Preeya Noronha Pinto is a partner in the FDA & Life Sciences practice group at King and Spalding.
Ms. Pinto represents pharmaceutical and medical device manufacturers, clinical laboratories, and other health care providers and suppliers regarding legal and regulatory issues involving the Medicare and Medicaid programs, Food and Drug Administration, health information privacy and security, health care-related transactions, and fraud and abuse matters. She also engages in legal and policy advocacy before government agencies and the Congress, and represents clients in health care litigation and enforcement matters. Ms. Pinto joined King & Spalding from Latham & Watkins, where she was a member of the firm’s health care and life sciences practice.
Prior to entering private practice, Ms. Pinto served as Deputy General Counsel, Principal Deputy General Counsel and Acting General Counsel of the United States Department of Health and Human Services (HHS). In these positions, she was legal advisor to the Secretary of HHS and supervised an office of more than 500 attorneys responsible for providing legal advice to the entire Department, including the Centers for Medicare & Medicaid Services (CMS), Food and Drug Administration, National Institutes of Health, Centers for Disease Control and Prevention, and Office for Civil Rights. In particular, Ms. Pinto advised HHS officials regarding legal issues involving CMS, including Medicare reimbursement methodologies and coverage determinations, Medicare Part D, and the durable medical equipment competitive bidding program. She provided legal review of CMS regulations and supervised the conduct of litigation involving the agency. Ms. Pinto also counseled HHS officials on government ethics matters, appropriations law, employment issues, torts matters, grants law, government contracts, information law such as the Freedom of Information Act and Privacy Act, and human services law relating to the programs of the Administration for Children and Families. Ms. Pinto also advised senior HHS officials regarding Congressional oversight and investigations of HHS programs.
Prior to her service at HHS, Ms. Pinto practiced constitutional and administrative law as a Trial Attorney in the Civil Division of the United States Department of Justice, where she was twice awarded the Attorney General’s Award for Distinguished Service.
Ms. Pinto graduated with honors from the Georgetown University School of Foreign Service and received a Juris Doctor from Columbia Law School, where she was a Harlan Fiske Stone Scholar. Following law school, Ms. Pinto served as law clerk to the Honorable Sue L. Robinson, United States District Judge for the District of Delaware.
Ms. Pinto serves as Vice Chair of the Payment and Reimbursement Interest Group of the American Bar Association’s Health Law Section. She is also an officer of the John Carroll Society in Washington, D.C.
Recent Presentations and Publications
- “The Challenges of Compassion: The Future of Expanded Access to Investigational Drugs,” Panelist, King & Spalding 2nd Annual Pharmaceutical University (West), San Francisco, CA, March 27, 2015.
- “Avoiding the Pitfalls of Privilege: A Guide for Pharma Counsel,” Panelist, Client CLE Presentation, March 16, 2015.
- “Medicare’s New Policy for Coverage of Medical Device Clinical Trials,” Speaker, American Bar Association Health Law Section, 16th Annual Conference on Emerging Issues in Healthcare Law, Payment and Reimbursement Interest Group Luncheon, Lake Buena Vista, FL, March 5, 2015.
- “The Challenges of Compassion: The Future of Expanded Access to Investigational Drugs,” Panelist, King & Spalding Pharma e-Learn Program, Washington, D.C., January 28, 2015.
- “Preparation for CMS’s New Centralized Clinical Trial Policy,” Speaker, Q1 Productions’ Ninth Semi-Annual Medical Device Coverage and Reimbursement Conference, San Diego, CA, December 5, 2014.
- “The Challenges of Compassion: The Future of Expanded Access to Investigational Drugs,” Panelist, King & Spalding 7th Annual Pharmaceutical University, Philadelphia, PA, November 11, 2014.
- “Biosimilars: Now Arriving in the U.S.,” Panelist, King & Spalding 7th Annual Pharmaceutical University, Philadelphia, PA, November 11, 2014.
- “Handling the Underinsured – How Pharma is Dealing with the ACA Patient Population,” Panelist, CBI’s Coupon and Co-Pay Off-Set Strategies Conference, Philadelphia, PA, September 29, 2014.
- “Creating a Pricing and Reimbursement Strategy for Doing Business with Exchanges,” Panelist, American Conference Institute’s 12th Annual In-House Counsel and Pricing Executive Forum on Government Regulation of Prescription Drug Pricing, New York, NY, June 23, 2014.
- “The CMS Coverage Process & Reimbursement Tools,” Speaker, AdvaMed Medical Technology Learning Institute’s Medical Device Reimbursement Workshop, Long Beach, CA, May 7, 2014.
- “Covered, But Not Paid For: Medicare’s Outpatient Packaged Payment Regime in 2014,” Speaker, American Bar Association Health Law Section, 15th Annual Conference on Emerging Issues in Healthcare Law, Payment and Reimbursement Interest Group Luncheon, Litchfield Park, AZ, February 27, 2014.
- “The CMS Coverage Process & Reimbursement Tools,” Speaker, AdvaMed Medical Technology Learning Institute’s Medical Device Reimbursement Workshop, Atlanta, GA, December 10, 2013.
- “Covered, But Not Paid For: Medicare’s Emerging Outpatient Packaged Payment Regime and Other Significant Reimbursement Issues for 2014,” Panelist, King & Spalding 6th Annual Pharmaceutical University, Philadelphia, PA, November 19, 2013.
- “Clinical Trials for Medical Devices—Will 2014 Bring Major Changes to Medicare Coverage?” Panelist, FX Conferences Audioconference, Washington, D.C., November 12, 2013.
- “Major Developments in Medicare Coverage of Medical Devices: CMS National Coverage Determinations and Proposed Revisions to Coverage of IDEs and Clinical Trials,” Speaker, King & Spalding 2013 Medical Device Summit, Wheeling, IL, October 2, 2013.
- “Expanded Access to Investigational Drugs: Challenges for Manufacturers and Healthcare Providers,” Panelist, King & Spalding Life Sciences Roundtable, Atlanta, GA, September 13, 2013.
- “Gaining Insight on Changing Regulatory Requirements in Light of 510(k) Reform and the Impact on Diagnostic Reimbursement,” Speaker, Q1 Productions’ Fourth Annual Diagnostic Coverage and Reimbursement Conference, Boston, MA, December 4, 2012.
- “What’s New, What’s Next, in Pharmaceutical Reimbursement,” Panelist, King & Spalding 5th Annual Pharmaceutical University, Philadelphia, PA, November 27, 2012.
- “Overview of Medicare and Medicaid,” Speaker, King & Spalding University, Washington, D.C., June 19, 2012.
- “Coordinating FDA and CMS Strategies in New Product Development,” Speaker, AHLA/FDLI Program on The Intersecting Worlds of Drug, Device, Biologics and Health Law, Washington, D.C., May 21, 2012.
- “Align Your Reimbursement and Regulatory Strategy Early in the Commercialization Process,” Speaker, CBI’s 7th Forum on Medical Device and Diagnostics Reimbursement Strategies, San Diego, CA, February 29, 2012.
- “Dollars and Discounts: 2011 Drug Reimbursement and Price Reporting Rights, Strategies and Compliance,” Panelist, King & Spalding 4th Annual Pharmaceutical University, Philadelphia, PA, November 29, 2011.
- “Understanding Payers,” Moderator, BayBio 2011 Annual Conference - Powering Global Innovation, San Francisco, CA, April 21, 2011.
- “Business Associates in a HITECH World,” Moderator, American Bar Association’s Health Law Section, 12th Annual Emerging Issues in Health Care Law Conference, New Orleans, LA, February 24, 2011.
- “Medical Devices After Health Reform - Challenges and Opportunities,” Panelist, MDMA General Counsel Event: The Health Care Reform Law, Menlo Park, CA, September 16, 2010.
- “For Biosimilars Under Medicare, It Is Just the Beginning,” Law360 Article, April 16, 2015.
- “CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid,” King & Spalding Client Alert, April 15, 2015.
- “Payment and Reimbursement Issues in Clinical Trials,” Chapter 12 in The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition, American Health Lawyers Association, 2014.
- “CMS Updates Policies and Procedures for National Coverage Determinations and Announces a New Expedited Process for Removing Certain Older NCDs,” King & Spalding Client Alert, August 12, 2013.
- “What May Come of CMS’s Proposed Device Regulations,” Law360 Article, August 6, 2013.
- “CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials,” King & Spalding Client Alert, July 25, 2013.
- “OCR Issues Long-Awaited Omnibus HIPAA/HITECH Rules: Significant Changes for Business Associates and Breach Analysis,” King & Spalding Client Alert, January 24, 2013.
- “IRS Issues Final Regulations Implementing the Affordable Care Act’s Medical Device Excise Tax,” King & Spalding Client Alert, December 11, 2012.
- “CMS Issues New Draft Guidance on Coverage with Evidence Development Policy for National Coverage Determinations,” King & Spalding Client Alert, December 6, 2012.
- “SCOTUS Ruling on the Affordable Care Act: Individual Mandate Upheld as a Tax, Limits Imposed on Medicaid Expansion,” King & Spalding Client Alert, July 2, 2012.
- “CMS Issues Final Rule on Changes to the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program for Contract Year 2013,” King & Spalding Client Alert, April 30, 2012.
- “Proposed ACA Medicaid Drug Pricing Rule: A Roadmap for Manufacturers of Drugs and Biologics,” King & Spalding Client Alert, February 3, 2012.
- “CMS Proposed ACA Medicaid Drug Pricing Rule: Many Proposed AMP, BP and URA Requirements for Manufacturers are Onerous to Implement and Costly to Satisfy,” King & Spalding Client Alert, January 30, 2012.
- “OIG Publishes Fiscal Year 2012 Work Plan,” King & Spalding Client Alert, October 11, 2011.
- “HHS Issues Final Rule Amending Regulations Regarding Investigator Financial Conflicts of Interest Related to Research Funded by PHS,” King & Spalding Client Alert, September 7, 2011.
- “The Medicare & Medicaid EHR Incentive Programs: Preparing for a Potential Audit,” ABA Health eSource, August 2011.
- “FDA Issues Draft Guidance for In Vitro Companion Diagnostic Devices,” Latham & Watkins Client Alert, July 20, 2011.
- “HHS Proposes Changes to the HIPAA Privacy Rule’s Requirement for Accounting of Disclosures and the Addition of a New Individual Right to an Access Report,” Latham & Watkins Client Alert, June 20, 2011.
- “CMS Announces Single Payment Amounts for the DMEPOS Competitive Bidding Program and Proposed Changes to Reimbursement Policies for DMEPOS Items,” Latham & Watkins Client Alert, August 3, 2010.
- “HHS Proposes Regulations to Implement the HITECH Act’s Expansion of HIPAA Requirements,” Latham & Watkins Client Alert, July 23, 2010.