[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48645-48646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10241, CMS-382, CMS-10247, and CMS-10246]


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: New Collection.
    Title of Information Collection: Annual State Report and Annual 
State Performance Rankings.
    Use: The Deficit Reduction Act of 2005 (DRA) requires CMS to 
contract with a vendor to conduct a monthly national survey of retail 
prescription drug prices and to report the prices to the States. These 
national average prices will be used as a benchmark by the States for 
the management of their prescription drug programs. The law also 
requires that States report their drug utilization rates for 
noninnovator multiple source drugs, their payment rates under their 
State plan, and their dispensing fees. A template will be used to 
facilitate data collection. The States' rankings are to be presented to 
the Congress and the States.
    Form Number: CMS-10241 (OMB: 0938-NEW).
    Frequency: Reporting--Yearly.
    Affected Public: States, Local or Tribal Governments.
    Number of Respondents: 51.
    Total Annual Responses: 51.
    Total Annual Hours: 765.
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection.
    Title of Information Collection: ESRD Beneficiary Selection and 
Supporting Regulations Contained in 42 CFR 414.330.
    Use: Section 2145 amended section 1881 of the Social Security Act 
and changes the way the Medicare program pays for home dialysis 
services. Medicare patients who currently receive dialysis in a 
facility but later become home dialysis patients must complete the CMS-
382 form at the time they go to the home setting. Facilities are 
required to have all Medicare home dialysis patients choose one of two 
payment methods. Under Method I, the dialysis facility assumes 
responsibility for patient care and the facility provides all dialysis 
equipment and supplies needed to dialyze at home. The facility is 
required to order, store, deliver, and pay the manufacturers and 
suppliers for these items. Under Method II, the beneficiary makes his/
her own arrangement for securing the necessary supplies and dialysis 
equipment. Then, the supplier bills the Medicare program (Carrier) for 
payment.
    Form Number: CMS-382 (OMB: 0938-0372).
    Frequency: Reporting--Yearly.
    Affected Public: Individuals or households.
    Number of Respondents: 7400.
    Total Annual Responses: 7400.
    Total Annual Hours: 617.
    3. Type of Information Collection Request: New collection.
    Title of Information Collection: Sponsor application for CMS 
coverage under the Medicare Clinical Trial Research Policy.
    Use: The Centers for Medicare & Medicaid Services (CMS) has 
supported the participation of beneficiaries in clinical research 
through its Clinical Trial Policy implemented through the National 
coverage determination (NCD) process since 2000. Support for 
participation in clinical research studies is provided through the 
coverage of items and services that are considered usual patient care. 
Usual patient care encompasses all items and services covered by the 
program for any beneficiary, i.e., reasonable and necessary for the 
diagnosis or treatment of illness or injury to improve the functioning 
of a malformed body member.
    In accordance with the Clinical Trial Policy/Clinical Research 
Policy (CTP/CRP), CMS requires study sponsors/principal investigators 
to meet a set of standards to (1) Ensure that all sponsors and 
investigators conduct clinical research so that Medicare covered items 
and services are reasonable and necessary to obtain valid research 
outcomes and for treating research participants, and (2) maximize the 
health outcomes (and minimize risk) for Medicare beneficiaries.
    One of the standards states, ``The clinical research study is 
registered on the ClinicalTrials.gov Web site by the study sponsor/
principal investigator prior to the enrollment of the first study 
subject.'' In practice, we anticipate that study sponsors/principal 
investigators wishing to have their research study listed as certified 
on our Web site, and in the Federal Register will register the study on 
ClinicalTrials.gov and complete a form to CMS describing the scope and 
nature of the clinical research, discussing each of the standards in 
this policy, and certifying that all standards in this policy have been 
met. CMS will only review this form for completeness. We are seeking 
OMB approval for the form.
    Form Number: CMS-10247 (OMB: 0938-New).
    Frequency: Reporting--one-time.
    Affected Public: Private Sector--Business or other for-profits and 
not-for-profit institutions.
    Number of Respondents: 4,524.
    Total Annual Responses: 4,524.
    Total Annual Hours: 4,524.
    4. Type of Information Collection Request: New collection.
    Title of Information Collection: Cost and Resource Utilization 
(CRU) Data Collection for the Medicare Post Acute Care Payment Reform 
Demonstration.
    Use: The CRU data collection is part of the Post-Acute Care Payment 
Reform Demonstration mandated by Section 5008 of the Deficit Reduction 
Act of 2005. This demonstration is intended to address problems with 
the current Medicare payment systems for post-acute care services, 
including those for Long Term Care Hospitals, Inpatient Rehabilitation 
Facilities, Skilled Nursing Facilities, and Home Health Agencies. Each 
of these four types of providers currently has a separate prospective 
payment system (PPS) with its own case-mix groups, payment units, and 
rates. Each case-mix grouper uses a unique set of items to measure 
patients,

[[Page 48646]]

making it difficult to compare severity, costs, and outcomes across 
settings. These four provider types form a continuum of care where 
patients may overlap in terms of the conditions being treated, but they 
primarily differ in terms of the severity of the patients' medical or 
functional impairments. The current payment methods are designed as 
silos that do not recognize the potential overlap in case mix or the 
complimentary nature of the services across an episode, nor does it 
allow for standardized measures of costs across settings since each PPS 
was developed independently using different measurement systems and 
underlying assumptions.
    The Post-Acute Care Payment Reform Demonstration will examine the 
relative costliness and outcomes of post acute cases admitted to 
different settings for similar conditions. The work will differ from 
past attempts in this area because it will use a standardized case mix 
tool for measuring patient severity and a standardized resource data 
collection tool in all four post acute settings. Specifically, the 
legislation requires that CMS provide information on both the fixed and 
variables costs for each individual treated in post acute care 
settings.
    The CRU data collection instruments are designed to collect a 
provider's routine costs to specific patients because in general, 
nurses' and many other direct care providers' time spent on behalf of 
specific patients and on activities not patient-specific, is not 
reported. In addition, charges for therapist services reported on 
claims may not sufficiently measure true relative differences in 
therapy resource costs among patients. The data will be used, along 
with Medicare claims and cost report data, to examine substitution 
issues: How do costs and outcomes differ for post acute care patients 
with similar case mix acuity when treated in one of the various 
settings. The results will be used to provide CMS and Congress 
information on setting-neutral payment models, revisions to single 
setting payment systems, current discharge placement patterns, and 
patient outcomes across settings.
    Form Number: CMS-10246 (OMB: 0938-New).
    Frequency: Reporting and Recordkeeping.
    Affected Public: Private Sector--Business or other for-profits and 
not-for-profit institutions.
    Number of Respondents: 138.
    Total Annual Responses: 61,589.
    Total Annual Hours: 28,783.
    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 at the address below, 
no later than 5 p.m. on October 23, 2007.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of 
Regulations Development--B, Attention: William N. Parham, III, Room C4-
26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    Dated: August 17, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E7-16805 Filed 8-23-07; 8:45 am]
BILLING CODE 4120-01-P