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Original Investigation
August 6, 2019

Financial Eligibility Criteria and Medication Coverage for Independent Charity Patient Assistance Programs

Author Affiliations
  • 1Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
  • 2Carey Business School, Johns Hopkins University, Baltimore, Maryland
JAMA. 2019;322(5):422-429. doi:10.1001/jama.2019.9943
Key Points

Question  What are the characteristics of independent charity patient assistance programs?

Findings  In this cross-sectional study of 6 independent charity organizations that included 274 patient assistance programs in 2018, 97% of the programs excluded uninsured patients, and the most common income eligibility limit was 500% of the federal income poverty level. In the drug-level analysis, the median 2016 Medicare Part D spending per beneficiary was $1157 for medications covered by these programs compared with $367 for the medications not covered.

Meaning  The majority of independent charity patient assistance programs in this study did not cover uninsured patients and were more likely to cover more expensive medications.

Abstract

Importance  Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage.

Objective  To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them.

Design, Setting, and Participants  Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10 000 in Medicare spending per beneficiary in 2016.

Exposures  Support by independent charity patient assistance programs.

Main Outcomes and Measures  The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs.

Results  Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment–related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10 000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs.

Conclusions and Relevance  In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.

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