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DOJ-HHS ARE INCREASING THEIR ENFORCEMENT CAPABILITIES, TARGETING FCA NON-COMPLIANCE

TARIFFS, HEALTHCARE, LIFE SCIENCES, AND PHARMACEUTICALS

The Department of Justice has tasked its MIMF (Market Integrity and Major Frauds) Unit with investigating fraud schemes by companies dodging U.S. tariffs. 

IN THE CROSSHAIRS:  KICKBACKS, AND MEDICARE ADVANTAGE FOR THE FIRST TIME, AMONG OTHERS, ARE IN THEIR SIGHTS  

1. “Medicare Advantage,” Selling Techniques, when the policy doesn’t provide the medical care needed or what was expected.

2. “Drugs, medical devices, or biologics pricing and discounts.” These are the discounts, rebates, and service fees paid by pharmaceutical, biologic, and medical device manufacturers for placement on an insurance company’s formulary – but should be passed on to patients, not kept by brokers and the like. Do I hear Antitrust?

3. “Barriers to patient access and violations of network adequacy requirements.” A relatively new category of enforcement, dealing with compliance and requirements for provider networks: Medicare, Medicaid, and Affordable Care Act exchange plans.

4 While Anti-Kickback Statutes are old hat, they continue to be a source of significant exposure for providers, plans, and manufacturers alike.

5, “Defective medical devices that impact patient safety.”

6. You Are Still Responsible. Outsourced health care billing and coding service providers, as well as software companies that develop billing and coding tools for providers, are now facing increased scrutiny, including from Medicare.

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The culture wars are a mess, as politics pushes its way into your doctor’s treatment room and medicine.

DOJ leadership has issued multiple memoranda stating the agency’s intention to pursue FCA cases against providers, hospitals, pharmaceutical companies, and others that provide gender-affirming care, as well as any ancillary services.

As if this is not enough, billing, coding, and running our practices and hospitals are much different today than they were yesterday.  As the highest court in the land tries to take us back to the life of the 1860s, do your best and keep moving forward.

Dollars are tight as rural hospitals close, and all are seeking a novel way to save money and increase the bottom line. A word of caution – do not stray across that gray line, because AI and Analytics are watching. 

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Preparing for Enforcement, like everything, is Documentation

  • Conducting regular audits of your country of origin
  • Assigning proper customs valuations by capturing dutiable costs, assessing lawful opportunities for reducing dutiable value, and eliminating riskier alleged practices such as “double booking”
  • Ensuring third-party due diligence compliance, including any shipping companies that promise to lower tariff exposure;
  • Reviewing Tariff Schedule classifications to ensure correct and optimal codes and tariff rates apply.

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If you sense trouble, you should consider seeking legal representation. As the DOJ is interested in ‘Civil Charges and Penalties’, pay the Piper.