Introduction

On July 13, 2017, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed updates to the Medicare Physician Fee Schedule for calendar year 2018 (CY 2018 Proposed PFS).1 In this rulemaking, CMS also released proposed changes and updates to the Medicare Diabetes Prevention Program (MDPP), which is currently scheduled to begin on January 1, 2018. These proposed changes and updates, summarized below, are intended to clarify or modify:

The scope of MDPP services; The eligibility and enrollment requirements for MDPP suppliers; The eligibility and conditions of coverage for Medicare beneficiaries; The structure of performance-based payments for MDPP suppliers; and The program integrity standards, documentation and reporting obligations for MDPP suppliers.

CMS also proposes a three-month delay (until April 1, 2018) before Medicare beneficiaries can receive MDPP services. The proposed time lag would give MDPP suppliers more time to enroll in Medicare and implement their compliance programs before they begin to furnish and bill for MDPP services. CMS elected to defer coverage for virtual MDPP services, except for a limited number of makeup sessions.

Comments are due on September 11, 2017 by 5:00 p.m. ET.

Background on the MDPP

The MDPP consists of coaching sessions that follow an approved curriculum in clinical or community settings for prediabetic Medicare beneficiaries. The MDPP aims to prevent the onset of type 2 diabetes in MDPP participants by helping them to lose weight through sustainable long-term changes to their diets and adoption of other healthy behaviors. The MDPP is based on the National Diabetes Prevention Program, which is administered by the Centers for Disease Control and Prevention (CDC).

The MDPP model was first tested by the Center for Medicare and Medicaid Innovation (CMMI) in eight states. The current year (CY) 2017 Final PFS, which provides for the MDPP model’s expansion by January 1, 2018, implemented aspects of the MDPP expanded model. The CY 2018 Proposed PFS builds on, and in some cases modifies, these rules.

Proposed Changes

1. Extension of Time to Enroll MDPP Suppliers. To allow more time for organizations to enroll in Medicare before they begin furnishing and billing for MDPP services, CMS proposes a three-month delay in the effective date when MDPP services can first be provided to beneficiaries. If finalized, the effective date would be delayed until April 1, 2018. The effective date for MDPP supplier enrollment remains January 1, 2018. MDPP suppliers’ compliance with MDPP supplier eligibility requirements begins on January 1, 2018.

2. Structure of MDPP Services. Under the proposal, MDPP services would consist of at least 16 “core” in-person sessions held in months 1 through 6, followed by at least 6 in-person monthly “core” maintenance sessions held in months 7 through 12 and no less than monthly in-person “ongoing maintenance sessions” in months 13 through 36. The proposal increases the overall time limit for MDPP services to 36 months, up from 24 months under the CY 2017 Final PFS. Core and ongoing maintenance sessions are grouped into three-month intervals.

3. Beneficiary Eligibility. The CY 2018 Proposed PFS maintains the following eligibility criteria for beneficiaries to receive coverage for MDPP services:

Enrollment in Part B BMI equal to or greater than 25 (or 23 for a self-identified Asian) In the preceding 12 months before the first core session, an A1c test value between 5.7 and 6.4, a fasting plasma glucose of 110-125 mg/dL or a two-hour plasma glucose of 140-199 mg/dL No previous type 1 or type 2 diabetes diagnosis No end-stage renal disease

CMS clarifies that beneficiaries will lose eligibility if they receive an end stage renal disease (ESRD) diagnosis after starting to receive MDPP services. However, beneficiaries who receive a diabetes diagnosis after attending the first core session would remain eligible for MDPP services, subject to other limits on eligibility described below.

4. Limits on Eligibility.

Once-in-a-Lifetime Limits. Earlier rulemaking established a rule that restricts a beneficiary’s eligibility for core MDPP services to once in a lifetime. CY 2018 Proposed PFS applies the once-in-a-lifetime rule to ongoing maintenance services, as well. Acknowledging the difficulty that MDPP suppliers will have in verifying that a beneficiary has not already received MDPP services from another vendor, CMS intends to propose an administrative solution at a later time. In the meantime, it proposes 17 Healthcare Common Procedure Coding System (HCPCS) billing codes that sequence MDPP services and provide for payment by time interval and achievement of performance goals. The new codes are a step toward developing a system for querying whether a particular MDPP service has been previously billed for a beneficiary. Attendance and Weight Loss Goals. Eligibility for core sessions is not tied to a beneficiary’s attendance or weight loss record. However, CMS proposes limits on eligibility for the ongoing maintenance sessions. For example, a beneficiary can maintain eligibility for the first ongoing maintenance interval (months 13 through 15) by:

Attending at least one in-person core maintenance session during the final core maintenance interval (months 10 through 12) and Achieving or maintaining a minimum weight loss at one or more sessions during the final core maintenance interval

Otherwise, a beneficiary’s eligibility for MDPP services ends after the core sessions (months 1-12) are complete. After the first ongoing maintenance interval, a beneficiary can maintain eligibility for subsequent intervals by attending all three ongoing maintenance sessions in the previous interval and maintaining a 5% weight loss from baseline at one or more of these sessions. Makeup Sessions. Under the proposed rule, an MDPP supplier can offer an in-person or virtual makeup session to a beneficiary who misses a scheduled session. Virtual Sessions. CMS acknowledges the emerging evidence that virtual delivery of MDPP services can deliver comparable benefits to in-person services and that the CDC’s Diabetes Prevention Recognition Program (DPRP) standards permit virtual makeup sessions. Accordingly, CMS proposes that virtual makeup sessions be permitted if they conform with DPRP standards, are offered based on a beneficiary’s request, and are not offered because the supplier cancels an in-person session. In addition, CMS proposes an upper limit of four virtual makeup sessions during the core intervals and three virtual makeup sessions during any rolling 12-month time period during the ongoing maintenance intervals. With the exception of virtual makeup sessions, CMS elects to defer coverage for virtual sessions. It explains that the original MDPP model tested only in-person sessions, implying a concern that CMS lacks authority under Section 1115A to include virtual modalities in the model’s expansion. To address this concern, CMS states in the CY 2018 Proposed PFS that it is developing a test for a virtual MDPP model through the Center for Medicare & Medicaid Innovation (CMMI).

5. Performance-Based Payment.

CMS proposes a performance-based payment methodology to replace the conceptual framework included in the CY 2017 Final PFS. Under the proposal, MDPP suppliers are paid in increments based on achievement of attendance and weight loss thresholds, with a maximum payout of $810 over the maximum 36-month service period. The table below summarizes the payment methodology. CMS declined to adopt a geographic or social risk adjustment with this methodology, but proposes an annual inflation adjustment tied to the Consumer Price Index for All Urban Consumers (CPI-U).

To view table clickhere

6. Interim Preliminary Recognition for MDPP Suppliers. Under the CY 2017 Final PFS, an eligible MDPP supplier must be fully recognized for meeting CDC-approved performance standards. In an effort to build capacity for MDPP services, CMS proposes an interim standard that will grant “interim preliminary recognition” to DPP organizations with pending CDC applications. They must also meet the following requirements to enroll as an MDPP supplier:

Continued adherence to current 2015 CDC DPRP Standards for data submission, and submission of at least 12 months of performance data to CDC on at least one completed cohort (n = 5+), of whom 60% or more attended at least 9 sessions in months 1 through 6 and 60% or more attended at least 3 sessions in months 7 through 12. The 12-month data submission to CDC includes at least 5 participants who attended at least 3 sessions in the first 6 months, and received MDPP services for at least 9 months.

CMS proposes to coordinate with the CDC to streamline submissions of cohort data. It also proposes to accept any interim preliminary recognition standard that the CDC advances in the future, which may occur in 2018.

7. MDPP Supplier Enrollment Application. CMS reports that the enrollment application for MDPP suppliers is still under development. While the enrollment application is being developed, CMS anticipates that the following information will be requested:

Identifying information for all coaches, including national provider identifiers (NPIs), first names, middle initials, last names, Social Security numbers and dates of birth in order for CMS to perform background checks (e.g., bars from federal program; felony convictions) and to distinguish between individuals who are entered in the Provider Enrollment, Chain and Ownership System. Identification of all administrative locations—that is, physical locations associated with the supplier’s operations, from which coaches are dispatched or based and where MDPP may be serviced (but excluding community settings). CMS gives notice in the proposed rules that these sites may be subject to site visits before approval of an MDPP supplier’s enrollment application. Updates, including coach roster changes or reportable adverse action history, to be reported within 90 days of a reportable event. Termination of a supplier’s Medicaid billing privileges are grounds for denial of an enrollment application or revocation.

8. Program Integrity. Given that MDPP is a new benefit and an expanded model, CMS acknowledges that many DPP suppliers will be new to the Medicare program. Accordingly, CMS has assigned MDPP suppliers to its “high risk” screening category and establishes detailed standards aimed at safeguarding the Medicare program from fraud, waste and abuse and protecting Medicare beneficiaries. CMS observes that these detailed compliance standards will increase the likelihood that MDPP suppliers will successfully operationalize their MDPP program integrity strategies. The enrollment and eligibility requirements for MDPP suppliers described above are representative of these detailed standards. Other examples include the following:

CMS will conduct independent background checks of proposed coaches to verify eligibility. Coaches cannot begin to furnish MDPP services until CMS completes its background check. Suppliers are required to maintain up-to-date information in the enrollment application at all times. CMS can revoke an MDPP supplier’s eligibility if it knowingly permits an ineligible coach to bill for MDPP services or another individual or entity to bill the program under its billing number. To help ensure that MDPP suppliers are operational and have the resources necessary to furnish MDPP services, they are required to maintain at least one administrative location and signage posted on the exterior of the building at a publicly accessible site. A private residence cannot be an administrative location. An MDPP supplier must permit scheduled or unscheduled on-site inspections and access to books and records. An MDPP supplier must adhere to specified documentation, data submission and recordkeeping requirements, including a 10-year minimum record retention requirement. Among other things, MDPP suppliers are required to maintain and submit a crosswalk file that documents beneficiary identifiers in claims and encounter data to permit auditing of performance data. As safeguards against discriminatory access to MDPP services, MDPP suppliers can only deny services to beneficiaries based on the supplier’s published capacity limits. MDPP suppliers cannot condition access to MDPP services on the basis of a beneficiary’s weight or health status, but may deny services if a beneficiary significantly disrupts the session for other participants or becomes abusive. Denials must be documented in the beneficiary’s record. MDPP suppliers must disclose information about the MDPP expanded model to beneficiaries, and answer, respond to and document their complaints and resolutions. MDPP must maintain and handle any beneficiary personally identifiable information (PII) and protected health information (PHI) in compliance with HIPAA, other state and federal privacy laws, and CMS standards.

9. Beneficiary Engagement Incentives. CMS proposes parameters for allowing suppliers to provide items or services to beneficiaries as engagement incentives, including the following:

Timing. Incentives must be furnished during the engagement incentive period. Permissible Items or Services. Incentives cannot be Medicare-covered items or services. They must be provided directly by the supplier or its agent, reasonably connected to the CDC-approved curriculum, and either a preventive care item or service or an item that advances clinical goals for the beneficiary (e.g., gym memberships, onsite child care, digital scales or pedometers). Anti-Tying. The incentive may not be tied to the receipt of items or services outside the MDPP services or tied to the receipt of items or services from a particular provider, supplier or coach. No Promotion. Incentives cannot be advertised or promoted as such; instead, an MDPP beneficiary may be made aware of its availability at a time when the beneficiary could reasonably benefit from it during the engagement incentive period. In-Kind Technology. The retail value of engagement incentives in the form of in-kind technology cannot exceed $1,000 in aggregate. The MDPP supplier must retain ownership of any technology with a retail value greater than $100, and the technology must be retrieved from the beneficiary at the end of the engagement incentive period. Cost-Shifting. The cost of incentives cannot be shifted to another federal healthcare program. Documentation. Contemporaneous documents must be maintained for each item or service with a retail value greater than $25, and for each attempt to retrieve in-kind technology incentives.

Conclusion

While the CY 2018 Proposed PFS brings needed clarity and regulatory relief to increase capacity for MDPP beneficiaries to access the MDPP expanded model, CMS’ proposals lay bare the significant operational investments that must be made by MDPP suppliers to meet the model’s compliance standards by January 1, 2018. While the implementation of program integrity strategies is justified, it is not clear that the proposed payment structure is sufficient to compensate DPP suppliers to justify the added costs associated with becoming an MDPP supplier. CMS’ decision not to limit coverage of virtual sessions to makeup sessions raises further questions about the MDPP expanded model’s prospects for building capacity to meet the need and demand for MDPP services among Medicare beneficiaries.