[Federal Register: June 29, 2007 (Volume 72, Number 125)]
[Notices]
[Page 35711-35713]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn07-63]
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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 Paperwork@cms.hhs.gov, 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