Document Headings

                    Document headings vary by document type but may contain                    the following:                  
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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:

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                           ( print 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#: 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 § 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                           ( print 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 RateReview@hhs.gov. 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                     *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 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