Attachment_J.11-A_SOW_TO_0003.pdf

Attachment J.11-A SOW TO 0003

Measure & Instrument Development and Support

(MIDS)

Statement of Work

Task Order 0003

Kidney Disease 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 National Kidney Foundation (NKF)-Dialysis Outcomes Quality Initiative (DOQI) (NKF-DOQI or DOQI) clinical practice guidelines. 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 Dialysis Facility Compare (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.

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 DFC found at www.medicare.gov/Dialysis/Home.asp.

Subsequent years will incorporate additional measures of quality as data becomes available through instruments such as Consolidated Renal Operations in a Web Enabled Network (CROWNWeb).

http://www.medicare.gov/ http://www.medicare.gov/Dialysis/Home.asp

The passage of the Medicare Access and Children’s Health Insurance Program (CHIP) Reauthorization Act of 2015 (MACRA) supports an ongoing transformation of health care delivery by furthering the development of new Medicare payment and delivery models for physicians and other clinicians. This includes the development of quality measures for certain clinical specialties at the clinician and clinician-group level, including clinical nephrology.

1.B - Purpose

The purpose of this MIDS TO SOW is to obtain the services for ongoing development of Chronic Kidney Disease (CKD), ESRD, and related quality measures attributable to at the clinician, clinician group, and/or dialysis facility, calculation and public reporting of quality measures, as well as providing measure development and maintenance support for the objectives established in section 153(c) of MIPPA and Section 1848(s)(1)(A), (5)(A) of MACRA.

This TO SOW adheres to all tasks within the MIDS Indefinite Delivery Indefinite Quantity (IDIQ) SOW Chapters. Those activities not specifically described in the MIDS IDIQ SOW shall be specified in this TO SOW. Those activities/tasks within the MIDS IDIQ SOW that are excluded or 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 IDIQ SOW, the contractor shall carry out all work/tasks described in sections 2.A. – 2.F.

Additional Requirements/More Specific Description:

IAW section 2.A., Basic Requirements:

Deliverable # 2-6 (Peer Reviewed Manuscripts): The contractor shall propose to the Contracting Officer’s Represenatative (COR) 2-3 abstracts for development into manuscripts for submission to a peer-reviewed journal for publication. The manuscripts shall address issues significant to the quality measures and quality programs supported under this TO. Topics may include, but are not limited to, risk-adjustment methodology, sociodemographic status adjustment, DFC Star Ratings methodology, quality measure specifications, measure results, and trends in measure performance.

IAW section 2.B., Fundamental Activities: The Contractor shall advise and support the implementation of data elements in data collection tools such as CROWNWeb (http://mycrownweb.org/) as directed by the CMS COR. 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 the following work relating to measures developed or maintained under the TO SOW: public reporting of measures on the DFC website, implementing measures on the ESRD Quality Improvement Program (QIP) and Quality Paymeny Program (QPP), supporting http://mycrownweb.org/ the use and consideration of the measures in other CMS quality programs as directed by the COR. Such coordination shall include but not be limited to advising on appropriate methods of displaying, reporting, and describing the quality measures, and providing language supporting these activities.

In addition, CMS makes available the Measures Management System (MMS), 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 MMS Blueprint. The MMS Blueprint should be considered guidance for measure development, and not mandatory requirements. The Contractor shall determine in consultation with the COR what specific elements of the MMS Blueprint applicable to the TO and described in the following Chapters are appropriate for the measure development cycle for each measure project. The required elements of the MMS Blueprint for each project shall be reflected in the Final Project Management Plan (PMP) (Deliverable #2-2). When a given element is applicable to a project, the Contractor shall carry out that element in accordance with the TO SOW.

IAW section 2.F., Ad Hoc Requests from CMS:

The contractor shall perform up to 10 ad hoc reports and analyses per year (Deliverable #2-5) at the request of the COR, for the purpose of supporting the development, maintenance, and implementation of quality measures supported under this TO. Ad hoc requests shall be completed within 60 days of request, or in a timeline approved by the COR.

CHAPTER 3. INFORMATION GATHERING

IAW Chapter 3 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 3.A. – 3.E.

Additional Requirements/More Specific Description:

IAW section 3., Measure Development Prioritization Deliverable # 3-7 (Draft Measure Prioritization Report): The contractor shall provide a Draft Measure Prioritization Report that prioritizes quality measures for development based upon several criteria, including:

1. Statutory requirements

2. Program gaps in meaningful measurement

3. Program priorities

4. Supporting evidence

5. Data availability

6. Outcomes-based measurement

7. Likely data collection burden

8. Existing measures

9. Stakeholder input (TEPs, public comments, rulemaking, National Quality Forum (NQF), the Measures Application Partnership (MAP), etc.)

Recommendations for priority of developement shall be stratified by measurement level (dialysis facility, physician, etc.). The contractor shall coordinate with CMS components, contractors, and external stakeholders as appropriate, to inform the criteria assessment prior to making recommendations. The contractor shall conduct sufficient literature review to inform the report recommendations. The report shall include recommendations for measure modification and retirement. The report shall be due 60 calendar days prior to the completion of each performance period.

CHAPTER 4. QUALITY MEASURE DEVELOPMENT &

REEVALUATION

IAW Chapter 4 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 4.A. – 4.C.

Additional Requirements/More Specific Description:

IAW section 4.A.1., Technical Expert Panels (TEP) The contractor shall develop and maintain quality measures that address a range of topics relevant to chronic kidney disease and acute kidney injury. With guidance from CMS based in part on the Measure Prioritization Report (Deliverable # 3-7), the contractor shall conduct up to three development projects. These projects may include de novo development of quality measures applicable to dialysis facilities, nephrologists and other clinicians responsible for the screening, diagnosis, and treatment of CKD and acute kidney injury. Projects may also address major measure maintenance projects if the contractor and CMS agree that additional technical expert input is required. A project may alternatively be tasked for the purpose of convening a Star Rating technical expert panel to maintain the quality measure set and scoring methodology.

Finally, a development project may consist of the collection and evaluation of test data for previously specified quality measure concepts for which performance data were not previously available (described in detail in Chapter 6). Topics for quality measure development may address a wide variety of topics, including, but not limited to:

1. Patient health outcomes (mortality, hospitalizations, complications, infections, etc.)

2. Patient-reported outcomes (patient-experience of care, quality of life, patient goals, pain management, etc.)

3. Medications (opioid use/avoidance, medication reconciliation, medication management, etc.)

4. Cost

5. Physician-level equivalents of quality care for the full spectrum of kidney disease care, from screening to transplant

6. Acute Kidney Injury

IAW section 4.A.4., Technical Specification & Documentation Deliverable # 4-13 (Measure Package): The contractor shall develop for each measure under development a Measure Package, a zipped file that incorporates a minimum of the following for each respective measure:

Information Gathering Report (Deliverable #3-1) Measure Information Form (Deliverable #3-3) Measure Justification Form (Deliverable #3-4) Expert Input Report (Deliverable #3-6) TEP Summary Evaluation (Deliverable #4-3) Code Pack (Deliverable #4-14)

Other materials may be included in consultation with the COR. The Contractor may propose alternate approaches to organizing the Measure Package (such as including related measures in a single package).

Deliverable # 4-14 (Code Pack): IAW direction from the COR, the Contractor shall develop code packs documenting the programming code required to calculate and implement quality measures developed and maintained under this TO. The Contractor shall take into account operational requirements for the CMS quality programs in which these measures are expected to be implemented while developing the Code packs. The Code Packs shall be developed IAW the Project Management Plan (Deliverable # 2-2).

IAW section 4.B., Measure Maintenance The contractor shall complete regularly scheduled measure maintenance projects in the form of annual measure update re-evaluations and comprehensive re-evaluation as appropriate to the NQF schedule.

Deliverable # 4-15 (Measure Maintenance Schedule): The contractor shall maintain an ongoing schedule of measure maintenance for all supported quality measures. For those measures not under NQF maintenance, the contractor shall devise a maintenance schedule in agreement with the COR. As measures developed under Chapter 4, Section A of this TO are completed, the contractor shall incorporate their maintenance on the schedule. The contractor shall be responsible for annual review of the maintenance schedule at the kick-off meeting with the COR. Measures maintained under this TO may expand prior to award of the contract, but currently include:

Dialysis Adequacy and Fluid Management

1. Minimum Delivered Hemodialysis Dose (NQF # 0249 – reserve status)

2. Delivered Dose of Peritoneal Dialysis Above Minimum (NQF # 0318)

3. Minimum spKt/V for Pediatric HD Patients (NQF # 1423)

4. Measurement of nPCR for Pediatric HD Patients (NQF # 1425)

5. Minimum Delivered Peritoneal Dialysis Dose (NQF #2704)

6. Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V (NQF #2706)

7. Ultrafiltration rate greater than 13 ml/kg/hr

8. Delivered Dose of Dialysis Above Minimum

9. Minimum Delivered Hemodialysis Dose

Vascular Access

10. Hemodialysis Vascular Access- Maximizing Placement of Arterial Venous Fistula (NQF #0257)

11. Hemodialysis Vascular Access- Minimizing use of catheters as Chronic Dialysis Access

(NQF #0256)

12. Hemodialysis Vascular Access: Standardized Fistula Rate (NQF # 2977)

13. Hemodialysis Vascular Access: Long-term Catheter Rate (NQF #2978 )

Mineral Bone Disease

14. Measurement of Serum Phosphorus Concentration (NQF # 0255 – reserve status)

15. Proportion of Patients with Hypercalcemia (NQF # 1454)

16. Measurement of PTH Concentration

Hospitalizations and Mortality

17. Standardized Mortality Ratio (NQF # 0369)

18. Standardized Hospitalization Ratio for Admissions (NQF # 1463)

19. Standardized Readmission Ratio (NQF #2496)

20. Standardized Emergency Department Encounters Ratio

21. ED Visits Occurring Within 4-30 Days of Hospitalization Discharge

Anemia Management

22. Monthly Hemoglobin Measurement for Pediatric Patients (NQF # 1424)

23. Anemia of Chronic Kidney Disease: Dialysis Facility Standardized Transfusion Ratio

(NQF #2979)

Vaccination

24. ESRD Vaccination - Full-Season Influenza Vaccination (Under Development)

25. ESRD Vaccination - Timely Influenza Vaccination (Under Development)

26. ESRD Vaccination - Lifetime Pneumococcal Vaccination (Under Development)

27. ESRD Vaccination - Pneumococcal Vaccination (PCV13) (Under Development)

28. ESRD Vaccination - Pneumococcal Vaccination (PPSV23) (Under Development)

Access to Transplantation

29. Standardized First Kidney Transplant Waitlist Ratio for Incident Dialysis Patients

30. Percentage of Prevalent Patients Waitlisted

Note that as new measures are developed under the TO, they may be added to this list for measure maintenance purposes. Additional publicly available details are available at dialysisdata.org. The Contractor shall receive full measure specification and testing information during the transition period.

IAW section 4.B.6., Technical Specification & Documentation The contractor shall develop or maintain for each measure under maintenance a Measure Package (Deliverable #4-13), a zipped file that incorporates a minimum of the following for each respective measure:

Information Gathering Report (Deliverable #3-1) Measure Information Form (Deliverable #3-3) Measure Justification Form (Deliverable #3-4) Expert Input Report (Deliverable #3-6) TEP Summary Evaluation (Deliverable #4-3) Code Pack (Deliverable #4-14)

Other materials may be included in consultation with the COR. The Contractor may propose alternate approaches to organizing the Measure Package (such as including related measures in a single package). The Contractor shall track version updates of each Measure Package and its constituent documents.

CHAPTER 5. INSTRUMENT/ITEM DEVELOPMENT

IAW Chapter 5 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 5.A. – 5.C.1, 5.D.

IAW Chapter 5 of the MIDS IDIQ SOW, the contractor shall not be required to carry out all work/tasks described in Section 5.C.2.

Additional Requirements/More Specific Description:

IAW section 5.B., Standards The contractor shall supply appropriate documentation for the purpose of implementing changes to data collection tools in order to implement quality measures developed and maintained under this TO. Documentation of business requirements for collection may be required for CROWNWeb, ESRD Quality Reporting System (EQRS), Medicare claims, Patient-Reported Outcomes (PRO) collection tools, and other items/instruments as determined to be appropriate for individual measures and data elements.

CHAPTER 6. TESTING/VALIDATION

IAW Chapter 6 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 6.A. – 6.D.

Additional Requirements/More Specific Description:

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.

The Contractor shall support CMS in identifying and prioritizing development projects (referenced in Chapter 4) for the purpose of collecting data to conduct alpha and beta testing for ESRD quality measures of dialysis facilities for which relevant testing data are not currently available to CMS or the Contractor through other means. When such a project is one of three selected for development under Chapter 4 during the performance period, the contractor shall obtain data for use in alpha testing measures under development in Chapter 4 of the IDIQ SOW, where existing data are not currently available. The contractor shall make use of CROWNWeb or other systems to obtain appropriate data for the purpose of beta testing measures under development in Chapter 4 of the IDIQ SOW.

Deliverable # 6-4 (Alpha Testing Report): The contractor shall provide to CMS alpha testing reports as directed by CMS in accordance with the agreed upon test bed project plan.

Deliverable # 6-5 (Beta Testing Reports): The contractor shall provide to CMS beta testing reports as directed by CMS in accordance with the agreed upon test bed project plan.

Deliverable # 6-6 (Testing Communication and Recruiting Materials): Subject to CMS approval, the Contractor shall develop facility communication and recruiting matierals, coordinate with other CMS contractors and community stakeholders to recruit participating facilities, develop any necessary training materials to support data submission (Deliverable #6-7

– Testing Training Materials), and provide appropriate training to participating facilities to ensure accurate data collection.

Deliverable # 6-8 (Change Request Documents): The contractor shall coordinate with other CMS contractors to specify business requirements to support data collection and testing, including providing documentation support to the business requirements contractors, such as change request forms. When testing data are available, the Contractor shall conduct validity and reliability testing as described in Chapter 6 of the IDIQ SOW.

IAW section 6.A., Reliability and Validity Testing The contractor shall consider previously developed measure specifications for prioritization of testing as appropriate for quality measures requiring alpha and beta testing, including, but not limited to:

Functional Status

1. Cognitive Testing for Dialysis Patients (Under Development)

2. Depressive Symptom Screening for Dialysis Patients (Under Development)

3. Support Needs/Caregiver Assistance Assessment for Dialysis Patients (Under

Development)

4. Core Functional Mobility for Dialysis Patients (Under Development)

5. Short Physical Performance Battery for Dialysis Patients (Under Development)

Access to Transplantation

1. Standardized Transplant Referral Ratio for Incident Dialysis Patients

2. Transplant Referral Rate for Prevalent Dialysis Patients

3. Standardized Waitlist Decision Ratio for Incident Dialysis Patients

4. Waitlist Decision Rate for Prevalent Dialysis Patients

Patient-Reported Outcomes The contractor shall coordinate with the COR to establish a timeline for collecting appropriate data and testing for measures for which administrative data are not readily available. As additional measures are developed and specified, the Contractor and COR shall evaluate need for collecting data to support full validity and reliability testing of measure specifications and recommend to CMS what measures are appropriate for such efforts.

CHAPTER 7. REPORTS/APPROVAL PACKAGES

IAW Chapter 7 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 7.A. – 7.H.

Additional Requirements/More Specific Description:

IAW section 7.A., Monthly Status Reports:

The contractor shall explicitly link Monthly Status Report (Deliverable #7-1) data to the labor category level of efforts in the monthly Cost Report (Deliverable #7-3) described in section 7.C

IAW section 7.E., Periodic Status Calls:

The contractor shall record and distribute minutes (Deliverable #7-6) for regularly scheduled status calls (Deliverable #7-5) and minutes for additional ad hoc calls for which the Contractor is delegated responsibility by the COR (Deliverable # 7-8 – Ad Hoc Meeting Minutes). These may include calls with CMS staff, contractors, and stakeholders convened by the Contractor for the purpose of carrying out work described under the TO SOW. Such minutes shall be distributed not more than 3 business days to meeting participants IAW the COR’s direction to allow for review and ensure accuracy.

CHAPTER 8. IMPLEMENTATION, PRODUCTION & ASSESSMENT

IAW Chapter 8 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 8.A. – 8.E.

Additional Requirements/More Specific Description:

IAW section 8.A.1., Measure Selection and Rule Making Process Deliverable # 8-7 (Measure Candidate Report): The contractor shall develop and maintain a spreadsheet of all measures developed and maintained under the TO SOW including relevant data elements required for inclusion in the a JIRA system used by CMS for the Measures Under

Consideration (MUC) List. The Contractor shall evaluate potential meaure candidates and provide recommendations for inclusion of measures as candidates for inclusion in DFC public reporting, DFC Star Ratings, and the ESRD QIP MUC List at least 30 calendar days prior to the conclusion of each performance period within a Measure Candidate Report.

IAW section 8.A.2., Development of Timeline Deliverable # 8-8 (DFC Measure Implementation Process Manual): The contractor shall develop and maintain a timeline that incorporates the operational timelines for the MUC List, NQF endorsement process, ESRD QIP rulewriting and implementation, and the DFC and DFC Star Rating measure candidate process. The Contractor shall develop and maintain the DFC Measure Implementation Process Manual.

IAW section 8.A.4., Measure Dry Run The contractor shall provide for a dry run of measure performance to dialysis facilities prior to the inclusion of new quality measures in DFC through the preview report process.

IAW section 8.A.5., Other Implementation Activities The contractor shall produce and maintain content relevant to quality measures and the DFC Star Ratings developed and maintained under the TO SOW for the ESRD Measures Manual in conjunction with other CMS contractors for DFC and the ESRD QIP. The Contractor shall support CMS in the development of business requirements for data collection and calculation of quality measures developed and maintained under the TO SOW for the ESRD QIP. The Contractor shall review and advise on the development of technical specifications for quality measures proposed and finalized for the ESRD QIP.

IAW section 8.B.2., Testing/Documenting/Producing Measure Calculations The Contractor shall develop and maintain Code Packs (Deliverable #4-14) to be utilized by the EQRS System (or equivalent system designated by CMS) to calculate measures and the DFC Star Rating methodology developed or maintained under the TO SOW for the ESRD QIP, DFC, or other quality program. The Code Packs shall include the code relevant for calculating the quality measure (in SAS, or a similar statistical package) and documentation necessary to make use of the code.

The Contractor shall develop and transmit test files and measure production files for the quarterly reporting of quality measures identified under section 9.B. that are included in DFC and the DFC Clinical Star Ratings. The Contractor shall document the processes and requirements for producing these files.

Deliverable # 8-9 (Center for Medicare & Medicaid Innovation (CMMI) Comprehensive ESRD Care (CEC) Measure File): The Contractor shall develop and produce an annual data file for the CMMI CEC Program, including facility-level results for measures. The CMMI data file shall include data for, but not necessarily limited to: The Standardized Waitlisting Ratio (SWR), the Proportion of Prevalent Patients Waitlisted (PPPW), and the Standardized Mortality Ratio (SMR).

IAW section 8.D., Program, Measures, and Initiative Assessment

Deliverable # 8-10 (DFC Handbook Requirements) and 8-11 (DFC Handbook): The contractor shall design and produce a DFC Handbook that assesses the performance of clinical measures and the Star Ratings publicly reported on DFC. The handbook shall assess distribution of performance across facilities, trends in performance over time, disparities in performance by facility characteristics, and unintended consequences of implementation. The Contractor shall finalize he format and requriements of the Handbook by the end of the Base Year performance period (Deliverable # 8-10). The Contractor shall produce and maintain Handbook requirements annually beginning in Option Year 1 IAW the Project Management Plan (Deliverable # 2-2).

Optional Task – 8.F., Transition Period In the event that the Contractor awarded the TO is not the Incumbent Contractor, the Successor Contractor shall conduct a transition period of 90 days following the award of the TO. The Successor Contractor shall coordinate with the Incumbent Contractor to transition responsibility for the quarterly public reporting of data on DFC, as described in Chapter 8. The Successor Contractor shall assume full responsibility for the following tasks and deliverables upon the completion of the transition period 90 days following the award of the TO:

Section 8.A.4 – Measure Dry Run Section 8.B.2 – Testing/Documenting/Producing Measure Calculations/Results Section 8.C – Provide Support for Public Outreach

9. PUBLIC REPORTING/COMPARE SITES

IAW Chapter 9 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 9.A. – 9.I.

Additional Requirements/More Specific Description:

IAW section 9.A., Coordination with other CMS Components The contractor shall coordinate with CMS components (Office of Communications (OC), Information Systems Group (ISG), Center for Medicare (CM), etc.), federal partners (Centers for Disease Control (CDC), National Institutes of Health (NIH), etc.), and other CMS Contractors for the purpose of ensuring the necessary data files, content files, and quality assurance processes are implemented to ensure the successful quarterly reporting of quality data on DFC.

IAW section 9.B., Content Management Support The contractor shall develop, maintain, and provide to CMS and its contractors the DFC Test Files (Deliverable # 9-4 – DFC Test Files), DFC Measure Data Files (Deliverable # 9-1), and DFC Measure Content Files (Deliverable # 9-5 – DFC Measure Content Files) for quality measures and the Star Rating Methodology publicly reported on DFC and/or reported on the downloadable database. These quality measures currently include the following, but may change subject to program needs:

1. Minimum Delivered Hemodialysis Dose (NQF # 0249 – reserve status)

2. Delivered Dose of Peritoneal Dialysis Above Minimum (NQF # 0318)

3. Minimum spKt/V for Pediatric HD Patients (NQF # 1423)

4. Measurement of nPCR for Pediatric HD Patients (NQF # 1425)

5. Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V (NQF #2706)

6. Hemodialysis Vascular Access: Standardized Fistula Rate (NQF # 2977)

7. Hemodialysis Vascular Access: Long-term Catheter Rate (NQF #2978 )

8. Measurement of Serum Phosphorus Concentration (NQF # 0255 – reserve status)

9. Proportion of Patients with Hypercalcemia (NQF # 1454)

10. Standardized Mortality Ratio (NQF # 0369)

11. Standardized Hospitalization Ratio for Admissions (NQF # 1463)

12. Standardized Readmission Ratio (NQF #2496)

13. Anemia of Chronic Kidney Disease: Dialysis Facility Standardized Transfusion Ratio

(NQF #2979)

IAW section 9.C., Provider Preview The contractor shall provide for Quarterly Preview Reports (Deliverable # 9-2) distributed to dialysis facilities for the purpose of facilities reviewing and requesting clarification and/or suppression of their quality meaure performance. The Contractor shall provide a vehicle for the public posting of documentation supporting the implementation of quality measures and the DFC Star Ratings methodology, distribution of the preview reports and for facilities to submit requests for suppression and patient lists. This vehicle shall conform to all relevant CMS security, legal, and operational requirements. The Contractor shall coordinate with CMS and other CMS contractors in migrating these functions and materials to QualityNet.org or another suitable location designated by CMS, through efforts, including, but not limited to, identifying necessary process and system requirements, developing or adapting content material to posting at the designated site, and modifying communications materials to direct the public to the designated location.

Deliverable # 9-6 (DFC Quarterly Report Guide): The Contractor shall maintain and distribute a DFC Quarterly Report Guide to support facilities in reviewing their preview reports.

CMS shall provide the templates for the guide and preview reports. The Contractor shall recommend and implement enhancements to the Guide and preview reports to the COR as appropriate. Preview reports shall be made available in February, May, July/August, and November in accordance with the DFC production timeline to support public reporting of data in, respectively, April, July, October, and January of each year.

IAW section 9.E., Measure File Production The contractor shall quarterly produce a data file (Deliverable # 9-1) in accordance with the DFC operational timeline that provides quality measure and Star Ratings performance data for dialysis facilities reported on DFC for measures identified in section 9.B. The data file shall also incorporate quality measure data received from CMS components, contractors, and federal stakeholders as appropriate. Currently, DFC data for the In-Center Hemodialysis-Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS) and CAHPS-based Star Ratings are received from the Center for Medicare, while data for the Bloodstream Infection measure are received from the CDC.

At present, DFC updates data annually during the October DFC Release for the following measures:

1. Standardized Mortality Ratio (NQF #0369)

2. Standardized Hospitalization Ratio for Admissions (NQF # 1463)

3. Standardized Readmission Ratio (NQF #2496)

4. Anemia of Chronic Kidney Disease: Dialysis Facility Standardized Transfusion Ratio

(NQF #2979)

5. NHSN Bloodstream Infection Measure (NQF #1460 – data provided by the CDC)

6. DFC Clinical Star Ratings

At present, DFC updates data twice annually during the October and April DFC Releases for the following measure:

1. ICH-CAHPS Measure (NQF #0258 – data provided by CMS and CMS contractors)

2. ICH-CAHPS Star Ratings

At present, DFC updates data quarterly during each DFC Release for the following measures:

1. Minimum Delivered Hemodialysis Dose (NQF # 0249 – reserve status)

2. Delivered Dose of Peritoneal Dialysis Above Minimum (NQF # 0318)

3. Minimum spKt/V for Pediatric HD Patients (NQF # 1423)

4. Measurement of nPCR for Pediatric HD Patients (NQF # 1425)

5. Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V (NQF #2706)

6. Hemodialysis Vascular Access: Standardized Fistula Rate (NQF # 2977)

7. Hemodialysis Vascular Access: Long-term Catheter Rate (NQF #2978 )

8. Measurement of Serum Phosphorus Concentration (NQF # 0255 – reserve status)

9. Proportion of Patients with Hypercalcemia (NQF # 1454)

IAW section 9.F., Communications Material The contractor shall support CMS in communicating with community stakeholders through the maintenance of a helpdesk for responding to inquirites about publicly available materials and information produced through under the TO SOW, a listserv of kidney disease providers, professional societies, ESRD Networks, patients, and other interested parties. Communications may come in the form of e-mail blasts, reports, memos, helpdesk responses, and other forms as appropriate. All communications shall conform to CMS direction regarding clearance requirements.

IAW section 9.H., Public Reporting Timeline The contractor shall coordinate with CMS and CMS contractors to develop and maintain a quarterly reporting timeline that includes the submission of a test file, data file, and website content file, the execution of a preview period, management of data suppression requests, and user acceptance testing. Additional elements necessary for impelementation of quarterly reporting of data on DFC may be identified in conjunction with the COR, CMS, and other CMS contractors, and included in the timeline.

Optional Task – 9.I., Transition Period In the event that the Contractor awarded the TO is not the Incumbent Contractor, the Successor Contractor shall conduct a transition period of 90 days following the award of the TO. The Successor Contractor shall coordinate with the Incumbent Contractor to transition responsibility for the quarterly public reporting of data on DFC, as described in Chapter 9. The Successor Contractor shall assume full responsibility for the following tasks and deliverables upon the completion of the transition period 90 days following the award of the TO:

Section 9.A – Coordination with Other Components (This will be covered under Chapter 12) Section 9.B – Content Management/Support Section 9.C – Provider Preview Section 9.D – Measure Implementation Algorithm Section 9.E – Measure File Production Section 9.F – Communication Material Section 9.H – Public Reporting Timeline

CHAPTER 10. ACCESS TO SYSTEMS/DATA

IAW Chapter 10 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in section 10.A.

CHAPTER 11. QUALITY ASSURANCE AND PERFORMANCE

EVALUATION

IAW Chapter 11 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 11.A – 11.D., as applicable to the contractor.

CHAPTER 12. TRANSITION FROM INCUMBENT TO SUCCESSOR

IAW Chapter 12 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 12.A – 12.D., as applicable to the contractor.

Optional Task 12.E Transition will be required if not awarded to Incumbent Contractor. Successor Contractor shall conduct a transition period of 90 days following the award of the TO. The Successor Contractor shall coordinate with the Incumbent Contractor to transition responsibility for the quarterly public reporting of data on DFC, as described in Chapter 9. IAW COR directions, both the Incumbent and Successor Contractors shall participate in all relevant meetings required for the implementation of quality reporting for the January 2019 DFC release. The Successor Contractor shall identify and implement the internal processes and infrastructure required to assume responsibility for all work described in Chapter 8 and Chapter 9 to support the continued quarterly public reporting of quality data on Dialysis Facility Compare. The Successor

Contractor shall assume responsibility for all public reporting-related tasks described in the TO no later than 90 days after the award of the TO.

B. Government Property: (If Applicable)

C. References: (If applicable)