Ron Lanton 6/25/21 Ron Lanton 6/25/21

Connecticut Has Enacted New Law Legalizing Adult-Use Cannabis

According to Governor Ned Lamont’s press release, the Governor has enacted a new law that legalizes and regulates adult-use cannabis in Connecticut. “The legislation Governor Lamont signed today is Senate Bill 1201. A proposal to legalize adult-use cannabis was initially put forward by Governor Lamont to the General Assembly earlier this year as Senate Bill 888. He also proposed similar legislation in February 2020 as Senate Bill 16.”

Key components of the new law include:

Possession: Possession of cannabis among adults age 21 and over will be legal in Connecticut beginning July 1, 2021. Adults cannot have more than 1.5 ounces of cannabis on their person, and no more than 5 ounces in their homes or locked in their car, truck or glove box.

Retail sales: Retail sales of cannabis aim to begin in Connecticut by the end of 2022. The sale, manufacture, and cultivation of cannabis (aside from home grown) requires a license from the state. Products that contain delta-8-THC, delta-9-THC, or delta-10-THC are considered cannabis and may only be sold by licensed retailers. Individuals who are not licensed by the state may gift cannabis to others but may not sell it. Individuals may not gift cannabis to another individual who has “paid” or “donated” for another product.

Homegrown: Patients who are participating in Connecticut’s medical marijuana program will be permitted to cultivate up to six cannabis plants (three mature, three immature) indoors within their homes beginning October 1, 2021. All adults age 21 and over will be permitted to grow a similar number of plants indoors within their homes beginning July 1, 2023. The law includes requirements to keep the plants secure from anyone else. Home grown of up to six cannabis plants is defelonized beginning July 1, 2021, and instead will result in infractions.

Erases prior convictions: Certain cannabis-related convictions that occurred between January 1, 2000 and October 1, 2015 will be automatically erased. Those seeking to erase cannabis-related convictions outside of that period will require petitioning.

Equity and investments: To start the necessary work of repairing the damage caused by decades of failed cannabis criminalization policies, the law implements equitable marketplace requirements under which at least half of all initial licenses are reserved for social equity applicants, targeting those communities that have been most negatively impacted by the so-called war on drugs. The Social Equity Council, which is created by this legislation, will launch programs and support for social equity applicants in the cannabis market.

Tax structure: The law enacts a tax rate structure on the retail sale of cannabis that includes a new source of revenue for municipalities. This includes (1) a 3% municipal sales tax, which will be directed to the town or city where the retail sale occurred; (2) the 6.35% state sales tax; and (3) a tax based on the THC content of the product, which will be 2.75 cents per milligram of THC for cannabis edibles; 0.625 cents per milligram of THC for cannabis flower; and 0.9 cents per milligram of THC for all other product types. This means that Connecticut generally will have about a 4% lower tax rate than New York and about the same as Massachusetts.

Revenue to support economic opportunities in targeted communities: Portions of the revenue obtained from retail sales of cannabis will be directed to communities that have been most negatively impacted by the war on drugs through the creation of the Social Equity and Innovation Fund. Funding from this account will be appropriated for use by the Social Equity Council to provide business capital, technical assistance for business start-ups and operations, workforce education, and community investments. These investments will not be limited to the cannabis market.

Revenue to support substance misuse prevention and recovery services: Portions of the revenue obtained from retail sales of cannabis will be directed to support substance misuse prevention, treatment, and recovery services through the creation of the Prevention and Recovery Services Fund. Connecticut’s health agencies, including the Department of Public Health, Department of Mental Health and Addiction Services, and Department of Children and Families will launch new programs and initiatives regarding prevention, treatment, and recovery in regard to cannabis.

Preventing underage use: This legislation adapts the state’s strong framework regarding preventing access to alcohol by minors in the context of cannabis. For example, it will be a Class A misdemeanor to sell or provide cannabis to a person under 21 years old. In addition, an individual allowing someone under 21 years old to loiter at a cannabis store will receive a $1,000 fine on the first offense with subsequent offenses as a Class B misdemeanor. It will be a Class D misdemeanor for a person under the age of 21 to lie about their age or use a fake ID in an attempt to buy cannabis. Delivery services will be required to use online ID and age verification.

Enforcement of safe driving: This law significantly strengthens Connecticut’s impaired driving statutes by requiring police to be trained in Advanced Roadside Impaired Driving Enforcement (ARIDE) and allows for Drug Recognition Expert (DRE) evaluations to result in license suspensions. This means that drivers who are impaired on any substance, whether cannabis or otherwise, will be more quickly taken off the roads.

Advertising: This law implements strong standards for advertising that exceed those for the tobacco and alcohol industries. All cannabis-related advertising will be banned on television, radio, internet, print, and billboards unless the advertiser has reliable evidence that more than 90% of the audience reached by the advertising is at least 21 years of age or older. Advertising of cannabis is restricted within 500 feet of a school. The advertising restrictions apply to all cannabis advertising, whether or not the advertiser is a state licensee.

Safe products: This legislation imposes strong requirements for product safety. Products will have to be lab tested and will have strict packaging and labeling standards. Edible cannabis products are limited to 5 milligrams of THC per serving, and most other products are subject to a potency cap. Products will be in child-safe packaging, and product types that appeal to children are banned.

Municipalities and zoning: Local officials will play an important role in the implementation of cannabis legalization. For example, local officials can control the number and locations of cannabis retailers through zoning. Municipalities can also determine where smoked or vaped cannabis can be consumed (e.g. in city parks or beaches, or on sidewalks or streets).

Employment: This legislation allows employers to continue to enforce drug-free workplaces, and respects the need for employers to maintain workplace safety and to remain in compliance with federal laws and contracts. As such, employers in certain industries, such as manufacturing and healthcare, are considered “exempt” from the employment provisions of this law. The law allows employers to take adverse actions against employees who are impaired at work. The law says that nonexempt employers may not prohibit the off-work use of cannabis or take adverse action against an employee or a potential employee for a positive THC test unless such employer has adopted employment policies stipulating as such. Generally, an employer may not take adverse action against an employee or potential employee for use of cannabis prior to applying for or working at such employer.

Medical marijuana program: The law protects Connecticut’s nation-leading medical marijuana program in many ways. For example, producers and dispensaries that currently operate in the medical marijuana program may expand or convert their licenses for adult-use cannabis, but they must prioritize serving the medical program. Medical marijuana users will soon be able to purchase medical marijuana from any dispensary rather than simply the one to which they are assigned.

State parks and beaches: Cannabis use is prohibited in state parks, state beaches, and on state waters.

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.

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 6/17/21 Ron Lanton 6/17/21

New Louisiana Law Bans White Bagging

The Governor has enacted Act No. 50 effective June 1, which seeks to ban “white bagging” in the state. White bagging is when a drug is delivered from an insurer’s preferred pharmacy to a physician’s office. This new law which is the first of its kind in the country provides that insurers cannot refuse to pay for physician-administered drugs to covered patients. Similar legislation has been seen in Massachusetts, New York and Texas.

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 6/17/21 Ron Lanton 6/17/21

Protecting Rural Telehealth Access Act Introduced

Via a recently released a press release describing how a group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent.

“This legislation would ensure rural and underserved community healthcare providers are able to continue offering telehealth services after the current public health emergency ends. These services include the ability to offer audio-only telehealth appointments because many rural Americans don’t have reliable, affordable broadband access.”

According to the press release the proposed Act would:

Allow payment-parity for audio-only health services for clinically appropriate appointments. During COVID-19, recognizing not everyone has access to the technology in their home, Congress made allowances for audio-only telephone services to be used to allow doctors to reach patients wherever they are.
Permanently waive the geographic restriction allowing patients to be treated from their homes. Pre-COVID-19, the home was allowed as an eligible originating site in Medicare and some Medicaid programs, but only for very specific services, and only for the patient, not the provider.
Permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services.
Lift the restrictions on “store and forward” technologies for telehealth. Currently this is only allowed in Hawaii and Alaska.
Allows Critical Access Hospitals (CAHs) to directly bill for telehealth services.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our telepharmacy practice has been helping pharmacies and physicians with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting.

Ron Lanton 6/17/21 Ron Lanton 6/17/21

White House Releases Report Outlining Steps to Strengthen Critical Supply Chains

In February 2021, President Biden issued an Executive Order to direct a government-wide “approach to assessing vulnerabilities in, and strengthening the resilience of, critical supply chains.”

The key findings highlight recommendations from its “comprehensive 100-day supply chain assessments for four critical products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).”

Lanton Law has several years of experience with supply chain issues. Our firm is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology.

Ron Lanton 6/17/21 Ron Lanton 6/17/21

Data Protection Agency (DPA) Legislation Reintroduced

U.S. Senator Gillibrand (D-NY) issued a press release announcing the Data Protection Act of 2021, which would create the DPA, an independent federal agency whose goal is to protect Americans’ data, instill privacy safeguards and work to ensure that there is transparency in data sharing practices.

There have been some changes to this proposed legislation since last year’s version of the bill. These changes include:

Supervision of Data Aggregators: Grants the DPA authority to review Big Tech mergers involving a large data aggregator, or any merger that proposes the transfer of personal data of 50,000 or more individuals.
Office of Civil Rights: Establishes the DPA Office of Civil Rights to advance data justice and protect individuals from discrimination.
Enforcement Powers: Improves DPA enforcement powers to oversee the use of high-risk data practices and to penalize, examine, and propose remedies to the social, ethical, and economic impacts of data collection.
Penalties and Fines: Prohibits data aggregators from committing any unlawful, unfair, deceptive, abusive, or discriminatory data practices; and allows for penalties and fines to be levied if violated, including triple penalties for violations against children.
Defines Key Terms for Transparency: Provides Key Definitions for Privacy Harm, Data Aggregators, and High-Risk Data Practice, among other key terms.

According to the release “The DPA would be an executive agency. The director would be appointed by the president and confirmed by the Senate, serves a 5-year term, and must have knowledge of technology, protection of personal data, civil rights, and law. The agency may investigate, subpoena for testimony or documents, and issue civil investigative demands. It may prescribe rules and issue orders and guidance as is necessary to carry out federal privacy laws. The authority of state agencies and state attorneys general are preserved in the Act. The DPA would have three core missions:

1. Give Americans control and protection over their own data by authorizing the DPA to create and enforce data protection rules.

2. Maintain the most innovative, successful tech sector in the world by ensuring fair competition within the digital marketplace.

3. Prepare the American government for the digital age.”

Lanton Law’s technology practice has been monitoring privacy developments nationwide. If you are a banking/finance, technology or healthcare/life science 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 6/17/21 Ron Lanton 6/17/21

House Lawmakers Release Anti-Monopoly Agenda for “A Stronger Online Economy: Opportunity, Innovation, Choice”

According to press release, the House Committee on the Judiciary’s Antitrust Subcommittee Chairman Cicilline (D-RI) and Ranking Member Buck (R-CO) announced their antitrust bi-partisan agenda outlined below:

“‘A Stronger Online Economy: Opportunity, Innovation, Choice’ consists of five bipartisan bills drafted by lawmakers on the Antitrust Subcommittee, which last year completed a 16-month investigation into the state of competition in the digital marketplace and the unregulated power wielded by Amazon, Apple, Facebook, and Google.”

The “American Innovation and Choice Online Act” to prohibit discriminatory conduct by dominant platforms, including a ban on self-preferencing and picking winners and losers online. The bill is sponsored by Chairman Cicilline and co-sponsored by U.S. Rep. Lance Gooden (TX-05).

The “Platform Competition and Opportunity Act” prohibits acquisitions of competitive threats by dominant platforms, as well as acquisitions that expand or entrench the market power of online platforms. The bill is sponsored by U.S. Rep. Hakeem Jeffries (NY-08) and co-sponsored by Ranking Member Buck.

The “Ending Platform Monopolies Act” eliminates the ability of dominant platforms to leverage their control over multiple business lines to self-preference and disadvantage competitors in ways that undermine free and fair competition. The bill is sponsored by U.S. Rep. Pramila Jayapal (WA-07) and co-sponsored by U.S. Rep. Lance Gooden (TX-05).

The “Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act” promotes competition online by lowering barriers to entry and switching costs for businesses and consumers through interoperability and data portability requirements. This bill is sponsored by U.S. Rep. Mary Gay Scanlon (PA-05) and co-sponsored by U.S. Rep. Burgess Owens (UT-04).

The “Merger Filing Fee Modernization Act” updates filing fees for mergers for the first time in two decades to ensure that the Department of Justice and Federal Trade Commission have the resources they need to aggressively enforce the antitrust laws. This bill is sponsored by U.S. Rep. Joe Neguse (CO-02) and co-sponsored by U.S. Rep. Victoria Spartz (IN-05).

Lanton Law has been monitoring both Congress and the FTC for our technology and healthcare clients, especially as both Congress and the FTC have taken a more aggressive tone on antitrust issues lately.

Lanton Law is a national boutique regulatory 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 6/17/21 Ron Lanton 6/17/21

Lina Khan Sworn in as FTC Chair

The Federal Trade Commission (FTC) released a June 15th press release announcing Lina Khan as the Chair of the FTC, with her term expiring on September 25, 2024. Ms. Khan was confirmed by the U.S. Senate on June 15, 2021.

Lanton Law has been monitoring the FTC for our technology and healthcare clients. This move may signal that the Biden Administration and Congress may take on a more aggressive role in antitrust policy. Technology stakeholders should take note.

Ron Lanton 6/17/21 Ron Lanton 6/17/21

New Proposed Congressional DIR Relief Bill

At Lanton Law we are constantly on the watch for issues impacting our specialty, retail and LTC pharmacy clients including the issue of DIR fees. Clients utilize our advocacy and legal tools while discussing business strategy to combat an ever changing reimbursement environment.

A bipartisan group of Congressional legislators have introduced the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, also known as S. 1909/H.R. 3554. Both companion bills propose to transfer all pharmacy DIR to the point of sale. As many in the industry know, DIR fees were intended to be applied here but the definition and application of DIR fees have been so convoluted that they are causing deep and long lasting damage to the pharmacy community.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science 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 section helps pharmacies nationwide achieve improved business climates through carefully crafted legislation.

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.”

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

NCPA Files Lawsuit on Pharmacy Direct & Indirect Remuneration (DIR) Fees

The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:

The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.
The rule is invalid as arbitrary and capricious. In 2014 CMS said that the “reasonably determined” exception leading to DIR fees would be “narrow,” but comment letters showed that not to be the case.3 A recent study showed that pharmacy DIR fees have increased 1600% since 2015, with $4 billion in DIR fees being squeezed from pharmacies in 2017 alone.
The Final Rule Was Not Adopted Through Proper Notice-and-Comment Rulemaking. The proposed rule defined negotiated prices to include all price concessions from pharmacies and did not discuss or address any exceptions. In the final rule, without giving interested parties notice or the opportunity to comment, CMS created the exception for price concessions that could not be reasonably determined at the point of sale.

HHS did file a motion to dismiss available here.

Lanton Law will continue to monitor the developments of this important case.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science 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 entity (Lanton Strategies) is helping pharmacies nationwide achieve improved business climates through carefully crafted legislation.

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

Biden Administration Files Motion Supporting Canadian Drug Imports

The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada.

The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada. This motion is aimed at prior enacted state legislation from both Florida and New Mexico, as both states have commenced the process of applying for Canadian imports. The Administration argues in its brief that the party opponent’s (Pharmaceutical Research & Manufacturers of America PhRMA) claim is not prudentially ripe.

Importation is an issue that Lanton Law has been monitoring for several years. As the drug pricing debate continues across Congress and state legislatures, we fully anticipate importation to continue to be a front and center policy issue.

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

Update on FTC Administrative Complaint Against Illumina

Lanton Law has been monitoring the developments around the FTC’s administrative complaint against Illumina on marketplace competition concerns. We have recently shared an industry blog about this issue.

As an update to this matter, the FTC has issued a press release that explained the agency’s Motion to Dismiss for Preliminary Relief in Illumina/GRAIL Case. According to the FTC, “In the wake of the European Commission’s announcement that it is investigating Illumina’s $7.1 billion proposed acquisition of DNA sequencing provider Illumina, the Federal Trade Commission has authorized staff to dismiss its federal court complaint for Preliminary Injunction and Temporary Restraining Order.”

Additionally, ““The FTC sought preliminary relief in federal court to prevent Illumina and GRAIL from merging while the case is being decided on the merits in administrative court. At the time, a district court order was necessary to prevent the parties from consummating their merger. The administrative trial is scheduled to begin on August 24, 2021. Now that the European Commission is investigating, Illumina and GRAIL cannot implement the transaction without obtaining clearance from the European Commission.”

Ron Lanton 5/14/21 Ron Lanton 5/14/21

New Executive Order on Cybersecurity Released in Response to Ransomware Attack

In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity.

In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity. The EO has a number of provisions including:

Establishes a “Cybersecurity Safety Review Board” comprising public- and private-sector officials, which can convene after cyber attacks to analyze the situation and make recommendations.
Requires IT service providers to tell the government about cybersecurity breaches that could impact U.S. networks, and removes certain contractual barriers that might stop providers from flagging breaches.
Plans for enhancing software supply chain security

This comes amid an increase in cyber attacks on private healthcare and technology companies as well as the federal government.

Ransomware attacks are becoming a bigger threat and being prepared from a compliance and risk management standpoint is becoming more crucial. Having appropriate cyber policies in place is one step. We have other solutions.

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. 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 4/20/21 Ron Lanton 4/20/21

Massachusetts Launches First in the Nation Marijuana Product Catalog For Public Awareness of the Regulated Supply Chain

The Massachusetts Cannabis Control Commission has distributed a press release announcing the first in the nation of a “Product Catalog that will provide the public with a comprehensive database of regulated marijuana products that are sold through the Commonwealth’s licensed Medical Marijuana Treatment Centers (MTCs) and Marijuana Establishments (MEs). The regulatory platform, which is considered the first of its kind in the nation, is hosted through the state’s seed-to-sale system of record, Metrc, and will be embedded on the Commission’s website.”

Furthermore according to the Commission:

“The Commission’s Product Catalog was designed to assist engaged stakeholders, such as school administrators, public safety officials, medical professionals, and parents, with identifying the source of legally produced cannabis merchandise. Under the Commission’s regulations, licensed Marijuana Product Manufacturers must provide information about the marijuana products they will produce and make available at wholesale, after receiving a provisional license and prior to commencing operations in the Commonwealth. Information must include:

The marijuana product type and brand name;
A list of direct and indirect ingredients in the product;
Product serving size, including a description of what constitutes a serving size for a product that is not already a single serving;
Potency;
Photographs of the product both inside its packaging, and outside of and next to its packaging, plus any external or internal packaging; and
A list of marijuana products to be sold based on anticipated or executed agreements between the Marijuana Product Manufacturer and the retail or delivery licensee.

Users will be able to easily look up an item on the Commission’s platform to verify its packaging and labels, ingredients, manufacturing information, which Product Manufacturers produce and wholesale the product in Massachusetts, and more. Marijuana product searches can be completed based on a product name, category, keywords, or other unique identifiers.”

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 4/12/21 Ron Lanton 4/12/21

Cybersecurity & FY 22 Discretionary Funding Request

The President’s request for fiscal year 2022 discretionary funding has been released. Below are a few mentions for cybersecurity:

To support agencies as they modernize, strengthen, and secure antiquated information systems and bolster Federal cybersecurity the discretionary equest recommends $500 million for the Technology Modernization Fund, an additional $110 million for the Cybersecurity and Infrastructure Security Agency, and $750 million as a reserve for Federal agency information technology enhancements.

With increased hacking and ransomware attacks, cybersecurity is going to be more front and center for both policy and legal discussions. For example in this request by the Administration, the attack on SolarWinds Corp. and Microsoft Exchange’s email servers were expressly mentioned. For stakeholders that traffic in data, cybersecurity policies are essential. Ensuring compliance with federal and state requirements are key and we can help.

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

Verizon Enters the Telehealth Market

According to a Verizon press release, the company announced its new telehealth venture called BlueJeans Telehealth.

“According to the “The Future of Telehealth - Balancing Security and Ease of Use” white paper, healthcare organizations (81%) expect to see a greater investment in telehealth solutions over the next 2-3 years, with 85% of decision-makers identifying “ease of use” as a top-five driver in producing good outcomes from telehealth. While many hospitals and health clinics have adopted video conferencing services during the pandemic for providing patient care, BlueJeans Telehealth was designed from the ground up for healthcare organizations to simplify the virtual join and visit experience and offer greater access to care, provide more flexibility for providers and patients, improve safety and extend the reach of services available.”

Verizon went on to describe the service.

“BlueJeans Telehealth delivers an intuitive experience for patients, providers and administrators. Using the device of their choice, patients can easily and quickly meet with their providers through their desktop or mobile browser or the BlueJeans app. BlueJeans with Dolby Voice Audio® provides high-quality audio, minimizing disruptions to the visit so patients and providers can communicate important clinical information clearly. Providers and administrators will also benefit from a streamlined experience, as visits are embedded directly within their existing Electronic Health Record (EHR) workflows.

To simplify administrations and reimbursements, licensing is based on a per-visit model, which allows for straightforward data capture and reporting—an important aspect considering 59% of survey respondents cited uncertainty about telehealth reimbursement as a top challenge for adoption and utilization moving forward. BlueJeans Telehealth licenses will also be available in a named host format.”

Lanton Law has been active with telehealth/telemedicine policy advocacy as well as interpreting current laws while giving clients strategic advice on potential regulatory pitfalls.

Lanton Law is a national boutique law andlobbying 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 3/18/21 Ron Lanton 3/18/21

HHS Delays Rebate Rule to 2023 Due to a Court Order

Health and Human Services (HHS) has announced that the Trump administration’s directive that would have implemented the drug rebate rule against pharmacy benefit managers (PBMs).

According to the final rule:

“As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (“Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees”) published on November 30, 2020. The new effective date for these certain amendments is January 1, 2023.”

Ron Lanton 3/15/21 Ron Lanton 3/15/21

Biosimilar Legislation Passes Senate

S. 164 titled the Advancing Education on Biosimilars Act of 2021 sponsored by Senator Hassan (D-NH) has passed the Senate on March 3, 2021. The proposed bill seeks to educate health care providers and the public on biosimilar biological products.

Specifically, the bill states that the Secretary may maintain and operate an internet website to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.