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

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

          - [Document Identifier: CMS-10052, CMS-10351 and CMS-R-216]

# 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:*                     Recognition of pass-through payment for additional (new) categories of devices under the Outpatient Prospective Payment System and Supporting Regulations in 42 CFR, Part 419;                     *Form Number:*                     CMS-10052 (OMB#: 0938-0857);                     *Use:*                     Section 201(b) of the Balanced Budget Act of 1999 amended section 1833(t) of the Social Security Act (the Act) by adding new section 1833(t)(6). This provision requires the Secretary to make additional payments to hospitals for a period of 2 to 3 years for certain drugs, radiopharmaceuticals, biological agents, medical devices and brachytherapy devices. Section 402 of the Benefits Improvement and Protection Act of 2000 made changes to the transitional pass-through provision for medical devices. The most significant change is the required use of categories as the basis for determining transitional pass-through eligibility for medical devices, through the addition of section 1833(t)(6)(B) of the Act. This information collection is necessary to determine eligibility of medical devices for establishment of additional device categories for payment under transitional pass-through payment provisions as required by section 1833(t)(6) of the Act.                     *Frequency:*                     Once;                     *Affected Public:*                     Private Sector: Business or other for-profits;                     *Number of Respondents:*                     10; Total                    *Annual Responses:*                     10;                     *Total Annual Hours:*                     160. (For policy questions regarding this collection contact Christina S. Ritter at 410-786-4636. For all other issues call 410-786-1326.)                

                    2.                     *Type of Information Collection Request:*                     New collection;                     *Title of Information Collection:*                     ESRD PPS Transition Election and attestations of Low-Volume;                     *Form Number:*                     CMS-10351 (OMB#: 0938-New);                     *Use:*                     The Medicare Improvement for Patients and Providers Act (MIPPA) requires implementation of an End Stage Rental Disease (ESRD) bundled prospective payment system (PPS) effective January 1, 2011. Once implemented, the ESRD PPS will replace the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD related items and services. The ESRD PPS will provide a single payment to the ESRD facilities that will cover all the resources used in providing an outpatient dialysis treatment. Also, as required my MIPPA, ESRD facilities are eligible to receive a low-volume adjustment when the facility furnished less than 4000 treatments in each of the three years pre-ceding the payment year.                

                    In order for an ESRD facility to receive the low-volume adjustment, CMS will require that an ESRD facility must provide an attestation to the fiscal intermediary or the Medicare administrative contractor (FI/MAC) that it has met the criteria to qualify as a low-volume facility. The FI or MAC would verify the ESRD facility's attestation of their low-volume status using the ESRD facility's final-settled cost reports. Also, an ESRD facility may make a one-time election to be excluded from the four-year transition to the ESRD PPS. A facility may elect to be paid entirely based on the ESRD PPS beginning January 1, 2011. If the ESRD facility fails to submit an election, or the ESRD facility's election is not received by their MAC by November 1, 2010, payments to the ESRD facility for items and services provided during the transition will be paid under the basic case-mix adjusted composite payment system.                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector: Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     5,808; Total                    *Annual Responses:*                     2,520;                           ( print page 69446)    *Total Annual Hours:*                     563.2. (For policy questions regarding this collection contact Janet Samen at 410-786-4533. For all other issues call 410-786-1326.)                

                    3.                     *Title of Information Collection:*                     Issuance of Advisory Opinions Concerning Physicians' Referrals;                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Form Number:*                     CMS-R-216 (OMB#: 0938-0714);                     *Use:*                     Section 1877(g)(6) of the Social Security Act requires that the Department of Health and Human Services accept requests for advisory opinions made after November 3, 1997 and before August 21, 2000. Section 543 of the Benefits Improvement and Protection Act of 2001, Public Law 106-554, extended indefinitely the period during which the Department of Health and Human Services accepts requests for these advisory opinions. CMS promulgated 42 CFR 411.370 through 411.389 to comply with this statutory mandate. The collection of information contained in 42 CFR 411.372 and 411.373 is necessary to allow CMS to consider requests for advisory opinions and provide accurate and useful opinions. ;                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector: Business or other for-profits and not- for profit institutions;                     *Number of Respondents:*                     25; Total                    *Annual Responses:*                     25;                     *Total Annual Hours:*                     500. (For policy questions regarding this collection contact John Davis at 410-786-0008. 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 13, 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 4, 2010.

Michelle Shortt,

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

[FR Doc. 2010-28332 Filed 11-10-10; 8:45 am]

BILLING CODE 4120-01-P