Anti-Kickback Statute

The Federal Anti-Kickback Statute (AKS) is a law governing patient assistance programs, which makes it a criminal offense to “knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals for, or purchases of, federally reimbursable items or services.” Essentially this means that manufacturers’ patient assistance programs that directly or indirectly subsidize cost-sharing obligations for their own drugs risk violating the AKS. The concern, cited by the Office of Inspector General (OIG) and Department of Justice (DOJ), is that these programs, which can provide financial assistance for drugs and other patient-related support services like reimbursement for travel, may steer patients to more expensive drugs (i.e. the manufacturers' drugs) in lieu of more affordable, equally effective products, which, in turn, drives up costs for government payers.

In recent years there has been a growing number of investigations and settlements for pharmaceutical companies donating to independent charities that provide financial assistance for patients taking their drugs. For example, the OIG determined Pfizer’s co-pay assistance programs for tafamidis (a heart disease treatment that costs $225,000 per year)  was ‘highly suspect’ under the AKS, and would induce the purchase of Pfizer’s drug. A number of other pharmaceutical companies have reached settlements with the DOJ to resolve allegations that their donations to patient assistance organizations violated the AKS.

Novartis’ CAR-T Patient Support Program Not a Kickback

Given the high price of CAR-T and the steep costs faced by patients, not only for treatment but for travel to CAR-T adminstration sites, it’s no surprise that many manufacturers are implementing patient support programs to increase patient access. Novartis’ CAR-T, Kymriah, was one of the first CAR-T’s on the market. Kymriah’s patient support program includes financial assistance (free CAR-T treatment) and travel assistance, which includes payment for travel, lodging & meals, for eligible patients. Many patients must travel out of state for CAR-T treatment, therefore travel assistance can significantly mitigate the financial burden.

The OIG was advised to evaluate whether Novartis’ program violated the AKS, based on the following criteria:

• Free travel, meals and other assistance constitute renumeration to beneficiaries may induce them to purchase Novartis’ drug

• Travel and other assistance offered allows patients to travel to centers they may not otherwise have selected for treatment

• Treatment centers could earn income on administering Kymriah to patients without incurring any acquisition costs, inducing them to prescribe the drug

The OIG determined Novartis’ patient support program for Kymriah was not a kickback, given that program was created to help financially needy patients; rural patients could be disproportionately impacted by health risks or even death if they can’t afford to travel; Novartis makes the drug free regardless of where the patient receives the drug, thus patients are not being steered to a care setting that might lead to higher costs for the federal government; and most importantly, the drug is a one-time, potentially curative treatment, so the program does not raise the same concerns present in other programs, which are generally for drugs treating chronic conditions that require long-term use, so there is less risk health care providers will overutilize the treatment to earn fees.

Among CAR-T manufacturers, OIG has only reviewed Novartis’ program, however there are other manufacturer support programs for CAR-T's: Bristol Meyers-Squibb (BMS), for example, offers “CellTherapy 360”, a program that provides copay assistance for CAR-T treatment and post-treatment monitoring assistance for financially eligible patients; and Janssen Biotech’s MyCARVYKTI™ Patient Support Program includes assistance for travel and lodging for CAR-T related travel.  

To reduce the risk of AKS violations, CAR-T manufacturers should emphasize how CAR-T is different from other chronic long-term drugs, and the unique factors associated with one-time treatment administration. The OIG opinion potentially paves the way for expansion of existing CAR-T patient support programs, as well as new programs, which may lead to improved patient access and utilization of this novel treatment.