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.
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