Howard J. Young

Clients turn to Howard for complex compliance and strategic business issues, internal and government investigations, self-disclosures, False Claims Act (FCA) qui tam litigation, and US Department of Health and Human Services (HHS) Office of Inspector General (OIG) inquiries and the negotiation of and compliance with corporate integrity agreements  (CIAs). Howard regularly advises strategic and private equity investors on the healthcare regulatory aspects of transactions, affiliations, and joint ventures.

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 device manufacturers and suppliers, telehealth providers, healthcare vendors and digital health companies, pharmacy benefit managers (PBMs), health plans, and distributors.

As a former senior managing lawyer with the HHS OIG, Howard has experience advising and litigating on OIG and state exclusion matters, and successfully litigated the only instance in which a federal court reversed an OIG exclusion action. He also assists clients responding to program integrity actions of the Centers of Medicare & Medicaid Services (CMS) contractors, such as the unified program integrity contractors (UPICs) and Supplemental Medical Review Contractor, regarding audits and billing revocation and payment suspensions. During the COVID-19 pandemic, Howard advised a wide array of healthcare organizations on federal and state waivers, Coronavirus Aid, Relief, and Economic Security (CARES) Act grant issues, OIG audit readiness, and OIG response issues.

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 teams. Howard also serves on the board of directors of the Elea Institute, a foundation that leads national efforts to expand access to high-quality hospice and palliative care in support of patients, caregivers, and healthcare providers through research, educational resources, grants and other initiatives.

• Advises national, regional and community hospice and palliative care organizations and industry trade groups on Medicare and Medicaid regulatory matters, transactions, audits, government investigations, and administrative appeals.
• Lead counsel to various hospice providers on federal and state government investigations and audits of hospice eligibility, levels of care (GIP and CHC), and associated Medicare and Medicaid billing issues. Howard advises on effective subpoena/CID response, coordination with senior management, and managing of clinical experts related to record reviews. Howard also has advised numerous hospices and home healthcare organizations to successfully resolve qui tam FCA complaints and litigation. 
• Lead counsel for Walgreens in resolving multiple qui tam complaint investigations related to Medicare and Medicaid billing issues, resulting in favorable settlements with the US Department of Justice (DOJ) and states. Also served as counsel to the company on several OIG CIAs in connection with multiple FCA settlements. 
• Obtained a federal and state government declination and complete dismissal of a qui tam whistleblower complaint in a nationwide investigation of a national retail pharmacy following complex CID subpoena response related to pharmacy billing and Drug Utilization Review issues.
• Advise providers and suppliers regarding potential repayment obligations to Medicare, Medicaid, other government-funded programs and commercial insurers, including potential assessment of FCA liability.
• Represented national pharmacy company in qui tam investigation of manufacturer co-pay coupon matters and medication therapy management services, and obtained government declination, followed by de minimis settlement after successful litigation with relators.
• 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.
• Represents retail and specialty pharmacies on a wide range of state and federal regulatory matters, including board of pharmacy and DEA oversight, controlled substance compliance, Medicare and Medicaid reimbursement matters, exclusion matters, internal investigations and compliance programs. 
• Advises several global medical device manufacturers with regard to various fraud and abuse compliance matters, government investigations, qui tam litigation, interactions with HCPs, and regulatory due diligence on transactions.
• 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 various post-acute care providers, including skilled nursing facilities, to resolve qui tam litigation, including intervened and declined qui tam matters.
• Represented providers in accountable care organizations (ACOs)–shared savings program and bundled payment arrangements and value-based enterprise arrangements.
• Advises digital health companies and medical device manufacturers on innovative programs to improve healthcare delivery through telehealth, remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM), including successful navigation of new Medicare coverage for RPM and RTM.
• Advises national and regional retailers and online retailers regarding new consumer-oriented healthcare delivery models.
• Advising private equity investors in the pain management, home health, hospice, pharmacy, vision care, wound care, sleep lab, dental services, addiction treatment, 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.
• Conduct independent compliance program assessments for various healthcare providers, investors, and lenders in connection with a large, national investor-owned hospital chain, national 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.
• Secured summary judgment dismissal of a major FCA 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 before OIG, administrative law judges (ALJs), and in federal district court.