Healthcare Regulatory and Operations
Despite a healthcare provider’s best intentions and efforts, noncompliance with state or federal regulations does occur. Kutak Rock is familiar with both the matters are regular sources of risk as well as first-impression matters that require novel approaches. We regularly advise multi-provider health systems, hospitals, physician practice entities, ambulatory surgery centers, home health agencies, nursing homes, pharmacies and other providers in the design, implementation and operation of compliance programs, including those voluntarily created by the provider and those mandated by federal regulators.
Kutak Rock views operations and compliance as a continuum that begins from the ground-up with structuring an organization, arrangement, or transaction, and continues with regular and vigilant internal monitoring. The continuum then extends to addressing any compliance matters with appropriate authorities (if necessary) and assisting clients with implementing corrective action plans that not only resolve government inquiries but also put in place real changes that ensure compliance going forward.
- Operational and Transactional Structuring
- Assessing and structuring business transactions to minimize the risk of violating state and federal fraud and abuse laws, including those with referral sources.
- Assisting in the negotiation, preparation, and/or maintenance of all contracts and leases with referral sources that are needed to assure compliance with healthcare fraud and abuse and related laws.
- Day-to-Day Operations and Corporate Compliance
- Educating clients and their personnel on practical compliance and legal risks
- Establishing, monitoring and enforcing effective corporate compliance programs.
- Developing processes that will keep existing compliance policies current and effective.
- Complying with EMTALA, licensure/certification, HIPAA, HITECH and Sarbanes-Oxley requirements, among other laws.
- Internal Investigations and Self-Disclosures
- Conducting thorough, discreet and efficient self-audits, gap analysis and internal investigations.
- Implementing internal reporting and self-disclosure processes.
- Noncompliance Responses and Corrective Action
- Handling government investigations and resolving potential fraud and abuse investigations and/or litigation.
- Responding to survey, accreditation, and other inspection issues.
- Negotiating corporate integrity agreements and providing compliance training.
- Resolving Medicare and Medicaid Medicare audits and reimbursement appeals.
- Litigation arising under the False Claims Act.
- Alleged violations of various healthcare fraud and abuse laws such as the Stark Law and the Anti-Kickback Statute.
Kutak Rock healthcare attorneys have extensive experience representing healthcare providers, suppliers, and facilities, including individual healthcare professionals; long-term care, home health, and hospice providers; ambulatory surgery centers; pharmacies; dialysis facilities and suppliers; durable medical equipment suppliers; diagnostic imaging suppliers and IDTFs; and behavioral health providers before state health care regulatory, professional licensing and enforcement agencies to achieve the following goals:
- State licensure, through providing advice regarding licensure requirements, preparation and submission of licensure documents;
- Certificate of need determinations;
- Obtaining accreditation; and
- Resolution of ownership and disciplinary actions and sanctions.
Healthcare Research and Sponsored Programs
Attorneys in the healthcare practice group routinely advise clients on matters relating to federal and industry-sponsored research and programs including contract matters, material transfer, grant administration, regulatory compliance (IRB, IACUC, IBC, radiation safety, conflict of interest), accreditations, research misconduct and federal agency relations (OHRP, OLAW, USDA, FDA, ORI, OIG). Kutak Rock attorneys have experience in matters ranging from reviewing industry contracts and drafting documents for federal subawards to advising on physician investigator compensation and resolving compliance issues arising in the conduct of sponsored research and programs. The clients to which the healthcare practice group have provided sponsored research and program support include academic medical centers, health systems, hospitals, and physician practices.