Attorneys in the health care practice group have an in-depth knowledge of the complicated regulatory requirements facing health care providers and a solid working relationship with regulators. We provide analysis and counseling regarding state and federal regulatory matters and compliance issues.
We regularly design, implement and manage corporate compliance programs. We have reviewed, revised and implemented effective compliance plans resulting in reduced penalties following investigations. We analyze fraud and abuse, false claims, anti-kickback, self-referral and EMTALA issues. We respond quickly to compliance issues, including questions on complicated interactions between hospitals and providers and suppliers.
Our practice includes counseling our clients with respect to maintaining the privacy and security of their business and patient records in accordance with state and federal law, including security breaches, mitigation of risk, conducting breach investigations and responding to inquiries and investigations from law enforcement authorities and the media when breaches occur. We have also counseled our clients on establishing health information exchanges and electronic health record systems and donation programs.
Issues of noncompliance frequently involve internal or governmental investigations. We regularly work with Medicare or its contractors (e.g. fiscal intermediaries, RACs), Medicaid, OIG, U.S. Attorney, licensure agencies, attorneys general, and the Joint Commission. We advise our clients on overpayment issues, including refunds and self disclosures. On licensure and other matters involving quality, we are responsive in developing Quality Assessment Performance Improvement Plans. We have responded to difficult billing inquiries and have negotiated consent orders and corporate integrity and compliance agreements.
We represent applicants and intervenors in certificate of need matters related to change of ownership, corporate affiliation, joint ventures, technology acquisitions and introduction and termination of services.
We advise our clients in handling difficult patient issues, including ethical issues relating to end-of-life decision making, competency and informed consent issues.
We advise health care providers and life sciences companies on clinical and translational research issues involving conflicts of interest, research misconduct, institutional review boards (IRBs), informed consent, privacy and data issues, and sponsor and investigator agreements.