Who we serve

Nelson Hardiman is driven to solve the toughest challenges of ambulance and medical transport industry-wide. We harness our in-depth knowledge of healthcare law to represent California ambulance companies and other medical transportation businesses, including wheelchair and stretcher van companies.

We have a keen grasp of the multiple layers of regulatory and statutory oversight governing ambulance and medical transport services in California and have advised on virtually every legal aspect of medical transportation. Our team of experienced healthcare attorneys counsel ambulance and other medical transport companies to meet business, regulatory, and strategic challenges at every phase of their business life cycle. We apply our strategic understanding of the underlying issues to navigate the complications resulting from healthcare reform and the challenges of doing business in the highly regulated healthcare industry.

Our Work Includes:

• Ambulance Transportation Agreements Negotiated contractual agreements with skilled nursing facilities, hospitals and other providers.
• Business Transactions Structured transactions involving sale and change of ownership.
• Documentation Provided documentation and claims processing solutions for documenting medical necessity, including non-emergency medical transports and dialysis clinic related transports.
• Fraud and Abuse Represented a large ambulance company in a government fraud investigation and response to subpoena involving over a million documents, and created cost-analyses to rebut government theories of false claims liability.
• Healthcare Reform Modified provider business plans and implemented new policies and procedures to comply with Medicare/Medi-Cal regulations.
• Medi-Cal Handled Medi-Cal fraud and abuse investigations by the Department of Health Care Services Audits and Investigation Unit.
• Medicare Defended Medicare fraud and abuse investigations by Safeguard Services, Office of Inspector General, and the Federal Bureau of Investigations.
• Medicare/Medi-Cal Counseled medical transport companies on reimbursement audits and investigations by private and government payors, including Medicare and Medi-Cal.
• Wrongful Termination Represented an ambulance company in a lawsuit against its outsourced human resource provider and liability insurer due to their failure to defend and indemnify the ambulance company in a wrongful termination lawsuit.

Nelson Hardiman is at the forefront of issues affecting the diagnostic imaging and testing industry and provides legal representation across the full spectrum of business regulatory and compliance issues. As the government continues to investigate and prosecute fraud and abuse within the diagnostic imaging and testing arena, we ensure that facilities rise to the challenge of maintaining compliance across a multitude of coverage, billing and coding rules and regulations.

Our experienced attorneys are masters of regulatory compliance. We understand and advise on the issues impacting the diagnostic imaging and testing industry as facilities work to control cost, integrate delivery systems and adapt to industry-wide changes fueled by increasingly stringent anti-fraud efforts. We provide our clients with essential counsel to stay in synch with the shifting regulatory climate and represent our clients before a variety of state and federal agencies, giving them peace of mind and a clean bill of regulatory health.

Our Work Includes:

• False Claims Act Successfully defended a histocompatibility laboratory against a whistleblower charge of Medicare claims for duplicative and redundant tests to determine the risk that a kidney transplant would be rejected.
• Fraud & Abuse Successfully defended Special Investigative Unit (SIU) investigation brought by insurance carrier alleging worker’s compensation billing fraud on behalf of prominent imaging facility.
• Mergers & Acquisitions Developed 50 state post-acquisition regulatory filing plan for large diagnostics company.
• Reimbursement Represented diagnostic imaging and testing providers on reimbursement audits and investigations by private and government payors.
• Stark & Anti-Kickback Statute Counseled on compliance issues for diagnostic imaging companies.
• Teleradiology Compliance Advised national teleradiology provider on compliance program for corporate practice of medicine issues in all “corporate practice” states.

Nelson Hardiman knows the durable medical equipment (DME) space and provides DME companies with turnkey legal counsel across a wide range of business, regulatory, and strategic challenges. In the face of escalating compliance issues, we help durable medical equipment companies provide a lifeline for people who depend on medical equipment for critical life-saving issues and day-to-day living needs.

We work with DME providers that provide mobility assistance equipment, hospital beds, oxygen equipment, prosthetics, orthotics and related supplies to ensure compliance with all state and federal laws. Our deep healthcare experience makes us hyper-aware that DME companies are vulnerable to allegations of fraud and abuse. We proactively help our clients identify and address potential issues and stay ahead of such charges to keep their businesses on track and operating smoothly.

Our Work Includes:

• Business Transactions Counseled on business formations, including drafting purchase and sale, wholesale and employment agreements.
• DME Compliance Consulted on licensing, operational, and reimbursement compliance, Medicare and Medi-Cal enrollment and changes of ownership, HIPAA and state patient data privacy and security requirements.
• False Claims Act Managed civil defense and general business litigation about fraudulent prescriptions for durable medical equipment and false documentation to support fraudulent claims.
• Fraud and Abuse Defended reimbursement audits by private and governmental payors and their contractors, and fraud and abuse investigations by government payors and their contractors.
• Litigation Handled Medicare enrollment and claim denial appeals, overpayment appeals involving power wheelchairs, electric hospital beds, infusion drugs and supplies, etc., exclusion and suspension appeals.

Our understanding of the healthcare industry’s regulatory landscape and trends gives Nelson Hardiman significant insight into the complex legal issues impacting medical laboratories. Independent clinical labs and those affiliated with hospitals and health systems are equally affected by ever-changing regulations and managed care contracting challenges. Nelson Hardiman has the knowledge and experience to ensure laboratories remain compliant and stay in business.

Whether you are concerned about the increasing frequency of audit activity, struggling to manage Medicare and Medicaid payment contracts, or challenged by the requirements and potential pitfalls of providing direct-to-consumer testing services, we have your back. Our team of experienced healthcare attorneys offer hands-on assistance tackling the most complex regulatory, business and strategic issues for healthcare and life sciences laboratories.

Our Work Includes:

• Arbitration Obtained a favorable settlement for a laboratory group in arbitration brought against a managed care plan to recover payments for pathology services and testing.
• Audits Provided strategic counsel on mitigating audit risk and effectively handled audit responses.
• Business formation Prepared essential documents required for a company setting up multiple laboratory businesses. Documents included articles of incorporation, bylaws, operating agreements, management services agreements and IP licensing agreements.
• FDA Investigation Defended FDA investigation of national clinical laboratory and persuaded FDA to refrain from action based on adoption of corrective action plan and compliance program.
• Laboratory Acquisitions Counseled laboratory acquisitions, handling CHOWs and regulatory approvals.
• Licensure and Certification Advised on licensure, certification and/or related matters with respect to laboratories.
• Merger & Acquisition Represented a large dermatology practice, including a dermatopathology lab, in an approximately $15 million acquisition. The complex transaction required a complicated series of financial tranches structured to meet tax and regulatory requirements.
• Regulatory Compliance Counseled on all regulatory aspects of healthcare for a laboratory client.

Nelson Hardiman understands the myriad laws and regulatory hurdles impacting pharmacies in an era of rapid growth and change for the healthcare industry. Fueled in part by the digital health revolution, new prescription standards and privacy and security requirements compound the challenge for digital and traditional pharmacies nationwide.

Our healthcare team, including attorneys from our transactional and litigation practices, focuses on long-term strategies and solutions for pharmacies, including retail pharmacies, compounding pharmacies, and long-term care pharmacies, in business and regulatory matters. We also represent re-packagers, pharmacy benefit managers (PBM’s), wholesalers, and individual pharmacists and pharmacy personnel, giving us experience across the broad spectrum of legal issues encountered by the pharmacy industry.

Our Work Includes:

• Benefits Dispute Represented a national provider of pharmacy services and a patient in federal lawsuit brought against insurer for denial of IVIG treatments.
• Board of Pharmacy Handled investigations and enforcement proceedings.
• Business Transactions Advised on the formation of entities, business structures and purchase/sale agreements for pharmacies and pharmacy-related entities.
• California Department of Healthcare Services Obtained favorable resolution for pharmacy by appealing audit findings of the California Department of Healthcare Services.
• HIPAA Consulted on HIPAA and state patient data privacy and security requirements.
• Licensure and Certification Advised on licensure, certification and/or related matters with respect to pharmacies.
• Litigation Defended regulatory compliance issues, reimbursement disputes, and business litigation, including partnership disputes.
• Management Service Organization (MSO) Worked with MSOs in connection with pharmacy business operations and other relationships.
• Pharmacy Acquisitions Counseled on pharmacy acquisitions, handling CHOWs and regulatory approvals; counseled on 340B program requirements for structuring cash flows in certain pharmacy acquisitions.
• Regulatory Compliance Researched and wrote comprehensive guidelines on behalf of a client that wanted to close a pharmacy and relinquish its license.
• Reimbursement Handled recovery audits by governmental payors, including Medicare and Medi-Cal Third party payor audits.

For more information or to speak with an attorney, please call 877.246.6423 or submit a contact form: