Health Care Regulatory
Overview
We assist clients with health care regulatory matters and compliance issues. Our regulatory representation for both federal and state issues is comprehensive, and includes:
- Medicare/Medicaid certification
- Provider Reimbursement Review Board representation
- Provider licensure, disciplinary proceedings, registration certification and survey requirements
- Reimbursement, coverage, benefit and billing issues
- Utilization review/Professional Review Organization (PRO) matters and utilization risk management
- State licensure and/or Medicare/Medicaid change of ownership
- Joint Commission (formerly known as JCAHO) and other accreditation organizations survey, appeal and review requirements
- State and federal emergency care services and Emergency Medical Treatment and Active Labor Act (EMTALA) requirements
- National Practitioners Data Bank reporting requirements
- 340b program
- Registration, termination and enforcement actions involving controlled substance registrations with the Drug Enforcement Agency and Texas Department of Public Safety
- Advice regarding potential diversion of controlled substances and required reporting
Our representative projects include:
- Representation of a publicly traded, national assisted living provider in health care regulatory matters, including changes of ownership following acquisitions of additional assisted living facilities.
- Representation of a national company that provides medical screenings in handling health care regulatory matters in Texas, Louisiana, California and Washington, D.C. and advising in general health law matters.
- Representation of three of the largest regional home health agencies in the Southwest in all of their health care regulatory matters, including compliance, Medicare and Medicaid reimbursement, HIPAA and adverse actions by the Texas Department of Aging and Disability Services.
- Representation of a regional pharmacy on licensure, accreditation, and Medicare/Medicaid reimbursement matters.
- Representation of an HIV specialty pharmacy on compliance with 340b and Medicare Part D matters.
- Representation of non-profit health care accreditation company on Medicare supplier accreditation matters.
- Representation of multiple infusion pharmacies on licensure and regulatory matters.
- Representation of a pharmacy regarding reporting and necessary steps following a diversion or theft of controlled substances and prescription pads.
- Representation of a pharmacy and chief pharmacist before the Texas Board of Pharmacy.
Fraud & Abuse / Stark Law & Illegal Remuneration
We help health care clients structure contracts, joint ventures and other transactions to comply with Stark Law, state and federal fraud and abuse laws, and other related state and federal laws. Our attorneys also have extensive experience dealing with government investigations, audits and claims disputes. We advise clients about sanctions, civil money penalties, false claims and qui tam matters. Our attorneys are experienced at analyzing health care transactions for compliance with:
- Medicare and Medicaid anti-kickback statutes
- Health care fraud investigations and enforcement
- Physician self-referral prohibitions
- Federal and state patient anti-dumping requirements
- State regulatory anti-referral initiatives
Locke Lord’s fraud and abuse counsel also includes:
- Defense of criminal and civil matters involving the fiscal intermediary/carrier, Medicare, Medicaid and third party payer fraud units.
- Enforcement actions by the Office of Inspector General, the Centers for Medicare and Medicaid Services (CMS) and state and U.S. Attorneys offices.
- Payment and reimbursement matters relative to Medicare/Medicaid and third party payers.
- Federal and state anti-kickback advice, as well as advice on advisory opinions and safe harbor protection.
Our representative projects include:
- Representation of health care system in internal investigation regarding allegedly improper financial arrangements and implementation of improved compliance program.
- Conducting audits and advice for numerous physician groups on effective corporate compliance and governance practices.
- Representation of health care providers in voluntary reporting and related submissions to government pertaining to internal whistleblower complaints.
- Representation of home health care providers in corporate investigation involving various compliance issues.
- Representation of managed care plans in structuring of physician incentive plans.
- Conducting compliance audits for pharmacies and durable medical equipment suppliers.
Publications
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