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New CURES Law and What It Means for Industry

Speaker(s): David J. Farber, Gary A. Heimberg
Recorded on: Feb. 10, 2017
PLI Program #: 206340

David Farber brings together the best of King & Spalding’s knowledge, combining his experience in both litigation and public policy to solve client needs. Having been trained as a litigator, Mr. Farber maintains a strong complex multiparty litigation practice, including serving as first chair in health care litigation, False Claims Act cases, and other commercial disputes. Mr. Farber also maintains a strong government advocacy practice before both the Congress and federal agencies, and  has  drafted  and  had passed legislation, as well as influenced and changed Agency policies, principally in the health care and insurance fields.

In his litigation practice, Mr. Farber began  his  career  working  on  environmental  and health and safety cases, including complex insurance coverage and trade secret matters. He has tried over 20 cases, ranging from expedited administrative law judge trials to a recent five-day broker malpractice case. He has also litigated False Claims Act and Trade Secret litigations. Mr. Farber has recently been involved in several international disputes, including international arbitrations and related litigation.

On the advocacy side, Mr. Farber’s work focuses on the health care and insurance industries. Clients often turn to him as the primary strategist and policy architect for a broad range of matters. Working with the Congress, the Executive (with particular focus on the Centers for Medicare & Medicaid Services and Food and Drug Administration) and academia, he  has successfully guided clients through the legislative enactment and the regulatory promulgation processes. He drafted, and had enacted, the SMART Act of 2012, which was the first major reform of the Medicare Secondary Payer system in over 30 years.

Mr. Farber excels at combining innovative legislative advocacy, regulatory change and litigation to help clients achieve solutions. His clients often comment on the unexpected and quick manner in which Mr. Farber is able to resolve disputes and obtain outcomes, using a combination of skills usually found across multiple specialists.

Finally, Mr. Farber has worked on a broad range of other client needs, ranging from representation of an international agricultural biotech foundation that has received the largest Gates grant given to an African  entity, to  his service  as personal  counsel to Secretary Jack Kemp from 1992 through his passing in 2009.

Recent Publications

  • “Risk Managers Face New Liabilities in Web of Medical Payment Rules,” Business Insurance (July 2016)
  • “Full Speed Ahead: FDA’s Expedited Access Pathway,” MedTech World, Medical Device Diagnostic Industry (July 2015)
  • “How State Right-To-Try Laws Create False Expectations,” Health Affairs Blog (May 2015) (co-author) 
  • “Individual Compassionate Use: Concerns for Drug Manufacturers Considering Participation,” Wolters Kluwer Law & Business White Paper (April 2015)
  • “FDA Makes Expanded Access Applications Easier As Industry Lawyers Urge Caution,” Pharma & Medtech Business Intelligence, The Pink Sheet DAILY (February 2015)
  • “20 States May Legislate “Right to Try” This Year,” (January 2015)
  • “Does ACA Meet Expectations for Pharmacies?” Chain Drug Review (December 2014) (co-author)
  • “Snapshot: The ACA Exchange Today,” PM360 (October 2014) (co-author)
  • “How the 2014 Part D Final Rule Threatens to Unsettle the Medicare Prescription Benefit,” American Bar Association, Health eSource Vol. 10, No. 12 (August 2014)
  • “CMS Proposal Leaves Part D Protected Class Unprotected,” Law360 (February 2014)
  • “The Fallout of the Budget Agreement and Other 2013 Pharma Surprises from Washington” PM360 (January 2014) (co-author)
  • “Medicaid Secondary Payer Changes Are Self-Defeating,” Law 360 (January 2014)
  • “The ACA Exchanges: Are Your Medications Really “Essential”? PM360 (September 2013) (co-author)
  • “A Broken Promise For Pharma Manufacturers,” Law360 (September 2013)
  • “CMS Medicaid Rule Greatly Restricts 2014 Mandatory Prescription Drug Coverage For “Expansion Population”” Health Lawyers Weekly, Vol. 11:32 (August 2013) (co-author) 
  • “How Congressional Staff Can Keep Their Healthcare Coverage,” The Hills Congress Blog (August 2013)
  • “Integrating Legislative Strategy into Brand Strategy,” PM360 (February 2013) (co-author)
  • “Odd Allies in Medicare Fight,” National Law Journal (August 2011) (quoted)
  • “New Medicare Secondary Payer Legislation – A Win For Beneficiaries And The Medicare Trust Fund,” (April 2011)
  • “Medicare Secondary Payer, The Law of Unintended Consequences, and a Call for Reform,” BNA Medicare Report, Vol. 22:3 (January 2011) (co-author) 
  • “Your Social Security Number or Your Money: Medicare Secondary Payer, the Law of Unintended Consequences, and a Call for Reform” - The Bureau of National Affairs, Inc. (January 2011)
  • “Don't Split It: Pill Splitting in Federal Health Care Programs,” BNA Medicare Report, Vol. 17 no. 5 February 2006
  • “Allocation in New Jersey – Too Many Open Questions Demand an Old Solution,” 13 Mealey's Lit. Rpt: Insurance 14 (February 1999)
  • “Determination on Silica May Expose Flaw in Rule,” National Law Journal (March 1997)


  • “The New FDA Approach for Expanded Access to Investigational Drugs,” (for King & Spalding FDA & Life Sciences Roundtable), July 2016
  • “Six Years In: The Affordable Care Act, the Exchange Plans, and the Controversy,” Webinar, PLI July 2016  
  • “MSP Panel Discussion,” RIMS on the Hill, June 2016
  • “Health Care Law Institute 2015: Emerging Challenges and Trends in Reimbursement, Enforcement and Other Hot Topics, ” November 2015
  • “Value-Based Pricing for Prescription Drugs: Today’s Challengesand Tomorrow’s Possibilities,” 8th Annual King & Spalding Pharmaceutical University, Philadelphia, PA, November 2015
  • “The ACA’s Cadillac Tax: Impact and Outlook,” Webinar, PLI, November 2015
  • “Weigh Uncertainty Of EAP Process Before Diving In, Experts Say,” Podcast, The Gray Sheet, July 2015
  • “King v. Burwell: Analysis and Implications of the Supreme Court’s Decision,” Practicing Law Institute, July 2015
  • “Navigating the Expedited Access Pathway: A New Program for Medical Devices,” (for King & Spalding FDA & Life Sciences Roundtable), June 2015
  • Congressional Briefing – The Impact of Medicare Secondary Payer Reporting Requirements on Settlement (for the Congressional Civil Justice Caucus), May 2015
  • Regulatory Acceleration and Healthcare Innovation, Presentation before the American Heart Association Innovation/Investment Forum, New York City, April 2015
  • “The Challenges of Compassion: The Future of Expanded Access to Investigational Drugs,”(King & Spalding e-LEARN), January 2015 
  • “How Secondary Payer Issues Will Be Driving Settlements and Claim Resolution; The Medicare Secondary Payer SUPER Roundtable: Controversial Perspectives and Viewpoints from the Secondary Payer Stakeholder Community,” Workers Compensation Institute, August 2014
  • “Shifting Dynamics Within the Medicare Part D Marketplace –What Does It All Mean for Rebates, Chargebacks, Discounts and Contracting,” CBI Conference, June 2014
  • “Current Status and Future Prospects of the Affordable Care Act,” (for King & Spalding Health Law & Policy Conference), March 2014
  • “MSP, the MMSEA, MSAs, CPLs and the SMART Act,” (Georgia State Bar Product Liability Seminar), February 2014
  • Congressional Briefing – Medicare Secondary Payer (for the Congressional Civil Justice Reform Caucus), April 2013 
  • “MSP – Proposed Reforms and Emerging Trends,” RIMS, April 2012
  • “Medicare Secondary Payer, Issue, Problems and Reforms,” NASCO, March 2012
  • “Medicare Secondary Payer: A Year of Interesting Cases and Legislation,” Perrin MSP Conference, December 2010
  • “Medicare Secondary Payer: Navigating the Battlefield,” National League of Cities RISC Conference, October 2010
  • “Medicare Secondary Payer: How Does It Work For Liability Claims,” Webinar, Perrin Conferences, October 2010
  • “Health Care Reform: What Next?” National Refractories Institute, October 2010
  • “Biologics in the United States, Good News, Bad News and the Emerging Regulatory Landscape,” World Congress of Pharmacy and Pharmaceutical Sciences, August 2010
  • “MSP Update,” GenRe Medicare Secondary Payer Act Conference, General Reinsurance Company, June 2010
  • “The Medicare Threat, It's Not Coming, It's Here!,” WPPC/CPPC Annual Meeting, June 2010
  • “The MSPEA, Politics and Process,” RIMS on the Hill, June 2010
  • “From the Hill: Biosimilars Legislative Perspectives,” CBI Summit on Biosimilars and Follow On Biologics, March 2010
  • “Health Care Reform – What Can Bio Expect in the Coming Months,” BioNJ, September 2009
  • “The Future of Healthcare: Unique Perspectives from the Investor and Policy Maker,” Health Technology Investment Forum, September 2009 
  • Health Care Reform – Presentation before Southwest Healthcare Conference, May 2008 

Awards & Recognition

  • Spirit of Community Action Award, the United Planning Organization (2005)


Representative Litigation Matters

  • Obtained successful result after five-day trial in broker malpractice litigation involving complex marine and general liability policies. OCI Chemical v. Aon Corporation (Sup.Ct. Ct 2008). 
  • Enjoined state reimbursement rate reduction on behalf of Medicaid service providers, resulting in $20 million gain for clients and millions more for industry. Long Term Care Pharmacy Alliance v. Ferguson, 260 F.Supp.2d 282 (D. Mass 2003), rev’d on other grounds,362 F.3d 50 (1st Cir. 2004). 
  • Litigated and successfully resolved trade secret, Lanham Act and misappropriation of business information claims involving recovery of forensic evidence wiped from opposing party’s computer. Winning Connections v. Chism,(D.D.C. 2005). Also prosecuted and defended numerous other trade secret cases to successful settlements, including Movado v. Gucci, (S.Ct. NY 2004); James Hardie v. Demey, (D.S.C. 2003); and Applied Discovery v. Bowne, (D.Wa. 2002). 
  • Lead counsel in successful settlement of complex multiparty False Claims Act case establishing jurisdiction precedent on materiality standards and pleading requirements. United States, ex rel. Wilkins v. North American Constr. Corp., 173 F.Supp.2d 601, (S.D.Tex.2001). 
  • Recovered looted funds on behalf of the Government of Rwanda following 1994 genocide: Rwanda v. Rwanda Working Group, 227 F. Supp.2d 45 (D.D.C. 2002), aff’d in part, 409 F.3d. 368 (DC Cir. 2005); Republic of Rwanda v. Uwimana (In re Uwimana), 255 B.R. 669 (D. Md. 2000); aff’d,274 F.3d 806, 811 (4th Cir.2001). 
  • Lead counsel in successful settlement of complex, multiparty environmental insurance coverage litigation which set national precedent on significant coverage issue. Pittston Co. v. Allianz Ins. Co., 905 F. Supp. 1279 (D.N.J. 1995), reversed in part, 124 F.3d 508, 521 (3d Cir.1997). 
  • Representative Advocacy Matters
  • Lead Counsel in enacting SMART Act of 2012 (112th Congress, H.R. 1845, Title II), in first major reform of Medicare Secondary Payer statute since 1980. 
  • Succeeded in enactment of December 2007 MMSEA provision significantly advancing client’s Medicare Part B reimbursement strategy. 
  • In 2006, led multi-firm advocacy team to reverse CMS coverage decision barring client’s flagship drug from Medicare Prescription Drug Program. As a result of intensive 45-day effort, the decision was reversed, drug was covered and shortly thereafter client sold company for over $3 billion. 
  • Represented major pharmacy trade association in all aspects of advocacy, including enactment of provisions in Medicare Modernization Act of 2003, promulgation of CMS policies related to industry and representation before multiple state Medicaid programs on advocacy and litigation (and combined advocacy and litigation) issues. 
  • Represented insurance trade association before Labor Department on promulgation of FLSA standards, and before numerous states on legislative issues (including resolution of complex litigation through legislative leverage).


FDA & Life Sciences
Health Govt Investigations
White Collar Defense & Government Investigations
Health IT and EHRs
Healthcare Industry
Healthcare  Litigation
Government Advocacy & Public Policy
Domestic  Arbitration/ADR Appellate, Constitutional and Administrative Law
International Arbitration


District of Columbia Bar Association
American Health Lawyers Association
American Jewish Committee, President Washington Region (2011-13), Member National Board of Governors (2013- present), Comay Fellowship (2008)
Jewish Federation of Greater Washington, Member of the Board of Directors  (2008-present)
German-Israel Young Leaders Exchange, Bertelsmann Foundation Fellow (2007)


J.D., Georgetown University Law Center
B.A. Economics, New York University


District of Columbia
New York Supreme Court of the United States
U.S. Court of Appeals for the Eleventh Circuit
U.S. Court of Appeals for the Fifth Circuit
U.S. Court of Appeals for the First Circuit
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Appeals for the Ninth Circuit
U.S. Court of Appeals for the Sixth Circuit
U.S. Court of Appeals for the Third Circuit
U.S. District Court for the District of Connecticut
U.S. District Court for the Western District of Michigan

Gary Heimberg’s practice focuses on public policy and government affairs matters for pharmaceutical and consumer health care clients. He has substantive knowledge of the current legislative and policy issues facing the pharmaceutical industry, including in the areas of intellectual property, OTC medicines, vaccines, biodefense, and FDA reform. Mr. Heimberg has also facilitated the implementation of internal policies and procedures to adhere to federal compliance requirements.

Mr. Heimberg’s pharmaceutical industry experience spans all spheres, including in-house, trade association, government and private practice positions. Prior to joining Covington, he served as the director of federal government relations for a major pharmaceutical company, as vice president of federal affairs for a major industry trade association, as a staff member with and on the floor of the U.S. Senate, and in private practice with another international law firm.