Health care compliance is about more than the Affordable Care Act and goes well beyond FDA regulation. Medicare reimbursement rules implicate payment issues and can lead to government actions and whistleblower suits under the federal False Claims Act. Today’s atmosphere of mergers and acquisitions among hospitals and doctor groups raises issues under the competition and Stark self-referral laws and the Anti-Kickback Statute. A reckless violation of any of those laws can result in triple damages, large penalties, exclusion from federal program reimbursement, and even criminal prosecution. And the scrutiny does not end with Medicare and Medicaid. Even private insurance billing violations, if found to be willful, can result in criminal enforcement action and loss of the ability to submit claims for insurance payment.
Add to that HIPAA and other federal regulations, state medical board, licensing, and prescribing requirements, and the result is a complex set of compliance priorities that can keep doctors and other health care professionals from doing what they do best: practice medicine.
Calfee attorneys regularly work with and advise health care provider compliance committees and professionals, prepare compliance plans and policies, establish systems to ensure timely contract renewals and renegotiations, and are there to help when a problem arises. We represent and counsel hospitals, doctors, pharmacy providers, long-term care facilities, and other providers, as well as medical device companies in compliance, licensing, negotiation, litigation and enforcement actions. We also represent companies embroiled in litigation concerning FDA-regulated products.
We counsel clients regarding compliance with the following:
- Medicare reimbursement issues
- False Claims Act
- Stark law
- Anti-Kickback Statute
- HIPAA matters
- Affordable Care Act
- Federal and state licensing boards
- FDA-regulated products including medical devices
- SEC, anti-trust, and other merger and acquisition client matters for health care facilities and practices