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FDA and Healthcare
John Gould's practice spans a broad range of compliance counseling and public policy matters, and focuses on drug price reporting obligations, the federal anti-kickback statute, and related state laws. In the pricing area, Mr. Gould advises on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting laws. Mr. Gould has also assisted clients with restatements, investigations, and litigation related to drug price reporting. Recently, Mr. Gould has spent significant time advising clients regarding the comprehensive healthcare reforms enacted in March 2010 and other changes to drug price reporting requirements. Mr. Gould also advises clients regarding compliance with US Food and Drug Administration requirements and state and federal requirements for reporting gifts to healthcare providers. Mr. Gould frequently speaks at industry conferences on these subjects.
Mr. Gould earned both a JD and a Master of Bioethics degree from the University of Pennsylvania. Prior to that, Mr. Gould developed pharmaceutical company sales and marketing strategies at the consulting firm ZS Associates, and performed scientific research in pharmaceutical manufacturer and academic laboratories.
- Counseling major pharmaceutical and medical device manufacturers on various sales, marketing, and other corporate programs, e.g., bundled sales, samples, patient assistance, product support services, product replacement, coupons, vouchers, and grants.
- Preparing drug price reporting policies and Medicaid rebate and Average Sales Price reasonable assumptions for major pharmaceutical manufacturers.
- Counseling regarding restatements of drug pricing metrics to the government, and disputes with states regarding Medicaid rebates.
- Drafting PBM, managed care, and Medicare Part D agreements for major pharmaceutical companies.
- Counseling drug manufacturers on avoiding "marketing the spread."
- Drafting comments on Centers for Medicare and Medicaid Services proposed rules and guidance regarding drug reimbursement and price reporting issues.
- Seconded to major pharmaceutical company to provide drug pricing counseling.
Daniel A. Kracov and John Gould "U.S. Healthcare Reform and the Pharmaceutical Industry" (PDF: 187 kB) This article appeared in The International Comparative Legal Guide to Pharmaceutical Advertising; published by Global Legal Group, London 2010
Jeffrey L. Handwerker and John Gould "Federal Government Prescription Drug Pricing: Statutory, Regulatory & Contractual Approaches to Cost Containment" (PDF: 121 kB) Briefing Papers 2D No. 05-4, Thompson/West 2005
"Post-Election Analysis: Healthcare and Pharmaceutical/Medical Device Regulation" (PDF: 536 kB) Nov 2012
"CMS Releases Draft Methodology for Calculating National Average Drug Acquisition Cost" (PDF: 429 kB) Jun 2012
"Medicaid Rebates: CMS Releases the Long-Anticipated Proposed AMP Rule" (PDF: 1.60 MB) Jan 2012
"HRSA Issues Proposed Rule on Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program" (PDF: 442 kB) May 2011
"Congress Changes Definition of Medicaid Average Manufacturer Price...Again" (PDF: 419 kB) Aug 2010
"UPDATE: Healthcare Reform: A Pocket Guide for Pharmaceutical and Device Manufacturers" (PDF: 403 kB) Mar 2010
"HRSA Issues Revised Guidelines for 340B Contract Pharmacy Services" (PDF: 240 kB) Mar 2010
"Senate Finance Committee Chairman Baucus Reveals Much-Awaited Legislative Proposals" (PDF: 325 kB) Sep 2009
"CMS Issues Final Rule Implementing Medicaid Provisions of Deficit Reduction Act" (PDF: 170 kB) Jul 2007
"CMS Issues Proposed Rule to Implement DRA Medicaid Drug Provisions" (PDF) Dec 2006
"HHS OIG Issues Criteria for Evaluating State False Claims Acts to Fight Medicaid Fraud" (PDF) Aug 2006