[Federal Register: August 24, 2007 (Volume 72, Number 164)]
[Notices]
[Page 48645-48646]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au07-71]
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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 Paperwork@cms.hhs.gov, 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