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On September 10, 2026, the U.S. Attorney\u2019s Office for the District of Massachusetts announced<\/a> that Domp\u00e9 U.S., Inc. agreed to pay $32 million to resolve allegations that it used patient assistance foundations to cover Medicare co-pays for patients receiving Oxervate, a biologic used to treat neurotrophic keratitis, a rare degenerative disease of the cornea. The settlement is the latest in a long line of government actions examining manufacturer support for patient assistance programs that subsidize Medicare beneficiaries\u2019 out-of-pocket costs through independent charitable foundations. The publicly available settlement agreement<\/a> contains a considerable amount of detail and provides useful insight into both the conduct at issue and the steps that earned the company cooperation credit.<\/p>\n Companies that have followed enforcement in this area will recognize many of the themes in DOJ\u2019s allegations. More noteworthy is DOJ\u2019s decision to highlight the company\u2019s disclosure, cooperation, and remediation efforts so prominently in announcing the settlement. Before turning to those aspects of the resolution, however, it is worth examining the conduct that prompted the investigation.<\/p>\n The Conduct at Issue<\/strong><\/p>\n According to the settlement agreement, prior to Oxervate\u2019s U.S. launch, employees expressed reservations about bringing the product to market before patient-assistance funding was available. Following discussions with Domp\u00e9 personnel, the National Organization for Rare Diseases (NORD) established a neurotrophic keratitis fund in late 2018, and the PAN Foundation later opened a similar fund in 2019, each receiving contributions from Domp\u00e9.<\/p>\n The agreement also describes a compliance consultant cautioning company personnel against using information concerning foundation activity to inform contribution decisions and warning that Domp\u00e9 should not \u201creverse engineer\u201d patient-assistance foundation data when determining funding levels. DOJ similarly focused on the company\u2019s collection of information from foundations and from a specialty pharmacy that provided patient-support and reimbursement services for Oxervate patients, including information reviewed by personnel involved in contribution decisions.<\/p>\n The government\u2019s concern was not simply that Domp\u00e9 contributed to charitable foundations. Rather, the allegations focused on whether the company\u2019s visibility into foundation funding needs and patient-assistance activity allowed it to make contribution decisions that benefited users of its own product. In DOJ\u2019s view, those types of insights may call into question whether a foundation is operating independently from a manufacturer or instead functioning, at least in part, as a mechanism for subsidizing demand for a particular drug.<\/p>\n The Legal Backdrop<\/strong><\/p>\n Medicare beneficiaries generally are required to bear a portion of the cost of covered drugs through co-payments, coinsurance, or deductibles. The government\u2019s position has long been that manufacturers may not eliminate those costs for their own products, directly or indirectly, because doing so can influence purchasing decisions and increase utilization. In the government\u2019s view, routing financial assistance through a nominally independent charitable foundation does not resolve that concern if the manufacturer effectively steers or influences the assistance being provided.<\/p>\n At its core, the case centers on a recurring DOJ concern: whether a manufacturer\u2019s interactions with a charitable foundation effectively allow it to influence the availability of financial assistance for its own products. The government alleged that Domp\u00e9\u2019s funding practices and access to foundation-related information crossed that line.<\/p>\n Those concerns have animated DOJ\u2019s co-pay foundation enforcement efforts for years. In 2019, the Chronic Disease Fund<\/a>, the Patient Access Network Foundation<\/a>, and the Patient Advocate Foundation<\/a> each resolved allegations that they functioned as conduits for pharmaceutical manufacturers to subsidize Medicare beneficiaries\u2019 use of the manufacturers\u2019 own products. Those settlements helped establish the enforcement framework that continues to shape DOJ\u2019s analysis of manufacturer interactions with patient assistance foundations today.<\/p>\n Self-Disclosure, Cooperation, and Remediation<\/strong><\/p>\n The settlement agreement sheds additional light on why DOJ emphasized the company\u2019s disclosure, cooperation, and remediation efforts in announcing the resolution.<\/p>\n According to the settlement agreement, Domp\u00e9 farmaceutici S.p.A., the company\u2019s Italian parent, voluntarily disclosed the conduct after issues were identified through an internal compliance review. The agreement notes that the company\u2019s then-Chief Executive Officer personally contacted the U.S. Attorney\u2019s Office for the District of Massachusetts to initiate the disclosure and that neither the U.S. Attorney\u2019s Office nor other DOJ components were investigating the conduct at the time. The agreement further describes the matter as among the first disclosures made by a pharmaceutical company under DOJ\u2019s False Claims Act self-disclosure guidelines that took effect in 2019.<\/p>\n By 2022, Domp\u00e9 had revised its foundation-contribution practices, including removing its general manager from foundation decision-making, restricting access to foundation data, requiring objective and documented budgeting criteria, and limiting communications regarding foundation approval status between commercial and patient-access personnel. The settlement agreement also states that Domp\u00e9 received cooperation credit under DOJ\u2019s False Claims Act guidelines for its disclosure, internal investigation, production of overseas evidence, witness cooperation, remediation efforts, and acceptance of responsibility.<\/p>\n In announcing the settlement, the Department stated that it \u201cencourages companies that uncover improper kickbacks to self-disclose such conduct,\u201d using the resolution to reinforce its broader message regarding disclosure and cooperation.<\/p>\n Self-disclosure plainly did not insulate the company from a substantial resolution. Nevertheless, DOJ\u2019s discussion of the company\u2019s disclosure, cooperation, and remediation efforts suggests that the Department continues to view these cases as opportunities to reinforce broader compliance incentives. Notably, the announcement devoted substantial attention to how the issue was discovered and addressed, rather than focusing exclusively on the underlying allegations. And the \u201cvalue\u201d of the disclosure is notable in the multiplier applied to the restitution amount ($29 million), which was just a touch above singles and divergent from the typical doubles required for settled matters.<\/p>\n Takeaways<\/strong><\/p>\n Foundation independence remains the core issue.<\/strong> The allegations centered on whether Domp\u00e9\u2019s visibility into foundation funding levels and patient-assistance activity influenced its contribution decisions in a manner inconsistent with foundation independence. The settlement serves as a reminder that seemingly routine decisions regarding contribution levels, reserve funding, and information sharing may later be cited as evidence that a foundation was not operating as independently as its structure might suggest.<\/p>\n DOJ continues to emphasize cooperation and remediation.<\/strong> The settlement agreement describes a proactive disclosure made before DOJ initiated an investigation, a substantial internal review, cooperation that included overseas evidence and witnesses, and significant remedial measures. While self-disclosure does not eliminate liability, the resolution provides another example of how DOJ evaluates disclosure, cooperation, and remediation under its False Claims Act enforcement policies.<\/p>\n Expect continued scrutiny of manufacturer-supported patient assistance programs.<\/strong> The U.S. Attorney\u2019s Office emphasized that it has recovered more than $1.4 billion through settlements and enforcement actions involving drug-company contributions to purported charities. That figure suggests that DOJ continues to view patient assistance programs involving co-pay foundations as an enforcement priority and that manufacturers should expect ongoing scrutiny of both the structure and operation of those arrangements.<\/p>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":" On September 10, 2026, the U.S. Attorney\u2019s Office for the District of Massachusetts announced that Domp\u00e9 U.S., Inc. agreed to pay $32 million to resolve allegations that it used patient assistance foundations to cover Medicare co-pays for patients receiving Oxervate, a biologic used to treat neurotrophic keratitis, a rare degenerative disease of the cornea. The […]<\/p>\n","protected":false},"author":1,"featured_media":7059070,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[97],"tags":[17021,221334,221333,11566,86076,1648,10956,26945,221335,8134,13819],"dealstore":[],"offerexpiration":[],"class_list":["post-7059069","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal","tag-allegations","tag-copay","tag-dompe","tag-foundation","tag-kickback","tag-million","tag-pays","tag-resolve","tag-selfdisclosure","tag-u-s","tag-voluntary"],"yoast_head":"\n