Attachment_1-_Statement_of_Work.pdf

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) and the Acute Kidney Disease Payment System (AKI PS).

I. Overall Purpose

Under this project the successful bidder will provide support in analyzing and implementing changes to the current end stage renal disease (ESRD) prospective payment system (PPS) and the acute kidney disease (AKI) payment system (PS), monitoring the impact of recent and any upcoming payment policy changes and providing support in analyzing other issues related to the ESRD PPS and AKI PS.

II. Background

End Stage Renal Disease

Section 153(b) of Pub. L. 110-275, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) amended section 1881(b) of the Social Security Act to require the implementation of an ESRD bundled payment system effective January 1, 2011. Under MIPPA, the ESRD PPS replaced the previous basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD-related items and services. The ESRD PPS provides a case-mix adjusted single payment to ESRD facilities for renal dialysis services provided in an ESRD facility or in a beneficiary’s home.

Renal dialysis services are all items and services used to furnish outpatient maintenance dialysis in the ESRD facility or in a patient’s home.

Renal dialysis services include but are not limited to:

• All items and services included under the composite rate as of December 31, 2010;

• Erythropoiesis stimulating agents (ESAs) and their oral or other forms of administration that are for renal dialysis services;

• Injectable drugs and biologicals and their oral or other forms of administration that are for renal dialysis services;

• Oral or other forms of non-injectable drugs and biologicals that are renal dialysis services;

• Diagnostic laboratory tests that are renal dialysis services;

• Home and self-dialysis training; and

• All supplies, equipment, and support services necessary for the effective performance of a patient’s dialysis furnished in the ESRD facility or in a patient’s home.

Per Treatment Basis

Under the ESRD PPS payment is made on a per treatment basis. The ESRD PPS base rate is the per treatment unit of payment that applies to both adult and pediatric patients. ESRD facilities furnishing dialysis treatments in-facility and in a patient’s home, regardless of modality, are paid for up to 3 treatments per week, unless there is medical justification for more than 3 weekly treatments. Meaning, ESRD facilities furnishing dialysis in-facility or in a patient’s home, regardless of modality, are paid for a maximum of 13 treatments during a 30 day month and 14 treatments during a 31 day month unless there is medical justification for additional treatments.

Market Basket Update

CMS updates on an annual basis, the ESRD PPS base rate by the ESRD bundled market basket percentage increase factor minus a productivity adjustment factor.

ESRD PPS Case-Mix Adjustments

The ESRD PPS includes patient-level adjustments (also known as the case-mix adjustments), facility-level adjustments, and training adjustments, as well as an outlier payment. Under the ESRD PPS, the beneficiary co-insurance amount is 20 percent of the total ESRD PPS payment, after the deductible.

Patient-level case-mix adjustments

The ESRD PPS base rate is adjusted for characteristics of both adult and pediatric patients to account for case-mix variability. The adult case-mix adjusters include variables (age, body surface area (BSA), and low body mass index (BMI)) that have been part of the basic case-mix adjusted composite rate payment system. In addition, the ESRD PPS includes adult case-mix adjustments for six co-morbidity categories (three acute and three chronic) as well as the onset of renal dialysis. Pediatric patient-level adjusters consist of combinations of two age categories and two dialysis modalities.

Onset of Dialysis

An ESRD facility may only receive the onset of dialysis adjustment for adult Medicare ESRD beneficiaries.

The onset period is defined as the initial 120 days of outpatient maintenance dialysis, which is designated by the first date regular chronic dialysis began as reported on the CMS Form 2728. The onset of dialysis adjustment factor is a multiplier used in the calculation of the ESRD PPS per treatment payment amount for dialysis furnished in either an ESRD facility or home setting.

Facility-level adjustments

There are two facility-level adjustments in the ESRD PPS. The first adjustment accounts for ESRD facilities furnishing a low-volume of dialysis treatments. The second adjustment reflects urban and rural differences in area wage levels using an area wage index developed from Core Based Statistical Areas (CBSAs).

Training Add-on

The training add-on payment is computed by using the national average hourly wage for nurses from the Bureau of Labor Statistics. The payment accounts for nursing time for each training treatment that is furnished and is adjusted by the geographic area wage index. The training add-on payment applies to both peritoneal dialysis and hemodialysis training treatments. This amount will be added to the ESRD PPS payment, each time a training treatment is provided by the Medicare certified training ESRD facility.

Outlier Policy

The ESRD PPS provides additional payment for high cost outliers due to unusual variations in the type or amount of medically necessary care when applicable. Outlier payments are based on a comparison of the predicted Medicare allowable payment (MAP) per treatment to actual incurred expenditure per treatment for services which were or would have been considered separately billable prior to the implementation of the ESRD PPS. ESRD outlier services include:

• Renal dialysis services that include drugs and biologicals that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B;

• Renal dialysis services that include laboratory tests that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B;

• Medical or surgical supplies used to administer a renal dialysis service drugs that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; and

• Renal dialysis services that were or would have been, prior to January 1, 2011, separately billable under Part D. Implementation of ESRD-related oral-only drugs, that is oral drugs that do not have an injectable equivalent, has been delayed until January 1, 2024.

The list of ESRD-related outlier services may be found at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Outlier_Services.html.

Acute Kidney Injury

On June 29, 2015, The Trade Preferences Act of 2015 was enacted in which section 808 amended Section 1861(s)(2)(F) of the Social Security Act (42 U.S.C. 1395x(s)(2)(F)) by extending renal dialysis services paid under section 1881(b)(14) to beneficiaries with acute kidney injury effective January 1, 2017.

III. Requirements

The contractor shall provide the necessary personnel, materials, equipment, support and supplies to accomplish the tasks and 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 supplies to accomplish the tasks and 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 discuss their findings inclusive, of additional analyses outside of the bi-weekly conference calls.

Task 1 – Project Management

Task 1a – Transition of workload from outgoing contractor (if required)

If the contractor will be assuming the workload from an outgoing contractor, the transitional phase may begin the day after task order award or another appropriate date as deemed necessary during the task order period of performance. This phase will include, but is not limited to, training staff, coordination, testing access to and ability to utilize claims or relevant data. All transitional activities will be included in the agreed upon. The contractor shall work closely with all appropriate CMS and outgoing contractor staff for the successful transition of workload(s). At the conclusion of the transition period, a fully http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Outlier_Services.html http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Outlier_Services.html operational period will begin. The contractor shall assume all functions prescribed in the SOW during the fully operational period.

Task 1a – Teleconferences and meeting notes

The contractor shall prepare for and participate in scheduled bi-weekly meetings to discuss ongoing research and administrative activities. Prior to each meeting, the contractor shall send out the agenda at least two (2) days before the call. After each meeting, the contractor shall prepare and submit meeting notes to CMS within three (3) days.

During rulemaking cycles, these meetings may need to occur as frequently as daily.

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: Work Plan

The contractor shall prepare a work plan to guide the performance of the work under this task. This plan shall include a narrative that will lay out the timing, sequencing, and duration of activities within the project. The work plan shall include specific deliverables outlined in this Statement of Work, such as progress updates, timing and purpose of reports and documents produced, including draft and final versions of reports. This work plan shall be updated periodically to reflect necessary changes approved by CMS during the Period of Performance (PoP) of the task order. Each time there is a task order modification or a reallocation of resources within the existing scope, budget, or time completion, this work plan will need to be updated.

Task 2 - Meetings

Task 2a – 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 2b – End of Year Project Meeting

The contractor shall present and summarize work conducted during the performance period and identify for the COR and other CMS staff additional findings. In conjunction with this meeting, a Final Analysis Report will be include payment model updates and operational issues associated with the updates. This meeting will focus on discussing and finalizing details associated with the report as well as any remaining contractual issues.

Task 3 – Analytics

Task 3a – Create an analytic plan

The contractor shall produce a plan that describes the approach that will be used to satisfy the deliverables outlined in this SOW. This plan shall include the methods that will be employed to answer analytic questions and also describe analytic methods to assess operational issues, CMS administrative and systems issues, and any potential vulnerabilities.

Task 3b – Create Analytic Files and Programs

The contractor shall develop and update analytical files on a recurring basis as updated data becomes available. The contractor shall have expertise with performing analyses on ESRD claims/cost report data, etc. Since this project is highly technical, the prime contractor (not subcontractors, if applicable) also must have experience with and the data use agreements required for downloading files directly from the CMS mainframe and other environments, such as the Chronic Conditions Warehouse (CCW) and Integrated Data Repository (IDR) in order to continually update analyses as more current data becomes available. The prime contractor must be able to download large data files directly from large CMS data repositories, link to data from other sources, bi-annually update the analytic files with more current data and perform extensive analyses on the data with 2 week turnaround periods (48 hours during rulemaking). A contractor (prime or sub) with experience developing payment systems is strongly preferred. Additionally, the prime contractor must meet the security/systems requirements to house/use CMS data. The contractor should also maintain proactive strategies and the infrastructure necessary for data warehousing and efficient data accessibility by using up-to-date software, hardware, and contractual relationships.

The contractor shall compile and document facility-specific analytical data files, including cost reports for ESRD facilities. In addition, the contractor shall compile and document analytical data files of ESRD PPS claims, Medicare cost report data, and other data determined appropriate for this project. These analytic data files shall be updated at least every year (or twice a year) with more current data. The contractor shall also design and create analytic programs (SAS/STATA programs, etc.) in order to https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html accomplish the tasks in this SOW. These analytic programs shall be used in the analysis. The contractor must be able to have a reasonably quick turnaround with developing the analytic data file and must have a turnaround a turnaround of 2 weeks (48 hours during rulemaking) with performing analysis. The contractor should expect iterative rounds of analysis with CMS comments/direction in each round of analysis. In other words, the results of an analysis may lead to further investigation of the data, which is why a quick turnaround of 2 weeks is essential for this project.

In addition to any preliminary data and analytic files/programs delivered to CMS during the project, the Contractor shall deliver to CMS a final copy of all analytic computer files generated during the study (databases/data files and analytic files/programs) at the end of the task order. All data files submitted to CMS during this project should be provided through CD-ROM, DVD-ROM, portable hard drive, or RACF access. Person or event-level data files should be provided in SAS version 9.4, ASCII and other appropriate data file formats at the COR’s request. The contractor shall encrypt all data delivered on portable media. All CDs, DVDs, data tapes, and other files submitted to the government shall be cleaned, edited, and contain appropriate documentation (e.g., data dictionary) to facilitate secondary analysis. The documentation shall be sufficiently detailed such that the data set(s) can be recreated from primary sources using said documentation. The Contractor will provide sufficient evidence of compliance with Data Use Agreements, e.g., return of original datasets and documentation/evidence of their destruction or archiving as required, covering primary and secondary data sources used in this task order.

All working documents, memoranda, spreadsheets, draft, revised, and final deliverables, survey instruments, data files, analytic files, and any other products related to this task order, which are created during the course of this task order, shall be the sole property of the Centers for Medicare & Medicaid Services.

Task 4 – Research Topics and Analyses

The contractor will perform analyses in order to assess the current payment system in support of our rulemaking and payment policy development. In addition, the contractor will perform any additional analyses to update/implement a revised payment model based upon direction provided. The contractor (or prime contractor, if there are subcontractors) is expected to have several programmers for the project so that analyses can be done in parallel and be performed as quickly as possible.

This is primarily an analytical contract. The contractor shall have quick turnaround in all analyses (at least a one or two week turnaround, 24-48 hours during rulemaking) and the contractor will present a clear write-up describing their methodology (including a clear description of the sample used) and the results along with their analysis. Additionally, the contractor should plan for multiple iterations/variations of the analyses in their budget and work plan. Often, the contractor will be asked to investigate specific findings and follow up with CMS. The contractor should expect a series of back and forth interactions with CMS while developing analyses and the payment methodology options. The contractor will adhere to the technical direction and input given by CMS on the analyses, and should expect that CMS will want the contractor to revise the approach used in their analysis based upon direction provided by the COR. In addition, the contractor will provide CMS with the contractor’s interpretation of the results of these analyses and propose next steps, if necessary, for each of the analyses performed under the task order.

Potential Areas of Study

Category CMS has identified the following issues and actions for monitoring and further research and investigation:

The ESRD PPS Bundle

• Analyze the incidence of procedures (e.g. 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.

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

Unit of Payment Assess and recommend other units of payment such as, a per-week or per-month payment.

ESRD PPS Base Rate • Evaluate and assess the effect of the standardization adjustment, outlier adjustment, budget neutrality adjustment and other adjustments on facilities,' staffing and medical costs.

• 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.

• Recommend other cost components of the base rate (e.g., staffing, other overhead measures) that can be further analyzed.

Analyses based on Current Regression Model

• Replicate the CY 2016 refinement to use as a base for potential future refinement and analysis.

• 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.

• Further study of the association of Medicaid status with cost of dialysis.

• 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.

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

Facility-Level Adjustments • Monitoring the extent to which facilities that provide home dialysis training receive the low volume adjustment and whether the number of low volume facilities increases

• 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.

Pediatric Patients • Research robust pediatric model in which pediatric facility costs are not commingled with ESRD costs from adult facilities

• 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.

Outlier Policy • Simulate outlier payments to update the fixed dollar loss thresholds and Medicare Allowable Payment (MAP) amounts for adult and pediatric patients for each proposed and final rule published during the period of performance.

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

• Explore/develop/test/recommend 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 (e.g. fistula, graft, and 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.

Drugs and Biologicals • Provide pharmaceutical expertise to analyze whether drugs are furnished for the treatment of ESRD.

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

Acute Kidney Injury (AKI) • Identify areas of variance between ESRD beneficiaries and AKI beneficiary’s use of renal dialysis services and identify other services common to AKI patients to ensure appropriate payment policy.

• Monitor outcomes to ensure no impact to beneficiary care.

Task 5 - Activities Necessary for Updating Selected Features of the ESRD PPS (Rulemaking Support and Documentation)

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 limited to, the preparation of new or revised tables in connection with selected features of the ESRD PPS, assistance with simulations of impact, preparation and review of proposed draft and final language for technical competency, and the preparation of analyses as a result of comments received from ESRD stakeholders to support responses. This task also includes the creation of the Public Use Files and data sets for the Office of the Actuary (which includes the Regulatory Impact Analysis).

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 other CMS personnel, as required. Regulation activities may also include participating in meetings with CMS leadership and other ESRD stakeholders. The contractor should anticipate quick turnaround times for these responses – generally 2 weeks, 48 hours during rulemaking.

The regulation cycle for the Notice of Proposed Rule Making (NPRM) is February to July and the regulation cycle for the Final Rule is August to November. During this time frame we anticipate short turnaround times for deliverables and shall require the contractor to be fully staffed to support our rulemaking activities.

Task 6 - 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 on an ad-hoc and 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 within 2 weeks after requirements are established.

Task 7 – Ad hoc analyses

The contractor shall prepare ad hoc analyses as requested by the COR or CMS staff. Deliverable dates will be determined after discussion when the report is discussed. This could include requests from other components within CMS, such as the Office of the Actuary.

Potential Ad Hoc Analyses and Updates

• Provide clinical expertise on advances in the treatment of ESRD (e.g.

equipment, labs, drugs, and 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 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.

• 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.

• Training case study regarding time and cost estimates related to training.

• Run other data analysis as warranted or assigned.

Task 8 – Preparation of annual technical reports

The contractor shall prepare annual reports on the research methods employed and summarize the findings of said research. These reports will be prepared upon 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. The contractor must be able to write a clear, detailed report that can be easily understood and does not need major grammatical or structural edits. The report should be easily understood by the common reader and avoid heavy statistical terminology or descriptions. At the same time, CMS needs adequate information to evaluate and be able to explain to the public methodologies used in the research. The report should be structured logically and effectively written. These reports are expected to be delivered within two (2) weeks of request from the CMS COR.

CMS will provide comments and feedback within two (2) weeks of receipt and will follow up with a discussion. Upon agreement, the final deliverable is due within one (1) week.

Task 9 – 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. This report will be due within 2 weeks of the conference. In the event that the contractor is presenting at a conference, the contractor shall provide the CMS COR with a copy of the presentation materials 2 weeks prior to the presentation for approval. Information regarding this CMS contract is not to be included in papers, presentations, posters, articles, or reports for purposes other than this contract without express written consent by CMS.

Task 10 – 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.

Schedule of Deliverables

Deliverable Number

Task Number

Deliverable Delivery Date

1a Transition Up to 60 days after award

1 2 Kick off meeting Two weeks from award date 2 2 Teleconferences & meeting notes Scheduled biweekly meetings with notes to be submitted within 3 business days, or as required. During rulemaking sessions, these meetings may need to occur as frequently as daily and notes would be expected within 24 hours of the meeting.

3 2 Monthly progress reports 5th of following month for preceding month's activities

4 3 Develop and update analytical files Ongoing 5 3 Develop analytical plans Biweekly 6 5 Updating Activities Within 48 hours of request 7 5 Limited data set Within 48 hours of request 8 5 Provider level impact file Within 48 hours of request 9 6 Reports (projected vs. actual) on selected payment variables Due two weeks from request

10 7 Conduct ad hoc analyses for CMS in response to other Government stakeholder requests

To be determined

11 8 Prepare methodological reports Due two weeks from request 12 9 Conference Reports To be determined 13 10 Final Report To be determined (final option year) 14 1 All data and models developed under this contract to be submitted to CMS at the end of the final option year.

To be determined (final option year)

All deliverables shall submitted via email to the COR.