SOW_ESRD.docx

STATEMENT OF WORK

The Analyses, Development of Methods and Special Studies Required for the Modifications to the Fully Bundled Outpatient Case-Mix Adjusted End Stage Renal Disease Prospective Payment System (ESRD PPS)

Specific Tasks under the Contract The Centers for Medicare and Medicaid Services (CMS) implemented the ESRD PPS in a final rule dated August 12, 2010 (75 FR 49030) for Calendar Year (CY) 2011 with a refinement implemented for CY 2016 in a final rule dated November 6, 2015 (80 FR 68967) that updated the system using more current data. Through comments received during the rulemaking process, CMS has identified numerous areas for research and monitoring in order that future refinements/modifications to the ESRD PPS could be considered and policy options formulated.

The research tasks outlined below represent topics for research/investigation which will comprise the scope of work under this contract. CMS reserves the right to select specific tasks based upon the emerging priorities and agency exigencies, changing requirements including, but not limited to the availability of data at a later date, stakeholder input, changes in legislation for the Base and succeeding Option Years.

The ESRD PPS Bundle

· Analyze the incidence of procedures (eg. Blood transfusions or vascular access procedures) for inclusion in the bundle.

· Use of Medicare Prescription Drug Plan Finder to price oral-equivalent ESRD drugs; consider impact on facilities, especially smaller facilities which have less purchasing power; could potentially be used to price oral-only drugs

· Assess potential problems with provision of oral drugs, which will inform bundling of oral-only or oral-equivalent drugs

· Analyze the need for additional clinical indicators for monitoring patient conditions treated with new drugs and biologicals (both oral and injectable).

· Monitor utilization of renal dialysis items and services, including drugs and labs that can be used for both ESRD treatment and non-ESRD treatment for inclusion in the consolidated billing list.

· Monitor procedures formerly performed in the Renal Dialysis Facility (such as vascular access procedures) to determine whether facilities are increasing referrals to emergency departments.

· Review cost report data to advise on potential changes to the report to provide more useful/granular data (e.g., breaking out overhead into components).

· Provide executive summary analyses that provide various cost and utilization breakouts related to ESRD services and Part D drugs.

· Maintain a DUA for CCW and IDR and ensure that requests for renewals are submitted timely with CMS

· Maintain proactive strategies and the infrastructure necessary for data warehousing and efficient data accessibility by using up-to-date software, hardware, and contractual relationships.

· Analyze the drug portion of the base rate to determine what amount can be attributed to drugs and how it changes from year to year.

· Determine whether there other cost components of the base rate (eg., staffing, other overhead measures) that can be further analyzed.

· Evaluate and develop other models for the ESRD PPS (e.g., additive, one-equation).

· Report on feasibility and methodology for a patient-level cost model.

· Update the 2-equation model, testing for model stability and new variables.

· Study onset patients and provide recommendations on alternative approaches to capturing the cost of new patients.

· Develop and test other calculation methods for the facility level adjustments (i.e., low volume, rural, wage index).

· Develop and test other methods for the body size adjustment and age.

· Identify, evaluate and monitor other cost predictors.

· Monitor access and quality by race/ethnicity/sex and continue analyses of these factors and correlated comorbidities.

· Study onset adjustment: access to care, effects of multiple comorbidities, effects on coinsurance, home dialysis and transfer to other facilities. Develop additional measures of functional limitations or other factors prevalent in nursing home (NH) population. How many NH ESRD patients are there and how does their care differ?

· Monitor prevalence of comorbidities reported and use of comorbidity adjustments reported by ESRD facilities vs. identified in other claims. Is there a higher increase in comorbidities reported for new Medicare patients for whom we have little history in our claims data?

· Continue to assess stability of the adjustments using new data.

· Develop and test alternatives for problematic portions of the PPS model.

· Monitor payments made under the ESRD PPS and trends to identify facilities billing incorrectly or not furnishing appropriate care.

· Monitor for changes in use of home dialysis.

· Monitor the location of new facilities to determine if the eligibility criteria for the low volume payment adjustment should be changed

· Monitor the number of low volume facilities and their practices to determine if a change in threshold (4,000 treatments) or other criteria is needed

· Evaluate number of low volume facilities identified by final settled/audited cost reports versus return code

· Monitor status of rural facilities and consider policy options to ensure that access to dialysis in rural areas is not compromised

· Provide recommendations for dealing with the low wage index areas. This will require expertise in and licenses for geographical mapping software.

· Research models that may be more effective for the pediatric population.

· Make recommendations for pediatric comorbid conditions such as developmental delay/mental retardation, growth retardation and renal osteodystrophy, deafness, seizure disorders, anxiety, secondary hyperparathyroidism, and rare genetic disorders such as cystinosis, primary hyperoxaluria, congenital hepatic fibrosis and other congenital diseases, chronic lung disease from hypoplastic lungs, and bone marrow and other solid organ transplants.

· Compute the percentage of total ESRD PPS payments made as outlier payments annually.

· Explore/develop/test other methods for computing outlier payments.

· Conduct ongoing review of outlier services and payments for outliers:

· Characteristics, including similarities and differences amongst patients and facilities that are eligible for outlier payments.

· Data to determine the impact of the predicted payment rates and application of the outlier payment policy on home hemodialysis patients.

· Impact on outlier payments based on type of vascular access (fistula, graft, catheter) – do beneficiaries with one type require more services than a beneficiary with another type.

· Possible collection of patient-level data on composite rate items and services utilized after CY 2011 implementation of the ESRD PPS, which might change the definition of outlier services and outlier payments.

· Upon the collection of claims data which reflect the utilization of outlier services under the ESRD PPS, identify which outlier services are associated with the greatest proportion of outlier payments and weigh those results against the administrative burden for any possible alterations to the definition of outlier services.

· Analyze and monitor data of the consumption of outlier eligible services under the ESRD PPS to monitor for inappropriate use of outlier services, which leads to excessive outlier payments.

· Analyze the extent of outlier payments under the ESRD PPS and consider using actual provider cost for pricing of outlier services.

· Explore alternative pricing approaches for calculating outlier eligibility.

· Outlier payments distribution in different race/ethnicity groups.

· Monitor and identify patterns of change in outlier services, and any associated outlier payments across ESRD facilities.

· Monitor the ESA utilization and develop reports to support or refute continued application of the ESA Monitoring Policy and examine the relationships among hemoglobin levels, ESA utilization, and clinical outcomes.

· Compare ESA utilization amongst frail and non-frail populations (as indicated by BSA) to identify and investigate variances

· Investigate ESA dosing and hemoglobin levels among home dialysis patients who self-administer ESAs and the extent to which home patients receive outlier payments

· Investigate anemia management among in-facility dialysis patients to identify alternate methods used by facilities to manage patients’ anemia.

· Monitor the effects of the PPS on small, medium, and large dialysis organizations, hospital based, rural, and independent ESRD facilities.

· Provide pharmaceutical expertise to support evaluation of drugs presented to the HCPCS committee.

· Prepare data sets for the Office of the Actuary.

· Provide clinical expertise on advances in the treatment of ESRD (equipment, labs, drugs, biologics).

· Proactive review of current models to propose alternatives.

· Monitor changes in coinsurance burden/distribution

· Update the ESRD PPS consolidated billing list of items and services to include emerging items and services that could be considered furnished for the treatment of ESRD. That is, identify HCPCS, CPT, and NDC codes to reflect new therapies and/or code changes.

· Update the composite rate items and services list. , which is also a part of the ESRD PPS CB list.

· Evaluations and reports on the LVPA, the rural adjustment, the nursing home ESRD population, patient-level cost model.

· Run other data analysis as warranted and/or assigned.

· Monitor outcomes to ensure no impact to beneficiary care.

· CMS must approve all papers, presentations, posters, articles or reports prior to publication for data related to this contract. A copy of all publications and/or presentations shall be provided to CMS.

· CMS retains the rights to work product developed under this contract.

· All website links included in proposed and final regulations must be maintained, or, if changed, must have a mechanism for redirection to the original information.

The contractor shall provide the necessary personnel, materials, equipment, support and/or supplies to accomplish the tasks and/or functions described for CMS selected areas of research and investigation. The Contracting Officer (CO) with the consideration of the Contracting Officer’s Representative (COR) shall notify the contractor when government materials, equipment, support and/or supplies to accomplish the tasks and/or functions are required. The contractor shall keep a record of the government property used.

The contractor shall be required to complete the analyses and report its findings to CMS in bi-weekly telephone conferences. The COR with the support of the CMS ESRD payment policy team shall provide guidance to the contractor for all work performed under this contract.

The COR has authority to request the contractor present and/or discuss their findings inclusive, of additional analyses outside of the bi-weekly conference calls.

The contractor shall perform research, analyses and investigations as detailed under each of the following topics:

Task 1 – Recurring Reports and Meetings Task 1a – Teleconferences and meeting notes The contractor shall prepare for and participate in bi-weekly meetings to discuss ongoing research and administrative activities. After each meeting, the contractor shall prepare and submit meeting notes to CMS within 3 days.

Task 1b - Monthly progress reports The contractor shall submit a monthly administrative report specifying all activities during the previous month.

At a minimum these reports should contain:

· Research and administrative activities during the month including data analysis, problems encountered, and specification of events that could result in potential delays of deliverables.

· Research, investigations, and administrative activities planned for the following month for the requested activities under this contract.

· Discussion of planned versus actual resource consumption by research task and changes in contractor allocation of resources, if required.

· A brief discussion of principal findings, if any.

· A detailed itemized log of the prior month's activities for the tasks performed under the scope of this contract, as requested by the COR and other CMS staff, including the contractor's activities necessary to perform them.

Monthly reports shall be submitted electronically to the COR within 15 days following the end of each month. The COR may grant a delay in the submission of the monthly report for extenuating circumstances.

Task 1c - Kick off meeting The contractor shall have reviewed the all ESRD PPS proposed and final rules as listed at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html in preparation for a kick off meeting. At this kick off meeting, CMS, in consultation with the contractor, shall identify priority research activities for the continued development/refinement of the ESRD PPS to be conducted during the base year of this contract. The contractor shall have also reviewed data requirements to determine what data needs to be provided and begin the set-up of the system for monitoring and creation of analyses. Shortly after the Kick off Meeting, the contractor will be expected to replicate the CY 2016 payment amounts.

Task 2 – Analytics Task 2a – Develop and update analytical files The contractor shall develop and update analytical files on a recurring basis as updated data becomes available.

Task 2b – Develop analytical plans The contractor shall develop analytical plans for ongoing research to support CMS decision making.

Task 3 – Ad hoc analyses The contractor shall prepare ad hoc analyses as requested by CMS. Deliverable dates will be determined after discussion when the report is discussed.

Task 4 – Preparation of methodological reports The contractor shall prepare reports on the research methods employed. These reports will be prepared up request from the CMS COR and will include the statistical principles employed, the background that supports decisions making, and tables and charts providing summary results of analysis.

Task 5 - Prepare Reports on Differences between Projected Estimates and Actual Incidence of Selected ESRD Payment Variables Task 5a- Prepare Reports on Actual Incidence of Selected ESRD Payment Variables CMS will determine if they have a need for the contractor to prepare reports comparing the projected estimates of specified ESRD payment variables as set forth in the final ESRD PPS rules published in the Federal Register with the actual incidence of the variables. The contractor shall prepare the reports in the timeframe specified under Task 4 entitled, "Prepare Reports Describing Proposed Methodological Revisions/Refinements to the ESRD PPS in Response to Specific Requests from CMS” on an ad-hoc and/or as-needed basis. Examples include, but are not limited to, the number of renal dialysis facilities qualifying for the low volume payment adjustment (projected versus actual), the average case-mix adjustment for renal dialysis facilities subsequent to the implementation of the ESRD PPS (projected versus actual), the difference between the projected incidence of outlier payments and the actual incidence, or the difference between the projected and actual incidence of specified comorbidities.

This task also includes the evaluation of alternative methodologies. This includes but is not limited to the review of outlier calculations, the carve-out of adjustment factors to determine their individual impact, revision of outlier thresholds, payment simulation to evaluate the impact of proposed changes. Additionally, the review of drug inclusion and utilization will be included under this task, and the evaluation of cost report changes to achieve a more specific patient level adjustment.

The contractor will re-run the current regression models when audited cost reports become available. This will be a comparison of unaudited cost report data and audited cost report data and the estimated impact on the regression coefficients. .

CMS expects the contractor to evaluate current methodologies regarding the low volume payment adjustment, rural adjustment, and wage index floor and in order to recommend alternative approaches using sophisticated mapping technologies.

Due dates for specific reports and analyses can be discussed as requirements are developed, but will generally be 2 weeks after requirements are established.

Task 6 - Activities Necessary for Updating Selected Features of the ESRD PPS The issuance of proposed and final rules incorporating revisions to the ESRD PPS shall require the contractor to perform activities necessary for the timely publication of modifications to the system through publication In the Federal Register. These activities shall include, but are not necessarily limited to, the preparation of new or revised tables in connection with selected features of the ESRD PPS under the responsibility of the ESRD PPS payment policy team, assistance with simulations of impact, preparation of, and/or review of, proposed draft and final language for technical accuracy as requested, and the preparation of analyses as a result of comments received from ESRD stakeholders. The contractor shall be required to cooperate with necessary CMS personnel for the accomplishment of these objectives. These personnel may include the COR, director of the ESRD payment policy team, members of the ESRD payment policy team, representatives from the Office of the Actuary, and/or other CMS personnel, as required. Regulation activities may also include participating in meetings with CMS leadership and other ESRD stakeholders.

These reports and analyses are generally time-sensitive and due dates will vary dependent upon stage of rule-making. During the rule-making season (generally March – June and August – October), the contractor will need to have staff available to quickly and accurately respond to urgent, time-sensitive requests, including narrative explanations and data.

Task 7 – Conference reports In the event that the contractor attends a conference on material relevant to this contract, the contractor will report back to CMS any information or knowledge obtained during the conference.

Task 8 – Final Report The contractor shall prepare a final report detailing the work prepared and completed throughout the period of performance.

This report will be developed and delivered in the final option year of this contract.

Task 9 – Return of data and models to CMS At the conclusion of the final option year of this contract, all data used and models created will be delivered to CMS.

Schedule of Deliverables

response to other Government stakeholder requests As requested and negotiated

All deliverables shall submitted via email to the COR.

Personnel Requirements The educational requirements for key contractor staff are high. Key staff requirements include advanced degrees (Masters, PhDs, and MDs) in health policy, economics, statistics, biostatistics, social sciences, nephrology, and other directly related fields.

The experience and required knowledge of key personnel are as follows:

· Demonstrated knowledge of prospective payment systems in general, including case-mix methods, with a history of research in connection with the ESRD PPS specifically.

· Demonstrated ability to create, update, analyze, and modify complex administrative databases used to develop, assess, monitor, and refine ESRD payment systems.

· Demonstrated expert knowledge of Medicare claims, cost report, and other administrative data pertinent to the development and refinement of the ESRD PPS.

· Demonstrated experience designing, assessing, monitoring, and making recommendations for development of the ESRD PPS.

· Demonstrated experience in the preparation of policy options and the development of alternative models for making modifications/refinements to ESRD PPSs.

· Demonstrated experience in extracting, analyzing, and making recommendations for the development of policy options using data from the CMS data center.

· Demonstrated technical and non-technical writing experience, particularly related to explaining complex clinical and statistical concepts and methods and making them understandable to non-clinicians and statisticians.

· Demonstrated expertise with geographical mapping software, including licenses for the software.

· Demonstrated clinical knowledge of kidney disease and its treatment.

· During peak rulemaking cycles, these employees may need to be dedicated to the development of reports and analyses to support the rule.

SECTION 508 - ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

(a) This task order is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection 508(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum. If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the Contracting Officer will promptly inform the Contractor in writing. The Contractor shall, without charge to the Government, repair or replace the non-compliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

1. Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

2. In the case of custom Electronic and Information Technology (EIT) being developed by a contractor for the Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the contractor liable for reimbursement to the Government for any expenses incurred thereby.

(d) The contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the contractor shall, at the discretion of the Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

Section 508 Compliance for Communications The (Contractor name goes here) shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents and this SOW, the SOW shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

2. 36 CFR 1194 (508 Standards)

3. http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards

4. FAR 39.2 (Section 508)

5. CMS/HHS Standards, policies and procedures (Section 508) In addition, all contract deliverables are subject to these 508 standards as applicable.

Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

36 CFR Part 1194.21 a - l 36 CFR Part 1194.22 a - p 36 CFR Part 1194.31 a - f 36 CFR Part 1194.41 a – c The contractor shall provide a completed Section 508 Product Assessment Template and the contractor shall state exactly how proposed EIT deliverable(s) meet or does not meet the applicable standards.

The following Section 508 provisions apply for software development material identified in this SOW:

For software development, the Contractor/Developer/Vendor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

36 CFR Part 1194.21 (a – l) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

a. Information Technology – General Information (http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/index.html) For web-based applications, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

36 CFR Part 1194.22 (a – p) 36 CFR Part 1194.41 (a – c)

a. Information Technology – General Information (http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/index.html)