```

[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Notices]               
[Page 51462-51463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au10-48]                         

[[Page 51462]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10052, CMS-R-216, CMS-R-53, CMS-10215, CMS-
724, CMS-116 and CMS-1500(08-05)]

 
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

[[Page 51463]]

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 Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    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.
[FR Doc. 2010-20385 Filed 8-19-10; 8:45 am]
BILLING CODE 4120-01-P
```