Aviva Morady

Regulatory Compliance

• Facility Licensure Obtained initial state licensure for addiction treatment facilities, social rehabilitation facilities, group homes, home health agencies, pharmacies, durable medical equipment providers, primary care clinics, and clinical laboratories in California and across the country.
• Changes of Ownership Provided regulatory licensing and enrollment advice in the acquisitions of addiction treatment facilities, hospice agencies, home health agencies, pharmacies, durable medical equipment providers, and clinical laboratories licensed in California and other states.
• Centers for Medicare & Medicaid Services Appeal Negotiated an extremely favorable settlement on behalf of a skilled nursing facility in a matter before The Centers for Medicare & Medicaid Services (CMS). Based on numerous deficiency findings by the California Department of Public Health (CDPH), CMS imposed a civil monetary penalty and a denial of payment for new admissions on our client. Brought in at the appeals stage, we negotiated a 50% reduction of the civil penalty, amended the survey report to reduce the scope and severity of the violations, and included a complete rescission of the denial of payment on new admissions, which would have resulted in severe financial loss for the facility.
• Compliance Programs Successfully guided medical device manufacturing company through California Department of Public Health investigation and developed standard operating procedures to ensure future compliance with all relevant regulations.
• Compliance Programs Counseled behavioral health providers on day-to-day operations and compliance with the Eliminating Kickbacks in Recovery Act (“EKRA”).
• Compliance Programs Advised clients on compliance with the Anti-Kickback Statute and the Stark Law.

Medicare/Medicaid/Medi-Cal

• Reinstatement Successfully petitioned the Office of Inspector General for reinstatement of an excluded physician into federal and state healthcare programs.
• Medicare Enrollment Successfully appealed the suspension of a physician’s Medicare enrollment and billing privileges.
• Pharmacy Acquisition Nelson Hardiman performed the regulatory due diligence, licensing and enrollment work for a pharmacy acquisition involving six brick and mortar pharmacies licensed in 50 states. The pharmacies were acquired for approximately $60 million and required the preparation and submission of more than 100 state licensing, Medicaid, Medicare, DEA and NCPDP applications. The large acquisition required the development and management of a complex timing status and strategy based on differing rules and regulations in each state to achieve a smooth close that did not negatively impact the pharmacies’ operations or reimbursement flows.
• Pharmacy & Home Health Acquisition Nelson Hardiman provided regulatory licensing and enrollment advice on a $163 million acquisition of a Home Health Agency (HHA) and two specialty infusion pharmacies that operate in 47 states. The NH team performed the nationwide research and logistic guidance necessary to comply with the regulatory filing and operations requirements applicable in all 47 states and successfully helped to ensure the transaction did not cause any disruptions in service to the current patients or negatively impact reimbursements applicable for those services.
• Hospital Bankruptcy & Sale Lead regulatory counsel to a large health system in its Chapter 11 bankruptcy case, the largest hospital bankruptcy in U.S. history. The matter has involved corporate and regulatory support for the system’s day-to-day operations as well as extensive regulatory work on the sale of the system’s six hospitals, including counsel regarding California attorney general conditions and approval process.
• Telehealth Regulations Advised a telehealth company regarding regulatory and operational issues for providing telemedicine services across state lines.

Reimbursement

• A major health insurer refused to pay numerous addiction treatment centers alleging fraudulent activity. Nelson Hardiman stepped in and negotiated confidential settlement agreements whereby our clients received payment for their claims and the insurer released their claims against our clients. We achieved this favorable result efficiently and cost-effectively without having to file expensive and time-consuming lawsuits, in large part, because of our deep industry knowledge and prior experience negotiating with the health insurer’s counsel.
• Represented addiction treatment centers in appealing third-party payors’ denials of benefits and/or overpayment demands.
• Represented addiction treatment center in successfully appealing a denial of benefits to the United States Office of Personnel Management.
• Resolved reimbursement dispute between residential addiction treatment facilities and Fortune 100 health insurance company.
• Negotiated favorable resolutions for healthcare providers investigated by insurance companies’ Special Investigations Units (SIU).

Litigation

• Complex Business Litigation Represented a national health system in a contract dispute with another health system and its management company involving an unsuccessful purchase of five financially distressed nonprofit hospitals. Our client was unable to move forward with the purchase of the hospitals because the Attorney General of California imposed conditions on the transaction that made it financially unfeasible to turn around the failing hospitals. The seller sued our client for allegedly breaching the contract by pulling out of the transaction and sought $40 million in liquidated damages plus attorneys’ fees and prejudgment interest. Our client countersued because the seller refused to release millions of dollars that had been deposited in escrow. The case turned on the economic impact of the AG’s conditions, which involved complex issues of hospital operations and finances. The case settled favorably for our client on the day before trial.
• False Claims Act Won a False Claims Act case decisively resolved on summary judgment for a large Southern California hospital. Two whistleblowers from a rival laboratory alleged that the hospital’s kidney transplant program had submitted millions of dollars of Medicare claims for duplicative and medically unnecessary histocompatibility testing for transplant candidates. After extensive discovery and numerous expert depositions, we moved for summary judgment on the ground that evidence of a good faith dispute about evolving testing standards cannot form the basis of an FCA case. The district court entered judgment in the hospital’s favor, holding that no jury could reasonably find that the hospital’s testing claims were false.