[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34742-34744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14780]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10179, CMS-R-234, CMS-2540-10, CMS-10108, 
CMS-10315, CMS-10302, CMS-2744 and CMS-2746]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

    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: 
Requests by Hospitals for an Alternative Cost-to-Charge Ratio. Use: 
Section 1886(d)(5)(A) of the Act provides for additional Medicare 
payments to Inpatient Prospective Payment System (IPPS) hospitals for 
cases that incur extraordinarily high costs. To qualify for outlier 
payments, a case must have costs above a predetermined threshold amount 
(a dollar amount by which the estimated cost of a case must exceed the 
Medicare payment). Hospital-specific cost-to-charge ratios are applied 
to the covered charges for a case to determine the estimated cost of 
the case. In general, additional outlier payments for eligible cases 
are made based on a marginal cost factor of 80 percent, i.e. a fixed 
percentage of the costs. Therefore, if the estimated cost of the case 
exceeds the Medicare payment for that discharge plus the outlier 
threshold, generally Medicare will pay the hospital 80 percent of the 
excess amount. The outlier threshold is updated annually at the 
beginning of the Federal Fiscal Year. Form Number: CMS-10179 
(OMB: 0938-1020); Frequency: Occasionally; Affected Public: 
Private Sector and Business or other for-profits, Not-for-profit 
institutions; Number of Respondents: 18; Total Annual Responses: 18; 
Total Annual Hours: 144. (For policy questions regarding this 
collection contact Michael Treitel at 410-786-4552. For all other 
issues call 410-786-1326.)
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Subpart D--Private Contracts and Supporting Regulations contained in 42 
CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455. Use: 
Section 4507

[[Page 34743]]

of Balancing Budget Act (BBA) 1997 amended section 1802 of the Social 
Security Act to permit certain physicians and practitioners to opt-out 
of Medicare and to provide through private contracts services that 
would otherwise be covered by Medicare. Under such contracts the 
mandatory claims submission and limiting charge rules of section 
1848(g) of the Act would not apply. Subpart D and the Supporting 
Regulations contained in 42 CFR 405.410, 405.430, 405.435, 405.440, 
405.445, and 405.455, counters the effect of certain provisions of 
Medicare law that, absent section 4507 of BBA 1997, preclude physicians 
and practitioners from contracting privately with Medicare 
beneficiaries to pay without regard to Medicare limits. Form Number: 
CMS-R-234 (OMB: 0938-0730); Frequency: Biennially; Affected 
Public: Private Sector and Business or other for-profits; Number of 
Respondents: 26,820; Total Annual Responses: 26,820; Total Annual 
Hours: 7,197. (For policy questions regarding this collection contact 
Fred Grabau at 410-786-0206. For all other issues call 410-786-1326.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Skilled Nursing 
Facility Health Care Complex Cost Report. Use: Providers of services 
participating in the Medicare program are required under sections 
1815(a), and 1861(v)(1)(A) of the Social Security Act to submit annual 
information to achieve settlement of costs for health care services 
rendered to Medicare beneficiaries. The CMS-2540-10 cost report is 
needed to determine the amount of reimbursement that is due to these 
providers furnishing medical services to Medicare beneficiaries.
    CMS is requesting review and approval of revisions made to the 
Skilled Nursing Facility (SNF) Cost Report FORM CMS-2540-10, (for cost 
reporting periods beginning on or after December 1, 2010) which 
replaces the existing FORM CMS 2540-96. Revisions made to update the 
forms currently in use are incorporated within this request for 
approval. Refer to the supporting documents for a list of revision to 
the cost reporting forms. Form Number: CMS-2540-10 (OMB: 0938-
0463); Frequency: Yearly; Affected Public: Private Sector and Business 
or other for-profits; Number of Respondents: 15,037; Total Annual 
Responses: 15,037; Total Annual Hours: 2,706,660. (For policy questions 
regarding this collection contact Edwin Gill at 410-786-4525. 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 Managed 
Care Regulations for 42 CFR 438.6, 438.8, 438.10, 438.12, 438.50, 
438.56, 438.102, 438.114, 438.202, 438.204, 438.206, 438.207, 438.240, 
438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 
438.604, 437.710, 438.722, 438.724, and 438.810; Use: These information 
collection requirements implement regulations that allow States greater 
flexibility to implement mandatory managed care program, implement new 
beneficiary protections, and eliminate certain requirements viewed by 
State agencies as impediments to the growth of managed care programs. 
Information collected includes information about managed care programs, 
grievances and appeals, enrollment broker contracts, and managed care 
organizational capacity to provide health care services. Form Number: 
CMS-10108 (OMB: 0938-0920); Frequency: Reporting: 
Occasionally; Affected Public: State, Local, or Tribal Government; 
Number of Respondents: 39,114,558; Total Annual Responses: 4,640,344; 
Total Annual Hours: 3,930,093.5. (For policy questions regarding this 
collection contact Angela Garner at 410-786-7062. For all other issues 
call 410-786-1326.)
    5. Type of Information Collection Request: New collection; Title of 
Information Collection: Patient Safety Survey Under the 9th Scope of 
Work: Nursing Home in Need (NHIN). Use: The Centers for Medicare & 
Medicaid Services (CMS) is requesting OMB clearance for the Nursing 
Homes in Need (NHIN) Survey. The NHIN is a component of the Patient 
Safety Theme of the Quality Improvement Organization (QIO) Program's 
9th Scope of Work (SOW). The statutory authority for this scope of work 
is found in Part B of Title XI of the Social Security Act (the Act) as 
amended by the Peer Review Improvement Act of 1982. The Act established 
the Utilization and Quality Control Peer Review Organization Program, 
now known as the Quality Improvement Organization (QIO) Program.
    The QIO in each State will provide special technical assistance to 
a small number of nursing homes in need of assistance with quality 
improvement efforts. This special technical assistance will be for the 
QIO to conduct a root cause analysis (RCA) with one nursing home in its 
state per year (three over three years). Under this component, it is 
expected that within the first quarter of the contract period, CMS will 
assign one nursing home to each QIO. The determination of which nursing 
homes are eligible under this component will be made by CMS. Some of 
these facilities may meet criteria for Special Focus Facilities (SFF). 
The intent of this component is that each State QIO will work with 
three nursing homes over the three-year contract period; these 
assignments are expected to be spaced out so that each State QIO will 
get one nursing home assigned approximately every 12 months.
    The NHIN Survey is a new information collection to be used by CMS 
to obtain information on nursing home satisfaction with technical 
assistance strategies delivered as a component of the NHIN. The NHIN 
Survey will be a census of 53 nursing homes working with their 
respective QIOs. The survey will be conducted one time for each of the 
nursing homes assisted in the first two years under the 9th SOW and it 
will be conducted twice with nursing homes assisted in the third year. 
The information collected through this survey will allow CMS to help 
focus the NHIN task to maximize the benefit to participating nursing 
homes. The NHIN Survey will be administered via telephone by trained 
and experienced interviewers. Responses will be entered into a pre-
programmed Computer-Assisted Telephone Interviewing (CATI) interface.
    The NHIN Survey will include questions to determine if the QIO has 
conducted a root cause analysis and developed an action plan. These 
will be followed by questions about their satisfaction with the QIO and 
their perceived value of the QIO's assistance. The NHIN Survey will 
address the following:
     Background information;
     Current work--information and assessment;
     Satisfaction with QIOs;
     Value of QIO assistance;
     Sources of information; and
     Respondent comments.
    All survey protocol and correspondence will be translated into 
Spanish and bi-lingual telephone interviewers will be used as needed. 
Form Number: CMS-10315 (OMB: 0938-New); Frequency: 
Occasionally; Affected Public: Businesses and other for-profit and not-
for-profit institutions; Number of Respondents: 53; Total Annual 
Responses: 106; Total Annual Hours: 17.5 hours (years 1 and 2), 35 
hours (year 3). (For policy questions regarding this collection contact 
Bob Kambic 410-786-1515. For all other issues call 410-786-1326.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of

[[Page 34744]]

Information Collection: Collection Requirements for Compendia for 
Determination of Medically-accepted Indications for Off-label Uses of 
Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen Use: 
Congress enacted the Medicare Improvement of Patients and Providers Act 
(MIPPA). Section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the 
Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the 
following new sentence: `On and after January 1, 2010, no compendia may 
be included on the list of compendia under this subparagraph unless the 
compendia has a publicly transparent process for evaluating therapies 
and for identifying potential conflicts of interest.' We believe that 
the implementation of this statutory provision that compendia have a 
``publicly transparent process for evaluating therapies and for 
identifying potential conflicts of interests'' is best accomplished by 
amending 42 CFR 414.930 to include the MIPPA requirements and by 
defining the key components of publicly transparent processes for 
evaluating therapies and for identifying potential conflicts of 
interests.
    All currently listed compendia will be required to comply with 
these provisions, as of January 1, 2010, to remain on the list of 
recognized compendia. In addition, any compendium that is the subject 
of a future request for inclusion on the list of recognized compendia 
will be required to comply with these provisions. No compendium can be 
on the list if it does not fully meet the standard described in section 
1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. 
Form Number: CMS-10302 (OMB: 0938-1078); Frequency: Reporting, 
Recordkeeping and Third-party disclosure; Affected Public: Business and 
other for-profits and Not-for-profit institutions; Number of 
Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 
5,135. (For policy questions regarding this collection contact Brijet 
Burton at 410-786-7364. For all other issues call 410-786-1326.)
    7. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: End Stage Renal Disease (ESRD) Medical Information Facility 
Survey; Form Number: CMS-2744 (OMB: 0938-0447); Use: The End 
Stage Renal Disease (ESRD) Medical Information Facility Survey form 
(CMS-2744) is completed annually by Medicare-approved providers of 
dialysis and transplant services. The CMS-2744 is designed to collect 
information concerning treatment trends, utilization of services and 
patterns of practice in treating ESRD patients. The information is used 
to assess and evaluate the local, regional and national levels of 
medical and social impact of ESRD care and is used extensively by 
researchers and suppliers of services for trend analysis. The 
information is available on the CMS Dialysis Facility Compare website 
and will enable patients to make informed decisions about their care by 
comparing dialysis facilities in their area. Frequency: Yearly; 
Affected Public: Business or other for-profit, Not-for-profit 
institutions; Number of Respondents: 5,465; Total Annual Responses: 
5,465; Total Annual Hours: 43,720. (For policy questions regarding this 
collection contact Connie Cole at 410-786-0257. For all other issues 
call 410-786-1326.)
    8. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: End Stage Renal Disease Death Notification P.L. 95-292; 42 
CFR 405.2133, 45 CFR 5-5b; 20 CFR Parts 401 and 422E Use: The ESRD 
Death Notification (CMS-2746) is completed by all Medicare-approved 
ESRD facilities upon the death of an ESRD patient. Its primary purpose 
is to collect fact of death and cause of death of ESRD patients. 
Certain other identifying information (e.g., name, Medicare claim 
number, and date of birth) is required for matching purposes. Federal 
regulations require that the ESRD Networks examine the mortality rates 
of every Medicare-approved facility within its area of responsibility. 
The Death Form provides the necessary data to assist the ESRD Networks 
in making decisions that result in improved patient care and in cost-
effective distribution of ESRD resources. The data is used by the ESRD 
Networks to verify facility deaths and to monitor facility performance. 
Form Number: CMS-2746 (OMB: 0938-0448); Frequency: On 
occasion; Affected Public: Business or other for-profit, Not-for-profit 
institutions; Number of Respondents: 5,173; Total Annual Responses: 
82,768; Total Annual Hours: 41,384. (For policy questions regarding 
this collection contact Connie Cole at 410-786-0257. For all other 
issues call 410-786-1326.)
    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.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on July 19, 2010. 
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, E-mail: [email protected].

    Dated: June 15, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2010-14780 Filed 6-17-10; 8:45 am]
BILLING CODE 4120-01-P