Agency Information Collection Activities: Proposed Collection; Comment Request, 16790-16792 [2011-7104]
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16790
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
information collection and
recordkeeping requirements must be
mailed and/or faxed to the designees
referenced below by April 25, 2011.
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
3. By Facsimile or E-mail to OMB.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: March 18, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–7106 Filed 3–24–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier CMS–370, CMS–377,
CMS–378; CMS–10145, CMS–10362, CMS–
10384, CMS–10342 and CMS–10338]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare and
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
erowe on DSK5CLS3C1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Titles of
Information Collection: (CMS–370)
Health Insurance Benefits Agreement,
(CMS–377) ASC Request for
Certification or Update of Certification
Information in the Medicare Program,
and (CMS–378) Ambulatory Surgical
Center (ASC) Survey Report Form; Use:
CMS–370 has not been revised and will
continue to be used to establish
eligibility for payment under Title XVIII
of the Social Security Act (the ‘‘Act’’). As
revised, CMS–377 will be used to
collect facility-specific characteristics
that facilitate CMS’ oversight of ASCs.
The data also enables CMS to respond
to inquiries from the Congress, GAO,
and the OIG concerning the
characteristics of Medicare-participating
ASCs. The data base that supports
survey and certification activities will
be revised to reflect changes in the data
fields on this revised form, such as the
data on the types of surgical procedures
performed in the ASC. CMS–378 will be
discontinued since it duplicates
information collected by other means;
Form Numbers: CMS–370, –377 and
–378 (OCN: 0938–0266); Frequency:
Occasionally (initially an then every
three years); Affected Public: Private
Sector: Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 7,213; Total Annual
Responses: 1,795; Total Annual Hours:
648. (For policy questions regarding this
collection contact Gail Vong at 410–
786–0787. For all other issues call 410–
786–1326.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare Part B
Drug and Biological Competitive
Acquisition Program (CAP) and
Supporting Regulations in 42 CFR
Sections 414.906, 414.908, 414.910,
414.914, 414.916, and 414.917; Use:
Section 303(d) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
provides an alternative payment
methodology for Part B covered drugs
that are not paid on a cost or
prospective payment basis. In
particular, Section 303(d) of the MMA
amends Title XVIII of the Social
Security Act by adding a new section
1847B, which establishes a competitive
acquisition program for the acquisition
of and payment for Part B covered drugs
and biologicals furnished on or after
January 1, 2006. Since its inception,
additional legislation has augmented the
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Fmt 4703
Sfmt 4703
CAP. Section 108 of the Medicare
Improvements and Extension Act under
Division B, Title I of the Tax Relief
Health Care Act of 2006 (MIEA–TRHCA)
amended Section 1847b(a)(3) of the
Social Security Act and requires that
CAP implement a post payment review
process. This procedure is done to
assure that payment is made for a drug
or biological under this section only if
the drug or biological has been
administered to a beneficiary. Form
Number: CMS–10145 (OCN: 0938–
0945); Frequency: Weekly, quarterly and
occasionally; Affected Public: Private
sector—Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 3000; Total Annual
Responses: 156,020; Total Annual
Hours: 31,208.
3. Type of Information Collection
Request: New collection; Title of
Information Collection: Autism
Spectrum Disorders (ASD): State of the
States Services and Supports for People
with ASD; Use: The information that is
collected in the interviews will be used
to communicate additional information
about services available to people with
ASD and the public policy issues that
affect people with ASD to key
stakeholder audiences. The format of
the report will include data tables from
various state programs and narrative
about the data being presented based on
the interviews with state agency staff.
We propose interviewing multiple staff
in each state because several state
agencies have an impact on services and
supports for people with ASD; Form
Number: CMS–10362 (OCN: 0938–
New); Frequency: Once; Affected Public:
State, local, or Tribal Governments;
Number of Respondents: 459; Total
Annual Responses: 459; Total Annual
Hours: 803. (For policy questions
regarding this collection contact Ellen
Blackwell at 410–786–4498. For all
other issues call 410–786–1326.)
4. Type of Information Collection
Request: New Collection; Title of
Information Collection: Health
Insurance Assistance Database; Use: In
October 2010, the Office of Consumer
Support began to take and respond to
direct consumer inquiries related to the
Affordable Care Act. As of February
15th 2011, CCIIO has received 906
consumer inquiries. Consumer inquiries
continue to come in to CCIIO at a rate
of 30 to 35 inquiries per week. Starting
in January 2011, the HHS Hotline will
begin to refer ACA calls to CCIIO. To
date, the HHS Hotline receives, on
average, 400 calls per month pertaining
to ACA.
Accordingly, a system to collect, track
and store consumer information is
urgently needed in order to accomplish
E:\FR\FM\25MRN1.SGM
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Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
successful case management to ensure
that the information, coverage, and
health care needs of consumers are
addressed fairly and in a timely fashion.
Further, the Team will provide detailed
reports on these consumer inquiries
with a focus on Affordable Care Act and
PHS Act compliance issues. These
reports will assist the Office of
Oversight in identifying areas where
compliance concerns may arise. Reports
will be stripped of any information in
identifiable form (IIF) and personal
health information when written and
prepared. Authority for maintenance,
collection and disclosures of this
information is given under sections
2719, 2723, and 2761 of the Public
Health Service Act (PHS Act) and
section 1321(c) of the Affordable Care
Act.
Analysis of this data reporting will
help identity patterns of practice in the
insurance marketplaces and uncover
suspected patterns of noncompliance.
HHS may share program data reports
with the Departments of Labor and
Treasury, and State regulators. Program
data also can offer CCIIO one indication
of the effectiveness of State
enforcement, affording opportunities to
provide technical assistance and
support to State insurance regulators
and, in extreme cases, inform the need
to trigger federal enforcement. Form
Number: CMS–10384 (OCN: 0938–
New); Frequency: Occasionally;
Affected Public: Individuals or
households; Number of Respondents:
1200; Number of Responses: 1,860;
Total Annual Hours: 195 (For policy
questions regarding this collection,
contact Paul Tibbits (301) 492–4229. For
all other issues call (410) 786–1326.)
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Annual Limits
Waiver Online Application Form; Use:
Under section 2711(a)(2) of the Public
Health Service Act, as amended by the
Affordable Care Act section 1302(b),
The Secretary of Health and Human
Services is required to impose
restrictions on the dollar value of
essential benefits provided by new or
existing group health plans or
individual policies in the market
between September 23, 2010 and
January 1, 2014. The interim final
regulations published June 28, 2010
(45 CFR § 147.126) give the Secretary
the authority to waive these restricted
annual limits if compliance would
result in a significant increase in
premium or significant decrease in
access to benefits for those already
covered. CMS is in the process of
evaluating applications for waivers of
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Jkt 223001
annual limits and seeks to publish an
updated Microsoft Excel spreadsheet to
standardize and simplify the data
collection process. Applicants must fill
out (1) spreadsheet per application. The
spreadsheet is a mandatory component
of each waiver application necessary to
fulfill the statutory requirements under
section 2711(a)(2) of the Public Health
Service Act. The information collected
includes applicant contact information;
information about the annual limit(s) on
the overall plan or policy and on
essential health benefits (as defined by
the Affordable Care Act section
1302(b)); information about plan design
such as copayment, coinsurance, and
deductibles; financial projections by
enrollee tier; and a description of how
a significant decrease in access to
benefits would result from compliance
with section 2711(a)(2) of the Affordable
Care Act. This information is required to
accurately and objectively assess
whether compliance with the restricted
annual limits would result in the
aforementioned significant increase in
premium or significant decrease in
access to benefits, on which the grant of
a waiver is conditioned in the interim
final regulations. The updated
spreadsheet contains a more detailed
description of what values should be
entered into each cell. This description
should save applicants time when
completing the spreadsheet initially,
and it should lessen the need for
applicants to go back and correct
mistakes after submission. Form
Number: CMS–10342 (OCN: 0938–
1105); Frequency: Annually; Affected
Public: Private Sector; Number of
Respondents: 4,872; Number of
Responses: 4,608,372; Total Annual
Hours: 178,183. (For policy questions
regarding this collection, contact Erika
Kottenmeier at (301) 492–4170. For all
other issues call (410) 786–1326.)
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Affordable Care
Act Internal Claims and Appeals and
External Review Procedures for Nongrandfathered Group Health Plans and
Issuers and Individual Market Issuers;
Use: The Patient Protection and
Affordable Care Act, Public Law 111–
148, (the Affordable Care Act) was
enacted by President Obama on March
23, 2010. As part of the Act, Congress
added PHS Act section 2719, which
provides rules relating to internal claims
and appeals and external review
processes. These interim final
regulations (IFR) set forth rules
implementing PHS Act section 2719 for
internal claims and appeals and external
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16791
review processes. With respect to
internal claims and appeals processes
for group health coverage, PHS Act
section 2719 and paragraph (b)(2)(i) of
the interim final regulations provide
that group health plans and health
insurance issuers offering group health
insurance coverage must comply with
the internal claims and appeals
processes set forth in 29 CFR 2560.503–
1 (the DOL claims procedure regulation)
and update such processes in
accordance with standards established
by the Secretary of Labor in paragraph
(b)(2)(ii) of the regulations. Paragraph
(b)(3)(i) requires issuers offering
coverage in the individual health
insurance market to also comply with
the DOL claims procedure regulation as
updated by the Secretary of HHS in
paragraph (b)(3)(ii) of the interim final
regulations for their internal claims and
appeals processes.
The DOL claims procedure regulation
requires plans to provide every claimant
who is denied a claim with a written or
electronic notice that contains the
specific reasons for denial, a reference
to the relevant plan provisions on which
the denial is based, a description of any
additional information necessary to
perfect the claim, and a description of
steps to be taken if the participant or
beneficiary wishes to appeal the denial.
The regulation also requires that any
adverse decision upon review be in
writing (including electronic means)
and include specific reasons for the
decision, as well as references to
relevant plan provisions. In addition,
paragraph (b)(3)(ii)(C) of the interim
final regulations adds an additional
requirement that non-grandfathered
ERISA-covered group health plans
provide to the claimant, free of charge,
any new or additional evidence
considered relied upon, or generated by
the plan or issuer in connection with
the claim.
Also PHS Act section 2719 and these
interim final regulations provide that
group health plans and issuers offering
group health insurance coverage must
comply either with a State external
review process or a Federal review
process. The regulations provide a basis
for determining when plans and issuers
must comply with an applicable State
external review process and when they
must comply with the Federal external
review process. Form Number: CMS–
10338 (OCN: 0938–1099); Frequency:
Occasionally; Affected Public: State,
Local, Tribal Governments; Number of
Respondents: 36,344; Number of
Responses: 2,762,824; Total Annual
Hours: 211,216,845. (For policy
questions regarding this collection,
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16792
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices
contact Tara Oakman at (301) 492–4253.
For all other issues call (410) 786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office at 410–786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by May 24, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: March 18, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–7104 Filed 3–24–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier CMS–10328 and CMS–
10319]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare and
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
erowe on DSK5CLS3C1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
15:16 Mar 24, 2011
Jkt 223001
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Medicare Self-Referral
Disclosure Protocol; Use: Section 6409
of the ACA requires the Secretary to
establish and post information on the
CMS’ public Internet Web site
concerning a self-referral disclosure
protocol (SRDP) that sets forth a process
for providers of services and suppliers
to self-disclose actual or potential
violations of section 1877 of the Act. In
addition, section 6409(b) of the ACA
gives the Secretary authority to reduce
the amounts due and owing for the
violations. This information collection
request is necessary in order to inform
the public of the process and the types
of information needed to participate in
the SRDP.
The SRDP is a voluntary selfdisclosure instrument that will allow
providers of services and suppliers to
disclose actual or potential violations of
section 1877 of the Act. CMS will
analyze the disclosed conduct to
determine compliance with section
1877 of the Act and the application of
the exceptions to the physician selfreferral prohibition. In addition, the
authority granted to the Secretary under
section 6409(b) of the ACA, and
subsequently delegated to CMS, may be
used to reduce the amount due and
owing for violations. Form Number:
CMS–10328 (OMB#: 0938–1106;
Frequency: Once; Affected Public:
Private Sector, Business and other forprofit and not-for-profit institutions;
Number of Respondents: 50; Total
Annual Responses: 50; Total Annual
Hours: 1,175. (For policy questions
regarding this collection contact Ronke
Fabayo at 410–786–4460. For all other
issues call 410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Pre-Existing
Condition Insurance Plan Program
Solicitation and Contractor’s Proposal
Package; Use: The Department of Health
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
and Human Services (HHS) is
requesting a renewal of this package by
the Office of Management and Budget
(OMB); specifically, HHS is now seeking
a three-year approval for this collection.
On March 23, 2010, the President signed
into law H.R. 3590, the Patient
Protection and Affordable Care Act
(Affordable Care Act), Public Law 111–
148. Section 1101 of the law establishes
a ‘‘temporary high risk health insurance
pool program’’ (which has been named
the Pre-Existing Condition Insurance
Plan, or PCIP) to provide health
insurance coverage to currently
uninsured individuals with pre-existing
conditions. The law authorizes HHS to
carry out the program directly or
through contracts with states or private,
non-profit entities.
This package renewal is requested as
a result of a possible transition in
administration of the program from a
federally-run to a State administered
program. A State who originally decided
to have HHS administer the program in
their State may in the future notify HHS
of their desire to administer the PreExisting Condition Plan (PCIP) program.
PCIP is also referred to as the temporary
qualified high risk insurance pool
program, as it is called in the Affordable
Care Act, but we have adopted the term
PCIP to better describe the program and
avoid confusion with the existing state
high risk pool programs. Form Number:
CMS–10319 (OMB#: 0938–1085);
Frequency: Occasionally; Affected
Public: State governments; Number of
Respondents: 2; Total Annual
Responses: 2; Total Annual Hours:
2,992. (For policy questions regarding
this collection contact Laura Dash at
301–492–4296. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on April 25, 2011. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, E-mail:
OIRA_submission@omb.eop.gov.
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]]>Agencies
[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16790-16792]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7104]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier CMS-370, CMS-377, CMS-378; CMS-10145, CMS-10362,
CMS-10384, CMS-10342 and CMS-10338]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare and Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
1. Type of Information Collection Request: Revision of a currently
approved collection; Titles of Information Collection: (CMS-370) Health
Insurance Benefits Agreement, (CMS-377) ASC Request for Certification
or Update of Certification Information in the Medicare Program, and
(CMS-378) Ambulatory Surgical Center (ASC) Survey Report Form; Use:
CMS-370 has not been revised and will continue to be used to establish
eligibility for payment under Title XVIII of the Social Security Act
(the ``Act''). As revised, CMS-377 will be used to collect facility-
specific characteristics that facilitate CMS' oversight of ASCs. The
data also enables CMS to respond to inquiries from the Congress, GAO,
and the OIG concerning the characteristics of Medicare-participating
ASCs. The data base that supports survey and certification activities
will be revised to reflect changes in the data fields on this revised
form, such as the data on the types of surgical procedures performed in
the ASC. CMS-378 will be discontinued since it duplicates information
collected by other means; Form Numbers: CMS-370, -377 and -378 (OCN:
0938-0266); Frequency: Occasionally (initially an then every three
years); Affected Public: Private Sector: Business or other for-profit
and Not-for-profit institutions; Number of Respondents: 7,213; Total
Annual Responses: 1,795; Total Annual Hours: 648. (For policy questions
regarding this collection contact Gail Vong at 410-786-0787. For all
other issues call 410-786-1326.)
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Medicare Part B Drug and Biological Competitive Acquisition Program
(CAP) and Supporting Regulations in 42 CFR Sections 414.906, 414.908,
414.910, 414.914, 414.916, and 414.917; Use: Section 303(d) of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) provides an alternative payment methodology for Part B covered
drugs that are not paid on a cost or prospective payment basis. In
particular, Section 303(d) of the MMA amends Title XVIII of the Social
Security Act by adding a new section 1847B, which establishes a
competitive acquisition program for the acquisition of and payment for
Part B covered drugs and biologicals furnished on or after January 1,
2006. Since its inception, additional legislation has augmented the
CAP. Section 108 of the Medicare Improvements and Extension Act under
Division B, Title I of the Tax Relief Health Care Act of 2006 (MIEA-
TRHCA) amended Section 1847b(a)(3) of the Social Security Act and
requires that CAP implement a post payment review process. This
procedure is done to assure that payment is made for a drug or
biological under this section only if the drug or biological has been
administered to a beneficiary. Form Number: CMS-10145 (OCN: 0938-0945);
Frequency: Weekly, quarterly and occasionally; Affected Public: Private
sector--Business or other for-profit and Not-for-profit institutions;
Number of Respondents: 3000; Total Annual Responses: 156,020; Total
Annual Hours: 31,208.
3. Type of Information Collection Request: New collection; Title of
Information Collection: Autism Spectrum Disorders (ASD): State of the
States Services and Supports for People with ASD; Use: The information
that is collected in the interviews will be used to communicate
additional information about services available to people with ASD and
the public policy issues that affect people with ASD to key stakeholder
audiences. The format of the report will include data tables from
various state programs and narrative about the data being presented
based on the interviews with state agency staff. We propose
interviewing multiple staff in each state because several state
agencies have an impact on services and supports for people with ASD;
Form Number: CMS-10362 (OCN: 0938-New); Frequency: Once; Affected
Public: State, local, or Tribal Governments; Number of Respondents:
459; Total Annual Responses: 459; Total Annual Hours: 803. (For policy
questions regarding this collection contact Ellen Blackwell at 410-786-
4498. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: New Collection; Title of
Information Collection: Health Insurance Assistance Database; Use: In
October 2010, the Office of Consumer Support began to take and respond
to direct consumer inquiries related to the Affordable Care Act. As of
February 15th 2011, CCIIO has received 906 consumer inquiries. Consumer
inquiries continue to come in to CCIIO at a rate of 30 to 35 inquiries
per week. Starting in January 2011, the HHS Hotline will begin to refer
ACA calls to CCIIO. To date, the HHS Hotline receives, on average, 400
calls per month pertaining to ACA.
Accordingly, a system to collect, track and store consumer
information is urgently needed in order to accomplish
[[Page 16791]]
successful case management to ensure that the information, coverage,
and health care needs of consumers are addressed fairly and in a timely
fashion. Further, the Team will provide detailed reports on these
consumer inquiries with a focus on Affordable Care Act and PHS Act
compliance issues. These reports will assist the Office of Oversight in
identifying areas where compliance concerns may arise. Reports will be
stripped of any information in identifiable form (IIF) and personal
health information when written and prepared. Authority for
maintenance, collection and disclosures of this information is given
under sections 2719, 2723, and 2761 of the Public Health Service Act
(PHS Act) and section 1321(c) of the Affordable Care Act.
Analysis of this data reporting will help identity patterns of
practice in the insurance marketplaces and uncover suspected patterns
of noncompliance. HHS may share program data reports with the
Departments of Labor and Treasury, and State regulators. Program data
also can offer CCIIO one indication of the effectiveness of State
enforcement, affording opportunities to provide technical assistance
and support to State insurance regulators and, in extreme cases, inform
the need to trigger federal enforcement. Form Number: CMS-10384 (OCN:
0938-New); Frequency: Occasionally; Affected Public: Individuals or
households; Number of Respondents: 1200; Number of Responses: 1,860;
Total Annual Hours: 195 (For policy questions regarding this
collection, contact Paul Tibbits (301) 492-4229. For all other issues
call (410) 786-1326.)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Annual Limits
Waiver Online Application Form; Use: Under section 2711(a)(2) of the
Public Health Service Act, as amended by the Affordable Care Act
section 1302(b), The Secretary of Health and Human Services is required
to impose restrictions on the dollar value of essential benefits
provided by new or existing group health plans or individual policies
in the market between September 23, 2010 and January 1, 2014. The
interim final regulations published June 28, 2010 (45 CFR Sec.
147.126) give the Secretary the authority to waive these restricted
annual limits if compliance would result in a significant increase in
premium or significant decrease in access to benefits for those already
covered. CMS is in the process of evaluating applications for waivers
of annual limits and seeks to publish an updated Microsoft Excel
spreadsheet to standardize and simplify the data collection process.
Applicants must fill out (1) spreadsheet per application. The
spreadsheet is a mandatory component of each waiver application
necessary to fulfill the statutory requirements under section
2711(a)(2) of the Public Health Service Act. The information collected
includes applicant contact information; information about the annual
limit(s) on the overall plan or policy and on essential health benefits
(as defined by the Affordable Care Act section 1302(b)); information
about plan design such as copayment, coinsurance, and deductibles;
financial projections by enrollee tier; and a description of how a
significant decrease in access to benefits would result from compliance
with section 2711(a)(2) of the Affordable Care Act. This information is
required to accurately and objectively assess whether compliance with
the restricted annual limits would result in the aforementioned
significant increase in premium or significant decrease in access to
benefits, on which the grant of a waiver is conditioned in the interim
final regulations. The updated spreadsheet contains a more detailed
description of what values should be entered into each cell. This
description should save applicants time when completing the spreadsheet
initially, and it should lessen the need for applicants to go back and
correct mistakes after submission. Form Number: CMS-10342 (OCN: 0938-
1105); Frequency: Annually; Affected Public: Private Sector; Number of
Respondents: 4,872; Number of Responses: 4,608,372; Total Annual Hours:
178,183. (For policy questions regarding this collection, contact Erika
Kottenmeier at (301) 492-4170. For all other issues call (410) 786-
1326.)
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Affordable Care
Act Internal Claims and Appeals and External Review Procedures for Non-
grandfathered Group Health Plans and Issuers and Individual Market
Issuers; Use: The Patient Protection and Affordable Care Act, Public
Law 111-148, (the Affordable Care Act) was enacted by President Obama
on March 23, 2010. As part of the Act, Congress added PHS Act section
2719, which provides rules relating to internal claims and appeals and
external review processes. These interim final regulations (IFR) set
forth rules implementing PHS Act section 2719 for internal claims and
appeals and external review processes. With respect to internal claims
and appeals processes for group health coverage, PHS Act section 2719
and paragraph (b)(2)(i) of the interim final regulations provide that
group health plans and health insurance issuers offering group health
insurance coverage must comply with the internal claims and appeals
processes set forth in 29 CFR 2560.503-1 (the DOL claims procedure
regulation) and update such processes in accordance with standards
established by the Secretary of Labor in paragraph (b)(2)(ii) of the
regulations. Paragraph (b)(3)(i) requires issuers offering coverage in
the individual health insurance market to also comply with the DOL
claims procedure regulation as updated by the Secretary of HHS in
paragraph (b)(3)(ii) of the interim final regulations for their
internal claims and appeals processes.
The DOL claims procedure regulation requires plans to provide every
claimant who is denied a claim with a written or electronic notice that
contains the specific reasons for denial, a reference to the relevant
plan provisions on which the denial is based, a description of any
additional information necessary to perfect the claim, and a
description of steps to be taken if the participant or beneficiary
wishes to appeal the denial. The regulation also requires that any
adverse decision upon review be in writing (including electronic means)
and include specific reasons for the decision, as well as references to
relevant plan provisions. In addition, paragraph (b)(3)(ii)(C) of the
interim final regulations adds an additional requirement that non-
grandfathered ERISA-covered group health plans provide to the claimant,
free of charge, any new or additional evidence considered relied upon,
or generated by the plan or issuer in connection with the claim.
Also PHS Act section 2719 and these interim final regulations
provide that group health plans and issuers offering group health
insurance coverage must comply either with a State external review
process or a Federal review process. The regulations provide a basis
for determining when plans and issuers must comply with an applicable
State external review process and when they must comply with the
Federal external review process. Form Number: CMS-10338 (OCN: 0938-
1099); Frequency: Occasionally; Affected Public: State, Local, Tribal
Governments; Number of Respondents: 36,344; Number of Responses:
2,762,824; Total Annual Hours: 211,216,845. (For policy questions
regarding this collection,
[[Page 16792]]
contact Tara Oakman at (301) 492-4253. For all other issues call (410)
786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site at https://www.cms.hhs.gov/PaperworkReductionActof1995, or e-
mail your request, including your address, phone number, OMB number,
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office at 410-786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by May 24, 2011:
1. Electronically. You may submit your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
Dated: March 18, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-7104 Filed 3-24-11; 8:45 am]
BILLING CODE 4120-01-P
