Digital Health Reimbursement: Getting Paid in the USA

Transcription

1 Digital Health Reimbursement: Getting Paid in the USA Prepared for 4 October 2017 Daniel A. Lace, MD, CPE, FAAPL 1

2 Reimbursement Strategies, LLC Edward Black President, CEO Daniel Lace, MD Chief Clinical Officer Worldwide Reimbursement Analysis, Planning and Advocacy for the MedTech, BioTech and Pharma Industries 2

3 World Wide Market Access through Life Sciences International, Inc. Mpls/St. Paul Chicago Mexico Brussels London Toronto Paris Italy Boston Valencia Stockholm Warsaw Munich Budapest Istanbul Jerusalem Seoul Tokyo Shanghai Bogota Mumbai São Paulo Santiago Melbourne 3

4 Today s Discussion Reimbursement Fundamentals Coding Payment Coverage Digital Health Reimbursement What To Do 4

5 US Government and Private Health Insurers Medicare is the largest single payer Private insurers often, but not always, follow Medicare coverage decisions Medicare, Medicaid, TRICARE and VA (government payers) all pay less than private insurers for the same services There are about 1,100 private health plans Most private payers make their own coverage decisions They also have varying payment levels, but they pay more than government payers 5

6 Commercial Insurers by Size Insurer United Healthcare Anthem BCBS Aetna Humana Cigna Other BCBS Enrollment 84 million people 54 million people 35 million people 30 million people 26 million people 46 million people Collectively, these commercial insurers cover about 75% of privately insured Americans under age 65 6

7 Reimbursement Trumps Regulatory as the No. 1 Concern for Medtech* At the IBF Medtech Investing Conference in Minneapolis (May 2014) audience members unanimously chose reimbursement as their biggest concern, ahead of raising capital and FDA, in an impromptu live poll I think we have to engage payers earlier, said Michael Liang, partner at Baird Capital, a private equity and venture capital firm. We ask companies to complete their clinical studies in conjunction with reimbursement studies. If you don t have a Reimbursement Strategy, you don t have a business plan * Posted in Medical Device Business by Arundhati Parmar on May 21,

8 Reimbursement Fundamentals Coding Is there a HCPCS (Healthcare Common Procedure Coding System) code that describes your device or the manner in which physicians will use it? Payment Will physicians and hospitals be paid enough to encourage product adoption without being too expensive thereby discouraging government and commercial insurance coverage? Coverage Do Medicare and most private insurers cover the procedures your devices permit and if so, under what clinical circumstances? All three variables must be in place to have a successful Reimbursement Strategy 8

9 Reimbursement Fundamental #1 - Product and Service Coding Coding is the common language of health care providers and insurers 9

10 Evidence for Coding In the hierarchy of evidence requirements you need more evidence to get a new CPT code than to get FDA clearance and even more evidence is required for coverage than for coding Level I CPT code evidence requirements 5 peer-reviewed, published references are required At least 3 of the 5 must report the procedure in a US patient population; Of these, at least 2 articles must report different patient populations or have different authors At least 1 of the publications must be based on results from welldesigned, non-experimental descriptive studies, i.e. comparative studies, correlation studies, or case control studies 10

11 Reimbursement Fundamental #2 Payment There are different payment methodologies for: Inpatient Hospital Services (DRGs) Outpatient Hospital Services (APCs) Ambulatory Surgery Centers (Fee Schedule) Physicians (RBRVS) DMEPOS (Fee Schedule) Lab Services (Clinical Lab Fee Schedule) 11

12 Reimbursement Fundamental #3 Coverage a code and Not all services that have a payment allowance are covered Obtaining Medicare and commercial insurer coverage has become the greatest barrier among the 3 Reimbursement variables. 12

13 Coverage Criteria Example: BCBSA Technology Evaluation Criteria 1. The technology must have final approval from the appropriate regulatory body 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes 3. The technology must improve the net health outcome 4. The technology must be as beneficial as any established alternatives 5. The improvement must be attainable outside the investigative setting 13

14 Payer Attitudes Toward New Technology "We can't be seduced by all of the wonderful technology toys and other stuff, because every good idea ain't good. At the end of the day, you have to ask yourself, -does the technology work, -will it improve quality, -help manage costs, -be good for the consumer, and -meet a real need? * Reed Tuckson, M.D., Executive VP and Chief of Medical Affairs, UnitedHealth Group, December 7, 2010 LifeScience Alley Annual Meeting and Expo 14

15 The Reimbursement Status of Your Device May Already Be Determined Your pathway to reimbursement may be easier (or harder) than you think Novel Devices longer process for reimbursement, with greater risk/reward opportunities Predicate-based Devices reasonable process for reimbursement with moderate risk/rewards Conventional Devices a reimbursement pathway for your device may already exist; this can either very good or very bad 15

16 Biggest Potential Disruptor? Think Digital Health 16

17 Big Digital Deals To-Date 17

18 Digital Medicine Lacks Industry Consensus and Definition You won t find the terms Connected Health, Wearables, e-health or Digital Health in reimbursement medical policies or health insurance parlance. The terms are too broad. What is wearable technology? Wearable technology includes items, such as jewelry, glasses and clothing worn on, in and around the body incorporating sensors and other electronic technologies. * Conceptually, government and private insurers see the value of telehealth, struggle to define and administer a broad telehealth/digital health policy. * PwC Health Institute Research, 2014 but 18

19 The AMA View of Digital Medicine "Even those digital products that might be helpful often lack a way of enriching the relationship between the physician and the patient. But appearing in disguise among these positive products are other digital so-called advancements that don't have an appropriate evidence base, or just don't work that well or actually impede care, confuse patients and waste our time. "From ineffective electronic health records, to an explosion of direct-toconsumer digital health products, to apps of mixed quality it's the digital snake oil of the early 21st century Digital tools that add layers onto our day are not helpful those are digital snake oil, we hate them hate, hate, hate them. AMA CEO James L Madara, M.D. Digital Dystopia An Address to the House of Delegates at the AMA Annual Meeting, June 11,

20 Key Reimbursement Considerations for Digital Technology Place of Service Where will the procedure most likely be performed? Hospital Inpatient? Outpatient? Physician s Office? What is the proposed cost of the product compared to the payment levels? It makes a difference in Coverage and Payment. Payer Mix - What is the patient profile for the new technology? What is the most likely payer mix of Medicare, Medicaid and private payer? Coverage - Are there existing coverage policies that fit the new technology and its clinical indications? Alternative Therapies/Competing Products What is the current standard of care? What are the alternative treatment options including doing nothing? What is the cost compared to the current treatment of choice? What is the clinical benefit compared to the current treatment of choice? 20

21 Coverage for Digital Health Technologies will be Evaluated Against the Following Criteria 1. Integration Can it be easily integrated into the care continuum? 2. Ease of Administration for patients, hospital and payers 3. Engaging - Will patients use it? 4. Clinical Soundness - What is the level of supporting evidence 5. Outcomes and Quality of Life Is it curative or preventative? 6. Payer Return on Investment Does it avoid cost, reduce cost and if so, over what period of time? Guiding Principles for Digital Health Adoption and Coverage (a Minneapolis Managed Medicare and Medicaid Health Plan) 21

22 You Must Market to Payers Clinical Trial Optimization the design of clinical trials that show cost substitution, savings or real world experience Health Economic Analyses Cost Effectiveness, Cost Minimization, Cost Substitution Studies Product (also referred to as a Clinical ) Dossier to describe how your technology works, the patients who will benefit from it, its intended use, summary of clinical support, FDA clearance why payers should cover it Payer Relations Campaign a strategy to use dossiers, published studies and payer relations experts to convince payers to cover your technology targeting markets in concert with your product Marketing/Sales plan. It will stratify the payers of choice in the regions most likely to be successful 22

23 The Reimbursement Planning Pathway A Reimbursement Assessment is the first step in understanding how to monetize your technology. It is an analysis of existing Coding, Coverage, and Payment issues that will affect your device. A Reimbursement Strategy follows. It is the set of business decisions about how to navigate any business barriers uncovered as a result of the Assessment (in medical terms, think of an Assessment as the diagnosis and the Strategy as the treatment plan) Strategy (Plan) Execution may include application for new HCPCS codes, Medicare and private insurance coverage campaign, negotiations for proper payment levels. 23

24 Final Advice: Plan Early for Reimbursement CMS and private payers have become as significant a factor to new product entry as the FDA Have a Reimbursement Assessment before you talk to the FDA federal agencies use different terms; a term used for FDA clearance might force you into an unfavorable reimbursement classification New products and services face higher hurdles for coverage they must be more than marginally better than the products they replace As the American health insurance changes, provider payments will go down. Policy makers consider it a net-net effect; the higher rate of coverage to be offset by lower payments per service. Payers may tell you that cost is not a consideration in coverage decisions but it is. Prepare to make the health economics case for adoption. 24

25 Reimbursement is Like Performing on the Balance Beam 1. Know what you need to win 2. Carefully plan your steps 3. Don t fall off the beam! 25

26 Thank You Lancaster Bay Saint Paul, MN USA Daniel A. Lace, MD, CPE, FAAPL 26