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Coverage, quality, and cost of cancer care under the Affordable Care Act and Medicare reforms Amy J. Davidoff, PhD Cancer Outcomes, Public Policy and Effectiveness Research Center (COPPER), Yale School of Medicine Department of Health Policy and Management, Yale School of Public Health [email protected] Connecticut Cancer Partnership Annual Meeting December 6, 2016 Disclosures • Research funding from the Pharmaceutical Research and Manufacturers of America Foundation • Consulting and research funding from Celgene Pharmaceuticals (spouse) Individuals may experience multiple barriers to cancer care access • Poor access to screening • Limited specialist access => delay in diagnostic confirmation, staging, care planning • Poor care coordination => patient slips between the cracks • Patient delays or defers therapy due to cost, lack of transportation, social supports • Job loss, leads to insurance loss. Can’t buy private insurance. • Early discontinuation of oral therapy due to out-of-pocket cost • Financial toxicity Outline • Key objectives, provisions of the ACA • Early evidence on ACA coverage • Other provisions of the ACA, Medicare reform • Remaining gaps • Discussion, next steps Individual insurance mandate • U.S. citizens and legal residents must have qualified insurance plan • Tax penalty – greater of $695 per year (up to three times that amount per family) or 2.5% of household income. – Phased in over time • Exemptions: financial hardship, religious objections, undocumented immigrants, prisoners ACA improves insurance access • Dependent coverage mandate (2010) • Eliminates health status as barrier to coverage • Employer mandate* • Marketplaces: New source of private coverage • Public coverage expansions * Implementation delayed until 2016 Buying insurance in the Marketplace • Centralized market for purchase of private insurance plans • Plans – cover essential health benefits – 4 standard plans defined by actuarial value • Bronze (60%) – platinum (90%) • OOP caps • No lifetime, annual coverage limits • Premiums vary by policy type (single, family), region, age, tobacco use • No health status underwriting • No pre-existing condition exclusions Subsidies, extra protections available for lower income • Advanced premium tax credits to subsidize premiums (100-400% FPG) • Cost-sharing reductions (CSR) – Lower caps on OOP spending – Available for families at 100-250% FPG • Eligibility for premium subsidies restricted to individuals w/o “alternative source of affordable coverage” Medicaid expanded for working-aged adults Income eligibility for insurance options Pre and Post ACA -- Connecticut Before ACA Early expansion (2010) After ACA (As of June 2016) Low-income children aged 018 185% 185% 196% Other children aged 0-18 (CHIP) 300% 300% 318% Pregnant women 250% 250% 258% Parents of dependent children 201% 201% 155% Childless Adults N/A 56% 138% Aged, aged, blind Detailed income or disabled and assets people criteria Income eligibility for ACA insurance options Medicaid expansion states M’caid preACA Mcaid expn Marketplace access w/o subsidies Marketplace premium tax credits Affordable alternative coverage States not expanding Medicaid M’caid pre & post ACA 0% Elig gap Marketplace access w/o subsidies Marketplace premium tax credits Affordable alternative coverage 100% 138% 400% Adjusted Income as % Federal Poverty Guideline Eligibility for Subsidized Coverage Under the ACA Working Aged Adult Cancer Survivors 100 90 Pre-ACA Post ACA Implementation 80 62 Percentage 70 61 60 50 40 30 20 15 19 2 10 10 7 0 Medicaid, ESI offer, CHIP Medicare, eligible Tricare Medicaid Alternative Not eligible coverage eligible Premium Income > tax credit 400% FPG eligible Source: Medical Expenditure Panel Survey, 2008-2010. Davidoff et al. JNCI 2015 Eligibility for subsidized coverage varies by state Medicaid expansion status Working Aged Adult Cancer Survivors 100 Pre-ACA 90 Post ACA Implementation 80 70 60 65 65 59 60 50 40 26 30 20 18 10 10 9 0 5 8 14 7 7 0 Medicaid, ESI offer, CHIP Medicare, eligible Tricare Medicaid Alternative Not eligible Premium Income > eligible coverage tax credit 400% FPG eligible Expansion State State Not Expanding Source: Medical Expenditure Panel Survey, 2008-2010. Davidoff et al. JNCI 2015 Evidence of substantial coverage gains for working-aged adults • Between 2010 and March 2016 – 21.3 M fewer uninsured – Uninsured rate declined from 22.3% to 11.9% • CT uninsured at 5.7% – Private coverage increased from 64.1% to 70.2% – Public coverage increased from 15% to 18.9% • Overall Marketplace enrollment, 2016 – 12.7 M enrolled – 80% receiving advanced premium tax credits, with or w/o additional OOP protections Cohen et al., http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201609.pdf ASPE issue brief, “HEALTH INSURANCE MARKETPLACES 2016 OPEN ENROLLMENT PERIOD: FINAL ENROLLMENT REPORT .” March 11, 2016. https://aspe.hhs.gov/sites/default/files/pdf/187866/Finalenrollment2016.pdf Trends in insurance coverage for working aged cancer survivors 80% 68% 70% 70% 68% 69% 60% 50% 40% 30% 20% 12% 13% 16% 16% 15% 9% 21% 6% 10% 0% Uninsured Private 2012 2013 2104 Source: NHIS 2012-2015. Davidoff et al., unpublished. Public 2015 Reductions in the Uninsured by Eligibility Category Working Aged Adult Cancer Survivors 60% 50% 50% 42% 40% 30% 20% 10% 16% 6% 22% 27% 26% 30% 23% 8% 6% 4% 4% 3% 0% Medicaid Newly Poor, Premium eligible pre- Medicaid Medicaid subsidies & ACA eligible post- eligibilty gap CSR ACA Pre-ACA Premium subsidies only Post-ACA Source: NHIS 2012-2015. Davidoff et al., unpublished. Alternative Income affordable >400% FPG coverage Half of previously uninsured remain without coverage – Many eligible, unenrolled – Family affordability glitch – Affordability an issue for Marketplace plans • Premiums increasing – Low cost plans have • High deductibles • Narrow networks High, increasing prevalence of high deductible plans Chart Title 60 56.4 54.7 52.4 54.1 50.9 48 50 40 36.2 36.6 32 30 26.9 29.2 23.3 20 10 0 2010 2011 2012 Employer 2013 2014 Direct Purchase Source: NHIS, 2010-2015. Cohen et al., http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201609.pdf 2015 Protection from financial “toxicity” in Marketplace plans? • Lifetime & annual $ coverage limits eliminated • Annual cost sharing capped, but can still be substantial. – Bronze plan: $5,950 for individuals and $11,900 for families – Even means-tested reductions in OOP spending caps are high • 100-200% FPL: $1,983/individual and $3,967/family Pause • Clarifying questions? The ACA also attempts to fix many coverage & delivery system problems Improved primary & preventive care access • Longer term – primary care workforce development • Enhanced primary care reimbursements under Medicaid x 2 years • Eliminated cost sharing for USPSTF recommended preventive care, including cancer screenings (2010) • Early evidence mixed States Required to Specify, Apply Essential Health Benefits • • • • • • • • • • • • • Primary Care Visit Specialist Visit • Inpatient Services • Hospice Services • Infertility Treatment • Routine Eye Exam • Home Health Care Services • Emergency Room Services Emergency Transportation/ Ambulance • • Skilled Nursing Facility • Mental/Behavioral Health Inpatient/Outpatient Services • Substance Abuse Disorder • Inpatient/Outpatient Services • Generic/Preferred Brand/Non• Preferred Brand/Specialty Drugs Durable Medical Equipment Diagnostic Test/Imaging Preventive Care/ Screening/ Immunization Nutritional counseling Prosthetic devices Off-label prescription drugs Chemotherapy Radiation Reconstructive surgery Clinical trials Rehabilitative services Bone marrow testing Post-Mastectomy care ACA mandates coverage of routine care for clinical trials • Goal = reduced financial barriers to clinical trial participation • How likely is the impact? – 18 states already had similar mandates • Ongoing issues – Out-of-network coverage – Delays in approval by insurers Kircher SM, Benson AB 3rd, Farber M, Nimeiri HS. Effect of the accountable care act of 2010 on clinical trial insurance coverage. J Clin Oncol. 2012 Feb 10;30(5):548-53. Jain et a. JOP 2016 Downstream availability of biosimilars likely to impact cost of cancer therapy • ACA authorized FDA to approve generic biologic agents • European Union experience suggests development of both: – “me too” biologics, slightly less expensive – truly interchangeable biosimilars much less expensive • Ultimately U.S. implementation regulatory process for biosimilars =>reduced cost sharing to individuals with cancer Megerlin F, Lopert R, Taymor K, Trouvin JH. Health Aff 2013 Oct;32(10):1803-10. FDA approved biosimilars to date Date of FDA Approval Biosimilar Product Original Product March 6, 2015 Filgrastimsndz/Zarxio filgrastim/Neupogen April 5, 2016 infliximabdyyb/Inflectra infliximab/Remicade August 30, 2016 etanerceptszzs/Erelzi etanercept/Enbrel September 23, 2016 adalimumabatto/Amjevita adalimumab/Humira • As of January 21, 2016, 59 proposed biosimilar products to 18 different reference products were enrolled in the Biosimilar Product Development Program • Likely next: rituximab, trastuzumab, bevacizumab, erythropoietin Barlas, S., Early Biosimilars Face Hurdles to Acceptance: The FDA Has Approved Few, So Lack of Competition Is Keeping Prices High. P T, 2016. 41(6): p. 362-5 Changes within Medicare • Closing the Part D coverage gap • Reducing excessive Medicare Advantage capitation payments • Improving patient safety through the Partnership for Patients • Cracking down on fraud and abuse in the Medicare system • Reforming provider payments incentivize quality, efficiency Prescription drug coverage essential benefit for adults with cancer • • • • Oral hormone therapy Oral chemotherapy, targeted therapy Supportive care medications OOP burden from – # medications – Cost of medications – Cost-sharing required • ACA closes Part D coverage gap The ACA initiated selected value-focused reimbursement changes • Established CMS Innovation Center (CMMI) • Charged with testing “innovative payment and service delivery models to reduce program expenditures …while preserving or enhancing the quality of care” for those individuals who receive Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) benefits. CMS/CMMI initiatives • $ Penalties for hospital acquired conditions • $ penalties for “avoidable” readmissions • Shared savings models – Accountable Care Organizations (ACOs) • Bundled payment mechanisms Medicare Care Choices Model Demonstration • Allows Medicare beneficiaries to receive hospice-like support services from certain hospice providers • Concurrent with care provided by their curative care providers • Initiated January 2016. 140 participating hospices. – Regional Hospice and Home Care of Western Connecticut Oncology Care Model Demonstration • Defines episodes of care initiated by chemotherapy • Practices agree to financial and performance accountability – OCM participant implements QI plan – Monthly payments to support enhanced quality, coordination – Potential for shared savings – Quality metrics, CAHPS • 195 OCM participants. Initiated July 2016. OCM in CT • Starling Physicians, Wethersfield, CT • Yale Medical Group/Smilow, New Haven,CT including Smilow Care Centers • Eastern Connecticut Hematology and Oncology, Norwich, CT • Hematology Oncology PC, Stamford, CT Medicare Part B Drugs Payment Model (On hold) • Tests $ incentives under Part B “buy & bill” • Phase I= mandatory experiment w/2 arms: – Current Average Sales Price + 6% – ASP + 2.5% + $16.80/drug administered/day • Phase II – value based drug pricing – Patient cost sharing to incentivize preferred drugs – Negotiated prices for drugs • Indication-specific pricing • Outcome-based pricing Policy issues not addressed by ACA • Cost sharing under Medicare Parts A & B – Lack of coordinated incentives – No OOP cap • Poor coordination between Part B & Part D drug coverage creates perverse incentives • Oral-parenteral cancer drug parity Questions/Discussion • What patient groups do you encounter who remain without insurance? • What strategies can be used in CT to further expand coverage? Facilitate enrollment? • How well do CT-Access plans meet the needs of adults with cancer? • How well does Husky D meet the needs of enrolled adults with cancer? • What resources are or should be available to fill gaps in coverage, OOP spending? Federal Poverty Guidelines Family Size 1 Income at 100% FPG $11,670 Income at 400% FPG $ 46,680 3 19,790 $ 79,160 5 27,910 $111,640 Source: ASPE 2014 Poverty Guidelines http://aspe.hhs.gov/poverty/14poverty.cfm Uninsured less likely to receive recommended cancer screenings Receipt of colon cancer screening (FOBT past year or colonoscopy past 10 years) Adults aged 50-64. NHIS 2003-2005. Ward et al. CA-Cancer J Clin 2008. Uninsured more likely to be diagnosed with late stage cancer Adjusted Odds of Being Uninsured on Stage III/IV vs Stage I 0 0.5 1 Adjusted Odds 1.5 2 2.5 Breast CRC Kidney Cancer Site Lung Melanoma NHL Prostate Bladder Uterus Thyroid Ovary Pancreas Source: NCDB 1998-2004. Halpern MT et al. Lancet Oncology 2008. 3 3.5 Uninsured less likely to receive definitive cancer therapy, have worse survival Among adults aged 20-40, being insured was associated with: • Higher odds of receiving definitive treatment Adj OR: 1.95 (95% CI 1.52-2.5) • Reduced mortality risk Adj HR: 0.84 (95% CI 0.75-0.94) Source: SEER, 2007-2009. Aizer AA et al. JCO 2014