Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Rules and Regulations 44491 

1The 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. 

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. 

VI. What references are on display? 

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. 

1. Petition from Neuronetics, Inc., May 23, 

2007. 

List of Subjects in 21 CFR Part 882 

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: 

PART 882—NEUROLOGICAL DEVICES 

■ 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: 

§ 882.5805 Repetitive transcranial 

magnetic stimulation system. 

(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 

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 

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. 

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. 


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44492 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. 

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 


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Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Rules and Regulations 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 

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 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: 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 

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 http://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 

http://www.regulations.gov or e-mail. 

http://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 

http://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. 


wreier-aviles on DSKDVH8Z91PROD with RULES