We work with clients on regulatory compliance issues including antitrust; anti-fraud and abuse compliance and litigation; Medicare and Medicaid reimbursement matters; Meaningful Use audits, e-health and telemedicine; EMTALA; human subject research and patient care regulation; and exempt organization tax.
Anti-Fraud and Abuse and Federal Health Program Compliance and Litigation
We have extensive compliance experience with state and federal health program laws, and the strategic transactions that often raise issues of fraud and abuse compliance, such as joint ventures, leases, investments and physician employment and alignment strategies. With our managed care experience, we provide insight and advice about emerging fraud and abuse theories that are targeted to managed care and insurance arrangements.
Our client work in this area includes transaction-specific legal risk analysis, developing and implementing compliance programs, conducting internal investigations, and mitigating non-compliance situations, including self-disclosure reporting. We also have a white collar defense and corporate investigations practice ready to serve clients in litigation defense, including grand jury proceedings and qui tam actions.
EMTALA, Human Subject Research and Patient Care Regulation
Our lawyers guide clients through patient care regulatory issues including informed consent; use of patient restraints; public health reporting requirements; compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA); patient and resident rights; human subject research and Institutional Review Board compliance; Medicare conditions of participation; and state licensure.
Our health care litigators have defended clients against governmental claims and investigations involving patient care issues, including “quality of care,” medical necessity and EMTALA cases, and assisted clients in resolving such matters with the U.S. Health and Human Services Office of Inspector General and state Medicaid Fraud Control Units.
We have defended hospitals, health systems and pharmaceutical and device manufacturers in government investigations and False Claims Act litigation. We also have experience conducting internal investigations and advising on remedial actions. These compliance matters have involved numerous substantive Medicare and health law issues, including:
- Defending investigations and litigation alleging Anti-Kickback Statute and Stark Law violations
- Billing one-day length of stay patients (inpatient versus outpatient/observation status)
- Self-disclosures under OIG Self-Disclosure Protocol and CMS Stark Law Self-Disclosure Protocol
- PPACA provisions regarding reporting Medicare and Medicaid overpayments
- Billing for allegedly non-covered implantable cardiac devices (e.g., implantable defibrillators)
- Compliance with Corporate Integrity Agreements
- DRG/ICD-9 coding
- Transfer-discharge (patient disposition) coding
- Physician CPT coding
- Inclusion of disallowed costs on Medicare cost reports
- Billing by physicians for services of physician extenders (e.g., physician assistants and nurse anesthetists)
- Time and effort reporting on NIH grants
- Violations of Medicare conditions of participation
- Physician-at-Teaching-Hospital rules
- Billing for implantation of non-FDA-approved devices
- Hospital laboratory “unbundling” and other laboratory billing issues
- Transactions with board members/IRS intermediate sanctions
- Requests for advisory opinions from HHS-OIG
- Medicare outlier payments due to alleged excessive charges
- Setting charges and collecting from uninsured patients