Bipartisan Bill Aimed At Expanding CMS Coverage Of Rx Digital Therapeutics Re-Introduced

The Access to Prescription Digital Therapeutics Act of 2025 (S1702/3288) seen here has been re-introduced by Senators Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH)) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA). The proposed legislation would do the following: 

• Create a reimbursement pathway for software that treats medical conditions

• Create a new Medicare benefit category for Food and Drug Administration (FDA)-cleared prescription digital therapeutics to be prescribed to seniors in the program.

• Require the CMS to develop payment methodologies for prescription digital therapeutics and create product-specific CPT codes to adequately reimburse for the products. 

Lanton Law through its Government Affairs Division Lanton Strategies has been following digital therapeutic policy as it unfolds. This is an oftentimes confusing area of policy since it is innovative and many times mistakenly tied to FDA approvals. 

Stakeholders who are interested in this issue and want to ensure compliance should ensure that an adequate and appropriate FDA approval and CMS reimbursement strategy is in place internally to avoid marketplace delays. Contact us to learn more.  

Lanton Law Interviewed by Pharmacy Times Over Prescription Drug Price Executive Order

Lanton Law was quoted in Pharmacy Times’ article titled “President Trump Signs Executive Order Aiming to Lower Prescription Drug Costs by Up to 90%.” The article can be accessed here.

Understanding the 2025 Executive Order on Most-Favored-Nation Drug Pricing: Implications for Healthcare Stakeholders

On May 12, 2025, President Trump signed an executive order titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," aiming to align U.S. prescription drug prices with the lowest prices paid by other developed nations.

Key Provisions:

• Most-Favored-Nation (MFN) Pricing: The order mandates that Americans should not pay more for prescription drugs than patients in other developed countries. It directs the Secretary of Health and Human Services (HHS) to establish MFN price targets within 30 days and communicate these to pharmaceutical manufacturers.

• Direct-to-Consumer Sales: HHS is instructed to facilitate programs allowing pharmaceutical manufacturers to sell directly to American patients at MFN prices, potentially reducing reliance on intermediaries.

• Addressing International Pricing Disparities: The Secretary of Commerce and the U.S. Trade Representative are directed to take action against foreign practices that may contribute to higher drug prices in the U.S., ensuring that American patients do not disproportionately fund global pharmaceutical research and development.

Potential Impact:

While the executive order sets forth ambitious goals to reduce drug prices, its implementation may face challenges, including legal scrutiny and resistance from stakeholders concerned about its impact on innovation and global pricing dynamics. The effectiveness of the order will depend on the specifics of the forthcoming regulations and the responses from pharmaceutical companies and international partners.

Call to Action:

Healthcare providers, insurers, and pharmaceutical companies should closely monitor developments related to this executive order. For a comprehensive analysis of its implications and guidance on navigating the evolving regulatory landscape, contact Lanton Law today.

New Federal Directives to Enhance U.S. Drug Manufacturing: Compliance Insights for Healthcare

On May 5, 2025, President Donald Trump signed the Executive Order on Regulatory Relief to Promote Domestic Production of Critical Medicines, marking a significant move to reduce America's reliance on foreign pharmaceutical manufacturing. This initiative aims to streamline regulatory processes, making it more feasible for domestic facilities to produce essential medicines.

Key directives include:

• FDA Regulatory Streamlining: The Food and Drug Administration (FDA) is tasked with reviewing and eliminating redundant regulations within 180 days to expedite the approval of domestic pharmaceutical manufacturing facilities.

• Enhanced Oversight of Foreign Producers: The FDA will increase inspections of overseas facilities to ensure they meet U.S. standards, aiming to level the playing field for domestic manufacturers.

• Accelerated Facility Construction: The Environmental Protection Agency is directed to expedite the permitting process for building pharmaceutical manufacturing plants in the U.S., addressing the current 5 to 10-year timeline deemed unacceptable for national security.

This executive order underscores a strategic pivot towards bolstering national security through domestic production of critical medicines. Healthcare organizations involved in pharmaceutical manufacturing, supply chain management, or regulatory compliance must assess their operations in light of these changes.

At Lanton Law, we specialize in guiding healthcare businesses through complex regulatory landscapes. Our expertise ensures your organization remains compliant and competitive. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.

Healthcare Compliance Alert: Navigating the New Biological Research Safety Mandates

On May 5, 2025, President Donald Trump signed the Executive Order on Improving the Safety and Security of Biological Research, marking a pivotal shift in U.S. biosecurity policy. This directive halts federal funding for "dangerous gain-of-function" (GoF) research, particularly in countries like China and Iran, where oversight is deemed insufficient. The move responds to concerns that such research—enhancing pathogens' transmissibility or virulence—could lead to lab accidents with catastrophic consequences, as speculated in the origins of COVID-19.

The order mandates the Office of Science and Technology Policy (OSTP) to collaborate with federal agencies to:

• Cease funding for high-risk GoF research abroad.

• Suspend ongoing domestic projects involving dangerous pathogens.

• Develop a comprehensive oversight framework within 120 days.

• Implement stringent compliance clauses in federal research contracts.

Healthcare entities engaged in biomedical research must now navigate a complex regulatory landscape. Compliance isn't optional; it's imperative. Institutions must audit current projects, reassess collaborations, and ensure alignment with the forthcoming policies.

At Lanton Law, we specialize in guiding healthcare organizations through regulatory transformations. Our expertise ensures that your research initiatives remain compliant and ethically sound. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.

Trump’s Pharmaceutical Tariffs: A New Operating Era for Healthcare

The Trump administration's recent trade and healthcare policies are poised to introduce significant uncertainty into the U.S. healthcare industry. Two pivotal executive actions—the initiation of a Section 232 national security investigation into pharmaceutical imports and the signing of the executive order titled “Lowering Drug Prices by Once Again Putting Americans First”—highlight the administration's approach.​

On April 1, 2025, the Department of Commerce commenced a Section 232 investigation to assess the national security implications of importing pharmaceuticals and their ingredients. This encompasses finished drug products, active pharmaceutical ingredients (APIs), and key starting materials. The investigation aims to determine whether reliance on foreign sources compromises national security, potentially leading to the imposition of tariffs ranging from 10% to 25% on these imports.

Simultaneously, President Trump signed the executive order “Lowering Drug Prices by Once Again Putting Americans First” on April 15, 2025. This order seeks to reduce prescription drug costs by enhancing Medicare drug price negotiations, reinstating discounted insulin programs, and increasing transparency in hospital drug acquisition costs.

While these measures aim to bolster domestic manufacturing and reduce drug prices, they introduce several uncertainties:​

1. Supply Chain Disruptions: Tariffs on imported pharmaceuticals could disrupt existing supply chains, leading to potential shortages and increased costs for healthcare providers and patients.​

2. Regulatory Ambiguity: The executive order lacks detailed implementation plans, leaving stakeholders uncertain about how the policies will be enforced and their practical implications.

3. Market Volatility: The potential for tariffs and changes in drug pricing regulations may lead to market instability, affecting investment decisions within the pharmaceutical industry.​

In this evolving landscape, healthcare entities must navigate the complexities of new trade policies and regulatory reforms. Lanton Law offers expertise in crafting targeted messaging and engaging with policymakers to advocate for client interests. Our team is equipped to assist clients in understanding and responding to these changes effectively. Contact us to learn more.​

Executive Action Targets High Drug Costs: What the Industry Needs to Know

On April 15, 2025, President Trump signed the executive order titled “Lowering Drug Prices by Once Again Putting Americans First,” signaling a significant shift in U.S. pharmaceutical policy. This directive aims to reduce prescription drug costs through a multifaceted approach, impacting various aspects of the healthcare industry.​

Key Provisions:

• Medicare Drug Price Negotiation: The order directs the Department of Health and Human Services (HHS) to enhance the Medicare Drug Price Negotiation Program. This includes prioritizing high-cost drugs and improving transparency to achieve greater savings for beneficiaries.​

• Alignment of Payment Structures: It proposes aligning Medicare payments for certain prescription drugs with the actual acquisition costs incurred by hospitals, potentially lowering prices by up to 35%. Additionally, the order seeks to standardize payments for treatments like cancer therapies, regardless of the care setting, which could reduce costs by as much as 60%. 

• Discounted Medications for Low-Income Patients: The executive order reinstates programs to provide insulin and injectable epinephrine at significantly reduced prices for low-income individuals and the uninsured, aiming to make these life-saving medications more accessible.

• Facilitation of Drug Importation: It instructs the FDA to streamline the approval process for state-run drug importation programs, potentially allowing states to source medications from countries like Canada to reduce costs.

• Acceleration of Generic Drug Approvals: The order calls for the FDA to expedite the approval of generic and biosimilar drugs, fostering competition and potentially leading to lower drug prices.

Implications for the Healthcare Industry:

While the executive order outlines ambitious goals, the industry is looking for additional details. The potential for new tariffs on imported pharmaceuticals, coupled with changes in Medicare payment structures, could disrupt supply chains and affect pricing strategies. Healthcare providers, pharmaceutical companies, and policymakers must navigate these changes carefully to mitigate risks and capitalize on opportunities.​

How Lanton Strategies Can Assist:

In this evolving policy landscape, Lanton Strategies offers strategic consulting and lobbying services to help clients understand and influence the implications of the executive order. Our expertise in healthcare policy and regulatory affairs positions us to provide targeted messaging and advocacy efforts, ensuring our clients' interests are represented before the Administration and Congress. Contact us to learn more about how we can help you navigate this period of change.​

Section 232 Targets Drug Imports: What It Means for Pharma and Healthcare

​On April 1, 2025, the U.S. Department of Commerce initiated a Section 232 national security investigation into the importation of pharmaceuticals and pharmaceutical ingredients. This inquiry aims to assess whether the reliance on foreign sources for essential medical products poses a threat to national security. The scope includes finished drug products, active pharmaceutical ingredients (APIs), key starting materials, and related derivatives.​

The Department of Commerce is soliciting public comments to inform this investigation. Stakeholders are encouraged to provide input on various factors, including:​

• The current and projected demand for pharmaceuticals and their ingredients in the U.S.​

• The capacity of domestic production to meet this demand.​

• The role and risks associated with foreign supply chains.​

• The impact of foreign government subsidies and trade practices on U.S. industry competitiveness.​

• The feasibility of expanding domestic manufacturing to reduce import reliance.​

Comments must be submitted by May 7, 2025, through the Federal Rulemaking Portal at www.regulations.gov, referencing Docket ID BIS-2025-0022. Submissions containing business confidential information should be clearly marked and accompanied by a non-confidential version.​

For further details, please refer to the official notice in the Federal Register: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.​

There are plenty of questions and speculation about what this means for specific supply chain participants. Contact Lanton Strategies to learn about how we can help you respond to these comments as well as help you speak with either Congress or the Administration to get your voice heard.   

The UK’s AI Regulation Bill: A Strategic Reboot for Trust and Innovation

The reintroduction of the Artificial Intelligence (Regulation) Bill [HL] by Lord Holmes of Richmond in March 2025 seen here marks a pivotal moment in the UK’s AI legislative journey—one that reflects both a pragmatic reassessment of regulatory gaps and a desire to reestablish public trust in AI.

At its core, this Private Members’ Bill proposes the creation of a centralized AI Authority—a move that industry and legal experts alike recognize as long overdue. Unlike the government’s earlier “pro-innovation” strategy, which leaned heavily on voluntary commitments, Lord Holmes’ bill brings needed structure and enforceability. It’s a shift that positions the UK to balance innovation with ethical safeguards, much like efforts underway in the EU and U.S.

The bill highlights key regulatory pillars: safety, transparency, accountability, fairness, and contestability meant to govern the development, deployment, and monitoring of AI systems across sectors, from healthcare and finance to defense and education.

Two provisions in particular deserve emphasis. First, the requirement for designated AI officers within organizations introduces a tangible compliance mechanism—ensuring there’s real human oversight in algorithmic decision-making. Second, the inclusion of regulatory sandboxes is a clear nod to innovation, giving developers a safe and supervised space to test new technologies before widespread release.

Notably, the bill also calls for disclosure of training data and IP usage, a provision that resonates with concerns from creative and scientific communities around data provenance and rights protections. And perhaps most crucially for public trust, it mandates ongoing public engagement, anchoring AI governance in democratic accountability.

While the bill still faces the typical uphill climb of any Private Members’ Bill, it serves as a blueprint for a more balanced, enforceable approach to AI regulation in the UK. For legal practitioners, AI developers, and policymakers, this reintroduction is more than legislative housekeeping—it’s a strategic reset.

At Lanton Strategies, we believe that regulatory clarity is not a barrier to innovation—it’s the very foundation for sustainable growth in the AI era. Lanton Strategies is an international government affairs consulting firm that specializes in healthcare and technology. Contact us today to learn more about how we can help you.

Lanton Law Speaks with Pharmaceutical Executive on Navigating NIH Funding Cuts, Diversity Bans, and Tariff Challenges

Lanton Law spoke with Pharmaceutical Executive on NIH Funding cuts. The interview is titled “Navigating NIH Funding Cuts, Diversity Bans, and Tariff Challenges: Legal and Industry Implications for Medical Research”

The interview can be seen here.

Lanton Law Quoted in Pharmacy Times Interview on Drug Pricing Reforms Amid the Repeal of Executive Order 14087

Lanton Law was quoted in the Pharmacy Times Article titled "Reversal of Executive Order (EO) 14087 Raises Questions About Future Drug Pricing Reforms.” We discuss the EO and how pharmacists are impacted. The article can be viewed here.

New Presidential Executive Order on Artificial Intelligence Released

According to the White House, the President has signed a January 23, 2025 Executive Order (EO) on artificial intelligence. According to the White House release the EO does the following: 

• This Executive Order establishes the commitment of the United States to sustain and enhance America’s dominance in AI to promote human flourishing, economic competitiveness, and national security.

• American development of AI systems must be free from ideological bias or engineered social agendas. With the right government policies, the United States can solidify its position as the leader in AI and secure a brighter future for all Americans.

• The order directs the development of an AI Action Plan to sustain and enhance America’s AI dominance, led by the Assistant to the President for Science & Technology, the White House AI & Crypto Czar, and the National Security Advisor

• It further directs the White House to revise and reissue OMB AI memoranda to departments and agencies on the Federal Government’s acquisition and governance of AI to ensure that harmful barriers to America’s AI leadership are eliminated.

  Lanton Law is a national boutiquelaw andgovernment affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and technology spaces.Contact us to learn about how either ourlegal orlobbying services can help you attain your goals.

Effects of the Federal Trade Commission's Repeal of Non-Compete Agreements on the Pharma Industry

In an interview with Associate Editor Donald Tracy, MA, Ron Lanton III, Esq., Partner, Lanton Law offers his thoughts on the recent Federal Trade Commission (FTC) repeal of non-compete agreements, and how it could effect the #pharma industry.

The interview can be viewedhere.

U.K. Launches It's Strategic Vision for Global Leadership and Ethical Innovation Using AI

At Lanton Law and our sister company Lanton Strategies International, we are watching multiple developments worldwide on the usage of AI. Most recently, our attention has focused on the events in the United Kingdom.

With the UK Prime Minister Sir Keir Starmer’s speech on the U.K.’s AI strategy, the Prime Minister has put forward a bold vision to position the United Kingdom as a global leader in artificial intelligence. With a focus on fostering innovation, ethical leadership, and practical application, the government is leveraging AI to drive economic growth, modernize public services, and secure its position in the competitive global AI landscape.

The AI Opportunities Action Plan serves as the cornerstone of this vision, laying out a comprehensive framework for integrating AI into the UK economy. The government has attracted significant private-sector investment, including a commitment of £14 billion from leading tech firms, and aims to create over 13,000 jobs. AI Growth Zones are a pivotal part of the strategy, designed to streamline planning for research and development hubs that will foster collaboration across academia, industry, and government.

Modernizing public services is another critical objective. AI tools like Parlex are already being developed to streamline decision-making processes within the public sector. By reducing administrative burdens, civil servants can focus on improving service delivery for citizens.

On the global stage, the UK is carving a niche in ethical AI leadership, hosting the inaugural AI Safety Summit in November 2023. The resulting Bletchley Declaration emphasizes international cooperation on the safe development and use of AI, aligning with the UK’s commitment to balancing innovation with responsibility.

Despite these efforts, challenges remain. Competing with AI superpowers like the US and China requires pragmatic goal-setting and leveraging the UK’s strengths in education and professional services. By focusing on fintech, ethical AI, and sustainable innovation, the UK can strategically navigate the competitive AI environment.

In summary, Prime Minister Starmer’s AI stance reflects a forward-thinking approach that combines ambition with practicality, ensuring the UK remains a key player in shaping the future of AI.

For additional questions on this and any other policy or regulatory matters where AI is concerned, contact us for details.

FTC, DOJ and HHS Extend RFI on Private Equity Control in Health Care Markets

The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) are extending the deadline by 30 days for the public to comment on a tri-agency Request for Information (RFI) examining private-equity and other corporations’ increasing control over health care markets. The new deadline is now June 5, 2024.

At Lanton Law not only do we understand the issues, but we provide you with timely solutions to help you make informed decisions about either an acquisition target or ways to maximize value. We counsel clients by performing corporate due diligence, provide strategic advice for growth and business strategies as well as structuring and executing M&A transactions.

Contact us today to learn more

Lanton Law Will Speak at New York Bar's Food Drug & Cosmetic Section's Annual Meeting

We are proud to announce that Lanton Law will be presenting at the NY State Bar Association's Spring Meeting. We are excited about our presentation titled Drug Pricing Wars: "Trends, Politics and Policies." To register and hear the other great presentations click the link below. To register click here

Federal Privacy Rights Legislaton Introduced into Congress

House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) and Senate Committee on Commerce, Science and Transportation Chair Maria Cantwell (D-WA) have introduced the American Privacy Rights Act. 

According to the legislator’s press release, this proposal seeks to establish national data privacy rights and protections for Americans, eliminates the existing patchwork of state comprehensive data privacy laws, and establishes robust enforcement mechanisms to hold violators accountable, including a private right of action for individuals.

Furthermore, the release describes other provisions of the proposed legislation: 

• Establishes Foundational Uniform National Data Privacy Rights for Americans

• Gives Americans the Ability to Enforce Their Data Privacy Rights

• Protects Americans’ Civil Rights

• Holds Companies Accountable and Establishes Strong Data Security Obligations

• Focuses on the Business of Data, Not Mainstreet Business

The draft can be seen here.

Lanton Law's experience in privacy and data protection enables these companies to navigate the complex legal and regulatory landscape effectively. By partnering with us, tech and healthcare organizations can develop robust strategies, ensuring compliance, safeguarding personal data, and maintaining trust among your consumers.

Contact us to learn more. 

CMS Makes An Impactful Change Regarding Biosimilars

Within its final calendar year 2025 Medicare Advantage and Part D final rule seen here, the Centers for Medicare and Medicaid Servces (CMS) is allowing Part D sponsors the ability to make midyear substitutions of biosimilars for their reference products on their formularies. 

Specifically:

•  All biosimilars may be substituted as formulary maintenance changes: Part D sponsors may treat formulary substitutions of all biosimilars for their reference products as “maintenance changes” that would not require explicit prior approval by CMS.  This option has previously been available only for interchangeable biological products. Part D sponsors previously had to obtain explicit approval prior to substituting biosimilars other than interchangeable biological products, and these substitutions applied only to enrollees who began therapy after the effective date of the change — delaying enrollees’ access to cheaper options. Treating all biosimilar substitutions as maintenance changes means that midyear formulary substitutions of biosimilars for their reference products would apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day advance notice to affected enrollees. 

• New interchangeable biological products may be immediately substituted: We are finalizing additional flexibility for interchangeable biological products not on the market at the time that Part D sponsors submit their initial formulary for CMS approval. Part D sponsors meeting certain requirements have the additional option to immediately substitute a new interchangeable biological product for a reference product and provide notice of the change to affected enrollees after making such change. 

Biosimilar policy continues to evolve. It’s important to be in the know to plan accordingly. 

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. 

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

U.S. Senate Finance Committee Hearing on AI in Health Care Shows AI Policy is Forthcoming

The U.S. Senate Finance Committee held a February 8, 2024 hearing titled “Artificial Intelligence and Health Care: Promise and Pitfalls.”

The following witnesses testified at the hearing:

• Peter Shen, Head of Digital & Automation for North America, Siemens Healthineers, Washington, DC

• Mark Sendak, MD, MPP, Co-Lead, Health AI Partnership, Durham, NC

• Michelle M. Mello, JD, Ph.D., Professor of Health Policy and of Law, Stanford University, Stanford, CA

• Ziad Obermeyer, MD, Associate Professor and Blue Cross of California Distinguished Professor, University of California – Berkeley, Berkeley, CA

• Katherine Baicker, Ph.D., Provost, University of Chicago, Chicago, IL

Senator Wyden (D-OR) made a few statements on AI. The Senator emphasized the importance of ensuring that AI in healthcare is used to improve patient outcomes and lower costs, rather than being driven by profit.. He also highlighted the need to address concerns regarding privacy, data security, and bias in AI algorithms.

Artificial Intelligence is clearly an emerging innovative field that is both exciting and risky. For tech and healthcare stakeholders, the possibilities can be endless when examining potential legal and regulatory pitfalls.

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and technology spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

California Passes First-in-Nation Law to Reduce Medication Errors, Address Pharmacy Staffing Concerns

Lanton Law speaks with Pharmacy Times on California's new Stop Dangerous Pharmacies Act (AB 1286). This new law aims to address understaffed chain pharmacies and reduce medication errors. Key aspects of the law included giving pharmacists more autonomy over staffing decisions, requiring reporting of unsafe conditions, and establishing a confidential medication error reporting system. Listen here for the interview.