Ron Lanton 4/9/24 Ron Lanton 4/9/24

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

Ron Lanton 4/8/24 Ron Lanton 4/8/24

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.

Ron Lanton 3/11/24 Ron Lanton 3/11/24

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.

Ron Lanton 3/11/24 Ron Lanton 3/11/24

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.

Ron Lanton 1/31/24 Ron Lanton 1/31/24

Pharmaceutical Commerce Speaks with Lanton Law about New Drug Pricing Models

Pharmaceutical Commerce interviews Ron Lanton; Partner at Lanton Law on newly emerging pricing models such as the cost plus drug model.

Pharmaceutical Commerce interviews Ron Lanton; Partner at Lanton Law on newly emerging pricing models such as the cost plus drug model. Ron gives his insight on what impacts these emerging models will have on the pharmaceutical industry. The interview can be seen here.

Ron Lanton 11/23/23 Ron Lanton 11/23/23

New York Proposes New Cybersecurity Regulations for State Hospitals

On November 13, the Governor unveiled new cyber regulations for state hospitals. The Governor’s FY24 budget includes $500 million in funding that health care facilities may apply to upgrade their systems in order to comply.

According to the release which can be read here states:

“The proposed regulations aim to strengthen the protections on hospital networks and systems that are critical to providing patient care, as a complement to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule that focuses on protecting patient data and health records. Under the proposed provisions, hospitals will be required to establish a cybersecurity program and take proven steps to assess internal and external cybersecurity risks, use defensive techniques and infrastructure, implement measures to protect their information systems from unauthorized access or other malicious acts, and take actions to prevent cybersecurity events before they happen.”

Lanton Law with offices in Boston and Washington D.C. is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and technology spaces.

Ron Lanton 11/23/23 Ron Lanton 11/23/23

Mass General Brigham partners with Best Buy to improve acute care at home via tech

Mass General Brigham has announced an innovative partnership with Best Buy.

Mass General Brigham has announced an innovative partnership with Best Buy. According to the press release:

“Together, they will develop solutions to support the transformational movement of shifting healthcare to patients’ homes by improving how quality and safe care are provided with technology and clinical expertise. Their first priority is to scale and support Mass General Brigham’s Home Hospital. This technology-enabled clinical delivery model will expand access to Massachusetts residents choosing to receive acute-level hospital care in the comfort of their home. This collaboration will also help address one of the biggest challenges the healthcare industry faces today — workforce shortages.”

They also addressed the future of care at home:

“While workforce shortages plague the healthcare industry and threaten the ability of healthcare systems, the Home Hospital experience has shown an increase in employee satisfaction through innovative hybrid practice options and a reduction of clinician burnout. As part of this relationship, Best Buy Health and Mass General Brigham will engage with and make significant investments in the community to enable the next generation of the Healthcare at Home workforce. To do this they will create equitable, academic opportunities for individuals interested in pursuing nursing, paramedic and digital technology careers by offering scholarships to students choosing the at-home setting of care as their desired professional environment. They will also work to bring care in the home to the forefront of curriculum within these industries to further support the growing home healthcare model.”

Their full press release can be found here.

Ron Lanton 10/30/23 Ron Lanton 10/30/23

U.S. Government Issues First Ever Artificial Intelligence (AI) Executive Order Via the Biden Administration

On October 30, 2023, President Biden issued an Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence (AI). The Order sets out a comprehensive approach to ensuring that AI is developed and used in a way that is aligned with American values and interests. This is a major development since this is the first action of its kind by the U.S. government addressing safety, civil rights, equity and research issues.

The Order includes a number of key provisions, including:

Establishing a National AI Advisory Council: The Council will be composed of experts from academia, industry, and civil society, and will advise the President on AI policy and strategy.

Directing the development of AI Risk Mitigation Guidelines: The National Institute of Standards and Technology (NIST) will develop guidelines for mitigating the risks associated with AI, such as bias and discrimination.
Promoting AI Research and Development: The Order directs the federal government to invest in AI research and development, with a focus on areas such as safety, security, and reliability.
Protecting Civil Rights and Liberties: The Order directs the federal government to ensure that AI is used in a way that protects civil rights and liberties, such as privacy and freedom of expression.
Promoting International Cooperation on AI: The Order directs the federal government to work with international partners to develop and promote responsible AI practices.

The Order also establishes a number of specific tasks for federal agencies, such as developing AI ethics principles, conducting risk assessments of AI systems, and ensuring that AI is used in a fair and equitable manner.

The Executive Order on Safe, Secure, and Trustworthy AI is a significant step forward in the United States' efforts to ensure that AI is developed and used in a responsible and ethical manner. The Order sets out a comprehensive approach to addressing the risks and challenges associated with AI, and it will help to ensure that AI is used in a way that benefits all Americans.

Ron Lanton 10/6/23 Ron Lanton 10/6/23

Lanton Law Speaks With Pharmacy Times About Provider Status

Below is the description from Pharmacy Times about our discussion with them on pharmacy provider status. You can listen to the interview here.

In this episode of Pharmacy Focus: Policy Edition, we delve into the intricacies of provider status for pharmacists, including challenges that have hindered pharmacists from attaining this recognition, the recent legislative strides, and the far-reaching implications for the field. Our guest, Ron Lanton III, Esq from Lanton Law, lends his expertise to shed light on the financial impacts and effective advocacy strategies.

Key Topics

Unpacking the concept of provider status for pharmacists and its significance
Recent legislative advancements that have propelled the provider status movement forward
Implications of achieving provider status: expanded clinical roles, reimbursement opportunities, and patient care improvements
Financial considerations for pharmacists and the broader healthcare landscape
Strategies for effective advocacy to accelerate provider status adoption

Ron Lanton 9/26/23 Ron Lanton 9/26/23

Congress Reintroduces the Access to Prescription Digital Therapeutics Act

Congress has introduced The Access to Prescription Digital Therapeutics Act of 2023

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise.

With that in mind, Congress has introduced The Access to Prescription Digital Therapeutics Act of 2023. The bill proposes to “expand Medicare coverage to include PDTs, which are software-based disease treatments designed to directly treat disease. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software. The treatments are tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA) and prescribed by health care providers.” The bill can be read here.

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 8/29/23 Ron Lanton 8/29/23

New York Proposes New PBM Regulations

The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.

This rulemaking is one to monitor especially with the recent events from the 10th Circuit. We have written a recent blog post on this developments surrounding this decision.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation as well as counseling clients on responding to relevant proposed rules.

Ron Lanton 8/29/23 Ron Lanton 8/29/23

Biden Administration Announces First Ten Drugs Selected for Medicare Price Negotiation

The Biden Administration has announced today that Medicare will be able to negotiate drug prices for the first time due to provisions within the Inflation Reduction Act.

The first ten selected drugs for negotiation are Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara and Fiasp.

The Administration stated that these drugs “accounted for $50,5 billion in total Part D gross covered prescription drug costs. The negotiations will occur in 2023 and 2024 and any negotiated prices will become effective beginning in 2026.

According to HHS press release read here, “In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the Inflation Reduction Act.”

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

Ron Lanton 8/19/23 Ron Lanton 8/19/23

Pharmacy Congressional Bills to Watch

Two pro-pharmacy bills continue to make their way through Congress.

S.1038 titled Drug Price Transparency in Medicaid Act of 2023 sponsored by Senator Welch (D-VT) requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with pharmacy benefit managers under Medicaid. The bill also extends funding for retail pharmacy surveys and requires additional information with respect to price concessions and survey participation to be made publicly available.

S2052 titled Protect Patient Access to Pharmacies Act proposes to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare Part D.

Ron Lanton 8/18/23 Ron Lanton 8/18/23

Tenth Circuit Deals Pharmacy a Set Back Regarding Oklahoma PBM Law

This week The U.S. Court of Appeals for the Tenth Circuit issued a decision agreeing with the Pharmaceutical Care Management Association (PCMA) that Oklahoma's Patient's Right to Pharmacy Choice Act (the Act) is preempted by ERISA because it interferes with central matters of plan administration by restricting ERISA plans from structuring their pharmacy networks in a particular manner.

In 2020 the pharmacy industry witnessed much needed relief with the U.S. Supreme Court ruling on behalf of pharmacy in the unanimous Rutledge v. PCMA case. That decision held that a federal law, the Employee Retirement Income Security Act of 1974 (ERISA), does not prevent states from enacting laws regulating the abusive payment practices of PBMs.

However; this week The U.S. Court of Appeals for the Tenth Circuit issued a decision agreeing with the Pharmaceutical Care Management Association (PCMA) that Oklahoma's Patient's Right to Pharmacy Choice Act (the Act) is preempted by ERISA because it interferes with central matters of plan administration by restricting ERISA plans from structuring their pharmacy networks in a particular manner. The court also held that ERISA preempted the Act's provision that would bar pharmacy benefit managers (PBMs) from denying, limiting, or terminating a pharmacy's contract because one of its pharmacists is on probation with the state pharmacy board.

This is definitely an inconsistent decision from Rutledge and should be overturned due to recent U.S. Supreme Court precedent.

Ron Lanton 8/18/23 Ron Lanton 8/18/23

Illinois Enacts Pro-Pharmacy Legislation

Illinois has enacted HB 3631, pro-pharmacy legislation sponsored by Senator Simmons. The new law prohibits pharmacy benefit managers from retaliating against pharmacists for disclosing information in government proceedings if they have reasonable cause to believe that the disclosed information is evidence of a violation of a state or federal law, rule, or regulation.

Ron Lanton 7/23/23 Ron Lanton 7/23/23

More Drugmakers Sue Biden Administration Over Medicare Negotiation

Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violates the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.

Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violate the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.

As part of the new law, the Centers for Medicare and Medicaid Services (CMS) will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.

Ron Lanton 7/21/23 Ron Lanton 7/21/23

Tech Firms Sign White House AI Pledge Over Concerns of Potential AI Risks

This week the Biden Administration secured voluntary commitments from seven leading artificial intelligence (AI) companies, including Amazon, Anthropic, Google, Inflection, Meta, Microsoft, and OpenAI, to promote the safe, secure, and transparent development of AI technology. These commitments focus on three fundamental principles: safety, security, and trust. The companies pledge to conduct internal and external security testing of their AI systems before release, share information on managing AI risks with various stakeholders, and invest in cybersecurity measures. They also commit to ensuring users can identify AI-generated content, publicly report on AI capabilities and limitations, prioritize research on societal risks like bias and discrimination, and develop AI systems to address significant challenges such as cancer prevention and climate change.

The Biden Administration will continue its efforts to establish an international framework for AI governance and has already consulted with numerous countries on the voluntary commitments. The administration aims to ensure AI development is conducted safely and responsibly to protect Americans from harm and discrimination. Prior actions include convening industry leaders to discuss AI risks, signing an Executive Order to address bias in technology, and investing in AI research and development institutes across the country. The administration is also preparing policy guidance for federal agencies to ensure AI systems prioritize the protection of citizens' rights and safety.

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

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Lanton Law Quoted in Pharmacy Times Article Titled "Mifepristone Has its Day in Court"

Lanton Law was quoted in Pharmacy Times article titled “Mifepristone Has its Day in Court.” The article discusses the drug amid its backdrop in the U.S. Supreme Court.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Lanton Law Lobbies on Beacon Hill in Boston, Massachusetts for Pharmacy Issues

Lanton Law was on Beacon Hill this week advocating for pharmacy issues.

Lanton Law was on Beacon Hill this week advocating for pharmacy issues. We are happy to be working with several pharmacy allies within the legislature on meaningful issues around health promotion screening and pharmacy benefit manager transparency.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Lanton Law Quoted in Pharmacy Times Article "FDA Approves First Nonprescription Daily Birth Control Pill"

Lanton Law was quoted in the Pharmacy Times article titled “FDA Approves First Nonprescription Daily Birth Control Pill.”

Lanton Law was quoted in the Pharmacy Times article titled “FDA Approves First Nonprescription Daily Birth Control Pill.” The article can be viewed here.