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Health Care Investigations & Enforcement Actions

Our firm has earned a reputation for outstanding defense work in both civil and criminal enforcement actions brought by the government in the health care sector.

Our lawyers know the government regulators and prosecutors, know how they apply complex regulatory interpretations to different factual scenarios, and understand how to negotiate for a dismissal, civil settlement or reduced charge. When negotiations fail, our lawyers also know how to explain a complex health care case to a judge or jury, and how to win at trial.

When the state or federal government initiates an investigation or enforcement action, clients know that Collora LLP is prepared to respond immediately and prudently for them. Our lawyers know how to respond to government requests, assert privileges, coordinate joint defense teams, and sort through thousands of complex medical documents quickly and effectively.

The following shows the kinds of health care clients we have represented in government enforcement actions, their industries, the legal issues we have handled and some of the results that we have obtained. (For information about our experience with other government enforcement matters, see the links at the bottom of this page.)

Clients

Collora LLP has represented a variety of clients in inquiries, investigations and actions related to health care enforcement, including but not limited to:

  • Pharmaceutical Companies     
  • Medical Device Manufacturers
  • Biotech and Life Sciences Companies
  • Clinical Laboratories
  • Hospitals
  • Nursing Homes
  • Medical Clinics
  • Dental Clinics
  • Executives and Managers
  • Physicians and Surgeons
  • Psychiatrists
  • Psychologists
  • Dentists
  • Pharmacists
  • Radiologists
  • Chiropractors
  • Physical and Occupational Therapists

Issues

We have successfully dealt with a variety of issues associated with health care investigations and enforcement actions, including but not limited to the following:

  • Alleged Anti-kickback Violations
  • Off-label Promotions/Allegations
  • False Claims Allegations
  • Fraud and Abuse Allegations
  • Overbilling and Billing for Services Not Rendered
  • Over-treating Allegations of Unnecessary Medical Service
  • Prescription Drug Act Violations
  • Physical and Sexual Assault Allegations
  • Pricing and Rebate Issues
  • Research Fraud
  • Stark Law Allegations
  • Up-coding Allegations

Results

The following summaries are a representative sampling of results we have produced for our clients in matters involving civil and criminal government enforcement actions aimed at the health care industry.

  • Successfully 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.
  • Successfully 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 the prosecutors to give up on felony charges, and convinced the U.S. District Court judge to dismiss all kickback charges. The government settled for a misdemeanor charge and a probation sentence with no prison time served and no federal program debarment.
  • Successfully 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.
  • Successfully 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.
  • Successfully represented physician indicted for Medicare fraud and obstruction in connection with sales of life-saving treatments for rare skin conditions. Our client, the doctor who developed the treatments, had all fraud claims dismissed against him, and he received a sentence of only six months of home detention for the alleged obstruction.
  • Won a motion to dismiss demonstrating insufficient evidence to support an indictment of a chiropractor client who was targeted for prosecution in alleged phony accident schemes.
  • Successfully 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 excluded from government programs. The investigation focused on allegations of kickbacks, off-label promotion, fraudulent pricing and Medicaid rebates.  A civil resolution was accepted by the government.
  • Successfully represented executives of pharmaceutical companies 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.
  • Successfully represented the vice president of a pharmaceutical company charged with conspiring to defraud Medicare and Medicaid, pay kickbacks to health care providers, and commit prescription drug marketing violations in the largest health care fraud prosecution of inidividuals in Massachusetts history. The case involved several novel interpretations of the governing statutes and regulations by the U.S. Attorney's Office. The client's company pleaded guilty to committing marketing violations and paid a multi-million dollar criminal penalty.  We took our client's case to trial, where he and his co-defendants were acquitted.
  • Successfully represented the vice president of marketing for a clinical laboratory who was 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.
  • Successfully 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.
  • Successfully represented top mangers 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.
  • Represented continuing medical education provider in False Claims Act case alleging illegal kickbacks.  Persuaded government and relator to dismiss client from case.

For more information about our experience with other kinds of government enforcement matters, click on any of the pertinent links below.

For more information about our experience with other health care matters, click on any of the relevant links below.