[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Notices]
[Pages 46085-46087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-308, CMS-116, CMS-1561/1561A, CMS-417, CMS-
10227, CMS-437, CMS-724, CMS-10116, CMS-10142, and CMS-10225]


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: State Children's 
Health Insurance Program and Supporting Regulations in 42 CFR

[[Page 46086]]

431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 
457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 
457.965, 457.985, 457.1005, 457.1015, and 457.1180; Form Number: CMS-R-
308 (OMB: 0938-0841) Use: States are required to submit title 
XXI plans and amendments for approval by the Secretary pursuant to 
section 2102 of the Social Security Act in order to receive funds for 
initiating and expanding health insurance coverage for uninsured 
children. States are also required to submit State expenditure and 
statistical reports, annual reports and State evaluations to the 
Secretary as outlined in title XXI of the Social Security Act. 
Frequency: Yearly and Quarterly; Affected Public: State, Local or 
Tribal governments; Number of Respondents: 56; Total Annual Responses: 
1,454,601; Total Annual Hours: 864,933.
    2. Type of Information Collection Request: Revision of a currently 
approved collection. In this revision, a number of changes were made to 
the form and accompanying instructions to facilitate the completion and 
data entry of the form. Specifically, the enumeration of individuals 
involved in laboratory testing was eliminated, and the reporting of 
hours of laboratory operations was streamlined. Some fields were 
expanded to reflect changes in laboratory demographics (added prison 
and assisted living facility to location of laboratory testing) and to 
collect complete information on the number of tests performed in 
laboratories. There are no program changes; Title of Information 
Collection: Clinical Laboratory Improvement Amendments Application Form 
and Supporting Regulations at 42 CFR 493.1-.2001; Form Number: CMS-116 
(OMB: 0938-0581); Use: The application must be completed by 
entities performing laboratory testing specimens for diagnostic or 
treatment purposes. This information is vital to the certification 
process. Frequency: Reporting--Biennially; Affected Public: Business or 
other for-profit and Not-for-profit institutions; Number of 
Respondents: 187,000; Total Annual Responses: 17,960; Total Annual 
Hours: 22,450.
    3. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR 
489; Form Numbers: CMS-1561 and 1561A (OMB: 0938-0832); Use: 
Applicants to the Medicare program are required to agree to provide 
services in accordance with Federal requirements. The CMS-1561 and 
1561A are essential for CMS to ensure that applicants are in compliance 
with the requirements. Applicants will be required to sign the 
completed form and provide operational information to CMS to assure 
that they continue to meet the requirements after approval; Frequency: 
Reporting--Other: All new applicants must complete; Affected Public: 
State, Local or Tribal Governments, Business or Other for-profits and 
Not-for-profit institutions; Number of Respondents: 3,300; Total Annual 
Responses: 3,300; Total Annual Hours: 275.
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Hospice Request 
for Certification in the Medicare Program; Form Number: CMS-417 
(OMB: 0938-0313); Use: The Hospice Request for Certification 
Form is the identification and screening form used to initiate the 
certification process and to determine if the provider has sufficient 
personnel to participate in the Medicare program; Frequency: 
Reporting--Yearly; Affected Public: Private Sector: Business or other 
for-profits; Number of Respondents: 2,286; Total Annual Responses: 
2,286; Total Annual Hours: 572.
    5. Type of Information Collection Request: Existing collection in 
use without an OMB Control Number; Title of Information Collection: 
PACE State Plan Amendment Pre-print; Form Number: CMS-10227 
(OMB: 0938-NEW); Use: The Balanced Budget Act of 1997 created 
section 1934 of the Social Security Act that established the Program 
for the All-Inclusive Care for the Elderly (PACE). The legislation 
established the PACE program as a Medicaid State plan option serving 
the frail and elderly in the home and community. In accordance with the 
rule published in the November 24, 1999 Federal Register (64 FR 66271), 
if a State elects to offer PACE as an optional Medicaid benefit, it 
must complete a State Plan Amendment described as Enclosures 
3, 4, 5, 6 and 7. In State Medicaid Director letters dated 
March 23, 1998 and November 9, 2000, CMS advised States that it had 
provided a suggested pre-print and supplemental pages for a State to 
express its intention to elect PACE as an option to its State plans. As 
pre-print packet Enclosures 3-7 were suggested and not 
required, CMS did not believe at the time that a suggested form 
required clearance from OMB. The PACE regulation 42 CFR Part 460 was 
first published in the Federal Register as an interim final rule on 
November 24, 1999. The final PACE rule was published on December 8, 
2006. CMS is seeking OMB approval to use Enclosures 3, 4, 5, 6 
and 7. The information is used by CMS to affirm that the State elects 
to offer PACE an optional State plan service and the specifications of 
eligibility, payment and enrollment for the program. Frequency: 
Reporting--Once; Affected Public: State, Local or Tribal Governments; 
Number of Respondents: 56; Total Annual Responses: 56 possible 
responses but we have only received 20 thus far; Total Annual Hours: 
1,120.
    6. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Psychiatric Unit Criteria Worksheet and Supporting 
Regulations at 42 CFR 412.25 and 412.27. Form Number: CMS-437 
(OMB 0938-0358); Use: The psychiatric unit criteria worksheets 
are necessary to verify that these units comply and remain in 
compliance with the exclusion criteria for the Medicare prospective 
payment system. Frequency: Reporting--Annually; Affected Public: 
Business or other for-profit, Not-for-profit institutions, and State, 
Local and Tribal Government; Number of Respondents: 1,333; Total Annual 
Responses: 1,333; Total Annual Hours: 333.
    7. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Psychiatric 
Hospital Survey Data and Supporting Regulations at 42 CFR 482.60, 
482.61, and 482.62; Form Number: CMS-724 (OMB: 0938-0378); 
Use: The Medicare/Medicaid Psychiatric Hospital Survey is used to 
collect data that is not collected elsewhere and assists CMS in program 
planning and evaluation of survey needs. In addition, the survey 
assists CMS in maintaining an accurate data base on providers 
participating in the Medicare psychiatric hospital program; Frequency: 
Reporting--Yearly; Affected Public: Private Sector: Business or other 
for-profits; Number of Respondents: 420; Total Annual Responses: 200; 
Total Annual Hours: 100.
    8. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Program; 
Conditions of Payment of Power Mobility Devices, Including Power 
Wheelchairs and Power-Operated Vehicles (CMS-3017-F); Form Numbers: 
CMS-10116 (OMB: 0938-0971); Use: The CMS is seeking the 
reapproval of the collection requirements associated with the final 
rule, CMS-3017-F (71 FR 17021), which was published on April 5, 2006, 
and

[[Page 46087]]

became effective on June 5, 2006. Specifically, we are seeking OMB 
approval for the following terms of clearance identified in the Notice 
of Action dated October 16, 2006, of which OMB has requested CMS to 
monitor the paperwork burden required of providers and suppliers to 
determine if the paperwork requirements impose any unnecessary burden 
on the industry and/or need to be revised in order to improve the 
utility of the information.
    After analyzing the documentation requirements burden, CMS does not 
believe that the documentation requirements impose any additional 
unnecessary burden on the durable medical equipment (DME) Industry. We 
believe that most physicians are already conducting a face-to-face 
examination before prescribing a wheelchair. Given that physicians and 
treating practitioners can now prescribe power-operated vehicles 
(POVs), thereby removing the requirement that a specialist can order a 
POV, CMS believes that the increased burden of 48,600 hours for 
physicians and treating practitioners is based on the Congressional 
decision to allow a broader range of physicians and treating 
practitioners to prescribe POVs. This increased burden is offset by the 
new payments implemented in connection with the Final Rule, which is 
demonstrated by the shift in prescriptions from one class of equipment, 
power wheelchairs, to another class of equipment, POVs.
    In addition, CMS believes that with the recent coverage decision on 
Mobility Assistive Equipment, the implementing details in the Final 
Rule (e.g., improved documentation for suppliers; physician and 
treating practitioner payments; improved classification of mobility 
equipment; the elimination of the certificate of medical necessity 
(CMN)), and the provider outreach and education provided by CMS, the 
DME program safeguard contractors (PSCs) and DME Medicare 
administrative contractors (MACs), the needs of mobility-impaired 
beneficiaries and the needs of suppliers have been better met. 
Frequency: Recordkeeping--On occasion; Affected Public: Business or 
for-profits, Not-for-profit institutions, and State, Local or Tribal 
governments; Number of Respondents: 38,000; Total Annual Responses: 
243,000; Total Annual Hours: 48,600.
    9. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Bid Pricing Tool 
(BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans 
(PDPs); Use: Under the Medicare Prescription Drug, Improvement, and 
Modernization (MMA), Medicare Advantage organizations (MAO) and 
Prescription Drug Plans (PDP) are required to submit an actuarial 
pricing ``bid'' for each plan offered to Medicare beneficiaries. CMS 
requires that MAOs and PDPs complete the BPT as part of the annual 
bidding process. During this process, organizations prepare their 
proposed actuarial bid pricing for the upcoming contract year and 
submit them to CMS for review and approval. The purpose of the BPT is 
to collect the actuarial pricing information for each plan. The BPT 
calculates the plan's bid, enrollee premiums, and payment rates. Form 
Number: CMS-10142 (OMB: 0938-0944); Frequency: Yearly; 
Affected Public: Business or other for-profit and Not-for-profit 
institutions; Number of Respondents: 550 Total Annual Responses: 6,050; 
Total Annual Hours: 42,350.
    10. Type of Information Collection Request: New collection; Title 
of Information Collection: Disclosures to Patients by Certain Hospitals 
and Critical Access Hospitals; Form Numbers: CMS-10225 (OMB: 
0938-New); Use: There is no Medicare prohibition against physician 
investment in a hospital or critical access hospital (CAH). Likewise, 
there is no Medicare requirement that a hospital or CAH have a 
physician on-site at all times, although there is a requirement that 
they be able to provide basic elements of emergency care to their 
patients. Medicare quality and safety standards are designed to provide 
a national framework that is sufficiently flexible to apply 
simultaneously to hospitals of varying sizes, offering varying ranges 
of services in differing settings across the Nation. At the same time, 
however, patients might consider an ownership interest by their 
referring physician and/or the presence of a physician on-site to be 
important factors in their decisions about where to seek hospital care. 
A well-educated consumer is essential to improving the quality and 
efficiency of the healthcare system. Accordingly, patients should be 
made aware of the physician ownership of a hospital, whether or not a 
physician is present in the hospital at all times, and the hospital's 
plans to address patients' emergency medical conditions when a 
physician is not present. The intent of the proposed disclosures are 
increase the transparency of the hospital's ownership and operations to 
patients as they make decisions about receiving care at the hospital.
    Based on public comments received during the 60-day comment period 
for the Federal Register notice (72 FR 21024) for this information 
collection request, we revised our burden estimates to include the 
burden associated with the physician-ownership disclosure and 
recordkeeping requirement for outpatient visits. In addition, we 
revised the burden associated with the disclosure requirement for 
critical access hospitals that may not have a physician on-site at all 
times to account for outpatient visits as well. Frequency: Reporting--
On occasion; Affected Public: Business or for-profits, Not-for-profit 
institutions; Number of Respondents: 2,679; Total Annual Responses: 
52,984,510; Total Annual Hours: 839,599.
    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.
    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: August 9, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E7-16160 Filed 8-15-07; 8:45 am]
BILLING CODE 4120-01-P