[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34740-34742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14781]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10219, CMS-10317, CMS-10069, CMS-367, CMS-
10068, CMS-R-13 and CMS-2728]
Agency Information Collection Activities: Proposed Collection;
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) 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: Revision of a currently
approved collection; Title of Information Collection: Healthcare
Effectiveness Data and Information Set (HEDIS[supreg]) Data Collection
for Medicare Advantage; Use: Medicare Advantage Organizations (MAOs)
and section 1876 cost contracting managed care are required to submit
HEDIS[supreg] data to CMS on an annual basis. Sections 422.152 and
422.516 of Volume 42 of the Code of Federal Regulations (CFR) specify
that Medicare Advantage organizations must submit performance measures
as specified by the Secretary of the Department of Health and Human
Services and by CMS. These performance measures include HEDIS[supreg].
HEDIS[supreg] is a widely used set of health plan performance measures
utilized by both private and public health care purchasers to promote
accountability and to assess the quality of care provided by managed
care organizations. HEDIS[supreg] is designed for private and public
health care purchasers to promote accountability and to assess the
quality of care provided by managed care organizations. CMS is
committed to the implementation of health care quality assessment in
the Medicare Advantage program. In January 1997, CMS began requiring
Medicare managed care organizations (MCOs) (these organizations are now
called Medicare Advantage organizations or MAOs) to collect and report
performance measures from HEDIS[supreg] relevant to the Medicare
managed care beneficiary population.
The data are used by CMS staff to monitor MAO performance and
inform audit strategies, and inform beneficiary choice through their
display in CMS' consumer-oriented public compare tools and Web sites.
Medicare Advantage organizations use the data for quality
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assessment and as part of their quality improvement programs and
activities. Quality Improvement Organizations (QIOs) and CMS
contractors use HEDIS[supreg] data in conjunction with their statutory
authority to improve quality of care, and consumers who are making
informed health care choices. Form Number: CMS-10219 (OMB:
0938-1028); Frequency: Yearly; Affected Public: Business or other for-
profits and not-for-profit institutions; Number of Respondents: 483;
Total Annual Responses: 483; Total Annual Hours: 154,560. (For policy
questions regarding this collection contact Lori Teichman at 410-786-
6684. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: New collection; Title of
Information Collection: The Medicare Acute Care Episode Demonstration;
Use: Medicare's Acute Care Episode (ACE) Demonstration is authorized
under Section 646 of the MMA (Pub. L. 108-173) that amends title XVIII
(42 U.S.C. 1395) of the Social Security Act. The ACE Demonstration
stems from a longstanding need for improved quality of care and
decreased costs.
As costs have risen over time, ideas to improve Medicare payment
systems and efficiency have been developed. Moving from a cost based
payment arrangement to a hospital prospective payment system has
dramatically simplified billing and coding procedures and generated
important impacts on Medicare savings and quality of care measures.
While prospective hospital payments based on diagnosis related groups
(DRGs) for acute care was the innovation of the 1980s, the Federal
government has taken interest in value-based purchasing (VBP) in recent
years. The VBP strategy rests on linking hospital performance to
financial incentives. VBP has been heralded as a method to increase
efficiency and quality of care while decreasing cost. In addition to
its use as a payment system, the VBP strategy allows for performance
scoring of hospitals based on the designated VBP quality measures.
In the case of the ACE Demonstration, the test has been designed to
address the use of a global payment for an episode of care as an
alternative approach to payment under traditional Medicare. The episode
of care is defined as the bundle of Part A and Part B services provided
during an inpatient stay for Medicare FFS beneficiaries for included
Medicare severity-based diagnosis-related groups (MS-DRGs). The ACE
Demonstration is limited to health care groups (i.e., physician-
hospital organizations--PHOs) with at least one physician group and at
least one hospital and that routinely provide care for at least one
group of selected orthopedic or cardiac procedures:
Hip/knee replacement or revision surgery; and/or
Coronary artery bypass graft (CABG) surgery or cardiac
intervention procedure (pace-maker and stent placement).
Evaluation of ACE will reveal whether the use of a bundled payment
system will produce savings for Medicare for episodes of care involving
the included DRGs. In addition to cost savings, the evaluation will
assess changes to quality of care at the demonstration sites; whether
or not the payment system creates better collaboration between
physicians and facilities leading to higher quality patient care. Form
Number: CMS-10317 (OMB: 0938-New); Frequency: Occasionally;
Affected Public: Individuals or households; Number of Respondents: 509;
Total Annual Responses: 509; Total Annual Hours: 763.5. (For policy
questions regarding this collection contact Jesse Levy at 410-786-6600.
For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Waiver
Demonstration Application; Use: The currently approved application has
been used for several congressionally mandated and Administration high
priority demonstrations. The standardized proposal format is not
controversial and will reduce burden on applicants and reviewers.
Responses are strictly voluntary. The standard format will enable CMS
to select proposals that meet CMS objectives and show the best
potential for success. Form Number: CMS-10069 (OMB: 0938-
0880); Frequency: Once; Affected Public: Private Sector: Business or
other for-profits and Not-for-profit institutions; Number of
Respondents: 75; Total Annual Responses: 75; Total Annual Hours: 6,000.
(For policy questions regarding this collection contact Diane Ross at
410-786-1169. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug
Program Monthly and Quarterly Drug Reporting Format; Use: In order for
payment to be made under Medicaid, the drug labeler must complete and
sign a drug rebate agreement and fill in the information on the related
documents. The Patient Protection and Affordable Care Act of 2010 added
two new data elements to potentially be reported by manufacturers. In
addition, the Food and Drug Administration has informed us that
``DESI'' is now obsolete; therefore, we are replacing it with a more
appropriate ``rebate eligibility code'' that will more accurately
describe how a product is eligible for coverage under the drug rebate
program. Form Number: CMS-367 (OMB: 0938-0578); Frequency:
Monthly and Quarterly; Affected Public: Private Sector: Business or
other for-profits; Number of Respondents: 580; Total Annual Responses:
9,280; Total Annual Hours: 137,344. (For policy questions regarding
this collection contact Samone Angel at 410-786-1123. For all other
issues call 410-786-1326.)
5. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Beneficiary Customer Service Feedback Survey; Use: The
Centers for Medicare & Medicaid Services (CMS) stresses a continuing
need for setting customer service goals that include providing
accurate, timely, and relevant information to its customers. With these
goals in mind, the Division of Medicare Ombudsman Assistance (DMOA)
needs to periodically survey its customers that correspond with CMS to
ensure that the needs of Medicare beneficiaries are being met. This
survey will be used to measure overall satisfaction of the customer
service that the DMOA provides to Medicare beneficiaries and their
representatives. The need for this previously OMB approved information
collection is to further meet the customer service goals that the CMS
has established and to continue to create a rapport within the Medicare
community. Form Number: CMS-10068 (OMB: 0938-0894); Frequency:
Quarterly; Affected Public: Individuals and Households; Number of
Respondents: 2,242; Total Annual Responses: 2,242; Total Annual Hours:
224. (For policy questions regarding this collection contact Nancy Conn
at 410-786-8374. For all other issues call 410-786-1326.)
6. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Conditions of Coverage for Organ Procurement Organizations
and Supporting Regulations in 42 CFR, Sections 486.301-.348; Use:
Section 1138(b) of the Social Security Act, as added by section 9318 of
the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509), sets
forth the statutory qualifications and requirements that OPOs must meet
in order for the costs of their services in procuring organs for
transplant centers to be reimbursable
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under the Medicare and Medicaid programs. An OPO must be certified and
designated by the Secretary as an OPO and must meet performance-related
standards prescribed by the Secretary. The corresponding regulations
are found at 42 CFR Part 486 (Conditions for Coverage of Specialized
Services Furnished by Suppliers) under subpart G (Requirements for
Certification and Designation and Conditions for Coverage: Organ
Procurement Organizations).
Since each OPO has a monopoly on organ procurement within its
donation service area, CMS must hold OPOs to high standards. Collection
of this information is necessary for CMS to assess the effectiveness of
each OPO and determine whether it should continue to be certified as an
OPO and designated for a particular donation service area by the
Secretary or replaced by an OPO that can more effectively procure
organs within the donation service area. Form Number: CMS-R-13
(OMB: 0938-0688); Frequency: Occasionally; Affected Public:
Not-for-profit institutions; Number of Respondents: 79; Total Annual
Responses: 79; Total Annual Hours: 15,178. (For policy questions
regarding this collection contact Diane Corning at 410-786-8486. For
all other issues call 410-786-1326.)
7. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: End Stage Renal
Disease Medical Evidence Report Medicare Entitlement and/or Patient
Registration; Use: The End Stage Renal Disease (ESRD) Medical Evidence
Report is completed for all ESRD patients either by the first treatment
facility or by a Medicare-approved ESRD facility when it is determined
by a physician that the patient's condition has reached that stage of
renal impairment that a regular course of kidney dialysis or a kidney
transplant is necessary to maintain life. The data reported on the CMS-
2728 is used by the Federal Government, ESRD Networks, treatment
facilities, researchers and others to monitor and assess the quality
and type of care provided to end stage renal disease beneficiaries. The
data collection captures the specific medical information required to
determine the Medicare medical eligibility of End Stage Renal Disease
claimants. Form Number: CMS-2728 (OMB: 0938-0046); Frequency:
Occasionally; Affected Public: Individuals or households; Number of
Respondents: 100,000; Total Annual Responses: 100,000; Total Annual
Hours: 75,000. (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 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.
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 August 17, 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: June 15, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2010-14781 Filed 6-17-10; 8:45 am]
BILLING CODE 4120-01-P