Last Friday, we wrote to HHS Inspector General Levinson in response to the Department of Health and Human Services’ Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalty (RFI).

Many of the FCA whistleblower cases that TAF members have brought to the attention of the DOJ and successfully litigated have involved illegal kickbacks between healthcare providers and suppliers, including pharmaceutical manufacturers, hospitals, pharmacies, clinical diagnostic laboratories, nursing homes, drug wholesalers, health plans and physicians. In 2010, recognizing the prevalence of fraud in the healthcare system, Congress amended the Anti-Kickback Statute to expressly provide that a claim to the government that includes items or services resulting from a violation of the Anti-Kickback Statute (AKS) “constitutes a false or fraudulent claim” for purposes of the FCA. 42 U.S.C. § 1320a-7b(g). Consequently, TAF members have a strong interest in ensuring that any changes to the Anti-Kickback Statute protect, rather than undermine, the interests of honest patients and providers, and those of taxpayers generally.

Below is a quick summary of our recommendations to HHS (read our full letter here):

1) Ensure that “Care Coordination” and “Value-Based Care” Do Not Open the Door to More Healthcare Fraud and Abuse More

2) Anticipate the Unintended Consequences of Any Changes to the Safe Harbors and Proceed with Utmost CautionMore

3) Dismiss the AHA’s Proposed Safe HarborsMore

The move to value-based and coordinated care does not eliminate the fundamental concern at the core of the AKS – limiting the role that profit plays in healthcare decisions affecting individual patients and subsidized in large part by the taxpayers. Before proposals to amend the law are seriously considered, we recommend that the Department carefully examine the claimed barriers to modernization and whether mechanisms do not already exist to address them. In addition, the Department should carefully consider whether the proposed “fixes,” which involve exempting providers, suppliers and manufacturers and various unspecified arrangements from a critical anti-fraud law, would allow conflicts of interest to improperly affect medical decision-making. Years of deliberate evaluation have produced substantial gains in reducing the role of financial self-interest in delivering patient care funded by the government, and the Department should not rush to take steps that could undermine that progress.

As the Department of Justice has stated, its enforcement of the AKS illustrates the importance that the government places on ensuring that healthcare decisions are based upon patient interest and not the financial interests of providers. These were not matters involving technical violations or mistakes. Due of the importance of the AKS to the government’s fraud-fighting efforts, we hope that HHS will not inadvertently open the door to new fraud schemes as part of its “Regulatory Sprint to Coordinated Care.”

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