Health Care External Investigations & Enforcement Actions

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Collora LLP attorneys reach outstanding defense results for clients in both civil and criminal enforcement actions brought by the government in the health care sector.  Our lawyers respond to government requests, assert privileges, coordinate joint defense teams and sort through thousands of complex medical documents quickly and effectively.  We successfully deal with a variety of issues associated with health care investigations and enforcement actions, including:

  • Alleged Anti-Kickback Violations
  • Discount Exceptions to Anti-Kickback Rules
  • False Claims Allegations
  • Fraud and Abuse Allegations
  • Off-Label Promotions
  • Overbilling and Billing for Services Not Rendered
  • Over-Treating Allegations
  • Physical and Sexual Assault Allegations
  • Pricing and Rebate Issues
  • Research Fraud
  • Stark Law Allegations
  • Up-Coding Allegations

Representative Experience

  • Represented health care companies and high-level executives against charges of health care fraud brought by the federal government in many cases, often obtaining dismissals, civil settlements or trial verdicts for our clients.
  • Represented a physician who was the president of a company that made medical devices in one of the first criminal enforcement actions related to the medical device rules of the Food and Drug Administration. After the company paid a settlement worth hundreds of millions of dollars, the president was indicted for alleged involvement in overbilling and payment of kickbacks to doctors. We persuaded prosecutors not to pursue felony charges and convinced the U.S. District Court judge to dismiss all kickback charges. The government settled for a misdemeanor charge and a probated sentence with no prison time served and no federal program debarment.
  • Represented eight orthopedic shoemakers and distributors in an industry-wide investigation by the Attorney General into Medicaid billing fraud. All cases were resolved administratively with no criminal charges and no civil complaints, fines or sanctions.
  • Won separate verdicts of “not guilty” on behalf of two psychiatrists, each of whom had been charged with sexually assaulting a patient.
  • Represented a dental clinic in a two-year criminal grand jury investigation of Medicaid fraud. No criminal charges were brought against the clinic or any of its employees after reaching a civil restitution agreement with no fines, penalties or sanctions, and no debarment from government programs.
  • Represented physician indicted for Medicare fraud and obstruction in connection with sales of life-saving treatments for rare skin conditions. All fraud claims again our client, the physician who developed the treatments, were dismissed and the client served just six months of home detention for the alleged obstruction.
  • Won a McCarthy motion demonstrating insufficient evidence to support an indictment of a chiropractor client that was targeted for prosecution in alleged phony accident schemes.
  • Represented Fortune 500 pharmaceutical company in multi-year, multi-issue parallel criminal and civil investigations by the U.S. Attorney’s Office in Boston. Neither the company nor any employees were charged with any crime, and they were not debarred from participating in government programs. A civil resolution was accepted by the government.
  • Represented executive of pharmaceutical company targeted for indictment in a federal criminal probe into off-label promotions. Despite a guilty plea by the company, our client avoided any criminal charges at all.
  • Represented the vice president of marketing for a clinical laboratory indicted for alleged violations of the anti-kickback statute. The charges against our client were ultimately dismissed, although the corporation pled out to a misdemeanor.
  • Represented a corporate pharmacy and its sole proprietor who were indicted for violations of Medicaid’s usual and customary charge rules, billing for services not rendered and submitting claims by a non-program provider. We negotiated a deal to have the charges dismissed after a short pre-trial probation had been served, enabling the proprietor to continue in his profession.
  • Represented top managers of a major mental health clinic in connection with an ongoing grand jury investigation into allegations of illegal Medicaid billing practices. Following an internal investigation, our lawyers persuaded the Medicaid Fraud Control Unit of the Attorney General to accept a civil settlement without admission of liability and discontinue proceedings without indictment.