Healthcare & Life Sciences Policy

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, regulations 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), substance abuse, electronic medical records, telemedicine, public health programs, medical research, disease-specific matters, medical devices, drugs and biologics, dietary supplements and food, 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), various versions of the 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 U.S. Food and Drug Administration (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 2,200 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:

Medicare and Medicaid Programs

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:

• Blocked potentially severe reductions in Medicare reimbursement for screening and diagnostic mammography. Such cuts would have resulted in diminished access to life-saving mammography services. In turn, there would be less early detection, greater mortality and elevated treatment expense for Medicare patients. In response, Holland & Knight developed the evidence against a cut in reimbursement and assembled a coalition of affected stakeholders. Holland & Knight led meetings with the principal deputy administrator at the CMS, the director of CMS' Hospital and Ambulatory Policy Group, and numerous stakeholders on Capitol Hill.
• Anticipated a potentially adverse change to trauma reimbursement. In response, Holland & Knight developed an alternative model of reimbursement prior to the issuance of an adverse proposed rule. This enabled swift and aggressive action to successfully avert finalization of a CMS proposal to bundle Medicare outpatient emergency department codes that would have devastated major trauma centers and their subsidization of trauma surgeons.
• Led the design of IPPS NTAP payments for multiple innovative products covering multiple therapeutic areas, including regenerative medicine, cellular therapies and neurological disorders, leading to a needed increase in reimbursement for these novel therapies while establishing a basis for CMS consideration of permanent reimbursement increases for the products in the future.
• Secured a significant and unprecedented change in reimbursement for biosimilar products. Rather than developing responses around a CMS payment proposal that would average reimbursements for all biosimilars tied to the same reference product, Holland & Knight worked diligently with Congress, the White House and CMS to reverse this payment policy, allowing biosimilars to be reimbursed under unique billing and payment codes.
• Worked with stakeholders to advocate for a change in Medicare and Medicaid policies, as well as CMS legal policies, that would allow for novel payment designs for innovative products in the context of the drug pricing debate in the 116th Congress. These interventions would allow for value-based payment arrangements for certain innovative products without violating long-standing healthcare legal constructs such as Stark Law or the Anti-Kickback Statute (AKS).
• Obtained substantial appropriations support for client-specific medical research initiatives, U.S. Department of Defense (DOD) health programs and research, and discrete public health programs within the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), and the HHS Assistant Secretary for Preparedness and Response.

Life Sciences Regulatory, Compliance and Reimbursement

Holland & Knight's Healthcare & Life Sciences Team includes a number of lawyers and professionals who are well versed in the niche practice of serving the full regulatory and compliance needs of life sciences companies.

Our team's extensive experience includes the development and execution of integrated strategies that leverage our attorneys' and professionals' substantial regulatory knowledge. This enables life sciences companies to develop, manufacture, market and distribute medical devices, prescription and over-the-counter (OTC) drugs, biologics, combination products, biosimilars, dietary supplements, food and other products regulated by the FDA with the assurance that they are complying with federal regulations as well as applicable state laws.

Holland & Knight literally helped write the book on such issues, as several of our attorneys authored the Bloomberg BNA portfolio Life Sciences Compliance: A Pre-Market and Post-Market Road Map.

Some of our team's sample representations include:

• advising companies on pre-market and post-market regulatory strategies, including product classification, navigating FDA enforcement policies and securing Emergency Use Authorizations (EUAs)
• advising manufacturers, distributors, importers and exporters of FDA-regulated products related to the diagnosis, treatment and prevention of COVID-19 regarding FDA enforcement policies, EUA requirements and other regulations during the COVID-19 public health emergency
• representing companies in meetings with FDA officials
• counseling companies on good manufacturing practice (GMP) requirements as well as manufacturing and supply chain issues
• performing regulatory due diligence for investors as well as participants in mergers and acquisitions (M&A) and other corporate transactions
• helping companies assess and navigate the regulatory pathway to market for novel technologies
• advising companies on FDA advertising, promotion and labeling claims
• advising companies on compliance with FDA regulations
• counseling and advising companies during product recalls
• counseling clients during inspections and post-inspection matters, responses to FDA Form 483s, untitled and warning letters, and other enforcement actions
• advising companies on clinical trial issues such as agreements with clinical sites and investigators, informed consent, Institutional Review Board (IRB) review and data collection
• representing client interests during FDA and other agency rulemaking proceedings
• lobbying for client interests before state and federal lawmakers and legislators, including the formation of coalitions to advance client healthcare priorities

We have significant experience working on matters involving:

• FDA Review, Approval and Compliance. Holland & Knight has more than 30 years combined experience in working with the product review divisions across the FDA. We assist companies seeking marketing approval, clearance or authorization. We have also successfully achieved changes to the Federal Food, Drug, and Cosmetic Act that will expedite review of products. Once products are legally marketed, we advise companies on the myriad of FDA regulations to help ensure compliance.
• Drug Pricing Issues. Holland & Knight has performed extensive work on the current drug pricing debate from a legislative, regulatory and political point of view. Holland & Knight performs consistent analysis of the issue and can hone analysis based on client needs. This includes design of value-based reimbursement for products.
• Reimbursement. As mentioned previously, Holland & Knight has extensive experience with an array of payment paradigms for healthcare products and services. Holland & Knight has negotiated and developed proposals that have resulted in direct and positive changes to the reimbursement for medical products and services, and has experience with billing practices in various public and private payer systems to ensure that clients understand the best path forward when advocating for a reimbursement or classification change.
• FDA User Fee Regulations. Holland & Knight has extensive experience understanding the user fee renewal process for multiple types of products and has consulted on user fee issues related to prescription drugs, medical devices and biosimilars. Holland & Knight most recently served as the main negotiator on behalf of industry for the Biosimilar User Fee Amendments (BsUFA).
• The 21st Century Cures Act. Holland & Knight was deeply involved in the development, drafting and negotiation of multiple provisions in the 21st Century Cures Act affecting numerous areas of healthcare, including FDA-regulated entities and healthcare technology.
• Human Subject Protection Issues. Holland & Knight has extensive experience monitoring and responding to changes in federal policy related to human subject protections. These issues can have a significant impact on product development, and Holland & Knight has experience analyzing complex issues in the field such as the transition to expand clinical research to additional populations and the transition from multiple institutional review boards (IRBs) to single-site IRBs for multiple clinical sites.

Our Healthcare Policy Team recently:

• Created and executed a comprehensive strategy that reversed the CMS policy on reimbursement for biosimilar products on behalf of the nonprofit Biosimilars Forum. The landmark effort involved extensive lobbying in Congress, as well as before regulatory agencies, two presidential administrations and other stakeholders.
• Founded a leading industry coalition that successfully enacted language establishing an expedited approval pathway for cell and gene therapy products. This work further prompted the FDA to issue new guidelines to expedite the introduction of these therapies. Holland & Knight continues to lead policy development and advocacy in this sector, while also consulting on the pathway's effects on individual products in the gene and cellular therapy space.
• Secured enactment of a new pathway for approval of sunscreen ingredients. This entailed the unanimous passage of legislation and working with the FDA to develop implementing guidelines and regulations.
• Influenced and advised the National Institutes of Health (NIH) to hold multiple workshops on mitochondrial disease issues that have led to a significant increase in research in the field and secured more than $24 million in funding for mitochondrial disease since Fiscal Year (FY) 2015 through the DOD's Peer Reviewed Medical Research Program (PRMRP).
• Secured funding for FY 2020 and subsequent Senate Commerce-Justice-Science Appropriations legislation for the development of regenerative medicine standards at the National Institute of Standards and Technology (NIST). Currently, the agency is handling the development of regenerative medicine standards, which was mandated under the 21st Century Cures Act, with existing funds, hampering NIST's other efforts in biological systems measurement.

Health IT, Telehealth and New Technologies

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:

• Developed a proposal selected by congressional members from more than 100 proposals, and subsequently drafted and introduced a bill that would authorize a demonstration project to provide funding for community health centers and health center controlled networks to establish e-consult programs, which allow a primary care physician to connect with a specialist physician remotely to assist with patient care.
• Led a successful coalition effort to organize as a Senate letter to the Federal Communications Commission (FCC) advocating for increased funding to the Rural Health Care Program, which provides subsidies for rural broadband development.
• Led a successful effort to omit language from the ACA that would have required prior authorization for advanced diagnostic imaging services.
• Instrumental in creating a new EHR-centered program that provides decision support for medical image ordering. Decision support tools are required in many diagnostic settings, and developing an EHR-based system is a significant step in bringing these capabilities in line with the overall increase in the uptake of health IT.
• Led the creation of Section 218(b) of the Protecting Access to Medicare Act (PAMA), which established a program to promote appropriate use criteria for diagnostic imaging services. Holland & Knight developed and continues to manage a successful coalition to champion this change to PAMA and additional modifications.

Emergency Medicine, Disaster Preparedness and Related Issues

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:

• Lobbied on Capitol Hill on behalf of a medical society and an ad hoc coalition of EMS groups to secure and enact stand-alone legislation protecting the ability of physician medical directors to provide standing orders allowing paramedics to administer lifesaving controlled substances to patients in need at the scene of an emergency.
• Drafted, championed and enacted a requirement for drug manufacturers to notify the FDA of all emergency drugs in shortage on behalf of an EMS association and successfully advocated to amend the ACA to create trauma care funding authorization.
• Secured appointment of multiple client members for membership on an agency committee with direct influence over air ambulance healthcare issues.
• Organized meetings for a client with the U.S. Drug Enforcement Administration (DEA) to provide direct guidance in drafting a proposed rule that would affect the ability of EMS physicians to administer controlled substances in the field.

Coalition and Stakeholder Development

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:

• Designed and continues to manage a coalition composed of more than 20 public health organizations, manufacturers, testing entities and individual physicians that led to the drafting and unanimous passage of a bill before Congress that governed FDA's consideration of pending sunscreen applications. The coalition has since been recognized as a leader in the FDA nonprescription drug space and has served as a negotiator in subsequent legislation to reform the FDA's process for considering over-the-counter health products.
• Formed a coalition composed of 18 public health organizations in the pain management, kidney, transplant and patient advocacy spaces to take a stance against a potential regulatory action from the FDA that would limit consumer access to extra strength acetaminophen. This coalition has engaged with personnel at all levels of government, including senior White House, HHS, FDA, CMS and NIH officials and has engaged with Congress to delay the FDA's action on acetaminophen, while also successfully advocating for bipartisan, bicameral appropriations report language requiring the FDA to add weight-based dosing information to the acetaminophen label for children ages 6 months to 2 years.
• Developed a coalition of companies with the top biosimilars portfolios in the nation and performed a full range of advocacy, management, communications and legal roles. Holland & Knight's advocacy on behalf of this coalition resulted in a significant and unprecedented reversal of a CMS payment policy for biosimilar products.
• Organized a diverse coalition of public health organizations and imaging companies that has numerous successes in the imaging space, including the formation of a program to promote appropriate use criteria for diagnostic imaging services and reject the use of prior authorization for advanced diagnostic imaging services.