[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<greek-i>: 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

[[Page 11249]]

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<greek-i>: 
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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Preliminary Justification Issuer Instructions: Health 
insurance issuer instructions for completing all three parts of the 
Preliminary Justification.
    <bullet> Part I Worksheet: A standardized Excel worksheet that must 
be used to complete Part I of the Preliminary Justification.
    <bullet> 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

[[Page 11250]]

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 <a href="/cdn-cgi/l/email-protection#25774451407740534c4052654d4d560b424a53"><span class="__cf_email__" data-cfemail="16447762734473607f7361567e7e6538717960">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#6636071603141109140d26050b15480e0e1548010910"><span class="__cf_email__" data-cfemail="1747766772656078657c57747a64397f7f6439707861">[email protected]</span></a>, 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


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