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

Unleashing the Power of Lanton Law: The Key to Effective Lobbying

When it comes to navigating the complex world of lobbying, choosing the right lobbyist will make all the difference. Lanton Law offers a unique approach that has proven to be highly effective in driving positive change.

One of the primary reasons for choosing us is the wealth of experience and expertise that our team brings to the table. From policy analysis and strategic planning to coalition building and stakeholder engagement, our approach ensures that our clients' interests are well represented and advocated for.

Leveraging our extensive network and deep industry connections, we develop tailored strategies that align with our clients' specific goals and priorities. Our personalized approach results in more effective and tangible results.

Ron Lanton 12/27/22 Ron Lanton 12/27/22

Prescription Digital Therapeutics Bill Introduced in Congress

The Medicaid and CHIP Access to Prescription Digital Therapeutics Act also known as S. 5238 seen here was introduced on December 12, 2022 by Senator Capito (R-WV).

The Medicaid and CHIP Access to Prescription Digital Therapeutics Act also known as S. 5238 seen here was introduced on December 12, 2022 by Senator Capito (R-WV). The bill seeks to “require the Administrator of the Centers for Medicare & Medicaid Services to provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children's Health Insurance Program.” While this bill is a step forward for digital therapeutics, questions remain about this bill such as whether this bill will get introduced in the new Congress, will this bill create more access, reduce costs and is the correct reimbursement model?

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.

Lanton Law is a national healthcare and technology 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 7/28/22 Ron Lanton 7/28/22

U.S. House Sends Chips and Science Act & Sends to the President For Signature

The U.S. House has passed the bipartisan Chips and Science Act of 2022. The bill can be viewed here. The bill aims to strengthen U.S. competitiveness with China by providing more than $52 billion for U.S. companies producing computer chips, as well as billions more in tax credits to encourage investment in chip manufacturing. It also provides tens of billions of dollars to fund scientific research, and to spur the innovation and development of other U.S. technologies.

This legislation will provide several opportunities for both technology companies and technology stakeholders to expand and thrive.

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. If you are a tech or healthIT 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 1/5/22 Ron Lanton 1/5/22

New York Enacts New Pharmacy Benefit Manager Law

Governor Kathy Hochul has issued a press release announcing the enactment of S3762/A.1396 which provides for PBM registration and licensure.

Governor Kathy Hochul has issued a press release announcing the enactment of S3762/A.1396 which provides for PBM registration and licensure. According to the release:

“Legislation S.3762/A.1396 requires licensure for pharmacy benefit managers and specifies their duties and obligations as service providers. This bill also allows the department of financial services to receive complaints when a PBM violates the law and will ensure PBMs abide by standards established by law and regulation.”

Why is this important?

Based on our experience and our clients, Lanton Law strongly believes that PBMs have been hindering pharmacy operations and reimbursement for far too long. This new law is a great step in the right direction. With PBMs there is always more work to be done. Pharmacy advocates can use this law as a model in their own respective states.

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.

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 11/23/21 Ron Lanton 11/23/21

CURES 2.0 Biomedical Legislation Introduced Into Congress

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are back as they recently introduced their long anticipated and bipartisan Cures 2.0 legislation. The bill is discussed via Congresswoman DeGette’s press release.

So what does this proposed legislation do:

Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.
Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it.
Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.
Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.
Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.
Conduct a nationwide study on the implications of long COVID; and
Develop a nationwide testing and vaccine distribution strategy to be used in future pandemics.

The proposed bill can be viewed here while a section by section summary can be viewed 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 life sciences practice can help stakeholders understand what’s at issue 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 10/8/21 Ron Lanton 10/8/21

California Enacts Genetic Privacy Legislation

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies.

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies. The bill can be viewed here. Below are the highlights of the bill:

This bill would establish the Genetic Information Privacy Act, which would require a direct-to-consumer genetic testing company, as defined, to provide a consumer with certain information regarding the company’s policies and procedures for the collection, use, maintenance, and disclosure, as applicable, of genetic data, and to obtain a consumer’s express consent for collection, use, or disclosure of the consumer’s genetic data, as specified.

This bill would require a direct-to-consumer genetic testing company to honor a consumer’s revocation of consent in accordance with certain procedures, and to destroy a consumer’s biological sample within 30 days of revocation of consent. The bill would further require a direct-to-consumer genetic testing company to implement and maintain reasonable security procedures and practices to protect a consumer’s genetic data against unauthorized access, destruction, use, modification, or disclosure, and develop procedures and practices to enable a consumer to access their genetic data, and to delete their account and genetic data, as specified. The bill would exclude from its provisions the California Newborn Screening Program, specific tests, and certain information, providers, entities, and activities subject to specified state and federal laws.

This bill would provide that the act does not reduce a direct-to-consumer genetic testing company’s duties, obligations, requirements, or standards under any applicable state and federal law for the protection of privacy and security and would further provide, if a conflict exists between the act and any other law, that the provisions of the law that afford the greatest protection for the right of privacy for consumers shall control.

This bill would impose civil penalties for a violation of those provisions, as specified. The bill would require actions for relief pursuant to these provisions to be prosecuted exclusively by the Attorney General, a district attorney, county counsel, city attorney, or city prosecutor, as specified, in the name of the people of the State of California upon their own complaint or upon the complaint of a board, officer, person, corporation, or association or upon a complaint by a person who has suffered injury in fact and has lost money or property as a result of the violation of the act. Because the bill would require local officials to perform additional duties, the bill would impose a state-mandated local program.

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

Ron Lanton 6/7/21 Ron Lanton 6/7/21

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.

According to Senator Cornyn’s press release “this legislation would direct HHS to establish a shared savings demonstration project to increase access to biosimilars in the Medicare program. This would encourage physicians to prescribe less-expensive biosimilars increasing patient access to more affordable, life-saving drugs and lowering patient out-of-pocket costs.

Under the demonstration, Medicare would provide an additional payment to providers for using lower-cost biosimilar products that reflects the savings created in contrast to administering the higher-cost reference biological product. Additionally, Medicare can use a portion of those savings to reduce the beneficiary’s coinsurance payment.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science 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 5/4/21 Ron Lanton 5/4/21

Florida Proposed Privacy Bill Fails

H.B. 969 titled Consumer Data Privacy has failed to become the nation’s third comprehensive consumer privacy law.

H.B. 969 titled Consumer Data Privacy has failed to become the nation’s third comprehensive consumer privacy law. The legislature adjourned without reaching a legislature agreement between the House and Senate as the Senate voted 29-11 to send the bill back to the House. The main controversy around this bill not being able to advance is centered on whether a consumer should have a private right of action to sue a company for an alleged violation.

Lanton Law’s technology practice has been monitoring privacy developments nationwide. 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 4/20/21 Ron Lanton 4/20/21

Two Biosimilar Bills Head to President Biden for Signature

Two Biosimilar Bills Head to President BIden for Signature

S. 164 titled the “Advancing Education on Biosimilars Act of 2021” sponsored by Senator Hassan (D-NH) has passed both the House and Senate and is on its way to the President. This bill requires the Food and Drug Administration (FDA) to advance education and awareness among health care providers about biological products as appropriate, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars. The FDA may also maintain and operate a website to provide educational materials about biological products.

Additionally, the Ensuring Innovation Act has passed both the House and Senate and is on its way to President for his signature. According to Senator Cassidy’s press release, the bill “would close loopholes to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generics from entering the market.”

Ron Lanton 4/8/21 Ron Lanton 4/8/21

Oregon Proposes New Policy to Control Drug Prices

Drug prices have been fiercely debated in Congress and in various state capitols before COVID-19 brought everything to a halt. Vermont was the first state in the country to require pharmaceutical manufacturers to explain drug price increases. That initiative was followed by Maryland in 2019 as the state created its five member Prescription Drug Affordability Board to monitor prices. It seems now the attention is focused on Oregon.

SB 844 proposes to establish a Prescription Drug Affordability Board in the Department of Consumer and Business Services to review prices for prescription drug products meeting specified cost criteria. Business Services will review prices for prescription drug products meeting specified cost criteria. The bill also requires the board to establish an upper payment limit for drugs that are or are expected to create affordability challenges for health systems and patients in Oregon or health inequities for communities of color.

An insurer, pharmacy benefit manager or other person that pays for or reimburses the cost of prescription drugs in this state may elect to opt out of the upper payment limit for specific drugs to allow the payer to negotiate with a manufacturer for the cost of the drug.

Additionally, the Prescription Drug Affordability Board shall annually assess fees to be paid by manufacturers that sell prescription drug products in this state. The fees shall be established in amounts necessary to meet the costs of the board. The fees shall be imposed based on a manufacturer’s share of gross revenue from sales of prescription drug products in this state.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current telemedicine 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 3/29/21 Ron Lanton 3/29/21

New York Reaches Agreement To Legalize Adult-Use Cannabis

According to Governor Cuomo’s press release, the Governor, “Senate Majority Leader Andrea Stewart-Cousins and Assembly Speaker Carl Heastie announced an agreement on legislation (S.854-A/A.1248-A) to legalize adult-use cannabis.

The bill would establish the Office of Cannabis Management to implement a comprehensive regulatory framework that would cover medical, adult-use and cannabinoid hemp. The bill would also expand New York State's existing medical marijuana and cannabinoid hemp programs. The legislation provides licensing for marijuana producers, distributors, retailers, and other actors in the cannabis market, and creates a social and economic equity program to assist individuals disproportionately impacted by cannabis enforcement that want to participate in the industry.”

The New York State Cannabis/Marijuana Regulation & Taxation Act address the following issues:

Establish the Office of Cannabis Management
Medical Cannabis
Adult-Use Cannabis
Cannabinoid Hemp
Adult-Use Cannabis Tax Revenue
Municipal Opt-Out
Traffic Safety
Personal Possession and Home Cultivation
Criminal Justice and Record Expungement
Protections for the Use of Cannabis and Workplace Safety
Public Health and Education Campaign

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically our cannabis practice helps all supply chain entities from growers, financiers, suppliers, dispensers to ancillary services.

Ron Lanton 3/29/21 Ron Lanton 3/29/21

Senator Markey and Congressman Lieu Reintroduce Bill Seeking to Improve the Cybersecurity of IoT Technology

Senator Markey (D-MA) and Congressman Lieu (D-CA) have reintroduced the Cyber Shield Act. The proposed legislation will create a voluntary program to identify and promote internet-connected products that meet industry-leading cybersecurity and data security standards, guidelines, best practices, methodologies, procedures, and proc- esses, and for other purposes.

According to the legislators’ press release, the proposal will specifically establish an advisory committee of cybersecurity experts from academia, industry, consumer groups, government, and the public to create cybersecurity benchmarks for IoT devices – such as baby monitors, home assistants, smart locks, cameras, cell phones, and laptops. IoT manufacturers can then voluntarily certify that their products meet those cybersecurity benchmarks, and display this certification to the public with a “Cyber Shield” label that will help consumers identify and purchase more secure technology for their homes.”

The bill can be viewed here.

Our reliance on technology has become even more vital with the effects of COVID-19. With all of the hacking and malware attacks we have witnessed against various data stakeholders, we foresee cybersecurity as a major policy area that will continue to be expanded.

Lanton Law is a national boutique law andlobbying firm that focuses on technology and Health IT.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 3/29/21 Ron Lanton 3/29/21

Congressional IoT Legislation Introduced to Prepare for 5G Networks.

Congresswoman DelBene (D-WA)and Congressman Katko (R-NY) have introduced the Internet of Things (IoT) Readiness Act of 2021.

Congresswoman DelBene (D-WA) and Congressman Katko (R-NY) have introduced the Internet of Things (IoT) Readiness Act of 2021. The bill proposes to direct the Federal Communications Commission to collect and maintain data on the growth in the use of Internet of Things devices and devices that use 5G mobile networks in order to determine the amount of electromagnetic spectrum required to meet the demand created by such use, and for other purposes. The proposed legislation can be viewed here. Both legislators are the co-chairs of the Internet of Things Caucus.

COVID-19 has directly resulted in ramping up our technology needs. We foresee policymakers placing more emphasis on infrastructure, especially around communications and technology so that our country can remain competitive.

Lanton Law is a national boutique law and lobbying firm that focuses on technology and Health IT. 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 3/21/21 Ron Lanton 3/21/21

U.S. House of Representatives Passes Farm Workforce Modernization Act

Last week the U.S. House of Representatives passed the Farm Workforce Modernization Act. The bill known as H.R. 1603 is sponsored by Representative Lofgren (D-CA).

Last week the U.S. House of Representatives passed the Farm Workforce Modernization Act. The bill known as H.R. 1603 is sponsored by Representative Lofgren (D-CA). According to the Congresswoman’s press release the bill “aims to provide a compromise solution that makes meaningful reforms to the H-2A agricultural guestworker program and creates a first-of-its-kind, merit-based visa program specifically designed for the nation’s agricultural sector.”

A summary of the bill can be found here. The bill now heads to the U.S. Senate.

At Lanton Law our food law practice helps farmers, ranchers and similarly situated stakeholders attain their strategic priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 3/2/21 Ron Lanton 3/2/21

Virginia Votes to Legalize the Sales & Recreational Use of Marijuana

Virginia has taken one step closer to becoming the first southern state to legalize marijuana. If enacted Virginia would follow Washington D.C. along with fifteen other states to do so. The proposed legislation would allow the possession of up to one ounce of marijuanato become legal starting January 1, 2024. This would be at the same time as sales and a regulatory scheme overseeing the new marijuana marketplace would take off. The bill is awaiting Governor Northam’s signature who is expected to sign the measure into law.

Ron Lanton 2/12/21 Ron Lanton 2/12/21

Maryland One Step Closer to Implementing a Digital Ad Tax

For a while we have seen the European Union (EU) grapple with the development of digital ad taxes which have had a significant impact on U.S. Big Tech companies. Now, Maryland is showing similar regulatory oversight on digital ads as the EU.

Last year HB 732 was passed which would have imposed a graduated tax on the annual gross revenue derived from digital advertising in Maryland. The graduated tax would be:

For persons with global annual gross revenues of $100 million through $1 billion, the rate would be 2.5% of the assessable base.
For persons with global annual gross revenues of more than $1 billion through $5 billion, the rate would be 5% of the assessable base.
For persons with global annual gross revenues of more than $5 billion through $15 billion, the rate would be 7.5% of the assessable base.
For persons with global annual gross revenues exceeding $15 billion, the rate would be 10% of the assessable base.

Last year Maryland Governor Hogan vetoed the bill stating “These misguided bills would raise taxes and fees on Marylanders at a time when many are already out of work and financially struggling. With our state in the midst of a global pandemic and economic crash, and just beginning on our road to recovery, it would be unconscionable to raise taxes and fees now.”

Besides looking at this from a political lens of whether technology companies are regulating content speech and whether Section 230 should be revisited, there is also an economic lens. The pandemic has caused people to migrate from physical office space to digital commerce platforms, meaning that states are now grappling with the virus and shrinking taxable income.

As far as Maryland goes the House of Delegates has voted to override the Governor’s veto of HB 732. The next step is for the Senate to override the legislation to implement it. The problem is there will be legal challenges to this law.

Additionally, we believe that this is not the last time that we’ll see legislation like this. Similar efforts in New York and West Virginia have failed while Connecticut, Indiana have been the latest to introduce similar legislation.

Technology stakeholders including those in digital commerce will continue to be at risk. We at Lanton Law can help. Our legal and policy tools can help offer your organization a clear path forward to navigate what will be changing policies for technology stakeholders. Contact us today to discuss your options.

Ron Lanton 2/7/21 Ron Lanton 2/7/21

Senator Klobuchar Introduces Sweeping Omnibus Antitrust Reform Legislation

U.S. Senator Amy Klobuchar (D-MN), the lead Democrat on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, recently introduced sweeping proposed legislation targeting antitrust reform.

According to her office’s release, the Competition and Antitrust Law Enforcement Reform Act will strengthen regulator oversight tools, reform enforcement and strengthen prohibitions on anticompetitive mergers and conduct.

Specifically the bill seeks to accomplish the following:

Increase enforcement resources
Strengthen prohibitions against anti competitive mergers
Prevent harmful dominant firm conduct
Establishes a new, independent FTC division to conduct market studies and merger retrospectives
Implement additional reforms to enhance antitrust enforcement

Interestingly, the The bill also clarifies that the law applies not only to monopoly power, but also to monopsony power, a company's power as a buyer or employer in the market.

There have been several mergers and acquisitions over the years that have raised questions about the long term effects of specific sectors, but the fears of a more aggressive regulator has not been of concern until now.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences, technology and clean energy. Contact us today to learn about your organization’s options to prepare for additional regulatory antitrust oversight.

Ron Lanton 2/7/21 Ron Lanton 2/7/21

The SAFE TECH Act Introduced into Congress

The ‘‘Safeguarding Against Fraud, Exploitation, Threats, Extremism, and Consumer Harms Act’’ or the "SAFE TECH Act" has been introduced into Congress. The proposal is led by Senators Warner (D-VA), Hirono (D-HI) and Klobuchar (D-MN), as the bill seeks changes to 47 U.S. Code § 230.

The law which is part of the Communications Decency Act (CDA), also called Title V of the Telecommunications Act of 1996, provides ISP’s with federal immunity to any cause of action that seeks to make ISP’s liable for information that originated with a third party service user.

Specifically, §230 states: “No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” The additional specifics of this law describe the liability shield that these companies currently enjoy which is further protected by federal preemption law.

We have written several blog post on this topic about prior legislation targeting the law as well as prior U.S. DOJ Scrutiny on the matter.

Since the SAFE TECH Act has been unveiled there have been multiple stakeholders expressing concern with unintended consequences this proposal in its current form has that will likely result in chilling of expression.

Regardless of your political viewpoint, if you are a tech stakeholder that has ISP capabilities or you are providing services that deal with the exchange of ideas, you should be monitoring this type of legislative action to avoid unnecessary surprises to your business model. We at Lanton Law can help.

Our legal and policy tools can help offer your organization a clear path forward to navigate what will be changing policies for technology stakeholders. Contact us today to discuss your options.

Ron Lanton 2/6/21 Ron Lanton 2/6/21

Cannabis Reform Legislation Anticipated in 117th Congress

We at Lanton Law have been closely monitoring cannabis policy developments as we fully anticipate federal action on this issue in 2021. How much activity remains to be seen.

We were encouraged by the joint statement issued by Senators Booker (D-NJ), Wyden (D-OR) and Schumer (D-NY) on comprehensive cannabis reform legislation in the 117th Congress. The statement in full reads:

“The War on Drugs has been a war on people—particularly people of color. Ending the federal marijuana prohibition is necessary to right the wrongs of this failed war and end decades of harm inflicted on communities of color across the country. But that alone is not enough. As states continue to legalize marijuana, we must also enact measures that will lift up people who were unfairly targeted in the War on Drugs.

“We are committed to working together to put forward and advance comprehensive cannabis reform legislation that will not only turn the page on this sad chapter in American history, but also undo the devastating consequences of these discriminatory policies. The Senate will make consideration of these reforms a priority.

"In the early part of this year, we will release a unified discussion draft on comprehensive reform to ensure restorative justice, protect public health and implement responsible taxes and regulations. Getting input from stakeholder groups will be an important part of developing this critical legislation.”

The promise of possible Congressional action on this issue is stronger this session than it has even been.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.