[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

[[Page 34741]]

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

[[Page 34742]]

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