Skip to main content
Healthcare Regulatory

Representative Regulatory Engagements – Manufacturers

  • We represent a coalition of pharmaceutical manufacturers seeking to secure OIG and FTC approval for a program that would offer subsidies to low income persons in the Part D coverage gap. 
  • We advise pharmaceutical manufacturers with respect to their Patient Assistant programs and review vendor contracts and services guidelines for conformance with applicable fraud and abuse laws. 
  • We review and negotiate Medicare Part D discount and rebate agreements on behalf of pharmaceutical manufacturers with Part D Plans, PBMs and GPOs. 
  • We conduct internal regulatory compliance reviews regarding promotional practices in numerous product lines and we assist manufacturers in the development of sales and marketing compliance programs. 
  • We advise pharmaceutical manufacturers on the establishment of reasonable methodologies for calculating the fair market value of physician consulting and speaker services. 
  • We advise medical device companies on the reimbursement implications under the Medicare physician fee schedule for use of its products in the physician office and ASC setting. 
  • We provide ongoing regulatory guidance regarding federal and state privacy law issues for pharmaceutical, biotech and device companies. 
  • We advise multiple pharmaceutical companies on the regulatory issues associated with releasing new formulations of a drug. 
  • We analyze relevant regulations and secure guidance from CMS in developing a pricing methodology and system for pharmaceutical manufacturers to estimate lagged price concessions and reduce variations for monthly and quarterly reporting of prices to CMS. 
  • We served as launch counsel for an innovative oral anti-cancer drug and securing mandatory coverage for the product on all Medicare Part D formularies. 
  • We act as pricing counsel for a biotech company, consulting as to the risks associated with all price adjustments to products. 
  • We secured a significant product coding change to ensure appropriate reimbursement for manufacturer’s flagship product. 
  • We advise various pharmaceutical manufacturer clients on healthcare regulatory considerations related to corporate restructuring. 
  • We conduct internal reviews of pharmaceutical manufacturers’ best price calculation methodologies.
  • We advise various pharmaceutical companies on potential healthcare regulatory considerations in connection with product withdrawal and new formulation issues. 
  • We prepare comments for various pharmaceutical manufacturer clients in connection with CMS proposed pricing regulations.