Medical Device Corporate Integrity Agreement
DEA requirements, CCO reporting rules. The CIA of AmerisourceBergen Corporation (ABC) appears to be the second open CIA (and so far only the second CIA) to explicitly abide by the rules of the DEA (i.e. the requirements of the Controlled Substance Act). 5 The requirements of the DEA are broad and must be considered throughout the company`s compliance program. It should also be noted that the ABC CIA provides that the Chief Compliance Officer reports “directly” to the Audit Committee of the Board of Directors and only “administratively” to the Chief Executive Officer. The agreement settles five complaints filed by whistleblowers under the provisions of qui Tam of the False Claims Act. These whistleblowers will together receive an estimated $6.2 million share in the transaction. FDA requirements. While CIAs with drug and device manufacturers regularly require compliance with FDA advertising rules, ACell, Inc. The CIA contained provisions regarding product recalls, correction and withdrawal procedures, risk management and non-conforming product procedures, product claims, and . [corrective action plans] recalls are also defined as “reportable events” under the CIA. Since such oversight activities often fall within the competence of a company`s regulatory group – not compliance – after placing it on the market, including these requirements in the CIA will likely require increased coordination between these two groups to ensure compliance with the reporting obligations of the FDA and HHS-OIG7. that the company met with the DOJ in the summer of 2019.
As we wrote at the time, “while some limited product wearing services may not violate the AKS [anti-kickback] status, compliance experts should not conclude that product wearing services generally fall into some sort of compliance safe harbor under the 2003 guidelines.” 13 oig.hhs.gov/compliance/corporate-integrity-agreements/risk.asp. “The payment of any form of illegal remuneration to cause patient transfers undermines the integrity of our country`s health care system,” said Assistant Attorney General Jody Hunt of the Justice Department`s Civil Department. “If a patient receives a prescription for a device to treat a medical condition, the patient deserves to know that the device was chosen based on a reflection on the quality of care and not on the basis of illegal payments made by device manufacturers.” While, as in previous years, a high number of HAIs took place in individuals, small group practices or small suppliers, an abnormally high number of ACIs in drug and equipment manufacturers, closely followed by hospitals and healthcare systems. Many ACIs did not fall neatly into one sector, but into the “other” category. These include a provider of electronic medical records, a laboratory, a public authority and a holding company. In 2019, HHS-OIG completed 37 new ASAs and IAs3, the number of ASAs in 2018. As of January 6, 2020, according to the HHS-OIG website, there were 234 CIAs open. Of the 39 agreements in 2019, two were amendments from a previous CIA, 21 were new AAs, 15 were AIs, and the other was a compliance agreement from a public authority. The agreement also provides for penalties for late submissions, errors and omissions, and compliance violations. HHS OIG`s most important policy initiative in 2018 — its new fraud risk indicator and public identification of companies that refused to enter into CIAs if the OIG believes a CIA was needed — continued to draw Congressional attention to how the agency set up its exclusion agencies and other program enforcement and integrity authorities.
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