[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Notices]
[Pages 54150-54151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21721]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10219, CMS-10317, CMS-10069, CMS-10068, CMS-
2728 and CMS-R-13]


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

AGENCY: Centers for Medicare and Medicaid Services, HHS.

    In compliance with the requirement of section 3506I(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: 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 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 group 
(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 
approval 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

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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: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Beneficiary Customer Service Feedback Survey; Use: The 
Centers for Medicare and 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.)
    5. 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.)
    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 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.)
    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 October 4, 2010.

OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, E-mail: [email protected].

    Dated: August 26, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2010-21721 Filed 9-2-10; 8:45 am]
BILLING CODE 4120-01-P