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Notice

Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Contracts (9th Scope of Work)

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Information about this document as published in the Federal Register.

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AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Notice with comment period.

SUMMARY:

This notice with comment period describes the general criteria we intend to use to evaluate the efficiency and effectiveness of the Quality Improvement Organizations (QIOs) who will enter into contract with CMS under the 9th SOW on August 1, 2008. The evaluation of the QIOs' performance related to their Statement of Work (SOW) will be based on evaluation criteria specified within the themes, tasks, and subtasks set forth in the QIO's 9th SOW.

DATES:

Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 20, 2008.

ADDRESSES:

In commenting, please refer to file code CMS-3189-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.regulations.gov. Follow the instructions for “Comment or Submission” and enter the filecode to find the document accepting comments.

2. By regular mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3189-NC, P.O. Box 8016, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3189-NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses.

a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

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FOR FURTHER INFORMATION CONTACT:

Cynthia Pamon (410) 786-9167.

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SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

I. Background

Section 1153(h)(2) of the Act requires the Secretary to publish in the Federal Register the general criteria and standards that will be used to evaluate the efficient and effective performance of contract obligations by QIOs and to provide the opportunity for public comment with respect to such criteria and standards. This notice describes the general criteria that will be used to evaluate QIO performance under the 9th SOW contract beginning in August 2008.

II. Themes, Tasks, Subtasks Description

Under the 9th SOW, QIOs are responsible for completing the requirements for the following themes: Beneficiary Protection, Patient Safety, Prevention and Care Transitions. (Detailed information for each theme may be found in Sections C.6. and C.7. Theme Requirements of the 9th SOW posted at the www.fedbizopps.gov Web site. On the home page of the Web site, type “QIO” into “Quick Search” and click on “GO” to view the RFP under solicitation numbers “9thSOWInStateQIOs-NAHC” and “CMS-2007-QIO9thSOW-NAHC”).

Beneficiary Protection (See Section C.6.1. of the 9th Statement of Work)

Beneficiary Protection activities will emphasize statutory and regulatory Start Printed Page 42353mandated review activity and quality improvement. Primary case review categories include utilization review, quality of care review, review of beneficiary appeals of certain provider notices, and reviews of potential anti-dumping cases. Quality of care review includes the review of beneficiary complaints. In conducting reviews of beneficiary complaints, the QIO shall utilize a number of tools intended to address the beneficiary's concerns, including implementation of quality improvement activities (QIAs), surveying of beneficiary satisfaction with the complaint process, and, if appropriate, alternative dispute resolution mechanisms. The Tasks under this theme will focus on conducting activities to meet, in an efficient and effective manner, regulatory and statutory requirements, to enhance QIO collaboration with the Beneficiary Complaint Survey Contractor, Fiscal Intermediaries (FIs), Carriers, Medicare Administrative Contractors (MACs), State Survey Agencies (SSAs), the Office of Inspector General (OIG), and the Medicare Office of Hearings and Appeals and to clearly establish the link between case review and quality improvement through data analysis and improvement assistance.

Patient Safety (See Section C.6.2. of the 9th Statement of Work)

QIO activities under the Patient Safety Theme will focus on six components: Improving inpatient surgical safety and heart failure (SCIP/HF), reducing rates of pressure ulcers (PrU-Nursing Homes and Hospitals), reducing rates of and use of physical restraints (PR), improving drug safety, reducing rates of healthcare associated Methicillin-resistant Staphylococcus aureus (MRSA) infections and activities aimed at nursing homes in need (NHIN). The requirements of the Patient Safety Theme are designed to address areas of patient harm for which there is evidence of how to improve safety by improving health care processes and systems.

Prevention (See Section C.6.3. of the 9th Statement of Work)

The Prevention Theme contains two cancer screening tasks (breast cancer and colorectal cancer (CRC)), two immunization tasks (influenza and pneumococcal) and Tasks on disparities related to diabetes self-management and chronic kidney disease (CKD) prevention.

Sub-National Theme Requirements

Prevention: Disparities (Directed Sub-National Task, See Section C.7.1. of the 9th Statement of Work)

Under this Theme, the QIO will work with practice sites and other organizations in its state/jurisdiction to improve diabetes measures within underserved populations. QIO Disparities work includes tasks related to Diabetes Self-Management Education. Diabetes Self-Management Education (DSME) is an approach that has been demonstrated to be effective in improving diabetes clinical outcomes and other related health dimensions. DSME is an intervention in itself for diabetes behavior and outcomes improvement. The QIO will facilitate training of appropriate personnel at organizational sites using evidence-based CMS-approved DSME programs within the underserved population of the qualified physician practices. The QIO will establish a partnership with the primary care physician, certified diabetes educators and community health workers to facilitate the accessibility of DSME services to patients. This task is directed and will be limited to a sub-set of States with sufficient underserved Medicare diabetes populations, as determined by CMS. See section C.7.1 of the 9th SOW for the list of the 33 states eligible for this task.

Care Transitions (Optional Sub-National Theme, See Section C.7.2. of the 9th Statement of Work)

The QIO work under the Care Transitions Theme aims to measurably improve the quality of care for Medicare beneficiaries who transition among care settings through a comprehensive community effort. These efforts aim to reduce readmissions following hospitalizations and to yield sustainable and replicable strategies to achieve high-value health care for sick and disabled Medicare beneficiaries.

Prevention: Chronic Kidney Disease (Optional Sub-National Task, See Section C.7.3 of the 9th Statement of Work)

The goal of this Task is to detect the incidence and decrease the progression of chronic kidney disease (CKD) and improve care among Medicare beneficiaries through provider adoption of timely and effective quality of care interventions; participation in quality incentive initiatives; beneficiary education; and key linkages and collaborations for system change at the state and local level.

In addition to improving the quality of care for the elderly and frail-elderly, this Task aims to reduce the rate of Medicare entitlement by disability through the delay and prevention of ESRD.

The focus areas for quality improvement in CKD include: Timely testing to detect the rate of kidney failure due to diabetes; slowing the progression of disease in individuals with diabetes through the use of ACE (angiotensin converting enzyme) inhibitors and/or an angiotensin receptor blocking (ARB) agent; and arteriovenous fistula (AV fistula) placement and maturation (as a first choice for arteriovenous access where medically appropriate) for individuals who elect, as a part of timely renal replacement therapy counseling, hemodialysis as their treatment option for kidney failure.

III. Measuring QIO Performance

Overall Contract Evaluation (See Section C.5 of the 9th SOW posted at www.fedbizops.gov for more detailed overall contract evaluation criteria. On the www.fedbizopps.gov home page, type “QIO” into “Quick Search” and click on “GO” to view the RFP under solicitation numbers “9thSOWInStateQIOs-NAHC” and “CMS-2007-QIO9thSOW-NAHC”).

Under the 9th SOW, the QIO's performance in undertaking activities to carry out the requirements of each of the Themes (Beneficiary Protection, Care Transitions, Patient Safety and Prevention) and components within those Themes will be used to determine the QIO's success or failure in meeting the overall evaluation criteria as specified below. The QIO shall be evaluated on the Themes and components under the Themes required under the contract. If a QIO is not tasked to work on a Theme or a specific component under the Theme, the QIO will not be evaluated under that particular Theme or component. Any Special Project (SP) that the QIO may carry out will be evaluated separately and will not be considered in the overall evaluation criteria.

There will be two periods of evaluation under the 9th SOW. The first evaluation will focus on the QIO's work in three Theme areas (Care Transitions, Patient Safety, and Prevention) and will occur at the end of 18 months using the most recent data available to CMS. The second evaluation will examine the QIO's performance on Tasks within all Theme areas (Beneficiary Protection, Care Transitions, Patient Safety, and Prevention). The second evaluation will take place at the end of the 28th month Start Printed Page 42354of the contract term and will be based on the most recent data available to CMS. The performance results of the evaluation at both time periods (that is, at 18 months and at 28 months) will be used to determine the performance on the overall contract.

The first contract evaluation will determine if the QIO has met the performance criteria in the Theme areas of Care Transitions, Patient Safety, and Prevention and in the components within those Themes. The Themes or components within the Theme as appropriate will be evaluated on an individual basis with the determination relative to only that area.

The second contract evaluation will determine if the QIO has met the performance criteria in all Theme areas of Beneficiary Protection, Care Transitions, Patient Safety and Prevention, and in the components within those Themes. The performance on the Beneficiary Protection Theme will cover the 28-month contract period.

The results of the first and second evaluations at the end of the 18 and 28 month periods will be used to determine how the contractor performed on the overall contract in total.

18-Month Evaluation Criteria (by Theme or component of the Theme excluding Beneficiary Protection)

  • Pass = Criteria met and CMS may elect the option to continue the work (and funding) of the Theme or component of the Theme where appropriate.
  • Fail = Criteria not met and we may, among other remedies, elect NOT to continue the work (or funding) for the Theme or component of the Theme where appropriate for the contract duration.

28-Month Evaluation Criteria (by Theme or component of the Theme including Beneficiary Protection for the 28-month contract period)

  • Pass = Criteria met for Theme or component of the Theme where appropriate.
  • Fail = Criteria not met for Theme or component of the Theme where appropriate.

Overall Contract Performance

  • Pass = Pass on all Themes and components within the Theme at both evaluation periods.
  • Fail = Fail any Theme or component within the Theme in either evaluation period.

If CMS chooses, we may notify the QIO of the intention not to renew the QIO contract, and inform the QIO of the QIO's rights under the then current statute.

The specific evaluation criteria are described below for each Theme or component within a Theme as appropriate. In general, for areas of work that have been performed under the 8th SOW or other recent QIO SOW where historical data is available for analysis, the acceptable performance expectation is a specific target or tighter target range than for areas of work that have not been in previous SOWs and where the experience under a previous SOW demonstrated that there was a range for acceptable performance. For the purpose of determining scores for all Themes, components within a Theme, or measures within a Theme, all percentages will be rounded to two places (with the value at or above five in the thousands position (for example, .005, .015, etc. rounded up).

Beneficiary Protection

  • Pass = 90% of Target
  • Fail = <90%

Patient Safety: Surgical Care Improvement Project/Heart Failure (SCIP/HF), Pressure Ulcers and Physical Restraints

  • Pass = 70-100% of Target
  • Fail = <70%

Patient Safety: Methicillin Resistant Staphylococcus Aureus (MRSA)

  • Pass = 70-100% of Target
  • Fail = <70%

Patient Safety: Drug Safety, Nursing Homes In Need (NHIN)

  • Pass = 70-100% of Target
  • Fail = <70%

Prevention: Cancer Screening, Mammograms, and Immunizations

  • Pass = 100% of Target
  • Fail = <100%

Prevention: Disparities

  • Pass = 80% of Target
  • Fail = <80%

Care Transitions

  • Pass = 100%-80% of Target
  • Fail = <80%

Prevention: Chronic Kidney Disease (CKD)

  • Pass = 100%-80% of Target
  • Fail = <80%

The list of measures and performance criteria for each QIO will be recorded on the CMS Dashboard, which will be available on QIOnet (http://qionet.sdps.org), the standard information system that supports the QIO Program. We will also post these measures on our publicly accessible Web site (http://www.cms.gov).

We will monitor the QIO's performance on Themes, components within the Themes and measures within Themes against established criteria on a quarterly basis, and may take appropriate contract action (for example, providing warning for the need for adjustment, instituting a formal correction plan, terminating an activity, or recommending early termination of a contract because of failure to meet contract timelines).

CMS reserves the right at any point prior to the notification of our intention not to continue the option for a Theme and/or to renew the contract to adjust the expected minimum thresholds for satisfactory performance or remove criteria from a Theme or Theme component evaluation protocol for any reason, including, but not limited to, data gathered based on experience with the amount of improvement achieved during the contract cycle or in pilot projects currently in progress, information gathered through evaluation of the QIO Program overall, or any unforeseen circumstances. Further, in accordance with standard contract procedures, we reserve the right at any time to discontinue a Theme or a component of a Theme regardless of QIO performance on the Theme or component of the Theme.

IV. Standards for Minimum Contract Performance Within a Theme

Beneficiary Protection Contract Evaluation (See Sections C.5 and C.6.1. of the 9th SOW)

CMS will evaluate, on a quarterly basis, achievement of minimum performance thresholds on timeliness of review activities, beneficiary satisfaction with the complaint process, beneficiary satisfaction generally and quality improvement activities. Additionally, CMS will evaluate system-wide change improvement activities and PPS inpatient hospital data reporting.

Patient Safety (See Sections C.5 and C.6.2. of the 9th SOW)

CMS will evaluate achievement of minimum performance thresholds on specific clinical measures at the 18th and 28th month evaluation periods. CMS will evaluate improvements in the SCIP (surgical care improvement program) measures, MRSA (methicillin Resistant Staphylococcus Aureus) hospital measures, PrU (pressure ulcers) in hospitals and nursing homes and PR (physical restraints) in nursing homes, and prescription drug safety measures.Start Printed Page 42355

CMS will also evaluate work and improvement with a small number of poorly performing nursing homes. CMS will evaluate the nursing homes' perception of the effectiveness of QIO technical assistance and on improvement in the quality measures.

Prevention (See Sections C.5 and C.6.3. of the 9th SOW)

CMS will evaluate achievement of minimum performance thresholds on specific clinical measures at the 18th and 28th month evaluation periods. CMS will evaluate the work with a selected group of participating practices (PPs) in its state/jurisdiction with already implemented electronic health records (EHRs) to assess improvements in breast cancer and CRC screening rates and to improvements in immunization rates for influenza and pneumococcal pneumonia among Medicare beneficiaries.

Sub-National Theme Requirements Prevention: Disparities (Directed Sub-National Task, See Sections C.5 and C.7.1. of the 9th SOW

CMS will evaluate achievement of minimum performance thresholds on specific measures on a quarterly basis and at the 18th and 28th month evaluation periods. CMS will evaluate recruitment of targeted providers and enrollment of targeted patients. CMS will also evaluate improvements in the rates for hemoglobin A1c testing, eye exams, lipid testing and blood pressure control for diabetic patients.

Care Transitions, (Optional Sub-National Theme, See Sections C.5 and C.7.2. of the 9th SOW)

CMS will evaluate achievement of minimum performance thresholds on specific clinical measures at the 18th and 28th month evaluation periods. CMS will evaluate patient care transitions that are: attributable to participating providers; related to implementation of interventions that address hospital/community system-wide processes; the potential subject of an implemented intervention that addresses acute myocardial infarction, congestive heart failure, and pneumonia; the potential subject of an implemented intervention that addresses specific reasons for readmission. CMS will also evaluate the percentage of implemented interventions that are measured and the percentage of patient care transitions to which implemented and measured interventions apply and show improvement. CMS will also evaluate patient satisfaction and patient readmission rates.

Prevention: Chronic Kidney Disease (Optional Sub-National Task, See Sections C.5 and C.7.3 of the 9th SOW)

CMS will evaluate achievement of minimum performance thresholds on all clinical outcome measures at the 18th and 28th month evaluation periods. CMS will evaluate timely testing to reduce the rate of kidney failure due to diabetes, improvement in the use of ACE inhibitor and/or ARB agent, and improvement in the rate of AV fistula placement.

V. Response to Comments

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program.

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Dated: April 25, 2008.

Kerry Weems,

Acting Administrator, Centers for Medicare & Medicaid Services.

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[FR Doc. E8-16757 Filed 7-18-08; 8:45 am]

BILLING CODE 4120-01-P