Amgen and Astellas each entered five-year corporate integrity agreements (CIAs) with OIG as part of their respective settlements. The CIAs require the companies to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs to which they donate.
Full Answer
What is a corporate integrity agreement (CIA)?
OIG negotiates corporate integrity agreements (CIA) with health care providers and other entities as part of the settlement of Federal health care program investigations arising under a variety of civil false claims statutes.
What is the corporate integrity agreement with OIG?
Jazz and Lundbeck each entered five-year corporate integrity agreements (CIAs) with OIG as part of their respective settlements. The CIAs require the companies to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs to which they donate.
What are Amgen and Astellas’ corporate integrity agreements with OIG?
Amgen and Astellas each entered five-year corporate integrity agreements (CIAs) with OIG as part of their respective settlements. The CIAs require the companies to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs to which they donate.
Can Novartis Pharmaceuticals Corporation submit an appeal for reimbursement?
Disclaimer: Reimbursement services support and Novartis Pharmaceuticals Corporation cannot guarantee success in obtaining reimbursement, nor can they submit appeals on behalf of providers or patients.
What is a corporate integrity agreement Healthcare?
A CIA is a document that specifies all of a healthcare organization's obligations under a civil settlement for violating the False Claims Act. It serves as a binding contract between the healthcare organization and the OIG.
What 3 elements are part of the corporate integrity agreement?
Corporate Integrity Agreementshire a compliance officer/appoint a compliance committee;develop written standards and policies;implement a comprehensive employee training program;retain an independent review organization to conduct annual reviews;establish a confidential disclosure program;More items...
What is the purpose of a corporate integrity agreement?
What is a Corporate Integrity Agreement? A corporate integrity agreement (CIA) is a document that outlines the obligations to which an entity agrees as part of a civil settlement.
How long does a corporate integrity agreement last?
5 yearsCIAs generally last 5 years. During this time the provider is usually required to implement or expand a comprehensive employee training program, a confidential disclosure program, written standards and policies, and designate a compliance officer and committee if these things are not already done.
What are the 7 elements of a compliance program?
Seven Elements of an Effective Compliance ProgramImplementing written policies and procedures. ... Designating a compliance officer and compliance committee. ... Conducting effective training and education. ... Developing effective lines of communication. ... Conducting internal monitoring and auditing.More items...
What is a CIA for Medicare?
Agreements Snapshot. A Corporate Integrity Agreement (CIA) is a document outlining the obligations a corporate provider agrees to as part of a civil settlement.
What three elements are part of the corporate integrity agreement quizlet?
MatchCode of Conduct- Values of company.Designation of a Compliance Officer or Contact- Responsible for overall administrative and compliance actives - have to have appropriate authority.More items...
What is considered to be a reportable event as defined by the CIA?
Providers under a Corporate Integrity Agreements (CIA) or Integrity Agreements (IA) with the OIG are required to disclose certain "Reportable Events" which include: a substantial overpayment, a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to ...
Is Pfizer under a CIA?
Pfizer has also entered into a corporate integrity agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).
Why would an entity enter into a CIA Walgreens?
The program was intended to give customers discounts when ordering drugs from Walgreens. Walgreens entered into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services (HHS) to build upon its existing compliance program, as part of the settlements.
What is a letter of agreement in healthcare?
A letter of agreement is an agreement between two parties that puts the terms of the agreement in writing as a means of resolving later disputes that may arise.
What do you think the role of the compliance officer was in securing the corporate integrity agreement?
a. Role of Compliance Officer. CIAs require that each company appoint a compliance officer to be responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the CIA and Federal health care program requirements.
What three elements are part of the corporate integrity agreement quizlet?
MatchCode of Conduct- Values of company.Designation of a Compliance Officer or Contact- Responsible for overall administrative and compliance actives - have to have appropriate authority.More items...
What is a corporate integrity agreement quizlet?
A CIA (Corporate Integrity Agreement) is. an imposed compliance program, usually in force for five (5) years. During the time (usually 5 years) of an imposed Corporate Integrity Agreement, the entity must demonstrate. on-going compliance relative to specifically-identified issues, and report annually to the HHS OIG.
What does the CVS health corporate integrity agreement reinforce?
The CIA reinforces our strong commitment to compliance with the law and the highest ethical standards of our employees. The CIA calls for certain practices that we have already had in place, including the maintenance of a compliance program, the Code of Conduct, the Ethics Line and employee training.
What is OIG self disclosure protocol?
OIG's contractor self-disclosure program enables contractors to self-disclose potential violations of the False Claims Act and various Federal criminal laws involving fraud, conflict of interest, bribery or gratuity.
What is the role of OIG in the CIA?from cia.gov
OIG advances CIA’s mission by offering findings and recommendations to the Agency, the Director of the CIA, and Congressional Intelligence Committees. When investigating alleged violations of law, OIG also works directly with CIA leadership, the Department of Justice, and other federal agencies.
Who is the director of the Carnegie Endowment for International Peace?from cia.gov
Director Burns retired from the State Department U.S. Foreign Service in 2014 before becoming president of the Carnegie Endowment for International Peace. Director Burns is a crisis-tested public servant who spent his 33-year diplomatic career working to keep Americans safe and secure.
How to do a CIA?from oig.hhs.gov
CIAs have many common elements, but each one addresses the specific facts at issue and often attempts to accommodate and recognize many of the elements of preexisting voluntary compliance programs. A comprehensive CIA typically lasts 5 years and includes requirements to: 1 hire a compliance officer/appoint a compliance committee; 2 develop written standards and policies; 3 implement a comprehensive employee training program; 4 retain an independent review organization to conduct annual reviews; 5 establish a confidential disclosure program; 6 restrict employment of ineligible persons; 7 report overpayments, reportable events, and ongoing investigations/legal proceedings; and 8 provide an implementation report and annual reports to OIG on the status of the entity's compliance activities.
Who can remove an IG from office?from cia.gov
Nominated by the president and confirmed by the Senate, only the president can remove the IG from office. The IG’s authorities and responsibilities are provided in 50 U.S.C. §3517. Audits. The Office of Audits conducts two types of audits:
Key Takeaways
Three of the five drug and device manufacturer CIAs entered into in 2021 were tied to False Claims Act (FCA) settlements premised on an alleged conspiracy to fix the prices of various generic drugs; these agreements resulted in the imposition of novel CIA provisions designed to increase transparency regarding the manufacturers’ internal deliberative processes around price increases and contract negotiations..
The Year in Numbers: CIA Statistics
The HHS-OIG entered into 30 new CIAs in 2021, which is far below the average of approximately 41 CIAs per year since 2012. 2 Of the 34 total agreements in 2021, four were amendments to prior CIAs, 15 were integrity agreements (IAs), and 15 were CIAs. 3
Conclusion
HHS-OIG continued to adapt CIAs to address factual scenarios underlying DOJ settlements in 2021 by introducing novel price transparency obligations.
What is a partial payment for Medicare?
When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Congress included copay requirements in the Medicare program, in part, to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. The Anti-Kickback Statute prohibits a pharmaceutical company from offering or paying, directly or indirectly, any remuneration — which includes money or any other thing of value — to induce Medicare patients to purchase the company’s drugs. This prohibition extends to the payment of patients’ copay obligations.
Did Amgen donate to Onyx?
The government alleged that Onyx was the sole donor to this travel fund and that Amgen, after integrating Onyx into its operations in 2015, continued to donate to the fund. The foundation also operated a second fund that covered copays for multiple myeloma drugs, including Kyprolis.
Did Astellas pay $100 million for Xtandi?
The government further alleged that, during the time that the ARI funds were open, Astellas promoted the existence of the ARI funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. Astellas has agreed to pay $100 million to resolve the government’s allegations.
Is Astellas an ARI only fund?
In July 2013, both foundations opened ARI-only copay funds; Astellas was the sole donor to both funds. The government alleged that Astellas knew that Xtandi would likely account for the vast majority of utilization from each fund, and, in fact, Medicare patients taking Xtandi received nearly all of the copay assistance from the two ARI funds.
Does Amgen sell Sensipar?
Amgen: Amgen sells the secondary hyperparathyroidism drug Sensipar and the multiple myeloma drug Kyprolis. Amgen acquired Kyprolis as part of its acquisition of Onyx Pharmaceuticals Inc. in 2013. With respect to Sensipar, the government alleged that, in late 2011, Amgen stopped donating to a foundation that provided financial support to patients taking any of several secondary hyperparathyroidism drugs and approached a new foundation about creating a “Secondary Hyperparathyroidism” fund that would support only Sensipar patients. Amgen allegedly worked with the new foundation to determine the fund’s coverage parameters and, in November 2011, the foundation launched a “Secondary Hyperparathyroidism” fund with Amgen as its sole donor. Until June 2014, the fund covered only Sensipar. Amgen allegedly made payments to the fund even though the cost of these payments exceeded the cost to Amgen of providing free Sensipar to financially needy patients. However, by enabling the fund to cover the copays of Medicare beneficiaries, Amgen caused claims to be submitted to Medicare and generated revenue for itself.
What is the Integrity Agreement for PSI?
As noted above, as part of the settlement, PSI agreed to a three-year Integrity Agreement with the Department of Health and Human Services Office of Inspector General, requiring PSI to “implement measures designed to ensure that it operates independently and that its arrangement and interactions with pharmaceutical manufacturer donors are compliant with the law.”
What is the alleged scheme with Aegerion?
In the alleged scheme with Aegerion, the DOJ alleged that PSI created a fund for homozygous familial hypercholesterolemia, which can be treated by an Aegerion drug, Juxtapid. Further, the DOJ alleged that Aegerion participated in establishing patient eligibility criteria for copay assistance, and that the fund allowed Aegerion to pay for Medicare patients’ copays to eliminate price sensitivity to physicians and patients.
What is the DOJ case for Alexion?
Finally, in the case of Alexion, the DOJ alleged that PSI created a Complement Mediated Diseases Fund to provide copay assistance to patients with diseases that can be treated by Alexion’s drug Soliris. In addition to copay assistance, the fund also paid other medical expenses for those patients. The DOJ alleged that PSI provided financial assistance from the fund only to patients taking Soliris, and PSI reported to Alexion, confirming which Soliris patients were approved for assistance, as well as details of those payments.
Can pharmaceutical companies use foundations to fund drug co-payments?
Commenting on the settlement, US Attorney Lelling noted “ [p]harmaceutical companies cannot use foundations to funnel drug co-payments disguised as routine charitable donations, all to prop up excessive drug prices.”
Does Patient Services Inc. have a corporate integrity agreement?
Patient Services Inc. also entered into a corporate integrity agreement governing the distribution of charity funds. Which could serve as a model of these charities to compliantly manage their funds.
Did PSI pay kickbacks to Medicare patients?
The DOJ alleged that PSI coordinated with Insys, Aegerion and Alexion to pay kickbacks to Medicare patients taking drugs manufactured by those companies . The DOJ further alleged that PSI worked with the companies to “design and operate certain funds that funneled money from the companies to patients,” and further that the “schemes minimized the possibility that the companies’ contributions to the funds would go to patients taking competing drugs … and undermined the nature of these contributions as bona fide donations.”
How much did Jazz Pharmaceuticals pay for the False Claims Act?
(Alexion) – have agreed to pay a total of $122.6 million to resolve allegations that they each violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program (ChampVA) copays for their own products, through purportedly independent foundations that the companies used as mere conduits.
Do you have to pay a copay for ChampVA?
Similarly, under ChampVA, patients may be required to pay a copay for medications.
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.
What is a meaningful review and processing of funding requests?
Meaningful Review and Processing of Funding Requests: All requests should follow the company’s customary and generally applicable grant request processes, and these requirements should be incorporated within the PAP policy/procedure described above. The PAP policy/procedure should specify standardized, objective criteria for assessing requests from independent PAPs for both initial and additional or supplemental funding (e.g., funding beyond that which is set forth in the annual budget). Supplemental requests for funding must be reviewed for compliance with applicable Federal health care program requirements, OIG guidance, and company policies and procedures.
What should compliance officers be reexamining?
In light of the recent and, likely, increasing enforcement in the area of patient support programs, including independent PAPs and free drug programs, compliance officers should be reexamining the processes and internal controls surrounding these activities . Although the historical OIG and industry compliance guidance remain instructive in mitigating risk, recent CIAs resulting from allegedly abusive independent PAP activities should also be examined to determine whether enhancements and improvements are necessary. This article contains a framework for this self-assessment, but a drug company’s specific activities will inform the level of compliance risk and the degree of customization necessary to make any mitigation efforts as effective as possible.
What are the restrictions on PAP data sharing?
Implementation of Data Sharing Restrictions: The company should take all necessary steps to ensure it does not receive (directly or indirectly through third parties) any data or information from the PAP that would enable the company to correlate the amount or frequency of its donations with support for its products or any related services. Such prohibited information may include individual patient information, or any information related to the identity, amount or nature of the products or services that are made available by the PAP from donations provided by the company, including any projections for additional funding required to continue a specific type of support. Within the company, the aggregate-level data received from independent PAPs should not be shared with commercial personnel.
What is compliance monitoring and auditing?
Conducting Monitoring and Auditing Activities: The compliance monitoring and auditing functions should conduct regular activities to identify and correct any issues of noncompliance with the PAP policy/procedure requirements. Such activities may include: (a) review of interactions with selected independent PAPs, by assessing the relevant documentation relating to the company’s decision to provide funding, the written agreement (s) in place between the company and the independent charity, and any correspondence, communications or other types of documentation reflecting interactions between the company and the independent PAP; and (b) performing appropriate review and follow up based on the results reported.
When did the DOJ issue subpoenas to Valeant Pharmaceuticals?
9 DOJ issued subpoenas to Valeant Pharmaceuticals in October 2015, and Horizon Pharmaceuticals in early 2016, requesting information on the drug makers’ relationships with independent PAPs, while investigating both companies for their relationships with specialty pharmacies.