Reimbursement for Medical Products: Ensuring Marketplace

Transcription

1 Reimbursement for Medical Products: Ensuring Marketplace Success by Securing Coverage and Payment Christopher J. Panarites, Ph.D. Director, Endovascular Products Health Economics and Outcomes Research Abbott Vascular Medical Electronics Symposium Tempe, AZ September 26 27, 2012

2 Medical innovation faces increased challenges in the current environment Healthcare Reforms Cost Effectiveness Health Technology Assessment Comparative Effectiveness Administrative Purchasers Risk Sharing 2

3 Today s United States Healthcare Environment Opportunities and Challenges Coverage and payment varies across private and public programs Legislation, policy changes and elections make future reimbursement policies difficult to predict Strategies for new and existing technologies must adapt to the changing reimbursement environment Reimbursement challenges create opportunities for manufacturers to differentiate themselves through product attributes, as well as customer support services Legal compliance and regulatory issues impact interactions between manufacturers and healthcare providers (and patients) 3

4 Regulatory Approval vs. Market Access 4

5 Regulatory Approval Distinct from Reimbursement FDA and CMS are two different and independent Federal agencies. CMS is the agency that that administers Medicare. FDA approval is generally necessary but may not be sufficient for CMS reimbursement. 5

6 Roles of FDA and CMS FDA Safe and Effective Mission to promote and protect the public health by helping safe and effective products reach the market Monitor products for continued safety after they are approved for marketing Provide the public with accurate, science-based information needed to improve health CMS Reasonable and Necessary Mission to ensure healthcare security for beneficiaries Administers the Medicare program and develops coverage and reimbursement policies Relies on local contractors for most coverage policies Works with States to administer Medicaid & State Children s Health Insurance Program (SCHIP) Safe and effective (FDA) is not same as reasonable and necessary (CMS for Medicare) 6

7 Reimbursement Fundamentals 7

8 Reimbursement Fundamentals Coverage Does a benefit/benefit category exist for a specific product/service? Is the product/service eligible for payment? Coding Does the patient s Dx justify the product/service being billed? How will the product/service be translated into a bill to be submitted for reimbursement? Payment How much will the provider be paid? How much of the bill is the patient s responsibility? 8

9 Coverage Is the product or service eligible for payment? Coverage for a drug, device or procedure is largely determined by the benefits, as defined by the healthcare insurance plan, the employer or state/federal regulations Benefit design impacts level of restrictions imposed on a treatment, routes of access to a treatment and cost-sharing requirements Generally Covered Benefits Major Medical (Hospital & Physician Services) Prescription Drug (Pharmacy) Durable Medical Equipment (DME) Wellness / Preventive Care Services Usually Excluded from Benefits Package Cosmetic Procedures Investigation al / Experimental Services or Drugs OTC Meds Vitamins / Supplements 9

10 Coding Language of Reimbursement, Fluency Required What do codes represent? Diseases and conditions Clinical procedures including lab tests Medical products (drugs, devices, supplies, DME) Why are codes and coding systems used? Mechanism by which providers translate services in to claims Facilitate e-processing of claims Allows for rapid statistical analysis and assessment What can happen when providers code incorrectly? Partial/no reimbursement Delayed/denied payment Prosecution for fraudulent billing 10

11 Coding Type of Code Used by Communicates ICD-9 diagnosis code Hospitals Physicians ICD = International Classification of Disease CPT = Common Procedures Terminology HCPCS = Health Care Common Procedure Coding System Providers identify diseases, procedures, drugs, devices, and other health-related items provided to patients through coding systems Identifies the patient s diagnosis (e.g., the reason for providing care) ICD-9 procedure code Hospital (Inpatient) Identifies the service provided in a hospital for an inpatient stay CPT procedure code C-code (HCPCS code) Hospitals (Outpatient) Physicians (All Settings) Hospitals (Outpatient) Identifies the service provided in a hospital to an outpatient Identifies the services provided by a physician in all settings of care and determines physician reimbursement Identifies the type of device a patient received in an outpatient setting DRG assignment (assignment based on ICD-9 diagnosis and procedure codes) APC assignment (assignment based on CPT codes) Hospitals (Inpatient) Hospitals (Outpatient) Identifies the primary treatment service and determines hospital payment for in inpatient services Identifies the treatment service(s) and level of reimbursement in outpatient setting 11

12 Payment Methodologies Retrospective Prospective Payment Methodologies Usual, Customary and Reasonable (UCR) Fee-for-Service Cost Based Diagnosis Related Groups (DRGs)* Case Rates Ambulatory Payment Classifications (APCs)* Per Diem Fee Schedules* Capitation Contracted Rates *Key Medicare payment systems. 12

13 Same Service May Result In Different Payments Type of Payer Medicare Medicaid Private/Commercial Site of Service Hospital Inpatient Hospital Outpatient Ambulatory Surgical Center Physician Office Reimbursement Type of payer and site of service drive reimbursement of services and products Understanding the reimbursement specifics with each payer and site of service is critical 13

14 Payment by Medicare: Hospital Inpatient Medicare Severity Diagnosis Related Groups (MS-DRGs) Hospital Claims Form ICD-9 Diagnosis and Procedure Codes Medicare Administrative Contractor (MAC) $$ based on DRG 1 DRG payment per patient admission - covers all hospital costs Based on codes submitted on the claim by the hospital Room and board, devices, supplies, drugs, labor, etc. DRG payment adjusted for hospital-specific factors (area wage rates, medical education programs, indigent care) No specific payment for medical devices Only the procedure Physician payment is separate 14

15 MS-DRG Assignment Example - Peripheral Stenting Payment (FY 2012) Peripheral Artery Angioplasty & Stent * MCC Diagnosis YES 252 $15,432 $16,817 NO * CC Diagnosis YES 253 $12,142 $13, $8,291 $9,303 NO * Major Complication / Comorbidity (e.g., streptococcol septicema, arterial dissection, viral pneumonia, acute renal failure; Complication / Comorbidity. (e.g., herpes simplex, dementia, arterial flutter, lower extremity embolism. 15

16 Payment for Physicians Medicare Physician Fee Schedule (Resource Based Relative Value System or RBRVS) Physician bills for services using CPT codes Payment rate established for EACH CPT code; adjusted for local wage rates Payment covers: Practice expense Rent Staff salaries Equipment Supplies Physician professional services Malpractice insurance premiums Certain practice expenses are only relevant when service is rendered in the physician s office (Non-facility vs. Facility Payment Rates) Physician (facility-based) Payment Physician (nonfacility / office) Payment Procedure (Vessel) CPT Rate Rate Angioplasty (Iliac) $428 $3,300 16

17 Demonstrating Value in Today s Environment 17

18 Strong data Starting point for value demonstration Rigorous clinical evidence is the starting point Safety Clinical effectiveness Value Valid evidence is needed to show superiority or parity Important differences exist between therapies and products Little can be learned unless there is high quality data (e.g., missing data can invalidate results) that is analyzed appropriately Real world evidence also can be useful Real world data can supplement but not replace randomized data Can show learning curve improvements over time 18

19 Rigorous clinical evidence published in peerreviewed journals is the benchmark 19

20 Types of health economic studies to define and assess value Cost/Burden of Illness Analysis Cost-Effectiveness Analysis Cost Utility Analysis Budget Impact Analysis Cost Minimization Analysis The type of analysis selected depends on whether the comparison: Includes only costs, or both costs and benefits Is in monetary terms only, or incorporates health outcomes Relates to a single disease state or crosses disease areas Specific endpoints can be included in clinical trial design 20

21 Thinking about health economics Economic data can be collected during clinical trials Resource utilization to capture costs Quality of life and mortality Multiple types of economic models Budget impact models Cost-effectiveness models Many technical challenges adapting models for different countries in a valid manner Often economic evaluations in randomized trials represent a worst case evaluation for new medical devices Physician learning curve and technology iterations lead to improved results over time Within trial modeling often underestimates long-term benefits 21

22 Health Technology Assessments 22

23 Worldwide engagement with decision makers is no longer optional for successful innovators - HTAi / INAHTA 50+ agencies 26 countries Global Networks of Health Technology Assessment Agencies - ISPOR 9,000 members - Payers - Trade Groups 23

24 Reimbursement and Market Access Planning 24

25 Evolving strategies to address evolving market needs Market Authorization/ Approval Market Access Safety Efficacy Quality Cost- Effectiveness Affordability Market Access strategies require timely preparation in collaboration with R&D, Regulatory and Clinical 4 th Hurdle 5 th Hurdle 25

26 Reimbursement and market access planning Key Questions Who typically presents with the disease or condition to treat? What is the likely site of service (hospital, physician office, ambulatory surgical center, home)? Provider Who are the likely payers for the patient population? Under which benefit will the product be classified? Will the product be separately reimbursed or will it be considered a part of a service or procedure? What incentives/disincentives for product adoption will the healthcare provider face? How will various provider stakeholders respond to the product (physicians, hospital administrators, practice managers)? Payer Patient 26

27 Early integration of market access strategy and health economic research Clinical Research Incorporate Health Economic Endpoints into Clinical Studies Health Economic Studies Market Access/ Launch PLAN Conduct literature reviews Determine requirements for reimbursement and market access Establish Product Value Profile per customer type Conduct a PE needs assessment Early modeling to estimate burden of disease and epidemiology Cost of illness Epidemiological studies BUILD Economic analysis/modeling alongside clinical trials (CEA, CUA) Retrospective database analysis Reimbursement dossier preparation Patient reported outcomes research Health related QOL studies Patient preference and symptom evaluation Functional status evaluation Clinical outcomes assessment Satisfaction studies DELIVER Scientific publications and articles Training Posters and conference presentations Patient education Payer submissions FDA submission report/label claims NICE/EU submission reports Adherence assessment 27