Comprehensive ESRD Care Initiative: Frequently Asked Questions

All Frequently Asked Questions (FAQs) on this web page were posted April 15, 2014, unless otherwise noted.

 

When are Letters of Intent due?

Letters of Intent (LOI) are due June 23, 2014 for large dialysis organization (LDO) applicants and September 15, 2014 for non-LDO applicants.  Applications are due on June 23, 2014 for LDO applicants and September15, 2014 for non-LDO applicants. Questions about the Letter of Intent or application should be directed to ESRD-CMMI@cms.hhs.gov.

 

I previously submitted a Letter of Intent and application. Do I have to do so again? (updated 4/16/14)

Yes, all applicants must file a Letter of Intent in order to be able to access the application portal to submit an application.

 

ESRD Seamless Care Organizations (ESCOS)

Who may form an ESCO?

The following providers are eligible to form an ESCO that may apply to participate in the Model:

  • Medicare Certified dialysis facilities, including facilities owned by large dialysis organizations (LDOs), facilities owned by small dialysis organizations (SDOs), hospital-based facilities, and independently-owned dialysis facilities;
  • Nephrologists and/or nephrology practices; and
  • Other Medicare enrolled providers and suppliers (other than durable medical equipment, prosthetics, orthodics and supplies (DMEPOS) suppliers, ambulance suppliers, and drug/device manufacturers).

 

What are the changes to the legal entity requirements in the revised RFA?

As stated in Section VII, Applicant Eligibility and Participation Requirements of the revised RFA, each ESCO must have at least one of each of the following included as participant owners:

  • A dialysis facility;
  • A nephrologist or a nephrology practice;
  • The requirement that a nephrologist and/or nephrology practice be an independent entity, i.e., not be employed by, have an ownership interest in, or be owned in whole or in part by, an ESCO participant owner dialysis facility, has been removed in the revised RFA.

 

What happens if I have already submitted an LOI and an application in a previous round?

If an applicant already submitted an LOI in a previous application round, the applicant is still required to resubmit an LOI. The applicant must also submit a new application.

 

What is an ESCO participant owner? What is an ESCO participant non-owner?

An ESCO participant may be either an ESCO participant-owner or an ESCO participant non-owner. ESCO participant-owners have an increased level of accountability to CMS in that they must (1) be signatories to the ESCO Model Participation Agreement with CMS, (2) have an ownership stake in the ESCO, and (3) for LDO ESCOs assume downside risk in the event of shared losses and be subject to recoupment for non-payment. LDO ESCO participant-owners must assume downside risk at a level that is equivalent to a minimum of 50% of their portion of the ESCO’s total revenue multiplied by the ESCO’s total shared losses. All dialysis facilities and nephrology group practices must participate in the model as participant-owners.

ESCO participant non-owners do not have to sign the ESCO Model Participant Agreement or take an ownership stake in the ESCO. They must, however, have a contractual relationship with the ESCO that requires them to comply with the terms and conditions of the ESCO Model Participation Agreement. ESCO participant non-owners are not required to assume downside risk, but are allowed to do so.

 

Are there any limitations on who can partner in forming an ESCO?

Yes. First, the same ESCO may not include dialysis facilities owned by different LDOs. Second, dialysis facilities owned by LDOs cannot partner with dialysis facilities owned by non-LDOs. There are no limitations on partnerships among non-LDO organizations/facilities in the submission of a single ESCO application.

 

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 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, and (3) drug and/or device manufacturers. Of note, Medicare-enrolled providers of services that are also DMEPOS suppliers are eligible to participate in the Model.

 

Other than dialysis facilities and nephrologists or nephrology practices, are ESCOs required to include other particular types of providers or suppliers?

CMS does not have requirements for how many other providers or suppliers should participate in the ESCO. CMS anticipates that an extended team of skilled clinical and non-clinical providers and practitioners would support the care of ESRD patients beyond the dialysis services included in the ESRD Prospective Payment System (PPS). Examples of physicians and non-physician practitioners that may be appropriately involved in an interdisciplinary team include, but are not limited to: general internists, endocrinologists, cardiologists, vascular surgeons, podiatrists, psychiatrists, nurse practitioners, physician assistants, registered nurses/licensed practical nurses, licensed clinical social workers, nurse case managers, dieticians/nutritionists, health educators, pharmacists, behavioral health specialists, and community health workers/patient navigators.

 

If I am already participating in another Shared Savings Program, am I eligible to participate in this initiative?

ESCO Participants are defined by a Taxpayer Identification Number (TIN). Each ESCO participant must have a Medicare-enrolled TIN through which its individual participating ESCO providers/suppliers bill. Not all of the providers/suppliers that bill under an ESCO participant’s TIN are required to participate in the Model as ESCO providers/suppliers. However, the TINs of Accountable Care Organization (ACO) participants and the TINs through which ACO providers/suppliers bill in the Medicare Shared Savings Program are NOT eligible to participate in the Comprehensive ESRD Care Initiative as ESCO Participants. Individual providers/suppliers participating in other shared savings programs, with the exception of primary care providers participating in the Pioneer ACO model, are eligible to participate in the Comprehensive ESRD Care Initiative subject to the rules of those other shared saving programs. All otherwise eligible ESCO providers/suppliers, except for dialysis facilities, may also participate in multiple ESCOs.  Because beneficiary matching to an ESCO is based on where a beneficiary receives dialysis care, dialysis facilities may only participate in one ESCO.

 

ESCO Market Areas

How is the market area defined? By where an ESCO operates?

The ESCO, rather than the CMS, defines the market in which an ESCO will operate. The area that an ESCO defines as its market area may be no larger than two contiguous Medicare core-based statistical areas (CBSA), with permissible inclusion of contiguous rural counties that are not included in a Medicare CBSA. In the case of rural-based applicants not included in any Medicare CBSA, the market area of the ESCO will be defined based on a geographic unit no larger than a state. A non-LDO may join aggregation pools either within or across markets.

 

The Letter of Intent (LOI) and Application Process

Does my organization need to submit a Letter of Intent if we are already planning on submitting an application?

Yes, all applicants must file a Letter of Intent in order to be able to access the application portal to submit an application.

 

If my organization submits a Letter of Intent, are we then required to submit an application? What if we no longer wish to apply?

No. The Letters of Intent are non-binding, and an organization filing a Letter of Intent is not required to apply or participate in the model. Because Letters of Intent are non-binding, an organization filing a Letter of Intent need not withdraw it or take any other action if it decides not to file an application.

 

Must my organization update its Letter if Intent if the participants listed in it change prior to my organization submitting an application?

No, but any changes should be reflected in the information submitted with your organization’s application.

 

Can my organization withdraw its application or amend it to remove specific CMS Certification Numbers (CCNs) and/or National Provider Identifier (NPI) numbers from an application?

Applicants seeking to withdraw their application must submit an electronic withdrawal request to CMS via the following mailbox: ESRD-CMMI@cms.hhs.gov. The request must be submitted as a PDF on the organization’s letterhead and signed by an authorized corporate official. It should include the following information: the applicant organization’s legal name; the organization’s primary point of contact; the full and correct address of the organization; and, if applicable, the specific CMS Certification Numbers (CCNs) and/or National Provider Identifier (NPI) numbers it seeks to remove from a pending application.

 

Payment Arrangements

How will payments to ESCOs be determined?

The payment arrangements applicable to ESCOs are described in detail in the Request for Application (RFA). The Comprehensive ESRD Care 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, experienced by Medicare for the particular ESCO’s matched 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 matched to the ESCO in each of the three years prior to the start of the first performance year for this model.

CMS will then adjust the baseline forward to develop an expenditure benchmark for the beneficiaries matched 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 matched population in a given performance year. The savings will be adjusted based on quality performance.

As described in the revised RFA, the Comprehensive ESRD Care model includes two possible payment arrangements. One of these arrangements applies to ESCOs that contain a large dialysis organization (LDO) participant owners, and the other applies for ESCOs that do not have an LDO participant owner. The extent to which the ESCOs may share in savings or losses depends upon whether the ESCOs contain an LDO participant.

 

In the revised RFA published on April 15, 2014, what are the changes to the LDO 2-sided risk track?

In the LDO 2-sided risk track, CMS has eliminated rebasing in performance years 4 and 5. In addition, CMS will only apply the guaranteed discount to the non-dialysis FFS Medicare Parts A and B per capita benchmark starting in year 2 at 1%, year 3 at 2%, year 4 and onwards at 3%.

 

In the revised RFA published on April 15, 2014, what are the changes to the non-LDO risk track?

CMS no longer is offering two risk track options for non-LDOs. The revised RFA describes in Section IX. Payment based on the one-sided risk track only is now being offered for non-LDO ESCOs. The shared savings percentage between CMS and the ESCO will be 50% in performance years 1 through 5. Like the LDO risk option, CMS has eliminated rebasing in performance years 4 and 5.

 

What limits are in place to protect participants from excessive financial risk?

ESCOs participating in all risk tracks will have the option of truncating a matched beneficiary’s total annual Medicare Parts A and B FFS per capita expenditures, for each benchmark and performance year, to minimize variation from catastrophically large claims. The truncation point for expenditures associated with a matched beneficiary in a given benchmark or performance year will be set at the 99th percentile of annual Medicare Parts A and B expenditures for non-ESRD beneficiaries plus the difference between the average annual Medicare Parts A and B expenditures for ESRD beneficiaries and the average annual Medicare Parts A and B expenditures for non-ESRD beneficiaries. The resulting truncation point is expected to be between the 90th and 95th percentile of annual Medicare Parts A and B expenditures for ESRD beneficiaries. To ensure appropriate comparability, benchmarks will be trended using the same truncation method for the national average annual Medicare Parts A and B expenditures for beneficiaries with ESRD.

 

Will the cost of items and services provided to beneficiaries prior to their deaths be accounted for in the baseline and benchmark expenditure calculations where the beneficiaries who would have been matched to an ESCO die before the start of the first performance year?

As stated in Section VI. Eligibility of Medicare and Medicaid Beneficiaries of the RFA, if a beneficiary dies during a base year or any of the performance years, all costs incurred during the measurement period will be counted in the expenditure calculations.

For purposes of clarification, the expenditure baseline calculation is comprised of expenditures for beneficiaries who would have been matched to the ESCO during the three years preceding the first performance year, based on the eligibility requirements described in the RFA. The cost of items and services provided to beneficiaries prior to their deaths will be included in both the expenditure baseline and expenditure benchmark.

 

Beneficiary Matching

How will beneficiaries be assigned to an ESCO?

ESCOs will not enroll beneficiaries in the model—nor will beneficiaries be permitted to sign up for the model. CMS will prospectively “match” eligible beneficiaries through a claims-based process. The beneficiary matching process identifies the Medicare beneficiaries with ESRD for whom CMS will hold an ESCO clinically and financially accountable. Beneficiaries will maintain full fee-for-service 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 a beneficiary’s first visit to a given dialysis facility during a particular period will prospectively match that beneficiary to the dialysis facility, and by extension the ESCO, for the upcoming performance year.

 

After the initial historical match, how will CMS match beneficiaries under the Comprehensive ESRD Care model?

CMS will match beneficiaries each quarter to an ESCO based on dialysis utilization using a “first touch” approach—meaning that a beneficiary’s first visit to a given dialysis facility during a particular period will prospectively match that beneficiary to the dialysis facility, and by extension the ESCO, for the duration of the model unless the beneficiary loses eligibility based on the criteria described in the RFA. This is in contrast to other approaches used in the Shared Savings Program or the Pioneer ACO Model that generally rely on a plurality of primary care services over an extended period of time.

 

Quality

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 administration of surveys as outlined in the RFA for assessing ESCO quality performance. A draft set of quality measures that CMS is considering for potential inclusion in the Comprehensive ESRD Care model quality measures was made available for public review and comments. For more information on the draft quality measure set, please visit the Comprehensive ESRD Care initiative web page. CMS will provide a final set of quality measures for review to selected participants prior to requiring participants to sign the CEC Model Participation Agreement.

 

How has CMS aligned ESCO quality assessment with the ESRD QIP?

CMS will require that the ESCOs’ participating dialysis facilities receive a minimum Total Performance Score (TPS) assigned by the ESRD Quality Incentive Program (QIP) for that ESCO to be eligible for any shared savings.

 

Is CMS hosting a quality Technical Evaluation Panel for the development of the quality performance measure set?

CMS is not itself establishing a quality technical evaluation panel for the development of the quality performance measure set. Instead, CMS awarded IMPAQ International a 5-year contract to provide a range of analytic and program support activities for the Comprehensive ESRD Care Initiative. As part of the contract, IMPAQ established a Measure Evaluation Technical Expert Panel (TEP) whose members were selected by IMPAQ and are assisting in developing clinical and patient experience quality measurement recommendations for IMPAQ to present to CMS. More information about the contractor's TEP and participant names can be found via the Comprehensive ESRD Care initiative web page.

 

Non-LDO Aggregation

What is non-LDO Aggregation and why is it important?

Non-LDO aggregation allows non-LDO ESCOs to more easily satisfy the requirement that an ESCO have  a minimum of 350 matched beneficiaries for financial purposes. CMS’ review of claims patterns suggests that many non-LDO ESCOs may have difficulty meeting the 350 matched beneficiary minimum on their own. In addition, a number of prospective applicants have indicated that the high minimum savings rate (MSR) is a deterrent to participation. Therefore, for purposes of the 350 matched beneficiary requirement and relevant financial calculations, we will offer each non-LDO ESCO applicant an opportunity to aggregate the beneficiaries it serves with those served by other non-LDO ESCO. Non-LDO ESCOs that aggregate matched beneficiaries with one another form an “aggregation pool.”

 

Who is eligible to participate in non-LDO Aggregation?

Only non-LDO applicants are eligible to select aggregation. This includes both non-LDO applicants that can meet the minimum threshold for matched beneficiaries as well as those ESCOs that are unable to meet the requirement. For the purposes of this Model, ESCOs in an aggregation pool will continue to operate as independent legal entities and will be treated as such for purposes of meeting all other program requirements such as governance and ownership structure.

 

When does a non-LDO ESCO select the option for aggregation?

All non-LDO ESCOs selected to participate in the model will be given the option to select aggregation prior to the signing of participation agreements before the start of the first performance year.  

 

What happens if a non-LDO ESCO drops out of the CEC Model?

If, during the life of the model, an ESCO is terminated for any reason (voluntary or not) and thereby affects the ability of an aggregation pool to collectively meet the minimum matched beneficiary threshold, CMS may disqualify and terminate the participation of remaining ESCOs in the pool unless those ESCOs can add sufficient clinical partners to meet the minimum threshold.

 

How will CMS determine aggregation pools?

CMS will take into account the applicant’s preferences for aggregation partners when making final decisions regarding the composition of aggregation pools, while also considering other factors including the location and size of specific applicants. After CMS selects finalists for the initiative, we will provide information on the matched population size, location, and organizational composition of all non-LDO finalists. All non-LDO finalists will be given the option to enter the model through a default aggregation pool that includes all non-LDO finalists. CMS will also consider requests by multiple subsets of such finalists to form a smaller aggregation pool as long as that smaller pool would still meet the 350 beneficiary minimum. CMS will provide additional details and may also add additional requirements as it further develops the model design, evaluates applications for participation in the model, and finalizes the CEC Model Participation Agreement.

How do eligible ESCOs submit their preference to be considered for aggregation?

If non-LDO applicants have preferences regarding which other organizations they should be aggregated with for purposes of financial calculations, they should send an email to ESRD-CMMI@cms.hhs.gov with a list of potential non-LDO aggregation partners before the close of the application period. The email should include the full legal name of each ESCO organization in the proposed aggregation pool and its address (including zip code), contact information for an executive at the applicant organization with the authority to represent the organization, and the applicant’s Letter of Intent (LOI) identification number. The information provided in this email is non-binding and will be used for CMS informational and planning purposes only.