Comprehensive ESRD Care Initiative: Frequently Asked Questions

All Frequently Asked Questions (FAQs) on this web page were posted October 7^th, 2015, unless otherwise noted.

 

What is the Comprehensive ESRD Care (CEC) Model?

The Comprehensive ESRD Care (CEC) model is a new accountable care organization (ACO) model developed under the authority of the Center for Medicare and Medicaid Innovation (Innovation Center) to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care. As the first Accountable Care Organization (ACO) model with a disease specific focus, the model aims to identify ways to improve the coordination and quality of care for Medicare beneficiaries living with ESRD, while reducing Medicare expenditures.

 

What is an ESCO?

An "ESCO" or "ESRD Seamless Care Organization" is an Accountable Care Organization (ACO) comprised of providers and suppliers who voluntarily come together to form a legal entity that offers coordinated care to beneficiaries with ESRD through the Comprehensive ESRD Care model. An ESCO is required to have participant owners that include at least one nephrologist or nephrology group practice and at least one dialysis facility.

 

When does the Comprehensive ESRD Care (CEC) Model begin? When does it end? How many ESCOs are participating?

The Model started October 1, 2015 with 13 participating ESCOs. The initial agreement period lasts for three years. CMS and ESCOs then have the option of extending this agreement for an additional two years based on the ESCO's performance.

 

What types of providers are eligible to participate in an ESCO?

Medicare-enrolled providers of services and suppliers are eligible to participate in the Comprehensive ESRD Care (CEC) Model. This includes physicians, non-physician practitioners, and other healthcare suppliers that are not: (1) Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; (2) ambulance suppliers; (3) drug and/or device manufacturers; or (4) excluded or otherwise prohibited from participation in Medicare or Medicaid. Medicare-enrolled providers of services that are also DMEPOS suppliers, but whose primary taxonomy is as a non-DMEPOS provider, are eligible to participate in the Model.

 

Can a Medicare provider participate in both the Shared Savings Program and the Comprehensive ESRD Care (CEC) Model?

The Medicare Shared Savings Program requires that each ACO participant taxpayer identification number (TIN) upon which beneficiary assignment is dependent must be exclusive to one Medicare Shared Savings Program ACO (see the Medicare Shared Savings Program regulations at Ă‚ §425.306(b)). This means that a TIN or CMS Certification Number (CCN) billing Medicare for primary care services (as defined in the Medicare Shared Savings Program regulations at Ă‚ §425.20) must be exclusive to one ACO's certified list of ACO participants. This means that providers billing under the same TIN will not be able to be a participant in both the Shared Savings Program and the CEC Model.

This exclusivity rule applies to the Medicare-enrolled billing TIN that is an ACO participant in the ACO, not to individual practitioners. Individual practitioners are free to participate in multiple ACOs if they bill under several different TINs. Also, the exclusivity rule applies only for Medicare Shared Savings Program operational purposes. In no way does it establish or otherwise imply a lock in of beneficiaries or a limitation of provider practice or referrals.

 

How will CMS offer ESCOs financial incentives to improve care?

The payment arrangements applicable to ESCOs are described in detail in the Request for Application (RFA) available on the Comprehensive ESRD Care (CEC) Model website. The CEC Model will use a shared savings and losses model, under which ESCOs will share savings, and in some instances be held accountable for a portion of losses, for the particular ESCO's aligned beneficiaries. To assess savings or losses to Medicare, CMS will develop an expenditure "baseline," based on historical Medicare Parts A and B expenditures incurred for beneficiaries who would have been aligned to the ESCO in each of the three years prior to the start of the first performance year for this model.

CMS will then trend the baseline forward using national data to develop an expenditure benchmark for the beneficiaries aligned to the ESCO. CMS will calculate savings or losses based on a comparison of the benchmark and the actual Medicare Fee-For-Service (FFS) Part A and B expenditures for the aligned population in a given performance year. The savings will be adjusted based on quality performance.

The Comprehensive ESRD Care (CEC) Model includes two payment arrangements. One of these arrangements is a two-sided payment track and applies to ESCOs that contain a large dialysis organization (LDO) participant owner, and the other (one-sided payment track) applies to ESCOs that do not have an LDO participant owner. ESCO participants who qualify for a two-sided payment arrangement are eligible for cost savings and will also be responsible for shared losses, while ESCOs who qualify for the one-sided payment track will be eligible for shared savings - but will not be responsible for losses.

 

How will beneficiaries be aligned to an ESCO?

ESCOs will not enroll beneficiaries in the model nor will beneficiaries have to sign up for the model. CMS will prospectively match eligible beneficiaries to ESCOs through a claims-based process. The matching process identifies the Medicare beneficiaries for whom CMS will hold an ESCO clinically and financially accountable. Beneficiaries will maintain full Medicare benefits, including the freedom to receive services from any Medicare-participating provider at any time.

CMS will match beneficiaries to an ESCO based on dialysis utilization using a "first touch" approach"”meaning that an eligible beneficiary's first visit to a Comprehensive ESRD Care (CEC) Model participant dialysis facility will prospectively match that beneficiary to the dialysis facility,
and by extension the ESCO, for the life of the model, unless the beneficiary loses eligibility (e.g., ceases dialysis treatment, joins Medicare Advantage, receives a functioning transplant, etc.).

 

How will beneficiaries be affected by the Comprehensive ESRD Care (CEC) Model? How many beneficiaries are expected to be affected by the CEC?

Many beneficiaries with ESRD also have multiple comorbidities. The Comprehensive ESRD Care (CEC) Model encourages dialysis facilities, nephrologists, and other providers to coordinate and manage the complete spectrum of care for their ESRD patients. ESCOs are designed to alleviate this burden for patients, while improving the partnership between patients and doctors in making health care decisions. The goal is for Medicare beneficiaries to have better control over their health care, and their dialysis providers and doctors to provide better care.

 

Can beneficiaries opt out of having their data shared with providers taking part in the CEC Model?

At the start of the first performance year and thereafter, CMS plans to provide medical information for beneficiaries receiving care to designated ESCOs providing medical care. Prior to CMS sharing any beneficiary data with ESCOs, ESCOs are required to notify aligned beneficiaries in writing that CMS will share their data with the ESCO unless the beneficiary opts out of data sharing. Beneficiaries aligned to the Comprehensive ESRD Care (CEC) Model will have the option to opt out of data sharing by calling 1-800 MEDICARE. CMS will only share data with the ESCO for aligned beneficiaries who have not opted out of data sharing.

 

What steps is CMS taking to prevent fraud, waste, and abuse?

The Comprehensive ESRD Care (CEC) Model includes numerous safeguards aimed at protecting beneficiaries and ensuring program integrity, including prohibitions on requiring referrals only to ESCO participants and conditioning participation on referrals for services provided to beneficiaries who are not assigned to the ESCO. CMS will work closely to monitor compliance with program requirements. In addition, CMS will employ routine analysis of Medicare data on service utilization and investigate aberrant utilization patterns.

When program monitoring efforts reveal potential non-compliance, CMS will employ a variety of different response tactics based on the level and type of issue identified, including termination of the ESCO from the model. These remediation responses do not limit or restrict the Office of the Inspector General's (OIG) authority to audit, evaluate, investigate, or inspect an ESCO and its ESCO participants.

 

What fraud and abuse waivers will CMS be providing to ESCOs participating in the Comprehensive ESRD Care (CEC) Model?

CMS and OIG have jointly issued notices setting out limited waivers of certain fraud and abuse laws for the CEC LDO and Non-LDO Models, subject to a number of conditions intended to prevent program and patient abuse. Specifically, the anti-kickback statute (OIG) and physician self-referral law (CMS) have been waived for certain arrangements involving the distribution of shared savings, the provision of health information technology to participants, performance-based payments to physician participants, and care coordination, as well as certain remuneration furnished by the LDO or non-LDO to the ESCO. In addition, OIG waived the anti-kickback statute and beneficiary inducement prohibition for certain patient engagement incentives furnished to ESCO beneficiaries for certain items of technology, free or discounted oral nutritional supplements, or free or discounted non-emergency transportation. Each waiver applies only to the individuals and entities that are specifically enumerated in the waiver and only to those arrangements that squarely meet all the conditions of the waiver. HHS intends to monitor the CEC Model for indicia of potential fraud and abuse. Participants in the CEC Model must comply with all applicable laws and regulations, except as explicitly provided in any waiver that may be granted.

 

How did CMS select the ESCOs participating in the Comprehensive ESRD Care (CEC) Model?

CMS conducted a competitive application process to select the participants in the CEC Model. CMS released a Request for Applications (RFA) in April 2014 that detailed selection criteria. Applicants were required to submit both a Letter of Intent and an application. Applications were reviewed by a panel of experts from the Department of Health and Human Services as well as from external organizations, with expertise in the areas of ESRD, ACOs, care improvement and coordination, and care of vulnerable populations. These panels assessed the applications based on the criteria detailed in the RFA. Based on these criteria, CMS chose selected ESCOs for participation in the model.

What is the set of quality measures that will be used for assessing ESCO quality performance?

CMS will require the assessment of claims-based and clinical quality measures as well as the administration of surveys as outlined in the RFA for assessing ESCO quality performance. A set of quality measures that CMS is using for the Comprehensive ESRD Care (CEC) Model quality measures was made available for public review and comments. For more information on the quality measure set, please visit http://innovation.cms.gov/initiatives/comprehensive-ESRD-care/.