07-3641. Agency Information Collection Activities: Submission for OMB Review; 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), Department of Health and Human Services, 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 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: Extension without change of a currently approved collection; Title of Information Collection: Transmittal and Notice of Approval of State Plan Material and Supporting Regulations in 42 CFR 430.10-430.20 and 440.167; Use: The CMS-179 is used by State agencies to transmit State plan material to the Centers for Medicare & Medicaid Services (CMS) for approval prior to amending their State plan. The State plan is the method in which States inform staff of State policies, standards, procedures and instructions. The CMS-179 is currently used by State agencies administering the Medicaid program and CMS regional offices (RO). State agencies use the form to submit State plan amendments (SPAs) (including supporting documentation) to the CMS RO for review and approval prior to amending their plan in accordance with 42 CFR 430.10-430.20. The CMS-179 includes instructions for completing the form. The inclusion of instructions is to assist State agencies in completing the form, thereby ensuring a more uniform and timely plan amendment approval process. The CMS-179 is the only source available to State agencies for submittal/approval of SPAs. This plan amendment approval process is necessary to ensure the State plan continues to meet statutory and regulatory requirements and thereby ensure the State's eligibility for Federal financial participation. CMS will use this information to track the estimated Federal budget impact associated with the SPAs. This information may result in more accurate Federal Medicaid expenditure estimates; Form Number: CMS-179 (OMB#: 0938-0193); Frequency: Reporting: Occasionally; Affected Public: State, Local or Tribal Government; Number of Respondents: 56; Total Annual Responses: 10; Total Annual Hours: 560.

2. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Imposition of Cost Sharing Charges Under Medicare and Supporting Regulations Contained in 42 CFR Section 447.53; Use: The purpose of this collection is to ensure that States impose nominal cost sharing charges upon categorically and medically needy individuals as allowed by law and implementing regulations. States must identify in their State plan the following: (1) The service for which the charge is made; (2) The amount of the charge; (3) The basis for determining the charge; (4) The method used to collect the charge; (5) The basis for determining whether an individual is unable to pay the charge and the way in which the individual will be identified to providers; and, (6) The procedures for implementing and enforcing the exclusions from cost sharing; Form Number: CMS-R-0053 (OMB#: 0938-0429); Frequency: Reporting: Occasionally; Affected Public: State, Local or Tribal Government; Number of Respondents: 56; Total Annual Responses: 2; Total Annual Hours: 20.

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records (CMS-1303-F); Form Number: CMS-10207 (OMB#: 0938-1009); Use: Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) directs the Secretary to create an exception to the physician self-referral prohibition in section 1877 of the Act for certain arrangements in which a physician receives compensation in the form of items, services (nonmonetary remuneration not including cash or cash equivalents) that is necessary and used solely to receive and transmit electronic prescription information. In addition, using our separate legal authority under section 1877(b)(4) of the Act, the regulation CMS-1303-F (71 FR 45140) created a separate regulatory exception for certain arrangements involving the provision of nonmonetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records to improve the quality and efficiency of health care while maintaining the levels of security and privacy that consumers expect.

The conditions for both exceptions require that arrangements for the items and services provided must be set forth in a written agreement, be signed by the parties involved, specify the items or services being provided and the cost of those items or services, and cover all of the electronic prescribing and/or electronic health records technology to be provided by the donating entity. We have suggested that, instead of one master agreement that is updated with each new donation, the parties may choose to create a specific new contract and then reference other agreements or cross-reference a master list of agreements.

The requirements associated with the exception for electronic prescribing items and services are limited to donations made by hospitals to members of their medical staffs; by group practices to their physician members; and by PDP sponsors and MA organizations to prescribing physicians. The requirements associated with the exception for electronic health records software or information technology and training services include donations by entities furnishing DHS to physicians. The paperwork burden is the creation and execution of the written agreements. The burden associated with the written agreement requirement is the time and effort necessary for documentation of the agreement between the parties, including the signatures of the parties. Frequency: Recordkeeping and Reporting—On occasion; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 27,440; Total Annual Responses: 54,730; Total Annual Hours: 17,545.

4. Type of Information Collection Request: New collection; Title of Information Collection: Regional Preferred Provider Organization (RPPO) Reconciliation Cost Report; Form Number: CMS-10233 (OMB#: 0938-New); Use: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Title II, Subtitle C (Offering of Medicare Advantage Regional Plans; Medicare Advantage Competition) provided for the establishment of Medicare Advantage Regional Plans. Subsequently, the Regional Preferred Provider Organization (RPPO) program was developed and began contracting with Managed Care Organizations (MCOs) and enrolling beneficiaries for the 2006 contract year. Section 1858 of the Social Security Act provides for risk sharing with RPPOs to be in place for contract years 2006 and 2007. The Code of Federal Regulations at 42 CFR 422.458 provides specific direction with respect to how the Centers for Medicare and Medicaid Services (CMS) will share risk with the RPPOs. The regulations require CMS to collect Allowable Cost data, and to compare this data to Target Amounts. If the comparison demonstrates that there were either savings or losses in the contract year, the regulations provide specific risk corridors to be used in determining the Risk Sharing Reconciliation amount due to either the plan or CMS. The Risk Sharing Reconciliation cost report will be used to collect the information necessary to accurately reconcile the payments made to RPPOs for the 2006 and 2007 contract years. Frequency: Reporting—Annually; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 14; Total Annual Responses: 14; Total Annual Hours: 1,120.

5. Type of Information Collection Request: New collection; Title of Information Collection: State Plan Pre-print implementing Section 6087 of the Deficit Reduction Act: Optional Self-Direction Personal Assistance Services (PAS) Program (Cash and Counseling); Form Number: CMS-10234 (OMB#: 0938-New); Use: Information submitted via the State Plan Amendment (SPA) pre-print will be used by the Centers for Medicare & Medicaid Services (CMS) Central and Regional Offices to analyze a State's proposal to implement Section 6087 of the Deficit Reduction Act (DRA). State Medicaid Agencies will complete the SPA pre-print, and submit it to CMS for a comprehensive analysis. The pre-print contains assurances, check-off items, and areas for States to describe policies and procedures for subjects such as quality assurance, risk management, and voluntary and involuntary disenrollment; Frequency: Reporting—Once; Affected Public: State, Local, or Tribal Government; Number of Respondents: 56; Total Annual Responses: 30; Total Annual Hours: 600.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at http://www.cms.hhs.gov/​PaperworkReductionActof1995,, or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to [e-mail], or call the Reports Clearance Office on [phone].

Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: [phone].

Dated: July 18, 2007.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.