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In 2019, HHS-OIG welcomed 37 new CIA and IAs,3 that match the number of CIA in 2018. As of January 6, 2020, according to the HHS-OIG website, there were 234 CIA open. Of the 39 agreements in 2019, two were amended to an earlier CIA, 21 were new ICAs, 15 were AI and one was an agreement on compliance with public authorities. In 2017, the CIA provided guidelines to companies in important risk sectors of the sector. Although the CIA does not link companies that do not sign, the CIA itself proposes the reflection and examination of topics in the sector by the OIG. ICAs can help companies define compliance policies or programs. In 2019, HHS-OIG imposed 12 sanctions on companies for non-compliance with CIA obligations. Eleven companies were fined $5,000 for not being able to repay excessive payments on time and $690,000 for non-compliance with written guidelines, staff training, compliance with disclosure program requirements, and implementation and compliance with procedures and requirements for agreements. In total, HHS-OIG imposed fines of $936,000. In addition, HHS-OIG has excluded a company for a period of five years after it failed to pay the penalties demanded by HHS-OIG in 2018, as it had not submitted a management report.9 Although the company, now excluded, had 25 days to request a hearing, following a notification of substantial violations and the intention of HHS-OIG to report an exclusion. society did not ask to be heard. In 2017, OIG entered a new field of application – the online health registration software – which could prove to be a big area of risk for businesses.

OIG stressed in its public statements and through the CIA 2017 that it takes the certification of electronic health registration software very seriously. The CIA informs companies of the strict requirements that the OIG can impose in case of poor software functionality. The CIA imposes a number of obligations on the company, including maintaining independent software quality monitoring to evaluate software quality control systems and reporting to oIG on audits. In addition, customers can receive free updated versions of the software and can transfer data without penalty to another provider of electronic health data software. Finally, the supplier must maintain an independent monitoring body to ensure compliance with anti-kickback status. In 2019, the total number of new insurance and integrity (IA) agreements remained unchanged, as in 2018, but was below the five-year average.

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