Lawmakers pushing for stronger HHS oversight of patient assistance charities

As an increasing number of drugmakers and patient assistance charities have settled lawsuits accusing them of violating the Anti-Kickback Statute, lawmakers are urging HHS to tighten oversight and require more information from the charities, according to STAT.  

Sens. Elizabeth Warren, D-Mass., and Sheldon Whitehouse, D-R.I., sent a letter Dec. 4 to Joanne Chiedi, acting inspector general for HHS, detailing their concerns that some drugmakers are using patient assistance charities to pay kickbacks to Medicare beneficiaries to entice them to use their drugs. In this way, drugmakers can boost their own sales while also benefiting from tax breaks. 

The senators say patient charity programs often favor more expensive brand-name drugs over low-cost generics and fail to help patients with the most need, according to STAT. Some charities have reportedly been found to deny patients without insurance.

The Anti-Kickback Statute prohibits drugmakers from directly or indirectly offering patients money or other valuables to entice them to buy drugs.

This year, eight drugmakers — including Pfizer, United Therapeutics and Amgen — paid more than $840 million to settle allegations that they used third-party foundations to enable kickbacks. Three patient charities have also recently settled cases. 

The senators asked HHS to require independent patient assistance charities to publicly disclose which drugs it covers and provide written justification for any FDA-approved drugs it may not cover, according to STAT. They also want to require all charities to cover generic drugs and prohibit them from refusing to cover people based on their insurance status. 

The senators also want HHS to prohibit drugmakers from donating to disease-specific charities and to require charities to release annual public reports detailing applicant characteristics, approval rates, insurance status and type for both applicants and participants, distribution of spending and data shared with others. 

"With little transparency, it is impossible for patients, the public, and HHS OIG to know whether drug assistance decisions correlate with donor interests and whether patient assistance programs are complying with HHS OIG guidance,” the senators wrote.

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