Clinical Trial Coverage Under the Affordable Care Act

Transcription

1 Clinical Trial Coverage Under the Affordable Care Act July 13, 2013 Yu-Ning Wong MD MSCE Fox Chase Cancer Center-Temple Health System ASCO Cancer Research Committee Member

2 Learning Objectives: Understand how state laws affect insurance coverage for clinical trials Understand the statutory provisions of Section 2709 of the Affordable Care Act Understand clinical trial coverage requirements under grandfathered plans Update on advocacy effort by ASCO and other advocacy groups

3 Heterogenous state laws and insurance agreements

4 Even among states with laws, protections vary widely 13 states do not require coverage for Phase I studies, or only on a case by case basis Self insured plans are governed by federal Employee Retirement Income Security Act ERISA precludes state laws from applying to the benefit plans of self-insured companies Kircher, JCO 2012

5 Medicare patients already have coverage for clinical trials Effective September 19, 2000 Medicare covers the routine costs of qualifying clinical trials as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials

6 Medicare defines routine costs as: Items or services that are typically provided absent a clinical trial; Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications.

7 Medicare does not cover: The investigational item or service, itself Items and services provided solely to satisfy data collection and analysis needs Items and services customarily provided by the research sponsors free of charge

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9 Section 2709 Sets a national minimum coverage standard Requires coverage for routine costs Studies must be Federally funded or approved Does not require insurer to cover experimental product or data collection required solely for the trial Not mandatory for grandfathered plans

10 Grandfathered plans If you like your plan you can keep it. Group health plan or health insurance coverage that was in existence as of March 23, 2010 Are exempt from certain ACA provisions, including the clinical trial provision Once a plan either reduces benefits or increases costs to enrollees, it loses grandfathered status and must comply with all ACA provisions, including the clinical trials coverage provision.

11 Definition of Approved Clinical Trial A phase I, II, III or IV trial that is (1) conducted for the prevention, detection, or treatment of cancer or another disease or condition likely to lead to death unless the course of the disease or condition is interrupted, and (2) is one of the following: (A) federally funded, or (B) is either: a) Conducted under an investigational new drug application (IND) b) A drug trial that is exempt from the IND application requirements.

12 Educational Materials

13 Issues raised with CMS Prevention of Delays and Administrative Barriers Prevention, Detection, and Treatment of Complications Geographic Safeguard to Preserve Local Access Clear Coverage Information for Enrollees Referral to Specialists Method for Consumer Reporting

14 Decision April 2013 The statutory language is self-implementing and the Departments do not expect to issue regulations in the near future.. Group health plans and health insurance issuers are expected to implement the requirements of PHS Act section 2709 using a good faith, reasonable interpretation of the law.

15 Continued The Departments will work together with employers, plans, issuers, states, providers, and other stakeholders to help them come into compliance with the law and will work with families and individuals to help them understand the coverage for clinical trials provision and benefit from it as intended.

16 For Complaints or Concerns State offices: get contact information from The Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight at For employment-based group health plan coverage: Department of Labor at or

17 In Summary In 2014, there will finally be a national minimum coverage standard for clinical trials. Some patients in grandfathered plans will not have these protections. We need to make sure that the implementation of the law reflects its spirit