Akin Gump Strauss Hauer & Feld LLP is nationally recognized for its experience in legislative and public policy matters affecting a wide range of health care participants, including drug and biologics companies, medical device and technology manufacturers, hospitals and health care systems, and physician groups and specialty associations. We counsel clients on a broad range of legal and policy issues arising under federal statutes, rules and regulatory provisions. We also have an active federal funding practice that has succeeded in securing funding for our clients for numerous health care initiatives. Many members of our health practice have served in high-ranking positions in administrative agencies and on congressional committees, helping us provide clients with a deeper understanding of health care regulatory systems and the development of health care policies on Capitol Hill.
Akin Gump’s health policy group advises health care participants on the full array of issues relating to federal and state health care systems and health care delivery methods. They also bring a substantial track record of advising clients on matters before the House Ways and Means Committee, the House Energy and Commerce Committee and the Senate Finance Committee, as well as the U.S. Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), the U.S. Department of Labor (DOL), the U.S. Food and Drug Administration (FDA), the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC), among others.
Our team is adept at developing allies for products and services, including outreach to patient communities, providers and other key stakeholders. We are also skilled at building markets for new products through legislative and policy developments. We have advised clients on many of the major congressional health care initiatives considered in the past 20 years, including the Patient Protection and Affordable Care Act of 2010 (PPACA or ACA), the Medicare Modernization Act of 2003 (MMA), the Benefits Improvement and Protection Act of 2000, the Balanced Budget Refinement Act of 1999, the Balanced Budget Act of 1997 and the Clinton administration health care reform proposal of 1993.
Center for Medicare and Medicaid Services (CMS) Experience
Due to the importance of CMS coverage decisions, we are particularly adept at advising clients of the value of initiating strong CMS advocacy positions concurrent with FDA approval strategies. We also help clients prepare for and defend themselves in connection with congressional oversight, understand the challenges and opportunities presented by new or proposed legislation, organize and convey their views on proposed legislation and use the legislative process to achieve their objectives.
Our representative matters related to CMS include the following:
- Representing PPS-exempt hospitals with applications to Services CMS for exceptions and adjustments to TEFRA cost limits.
- Representing client in connection with policy issues, including dialysis provider issues, related to Medicaid legislation and CMS regulations.
- Representing a client in connection with policy issues, including matters before Congress, CMS, HHS and the administration relating to funding for kidney disease screening and Medicare/Medicaid funding of End Stage Renal Disease and other kidney-related treatments.
- Advocating on behalf of pharmaceutical and medical device manufacturers with regard to FDA processes for product review and approval and CMS coding, coverage and reimbursement policies.
- Providing advice regarding CMS coverage determinations and policies, including coverage and coding for new medical technologies, such as those related to precision medicine.
- Improving federal quality metrics to better account for the needs of cancer hospitals.
- Analyzing numerous Medicaid rebate program issues and working with CMS officials in implementing related requirements, including issues relating to discounts for pharmacy benefit managers (PBMs).
- Engaging CMS, on behalf of clients, to secure federal support for initiatives to promote best practices and expand successful models of care.
- Organizing effective responses to CMS audits of a Part D prescription drug plan and developing policy and procedures to ensure continued compliance with Part D regulations.
- Engaging the CMS Innovation Center to advance a successful model for enhanced care coordination.
- Obtaining favorable Medicare coverage decisions for vital treatments, including colorectal cancer and prescription heart medications.
- Advancing health information technology solutions to strengthen Medicare program integrity and improve health care quality.
- Expanding care coordination options for chronically ill Medicare and Medicaid beneficiaries.
- Advocating inclusion of screening for cognitive impairment as part of Medicare preventive physical examination.
- Promoting industry best practices as the standard of care for pharmacy services to Medicare beneficiaries in long-term care.
For our pharmaceutical, medical device, biotechnology and other health care industry clients, we understand the enormous undertaking of introducing new and existing products to the marketplace. Collectively, our team has decades of government experience, with members having served in prominent roles with HHS, including within CMS, FDA and the Center for Consumer Information and Insurance Oversight (CCIIO). Our innovations team has helped many clients successfully commercialize new products by providing strategic advice and engaging with regulatory authorities through all stages of the process.
Medicare and Medicaid Coverage and Reimbursement
A key component of our health care practice includes helping our clients navigate the intricacies of Medicare and Medicaid, programs our professionals were intimately involved in shaping over the years. We have a depth of historical knowledge about the Medicare and Medicaid programs and pride ourselves on our battle-tested familiarity with the range of possible approaches to success.
Our team has extensive experience working with a myriad of provider types, including hospitals, nursing homes, pharmacies, home health agencies, hospices, dialysis centers, outpatient clinics, community health centers and specialty providers, among others. Our representations have ranged from legislative and regulatory advocacy on client priorities, to litigation on Medicare and Medicaid reimbursement issues involving specific provider sectors, to individualized counseling on program compliance matters. We understand the significant challenges facing all providers in the current budgetary environment and are well versed in assisting our clients in articulating their “value proposition” to federal policy-makers.
The leaders of Akin Gump’s reimbursement practice are particularly well known for big wins in cutting-edge cases of first impression. We regularly represent hospitals individually and in group appeals before administrative tribunals and in federal court challenging Medicare, Medicaid and other federal program reimbursement denials. Collectively, the lawyers in our group have represented more than 1,000 hospitals in appeals involving tens of thousands of fiscal years and approximately $2.5 billion in aggregate claims.
We continually work with the industry’s leading health care experts and analysts to monitor the government’s formulas and calculations to assure that our clients are receiving fair payment. These alliances, merged with our vigorous legal advocacy, have helped us build Akin Gump’s reputation with government policy-makers, administrators and contractors for having the highest integrity. We consistently and effectively build claims on solid facts and sophisticated legal theories.
Akin Gump’s reimbursement team recognizes that extended litigation is not always necessary or the best course. We counsel our clients to maximize the prospect of avoiding disputes and settling their appeals. With the support of the largest public policy practice in the country, when appropriate, we also develop multipronged strategies for resolving complex payment issues, including mobilizing congressional delegations and engaging leaders of the executive branch.
Our recent work on Medicaid has involved the development and implementation of successful advocacy strategies to ensure continued access to essential services and to expand coverage to individuals in need, in some cases faced with strong political opposition in states with high levels of uninsured. We also worked actively on issues related to the transition of dual eligibles’ drug coverage to Medicare Part D and to shape the implementation of reforms mandated under the 2005 Deficit Reduction Act.
Members of our team also have relevant experience advising a leading pharmacy benefit management company on various federal and state regulations affecting the provision of pharmacy services under Medicaid managed care contracts. In addition, we are actively monitoring the implementation of statewide Medicaid managed care waivers and analyzing their impact on the pharmaceutical sector and other industry stakeholders.
Affordable Care Act Implementation
Our multidisciplinary team helps our clients position themselves to successfully navigate the opportunities and challenges emerging from the implementation of health care reform under the Affordable Care Act. Using our team's broad-based expertise gained working in the private sector and with key government agencies, we help clients advance creative strategies to achieve their business goals.
Our experience includes assessing and shaping the requirements for private insurers and health insurance exchanges, evaluating Medicaid expansions, promoting innovations in program design in Medicare (including Accountable Care Organizations and bundled payments), and implementing programs for beneficiaries dually eligible for Medicare and Medicaid. We also have successfully engaged the Center for Medicare and Medicaid Innovation within CMS to secure federal support for initiatives to promote best practices and expand successful models of care.
In addition, we are actively monitoring state payment and delivery system reforms and assessing their impact on industry stakeholders in the pharmacy and pharmaceutical sectors. Our work addresses issues such as how states are measuring value, the expansion of managed care and the impact on access to specialty pharmacy products across Medicaid and exchange plans.
Our team has broad and deep experience on payment and policy issues in Medicare, Medicaid and the exchanges—no other firm has this policy knowledge, breadth of contacts or the experience in working with key agencies, including CMS.