- Email: [email protected]
Proposed Medicare Coverage for Diabetes Prevention: Strengths, Limitations, and Recommendations for Improvement
CURRENT ISSUES
Proposed Medicare Coverage for Diabetes Prevention: Strengths, Limitations, and Recommendations for Improvement Natalie D. Ritchie, PhD,1,2 Edward P. Havranek, MD,3,4 Susan L. Moore, PhD, MSPH,4,5 Rocio I. Pereira, MD3,6
INTRODUCTION
I
n July 2016, the Centers for Medicare and Medicaid Services announced new proposed Medicare coverage for the National Diabetes Prevention Program (DPP) that leverages provisions of the Affordable Care Act.1 The National DPP is a year-long lifestyle change intervention available through structured in-person or online classes. The National DPP has been widely disseminated following efforts led by the Centers for Disease Control and Prevention (CDC) to translate a successful clinical trial of intensive lifestyle support that led to a 58% reduction in diabetes incidence in adults with prediabetes.2 The Centers for Medicare and Medicaid Services proposal offers an unprecedented opportunity to ensure coverage starting in 2018 for the estimated 51% of seniors who have prediabetes.3 Notable strengths include allowing lay healthcare professionals to deliver the National DPP and offering extended diabetes prevention coverage beyond an initial 1-year period. However, the proposal also has critical limitations that are important to address, especially given implications of setting precedent for Medicaid and other third-party payers to follow. As researchers and professionals at a large safety net healthcare organization delivering the National DPP, the authors offer a critical analysis of proposed Medicare coverage along with suggested improvements. Denver Health has offered the National DPP since March 2013 with more than 2,500 enrollees to date. A diverse group of high-risk participants was reached comprising 60% Latino, 20% African American, and 20% non-Hispanic white. One quarter of all enrollees were Medicare beneficiaries, while nearly one half had Medicaid. Additional expertise was gained through extensive research and program evaluation, participation in state and regional meetings to share best practices, and presentations to legislators and insurers to promote coverage. Reimbursement through Medicare and other payers is essential for long-term program sustainability. The current proposed rules have three conditions that would greatly constrain access at Denver Health and other sites.
SITES MUST HAVE PENDING OR FULL RECOGNITION IN THE CDC’S DIABETES PREVENTION RECOGNITION PROGRAM Standards were established by CDC’s Diabetes Prevention Recognition Program to ensure effectiveness and fidelity of the National DPP across sites.4 There is concern that the standards appear unattainable in many settings. Among more than 1,200 participating sites that were listed, only 72 sites (6%) were listed as having achieved full recognition to date, although the registry does not denote newly enrolled sites that are not yet eligible for full recognition.5 Achieving CDC recognition largely hinges on showing that participants obtain at least 5% weight loss on average. However, a meta-analysis of early translations of the National DPP showed average weight loss was 4.0%.6 More recently, data from large-scale National DPP dissemination across YMCA sites showed that active participants achieved an average of 4.5% weight loss.7 These results fall below CDC standards, calling into question the suitability of a 5% mean weight loss threshold for reimbursement eligibility. It is also unclear whether achieving at least 5% weight loss is necessary to realize program benefits. In the original clinical trial on which the National DPP is based, each kilogram of weight loss was associated with a 16% reduction in diabetes incidence.8 Incidence rates appeared to decline From the 1Ambulatory Care Services, Denver Health and Hospital Authority, Denver, Colorado; 2Department of Psychiatry, University of Colorado School of Medicine, Aurora, Colorado; 3Department of Medicine, Denver Health and Hospital Authority, Denver, Colorado; 4Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado; 5 Department of Patient Safety and Quality, Denver Health and Hospital Authority, Denver, Colorado; and 6Department of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado Address correspondence to: Natalie D. Ritchie, PhD, Denver Health and Hospital Authority, 777 Bannock St., MC 6000, Denver CO 80204. E-mail: [email protected]. 0749-3797/$36.00 http://dx.doi.org/10.1016/j.amepre.2017.02.005
& 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Am J Prev Med 2017;](5):]]]–]]] 1
2
Ritchie et al / Am J Prev Med 2017;](5):]]]–]]] 8
linearly with weight loss. As such, weight loss of 3% or 4% would likely reduce diabetes incidence rates compared with no intervention at all. Organizations can avoid failing standards by withdrawing from the CDC recognition program and reapplying, which offers a “clean slate” and the opportunity to submit only new data. The proposed Medicare model would allow sites to be re-eligible for payment after 1 year, as opposed to the immediate re-eligibility permitted under current CDC rules. However, a 1-year absence from the recognition program would likely create a coverage gap for many Medicare beneficiaries. More concerning, there is no provision to ensure that programs adhere to agreed-upon methods for reporting participation and outcomes. Organizations with full recognition have shared in National DPP workgroups that they have used differential methods of reporting to meet requirements. An example is limiting the pool of participants for whom data is reported to only those who have signed agreements to confirm their utmost commitment to the year-long program and weight loss. It is especially concerning that underserved patients who experience systemic barriers to full engagement may be reluctant to sign such agreements and thus dissuaded from participating. Inconsistent reporting standards may also unintentionally penalize organizations using broader eligibility definitions. A proposed solution is oversight to ensure dissemination sites follow delivery standards and report data appropriately and uniformly, but without imposing requirements to achieve unrealistic outcomes. Following many of the American Diabetes Association’s requirements for diabetes self-management programs,9 which ensure effectiveness and fidelity through robust training, continuing education, quality assurance metrics for program delivery, and record audits, may be helpful.
INDIVIDUAL MEDICARE BENEFICIARIES MUST ACHIEVE 5% OR MORE WEIGHT LOSS TO RECEIVE COVERED SERVICES IN MONTHS 7–12 OF THE NATIONAL DIABETES PREVENTION PROGRAM The proposed rules for Medicare coverage are more stringent than CDC standards in requiring that individual participants achieve a minimum of 5% weight loss by 6 months to receive covered services in months 7–12. A recent systematic review noted only 20%–64% of participants achieved this goal across programs.10 For the many participants who may be unlikely to achieve weight loss goals, organizations would be left with the option of continuing to provide the year-long program at the organizations’ own cost, charging the participants, or
denying services. Requiring individual weight loss also may further health disparities. Specifically, Latinos have been shown to lose less weight in the National DPP than white participants.11 Thus, Latino seniors may be asked to leave the program at higher rates than white participants. Requiring quick weight loss to receive covered services in months 7–12 also contradicts evidence that each session is associated with 0.26% weight loss.6 Greater engagement is expected to yield better outcomes and reimbursement policies should encourage more attendance, not less. Participants in the original lifestyle intervention group also experienced considerable weight regain over time,12 which is consistent with the poor results of short-term diets expected for the general Medicare population.13 Likely consequences of denying coverage are missed opportunities to prevent or delay diabetes onset among the very individuals who want to complete the National DPP. A proposed solution is to support greater duration of engagement, even among participants who lose weight slowly, or who perhaps lose none at all. These participants may experience other health benefits of risk reduction through lifestyle change, although further research is needed to confirm benefits such as improved hemoglobin A1c. Encouraging sustainable weight loss and other risk reduction behaviors in the National DPP that participants are able to maintain over time is recommended. As such, Medicare’s proposal to cover extended maintenance sessions beyond the year-long program is encouraging, but this service is important for all participants who want ongoing support. Each year of prevented or delayed incidence matters from a return on investment perspective. Annual healthcare expenditures for prior participants are considerably reduced,7 and annual healthcare costs can otherwise double after diabetes onset.14
THE PROPOSED REIMBURSEMENT AMOUNTS ARE LOW AND LARGELY CONTINGENT ON PROGRAM COMPLETION AND WEIGHT LOSS The proposed Medicare payment structure for the National DPP does not appear to support a sustainable business model with reimbursement rates tied to individual participant performance. The current payment model offers up to $450 for each participant who completes the year-long program and loses 5% of their body weight at 6 months, and further maintains this loss at 12 months. However, organizations will only be reimbursed up to $175 for each of the many participants (46%–80%10) who lose less weight—a difference of $275 per person. A challenge with pay-for-performance models is that organizations must finance the program www.ajpmonline.org
Ritchie et al / Am J Prev Med 2017;](5):]]]–]]]
regardless of participant performance. If costs cannot be recouped, organizations will be unable to support access to Medicare beneficiaries. Rigorous cost analyses of the National DPP are lacking and no reports published to date of actual costs by amount of weight loss. The original lifestyle intervention cost $2,780 for each participant in 2000 dollars.15 A 2012 review noted that among six translational programs, costs ranged from $10 to $15 per person per session for programs led by lay healthcare professionals.6 However, it seems doubtful that such low-cost delivery models are sustainable on a large scale. For example, a 1-hour session with five participants would cost $50–$75 per this model, which appears grossly inadequate to cover all costs of resources and activities such as staff training and management, marketing, recruitment, travel to session locations, supplies, class preparation and clean up, and data entry. On the high end, a 2015 report for the State of Colorado showed the estimated direct cost of implementing the program was $1,063 for each participant who attended nine or more sessions.16 Higher reimbursement rates are justifiable given the considerable return on investment expected for the program. According to the YMCA report, average savings on healthcare expenditures equated to an annualized amount of $1,820 per participant.7 Likely consequences of low reimbursement rates are coverage gaps and insufficient capacity to serve Medicare recipients. A previous analysis showed 47.1% of eligible patients referred to the National DPP by their healthcare provider enroll in the program.17 Thus, if all Medicare recipients with prediabetes were referred, capacity to serve more than 13 million individuals would be needed (based on an estimated 55 million Medicare recipients).18 Although programs delivered online or through mobile applications can help increase reach, they are insufficient to address the needs of participants who prefer in-person classes. Medicare beneficiaries appear particularly unlikely to use an Internet-based National DPP—a newly released report showed that as few as 5%–16% of seniors nationwide use digital health technologies. Rates were lower yet among seniors who represent racial and ethnic minorities or who have low incomes.19 Low reimbursement rates may prevent sites from attracting and retaining talented staff to deliver the National DPP. High demands and low pay of many lay healthcare positions have contributed to turnover and staffing challenges in diabetes management programs.20 Given the year-long duration of the National DPP, it may be especially important to have committed coaches who are skilled at engaging participants and supporting lasting behavior change. Suggestions include conducting more-rigorous cost analyses to guide a reimbursement model that covers the full costs of operating the National DPP for all ] 2017
3
participants. Resulting rates need to be competitive and incentivize current sites to both sustain and expand delivery, as well as attract new sites with high capacity. Lastly, rates need to allow coaches to receive a living wage to prevent turnover and facilitate their commitment to the program.
CONCLUSIONS Proposed Medicare coverage for the National DPP provides an unprecedented opportunity to reach at-risk seniors and to lower diabetes incidence rates. Despite notable strengths, several proposed coverage rules are contradicted by current evidence and may impede reach and perpetuate health disparities. Summarized recommendations to improve on the Medicare proposal are: 1. Provide governance to ensure dissemination sites follow high-quality delivery standards and report data accurately, but without requirements for unrealistic outcomes, such as 5% average weight loss. 2. Remove requirements for individual participants to lose 5% or more of their body weight. Rather, encourage ongoing attendance and sustainable weight loss to lower diabetes risk. 3. Conduct rigorous cost analyses that take into consideration the full costs of operating the National DPP for all participants. 4. Enact reimbursement rates that are competitive and provide sufficient reimbursement to incentivize current sites to both sustain and expand delivery, as well as attract new delivery sites with high capacity. 5. Provide reimbursement rates that allow National DPP coaches to be provided a living wage to prevent turnover and facilitate their commitment to the program. Promptly correcting the proposed Medicare coverage rules is essential given the high costs of diabetes and implications of establishing precedent for Medicaid and other third-party payers to follow. Ensuring that reimbursement models for the National DPP are more closely aligned with the needs of diverse healthcare settings and the patients they serve is critical.
ACKNOWLEDGMENTS The National Diabetes Prevention Program at Denver Health was funded by the Amendment 35 Cancer, Cardiovascular Disease, and Pulmonary Disease Grant Program administered by the Colorado Department of Public Health and Environment, and by an award from America’s Health Insurance Plans in partnership with the Centers for Disease Control and Prevention. Additional funding was provided by Denver Health. The contents of this publication are solely the responsibility of the
4
Ritchie et al / Am J Prev Med 2017;](5):]]]–]]]
authors and do not represent the official views of these organizations. No financial disclosures were reported by the authors of this paper.
REFERENCES 1. Centers for Medicare and Medicaid Services (CMS). Medicare program; revisions to payment policies under the Physician Fee Schedule and other revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model. www.feder alregister.gov/articles/2016/07/15/2016-16097/medicare-program-revi sions-to-payment-policies-under-the-physician-fee-schedule-andother-revisions. Accessed August 3, 2016. 2. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403. http://dx.doi.org/10.1056/NEJMoa012512. 3. CDC. National Diabetes Statistics Report: Estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: CDC, U.S. DHHS; 2014. 4. CDC. Diabetes Prevention Recognition Program. www.cdc.gov/diabe tes/prevention/recognition/curriculum.htm. Accessed August 1, 2016. 5. CDC. Registry of Recognized Organizations. https://nccd.cdc.gov/ DDT_DPRP/Programs.aspx. Accessed July 26, 2016. 6. Ali MK, Echouffo-Tcheugui JB, Williamson DF. How effective were lifestyle interventions in real-world settings that were modeled on the Diabetes Prevention Program? Health Aff (Millwood). 2012;31(1):67– 75. http://dx.doi.org/10.1377/hlthaff.2011.1009. 7. Evaluation of the Health Care Innovation Awards: Community Resource Planning, Prevention, and Monitoring, Annual Report 2015. AwardeeLevel Findings: YMCA of the USA. https://innovation.cms.gov/Files/ reports/hcia-ymcadpp-evalrpt.pdf. Accessed Aug 8, 2016. 8. Hamman RF, Wing RR, Edelstein SL, et al. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006;29 (9):2102–2107. http://dx.doi.org/10.2337/dc06-0560. 9. American Diabetes Association. Education Recognition Program, 9th Ed. http://professional.diabetes.org/sites/professional.diabetes.org/ files/media/erp-9th-edition-recognition-requirements11-16.pdf. Accessed July 27, 2016.
10. Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: Learnings from the last 15 years. Implement Sci. 2015;10(1):1. http://dx.doi.org/10.1186/ s13012-015-0354-6. 11. Ritchie N, Christoe-Frazier L, McFann K, Havranek E, Pereira RI. Effect of the National Diabetes Prevention Program on weight loss for English- and Spanish-speaking Latinos. Am J Health Promot. In press. 12. Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677–1686. http://dx.doi. org/10.1016/S0140-6736(09)61457-4. 13. Mann T, Tomiyama AJ, Westling E, Lew AM, Samuels B, Chatman J. Medicare’s search for effective obesity treatments: diets are not the answer. Am Psychol. 2007;62(3):220. http://dx.doi.org/10.1037/ 0003-066X.62.3.220. 14. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033. http://dx.doi.org/10.2337/ dc12-2625. 15. Herman WH, Brandle M, Zhang P, et al. Diabetes Prevention Program Research Group costs associated with the primary prevention of type 2 diabetes mellitus in the Diabetes Prevention Program. Diabetes Care. 2003;26(1):36–47. http://dx.doi.org/10.2337/diacare.26.1.36. 16. Gritz M, Jones W. Independent Evaluation: Patient Navigator and Community Health Worker Program components cost analysis. Aurora, CO: Community Epidemiology and Program Evaluation Group; June 2015. 17. Ritchie ND, Swigert TJ. Establishing an effective primary care provider referral network for the National Diabetes Prevention Program. AADE in Practice. 2016;4(4):20–25. http://dx.doi.org/10.1177/2325160316647707. 18. Centers for Medicare and Medicaid Services. On its 50th anniversary, more than 55 million Americans covered by Medicare [press release]. Baltimore, MD: CMS, U.S. DHHS; 2015. 19. Levine D, Lipsitz S, Linder J. Trends in seniors use of digital health technology in the United States, 2011-2014. JAMA. 2016;316(5):538– 540. http://dx.doi.org/10.1001/jama.2016.9124. 20. Cherrington A, Ayala GX, Amick H, Allison J, Corbie-Smith G, Scarinci I. Implementing the community health worker model within diabetes management challenges and lessons learned from programs across the United States. Diabetes Educ. 2008;34(5):824–833. http://dx. doi.org/10.1177/0145721708323643.
www.ajpmonline.org
Proposed Medicare Coverage for Diabetes Prevention: Strengths, Limitations, and Recommendations for Improvement Natalie D. Ritchie, PhD,1,2 Edward P. Havranek, MD,3,4 Susan L. Moore, PhD, MSPH,4,5 Rocio I. Pereira, MD3,6
INTRODUCTION
I
n July 2016, the Centers for Medicare and Medicaid Services announced new proposed Medicare coverage for the National Diabetes Prevention Program (DPP) that leverages provisions of the Affordable Care Act.1 The National DPP is a year-long lifestyle change intervention available through structured in-person or online classes. The National DPP has been widely disseminated following efforts led by the Centers for Disease Control and Prevention (CDC) to translate a successful clinical trial of intensive lifestyle support that led to a 58% reduction in diabetes incidence in adults with prediabetes.2 The Centers for Medicare and Medicaid Services proposal offers an unprecedented opportunity to ensure coverage starting in 2018 for the estimated 51% of seniors who have prediabetes.3 Notable strengths include allowing lay healthcare professionals to deliver the National DPP and offering extended diabetes prevention coverage beyond an initial 1-year period. However, the proposal also has critical limitations that are important to address, especially given implications of setting precedent for Medicaid and other third-party payers to follow. As researchers and professionals at a large safety net healthcare organization delivering the National DPP, the authors offer a critical analysis of proposed Medicare coverage along with suggested improvements. Denver Health has offered the National DPP since March 2013 with more than 2,500 enrollees to date. A diverse group of high-risk participants was reached comprising 60% Latino, 20% African American, and 20% non-Hispanic white. One quarter of all enrollees were Medicare beneficiaries, while nearly one half had Medicaid. Additional expertise was gained through extensive research and program evaluation, participation in state and regional meetings to share best practices, and presentations to legislators and insurers to promote coverage. Reimbursement through Medicare and other payers is essential for long-term program sustainability. The current proposed rules have three conditions that would greatly constrain access at Denver Health and other sites.
SITES MUST HAVE PENDING OR FULL RECOGNITION IN THE CDC’S DIABETES PREVENTION RECOGNITION PROGRAM Standards were established by CDC’s Diabetes Prevention Recognition Program to ensure effectiveness and fidelity of the National DPP across sites.4 There is concern that the standards appear unattainable in many settings. Among more than 1,200 participating sites that were listed, only 72 sites (6%) were listed as having achieved full recognition to date, although the registry does not denote newly enrolled sites that are not yet eligible for full recognition.5 Achieving CDC recognition largely hinges on showing that participants obtain at least 5% weight loss on average. However, a meta-analysis of early translations of the National DPP showed average weight loss was 4.0%.6 More recently, data from large-scale National DPP dissemination across YMCA sites showed that active participants achieved an average of 4.5% weight loss.7 These results fall below CDC standards, calling into question the suitability of a 5% mean weight loss threshold for reimbursement eligibility. It is also unclear whether achieving at least 5% weight loss is necessary to realize program benefits. In the original clinical trial on which the National DPP is based, each kilogram of weight loss was associated with a 16% reduction in diabetes incidence.8 Incidence rates appeared to decline From the 1Ambulatory Care Services, Denver Health and Hospital Authority, Denver, Colorado; 2Department of Psychiatry, University of Colorado School of Medicine, Aurora, Colorado; 3Department of Medicine, Denver Health and Hospital Authority, Denver, Colorado; 4Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado; 5 Department of Patient Safety and Quality, Denver Health and Hospital Authority, Denver, Colorado; and 6Department of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado Address correspondence to: Natalie D. Ritchie, PhD, Denver Health and Hospital Authority, 777 Bannock St., MC 6000, Denver CO 80204. E-mail: [email protected]. 0749-3797/$36.00 http://dx.doi.org/10.1016/j.amepre.2017.02.005
& 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Am J Prev Med 2017;](5):]]]–]]] 1
2
Ritchie et al / Am J Prev Med 2017;](5):]]]–]]] 8
linearly with weight loss. As such, weight loss of 3% or 4% would likely reduce diabetes incidence rates compared with no intervention at all. Organizations can avoid failing standards by withdrawing from the CDC recognition program and reapplying, which offers a “clean slate” and the opportunity to submit only new data. The proposed Medicare model would allow sites to be re-eligible for payment after 1 year, as opposed to the immediate re-eligibility permitted under current CDC rules. However, a 1-year absence from the recognition program would likely create a coverage gap for many Medicare beneficiaries. More concerning, there is no provision to ensure that programs adhere to agreed-upon methods for reporting participation and outcomes. Organizations with full recognition have shared in National DPP workgroups that they have used differential methods of reporting to meet requirements. An example is limiting the pool of participants for whom data is reported to only those who have signed agreements to confirm their utmost commitment to the year-long program and weight loss. It is especially concerning that underserved patients who experience systemic barriers to full engagement may be reluctant to sign such agreements and thus dissuaded from participating. Inconsistent reporting standards may also unintentionally penalize organizations using broader eligibility definitions. A proposed solution is oversight to ensure dissemination sites follow delivery standards and report data appropriately and uniformly, but without imposing requirements to achieve unrealistic outcomes. Following many of the American Diabetes Association’s requirements for diabetes self-management programs,9 which ensure effectiveness and fidelity through robust training, continuing education, quality assurance metrics for program delivery, and record audits, may be helpful.
INDIVIDUAL MEDICARE BENEFICIARIES MUST ACHIEVE 5% OR MORE WEIGHT LOSS TO RECEIVE COVERED SERVICES IN MONTHS 7–12 OF THE NATIONAL DIABETES PREVENTION PROGRAM The proposed rules for Medicare coverage are more stringent than CDC standards in requiring that individual participants achieve a minimum of 5% weight loss by 6 months to receive covered services in months 7–12. A recent systematic review noted only 20%–64% of participants achieved this goal across programs.10 For the many participants who may be unlikely to achieve weight loss goals, organizations would be left with the option of continuing to provide the year-long program at the organizations’ own cost, charging the participants, or
denying services. Requiring individual weight loss also may further health disparities. Specifically, Latinos have been shown to lose less weight in the National DPP than white participants.11 Thus, Latino seniors may be asked to leave the program at higher rates than white participants. Requiring quick weight loss to receive covered services in months 7–12 also contradicts evidence that each session is associated with 0.26% weight loss.6 Greater engagement is expected to yield better outcomes and reimbursement policies should encourage more attendance, not less. Participants in the original lifestyle intervention group also experienced considerable weight regain over time,12 which is consistent with the poor results of short-term diets expected for the general Medicare population.13 Likely consequences of denying coverage are missed opportunities to prevent or delay diabetes onset among the very individuals who want to complete the National DPP. A proposed solution is to support greater duration of engagement, even among participants who lose weight slowly, or who perhaps lose none at all. These participants may experience other health benefits of risk reduction through lifestyle change, although further research is needed to confirm benefits such as improved hemoglobin A1c. Encouraging sustainable weight loss and other risk reduction behaviors in the National DPP that participants are able to maintain over time is recommended. As such, Medicare’s proposal to cover extended maintenance sessions beyond the year-long program is encouraging, but this service is important for all participants who want ongoing support. Each year of prevented or delayed incidence matters from a return on investment perspective. Annual healthcare expenditures for prior participants are considerably reduced,7 and annual healthcare costs can otherwise double after diabetes onset.14
THE PROPOSED REIMBURSEMENT AMOUNTS ARE LOW AND LARGELY CONTINGENT ON PROGRAM COMPLETION AND WEIGHT LOSS The proposed Medicare payment structure for the National DPP does not appear to support a sustainable business model with reimbursement rates tied to individual participant performance. The current payment model offers up to $450 for each participant who completes the year-long program and loses 5% of their body weight at 6 months, and further maintains this loss at 12 months. However, organizations will only be reimbursed up to $175 for each of the many participants (46%–80%10) who lose less weight—a difference of $275 per person. A challenge with pay-for-performance models is that organizations must finance the program www.ajpmonline.org
Ritchie et al / Am J Prev Med 2017;](5):]]]–]]]
regardless of participant performance. If costs cannot be recouped, organizations will be unable to support access to Medicare beneficiaries. Rigorous cost analyses of the National DPP are lacking and no reports published to date of actual costs by amount of weight loss. The original lifestyle intervention cost $2,780 for each participant in 2000 dollars.15 A 2012 review noted that among six translational programs, costs ranged from $10 to $15 per person per session for programs led by lay healthcare professionals.6 However, it seems doubtful that such low-cost delivery models are sustainable on a large scale. For example, a 1-hour session with five participants would cost $50–$75 per this model, which appears grossly inadequate to cover all costs of resources and activities such as staff training and management, marketing, recruitment, travel to session locations, supplies, class preparation and clean up, and data entry. On the high end, a 2015 report for the State of Colorado showed the estimated direct cost of implementing the program was $1,063 for each participant who attended nine or more sessions.16 Higher reimbursement rates are justifiable given the considerable return on investment expected for the program. According to the YMCA report, average savings on healthcare expenditures equated to an annualized amount of $1,820 per participant.7 Likely consequences of low reimbursement rates are coverage gaps and insufficient capacity to serve Medicare recipients. A previous analysis showed 47.1% of eligible patients referred to the National DPP by their healthcare provider enroll in the program.17 Thus, if all Medicare recipients with prediabetes were referred, capacity to serve more than 13 million individuals would be needed (based on an estimated 55 million Medicare recipients).18 Although programs delivered online or through mobile applications can help increase reach, they are insufficient to address the needs of participants who prefer in-person classes. Medicare beneficiaries appear particularly unlikely to use an Internet-based National DPP—a newly released report showed that as few as 5%–16% of seniors nationwide use digital health technologies. Rates were lower yet among seniors who represent racial and ethnic minorities or who have low incomes.19 Low reimbursement rates may prevent sites from attracting and retaining talented staff to deliver the National DPP. High demands and low pay of many lay healthcare positions have contributed to turnover and staffing challenges in diabetes management programs.20 Given the year-long duration of the National DPP, it may be especially important to have committed coaches who are skilled at engaging participants and supporting lasting behavior change. Suggestions include conducting more-rigorous cost analyses to guide a reimbursement model that covers the full costs of operating the National DPP for all ] 2017
3
participants. Resulting rates need to be competitive and incentivize current sites to both sustain and expand delivery, as well as attract new sites with high capacity. Lastly, rates need to allow coaches to receive a living wage to prevent turnover and facilitate their commitment to the program.
CONCLUSIONS Proposed Medicare coverage for the National DPP provides an unprecedented opportunity to reach at-risk seniors and to lower diabetes incidence rates. Despite notable strengths, several proposed coverage rules are contradicted by current evidence and may impede reach and perpetuate health disparities. Summarized recommendations to improve on the Medicare proposal are: 1. Provide governance to ensure dissemination sites follow high-quality delivery standards and report data accurately, but without requirements for unrealistic outcomes, such as 5% average weight loss. 2. Remove requirements for individual participants to lose 5% or more of their body weight. Rather, encourage ongoing attendance and sustainable weight loss to lower diabetes risk. 3. Conduct rigorous cost analyses that take into consideration the full costs of operating the National DPP for all participants. 4. Enact reimbursement rates that are competitive and provide sufficient reimbursement to incentivize current sites to both sustain and expand delivery, as well as attract new delivery sites with high capacity. 5. Provide reimbursement rates that allow National DPP coaches to be provided a living wage to prevent turnover and facilitate their commitment to the program. Promptly correcting the proposed Medicare coverage rules is essential given the high costs of diabetes and implications of establishing precedent for Medicaid and other third-party payers to follow. Ensuring that reimbursement models for the National DPP are more closely aligned with the needs of diverse healthcare settings and the patients they serve is critical.
ACKNOWLEDGMENTS The National Diabetes Prevention Program at Denver Health was funded by the Amendment 35 Cancer, Cardiovascular Disease, and Pulmonary Disease Grant Program administered by the Colorado Department of Public Health and Environment, and by an award from America’s Health Insurance Plans in partnership with the Centers for Disease Control and Prevention. Additional funding was provided by Denver Health. The contents of this publication are solely the responsibility of the
4
Ritchie et al / Am J Prev Med 2017;](5):]]]–]]]
authors and do not represent the official views of these organizations. No financial disclosures were reported by the authors of this paper.
REFERENCES 1. Centers for Medicare and Medicaid Services (CMS). Medicare program; revisions to payment policies under the Physician Fee Schedule and other revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model. www.feder alregister.gov/articles/2016/07/15/2016-16097/medicare-program-revi sions-to-payment-policies-under-the-physician-fee-schedule-andother-revisions. Accessed August 3, 2016. 2. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403. http://dx.doi.org/10.1056/NEJMoa012512. 3. CDC. National Diabetes Statistics Report: Estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: CDC, U.S. DHHS; 2014. 4. CDC. Diabetes Prevention Recognition Program. www.cdc.gov/diabe tes/prevention/recognition/curriculum.htm. Accessed August 1, 2016. 5. CDC. Registry of Recognized Organizations. https://nccd.cdc.gov/ DDT_DPRP/Programs.aspx. Accessed July 26, 2016. 6. Ali MK, Echouffo-Tcheugui JB, Williamson DF. How effective were lifestyle interventions in real-world settings that were modeled on the Diabetes Prevention Program? Health Aff (Millwood). 2012;31(1):67– 75. http://dx.doi.org/10.1377/hlthaff.2011.1009. 7. Evaluation of the Health Care Innovation Awards: Community Resource Planning, Prevention, and Monitoring, Annual Report 2015. AwardeeLevel Findings: YMCA of the USA. https://innovation.cms.gov/Files/ reports/hcia-ymcadpp-evalrpt.pdf. Accessed Aug 8, 2016. 8. Hamman RF, Wing RR, Edelstein SL, et al. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006;29 (9):2102–2107. http://dx.doi.org/10.2337/dc06-0560. 9. American Diabetes Association. Education Recognition Program, 9th Ed. http://professional.diabetes.org/sites/professional.diabetes.org/ files/media/erp-9th-edition-recognition-requirements11-16.pdf. Accessed July 27, 2016.
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