How Healthcare is Paid in the US

Coloplast Capital Market Day 2009 How Healthcare is Paid in the US Coloplast p Capital p Market Day y 2009 Russ Miller, Director of Reimbursement 29 ...
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Coloplast Capital Market Day 2009

How Healthcare is Paid in the US Coloplast p Capital p Market Day y 2009 Russ Miller, Director of Reimbursement 29 September 2009 How Healthcare is Paid in the US Page 1

Coloplast Capital Market Day 2009

The U.S. Health Insurance Environment and its Applicability to Coloplast Products

Providers Patients Coloplast Corp. Private Payers Employers p y

29 September 2009 How Healthcare is Paid in the US Page 2

Suppliers

Government Payers

Coloplast Capital Market Day 2009

How Healthcare is paid in the U.S. Employers

Insurance Claims

Patient

Providers

Product Sales P s

Reimbursement

Payment

Ins surance Claims

Reimbursement R

Payers

Product Sales

Suppliers 29 September 2009 How Healthcare is Paid in the US Page 3

Payment

Coloplast Corp.

Coloplast Capital Market Day 2009

Agenda • Payers • Providers and Suppliers • Insurance Transactions (Coverage, Coding and

P Payment) t) • Insurance Reimbursement for the Surgical

Urology Patient • Reimbursement for the Ostomy, Wound or

Continence Patient • Reimbursement for Med Tech Innovation

29 September 2009 How Healthcare is Paid in the US Page 4

Coloplast Capital Market Day 2009

Health Insurance by Payer Segment Lives (millions) Medicare Employment-based insurance (Private Payers) Directly purchased/Individual market (Private Payers) Medicaid Military healthcare coverage Uninsured

40.2 174.8 26.8 38.1 11.2 46.6

Total Coverage Arrangements

337.7

2008 US Population: 304,000,000

Source: United States Census Bureau, Current Population Reports, August 2006, Table C-1; Income Poverty and Health Insurance Coverage in the U.S.; 2005, p.60.

29 September 2009 How Healthcare is Paid in the US Page 5

Coloplast Capital Market Day 2009

Payer Mix for Product Categories Medicare

Medicaid

Private Payers

Self Pay

2%

Surgical Urology ▪ Men ▪ Women

68% 40%

30% 60%

Continence Care

63%

37%

Ostomy Care

70%

30%

Wound Care

40%

29 September 2009 How Healthcare is Paid in the US Page 6

25%

25%

10%

Coloplast Capital Market Day 2009

The Medicare Program: For people age 65+ or with certain disabilities.

Types of Medicare Insurance: Part A – Inpatient Hospital Care, Skilled Nursing Facilities, Home Health Care Part B – Physician Services, Outpatient Hospital, Medical Supplies, Ambulatory Surgery Centers Part C – Medicare Advantage Plans (HMOs and PPOs)

Primary Sites-of Service (SOS) for Coloplast Corp. 22% of Medicare beneficiaries. 29 September 2009 How Healthcare is Paid in the US Page 7

Coloplast Capital Market Day 2009

The World of Private Payers Private sector companies p who administer health p plans that utilize governmental or private sector dollars ¾ Approximately 1500 – 1700 private health insurance companies

29 September 2009 How Healthcare is Paid in the US Page 8

Coloplast Capital Market Day 2009

Private Payers in the U.S. Private health insurance companies p operate p as: ¾ Health Insurance Companies (for individuals or groups) ¾Third Party Administrators (for employers or unions) ¾ Government Contractors (for the Medicare program)

29 September 2009 How Healthcare is Paid in the US Page 9

Coloplast Capital Market Day 2009

Medicaid A state state-administered administered insurance program for low-income low income persons: ¾ Who are aged, blind, disabled or low-income families with dependent children ¾ Who receive public assistance ¾ Other low income disabled groups with high medical expenses.

Eligibility is determined by federal and state law. Medicaid programs are jointly funded by federal & state government government.

29 September 2009 How Healthcare is Paid in the US Page 10

Coloplast Capital Market Day 2009

Agenda • Payers • Providers and Suppliers • Insurance Transactions (Coverage, Coding and

P Payment) t) • Insurance Reimbursement for the Surgical

Urology Patient • Reimbursement for the Ostomy, Wound or

Continence Patient • Reimbursement for Med Tech Innovation

29 September 2009 How Healthcare is Paid in the US Page 11

Coloplast Capital Market Day 2009

Product Categories by Provider/Supplier Type SU

Parrt A

Hospital Inpatient

CC

OC

WC

SC

g Facilities Skilled Nursing Home Health Agencies Physician Practices p Outpatient p / Clinic Hospital Ambulatory Surgery Centers Medical Supplies (home use) - Primary 29 September 2009 How Healthcare is Paid in the US Page 12

N/A - Secondary

Coloplast Capital Market Day 2009

Providers and Suppliers Integrated Delivery Network

Hospital

Local Dealers

GPO

National Distributors

A healthcare system of multidisciplinary providers owned or affiliated under common management. May include several hospitals, physician groups, rehabilitation centers, home health agencies, long-term care facilities and providers of Durable Medical Equipment and Supplies. There are approximately 300 IDNs in the US. Examples include: UCLA, Baylor and Mayo System. An acute care facility that may or may not be part of an Integrated Delivery Network.

Regional and local providers of medical equipment and supplies to local healthcare facilities and patients. There are approximately 64,000 dealers in the US.

For profit F fit companies, i usually ll corporations, ti th thatt engage iin contract t t negotiations ti ti on behalf b h lf off th their i member IDNs. The GPO retains an “admin fee” paid by the supplier, in exchange for the GPOs services. There are 6 national GPOs. Examples include MedAssets, Premier and Novation. Distribute Distrib te large volumes ol mes of prod products cts to m multiple ltiple healthcare entities entities, incl including ding hospitals hospitals, D Durable rable Medical Equipment companies, and home healthcare organizations. Examples include: McKesson, Cardinal Health, Invacare Supply Group, Owens & Minor, Gulf South.

29 September 2009 How Healthcare is Paid in the US Page 13

Coloplast Capital Market Day 2009

Agenda • Payers • Providers and Suppliers • Insurance Transactions (Coverage, Coding

and d Payment) P t) • Insurance Reimbursement for the Surgical

Urology Patient • Reimbursement for the Ostomy, Wound or

Continence Patient • Reimbursement for Med Tech Innovation

29 September 2009 How Healthcare is Paid in the US Page 14

15

Coloplast Capital Market Day 2009

The Building Blocks of Reimbursement • Coverage: Defines the clinical conditions of a service or technology. • Coding: The nomenclature used to classify medical services, supplies and

g categories. g Required q for filing g insurance claims with p payers. y diagnostic

• Payment: Payments are made via defined payment systems and contracts.

Payment assignment is driven by the coding on the insurance claim.

• Compliance: Providers, suppliers and manufacturers are subject to

government oversight and audits. Applicable statutes include: ƒ False Claims Act, ƒ Anti-Kickback statutes ƒ FDA prohibitions on off-label promotion.

29 September 2009 How Healthcare is Paid in the US Page 15

Coloplast Capital Market Day 2009

The Building Blocks of Reimbursement M di Medicare Coverage Policies

Pi Private Payers P

National / Local

Coding Systems

Made by each entity Universal

Payment Systems S

Defined f system for f each site-of-service

29 September 2009 How Healthcare is Paid in the US Page 16

16

Often adopt Medicare Of site-of-service structure / pay rates sett by b contracts t t

Coloplast Capital Market Day 2009

Coding – The Language of Reimbursement CPT ® Coding (Current Procedural Terminology) – used for reporting procedures and services performed by physicians. HCPCS Coding (Level II) – identification of devices, drugs, and supplies. ICD-9-CM Procedure Coding – identification of inpatient hospital services. ICD 9 CM Di ICD-9-CM Diagnostic ti C Coding di – identification id tifi ti off the th reason for f the th encounter. t

® CPT is a registered trademark of the American Medical Association.

29 September 2009 How Healthcare is Paid in the US Page 17

Coloplast Capital Market Day 2009

Coding drives Payment

XX = payment ‘driver’ driver

x = required, required but not a payment driver

C di Coding Site-ofService

CPT

ICD-9 **

HCPCS

Diagnosis

Medical Supplies

X **

ICD-9 Procedure

XX

Critical for meeting payer coverage requirements

29 September 2009 How Healthcare is Paid in the US Page 18

Payment Fee Schedule

Coloplast Capital Market Day 2009

C di d Coding drives i P Paymentt

XX = payment ‘driver’

x = required, but not a payment driver Coding

Site-ofService

CPT

Hospital H it l Outpatient

XX

Amb Surg S Center

HCPCS

Diagnosis

Hospital Inpatient Physician Practice

ICD-9 **

X

Medical Supplies

XX

MS-DRG (PPS)

X

X

Fee Schedule

X

X

Fee Schedule

X

XX

Fee S h d l Schedule

** Critical for meeting payer coverage requirements. PPS – Prospective Payment System. 29 September 2009 How Healthcare is Paid in the US Page 19

Payment APC Group (PPS)

X

XX XX XX

ICD-9 Procedure

Coloplast Capital Market Day 2009

Agenda • Payers • Providers and Suppliers • Insurance Transactions (Coverage, Coding and

P Payment) t) • Insurance Reimbursement for the Surgical

Urology Patient • Reimbursement for the Ostomy, Wound or

Continence Patient • Reimbursement for Med Tech Innovation

29 September 2009 How Healthcare is Paid in the US Page 20

Coloplast Capital Market Day 2009

Medicare Prospective Payment Systems ¾ Hospital Inpatient and Outpatient Example: Virtue Male Sling System

Inpatient (choose 1)

• • • • •

MS-DRG 662

$15,690

MS-DRG 663

$7,752

MS-DRG 664

$5,762

> 24 hour stay (patient in bed). Based on diagnosis and procedure. Subdivided by Severity Severity. Data-driven Payment (Claims data). Geographic adjustment. 29 September 2009 How Healthcare is Paid in the US Page 21

Outpatient APC 385

$6 447 $6,447

Benchmark

• < 24 hour stay (observation room). • Based on procedures only. • Data-driven Data driven Payment (Claims data) data). • Geographic adjustment.

Coloplast Capital Market Day 2009

Private Payer y Reimbursement is critical for Hospital p Profitability 140%

Community Hospital Payment-to-Cost Ratios by Source, 1980-2006

132% in 2007

130% 120% 110% 100% 90% Private Payers Medicare

80%

Medicaid 70% 1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

Source: American Hospital Association.

29 September 2009 How Healthcare is Paid in the US Page 22

Coloplast Capital Market Day 2009

Medicare Fee Schedules ¾ Physician y and Ambulatoryy Surgery g y Center Example: Virtue Male Sling System Physician Fee CPT 53440

$905

• Formula-driven Payment

Ambulatory Surgery Center CPT 53440

$4,811

• Factored from the Hospital

Outpatient Payment • Relative Value Units (RVUs) g p adjustments j • Sustainable Growth Rate (SGR) • Geographic • Geographic adjustments

Private Payers ≈ Medicare + 25% 29 September 2009 How Healthcare is Paid in the US Page 23

Coloplast Capital Market Day 2009

Agenda • Payers • Providers and Suppliers • Insurance Transactions (Coverage, Coding and

P Payment) t) • Insurance Reimbursement for the Surgical

Urology Patient • Reimbursement for the Ostomy, Wound or

Continence Patient • Reimbursement for Med Tech Innovation

29 September 2009 How Healthcare is Paid in the US Page 24

Coloplast Capital Market Day 2009

Insurance Reimbursement Two Important p Variables ¾ A Reimbursement Rate that allows for Supplier Margin ¾ A Utilization Rate that reflects Accepted Clinical Practice ƒ Defined by Coverage Policies

Product

Rate

One-Piece Ostomy Pouch (drainable, with filter) Intermittent Urinary Catheter Foam Dressing, < 4” x 4”

29 September 2009 How Healthcare is Paid in the US Page 25

Medicare Utilization

$4 99 $4.99

Max 20 / month Max.

$1.62 - $1.90

Max. 200 / month

$7.85

3 changes / week

Coloplast Capital Market Day 2009

Agenda • Payers • Providers and Suppliers • Insurance Transactions (Coverage, Coding and

P Payment) t) • Insurance Reimbursement for the Surgical

Urology Patient • Reimbursement for the Ostomy, Wound or

Continence Patient • Reimbursement for Med Tech Innovation

29 September 2009 How Healthcare is Paid in the US Page 26

Coloplast Capital Market Day 2009

re'im·burse'ment n. – a.)) repayment p y for expenses p incurred,, b.) payments given to healthcare providers for services rendered or supplies provided, base on benefits covered under an insurance plan.

…but more importantly…

It’s a critical factor for: ¾Determining the speed of market acceptance for new technology, ¾Providing the appropriate margin for product pricing. ¾Creating the space for volume growth of existing technologies.

29 September 2009 How Healthcare is Paid in the US Page 27

Coloplast Capital Market Day 2009

From a Foundation of Clinical Effectiveness Patient Access and Utilization

Coverage Coding Payment P t

Customer Acceptance

Evolving in Importance Clinical Effectiveness

29 September 2009 How Healthcare is Paid in the US Page 28

Health Economic Outcomes

Coloplast Capital Market Day 2009

How Medicare determines coverage

““No payment may be made under [Medicare] ffor any expenses incurred for f items or services [that] are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Section 1862(a)(1)(A) of the SSA* SSA ¾ The absence of formal criteria gives CMS discretion and results in a “quasi-

case law” approach to establishing coverage policies. ¾ Generally, a technology is considered “reasonable and necessary” when it: 1. Produces a demonstrable clinical benefit for the Medicare population, and 2 Is supported by methodologically sound evidence 2. evidence.

29 September 2009 How Healthcare is Paid in the US Page 29

Coloplast Capital Market Day 2009

How Private Payers determine coverage ¾ Few payers have published clinical criteria criteria. Technology Evaluation Center Criteria

1.

The technology must have final approval from the appropriate governmental regulatory bodies

2.

The scientific evidence must p permit conclusions concerning g 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 investigational settings 29 September 2009 How Healthcare is Paid in the US Page 30

Coloplast Capital Market Day 2009

New Coding requires Clinical Evidence Requirements AMA Website – Requirement q for New CPT Coding: g ¾ “…the clinical evidence of the service/procedure is well-established and documented in U.S. peer-reviewed literature.” CMS Requirements - HCPCS Request Process: ¾ Requires evidence for claims of “significant therapeutic distinction.” ¾ CMS Denial Letters often state – “Clinical information…does not demonstrate superior clinical outcomes.”

29 September 2009 How Healthcare is Paid in the US Page 31

Coloplast Capital Market Day 2009

Successful Execution of Concurrent Pathways

C Clearanc ce

Execute Payer Coverage Tactics

12 mos.

24 mos.

Secure Coding Secure Payment Class

29 September 2009 How Healthcare is Paid in the US Page 32

36 mos.

Coloplast Capital Market Day 2009

Reimbursement / Health Economic Assessment Model Integrate A Analyze A. A l th Pathway the P th &E Environment i t

in AIM Process

F Monitor & Revise F. B1. Analyze Competing Therapies

Execution D. Strategic g Plan

C. Gap Analysis 29 September 2009 How Healthcare is Paid in the US Page 33

B2. Determine “Fit” of the Proposed Therapy

Coloplast Capital Market Day 2009

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29 September 2009 How Healthcare is Paid in the US Page 34

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