Red Tape for Wearables and Diabetes Prevention

Under the recently released “Revisions to Payment Policies under the Physician Fee Schedule and
Other Revisions to Part B for CY 2018”, CMS shared regulations limiting the inclusion of wearable and other self-reporting technology for payment-based outcomes. The restrictions relate to the Medicare Diabetes Prevention Program (MDPP), which under its current model is a structured intervention with the goal of preventing type 2 diabetes in individuals with an indication of prediabetes. The clinical interventions in the MDPP consists of a minimum of 16 intensive “core” sessions of an approved curriculum furnished over six months in a group-based, classroom-style setting. These events focus on transitional care topics, such as practical training in long-term dietary change, increased physical activity, and behavior change strategies for weight control. After completing the core sessions, less intensive monthly transitional care follow-up meetings help ensure that the participants maintain healthy behaviors.

In this proposed rule, CMS stated that because weight measurements are used for determining both beneficiary eligibility for coverage and supplier payment, the weight must be taken inperson. Specifically, CMS states that the “in-person measurements are the most feasible method for weight ascertainment at this time for services where the beneficiary would have regular in-person sessions with the MDPP supplier.” CMS went a step further to clarify it does not accept alternative self-reporting, regardless of supportive technology as CMS’ belief is that “self-reported weight loss is not reliable for the purposes of determining continued coverage of MDPP services for a beneficiary.”

While the proposed rule does allow for a preventable care item or services to be provided to an MDPP beneficiary by engaging him or her in better managing his or her own health, there are several conditions that providers must follow. Some of these include:


  • 3rd-party distribution restrictions - The item or service must be furnished directly to an MDPP beneficiary by an MDPP supplier or by an agent of the MDPP supplier, such as a coach, under the MDPP supplier’s direction and control.
  • Prohibited use as a beneficiary recruitment tool - The availability of the item or service must not be advertised or promoted as an in-kind beneficiary engagement incentive available to an MDPP beneficiary receiving MDPP services from the MDPP supplier except that an MDPP beneficiary may be made aware of the availability of the item or service at the time the MDPP beneficiary could reasonably benefit from it during the engagement incentive period.
  • Prohibited use as a customer loyalty program - The item or service must not be tied to the receipt of services from a particular provider, supplier, or coach.

The proposed rule offers some insight into CMS’ support for wearable and self-reporting technologies. Although Medicare spent $42 billion more in the single year of 2016 on beneficiaries with diabetes than it would have spent if those beneficiaries did not have diabetes; per-beneficiary, CMS is not willing to risk providing payments based on data provided directly from those beneficiaries. Instead, CMS looks to continue to focus on live, transitional care, interventions.

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