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By Eric Topor
Nov. 2 — The HHS Office of Inspector General has modified two prior advisory opinions to require that charitable organizations add new fraud protection measures to their drug assistance programs in order to keep the favorable opinions.
Both advisory opinions dealt with independent charitable patient assistance programs (PAPs) that provide low-income patients with assistance to obtain high-cost drugs, and the possible anti-kickback law implications of accepting monetary donations from drug manufacturers who made the drugs that the charity subsidized.
The OIG said the unnamed charities that requested the prior advisory opinions have already modified their PAPs to address concerns that the programs may direct patients to certain drugs or drugmakers.
These changes were previously outlined in a Supplemental Special Advisory Bulletin issued on May 21, 2014, and were broadly intended to ensure that financial assistance was available for more than one type of drug or from more than one drug manufacturer, and that assistance wasn't limited to high-cost drugs.
Both modified advisory opinions specified several changes to the requesting charities' PAPs in order to mollify the OIG's anti-kickback concerns.
The first change was to maintain broad disease definitions for specific disease funds (an assistance program focused on helping patients suffering from a particular disease) that weren't limited by symptoms, severity, drug treatment or stage of disease. Both charities maintained disease funds for specific metastatic cancers, and the OIG required the charities to cover all FDA-approved drugs for that type of cancer.
Further, the OIG said the charities couldn't maintain disease funds that provided payment assistance for only one drug, or for drugs from only one manufacturer, unless the Food and Drug Administration has approved only one drug or drugs from only one manufacturer for that disease type. If only one drug or drugs from only one manufacturer are FDA-approved, then the OIG said the PAP must also provide assistance for other patient medical needs, including FDA-approved prescription drugs used to treat disease symptoms like pain and nausea.
The OIG also directed the charities to provide assistance for all prescription drugs approved to treat a disease fund's specified disease, including generic and bioequivalent drugs, and not just higher-cost or specialty medications.
The OIG further specified that while assistance programs are allowed to require a minimum claim amount for providing assistance payments for logistical purposes, a minimum claim requirement can't be applied to deny patient assistance for lower copayment amounts under the minimum but pay for higher copayment amounts above the minimum. The OIG said a system that resulted in “patients paying more for an inexpensive drug than they would for a high-cost drug would be inconsistent with the Charity's certification that it would not limit its assistance to high-cost drugs.”
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The modification to advisory opinion No. 06–10 is at http://oig.hhs.gov/fraud/docs/advisoryopinions/2015/mod-advopn0610.pdf.
The modification to advisory opinion No. 07–18 is at http://oig.hhs.gov/fraud/docs/advisoryopinions/2015/mod-advopn0718.pdf.
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