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, biologics and medical device manufacturers for placement with that insurance companies formulary – but should be passed onto 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. 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.
The culture wars are a mess as politics enter 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 and, presumably, any ancillary services.
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 Harmonized Tariff Schedule classifications to ensure correct and optimal codes and tariff rates apply.
If you sense trouble, you need legal representation. As the DOJ is interested in CIVIL charges and Penalties, pay the Piper.
Otherwise, Civil Charges today can become Criminal Tomorrow – And You Don’t Want That!