In FY 2019, the Department of Justice (DOJ) recovered over $3 billion in judgments and settlements from civil cases involving false claims against the government. According to the False Claims Act (FCA), anyone who knowingly submits a false claim to the government is liable for triple the government’s damages plus a penalty for each violation. Recently, DOJ has gradually increased the penalty for each violation of the FCA.
On June 19, 2020, the DOJ published a final rule, Civil Monetary Penalties Inflation Adjustment, to increase the minimum penalty from $11,181 per violation to $11,665 per violation. The DOJ also increased the maximum penalty from $22,363 to $23,331 per violation. This new amount applies to all violations that occurred on or before November 2, 2015 and are not yet assessed.
Of the $3 billion plus recovered by DOJ, $2.6 billion was obtained from manufacturers of drugs, medical devices, hospitals, pharmacies, laboratories, and physicians. Most of the civil judgments recovered by DOJ reflect federal losses, but a million of additional dollars was recovered for state Medicaid programs as well.
What is the Importance of this DOJ Trend to the #Medtech Industry?
Given the high priority of the DOJ in deterring fraud against the government as evidenced by the increasing number of judgements and settlements, it is even more important that:
- Manufacturers need to ensure that they are setting up and implementing their compliance programs.
- providers submit clean and accurate claims and documentation is kept on files or provided to the payer as required by each payer,
- manufacturers develop their Billing Guides with the help of qualified expert coders who base their research on authoritative guidance from payer policy staff, and reimbursement lawyers – please review our Coding Myths Blog, for more specific details.
- manufacturers keep their billing guides updated as coding, coverage and payment are dynamic, and
- manufacturers develop and effective compliance program to prevent and detect violations, which protects organizations penalties and lawsuits.
- Medical technology hotline services should be set up in consultation with reimbursement lawyers and qualified reimbursement consultants with Standard Operation Procedures (SOPs) that are compliant with DOJ guidelines.
Also, with the billing, coding, and coverage flexibilities in place during the Covid-19 pandemic, there are likely heightened audits and enforcement risks to follow.
Telehealth coding, covering, and payment policies are dynamic, and the Billing Guides and coding need to be researched and kept updated frequently as policies and billing guidelines change.
Why Partner with GIRS
Develop your Coding Strategies with Us: Our decryptase Coding Strategies Team has over 17 years of experience developing coding strategies and billing guidance based on authoritative sources with certified coders who also are auditors.
Develop and Update Billing Guides with Us: Billing Guides are considered marketing materials and need to be developed and reviewed by experts including reimbursement lawyers. We have over 17 years of experience developing and updating Billing Guides with appropriate disclaimers.
Let us Develop Sales Force Education Tools: To assist you with implementing safe selling initiatives we can develop Sales Force Education Tools to educate them for every reimbursement milestone including new codes, new coverage, and payment changes.
Let us Set up Medical Technology Hotline Services that are Compliant: The GIRS InContact Reimbursement Hotline® Support has over 17 years of experience setting up program SOPs with lawyers that are compliant with DOJ guidance.
Sources:
- https://bit.ly/2WU6ULJ
- https://bit.ly/3hjtrZS
- https://bit.ly/32Axgpr
- https://bit.ly/3hhZlG9
- https://bit.ly/2OGkyNN
About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us or call us at 901-834-9119.