E7-12655. 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: Information Collection Requirements (ICRs) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR part 493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235, 493.1236, 493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493.1252, 439.1253, 493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 493.1273, 493.1274, 493.1278, 493.1283, 493.12889, 493.1291, and 493.1299; Form Numbers: CMS-R-26 (OMB#: 0938-0612); Use: The ICRs referenced in 42 CFR part 493 outline the requirements necessary to determine an entity's compliance with CLIA. CLIA requires laboratories that perform testing on human beings to meet performance requirements (quality standards) in order to be certified by the Department of Health and Human Services (HHS). HHS conducts inspections to determine a laboratory's compliance with CLIA requirements. CLIA implements the certificate, laboratory standards and inspection requirements; Frequency: Reporting—As needed; Affected Public: State, Local or Tribal Governments, Federal Government, Business or Other for profits and Not-for-profit institutions; Number of Respondents: 168,688; Total Annual Responses: 756,241; Total Annual Hours: 11,363,680.

2. Type of Information Collection Request: New collection; Title of Information Collection: Physician Survey for the 2006 Medicare Oncology Demonstration Program; Form Numbers: CMS-10217 (OMB#: 0938-New); Use: The 2006 Oncology Demonstration Program aimed to: (1) Have oncology payments increasingly focused on patient-centered care, rather than chemotherapy administration; (2) learn to what extent Medicare beneficiaries are being treated in a manner that yields the best outcomes; (3) understand clinical cancer scenarios where there is not clinical consensus among physicians on the relevance of specific evidence-based practice guidelines; and, (4) ensure that due emphasis is placed on multi-disciplinary, comprehensive approach to palliation and end of life care. In addition, CMS hoped to reduce the potential that unnecessary services and tests are being performed, thereby lowering program costs while yielding better quality of life for Medicare beneficiaries with cancer. This survey will provide information on how physicians, particularly oncologists and hematologists, adapted their practice in response to the CMS payment incentive, to guide future CMS demonstration projects involving oncologists and all specialists. Frequency: Reporting—Once; Affected Public: Individuals or households; Number of Respondents: 600; Total Annual Responses: 600; Total Annual Hours: 100.

3. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Request for Employment Information; Form Numbers: CMS-R-297 (OMB#: 0938-0787); Use: Section 1837(i) of the Social Security Act provides for a special enrollment period for individuals who delay enrolling in Medicare Part B because they are covered by a group health plan based on their own or a spouse's current employment status. When these individuals apply for Medicare Part B, they must provide proof that the group health plan coverage is (or was) based on current employment status. This form is used by the Social Security Administration to obtain information from employers regarding whether a Medicare beneficiary's coverage under a group health plan is based on current employment status. Frequency: Reporting—Once; Affected Public: Business or Other for profits and Not-for-profit institutions; Number of Respondents: 5000; Total Annual Responses: 5000; Total Annual Hours: 1250.

4. Type of Information Collection Request: New collection; Title of Information Collection: Medicare Competitive Acquisition Program (CAP) for Part B Drugs Evaluation: CAP Physician Survey; Form Numbers: CMS-10223 (OMB#: 0938-New); Use: This physician survey is part of an overall evaluation of the Centers for Medicare and Medicaid Services congressionally mandated Competitive Acquisition for Part B Drugs and Biologicals Program (CAP). Medicare Prescription Drug Improvement and Modernization Act (MMA) section 303(d) requires the implementation of the CAP for those drugs and biologicals covered by Medicare part B that are not paid on a cost or prospective payment system. Since July 1, 2006, physicians have been given a choice between (1) Buying and billing for these covered drugs under the average sales price (ASP) system mandated in section 303(c) of the MMA; or (2) obtaining these drugs from vendors selected for the CAP in a competitive bidding process. If the physician elects to obtain drugs from a CAP vendor, the vendor, rather than the physician, will bill Medicare for the drug. The CAP is therefore a major change in the way Part B-covered drugs and biologicals are acquired and reimbursed for, requiring CMS to consider many design options. The CAP mandate includes a Report to Congress due July 1, 2008, which will include results from this physician survey; Frequency: Reporting—Once; Affected Public: Business or Other for profits; Number of Respondents: 1560; Total Annual Responses: 1560; Total Annual Hours: 297.50.

5. Type of Information Collection Request: Revision 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.

Since the last submission of this information collection request, we discontinued form CMS-1490U which was used by employers, unions, employer-employee organizations that pay physicians and suppliers for their services to employees, group practice prepayment plans, and health maintenance organizations. Therefore, this collection will no longer contain the CMS-1490U.

In sum, the CMS-1500 and CMS-1490S result in less paperwork burden placed on the public. The CMS-1500 provides efficiency in office procedures for physicians and suppliers; the CMS-1490S provides beneficiaries with a relatively easy form to use when filing their claims. Without the collection of this information, claims for reimbursement relating to the provision of Part B medical services/supplies could not be acted upon. This would result in a nationwide paralysis of the operation of the Federal Government's Medicare Part B program, and major problems for the other health plans that use the CMS-1500, inflicting severe physical and financial hardship on providers/suppliers as well as beneficiaries. 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: 970,174,260; Total Annual Hours: 33,067,757.

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: June 21, 2007.

Michelle Shortt,

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