Biotechnology is continually evolving towards new frontiers and medical, agricultural and environmental companies face ethical, legislative, regulatory and business issues on a daily basis. The biotech field is closely linked to McKenna Long & Aldridge's other areas of industry expertise, including pharmaceuticals and life sciences.
At MLA, we help biotech companies maximize value, minimize risk, facilitate financing and build more productive business relationships.
Our biotech attorneys and policy advisors assist companies on a wide range of areas:
Training Programs Available
We also also offer the following Public Sector Training Programs For Pharmaceutical, Biotechnology, Medical Products and Medical Equipment Clients. For more information on any of the programs listed below, please contact Frank Rapoport.
Program Focus
The programs outlined below help to explain issues and strategies related to selling pharmaceuticals, medical products and medical equipment to the Veteran Administration and Department of Defense hospital system, the Public Health Service, Medicaid and Medicare. Some commentators predict these public sector markets could exceed 40% of a health care business's revenue. The training focuses on how to build market share while maintaining compliance with fraud and abuse laws.
Target Audience
McKenna Long & Aldridge's series of training programs is ideal for corporate and health care legal departments, product managers, employees from contracting, finance and information services, sales and marketing executives and other leaders in companies doing business - or wanting to do business - with the federal government.
Location and Cost
All programs are confidential and customized to your specific company's requirements. In addition, they are taught at your facility, or a facility of your choice to maximize the privacy of all discussions and encourage attendees to feel free to raise issues of particular concern to their company. The number of attendees routinely ranges from as small as five to upwards of 50. Our fee for these programs depends on the size of your company, whether we review your contracts or systems in advance and the detail and scope of training required by your employees. To add value, we allow you to videotape our presentation to become an integral part of your compliance program.
We offer the following training courses:
Pharmaceutical Pricing Compliance Audit
A step by step course on how to audit and test whether a company's pricing formulae and marketing policies are in compliance with State and Federal law. Areas covered include: Medicaid "best price" (BP), average manufacturers price (AMP), unit rebate amount calculation, AWP and WAC issues, rebates and incentives to pharmacy benefit managers, gifts and gratuities, grants, programs and preceptorship, conflict of interest, public health service (PHS) 340b pricing, DOD/VA federal ceiling price (FCP) and non-FAMP, Federal Supply Schedule price reduction clause, and policies for a model compliance program.
HHS OIG Compliance Program Elements and Risk Areas
The HHS OIG has issued a draft Compliance Program Guidance for the pharmaceutical industry. This course discusses the Guidance and the steps required to develop the seven basic elements of a corporate compliance program. In addition, the course discusses the three areas identified by the OIG as presenting the most risk for the pharmaceutical industry of non-compliance with laws and regulations governing purchases by federal health care programs - integrity of data, kickbacks and illegal remuneration, and samples - and how companies can reduce those risks.
Detailing Post Launch Obligations Under the Veterans Health Care Act
This program demonstrates how to design pricing systems to comply with the Veterans Health Care Act. The Act requires manufacturers of covered drugs (e.g., single source innovator and multiple source innovator) to place products on a contract with the Department of Veterans Affairs within 30 days after the product's entry into the commercial marketplace. Pricing is set by a formula requiring at least a 24 percent discount. Failure to comply will lead to exclusion from Medicaid eligibility.
Strategies for Adding Products to the VA/DOD National Formulary
The VA and DOD have moved toward a closed national formulary specifying one or two products per therapeutic class. Selection criteria vary from price alone to a best value procurement, where agency medical personnel evaluate and score clinical studies relating to efficacy, safety, outcome, mail order suitability and price. Formulary placement assures large volume, while loss of formulary status means few if any sales from the entire VA and DOD market, even at the local hospital level. Learn the rules for protesting the rejection of formulary status. This course reviews each drug class standardized, analyzes bid protests filed against the DOD and VA, and other marketing strategies for growing your VA/DOD business.
The Medicaid Diagnostic Audit
The Health Care Financing Administration oversees compliance with state Medicaid rebate calculations under the Veterans Health Care Act. Manufacturers' AMP and best price calculations used to determine unit rebates are audited by the HCFA Inspector General. Learn the rules for calculating AMP and best price to reduce rebates, how to implement internal audits and how to manage any Inspector General audits. Don't lose the opportunity for reducing rebates due in prior years - HCFA regulations due by the end of 1999 would prohibit manufacturers from going back more than three years to recalculate their AMP and best price. This is a comprehensive training and diagnostic course tailored to your product line.
Preparing for Expanded Medicare Prescription Drug Coverage
(Half day course)
Learn how pharmacy benefit managers (PBMs) may be asked to contract with the Department of Health and Human Services to purchase pharmaceuticals at a discount for delivery to the Medicare population. Learn how these PBMS may ask for discounts or construct closed formularies. Plan now to deal with the inevitable in this half-day review of legislative proposals for extending prescription drug benefits to pharmaceuticals. Develop a pricing strategy now that can be used to negotiate with PBMs for favorable pricing and possible formulary strategy.
Profiting from Contracting with the Department of Veterans Affairs, Department of Defense and Public Health Service
Manufacturers wishing to sell pharmaceuticals to the VA, DOD and PHS must disclose their most-favored customer pricing. This requires a computer and accounting system capable of timely reporting of rebates, bundling, free goods, concessions and discounts of any kind. During contract performance, manufacturers must track pricing to a designated commercial customer and pass on promptly to the government any discounts made to that commercial customer (the Price Reduction Clause).
Develop SOPs for Public Sector Business
The VA Inspector General requires that manufacturers have written policies and procedures governing disclosure of most-favored customer pricing, Price Committee operations, checks and balances, and corporate structure to ensure integrity with federal contracting rules and regulations, particularly the Veterans Health Care Act of 1992. Includes three-ring binder titled "Public Sector Policies and Procedures."
The VA Federal Supply Schedule Diagnostic Audit
Federal auditors oversee compliance with most-favored customer and tracking customer reporting obligations, industrial funding fee remittance and access record-keeping requirements. Learn how to implement an internal audit and how to use the VA's voluntary disclosure program should the audit reveal problems. Learn how to manage any VA Inspector General audit. This is a comprehensive training and diagnostic course tailored to your product line.
Training for Public Sector Sales Force
(Customized course for NAMs and sales force)
Learn how:
Training on Public Sector Ethics Rules
(Half day course)
Avoid problems with federal investigations by learning the rules on entertaining, giving gifts and paying honoraria to federal employees, and developing corporate ethics policies that incorporate these rules. This course covers how to legally influence government physicians/clinicians to drive market share.