TABLE OF CONTENTS

1 INTRODUCTION
    1.1 KEY TAKE-AWAYS
    1.2 REPORT DESCRIPTION
    1.3 STAKEHOLDERS
    1.4 RESEARCH METHODOLOGY
2 U.S. HEALTHCARE INDUSTRY OVERVIEW
    2.1 OVERVIEW OF HEALTHCARE SYSTEM IN U.S.
    2.2 HEALTHCARE REFORMS IN THE U.S.
        2.2.1 AGENDA OF OBAMA’S HEALTHCARE REFORMS
        2.2.2 CHALLENGES FOR OBAMA’S HEALTHCARE REFORMS
        2.2.3 IMPACT OF OBAMA’S HEALTHCARE REFORMS ON THE HEALTHCARE INDUSTRY
            2.2.3.1 Impact on Health Insurance Industry
            2.2.3.2 Impact of on Pharmaceutical and Medical Devices Industries
            2.2.3.3 Empowerment of Healthcare consumers and its impact on U.S. economy
3 U.S. HEALTHCARE SYSTEM
    3.1 HEALTHCARE STRUCTURE IN THE U.S.
        3.1.1 REIMBURSEMENT AND FINANCING.
            3.1.1.1 Public health insurance
                3.1.1.1.1 Medicare.
                3.1.1.1.2 Medicaid
                3.1.1.1.3 Other public systems.
            3.1.1.2 Private health insurance
                3.1.1.2.1 Employer-sponsored insurance.
                3.1.1.2.2 Private non-group insurance (individual market).
                3.1.1.2.3 Private group insurance (cooperative)
        3.1.2 REGULATORY ENVIRONMENT
            3.1.2.1 Healthcare laws
            3.1.2.2 Regulating bodies
                3.1.2.2.1 The Center for Devices and Radiological Health (CDRH)
                3.1.2.2.2 U.S. Food and Drug Administration (FDA)
    3.2 HEALTHCARE EXPENDITURE.
        3.2.1 TOTAL HEALTHCARE EXPENDITURE.
        3.2.2 PER CAPITA HEALTHCARE EXPENDITURE.
        3.2.3 HEALTHCARE BUDGET AND HEALTH REFORMS
        3.2.4 OBAMA’S STIMULUS PACKAGE FOR HEALTHCARE SECTOR
    3.3 NEED FOR HEALTHCARE REFORMS
        3.3.1 RISING HEALTHCARE COSTS.
        3.3.2 UNAFFORDABLE HEALTH INSURANCE.
        3.3.3 UNEVEN HEALTH COVERAGE.
        3.3.4 LACK OF QUALITY HEALTHCARE
4 OBAMA’S HEALTHCARE REFORMS
    4.1 OBAMA’S PROPOSED STRATEGIES FOR HEALTHCARE REFORMS.
        4.1.1 INCREASING AFFORDABILITY AND ACCESSIBILITY OF HEALTHCARE
        4.1.2 IMPROVING PUBLIC HEALTH
        4.1.3 LOWER HEALTHCARE COSTS
        4.1.4 IMPROVING QUALITY OF HEALTHCARE.
    4.2 OBAMA’S INITIATIVES IN HEALTHCARE
        4.2.1 OBAMA’S HEALTHCARE REFORMS
            4.2.1.1 Patient Protection and Affordable Care Act, 2009
            4.2.1.2 Health Care and Education Reconciliation Act 2010.
            4.2.1.3 Healthcare Reforms – Implementation Timeline
        4.2.2 OTHER HEALTH INITIATIVES
            4.2.2.1 Children’s Health Insurance Program Reauthorization Act, 2009 (CHIPRA)
            4.2.2.2 American Recovery and Reinvestment Act, 2009
5 IMPACT OF OBAMA’S HEALTH REFORM PROVISIONS ON THE U.S. HEALTHCARE INDUSTRY
    5.1 IMPACT ON MEDICAL DEVICES INDUSTRY
        5.1.1 EXCISE TAX
        5.1.2 INCREASED FDA COMPLIANCE
        5.1.3 INCREASED TRANSPARENCY THROUGH CER AND BAN ON SUNSHINE PROVISION.
        5.1.4 INDIRECT IMPACTS
        5.1.5 BUSINESS IMPLICATIONS FOR MEDICAL DEVICE MANUFACTURERS.
    5.2 IMPACT ON PHARMACEUTICAL INDUSTRY
        5.2.1 EXCISE TAX: A POTENTIAL NEGATIVE IMPACT
        5.2.2 LOWER DRUG PRICES THROUGH MEDICARE AND MEDICAID
        5.2.3 REBATES FOR NEW FORMULATIONS OF BRANDED DRUGS
        5.2.4 INCREASE INSPECTION AND COMPLIANCE COSTS
        5.2.5 12-YEAR EXCLUSIVITY FOR BIOLOGICS AND NEW REGULATORY PATHWAY FOR BIOSIMILARS.
        5.2.6 COVERAGE OF CLINICAL TRIAL COSTS
        5.2.7 BUSINESS IMPLICATIONS FOR PHARMA/ BIOTECH INDUSTRY
    5.3 IMPACT ON INSURANCE INDUSTRY
        5.3.1 MEDICAL LOSS RATIO (MLR)
        5.3.2 MANDATORY COVERAGE PROVISIONS
            5.3.2.1 Guaranteed eligibility
            5.3.2.2 Ban on annual and lifetime limits
            5.3.2.3 Mandatory preventive care and immunizations without cost sharing
        5.3.3 ANNUAL FEES AND TAX IMPLICATIONS
        5.3.4 HEALTH INSURANCE EXCHANGE
        5.3.5 IMPROVEMENT IN CHILD COVERAGE.
        5.3.6 COST CONTAINMENT PROVISIONS
        5.3.7 EMPLOYER PLAY-OR-PAY POLICY
        5.3.8 BUSINESS IMPLICATIONS FOR INSURANCE INDUSTRY
    5.4 IMPACT ON OTHER STAKEHOLDERS (BENEFICIARIES AND HOSPITALS)
        5.4.1 IMPACT OF HEALTHCARE REFORMS ON BENEFICIARIES.
        5.4.2 IMPACT OF HEALTHCARE REFORMS ON HOSPITALS
6 ECONOMIC IMPACT OF OBAMA’S HEALTHCARE REFORMS.
    6.1 ECONOMIC IMPACT



LIST OF TABLES

TABLE 1 STRATEGIES PROPOSED BY OBAMA & STATE OF ENACTMENT 
TABLE 2 IMPACT OF HEALTHCARE REFORMS ON HEALTH COVERAGE (POPULATION IN MILLION) 
TABLE 3 MAJOR ENACTMENTS IN PAST TWO DECADES
TABLE 4 DISTRIBUTION OF HEALTHCARE EXPENDITURE 2009 ($BILLION) 
TABLE 5 HEALTHCARE REFORMS SPENDING 2010-2019 (TOTAL - $938 BILLION) 
TABLE 6 HEALTHCARE REFORMS FUNDING ($1,081 BILLION) 
TABLE 7 OBJECTIVES AND PROVISIONS OF HEALTHCARE AND EDUCATION RECONCILIATION ACT (2010) 
TABLE 8 TIMELINE FOR IMPLEMENTATION OF HEALTHCARE REFORMS 
TABLE 9 OBJECTIVES AND PROVISIONS OF CHIPRA (2009) 
TABLE 10 ANALYSIS OF HEALTHCARE REFORMS (2010 – 2020) 
TABLE 11 CRITERIA FOR ASSEESMENT OF ANNUAL FEE ON THE INDUSTRY 
TABLE 12 OPPORTUNITY ANALYSIS FOR LARGE PLAYERS 
TABLE 13 PROPOSED STRATEGIES FOR THE MEDICAL DEVICES INDUSTRY
TABLE 14 TAX RATES FOR TOP U.S. DRUG COMPANIES (2009) 
TABLE 15 ASSESSMENT OF ANNUAL FEE ON BRANDED DRUG MANUFACTURERS 
TABLE 16 EXPECTED LOSS TO PHARMA COMPANIES DUE TO HEALTH REFORMS 
TABLE 17 EFFECTIVE RISK EXPOSURE FOR TOP DRUG COMPANIES 
TABLE 18 PATENT EXPIRATION OF TOP BIOLOGIC DRUGS 
TABLE 19 MEDICAL LOSS RATIO BY MARKET SEGMENT (2009) 
TABLE 20 ANNUAL FEE ON HEALTH INSURANCE INDUSTRY 
TABLE 21 CALCULATION OF SHARE OF FEE FOR NET PREMIUMS WRITTEN
TABLE 22 CALCULATION OF SHARE OF FEE FOR THIRD PARTY ADMINISTRATION AGREEMENT
TABLE 23 BENEFICIARIES OF HEALTH REFORMS AND RELATED PROVISIONS 



LIST OF FIGURES

FIGURE 1 CLASSIFICATION OF UNINSURED POPULATION BY AGE (2008)
FIGURE 2 CLASSIFICATION OF UNINSURED POPULATION BY INCOME (2008) 
FIGURE 3 IMPACT OF HEALTHCARE REFORMS ON HEALTH INSURANCE INDUSTRY 
FIGURE 4 OPPORTUNITIES AND THREATS FOR U.S. PHARMA AND MEDICAL DEVICE INDUSTRIES 
FIGURE 5 HOLISTIC IMPACT OF HEALTH REFORMS 
FIGURE 6 FINANCING AND REIMBURSEMENTS IN U.S. HEALTH INSURANCE SECTOR 
FIGURE 7 DISTRIBUTION OF HEALTH COVERAGE 
FIGURE 8 U.S. MULTI-PAYER HEALTHCARE SYSTEM 
FIGURE 9 ACTUAL AND PROJECTED HEALTHCARE SPEND (2005 – 2019)
FIGURE 10 U.S. HEALTH EXPENDITURE, PER CAPITA PER YEAR (2000 – 2008) 
FIGURE 11 HEALTHCARE STIMULUS PACKAGE(2009)
FIGURE 12 ANNUAL HEALTH INSURANCE PREMIUM FOR SINGLE AND FAMILY (1999 – 2009)
FIGURE 13 PROPOSED MEASURES TO INCREASE AFFORDABILITY AND ACCESSIBILITY OF HEALTHCARE COVERAGE 
FIGURE 14 STRATEGIES PROPOSED FOR IMPROVING PUBLIC HEALTH 
FIGURE 15 STRATEGIES TO IMPROVE QUALITY OF HEALTHCARE
FIGURE 16 BENEFITS OF COMPARATIVE EFFECTIVENESS REASEACH 
FIGURE 17 PHARMA INDUSTRY SCENARIO (2010 ONWARDS) 
FIGURE 18 EFFECT OF FINANCIAL BURDEN ON THE DRUG MANUFACTURERS 
FIGURE 19 POST REFORM CONSOLIDATION IN THE BIOSIMILARS MARKET 
FIGURE 20 POSSIBLE STRATEGIES FOR DRUG MANUFACTURERS 
FIGURE 21 PROVISIONS OF HEALTHCARE REFORMS AFFECTING U.S. HEALTH INSURANCE INDUSTRY 
FIGURE 22 IMPACT OF INCREASED MLR ON HEALTH INSURANCE INDUSTRY 
FIGURE 23 MANDATORY COVERAGE PROVISIONS AND THEIR IMPACT ON INSURANCE INDUSTRY 
FIGURE 24 OPPORTUNITIES AND THREATS OF HEALTH INSURANCE EXCHANGE 127
FIGURE 25 COST CONTAINMENT PROVISIONS AND THEIR IMPACT ON INSURANCE INDUSTRY
FIGURE 26 CHANGE IN COST OF EMPLOYER-SPONSORED COVERAGE (PER ANNUM) 
FIGURE 27 ECONOMIC IMPACT OF U.S. HEALTH REFORMS