At Reed Smith, we have a team of lawyers who focus their work nearly exclusively on assisting life sciences clients like you in commercial/operational contracting matters. Our services include contract template development, individual negotiation assistance, advising on discounting strategies and compliance, and assisting with contractual disputes. In assisting in these areas, we combine our commercial contracting skill sets with strong regulatory capabilities in fraud and abuse, government price regulation, data privacy, and related areas.

We regularly assist on matters involving:

• Wholesaler and specialty distribution contracts
• GPO contracts
• Specialty and long term care pharmacy contracts
• Commercial rebate agreements with third party payors such as MCOs and PBMs
• Medicare Part D plan agreements, with special focus on strategies designed in light of the Part D benefit and plan requirements
• Emerging assistance developing contracting mechanisms and forms for use with Exchange Plans under the Affordable Care Act
• Service agreements relating to data, adherence, reimbursement and patient assistance, “HUBs” and related functions
• Review and administration of state pharmaceutical assistance program agreements

Most recently, for example, we have assisted several life sciences manufacturers in a “top to bottom” review of their contracting approaches and templates in light of recent enforcement activity challenging “market share rebate” strategies, and have also worked with early biosimilars entrants on distribution and contracting support. We will do all the same for you.

Counseling companies in the life sciences industry often involves assessment of your business’s activities in relation to federal and state anti-kickback laws. At Reed Smith, our  experience in this area is significant and diverse. We help you stay on top of developments in the anti-kickback, Stark and similar laws, including identifying the potential risks arising from marketing, sales and pricing programs. When the need arises, we regularly assist clients like you who are subject to civil and criminal investigations, lawsuits, and administrative actions brought by federal agencies such as the Office of Inspector General and the Department of Justice for alleged violations of the anti-kickback law, the Stark law, the federal False Claims Act and other statutes.

Our lawyers recommend compliance procedures, conduct training, and perform audits to prevent enforcement actions and penalties. We have obtained advisory opinions that help you manage risk and structure your business initiatives with a better understanding of federal enforcement intentions.

We will stand by businesses like yours when you are faced with civil and/or criminal investigations, help you to negotiate settlements and defend you in government and qui tam (whistleblower) litigation, as well as help you implement corporate integrity agreements.

As concerns over the security of confidential, personal health-related information increases around the globe, so do the rules and regulations put in place to protect this information from theft, loss, or public disclosure. Because our team is global, we can help your company mitigate risk and appropriately respond to any real or perceived threat, and put the appropriate policies in place to protect confidential information before any possible issues arise.

In the United States, we help pharmaceutical companies, device manufacturers and other companies determine how HIPAA affects their businesses, and we  structure innovative data-sharing arrangements that limit the reach of the law. Where necessary, we have also drafted and implemented business associate contracts to comply with HIPAA. Our experience in this area is well-regarded by industry organizations and companies. Notably, we were chosen by the Healthcare Leadership Council and the members of its broad coalition on patient privacy to develop an online, comprehensive, 50-state study of privacy rules and their relationship to HIPAA, funded by top life sciences and health care entities.

We are also assisting global life sciences companies like yours on compliance with the EU General Data Protection Regulation (GDPR).We have carried out audit programs for compliance with data protection rules applicable in different countries, including in relation to clinical data and information. Following such audits, we are able to provide you with a tailored compliance program and are able to assist with implementation. We also regularly draft contracts in compliance with data protection rules.

Today’s health care environment places new pressures on the successful commercialization of innovative medical products ranging from market-driven demands for clinical and economic outcomes data to more formal government price regulation. For medical device, diagnostic, pharmaceutical, biologic and biotechnology firms looking to market new or existing drugs, devices or medical technology, we provide counseling and support in the development of pricing, contracting and promotional strategies in light of the reimbursement environment. We frequently advise companies on the health care regulatory compliance implications of reimbursement support hotlines and similar programs, as well as on patient-focused cost sharing support and similar programs to promote product access. As a result, we work to ensure your business goals can be met, and you are able to anticipate and respond to various regulatory and marketing pressures in the course of developing and marketing advanced therapeutic, rehabilitative, diagnostic and monitoring technologies.

Our lawyers work with life sciences companies on all manner of coverage and payment issues, including drug payment under AWP, FULs and related authorities. We bring experience from the health care, government, industry and non-profit sectors to help you understand the mindset of Medicare, Medicaid and private payors, and develop effective partnerships to accelerate patient access and market success.

Our team has also worked on federal drug pricing programs for decades, and is well-versed when it comes to reimbursement and pricing reporting issues.  We regularly provide guidance to manufacturers with respect to pharmaceutical pricing issues associated with managed care, federal program reimbursement, the Medicaid Rebate Program and Section 340B of the Public Health Service Act, the Veterans Health Care Act, Medicare Average Sales Price requirements and Medicare Part D.