The Diabetes Prevention Program is a structured lifestyle intervention that includes dietary coaching, lifestyle intervention, and moderate physical activity, all with the goal of preventing the onset of diabetes in individuals who are pre-diabetic. The clinical intervention consists of 16 intensive “core” sessions of a curriculum 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 the 16 core sessions, less intensive monthly follow-up meetings help ensure that the participants maintain healthy behaviors. The primary goal of the intervention is at least 5 percent average weight loss among participants.
In March 2016, Department of Health and Human Services (HHS) announced that the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary (OACT) certified the pilot Diabetes Prevention Program (DPP) model as a cost savings program that reduced net Medicare spending. The Secretary then determined that the program demonstrated the ability to improve the quality of patient care without limiting coverage or benefits. Together, these determinations fulfilled the expansion requirements of Section 1115A of the Social Security Act making DPP the first ever preventive service model certified for expansion from the CMS Innovation Center.
On July 7th, CMS outlined proposals for expanding DPP to benefit more Medicare beneficiaries beginning January 1, 2018. To help inform implementation, CMS is specifically seeking comments on the following:
Medicare Diabetes Prevention Program Supplier Enrollment: CMS is contemplating requiring each person who provides services as part of a Centers for Disease Control and Prevention (CDC)-recognized Diabetes Prevention Program organization delivering Diabetes Prevention Program services to obtain a National Provider Identification number in order to provide Medicare Diabetes Prevention Program services, allowing suppler enrollment beginning as early as January 1, 2017.
Payment Structure: CMS envisions a payment structure tying payment for Medicare Diabetes Prevention Program services on the number of Medicare Diabetes Prevention Program sessions attended and the achievement and maintenance of minimum weight loss. Further, claims for payment under the Medicare Diabetes Prevention Program would be submitted following the achievement of core session attendance and minimum weight loss, and following maintenance session attendance and maintenance of minimum weight loss.
IT Considerations and Capabilities: CMS is proposing requiring CDC-recognized DPP entities to submit claims to Medicare using standard claims forms and procedures, submitted electronically in batches. Claims submitted would be required to be traceable to care documented by the entity’s beneficiary records, which should include the requisite amount of detail associated with participation. Entities would also be required to maintain and handle any beneficiary Protected Health Information or Personally Identifiable Information, in compliance with Health Insurance Portability and Accountability Act (HIPAA) and CMS standards.
Eligible Beneficiaries: CMS is considering defining an eligible pre-diabetic patient as a beneficiary having a body mass index (BMI) of 25 or greater (a BMI of 23 or greater for Asian beneficiaries) in addition to a hemoglobin A1c test with a value of 5.7-6.4 percent, or a fasting plasma glucose of 110-125 mg/dL within the last 12 months, or 2-hour plasma glucose of 140-199 mg/dl after the 75 gram oral glucose tolerance test, and no previous diagnosis of diabetes or life-threatening conditions, mobility issues, etc. that would prohibit them from participating in the program.
Program Integrity Initiatives: CMS is contemplating the best approaches to mitigate program integrity risks, with the intent to develop policies to monitor and audit Medicare Diabetes Prevention Program entities.
Site of Service Requirements: CMS is contemplating allowing service delivery in-person or virtually, clarifying that virtual services would not be considered part of current telehealth benefits.
Learning and Technical Assistance Requirements: CMS envisions providing education, training, and technical assistance on Medicare enrollment, data security, claims submission, and medical record keeping for Medicare Diabetes Prevention Program entities.
Quality Measurement and Reporting: CMS is considering which quality metrics should be reported by Medicare Diabetes Prevention Program entities, specifically what quality metrics should be considered for public reporting (not for payment) to guide beneficiary choice of entities.
Timeframe: CMS is contemplating whether the Medicare Diabetes Prevention Program should be expanded nationally in the first year of the program or if it should be phased in. If phased in, the rule contemplates whether the Medicare Diabetes Prevention Program would be offered initially for a period in certain geographic markets or regions or to a subpopulation of provider/suppliers.
CMS will accept comments on the proposed rule until September 6, 2016, and will respond to comments in a final rule. The proposed rule will appear in the July 15, 2016, Federal Register and can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection.