Sidley’s Government Strategies practice, consisting of more than a dozen lawyers and government relations professionals, is one of the most diverse in Washington, D.C. Our firm represents a significant array of clients on legislative matters before the U.S. Congress and the States and develops the public policy rationale behind the modification of healthcare, food and drug and public health laws. Our practice includes several partners who have held senior positions in government and played a major role in the drafting and implementation of many major healthcare laws.
Sidley’s Government Strategies practice is distinctive because we have multidisciplinary experience. On any particular problem, Sidley may utilize a team of lawyers and professionals consisting of four former Associate White House counsels, the former Acting Chief Counsel of the FDA, the former General Counsel to the Department of Agriculture and the Office of Management and Budget, the former General Counsel to the United States Trade Representative and over a dozen registered lobbyists. We develop creative solutions to problems because our experience is so deep and diverse. Whether the issue requires knowledge of food and drug law, Medicare, Medicaid, tort law, public health, health financing or trade policy, or knowledge of the players or process involved in a particular Congressional action, Sidley possesses full service capabilities.
Public Policy and Legislative Counseling and Advocacy
Our lawyers closely monitor all healthcare legislation on the federal level and regularly weigh in with key policymakers to advocate positions on behalf of clients. Over the years, Sidley has represented pharmaceutical and biotech manufacturers, device companies, hospitals, large trade associations, clinical diagnostic laboratories, physician organizations, managed care plans, DME suppliers, pharmaceutical distributors, ambulatory surgery centers and other issue-specific coalitions on significant matters pending in Congress or in the Executive branch. We believe that the most effective legislative advocacy combines a substantive knowledge of an issue with a thorough understanding of the legislative process and strong relationships with key policymakers. Our lawyers are highly regarded within their substantive field and are called upon frequently by clients to make presentations before HHS, CMS, FDA, key committees, staff, members of Congress, House and Senate leadership and State legislatures.
As clients grapple with increasingly challenging public policy problems, they frequently turn to Sidley. We work closely with both Democratic and Republican Members of Congress in the House and Senate. We represent clients on “regulatory advocacy” matters – where Members of Congress are called upon to weigh in on implementation of an important rulemaking or Agency decision. Additionally, we lead coalition advocacy efforts on Capitol Hill and develop “white papers,” legal briefs and advocacy presentations to facilitate discussions with lawmakers.
Reimbursement, Coding and Coverage Advocacy
We have substantial experience on coverage, coding and reimbursement issues, and we advocate on such issues on behalf of an impressive array of leading healthcare clients, including pharmaceutical, device and diagnostics manufacturers. We also represent medical societies and healthcare providers in their efforts to interpret and navigate effectively through local contractor and CMS policies. We have years of experience – both inside and outside the government – handling high profile coding, coverage and reimbursement issues. In addition, we are experienced in:
- developing alternative pricing and reimbursement mechanisms;
- obtaining rate “exceptions” under various pricing methodologies;
- facilitating pass-through determinations;
- securing new and temporary codes for reimbursement and coverage;
- working with local contractors on the development of Local Coverage Determinations and CMS on the formulation and implementation of National Coverage Analysis policies;
- successfully opposing the application of price referencing (such as a Least Costly Alternative policy) to clients' products;
- correcting data methodology and payment issues; and
- applying our deep understanding of various drug and device rules to secure appropriate reimbursement across various sites of service.
Sidley’s lawyers have significant experience working on contractor issues and the national policies that dictate the scope of the local contractors’ authority. Several of Sidley’s professionals served as staff co-authors of the relevant statutory provisions governing the Medicare Administrative contractors and revised coverage and reimbursement provisions of the Medicare law. We have represented dozens of clients on pricing and governmental reimbursement issues (including Average Wholesale Price, Average Sales Price, Competitive Acquisition Program, Widely Available Market Price, Average Manufacturer Price, Medicare Part D and Medicaid rebate issues) and work closely with them to ensure the appropriate scope of coverage is provided for their products.
Sidley also provides assistance to clients on the regulatory, strategic pricing and business issues associated with Medicare Part D. Our professionals are highly regarded in Part D and Part B matters in the country and have worked extensively with all of the relevant federal agencies with oversight over regulatory matters.
In connection with our coverage, coding and reimbursement practice, we also meet regularly with various personnel in Congress, CMS, MedPAC, the Office of the Inspector General for the Department of Health and Human Services (HHS-OIG) and other relevant agencies and committees.
In recent years, we have successfully undertaken a significant number of legislative and “regulatory advocacy” projects. An illustrative list follows:
- Developed, oversaw and implemented legislative and regulatory strategies for a broad coalition of medical device manufacturers, medical societies and patient groups to enact a new preventive benefit in Medicare to detect abdominal aortic aneurysms;
- Led Congressional and Agency advocacy efforts to oppose the application of price controls on an important, branded pharmaceutical product;
- Secured Part D coverage for several drugs previously ruled to be “non-covered” under the Medicare Program;
- Spearheaded Congressional and Agency efforts to exclude “bona fide service fees” from the definition of ASP on behalf of a trade association of specialty distributors;
- Secured favorable legislative language regarding the importance of limiting “hospital acquired infections,” on behalf of a medical device manufacturer; and
- Working with physician societies, patient groups and others, secured coding and coverage for a number of drugs, devices and other items and services.