John D Shakow

Partner

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John Shakow

WASHINGTON, D.C.
T: +1 202 626 5523
F: +1 202 626 3737

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Profile   |   News & Insights

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.  He 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 in September 2016 with the MDRP 2016 Lifetime Achievement Award for service to the government price reporting industry.  He has been named a “Life Sciences Star” for pricing and reimbursement in the 2012, 2013, 2014, and 2015 editions of Legal Media Group’s Guide to Leading Life Sciences Firms and Attorneys in North America.  He is also a Vice Chair of the ABA Health Care Contracting Committee.

For more information, please see www.kslaw.com/practice_areas/pags/PharmaGovPricingCompliance.PDF

Recent Articles

  • “Implications of the Final AMP Rule for Community Rx,” published in Chain Drug Review, July 25, 2016

  • “All Foam, No Beer: Broad Uptake of Value-Based Pricing for Prescription Drugs Unlikely Without Serious Legislative Change,” published in Bloomberg BNA’s Pharmaceutical Law and Industry Report, 14 PLIR 10, March 4, 2016

Recent Presentations

  • “Legal Perspective:  Key Implications of the Evolving Regulatory Landscape for Government Programs,”  Second Annual Managed Care and Government Programs Congress, Arlington, VA, February 28, 2017

  • “HRSA Final Rule for 340B: New Requirements for Ceiling Prices and Civil Monetary Penalties” Q1 Productions Webinar, February 14, 2017

  • “The 340B Drug Discount Program,” 8th Annual CBI Federal Pricing and Reporting Conference, Philadelphia, PA, November 16, 2016

  • “Managed Care Contracting Risks:  An Antitrust, Government Pricing and Fraud and Abuse Analysis,” 2016 King & Spalding Pharmaceutical University, Philadelphia, PA, November 15, 2016

  • “Bringing It All Together:  MDRP 2016 Summary & Critical Takeaways,” 2016 MDRP Conference, Chicago, IL, September 22, 2016

  • “Fireside Chat:  External Counsel,” 2016 MDRP Conference, Chicago, IL, September 22, 2016

  • “MDRP Expansion to Puerto Rico in Crisis:  The Manufacturer Perspective,” 2016 MDRP Conference, Chicago, IL, September 21, 2016

  • “Service Fees:  Bona Fide or Constructive Price Concessions,” 2016 MDRP Conference, Chicago, IL, September 20, 2016

  • “5i AMP:  Eligibility, Calculations and Implications,” 2016 MDRP Conference, Chicago, IL, September 20, 2016

  • “Managed Markets Government Payers and Providers - An Overview from the Pharmaceutical Perspective,” Pharmaceutical Summit on Business & Compliance Issues in Managed Markets, Washington, DC, June 8, 2016

  • “Authorized Generics and AMP:  Where We Are Post Final Rule,” Q1 Pharmaceutical Government Pricing & Contracting Conference, Arlington, VA, June 6, 2016

  • “Industry & Legal Interpretations on AMP Final Rule,” Q1 Pharmaceutical Government Pricing & Contracting Conference, Arlington, VA, June 6, 2016

  • “AMP Final Rule Recap,” ACI Conference on The AMP Final Rule, New York, NY, May 23, 2016

  • “Taking a Pulse Post AMP Final Rule Implementation: Insights and Considerations,” 18th Annual CBI Medicaid and Government Pricing Congress, Orlando, FL, May 19, 2016

  •  “Final Rule Breakdown:  Reasonable Assumptions and their Role in Sorting Out the Final Rule’s Unanswered Questions,” 18th Annual CBI Medicaid and Government Pricing Congress, Orlando, FL, May 19, 2016

  • “Pharma 20/20: A Panel Discussion,” Model N Rainmaker Conference, Scottsdale, AZ, February 23, 2016

  • “The Clock Has Struck!  Are You Ready?,” Model N Rainmaker Conference, Scottsdale, AZ, February 23, 2016

  • “BFSFs and FMV Under the Final Rule: Outlook for the Compliance Professional,” CBI Final Rule Forum, Philadelphia, PA, February 22, 2016

  • “5i AMP and the Medicaid Final Rule,” IIR’s Digital AMP Week Webinar, February 18, 2016

  • “The CMS Final Rule for Covered Outpatient Drugs: A View from the Compliance Office,” Huron Life Sciences Webinar, February 12, 2016

  • “The Impact of the AMP Final Rule; Legal and Operational Considerations,” Deloitte & Touche and K&S Webinar, February 5, 2016

  • “The Insider’s Guide to the AMP Final Rule,” Paragon Solutions and K&S Webinar, February 4, 2016

  • “The AMP Rule is Final – What is the Impact?,” Model N Webinar Series, February 2, 2016

  • “Definition of Specialty Pharmacy, Threshold for 5i and Business Implications,” CBI Final Rule Forum, Philadelphia, PA, November 20, 2015

  • “Government Price Reporting:  Agency Action and Manufacturer Reaction in 2015,” 8th Annual King & Spalding Pharmaceutical University, Philadelphia, PA, November 10, 2015

  • “Government Price Reporting for Compliance Officers,” 16th Annual Pharmaceutical Regulatory and Compliance Congress, Washington, DC, October 21, 2015

  • “Other Federal Drug Pricing Programs:  Parsing the differences between terminology and methodologies under the VHCA, Medicare Part B and the Medicaid Drug Rebate programs,” ABA Section of Public Contract Law 7th Biennial Federal Drug Pricing Conference, Washington, DC, October 20, 2015

  • “Compliance and Legal Risks Impacting Distribution and Data Management:  Service Fee Effects,” CBI’s Specialty Product Distribution Conference, Philadelphia, PA, October 14, 2015

  • “New Developments in 340B Program Guidance:  Effect on Manufacture Stakeholders,” Q1 Webinar, October 13, 2015

  • “Bringing It All Together:  MDRP 2015 Summary & Critical Takeaways,” MDRP Conference, Chicago, IL, October 2, 2015

  • “External Counsel Forum,” MDRP Conference, Chicago, IL, October 2, 2015

  • “Bundling 101:  Identification and Allocation,” MDRP Conference, Chicago, IL, October 1, 2015

  • “HRSA’s Proposed Rule:  340B Ceiling Price and Manufacturer CMPs,” MDRP Conference, Chicago, IL, September 30, 2015

  • “The AMP Rule is with OMB – What’s the Impact?,” Model N Webinar, August 13, 2015 (available at https://www.youtube.com/watch?v=cIHHfVesor8&feature=youtu.be)

  • “Dissect 340B Program Evolution and Complexities:  340B Program Primer,” CBI’s 11th Annual Commercial Contracts & Chargeback Management Conference, Philadelphia, PA, June 22, 2015

  • “Update on 340B Program Integrity and Processes,” CBI’s 17th Annual Medicaid and Government Pricing Congress, Orlando, FL, June 4, 2015

  • “Managing the Implementation and Operational Challenges Resulting from Significant Changes to the 340B Program,” ACI’s 9th Annual “Big Four” Pharmaceutical Pricing Boot Camp, New York, NY, May 28, 2015

  • “Advanced GP Forum (full day preconference),” IIR’s 7th Annual Government Programs Summit, Arlington, VA, March 23, 2015

  • “The 340B Drug Discount Program:  Challenges & Forthcoming Developments for Manufacturers,” Q1 Productions Webinar, March 12, 2015

  • “The AMP Rule Cometh:  Preparing C-Suite Executives and Your Company for the Final AMP Rule,” CIS Webinar, March 4, 2015

  • “AMP Final Rule:  Endgame Preparations,” Government Drug Pricing Forum, Washington, DC, February 12, 2015

  • “Pharma 2020:  Evolution of Government and Commercial Payor Influence on Markets and Pricing in the Next Five Years,” Government Drug Pricing Forum, Washington, DC, February 12. 2015

  • “Cranking Up the AMP Volume:  A Diagnostic of the Forthcoming Rule,” Model N Rainmaker Summit 2015, San Francisco, CA, February 4, 2015

Recent Client Alerts (available at www.kslaw.com; also see many of these and other posts on www.linkedin.com/in/johnshakow)

  • “HRSA Issues Final Rule on Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties,” January 6, 2017

  • “Manufacturer Release 103 Regarding BLAs and Authorized Generics,” December 22, 2016

  • “Territorial Expansion of MDRP Delayed Three Years,” November 14, 2016

  • “340B Dispute Resolution Proposed Rule Issued by HRSA,” August 11, 2016

  • “ACA Final Rule FAQs Published,” July 6, 2016

  • “Texas to Remove Monthly Drug Price Reporting Requirements,” May 6, 2016

  • “VA Now Requires TAA Non-Compliant Covered Drugs to be Available on FSS Contracts,” April 22, 2016

  • “340B Pricing Proposed Rule Reopened for Comment,” April 18, 2016

  • “CMS Unveils Proposed Part B Drug Payment Demo,” March 16, 2016

  • “Final ACA Medicaid Drug Pricing Rule Published:  Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to Consider,” January 25, 2016

  • “HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance,” September 6, 2015

  • “HRSA Publishes Proposed Rule on the Calculation of 340B Ceiling Prices and Manufacturer Civil Monetary Penalties,” June 17, 2015

  • “CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid,” April 15, 2015

  • “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, 2014

  • “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 340(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
EDUCATION
J.D., University of Virginia
B.A., Swarthmore College

ADMISSIONS
District of Columbia
U.S. Court of Appeals for the D.C. Circuit
U.S. District Court for the Central District of Illinois
U.S. District Court for the District of Columbia
U.S. District Court for the Eastern District of Virginia
Virginia