Holland & Knight's Healthcare Policy Team provides full-service, turn-key government strategy solutions that champion our clients' objectives. Our integrated team includes individuals with legal and policy experience who work tirelessly to create positive change for our clients and help meet the challenges posed by today's rapidly evolving healthcare environment.
We understand our clients' businesses and goals, anticipate problems and challenges, and execute sound strategies based on what is politically achievable. Then, through lobbying and leveraging our key relationships with Congress and the Administration, we execute those strategies to advance client solutions.
We have deep policy knowledge and have a developed understanding of the intersection between policy, regulatory matters, public affairs and coalition building. We have great depth in legislative drafting and analysis, development of regulatory strategies, identifying and securing federal funding, and policy forecasting that informs client business plan development. Key to our success is our ability to translate complex legal and regulatory issues into a practical real-world framework to find solutions to healthcare's most challenging problems
Healthcare is a significant focus area for the Public Policy & Regulation (PP&R) Group at Holland & Knight. We have represented and advised clients across the healthcare spectrum, including pharmaceutical and biotech companies, physician and other provider organizations, hospitals, health information technology companies, nonprofit entities and others regarding federal healthcare programs and policies. Our track record of success in public policy advocacy is extensive. We actively negotiate on behalf of clients regarding the content of legislation and regulations related to Medicare, Medicaid, the Children's Health Insurance Program (CHIP), U.S. Food and Drug Administration (FDA), substance abuse, electronic medical records, telemedicine, public health programs, medical research, disease-specific matters, drugs and biologics, federal funding and the regulation of insurers, providers and other stakeholders. Many major pieces of healthcare legislation have included provisions that we spearheaded, including the Affordable Care Act (ACA), Prescription Drug User Fee Act (PDUFA), Medicare Improvements for Patients and Providers Act (MIPPA), and Medicare Access and CHIP Reauthorization Act (MACRA).
We have organized and led numerous coalitions to address health policy concerns that range from formal (e.g., incorporated nonprofit with bylaws and governing board) to ad hoc entities. We are adept at helping often disparate organizations to coalesce around common policy goals, crafting concise, compelling messages and leading coalition members in executing effective advocacy. From the over-the-counter and prescription drug space to the diagnostic imaging space, Holland & Knight has particular and well-known experience in coalition formation and management that has generated significant and lasting results in multiple healthcare sectors.
Our team is bipartisan and collaborative, and has strong working relationships with key healthcare decision-makers on Capitol Hill, the FDA, Centers for Medicare & Medicaid Services (CMS), and political and career officials at the U.S. Department of Health and Human Services (HHS). Members of our group not only were in Congress but served on pivotal committees, including the House Ways and Means Committee and the House Committee on Energy and Commerce. Our collective reach spans the entirety of the memberships of the key healthcare authorizing and appropriating bodies, including the Senate Health, Education, Labor and Pensions (HELP) Committee, Senate Finance Committee, House and Senate Appropriations Committees, House Energy and Commerce Committee, and House Ways and Means Committee. Holland & Knight has extensive experience preparing clients for testimony before relevant congressional committees and has testified before Congress on behalf of clients and their interests numerous times on diverse healthcare topics.
Our dedicated, "hands-on" Healthcare Policy Team draws on the considerable resources of Holland & Knight's more than 1,300 lawyers and other professionals to offer a full range of services – from scheduling key meetings, writing white papers, and organizing successful coalitions and trade associations to effective lobbying, improving clients' internal processes and compliance procedures, and evaluating potential litigation defense strategies.
Please see a description below of some of Holland & Knight's relevant abilities in the healthcare sphere:
Our team helps providers navigate the complex legal, economic and policy issues surrounding Medicare and Medicaid reimbursement that are essential to their fiscal health and continuing viability. We regularly lobby for Medicare improvements for hospitals, physicians and other healthcare interests on a variety of complex issues.
We counsel clients addressing issues with the CMS on a broad range of administrative and regulatory matters, as well as on MACRA and ACA value-based payment requirements and delivery model innovations. Our team also provides an in-depth analysis of all the major annual administrative rulemakings impacting Medicare.
Holland & Knight's experience encompasses the gamut of Medicare program issues, including a deep understanding of Medicare's Inpatient Prospective Payment System (IPPS), Outpatient Prospective Payment System (OPPS), Medicare Physician Fee Schedule (MPFS) and Medicare for End-Stage Renal Disease (ESRD). Holland & Knight has extensive experience with the New Technology Add-On Payment (NTAP) for a variety of new, inadequately reimbursed therapies and medical devices, including those awarded breakthrough status. Holland & Knight has significant experience working with CMS leadership as well as individual career staff within the CMS to influence overall structural changes to the Medicare program but also to engage on specific policies that affect individual products and populations.
With more than three decades of experience in Medicaid law, analysis and advocacy, we regularly work on intricate and varying state laws governing the program and the complicated financing arrangements involved. Our attorneys and policy advisors are proficient with disproportionate share hospital payments, Section 1115 demonstration waivers and funding mechanisms (such as intergovernmental transfers, provider taxes and donations), designing innovative interventions to improve the Medicaid program for large hospital systems under significant financial strain because of disproportionately low-income payer mixes, and drug utilization review and rebate issues. We also have the skills and knowledge to develop and evaluate demonstration programs for consideration by the Center for Medicare and Medicaid Innovation (CMMI) and are well positioned to engage directly with HHS officials on these initiatives.
Our team has decades of experience working with physician organizations and associations to counter cuts in reimbursement, negotiate new billing and payment codes for medical procedures and other medical care, and perform analysis of regulations specifically tailored to the needs of individual physician organizations and their members.
Our Healthcare Policy Team recently:
Rapid advances in research and technology are revolutionizing the life sciences sector, with drug, biotech and pharmaceutical companies striving to accelerate innovation and deliver greater value in the face of mounting regulatory and pricing pressures. With the approval of the first gene therapy product in 2017, the healthcare system has begun to transition to a system that is tied to long-term value rather than volume. Significant challenges now exist in providing a balance between the increasing costs of novel therapies with the long-term value that they present to patients through increased quality and length of life. Key in this discussion is the effect of these new products and associated payment paradigms on patients, caregivers and the patient advocacy community. Holland & Knight is recognized as a leader in Washington, D.C., in ensuring that clients successfully navigate this delicate balance.
Our experienced Healthcare Policy Team represents innovators and leaders in the life sciences industry on drug and biological regulatory matters, including FDA compliance, legislative issues, biomedical research and reimbursement matters. Holland & Knight has experience getting products approved by the FDA and working with CMS and other entities to establish or amend payments for new and existing products. This includes brokering client meetings with reviewers at the individual divisions of the FDA to develop solutions to challenging issues related to product approval while also understanding the overall political and stakeholder environments to ensure cooperation among entities with similar goals. In addition, we also have significant experience in the rare disease space, having represented a rare disease advocacy organization for years in front of Congress and the Administration, securing millions of dollars in funding as well as the support of the National Institutes of Health (NIH), DOD and FDA.
We have significant experience working on matters involving:
Our Healthcare Policy Team recently:
Members of our Healthcare Policy Team regularly advise clients on electronic health records (EHR), telehealth, broadband access and cybersecurity issues. Holland & Knight also successfully advises clients on health information technology (IT) issues, including navigating certification and compliance requirements, understanding new requirements on interoperability and information blocking/sharing, and healthcare data collection, analysis and sharing.
Health IT issues, including and especially telehealth, has garnered significant recent attention from the public, Administration and Congress for the potential to expand care to underserved populations, maximize the reach of specialty care and reduce overall healthcare spending by diverting patients from crowded healthcare sites. This recent attention has come in the form of new legislation, requests for information (RFIs), new regulations on interoperability, information blocking, and sharing data with patients, providers and third parties.
Holland & Knight has significant resources in the telehealth space and has provided clients with valuable guidance in the field since before the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) was signed into law, which promised to spur the development and uptake of health IT systems nationally. Since that time, Holland & Knight has provided detailed analysis and recommendations related to meaningful use, the Advancing Care Information mandates under the Medicare Merit-Based Incentive Payment System (MIPS), provisions and funding opportunities tied to the 21st Century Cures Act,and, most recently, the proposed rules from CMS and the Office of the National Coordinator for Health Information Technology (ONC) related to enhancing the interoperability of electronic health information (EHI) and increasing patient access to health information and what those rules may mean for healthcare entities.
Holland & Knight has also bolstered efforts in the health IT space related to the care of specific populations, such as those affected by the opioid epidemic. Holland & Knight has worked to lead coalition efforts to amend 42 CFR Part 2 (Confidentiality of Substance Use Disorder Patient Records), a decades-old regulation that limits providers' abilities to share patient records of those with substance use disorder to ensure safe and effective care for those patients in other parts of the healthcare system. Similarly, Holland & Knight has also helped clients interpret provisions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which addresses numerous factors related to the opioid epidemic, including the use of telehealth and other constructs to treat substance use disorder.
Our clients include a large health IT collaborative providing EHR support and resources to hundreds of community health centers in 48 states, the largest provider of freestanding imaging systems in U.S., the largest freestanding provider of mammography screening services in the nation and a coalition of organizations developing state-of-the-art support tools to guide the ordering of imaging services.
Our Healthcare Policy Team recently:
Holland & Knight has established a niche practice in Emergency Medical Services (EMS), representing a wide range of emergency and trauma care providers, including critical care transport services for ground and air. The knowledge and experience we offer extends not only to the transport technologies themselves but also to the reimbursement structures for these services, how they change over time and how these constructs can be amended or further developed to benefit our clients. Holland & Knight has substantial experience and personal relationships with several entities in this space that allow for effective solutions to be developed.
Our group also has substantial experience with the Pandemic and All-Hazards Preparedness Act and in obtaining funding for disaster response programs. These programs are complex and diverse, and Holland & Knight has specific and successful skills in related hospital and health system-based programs that affect our clients, such as the Public Health Emergency Preparedness (PHEP) Cooperative Agreements and the Hospital Preparedness Program (HPP), as well as a wealth of knowledge with individual public health programs that receive federal support, such as Ebola center funding.
Our Healthcare Policy Team recently:
Across the healthcare space, coalition development and management, as well as stakeholder engagement, is crucial for developing and gaining consensus on policy and legislation. Holland & Knight is seen as a leader in Washington, D.C., in the formation and management of coalitions to address specific policy issues and to represent the entirety of healthcare sectors and industries. Holland & Knight's healthcare team each has extensive experience in engaging with experts in a given field, finding and developing areas of collaboration between diverse stakeholders, and designing a multifactor advocacy agenda that involves Congress, the Administration, White House and external policymakers to ensure the coalition's effectiveness in making meaningful policy change.
Our Healthcare Policy Team recently:
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