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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10207, CMS-R-131, CMS-10215, CMS-724, CMS-10227, and CMS-10244]

# 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 of a currently approved collection;                     *Title of Information Collection:*                     Physician Self-Referral Exceptions for Electronic Prescribing and Electronic Health Records;                     *Form Number:*                     CMS-10207 (OMB#: 0938-1009);                     *Use:*                     Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) directed the Secretary to create an exception to the physician self-referral prohibition in section 1877 of the Social Security Act for certain arrangements in which a physician receives compensation in the form of items or services (not including cash or cash equivalents) (“nonmonetary remuneration”) that is necessary and used solely to receive and transmit electronic prescription information. Also, CMS 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.                

                    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. CMS would use the collected information for enforcement purposes; specifically, if we were investigating the financial relationships between the donors and the physicians to determine whether the provisions in the exceptions were met.                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector: Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     9,796; Total                    *Annual Responses:*                     38,959;                     *Total Annual Hours:*                     12,451.5. . (For policy questions regarding this collection contact Kristin Bohl at 410-                          ( print page 70927)                        786-8680. For all other issues call 410-786-1326.)                

                    2.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Advance Beneficiary Notice of Noncoverage (ABN);                     *Form Number:*                     CMS-R-131 (OMB#: 0938-0566);                     *Use:*                     Under section 1879 of the Social Security Act, a physician, provider, practitioner, or supplier of items or services participating in the Medicare program, or taking a claim on assignment, may bill a Medicare beneficiary for items or services usually covered under Medicare, but denied in an individual case under one of the several statutory exclusions, if they inform the beneficiary, prior to furnishing the service, that Medicare is likely to deny payment. Sections 42 CFR 411.404(b) and (c), and 411.408(d)(2) and (f), require written notice be provided to inform beneficiaries in advance of potential liability for payment.                     *Frequency:*                     Once;                     *Affected Public:*                     Reporting: Weekly, Monthly, Yearly, Biennially and Occasionally;                     *Number of Respondents:*                     1,326,282; Total                    *Annual Responses:*                     43,725,850;                     *Total Annual Hours:*                     5,099,309. (For policy questions regarding this collection contact Evelyn Blaemire at 410-786-1803. For all other issues call 410-786-1326.)                

                    3.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Medicaid Payment for Prescription Drugs—Physicians and Hospital Outpatient Departments Collecting and Submitting Drug Identifying Information to State Medicaid Programs;                     *Use:*                     Section 6002 of the Deficit Reduction Act (DRA) of 2005 added provisions under section 1927 of the Social Security Act to require physicians in their offices and hospital outpatient settings or other entities (                    *e.g.,*                     non-profit facilities) to collect and submit the drug National Drug Code (NDC) numbers on Medicaid claims to their State in order for Federal Financial Participation to be available for these drugs.                     *Form Number:*                     CMS-10215 (OMB#: 0938-1026);                     *Frequency:*                     Weekly;                     *Affected Public:*                     Private Sector: Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     20,000; Total                    *Annual Responses:*                     3,910,000;                     *Total Annual Hours:*                     15,836. (For policy questions regarding this collection contact Bernadette Leeds at 410-786-9463. For all other issues call 410-786-1326.)                

                    4.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Medicare/Medicaid Psychiatric Hospital Survey Data;                     *Use:*                     The CMS-724 form is used to collect data that is not collected elsewhere and assists CMS in program planning and evaluation and in maintaining an accurate database on providers participating in the psychiatric hospital program.                     *Form Number:*                     CMS-724 (OMB#: 0938-0378);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector: Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     500; Total                    *Annual Responses:*                     150;                     *Total Annual Hours:*                     75. (For policy questions regarding this collection contact Kelley Leonette at 410-786-6664. For all other issues call 410-786-1326.)                

                    5.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     PACE State Plan Amendment Pre-print;                     *Use:*                     The Balanced Budget Act of 1997 created section 1934 of the Social Security Act that established the Program for the All-Inclusive Care for the Elderly (PACE). The legislation established the PACE program as a Medicaid State plan option serving the frail and elderly in the home and community. Pursuant to the notice given in 64 FR 66271 (November 24, 1999), if a State elects to offer PACE as an optional Medicaid benefit, it must complete a State Plan Amendment described as Enclosures #3, 4, 5, 6 and 7. The information collected is used by CMS to affirm that the State elects to offer PACE an optional State plan service and the specifications of eligibility, payment and enrollment for the program.                     *Form Number:*                     CMS-10227 (OMB#: 0938-1027);                     *Frequency:*                     Once;                     *Affected Public:*                     State, Local, or Tribal Governments;                     *Number of Respondents:*                     36; Total                    *Annual Responses:*                     12;                     *Total Annual Hours:*                     240. (For policy questions regarding this collection contact Angela Taube at 410-786-2638. For all other issues call 410-786-1326.)                

                    6.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Medicaid State Program Integrity Assessment (SPIA);                     *Use:*                     Under the provisions of the Deficit Reduction Act (DRA) of 2005, the Congress directed CMS to establish the Medicaid Integrity Program (MIP), CMS' first national strategy to combat Medicaid fraud, waste, and abuse. CMS has two broad responsibilities under the MIP: (1) Reviewing the actions of individuals or entities providing services or furnishing items under Medicaid; conducting audits of claims submitted for payment; identifying overpayments; and educating providers and others on payment integrity and quality of care; and (2) Providing effective support and assistance to States to combat Medicaid fraud, waste, and abuse.                

                    In order to fulfill the second of these requirements, CMS developed SPIA. CMS uses SPIA to collect data on State Medicaid program integrity activities, develop reports for each State based on these data, determine areas to provide States with technical support and assistance, and develop measures to assess States' performance.                     *Form Number:*                     CMS-10244 (OMB#: 0938-1033);                     *Frequency:*                     Annually;                     *Affected Public:*                     State, Local, or Tribal Governments;                     *Number of Respondents:*                     56; Total                    *Annual Responses:*                     56;                     *Total Annual Hours:*                     1,400. (For policy questions regarding this collection contact Mary Jo Cook at 410-786-3231. 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                     *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 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                     *December 20, 2010.*                     OMB, Office of Information and Regulatory Affairs,                     *Attention:*                     CMS Desk Officer.                     *Fax Number:*                     (202) 395-6974.                     *E-mail: OIRA_submission@omb.eop.gov.*

Dated: November 12, 2010.

Michelle Shortt,

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

[FR Doc. 2010-29074 Filed 11-18-10; 8:45 am]

BILLING CODE 4120-01-P