Full Answer
What is the assistance fund?
The Assistance Fund is an independent 501(c)(3) organization that helps patients and families facing high medical out-of-pocket costs by providing financial assistance for their copayments, coinsurance, deductibles, and other health-related expenses.
What is the PSI settlement with HHS-OIG?
“This settlement demonstrates the FBI’s resolve to ensure that patients receive care that is based solely on sound medical judgment, and not compromised by kickbacks.” PSI has agreed to a three-year Integrity Agreement (IA) with HHS-OIG as part of the settlement.
How was the amount of the settlement announced today determined?
The amount of the settlement announced today was determined based on analysis of PSI’s ability to pay after review of its financial condition.
Do you provide financial assistance for patients with no insurance?
If you are eligible for support, we provide financial assistance to cover costs not paid by insurance. Our Patient Advocates work with you to make the process easy so you can focus on your health.
What is the integrity agreement for PSI?
How much did PSI pay?
What is PSI allegedly?
When did Alexion contact PSI?
What is the number to report healthcare fraud?
Is there a determination of liability in a settlement?
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What is the DOJ settlement with PSI?
On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three pharmaceutical companies to pay kickbacks to patients by funneling money to patients taking drugs manufactured by those same pharmaceutical companies. In addition to the $3 million, PSI has entered into a three-year integrity agreement with Health and Human Services’s Office of the Inspector General. The settlement involved no determination of liability.
What is the fund that Alexion and PSI created?
The DOJ alleged that PSI and Alexion created a “Complement Mediated Diseases” fund that provided co-payment and other financial assistance to patients prescribed Alexion’s drug, Soliris. According to the allegations, Alexion contributed financially to the fund, and except in rare instances, patients received assistance from the fund only if they were taking Soliris. The DOJ also alleged that PSI reported to Alexion detailed information regarding payments made to patients from the fund.
What is the Breakthrough Cancer Pain Fund?
According to the DOJ, PSI and Insys allegedly developed the “Breakthrough Cancer Pain” fund for their opioid painkiller Subsys, which was approved for pain management in cancer patients. The DOJ alleged that Insys was the only donor to this fund and that PSI allowed Insys to see whether referred patients received financial assistance and the amount of such assistance. The government also alleged that PSI knew that Insys was referring patients who did not have cancer to the Breakthrough Cancer Pain fund, but PSI stated that it would prevent off-label use of Subsys only if Insys requested.
How was the settlement of the TAF settlement determined?
The amount of the settlement announced today was determined based on analysis of TAF’s ability to pay after review of its financial condition.
When did Biogen pay TAF?
TAF’s coordination with Biogen. Biogen made payments to TAF’s MS fund on May 24 and July 17, 2012, as part of a coordinated effort by TAF and Biogen to use Biogen’s money to cover Medicare co-pays for Tysabri patients. TAF knew that, when the fund opened after each of these two Biogen payments, ACS immediately would send a “batch file” of Medicare co-pay assistance applications for Tysabri patients. As a result, when TAF’s MS fund opened after Biogen’s payments on May 24 and July 17, 2012, Tysabri patients received a disproportionate share of the grants that the fund provided. During the course of this scheme, a TAF co-founder e-mailed a Biogen vice president and referred to the scheme as the “TYS [abri] project.” The e-mail confirmed that the scheme had succeeded in funneling money from Biogen to Tysabri patients through TAF’s MS fund.
Why did TAF conspire with MS drug manufacturers?
The government alleged, however, that TAF conspired with three MS drug manufacturers so that the fund functioned as a conduit for money from those manufacturers to patients taking their MS drugs. The conspiracy enabled the pharmaceutical companies to ensure that Medicare patients did not consider the high costs that the companies charged ...
How much did the TAF pay?
BOSTON – The U.S. Attorney’s Office announced today that The Assistance Fund (“TAF”), a foundation based in Orlando, Fla., has agreed to pay $4 million to resolve allegations that it violated the False Claims Act by enabling certain pharmaceutical companies to pay kickbacks to Medicare patients taking the companies’ drugs.
Does Teva sell Copaxone?
TAF’s solicitation and receipt of payments from Teva that correlated with TAF’s spending on Copaxone renewal patients. Teva sells Copaxone, and TAF’s MS fund provided grants to cover Medicare co-pays for patients taking Copaxone. TAF’s MS fund also provided grants to cover Medicare co-pays for patients taking other MS drugs, such as Avonex and Tysabri, which Biogen sells, and Gilenya, which Novartis sells. In the month of December prior to each of the years 2011-2015, TAF conveyed to Teva how much money TAF’s MS fund needed to renew co-pay grants for the fund’s existing Copaxone patients in the upcoming year. In order to determine these amounts, which ranged from over $18 million to over $30 million per year, TAF multiplied the number of Copaxone patients in the fund by the fund’s average grant amount, and then added the cost of TAF’s administrative fee. TAF understood that Teva knew how TAF was calculating the amounts of these funding requests, and that, accordingly, Teva was using TAF’s MS fund as a conduit to cover Medicare co-pays for Copaxone patients.
Does TAF have a wait list?
TAF’s practice of not maintaining wait lists and its coordination of the openings of the MS fund with Teva, Biogen, and Novartis. During the period from 2011-2014, TAF’s MS fund frequently ran out of funding and was closed to new patients. If any patients applied for co-pay assistance at that time, TAF did not maintain a wait list of such patients. As a consequence, whenever TAF’s MS fund received a payment and opened to new patients, the fund provided grants to the patients who applied immediately after the opening and did not provide grants to patients who had sought to apply earlier, but at a time when the fund was closed. As described further below, TAF’s practice of not maintaining wait lists enabled TAF to coordinate with Teva, Biogen, and Novartis to ensure that TAF used the companies’ funding to cover the co-pays of patients taking their respective drugs.
Does Teva pay for MS?
TAF’s coordination with Teva. During the period from 2011 to 2014, Teva not only made large payments to TAF’s MS fund to cover the renewal of grants for Copaxone patients at the beginning of each year, Teva also made numerous smaller payments, typically less than $3 million each, to TAF’s MS fund at subsequent times during each year. In conjunction with each of these smaller payments, TAF coordinated with Teva and Teva’s vendor, Advanced Care Scripts (“ACS”), to ensure that Copaxone patients received a disproportionate share of the grants from the fund during each window when the fund opened after a Teva payment. Each time that Teva was prepared to make a payment, TAF understood that ACS had told Teva how many Copaxone patients were awaiting assistance. Meanwhile, TAF had told Teva the average MS fund grant amount at the time of the payment. TAF knew that Teva was multiplying the average grant amount by the number of waiting Copaxone patients to determine the amounts Teva would pay to TAF’s MS fund. TAF further knew that, whenever Teva made a payment to TAF’s MS fund and the fund opened, ACS immediately would send a “batch file” of Medicare co-pay assistance applications for Copaxone patients. As a result, each time TAF’s MS fund opened after one of Teva’s post-January payments during this period, Copaxone patients received a substantial majority of the grants that the fund provided, even though Copaxone accounted for much less than a majority of the overall MS drug market. Further, TAF maintained a “portal” that gave ACS real-time access to the enrollment status of the patients ACS referred; the portal, as TAF knew, enabled ACS to update Teva on the number of Copaxone patients who had received grants from TAF’s MS fund.
How many children have been helped by the Assistance Fund?
Since its founding in 2009, The Assistance Fund has helped nearly 135,000 children and adults access the treatment they need to stay healthy or manage a life-threatening, chronic, or rare disease. Learn more about how we serve our patients.
What is TAF provider portal?
TAF’s Provider Portal is a one-stop-shop for providers to see up-to-date patient information and so much more.
What are the charities involved in the DOJ settlements?
The 3 charities involved in the DOJ settlements, Good Days, the Patient Access Network Foundation (“PANF) and The Assistance Fund (“TAF”) help patients obtain medications by operating patient assistance programs (“PAPs”). PAPs typically provide financial support to uninsured or underinsured individuals, often through health insurance premium payments or copayment assistance. When operated in strict compliance with existing federal guidance, PAPs operate independent of the entities that contribute financially to their funds and have structural guardrails to protect against violations of the federal Anti-Kickback Statute and Civil Monetary Penalties Law. [1] However, the DOJ alleged that Good Days, PANF and TAF conspired with pharmaceutical companies to violate federal law by:
What is the DOJ settlement?
The DOJ settlements come amidst calls from both the federal executive and legislative branches to increase scrutiny of pharmaceutical manufacturers’ pricing and other practices. For example, in a December 4, 2019 letter to the OIG (“December 4 Letter”), Senators Elizabeth Warren (D-MA) and Sheldon Whitehouse (D-RI) urged the OIG to update a 2014 Special Advisory Bulletin to PAPs to:
How much did Good Days pay for the PAPs?
As part of the settlement, Good Days agreed to pay $2 million , PANF agreed to pay $4 million and TAF agreed to pay $4 million. Each of the PAPs also agreed to enter into integrity agreements with the Department of Health & Human Services (“DHHS”) Office of the Inspector General (“OIG”) for the next 3 years to ensure that their relationships with pharmaceutical companies comply with federal law. For their alleged involvement in the scheme to increase drug purchases by providing donations to charities, the DOJ filed charges against, or settled with, several pharmaceutical companies earlier this year. Among them, Amgen settled for $24.75 million, Astellas settled for $100 million, and Pfizer settled for $23.85 million.
How much did Amgen settle for?
Among them, Amgen settled for $24.75 million, Astellas settled for $100 million, and Pfizer settled for $23.85 million.
How much did the DOJ pay to charities?
Recently, the U.S. Department of Justice (“DOJ”) announced that 3 charities will pay a total of $10 million to settle claims that the charities operated as conduits for illegal kickbacks to pharmaceutical companies. The industry-wide probe also implicated several pharmaceutical companies that, according to the DOJ, ...
Do PAPs have to disclose their treatments?
Require independent charity PAPs to publicly disclose which treatments they cover, and to provide written justifications for any deviations from the U.S. Food and Drug Administration’s full list of approved treatments for any specific disease or condition;
Can a PAP be used for medical care?
PAPs can fill a gap in the health care industry and open the door to necessary care for financially needy individuals if they are properly structured. Current available guidance suggests that PAPs should involve funds that are independent of their donors without earmarks for certain treatments, provide for patient choice and use uniform financial eligibility determination criteria when evaluating assistance applications. Health care providers interested in making donations to a charity operating a PAP or establishing a charitable foundation to operate a PAP should consult their compliance and legal counsel to ensure adherence to applicable laws and regulatory guidance.
Alleged Arrangement with Insys
According to the DOJ, PSI and Insys allegedly developed the “Breakthrough Cancer Pain” fund for their opioid painkiller Subsys, which was approved for pain management in cancer patients.
Alleged Arrangement with Aegerion
PSI and Aegerion allegedly established a fund where Aegerion contributed donations and assisted in creating the patient eligibility criteria used to determine whether PSI would provide copayment assistance to patients taking Juxtapid, an Aegerion drug.
Alleged Arrangement with Alexion
The DOJ alleged that PSI and Alexion created a “Complement Mediated Diseases” fund providing copayment and other financial assistance to patients prescribed Alexion’s drug, Soliris.
U.S. v. Regeneron Pharmaceuticals, Inc
Regeneron manufactures Eylea, a prescription drug that treats degenerative eye disease. Eylea costs about $1,850 per dose and is covered under Medicare Part B as a physician-administered drug.
Recent Related Government Action
On December 17, 2020, the DOJ announced a $22 million settlement with pharmaceutical company Biogen, Inc. to resolve claims that Biogen violated the FCA by channeling money through two nonprofit foundations, one being the CDF, to cover patient copays for patients using Biogen drugs for the treatment of multiple sclerosis.
Practical Takeaways
As case law and HHS-OIG guidance have established, companies’ practices of waiving patient copays or making donations to offset the cost of copays may violate the AKS if they are made with the intent to induce Medicare-funded referrals or drug purchases.
What is the integrity agreement for PSI?
PSI has agreed to a three-year Integrity Agreement (IA) with HHS-OIG as part of the settlement. The IA requires, among other things, that PSI implement measures designed to ensure that it operates independently and that its arrangements and interactions with pharmaceutical manufacturer donors are compliant with the law. In addition, the IA requires compliance-related certifications from PSI’s Board of Directors and detailed reviews by an independent review organization.
How much did PSI pay?
Patient Services Inc. (PSI), a foundation based in Midlothian, Virginia, has agreed to pay $3 million to resolve allegations that it violated the False Claims Act by acting as a conduit to enable certain pharmaceutical companies to provide kickbacks to Medicare patients taking the companies’ drugs by paying the patients’ copayments, the Department of Justice announced today. The amount of the settlement announced today was determined based on analysis of PSI’s ability to pay after review of its financial condition.
What is PSI allegedly?
PSI allegedly operated as a vehicle for specific pharmaceutical companies essentially to pay kickbacks at the ultimate expense of the American taxpayers who support the Medicare program ,” said U.S. Attorney Andrew E. Lelling of the District of Massachusetts.
When did Alexion contact PSI?
The government further alleged that Alexion approached PSI in January 2010 to request that PSI create a fund to provide financial assistance to Soliris patients, including by paying patients’ Medicare copays and other medical expenses for Soliris patients.
What is the number to report healthcare fraud?
Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
Is there a determination of liability in a settlement?
The claims resolved by the settlement are allegations only; there has been no determination of liability.
