Shareplus patient assistance program6/4/2023 1 However, federal health programs allow patients to participate in disease-specific independent charity patient assistance programs based on the assumption that these programs do not violate anti-kickback laws. Federal health programs, including Medicare, prohibit the use of manufacturer-sponsored drug-specific patient assistance programs due to the federal Anti-Kickback Statute that forbids manufacturers from offering any remuneration for a federally reimbursable item. Patient assistance programs help patients afford prescription drugs by subsidizing their out-of-pocket costs. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered. 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.Ĭonclusions 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. 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. The most common income eligibility limit was 500% of the federal poverty level. A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). 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%). 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. 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. Main Outcomes and Measures The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. 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.Įxposures Support by independent charity patient assistance programs. These charities offered 274 different disease-specific patient assistance programs. Objective To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them.ĭesign, 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. Little is known about the design of the programs, patient eligibility, or drug coverage. 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. Shared Decision Making and Communication. Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.
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