Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and External Review Processes; Correction, 44491-44493 [2011-18820]
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Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Rules and Regulations
the Federal statute.’’ Federal law
includes an express preemption
provision that preempts certain state
requirements ‘‘different from or in
addition to’’ certain Federal
requirements applicable to devices. 21
U.S.C. 360k. See Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996); and Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008).
The special controls established by this
final rule create ‘‘requirements’’ to
address each identified risk to health
presented by these specific medical
devices under 21 U.S.C. 360k, even
though product sponsors may have
flexibility in how they meet those
requirements. Cf. Papike v. Tambrands,
Inc., 107 F.3d 737, 740–42 (9th Cir.
1997).
V. How does this rule comply with the
paperwork reduction Act of 1995?
FDA concludes that this final rule
contains no new collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520) is not required.
of major depressive disorder without
inducing seizure in patients who have
failed at least one antidepressant
medication and are currently not on any
antidepressant therapy.
(b) Classification. Class II (special
controls). The special control is FDA’s
‘‘Class II Special Controls Guidance
Document: Repetitive Transcranial
Magnetic Stimulation System.’’ See
§ 882.1(e) for the availability of this
guidance document.
Dated: July 20, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–18806 Filed 7–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[TD 9532]
RIN 1545–BK30
VI. What references are on display?
DEPARTMENT OF LABOR
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
Employee Benefits Security
Administration
29 CFR Part 2590
RIN 1210–AB45
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. Petition from Neuronetics, Inc., May 23,
2007.
45 CFR Part 147
List of Subjects in 21 CFR Part 882
[CMS–9993–CN]
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is
amended as follows:
RIN 0938–AQ66
PART 882—NEUROLOGICAL DEVICES
AGENCIES:
1. The authority citation for 21 CFR
part 882 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 882.5805 is added to
subpart F to read as follows:
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■
§ 882.5805 Repetitive transcranial
magnetic stimulation system.
14:34 Jul 25, 2011
Jkt 223001
Internal Revenue Service,
Department of the Treasury; Employee
Benefits Security Administration,
Department of Labor; Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services.
ACTION: Correction of amendment to
interim final rules with request for
comments.
This document corrects
technical errors that appeared in the
June 24, 2011 amendment to the interim
final rules (76 FR 37208) entitled,
‘‘Group Health Plans and Health
Insurance Issuers: Rules Relating to
Internal Claims and Appeals and
External Review Processes.’’
SUMMARY:
(a) Identification. A repetitive
transcranial magnetic stimulation
system is an external device that
delivers transcranial repetitive pulsed
magnetic fields of sufficient magnitude
to induce neural action potentials in the
prefrontal cortex to treat the symptoms
VerDate Mar<15>2010
Group Health Plans and Health
Insurance Issuers: Rules Relating to
Internal Claims and Appeals and
External Review Processes; Correction
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DATES:
44491
Effective Date: July 22, 2011.
FOR FURTHER INFORMATION CONTACT:
Ellen Kuhn, Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, at (301)
492–4263; Amy Turner, Employee
Benefits Security Administration,
Department of Labor, at (202) 693–8335;
or Karen Levin, Internal Revenue
Service, Department of the Treasury, at
(202) 622–6080.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
In FR Doc. 2011–15890 of June 24,
2011 (76 FR 37208), there were
technical errors that are identified in the
‘‘Summary of Errors’’ section and
corrected in the ‘‘Correction of Errors’’
section below. The provisions in this
correction notice are effective as if they
had been included in the June 24, 2011
interim final rule with request for
comments entitled, ‘‘Group Health Plans
and Health Insurance Issuers: Rules
Relating to Internal Claims and Appeals
and External Review Processes.’’
Accordingly, the corrections are
effective July 22, 2011.
B. Regulations Overview
On July 23, 2010, the Departments of
Health and Human Services (HHS),
Labor (DOL), and the Treasury
(collectively, the Departments) issued
interim final rules implementing section
2719 of the Public Health Service (PHS)
Act (75 FR 43330) (July 2010
regulations), regarding internal claims
and appeals and external review
processes for group health plans and
health insurance issuers offering
coverage in the group and individual
markets.1 The Departments issued an
amendment to the interim final rules
that was published in the Federal
Register on June 24, 2011 (76 FR 37208)
(June 2011 amendments). Below, we
summarize the errors in the June 2011
amendments and describe the
corrections we are making in this notice.
II. Summary of Errors
A. Error in the Preamble
In the FOR FURTHER INFORMATION
CONTACT section of the June 2011
amendments (page 37208), we listed an
incorrect telephone number for Ellen
Kuhn, Centers for Medicare & Medicaid
Services, Department of Health and
Human Services. We are correcting the
telephone number.
1 The requirements of PHS Act section 2719 and
the July 2010 regulations do not apply to health
plans grandfathered under section 1251 of the
Affordable Care Act.
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Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Rules and Regulations
B. Errors in the Regulations Text
In the June 2011 amendments (page
37231), we inadvertently made a
typographical error in the DOL
regulations text that could cause
confusion. The text pertains to the
effective date of the suspension of the
general rule defining the scope of what
is appealable in external review. We are
correcting this typographical error. We
note that the regulation text for HHS
and the Department of the Treasury
were correct and therefore are
unchanged.
In the joint preamble to the June 2011
amendments (pages 37209 through
37215), we explain that the July 2010
regulations established requirements for
group health plans and health insurance
issuers offering both individual and
group health coverage and that the June
2011 amendments were modifying those
requirements. However, the regulations
text in the June 2011 amendments only
reflected the changes to the group
market provisions, which appear in all
three Departments’ regulations (pages
37228 through 37229; 37230 through
37231; and 37232 through 37233).
Requirements that apply to the
individual market only appear in HHS
regulations, and conforming
amendments to those requirements were
inadvertently omitted from the
regulation text of the June 2011
amendments. In the regulations text at
45 CFR 147.136, HHS is correcting this
technical error. Specifically, we are
reorganizing § 147.136(b)(3)(ii) and
adding language to clarify that these
amendments apply to health insurance
issuers offering individual health
coverage. These changes relate to
internal claims and appeals processes
requirements for individual health
insurance issuers in the HHS
regulations text. We note that the
regulations text for the DOL and the
Department of the Treasury were correct
and therefore are unchanged.
wreier-aviles on DSKDVH8Z91PROD with RULES
III. Waiver of Proposed Rulemaking
and Waiver of the Delay in Effective
Date
IV. Correction of Errors
Under the Administrative Procedure
Act (APA) (5 U.S.C. 551 et seq.), while
a general notice of proposed rulemaking
and an opportunity for public comment
is generally required before the
promulgation of regulations, this is not
required when an agency, for good
cause, finds that notice and public
comment are impracticable,
unnecessary, or contrary to the public
interest, and incorporates a statement of
the reasons for that finding in the
notice.
VerDate Mar<15>2010
14:34 Jul 25, 2011
Jkt 223001
The APA also generally requires that
a final rule be effective no sooner than
30 days after the date of publication in
the Federal Register. This 30-day delay
in effective date can be waived,
however, if an agency finds good cause
why the effective date should not be
delayed, and the agency incorporates a
statement of the findings and its reasons
in the rule issued.
This document merely corrects
technical errors made in the June 2011
amendments published in the Federal
Register on June 24, 2011 (76 FR 37208),
which will be effective on July 22, 2011.
The corrections contained in this
document are consistent with and do
not make substantive changes to the
policies adopted in the June 2011
amendments. The preamble to the June
2011 amendments correctly refers to
and discusses the substance of the
sections affected by this technical
correction. Therefore, we find for good
cause that it is unnecessary and would
be contrary to the public interest to
undertake further notice and comment
procedures to incorporate these
corrections. Furthermore, we note that
the June 2011 amendments were
published, for good cause, as interim
final rules, and that all the reasons
stated in the June 2011 amendments for
waiving notice and comment
procedures with respect to the June
2011 amendments are applicable to this
correction notice.
We are also waiving the 30-day delay
in effective date for these corrections.
We believe that it is in the public
interest to ensure that the June 2011
amendments setting forth requirements
for group health plans and health
insurance issuers relating to internal
claims and appeals and external review
processes accurately states our policies
as of the date they take effect. Therefore,
we find that delaying the effective date
of these corrections beyond the effective
date of the June 2011 amendments
would be contrary to the public interest.
In doing so, we find good cause to waive
the 30-day delay in the effective date.
In FR Doc. 2011–15890 of June 24,
2011 (76 FR 37208), make the following
corrections:
A. Correction to the Preamble
On page 37208, in the third column,
under the FOR FURTHER INFORMATION
CONTACT section, the telephone number
‘‘(301) 492–4100’’ for Ellen Kuhn,
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, is corrected to read
‘‘(301) 492–4263.’’
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B. Correction to the Regulations Text
29 CFR 2590.715–2719 [Corrected]
1. On page 37231, in the third
column, in paragraph (d)(1)(ii), the
phrase ‘‘with respect to claims for
which external review has not been
initiated before the effective date of this
paragraph (d)(1) (September 20, 2011),’’
is corrected to read ‘‘with respect to
claims for which external review has
not been initiated before September 20,
2011,’’.
45 CFR 147.136 [Corrected]
2. On page 37232, in the third
column, after the amendatory
instruction 3. and before the phrase
‘‘The revisions and additions read as
follows’’, add the following amendatory
instructions to read as follows:
‘‘4. Revising paragraphs (b)(3)(ii)(B),
(b)(3)(ii)(E)(1), and (b)(3)(ii)(F).’’
‘‘5. Redesignating paragraphs
(b)(3)(ii)(E)(2), (b)(3)(ii)(E)(3), and
(b)(3)(ii)(E)(4), as (b)(3)(ii)(E)(3),
(b)(3)(ii)(E)(4), and (b)(3)(ii)(E)(5),
respectively.’’
‘‘6. Adding a new paragraph
(b)(3)(ii)(E)(2).’’
3. On page 37233, in the second
column, after the five asterisks
‘‘* * * * *’’ and before the paragraph
‘‘(c) * * *,’’ add the following:
(b) * * *
(3) * * *
(ii) * * *
(B) Expedited notification of benefit
determinations involving urgent care.
The requirements of 29 CFR 2560.503–
1(f)(2)(i) (which generally provide,
among other things, in the case of urgent
care claims for notification of the
issuer’s benefit determination (whether
adverse or not) as soon as possible,
taking into account the medical
exigencies, but not later than 72 hours
after receipt of the claim) continue to
apply to the issuer. For purposes of this
paragraph (b)(3)(ii)(B), a claim involving
urgent care has the meaning given in 29
CFR 2560.503–1(m)(1), as determined
by the attending provider, and the issuer
shall defer to such determination of the
attending provider.
*
*
*
*
*
(E) * * *
(1) The issuer must ensure that any
notice of adverse benefit determination
or final internal adverse benefit
determination includes information
sufficient to identify the claim involved
(including the date of service, the name
of the health care provider, the claim
amount (if applicable), and a statement
describing the availability, upon
request, of the diagnosis code and its
corresponding meaning, and the
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Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Rules and Regulations
treatment code and its corresponding
meaning).
(2) The issuer must provide to
participants and beneficiaries, as soon
as practicable, upon request, the
diagnosis code and its corresponding
meaning, and the treatment code and its
corresponding meaning, associated with
any adverse benefit determination or
final internal adverse benefit
determination. The issuer must not
consider a request for such diagnosis
and treatment information, in itself, to
be a request for an internal appeal under
this paragraph (b) or an external review
under paragraphs (c) and (d) of this
section.
*
*
*
*
*
(F) Deemed exhaustion of internal
claims and appeals processes—(1) In
the case of an issuer that fails to adhere
to all the requirements of this paragraph
(b)(3) with respect to a claim, the
claimant is deemed to have exhausted
the internal claims and appeals process
of this paragraph (b), except as provided
in paragraph (b)(3)(ii)(F)(2) of this
section. Accordingly, the claimant may
initiate an external review under
paragraph (c) or (d) of this section, as
applicable. The claimant is also entitled
to pursue any available remedies under
State law, as applicable, on the basis
that the issuer has failed to provide a
reasonable internal claims and appeals
process that would yield a decision on
the merits of the claim.
(2) Notwithstanding paragraph
(b)(3)(ii)(F)(1) of this section, the
internal claims and appeals process of
this paragraph (b) will not be deemed
exhausted based on de minimis
violations that do not cause, and are not
likely to cause, prejudice or harm to the
claimant so long as the issuer
demonstrates that the violation was for
good cause or due to matters beyond the
control of the issuer and that the
violation occurred in the context of an
ongoing, good faith exchange of
information between the issuer and the
claimant. This exception is not available
if the violation is part of a pattern or
practice of violations by the issuer. The
claimant may request a written
explanation of the violation from the
issuer, and the issuer must provide such
explanation within 10 days, including a
specific description of its bases, if any,
for asserting that the violation should
not cause the internal claims and
appeals process of this paragraph (b) to
be deemed exhausted. If an external
reviewer or a court rejects the claimant’s
request for immediate review under
paragraph (b)(3)(ii)(F)(1) of this section
on the basis that the issuer met the
standards for the exception under this
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14:34 Jul 25, 2011
Jkt 223001
paragraph (b)(3)(ii)(F)(2), the claimant
has the right to resubmit and pursue the
internal appeal of the claim. In such a
case, within a reasonable time after the
external reviewer or court rejects the
claim for immediate review (not to
exceed 10 days), the issuer shall provide
the claimant with notice of the
opportunity to resubmit and pursue the
internal appeal of the claim. Time
periods for re-filing the claim shall
begin to run upon claimant’s receipt of
such notice.
Signed this 15th day of July 2011.
Diane O. Williams,
Federal Register Liaison, Internal Revenue
Service, Department of the Treasury.
Signed this 20th day of July 2011.
Daniel J. Maguire,
Director, Office of Health Plan Standards and
Compliance Assistance, Employee Benefits
Security Administration, Department of
Labor.
Signed this 20th day of July 2011.
Dawn Smalls,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2011–18820 Filed 7–22–11; 4:15 pm]
BILLING CODE 4820–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2011–0042;FRL–9279–3]
Revisions to the California State
Implementation Plan, Northern Sierra
Air Quality Management District,
Sacramento Metropolitan Air Quality
Management District, and South Coast
Air Quality Management District
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
EPA is taking direct final
action to approve revisions to the
Northern Sierra Air Quality
Management District (NSAQMD),
Sacramento Metropolitan Air Quality
Management District (SMAQMD), and
South Coast Air Quality Management
District (SCAQMD) portions of the
California State Implementation Plan
(SIP). These revisions concern volatile
organic compound (VOC) emissions
from gasoline dispensing facilities,
polyester resin operations, and spray
booth facilities. We are approving local
rules that regulate these emission
sources under the Clean Air Act as
amended in 1990 (CAA or the Act).
DATES: This rule is effective on
September 26, 2011 without further
notice, unless EPA receives adverse
SUMMARY:
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44493
comments by August 25, 2011. If we
receive such comments, we will publish
a timely withdrawal in the Federal
Register to notify the public that this
direct final rule will not take effect.
ADDRESSES: Submit comments,
identified by docket number EPA–R09–
OAR–2011–0198, by one of the
following methods:
1. Federal eRulemaking Portal: http:
//www.regulations.gov. Follow the online instructions.
2. E-mail: steckel.andrew@epa.gov.
3. Mail or deliver: Andrew Steckel
(Air-4), U.S. Environmental Protection
Agency Region IX, 75 Hawthorne Street,
San Francisco, CA 94105–3901.
Instructions: All comments will be
included in the public docket without
change and may be made available
online at https://www.regulations.gov,
including any personal information
provided, unless the comment includes
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Information that
you consider CBI or otherwise protected
should be clearly identified as such and
should not be submitted through
https://www.regulations.gov or e-mail.
https://www.regulations.gov is an
‘‘anonymous access’’ system, and EPA
will not know your identity or contact
information unless you provide it in the
body of your comment. If you send email directly to EPA, your e-mail
address will be automatically captured
and included as part of the public
comment. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: The index to the docket for
this action is available electronically at
https://www.regulations.gov and in hard
copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, California. While
all documents in the docket are listed in
the index, some information may be
publicly available only at the hard copy
location (e.g., copyrighted material), and
some may not be publicly available in
either location (e.g., CBI). To inspect the
hard copy materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT:
David Grounds, EPA Region IX, (415)
972–3019, grounds.david@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us,’’
and ‘‘our’’ refer to EPA.
E:\FR\FM\26JYR1.SGM
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Agencies
[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Rules and Regulations]
[Pages 44491-44493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18820]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[TD 9532]
RIN 1545-BK30
DEPARTMENT OF LABOR
Employee Benefits Security Administration
29 CFR Part 2590
RIN 1210-AB45
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 147
[CMS-9993-CN]
RIN 0938-AQ66
Group Health Plans and Health Insurance Issuers: Rules Relating
to Internal Claims and Appeals and External Review Processes;
Correction
AGENCIES: Internal Revenue Service, Department of the Treasury;
Employee Benefits Security Administration, Department of Labor; Centers
for Medicare & Medicaid Services, Department of Health and Human
Services.
ACTION: Correction of amendment to interim final rules with request for
comments.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical errors that appeared in the
June 24, 2011 amendment to the interim final rules (76 FR 37208)
entitled, ``Group Health Plans and Health Insurance Issuers: Rules
Relating to Internal Claims and Appeals and External Review
Processes.''
DATES: Effective Date: July 22, 2011.
FOR FURTHER INFORMATION CONTACT: Ellen Kuhn, Centers for Medicare &
Medicaid Services, Department of Health and Human Services, at (301)
492-4263; Amy Turner, Employee Benefits Security Administration,
Department of Labor, at (202) 693-8335; or Karen Levin, Internal
Revenue Service, Department of the Treasury, at (202) 622-6080.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
In FR Doc. 2011-15890 of June 24, 2011 (76 FR 37208), there were
technical errors that are identified in the ``Summary of Errors''
section and corrected in the ``Correction of Errors'' section below.
The provisions in this correction notice are effective as if they had
been included in the June 24, 2011 interim final rule with request for
comments entitled, ``Group Health Plans and Health Insurance Issuers:
Rules Relating to Internal Claims and Appeals and External Review
Processes.'' Accordingly, the corrections are effective July 22, 2011.
B. Regulations Overview
On July 23, 2010, the Departments of Health and Human Services
(HHS), Labor (DOL), and the Treasury (collectively, the Departments)
issued interim final rules implementing section 2719 of the Public
Health Service (PHS) Act (75 FR 43330) (July 2010 regulations),
regarding internal claims and appeals and external review processes for
group health plans and health insurance issuers offering coverage in
the group and individual markets.\1\ The Departments issued an
amendment to the interim final rules that was published in the Federal
Register on June 24, 2011 (76 FR 37208) (June 2011 amendments). Below,
we summarize the errors in the June 2011 amendments and describe the
corrections we are making in this notice.
---------------------------------------------------------------------------
\1\ The requirements of PHS Act section 2719 and the July 2010
regulations do not apply to health plans grandfathered under section
1251 of the Affordable Care Act.
---------------------------------------------------------------------------
II. Summary of Errors
A. Error in the Preamble
In the FOR FURTHER INFORMATION CONTACT section of the June 2011
amendments (page 37208), we listed an incorrect telephone number for
Ellen Kuhn, Centers for Medicare & Medicaid Services, Department of
Health and Human Services. We are correcting the telephone number.
[[Page 44492]]
B. Errors in the Regulations Text
In the June 2011 amendments (page 37231), we inadvertently made a
typographical error in the DOL regulations text that could cause
confusion. The text pertains to the effective date of the suspension of
the general rule defining the scope of what is appealable in external
review. We are correcting this typographical error. We note that the
regulation text for HHS and the Department of the Treasury were correct
and therefore are unchanged.
In the joint preamble to the June 2011 amendments (pages 37209
through 37215), we explain that the July 2010 regulations established
requirements for group health plans and health insurance issuers
offering both individual and group health coverage and that the June
2011 amendments were modifying those requirements. However, the
regulations text in the June 2011 amendments only reflected the changes
to the group market provisions, which appear in all three Departments'
regulations (pages 37228 through 37229; 37230 through 37231; and 37232
through 37233). Requirements that apply to the individual market only
appear in HHS regulations, and conforming amendments to those
requirements were inadvertently omitted from the regulation text of the
June 2011 amendments. In the regulations text at 45 CFR 147.136, HHS is
correcting this technical error. Specifically, we are reorganizing
Sec. 147.136(b)(3)(ii) and adding language to clarify that these
amendments apply to health insurance issuers offering individual health
coverage. These changes relate to internal claims and appeals processes
requirements for individual health insurance issuers in the HHS
regulations text. We note that the regulations text for the DOL and the
Department of the Treasury were correct and therefore are unchanged.
III. Waiver of Proposed Rulemaking and Waiver of the Delay in Effective
Date
Under the Administrative Procedure Act (APA) (5 U.S.C. 551 et
seq.), while a general notice of proposed rulemaking and an opportunity
for public comment is generally required before the promulgation of
regulations, this is not required when an agency, for good cause, finds
that notice and public comment are impracticable, unnecessary, or
contrary to the public interest, and incorporates a statement of the
reasons for that finding in the notice.
The APA also generally requires that a final rule be effective no
sooner than 30 days after the date of publication in the Federal
Register. This 30-day delay in effective date can be waived, however,
if an agency finds good cause why the effective date should not be
delayed, and the agency incorporates a statement of the findings and
its reasons in the rule issued.
This document merely corrects technical errors made in the June
2011 amendments published in the Federal Register on June 24, 2011 (76
FR 37208), which will be effective on July 22, 2011. The corrections
contained in this document are consistent with and do not make
substantive changes to the policies adopted in the June 2011
amendments. The preamble to the June 2011 amendments correctly refers
to and discusses the substance of the sections affected by this
technical correction. Therefore, we find for good cause that it is
unnecessary and would be contrary to the public interest to undertake
further notice and comment procedures to incorporate these corrections.
Furthermore, we note that the June 2011 amendments were published, for
good cause, as interim final rules, and that all the reasons stated in
the June 2011 amendments for waiving notice and comment procedures with
respect to the June 2011 amendments are applicable to this correction
notice.
We are also waiving the 30-day delay in effective date for these
corrections. We believe that it is in the public interest to ensure
that the June 2011 amendments setting forth requirements for group
health plans and health insurance issuers relating to internal claims
and appeals and external review processes accurately states our
policies as of the date they take effect. Therefore, we find that
delaying the effective date of these corrections beyond the effective
date of the June 2011 amendments would be contrary to the public
interest. In doing so, we find good cause to waive the 30-day delay in
the effective date.
IV. Correction of Errors
In FR Doc. 2011-15890 of June 24, 2011 (76 FR 37208), make the
following corrections:
A. Correction to the Preamble
On page 37208, in the third column, under the FOR FURTHER
INFORMATION CONTACT section, the telephone number ``(301) 492-4100''
for Ellen Kuhn, Centers for Medicare & Medicaid Services, Department of
Health and Human Services, is corrected to read ``(301) 492-4263.''
B. Correction to the Regulations Text
29 CFR 2590.715-2719 [Corrected]
1. On page 37231, in the third column, in paragraph (d)(1)(ii), the
phrase ``with respect to claims for which external review has not been
initiated before the effective date of this paragraph (d)(1) (September
20, 2011),'' is corrected to read ``with respect to claims for which
external review has not been initiated before September 20, 2011,''.
45 CFR 147.136 [Corrected]
2. On page 37232, in the third column, after the amendatory
instruction 3. and before the phrase ``The revisions and additions read
as follows'', add the following amendatory instructions to read as
follows:
``4. Revising paragraphs (b)(3)(ii)(B), (b)(3)(ii)(E)(1), and
(b)(3)(ii)(F).''
``5. Redesignating paragraphs (b)(3)(ii)(E)(2), (b)(3)(ii)(E)(3),
and (b)(3)(ii)(E)(4), as (b)(3)(ii)(E)(3), (b)(3)(ii)(E)(4), and
(b)(3)(ii)(E)(5), respectively.''
``6. Adding a new paragraph (b)(3)(ii)(E)(2).''
3. On page 37233, in the second column, after the five asterisks
``* * * * *'' and before the paragraph ``(c) * * *,'' add the
following:
(b) * * *
(3) * * *
(ii) * * *
(B) Expedited notification of benefit determinations involving
urgent care. The requirements of 29 CFR 2560.503-1(f)(2)(i) (which
generally provide, among other things, in the case of urgent care
claims for notification of the issuer's benefit determination (whether
adverse or not) as soon as possible, taking into account the medical
exigencies, but not later than 72 hours after receipt of the claim)
continue to apply to the issuer. For purposes of this paragraph
(b)(3)(ii)(B), a claim involving urgent care has the meaning given in
29 CFR 2560.503-1(m)(1), as determined by the attending provider, and
the issuer shall defer to such determination of the attending provider.
* * * * *
(E) * * *
(1) The issuer must ensure that any notice of adverse benefit
determination or final internal adverse benefit determination includes
information sufficient to identify the claim involved (including the
date of service, the name of the health care provider, the claim amount
(if applicable), and a statement describing the availability, upon
request, of the diagnosis code and its corresponding meaning, and the
[[Page 44493]]
treatment code and its corresponding meaning).
(2) The issuer must provide to participants and beneficiaries, as
soon as practicable, upon request, the diagnosis code and its
corresponding meaning, and the treatment code and its corresponding
meaning, associated with any adverse benefit determination or final
internal adverse benefit determination. The issuer must not consider a
request for such diagnosis and treatment information, in itself, to be
a request for an internal appeal under this paragraph (b) or an
external review under paragraphs (c) and (d) of this section.
* * * * *
(F) Deemed exhaustion of internal claims and appeals processes--(1)
In the case of an issuer that fails to adhere to all the requirements
of this paragraph (b)(3) with respect to a claim, the claimant is
deemed to have exhausted the internal claims and appeals process of
this paragraph (b), except as provided in paragraph (b)(3)(ii)(F)(2) of
this section. Accordingly, the claimant may initiate an external review
under paragraph (c) or (d) of this section, as applicable. The claimant
is also entitled to pursue any available remedies under State law, as
applicable, on the basis that the issuer has failed to provide a
reasonable internal claims and appeals process that would yield a
decision on the merits of the claim.
(2) Notwithstanding paragraph (b)(3)(ii)(F)(1) of this section, the
internal claims and appeals process of this paragraph (b) will not be
deemed exhausted based on de minimis violations that do not cause, and
are not likely to cause, prejudice or harm to the claimant so long as
the issuer demonstrates that the violation was for good cause or due to
matters beyond the control of the issuer and that the violation
occurred in the context of an ongoing, good faith exchange of
information between the issuer and the claimant. This exception is not
available if the violation is part of a pattern or practice of
violations by the issuer. The claimant may request a written
explanation of the violation from the issuer, and the issuer must
provide such explanation within 10 days, including a specific
description of its bases, if any, for asserting that the violation
should not cause the internal claims and appeals process of this
paragraph (b) to be deemed exhausted. If an external reviewer or a
court rejects the claimant's request for immediate review under
paragraph (b)(3)(ii)(F)(1) of this section on the basis that the issuer
met the standards for the exception under this paragraph
(b)(3)(ii)(F)(2), the claimant has the right to resubmit and pursue the
internal appeal of the claim. In such a case, within a reasonable time
after the external reviewer or court rejects the claim for immediate
review (not to exceed 10 days), the issuer shall provide the claimant
with notice of the opportunity to resubmit and pursue the internal
appeal of the claim. Time periods for re-filing the claim shall begin
to run upon claimant's receipt of such notice.
Signed this 15th day of July 2011.
Diane O. Williams,
Federal Register Liaison, Internal Revenue Service, Department of the
Treasury.
Signed this 20th day of July 2011.
Daniel J. Maguire,
Director, Office of Health Plan Standards and Compliance Assistance,
Employee Benefits Security Administration, Department of Labor.
Signed this 20th day of July 2011.
Dawn Smalls,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2011-18820 Filed 7-22-11; 4:15 pm]
BILLING CODE 4820-01-P