In the era of health care reform, it is critical that you prepare for scrutiny by payers as you develop plans for drug coverage and reimbursement, craft promotional materials, and consider pricing parameters. Our attorneys work with life sciences companies like yours to create successful strategies for drug and medical device products. We also provide counsel on government compliance and defense in enforcement actions, such as class action suits and whistleblower cases related to allegations of improper payments (kickbacks) to health care practitioners (HCPs), product pricing, and off-label promotion. Our team includes former attorneys from FDA, CMS, OIG, and DOJ.
In addition, we regularly counsel our life sciences clients on health-care-related issues, including: clinical trial design and reimbursement; IRBs; clinical lab certifications; privacy and consent issues, “Sunshine Act” and state reporting of payments to HCPs; 340B participation; government-required drug price reporting; labor and employment issues unique to this highly regulated sector; compliant business structures and customer contracts; sponsored CME; beneficiary inducements; patient assistance programs; negotiation of corporate integrity agreements with the OIG; and general regulatory and governmental compliance.