[Federal Register Volume 72, Number 125 (Friday, June 29, 2007)]
[Notices]
[Pages 35711-35713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-26, CMS-10217, CMS-R-297, CMS-10223, and 
CMS-1500 (08-05)]


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

[[Page 35712]]

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

[[Page 35713]]

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.
    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: (202) 395-6974.

    Dated: June 21, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E7-12655 Filed 6-28-07; 8:45 am]
BILLING CODE 4120-01-P