On a daily basis, members of Morgan Lewis's FDA and Healthcare Practice work closely with a wide variety of health service providers, such as hospitals, health systems, academic medical centers, inpatient rehabilitation facilities, and long-term care hospitals. Our attorneys advise our health service clients on a broad array of matters, including the following:
- Structuring compliant relationships with healthcare professionals, including recruitment, employment, medical directorship, and professional services arrangements.
- Counseling on a wide variety of Medicare reimbursement issues, such as GME/IME, DSH, and provider-based arrangements, and appealing reimbursement disputes to administrative tribunals and federal courts.
- Advising on HIPAA compliance matter.
- Responding to government investigations and conducting internal reviews related to financial relationships with physicians, coding and billing questions, cost-reporting issues, and quality of care issues.
- Responding to MAC, ZPIC, and RAC audits and handling administrative appeals before various agencies and at different levels.
- Developing and implementing compliance programs that address areas such as physician self-referral (Stark) and antikickback prohibitions, RAC readiness, privacy and information security, tax-exempt status, and regulatory compliance.
- Supporting clinical research activities, including IRBs, Clinical Trial Agreements, research grants, billing issues, and FDA matters.
- Establishing effective business combinations, such as mergers, acquisitions, restructurings, divestitures, and joint ventures.
- Serving as general outside counsel to address those issues that confront hospital lawyers, executives, and compliance officers on a day-to-day basis.
Many of our attorneys have spent their entire careers representing clients in the healthcare industry (our team includes former government prosecutors, OIG attorneys, and lawyers who have worked "in house") and have developed the technical experience and national perspective necessary to assist healthcare clients conducting business in one of our nation's most highly regulated industries. We also appreciate the vital role healthcare institutions play in our economy and the financial challenges facing many healthcare providers, and strive to furnish innovative, cutting-edge legal services in a timely and cost-effective manner.
Accountable Care Organizations
We are working with a health system that is participating in the Brookings-Dartmouth ACO Pilot Project, as well as other hospitals and health systems considering creating and/or participating in an ACO. We have reviewed and are preparing comments on behalf of clients on CMS' proposed regulations addressing ACOs and their participation in the Shared Savings Program, and we will be closely following these development and advising clients regarding changes that may affect their ACO strategies. We work with healthcare providers to assess and advise regarding possible implications of the existing fraud and abuse laws on ACOs and stand ready to assist them in structuring their arrangements with other healthcare providers and practitioners in ways that will comply with the fraud and abuse laws. Our HIPPA and data privacy attorneys routinely advise clients on issues of information technology and electronic medical records upkeep, which are of critical importance to the success of ACOs.