Donald H. Romano

Practice Areas

Don Romano is a partner in the firm’s health care practice.  His work focuses on physician self-referral (Stark) anti-kickback matters, and Medicare reimbursement issues affecting hospitals, physicians and other providers. 

Previous Work

Prior to joining Arent Fox, Don was a division director at the Centers for Medicare and Medicaid Services (CMS).  Among his CMS division’s responsibilities were developments 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 also served as a senior attorney in HHS’s Office of the General Counsel, where he handled litigation, program integrity (including the Columbia / HCA False Claims Act Cases) and program advice matters affecting the Medicare program.

Publications, Presentations and Recognitions

Don’s recent speaking engagements include:

• “Dollars for Doctors? What you need to Know about the Stark Law,” ABA Annual Meeting; Chicago, IL; July 2009
• “Stark Law Changes: Complying with the 2009 Inpatient Prospective Payment System Final Rule,” Strafford Publications; July 2009
• “Restructuring Hospital-Physician Relationships Due to Recent Stark Changes,” Stafford Publications; June 2009
• “Self-Referral of Imaging and Increased Utilization: Some Practical Perspectives on Tackling the Dilemma,” American College of Radiology; Washington, DC; May 2009
• “Update on Stark Law Developments and Related Issues,” HCCA 13th Annual Compliance Institute; Las Vegas, NV; April 2009
• “New Developments in DME, Prosthetics, Orthotics and Supplies,” AHLA Institute on Medicare and Medicaid Payment Issues; Baltimore, MD; March, 2009
• “Operationalizing Stark: From Complexity to Reality,” AHLA Institute on Medicare and Medicaid Payment Issues; Baltimore, MD; March, 2009
• “The Stark Law and Regulations in 2009: Coming into Compliance,” New Jersey Hospital Assoc.; March, 2009
• “New Anti-Markup Rule Revisions for Diagnostic Testing Billing: Avoiding Medicare Exclusion, False Claims Liability, and CMS Penalties,” Strafford Publications; January, 2009
• “Recent Developments in Physician Self-Referral,” Florida Bar Ass’n, Miami, FL; January, 2009
• “Changes to the 2009 Physician Fee Schedule”,College of American Pathologists; December 2008
• “Imaging Center Joint ventures: What is the State of the Regulatory Landscape?,” RSNA Annual Meeting; December 2008
• “Challenges to Physician In-Office Testing: Anti-markup Rules, IDTF Rules and Stark,” GI Carrier Advisory Committee Meeting, Washington, DC; November 2008
• “The Year of Living Dangerously: The FY 2009 IPPS & CY 2009 PFS Stark Rules,” Texas Hospital Association; Austin, TX; November 2008
• “Someone Restored (A portion of) My Same Building: The Anti-Markup Rule – The Final Version?,” AHLA; November 2008
• “The 2009 Physician Fee Schedule: Anti-Markup, IDTF and Gainsharing Developments,” ABA; November 2008
• “Physician Self-Referral: The Year in Review”; AHLA / HCCA Fraud & Compliance Forum, Baltimore, MD; October 2008
• “Provider Based and Under Arrangements Billing”, AHLA / HCCA Fraud & Compliance Forum, Baltimore, MD; October 2008
• “The New Stark Regulations: Content and CMS Commentary”, Health Care Law Section of the State Bar of Michigan; October 2008
• “The Revised PRRB Regulations”, ABA; October 2008
• “CMS’ New PRRB Rules,” AHLA; September 2008
• “2009 InpatientPPS Stark Changes,” Strafford Publications; September 2008
• “More Changes to the Stark Law Regulations: What Providers Need to Know”Beard Group; September 2008
• “Recent Physician Self Referral Provisions – Realignment in Hospital and Physician Relationships?, National Congress on Health Reform, Washington, DC; September 2008
• “Stark Perspectives: Self-Referral Provisions in the 2009 IPPS Final Rulemaking,” ABA; August 2008
• “A Stark Reality: New Rules We Need to Know (Part 2),” AHLA; August 2008
• “A Stark Reality: New Rules We Need to Know (Part 1),” AHLA; August 2008
• “The 2009 Physician Fee Schedule Proposed Rule What Providers Need To Know,” The Beard Group; July 2008
• “The 2009 Physician Fee Schedule: Tomorrow’s Payment Issues and More,” ABA Health Law Section; July 2008
• “The New PRRB Appeals Procedures Regulation,” Federation of American Hospitals Policy Conference; June 2008
• “Stark Law Developments,”ABA National Institute on Health Care Fraud; May 2008
• “Interpreting and Implementing the Physician Self-Referral Law,” American Conference Institute on Healthcare Fraud Investigations, Washington, DC; April 2008
• “Update to Stark Phase III,” AHLA Institute on Medicare and Medicaid Payment Issues, Baltimore, MD; April 2008
• “Non-Hospital Diagnostic Imaging: Focus of Regulatory Scrutiny,” AHLA Institute on Medicare and Medicaid Payment Issues, Baltimore, MD; April 2008
• “What’s a Doc to Do? Stark Phase III and Anti-Markup Rules: The Impact on Physician Relationships and Ventures,” ABA Health Law Section; February 2008
• “Stark Reality: Analysis Evolves into Implementation,” ABA Annual Conference on Emerging Issues in Healthcare Law, San Diego, CA; February 2008
• “Representing the Physician 2008,” Florida Bar Association, Miami, FL; January 2008
• Recent Policy Changes Affecting Physician Self-Referral
• ABA Washington Healthcare Summit, Washington, DC; December 2007
• “Who Moved My Same Building? The Practical Implications of the New Purchased Diagnostic Rule,” AHLA; December 2007
• “New Medicare Anti-Mark Up Rule: Changes for Diagnostic Service Billings,” Beard Group; November 2007
• “Stark II Phase III: The Effective Date Approaches – What Should You Know Before December 4?,” AHLA; November 2007
• “Complying with the New Stark Phase III Regulations,” Strafford Publications; October 2007
• “Stark III Physician Self-Referral Rules - Understanding the Changes and Expectations,” BNA; October 2007
• “CMS’s Disclosure of Financial Relationships Report (“DFRR”): What Every Hospital Compliance Professional Needs to Know,” HCCA; October 2007
• “Stark Provisions in the Final Phase III Rule,” HCCA; October 2007
• “Stark Provisions in the Proposed Fee Schedule Rule,” HCCA; October 2007
• “Stark Phase III Stark II: The Journey Continues,” AHLA; September 2007
• “Physician Self-Referral Enforcement Initiatives,” AHLA / HCCA Fraud & Compliance Forum, Baltimore, MD; September 2007
• “Recent developments in Stark,” AHLA/HCCA Fraud & Compliance Forum, Baltimore, MD; September 2007
• “Stark Phase III Final Regulation Part I: Phase III Stark II: The Journey Continues;” AHLA; September 2007
• “Update on Specialty Hospitals and other Stark Issues,” Federation of American Hospitals’ Health Finance Committee/Legal and Operational Policy Committee Joint Meeting, Baltimore, MD; September 2007
• “Proposed Stark Law Changes in 2008 Physician Fee Schedule,” AHLA; August 2007
• “Specialty Hospital Update,” Austin Health Law Seminar, Austin, TX; August 2006
• “Update on Specialty Hospitals and other Stark Issues,” Federation of American Hospitals’ Health Finance Committee/Legal and Operational Policy Committee Joint Meeting, Baltimore, MD; December 2005
• “Advanced Stark,” AHLA/HCCA Fraud & Compliance Forum, Baltimore, MD; September 2005

Don’s recent publications include:

• “The fraud and abuse laws that compliance professionals need to know,” Compliance Today, March 2010  (*This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call 888/580-8373 with all reprint requests)
• “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,” BNA's Health Law Reporter, Vol. 17, No. 47, December 4, 2008, co-authored with Linda Baumann

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

Bar and Court Admissions

District of Columbia Bar
Maryland Bar
Massachusetts Bar

Education

University of Baltimore, JD
 -Law Review

Life Beyond the Law

In his free time, Don enjoys playing the piano, woodworking and tinkering with his British motorcycle and British sports car.