Donald H. Romano

Of Counsel

Overview

Don Romano is of counsel and a practicing health care lawyer with Foley & Lardner LLP. Mr. Romano has extensive experience counseling hospitals, skilled nursing facilities and academic medical centers and health systems on compliance, reimbursement and litigation issues involving the complex array of federal regulations governing relationships with physicians. He counsels clients on payment issues relating to the Medicare and Medicaid programs, and regulatory compliance matters, particularly those pertaining to the Anti-Kickback Statute, the physician self-referral statute (Stark Law), HIPAA, and the Medicare enrollment regulations.

Prior to joining Foley, Mr. Romano was a partner in another D.C. based law firm, and prior to that he had over 25 years of experience in the Department of Health and Services, including as a senior attorney in the Office of General Counsel. In that capacity, Mr. Romano provided program advice on a wide variety of issues affecting the Medicare and Medicaid programs, and handled major litigation affecting those programs. Mr. Romano was also a division director in the Centers for Medicare & Medicaid Services (CMS), In this role, his responsibilities included the development of regulatory policy for the physician self-referral (Stark) law, the anti-mark-up payment limitation for diagnostic tests, transplant center certification and decertification, assignment and reassignment, private contracting, boutique medicine, mandatory claims filing, Provider Reimbursement Review Board appeals procedures and various statutory payment exclusions. Mr. Romano is one of the very few practicing attorneys with CMS policy-making experience.

Recognition

Mr. Romano was recently recognized by The Legal 500 for his work in the area of health care – service providers (2015 and 2016). He has received several awards from HHS and CMS, including the Secretary’s Award for Distinguished Service, the Department’s highest individual award.

Education

Mr. Romano joined HHS as an attorney after graduating from the University of Baltimore Law School (J.D., 1984), where he was a member of Law Review. He obtained his Bachelor of Arts from Towson State University in Maryland.

Selected Publications and Presentations

Mr. Romano is a frequent author on health law topics and speaker at national conferences on Medicare and Medicaid issues. His most recent articles and presentations include:

Articles

  • "The Medicare Enrollment Process—CMS’s Most Potent Program Integrity Tool," co-author, ABA’s The Health Lawyer, April 2011
  • "Manufacturer Payment Sunshine Provisions under PPACA: New Reasons to Substantiate Payments as to Fair Market Value," co-author, AHLA’s Life Sciences, December 2010 
  • "DME Surety Bonds - Only the Beginning of New Pay to Play Requirements?" AHLA's The RAP Sheet, June 2010
  • "The Fraud and Abuse Laws That Compliance Professionals Need to Know," Compliance Today, March 2010
  • "Self-Referral of Imaging and Increased Utilization: Some Practical Perspectives on Tackling the Dilemma," Journal of the American College of Radiology, November 2009
  • "What to Do When Your Recruitment Agreement Leaves Town," AHLA Connections, October 2009
  • "Self-discovered Overpayments: Do I Have to Give the Money Back?" Journal of Health Care Compliance, September/October 2009
  • "A Fresh Look At The CMP Statute: It May Not Be As Proscriptive For Gainsharing Arrangements As The OIG Believes," American Health Lawyers, March 6, 2009
  • "The New 2009 Physician Fee Schedule: Key Changes in Connection With Furnishing, Billing for Diagnostic Tests But No Stark Gainsharing Exception," co-author, BNA's Health Law Reporter, Vol. 17, No. 47, December 4, 2008

Presentations

  • "What to Tell Your CEO and Board About Compliance," HCCA's 16th Annual Compliance Institute, Orlando, FL (April 2011)
  • "Compliance in the Age of Electronic Health Records," HCCA's 15th Annual Compliance Institute, Orlando, FL (April 2011)
  • "Advanced Provider and Supplier Enrollment: Pulling it all Together," AHLA Medicare and Medicaid Institute, Baltimore MD (March 2011)
  • "The Year in Review," AHLA Medicare and Medicaid Institute, Baltimore MD (March 2011)
  • "Stark Basics," ABA (February 2011)
  • "Final Physician Supervision Rules for Hospital Outpatient Services," AHLA (January 2011)
  • "Co-Management Arrangements in Healthcare on the Rise: Complying with Legal and Regulatory Requirements in Structuring Hospital-Physician Arrangements," Strafford Publications (December 2010)
  • "PPACA Fraud and Abuse Provisions," Maryland State Bar Association, Ellicott City, MD (December 2010)
  • "Managing Stark Law Risks Under Health Care Reform," Michigan State Bar Association (December 2010)
  • "To Disclose or Not to Disclose: An Analysis of the New CMS Voluntary Self-Disclosure Protocol," ABA (November 2010)
  • "Legal Constraints on Joint Ventures Between Hospitals and Physicians," Louisiana State Bar Association, New Orleans, LA (November 2010)
  • "Health Care Reform: The New Program Integrity Provisions," Louisiana State Bar Association, New Orleans, LA (November 2010)
  • "Physician Self-Referral Disclosure After PPACA: Navigating New Stark Law Complexities Following Healthcare Reform," Strafford Publications (October 2010)
  • "Rain with a Chance of Hail: The Post-PPACA Healthcare Enforcement Environment," (2010)
    Texas Health Law Conference, Austin, TX (October 2010)
  • "Physician Payments Under PPACA's Sunshine Provisions and State Law Government in the Sunshine Act," Strafford Publications (October 2010)
  • "Legal Considerations for Physician Compensation Arrangements," American Academy of Orthopedic Surgeons, Chicago, IL (September 2010)
  • "Legal Considerations for Physician Compensation Arrangements," American Academy of Orthopedic Surgeons, Chicago, IL (September 2010)
  • "The Post-PPACA False Claims Act and Health Care Enforcement Environment," Strafford Publications (June 2010)
  • "DME Surety Bonds-- Only the Beginning of New Pay to Play Requirements?" AHLA's The RAP Sheet (June 2010)
  • "Healthcare Reform's Immediate Impact on Hospitals and Providers: Prepare Now to Comply With the Tough New Program Integrity Provisions," Strafford Publications (May 2010)
  • "The Impact of the PPACA on Fraud and Abuse Issues," ABA (May 2010)
  • "Stark Basics," ABA 20th Annual Conference on Health Care Fraud, Miami, FL (May 2010)
  • "Co-Management Arrangements: Legal, Structural and FMV Implications," AHLA (May, 2010)
  • "The Hospice and Nursing Home Partnership: How to Get it Right!" HCCA's 15th Annual Compliance Institute, Dallas, TX (April 2010)
  • "Program Integrity and Enrollment Initiatives affecting DMEPOS & Other Providers and Suppliers," AHLA Institute on Medicare and Medicaid, Baltimore, Maryland (March 2010)
  • "The RAP Practice Group's Year in Review," AHLA Institute on Medicare and Medicaid, Baltimore, Maryland (March 2010)
  • "Basic Stark," ABA (February 2010)
  • "Physician Recruitment: Ensuring Stark Compliance," Strafford Publications (January 2010)

Admissions and Professional Memberships

Mr. Romano is admitted to practice in the District of Columbia, Maryland and Massachusetts. He is past chair of the ABA’s Healthcare Fraud & Compliance Interest Group and past vice chair of the AHLA’s Regulation, Accreditation and Payment Practice Group. He is also a member of the AHLA’s Accountable Care Organization task force.

Representative Matters

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Filed an amicus brief with the U.S. Supreme Court on behalf of the American Immigration Lawyers Association supporting a Petition for a Writ of Certiorari challenging a Ninth Circuit ruling granting Chevron deference to U.S. Department of Homeland Security regulations inconsistent with the Asylum Statute and associated International Law.
Filed an amicus brief with the U.S. Supreme Court on behalf of the American Immigration Lawyers Association supporting a Petition for a Writ of Certiorari challenging the statutory grounds for expedited removal in asylum cases involving changed circumstances.
A team of Foley lawyers represented New York private equity firm Clayton Dubilier & Rice in conducting the health regulatory due diligence and advising in connection with a $910 million deal to take Healogics Holding Corp., the largest advanced wound care services provider in the U.S., from Metalmark Capital and Scale Venture Partners.

Capabilities