Proposed Policies for the Medicare Diabetes Prevention Program Expanded Model in the Calendar Year 2018 Physician Fee Schedule Proposed Rule

Proposed Policies for the Medicare Diabetes Prevention Program Expanded Model in the Calendar Year 2018 Physician Fee Schedule Proposed Rule

On July 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2018 Physician Fee Schedule (PFS) proposed rule that would make additional proposals to implement the Medicare Diabetes Prevention Program (MDPP) expanded model starting in 2018.  The MDPP expanded model was announced in early 2016, when it was determined that the Diabetes Prevention Program (DPP) model test through the Center for Medicare and Medicaid Innovation’s Health Care Innovation Awards met the statutory criteria for expansion. Through expansion of this model test, more Medicare beneficiaries will be able to access evidence-based diabetes prevention services, potentially resulting in a lowered rate of progression to type 2 diabetes, improved health, and reduced costs.

The Medicare Diabetes Prevention Program expanded model is a structured intervention with the goal of preventing progression to type 2 diabetes in individuals with an indication of pre-diabetes. The clinical intervention, the result of National Institutes of Health-funded research, consists of a minimum of 16 intensive “core” sessions of a Centers for Disease Control and Prevention (CDC) approved curriculum furnished over six months in a group-based, classroom-style setting that provides practical training in long-term dietary change, increased physical activity, and behavior change strategies for weight control. After completing the core sessions, less intensive follow-up meetings furnished monthly will help ensure that the participants maintain healthy behaviors. The primary goal of the expanded model is at least 5 percent average weight loss by participants.

The CY 2017 Medicare PFS final rule, published in November 2016, established the expansion and aspects of the expanded model policy framework. The CY 2018 PFS proposes additional policies necessary for suppliers to begin providing MDPP services nationally in 2018, including the MDPP payment structure, as well as additional supplier enrollment requirements and supplier compliance standards aimed to ensure program integrity. Services provided under the expanded model would largely be furnished in-person. We present a new proposal on beneficiary engagement incentives. We also include in this proposed rule amendments on previous policies finalized in the CY 2017 PFS regarding MDPP services and beneficiary eligibility. Highlights of these policies are summarized below.

CMS will accept comments on the proposed rule until September 11, 2017, and will respond to comments in a final rule. The proposed rule will appear in the July 13, 2017 Federal Register and can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection.

Effective Dates

Effective Dates of MDPP Services, Enrollment and Billing Privileges: The CY 2017 PFS established that MDPP services would be available on January 1, 2018. We propose to revise our policy to state that MDPP services would be available on April 1, 2018 in order to ensure that MDPP suppliers have sufficient time to enroll in Medicare after the effective date of the CY 2018 PFS final rule. We propose that prospective MDPP suppliers may begin enrolling on January 1, 2018. We propose that for MDPP supplier enrollment applications that are submitted and subsequently approved, the effective date for billing privileges would be the date the application was submitted, with the exception of applications submitted and subsequently approved prior to April 1, 2018. We propose that MDPP suppliers will enroll through a new, MDPP-specific enrollment application. We will make the application available prior to January 1, 2018. 

MDPP Services, Beneficiary Eligibility & Payment

Diabetes Diagnosis during the MDPP Services Period: In the CY 2017 PFS, we established eligibility criteria for beneficiaries to receive the set of MDPP services, which excluded individuals with previous diagnosis of diabetes (with the exception of gestational). In this rule, we propose that if a beneficiary develops diabetes during the MDPP services period, this diagnosis would not prevent the beneficiary from continuing to receive MDPP services. 

Ongoing Maintenance Sessions: We propose a two-year limit on ongoing maintenance sessions (assuming attendance and weight loss performance goals are met), making the total MDPP services period three years (consisting of one year of core and core maintenance sessions, followed by up to two years of ongoing maintenance sessions, depending on eligibility, as described below). We propose that MDPP beneficiaries must attend three sessions and maintain 5 percent weight loss at least once in the previous ongoing maintenance session interval to be eligible for additional intervals after the first.   

Payment Structure: We propose a performance-based payment structure, which ties payment to performance goals based on attendance and/or weight loss, as displayed in the table below. The proposed payment structure values beneficiary weight loss most significantly, as weight loss is a key indicator of success among individuals enrolled in a DPP due to the strong association between weight loss and reduction in the risk of type 2 diabetes. ^{The proposed payment structure also values beneficiary attendance throughout the first year core services, because, in the DPP model test, session attendance was associated with greater weight loss. We have proposed corresponding Healthcare Common Procedure Coding System (HCPCS) G-codes that MDPP suppliers may use to submit claims for payment when all the requirements for billing the codes have been met.}

* = The required minimum weight loss from baseline must be achieved or maintained during the core maintenance session 3-month interval or maintained during the ongoing maintenance session 3-month interval.

** = A beneficiary must achieve or maintain the required minimum weight loss at least once during the final core maintenance session 3-month interval to have coverage of the first ongoing maintenance session interval.

Bridge Payment: In cases where a beneficiary changes MDPP suppliers, we propose to provide a bridge payment as a one-time $25 payment to an MDPP supplier for furnishing its first session to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier.   

The bridge payment would account for the financial risk a subsequent MDPP supplier takes on by furnishing services to a beneficiary changing MDPP suppliers during the MDPP services period and helps ensure beneficiary freedom of choice of supplier. MDPP suppliers may need to obtain a beneficiary’s MDPP record from the previous MDPP supplier as part of the billing supplier’s documentation to demonstrate that the attendance and weight loss, if applicable, performance goal(s) for the performance payment were achieved.

MDPP Supplier Enrollment & Compliance 

Interim Preliminary Recognition: In this rule, we propose that an entity may be eligible to enroll in Medicare as an MDPP supplier if they have achieved CMS interim preliminary recognition, CDC preliminary recognition (if established), or CDC full recognition.  Our intent with CMS interim preliminary recognition is to bridge the gap until any CDC preliminary recognition standards are established and to allow organizations who have met this standard to enroll in Medicare. 

Entities that have not yet reached CDC full recognition status may be able to enroll as an MDPP supplier if they meet interim preliminary recognition standards (if finalized as proposed) with a 12-month data submission to CDC. CDC would perform the assessment for interim preliminary recognition on our behalf (though CMS would make the determination). If and when CDC establishes any preliminary recognition standard, we intend to ensure the transition to any new CDC preliminary standards does not disrupt MDPP supplier status.  

MDPP Supplier Standards: We propose to establish standards to mitigate fraud, waste, and abuse and to ensure fidelity to the MDPP expanded model. These standards are designed to make sure MDPP suppliers are operational, protect beneficiary access and service quality, and provide program integrity safeguards. These standards also establish eligibility requirements for coaches who furnish services on behalf of MDPP suppliers. If an MDPP supplier reports an ineligible coach, CMS may take administrative action to deny or revoke the MDPP supplier’s enrollment. We propose that a supplier could respond to the enrollment denial or revocation by submitting a corrective action plan that would include the removal of the coach from its roster.

Revalidation: While CMS will screen newly enrolling MDPP suppliers at high categorical risk (as established in the CY 2017 PFS), we propose that MDPP suppliers that are revalidating their enrollment will be screened at moderate categorical risk level. This means that revalidating MDPP suppliers would not have to undergo the same high risk screening such as fingerprinting and background checks for those individuals who maintain a 5% or greater direct or indirect ownership interest in the supplier. We also propose that MDPP suppliers revalidate every three years after their initial enrollment.

Beneficiary Engagement Incentives

Beneficiary Engagement Incentives: We propose that an MDPP supplier may choose to provide in-kind patient engagement incentives to a MDPP beneficiary to assist the supplier in furnishing high quality services and engaging in health behavior change programs that lead to improved beneficiary health and reductions in Medicare spending. We further propose certain conditions on these incentives to ensure that their provision is solely for the purpose of achieving the MDPP expanded model goal of engaging beneficiaries in making sustainable, healthy behavior changes to reduce their risk of type 2 diabetes.

Virtual DPP 

Virtual DPP: We considered including exclusively virtual service provision in the MDPP expanded model. However, the DPP model test that met the statutory requirements for expansion did not include virtual services. Therefore, we do not propose including DPP that is furnished exclusively through remote technologies with no in-person delivery. We propose to allow in-person suppliers to offer a limited number of virtual make-up sessions to beneficiaries who miss a session. We intend to develop a separate model under CMS Innovation Center authority to test and evaluate MDPP services that are exclusively furnished virtually. Additional details about the separate virtual model will be released in guidance outside of this rulemaking. 

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