Donald H. Romano

Of Counsel

Overview

Donald H. Romano is of counsel and a practicing health care lawyer with Foley & Lardner LLP. Don 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, Don 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, Don provided program advice on a wide variety of issues affecting the Medicare and Medicaid programs, and handled major litigation affecting those programs. Don 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. Don is one of the very few practicing attorneys with CMS policy-making experience.

Recognition

Don has received several awards from HHS and CMS, including the Secretary’s Award for Distinguished Service, the Department’s highest individual award.

Education

Don 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

Don 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

  • Author, “Unlawful, Unfair and Unwise: Constitutional and Rulemaking Infirmities In CMS’s Enrollment Revocation Regulations and how to Challenge Them,” American Bar Association’s The Health Lawyer (August 2019)*
    * Winner of 2020 Burton Award/Law360 Distinguished Legal Writing Award
  • Co-author, “The Alphabet Soup of Medicare and Medicaid Contractors”, Chapter 9, Physician Law: Evolving Trends and Hot Topics 2019, (with Jessica Lamanna and Emily Wein), ABA (2019)
  • “Medicare Requirements for Hospital Provider Agreements: Sub-Regulatory Guidance on ‘Primarily Engaged in Providing Inpatient Services,’” AHLA’s The RAP Sheet (March 2018)
  • “How Safe are The Safe Harbors? An In-Depth Look at Statutory and Regulatory Exceptions to the Anti-Kickback Statute,” ABA’s The Health Lawyer (December 2017)
  • Co-author, “The Alphabet Soup of Medicare and Medicaid Contractors,” (with Jennifer Colgiovanni), ABA’s The Health Lawyer (August 2015)
  • Co-author, “Medicare Administrative Litigation,” (with Melissa A. Hudzik and Brian D. Schneider), Chapter 14, HealthCare Litigation and Risk Management, PLI (2015)
  • Editor, “What is . . . Stark Law?,” ABA
  • Co-author, “Hospital Billing under Medicare Part B Following a Denial under Part A” (with Katherine Kraschel) AHLA’s The RAP Sheet (June 2013)
  • “Conditions for Coverage and Payment,” Chapter 9, Medicare and Medicaid Law, Thomas W. Coons, ed. (AHLA rev. ed. 2013)
  • Co-author, “Navigating the Stark Self-Referral Disclosure Protocol,” (with Torrey Young), AHLA’s The RAP Sheet (March 2012)
  • “Provider and Supplier Enrollment: The New Compliance Frontier for Providers and Suppliers,” Chapter 3, 2012 Health Law and Compliance Update, John Steiner ed., Wolters Kluwer (January 2012)
  • Co-author, “The SRDP – The Newest Component to the Stark Equation,” (with Torrey Young), Advisory Board Company (December 2011)
  • Co-author, "The Medicare Enrollment Process—CMS’s Most Potent Program Integrity Tool," (with Adrienne Dresevic)ABA’s The Health Lawyer (April 2011)
  • Co-author, "Manufacturer Payment Sunshine Provisions under PPACA: New Reasons to Substantiate Payments as to Fair Market Value," 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)
  • Author, "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)
  • Co-author, "The New 2009 Physician Fee Schedule: Key Changes in Connection With Furnishing, Billing for Diagnostic Tests But No Stark Gainsharing Exception," BNA's Health Law Reporter, Vol. 17, No. 47 (December 4, 2008)

Presentations and Speaking Engagements

  • Virtual Conference, “Stark and Anti-Kickback Update,” 2020 Texas Health Law Conference (October 2020)
  • “Overview of the New Proposed Stark Exceptions and AKS Safe Harbors,” Louisiana Bar Association, New Orleans, LA (December 6, 2019)
  • Webinar, “Head Start: What You Need To Know Now About the Newly Proposed AKS Regulations,” ABA/OIG (November 5, 2019)
  • Webinar, “Forming Physician Super Groups: Structural and Regulatory Challenges,” Strafford Publications (October 8, 2019)
  • “Physician Compensation Issues in The New Value-Based World,” ABA Physicians’ Legal Institute, Chicago, IL (September 2019)
  • “Stark Law and Anti-Kickback: Update and Examples,” U of Texas Health Law Conference, Houston, TX (March 2019)
  • “Alternative Payment Models and Related Regulatory Issues: Stark Law, Anti-Kickback Statute, Gainsharing, PIP, MLR,” Strafford Publications (December 2018)
  • “Current Risks, Enforcement and Rulemaking Initiatives in Fraud & Abuse,” Florida Bar Association Orlando, FL (November 2018)
  • “Compliance Update: CMS and OIG RFIs; 60-Day Rule Takes a Hit; and Is Congress Ready to Act?” Louisiana Bar Association, New Orleans, LA (November 2018)
  • “So you want to be a Super Group? How do you get there and then what?” ABA Physician Legal Institute, Chicago (September 2018)
  • Webinar, “Co-Management Arrangements in Healthcare: Latest Developments,” Strafford Publications (December 2017)
  • “Compliance Programs and Investigations in Health Care Organizations,” Practising Law Institute, New York, NY (December 2017)
  • “Revocations of Medicare Billing Privileges, Louisiana State Bar Association,” New Orleans, LA (November 2017)
  • “Stark and AKS Considerations for Physician Arrangements,” Louisiana Bar Association, New Orleans, LA (December 2016)
  • “Compliance Programs and Investigations in Health Care Organizations,” Practising Law Institute, New York, NY (December 2016)
  • “Anti-Kickback Statute and Stark Law Compliance in Managed Care Contracts: A Focus on the AKS Safe Harbors, Stark Exceptions, and the PIP Rule,” Strafford Publications (November 2016)
  • “Stark and AKS Considerations for Physician Arrangements,” Florida Bar Association, Orlando, FL (November 2016)
  • “Anti-Kickback Statute Compliance in Health Care Transactions,” Strafford Publications (July 2016)
  • “Co-Management Arrangements in Healthcare: Latest Developments and FMV Considerations,” Strafford Publications (January 2016)
  • “Medicare Provider Enrollment: Strategies for Denials, Revocations and Appeals,” Strafford Publications (January 2016)
  • “ACC Quick Hits: Let’s Stark the New Year Off Right: Updates to the Stark Law with Don Romano,” ACC (January 2016)
  • “The 2015 Revisions to the Stark Rules,” Louisiana Bar Association, New Orleans, LA (December 2015)
  • “Recent Stark Law Developments,” Michigan Bar Association (December 2015)
  • “Update on Stark Rules, Florida Bar Association,” Orlando, FL (November 2015)
  • “Anatomy of Physician Arrangements,” Florida Bar Association, Orlando, FL (November 2015)
  • “Enforcement Trends,” PLI, New York, NY (November 2015)
  • “Major 2016 Stark Law Changes: Hear from CMS About the Final Rule,” ABA (November 2015)
  • “Opening Pandora’s Box: Regulatory Due Diligence in Healthcare Deals,” UT Healthlaw Conference, Houston, TX (May 2015)
  • “The Intersection of Stark Law and Medicaid Claims: A Panel Discussion of Recent Litigation and the Government’s Evolving Position,” AHLA (February 2015)
  • “Opening Pandora’s Box: Managing Regulatory Issues in Mergers and Acquisitions,” National CLE Conference, Aspen, CO (January 2015)
  • “Current Reimbursement Issues for Hospitals,” Louisiana Chapter HFMA Winter Institute 2015, Baton Rouge, LA (January 2015)
  • “Current Compliance and Reimbursement Issues for Hospitals,” Louisiana Bar Association, New Orleans, LA (December 2014)
  • “Current Trends in Scrutiny of Physician Compensation Methodology,” Florida Bar Association, Orlando, FL (November 2014)
  • “Medicare Provider Enrollment: Preventing Your Cattle from Drowning in the Ford, Texas Hospital Association, Austin, TX (October 2014)
  • “Anti-Kickback Statute and Stark Law Compliance in Managed Care Contracts,” Strafford Publications (August 2014)
  • “Fraud and Compliance Laws Physicians Need to Know: From the Basics of the Stark Law, Anti-Kickback Statute and CMP Statute to Current OIG Enforcement Priorities,” ABA Physicians Issues Conference, Chicago, IL (June 2014)
  • “Opening Pandora’s Box: Managing Regulatory Issues in Mergers and Acquisitions,” AHLA Transactions Conference, Nashville, TN (April 2014)
  • “Co-Management Arrangements in Healthcare: Latest Developments and FMV Considerations,” Strafford Publications (March 2014)
  • “Fair Market Value in Health Care Transactions: Advanced and Thorny Issues, Part III: Commercial Reasonableness in Contrast with Fair Market Value: What’s the Difference and Who Makes the Call?” AHLA (March 2014)
  • “Fair Market Value: Year in Review,” Physicians and Hospitals Law Institute, AHLA, New Orleans, LA (February 2014)
  • “PODs – What Next? The Impact of the OIG’s Special Fraud Alert,” ABA EMI Conference, Phoenix, AZ (February 2014)
  • Webinar, “Fraud and Compliance Update,” ACC Quick Hits (December 2013)
  • “Fraud and Compliance Update,” Louisiana Bar Association, New Orleans, LA (November 2013)
  • “Traps to Avoid: Stark Law, Anti-kickback Statute and Select State Laws,” ACC Annual Meeting, Los Angeles, CA (October 2013)
  • “Latest Developments in Medicare and Medicaid Audits and the Impact of Recent CMS Rulemaking on Part A and Part B Reimbursement,” AHLA Fraud and Compliance Forum (September 2013)
  • “Anti-Kickback Statute and Stark Law Compliance in Managed Care Contracts: A Focus on the AKS Safe Harbors, Stark Exceptions, and the PIP Rule,” Strafford Publications (July 2013)
  • “Advanced Provider and Supplier Enrollment,” AHLA Medicare & Medicaid Institute, Baltimore, MD (March 2013)
  • “Co-Management Arrangements in Healthcare: Latest Developments -- Complying With Legal and Regulatory Requirements in Structuring Hospital-Physician Arrangements,” Strafford Publications (February 2013)
  • “Anti-Kickback Statute and Stark Law Compliance in Managed Care Contracts: A Focus on the AKS Safe Harbors, Stark Exceptions, and the PIP Rule,” Strafford Publications (June 2012)
  • “Demystifying the Self-Referral Protocol,” Advisory Board Company (March 2012)
  • “Anti-Kickback Basics,” ABA (March 2012)
  • “Diagnostic Imaging: Accreditation and Regulatory Requirements,” AHLA Medicare and Medicaid Institute, Baltimore, MD (March 2012)
  • “Compliance Risks with EHR Implementation and How to Minimize Them,” AAOS Annual Meeting, San Francisco, CA (February 2012)
  • “Fraud and Abuse Bootcamp Webinar Series Part II: Stark Law Soup to Nuts,” AHLA (February 2012)
  • “Stark Law Basics,” ABA (February 2012)
  • “What’s Inside This Pretty Box? Compliance Issues in Due Diligence,” ABA, 13th Annual Conference on Emerging Issues in Healthcare Law, San Diego, CA (February 2012)
  • “Physician Supervision Requirements and False Claims Implications for Diagnostic Testing,” AHLA (January 2012)
  • “Defending Against Terminations and Other Sanctions,” American College of Health Care Administrators, Winter Meeting - Woodstock, VT (January 2012)
  • “Medicare Value-Based Purchasing for Hospitals,” Lorman (December 2011)
  • “Co-Management Arrangements in Healthcare,” Strafford Publications (November 2011)
  • “Medicare Provider Enrollment: When did it become a full contact sport?” 2011 Texas Health Law Conference, Austin, TX (October 2011)
  • “Handling Fraud and Abuse Allegations,” 8th Annual Healthcare Law Compliance Symposium, Los Angeles County Bar Association, Los Angeles, CA (October 2011)
  • “Revenue Capture in a New Era of Reimbursement,” 29th Annual Illinois Association of Health Care Attorneys Symposium, Chicago, IL (October 2011)
  • “The Alphabet Soup of Medicare Contractors,” HCCA Regional Conference, Boston, MA (September 2011)
  • “Bradford Case’s Impact on Hospital Physician Arrangements,” AHLA (June 2011)
  • “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,” 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, MD (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

Don 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.