John Shakow

is a partner in the FDA & Life Sciences Practice in the Washington, D.C., office of King & Spalding. Mr. Shakow’s practice focuses on complex regulatory, commercial and litigation issues related to all aspects of pharmaceutical government price reporting, including day-to-day counseling, strategic planning, merger integration, internal investigations, civil litigation and defense in government investigations.

He counsels numerous pharmaceutical and biotechnology manufacturers with regard to their rights and obligations under the Medicaid, Medicare, Federal Supply Schedule, 340B and related programs, and regularly assists clients in interactions with CMS, HRSA, HHS OIG and the VA. Mr. Shakow often conducts in-depth pricing assessments and works with clients to develop and implement government price calculation and reporting policies, procedures, systems and methodologies.

He has extensive experience helping clients resolve commercial and organizational challenges while maintaining the integrity of their price reporting compliance efforts, including managing the coordination and integration of pricing methodologies in major pharma mergers. He is a frequent speaker at pricing and price reporting conferences and symposia.

Mr. Shakow has significant litigation and investigation experience in the pharmaceutical area. He co-authored PhRMA amicus briefs in the Santa Clara Supreme Court 340B case. He has counseled drug manufacturers before the House Energy & Commerce and Senate Finance Committees in drug pricing investigations and inquiries, and represented a major pharmaceutical manufacturer in the nationwide AWP litigation. Other pharmaceutical litigation experience includes best-efforts marketing arbitration between manufacturers and litigation before the Drug Enforcement Administration over licensure to import controlled substances.

Mr. Shakow was recognized as a “Life Sciences Star” for pricing and reimbursement in the 2012, 2013 and 2014 editions of Legal Media Group’s Guide to Leading Life Sciences Firms and Attorneys in North America.

Recent Presentations

“Mini Summit X: Government Pricing and Contracting,” P.C.F.’s Pharmaceutical Regulatory and Compliance Congress, Washington, DC, November 4, 2014

“Challenges and Opportunities of Various Distribution Strategies and Channel Options,” CBI 5th Annual Specialty Pharmacy and Distribution Networks Conference, Philadelphia, PA, October 29, 2014

“Best of MDRP 2014: A Retrospective,” IIR’s MDRP & Other Public Sector Reimbursement Programs Conference, Chicago, IL, September 17, 2014

“Service Fees: Bona Fide or Constructive Price Concessions?,” IIR’s MDRP & Other Public Sector Reimbursement Programs Conference, Chicago, IL, September 15, 2014

“Elements of the Final Rule: “Clarification” of the Bundled Sales Definition,” IIR’s MDRP & Other Public Sector Reimbursement Programs Conference, Chicago, IL, September 15, 2014

“Manufacturer Risk in a 340B Regulatory Vacuum,” CBI’s 340B Manufacturer Summit, Alexandria, VA, August 20, 2014

“Master Class on 340B Managing the Challenges of Significant Changes to the 340B Program,” ACI’s 12th Annual In-House Counsel Forum on Prescription Drug Pricing, New York, NY, June 25, 2014

“Unravel 340B Program Complexities Part 1: Primer and Legal Issues,” CBI’s 10th Annual Contracts, Chargebacks & Rebates Conference, Philadelphia, PA, June 23, 2014

“Medicaid and 340B: Healthcare Reform Impacts on Accruals and Liability,” IIR’s 2nd Annual Gross-to-Net Accounting Forum, Philadelphia, PA, June 17, 2014

“Fair Market Value and Bona Fide Service Fees: Legal Foundations and Risk Mitigation,” CBI Medicaid and Government Pricing Congress, Orlando, FL, June 3, 2014

“Executive Summit: Deep Dive Into the ACA Proposed Rule and Potential Legal and Operational Impacts of the Final Rule,” CBI Medicaid and Government Pricing Congress, Orlando, FL, June 2, 2014

“340B in 2014: Compliance and Developments,” ACI’s 8th Annual “BIG FOUR” Pharmaceutical Pricing Boot Camp, New York, NY, May 19-20, 2014

“ Medicaid Rebate Elements 2014,” ACI’s 13th Annual Rx Drug Pricing Boot Camp, San Francisco, CA, April 29, 2014

“Government Payor Pricing 101: Primer for Professionals New to Pharmaceutical Pricing,” ACI’s 13th Annual Rx Drug Pricing Boot Camp, San Francisco, CA, April 28, 2014

“Doom and Gloom or Opportunity to Bloom? Impending Regulatory Changes: Impacts and Solutions, Model N’s Rainmaker 2014, Savannah, GA, April 24, 2014

“Panel Presentation: The New Reality of Life Sciences – Navigating the Effects of Evermore Regulation, Consolidation, Competition, and Globalization,” Model N’s Rainmaker 2014, Savannah, GA, April 24, 2014

“Overview of the Current Government Programs Landscape,” IIR’s 6th Annual Government Programs Summit 2014, Alexandria, VA, March 26, 2014

“Medicaid Rebate Liability: Primer on Calculation and Forthcoming Reform,” 3rd Annual Gross-to-Net Accounting and Accruals Summit, Philadelphia, PA, November 20, 2013

“The Medicaid Rebate Part 1: URA, Best Price and Bona Fide Service Fees,” ACI’s 12th National Drug Pricing Boot Camp, New York, NY, November 12, 2013

“Medicaid Drug Rebate Program: Background and Briefing,” U.S. House of Representatives Energy & Commerce Committee, Washington, DC, November 7, 2013

“Texas Medicaid Price Reporting Requirements and Compliance,” CBI's West Coast GP and Commercial Contract Operations Conference, San Francisco, CA, October 23, 2013

“Legislative and Regulatory Foundation of the Bona Fide Service Fee Test and FMV Prong,” CBI Fair Market Value of Bona Fide Service Fees Conference, Philadelphia, PA, October 7, 2013

“Government Pricing Policies and Methodologies: The Foundation of Compliance,” 18th Annual MDRP Summit, Chicago, IL, September 10, 2013

“340B Refund Management and Implications for Reported Price Points,” 18th Annual MDRP Summit, Chicago, IL, September 9, 2013

“340B Policy and Compliance: 340B Repayment Options for Providers and Manufacturers,” 20th Annual 340B Coalition Conference, Washington, DC, July 17, 2013

“Overview of the Medicaid Rebate: The Basic Building Blocks,” ACI’s 11th National Drug Pricing Boot Camp, San Francisco, CA, June 19, 2013

“Medicaid Rebate Liability: Primer on Calculation and Forthcoming Reform,” IIR’s Gross-to-Net Accounting Conference, Boston, MA, June 18, 2013

“The 340B Program for Manufacturers: Compliance and Developments,” ACI’s 7th Annual “Big Four” Pharmaceutical Pricing Boot Camp, New York, NY, May 22, 2013

“Enforcement Panel: Update on Recent Settlements” and “Analyzing Bona Fide Service Fees and Fair Market Value,” CBI Medicaid and Government Pricing Congress, Orlando, FL, May 15- 16, 2013

“Regulatory State of the State 2013 for Biopharma,” Model N’s Rainmaker Summit 2013, Phoenix, AZ, March 7, 2013

“Bundled Arrangements: A Primer on Identification and Allocation,” ACI In-House Counsel and Pricing Executive Forum on Prescription Drug Pricing, New York, NY, February 26, 2013

“Overview of the Medicaid Rebate: The Basic Building Blocks ,” ACI’s 10th Annual Drug Pricing Boot Camp, New York, NY, January 15, 2013

Recent Client Alerts (available at www.kslaw.com)

“False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements Act Compliance,” September 4, 2014

“Court Permits Orphan Drug Rule to Stand,” August 27, 1014

“OIG Report on AMP Methodologies,” June 6, 2014

“CMS Medicaid Rule Greatly Restricts 2014 Mandatory Prescription Drug Coverage for “Expansion Population: May Also Impact Calculation of Medicaid Rebates and Best Price,” August 5, 2013

“HRSA Issues Final 240(B) Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance Responsibility in the Hands of Covered Entities,” July 31, 2013

"CMS Issues Final Rule on Changes to the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program for Contract Year 2013," April 30, 2012

"Proposed ACA Medicaid Drug Pricing Rule: A Roadmap for Manufacturers of Drugs and Biologics," February 3, 2012

"CMS Proposes ACA Medicaid Drug Pricing Rule," January 30, 2012

“Proposed ACA AMP/URA Rule Released,” January 27, 2012

"CMS Holds External Stakeholders Meeting Regarding the Development of National Average Drug Acquisition Cost," August 8, 2011

"CMS Takes Steps to Implement Actual Acquisition Cost," July 11, 2011

“Supreme Court Rejects 340B Pricing Case,” April 4, 2011

“Acquisition Price Metric Proposed for Medi-Cal Rx Reimbursement,” February 22, 2011

“President Obama's FY 2012 Budget Plan Includes Provisions that Impact Pharmaceutical and Device Manufacturers,” February 15, 2011

“CMS Finalizes Withdrawal of AMP and FUL Regulations: Withdrawal Creates Further Uncertainty for Manufacturers in AMP Calculation,” November 11, 2010

“HRSA Seeks Input on New 340B Rules,” September 20, 2010

“CMS Proposes to Withdraw AMP, FUL and Multiple Source Drug Regulations,” September 3, 2010

“AMP ‘Fix’ Amendment Approved,” August 10, 2010

“Part D Coverage Gap Discount Program: Draft Agreement and Revised Guidance,” May 26, 2010

“Passage of Health Care Reform: Key Provisions Impacting Manufacturers of Pharmaceuticals, Biologics,” March 24, 2010