[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Pages 69445-69446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28332]


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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 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 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;

[[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 [email protected], 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: [email protected].

    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