[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Pages 11248-11250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4552]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-185, CMS-10303 and CMS-10379]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & 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: Extension of currently
approved collection; Title of Information Collection: Granting and
Withdrawal of Deeming Authority to Private Nonprofit Accreditation
Organizations and of State Exemption Under State Laboratory Programs
and Supporting Regulations; Form No.: CMS-R-185 (OMB: 0938-
0686); Use: The information required is necessary to determine whether
a private accreditation organization/State licensure program standards
and accreditation/licensure process is at least equal to or more
stringent than those of the Clinical Laboratory Improvement Amendments
of 1988 (CLIA). If an accreditation organization is approved, the
laboratories that it accredits are ``deemed'' to meet the CLIA
requirements based on this accreditation. Similarly, if a State
licensure program is determined to have requirements that are equal to
or more stringent than those of CLIA, its laboratories are considered
to be exempt from CLIA certification and requirements. The information
collected will be used by HHS to: determine comparability/equivalency
of the accreditation organization standards
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and policies or State licensure program standards and policies to those
of the CLIA program; to ensure the continued comparability/equivalency
of the standards; and to fulfill certain statutory reporting
requirements; Frequency: Occasionally; Affected Public: Private Sector:
Business or other for-profits, Not-for-profit institutions; Number of
Respondents: 8; Total Annual Responses: 96; Total Annual Hours: 384.
(For policy questions regarding this collection contact Minnie
Christian at 410-786-3339. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: Revision of currently
approved collection; Title of Information: Medicare Gainsharing
Demonstration Evaluation: Physician Focus Groups; Use: The proposed
physician focus groups are part of the evaluation of the Centers for
Medicare and Medicaid Services (CMS)'s Medicare Physician Hospital
Collaboration Demonstration. The Congress, under Section 646 of the
Medicare Modernization Act (MMA) of 2003 permitted CMS to conduct
demonstrations to test methods for the provision of incentives for
improving the quality and safety of care and achieving the efficient
allocation of resources. The primary goal of the demonstration is to
evaluate gainsharing as means to align physician and hospital
incentives to improve quality and efficiency. This demonstration plans
to use the physician focus group protocols approved by OMB for the DRA
5007 Gainsharing Demonstration. Form Number: CMS-10303 (OMB:
0938-1103); Frequency: Once; Affected Public: Private Sector, Business
or other for profits; Number of Respondents: 288; Total Annual
Responses: 144; Total Annual Hours: 144 (For policy questions regarding
this collection contact William Buczko at 410-786-6593. For all other
issues call 410-786-1326.)
3. Type of Information Collection Request: New Collection; Title of
Information Collection: Rate Increase Disclosure and Review Reporting
Requirements (45 CFR Part 154) Use: Under the Section 1003 of the
Affordable Care Act (Section 2794 of the Public Health Service Act),
the Secretary, in conjunction with the States, is required to establish
a process for the annual review, beginning with the 2010 plan year, of
unreasonable increases in premiums for health insurance coverage.
Section 2794 directs the Secretary to ensure the public disclosure of
information of unreasonable rate increases and justification for those
increases.
General Information
On December 23, 2010, HHS published a proposed regulation in the
Federal Register defining the unreasonable rate review process and
issuer reporting and disclosure requirements (Rate Increase Disclosure
and Review Proposed Rule, 75 FR 81004). The proposed regulation
establishes the following reporting requirements:
The Preliminary Justification: This data collection is
required of all health insurance issuers for all rate increases that
exceed the ``subject to review''' reporting threshold as defined in the
proposed rule. This information will be posted on an HHS Web site.
Rate Review Final Determination: This data collection
requires States with effective rate review programs and HHS to report
their review findings and unreasonable rate increase determinations on
all rate increases that are subject to review. This information will be
posted on an HHS Web site.
The Final Justification for an Unreasonable Rate Increase:
This data collection is required of health insurance issuers that elect
to implement a rate increase that is determined to be unreasonable
based on State or HHS review. This information will be posted on the
Health Insurance Issuer's Web site and on an HHS Web site.
Preliminary Justification
CCIIO is also requesting comments on the presentation and content
of the consumer information contained in Parts I and II of the
Preliminary Justification. Specifically, CCIIO would like comments on
the usefulness and clarity of this information for consumers.
Additionally, the Preliminary Justification is designed to limit burden
on health insurance issuers by collecting data that most issuers should
have readily available either through their State rate filing
requirements or internal rate making analysis. CCIIO is requesting
comments on the extent to which the data elements and definitions
utilized in the Preliminary Justification align with current industry
data collection and reporting standards.
The Preliminary Justification consists of three parts, Part I: Rate
Increase Summary, Part II: Written Explanation of the Rate Increase,
and Part III: Rate Filing Documentation. Issuers must complete Parts I
and II for all rate increases that exceed the reporting threshold as
defined in the proposed rule. As described in the preamble of the
proposed rule, this information would be collected to provide consumers
with basic information on all rate increases that are subject to review
under the rate review program. Under the proposed rule, ``subject to
review'' rate increases would be reviewed by either States or HHS,
depending on whether a State has an effective rate review program.
Issuers would only be required to submit Part III of the Preliminary
Justification when HHS is conducting the review of a ``subject to
review'' rate increase. Accordingly, Part III requires health insurance
issuers to provide detailed rate data that would be used for the
purposes of conducting thorough actuarial reviews and for making
determinations about whether rate increases are unreasonable. This
Notice contains the following information about the Preliminary
Justification:
Preliminary Justification Issuer Instructions: Health
insurance issuer instructions for completing all three parts of the
Preliminary Justification.
Part I Worksheet: A standardized Excel worksheet that must
be used to complete Part I of the Preliminary Justification.
Sample internet display of the Rate Review Consumer
Disclosure: Information provided in the Preliminary Justification would
be posted on an HHS Web site. This sample display shows how the
information contained in the Part I Worksheet would be displayed to
consumers.
Rate Review Final Determination
Under the proposed rule States and HHS would have to provide a Rate
Review Final Determination at the close of their review of all
``subject to review'' rate increases. The Rate Review Final
Determination must provide the State's or HHS' determination on whether
a rate increases is `unreasonable'. Section 154.301(a)(3) of the
proposed rule provides a list of actuarial review elements that must be
taken into account as part of the rate review process. The Final
Determination must provide a brief statement explaining how the review
of elements set forth in Sec. 154.301(a)(3) caused the State or HHS to
arrive at its determination that the rate is unreasonable.
The Rate Review Final Determination will be entered into a data
entry text box in the Rate Review Data Collection System. HHS is
estimating that this statement would be approximately a paragraph in
length. There is no specific form or set of instructions associated
with this reporting requirement, apart from the reporting requirements
provided in the proposed rule. The information provided in the Rate
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Review Final Determination will be posted as part of the rate review
consumer disclosure information on an HHS Web site.
Final Justification for an Unreasonable Rate Increase
The proposed rule states that if a health insurance issuer
implements a rate increase determined by HHS or a State to be
unreasonable, the health insurance issuer must provide a Final
Justification for an Unreasonable Rate Increase. In the Final
Justification, issuers would have to provide a short statement about
why they are electing to implement an unreasonable rate increase. This
statement would be entered into a data entry text box in the Rate
Review Data Collection System and would not need to be more than a
paragraph or two in length. There is no form or instructions associated
with this statement apart from the requirements provided in the
proposed regulation.
The Final Justification Statement will be posted on an HHS Web site
in the same location as the Preliminary Justification and Rate Review
Final Determination. Additionally, health insurance issuers
implementing rate increases that were determined to be unreasonable,
must post all of this information--the Preliminary Justification, the
Rate Review Final Determination, and the Final Justification Statement
on their Web sites for a period of 3 years.
Form Number: CMS-10379; (OMB Control No. 0938-NEW) Frequency:
Annually; Affected Public: Private Sector; Number of Respondents: 1,543
Number of Responses: 1,546; Total Annual Hours: 8,418. (For policy
questions regarding this collection, contact Sally McCarty at (301)
492-4489 or [email protected]. 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 http://www.cms.hhs.gov/PaperworkReductionActof1995, or e-
mail your request, including your address, phone number, OMB number,
and CMS document identifier, to [email protected], 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 2, 2011:
1. Electronically. You may submit your comments electronically to
http://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: February 23, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-4552 Filed 2-25-11; 11:15 am]
BILLING CODE 4120-01-P