Howard J. Young

Howard’s clients include a wide range of providers, including hospice and palliative care, home health, long term care, specialty and retail pharmacies, hospitals and academic medical centers, behavioral health providers, physician practices, vision care providers, medical suppliers, telehealth providers, healthcare vendors, pharmacy benefit managers (PBMs), health plans, and distributors. He also counsels private equity firms and lenders as well as pharmaceutical, biologic, and medical device manufacturers.

Howard represents healthcare clients that are the targeted by  federal and state investigations (many of them triggered by qui tam lawsuits) involving the False Claims Act (FCA), the Anti-Kickback Statute, the Civil Monetary Penalty Law, and the Stark Law, as well as quality of care, medical necessity, coding, and billing matters. He has successfully avoided Department of Justice (DOJ) intervention on many FCA investigations, and has successfully litigated FCA matters.

Howard also has experience advising and litigating on US Department of Health and Human Services Office of Inspector General (OIG) and state exclusion matters, and was successful as co-counsel on the only mandatory exclusion matter overturned in federal court. He also  assist clients responding to program integrity actions of Centers for Medicare and Medicaid Services (CMS) contractors, such as recovery audit contractors and zone program integrity contractors (ZPICs), to Center for Program Integrity billing revocation and Medicare payment suspension matters, as well as to HHS and state and OIG audits.

From 1997 to 2002, Howard was a senior attorney and Deputy Branch Chief with the HHS-OIG. There he coordinated with the DOJ, state attorneys general, and CMS on criminal and civil healthcare fraud matters. He negotiated, developed, and monitored hundreds of corporate integrity agreements (CIAs), and supervised a staff of OIG lawyers and analysts.

Howard frequently writes and presents on fraud and abuse and healthcare regulatory issues to major healthcare trade and professional associations as well as to clients’ executive teams, boards of directors, and sales and marketing personnel.

• Serving as lead counsel to various hospice organizations on federal and state government investigations of hospice eligibility, levels of care (GIP and CHC), and associated Medicare and Medicaid billing issues. Howard advises on complex and strategic subpoena response, careful coordination with senior management to ensure the hospice business continues during pendency of the investigation, and managing of hospice experts related to clinical record reviews.
• Obtained a federal and state government declination and complete dismissal of a qui tam whistleblower complaint in a nationwide investigation of a chain retail pharmacy following complex CID subpoena response related to pharmacy billing and Drug Utilization Review issues.
• Advises providers and suppliers, including retail pharmacy chains, regarding potential repayment obligations to Medicare, Medicaid, other government-funded programs and commercial insurers, including potential assessment of False Claims Act liability.
• Counsel in FCA litigation for a hospice in federal district court following DOJ intervention in a qui tam lawsuit on allegations related to clinical ineligibility of hospice patients, improper physician billing and improper face-to-face compliance, resulting in highly favorable out of court settlement.
• Represented a hospice seller in a complex arbitration proceeding related to sale of a hospice company to a private equity-backed hospice company, including a highly favorable resolution of an OIG self-disclosure related to various hospice compliance issues.
• Represent retail and specialty pharmacies on a wide range of state and federal regulatory matters, including board of pharmacy and DEA oversight, Medicare and Medicaid reimbursement matters, exclusion matters, internal investigations and compliance program matters.
• Obtained a declination and complete dismissal of a federal qui tam investigation of a dental management company following an innovative response to a DOJ civil investigative demand.
• Represented providers in accountable care organizations (ACOs)–shared savings program and bundled payment arrangements.
• Representing numerous hospices and home health agencies in connection with ongoing OIG self-disclosures, ZPIC audits, MFCU audits and related overpayment appeals.
• Representing hospice and home health providers on purchase and sale transactions.
• Advising private equity investors in the pain management, home health, hospice, pharmacy, vision care, wound care, sleep lab, outpatient services, urgent care clinic and telehealth sectors.
• Served as lead counsel in the successful representation of two hospitals in a large healthcare system to settle a qui tam investigation for considerably less than the government was seeking, and with no CIA, of Medicare inpatient short stays for kyphoplasty.
• Conducted independent compliance program assessments for various healthcare providers, investors, and lenders in connection with a large, national investor-owned hospital chain, home health agency chain, behavioral health companies, several large and midsized hospice organizations, and multiple retail and specialty pharmacy companies.
• Represented a national PBM organization in connection with a first of its kind CIA and resolution of a government investigation.
• Advising healthcare providers, pharmaceutical companies, and medical device manufacturers on CIA negotiation and CIA monitoring matters.
• Served as lead counsel to a not-for-profit hospital on CMS Physician Self-Referral Protocol disclosure (Stark Law).
• Secured summary judgment dismissal of a major False Claims Act lawsuit, following intervention by the DOJ, for a durable medical equipment supplier of wound care mattress overlays after extensive discovery. The decision was upheld on appeal to the US Court of Appeals for the Fifth Circuit. (US ex rel. Carter v. Medica-Rents).
• Defending physicians and other individuals, including healthcare executives, on OIG exclusion matters, including before ALJs and in federal district court.