2010-20385. Agency Information Collection Activities: Proposed Collection; 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) 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 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; 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. Form Number: CMS-10052 (OMB#: 0938-0857); 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: Extension of a currently approved collection; Title of Information Collection: Issuance of Advisory Opinions Concerning Physicians' Referrals ; 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. Form Number: CMS-R-216 (OMB#: 0938-0714); 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.)

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Imposition of Cost Sharing Charges under Medicaid and Supporting Regulations in 42 CFR 447.53; Use: The purpose of this collection is to ensure that States impose normal cost sharing charges upon categorically and medically needy individuals as allowed by law and implementing regulations. States must identify in their State plan the service for which the charge is made, the amount of the charge, the basis for determining the charge, 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 the procedures for implementing and enforcing the exclusions from cost sharing. Form Number: CMS-R-53 (OMB#: 0938-0429); Frequency: Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 2; Total Annual Hours: 20. (For policy questions regarding this collection contact Barbara Washington at 410-786-9964. For all other issues call 410-786-1326.)

4. 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.)

5. 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.)

6. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Clinical Laboratory Improvement Amendments (CLIA) Application Form and Supporting Regulations in 42 CFR 493.1-.2001 Medicare/Medicaid Psychiatric Hospital Survey Data; Use: The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process. Form Number: CMS-116 (OMB#: 0938-0581); Frequency: Biennially and Occasionally; Affected Public: Private Sector: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 219,000; Total Annual Responses: 31,520; Total Annual Hours: 23,640. (For policy questions regarding this collection contact Sheila Ward at 410-786-3115. For all other issues call 410-786-1326.)

7. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Health Insurance Common Claims Form and Supporting Regulations at 42 CFR Part 424, Subpart C; Form Number: CMS-1500(08-05), CMS-1490-S (OMB#: 0938-0999); Use: The Form CMS-1500 answers the needs of many health insurers. It is the basic form prescribed by CMS for the Medicare program for claims from physicians and suppliers. The Medicaid State Agencies, CHAMPUS/TriCare, Blue Cross/Blue Shield Plans, the Federal Employees Health Benefit Plan, and several private health plans also use it; it is the de facto standard “professional” claim form.

Medicare carriers use the data collected on the CMS-1500 and the CMS-1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS-1500 is submitted by physicians/suppliers for all Part B Medicare. Serving as a common claim form, the CMS-1500 can be used by other third-party payers (commercial and nonprofit health insurers) and other Federal programs (e.g., CHAMPUS/TriCare, Railroad Retirement Board (RRB), and Medicaid).

However, as the CMS-1500 displays data items required for other third-party payers in addition to Medicare, the form is considered too complex for use by beneficiaries when they file their own claims. Therefore, the CMS-1490S (Patient's Request for Medicare Payment) was explicitly developed for easy use by beneficiaries who file their own claims. The form can be obtained from any Social Security office or Medicare carrier. Frequency: Reporting—On occasion; Affected Public: State, Local, or Tribal Government, Business or other-for-profit, Not-for-profit institutions; Number of Respondents: 1,048,243; Total Annual Responses: 991,160,925; Total Annual Hours: 23,815,541.

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 [e-mail], or call the Reports Clearance Office on [phone].

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 October 19, 2010:

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: August 13, 2010.

Michelle Shortt,

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