Kidney Care Choices (KCC) Model

Centers for Medicare & Medicaid Services (CMS)

Center for Medicare and Medicaid Innovation (Innovation Center)

PY2023 Request for Applications (RFA)

Table of Contents

I. The Kidney Care Choices (KCC) Model Overview ............................................................................. 3

A. Background and Introduction ............................................................................................. 3

B. The KCC Model .................................................................................................................. 4

C. Timeline .............................................................................................................................. 5

II. General Provisions ................................................................................................................................ 7

A. Monitoring and Oversight ................................................................................................... 7

B. Remedial Action and Termination ...................................................................................... 7

C. Screening ............................................................................................................................ 8

D. Evaluation ........................................................................................................................... 8

E. Learning and Diffusion Resources ...................................................................................... 9

F. CEHRT Requirements ...................................................................................................... 10

G. Waivers ............................................................................................................................. 10

H. Amendment ....................................................................................................................... 11

III. CMS Kidney Care First (KCF) Option ............................................................................................... 13

A. Legal Entity ....................................................................................................................... 13

B. Governance Structure Requirements ................................................................................ 13

C. Applicant Eligibility ......................................................................................................... 13

D. Beneficiary Alignment ...................................................................................................... 15

E. Finance and Payment ........................................................................................................ 20

F. Quality Strategy ................................................................................................................ 29

G. Benefit Enhancements ...................................................................................................... 29

H. Beneficiary Engagement Incentives ................................................................................. 32

I. Termination ....................................................................................................................... 34

J. Application for KCF Option ............................................................................................. 35

IV.

Comprehensive Kidney Care Contracting (CKCC) Options .............................................................. 40

Legal Entity and Governance Requirements .................................................................... 40

KCE Composition ............................................................................................................. 42

Beneficiary Alignment ...................................................................................................... 44

Finance and Payment ........................................................................................................ 50

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Quality Measures and Scoring .......................................................................................... 65

Benefit Enhancements ...................................................................................................... 66

Beneficiary Engagement Incentives ................................................................................. 73

Termination ....................................................................................................................... 75

Application for CKCC Option .......................................................................................... 76

Appendix A: Glossary of Key Definitions .......................................................................................... 83

VI.

Appendix B. Applicant Selection Criteria and Scoring ...................................................................... 87

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I. The Kidney Care Choices (KCC) Model Overview

A. Backg

round and Introduction

According to 2019 data from the Centers for Disease Control and Prevention (CDC), Chronic Kidney

Disease (CKD) impacts over 37 million or 15% of Americans, and most of them are unaware that their

kidneys have reduced function or are failing. While there are certain factors predisposing people to CKD,

most causes of CKD are acquired rather than inherited. Diabetes and hypertension accounted for up to

two-thirds of all cases, followed by diseases that damage the kidney’s filtration units.

According to the United States Renal Data System (USRDS), in 2017 Medicare beneficiaries with CKD

ccounted for $84 billion in Medicare spending, in addition to $35.9 billion for the End-Stage Renal

Disease (ESRD) population, for approximately $120 billion in total expenditures.

Once an individual has progressed to stage 4 CKD, when their glomerular filtration rate (GFR) has

ecreased to 15-30ml/min, kidney disease has become severe enough that the individual will likely

experience specific symptoms and need to consider planning for dialysis or kidney transplantation. Those

in stage 4 CKD are likely to develop more severe complications such as hypertension, anemia, bone

disease, heart disease, ischemic stroke, and other cardiovascular diseases. Once an individual’s GFR

drops below 15ml/min, they have progressed to stage 5 CKD. During this advanced stage, the kidneys

have lost nearly all function. Without intervention, the patient will progress to ESRD, at which point

dialysis or a kidney transplant is required for survival (National Kidney Foundation, 2018).

A major challenge in the study and treatment of CKD is the heterogeneity of the condition. For most

atients, CKD is asymptomatic and can only be detected with laboratory studies. The time of progression

to ESRD requiring renal replacement is variable depending on the patient and comorbidities. Early

intervention can sometimes slow the progression of CKD and ESRD.

The best renal replacement therapy for most patients with ESRD is a kidney transplant, which replaces

the failed kidneys with a more functional, healthy kidney from either a living or deceased donor. In 2018,

22,393 kidney transplants were performed in the United States, more than half of which were from

deceased donors. Patients who have received a kidney transplant still have kidney disease and still

require long term medications and medical care to ensure the health and function of their transplanted

kidney. However, kidney transplants are associated with improved quality of life, reduced cardiovascular

complications, improved morbidity and mortality, and reduced oxidative stress relative to dialysis. If the

transplanted kidney stops functioning, dialysis or another transplant is needed.

As patients with CKD are educated about their treatment options, some patients consider transplantation

efore, and others after, the initiation of dialysis. At the end of 2020, approximately 92,000 patients were

on the Organ Procurement and Transplantation Network (OPTN) deceased donor kidney transplant

waiting list. The demand for kidney transplant far exceeds the supply. Other barriers to transplantation

include: financial burdens, poor communication between provider and patient, poor patient education

regarding transplantation, lack of access to high quality health care services, and the absence of a

committed care taker.

The Comprehensive ESRD Care (CEC) Model began in October, 2015, and ended March 31, 2021. The

C Model provided financial incentives for dialysis facilities, nephrologists, and other Medicare

providers and suppliers to work together to improve outcomes and reduce per capita expenditures for

aligned ESRD beneficiaries in an accountable care organization (ACO) framework. Key features of the

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CEC Model included: 1) total cost of care accountability; 2) comprehensive and coordinated care

elivery; and 3) improved access to care.

Evaluation of the first four Performance Years (PYs) of the CEC Model for the 37 ESRD Seamless Care

ganizations (ESCOs) that participated in the CEC Model between October 1, 2015 through December

31, 2019) demonstrated promising findings, showing lower spending and improvements on some

utilization and quality measures. Reduced spending for ESCO beneficiaries was primarily attributed to a

reduction in hospitalizations and post-acute care. The CEC Model also showed improvement in quality of

care as demonstrated through a decline in catheter utilization among aligned beneficiaries relative to the

comparison (non-ESCO beneficiary) group.

While the CEC Model showed some positive results, the design had several limitations. Based on lessons

earned from the CEC Model, we have identified the following areas for potential improvement. We have

incorporated these areas in the design of the Kidney Care Choices (KCC) Model, which includes the

CMS Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Options:

•

Including beneficiaries with CKD stage 4 and 5 before they progress to ESRD in the KCC Model

to promote later and better starts on dialysis, or to avoid dialysis entirely.

•

Including beneficiaries after they receive a transplant and incorporating financial incentives to

promote greater utilization of transplants.

•

Empowering nephrologists to take the lead in coordinating care for beneficiaries across the care

spectrum.

•

Including Benefit Enhancements to support improved utilization of skilled nursing facilities

(SNFs) and hospice care, telehealth services, and the Kidney Disease Education (KDE) benefit

•

Addressing nephrologist payment in order to better align payments with care.

The KCC Model seeks to address the limitations observed in the CEC Model in its test of whether a

odel of care in which a single set of health care providers with aligned incentives are responsible for a

patient’s care from the later stages of CKD to and through dialysis, transplantation, or end of life care will

improve overall quality of care and reduce the cost of care for beneficiaries with kidney disease. Statutory

Authority

Section 1115A of the Social Security Act (added by section 3021 of the Affordable Care Act) (42 U.S.C.

1315a

) authorizes the CMS Innovation Center to test innovative payment and service delivery models that

have the potential to lower Medicare, Medicaid, and CHIP spending while maintaining or improving the

quality of beneficiaries’ care. Under the law, preference is to be given to selecting models that also

improve coordination, efficiency and quality of health care services furnished to beneficiaries. Section

1899 of the Social Security Act establishes the Medicare Shared Savings Program, and authorizes CMS to

share Medicare savings with participating accountable care organizations under certain circumstances.

The KCC Model described in this Request for Applications (RFA) uses the CMS Innovation Center’s

thority to test a new model of care delivery and payment for Medicare beneficiaries with late stage

CKD and ESRD. CMS is testing whether the financial risk arrangements outlined in this RFA improve

quality of care for beneficiaries with CKD and ESRD and reduce Medicare costs.

B. The KCC Model

For the KCC Model (or the Model), the Innovation Center builds upon and improves the structure of the

financial and payment elements used in the CEC Model to address areas for potential improvement that

have been identified through testing the CEC Model. The KCC Model has four Model Options fitting in

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with the Innovation Center’s suite of total cost of care models. These Model Options will test whether

hese design elements reduce Medicare spending and improve the quality and coordination of care for

beneficiaries with late stage CKD, ESRD, and kidney transplants.

Under the CMS Kidney Care First (KCF) Option, CMS will make adjusted capitated payments to

rticipating nephrology practices (KCF Practices) for managing beneficiaries with CKD Stages 4 and 5

and ESRD. CMS will additionally make performance-based payment adjustments to both participating

nephrology practices and, separately, to their nephrology professionals based on how well the practice

performs on specified quality measures. The KCF Option is designed to emulate the basic design of the

PCF Model, in which participating practices are accountable for managing the care of attributed

Medicare beneficiaries. The KCF Option further includes Benefit Enhancements and Beneficiary

Engagement Incentives that participating nephrology practices may choose to make available in order to

support high-value services and allow the practices to more effectively manage the care of their aligned

beneficiaries. The KCF Option is a Merit-based Incentive Payment System (MIPS) Alternative Payment

Model (APM) and an Advanced Alternative Payment Model (Advanced APM) beginning in 2022.

For the three Comprehensive Kidney Care Contracting (CKCC) Options, nephrology professionals must

rtner with transplant providers, and may partner with dialysis facilities and other providers and

suppliers to become Kidney Contracting Entities (KCEs). KCEs will receive adjusted capitated payments

for managing beneficiaries with CKD Stages 4 and 5, ESRD, and kidney transplants. The KCE will

select a total cost of care accountability framework, and its payments under the Model will be adjusted

based on its performance on quality measures. KCEs participating in the CKCC Options select one of

following three options: the Graduated Option, the Professional Option, and the Global Option. The

CKCC Options are currently Advanced APMs for PY2022, with the exception of the one-sided Level 1 of

the Graduated Option. Guidance on Advanced APM status for PY2023 is forthcoming. KCEs affiliated

with Large Dialysis Organizations (LDOs) may not participate in the Graduated Option. For the purposes

of the KCC Model, CMS defines an LDO as an entity that as of the effective date of the applicable

Participation Agreement, owns in whole, or in part, more than 500 dialysis facilities. All of the CKCC

Options, including the one-sided Level 1 of the Graduated Option, are MIPS APMs beginning in 2022.

KCEs will also have access to Benefit Enhancements and Beneficiary Engagement Incentives to

strengthen care coordination for aligned beneficiaries and alternative payment mechanisms to manage

cash flow.

The terms of the KCF and CKCC Options of the Model will be set forth in separate participation

agreements

C. Timeline

The KCC Model performance period began on January 1, 2022, and will continue through December 31,

202

6. CMS solicited applications for the first cohort of KCC Model participants in October 2019. The

first cohort of KCC Model participants began their participation in the Model performance period on

January 1, 2022. CMS is now soliciting applications for a second cohort of KCC Model participants.

CMS invites interested applicants to submit their applications to CMS by March 25, 2022. If selected to

rticipate in the Model, the second cohort of KCC Model participants would begin Model participation

on January 1, 2023, after executing performance period participation agreements that will set forth the

terms of the KCF Option or the CKCC Options of the KCC Model, as applicable. The performance period

participation agreements for these KCC Model participants will have a term of four Performance Years

(PYs) (2023, 2024, 2025, and 2026). CMS does not plan to conduct any further solicitations for KCC

Model participants.

Updated 03/06/2022 6

Table 1 provides a high-level timeline of key milestones in the Model.

Table 1. Milestone Timeline

TARGET DATE MILESTONE

July 10, 2019 Advancing American Kidney Health initiative announced, including the

Kidney Care Choices Model

October 2019 Request for Applications for Cohort 1 of the KCC Model released

January 1, 2022 KCC Model PY2022 begins

February 28, 2022 Request for Applications for Cohort 2 of the KCC Model for PY2023

Released

March 25, 2022 Application responses to RFA due from potential KCF Practices and

KCEs

May 13, 2022 CMS releases decisions on Cohort 2 applications

June 1, 2022 Accepted applicants notify CMMI of intent to participate in the KCC

Model

June 29, 2022 Final deadline to add participants to KCF Nephrology Professional List

or KCE Participant or Preferred Provider Lists

No later than November 30,

2022

Selected applicants execute Performance Year Participation Agreements

2023 KCC Model PY2023 begins

2024 KCC Model PY2024 begins

2025 KCC Model PY2025 begins

2026 KCC Model PY2026 begins

December 31, 2026 End of KCC Model performance period

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II. General Provisions

A. Monitoring and Oversight

CMS will conduct monitoring and oversight activities to evaluate participants’ compliance with the terms

the participation agreement and to identify fraudulent behavior or program integrity risks, such as

inappropriate reductions in care, efforts to manipulate risk scores or aligned populations, overutilization,

and cost-shifting to other payers or populations. Each Model participant will be required to cooperate

with, and require its downstream providers and suppliers to cooperate with, CMS monitoring and

oversight activities.

CMS’s monitoring and oversight activities may include, but are not limited to, the following:

•

Analysis of specific financial and performance data reported by the KCF Practice or KCE;

•

Analysis of beneficiary and provider/supplier complaints including, but not limited to, those

submitted through 1-800-MEDICARE, surveys, and internal processes established and supported

by the KCF Practice or KCE for managing such complaints; and

•

Audits, including claims data mining, medical chart review, beneficiary survey data, coding

audits, and on-site compliance reviews.

•

Audit of samples of medical charts;

•

Monitoring of beneficiary complaints and surveys;

•

Interviews with beneficiaries, providers and suppliers

•

Analysis of claims and quality data;

•

Vetting of model participants and their providers/suppliers on the basis of program integrity

issues; and

•

Monitoring for appropriate use of Benefit Enhancements.

B. Re

medial Action and Termination

CMS may take remedial action against a participant for a variety of reasons, including but not limited to

the following:

• The participating entity (KCF Practice or KCE) or its participants’ noncompliance with any term

of the participation agreement;

•

Failure to submit or implement a corrective action plan;

•

Participating entity or its participants’ engage in actions that threaten the health or safety of a

patient or patient quality of care;

•

Submission of false data or other information in connection with the Model; and

•

Participating entity or participants’ past or present program integrity issues.

When grounds for remedial action exist, CMS may employ a variety of actions based on the nature and

severity of the issue identified, including, but not limited to:

•

Notify the participating entity of the grounds for remedial action;

•

Request additional information

•

Request a Corrective Action Plan (CAP);

•

Remove, or require the KCF Practice or KCE to remove, downstream provider or supplier;

•

Discontinue data sharing and reports;

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• Suspend or terminate the use of one or more Benefit Enhancements or Beneficiary Engagement

Incentives; and

• Recalculate payment amounts and recoup amounts owed.

In addition, nothing in the Participation Agreement would prevent CMS from exercising its authority to

make referrals to the Secretary for consideration under Section 1881(c)(3) of the Act or referrals to law

enforcement.

CMS may immediately or with advance notice terminate a participation agreement if grounds for

rem

edial action exist, if CMS determines that it no longer has the funds to support the Model, or as

otherwise specified in the relevant participation agreement. We also note that CMS is required to modify

or terminate the Model unless it is determined that the Model is expected to: (1) improve the quality of

care without increasing spending; (2) reduce spending without reducing the quality of care; or (3)

improve the quality of care and reduce spending.

CMS may add additional program integrity safeguards or other terms to the Model based on experience

during the Model performance period.

C. Screening

CMS may reject an application or terminate a Participation Agreement on the basis of the results of a

ogram Integrity (PI) screening regarding the applicant, its affiliates, and any other relevant individuals

or entities. The PI screening may include, without limitation, the following:

• Confirmation of current Medicare enrollment status and history of adverse enrollment actions;

• Identification of delinquent debt;

• Review of performance in, and compliance with the terms of, other CMS models, demonstrations,

ograms, and initiatives;

• Review of compliance with Medicare program requirements;

• Review of billing history and any administrative audits, investigations, or other activities

conduc

ted regarding suspicious billing or other potential program fraud and abuse;

• Review of any civil or criminal actions related to participation in a federal health care program;

and

• Confirmation that the Applicant ACO has not engaged in anti-competitive practices.

D. Evaluation

In accordance with Section 1115A(b)(4) of the Act, an evaluation of the KCC Model will be conducted to

det

ermine whether the Model results in improved quality of care and reduced Medicare spending.

Pursuant to section 42 CFR 403.1110(b), participants must cooperate with CMS’s evaluation contractor

and provide data as requested. CMS’s model evaluation contractor will perform rigorous quantitative and

qualitative analysis to assess the impact of the KCC Model. A combination of administrative, claims, and

registry data, beneficiary surveys and focus groups, and interviews with providers and suppliers will

inform the research questions for the Model. The CMS Office of the Actuary (OACT) and the HHS

Secretary will take into account this evaluation in determining whether the criteria have been met to

expand the scope and duration of the Model through rulemaking in the future. Specifically, in accordance

with section 1115A(c) of the Act, the Secretary may expand the Model if: (1) the Secretary determines

that expansion is expected to either reduce Medicare expenditures without reducing care quality or

improve the quality of care without increasing spending; (2) the chief actuary of CMS certifies that such

expansion would reduce (or would not result in any increase in) net Medicare program expenditures; and

Updated 03/06/2022 9

(3) the Secretary determines that such expansion would not deny or limit the coverage or provision of

enefits for applicable individuals.

E. Learning and Diffusion Resources

The Innovation Center is working with national healthcare experts to develop resources and activities to

upport participants in the KCC Model. The Innovation Center will support KCEs and KCF Practices in

accelerating their progress towards improving care for CKD Stages 4 and 5, ESRD, and transplant

beneficiaries and achieving financial benchmarks by providing them with opportunities to learn how care

delivery organizations can achieve performance improvements quickly and effectively, and opportunities

to share their experiences with one another and with participants in other Innovation Center

initiatives. The Innovation Center will test various approaches to group learning and exchange, helping

Model participants effectively share their experiences, track their progress, and rapidly adopt new ways of

achieving improvements in quality, efficiency, and population health.

All selected KCF Practices and KCEs will be expected to participate in periodic conference calls and

eetings, and to actively share resources, tools, and ideas with each other.

The aim of the learning and diffusion strategy will be to establish an infrastructure to support shared

earning, improvement efforts, and innovations in care delivery among KCC participants by addressing

the following areas:

1. Assisting participants in applying improvement methods, with rigorous measurement that guides

apid cycle, iterative testing to achieve results.

2. Development of affinity groups among the participants for focused collaboration and sharing on

mmon strategies and topics, leveraging resources, and accelerating learning.

3. Disseminating good ideas and effective practices for both KCEs and KCF Practices as they

erge, thus allowing all participants to benefit from the work of their peers. These efforts will

result in structured case studies, useful and practical metrics, and prepared packages of change

concepts, and best practices.

Figure 1. Learning System

Participants will be expected to actively participate in and shape Learning System activities as part of

their participation in the KCC Model. The Learning System will facilitate peer learning and information

sharing around how best to achieve quick and effective performance improvement. The Learning System

will allow participants to glean promising practices from their peers and to further develop their own

Updated 03/06/2022 10

programs during their participation in the Model performance period. The Innovation Center will

unde

rtake various approaches to group learning and exchange, helping participants to effectively share

their experiences, track their progress, and rapidly adopt new ways of achieving improvements in care

quality, as well as reductions in Medicare FFS expenditures. Potential Learning System activities include

virtual learning sessions, topic-specific webinars, group-specific virtual collaboration, access to data

dashboards, a learning collaborative virtual platform, case studies/toolkits, and an annual face to face

collaborative.

As part of these Learning System activities, participants may also be expected to:

1. Participate in targeted learning on Driver Diagrams, develop and submit to CMS, or its

ontractors, an individualized participant Driver Diagram (after submission to CMS, the Driver

Diagram should be maintained and updated by the participant throughout the life of the Model as

a framework to guide and align the intervention design and implementation activities and shared

with CMS upon request).

2. Answer surveys, participate in interviews or engage in other activities to assist CMS and its

ontractors in identifying their learning needs.

3. Participate in the identification and dissemination of practices that are showing positive outcomes

sharing lessons learned with other Model participants (e.g. presenting on webinars).

4. Participate in at least one virtual KCF or CCKC Model learning activity every quarter during the

odel period.

5. Share with CMS, its contractors, and if relevant, other model participants, information on state

nd federal programs that complement the KCF and CCKC model interventions in the

communities they serve.

6. De

velop, track, and report to CMS on quality improvement efforts, activities, and program

measures, at regular intervals.

7. Par

ticipate in in-person events during some years of the model (TBD). These in-person events

will be held in the Baltimore/District of Columbia area and will be geared towards participant

learning, collaboration, and dissemination of promising practices for KCEs and KCF Practices,

and another participant needs.

F. CEHRT Requirements

KCF Practices and their KCF Nephrology Professionals and KCEs and their KCE Participants must use

ertified Electronic Health Record Technology (CEHRT), as such term is defined under 42 CFR §

414.1305, in a manner sufficient to meet the applicable requirements of 42 CFR § 414.1415(a)(1)(i),

including any amendments.

G. Waivers

The authority for the KCC Model is section 1115A of the Social Security Act (SSA). Under section

115A(d)(1) of the SSA, the Secretary of Health and Human Services may waive such requirements of

Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii) as may be necessary

solely for purposes of carrying out section 1115A with respect to testing models described in section

1115A(b). CMS has waived certain Medicare payment requirements as necessary solely for purposes of

testing the KCF and CKCC Options. Certain payment rule waivers, referred to as “Benefit

Enhancements”, are detailed in Table 8 (KCF Option) and Table 18 (CKCC Option).

For the CKCC Option, and consistent with the authority under section 1115A(d)(1), the Secretary issued a

wai

ver of 1877(a) of the Act (relating to the Federal physician self-referral law) and sections 1128B(b)(1)

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and (2) of the Act (relating to the Federal anti-kickback statute) with respect to any startup arrangement

etween a KCE that has entered into an Implementation Period Participation Agreement and one or more

KCE Participants or Preferred Providers or both (as such terms were defined in the Participation

Agreements for the Implementation Period of the Model), provided that the conditions of the waiver are

satisfied. Because there is no Implementation Period for new applicants, this waiver is not available for

the second cohort of the CKCC Option.

For the CKCC Option, the anti-kickback statute safe harbor for CMS-sponsored model arrangements (42

FR § 1001.952(ii)(1)) is available to protect certain KCE financial arrangements between or among the

KCE, one or more KCE Participants, one or more Preferred Providers or a combination thereof, provided

that such arrangements comply with the applicable requirements set forth in the Performance Period

Participation Agreement for the CKCC Option. In addition, the anti-kickback statute safe harbor for

CMS-sponsored model patient incentives (42 CFR § 1001.952(ii)(2)) is available to protect the following

patient incentives in the CKCC Option, provided that they are furnished in a manner that complies with

the terms of the safe harbor and the relevant requirements set forth in the Performance Period

Participation Agreement: (i) certain in-kind incentives furnished by a KCE, KCE Participant, or Preferred

Provider; (ii) certain cost sharing support for Part B services provided to certain KCE Beneficiaries by a

KCE, KCE Participant, or Preferred Provider; and (iii) certain chronic disease management rewards

furnished by a KCE to certain KCE Beneficiaries.

For the KCF Option, the anti-kickback statute safe harbor for CMS-sponsored model patient incentives

(

42 CFR § 1001.952(ii)(2)) is available to protect the following patient incentives, provided that such

remuneration is furnished in a manner that complies with the terms of the safe harbor and the relevant

requirements set forth in the Performance Period Participation Agreement for the KCF Option: (i) certain

in-kind items and services furnished by a KCF Practice or a KCF Nephrology Professional to a KCF

Beneficiary; (ii) certain cost sharing support for face-to-face visits with KCF Beneficiaries; and (iii)

certain chronic disease management rewards furnished by the KCF Practice to certain KCF Beneficiaries.

Notwithstanding any other provision of this RFA, all individuals and entities must comply with all

plicable laws and regulations, except as explicitly provided in any separately documented waiver issued

pursuant to Section 1115A(d)(1)specifically for the KCC Model. We note that the applicable law does not

include the anti-kickback statute safe harbor for CMS-sponsored models safe harbor, except to the extent

that CMS has made a determination that such safe harbor is applicable to the KCC Model.

Execution of a Participation Agreement to participate in the KCC Model is not intended and shall not be

construed as a waiver by the United States Department of Justice, the Internal Revenue Service, the

Federal Trade Commission, United States Department of Health and Human Services (HHS) Office of

Inspector General, or CMS of any right to institute any proceeding or action against a KCF Practice,

KCE, or any of its affiliated entities for violations of any statutes, rules or regulations administered by the

government, or to prevent or limit the rights of the government to obtain relief under any other federal

statutes or regulations, or on account of any violation of the respective Participation Agreement or any

other provision of law. The Participation Agreements for the KCC Model shall not be construed to bind

any government agency except CMS, and they bind CMS only to the extent provided therein.

H. Amendment

CMS may modify the terms of the KCC Model in response to stakeholder input, to reflect the agency’s

perience with the Model, or as may be required under section 1115A of the Act or any other applicable

provision of law. The terms of the KCC Model as set forth in this Request for Applications may differ

from the terms of the Model as set forth in the Participation Agreement between CMS and the KCF

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Practice or between CMS and the KCE. Unless otherwise specified in the applicable Participation

Agreement, the terms of that Participation Agreement, as amended from time to time, shall constitute the

terms of the KCC Model’s performance period.

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III. CMS Kidney Care First (KCF) Option

Under the KCF Option, participating nephrology practices (referred to as KCF Practices) and their

rticipating nephrologists and non-physician clinicians who specialize in nephrology (referred to

collectively as “nephrology professionals”) will receive capitated payments for managing beneficiaries

with CKD Stages 4 and 5 and ESRD who are aligned to the KCF Practice. KCF Practices will also

receive performance-based payment adjustments to those capitated payments, based on how well the KCF

Practice performs on quality and utilization measures.

A. Leg

al Entity

The applicant must be a Medicare-enrolled entity (i.e., physician practice or professional corporation) that

bills Medicare for physician services rendered by one or more nephrologists by the start of the

performance period. Each applicant must be recognized and authorized to conduct business under

applicable state law.

B. Governance Structure Requirements

A KCF Practice can be governed through the existing organizational structure of the practice, as long as

he existing structure is a single legal entity authorized to undertake the activities required under the

applicable KCF Participation Agreement and meets the requirements stated in this RFA. A separate

governing body or governance structure is not required for participation in the KCF Option.

C. Applicant Eligibility

Nephrology practices are the only entities eligible to apply for the KCF Option. Nephology practices that

articipated in a KCE as a KCE Participant in 2022 cannot apply to be a KCF Practice in 2023 unless

their KCE is terminating effective December 31, 2022 or earlier. KCF Practices include nephrology

professionals, which refers collectively to nephrologists and non-physician clinicians – such as Nurse

Practitioners and Physician Assistants – who specialize in nephrology or primarily provide nephrology

services. Dialysis facilities and other non-nephrologist supplier and provider types cannot to participate

in the KCF Option.

Nephrology professionals in KCF Practices must meet all of the following requirements for the duration

of their participation in the Model:

• Must be enrolled in Medicare.

•

Must have an NPI associated with a primary taxonomy/specialty in kidney health and the

treatment of kidney diseases or self-identify as nephrology professionals for the purposes of this

Model.

CMS will verify this information against PECOS, or through other means, including claims data.

The following is a list of Model policies and requirements that practices must meet in order to participate

n the KCF Option and for the duration of their participation:

• A practice is defined as all individual National Provider Identifiers (NPIs) billing under a single

TIN, which can include practices with a main billing address, but multiple physical locations;

•

The practices will need to demonstrate that at least 50% of the practice’s total Medicare payments

from the previous 12 months comes from nephrology services furnished by nephrologists to

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beneficiaries with CKD Stages 4 or 5, beneficiaries with ESRD, or beneficiaries with a

unctioning kidney transplant. CMS will calculate this threshold based on claims data.

•

CMS encourages participation by practices of all size, including multispecialty practices;

•

At least 80% of all nephrologists that have reassigned their rights to receive Medicare payment to

the practice and provide dialysis management services included in the Monthly Capitation

Payment (MCP) in an outpatient setting must participate in the Model;

•

The practice must maintain a minimum of 350 CKD Stages 4 and 5 and 200 ESRD aligned

Medicare beneficiaries over the course of the Model. There is no requirement that the KCF

Practice furnish services to a minimum number of transplant beneficiaries;

•

The practice and its nephrology professionals must use the CEHRT as such term is defined under

42 CFR § 414.1305;

•

The practice must demonstrate the ability to assume financial risk and make any required

repayments to the Medicare program; and

•

KCF Practices will not be restricted to a specific market area. However, in order to conduct

alignment, CMS will need to determine a KCF Practice’s Service Area. A KCF Practice’s

Service Area is defined as the Medicare Core Based Statistical Areas (CBSAs) and rural counties

in which the KCF Practice’s participating nephrologists and nephrology professionals provide

nephrology services to CKD and ESRD beneficiaries under the practice Tax Identification

Number (TIN).

Nephrology professionals participating in the KCF Option may not participate contemporaneously in a

E or in more than one KCF Practice because CMS uses participating nephrology professionals to align

beneficiaries. A nephrology practice may apply to participate in both the KCF Option and one of the

CKCC Options for 2023. However, if selected for participation in both the KCF Option and one of the

CKCC Options, the practice will have to decide whether to participate in either the KCF Option or one of

the CKCC Options by June 1, 2022.

KCF Nephrology professionals and KCF Practices (collectively known as KCF Participants) and

beneficiaries aligned to a practice participating in the KCF Option, will be able to overlap with an ACO

participating in the Medicare Shared Savings Program. However, KCF Practices participating in both the

KCF Option and a Shared Savings Program ACO are required to have a written statement signed by a

representative of the leadership of the ACO acknowledging that the KCF Practice’s simultaneous

participation in the KCF Option may impact the ACO’s total expenditure calculations under the Shared

Savings Program. KCF Participants will not be allowed to simultaneously participate in other ACO

initiatives or models.

KCF Practices and their nephrology professionals are not permitted to simultaneously participate in the

ndependence at Home Demonstration (IAH), Primary Care First (PCF) Model, ACO Realizing Equity,

Access, and Community Health (ACO REACH) Model (formerly known as Global Direct and

Professional Contracting (GPDC) Model), or Vermont All-Payer ACO Model. For the Maryland Total

Cost of Care Model (MD TCOC), KCF Participants may simultaneously participate in the Maryland

Hospital Payment Program (HPP) and Care Redesign Program (CRP) options, but not the Maryland

Primary Care Program. CMS will use the KCF Practice’s TIN to check whether the KCF Practice is also

participating in the Shared Savings Program, while all other initiatives are checked using both the TIN

and NPIs of the KCF Practice’s nephrology professionals.

Updated 03/06/2022 15

D. Beneficiary Alignment

The patient population for the KCF Option is Medicare beneficiaries with CKD Stages 4 and 5, ESRD,

and kidney transplant recipients. It is important to note that the alignment of beneficiaries to KCF

Practices is for Model test purposes only. Beneficiary alignment is relevant for each KCF Practice’s

utilization calculations, quality performance measurement, and CMS monitoring of claims data.

Beneficiary alignment to a KCF Practice does not inhibit beneficiaries’ freedom to choose to receive care

from other Medicare providers and suppliers within Medicare Fee-For-Service (FFS). Similar to other

CMS programs and models, CMS will not allow beneficiaries that have been aligned to a KCF Practice to

opt out of alignment, but beneficiaries may opt out of CMS sharing certain information about them with

the KCF Practice. CMS will prospectively align eligible beneficiaries to KCF Practices through a claims-

based alignment process. Aligned beneficiaries may obtain nephrology services from nephrology

professionals not participating in a KCF Practice, as well as practices that are not participating in the KCF

Option, which could cause them to be de-aligned from a KCF Practice retroactively during alignment

reconciliation.

1. Beneficiary Eligibility

To be eligible for alignment and to remain aligned to a KCF Practice for a Performance Year,

ben

eficiaries must meet all of the following criteria, except where otherwise noted:

• Have either CKD Stage 4 or 5, or ESRD, or be a transplant recipient with a functioning kidney

who

was previously aligned to the KCF Practice while the beneficiary had CKD Stage 4 or 5 or

ESRD;

• Be enrolled in Medicare Parts A and B;

• Not be enrolled in a Medicare Advantage plan, cost plan, or other non-Medicare Advantage

Medicare managed care plan;

• Reside in the United States;

• Received greater than 50% of their nephrology services and MCP claims within the KCF

actice’s Service Area during the Alignment Lookback Period;

• Be 18 years of age or older;

• Be alive;

• Not have already been aligned to another participant in a Medicare program/demonstration/model

nvolving shared savings or another participant in a Medicare program/demonstration/model

where overlap is not allowed as of the date of alignment for the KCF Option.

• Not have Medicare as a secondary payer;

• Not had a kidney transplant in the last 13 months (initial alignment only);

• Not in an active election period of hospice care at the time CMS conducts alignment; and

• Not received hospice care at any time during the last three months of the 12-month period that

ends

3 months prior to the start of the quarter for which CMS is conducting alignment to the

Practice (“Alignment Lookback Period”) or during the period between the end of the Alignment

Lookback Period and the alignment run date (initial alignment only).

If a beneficiary meets the alignment eligibility criteria described above, the beneficiary will be initially

ali

gned to the KCF Practice if the beneficiary also meets the applicable criteria described in Table 2

below.

After each Performance Year, KCF Practices must have a minimum of 350 aligned Medicare

ben

eficiaries with CKD Stages 4 and 5 and 200 aligned Medicare ESRD beneficiaries or else they will

Updated 03/06/2022 16

have to aggregate their performance. CMS does not require the KCF Practice to have a minimum number

aligned transplant beneficiaries. Once an aligned beneficiary receives a kidney transplant, they do not

count towards a KCF Practice’s minimum required number of aligned CKD or ESRD beneficiaries.

However, if the beneficiary was aligned to a KCF Practice and had CKD Stages 4 or 5 or ESRD for a

period of time during the relevant Performance Year prior to receiving a kidney transplant, that period of

time may count towards the KCF Practice’s applicable alignment.

2. Alignment Process

Beneficiaries will be aligned to a KCF Practice based on services furnished by nephrology professionals

billing under the TIN of the KCF Practice. Aligned beneficiaries will be assigned a status, depending on

whether they have CKD Stages 4 and 5, ESRD, or are a transplant recipient who was previously aligned

to the KCF Practice while they had CKD Stages 4 and 5 or ESRD. This is different than the CEC Model,

where beneficiaries were aligned through the dialysis facility.

CMS believes that aligning beneficiaries to a KCF Practice through the nephrology professional has the

following advantages:

• Prioritizes the nephrologist relationship as the most important one for beneficiaries with CKD

Stages 4 or 5, ESRD, or a kidney transplant;

• Protects the continuity of care by aligning a beneficiary with the same nephrology professional(s)

who

furnished services to them in the past and may still be furnishing services to them at the time

of alignment; and

• Allows for beneficiaries who only dialyze at nursing facilities, instead of outpatient dialysis

cilities, to be aligned to KCF Practices and included in the Model test, if they are seen by the

KCF Practice’s nephrology professionals.

Initial and Quarterly Alignment

CMS will initially align eligible beneficiaries to KCF Practices based on claims for nephrology or dialysis

services during a specified lookback period and the beneficiary’s kidney disease status (i.e. CKD Stages 4

or 5, ESRD, or kidney transplant recipient) at the time of alignment, as summarized in Table 2 below.

CMS will also retrospectively finalize beneficiary alignment as part of a reconciliation process after each

Performance Year, allowing for a minimum of three months claims run-out. CMS will identify the final

aligned beneficiary population for the KCF Practice. Beneficiaries will be de-aligned from a KCF

Practice’s list of aligned beneficiaries if they do not receive certain health services from a KCF Practice

nephrology professional during the Performance Year, or receive the majority of certain health services

outside of the KCF Practice’s Service Area.

KCF Practices will receive a list of initially aligned beneficiaries before the start of the performance

per

iod. KCF Practices will be accountable for the quality of care furnished to these beneficiaries during

the performance period. New beneficiaries who satisfy the alignment eligibility criteria will be added to

each KCF Practice’s alignment list on a quarterly basis. Once aligned, beneficiaries remain aligned to the

KCF Practice until they meet one of the criteria for de-alignment.

Updated 03/06/2022 17

Table 2. Some Alignment Criteria by Beneficiary Type

Beneficiaries with CKD Beneficiaries with ESRD Beneficiaries who

Receive Kidney

Transplants

Aligning

Participant

Nephrology professional Nephrology professional N/A – Must have been

previously aligned by

virtue of CKD or ESRD

Criteria for

Alignment

Diagnosis of CKD Stages

4 or 5; 2 or more

Nephrology Services

(Professional/Carrier

claims) within a 12-month

period with a KCF

Nephrology Professional;

50% or more of

Nephrology Services

within the KCF Practice

Service Area; no MCP

claims

Kidney disease status of

ESRD; 2 or more MCP

claims with a KCF

Nephrology Professional

within a 3-month period;

50% or more MCP claims

within the KCF Practice’s

Service Area;

Being previously aligned

to the KCF Practice as a

CKD or ESRD beneficiary

and receiving a kidney

transplant

Criteria for

De-alignment

Beneficiaries received the

majority of Nephrology

Services outside the KCF

Practice Service Area; or

did not receive any

Nephrology Services from

a KCF Nephrology

Professional during the

months of the performance

year in which they were an

eligible beneficiary.

Beneficiaries received the

majority of MCP claims

outside the KCF Practice

Service Area or did not

receive any MCP claims

with a KCF Nephrology

Professional during the

months of the Performance

Year in which they were

an eligible beneficiary, or

did not receive any

maintenance dialysis

treatments during the

Performance Year.

Kidney transplant failure

(the beneficiary may be

aligned as a CKD or

ESRD beneficiary post-

transplant failure if the

applicable requirements

for alignment are met); 3

years past their transplant

The alignment lookback period is the 12-month period that ends 3 months prior to the start of the quarter

for which CMS is conducting beneficiary alignment within which claims must occur in order to be

considered for the quarterly alignment process. For example, for PY2023 Quarter 1 (PY2023 Q1), the

lookback period is October 2021 to September 2022. CMS will run beneficiary alignment for PY2023 Q1

in October 2022. CMS will then send beneficiary alignment lists to KCF Practices in advance of the start

of the performance period (January 1, 2023).

Ineligibility and Dealignment

If an aligned beneficiary no longer meets certain eligibility criteria, they will remain aligned to the KCF

Pract

ice for the remainder of the Performance Year, but CMS will assign to them an eligibility status of

“ineligible.” Beneficiaries aligned to a KCF Practice during one Performance Year will remain aligned to

the KCF Practice in the next Performance Year, unless they are de-aligned during the annual alignment

reconciliation that occurs after the end of the Performance Year. Ineligible beneficiaries' expenditures are

not counted toward utilization performance calculations for months in which they are ineligible.

Ineligible beneficiaries may become eligible again in the future if CMS determines that they meet

alignment criteria.

Updated 03/06/2022 18

When an aligned CKD or ESRD beneficiary receives a kidney transplant, they will remain aligned to their

KCF Pr

actice for three years from the month of transplant. While the KCF Practice will be eligible to

receive Kidney Transplant Bonus payments, the beneficiary will no longer be included in the KCF

Practice’s quality and utilization performance calculations. If the transplant fails within three years, the

beneficiary will be de-aligned from the KCF Practice. It is possible for a beneficiary whose transplant has

failed to be realigned as a CKD or ESRD beneficiary to the original KCF Practice or to a different KCF

Practice if they meet eligibility requirements. It is also possible that an aligned beneficiary progresses

from CKD to ESRD during the Performance Year. CMS reviews and updates each aligned beneficiary’s

kidney disease status (e.g., CKD, ESRD, or transplant recipient) on a quarterly basis. CMS will also

determine each aligned beneficiary’s final kidney disease status for each month that the beneficiary was

aligned to the practice during a Performance Year after the end of the Performance Year.

De-alignment criteria, including de-alignment based on a beneficiary not receiving care from a KCF

Prac

tice nephrology professional during the Performance Year or receiving the majority of claims for

Nephrology Services or MCP claims outside the KCF Practice’s Service Area, are designed to ensure an

accurate measure of the cost and quality of the beneficiary care in the model test. The de-alignment

criteria are based on the care relationship between the KCF Practice and the aligned beneficiaries. While

there may be some incentive for a KCF Practice to refer aligned beneficiaries outside of the Service Area

in order to de-align them from the KCF Practice (and in doing so, take advantage of the de-alignment

criteria), experience in the CEC Model has shown that the market areas, as defined above, tend to be large

enough that seeking care outside of the market area truly represents a change in beneficiary residence

rather than strategic referrals. This approach balances predictability in beneficiary populations, accuracy

in alignment, and the unique way CKD and ESRD beneficiaries interact with the health care system.

Finalizing Alignment

Alignment will be retrospectively finalized as part of a reconciliation process after each Performance

Year. CMS will identify the final aligned population for the KCF Practice after the Performance Year

allowing for a minimum of three months claims run-out. In certain cases, a beneficiary may become de-

aligned from the KCF Practice alignment list for the entire Performance Year at reconciliation if they:

• Received the majority of their Nephrology Services or MCP claims outside of the KCF Practice’s

Service Area.

• Did not receive any Nephrology Services or MCP claims from a KCF Practice Nephrology

Prof

essional during the months of the Performance Year in which their eligibility status was

“eligible.”

As a result of the quarterly alignment review and/or the reconciliation process, an aligned beneficiary may

be rem

oved from a KCF Practice’s list of aligned beneficiaries for certain months (e.g., months following

a beneficiary’s death).

3. Beneficiary Minimums and Aggregation

During each Performance Year, KCF Practices must have a minimum of 350 aligned Medicare

benefi

ciaries with CKD Stages 4 or 5 and 200 aligned ESRD beneficiaries. If at any point a KCF Practice

drops below the minimum aligned beneficiary threshold, the KCF Practice may be required to submit a

Corrective Action Plan (CAP) explaining the steps it will take to meet the minimum threshold for CMS

review and approval. If, after the end of the Performance Year CMS determines that a KCF Practice did

not maintain these beneficiary minimums during the Performance Year, the KCF Practice will be

required to aggregate its performance with other KCF Practices for purposes of calculating performance

Updated 03/06/2022 19

on quality and utilization measures. If the minimum threshold remains unmet prior to the start of the next

Performance Year , CMS may pursue additional remedial actions including, but not limited to,

termination of the KCF Practice’s Participation Agreement. CMS does not require the KCF Practice to

have a minimum number of aligned transplant beneficiaries.

KCF Practices will have the opportunity to choose an aggregation partner for the purposes of meeting the

minimum number of aligned beneficiaries, subject to CMS approval. The aggregation partner or partners

must be chosen before the deadline specified in the Participation Agreement for the given Performance

Year. If an aggregation partner is not chosen, then CMS will assign an aggregation partner or partners.

A KCF Practice cannot aggregate with a KCE. If at the end of the Performance Year one aggregation

partner meets the minimum aligned beneficiary threshold and others does not, then the performance for

the practices in the aggregation group will still be aggregated. If all aggregation partners meet the

minimum aligned beneficiary threshold at the end of the Performance Year, then the KCF Practices in the

aggregation group will no longer be required to aggregate. There can be up to 5 aggregation partners in a

group in order to meet the minimum aligned beneficiary threshold.

4. Beneficiary Notifications and Marketing Materials

All KCF Practices will be required to share with aligned beneficiaries certain details about their alignment

to the KCF Practice and the practice’s participation in the Model. For KCF Practices’ ease, CMS will

provide templates that participants may use for aligned beneficiary notification purposes. If CMS

provides a template to be used for these notification requirements, such template will include all of the

required information described below and will indicate the required content that the KCF Practices may

not change as well as the places where KCF Practices can insert their own content. The KCF Practice and

its nephrology professionals must also comply with all applicable federal laws regarding interaction with

Medicare FFS beneficiaries.

Specifically, KCF Practices will be required to display materials in their office or facility locations

notifying beneficiaries that they are participating in the Model. KCF Practices are also required to

distribute a paper copy of the informational materials to each aligned beneficiary at the beneficiary’s first

office visit with KCF Practice nephrology professional after the nephrology professional receives notice

that the beneficiary is aligned to the KCF Practice.

The notification must include the following elements:

• A short description of the KCF Option and what that means for their care.

• An explanation that the beneficiary retains full Medicare FFS benefits and the freedom to choose

his or her providers and suppliers, including his or her nephrology professionals.

• Information on how to opt out of CMS sharing certain information about them with the KCF

Practice (described in more detail in the Data Sharing section, below).

• Contact information for the KCF Practice and 1-800-MEDICARE for questions and/or concerns

about beneficiary protections and the KCF Practice’s participation in the KCC Model.

KCF Practices and their nephrology professionals must provide any KCF marketing materials and

activities to CMS upon request. If CMS requests such materials and activities, CMS will review them to

ensure that the materials comply with the terms of the KCF Participation Agreement, including that they

The beneficiary maintains the right to see any Medicare participating healthcare provider at any time under the traditional

Medicare FFS benefit structure. Example language may read “You still have the right to visit any dialysis facility, doctor,

hospital, or healthcare provider that accepts Medicare” and/or “This is not a Medicare Advantage Plan or any kind of managed

care plan.”

Updated 03/06/2022 20

are not inaccurate or misleading, are not discriminatory or used in a manner that is discriminatory, and

make

clear that alignment to a KCF Practice does not remove or otherwise affect a beneficiary’s freedom

to choose a provider or supplier. Additional requirements concerning this review process will be

provided in the KCF Participation Agreement.

To ensure beneficiary freedom of choice, the KCF Practice shall not, and shall require its KCF

Nephr

ology professionals to not, commit any act or omission, nor adopt any policy that inhibits Medicare

beneficiaries from exercising their freedom to obtain health services from providers or suppliers who are

not KCF Participants.

5. Data Sharing

CMS will make historical and monthly claims data available to KCF Practices upon request, consistent

with

data sharing practices in shared savings models and programs, and consistent with all applicable

laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) and the

Part 2 regulations governing the disclosure and use of certain substance use disorder patient records.

Upon a KCF Practice’s request, CMS will make available several types of Medicare data for the sole

pur

poses of developing and implementing activities related to care coordination and quality assessment

and improvement for beneficiaries aligned to the KCF Practice under the KCF Option. Such data may

include: (1) individually identifiable demographic and Medicare eligibility status information about

aligned beneficiaries and various summary reports with data relevant to the KCF Practice’s operations

and performance in the Model (such as data related to quality, expenditures, etc.); and (2) detailed claims

data files that will include individually identifiable claim and claim line data for services furnished by

Medicare-enrolled providers and suppliers to aligned beneficiaries. Historical data files for aligned

beneficiaries will be limited to three years of historical data, consistent with the approach under the CPC+

Model and shared savings models and programs.

The claims data provided to the KCF Practice will not include individually identifiable data for aligned

benef

iciaries who have opted out of data sharing. KCF Practices are required to provide aligned

beneficiaries who inquire about or wish to modify their preferences regarding claims data sharing with

information regarding how to modify their data sharing by calling 1-800-MEDICARE. The

communications that the KCF Practices share with such beneficiaries must note that, even if a beneficiary

has elected to decline claims data sharing, CMS may still engage in certain limited data sharing for care

coordination, quality improvement activities for aligned beneficiaries, and population-based activities

relating to improving health or reducing health care costs, as well as claims data sharing regarding claims

subject to the CKD QCP Fee Reduction.

E. Finance and Payment

CMS will make

the following payments to KCF Practices for aligned beneficiaries with CKD Stages 4

and 5, ESRD, and kidney transplants: :

• CKD Quarterly Capitation Payment (CKD QCP)

• Adjusted Monthly Capitation Payment (A

MCP)

• Kidney Transplant Bonus (KTB)

Updated 03/06/2022 21

The use of this code was discontinued in the CY 2020 PFS final rule. As this code is no longer used, it will not generate

claims. However, we are retaining the code for documentation purposes, as it was used in analyses supporting the development

of the CKD QCP methodology.

1. Payment Types

CKD Quarterly Capitated Payment

CMS will pay KCF Practices through an innovative per beneficiary CKD Quarterly Capitated Payment

(CKD QCP), which combines payment for several different outpatient Evaluation and Management

(E/M) services and other care management services listed below, referred to as Nephrology Services, into

a single capitated payment. The CKD QCP is intended to provide an upfront payment to facilitate

delivery of care for aligned beneficiaries with CKD Stages 4 or 5. The CKD QCP will replace Medicare

FFS payments for Nephrology Services furnished to aligned beneficiaries by nephrology professionals in

the KCF Practice.

KCF Practices will be required to have financial arrangements with their nephrology professionals to

reimburse these practitioners for services provided. These arrangements must be negotiated in good faith

and be consistent with fair market value. Nephrology professionals will still be required to submit

Medicare FFS claims as they would otherwise for services for which CMS pays the CKD QCP . CMS

will only pay the CKD QCP to the KCF Practice for Nephrology Services furnished to aligned

beneficiaries with CKD Stages 4 or 5. The CKD QCP is designed to allow flexibility in care delivery and

provide a more stable payment stream to deliver advanced care for aligned beneficiaries with CKD Stages

4 or 5. The prospective increase in cash-flow may result in increased beneficiary access to nephrologist

care for their CKD, improved efficiency and coordination in addressing health issues, and improved

patient experience. The Model will test whether upfront, predictable revenue will help nephrology

professionals or the KCF Practice to coordinate care for aligned beneficiaries with other specialists to

better address their renal needs.

Table 3. Nephrology Services Included in the CKD QCP

Service Type Codes

Office/Outpatient Visit E/M 99201-99205,

99211-99215,

Complex Chronic Care Coordination Services 99487

Home Care / Domiciliary Care E/M 99348-99349

Prolonged E/M 99354-99355

Transitional Care Management Services 99495-99496

Advance Care Planning 99497-99498

Welcome to Medicare and Annual Wellness Visits G0402, G0438,

G0439

Chronic Care Management Services 99490

Prolonged non-face-to-face E/M Services 99358

Assessment/care planning for patients requiring CCM services G0506

Online digital E/M for an est. patient, for up to 7 days 99421 – 99423

Phone E/M phys/qhp 99441 – 99443

Updated 03/06/2022 22

Nephrology professionals in KCF Practices will continue to receive normal fee-for-service payments for

services furnished to aligned beneficiaries that are not included in the CKD QCP, such as inpatient visits,

and services for beneficiaries with CKD Stages 4 and 5 who have received transplants. Nephrology

professionals in KCF Practices will also continue to receive normal fee-for-service payments, rather than

the CKD QCP, for services furnished to beneficiaries who are not aligned to the KCF Practice. Aligned

beneficiary cost sharing for the services included in the CKD QCP will be set at the cost-sharing amount

which a beneficiary would have paid for the particular Nephrology Service furnished to the beneficiary

during a particular encounter, rather than the amount the beneficiary would have had to pay based on the

CKD QCP amount. The CKD QCP amount will be approximately one third the KCF Practice’s

anticipated two- or three-monthly recent visit MCP rate from the most recent Physician Fee Schedule.

The CKD QCP payment amount will be the same amount for a CKD Stage 4 or CKD Stage 5 beneficiary.

These payments will not be risk adjusted, given very similar risk profiles in the CKD Stages 4 and 5

populations.

Because the CKD QCP is paid prospectively, KCF Practices may receive CKD QCPs for beneficiaries

who

are deemed eligible at the time of alignment but are subsequently found ineligible for some period of

time during the quarter. As a result, CMS will withhold a percentage of the CKD QCP amount paid each

quarter to account for these changes in alignment status and will calculate alignment-based adjustments

after the Performance Year to ensure CMS did not overestimate the withhold. The withhold and

adjustments ensure that the CKD QCP (and corresponding FFS claims for services included in the CKD

QCP) is paid accurately for services provided. For PY2023 CMS will withhold 20 percent of CKD QCP

amounts that would otherwise be paid to participants during the Performance Year. This percentage is

unlikely to change and CMS currently plans a 20% withhold for PY2023, but CMS may increase or

decrease the withhold percentage for entities participating in PY2023 and subsequent Performance Years

if indicated by the KCC’s Model’s prior financial data. We refer to this withhold as the CKD QCP

Alignment Withhold (note that this withhold is different from the CKD QCP reduction applied above for

cost-sharing). After the end of each Performance Year, CMS will reconcile the CKD QCP Alignment

Withhold against the value of the KCF Practice’s alignment adjustments. Based on this analysis of

changes in beneficiary alignment, CMS will pay to the KCF Practice any amount owed to the Practice,

but the KCF Practice will not be liable for payments to CMS even if the KCF Practice is deemed to owe

CMS.

CMS will adjust the CKD QCP to account for “leakage,” or the dollar value of FFS claims for

phrology Services furnished to aligned beneficiaries by nephrology professionals that are not in the

KCF Practice that receives the CKD QCP during a Performance Year. CMS will do so through a

prospective CKD QCP leakage withhold, which is 10% of the CKD QCP paid to a KCF Practice. This

adjustment incentivizes a sustained doctor-patient relationship; increases in services delivered by

nephrology professionals outside of the KCF Practice to aligned beneficiaries will lead to a reduction in

the CKD QCP paid to the KCF Practice. CMS will determine leakage for each KCF Practice, and after the

Performance Year, CMS will reconcile the 10% CKD QCP leakage withhold to the actual amount of the

leakage. Based on this analysis, CMS will either pay the KCF Practice any amount of the leakage

withheld in excess of actual leakage during the Performance Year, or recoup from the KCF Practice any

amount that the KCF Practice owes to CMS because the actual leakage exceeded the CKD QCP leakage

withhold. Consistent with PCF, to support continuous care, CMS may also share data with participants on

Nephrology Services delivered outside of the KCF Practice to the KCF Practice’s aligned beneficiaries.

Updated 03/06/2022 23

Adjusted Monthly Capitation Payment (AMCP)

Currently, Medicare pays physicians and other practitioners who manage dialysis care for beneficiaries

receiving dialysis through the MCP. The per-patient-per-month MCP is for all outpatient visit services

related to the dialysis patient’s ESRD. The amount of the MCP varies based on several criteria:

• The location where the beneficiary dialyzes (at home or in center).

• The number of face-to-face visits with the beneficiary for beneficiaries who dialyze in center (one

monthly visit, two- or three-monthly visits, or four or more monthly visits).

• The age of the beneficiary.

Under the KCF Option, CMS will modify payments made to KCF Practices under the current MCP

structure. KCF Practice nephrologists and nephrology professionals will continue to bill the MCP as they

ordinarily would and will receive the MCP FFS amount from CMS that they would have received had

they not been in the Model.

However, the current payment structure of the MCP can create a bias towards in-center hemodialysis

because the highest MCPs are available for beneficiaries who dialyze in-center and receive four in-person

visits a month. According to a 2015 Government Accountability Office (GAO) report, equalizing

nephrologist payments for home and in-center dialysis removes the financial disincentive for prescribing

home dialysis and supports beneficiaries dialyzing at home.

The AMCP addresses this disincentive for prescribing home dialysis through the Home Dialysis True-Up,

which will standardize MCP reimbursement amounts for nephrology services regardless of where a

beneficiary dialyzes. The national average MCP for a nephrologist who visits a patient in-center 4 or

more times per month is $221 PBPM. The majority of MCP claims (over 70%) are billed at this 4+

monthly visit level. The national average MCP for a nephrologist who delivers care to a patient who

dialyzes at home is approximately $185 PBPM. The AMCP standardizes the MCP for home dialysis and

in-center dialysis patients by paying KCF Practices an additional $35 per MCP home dialysis claim for

services delivered to aligned ESRD beneficiaries. CMS will make this payment to KCF Practices at the

end of the Performance Year.

Therefore, the AMCP consists of the MCP, which is paid to each nephrology professional at current FFS

rates, plus the Home Dialysis True-Up, which is paid to the KCF Practice after financial reconciliation

after the end a given Performance Year. As a result, the AMCP reduces the variance in reimbursement

for ESRD dialysis services delivered to aligned beneficiaries who dialyze in center compared to at home.

Unlike the CKD QCP, which is paid to the KCF Practice on a prospective basis, CMS will pay the KCF

Practice the Home Dialysis True-Up component of the AMCP in a lump sum after the end of the

Performance Year.

Kidney Transplant Bonus (KTB)

KCF Practices are eligible for a Kidney Transplant Bonus (KTB) payment for every kidney transplant

received by an aligned beneficiary with CKD or ESRD during the Model performance period, regardless

of whether it is a living or deceased donor transplant.

The KTB will create a direct incentive for model

participants to support beneficiaries through the transplant process, including continued care management

of patients to support graft success.

CMS recognizes the lack of supply of available kidneys and that nephrologists do not control access to

the transplant wait list. However, CMS believes that this payment could better incentivize providers and

KCEs and KCF Practices would also receive the KTB payment when an aligned beneficiary receives any future FDA-approved

products that replace physiological kidney function.

Updated 03/06/2022 24

suppliers to move beneficiaries onto the waitlist, assist beneficiaries with understanding and progressing

through the living donation process, and support beneficiaries after they receive a transplant in

maintaining the health of the transplanted organ.

As stated, the purpose of the KTB is to incentivize KCF Practices to support beneficiaries during and after

the transplant process through care coordination and other services – including patient engagement and

support – that are necessary to maximize the likelihood of long-term success for an organ transplant.

CMS does not intend that the KTB be used for, or imply that model participants are permitted to, exert

inappropriate influence over the transplant process, or that model participants can acquire, receive, or

otherwise transfer organs in exchange for valuable consideration. The exchange or transfer of valuable

consideration for a human organ for transplantation is in violation of section 301 of the National Organ

Transplant Act of 1984 (NOTA), as amended. Certain payments, including “reasonable payments

associated with the removal, transportation, implantation, processing, preservation, quality control, and

storage of a human organ,” are not valuable consideration for purposes of this criminal prohibition.

Inappropriate or illegal use of the KTB, in violation of NOTA or any other laws or regulations, would

result in removal from the Model and referral to the appropriate law enforcement organization.

The KTB is up to $15,000 per successful transplant, paid in installments to the KCF Practice at set

intervals following the transplant. In particular, the KTB will be disbursed to the KCF Practice in three

installments as follows: $2,500 one year after transplant, $5,000 two years after the transplant, and $7,500

three years after the transplant. In order to receive KTB installment payments, three criteria must be met

at the time of disbursement, as follows:

• The beneficiary must remain alive.

• The beneficiary’s kidney transplant has not failed (e.g., the beneficiary must not have returned to

maintenance dialysis).

• The KCF Practice must be participating in the Model.

The KTB installment schedule and amounts differ depending on when the beneficiary receives their

transplant. To ensure that CMS makes all KTB payments before the final settlement for the final

Performance Year is completed, CMS will alter both the amount and schedule of KTB installments for

transplants made in PY2025 and PY2026. CMS will increase the proportion of the KTB paid to

participants in CY2027 to ensure that no KTB payments are made to KCF Practices after CY 2027.

Table 4. Schedule of KTB Installments

Installment

Transplants

PY2022 – PY2024

Transplants PY2025 Transplants PY2026

Amount per

Transplant

Date of

Payment*

Amount per

Transplant

Date of

Payment*

Amount per

Transplant

Date of

Payment*

Installment $2,500 1 year after

transplant

$2,500 1 year after

transplant

$2,500 1 year after

transplant

Installment

$5,000 2 years after

transplant

$5,000 2 years after

transplant

$2,500 1 year after

transplant

Installment

$7,500 3 years after

transplant

$3,750 2 years after

transplant

$3,750 1 year after

transplant

Maximum

Total KTB

$15,000 $11,250 $8,750

*Provided transplant remains successful

Updated 03/06/2022 25

2. Performance-Based Adjustment (PBA)

In addition to the CKD QCP and AMCP, the KCF Option will include a Performance-Based Adjustment

BA), which could increase the amount of the CKD QCP and the MCP component of the AMCP for a

KCF Practice by up to 20 percent, or reduce that amount by as much as 20 percent.

Two distinct sets of performance measures will be used in calculating the PBA, which are described in

etail under Quality Strategy:

•

Quality Gateway Measures – a set of quality measures, with performance thresholds, designated

to reflect appropriate clinical care and patient experience for the affected population.

•

Utilization Measures - aimed at incentivizing efficient and appropriate provision of

health care services for the patient population.

There are two components of the PBA, each of which factors in the Quality Gateway and Utilization

easures:

•

Relative Performance (RP) Component – Each KCF Practice’s performance is assessed using a

set of the Quality Gateway measures. If the KCF Practice passes the Quality Gateway then CMS

will assess its performance on the Utilization measures relative to other KCF Practices.

Depending on this relative performance, the KCF Practice’s performance on the Utilization

measures may also be compared to that of all nephrology practices nationwide. As a distinct

component of the PBA, this financial adjustment based on relative performance could be either

positive or negative.

•

Continuous Improvement (CI) Component – For each KCF Practice that passes the Quality

Gateway threshold and achieves sufficient improvement on Utilization measures as compared to a

prior performance period, the PBA will include the CI component.

The PBA is the sum of the RP Component and the CI Component, which are assessed based on the KCF

actice’s performance during 12-month performance periods. After the end of the performance period,

CMS calculates the RP and CI Components, to determine the KCF Practice’s PBA. The PBA is applied to

the CKD QCP and the MCP component of the AMCP beginning in the third quarter that follows the end

of the performance period. Table 5, below, illustrates the relationship between PBA performance periods

and PBA payment adjustment periods.

Table 5. Timeline for Applying PBA to Model Payments

PBA Performance, Calculation, and Payment Adjustment Period

PBA

Payment

Applied

PY2023 PY2024 PY2025 PY2026

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

PY2024Q3 -

PY2025Q2

(for RP

only)

Measurement

Period

Calculate Adjustment Period

PY2025Q3 -

PY2026Q2

(RP and CI)

Measurement Period Calculate Adjustment Period

Updated 03/06/2022 26

PBA Performance, Calculation, and Payment Adjustment Period

PBA

Payment

Applied

PY2023 PY2024 PY2025 PY2026

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

PY2026Q3-

PY2026Q4

(RP and CI)

Measurement Period Calculate

Adjustment

Period

Measurement

Period

Data collection on measure performance concludes at end of PBA performance period

Calculation

Period

PBA amount calculated during PBA calculation period based on performance during PBA performance

period

Adjustment

Period

Performance-based adjustment applied to CKD QCP and AMCP during the PBA payment adjustment

period

For each KCF Practice, determination of the PBA will proceed according to a sequence of steps.

Relative Performance (RP) Component Calculation

Each KCF Practice will be placed into one of five performance levels (RP Level(s)), based on the

following determinations:

For each 12-month performance period, CMS will calculate the KCF Practice’s performance on the

uality Gateway measures to determine if the KCF Practice achieved the Quality Gateway threshold, and

will calculate the KCF Practice’s performance on the Utilization measures.

• If the KCF Practice passes the Quality Gateway threshold, then it will be placed in RP Levels 1

through 5;

•

If the KCF Practice does not pass the Quality Gateway threshold, it will automatically be placed

in RP Level 5.

For KCF Practices that pass the Qu

ality Gateway threshold, the RP Level (1 through 5) and the

corresponding RP Component of the PBA will be determined by performance on the Utilization

measures:

• First, the KCF Practice’s performance on the Utilization measures will be compared to all other

KCF Practices.

•

If the KCF Practice’s performance on the Utilization measures is in the top 50 percent of all KCF

Practices, then it is placed within RP Levels 1 or 2, with the specific level depending on the KCF

Practice’s performance. The RP Component for these RP Levels will be positive, with the

magnitude of adjustment increasing with relative performance.

•

If the KCF Practice’s performance on the Utilization measures is in the bottom 50 percent of all

KCF Practices, then the RP Level will be determined by its performance in comparison to all

nephrology practices nationwide. If the KCF Practice’s performance on the Utilization measures

falls:

Within the top 50 percent of nephrology practices nationwide, then the KCF Practice will

be placed in RP Level 3, which results in a 0% RP Component of the PBA.

Updated 03/06/2022 27

o Between the 50

and 25

percentile of nephrology practices nationwide, then the KCF

Practice will be placed in RP Level 4, which results in a negative RP Component of the

PBA.

o In the bottom 25

percent, or below the 25

percentile, of nephrology practices

nationwide, then the KCF Practice will be placed in RP Level 5, which results in the

largest negative RP Component of the PBA.

Table 6 summarizes the RP Levels, along with the resulting either positive or negative RP adjustments.

Table 6. Magnitude of the RP Component by RP Level

RP Level Criteria for RP Level RP Component

Level 1 Top 25% of KCF Practices +10%

Level 2 26% – 50% of KCF Practices +2%

Level 3 Bottom 50% of KCF Practices and the top 50% of nephrology

practices nationally

Level 4 Bottom 50% of KCF Practices and 51% – 75% (25

to 50

percentile) of nephrology practices nationally

-6%

Level 5 Bottom 50% of KCF Practices and bottom 25 percent (below

the 25

percentile) of nephrology practices nationally or did

not pass Quality Gateway

-20%

Continuous Improvement (CI) Component Calculation

For each 12-month period, starting in PY2024, the KCF Practice’s PBA may include a CI Component.

• If the KCF Practice passes the Quality Gateway threshold, then it will be eligible for the CI

Component. The extent of improvement needed on the Utilization measures to receive the CI

Component of the PBA, as well as the magnitude of the CI Component, will depend on the RP

Level for the KCF Practice.

• If the KCF Practice does not pass the Quality Gateway threshold, then it will not be eligible for

the CI Component.

CMS will assess KCF Practice improvement based on comparing the KCF Practice’s performance on the

Utilization measures to a previous performance period. For KCF Practices that begin participation in

PY2023, the first CI Component will be determined by comparing a KCF Practice’s performance on

utilization between the 12-month performance period for PY2023 and the 12-month period for? PY2024.

The CI Component and RP Component are added to calculate the PBA, and the PBA is then applied to

the CKD QCP and MCP component of the AMCP for a KCF Practice beginning in PY2025 Q3. The

target improvement on Utilization measures from one performance period to another will range from 3.5

to 5 percent.

The CI Component will range between 4 percent and 10 percent. Table 7 details the percent improvement

in Utilization measures needed for each RP Level, and the amount of the CI Component, as a percentage

of the CKD QCP and MCP component of the AMCP.

Updated 03/06/2022 28

Table 7. Magnitude of CI Component and percent improvement on Utilization measures needed by PBA

performance level

RP Level Target: Required Percent

Improvement on Utilization

Measures to receive CI

Component

CI Component

Level 1 +3.5% +10%

Level 2 +4.0% +5%

Level 3 +4.5% +4%

Level 4 +4.5% +4%

Level 5 +5.0% +10%

Magnitude of the PBA

For KCF Practices entering the Model in PY2023, the PBA will be based solely on the RP Component.

Therefore, for PBAs applied from July of PY2024 through June of PY2025, the PBA will range from +20

percent (maximum upside potential) to -20 percent (downside risk) adjustment to the CKD QCP and the

MCP component of the AMCP for the measurement period. We believe that this risk structure, along

with the frequency of assessment, will provide an incentive for continuously improving health outcomes

for aligned beneficiaries and reducing unnecessary utilization.

Table 8. PBA Magnitude by PBA Level –Starting in PY2024

PBA RP Level PBA Components (Percent

Adjustment to CKD QCP & MCP

component of the AMCP)

Total PBA Impact (% Adjustment

to CKD QCP and MCP component

of the AMCP)

Relative

Performance RP

Component

Continuous

Improvement CI

Component

(Available

starting PY2025)

RP + CI

(Maximum

Upward PBA

Adjustment)

(Available

Starting PY2025)

RP Only

(Does not qualify

for CI)

Level 1

+10% +10% +20% +10%

Level 2 +2% +5% +7% +2%

Level 3

+0% +4% +4% 0%

Level 4

-6% +4% -2% -6%

Level 5

Passed Quality

Gateway

-20% +10% -10% -20%

Failed to Pass

Quality Gateway

-20% 0% -20% -20%

Updated 03/06/2022 29

F. Quality Strategy

ere are two sets of measures that CMS will use to evaluate the performance of KCF Practices: Quality

Gateway measures and Utilization measures. The Quality Gateway measure set includes measures that

indicate appropriate clinical care and engagement for the patient population. These measures are directly

and indirectly related to the beneficiary’s kidney disease, and applicable to both patients with CKD Stages

4 or 5 and patients with ESRD. The Utilization measure set includes measures of health care utilization

that are direct outcomes of quality clinical care, care management, and care coordination. These will be

adapted for the Model context from existing measures with demonstrated reliability and validity, if

adaptions are necessary.

As described above, both the Quality Gateway and Utilization measures will be used to determine the RP

nd CI components of the PBA.

The Quality Gateway measures are:

•

Gains in Patient Activation (PAM®) Scores at 12 Months; NQF ID #2483

•

Depression Remission at Twelve Months – Progress Towards Remission; NQF ID #1885

The Utilization measures are:

•

Optimal End Stage Renal Disease (ESRD) Starts; NQF ID #2594 – This measures the percentage

of new ESRD patients during the measurement period who experience a planned start of renal

replacement therapy by receiving a preemptive kidney transplant, by initiating home dialysis, or

by initiating outpatient in-center hemodialysis via arteriovenous fistula or arteriovenous graft.

•

Per Capita Costs Measures – The Innovation Center has worked with CMS Center for Clinical

Standards and Quality (CCSQ) to develop two total cost of care measures that are similar to the

Total Per Capita Costs (TPCC) measure that CMS currently uses in MIPS, but are appropriate for

the KCC Model's patient and participant population. There are two cost measures: one for CKD

Stages 4 or 5 and one for ESRD. These measures are payment standardized, annualized, risk

adjusted, and specialty adjusted to evaluate the overall efficiency of care provided to KCF

Beneficiaries.

Measures to be developed

CMS will develop new performance measures for the specific patient population that incentivize optimal

care management that delays progression to ESRD or dialysis and lowers mortality. The measures under

development – i.e., Standardized Mortality Ratio for Late Stage CKD and ESRD, and Measure of Delay

or Reduction of Progression to ESRD (or dialysis) – will be incorporated into the KCF quality strategy as

they become available.

G. Benefit Enhancements

Under section 1115A(d)(1) of the Act, the Secretary of Health and Human Services may waive such

requirements of Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and

certain provisions of section 1934 of the Act as may be necessary solely for purposes of carrying out

section 1115A with respect to testing models described in section 1115A(b). CMS has found that it is

necessary for purposes of testing the KCF Option to waive certain provisions of the Medicare statute and

regulations. As a result of these waivers, participating KCF Practices can choose to make certain

additional benefits available to their aligned beneficiaries during the performance period of the Model.

Updated 03/06/2022 30

These additional benefits are referred to as benefit enhancements. CMS anticipates that the following

ben

efit enhancements will be available for PY2023:

Table 9. Benefit Enhancements

Name Description

Kidney Disease

Education (KDE)

Benefit Enhancement

Medicare currently covers up to six 1-hour sessions of KDE services for

beneficiaries that have CKD Stage 4. While the KDE benefit is intended to

ensure beneficiaries are informed about the effects and treatment of kidney

disease, diet and nutrition, transplantation, dialysis modalities, and vascular

access, the uptake of this service has been exceptionally low at less than two

percent of eligible patients. In the KCC Model, beneficiary education is a

crucial component of increasing rates of transplants and home dialysis and

delaying the onset of ESRD. Therefore, CMS will make available to KCF

Practices a conditional waiver of certain KDE requirements as necessary to

test ways to increase the provision of the KDE benefit under the KCC Model.

The programmatic waivers would:

• Waive the requirement that the KDE be performed by a physician,

physician assistant, nurse practitioner, or clinical nurse specialist to allow

certain additional types of clinical staff to furnish KDE services incident to

the services of a participating KCF Nephrology Professional.

• Waive the requirement that a beneficiary have Stage 4 CKD in order to

test furnishing the KDE benefit to beneficiaries with CKD Stage 5 and

those in the first 6 months of starting dialysis, who can also benefit from

KDE.

• Waive the requirement that the content of KDE services include the

management of comorbidities, including for the purpose of delaying

initiation of dialysis, to allow participating nephrologists to cover this

topic only where relevant to a beneficiary, as delaying dialysis would not

be relevant to beneficiaries with ESRD who have already begun dialysis.

• Waive the requirement that an outcomes assessment designed to measure

beneficiary knowledge of chronic kidney disease and its treatment be

conducted during one of the KDE sessions, provided that such an

assessment is administered by a qualified person (as that term is defined

under 42 CFR 410.48(a)) within one month of a beneficiary’s final KDE

session.

Updated 03/06/2022 31

Name Description

Post-Discharge Home

Visits Benefit

Enhancement

CMS will make available to KCF Participants a conditional waiver of certain

supervision requirements in order to allow payment for certain home visits to

eligible, non-homebound aligned beneficiaries when such home visits are

furnished “incident to” a physician’s (or other practitioner’s) professional

services by “auxiliary personnel” as defined in 42 CFR §410.26(a)(1), under

general supervision (instead of direct supervision) of a physician or other

practitioner who is a KCF Participant.

Payment for these visits will only be allowed when visits are furnished

following the beneficiary’s discharge from an acute inpatient hospital,

inpatient psychiatric facility, inpatient rehabilitation facility, long-term care

hospital, or skilled nursing facility. The beneficiary must not qualify for

Medicare coverage of home health services (or qualifies for Medicare

coverage of home health services on the sole basis of living in a medically

underserved area). Further, a beneficiary would not be eligible to receive

covered home visits under this Benefit Enhancement if they are receiving

services under the Home Health Homebound Waiver Benefit Enhancement.

Also, under this benefit enhancement, a beneficiary is eligible to receive up to

nine post-discharge home visits within 90 days following discharge. The nine

home visits do not accumulate across multiple discharges; if the beneficiary is

admitted within 90 days of the initial discharge and before receiving nine

home visits, the beneficiary may receive only nine home visits in connection

with the subsequent discharge.

Telehealth Benefit

Enhancement

CMS will make available to qualified KCF practices a conditional waiver of

the following requirements with respect to otherwise covered telehealth

services furnished by an Eligible Telehealth Provider to a KCF Beneficiary

when furnished in accordance with the CKCC PA :

1. Waiver of Originating Site Requirements. CMS waives the

requirements in Section 1834(m)(4)(C) of the Act and 42 CFR §

410.78(b)(3)–(4) with respect to telehealth services furnished in

accordance with the CKCC PA.

2. Waiver of Originating Site Requirement in the Eligible Telehealth

Individual Provision. CMS waives the requirement in Section

1834(m)(4)(B) of the Act that telehealth services be “furnished at an

originating site” when the services are furnished in accordance with

the CKCC PA.

3. Waiver of Originating Site Facility Fee Provision. CMS waives the

requirement in Section 1834(m)(2)(B)(ii) of the Act and 42 CFR §

414.65(b)(3) with respect to telehealth services furnished to a

Beneficiary at his/her home or place of residence when furnished in

accordance with the CKCC PA.

Updated 03/06/2022 32

H. Beneficiary Engagement Incentives

General

Except as permitted by applicable law and the KCF Participation Agreement, KCF Practices are

rohibited and shall ensure that its and KCF Nephrology Professionals, and other individuals or entities

performing functions and services related to KCF activities shall not provide gifts or other remuneration

to beneficiaries to induce them to receive items or services from the KCF Practice or KCF Nephrology

Professionals, or to induce them to receive or to continue to receive items or services from the KCF

Practice or KCF Nephrology Professionals. During a performance year, KCF Practices, KCF Nephrology

Professionals, and other individuals or entities performing functions or services related to KCF Practice

activities will be permitted to furnish certain in-kind incentives described below in accordance with

requirements set forth in the KCF Participation Agreement and applicable law. In addition, a KCF

Practice may elect to offer the Cost-Sharing Support for Face-to-Face Visits Beneficiary Engagement

Incentive, the Chronic Disease Management Reward Beneficiary Engagement Incentive, or both (each, a

“Beneficiary Engagement Incentive”) to certain KCF Beneficiaries subject to compliance with the KCF

Participation Agreement and applicable law.

In-kind Incentives

CMS believes that beneficiary engagement is an important part of encouraging more active participation

beneficiaries in their health care. Beneficiary engagement and coordination of care could be enhanced

by providing certain in-kind incentives to beneficiaries that would potentially encourage beneficiaries to

become actively involved in their care. Subject to compliance with all applicable laws and regulations and

the terms of the KCF Participation Agreement, KCF Practices, KCF Nephrology Professionals, and other

individuals or entities performing functions or services related to KCF activities will be permitted to

provide in-kind items or services to certain KCF Beneficiaries, if the following conditions are satisfied:

1. There is a reasonable connection between the in-kind items or services and the medical care of the

eneficiary;

2. The items or services are preventive care items and services or advance a one or more of the

ollowing clinical goals for the KCF Beneficiary: including adherence to a treatment regime

(including prescribed medication); adherence to a follow-up care plan; or management of a chronic

disease or condition;

3. The in-kind item or service is not a Medicare-covered item or service for the KCF Beneficiary on the

ate the in-kind item or service is furnished to that beneficiary (for purposes of this exception, an item

or service that could be covered pursuant to a Benefit Enhancement is considered a Medicare-covered

item or service, regardless of whether the KCF Practice selects to participate in such Benefit

Enhancement for a given Performance Year); and

KCF Practices and KCF Nephrology Professionals would pay for in-kind incentives from their own funds

nd at their discretion. Calculation of the KCF Practice’s benchmark and Performance Year expenditures

will not account for any of these items or services.

1. Cost-Sharing Support for Face-to-Face Visits Beneficiary Engagement Incentive

Subject to compliance with all applicable laws and regulations, the terms of the KCF Participation

Agreement, and CMS approval, a KCF practice may select to participate in the Cost-Sharing Support for

Face-to-Face Visits Beneficiary Engagement Incentive. Under the terms of the KCF Participation

Updated 03/06/2022 33

Agreement, a KCF Practice that selects and who has not been rejected by CMS for this option may offer

ost sharing support in the form of reduced or eliminated cost sharing for Medically Necessary Face-to-

Face Visits furnished by the KCF Practice under the KCC Model. The cost-sharing support must be

provided uniformly and consistently to certain KCF Beneficiaries by the KCF Practice. The KCF Practice

must not offer cost-sharing support to any KCF Beneficiary unless the beneficiary has no secondary

insurance that covers cost-sharing for the Face-to-Face visits and either: is experiencing documented

financial hardship, has documented evidence of high disease burden and Medically Necessary Face-to-

Face Visits may avoid hospitalization of the KCF beneficiary, or there is documented evidence of a recent

hospitalization or emergency department visit. KCF Practices that elect to offer cost-sharing support will

be required to submit an Implementation Plan detailing the procedures to be used to determine whether a

KCF beneficiary is eligible to receive the cost-sharing support.

The principal aim of allowing KCF Practices to offer this cost sharing support is to reduce financial

arriers so that certain beneficiaries may obtain needed care and better comply with treatment plans,

thereby improving their own health outcomes. In addition, permitting KCF Practices this flexibility will

provide a critical tool to engage aligned beneficiaries, promote the utilization of high-value services, and

incentivize aligned beneficiaries to continue receiving their care from KCF Practices.

The cost of providing the cost sharing support must not be shifted to Medicare or another federal health

car

e program. The KCF Practice shall note advertise or promote the availability of the Cost-Sharing

Support, except that the eligible KCF Beneficiary may be made aware of the availability of the benefit at

the time that KCF Beneficiary could reasonably benefit from it.

Participating KCF Practices will be

subject to monitoring and compliance activities in connection with the use of cost sharing support,

including all remedial actions in the Participation Agreement. To minimize possible abuse of this

Beneficiary Engagement Incentive, CMS will incorporate certain beneficiary protections and other

safeguards into the KCF Participation Agreement.

2. Chronic Disease Management Reward Beneficiary Engagement Incentive

Subject to compliance with all applicable laws and regulations, the terms of the KCF Participation

Agreement, and CMS approval, a KCF Practice may select to offer a Chronic Disease Management

Reward Beneficiary Engagement Incentive. Under this option, a KCF Practice, whose selection has not

been rejected by CMS, may provide gift cards to certain KCF Beneficiaries, up to an annual limit of $75,

for the purpose of incentivizing participation in a chronic disease management program. KCF Practices

will pay for the gift cards out of their own funds and at their discretion, subject to certain conditions. We

believe that allowing KCF Practices to incentivize beneficiary participation in a chronic disease

management program will promote beneficiary self-management, and ultimately improve quality and

reduce costs.

KCF Practices that elect to offer a Chronic Disease Management Reward Beneficiary Engagement

ncentive and whose election has not been rejected by CMS, will be required to submit an Implementation

Plan detailing how they will structure their program. KCF Practices will be permitted to offer programs

that focus on any KCF beneficiaries with a specific disease or chronic condition, as long as the program

does not discriminate against any KCF beneficiary who would otherwise qualify for participation. KCF

Practices that elect to offer a Chronic Disease Management Reward Beneficiary Engagement Incentive

will be required to maintain records of their reward program, including documentation of the amount and

type of each gift card awarded and the basis for beneficiary eligibility. Participating KCF Practices will be

subject to monitoring and compliance activities in connection with their reward program. To minimize

possible abuse of this Beneficiary Engagement Incentive, we will incorporate certain beneficiary

Updated 03/06/2022 34

protections and other safeguards into the KCF Participation Agreement and the Practice will be subject to

l applicable remedial actions for failure to comply with the terms of the Agreement.

I. Termination

CMS may immediately or with advance notice terminate a KCF Practice’s Participation Agreement if

ounds for remedial action exist (including noncompliance with the terms of the participation agreement

or other program integrity issues), or as otherwise specified in the KCF Participation Agreement or

required by section 1115A(b)(3)(B) of the Social Security Act.

All KCF Practices will be expected to participate in the Model for at least two Performance Years.

However, a KCF Practice may terminate its Participation Agreement and exit the Model by providing

notice to CMS specifying an effective date of termination that is at least 30 days following the date of the

notice. KCF Practices may terminate the Participation Agreement without any financial liability by giving

notice to CMS by February 28, 2023 with an effective date of termination of the Participation Agreement

that is no later than March 30, 2023. A KCF Practice that submits a notice of termination for PY2023 to

CMS after February 28, 2023, or with an effective date of termination of the Participation Agreement that

is on or after March 31, 2023, will be subject to financial reconciliation for the full Performance Year,

and may be prohibited from participating in other Innovation Center Models.

Updated 03/06/2022 35

J. Application for KCF Option

1. Instructions

Practices interested in participating in the KCF Option must file an application by no later than March 25,

2022, at 11:59pm. To file an application, applicants must fill out and complete the Qualtrics form

available here.

CMS reserves the right to request additional information (interviews, site visits, or additional information

related to application responses) from applicants in order to assess their applications.

Applicants seeking to withdraw their application must submit an electronic withdrawal request to CMS

via

the following mailbox: KCF-CKCC-[email protected]. The request must be submitted as a PDF on

the organization’s letterhead and must be signed by a corporate official authorized to bind the applicant.

It should include: the applicant organization’s legal name; the organization’s primary point of contact; the

full and correct address of the organization; and a description of the nature of the withdrawal.

2. Application Template for KCF Option

Practices should include a description of the nephrology professionals that they will include in their KCF

appl

ication. However, there will be a later opportunity to submit detailed information about these

nephrology professionals.

Questions about the application should be directed to KCF-CKCC-[email protected].

Section A – Applicant Practice Information and Eligibility

1. Applicant is a(n):

 Individual Nephrologist(s) Professional Corporation

 Nephrology Physician Practice

2. Applicant Contact Information

• Applicant Practice Legal Business Name:

• Tax Identification Number (TIN)

• Mailing Address (Street, City, State, Zip Code):

You will now be asked to identify each individual or entity that has an ownership or investment interest in

the

Applicant practice. After entering the information for one individual or entity you will be asked if you

would like to identify additional individuals or entities.

3. Please identify each individual or entity that has an ownership or investment interest in the

App

licant practice. For each entity please include the following:

• Corporate Name:

• Corporate TIN:

• Corporate Street Address:

• Corporate County:

• Corporate State:

• Corporate Zip Code:

• Corporate Phone Number:

Updated 03/06/2022 36

4. Name of primary organizational contact for the individual or entity previously entered. We will

se this information to link practices within the same larger health care/parent organization.

First Name:

o Last Name:

Email:

o Phone Number:

5. Please describe the nature of the organization (e.g., another physician organization, public or

private hospital, health system, or foundation owned by a hospital, insurance company, health

plan or HMO, medical school or university, etc.):

6. Do you wish to identify another individual or entity that has an ownership or investment interest

in the Applicant practice?



Yes



7. If Applicant is not owned by an outside entity, who owns this practice? Select all that apply.

 Physicians in the practice



Non-physician practitioners (nurse practitioners or physician assistants) in the practice

 Other (Please describe) _________________________________________

8. Does your practice share a TIN for billing with other practices that are part of the same health

group or system?



Yes

 No

9. Please provide the following contact information for the Applicant’s Executive Contact. Note

the executive contact must have the authority to act as the Applicant’s authorized corporate

official.

•

Name:

•

Organizational Title:

•

Phone Number:

•

E-mail Address:

10. Please provide the following contact information for the Applicant’s Primary Contact.

•

Name:

•

Organizational Title:

•

Phone Number:

•

E-mail Address:

11. Please provide the following contact information for the Applicant’s Secondary Contact.

•

Name:

•

Organizational Title:

•

Phone Number:

•

E-mail Address:

Updated 03/06/2022 37

12. Did any of your nephrology professionals participate in the Comprehensive ESRD Care Choices

(CEC) Model or are they currently participating in the KCC Model?



Yes



If so, please describe the nature of their participation in the CEC and/or KCC Model (ex. participant

owner or participant non-owner, etc.) ___________

13. Please indicate if any of the Applicant’s nephrology professionals have participated in or are

articipating in any of the following:

 Accountable Health Communities

 ACO Investment Model

 Advance Payment ACO Model

 Bundled Payments for Care Improvement

 Bundled Payments for Care Improvement Advanced

 Comprehensive Care for Joint Replacement

 Comprehensive Primary Care Initiative

 Comprehensive Primary Care Plus

 Global and Professional Direct Contracting Model (GPDC)

 Independence at Home Demonstration

 Maryland All-Payer Model

 Maryland Total Cost of Care Model

 Medicare Care Choices Model

 Medicare Shared Savings Program

 Medicare ACO Track 1+ Model

 Next Generation ACO Model

 Oncology Care First

 Oncology Care Model

 Pioneer ACO Model

 Private, For-Profit Demo Project for the Programs of All-Inclusive Care for the Elderly

(PACE)

 State Innovation Models Initiative

 Transforming Clinical Practice Initiative

 Other (please specify)

 Not Applicable

14. Please describe the nephrology professionals whom the Applicant expects will participate in the

KCF Option as a part of your KCF Practice, including the number of clinical and non-clinical

care providers and their roles. Please note that Applicant will have a later opportunity to provide

CMS with updated information regarding its nephrology professionals.

15. Please describe the Applicant’s performance under prior or current risk sharing arrangements, if

any. Risk sharing arrangements must include: (1) financial accountability; (2) evaluation of

patient experiences of care; and (3) substantial quality performance incentives. If applicable,

please include performance under CMS programs, demonstrations, and models that meet the

Updated 03/06/2022 38

definition of outcomes-based contracts. Provide an “N/A” response if no prior or current risk

aring arrangements. Please keep responses to a maximum of approximately 500 words.

16. I certify that my organization is a recognized legal entity formed under applicable state, federal,

tribal law and authorized to conduct business in each state in which it operates or will be by

the time the Participation Agreement is signed. You must certify to proceed with the application.

 Yes

Section B – Or

ganizational Structure, Leadership and Management, and Governance Structure

17. Please provide a paragraph summarizing your pr

actice. This may include: the practice’s history,

mission, and organization, including your practice’s affiliations; the practice’s composition,

geographic service area including where most of the practice's patients reside, if the service area

encompasses urban, suburban, and/or rural locations, if the area includes underserved

beneficiaries, and if the practice will work with other community-based organizations under the

KCF Option if selected to participate (e.g., care management organization, ESRD networks,

quality improvement organization, etc.). Please include any other applicable narrative

describing the practice. Please keep responses to a maximum of approximately 500 words

Section C –

Care Model Patient Centeredness

18. Please provide a narrative explanation of why the App

licant wishes to participate in the KCF

Model Option and how the Applicant will achieve the goals of better health and better care for

Medicare beneficiaries with CKD, ESRD, and kidney transplants. Please keep responses to a

maximum of approximately 500 words.

19. Please provide a narrative description of the App

licant’s plan for engaging with CKD and ESRD

beneficiaries and their caregivers. At a minimum, please address the following:

a. Managing the progression of CKD

b. Modality options and tr

ansition onto dialysis

c. Coordination of care with different providers and suppliers

d. Transplant process and mana

ging post-transplant care

e. Health I.T. and data sharing

f. Prescription drug utilization

g. Shared decision-m

aking, self-management and self-care skill development

Please keep responses to a maximum of approximately 1000 w

ords.

20. Please describe the App

licant’s historical and planned population health management and/or

population health tools. If applicable, please describe the metrics the Applicant has historically

used or plans to use to understand how to deploy clinicians, invest resources, and generally

improve health equity in managing the Applicant’s potential attributed beneficiary population.

At a minimum, please address the following:

a. Experience with social determinants of health and furnishing care to underserved

ommunities

b. Managing care for dually eligible beneficiaries

c. Metrics used for identifying health inequities in patients served

Updated 03/06/2022 39

d. Processes used to make improvements to address and mitigate identified health disparities

e. Decision support tools for use by providers/suppliers and/or patients/caregivers, and any tools

or approaches for fostering what might be termed “health literacy” in patients and their

families.

f. Processes for ensuring that the Applicant provides culturally-competent care

g. Approaches for providing high-quality-care to patients who do not speak English or for

whom English is a second language.

Please keep responses to a maximum of approximately 1000 words.

Section D – Community Engagement

21. Please describe the history of collaboration among major stakeholders in the community(ies)

being served and commitment from relevant community stakeholders to achieve seamless and

comprehensive care. Please include specific examples of community stakeholders with whom

the Applicant has a relationship and the nature of each relationship. Please keep responses to a

maximum of approximately 500 words.

Section E – Attestation and Signature

I have read the contents of this application. By my signature, I certify to the best of my knowledge,

information, and belief that the information contained herein is true, correct, and complete, that I am

authorized to sign this application on behalf of the applicant organization. I understand that the applicant

must not engage in anti-competitive practices, and if it has engaged in such practices, it may not get

accepted into the Model. If accepted into the Model, I understand that CMS can rescind the offering of a

Participation Agreement or terminate the Participation Agreement if it is determined that the applicant has

engaged in anti-competitive practices. I authorize the Centers for Medicare & Medicaid Services (CMS)

to verify this information. If I become aware that any information in this application is not true, correct, or

complete, I agree to notify CMS of this fact immediately and to provide the correct and/or complete

information.

____________

Printed Name of Applicant’s Authorized Corporate Official Date

____________

Signature of Applicant’s Authorized Corporate Official Date

Any race or ethnicity-conscious strategies must be supported by specific data or other information demonstrating a need for the

race or ethnicity-conscious strategy, and must demonstrate a close fit between disparities and the race or ethnicity-conscious

action that the Applicant intends to take. Additionally, any race or ethnicity-conscious strategies should be supported by

information demonstrating that alternative strategies that do not involve race or ethnicity will not be sufficient or effective to

address this disparity.

IV. Comprehensive Kidney Care Contracting (CKCC) Options

KCEs must be comprised of one or more nephrologists or non-physician clinicians who specialize in

nephrology (referred to collectively as “nephrology professionals”) and at least one transplant provider,

and may include other providers and suppliers that help to coordinate the care for beneficiaries with CKD

Stages 4 and 5, ESRD, and kidney transplants, such as dialysis facilities. KCEs will focus on improving

the quality of care, reducing total cost of care, delaying the progression of kidney disease, and increasing

the transplant rate.

The CKCC

Options include three options: the Graduated Option, the Professional, and the Global

Options. In all three Options, participants will receive capitated payments for care furnished to Medicare

beneficiaries with CKD Stages 4 and 5 and ESRD who are aligned to the KCE. The KCE will select a

risk sharing option, and will be accountable for quality outcomes.

KCEs will have the choice to move from a lower risk option to a higher risk option at the start of each

erformance Year beginning for their third Performance Year, but would not be able to move to a lower

risk option from a higher risk option. For instance, a KCE that is in the Professional Option in its second

performance year can move to the Global Option for its third Performance Year, but not vice versa.

A. Legal Entity and Governance Requirements

The KCE should be formed by one or more KCE Participants, which are Medicare-enrolled providers and

suppliers who have a participant agreement in place with the KCE and are identified on the KCE’s KCE

Participant List, as described further below. Each KCE must be identified by a single TIN and, unless

there is only one KCE Participant, must be a separate and unique legal entity that is recognized and

authorized to conduct business under applicable federal, state, or tribal law. The KCE may be an existing

legal entity if it conforms to all of the requirements set forth in this RFA and the CKCC Participation

Agreement (e.g., governance and composition requirements). To participate in the Model, the KCE must

be capable of:

•

Receiving and distributing shared savings payments or other payments received from CMS.

•

Collecting and repaying shared losses, if applicable.

•

Establishing reporting mechanisms and ensuring compliance with applicable Model requirements,

including but not limited to reporting on quality measures.

•

Securing a financial guarantee, if applicable.

KCEs must include as KCE Participants at least one nephrology professional, and at least one transplant

ovider. Transplant providers can include: a transplant program (as defined in 42 CFR § 482.70) that

provides kidney transplants, a transplant hospital (as defined in 42 CFR § 428.70) that provides kidney

transplants, a transplant surgeon (as that term is used in 42 CFR § 482.98) who provides kidney

transplants, a transplant nephrologist, a transplant nephrology practice, an Organ Procurement

Organization (OPO), or another Medicare-enrolled provider or supplier who provides kidney transplant

related Covered Services to Medicare beneficiaries. Nephrology professionals may only participate in one

KCE, while transplant providers may participate in multiple KCEs. A transplant nephrologist would

participate in the KCE in their capacity as a transplant provider and could participate in multiple KCEs if

they do not identify themselves as an alignment eligible nephrologist. If the transplant nephrologist self-

identifies as an alignment eligible nephrologist, they may only participate in one KCE.

Most other providers and suppliers may participate in multiple KCEs and other CMS initiatives, if

nsistent with the rules governing the other initiative. Other Medicare-enrolled providers and suppliers

Updated 03/06/2022

(other than durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers,

ambulance suppliers and drug/device manufacturers) are able to join a KCE as a KCE Participants, but

their participation is not mandatory for KCE eligibility.

KCE Governance Requirements

A KCE must maintain an identifiable governing body with sole and exclusive authority to execute the

functions and make the final decisions on behalf of the KCE. The KCE’s legal entity and governing body

must be separate and unique to the KCE, except that where the KCE is formed by a single KCE

Participant, the KCE’s legal entity and governing body may be the same as that of the KCE Participant.

The governing body may be a board of directors, board of managers or any other governing body

structure that provides a mechanism for shared governance and decision making. The KCE governing

body must:

•

Have authority to execute the functions of the KCE including defining the processes to promote

evidence-based medicine and patient engagement, reporting on quality and cost measures and

coordination of care, and the appointment and removal of an executive officer.

•

Have authority for final decision-making for the KCE, including responsibility for oversight and

strategic direction of the KCE and responsibility for holding the KCE management accountable

for the KCE’s activities.

•

Have a conflict of interest policy that applies to members of the governing body, requires

disclosure of all relevant financial interests and other conflicts of interest, identifies processes for

resolution of conflicts of interest, and sets forth remedial processes for non-compliance.

•

Have a transparent governing process.

•

Receive regular reports from the designated compliance official of the KCE, who is not legal

counsel to the KCE and who must report directly to the governing body.

Members of the governing body have a fiduciary duty to the KCE and are required to act consistent with

hat duty when engaging in governing body duties.

The KCE governing body must be structured as follows:

•

The governing body must ensure representation of patient interests by including an independent

Medicare beneficiary with CKD Stages 4 or 5 or ESRD who received nephrology services from a

KCE Participant at any time during the 15 months prior to the start of the Performance Year or an

experienced consumer advocate on the governing body. This representative must not have a

conflict of interest with the KCE or have an immediate family member with a conflict of interest

with the KCE. The representative must not be a participant in the KCE and not have a direct or

indirect financial relationship with the KCE or its KCE Participants, except that the person may

be reasonably compensated by the KCE for his or her duties as a member of the governing body

of the KCE.

•

Decision-making must be KCE participant-driven, as evidenced by KCE Participants or their

representatives having at least 75% control of the KCE’s governing body. The beneficiary

representative and/or consumer advocate shall not be included in either the numerator or

denominator when calculating percent control. The KCE may seek an exception from the 75

percent control requirement by submitting a proposal to CMS describing the current composition

of the KCE's governing body and how the KCE will involve KCE Participants in innovative ways

in KCE governance. Any exception to the 75 percent control requirement will be at the sole

discretion of CMS.

Updated 03/06/2022

• KCE Participants who are KCE Nephrology Professionals or KCE Nephrology Practices (or their

representatives) must represent at least 30% of the membership of the governing body. The

beneficiary representative and/or consumer advocate shall not be included in either the numerator

or denominator when calculating percent control.

• At least one governing body member must be a transplant provider or a representative a

transplant provider.

• KCE Participant Dialysis facility executives, employees or representatives may not exceed 50

percent control of the governing body. The beneficiary representative and/or consumer advocate

shall not be included in either the numerator or denominator when calculating percent control.

• The KCE governing body may not include any of the following: durable medical equipment,

prosthetics, orthotics, and supplies (DMEPOS) suppliers, ambulance suppliers, drug/device

manufacturers, or individual or entities that are excluded or otherwise prohibited from

participation in Medicare or Medicaid.

B. KCE Composition

A KCE must include at least one of each of the following as a KCE Participant in each Performance Year:

• A nephrology professional

• A transplant provider

Transplant providers may participate in multiple KCEs as KCE Participants or Preferred Providers.

Nephrologists, nephrology professionals, nephrology practices, and dialysis facilities may only participate

in a single KCE as a KCE Participants, a restriction that does not apply to other types of participants. In

addition to the required types of KCE Participants noted above, a KCE may include any of the following

optional Medicare-enrolled providers or suppliers as KCE Participants:

• Medicare-certified dialysis facilities, including facilities owned by large dialysis organizations

(LDOs), facilities owned by small dialysis organizations (SDOs), or independently-owned

dialysis facilities. LDOs may only participate in the Professional and Global options of CKCC.

• Other Medicare-enrolled providers and suppliers.

All types of providers and suppliers other than nephrology professionals and transplant providers, are

optional KCE Participants, including dialysis facilities, dieticians, and SNFs. DMEPOS suppliers,

ambulance suppliers, and drug/device manufacturers are prohibited from participating in a KCE. While

the KCE will not be required to be a Medicare-enrolled provider or supplier, KCE Participants under the

KCE must be a Medicare-enrolled provider or supplier by a date specified by CMS.

The KCE’s Market Area is the geographic area in which the main practice locations of the KCE’s

nephrology professionals are physically located. Generally, a KCE’s Market Area is defined as no more

than five CBSAs, which must be connected by no more than three rural counties and/or no more than one

CBSA. If the Market Area CBSAs are in more than one state, then those states must be contiguous. The

only exception to this requirement would be in the case of rural applicants whose locations are not

included in any Medicare CBSA. For rural applicants not located in any Medicare CBSA, the KCE

Market Area will be composed of the rural counties in a single state in which KCE nephrology

professionals have their main practice location.

In order to align beneficiaries, CMS will also need to determine a KCE’s Service Area. For a KCE, the

Service Area is defined as the KCE’s Market Area, and any CBSAs that are contiguous to the KCE’s

Market Area and any rural counties located in the same state(s) as the KCE’s Market Area in which

Updated 03/06/2022

participating nephrology professionals provide nephrology services (see Table 10) to beneficiaries with

CKD or ESRD .

If a KCE includes dialysis facilities, then all dialysis facilities that participate in that KCE must be owned

in w

hole or in part by the same dialysis organization., Additionally, at least 85% of the dialysis facilities

owned in whole or in part by that dialysis organization that are located within the KCE’s Market Area

must participate in the KCE. Furthermore, all dialysis facilities that participate in a KCE must be located

in the KCE’s Service Area.

Participating providers and suppliers other than nephrology professionals and dialysis facilities would not

be su

bject to Market Area or Service Area constraints.

The CKCC Options define categories of Medicare providers/suppliers and their respective relationships to

the

KCE. The two primary categories are KCE Participants and Preferred Providers in all three options:

•

KCE Participants are the core providers/suppliers in the Model. KCE Participants are Medicare-

enrolled providers or suppliers that bill for items and services they furnish to beneficiaries under a

Medicare billing number assigned to a TIN in accordance with the applicable Medicare

regulations and have agreed to participate in the Model. KCE Participants enter into a written

agreement with a KCE that satisfies the requirements of that KCE’s CKCC Participation

Agreement, and are identified on that KCE’s list of KCE Participants. In addition, a KCE

Participant cannot be a Preferred Provider (as described below) or a prohibited participant (i.e., a

DMEPOS supplier, an ambulance supplier, a drug or device manufacturer, or a provider/supplier

that is otherwise prohibited from participation in Medicare or Medicaid). The services furnished

by nephrology professionals that are KCE Participants are used for purposes of aligning

beneficiaries to the KCE.

•

Preferred Providers contribute to KCE goals by promoting better care for beneficiaries by

extending and facilitating valuable care relationships beyond the KCE. Preferred Providers are

Medicare-enrolled providers or suppliers that bill for items and services they furnish to

beneficiaries under a Medicare billing number assigned to a TIN in accordance with applicable

Medicare regulations, and have agreed to participate in the Model. Preferred Providers enter into

a written agreement with a KCE that satisfies the requirements of that KCE’s CKCC

Participation Agreement, and are identified on that KCE’s list of Preferred Providers. A Preferred

Provider cannot be a KCE Participant or a prohibited participant (as described above). Services

furnished by Preferred Providers will not be considered in beneficiary alignment. Nephrologists,

nephrology professionals, and nephrology practices cannot be Preferred Providers. Preferred

Providers are not considered participants in an Advanced Alternative Payment Model for the

purpose of the Quality Payment Program.

Both KCE Participants and Preferred Providers have the opportunity to participate in the Benefit

Enh

ancements selected by the KCE.

Individual providers and suppliers can be added to the Model as KCE Participants or Preferred Providers

only a

t the beginning of each Performance Year.

KCE Participants may not be KCE Participants in another KCE in the KCC Model, except as specified by

CMS,

or participate in the KCF Option. Likewise, KCE Participants are not permitted to participate in

the Medicare Shared Savings Program, other Medicare shared savings initiatives (except as expressly

permitted by CMS), the Independence at Home Demonstration (IAH), Primary Care First (PCF), ACO

Realizing Equity, Access, and Community Health (ACO REACH) Model (formerly known as the Global

Updated 03/06/2022

and Professional Direct Contracting (GPDC) Model, and Vermont Medicare ACO Initiative, or the

Maryland Primary Care Program (MDPCP) portion of the Maryland Total Cost of Care Model (MD

TCOC). For KCE Participants, overlaps are checked at the TIN level for the Medicare Shared Savings

Program and NPI-TIN level for the other models discussed above. The only exception is dialysis

facilities, for which overlaps are checked based on CCN for all initiatives except the Medicare Shared

Savings Program – which is checked based on TIN. Preferred Providers may overlap with the Medicare

Shared Savings Program and the other models discussed above.

C. Beneficiary Alignment

The patient population for the CKCC Options is Medicare beneficiaries with CKD Stages 4 and 5, ESRD,

nd kidney transplant recipients. CMS will prospectively align eligible beneficiaries to KCEs through a

claims-based alignment process. It is important to note that the alignment of beneficiaries to KCEs is for

Model test purposes only. Model activities for which beneficiary alignment under this Model is relevant

include expenditure calculations for KCEs, quality performance measurement, and CMS’ monitoring of

claims data. Beneficiary alignment to a KCE does not inhibit beneficiaries’ freedom to choose to receive

care from other Medicare providers and suppliers within Medicare FFS. Similar to other CMS programs

and models, the CKCC Options do not include provisions for beneficiaries that have been aligned to a

KCE to opt out of alignment, but they may opt out of certain data sharing with the KCE. Aligned

beneficiaries may obtain nephrology services from health care providers not participating in a KCE,

which could cause them to be de-aligned to a KCE retroactively during alignment reconciliation.

1. Beneficiary Eligibility

To be eligible for alignment and to remain aligned to a KCE during a Performance Year, a beneficiary

ust meet all of the following criteria, except where otherwise noted:

• Has either CKD Stages 4 or 5 or ESRD, or is a transplant recipient with a functioning kidney who

was previously aligned to the KCE while the beneficiary had CKD Stages 4 or 5 or ESRD;

•

Is enrolled in Medicare Parts A and B;

•

Is not enrolled in a Medicare Advantage plan, cost plan, or other non-Medicare Advantage

Medicare managed care plan;

•

Resides in the United States;

•

Receives greater than 50% of their nephrology services or MCP claims furnished in the KCE’s

Service Area;

•

Is 18 years of age or older;

•

Is alive;

•

Is not already aligned to a Medicare ACO or another participant in a Medicare

program/demonstration/model where overlap is not allowed;

•

Is not aligned to another KCE;

•

Does not have Medicare as a secondary payer;

•

Not received a kidney transplant in the last 13 months (initial alignment only);

•

Not in an active election period of hospice care at the time CMS conducts alignment, as

determined using Medicare enrollment data (initial alignment only); and

•

Not received hospice care at any time during the last three months of the 12-month period that

ends 3 months prior to the start of the quarter for which CMS is conducting initial alignment to

the KCE (“Alignment Lookback Period”) or during the period between the end of the Alignment

Lookback Period and the alignment run date (initial alignment only).

Updated 03/06/2022

If a beneficiary meets the alignment eligibility criteria described above, the beneficiary will be initially

aligned to the KCE if the beneficiary also meets the applicable criteria described in Table 9 below.

After each Performance Year, KCEs must have a have minimum of 750 aligned Medicare beneficiaries

th CKD Stages 4 or 5 and 350 aligned Medicare beneficiaries with ESRD or else they will in most

cases have to aggregate their performance. CMS does not require that the KCE furnish services to a

minimum number of aligned transplant beneficiaries. Once an aligned beneficiary receives a kidney

transplant, they do not count towards a KCE’s minimum required number of aligned CKD or ESRD

beneficiaries. However, if the beneficiary was aligned to a KCE and had CKD Stages 4 or 5 or ESRD for

a period of time during the relevant Performance Year prior to receiving a kidney transplant, that period

of time may count towards the KCE’s applicable beneficiary minimum.

2. Alignment Process

Alignment to KCEs participating in the CKCC Options will occur through nephrology professionals that

e KCE Participants for each stage of kidney care (CKD Stages 4 and 5, ESRD, or transplant recipient

who was previously aligned while they had CKD Stages 4 or 5 or ESRD) and will differ based on the

beneficiary’s kidney disease status. This is different than the CEC Model, where beneficiaries were

aligned through the dialysis facility.

CMS believes that aligning beneficiaries through participating nephrology professionals has the following

vantages:

•

Prioritizes the nephrology professional relationship as the most important one for beneficiaries

with CKD Stages 4 or 5, ESRD, or kidney transplant.

•

Protects the continuity of care by aligning a beneficiary with CKD Stages 4 or 5 with the same

nephrology professional who might then be treating them for ESRD, although it does not have to

be the same nephrology professional.

•

Allows beneficiaries who only dialyze at nursing facilities, instead of outpatient dialysis facilities,

to be aligned to KCEs and included in the Model test if they receive care furnished by the KCE’s

nephrology professionals.

Initial and Quarterly Alignment

Alignment will be as prospective as is feasible given particular mechanisms, summarized in Table 9

below, and will be retrospectively finalized as part of a reconciliation process after each Performance

Year, allowing for a minimum of three months claims run-out. CMS will identify the final aligned

beneficiary population for the KCE following this reconciliation process. Beneficiaries will be de-aligned

from the KCE’s list of aligned beneficiaries if they do not receive certain health services from a

nephrology professional identified by the KCE as an aligning provider during the Performance Year, or

receive the majority of certain health services outside of the KCE’s Service Area.

KCEs will receive a list at the start of their first Performance Year with the aligned beneficiaries whose

car

e they will be accountable for based on visits in the past year. New eligible beneficiaries who satisfy

the alignment criteria described in Table 10 will be added to each KCE’s alignment list on a quarterly

basis. Once aligned, beneficiaries remain aligned to the KCE until they meet one of the criteria for de-

alignment.

Updated 03/06/2022

Table 10. Some Alignment Criteria by Beneficiary Type

Eligible Beneficiaries with

CKD

Eligible Beneficiaries with

ESRD

Eligible

Beneficiaries who

Receive Kidney

Transplants

Aligning

Participant

Nephrology professional Nephrology professional N/A – Must have

been previously

aligned by virtue of

CKD or ESRD

Criteria for

Alignment

Diagnosis of CKD Stages 4

or 5; No MCP claims; 2 or

more Nephrology Services

(Professional/Carrier claims)

within a 12-month period

with a KCE nephrology

professional; 50% or more

nephrology services within

the KCE Service Area;

Kidney disease status of

ESRD; 2 or more MCP claims

with a KCE nephrology

professional within a 3-month

period; 50% or more MCP

services within the KCE

Service Area.

Being previously

aligned to the KCE as

a CKD or ESRD

beneficiary and

receiving a kidney

transplant

Criteria for

De-alignment

Beneficiaries received the

majority of Nephrology

Services outside the KCE

Service Area; or did not

receive any Nephrology

Services from a KCE

nephrology professional

during the months of the

performance year in which

they were an eligible

beneficiary.

Beneficiaries received the

majority of MCP claims

outside the KCE Service

Area, did not receive any

MCP claims with a KCE

nephrology professional

during the months of the

performance year in which

they were an eligible

beneficiary, or did not receive

any maintenance dialysis

treatments during the

Performance Year.

Kidney transplant

failure (the

beneficiary may be

aligned as a CKD or

ESRD beneficiary

post-transplant

failure if the

applicable

requirements for

alignment are met); 3

years past their

transplant

The alignment lookback period is the 12-month period that ends 3 months prior to the start of quarter for

which CMS is conducting beneficiary alignment within which claims must occur in order to be

considered for the quarterly alignment process. For example, for PY2023 Quarter 1 (PY2023 Q1), the

lookback period is October 2021 to September 2022.

CMS will run beneficiary alignment for PY2023 Q1 in October 2022. CMS will then send beneficiary

ignment lists to KCEs in advance of the start of their first Performance Year (January 1, 2023).

Ineligibility and Dealignment

Beneficiaries aligned during one Performance Year will roll over to the next Performance Year , unless

they are de-aligned during the Annual Alignment Reconciliation that occurs at the end of the Performance

Year. If an aligned beneficiary no longer meets certain eligibility criteria during a Performance Year ,

they will remain aligned for the remainder of the Performance Year but CMS will assign to them an

eligibility status of “ineligible” and their expenditures will not be counted toward financial calculations

Updated 03/06/2022

for months in which they are ineligible. Aligned beneficiaries who become ineligible may be moved back

to eligible status again if they meet certain eligibility criteria again in the future.

When an aligned CKD or ESRD beneficiary receives a kidney transplant, they will remain aligned to the

E for up to three years from the month of transplant in order for the KCE to be eligible to receive

Kidney Transplant Bonus payments, but the beneficiary’s expenditures will no longer be counted toward

financial calculations and the beneficiary will not be included in the quality performance sample for the

KCE. If the transplant fails within three years, the beneficiary will be de-aligned from the KCE. It is

possible for a kidney transplant beneficiary to become realigned (either to the original KCE or to a

different KCE) as a CKD or ESRD beneficiary in the event their transplant fails and they subsequently

meet the criteria required to be eligible for initial alignment. It is also possible for an aligned beneficiary

to progress from CKD to ESRD during the Performance Year . CMS reviews and updates each aligned

beneficiary’s kidney disease status (e.g., CKD, ESRD, or transplant recipient) on a quarterly basis. CMS

will also determine each aligned beneficiary’s final kidney disease status for each month that the

beneficiary was aligned to the KCE during a Performance Year after the end of the Performance Year.

De-alignment criteria, including de-alignment based on a beneficiary not receiving care from a

phrology professional identified by the KCE as an aligning provider during the Performance Year or

receiving the majority of nephrology services or MCP claims outside the KCE’s Service Area, are

designed to ensure an accurate measure of the cost and quality of the beneficiary care in the model test.

The de-alignment criteria are intended to capture situations where there is no longer a care relationship

between the KCE nephrology professional and the aligned beneficiary. While there may be some

incentive for a KCE and its KCE Participants to refer aligned beneficiaries outside of the KCE Service

Area in order to take advantage of the de-alignment criteria – experience in the CEC Model has shown

that the market areas, as defined above, tend to be large enough that seeking care outside of the market

area truly represents a change in beneficiary residence rather than strategic referrals. This approach to de-

alignment balances predictability in beneficiary populations and accuracy in alignment, while reflecting

the unique way CKD and ESRD beneficiaries interact with the health care system.

Finalizing Alignment

Alignment will be retrospectively finalized as part of a reconciliation process after each Performance

Year. Through this reconciliation process, which will allow for a minimum of three months claims run-

out, CMS will identify the final aligned population for the KCE for the Performance Year, including each

beneficiary’s months of alignment within the Performance Year. In certain cases, a beneficiary may

become de-aligned from the KCE for the entire Performance Year at reconciliation if they meet the

Criteria for De-alignment described in Table 9 above:

•

Received the majority of their Nephrology Services or MCP claims outside of the KCE’s Service

Area;

•

Did not receive any Nephrology Services or MCP claims from one of the KCE’s aligning

providers; or

•

Did not receive any maintenance dialysis treatments during the Performance Year (ESRD

beneficiaries only).

3. Beneficiary Minimums and Aggregation

As previously noted, during each Performance Year, the KCE must have a minimum of 750 aligned

edicare beneficiaries with CKD Stages 4 or 5 and 350 aligned Medicare beneficiaries with ESRD. If a

KCE fails to meet either minimum threshold for a Performance Year, as determined by CMS during the

Updated 03/06/2022

annual alignment reconciliation process, CMS may take remedial actions, including requiring the KCE to

submit a Corrective Action Plan (CAP) explaining the steps it will take to meet the minimum threshold

for CMS’ review and approval, or termination of the KCE’s Participation Agreement.

In addition, a KCE that does not meet these minimum alignment thresholds at the end of the Performance

ear, and does not include an LDO as a KCE Participant or KCE Preferred Provider, will generally be

required to aggregate its financial performance and quality performance with that of certain other KCEs

in the same option (referred to as the KCE’s aggregation partners). KCEs that may be required to

aggregate will have the opportunity to request one or more (up to 5) aggregation partners for the purposes

of creating a group of KCEs (an aggregation group) that collectively meet the minimum number of

aligned beneficiaries. The KCE must submit its preferred aggregation partner or partners for a given

Performance Year by a date specified by CMS. CMS will review any requests for preferred aggregation

partners and may accept, modify, or reject such requests at CMS’s sole discretion, using criteria specified

in the CKCC Participation Agreement. If a KCE that is required to aggregate does not submit a request

for its preferred aggregation partner(s), then CMS will assign an aggregation partner or partners based on

the KCE Service Area and geographic proximity of other KCEs in the same option that are also required

to aggregate. If at the end of the Performance Year one or more aggregation partners in an approved

aggregation group meet the minimum alignment thresholds and one or more other aggregation partners in

the same group do not, then the performance for the KCEs in the aggregation group will still be

aggregated. If all aggregation partners in an approved aggregation group meet the minimum alignment

thresholds at the end of the Performance Year, then the performance of the entities in the aggregation

group will not be aggregated.

However, if a KCE that includes dialysis facilities owned in whole or in part by an LDO does not meet

e minimum alignment thresholds at the end of the Performance Year, or if CMS determines that there

is not aggregation group available for a KCE that does not meet the minimum alignment thresholds at the

end of the Performance Year, the KCE will not be required to aggregate its quality performance or

financial performance with other KCEs. Rather, in these situations, the KCE’s financial performance for

the Performance Year will be subject to a Minimum Savings Rate or Minimum Losses Rate (MSR or

MLR). In order to start in the Model, KCEs must have at least 50% of the required minimum aligned

beneficiary thresholds. The required number of beneficiaries is at least 375 CKD Stages 4 or 5

beneficiaries and 175 ESRD beneficiaries. Entities that do not meet these requirements will be notified

and will not be offered a CKCC Participation Agreement for PY2023.

4. Beneficiary Notifications and Marketing Materials

All KCEs will be required to share with aligned beneficiaries certain details about their alignment to the

E and the KCE’s participation in the Model. For KCEs’ ease, CMS will provide templates that

participants may use for aligned beneficiary notification purposes. If CMS provides a template to be used

for these notification requirements, such template will include all of the required information described

below and prior CMS review/approval of the template will not be needed. The KCE must also comply

with all applicable federal laws regarding interaction with Medicare FFS beneficiaries.

Specifically, KCEs will be required to ensure that their KCE Participants display materials in their office

or facility locations notifying beneficiaries that they are participating in the Model. KCEs are also

required to ensure that their KCE Participants distribute a paper copy of the informational materials to

each aligned beneficiary at the beneficiary’s first office visit with a KCE Participant after the KCE

Participant receives notice that the beneficiary is aligned to the KCE.

Updated 03/06/2022

The notification must include the following elements:

• A short description of the CKCC Option the KCE is participating in and what that means for their

care.

• The beneficiary’s option to opt out of certain data sharing, with instructions for how to modify his

or her data sharing preferences by calling 1-800-MEDICARE;

• Affirmation of beneficiary protections under Medicare, including beneficiary freedom of choice

;

and

• Instructions on whom to contact with concerns about beneficiary protections and the KCE

Participants’, as applicable, participation in the Model.

KCEs and their nephrology professionals must provide any KCE marketing materials and activities to

CMS upon request. If CMS requests such materials and activities, CMS will review them to ensure that

the materials comply with the terms of the CKCC Participation Agreement, including that they are not

inaccurate or misleading, are not discriminatory or used in a manner that is discriminatory, and make

clear that alignment to a KCE does not remove or otherwise affect a beneficiary’s freedom to choose a

provider or supplier. Additional requirements concerning this review process will be provided in the

CKCC Participation Agreement.

To ensure beneficiary freedom of choice, the KCE shall not, and shall require its KCE Participants and

Preferred Providers to not, commit any act or omission, nor adopt any policy that inhibits Medicare

beneficiaries from exercising their freedom to obtain health services from providers or suppliers who are

not KCE Participants or Preferred Providers.

5. Data Sharing

CMS will make historical and monthly claims data available to KCEs upon request, consistent with data

sharing practices in other comparable models and programs, and consistent with all applicable laws and

regulations, including HIPAA and the Part 2 regulations governing the disclosure and use of certain

substance use disorder patient records.

Upon a KCE’s request, CMS will make available several types of Medicare data for the purposes of the

health care operations work of the KCE, including developing and implementing activities related to care

coordination and quality assessment and improvement for beneficiaries aligned to the KCE under the

CKCC Options. Such data may include:

(1) individually identifiable demographic and Medicare eligibility status information about aligned

beneficiaries and various summary reports with data relevant to the KCE’s operations and performance in

the Model (such as data related to quality, expenditures, etc.); and (2) detailed claims data files that will

include individually identifiable claim and claim line data for services furnished by Medicare-enrolled

providers and suppliers to aligned beneficiaries. Historical data files for aligned beneficiaries will be

limited to three years of historical data, consistent with the approach under the CEC Model and other

shared savings models and programs.

The claims data provided to the KCE will not include individually identifiable data for aligned beneficiaries

who have opted out of data sharing. Moreover, CMS will honor the data sharing opt out decisions by

The beneficiary maintains the right to see any Medicare participating healthcare provider at any time under the traditional

Medicare FFS benefit structure. Example language may read “You still have the right to visit any dialysis facility, doctor,

hospital, or healthcare provider that accepts Medicare” and/or “This is not a Medicare Advantage Plan or any kind of managed

care plan.”

Updated 03/06/2022

beneficiaries who were previously given that choice while an aligned beneficiary in another Medicare ACO

initiative. KCEs are required to provide aligned beneficiaries who inquire about or wish to modify their

data sharing preferences with information regarding how to modify their data sharing preferences by calling

1-800-MEDICARE. The communications that the KCEs share with such beneficiaries must note that, even

if a beneficiary has elected to decline claims data sharing, CMS may still engage in certain limited data

sharing for care coordination and quality improvement activities for aligned beneficiaries, and population-

based activities relating to improving health or reducing health care costs, as well as claims data sharing

regarding claims subject to the CKD QCP Fee Reduction.

D. Finance and Payment

KCE

s will be eligible for the following payments:

•

CKD Quarterly Capitation Payment (CKD QCP)

•

Adjusted Monthly Capitation Payment (AMCP)

•

Kidney Transplant Bonus (KTB)

•

Shared savings/shared losses under one of the following Options:

o Graduated

Professional

Global

1. Payment Types

CKD Quarterly Capitation Payment (CKD QCP)

CMS will pay KCEs through an innovative per beneficiary CKD QCP, which combines payment for

several different outpatient E/M services and other care management services listed below, collectively

referred to as Nephrology Services, into a single capitated payment. The CKD QCP is intended to

provide an upfront payment to facilitate delivery of care for aligned beneficiaries with CKD Stages 4 or 5.

The CKD QCP replaces Medicare FFS payments for Nephrology Services when furnished to aligned

beneficiaries by nephrology professionals participating in the KCE. KCEs will be required to have

financial arrangements with these nephrology professionals to reimburse these practitioners for services

provided. Nephrology professionals will still be required to submit claims with the relevant codes for data

collection and quality purposes, but CMS will only pay the CKD QCP for Nephrology Services furnished

to aligned beneficiaries with CKD Stages 4 or 5. The CKD QCP is designed to allow flexibility in care

delivery and to give providers/suppliers a more stable payment stream to deliver advanced care for

aligned beneficiaries with CKD Stages 4 or 5. For the beneficiary, this may result in increased access to

nephrology care for their CKD, improved efficiency and coordination in addressing health issues, and

improved patient experience. The Model will test whether upfront, predictable revenue will help

nephrology professionals coordinate care for aligned beneficiaries with other specialists to better address

their renal needs.

Updated 03/06/2022

Table 11. Nephrology Services Included in the CKD QCP

Service Type CPT Codes

Office/Outpatient Visit E/M 99201-99205,

99211-99215,

Complex Chronic Care Coordination Services 99487

Home Care / Domiciliary Care E/M 99348-99349

Prolonged E/M 99354-99355

Transitional Care Management Services 99495-99496

Advance Care Planning 99497-99498

Welcome to Medicare and Annual Wellness Visits G0402, G0438, G0439

Chronic Care Management Services 99490

Prolonged non-face-to-face E/M Services 99358

Assessment/care planning for patients requiring CCM services G0506

Online digital E/M for an est. patient, for up to 7 days 99421 – 99423

Phone E/M phys/qhp 99441 – 99443

KCE Participants will continue to receive normal fee-for-service payments for services furnished to

aligned beneficiaries that are not included in the CKD QCP, such as inpatient visits, and services for

beneficiaries who have received transplants. KCE Participants will also continue to receive normal fee-

for-service payments, rather than CKD QCPs, for services furnished to beneficiaries not aligned to the

KCE. Beneficiary cost sharing for the services included in the CKD QCP will be set at the cost-sharing

amount which the beneficiary would have paid for the particular Nephrology Service furnished to the

beneficiary during a particular encounter, rather than the amount the beneficiary would have had to pay

based on the CKD QCP amount. The CKD QCP amount will be approximately one third of the amount

of the MCP that participating nephrology professionals are paid during the Performance Year for aligned

beneficiaries who are receiving dialysis services. The CKD QCP payment amount will be the same

amount for a beneficiary with CKD Stage 4 or CKD Stage 5. These payments will not be risk adjusted,

given very similar risk profiles in the CKD Stages 4 and 5 populations.

Because the CKD QCP is paid prospectively, KCEs may receive CKD QCPs for beneficiaries who are

deemed eligible at the time of alignment but are subsequently found ineligible for the period. As a result,

CMS will withhold a percentage of the CKD QCP amount paid each quarter to account for these changes

in alignment and will calculate alignment-based adjustments after the Performance Year to ensure CMS

did not overestimate the withhold. The withhold and adjustments ensure that the CKD QCP (and

corresponding FFS claims for services included in the CKD QCP) are paid accurately for services

The use of this code was discontinued in the CY 2020 PFS final rule. As this code is no longer used, it will not generate claims.

However, we are retaining the code for documentation purposes, as it was used in analyses supporting the development of the

CKD QCP methodology.

Updated 03/06/2022

provided. CMS will withhold 20 percent of CKD QCP amounts that would otherwise be paid to

participants during the Performance Year, and although this percentage is unlikely to change, CMS

maintains the right to increase or decrease the withhold percentage in subsequent Performance Years. We

refer to this withhold as the CKD QCP Alignment Withhold. After the end of each Performance Year,

CMS will reconcile the CKD QCP Alignment Withhold against the value of the KCE’s alignment

adjustments. Based on this analysis, CMS will return to the KCE any amounts owed by CMS to the KCE

but will not hold the KCE liable for recoupments beyond the amount of the withhold during the

Performance Year if the KCE is deemed to owe CMS.

CMS will also adjust the CKD QCP to account for “leakage,” meaning the dollar value of Medicare FFS

claim pa

yments for Nephrology Services furnished to aligned beneficiaries with CKD Stages 4 or 5 by

nephrology professionals who are not in the KCE that would have been subject to the CKD QCP fee

reduction if the services had been furnished by nephrology professionals in the KCE. This adjustment

incentivizes a sustained doctor-patient relationship. Increases in services delivered by nephrology

professionals outside of the KCE to aligned beneficiaries will lead to a reduction in the CKD QCP paid to

the KCE. CMS will determine actual leakage for each KCE following the end of each Performance Year ,

but CMS will use a prospective withhold to reduce the likelihood of recoupments for leakage. CMS will

withhold 10% of all CKD QCP payments to KCE to account for leakage. After the Performance Year,

CMS will reconcile the 10% withhold for leakage to the amount of leakage that occurred during the

Performance Year. CMS will either pay the KCE any excess leakage withheld if leakage is under the

amount withheld or recoup additional leakage from the KCE if leakage is over the amount withheld.

Consistent with PCF, to support continuous care, CMS may also share data with participants on

Nephrology Services delivered outside of the KCE to the KCE’s aligned beneficiaries.

Adjusted Monthly Capitation Payment (AMCP)

Currently, Medicare pays physicians and other practitioners who manage dialysis care for beneficiaries

receiving dialysis through the MCP. The per-patient-per-month MCP payment is for all routine

outpatient physicians’ services related to the dialysis patient’s renal condition. The amount of the MCP

varies based on several criteria:

• The location where the beneficiary dialyzes (at home or in center).

•

The number of face-to-face visits with the beneficiary for beneficiaries who dialyze in center (one

monthly visit, two- or three-monthly visits, or four or more monthly visits).

•

The age of the beneficiary.

Under the CKCC Options, CMS will modify the current MCP payment structure. Nephrology

pro

fessionals in the KCE will continue to bill the MCP as they ordinarily would and will receive the MCP

FFS amount from CMS that they would have received had they not been in the Model.

However, the current payment structure of the MCP creates a bias towards in-center hemodialysis

because

the highest MCPs are available for beneficiaries who dialyze in-center and receive four in-person

visits a month. According to a 2015 GAO report, equalizing nephrologist payments for home and in-

center dialysis removes the financial disincentive for prescribing home dialysis and supports beneficiaries

dialyzing at home.

The AMCP addresses this disincentive for prescribing home dialysis through the Home Dialysis True-Up,

which will standardize MCP reimbursement amounts for Nephrology Services regardless of where a

beneficiary dialyzes. The national average MCP for a nephrologist who visits a patient in-center 4 or

more times per month is $221 PBPM. The majority of MCP claims, over 70%, are billed at this 4+

Updated 03/06/2022

monthly visit level. The national average MCP for a nephrologist who delivers care to a patient who

dialyzes at home is approximately $185 PBPM. The AMCP standardizes the MCP for home dialysis and

in-center dialysis patients by paying KCEs an additional $35 per MCP home dialysis claim for services

delivered to aligned ESRD beneficiaries. CMS will make this payment to KCEs at the end of the

Performance Year.

The total amount of the AMCP is the MCP, which is paid to the nephrology professional at current FFS

rates, plus the Home Dialysis True-Up, which is paid retrospectively to the KCE. As a result, the KCC

Model reduces the variance in reimbursement for ESRD dialysis services delivered to aligned

beneficiaries who dialyze in center compared to at home. Unlike the CKD QCP that CMS pays

prospectively to the KCE, CMS will pay the KCE the Home Dialysis True-Up component of the AMCP

in a lump sum at after the end of the Performance Year.

Kidney Transplant Bonus (KTB)

In addition to the payments described above, KCEs are eligible for up to three KTB payments for every

aligned beneficiary with CKD or ESRD who receives a kidney transplant, whether from a living or

deceased donor, provided the transplant remains successful. The KTB will create a direct incentive for

model participants to support beneficiaries through the transplant process, including continued care

management of transplant recipients to support graft success.

CMS recognizes the lack of supply of available kidneys and that nephrologists do not control access to

the transplant wait list. However, CMS believes that this payment could better incentivize providers and

suppliers to move beneficiaries onto the waitlist, assist beneficiaries with the living donation process, and

support beneficiaries after they receive a transplant in maintaining the health of the transplanted organ.

As stated, the purpose of the KTB is to incentivize KCEs to support beneficiaries during and after the

ransplant process through care coordination and other services – including patient engagement and

support – that are necessary to maximize the likelihood of long-term success for an organ transplant.

CMS does not intend that the KTB be used for, or imply that Model participants are permitted to, exert

inappropriate influence over the transplant process, or that Model participants can acquire, receive, or

otherwise transfer organs in exchange for valuable consideration. The exchange or transfer of valuable

consideration for a human organ for transplantation is in violation of section 301 of the National Organ

Transplant Act of 1984 (NOTA), as amended. Certain payments, including “reasonable payments

associated with the removal, transportation, implantation, processing, preservation, quality control, and

storage of a human organ,” are not valuable consideration for purposes of this criminal prohibition.

Inappropriate or illegal use of the KTB, in violation of NOTA or any other laws or regulations, would

result in removal from the Model and referral to the appropriate law enforcement organization.

CMS will make up to $15,000 in KTB payments per transplant, paid to the KCE at set intervals following

e transplant. In general, the KTB will be disbursed to the KCE in three installments as follows: $2,500

one year after transplant, $5,000 two years after the transplant, and $7,500 three years after the transplant.

In order to receive KTB installment payments, three criteria must be met at the time of disbursement, as

follows:

•

The beneficiary must remain alive.

•

The beneficiary’s kidney transplant has not failed (e.g., the beneficiary must not have returned to

maintenance dialysis).

•

The KCE must be participating in the Model.

Updated 03/06/2022

Payment of the KTB in installments over three calendar years introduces challenges for transplants that

occur in PY2025 and PY2026. Transplants during these Performance Years would result in KTB

payments being made after the performance period for the KCC Model ends in 2026 and settlement is

completed in 2027. Transplants that occur in PY2025 would require CMS make KTB payments in 2026 –

2028 and transplants that occur in PY2026 would require CMS make KTB payments in 2027 – 2029. To

address this dynamic, the KCC Model will alter both the amount and schedule of KTB installments for

transplants made in PY2025 and PY2026. Specifically, CMS will increase the proportion of the KTB paid

to participants in CY2027 for PY2025 and PY2026 transplants to ensure no payments need to be made

after CY2027.

At least 20 percent of KTB payments must be shared with KCE Participants who are transplant providers

(e.g., transplant surgeons, OPOs, etc.), and an additional 20 percent of the KTB payment must be shared

with KCE Participants who are nephrology professionals in order to ensure that the work of these KCE

Participants in the transplant process is recognized. The distribution of the remaining 60 percent of the

KTB payments is at the discretion of the governing body of the KCE, subject to the requirements of

applicable law.

Table 12. Schedule of KTB Installments

Installment

Transplants PY2022 – PY2024 Transplants PY2025 Transplants PY2026

Amount

per

Transplant

Date of Payment*

Amount

per

Transplant

Date of

Payment*

Amount

per

Transplant

Date of

Payment*

Installment

$2,500 1 year after

transplant

$2,500 1 year after

transplant

$2,500 1 year

after

transplant

Installment

$5,000 2 years after

transplant

$5,000 2 years

after

transplant

$2,500 1 year

after

transplant

Installment

$7,500 3 years after

transplant

$3,750 2 years

after

transplant

$3,750 1 year

after

transplant

Maximum

Total KTB

$15,000 $11,250 $8,750

*Provided transplant remains successful

2. CKCC Model Options

KCEs in the CKCC Options have two sources of income or losses from CMS. First, KCEs receive the

CKD QCP and AMCP and can be eligible to receive the KTB discussed earlier. Second, KCEs can be

eligible for shared savings or (with the exception of KCEs participating in Level 1 of the Graduated

Option) be liable for shared losses. CMS will calculate a prospective total cost of care benchmark based

on total Medicare Part A and Part B expenditures for aligned beneficiaries. CMS will reconcile the total

cost of care for the aligned beneficiaries during the Performance Year against the Performance Year

benchmark, giving KCEs the opportunity to be eligible to earn shared savings or be liable for shared

Updated 03/06/2022

losses depending on their expenditures compared to the benchmark. The amount that a KCE can retain or

will owe to CMS varies depending on the CKCC Option in which the KCE participates.

The CKD QCP and AMCP (and TCC if added to the CKCC Global Option in a future Performance Year)

coun

t as expenditures against the Performance Year benchmark, while the KTB does not. More details on

the financial methodology can be found below.

KCEs will have the option to select from among the following options:

•

CKCC Graduated Option: KCEs participating in this option will enter into a path that allows the KCE

to enter the Model at a lower level of risk and transition into a higher level of risk in future years.

Under the Graduated Option, KCEs may choose to begin participation under a lower-reward one-

sided option or a two-sided option with a lower level of risk and incrementally phase in risk and

additional potential reward. The Graduated Option is intended for KCEs with either no dialysis

facility participants or only dialysis facility participants with small dialysis organization ownership

(i.e., dialysis organizations with 500 or fewer dialysis facilities). KCEs with dialysis facility

participants owned by dialysis organizations that own, in whole or in part, more than 500 dialysis

facilities will not be allowed to participate in this option. KCEs entering into the Graduated Option

may select either level of risk (Level 1 or Level 2) at the start of their first Performance Year:



Level 1 – a one-sided arrangement where KCEs will share in up to 40% of savings in the total

cost of care for Medicare Part A and B services for aligned beneficiaries relative to a

benchmark calculated in the manner specified below. Level 1 is available only for the KCE’s

first Performance Year; and



Level 2 – a two-sided arrangement where KCEs will share in up to 50% of savings but only

30% of losses in the total cost of care for Medicare Part A and B services for aligned

beneficiaries relative to a benchmark calculated in the manner specified below.

If the KCE selects Level 1 for its first Performance Year, the KCE will automatically graduate to

Level 2

for its second Performance Year, and will then graduate to either Professional Option or the

Global Option for its third Performance Year. If the KCE selects Level 2 for its first Performance

Year, the KCE will automatically graduate to the Professional Option for its second Performance

Year.

•

CKCC Professional Option: KCEs participating in this option will share in 50% of savings or losses

in the total cost of care for Medicare Part A and B services for aligned beneficiaries relative to a

benchmark calculated in the manner specified below.

•

CKCC Global Option: KCEs participating in the Global Option will be at risk for 100% of the total

cost of care for all Medicare Part A and B services for aligned beneficiaries relative to a benchmark

calculated in the manner specified below.

While the payment methodology and degree of risk varies across CKCC options, a common

benchm

arking methodology will apply across all three options. In this section, the benchmarking

methodology will be described first, then the differences between the payment methodologies under the

three options will be discussed.

3. Benchmarking Methodology

Each option will use the same benchmark process, which will include the following steps:

1. Determine the baseline/historical expenditure

2. Apply trending and geographic adjustment factor (GAF)

3. Incorporate regional expenditures

Updated 03/06/2022

4. Risk adjust

5. Discount and quality adjustments

The benchmarks will be calculated prospectively and given to KCEs at the start of each Performance Year

and may be adjusted to account for CKD progression. Separate benchmarks will be calculated for CKD

and ESRD beneficiaries

and will cover all Medicare Part A and B costs, including those not related to

kidney disease, with a few exceptions. These exceptions are designed to avoid negative cost incentives

for behaviors CMS wishes to promote and include kidney transplant-related costs, such as: evaluation of

the recipient and donor, blood and tissue typing of the recipient and donor, organ acquisition, execution of

the transplant itself, and services following the transplant.

CMS reserves the right to change financial model provisions to respond to specific circumstances in a

particular market, such as a natural disaster or other emergency.

Step 1: Determine the baseline / historical expenditure

For all three CKCC options, the baseline period is a fixed three-year period for the duration of the KCC

Model: 2017, 2018, and 2019. These baseline years will be weighted to give additional weight to the

most recent base year (BY), recognizing that the population of base year-aligned beneficiaries for the

most recent base year is likely more comparable to the KCE’s Performance Year population of aligned

beneficiaries. The Model incorporates the weighting scheme used in the Shared Savings Program for

ACOs in their first agreement period (BY1 [2017] at 10%, BY2 [2018] at 30%, BY3 [2019] at 60%) in

determining a KCE’s CKD and ESRD Performance Year benchmarks. The baseline period will be static

across all of the Performance Years of the Model. However, the baseline expenditures will be updated

each year, as CMS will use a KCE’s most recent Participant List to identify the beneficiaries that would

have been aligned to the KCE for each of the base years and their associated expenditures. For example,

the baseline expenditures that will apply for purposes of calculating the PY2023 benchmarks will be

determined based on the KCE’s Participant List for PY2023. For PY2024, the same baseline period will

be used, but the baseline expenditures will be determined based on the KCE’s Participant List for

PY2024.

Step 2: Apply trending and Geographic Adjustment Factor (GAF)

Trending is determined by the year-over-year projected percent change in the U.S. Per Capita Cost

(USPCC). The USPCC is developed annually by the CMS Office of the Actuary and announced in the

annual Announcement of Calendar Year (CY) Medicare Advantage Capitation Rates and Medicare

Advantage and Part D Payment Policies. The CKCC Options will use the USPCC’s general FFS trend

rate for the CKD benchmarks and the USPCC’s ESRD trend rate for the ESRD benchmarks. CMS will

make adjustments to the USPCC, such as an adjustment based on a comparison of the projected USPCC

to the experience and trend for specific populations, to take into account differences in the expenditure

trend of the FFS population as a whole compared to the subset of FFS beneficiaries eligible to be aligned

to KCEs. Under limited circumstances, CMS may use an adjusted projected trend figure in response to

unforeseeable events that have a substantial impact on Medicare FFS expenditures. Any such adjustment

to the trend projections would be intended to prevent KCEs from being unfairly penalized or rewarded for

major payment changes beyond their control.

The USPCC growth trend will be adjusted to reflect the anticipated impact of changes in the regional

GAFs applied to payment amounts under the Medicare FFS payment systems. This GAF adjustment is

intended to prevent the benchmarks from being unfairly understated (or overstated) because of differences

No separate benchmark will be calculated for kidney transplant beneficiaries.

Updated 03/06/2022

in the local geographic price adjustments that Medicare uses to calculate provider and supplier payments

between the baseline period and the Performance Year. This process accounts for variations in the cost-

of-doing-business adjustments that Medicare applies under most of its FFS fee schedules (e.g., the

Medicare area wage index, the geographic practice cost index), which are typically updated annually.

Step 3: Incorporate regional expenditures

CMS incorporates regional expenditures into the historical baseline to generate the Performance Year

bench

marks. Incorporating regional expenditures will enable the Performance Year benchmarks to better

reflect the KCE’s regional environment while also providing a simple and predictable methodology

synchronized with other Medicare payment policies. To that end, CMS will test the use of county level

benchmarks from an ACO REACH/KCC Rate Book (previously known as the GPDC/KCC Rate Book),

modeled after the Medicare Advantage (MA) Rate Book to establish regional expenditures for KCEs

participating in the CKCC Options. These county level benchmarks will be established prospectively and

published in advance of the Performance Year . CMS will publish an updated ACO REACH/KCC Rate

Book prior to each Performance Year. CMS will blend the regional expenditures with the KCE’s

historical baseline expenditures, which have been trended forward to the Performance Year, in

determining the KCE’s Performance Year benchmarks.

Use of regional expenditures in the CKCC Options will depart from the use of regional expenditures in

pre

vious ACO initiatives, in that an ACO REACH/KCC Rate Book will be used to derive the regional

expenditures. This approach, which departs from the CEC methodology of developing an ESCO-specific

calculation of regional expenditures, is intended to be responsive to stakeholder feedback that the CEC

Model’s benchmarking methodology was too complex and gave rise to uncertainty throughout the

Performance Year. In making use of a rate book modeled after the MA Rate Book, CMS will be able to

capitalize on an existing rate setting methodology.

Despite sharing similarities with the MA Rate Book, CMS has made several deviations from the MA Rate

Book i

n constructing the ACO REACH/KCC Rate Book to ensure that the rates used for this Model serve

as an accurate representation of the regional costs for purposes of benchmarking.

1. Exclusion of adjustments based on health plan performance: CMS will remove the impact of

certai

n adjustments that are incorporated into the MA Rate Book for purposes of MA plan

payment, but that are not relevant to the CKCC Options, such as the Quality Bonus Payment

(QBP) percentage based on star ratings.

2. Removal of Quartile Adjustments: CMS will remove the MA quartile adjustments to the county

Aged

& Disabled rates from the ACO REACH/KCC Rate Book.

3. Reduction in Calendar Years Contributing to Rate Book: Whereas MA looks back 7 years to

establ

ish the MA rates (using an average of 5 years of claims data per county (or state for

ESRD) and with a 2 year gap for claims lag), the ACO REACH/KCC Rate Book for CKCC will

look back 4 years, using an average of 3 years of claims data with a single year gap between the

last year in the AC ACO REACH/KCC Rate Book and the Performance Year to account for

claims lag. For example, for the PY2023 ACO REACH/KCC Rate Book, claims for 2019,

2020, and 2021 will contribute to the ACO REACH/KCC Rate Book.

4. Removal from the Rate Book of Excluded Expenditures: CMS will make adjustments to account

for

differences in expenditure types that are included for purposes of the MA rate book but are

not relevant for purposes of the CKCC Options. CMS will make adjustments to account for

differences between the subset of FFS beneficiaries eligible to be aligned to KCEs and Medicare

FFS beneficiaries generally.

Updated 03/06/2022

Once CMS makes its adjustments to the ACO REACH/KCC Rate Book for purposes of this Model, a

specified percent of the KCE’s regional expenditures would be “blended” into the KCE’s benchmarks.

The percentage of regional baseline expenditures and the KCE’s baseline expenditures for each

Performance Year of the Model is described in the Table 13, below.

Table 13. Regional and KCE Historical Blend for KCE Benchmarks by Performance Year

Benchmark Component PY2023 PY2024 PY2025 PY2026

Composition of the

KCE Benchmark

KCE’s Weighted Baseline

Expenditure

65% 60% 55% 50%

KCE’s Weighted Regional

Rate (derived from ACO

REACH/KCC Rate Book)

35% 40% 45% 50%

For purposes of incorporating regional expenditures into a KCE’s benchmarks, a KCE’s region will

include all counties (or states, for the ESRD population) where one or more beneficiaries aligned to the

KCE in the baseline period reside. Regional expenditures are calculated using a beneficiary-month

weighted average of county-level or state-level FFS expenditures for the KCE’s aligned beneficiaries in

each county or state. General MA rates for the Aged & Disabled (i.e. non-ESRD) population are

calculated at the county level, while ESRD MA rates are calculated at the state level. Specifically, CMS

will calculate a beneficiary month-expenditure weighted average of each county’s (or state’s, for ESRD)

ACO REACH/KCC rate for which the KCE has aligned beneficiaries; the weights will be the proportion

of the KCE’s beneficiaries residing in that county . Note that the “region” for purposes of the financial

benchmark methodology is separate and distinct from the KCE’s “service area” that is used for purposes

of alignment.

We will establish limits on the maximum upward and downward adjustment that can result from

ncorporating regional expenditures into the benchmarks. To align with the ACO REACH Model, we

will limit the overall upward adjustment from incorporating the regional expenditures to a flat dollar

amount equal to 5 percent of the FFS USPCC described above for the Performance Year (e.g., PY2023

will use the 2023 ACO REACH/KCC Rate Book USPCC Rate adjusted as described above). We will

limit the overall downward adjustment from incorporating the regional expenditures to a flat dollar

amount equal to 2 percent of the FFS USPCC for that Performance Year. For example, in a hypothetical

Performance Year in which the FFS USPCC rate for Aged and Disabled beneficiaries was $891.07, then

this rate would result in a maximum upward adjustment of +$44.55 (=$891.07 * 5%) PBPM to the

historical benchmark (Aged and Disabled) and a maximum downward adjustment of -$17.82 (=$891.07 *

-2%) PBPM to the historical benchmark (Aged and Disabled).

Limiting the impact of the regional expenditures in calculating the benchmarks accomplishes three goals.

irst, the upward limit serves as a buffer against excessive increases to the benchmarks that would stem

solely from the incorporation of regional expenditures. The regional expenditures can otherwise provide

overly inflated benchmarks for KCEs that are relatively low-spending compared to their region. Second,

the downward limit recognizes that higher-cost KCEs may be particularly sensitive to the inclusion of

regional expenditures into the baseline. KCEs with higher spending compared to the region may choose

not to participate in the Model when otherwise faced with significantly lower benchmarks. Third, the use

of a flat dollar cap, rather than a cap based on a percentage of benchmark, provides a relatively higher

adjustment for those lower spending KCEs and a relatively lower adjustment for higher spending KCEs.

Updated 03/06/2022

As we would expect most KCEs to be efficient relative to their region, this would have the effect of

providing a greater relative adjustment for low spending KCEs than higher spending KCEs.

Limitations on the maximum upward/downward adjustments to the Performance Year benchmarks

temming from inclusion of regional expenditures have previously been introduced in ACO

benchmarking, including in the Next Generation ACO Model and in the Shared Savings Program

benchmarking methodology as part of the December 2018 final rule.

Step 4: Risk adjustment

Risk adjustment is necessary in the CKCC Options to ensure that benchmarks account for differences in

he risk of beneficiaries aligned to the KCE in the base and Performance Years. Existing ACO risk

adjustment models used in current Medicare ACO initiatives are based on the prospective CMS

Hierarchical Condition Category (HCC) risk model, which relies on provider-supplied diagnostic codes

for a prior calendar year to predict costs in the Performance Year (e.g., diagnoses from 2018 to predict

2019 costs).

CMS will continue to use the CMS HCC risk model to risk adjust the benchmarks for the CKD Stages 4

and 5 population. Furthermore, for beneficiaries with ESRD, CMS will continue to use the same CMS-

HCC ESRD prospective model which is applied in Medicare Advantage. Internal analyses indicate that

these risk adjustment models yield benchmarks that effectively predict medical expenditures for eligible

beneficiaries.

Consistent with the Next Generation ACO Model, CMS will apply a Symmetric Risk Score Cap to the

KCE’s risk score growth (relative to a prior year) to mitigate against coding intensity. The cap will be

applied separately for the CKD Stages 4 or 5 (Aged/Disabled) and ESRD populations. For the CKD

Stages 4 and 5 population the Symmetric Risk Score Cap will be +/- 6%. The +/- 6% Symmetric Risk

Score Cap was set at a level such that approximately 30% of KCEs would be expected to have changes in

risk scores that meet or exceed the cap; based on analyses of CKD Stages 4 and 5 aligned beneficiary risk

scores in Next Generation ACO beneficiaries. For the ESRD population, the Symmetric Risk Score Cap

will be +/-3%; consistent with the Next Generation ACO Model.

Step 5: Apply discount and quality adjustments

CMS will incorporate a discount to the trended, risk adjusted ESRD benchmarks for KCEs participating

the Global Option. KCEs participating in the Global Option will retain 100% of savings in relation to

their Performance Year benchmarks, and as such, the discount to the ESRD benchmark represents the

only mechanism for CMS to obtain savings from this Model Option (e.g., CMS does not “share” in the

savings generated by the KCE). This discount effectively reduces the total benchmark expenditures by a

specified percentage, in an effort to ensure that savings accrue to CMS from the KCC Model. The

discount will only apply to the ESRD benchmark and not the CKD benchmark. The discount will be set at

3% of the ESRD benchmark for PY2023. Subsequently, the discount will increase by a percentage point

each year, subject to the adjustments described below, thereby requiring continuous improvement by

KCEs in the Global Option. No discount will apply to the benchmarks for KCEs participating in the

Graduated or Professional Options.

The discounts applied to the ESRD benchmark for KCEs that select the Global Option could be reduced

0.5% for the Performance Year if the KCE includes one or more dialysis facilities owned by a dialysis

organization as KCE Participants or Preferred Providers, and more than 90% of the dialysis facilities

owned in whole or in part by that dialysis organization are participating in one or more KCEs across the

country. The discount applied to the ESRD benchmark may also be reduced if the KCE participates in

Updated 03/06/2022

future multi-payer payment strategies still to be developed, if a multi-payer component is added to the

Model in future years. Because the majority of patients with CKD are not on Medicare, CMS believes

that coordination across multiple payers is important to fully address CKD.

Additionally, if an aligned beneficiary has remained in CKD Stages 4 and 5 for over two years and has

not

progressed to ESRD, CMS will apply an upward adjustment to the KCE’s CKD benchmark to reward

the KCE for keeping these beneficiaries off dialysis. To determine this adjustment, the proportion of

CKD Stages 4 and 5 beneficiary months contributed by CKD Stages 4 and 5 beneficiaries who have been

continuously aligned to the KCE for at least 24 months and have not progressed to ESRD will be

multiplied by 1%; and this product will be applied as an upward adjustment to the CKD PY benchmark.

For practical purposes, this adjustment cannot be made to benchmarks until PY2025 for KCEs that begin

participation in PY2023. CMS will begin measuring beneficiary alignment for the 24-month continuous

alignment requirement at the start of PY2023.

Finally, adjustments will be made to the benchmarks to account for the KCE’s performance on quality

easures. Most KCEs will be subject to a quality withhold, a reduction in their Performance Year

benchmarks. KCEs in Level 1 of the Graduated Option do not have a quality withhold, KCEs in Level 2

of the Graduated Option have a quality withhold of 2.5%, and KCEs in the Professional and Global

Options have quality withholds of 5%. KCEs can recoup a portion or all of their quality withhold based

on their performance on the quality measures. The determination of the portion of the quality withhold

that the KCE recoups is made at final reconciliation. High performing KCEs may also have the

opportunity to participate in the High Performers Pool, should they qualify. Additional details on the

quality program and its impact on the financial methodology are discussed in the quality section of this

RFA.

4. Features Specific to the

CKCC Graduated Option

Minimum Savings Rate (MSR)/M

inimum Loss Rate (MLR)

The MSR is the minimum percentage of the total Performance Year expenditure benchmark that the KCE

must have in preliminary savings to be able to receive shared savings. Conversely, to be required to pay

back shared losses, preliminary losses must exceed the minimum loss rate or the MLR.

For KCEs participating in Graduated Level 1 (under a one-sided risk arrangement), preliminary savings

ust exceed the MSR to be eligible to receive shared savings. CMS will use a sliding scale, based on the

number of beneficiaries aligned to the KCE to establish the MSR for the KCE.

For KCEs participating in Graduated Level 2 (which involves taking on downside risk under a two-sided

isk arrangement) no MSR or MLR will apply to aggregate savings or losses, and as such KCEs

participating in Graduated Level 2 will retain “first dollar” savings and be responsible for “first dollar

losses,” provided that the KCE meets the beneficiary minimums.

Aggregate Savings/Losses Cap (Risk Corridor)

For Graduated Level 1, shared savings will be capped at 10% of the KCE’s Performance Year

nchmark. In Graduated Level 2, the aggregate amount of shared savings that KCEs will be eligible to

receive if their actual Performance Year expenditures are lower than their Performance Year benchmark

will be limited, or “capped” using a series of caps that are set as a percent of the Performance Year

benchmark, as shown in Table 14. Similarly, in the event that KCEs generate shared losses, those shared

losses will also be capped.

Updated 03/06/2022

Table 14. Series of Shared Savings and Shared Losses Caps (Level 2 of the Graduated Option)

Shared savings/losses cap as a

% of the Performance Year

benchmark

Portion of savings/losses

above the cap accruing to the

KCE’s shared savings/losses

Portion of savings/losses

above the cap accruing to

CMS’ shared savings/losses

Gross Savings/Losses

Less than 5%

50% of Saving

30% of Losses

50% of Savings

70% of Losses

Gross Savings/Losses

Between 5% and 10%

35% of Savings

20% of Losses

65% of Savings

80% of Losses

Gross Savings/Losses

Between 10% and 15%

15% of Savings

10% of Losses

85% of Savings

90% of Losses

Gross Savings/Losses

Greater than 15%

5% of Savings

5% of Losses

95% of Savings and Losses

Truncation and Optional Stop-Loss

For KCEs participating in Graduated Level 1, for expenditure calculations, CMS will truncate annualized

expenditures at the 99th percentile for CKD and at the 95th percentile for ESRD beneficiaries aligned to

the KCE. For KCEs participating in Graduated Level 2 and through transition into the Professional

Option, a stop-loss arrangement will be available as an optional feature that may be selected by KCEs at

the start of each Performance Year.

The purpose of the stop-loss arrangement is to reduce financial uncertainty associated with infrequent, but

high-cost, expenditures at the level of the individual aligned beneficiary. Stop-loss protects KCEs from

financial liability on individual beneficiary expenditures that are above the stop loss “attachment points.”

An attachment point is the dollar threshold at which stop-loss protection begins. A portion of the

expenditures accrued above each attachment point and below the next highest attachment point will be

included in the KCE’s Performance Year expenditure calculations. The percent of expenditures for each

of the three attachment points will be 30%, 20%, and 10% respectively (See Table 16).

KCEs that choose the stop-loss arrangement are effectively charged for this protection. CMS will apply a

PBP

M stop loss “charge” to the KCE’s final Performance Year Benchmark, which will be based upon the

percent of expenditures above each of the KCE’s attachment points in the baseline period. Following

adjustments to PY expenditures and/or Performance Year Benchmarks to account for truncation or

selection of the stop-loss arrangement, CMS will reconcile the KCE’s Performance Year expenditures

against the KCE’s Performance Year benchmark to determine the amount of the KCE’s shared savings, as

applicable with retrospective reconciliation.

5. Features Specific to the

Professional Option

MSR/MLR

Provided that the KCE achieves the beneficiary minimums, no MSR or MLR will apply to aggregate

savings/losses for the Professional Option. As such, KCEs will retain “first dollar” savings and be

responsible for “first dollar” losses.

Updated 03/06/2022

Aggregate Savings/Losses Cap (Risk Corridor)

The aggregate amount of shared savings that KCEs will be eligible to receive if their actual Performance

Year expenditures are lower than their Performance Year benchmarks will be limited, or “capped” using

a series of caps that are set as a percent of the applicable Performance Year benchmark. Similarly, in the

event that KCEs generate shared losses, those shared losses will be capped, as shown in Table 15. KCEs

will be eligible to receive a portion of shared savings, or liable for a portion of shared losses, above each

threshold, with the portion decreasing with each threshold. The shared savings/shared losses caps will be

set at the following amounts:

Table 15. Series of Shared Savings and Shared Losses Caps (Professional Option)

Shared savings/losses cap as a

% of the Performance Year

benchmark

Portion of savings/losses

above the cap accruing to

the KCE’s shared

savings/losses

Portion of savings/losses above

the cap accruing to the CMS’

shared savings/losses

Gross Savings/Losses

Less than 5%

50% of savings/losses 50% of savings/losses

Gross Savings/Losses

Between 5% and 10%

35% of savings/losses 65% of savings/losses

Gross Savings/Losses

Between 10% and 15%

15% of savings/losses 85% of savings/losses

Gross Savings/Losses

Greater than 15%

5% of savings/losses 95% of savings/losses

Stop Loss Arrangement (Optional)