Our regulatory and investigations team advises on virtually every aspect of federal and state regulation of the industry, including matters involving claims to federal and state healthcare program, anti-kickback laws and physician self-referral regulations, the False Claims Act (FCA), civil monetary penalties, licensure, certification, accreditation, coverage, clinical research and institutional review boards.
Our lawyers, including former federal prosecutors with substantial trial and healthcare fraud experience, have handled numerous complex healthcare fraud and abuse investigations and resulting cases, both civil and criminal.
We are also well recognized for our experience with federal and state medical device and pharmaceutical regulatory compliance at the FDA, as well as federal and state laws governing the sale and distribution of medical products.
We have developed significant experience with a wide variety of other federal regulatory and prosecutorial bodies, including:
- US Department of Health and Human Services (HHS)
- Centers for Medicare & Medicaid Services (CMS)
- HHS Office of Inspector General (OIG)
- Food and Drug Administration (FDA)
- Department of Justice (DOJ)
- National Institutes of Health (NIH)
- Drug Enforcement Agency (DEA)
- Medicare Contractors
Our areas of work include
- Sunshine Act/Open Payment Act. We have also developed a proprietary data platform combining Sunshine data with Medicare Part B and Part D data to provide customized risk analysis for our clients.
- Criminal investigations into the marketing of drugs for "off label" uses and "drug diversion" under the Prescription Drug Marketing Act.
- FCA litigation on a wide variety of issues, including both “Reverse” and “Direct” false claims and whistleblower cases. We also advise on corporate integrity agreements with the OIG.
- Antitrust planning, training, prevention and compliance, including advising on the antitrust impact of M&A activity and coordinating/obtaining clearance by multi-state, national and international agencies.
Our recent work
- Experience at the Center for Drug Evaluation and Research with diverse product areas, such as cardiology, nephrology, neuropharmacology, oncology, pulmonology, anti-infectives, anti-virals, generics and over-the counter drugs, generics and orphan products and compassionate use and emergency INDs.
- Experience at the Center for Biologics Evaluation and Research on a wide variety of products and services, including interferon, vaccines and blood banks.
- Experience at the Center for Medical Devices and Radiological Health with restorative, clinical laboratory, cardiovascular, respiratory, neurological, ophthalmic, reproductive, abdominal, ENT, dental and orthopedic devices. We received the first 510k clearance in the global harmonized (STED) format, which is now being processed in two other signatory countries.
- Experience with inspections (QSIT), study audits (BIMO), IRBs, ethics and other serious regulatory processes.
- Experience with Medicare reimbursement for clinical laboratory and surgical services involving non-approved biologics and devices.
Qui Tam/False Claims Act
- Representation of an academic medical center against claims by the DOJ and the state AG’s Office on a qui tam action under the False Claims Act in which it was alleged that the university had submitted false claims to Medicare and the state Medicaid. We convinced the government to allow us to conduct an internal investigation into the allegations, which we completed within three months. We were able to demonstrate to the government that any billing errors were limited in scope, which allowed us to settle the matter promptly and without the university having to enter into a corporate integrity agreement with the OIG.
- Defense of a medical device manufacturer in a qui tam matter under the False Claims Act in which two former employees of the company allege that the company submitted false claims to federal healthcare programs for various medical devices. The allegations concern both improper coding of claims and the payment of kickbacks to physicians and other referral sources. The government declined to intervene in this case, and discovery is still ongoing.
- Representation of a pharmaceutical manufacturer in connection with federal and state investigations, litigation and qui tam False Claims Act actions involving Average Wholesale Price, Medicaid Rebate arising out of pricing, and sales and marketing practices.
- Conducted an internal investigation and defended a multinational medical device manufacturer in a qui tam False Claims Act action arising out of sales and marketing practices.
- Represented a British multinational consumer goods company, producer of health, hygiene and home products, in the purchase of a brand of personal lubricants from American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer. We handled the corporate aspects of the transaction, as well as the merger review, which included applicable filings in seven global jurisdictions and the HSR clearance in 50 jurisdictions.
- Represented a national healthcare network in a US $390m acquisition of substantially all of the assets of an alliance of leading academic medical centers. The new combined enterprise is the largest member-owned healthcare company in the US. The merger was reportable under HSR and we obtained clearance for our client.
- Assisted in the acquisition of large pharmaceutical company by international competitor.