J.3-B_ESRD_Statement_of_Work.docx

J.3-A ESRD Quality Measure Development and Maintenance Support

RFP-CMS-MIDS-2013-0001

Measure & Instrument Development and Support (MIDS) Contractor

Task Order (TO) Statement of Work (SOW)

End Stage Renal Disease (ESRD) Quality Measure Development, Maintenance, and Support

A. Statement of Work (SOW)

CHAPTER 1. SCOPE

1.A. - Background The Social Security Act of 1972 (P.L. 92-603) extended Medicare coverage to patients with End Stage Renal Disease (ESRD) who require dialysis or kidney transplantation to survive. As of December 31, 2003, there were 310,095 patients receiving dialysis treatment in the United States. The incidence of treated ESRD patients in the United States is 333 per million population and continues to rise at a rate of almost 8 percent per year, while hospitalization costs related to patients with ESRD account for approximately 40% of the cost to Medicare for health care for this patient population.

The Centers for Medicare & Medicaid Services (CMS) initiated the ESRD Core Indicators Project in 1994. The Project began collecting clinical data on this patient population and reported improvement in the national percent of adult in-center hemodialysis (HD) patients receiving adequate dialysis as 43% (late 1993) and 72% (late 1997).

In 1997, Congress passed the Balanced Budget Act (BBA). Section 4558(b) of the BBA, Renal Dialysis Related Services, Implementation of Quality Standards, directed the Secretary of Health and Human Services to develop, by not later than January 1, 1999, and implement, by not later than January 1, 2000, a method to measure and report quality of renal dialysis services provided under the Medicare program under title XVIII of the Social Security Act. CMS was assigned the responsibility for the implementation of this section of the BBA.

To meet this BBA requirement, CMS funded the development of ESRD Clinical Performance Measures (CPMs) based on the NKF-Dialysis Outcomes Quality Initiative (NKF-DOQI or DOQI) clinical practice guidelines. Information on the development of the ESRD CPMs can be found at http://www.cms.hhs.gov/esrd/1.asp. Also in 1999, in response to the BBA of 1997, CMS funded the development of dialysis facility-specific measures that could be released in reports to the public for their use in making dialysis treatment choices. In January 2001, the DFC tool was launched on www.medicare.gov, providing information on nine facility characteristics and three quality measures on over 4,500 dialysis facilities in the United States.

Additionally, in 2008, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) was enacted. Section 153 (c) of this law requires the development and implementation of bundled payment for ESRD services by January 1, 2011 and a quality incentive program by January 1, 2012. The quality incentive program will decrease the payment to a provider by an amount up to 2% for failure to achieve a set performance standard for designated measures of quality which are currently publicly reported on Dialysis Facility Compare found at www.medicare.gov/Dialysis/Home.asp. Subsequent years will incorporate additional measures of quality as data becomes available through instruments such as CROWNWeb (Consolidated Renal Operations in a Web Enabled Network).

On January 16, 2009, the Department of Health and Human Services released the HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards to Adopt ICD-10-CM and ICD-10-PCS Final Rule (CMS-0013-F). Currently, the compliance date for implementation of the ICD-10-CM/PCS Coding System is October 1, 2014 for all covered entities. The statute, regulation and additional details of ICD-10 implementation can be found at http://www.cms.gov/Medicare/Coding/ICD10/Statute_Regulations.html. The measures currently used and proposed under the ESRDTO will need evaluation and possible modification to capture the impact of the change to ICD-10.

1.B - Purpose The purpose of this MIDS TO SOW (Measure and Instrument Development and Support Task Order Statement of Work) is to obtain the services for ongoing support to ESRD quality measure development, calculation and public reporting of quality measures, as well as providing measure development and maintenance support for the objectives established in section 153(c) off MIPPA.

This TO SOW adheres to all tasks within the MIDS USOW (Umbrella Statement of Work) Chapters. Those activities not specifically described in theMIDS USOW shall be specified in this TO SOW. Those activities/tasks within the MIDS USOW that are excluded and not required for this TO SOW shall be noted within this TO SOW.

CHAPTER 2. GENERAL REQUIREMENTS

In accordance with (IAW) Chapter 2 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 2.A. – 2.G. The Contractor’s efforts will support the development, maintenance, and implementation of new quality measures, as well as existing quality measures in support of the Dialysis Facility Compare (DFC) website, the Quality Incentive Program (QIP), and, on an ad hoc basis, other projects related to ESRD quality of care.

Additional Requirements/More Specific Description:

IAW section 2.B., Fundamental Activities: The Contractor shall advise and support the implementation of data elements in data collection tools such as CROWNWeb as directed by the CMS GTL. CROWNWeb is a data collection tool owned and supported by CMS that collects data elements unobtainable through other means, such as claims. Such work includes, but is not limited to, assisting with the development of business requirements to ensure appropriate data collection.

IAW section 2.C., Coordination: The Contractor shall coordinate with CMS and other contractors to support public reporting of ESRD measures on the DFC website, the QIP, and the production of Dialysis Facility Reports (DFR) as directed by the CMS GTL. Such coordination shall include but not be limited to advising on appropriate methods of displaying, reporting, and describing quality measures developed and maintained by the project.

In addition, CMS makes available the Measures Management System, which provides the critical processes and decision criteria necessary to support the development, maintenance, and implementation of the ESRD quality measures related to this project. The Contractor shall coordinate with the Measures Management Contractor to ensure all development activities adhere to the requirements of the Measures Management System Blueprint.

IAW section 2.G., Ad Hoc Requests from CMS: The Contractor shall provide up to 2 ad hoc analyses per month as directed by the CMS GTL. Such analyses shall be completed within 60 days following the CMS request or on a date agreed upon by the GTL. Such analyses include but are not limited to sensitivity analyses, analyses responding to stakeholder feedback, and supplementary monitoring of data.

CHAPTER 3. INFORMATION GATHERING

In accordance with (IAW) Chapter 3 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 3.A. – 3.E.

Additional Requirements/More Specific Description:

The Contractor shall conduct and document an environmental scan for the purpose of refining existing and/or developing new quality measures to reflect the quality of the care provided to ESRD patients by dialysis facilities and providers. In addition to directly supporting the measures currently on DFC and those measures which have been adopted for the ESRD QIP , the MIDS Contractor shall expand the environmental scan to:

3.1 Identify and propose potential new quality measures that address domains or aspects of ESRD care in areas of interest that include, but are not limited to:

· Mineral Metabolism

· Serum Ferritin

· Transferrin Saturation

· Calcium

· Phosphorus

· Parathyroid Hormone

· Hospitalization

· Access Pediatric Measures –

· Anemia management

· Adequacy of dialysis

· Vascular Access Type

· Cross-cutting Measures –

· Functional status

· Healthcare-acquired conditions

· Immunization

· Quality of Life

· Patient-Centered Measures

· Utilization

· Cost measures

CHAPTER 4. QUALITY MEASURE DEVELOPMENT & REEVALUATION

In accordance with (IAW) Chapter 4 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 4.A. – 4.C.

Additional Requirements/More Specific Description:

IAW Chapter 4.A, Quality Measure Development and Reevaluation: The Contractor shall develop and refine quality measures under this TO SOW which are framed and constructed in a “positive” sense. For example, “Percent of ESRD patients not achieving a clearance (Kt/V) <1.2” (Lower value equals better quality), shall be constructed as “Percent of ESRD patients achieving adequate dialysis as indicated by a Kt/V >1.2” (Higher value equals better quality). Kt/V is a number used to quantify hemodialysis and peritoneal dialysis treatment adequacy when K equals the dialyzer clearance of urea; t equals dialysis time; and v equals volume of distribution of urea.

Additionally, new or revised measures should measure intermediate outcomes rather than processes to the extent feasible. The Contractor shall evaluate and modify all measures currently used or proposed under this Task Order to capture the impact of the planned transition to ICD-10 (see prior details provided in 1.A. Background).

IAW with Chapter 4.A of the MIDS USOW, the Contractor shall consider the results of the Environmental Scan conducted in Task 3 and shall:

· Propose quality measure specification revisions to the current measures on DFC and maintain forms for quality measures supporting the DFC, QIP, and other ESRD-associated programs as outlined by the CMS Measures Manager System (MMS) as directed by CMS.

· Propose new quality measures to expand the level of public reporting on DFC and for possible inclusion in the ESRD QIP.

· Maintain specified templates, data sources, data analytic methodologies, etc necessary to produce data files for facility previews and public reporting on DFC.

· Develop and maintain National Quality Forum (NQF) submission documentation and provide measure support through the NQF process.

IAW Sections 4.A.1 and 4.B.4, the Contractor shall convene up to three Technical Expert Panels (TEP) to support develop measures in specific areas of interest to be agreed upon by the CMS GTL. The Contractor shall organize one in-person conference meeting for each TEP and supporting conference calls in preparation for, and subsequent to the in-person conference as agreed upon by the CMS GTL.

CHAPTER 5. INSTRUMENT/ITEM DEVELOPMENT

In accordance with (IAW) Chapter 5 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 5.A - 5.D. as directed by CMS GTL.

Additional Requirements/More Specific Description:

IAW with Chapter 5.A through 5.C of the MIDS USOW, the Contractor shall propose new data collection vehicles or revisions to existing data collection vehicles required to collect the data elements necessary to calculate measures specified in Chapter 3. The Contractor shall make available updated data and business requirements as appropriate to support measures specified in Chapter 3. These data sources include, but are not limited to, ESRD patient-level or dialysis-facility level CMS administrative or other data, CROWN data, CMS CROWNWeb data, CPM data, ESRD Network Standard Information System Management (SIMS) data, ESRD claims data, National Healthcare Safety Network (NHSN) data, and so on.

CHAPTER 6. TESTING/VALIDATION

In accordance with (IAW) Chapter 6 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 6.A. – 6.D as directed by CMS GTL.

IAW Chapter 6, the Contractor shall support measure recommendations and implementations with empirical data analysis where appropriate and feasible. In addition to those analyses necessary to demonstrate the reliability and validity of the measures specified in Chapter 3, such analyses shall be incorporated in the Measure Testing Summary report where appropriate.

CHAPTER 7. REPORTS/APPROVAL PACKAGES

In accordance with (IAW) Chapter 7 of the MIDS USOW, the contractor shall carry out all work/tasks described in sections 7.A. – 7.G, 7.I. Work/tasks required in section 7.H. are not required for this TO SOW.

CHAPTER 8. IMPLEMENTATION, PRODUCTION & ASSESSMENT

In accordance with (IAW) Chapter 8 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 8.A. – 8.E. as directed by CMS GTL.

Additional Requirements/More Specific Description:

The Contractor shall provide technical support to CMS in responding to public comments and/or questions related to quality measures implemented in the QIP, including coordination with CMS components and contractors.

IAW Section 8.A.1 of the MIDS USOW, the Contractor shall support CMS in responding to comments received during the Notice of Proposed Rule Making (NPRM) comment period that are relevant to the measures specified in Chapter 3. The Contractor shall draft responses to such comments

IAW section 8.A.4. of the MIDS USOW, the Contractor shall conduct a dry run of the 30-day ESRD readmission measure during the base year of the contract in a manner consistent with the MMS Blueprint, and shall submit a report to CMS assessing the results of the dry run.

IAW Section 8.B of the MIDS USOW, the Contractor shall:

· Implement the data collection changes developed and specified in Chapter 3.

· Calculate the quality measures developed/revised in Chapter 3 in support of quality reporting for DFC as directed by the CMS GTL.

9. PUBLIC REPORTING/COMPARE SITES

In accordance with (IAW) Chapter 9 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 9.A. – 9.I in support of public reporting for the DFC website.

IAW section 9.C., Provider Preview: The Contractor shall provide for and manage a preview and comment period for the dialysis facilities to:

· Review, ask questions, and provide comments about their DFC calculated quality measure results prior to public reporting the results

· To support the preview period, the MIDS Contractor shall:

a. Provide an internet site/web-based mechanism (or other means as approved by CMS) for the dialysis facilities to submit comments on their updated DFC quality measures. The preview period for DFC (typically two weeks to 30 days) shall be activated no later than 2 months prior to each scheduled quarterly DFC update as directed by the CMS GTL. The Contractor shall:

b. Provide support to questions submitted by adhering to the following process:

b.1: Set up an electronic mailbox so that questions received are forwarded to the Contractor.

b.2: Acknowledge the receipt of all questions to submitters within five (5) business-days of Contractor-receipt.

b.3: Log all questions into a question-tracking tool that provides a unique identifier to each submitted question. The Contractor shall provide this log to CMS. The log must be searchable by facility, facility chain (defined as separate facilities with a single corporate owner), and question type.

b.4: The Contractor shall research each question and provide a synopsis of the underlying issues associated with each question.

b.5: The Contractor shall propose a response for each question.

b.6: The Contractor shall triage questions (by nature) whereby:

b.6.a: For questions whose answers are already apparent in publicly available ESRD Quality Measure information published by CMS, responses shall be provided to the submitters with direction to the authoritative publication, section and specific reference, or b.6.b: All others questions are directed to the appropriate subject matter expert or ESRD Network or State Survey Agency within the submitter’s state.

b.7: The Contractor shall forward all questions and proposed responses to CMS.

b.8: Based upon feedback from CMS, the Contractor shall prepare a final-draft response for approval.

b.9: Once CMS-approval is received, the Contractor shall provide the response to the submitter within five (5) business-days.

b.10: The Contractor shall maintain a catalogue of questions and answers (Entitled “ESRD Quality Measure Q & A Database”) to include:

b.10.i: Date of Draft-Response Receipt (From CMS)

b.11: The Contractor shall provide reports of all submitted questions to CMS on a weekly-basis during and 30 days following the preview period and on a quarterly basis (or monthly-basis, based on volume and complexity) outside of this period. The Contractor shall submit a report for QM and DFC related questions. The Report shall include:

b.11.a: Volume of questions (by data-item and by quality measure and category), b.11.b: Categorization of questions submitted into topical areas of industry concern, to include:

b.11.b.1: Time periods (look-back) b.11.b.2: Quantities of service (numbers of services, visits, medications, wounds, etc.)

b.11.b.3: Clinical judgment b.11.b.4: Clarify Gguidelines (coding or assessment instructions) b.11.b.5: Problematic questions.

b.12: Recommendation as to whether certain high-frequency questions are made available to the public using a Frequently Asked Question (FAQ)-style, public-dissemination method. If questions and answers are approved for public-dissemination, the Contractor shall prepare materials for posting, in accordance with the standards for web-posting. See USOW Chapter 2 § D-508 Compliance).

c. Maintain a database of the inquiries received and coordinate and analyze the inquiries submitted during the preview period and provide recommendations to CMS for the suppression of any facility’s quality measures or measure scores within seven days of the close of the preview period.

d. Maintain and submit to CMS a log or report of the inquiries received, suppression decisions, and responses made to the inquiries within 30 days after the end of the preview period. The Contractor shall provide this log to CMS. The log must be searchable by facility, chain, and question type.

e. Prepare and send responses to inquiries that relate to methodological issues or other issues as directed by CMS. Respond to questions from the ESRD Networks, dialysis facilities, or other stakeholders about the measures, the methodology used to calculate the measures and other issues, as appropriate.

IAW section 9.F., Measure File Production: The Contractor shall produce a data file using the results calculated in Chapter 8 as directed by the CMS GTL, typically on a quarterly basis in accordance with the DFC website production timeline. The Contractor shall submit that file to CMS or a CMS contractor for the purpose of publicly reporting data on DFC

CHAPTER 10. ACCESS TO SYSTEMS/DATA

In accordance with (IAW) Chapter 10 of the MIDS USOW, the Contractor shall carry out all work/tasks described in section 10.A.

CHAPTER 11. QUALITY ASSURANCE AND PERFORMANCE EVALUATION

In accordance with (IAW) Chapter 11 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 11.A – 11.D., as applicable to the Contractor.