1. HEALTH CARE RIGHTS ENFORCEMENT INITIATIVE ABA M IDYEAR M EETING HIV L AW & P RACTICE C ONFERENCE F EBRUARY 4, 2016 Center for Health Law and Policy Innovation1 Kevin Costello Litigation Director kcostello@law.harvard.edu (617) 390-2578

2. 56,000 uninsured individuals in ADAP pre-ACA 13,000 enrolled in plans offered through the Marketplaces, mostly with subsidies 12,000 enrolled in Medicaid expansion 19,000 did not gain coverage because their states rejected Medicaid expansion 12 million Americans successfully transitioned from being uninsured to insured in 2014, including 56,000 people living with HIV Complete 2015 enrollment numbers not yet available Medicaid expansion appears to be working well in terms of coverage and cost of HIV care & treatment Marketplace plans, however, are becoming increasingly hostile to individuals living with HIV Insurers are finding ways to move costs from the general population to the chronically ill Trends in affordability and cost-sharing across all states are increasingly alarming Insurers are able to do so due to regulations that do not offer adequate protections I MPORTANCE OF Q UALIFIED H EALTH P LANS

3.  The ACA requires plans to meet certain actuarial values –Actuarial Value: The average total spending for all enrollees that is covered by premiums –Example: A plan with an actuarial value of 80% will pay, on average, 80% of all health costs of enrollees, while enrollees will pay, on average, 20% of the total costs via deductibles and cost-sharing (including medication cost sharing) –Silver Plans must have an actuarial value of 70%  The Flaw: Actuarial value is just the average cost for enrollees –Plans can be constructed in which most enrollees pay less than their share while other individuals pay much more  To meet required actuarial values, insurers can either: –Adjust premiums to cover medical and pharmacy costs, assigning costs more evenly among all plan beneficiaries; or –Disproportionately push the cost of treatment for certain conditions onto beneficiaries, causing them to bear a much higher percentage of costs Accomplished through adverse tiering practices, such as placing all HIV medications on the highest cost-sharing tiers A CTUARIAL V ALUES

4.  January 2015 article in the New England Journal of Medicine noted: –Many insurers may be using adverse tiering and benefit design to dissuade sicker people from choosing their plans and to push actuarial cost to these patients who do enroll –52% of Marketplace plans required at least 30% co-insurance for all covered drugs in at least one class for high-cost chronic conditions such as HIV, mental illness, cancer, diabetes and rheumatoid arthritis An individual living with HIV enrolled in a plan with adverse tiering will spend $3,000 more per year than an individual enrolled in a different plan Plans with Adverse Tiering Annual cost per HIV drug: $4,892 % of plans that had drug-specific deductibles: 50% Plans without Adverse Tiering Annual cost per HIV drug: $1,615 % of plans that had drug specific deductibles: 19% I MPACT OF A DVERSE T IERING

5. Alabama Georgia Illinois Minnesota Mississippi North Carolina South Carolina California Ohio Oregon Pennsylvania Tennessee Texas Wisconsin Massachusetts Michigan QHP S ILVER P LAN A NALYSIS HTTP :// WWW. CHLPI. ORG / PLAN - ASSESSMENT / Center for Health Law and Policy Innovation 5

6. CMS G UIDANCE  Notices of Benefit and Payment Parameters – Examples of prohibited plan benefit designs Exclusion of common STR or extended release regimens Placing all or most of the drugs that treat a specific condition on the highest cost tier without regard to cost impact Making changes to tiering structure midyear.  Outlier reviews  Largely leaves enforcement to the States. Center for Health Law and Policy Innovation 6

7. A DVOCACY T OOLS : R EGULATORY A DVOCACY  State insurance regulators have frontline oversight of the insurance market –Now oversee both the ACA Marketplaces & the traditional health insurance –Some states are actively engaged in their ACA responsibilities  State Department of Insurances (DOIs) must face consumer pressure –Few insurance regulators receive complaints from the HIV community documenting discriminatory practices –The lack of complaints allows them to ignore  HHS – OCR  Appropriate topics for complaints: –Transparency issues –Changing coverage after the open enrollment period ends –Refusing to cover the care and treatment people living with HIV need –Requiring unreasonably high cost-sharing for HIV treatment

8. A DVOCACY T OOLS : L ITIGATION  Litigation can be necessary, despite being costly and time consuming –State and federal regulators have said that litigation can provide helpful political cover –For example, the federal government issued an interim final rule requiring issuers of Marketplace plans to accept premium and cost-sharing payments made by the Ryan White program only after CHLPI filed a lawsuit against Louisiana insurers refusing to accept third party paymentsinterim final rule  Litigation can and should happen at the same time as consumer feedback, plan analysis, outreach to insurers, and regulatory advocacy –Proposed regulations implementing Section 1557 of the ACA provide consumers with a private right of action “[A]n individual shall not... be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance”

9. M EDICAID C OVERAGE OF HCV  Rationing of treatment in response to drug costs  CMS Guidance – November 5, 2015  42 U.S.C. Sec. 1983 based action to enforce Medicaid Act –Provision of “Medical Assistance” – Imports concept of medical necessity. –Reasonable Promptness provision –Comparability provision Amount, duration and scope must be comparable based on categorical eligibility Is HCV a “condition” or a “disease”? Center for Health Law and Policy Innovation 9

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