What has Aegerion done to settle a lawsuit?
In addition, Aegerion has agreed to settle allegations that it caused false claims to be submitted to federal health care programs for Juxtapid. Aegerion has agreed to pay more than $35 million to resolve criminal and civil liability arising from these matters.
What did Aegerion settle under HIPAA?
The resolution also includes a deferred prosecution agreement relating to criminal liability under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In addition, Aegerion has agreed to settle allegations that it caused false claims to be submitted to federal health care programs for Juxtapid.
What is the Allergan Patient Assistance Program?
The Allergan Patient Assistance Program provides certain products to patients in the United States who are unable to afford the cost of their medication and who meet other eligibility requirements.
What is the five-year CIA requirement for Aegerion?
The five-year CIA requires, among other things, that Aegerion implement measures designed to ensure that its promotional activities and any arrangements and interactions with third-party patient assistance programs comply with the law.
How much did Aegerion pay?
What is the deferred prosecution agreement for Aegerion?
How much did Aegerion pay for false claims?
Who filed the Aegerion lawsuit?
Is Aegerion Pharmaceuticals a subsidiary of Novelion?
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How much did Aegerion pay?
Plea Agreement. In addition to pleading guilty to the two-count Information, Aegerion agreed to pay a $6.2 million criminal fine and $1 million in restitution. The plea agreement also requires that for three years, Aegerion, its president and its parent company’s board of directors annually review and certify compliance with the plea agreement and consent decree.
How did Aegerion violate HIPAA?
Aegerion acknowledged that at the direction of and with the approval of senior management, Aegerion sales employees violated HIPAA by (1) gaining access to physicians’ electronic medical record systems to identify potential patients for Juxtapid; (2) completing or assisting with completion of statements of medical necessity or prior authorizations for insurance coverage; (3) contacting patients directly to convince them to use Juxtapid or to obtain authorization to allow Aegerion customer service personnel to access their protected health information; (4) forging signatures on patient authorization forms; (5) obtaining patient signatures on HIPAA authorizations in English from non-English speaking patients who did not understand the nature of the HIPAA release; and (6) providing gifts or benefits to medical staff in exchange for access to patient data. The DPA also states that Aegerion sales managers and executives instructed sales employees to wear surgical scrubs in order to blend in with the office staff to facilitate access to HIPAA-protected information and implemented incentive compensation programs that motivated sales personnel to improperly access protected health information.
When did Aegerion Pharmaceuticals settle the DOJ probe?
On September 22, 2017 , Aegerion Pharmaceuticals resolved a wide-ranging DOJ probe regarding the company’s U.S. commercial activities relating to the prescription drug Juxtapid. The settlement is sweeping in its scope and detail, and companies have the opportunity to assess their compliance programs and controls against those found in the Aegerion settlement materials.
What is a DPA?
a deferred prosecution agreement (DPA) to resolve charges of conspiracy to violate the Health Insurance Portability and Accountability Act (HIPAA); and
Did Aegerion conduct REMS training?
Aegerion failed to conduct REMS training for physicians who supervised nurse practitioners who were prescribing Juxtapid; and
What is the OIG opinion on Caring Voice?
The Office of Inspector General’s (OIG) advisory opinion protected Caring Voice Coalition from liability under the Anti-Kickback Statute for its work providing financially needy Medicare patients with premium and cost-sharing assistance. Drug companies are the primary donors to almost all charity patient assistance programs (PAPs), including Caring Voice Coalition, while some drug companies also create their own charity PAPs. The OIG’s 2006 opinion issued to Caring Voice Coalition was fact-specific, as are all advisory opinions, and in this case was predicated on commitments the charity made to implement certain safeguards regarding contributions from donors and grants to beneficiaries.
What is the alleged violation of the OIG?
According to the OIG, the alleged violations “materially increased the risk that [the charity] served as a conduit for financial assistance from a [drug company] donor to a patient,” and thus increased the risk that the charity’s Medicare patients would be steered to that company’s federally reimbursable drugs.
What is the OIG CIA?
The December 2017 OIG CIA was announced as part of a settlement between United Therapeutics and the Department of Justice (DOJ), which alleged that United Therapeutics induced patients to purchase its drugs by donating to charity PAPs over which it exerted some control.
Is Caring Voice Coalition offering financial assistance?
Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018.
When did Aegerion Pharmaceuticals settle?
Aegerion Pharmaceuticals, Inc. Settlement. On September 22, 2017 , Aegerion Pharmaceuticals (“Aegerion”) entered into a $28.8 million settlement of a False Claims Act lawsuit with the U.S. Attorney General for the District of Massachusetts.
What is the purpose of PAPs?
Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) has continually acknowledged that properly structured PAPs can provide important “safety net assistance” to patients with limited financial means who cannot afford necessary drugs. This Client Alert provides a comprehensive review ...
What is the OIG opinion on CVC?
In December 2015, the OIG published a Modified Advisory Opinion 06-04, following the OIG’s request that CVC certify compliance with the additional factors outlined in the 2014 Special Advisory Bulletin. The Modified Advisory Opinion stated that CVC had certified compliance to each additional factor, and further that CVC had proposed additional modifications to its current operations. [13] The OIG concluded in the Modified Advisory Opinion 06-04 that CVC’s PAP was sufficiently low risk and the OIG would not impose CMPs or sanctions on CVC under the AKS.
What are the two aspects of PAP?
The OIG has indicated that PAPs generally have two “remunerative aspects” that require scrutiny under the AKS: i) donor contributions , which the OIG stated can be analyzed as indirect remuneration to patients , and ii) financial assistance remuneration provided directly to patients. The OIG states that the AKS could be violated “if a donation is made to a PAP to induce the PAP to recommend or arrange for the purchase of the donor’s federally reimbursable items,” as well as if a PAP’s grant of financial assistance to a patient is made “to influence the patient to purchase (or induce the patient’s physician to prescribe) certain items.” [5]
What is the focus of PAPs?
Ultimately, data sharing and communication between charity PAPs and donors appears to be the key area of focus for OIG, DOJ, and IRS enforcement. If such communication and data sharing is prohibited, whether by state statute or federal regulatory enforcement, it is remains to be seen whether PAPs will continue to operate as they are currently structured. In any event, it is incumbent upon interested parties to stay abreast of changes in the law and developing enforcement trends, and to continually monitor and update their compliance programs accordingly. For example, given the amount of scrutiny applied to coordination between the business and charitable giving arms of medical product manufacturers, compliance programs should be actively examining all intra-firm transactions to assure that no improper influence is being exerted over communications with and donations to charity PAPs.
When did the OIG change its advisory opinion?
Beginning in December 2015, the OIG modified five Advisory Opinions in order to update the analyses pursuant to certifications received. [9]
Does UT require a PAP review?
Unlike the Aegerion CIA, however, the UT CIA does not require the establishment of an independent PAP review program, and rather than requiring written agreements with PAPs to include certain provisions, the CIA requires UT to issue those guidelines as a policy for future interactions with PAPs. Recent IRS Scrutiny.
What information should a PAP provider share with patients?
The company should also limit the information it shares about independent PAPs with patients and providers. For example, if the company’s reimbursement hub triages requests for co-pay or other financial assistance, the hub should provide only a general overview of the third-party assistance options to the patient or provider, along with contact information for each independent PAP that has an applicable fund and is currently accepting new applications (i.e., a “cold transfer”). Hub representatives should explicitly inform the patient or the patient’s provider that the referral to the independent PAP is not a guarantee of assistance and that the PAP has full discretion whether to provide assistance based on its own independent eligibility criteria. To this end, company personnel should generally be restricted from (a) filling out applications for patients or seeking information about the status of any individual application for assistance from any PAP, or (b) seeking detailed information regarding why and from which PAP any patients received or were denied assistance. In addition, the company should limit, as much as possible, the information coming from patients who were transferred to PAPs for assistance and who were denied or received assistance; if company personnel receive such information, they should not (1) share it beyond reimbursement support personnel, or (2) record it in the patient’s case notes.
What is the DOJ's interest in PAPs?
DOJ interest in drug company relationships with independent PAPs began in earnest in the midst of larger concerns regarding sharply rising drug prices. While investigating pricing schemes and specialty pharmacy relationships in 2015, DOJ began issuing subpoenas to pharmaceutical companies that manufacture expensive and specialty drugs that requested information on the companies’ relationships with independent PAPs. 9 Since then, the DOJ has broadened its inquiry to numerous pharmaceutical companies and independent PAPs.
Does a Hub representative have to inform the patient or the patient's provider that the referral to the independent PAP?
Hub representatives should explicitly inform the patient or the patient’s provider that the referral to the independent PAP is not a guarantee of assistance and that the PAP has full discretion whether to provide assistance based on its own independent eligibility criteria.
Is it permissible for a charitable organization partly funded by kidney dialysis providers to pay Medicare Part B?
4 See OIG Adv. Op. 97-01 (June 11, 1997) (advising that it is permissible for a charitable organization partly funded by kidney dialysis providers to pay Medicare Part B, Medigap and other health insurance premiums for end-stage renal disease patients who are financially needy).
Is PAP independent?
Independence of PAP with Respect to Patient Eligibility: The company may not ex ert (directly or through any affiliate) any influence or control over the independent PAP’s process or criteria for determining eligibility of patients who qualify for assistance. Part Three: A Developing Risk Area — Free Drug Programs.
Is donating to PAPs a high risk activity?
In light of this emerging enforcement trend, donating to independent PAPs should now be considered a high-risk activity for any pharmaceutical company — especially those companies with high-cost drugs. To help navigate these waters, this article offers: (1) brief history on the guidance applicable to independent PAP activities and recent enforcement activities; (2) practical guidance and tips on compliance controls that companies should consider in order to mitigate risk when engaging in these activities; and (3) additional guidance on applying these germane compliance lessons to the operation of free drug programs, which arguably carries a similar level of compliance risk.
What is Aegerion's DPA?
Aegerion entered into a three-year DPA to resolve a charge that it conspired to violate HIPAA’s patient privacy provisions. According to the DPA’s agreed statement of facts, from January 2013 through 2015, Aegerion sales personnel obtained access to patients’ protected health information without the requisite patient authorization in order to market Juxtapid to physicians and patients. Aegerion acknowledged that at the direction of and with the approval of senior management, Aegerion sales employees violated HIPAA by (1) gaining access to physicians’ electronic medical record systems to identify potential patients for Juxtapid;
What is the Aegerion settlement?
TheAegerion global settlement is sweeping in its scope and detail. The settlement addresses alleged misconduct in several emerging risk areas, including compliance with FDA-mandated REMS requirements, access to protected health information under HIPAA, the accuracy and completeness of prior authori-zation and letters of medical necessity provided by companies to insurers, and relationships with and donations to charitable copay foundations.
What are the components of the Aegerion settlement?
Two components of the settlement — the criminal plea agree-ment and the FDA consent decree — resolve Aegerion’s FDCA liability. The factual basis for that liability is set forth in an Infor-mation that charges two separate misdemeanor FDCA violations.
How much did Aegerion pay?
Aegerion has agreed to pay more than $35 million to resolve criminal and civil liability arising from these matters. Aegerion has also agreed to enter into a civil consent decree of permanent injunction aimed at preventing future violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
What is the deferred prosecution agreement for Aegerion?
In a deferred prosecution agreement to resolve a felony charge that Aegerion conspired to violate HIPAA, 42 U.S.C. §§ 1320d-6 (a) and 1320-6 (b) (3) , Aegerion admitted that it conspired to obtain patients’ personally identifiable health information, without patient authorization, for commercial gain. Under the terms of the deferred prosecution agreement, Aegerion will implement enhanced compliance provisions, including periodic certifications to the government concerning its implementation of those provisions.
How much did Aegerion pay for false claims?
Under the civil false claims settlement, Aegerion will pay $28.8 million over three years to resolve federal and state civil liability for causing false claims for Juxtapid to be submitted to government health care programs (Medicare, Medicaid, and TRICARE) arising from its promotion of Juxtapid for patients without a diagnosis of, or consistent with, HoFH; false and misleading statements to doctors that the use of Juxtapid was appropriate in patients with symptoms including high cholesterol, irrespective of whether such patients had a diagnosis of HoFH and despite counter-indications to a diagnosis of HoFH; and alteration or falsification of statements of medical necessity and prior authorizations that were submitted to federal health care programs. The government further alleged that Aegerion defrayed patients’ copayment obligations for Juxtapid, in violation of the Anti-Kickback Statute (AKS), by funneling funds through Patient Services Inc. (PSI), an entity that claimed to be a non-profit patient assistance organization. The federal share of the $28.8 million civil false claims settlement is $26.1 million and the state portion is $2.7 million.
Who filed the Aegerion lawsuit?
The civil false claims settlement resolves a lawsuit filed by Michele Clarke, Tricia Mullins, and Kristi Winger Szudlo, former employees of Aegerion, under the qui tam or whistleblower, provisions of the False Claims Act, which permit private individuals, known as relators, to sue on behalf of the government for false claims and to share in any recovery. The qui tam suit was filed in the District of Massachusetts and is captioned United States ex rel. Clarke, et al. v. Aegerion Pharmaceuticals, Inc., et al., No. 13-CV-11785 (D. Mass.). Relators will receive $4.7 million from the federal proceeds of the civil false claims settlement.
Is Aegerion Pharmaceuticals a subsidiary of Novelion?
Aegerion Pharmaceuticals Inc., a Cambridge, Massachusetts-based subsidiary of Novelion Therapeutics Inc., has agreed to plead guilty to charges relating to its prescription drug, Juxtapid, the Justice Department announced today.
