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1、SPECIAL REPORTUnlocking the Potential of Medical Device Reimbursement for Better Health OutcomesSPECIAL REPORTContentsAbout L.E.K.ConsultingWere L.E.K.Consulting,a global strategy consultancy working with business leaders to seize competitive advantage and amplify growth.Our insights are catalysts t

2、hat reshape the trajectory of our clients businesses,uncovering opportunities and empowering them to master their moments of truth.Since 1983,our worldwide practice spanning the Americas,Asia Pacific and Europe has guided leaders across all industries from global corporations to emerging entrepreneu

3、rial businesses and private equity investors.Looking for more?Visit .L.E.K.Consulting is a registered trademark of L.E.K.Consulting LLC.All other products and brands mentioned in this document are properties of their respective owners.2023 L.E.K.Consulting LLCExecutive summary.3Indias transition fro

4、m volume-based care to value-based care.4Key challenges.8Proposed changes.10Conclusion.15About the authors.16Participating experts.172 L.E.K.ConsultingSPECIAL REPORTExecutive summaryThe introduction of Indias largest social health insurance scheme,Ayushman Bharat Pradhan Mantri Jan Arogya Yojana(AB-

5、PMJAY)has expanded healthcare access for millions of the countrys vulnerable population.The project has been marked by a key drive to increase healthcare access in different parts of the country across multiple specialties.Considering these promising changes,we recommend an enhanced patient-centric

6、stance toward improving healthcare outcomes as the way forward.Initiatives for inclusion of high-quality,innovative medical technologies within the reimbursement system is an established approach to improving short-and long-term patient outcomes.To this end,we propose the creation of a more inclusiv

7、e reimbursement process that engages physicians and patient stakeholders at every step starting with prioritization,technical appraisal,and final decision.Complementing this approach,the introduction of quality-based incentives for implantable medical devices,in addition to existing service-based in

8、centives within the reimbursement regime,will be the key to achieving a positive impact on patient outcomes.A move toward transparent,value-based pricing is expected to benefit public insurance beneficiaries as well as set positive benchmarks for private insurers to follow suit.3 L.E.K.ConsultingSPE

9、CIAL REPORTSPECIAL REPORTIndias transition from volume-based care to value-based careIndias commitment to equality and equity is repeatedly echoed in the initiatives taken within education and social development and more recently in its ambition of providing Universal Health Coverage(UHC)through the

10、 launch of Ayushman Bharat Mission in 2018.AB-PMJAY is the worlds largest tax-funded social health insurance scheme and provides cashless hospitalization of upto INR 500,000 per year to each family,currently covering over 500 million Indians who are in the countrys bottom 40%in terms of socio-econom

11、ic status(See Figure 1).While focusing on increased coverage is a powerful starting point for India,improving the quality of patient outcomes should also be a key component of UHC.Private insuranceEmployee schemes(CGHS,ESIS)Government schemesUncovered population020406080100Percentage of population20

12、14-152018-1963%31%6%6%10%12%25%47%Figure 1India health insurance population coverage(2014-2019)Source:L.E.K.research and analysisIt is notable that across low and middle-income countries,deaths from conditions amenable to health care are often caused by low-quality care,with others resulting from no

13、n-utilization of the healthcare system.Unsurprisingly,in these countries,access to quality care is a bigger barrier to reducing mortality than insufficient access.The importance of high-quality care will continue to grow,driven by aging 4 L.E.K.ConsultingSPECIAL REPORTpopulations and a higher incide

14、nce of non-communicable diseases.Poor-quality care also increases distrust in healthcare systems resulting from adverse events due to poor quality medical devices,persistent symptoms,or loss of function.Promising policy changes in the Indian landscape have bought a value-based healthcare model to th

15、e forefront,with policy makers increasingly focused on incentivizing empaneled healthcare providers(EHCPs)to provide high-quality care and improve patient outcomesa shift from the traditional focus on volume-based care.A recent policy brief published by the National Health Authority(NHA)elegantly sh

16、owcases the key goalsreduction in mortality and improvement in patient Health Related Quality of Life(HRQoL)and a proposed implementation framework for a value-based healthcare delivery model in India(See Figure 2).Figure 2Key components of value-based care in AB-PMJAYSource:L.E.K.research and analy

17、sisOrganizing delivery of care around patients medical conditions rather than physicians medical specialtiesSystematic measurement of outcomes and costs at the patient levelPerformance-based payments for care cycles(to replace simple case-based payment for separate services)Integration of care deliv

18、ery systems by clearly defining the scope of the servicesExpanding geographic reach of providers,especially for specialized providersConstruction of an information technology platform that supports integrated,multidisciplinary care across hospitals5 L.E.K.ConsultingSPECIAL REPORTAs India transitions

19、 toward value-based care,the NHA has increasingly focused on the use of Health Technology Assessment(HTA)for decisions on inclusion of new and innovative health technologies as well as value-based pricing.The NHA recently created the Health Financing and Technology Assessment(HeFTA)unit with a defin

20、ed institutional and operating structure for new technology inclusion.The HeFTA unit will inform decisions regarding the inclusion and pricing of new technologies/therapies in Health Benefit Packages(HBPs)(See Figure 3).A Price Negotiation and Strategic Purchasing Committee will be established to ne

21、gotiate the ceiling price of health technologies with providers(hospitals,pharmaceutical companies and medical device manufacturers).Figure 3Institutional structure and functioning of the HeFTA unit for new technology inclusionNote:SHA=State Health Agency;PNSP=Price Negotiation and Strategic Purchas

22、ing;HeFTA=Health Financing and Technology Assessment;HTA=Health Technology Assessment;HTAIn=Health Technology Assessment in India Source:NHA Consultation Paper on Payments and Price Setting under Ayushman Bharat PM-JAY Scheme in IndiaKey stakeholdersPNSP CommitteeStrategic purchasingNational referen

23、ce priceTechnical assessment Evidence synthesis unitEvidence appraisal unitHeFTA unit secretariatNational Health AgencyHTAInHealthcare servicesDoctorsHealthcare servicesState Health AgencyIndustryProfessional associationsReferral for full HTAPrice negotiationThe NHA has also proposed the introductio

24、n of service-based incentives for empaneled hospitals based on both certifications and systematic measurement of outcomes.In the newer policy of providing value-based incentives,a maximum financial benefit of 15%will be provided based on two categoriescertification-based incentives and outcome-based

25、 incentiveswith equal weightage accorded to both criteria.The NHA has also introduced a Diagnosis Related Group(DRG)pilot in five states under AB-PMJAY,making it the first scheme in India to provide payment through use of DRGs.6 L.E.K.ConsultingSPECIAL REPORTSPECIAL REPORTIn addition to the above pr

26、omising changes in the policy landscape and an increase in healthcare spends,NHAs initiative to invite stakeholder comments on recent policy papers“Provider Payments and Price Setting under Ayushman Bharat Pradhan Mantri Jan Arogya Yojana”and“Volume-Based to Value Based Care:Ensuring Better Health O

27、utcomes and Quality Healthcare under AB PM-JAY”is a welcome step.However,a strong shift toward a more inclusive reimbursement decision making is yet to be implemented.In this regard,we highlight three key challenges to bringing patient-centric and inclusive reimbursement decision making to the foref

28、ront:1.Limited involvement of critical stakeholders in reimbursement decisions often leading to partial assessments precluding patient access to innovative technologies An infrequent involvement of diverse stakeholders often leads to physicians,the actual therapy users having an incomplete view of t

29、he topic selection and prioritization process used for reimbursement decisions within the HTAs.A second challenge in this context is the general representation of broader clinical experts(e.g.,cardiologists)instead of specialized therapy users(e.g.,pediatric cardiologists,electrophysiologists)who ca

30、n effectively identify patients interests.Underrepresentation of patient and physician voices disproportionately affects patients with life-threatening diseases,who are most often poorly served by healthcare systems.A lack of structured physician and patient societies in India and their limited awar

31、eness of HTA processes is also an impediment to increased representation of diverse stakeholders within topic selection and technical appraisal committees.Key challenges7 L.E.K.ConsultingSPECIAL REPORT2.An incentive disbursement structure with an uneven focus on healthcare services Service-based inc

32、entives do not comprehensively capture or reward the key success factors that drive positive outcomes.High quality implantable medical technologies play an equally important part in improving health outcomes.It is thus essential to focus beyond the existing metrics and capture other relevant success

33、 factors contributing to quality healthcare(See Figure 4).Incentive structurePayment structureImpact on patient outcomes A simple case-based payment system often incentivizes efficiency and cost-cutting at the cost of patient outcomes Case-based payments are a key driver for hospital participation i

34、n social health programs Patient outcomes are typically not monitored or have little bearing on payments to providers A service-based incentive structure within case-based payments increases accountability for clinicians and hospital providers Service-based incentives do not take a granular view of

35、factors that drive patient outcomes e.g.,use of high-quality implantable devices Patient outcomes are monitored within transaction management systems A granular view of key success factors is often missing due to focus on services aloneValue-based incentivesService-based incentivesNo incentives Intr

36、oduction of value-based incentives generates high degree of accountability in the system aligning payors,physicians,providers and industry towards the common goal of enhancing patient outcomes Patient outcomes are monitored within transaction management systems with contextual data clinician informa

37、tion,device identifiers A granular view of key success factors emerges,strongly driving future outcomesNo incentivesIncentivesPayorPayorPayorPatientsImplantsDoctorServicesPatientsImplantsDoctorServicesPatientsImplantsDoctorServicesFigure 4Value-based incentives for implantable devices aligns all sta

38、keholders to drive positive patient outcomesSource:L.E.K.research&analysis 8 L.E.K.ConsultingSPECIAL REPORT3.Lack of defined measures to reward high quality implantable medical technology The current approach for ascertaining the eligibility of a device for inclusion is based on some minimum safety

39、and efficacy data requirements(regulatory approvals).However,long term data to suggest a positive impact of these devices on quality of care or improvement of patient outcomes is largely missing.These devices have varied level of clinical evidence that are often not comparative in nature.Consequentl

40、y,it is often difficult to ascertain whether these devices will have a comparable impact on long-term patient outcomes.The healthcare system currently has no mechanism to promote the use of high-quality medical devices by service providers.The lack of minimum standards and specifications for product

41、s and for manufacturers for reimbursement eligibility is a key challenge in this context.Additionally,the absence of real-world evidence to support claims of medical device manufacturers is a common challenge for both private and public payors.This highlights an opportunity for creation of well-defi

42、ned,evidence-driven measures for rewarding high-quality implantable medical technology.9 L.E.K.ConsultingSPECIAL REPORTSPECIAL REPORTProposed changesProposed change 1:Bringing care providers and patients closer to the reimbursement processStakeholderPrioritizationProposalReviewDecision makingPublic

43、HCPsPrivate HCPsClinical societiesPatient groupsPayersDHR/health economistsNHA Specialist CommitteeNHA Review CommitteeState health agenciesNational Health ProgramRegulatorsDegree of inclusionLowHighFocus of the discussionKOLs and patientsPayersDecision makersNote:KOL=key opinion leader;HCP=healthca

44、re provider;DHR=Department of Health Research;NHA=National Health AuthoritySource:L.E.K.research&analysisFigure 5Key areas for involvement of key opinion leaders and patients in the reimbursement process Proposed change 1A:Deeper involvement of Key Opinion Leaders(KOLs)in topic prioritization One pr

45、oposed,elemental change is a concerted effort to involve KOLs including therapy users on a rotational basis through a structured nomination and selection process during topic prioritization at NHA level to drive greater focus on patient access in the local healthcare context.Key opinion leaders and

46、patients can be involved in distinct parts of the process(See Figure 5).A study of global approaches on topic selection for health technology assessment(HTA)shows that numerous nations have endeavored to involve stakeholders such as health professional bodies and the general public in this process1.

47、10 L.E.K.ConsultingSPECIAL REPORTcommittees composed of public and private physicians as well as industry representatives.For instance,in Korea,the HTA committee comprises 20 permanent members with five additional subcommittees specific to specialties comprising a minimum of 30 members2.Proposed cha

48、nge 1C:Leveraging clinician and patient societies for generating awareness We recommend driving campaigns through creation of a common platform for knowledge sharing of the latest technologies and HTA processes between the clinical experts and the evaluation body.The technical complexity of these to

49、pics merits a continuing dialogue with the public aimed at creating awareness and encouraging stronger involvement from diverse stakeholders.Proposed change 1D:Creation of a mechanism for feedback collection and incorporation We propose creation of a formal,streamlined process for wider feedback col

50、lection and dissemination and focused consultation with therapy users,patients,and professional societies on HTA proposals and outcome reports.Use of email campaigns,telephonic contact,and roundtable discussions to collect feedback on key issues is highly recommended.Another recommended change is th

51、e creation of a mechanism for reappeal,post publication of an HTA outcome report,with an appeal panel also composed of independent reviewers.This will allow diverse stakeholders,including patients,physicians and manufacturers,to have ongoing dialogue with the HTA body on individual decisions.For ins

52、tance,The National Institute for Health and Care Excellence allows appeals to be lodged against the final draft guidance by any of the appraisal consultees within 15 days on specified grounds(e.g.,unfair assessment,unverified recommendations,etc.).The five-member appeal panel also includes four inde

53、pendent reviewers,giving medical technologies a fair chance in patient care.Proposed change 1B:Wider representation of clinical experts within the Technical Appraisal Committee(TAC)A second recommended change is to initiate topic specific representation within the TAC of the HTA body through formati

54、on of specialist sub-11 L.E.K.ConsultingSPECIAL REPORTThe use of high-quality,newer technologies contributes to reduced mortality,shortened recovery times and significant improvements to HRQoL among patients with life-threatening diseases(e.g.,ischemic heart disease).Therefore,addition of value-base

55、d incentives for medical devices along with the existing service-based incentives in the current structure will encourage delivering high-quality healthcare and improve patient outcomes.We propose a two-step pathway for reimbursement aimed at provision of high-quality implantable medical devices in

56、India.All included products should adhere to essential principles of safety and performance for implantable devices established by the regulatory body.Manufacturers that demonstrate a commitment to patient safety(e.g.,consistent product event report filing,clinical evidence,strong documentation)shou

57、ld be preferentially considered for reimbursement eligibility.This will further encourage manufacturers to strengthen their product quality processes and systems where lacking.As a second step,manufacturers will be invited to submit additional information supporting their application for value-based

58、 incentives.Here,we recommend adopting the existing framework of value-based incentives ideated by AB-PMJAY for medical devices.We recommend providing incentives based on two key categoriesincentives based on robustness of clinical evidence and outcome-based incentiveswith equal weightage given to b

59、oth criteria(See Figure 6).Proposed change 2:Introduction of a two-step pathway for provision of value-based incentives for implantable medical devices12 L.E.K.ConsultingSPECIAL REPORTFigure 6Proposed pathway for value-based reimbursement of high-quality implantable medical devices in IndiaOutcome-b

60、ased incentivesValue-based incentivesProduct inclusion2bOutcome-based incentives Establish data collection and feedback mechanism Adopt use of key metrics collected within AB-PMJAY for analysis of key patient outcomesIncentives based on robustness of clinical evidence2a1Nationally recognized high-qu

61、ality devices Use of a globally accepted framework to grade the devices based on the level of evidence Establishment of an independent body for grading of medical devices to be incentivizedLeverage regulatory approvals for product inclusion Inclusion of devices adhering to essential principles of sa

62、fety and performance Prioritize medical devices from manufacturers consistently demonstrating commitment to patient safetyApprovals from international regulatory bodies Evaluate evidence and approvals by other international organizations(FDA,CE mark)Note:FDA=U.S.Food and Drug AdministrationSource:L.

63、E.K.research&analysis Incentives based on robustness of clinical evidence Inferior medical devices often have insufficient high-quality clinical evidence establishing long term patient outcomes.We recommend the use of a globally accepted framework to grade and incentivize devices based on the qualit

64、y of clinical evidence through establishment of an independent body(See Figure 7).Alternatively,the approvals by other stringent regulatory bodies(e.g.,U.S.Food and Drug Administration,CE-mark)can act as a proxy for identifying and incentivizing high-quality medical devices.13 L.E.K.ConsultingSPECIA

65、L REPORTIncentives based on robustness of clinical evidenceLevel of clinical evidence(AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation)2aNationally certified high-quality devices Use of a globally accepted framework to grade the devices based on the level of clinical evi

66、dence Establishment of an independent body for grading of medical devices to be incentivizedApprovals from international regulatory bodies Evaluate evidence and approvals by international organizations(e.g.,FDA,CE mark)Level A High-quality evidence from more than 1 RCT Meta-analyses of high-quality

67、RCTs One or more RCTs corroborated by high-quality registry studiesLevel B Moderate-quality evidence from 1 or more RCTs Meta-analyses of moderate-quality RCTsLevel C-LD Randomized or non-randomized observational or registry studies with limitations of design or execution Meta-analyses of such studi

68、es Physiological or mechanistic studies in human subjectsLevel C-EO Consensus of expert opinion based on clinical experienceLevel B-NR Moderate-quality evidence from 1 or more well-designed,well-executed non-randomized studies,observational studies or registry studies Meta-analyses of such studiesFi

69、gure 7Suggested clinical framework for grading of implantable medical devicesFDA=U.S.Food and Drug Administration;RCT=randomized controlled trial Source:L.E.K.research&analysis Outcome-based incentives Out of the five existing outcome-based indicators being collected under the AB-PMJAY Transaction M

70、anagement System(TMS),we suggest adoption of two key metrics for providing outcome-based incentives for medical devices:HRQoL and hospital readmission rate(See Figure 8).14 L.E.K.ConsultingAs an initial step to implement this framework,we recommend collection and linking of minimum device identifica

71、tion data to the TMS to allow long-term monitoring of patient outcomes.Outcome-based incentivesOutcome-based Indicators under AB-PMJAYHealth-related quality of lifeHospital readmission rateBeneficiary satisfaction rateExtent of OOP expenditureConfirmed grievances2bOutcome-based incentives Establish

72、data collection and feedback mechanism Adopt use of key metrics collected within AB-PMJAY for analysis of key patient outcomesFigure 8Adapted framework for outcome-based incentivesNote:OOP=out-of-pocket Source:L.E.K.research&analysis SPECIAL REPORT15 L.E.K.ConsultingSPECIAL REPORTSPECIAL REPORTOver

73、25 key stakeholders(participating experts)across key opinion leaders,government authorities,private insurance experts,health policy experts and industry attended a roundtable meeting to discuss the proposed changes to enhance the medical device reimbursement process in India.This quorum is a key ste

74、p toward a reimbursement process that facilitates patient-centric decision-making by creating processes for inclusion of diverse stakeholders.Overall,we hope that these key recommendations will enable access to high-quality healthcare through AB-PMJAY with the introduction of quality-based incentive

75、s.Conclusion16 L.E.K.ConsultingEndnotes1 Qiu Y,Thokala P,Dixon S,Marchand R,Xiao Y.Topic selection process in health technology assessment agencies around the world:a systematic review.Int J Technol Assess Health Care.2022 Feb 7;38(1):e19.doi:10.1017/S0266462321001690.PMID:35129112.t2 Kim,C.(2009).H

76、ealth technology assessment in South Korea.International Journal of Technology Assessment in Health Care,25(S1),219-223.doi:10.1017/S0266462309090667SPECIAL REPORT17 L.E.K.ConsultingSPECIAL REPORTAbout the authorsShruti SrinivasanLIFE SCIENCES SPECIALIST,INDIA Shruti Srinivasan is a Life Sciences Sp

77、ecialist at L.E.K.Consultings Mumbai office and is a member of the Southeast Asia Healthcare and Life Sciences Practice.Shruti has worked with clients across diagnostics,Medtech,and digital health focused on regulatory and reimbursement pathways.Ashwin GoelPARTNER,INDIA Ashwin Goel,based in the Mumb

78、ai office,is a Partner at L.E.K.Consulting.Ashwin co-leads the Healthcare and Life Sciences practice in India and is a member of the Global Education Practice.Within the healthcare sector,Ashwin advises biopharmaceutical and manufacturing services clients over a range of topics such as growth strate

79、gy,new market entry,international expansion and buy-and sell-side commercial due diligences.Stephen SunderlandPARTNER,SINGAPOREStephen is a Partner based in L.E.K.s Singapore office.He has more than 20 years of experience spanning Asia and Europe working with multinational corporations,midsize compa

80、nies,social enterprises and nonprofits,financial investors,and governments.He leads L.E.K.s Healthcare and Life Science practice in South East Asia,L.E.K.s Medtech practice in China and is the Executive Director of L.E.K.s Asia-Pacific Life Sciences Centre of Excellence.18 L.E.K.ConsultingSPECIAL RE

81、PORTParticipating experts(In alphabetical order)Arif Fahim,Regional Director,Health Economics&Reimbursement,Asia Pacific,Abbott Dr.Abhijit K Chattoraj,Dean,Programme Chairperson,PGDM and Professor,Birla Institute of Management Technology Dr.Ajay Nair,CEO,Swasth Alliance Dr.Anil Saxena,Executive Dire

82、ctor-Cardiac Pacing&Electrophysiology,Fortis Escorts Heart Institute Dr.Anita Saxena,Vice Chancellor,Pandit Bhagwat Dayal Sharma University of Health Sciences,Rohtak Dr.Bhabatosh Mishra,Director Underwriting,Products&Claims,Niva BUPA Dr.Deepika Singh Saraf,Member,National Health Research Policy Comm

83、ittee,Ministry of Health&Family Welfare,GoI,Former Deputy Director General,Indian Council of Medical Research,New Delhi Dr.K.Madan Gopal,Sr.Consultant(Health),NITI Aayog Dr.Kirti Kataria,Associate Manager,Health Economics and Reimbursement,Abbott Dr.Monika Pusha,Head,Market Access India&Subcontinent

84、,Health Economics&Reimbursement,Abbott Dr.Neeraj Awasthy,Director,Paediatric Cardiology,Fortis Escorts Heart Institute Nikhil Apte,Chief Product Officer,Product Factory(Health Insurance),Royal Sundaram General Insurance Co.Limited Dr.Priyanka Bhadoria,Consultant,Health Policy and Quality Assurance,N

85、HA Dr.Ratna Devi,CEO and Co-founder,Dakshayani and Amaravati Health and Education Dr.Sandeep Sharma,General Manager,H,S&E Medical,Indian Oil Corporation Dr.Sangeetha M R,Assistant Project Manager,Suvarna Arogya Suraksha Trust,Karnataka Dr.Shankar Prinja,Professor of Health Economics,Department of Co

86、mmunity Medicine and School of Public Health,PGIMER,Chandigarh Dr.Shayhana Ganesh,Head of Health Risk Management,Aditya Birla Health Insurance Dr.Sitanshu Sekhar Kar,Professor and Head,Preventive and Social Medicine,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)Dr.Sree G

87、anesh,Chief Medical Officer,Medi-Assist India Dr.Sudha Chandrashekar,Executive Director,Health Policy and Hospital Engagement,NHA Dr.Surendra Gulabchandra Jain,Assistant Director,PMJAY-Mukhyamantri Amrutum Yojana,Gujarat Dr.Vivek Chaturvedi,Professor&Head of Department,Department of Cardiology,Amrit

88、a Hospital,Faridabad Dr.Viveka Kumar,Principal Director&Chief of Cath Labs(Pan Max),Cardiac Sciences,Max Healthcare Jayakrishna Thadakamalla,Consultant,Health Economics and Reimbursement,Abbott Kumar Vikram Singh,Senior Vice President,HDFC ERGO General Insurance Co.Ltd.P Sashidharan Nair,Insurance I

89、ndustry Expert Richa Debgupta,Chief of Strategy&Operations,Fortis Healthcare19 L.E.K.ConsultingThe scientific initiative has been made possible with the support of St.Jude Medical India Pvt Ltd.(now Abbott).The opinions expressed in this paper reflect the opinion of the group of participants at the annual healthcare payers roundtable,hosted by SJM,and are purely academic and personal in nature.Abbott and L.E.K.Consulting do not have any influence on the expressed views in any form.SPECIAL REPORTDisclaimer20 L.E.K.Consulting