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 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.

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 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.

Ron Lanton 3/31/21 Ron Lanton 3/31/21

New York Enacts Legislation Legalizing Adult Use Cannabis

New York Governor Cuomo (D-NY) has signed (S.854-A/A.1248-A) which legalizes adult-use cannabis.

New York Governor Cuomo (D-NY) has signed (S.854-A/A.1248-A) which legalizes adult-use cannabis. According to the Governor’s press release the “bill signing comes after the Governor, Senate Majority Leader Andrea Stewart-Cousins and Assembly Speaker Carl Heastie announced this past Sunday, March 28, that an agreement had been reached on the legislation. The bill establishes the Office of Cannabis Management to implement a comprehensive regulatory framework that covers medical, adult-use and cannabinoid hemp. The bill also expands 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.”

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

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

Ron Lanton 2/16/21 Ron Lanton 2/16/21

New York Governor Cuomo Announces 30-Day Amendments to Legislation Establishing Comprehensive Adult-Use Cannabis Program in New York

New York Governor Andrew Cuomo has announced in a press release detailing “30-day amendments to the Governor's proposal to establish a comprehensive adult-use cannabis program in New York. Specifically, these amendments will detail how the $100 Million in Social Equity funding will be allocated, enable the use of delivery services, and refine which criminal charges will be enforced as it relates to the improper sale of cannabis to further reduce the impact on communities hit hardest by the war on drugs.”

New York has been a policy leader along with other innovative states on cannabis. 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.

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

New York Powers Ahead with Clean Energy Standard

New York State is on an aggressive path towards zero-carbon emissions along with pursuing ambitious goals to fight climate change.

Recently, Governor Cuomo announced plans via a press release that the “New York State Public Service Commission approved an expansion of the landmark Clean Energy Standard to refocus New York's existing regulatory and procurement structure on achieving the goals laid out in New York's nation-leading Climate Leadership and Community Protection Act, or CLCPA. The CLCPA established a 70 percent renewable electricity by 2030 mandate, setting the State on an ambitious trajectory to a zero-emission power sector by 2040. The expanded Clean Energy Standard gives the state the authority to issue a Request for Proposals for the renewable power generation sources needed to implement this plan.”

According to the release, goals of the New York Public Service Commission (PSC) are as follows:

• Implements key provisions in the CLCPA related to securing 70 percent renewable energy by 2030, including defining renewable energy technology eligibility and the amount of renewable energy needed to meet New York's goal, identifies annual procurement targets for the Tier 1 large- scale renewable energy program adopted under the CES, and recommends changes to the existing Tier 1 procurement processes;

• Sets targets for offshore wind renewable energy intended to meet the requirement of securing nine gigawatts of offshore wind by 2035;

• Creates a new methodology for extending Tier 1 renewable energy eligibility to renewable energy facilities that undergo repowering;

• Creates a competitive five-year Tier 2 program under the CES to preserve existing renewable baseline generation to support the 70 x 30 goal;

• Creates a new Tier 4 large-scale renewable program to specifically value environmental attributes associated with renewable energy delivered into New York City that will be in addition to annual Tier 1 procurement targets; and

• Creates tangible approaches to ensure that the State's renewable energy programs provide substantial benefits for disadvantaged communities, including low to moderate income customers as called for under the

CLCPA, and builds upon its workforce development policies to specifically promote good jobs, including prevailing wage requirements.

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

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

New York Proposing Its Own Biometric Law

The New York State legislature has introduced Assembly Bill 27, which seeks to make New York the fourth state to enact a biometric privacy law. If successful it will be the second state that will allow consumers a private right of action to see companies for improper data handling.

New York is definitely taking its cue from Illinois, as that state became the first to require businesses to collect biometric data to provide notice and obtain the owner’s written consent prior to using this information. We have written about the Illinois Information Privacy Act or (BIPA) in a previous post.

The New York proposal seeks to do the following:

Establishes the biometric privacy act; requires private entities in possession of biometric identifiers or biometric information to develop a written policy establishing a retention schedule and guidelines for permanently destroying biometric identifiers and biometric information when the initial purpose for collecting or obtaining such identifiers or information has been satisfied or within three years of the individual's last interaction with the private entity, whichever occurs first.

New York has enacted facial recognition laws in the past. In December 2020 Governor Cuomo released a press statement where he signed A6787-D/S5140-B into law that suspended “the use of facial recognition technology and other kinds of biometric technology in schools, directing a study of whether its use is appropriate in schools and issuing recommendations. The legislation places a moratorium on schools purchasing and using biometric identifying technology until at least July 1, 2022 or until the report is completed and the State Education Commissioner authorizes its use, whichever occurs later. It applies to both public and private schools in New York State.”

Proposed Assembly Bill 27 shows that New York will continue to press forward in this area and will likely inspire other states. If you are a biometric, Health IT/digital health or technology stakeholder, your interests will be impacted.

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

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

New York State of the State 2021 Calls for Proposal to Safeguard Data Security Rights

Last month as part of the State of the State 2021, Governor Cuomo announced a comprehensive law around personal data and privacy protections for New York state residents.

So what does this proposal outline?

According to the Governor’s proposal “This law will mandate that companies that collect information on large numbers of New Yorkers disclose the purposes of any data collection and collect only data needed for those purposes. Governor Cuomo will also establish a Consumer Data Privacy Bill of Rights guaranteeing every New Yorker the right to access, control, and erase the data collected from them; the right to nondiscrimination from providers for exercising these rights; and the right to equal access to services.”

“The proposal also expressly protects sensitive categories of information including health, biometric and location data and creates strong enforcement mechanisms to hold covered entities accountable for the illegal use of consumer data. New York State will work with other states to ensure competition and innovation in the digital marketplace by promoting coordination and consistency among their regulatory policies.

New York’s proposal seems to be following a trend set by California’s Privacy Rights and Enforcement Act. We believe that we are witnessing a slow moving transition towards similar oversight in other states.

The increasing demands around data security and data privacy has presented new challenges to business operations and compliance efforts. Not to mention there are new rising risks around consumer data privacy expectations.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. We are the dedicated business partner that you need behind you to help you confront the changing regulatory landscape around data.

Ron Lanton 1/11/21 Ron Lanton 1/11/21

Biometric Policies Will Likely Be Debated Nationwide in 2021

New York has introduced Assembly Bill 27. According to the proposed bill, AB 27 seeks “to establish the biometric privacy act;

New York has introduced Assembly Bill 27. According to the proposed bill, AB 27 seeks “to establish the biometric privacy act; requires private entities in possession of biometric identifiers or biometric information to develop a written policy establishing a retention schedule and guidelines for permanently destroying biometric identifiers and biometric information when the initial purpose for collecting or obtaining such identifiers or information has been satisfied or within three years of the individual's last interaction with the private entity, whichever occurs first.”

Currently, the Illinois Biometric Information Privacy Act, commonly known as BIPA, is the only state with a biometric privacy statute that provides for a similar private right of action. We have been writing in previous posts about how state policies have been taking shape regarding this subject.

We expect this and other technology questions to be debated in various state houses throughout 2021. It is imperative for interested stakeholders to be prepared for what new potential legislation requires. Contact Lanton Law to discuss your lobbying and legal strategies.

Ron Lanton 12/26/19 Ron Lanton 12/26/19

Conflicting CBD Activity Calls for Increased Compliance and Business Planning

Lanton Law gave a December 2019 webinar with the American College of Apothecaries ACA on CBD. Since then we have seen two significant developments.

The first was with the U.S. Food and Drug Administration (FDA) itself. In November 2019, the industry saw the agency’s announcement of 15 warning letters it sent to companies for illegally selling products containing CBD in “ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA shortly afterwards issued a revised Consumer Update detailing safety concerns about CBD products more broadly. In the document titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” FDA indicated that “Based on the lack of scientific information..., it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

With the industry already facing several compliance questions, this new information from FDA has definitely made this issue even more confusing.

States on the other hand have been pressing forward with making their own policies. In New York, Governor Cuomo signed (S.6184/A.7680) which establishes a regulatory framework for the production and sale of hemp and hemp extract in New York State.

According to the Governor’s press release “The measure also requires the hemp industry to test and label their products, protecting consumers from potential harm. The legislation was signed pursuant to a chapter agreement, which provided for a more streamlined regulatory pathway for hemp products, granted the Department of Agriculture and Markets supervision over hemp growers and the Department of Health supervision over hemp extract; created a registration requirement for sellers of hemp extract products; made conforming regulatory changes to the 2018 Farm Bill; and defers decision making on hemp extracts, including CBD, as additives for food and beverages.”

The state will host a hemp summit in January to continue policy discussions on this issue.

With the collective market for CBD sales expected to exceed $20 billion in the United States by 2024, according to BDS Analytics and Arcview Market Research, there are many stakeholders who would benefit from clarity in this area. If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.