 
Act (ERISA) and section 9815 to the Internal Revenue Code (the Code) to 
incorporate the provisions of part A of title XXVII of the PHS Act into 
ERISA and the Code, and make them applicable to group health plans, and 
health insurance issuers providing health insurance coverage in 
connection with group health plans. Accordingly, sections 2701 through 
2728 of the PHS Act are incorporated into the Code and ERISA.
    Section 2719A of the PHS Act, which is entitled ``Patient 
Protections,'' provides requirements relating to coverage of emergency 
services for non-grandfathered group health plans and health insurance 
issuers offering non-grandfathered group or individual health insurance 
coverage \1\ and states, in general, that if a group health plan, or a 
health insurance issuer offering group or individual health insurance 
coverage, provides or covers any benefits with respect to services in 
an emergency department of a hospital, the plan or issuer shall cover 
emergency services--(A) without the need for any prior authorization 
determination; (B) whether the health care provider furnishing such 
services is a participating provider with respect to such services; (C) 
in a manner so that, if such services are provided to a participant, 
beneficiary, or enrollee--(i) by a nonparticipating health care 
provider with or without prior authorization; or (ii)(I) such services 
will be provided without imposing any requirement under the plan for 
prior authorization of services or any limitation on coverage where the 
provider of services does not have a contractual relationship with the 
plan for the providing of services that is more restrictive than the 
requirements or limitations that apply to emergency department services 
received from providers who do have such a contractual relationship 
with the plan; and (II) if such services are provided out-of-network, 
the cost-sharing requirement (expressed as a copayment amount or 
coinsurance rate) is the same requirement that would apply if such 
services were provided in-network.
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    \1\ Section 2719A of the PHS Act also provides, for non-
grandfathered group health plans and health insurance issuers 
offering non-grandfathered group or individual health insurance 
coverage, rules regarding designation of primary care providers, 
access to pediatric care, and patient access to obstetrical and 
gynecological care. This document does not address those aspects of 
section 2719A of the PHS Act.
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    Therefore, among other things, the statute requires non-
grandfathered group health plans and health insurance issuers offering 
non-grandfathered group or individual health insurance coverage that 
cover emergency services to do so even if the provider is not one of 
the plans' or issuers' ``participating provider[s].'' \2\ In addition, 
section 2719A of the PHS Act requires non-grandfathered group health 
plans and health insurance issuers offering non-grandfathered group or 
individual health insurance coverage to apply the same cost-sharing 
requirement (expressed as copayments and coinsurance) for emergency 
services provided out-of-network as emergency services provided in-
network; however, the statute does not expressly address how much the 
out-of-network provider of emergency services must be paid for 
performing such services by the non-grandfathered group health plan or 
health insurance issuer offering non-grandfathered group or individual 
health insurance coverage.
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    \2\ See section 2719A(b)(1)(B) of the PHS Act.
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    As background, the amount an out-of-network provider may charge for 
emergency services may exceed the group health plan's or health 
insurance issuer's ``allowed amount'' (the ``[m]aximum amount on which 
payment is based for covered health care services'').\3\ The allowed 
amount may be subject to deductibles and other cost-sharing in terms of 
a fixed-amount per service and/or a coinsurance percentage of the 
allowed amount. In circumstances in which a provider's charge exceeds 
the allowed amount, some states allow an out-of-network provider to 
``balance bill'' the patient for the amount of the provider's charge 
that exceeds the allowed amount.
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    \3\ See definition of ``allowed amount'' and ``balance billing'' 
in the Uniform Glossary of Health Care Coverage and Medical Terms, 
https://www.dol.gov/sites/default/files/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/sbc-uniform-glossary-of-coverage-and-medical-terms-final.pdf.
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    Section 2719A of the PHS Act does not prohibit an out-of-network 
provider from balance billing a participant or beneficiary because 
although it includes a cost-sharing rule, ``cost sharing'' is a 
statutorily defined term that ``does not include . . . balance billing 
amounts for non-network providers'' and the cost-sharing requirement in 
section 2719A(b)(1)(C)(ii)(II) of the PHS Act applies to cost sharing 
``expressed as a copayment amount or coinsurance rate.'' \4\
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    \4\ See PPACA section 1302(c)(3)(B). See also 80 FR 72192, 
72212-13 (Nov. 18, 2015).
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ii. The Departments' Regulation and Related Comments
    On June 28, 2010, the Departments published an interim final rule 
(IFR) in the Federal Register titled ``Patient Protection and 
Affordable Care Act; Requirements for Group Health Plans and Health 
Insurance Issuers Under the Patient Protection and Affordable Care Act 
Relating to Preexisting Condition Exclusions, Lifetime and Annual 
Limits, Rescissions, and Patient Protections,'' 75 FR 37188 (the June 
2010 IFR). The June 2010 IFR preamble on section 2719A of the PHS Act 
stated, in part, that, because the statute does not require plans or 
issuers to cover balance billing amounts, and does not prohibit balance 
billing, even where the protections in the statute apply, patients may 
be subject to balance billing. It would defeat the purpose of the 
protections in the statute if a plan or

[[Page 19433]]

issuer paid an unreasonably low amount to a provider, even while 
limiting the coinsurance or copayment associated with that amount to 
in-network amounts. To avoid the circumvention of the protections of 
section 2719A of the PHS Act, it is necessary that a reasonable amount 
be paid before a patient becomes responsible for a balance billing 
amount. Thus, these interim final regulations require that a reasonable 
amount be paid for services by some objective standard. In establishing 
the reasonable amount that must be paid, the Departments had to account 
for wide variation in how plans and issuers determine both in-network 
and out-of-network rates. For example, for a plan using a capitation 
arrangement to determine in-network payments to providers, there is no 
in-network rate per service.
    Accordingly, these interim final regulations considered three 
amounts: The in-network rate, the out-of-network rate, and the Medicare 
rate. Specifically, a plan or issuer satisfies the copayment and 
coinsurance limitations in the statute if it provides benefits for out-
of-network emergency services in an amount equal to the greatest of 
three possible amounts--(1) The amount negotiated with in-network 
providers for the emergency service furnished; (2) The amount for the 
emergency service calculated using the same method the plan generally 
uses to determine payments for out-of-network services (such as the 
usual, customary, and reasonable charges) but substituting the in-
network cost-sharing provisions for the out-of-network cost-sharing 
provisions; or (3) The amount that would be paid under Medicare for the 
emergency service. Each of these three amounts is calculated excluding 
any in-network copayment or coinsurance imposed with respect to the 
participant, beneficiary, or enrollee.\5\
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    \5\ 75 FR at 37194 (footnote omitted). For the interim final 
regulation text, see 75 FR at 37225, 37232, and 37238.
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    This is sometimes referred to as the ``Greatest of Three'' or the 
``GOT'' regulation because it sets a floor on the amount non-
grandfathered group health plans and health insurance issuers offering 
non-grandfathered group or individual health insurance coverage are 
required to pay for out-of-network emergency services under this 
provision at the greatest of the three listed amounts.
    During the comment period for the June 2010 IFR, some commenters 
were in favor of the GOT regulation while others expressed concerns. 
Several commenters, including ACEP, objected to the second prong of the 
GOT regulation, which relates to the method the plan generally uses to 
determine payments for out-of-network services, such as the usual, 
customary, and reasonable amount (henceforth referred to as the UCR 
amount). ACEP's August 3, 2010 comment letter \6\ stated the following:
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    \6\ Available at https://www.regulations.gov/contentStreamer?documentId=EBSA-2010-0016-0022&attachmentNumber=1&contentType=pdf.

. . . [W]e appreciate the clearly stated acknowledgement that 
allowing plans and insurersto pay emergency physicians whatever they 
see fit defeats the purpose of protecting patients from potentially 
large bills. In that light, we also support development of an 
objective standard to establish `fair payment.' Insurers know that 
emergency physicians will see everyone who comes to the ED due to 
EMTALA responsibilities, and many leverage that fact to impose 
extremely low reimbursement rates. While a large majority of our 
members participate in nearly every plan or insurer network in their 
area, the primary reason they cite for not joining a plan's network 
is that the plan has arbitrarily offered an in-network payment rate 
that fails to cover the costs of providing the service. This forces 
the physicians to balance bill the patients, which often results in 
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an unsatisfactory experience for everyone but the insurer. . .

    As noted in the IF rule, `there is wide variation in how plans and 
issuers determine in [network] and out-of-network rates.' The term 
`reasonable' is in the eye of the beholder. For many years, usual and 
customary rates referred to charges or a proportion of charges. This 
has changed in recent years and physicians, particularly emergency 
physicians, have had problems with the `black box' approach that 
commercial insurers have used to determine [the] usual and customary 
`rates' for out-of-network providers. At this time, we are unaware of a 
national database that is widely available and provides timely data for 
objective comparisons of charges and/or costs that could be used to 
implement this part of the regulation. A new database, perhaps the FAIR 
Health data[base] that is currently being developed as a result of the 
settlement with Ingenix, may prove to be more timely and accurate, but 
any database used to establish usual and customary reasonable rates 
will require transparent validation, monitoring, and active enforcement 
by state and federal insurance officials.''
    Other groups, such as Advocacy for Patients with Chronic Illness, 
Inc. and Lybba, the Emergency Department Practice Management 
Association, the American Medical Association, the American Hospital 
Association, the Texas Medical Association, the Healthcare Association 
of New York State, and the California Chapter of ACEP, submitted 
similar comments expressing their concern about the lack of 
transparency and potential for manipulation of rates under the second 
prong of the GOT regulation. Like ACEP, several of these commenters 
referenced the FAIR Health database as a potential alternative 
solution.\7\
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    \7\ The FAIR Health Database was created by FAIR Health, an 
independent nonprofit that collects data for and manages the 
nation's largest database of privately billed health insurance 
claims. See https://www.fairhealth.org/about-us.
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    On November 18, 2015, the Departments finalized the regulation 
under section 2719A of the PHS Act, including the GOT regulation (80 FR 
72192). The November 2015 final rule adopted the GOT regulation without 
substantive revision from the June 2010 IFR and incorporated a 
clarification that had been issued in subregulatory guidance.\8\ In the 
November 2015 final rule, the Departments reiterated the need for the 
GOT regulation, and in response to the comments described above 
regarding the GOT regulation, the Departments stated that ``[s]ome 
commenters expressed concern about the level of payment for out-of-
network emergency services and urged the Departments to require plans 
and issuers to use a transparent database to determine out-of-network 
amounts. The Departments believe that this concern is addressed by our 
requirement that the amount be the greatest of the three amounts 
specified in [the GOT regulation].'' \9\
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    \8\ The final regulations incorporated guidance that had been 
provided in FAQs about Affordable Care Act Implementation (Part I), 
Q15, available at www.dol.gov/ebsa/faqs/faq-aca.html and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs.html. The FAQ and final regulations provide 
that if state law prohibits balance billing, or in cases in which a 
group health plan or health insurance issuer is contractually 
responsible for balance billing amounts, plans and issuers are not 
required to satisfy the GOT regulation, but may not impose any 
copayment or coinsurance requirement for out-of-network emergency 
services that is higher than the copayment or coinsurance 
requirement that would apply if the services were provided in-
network. See 26 CFR 54.9815-2719A(b)(3)(iii); 29 CFR 2590.715-
2719A(b)(3)(iii); and 45 CFR 47.138(b)(3)(iii).
    \9\ 80 FR 72192, 72213 (Nov. 18, 2015).
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B. Other Guidance

    In response to concerns about transparency with respect to the 
second prong of the GOT regulation raised by ACEP in its comment and in 
subsequent communications to the Departments, on April 20, 2016, the 
Departments issued Frequently Asked Questions About Affordable Care Act 
Implementation Part 31, Mental Health Parity Implementation, and 
Women's Health

[[Page 19434]]

and Cancer Rights Act Implementation, which addressed, in part, the GOT 
regulation.\10\ In Question & Answer number 4, the Departments 
clarified that a group health plan or health insurance issuer of group 
or individual health insurance coverage is required to disclose how it 
calculates the amounts under the GOT regulation, including the UCR 
amount. These disclosure requirements would also apply to a request for 
disclosure of payment amounts for in-network providers. Specifically, 
for group health plans subject to ERISA, documentation and data used to 
calculate each of the amounts under the GOT regulations for out-of-
network emergency services, including the UCR amount, are considered to 
be instruments under which the plan is established or operated and 
would be subject to the disclosure provisions under section 104(b) of 
ERISA and 29 CFR 2520.104b-1, which generally require that such 
information be furnished to plan participants (or their authorized 
representatives) within 30 days of request.\11\ In addition, the 
Department of Labor claims procedure regulations, as well as the 
internal claims and appeals and external review requirement under 
section 2719 of the PHS Act, which apply to both ERISA and non-ERISA 
non-grandfathered group health plans and health insurance issuers of 
non-grandfathered group or individual coverage, set forth rules 
regarding claims and appeals, including the right of a claimant (or the 
claimant's authorized representative) upon appeal of an adverse benefit 
determination (or a final internal adverse benefit determination) to be 
provided upon request and free of charge, reasonable access to, and 
copies of, all documents, records, and other information relevant to 
the claimant's claim for benefits, and a failure to provide or make 
payment of a claim in whole or in part is an adverse benefit 
determination.\12\
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    \10\ See https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf, or https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.
    \11\ See DOL Advisory Opinion 96-14A (July 31, 1996). See also 
FAQs about Affordable Care Act Implementation (Part XXIX) and Mental 
Health Parity Implementation, Q12, available at www.dol.gov/ebsa/faqs/faq-aca29.html and www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-XXIX.pdf, providing that a plan's or 
issuer's characterization of information as proprietary or 
commercially valuable cannot be a basis for non-disclosure.
    \12\ 29 CFR 2560.503-1, 26 CFR 54.9815-2719, 29 CFR 2590.715-
2719, and 45 CFR 147.136. For additional requirements for the full 
and fair review standard that applies under PHS Act section 2719, in 
addition to 29 CFR 2560.503-1(h)(2), see 26 CFR 54.9815-
2719(b)(2)(ii)(C), 29 CFR 2590.715-2719(b)(2)(ii)(C), and 45 CFR 
147.136(b)(2)(ii)(C) and (b)(3)(ii)(C).
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C. The Court's Remand Order

    On May 12, 2016, ACEP filed a lawsuit against the Departments, 
asserting that the final GOT regulation should be invalidated because 
it does not ensure a reasonable payment for out-of-network emergency 
services as required by the statute, and that the Departments did not 
respond meaningfully to ACEP's comments about purported deficiencies in 
the regulation.\13\
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    \13\  See https://www.acep.org/Legislation-and-Advocacy/Regulatory/ACEPvsHHS_051216/.
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    Following briefing by both parties, on August 31, 2017, the United 
States District Court for the District of Columbia issued a memorandum 
opinion that granted in part and denied in part without prejudice 
ACEP's motion for summary judgment, and remanded the case to the 
Departments for further explanation of the November 2015 final 
rule.\14\ The court concluded that the Departments did not adequately 
respond to comments and proposed alternatives submitted by ACEP and 
others regarding perceived problems with the GOT regulation. In 
particular, the court stated that the Departments' response in the 
November 2015 final rule ``to numerous comments raising specific 
concerns about the method used in the GOT regulation for determining 
the amounts insurers would be required to pay for out-of-network 
emergency medical services--e.g., the rates' lack of transparency or 
their vulnerability to manipulation'' did not ``seriously respond to 
the actual concerns raised about the particular rates, and it ignore[d] 
altogether the proposed alternative of using a database to set 
payment.'' The court stated that its holding was ``a narrow one,'' 
relating ``only to the sufficiency of the Departments' response to 
comments and proposed alternatives.''
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    \14\ See American College of Emergency Physicians v. Price, et 
al., 264 F. Supp. 3d 89 (D.D.C. 2017).
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    The court did not vacate the November 2015 final rule but ordered 
that ``this matter is remanded to the Departments of Health and Human 
Services, Labor, and the Treasury so that they can adequately address 
the comments and proposals at issue in this case. On remand, the 
Departments are free to exercise their discretion to supplement their 
explanation as they deem appropriate and to reach the same or different 
ultimate conclusions. At a minimum; however, the Departments are 
required to respond to [ACEP's] comments and proposals in a reasoned 
manner that `enable[s] [the Court] to see what major issues of policy 
were ventilated . . . and why the agency reacted to them as it did.' '' 
\15\
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    \15\ Id.
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    The Departments are issuing this document to provide the additional 
consideration required by the court's remand order. Specifically, the 
Departments are responding more fully to ACEP's written comment dated 
August 3, 2010 in reference to the June 2010 IFR.

II. Further Consideration of the Departments' Final Rule in Response to 
the Court's Remand Order

    In light of the statutory language in section 2719A of the PHS Act 
and the totality of the comments received in response to the June 2010 
IFR, the Departments continue to believe that the implementing 
regulations provide a reasonable and transparent methodology to 
determine appropriate payments by non-grandfathered group health plans 
and health insurance issuers offering non-grandfathered group or 
individual health insurance coverage for out-of-network emergency 
services. ACEP's proposal that the GOT regulation require the 
development of a new database and/or utilization of a publicly-
available database to set UCR amounts would require the Departments to 
extend the scope of their authority under section 2719A of the PHS Act 
beyond the establishment of a minimum payment amount to facilitate the 
cost-sharing requirements in section 2719A(b) of the PHS Act, to the 
development of specific provider reimbursement rates for group health 
plans and health insurance issuers, which is an area that, up to this 
point, has been reserved for the states, issuers, and health plans. 
Accordingly, the Departments decline to adopt such a requirement. 
Finally, even if the Departments were prepared to extend their 
authority in this manner, creating and maintaining a database or 
assessing, validating, and monitoring publicly available databases 
would be costly and time-consuming, and there is no indication in 
either case that such a database would provide a better method for 
determining UCR amounts than the methods group health plans and health 
insurance issuers currently use.

A. GOT Regulation Is Reasonable and Transparent

    The Departments believe that ACEP and other commenters did not 
provide adequate information to support their assertion that the 
methods used for determining the minimum payment for

[[Page 19435]]

out-of-network emergency services under the GOT regulation are not 
sufficiently transparent or reasonable. In developing the GOT 
regulation, the Departments accounted for wide variation in how group 
health plans and health insurance issuers determine both in-network and 
out-of-network rates, and made a determination to base the GOT criteria 
on existing provisions of federal law. The Departments have not 
received any information regarding ACEP's concerns, as part of the 
comment record or otherwise, that persuaded us that these standards are 
insufficiently transparent or otherwise unreasonable, and we conclude 
that the methodology for determining payment amounts under all three 
prongs of the GOT regulation is sufficiently transparent and 
reasonable.
    Under the GOT regulation, the three prongs work together to 
establish a floor on the payment amount for out-of-network emergency 
services, and each state generally retains authority to set higher 
amounts for health insurance issued within the state. The GOT 
regulation requires that a group health plan or health insurance issuer 
must pay the highest amount determined under the three prongs, which 
reflect amounts that the federal government itself or group health 
plans and health insurance issuers have established as reasonable.
    The Departments determined the GOT methodology was sufficiently 
transparent by taking into account other federal laws which require 
disclosure in certain circumstances. Specifically, a group health plan 
subject to ERISA must disclose how it calculates a payment amount under 
the GOT regulation, including payment amounts to in-network providers, 
and the method the group health plan or health insurance issuer used to 
determine the UCR amount to a claimant or the claimant's authorized 
representative.\16\
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    \16\ See DOL Advisory Opinion 96-14A (July 31, 1996). See also 
FAQs about Affordable Care Act Implementation Part 31, Mental Health 
Parity Implementation, and Women's Health and Cancer Rights Act 
Implementation, available at https://www.dol.gov/sites/default/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.
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    Additionally, as described above, under the internal claims and 
appeals and external review requirements of section 2719 of the PHS 
Act, which apply to plans that are subject to the protections of 
section 2719A of the PHS Act, a claimant (or the claimant's authorized 
representative) upon appeal of an adverse benefit determination must be 
provided reasonable access to, and copies of, all documents, records, 
and other information relevant to the claim for benefits, including 
information about the plan's determination of the UCR amount. A failure 
to provide or make payment of a claim in whole or in part is considered 
an adverse benefit determination.\17\
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    \17\ 26 CFR 54.9815-2719(b); 29 CFR 2590.715-2719(b); 45 CFR 
147.136(b). See also footnote 11.
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    Further, the Medicare rate is transparent because the Medicare 
statute's provisions on setting physician payment rates are objective 
and detailed, and provide payment at a level that reflects the relative 
value of a service.\18\ Medicare rates for physicians' services are 
established and reviewed every year through a rulemaking in which all 
physicians and other stakeholders are invited to submit public comment 
on the agency's proposed calculations.\19\
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    \18\ See Social Security Act Section 1848(b)(1).
    \19\ See id.
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    As a result, patients who are to be protected by the statute have a 
right to transparent access to the calculations used to arrive at the 
allowed amount for out-of-network emergency services, and a provider 
can obtain this information as a patient's authorized 
representative.\20\ To the extent that a provider is not able to obtain 
these calculations, the Departments believe that the patients' ability 
to obtain and to potentially challenge the information through 
litigation or the appeals process creates adequate safeguards with 
respect to ACEP's concerns regarding health insurance issuer 
manipulation of UCR amounts. This provides sufficient protections, 
especially in light of the focus of section 2719A of the PHS Act on the 
protection of patients, rather than physicians. For all these reasons, 
the Departments believe that the methodology in the GOT regulations is 
sufficiently transparent and reasonable.
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    \20\ See 29 CFR 2560.503-1(b)(4). See also 26 CFR 54.9815-
2719(b)(2)(i), 29 CFR 2590.715-2719(b)(2)(i), and 45 CFR 
147.136(b)(2)(i), requiring non-grandfathered group health plans and 
issuers to incorporate the internal claims and appeals processes set 
forth in 29 CFR 2560.503-1.
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B. Creation of a Database or Use of a Publicly Available Database Is 
Problematic

    The creation and use of ACEP's proposed database on payments and 
charges would be problematic in a number of ways. The establishment and 
maintenance of a publicly available database would be time-consuming, 
would require contracting assistance, and would be costly and 
burdensome to maintain. Furthermore, there is no indication that such a 
database would be a better barometer of UCR amounts than the current 
methodology used by group health plans and health insurance issuers.
    ACEP's suggestion that the Departments mandate the use of an 
existing database (for example, FAIR Health) presents similar issues. 
As an initial matter, determining which existing database (if any) is 
appropriate for calculating UCR, and then monitoring the database, 
would be costly and time-consuming. And, as with ACEP's suggestion that 
the Departments create a database, there is no indication that a 
publicly available database would be a better barometer of UCR amounts 
than the current methodology used by group health plans and health 
insurance issuers.
    Thus, the Departments concluded in the November 2015 final rule, 
and still maintain, that the existing GOT regulation provides a 
statutorily supportable, and also a more practical, and cost-effective 
approach for group health plans and health insurance issuers to 
determine the required minimum payment amounts. Further, the 
Departments did not have a mandate to require plans and issuers to use 
different databases for the purposes of implementing the Patient 
Protections statutory requirements from what they may currently use, 
and the Departments decline to mandate the use of one particular 
database in the limited context of this rulemaking. It is the 
Departments' view that it is appropriate to continue to reserve the 
determination of the relative merits of each database to the discretion 
of the states, insurers, and health plans.\21\
---------------------------------------------------------------------------

    \21\ The website of the All Claims Payable Database Council 
lists 19 states with legislation enabling the collection of claims 
and databases. https://www.apcdcouncil.org/apcd-legislation-state.
---------------------------------------------------------------------------

III. Conclusion

    The Departments believe that the November 2015 final rule provides 
a reasonable methodology to determine appropriate payments by group 
health plans and health insurance issuers for out-of-network emergency 
services, in light of the statutory language in section 2719A of the 
PHS Act and the totality of the comments received in response to the 
June 2010 IFR. The Departments also believe that the three prongs of 
the GOT regulation are sufficiently transparent. ACEP's proposal that 
the GOT regulation require the development of a database or utilization 
of a publicly available database to set UCR amounts would require the 
Departments to extend the scope of authority provided under section 
2719A of the PHS Act to

[[Page 19436]]

intrude on state authority and group health plan and health insurance 
issuer discretion; and even if the Departments were prepared to extend 
their authority in this manner, the establishment and maintenance of a 
database or the assessment, validation, and monitoring of a publicly 
available database would be costly and time-consuming. Further, there 
is no indication that such a database would provide a better method for 
determining UCR amounts than the methods group health plans and health 
insurance issuers currently use. The Departments therefore decline to 
adopt the suggestions of ACEP and other commenters that made similar 
suggestions regarding the GOT regulation.

IV. 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.).

Kirsten B. Wielobob,
Deputy Commissioner for Services and Enforcement, Internal Revenue 
Service.

    Approved: April 25, 2018.
David J. Kautter,
Assistant Secretary of the Treasury (Tax Policy).

    Approved: April 25, 2018.

    Signed this 25th day of April 2018.
Preston Rutledge,
Assistant Secretary, Employee Benefits Security Administration, 
Department of Labor.
    Dated: April 25, 2018.

Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: April 27, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-09369 Filed 4-30-18; 4:15 pm]
BILLING CODE 4120-01-P
Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations 19431

The full analysis of economic impacts is in the Federal Register, but websites are DEPARTMENT OF THE TREASURY
available in the docket for this final rule subject to change over time.
(Ref. 1). Internal Revenue Service
1. FDA, ‘‘Crabmeat; Amendment of Common
V. Analysis of Environmental Impact or Usual Name Regulation: Final
26 CFR Part 54
Regulatory Impact Analysis,’’ 2017. Also
We have determined under 21 CFR available at https://www.fda.gov/ [TD 9744]
25.30(k) that this action is of a type that AboutFDA/ReportsManualsForms/
does not individually or cumulatively RIN 1545–BJ45, 1545–BJ50, 1545–BJ62,
Reports/EconomicAnalyses/default.htm.
have a significant effect on the human 1545–BJ57
environment. Therefore, neither an List of Subjects in 21 CFR Part 102
DEPARTMENT OF LABOR
environmental assessment nor an
environmental impact statement is Beverages, Food grades and standards,
Food labeling, Frozen foods, Oils and Employee Benefits Security
required.
fats, Onions, Potatoes, Seafood. Administration
VI. Paperwork Reduction Act of 1995
Therefore, under the Federal Food, 29 CFR Part 2590
This final rule contains no collection Drug, and Cosmetic Act and under
of information. Therefore, clearance by authority delegated to the Commissioner RIN 1210–AB72
the Office of Management and Budget of Food and Drugs, 21 CFR part 102 is
under the Paperwork Reduction Act of DEPARTMENT OF HEALTH AND
amended as follows:
1995 is not required. HUMAN SERVICES
VII. Federalism PART 102—COMMON OR USUAL
NAME FOR NONSTANDARDIZED 45 CFR Parts 144, 146, and 147
We have analyzed this final rule in FOODS [CMS–9993–N]
accordance with the principles set forth
in Executive Order 13132. FDA has RIN 0938–AS56
■ 1. The authority citation for part 102
determined that the rule does not continues to read as follows:
contain policies that have substantial Clarification of Final Rules for
direct effects on the States, on the Authority: 21 U.S.C. 321, 343, 371. Grandfathered Plans, Preexisting
relationship between the National Condition Exclusions, Lifetime and
■ 2. In § 102.50 revise the table to read Annual Limits, Rescissions,
Government and the States, or on the
as follows: Dependent Coverage, Appeals, and
distribution of power and
responsibilities among the various Patient Protections Under the
§ 102.50 Crabmeat. Affordable Care Act
levels of government. Accordingly, we
* * * * *
conclude that the rule does not contain AGENCY: Internal Revenue Service,
policies that have federalism Common or usual name Department of the Treasury; Employee
Scientific name of crab
implications as defined in the Executive of crabmeat Benefits Security Administration,
order and, consequently, a federalism Department of Labor; and Centers for
Chionoecetes opilio, Snow crabmeat.
summary impact statement is not Chionoecetes tanneri, Medicare & Medicaid Services,
required. Chionoecetes bairdii, Department of Health and Human
and Chionoecetes Services.
VIII. Consultation and Coordination angulatus.
With Indian Tribal Governments Erimacrus isenbeckii ....... Korean variety crabmeat ACTION: Final rule; clarification.
or Kegani crabmeat.
We have analyzed this rule in Lithodes aequispinus ...... Golden King crabmeat. SUMMARY: On November 18, 2015, the
accordance with the principles set forth Paralithodes brevipes ..... King crabmeat or Departments of Labor, Health and
in Executive Order 13175. We have Hanasaki crabmeat. Human Services, and the Treasury (the
determined that the rule does not Paralithodes King crabmeat. Departments) published a final rule in
camtschaticus and
contain policies that have substantial Paralithodes platypus.
the Federal Register titled ‘‘Final Rules
direct effects on one or more Indian for Grandfathered Plans, Preexisting
Tribes, on the relationship between the Condition Exclusions, Lifetime and
Federal Government and Indian Tribes, Dated: April 27, 2018. Annual Limits, Rescissions, Dependent
or on the distribution of power and Leslie Kux, Coverage, Appeals, and Patient
responsibilities between the Federal Associate Commissioner for Policy. Protections Under the Affordable Care
Government and Indian Tribes. [FR Doc. 2018–09371 Filed 5–2–18; 8:45 am] Act’’ (the November 2015 final rule),
Accordingly, we conclude that the rule BILLING CODE 4164–01–P regarding, in part, the coverage of
does not contain policies that have emergency services by non-
tribal implications as defined in the grandfathered group health plans and
Executive Order and, consequently, a health insurance issuers offering non-
tribal summary impact statement is not grandfathered group or individual
required. health insurance coverage, including the
requirement that non-grandfathered
IX. References
group health plans and health insurance
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The following reference is on display issuers offering non-grandfathered
in the Dockets Management Staff (see group or individual health insurance
ADDRESSES) and is available for viewing coverage limit cost-sharing for out-of-
by interested persons between 9 a.m. network emergency services and, as part
and 4 p.m., Monday through Friday. of that rule, pay at least a minimum
FDA has verified the website addresses, amount for out-of-network emergency
as of the date this document publishes services. The American College of

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19432 Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations

Emergency Physicians (ACEP) filed a health insurance coverage 1 and states, performing such services by the non-
complaint in the United States District in general, that if a group health plan, grandfathered group health plan or
Court for the District of Columbia, or a health insurance issuer offering health insurance issuer offering non-
which on August 31, 2017 granted in group or individual health insurance grandfathered group or individual
part and denied in part without coverage, provides or covers any health insurance coverage.
prejudice ACEP’s motion for summary benefits with respect to services in an As background, the amount an out-of-
judgment and remanded the case to the emergency department of a hospital, the network provider may charge for
Departments to respond to the public plan or issuer shall cover emergency emergency services may exceed the
comments from ACEP and others. In services—(A) without the need for any group health plan’s or health insurance
response, the Departments are issuing prior authorization determination; (B) issuer’s ‘‘allowed amount’’ (the
this notice of clarification to provide a whether the health care provider ‘‘[m]aximum amount on which payment
more thorough explanation of the furnishing such services is a is based for covered health care
Departments’ decision not to adopt participating provider with respect to services’’).3 The allowed amount may be
recommendations made by ACEP and such services; (C) in a manner so that, subject to deductibles and other cost-
certain other commenters in the if such services are provided to a sharing in terms of a fixed-amount per
November 2015 final rule. participant, beneficiary, or enrollee—(i) service and/or a coinsurance percentage
by a nonparticipating health care of the allowed amount. In circumstances
DATES: This clarification is applicable in which a provider’s charge exceeds
provider with or without prior
beginning May 3, 2018. the allowed amount, some states allow
authorization; or (ii)(I) such services
FOR FURTHER INFORMATION CONTACT: will be provided without imposing any an out-of-network provider to ‘‘balance
Amber Rivers, Employee Benefits requirement under the plan for prior bill’’ the patient for the amount of the
Security Administration, Department of authorization of services or any provider’s charge that exceeds the
Labor, at (202) 693–8335; Dara R. limitation on coverage where the allowed amount.
Alderman, Internal Revenue Service, provider of services does not have a Section 2719A of the PHS Act does
Department of the Treasury, at (202) contractual relationship with the plan not prohibit an out-of-network provider
317–5500; and Katherine Carver, for the providing of services that is more from balance billing a participant or
Centers for Medicare & Medicaid restrictive than the requirements or beneficiary because although it includes
Services, Department of Health and limitations that apply to emergency a cost-sharing rule, ‘‘cost sharing’’ is a
Human Services, at (410) 786–1565. department services received from statutorily defined term that ‘‘does not
providers who do have such a include . . . balance billing amounts for
SUPPLEMENTARY INFORMATION:
contractual relationship with the plan; non-network providers’’ and the cost-
I. Background and (II) if such services are provided sharing requirement in section
out-of-network, the cost-sharing 2719A(b)(1)(C)(ii)(II) of the PHS Act
A. The Rulemaking at Issue applies to cost sharing ‘‘expressed as a
requirement (expressed as a copayment
i. Statutory Background amount or coinsurance rate) is the same copayment amount or coinsurance
requirement that would apply if such rate.’’ 4
The Patient Protection and Affordable services were provided in-network.
Care Act (Pub. L. 111–148), was enacted ii. The Departments’ Regulation and
Therefore, among other things, the Related Comments
on March 23, 2010; the Health Care and statute requires non-grandfathered
Education Reconciliation Act of 2010 group health plans and health insurance On June 28, 2010, the Departments
(Pub. L. 111–152) was enacted on March issuers offering non-grandfathered published an interim final rule (IFR) in
30, 2010. These statutes are collectively group or individual health insurance the Federal Register titled ‘‘Patient
referred to as ‘‘PPACA’’ in this coverage that cover emergency services Protection and Affordable Care Act;
document. The PPACA reorganized, to do so even if the provider is not one Requirements for Group Health Plans
amended, and added to the provisions of the plans’ or issuers’ ‘‘participating and Health Insurance Issuers Under the
of part A of title XXVII of the Public provider[s].’’ 2 In addition, section Patient Protection and Affordable Care
Health Service Act (PHS Act). PPACA 2719A of the PHS Act requires non- Act Relating to Preexisting Condition
also added section 715 to the Employee grandfathered group health plans and Exclusions, Lifetime and Annual Limits,
Retirement Income Security Act (ERISA) health insurance issuers offering non- Rescissions, and Patient Protections,’’
and section 9815 to the Internal grandfathered group or individual 75 FR 37188 (the June 2010 IFR). The
Revenue Code (the Code) to incorporate health insurance coverage to apply the June 2010 IFR preamble on section
the provisions of part A of title XXVII same cost-sharing requirement 2719A of the PHS Act stated, in part,
of the PHS Act into ERISA and the (expressed as copayments and that, because the statute does not
Code, and make them applicable to coinsurance) for emergency services require plans or issuers to cover balance
group health plans, and health provided out-of-network as emergency billing amounts, and does not prohibit
insurance issuers providing health services provided in-network; however, balance billing, even where the
insurance coverage in connection with the statute does not expressly address protections in the statute apply, patients
group health plans. Accordingly, how much the out-of-network provider may be subject to balance billing. It
sections 2701 through 2728 of the PHS of emergency services must be paid for would defeat the purpose of the
Act are incorporated into the Code and protections in the statute if a plan or
ERISA. 1 Section 2719A of the PHS Act also provides, for
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Section 2719A of the PHS Act, which non-grandfathered group health plans and health 3 See definition of ‘‘allowed amount’’ and

insurance issuers offering non-grandfathered group ‘‘balance billing’’ in the Uniform Glossary of Health
is entitled ‘‘Patient Protections,’’ or individual health insurance coverage, rules Care Coverage and Medical Terms, https://
provides requirements relating to regarding designation of primary care providers, www.dol.gov/sites/default/files/ebsa/laws-and-
coverage of emergency services for non- access to pediatric care, and patient access to regulations/laws/affordable-care-act/for-employers-
grandfathered group health plans and obstetrical and gynecological care. This document and-advisers/sbc-uniform-glossary-of-coverage-and-
does not address those aspects of section 2719A of medical-terms-final.pdf.
health insurance issuers offering non- the PHS Act. 4 See PPACA section 1302(c)(3)(B). See also 80 FR
grandfathered group or individual 2 See section 2719A(b)(1)(B) of the PHS Act. 72192, 72212–13 (Nov. 18, 2015).

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Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations 19433

issuer paid an unreasonably low amount to the second prong of the GOT Healthcare Association of New York
to a provider, even while limiting the regulation, which relates to the method State, and the California Chapter of
coinsurance or copayment associated the plan generally uses to determine ACEP, submitted similar comments
with that amount to in-network payments for out-of-network services, expressing their concern about the lack
amounts. To avoid the circumvention of such as the usual, customary, and of transparency and potential for
the protections of section 2719A of the reasonable amount (henceforth referred manipulation of rates under the second
PHS Act, it is necessary that a to as the UCR amount). ACEP’s August prong of the GOT regulation. Like
reasonable amount be paid before a 3, 2010 comment letter 6 stated the ACEP, several of these commenters
patient becomes responsible for a following: referenced the FAIR Health database as
balance billing amount. Thus, these . . . [W]e appreciate the clearly stated a potential alternative solution.7
interim final regulations require that a acknowledgement that allowing plans and On November 18, 2015, the
reasonable amount be paid for services insurersto pay emergency physicians Departments finalized the regulation
by some objective standard. In whatever they see fit defeats the purpose of under section 2719A of the PHS Act,
establishing the reasonable amount that protecting patients from potentially large including the GOT regulation (80 FR
must be paid, the Departments had to bills. In that light, we also support 72192). The November 2015 final rule
development of an objective standard to adopted the GOT regulation without
account for wide variation in how plans
establish ‘fair payment.’ Insurers know that
and issuers determine both in-network emergency physicians will see everyone who substantive revision from the June 2010
and out-of-network rates. For example, comes to the ED due to EMTALA IFR and incorporated a clarification that
for a plan using a capitation responsibilities, and many leverage that fact had been issued in subregulatory
arrangement to determine in-network to impose extremely low reimbursement guidance.8 In the November 2015 final
payments to providers, there is no in- rates. While a large majority of our members rule, the Departments reiterated the
network rate per service. participate in nearly every plan or insurer need for the GOT regulation, and in
Accordingly, these interim final network in their area, the primary reason response to the comments described
they cite for not joining a plan’s network is
regulations considered three amounts: above regarding the GOT regulation, the
that the plan has arbitrarily offered an in-
The in-network rate, the out-of-network network payment rate that fails to cover the Departments stated that ‘‘[s]ome
rate, and the Medicare rate. Specifically, costs of providing the service. This forces the commenters expressed concern about
a plan or issuer satisfies the copayment physicians to balance bill the patients, which the level of payment for out-of-network
and coinsurance limitations in the often results in an unsatisfactory experience emergency services and urged the
statute if it provides benefits for out-of- for everyone but the insurer. . . Departments to require plans and
network emergency services in an As noted in the IF rule, ‘there is wide issuers to use a transparent database to
amount equal to the greatest of three variation in how plans and issuers determine out-of-network amounts. The
possible amounts—(1) The amount determine in [network] and out-of- Departments believe that this concern is
negotiated with in-network providers network rates.’ The term ‘reasonable’ is addressed by our requirement that the
for the emergency service furnished; (2) in the eye of the beholder. For many amount be the greatest of the three
The amount for the emergency service years, usual and customary rates amounts specified in [the GOT
calculated using the same method the referred to charges or a proportion of regulation].’’ 9
plan generally uses to determine charges. This has changed in recent B. Other Guidance
payments for out-of-network services years and physicians, particularly
(such as the usual, customary, and emergency physicians, have had In response to concerns about
reasonable charges) but substituting the problems with the ‘black box’ approach transparency with respect to the second
in-network cost-sharing provisions for that commercial insurers have used to prong of the GOT regulation raised by
the out-of-network cost-sharing determine [the] usual and customary ACEP in its comment and in subsequent
provisions; or (3) The amount that ‘rates’ for out-of-network providers. At communications to the Departments, on
would be paid under Medicare for the this time, we are unaware of a national April 20, 2016, the Departments issued
emergency service. Each of these three database that is widely available and Frequently Asked Questions About
amounts is calculated excluding any in- provides timely data for objective Affordable Care Act Implementation
network copayment or coinsurance comparisons of charges and/or costs that Part 31, Mental Health Parity
imposed with respect to the participant, could be used to implement this part of Implementation, and Women’s Health
beneficiary, or enrollee.5 the regulation. A new database, perhaps
This is sometimes referred to as the the FAIR Health data[base] that is 7 The FAIR Health Database was created by FAIR

‘‘Greatest of Three’’ or the ‘‘GOT’’ Health, an independent nonprofit that collects data
currently being developed as a result of for and manages the nation’s largest database of
regulation because it sets a floor on the the settlement with Ingenix, may prove privately billed health insurance claims. See
amount non-grandfathered group health to be more timely and accurate, but any https://www.fairhealth.org/about-us.
plans and health insurance issuers database used to establish usual and 8 The final regulations incorporated guidance that

offering non-grandfathered group or customary reasonable rates will require had been provided in FAQs about Affordable Care
Act Implementation (Part I), Q15, available at
individual health insurance coverage transparent validation, monitoring, and www.dol.gov/ebsa/faqs/faq-aca.html and https://
are required to pay for out-of-network active enforcement by state and federal www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
emergency services under this provision insurance officials.’’ FAQs/aca_implementation_faqs.html. The FAQ and
at the greatest of the three listed Other groups, such as Advocacy for final regulations provide that if state law prohibits
balance billing, or in cases in which a group health
amounts. Patients with Chronic Illness, Inc. and plan or health insurance issuer is contractually
During the comment period for the Lybba, the Emergency Department responsible for balance billing amounts, plans and
June 2010 IFR, some commenters were Practice Management Association, the
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issuers are not required to satisfy the GOT
in favor of the GOT regulation while American Medical Association, the regulation, but may not impose any copayment or
coinsurance requirement for out-of-network
others expressed concerns. Several American Hospital Association, the emergency services that is higher than the
commenters, including ACEP, objected Texas Medical Association, the copayment or coinsurance requirement that would
apply if the services were provided in-network. See
5 75 FR at 37194 (footnote omitted). For the 6 Available at https://www.regulations.gov/ 26 CFR 54.9815–2719A(b)(3)(iii); 29 CFR 2590.715–
interim final regulation text, see 75 FR at 37225, contentStreamer?documentId=EBSA-2010-0016- 2719A(b)(3)(iii); and 45 CFR 47.138(b)(3)(iii).
37232, and 37238. 0022&attachmentNumber=1&contentType=pdf. 9 80 FR 72192, 72213 (Nov. 18, 2015).

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19434 Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations

and Cancer Rights Act Implementation, C. The Court’s Remand Order manner that ‘enable[s] [the Court] to see
which addressed, in part, the GOT On May 12, 2016, ACEP filed a what major issues of policy were
regulation.10 In Question & Answer lawsuit against the Departments, ventilated . . . and why the agency
number 4, the Departments clarified that asserting that the final GOT regulation reacted to them as it did.’ ’’ 15
a group health plan or health insurance The Departments are issuing this
should be invalidated because it does
issuer of group or individual health document to provide the additional
not ensure a reasonable payment for
insurance coverage is required to consideration required by the court’s
out-of-network emergency services as
disclose how it calculates the amounts remand order. Specifically, the
required by the statute, and that the
under the GOT regulation, including the Departments are responding more fully
Departments did not respond
UCR amount. These disclosure to ACEP’s written comment dated
meaningfully to ACEP’s comments
requirements would also apply to a August 3, 2010 in reference to the June
about purported deficiencies in the
request for disclosure of payment 2010 IFR.
regulation.13
amounts for in-network providers. Following briefing by both parties, on II. Further Consideration of the
Specifically, for group health plans August 31, 2017, the United States Departments’ Final Rule in Response to
subject to ERISA, documentation and District Court for the District of the Court’s Remand Order
data used to calculate each of the Columbia issued a memorandum
amounts under the GOT regulations for In light of the statutory language in
opinion that granted in part and denied section 2719A of the PHS Act and the
out-of-network emergency services, in part without prejudice ACEP’s
including the UCR amount, are totality of the comments received in
motion for summary judgment, and response to the June 2010 IFR, the
considered to be instruments under remanded the case to the Departments
which the plan is established or Departments continue to believe that the
for further explanation of the November implementing regulations provide a
operated and would be subject to the 2015 final rule.14 The court concluded
disclosure provisions under section reasonable and transparent methodology
that the Departments did not adequately to determine appropriate payments by
104(b) of ERISA and 29 CFR 2520.104b– respond to comments and proposed
1, which generally require that such non-grandfathered group health plans
alternatives submitted by ACEP and and health insurance issuers offering
information be furnished to plan others regarding perceived problems
participants (or their authorized non-grandfathered group or individual
with the GOT regulation. In particular, health insurance coverage for out-of-
representatives) within 30 days of the court stated that the Departments’
request.11 In addition, the Department of network emergency services. ACEP’s
response in the November 2015 final proposal that the GOT regulation
Labor claims procedure regulations, as rule ‘‘to numerous comments raising
well as the internal claims and appeals require the development of a new
specific concerns about the method database and/or utilization of a
and external review requirement under used in the GOT regulation for
section 2719 of the PHS Act, which publicly-available database to set UCR
determining the amounts insurers amounts would require the Departments
apply to both ERISA and non-ERISA would be required to pay for out-of-
non-grandfathered group health plans to extend the scope of their authority
network emergency medical services— under section 2719A of the PHS Act
and health insurance issuers of non- e.g., the rates’ lack of transparency or
grandfathered group or individual beyond the establishment of a minimum
their vulnerability to manipulation’’ did payment amount to facilitate the cost-
coverage, set forth rules regarding not ‘‘seriously respond to the actual
claims and appeals, including the right sharing requirements in section
concerns raised about the particular 2719A(b) of the PHS Act, to the
of a claimant (or the claimant’s rates, and it ignore[d] altogether the
authorized representative) upon appeal development of specific provider
proposed alternative of using a database reimbursement rates for group health
of an adverse benefit determination (or to set payment.’’ The court stated that
a final internal adverse benefit plans and health insurance issuers,
its holding was ‘‘a narrow one,’’ relating which is an area that, up to this point,
determination) to be provided upon ‘‘only to the sufficiency of the
request and free of charge, reasonable has been reserved for the states, issuers,
Departments’ response to comments and and health plans. Accordingly, the
access to, and copies of, all documents, proposed alternatives.’’
records, and other information relevant Departments decline to adopt such a
The court did not vacate the requirement. Finally, even if the
to the claimant’s claim for benefits, and November 2015 final rule but ordered
a failure to provide or make payment of Departments were prepared to extend
that ‘‘this matter is remanded to the their authority in this manner, creating
a claim in whole or in part is an adverse Departments of Health and Human
benefit determination.12 and maintaining a database or assessing,
Services, Labor, and the Treasury so that validating, and monitoring publicly
10 See https://www.dol.gov/sites/default/files/
they can adequately address the available databases would be costly and
ebsa/about-ebsa/our-activities/resource-center/faqs/ comments and proposals at issue in this time-consuming, and there is no
aca-part-31.pdf, or https://www.cms.gov/CCIIO/ case. On remand, the Departments are indication in either case that such a
Resources/Fact-Sheets-and-FAQs/Downloads/ free to exercise their discretion to database would provide a better method
FAQs-31_Final-4-20-16.pdf. supplement their explanation as they
11 See DOL Advisory Opinion 96–14A (July 31,
for determining UCR amounts than the
1996). See also FAQs about Affordable Care Act
deem appropriate and to reach the same methods group health plans and health
Implementation (Part XXIX) and Mental Health or different ultimate conclusions. At a insurance issuers currently use.
Parity Implementation, Q12, available at minimum; however, the Departments
www.dol.gov/ebsa/faqs/faq-aca29.html and are required to respond to [ACEP’s] A. GOT Regulation Is Reasonable and
www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
comments and proposals in a reasoned Transparent
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FAQs/Downloads/FAQs-Part-XXIX.pdf, providing
that a plan’s or issuer’s characterization of The Departments believe that ACEP
information as proprietary or commercially 54.9815–2719(b)(2)(ii)(C), 29 CFR 2590.715– and other commenters did not provide
valuable cannot be a basis for non-disclosure. 2719(b)(2)(ii)(C), and 45 CFR 147.136(b)(2)(ii)(C) adequate information to support their
12 29 CFR 2560.503–1, 26 CFR 54.9815–2719, 29 and (b)(3)(ii)(C).
13 See https://www.acep.org/Legislation-and-
assertion that the methods used for
CFR 2590.715–2719, and 45 CFR 147.136. For
additional requirements for the full and fair review Advocacy/Regulatory/ACEPvsHHS_051216/. determining the minimum payment for
standard that applies under PHS Act section 2719, 14 See American College of Emergency Physicians

in addition to 29 CFR 2560.503–1(h)(2), see 26 CFR v. Price, et al., 264 F. Supp. 3d 89 (D.D.C. 2017). 15 Id.

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Document Created: 2018-05-02 23:48:41
Document Modified: 2018-05-02 23:48:41
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; clarification.
Dates		This clarification is applicable beginning May 3, 2018.
Contact		Amber Rivers, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335; Dara R. Alderman, Internal Revenue Service, Department of the Treasury, at (202) 317-5500; and Katherine Carver, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (410) 786-1565.
FR Citation		83 FR 19431
RIN Number		1545-BJ45, 1545-BJ50, 1545-BJ62, 1545-BJ57, 1210-AB72 and 0938-AS56
CFR Citation		26 CFR 54 29 CFR 2590 45 CFR 144 45 CFR 146 45 CFR 147
83 FR 19431 - Clarification of Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act

DEPARTMENT OF THE TREASURYInternal Revenue ServiceDEPARTMENT OF LABOREmployee Benefits Security AdministrationDEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 86 (May 3, 2018)

DEPARTMENT OF THE TREASURY
Internal Revenue Service
DEPARTMENT OF LABOR
Employee Benefits Security Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
