Senator Wyden Requests FTC To Investigate Retail Pharmacy Market Consolidation

In a recent press release Senator Wyden (D-OR) has sent a letter to the Federal Trade Commission (FTC) to according to “investigate recent consolidations in Oregon’s retail pharmacy market to assess whether large national pharmacy chains and health plans have acted to make this market less competitive.”

In a recent press release Senator Wyden (D-OR) has sent a letter to the Federal Trade Commission (FTC) to according to “investigate recent consolidations in Oregon’s retail pharmacy market to assess whether large national pharmacy chains and health plans have acted to make this market less competitive.”

“Wyden’s letter highlights ongoing industry dynamics that pose significant challenges to small, independent pharmacies. One particular practice known as direct and indirect remuneration, a form of retrospective fees imposed on pharmacies by pharmaceutical benefit managers (PBMs) has been cited as a particular challenge for these pharmacies to maintain healthy finances. According to a report by the Centers for Medicare and Medicaid Services (CMS), PBMs increased pharmacy DIR fees under Medicare Part D by 91,500 percent from 2010 to 2019.”

DIR fees have been something that the Senator has been monitoring. His press release states “In October, Wyden also urged the federal Centers for Medicare and Medicaid Services (CMS) to review pharmacy closures nationwide in the last five years with a focus on how fees imposed by Medicare Part D plans and middlemen known as pharmacy benefit managers are driving those closures.”

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.

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House Committee on Oversight and and Reform Releases Report on Drug Pricing

Last week Representative Maloney (D-NY) who is the Chairwoman of the Committee on Oversight and Reform released the final staff report, resulting from a multi-year investigation into drug pricing. The Committee investigation was originally started by the late Representative Cummings.

Last week Representative Maloney (D-NY) who is the Chairwoman of the Committee on Oversight and Reform released the final staff report, resulting from a multi-year investigation into drug pricing. The Committee investigation was originally started by the late Representative Cummings. 

Here are a few findings from the report.

  • Drug companies aggressively raise prices to meet revenue targets, and executive compensation structures create incentives to raise prices.  The companies in the Committee’s investigation collectively raised prices more than 250 times on the 12 drugs examined.  The drugs in the Committee’s investigation are now priced at a median of almost 500% higher than when they were brought to market.  The Committee ’s investigation revealed evidence that company executives made aggressive price increases to meet ever-increasing revenue targets and earnings goals.  All ten companies have compensation structures that tie incentive payments to revenue and other financial targets, and several companies directly tied incentive compensation to drug-specific revenue targets. 
     

  • Drug companies target the U.S. market for higher prices and use the Medicare program to boost revenue.  Internal strategy documents show that drug companies targeted the U.S. market for price increases—while maintaining or lowering prices in the rest of the world—in part because Medicare cannot negotiate directly for lower prices.  The Committee’s analysis found that taxpayers could have saved more than $25 billion over a five-year period for just seven of the drugs investigated—Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog, and Lyrica—if private Medicare Part D plans had obtained the same discounts as other federal health programs that are empowered to negotiate. 
     

  • Drug companies abuse the patent system and FDA market exclusivities to suppress competition.  Collectively, the companies in the Committee’s investigation have obtained more than 600 patents on the 12 drugs examined, which could potentially extend their monopoly periods to a combined total of nearly 300 years. 
     

  • Drug companies use strategies to suppress competition and maintain monopoly pricing.  Every company in the Committee’s investigation engaged in one or more strategies to suppress competition from generics or biosimilars.  These strategies include what are often described as “life-cycle management” or “loss of exclusivity” strategies:  (1) shifting patients to new products or formulations of a drug just before facing generic competition for the old formula (known as “product hopping” or “evergreening”); (2) pursuing contracts with PBMs and insurers that condition rebates and discounts on excluding competitor products; and (3) aggressively marketing directly to patients and physicians to drive sales, especially as drugs faced generic competition. The Committee’s investigation also uncovered new evidence of “shadow pricing,” a practice in which would-be competitor companies follow each other’s price increases.
     

  • Drug companies use patient assistance programs as a public relations tool to boost sales.  The Committee’s investigation uncovered new evidence that companies emphasized the significant returns on investment from these programs in the form of increased sales, particularly for drugs approaching loss of exclusivity.  Internal documents show that companies view these programs as an important public relations tool, but that companies’ spending on patient assistance programs is minimal compared to the enormous amount of revenue brought in by these drugs.  These programs often do not provide sustainable support for patients and do not address the burden that the company’s pricing practices have placed on the U.S. health care system.
     

  • Research and manufacturing costs do not justify price increases.  The Committee’s investigation found that companies’ investments in R&D are far outpaced by revenue gains.  The investigation also found that even if the pharmaceutical industry collected less revenue due to pricing reforms, drug companies could maintain or even exceed their current R&D expenditures if they reduced spending on stock buybacks and dividends.  From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.  In addition, companies dedicated a significant portion of their R&D expenditures to research intended to extend market monopolies, support the companies’ marketing strategies, and suppress competition.

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

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The Platform Accountability and Transparency Act (PATA) Introduced to Ensure Social Media Platform Transparency

Senators Coons (D-DE), Kloubuchar (D-MN) and Portman (R-OH) have introduced a bi-partisan proposed bill that would require social media companies to provide vetted, independent researchers and the public with access to certain platform data.

Senators Coons (D-DE), Kloubuchar (D-MN) and Portman (R-OH) have introduced a bi-partisan proposed bill that would require social media companies to provide vetted, independent researchers and the public with access to certain platform data.

According to the bill’s press release, PATA proposes the following:

  • Under PATA, independent researchers would be able to submit proposals to the National Science Foundation, an independent agency designed to promote the progress of science by approving research and development proposals from researchers across the sciences. If the requests are approved, social media companies would be required to provide the necessary data subject to certain privacy protections.

    • Companies that failed to comply would be subject to enforcement from the Federal Trade Commission (FTC) and face the potential loss of immunity under Section 230 of the Communications Decency Act.  

  • Additionally, the bill would give the FTC the authority to require that platforms proactively make certain information available to researchers or the public on an ongoing basis, such as a comprehensive ad library with information about user targeting and engagement.

  • The proposal would also protect researchers from legal liability that may arise from automatically collecting platform information if they comply with various privacy safeguards.  

The bill can be viewed here

This bill is important to watch as part of an ongoing trend of increasing policy scrutiny on the tech sector.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. Our technology practice monitors relevant policy and regulatory decision makers and we counsel clients on emerging trends within this rapidly developing field. 

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.

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New Congressional CBD Bill Introduced to Give Policy Clarity for CBD Products

Congress has introduced the CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.”

Congress has introduced the bi-partisan CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.” The bill is sponsored by U.S. Representatives Rice (NY-04), Griffith (VA-09), Craig (MN-02), and Crenshaw (TX-02).

According to the bill’s press release

“While the 2018 Farm Bill removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, it did not make changes to existing Food and Drug Administration (FDA) law or regulatory policies governing its use in FDA-regulated products. Since then, the market for CBD products has exploded, and CBD is ubiquitously available to consumers in oils, cosmetics, supplements, and foods, and it is even marketed in products for pets. The discrepancy between the Controlled Substances Act and FDA law has created a regulatory gray area in which CBD is widely available but unregulated – and considered illegal – by FDA. 

The bipartisan CBD Product Safety and Standardization Act would allow FDA to regulate CBD as it would any other food ingredient and subject these products to enforceable safeguards to ensure accountability. It also charges the agency with establishing CBD content limits and packaging and labeling requirements and determining in which categories of food CBD is appropriate for use. This bill will help distinguish responsible players from bad actors that ignore federal requirements for quality, manufacturing, labeling, and claims, and it will bring safety and clarity to the market.”

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.

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Congressional Cannabis Caucus Advocates for Medical Marijuana Access to Veterans

On December 1, 2021 the Congressional Cannabis Caucus composed a letter to the Secretary of Veterans Affairs regarding the Caucus’ advocacy for medical marijuana access for veterans.

The letter stated “As bipartisan Co-Chairs of the Congressional Cannabis Caucus, we are pleased to learn the Department of Veterans Affairs (VA) is considering a change in policy to allow for access to medical cannabis for VA patients. We implore your agency to act swiftly and implement this change as soon as possible.”

On December 1, 2021 the Congressional Cannabis Caucus composed a letter to the Secretary of Veterans Affairs regarding the Caucus’ advocacy for medical marijuana access for veterans. 

The letter stated “As bipartisan Co-Chairs of the Congressional Cannabis Caucus, we are pleased to learn the Department of Veterans Affairs (VA) is considering a change in policy to allow for access to medical cannabis for VA patients. We implore your agency to act swiftly and implement this change as soon as possible.” 

The letter provides useful statistics and suggests benefits against certain disease states with the utilization of cannabis. 

As time goes on we are seeing more opportunities for policy cooperation where cannabis is concerned, which means more marketplace opportunities for interested stakeholders. 

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.

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New Congressional Pharmacy Benefit Manager Bill Aimed at Spread Pricing Reintroduced

According to a December 1, 2021 press release, Representatives Carter (R-GA) and Gonzalez (D-TX) have reintroduced the Drug Price Transparency in Medicaid Act. The legislation “would limit the power of pharmacy benefit managers (PBMs) to artificially spike Medicaid drug prices. The Drug Price Transparency in Medicaid Act bans the use of spread pricing by middlemen (PBMs) in Medicaid managed care. PBMs drive up prescription drug costs without adding any value to the consumer.”

According to a December 1, 2021 press release, Representatives Carter (R-GA) and Gonzalez (D-TX) have reintroduced the Drug Price Transparency in Medicaid Act. The legislation “would limit the power of pharmacy benefit managers (PBMs) to artificially spike Medicaid drug prices. The Drug Price Transparency in Medicaid Act bans the use of spread pricing by middlemen (PBMs) in Medicaid managed care. PBMs drive up prescription drug costs without adding any value to the consumer.” 

This legislation would help stop the under reimbursement that pharmacies are experiencing, while also helping to create much needed drug price transparency where Medicaid programs nationwide are concerned. 

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.

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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.

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.

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Pharmacy Celebrates Another Win Over PBMs in the 8th Circuit

This week the 8th Circuit issued a decision in the case of Pharmaceutical Care Management Association v. Wehbi, which supported North Dakota’s legislative actions to regulate pharmacy benefit managers (PBMs). PCMA v. Wehbi is the first case at the federal appellate level since the landmark Rutledge v. PCMA decision last year that upheld Arkansas law also regulating PBMs.

This week the 8th Circuit issued a decision in the case of Pharmaceutical Care Management Association v. Wehbi, which supported North Dakota’s legislative actions to regulate pharmacy benefit managers (PBMs). PCMA v. Wehbi is the first case at the federal appellate level since the landmark Rutledge v. PCMA decision last year that upheld Arkansas law also regulating PBMs. 

The PCMA v. Wehbi case can be found here

With these huge decisions serving as tailwinds for pharmacy there is still more work to be done. 

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.

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Newly Introduced States Reform Act Proposes to End Current Federal Prohibition on Marijuana

Rep. Nancy Mace (R-SC) has introduced The States Reform Act, which is aimed at becoming the first prominent policy push by a House Republican to end the current federal prohibition on marijuana.

Rep. Nancy Mace (R-SC) has introduced The States Reform Act, which is aimed at becoming the first prominent policy push by a House Republican to end the current federal prohibition on marijuana.

Rep Mace said the following regarding her legislation in a newly released press statement:

“Today, only 3 states lack some form of legal cannabis. My home state of South Carolina permits CBD, Florida allows medical marijuana, California and others have full recreational use, for example. Every state is different. Cannabis reform at the federal level must take all of this into account. And it’s past time federal law codifies this reality,”

“This is why I’m introducing the States Reform Act, a bill which seeks to remove cannabis from Schedule I in a manner consistent with the rights of states to determine what level of cannabis reform each state already has, or not. 

“This bill supports veterans, law enforcement, farmers, businesses, those with serious illnesses, and it is good for criminal justice reform. Furthermore, a super-majority of Americans support an end to cannabis prohibition, which is why only 3 states in the country have no cannabis reform at all.  

“The States Reform Act takes special care to keep Americans and their children safe while ending federal interference with state cannabis laws. Washington needs to provide a framework which allows states to make their own decisions on cannabis moving forward. This bill does that.”

  • The U.S. Department of Agriculture would oversee growers 

  • The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives would oversee the cannabis industry. 

  • Medical marijuana would be regulated by the Food and Drug Administration,

  • There would also be a 3% federal excise tax on all cannabis products, where these proceeds would be reinvested in small businesses, mental health and law enforcement

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.

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Rohit Chopra of the Consumer Financial Protection Bureau testified before the House Financial Services Committee on Changing Tech Stakeholder Influence

Rohit Chopra who is the Director of the Consumer Financial Protection Bureau testified before the House Financial Services Committee regarding how “Congress has tasked the CFPB with monitoring market conditions to spot risks, ensure compliance with existing law, and promote competition in order to protect families and honest businesses.”

Rohit Chopra who is the Director of the Consumer Financial Protection Bureau testified before the House Financial Services Committee regarding how “Congress has tasked the CFPB with monitoring market conditions to spot risks, ensure compliance with existing law, and promote competition in order to protect families and honest businesses.”

He outlined the Bureau’s concerns with today’s tech and fintech market influences. 

“Technological progress holds the potential for enormous benefits to households and the economy, particularly with respect to real-time consumer payments. At the same time, the desire of Big Tech to gain greater control over the flow of money in the economy raises a number of questions. For example, how will these firms harvest 2 and monetize data they collect on our transactions? What criteria will they use to decide who is removed from the platform? How will they ensure that payment systems adhere to consumer protections? Will Big Tech giants have an incentive to impede the entry of new firms seeking to offer competitive products and services? With this in mind, the CFPB has issued orders to dominant firms such as Facebook, Google, Apple, Amazon, Square, and PayPal to shed light on some of these questions. We will also be studying some of the practices of Chinese tech giants, including services provided by WeChat Pay and AliPay. These efforts complement other work within the Federal Reserve System to ensure families and businesses can rely on a fast and reliable payments system. It will also inform other initiatives to ensure that our evolving payments landscape is in alignment with our national interest. Given the state of today’s economic conditions, the Bureau also intends to ramp up its monitoring of other markets and their impact on specific population segments.”

Mr. Chopra’s testimony can be viewed here. Throughout the year we have seen where the fintech and technology stakeholder interests have begun to merge due to a changing marketplace. 

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

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FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for),  its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.” 

Furthermore, “The FDA granted approval of Cyltezo to Boehringer Ingelheim on October 15, 2021. To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.”

The FDA’s announcement can be viewed here

This is an exciting announcement by the FDA, as competitors to the originator now have a viable path forward to make market inroads. 

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.  

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Antitrust Legislation Targeting Merger Filing Fees Passes Senate

U.S. Senator Amy Klobuchar (D-MN), Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, and Senator Chuck Grassley (R-IA) who along with Senator Durbin (D-IL) as cosponsors have announced Senate passage of the Merger Filing Fee Modernization Act.

U.S. Senator Amy Klobuchar (D-MN), Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, and Senator Chuck Grassley (R-IA) who along with Senator Durbin (D-IL) as cosponsors have announced Senate passage of the Merger Filing Fee Modernization Act. 

The bill which can be found here, proposes to “Promote antitrust enforcement and protect competition through adjusting premerger filing fees, and increasing antitrust enforcement resources.”  

With a more aggressive FTC and a renewed emphasis on antitrust policy, commerce stakeholders should definitely pay attention to recent proposals on how to modify antitrust laws for the 21st century. 

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

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New Congressional Privacy Legislation Proposes Mandated Warrants to Search Americans’ Digital Devices at the Border

Senators Ron Wyden (D-OR) and Rand Paul (R-KY) have introduced the Protecting Data at the Border Act .

Senators Ron Wyden (D-OR) and Rand Paul (R-KY) have introduced the Protecting Data at the Border Act .

According to the press release “The bipartisan bill prevents law enforcement agencies from continuing to take advantage of the so-called border search “exception” in order to conduct warrantless searches of Americans’ phones and laptops.” 

“The Protecting Data at the Border Act would provide statutory clarity by recognizing that the principles from Riley v. California extend to searches of digital devices at the border. In addition, this bill requires that U.S. persons know their rights before they consent to giving up online account information (like social media account names or passwords) or before they consent to give law enforcement access to their devices.”

The bill summary can be found here.  

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. Our privacy practice monitors relevant policy and regulatory decision makers and we counsel clients on emerging trends within this rapidly developing field. 

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.

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Senator Markey (D-MA) and Representatives Castor (D-FL) and Trahan (D-MA) Urge FTC To Use Authority to Make Tech Companies More Accountable

According to Senator Markey’s press release Senator Markey and Representatives Castor and Trahan have sent a letter to the Federal Trade Commission, urging the agency to use its full authority—including its authority under Section 5 of the FTC Act—to ensure these companies comply with their new policies.

According to Senator Markey’s press release Senator Markey and Representatives Castor and Trahan have sent a letter to the Federal Trade Commission, urging the agency to use its full authority—including its authority under Section 5 of the FTC Act—to ensure these companies comply with their new policies. The Age Appropriate Design Code (AADC) took effect in the U.K. this September and requires online services available to children and teens to meet 15 key children’s privacy standards, many of which are similar to legislative proposals to update Senator Markey’s 1998 law, the Children’s Online Privacy and Protection Act (COPPA), in the United States.

It is no secret that technology stakeholders should be mindful of additional regulatory and policy scrutiny. Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. We continue to monitor the policy and legal developments around the FTC.

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.

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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. 

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.

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Biden Administration Issues Interim Final Rule on Surprise Medical Billing

The Centers for Medicare and Medicaid Services (CMS) in conjunction with the Departments of Health and Human Services (HHS), Labor (DOL), Treasury (collectively, the Departments), and the Office of Personnel Management (OPM) has issued an interim final rule with a comment period that seeks to implement the No Surprises Act aimed at surprise medical billing.

The Centers for Medicare and Medicaid Services (CMS) in conjunction with the Departments of Health and Human Services (HHS), Labor (DOL), Treasury (collectively, the Departments), and the Office of Personnel Management (OPM) has issued an interim final rule with a comment period that seeks to implement the No Surprises Act aimed at surprise medical billing. 

According to the CMS announcement “This rule details a process that will take patients out of the middle of payment disputes, provides a transparent process to settle out-of-network (OON) rates between providers and payers, and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals. It also adds protections in the external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims.”

The interim final rule can be viewed here.  

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.

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First Meeting of the President’s Council of Advisors on Science and Technology Occurs

The White House held the first meeting of the President’s Council of Advisors on Science and Technology Occurs (PCAST). PCAST deals with “1) U.S. competitiveness, security, and international science and technology leadership; and 2) U.S. public health and pandemic preparedness.”

The White House held the first meeting of the President’s Council of Advisors on Science and Technology (PCAST). PCAST deals with “1) U.S. competitiveness, security, and international science and technology leadership; and 2) U.S. public health and pandemic preparedness.” 

“PCAST focused its meeting on two topics: U.S. competitiveness, security, and international science and technology leadership; and U.S. public health and pandemic preparedness. The meeting provided PCAST with an opportunity to hear from representatives of a broad range of sectors, including federal, state, and local governments, academia, and industry.”

Additional details on this meeting can be found here

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. We continue to monitor the policy and legal developments around the FTC.

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.

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FTC Report to Congress on Privacy and Security

The Federal Trade Commission (FTC) last month issued the FTC Report to Congress on Privacy and Security.

The Federal Trade Commission (FTC) last month issued the FTC Report to Congress on Privacy and Security

What’s in the Report? 

According to the agency “This report responds to the Joint Explanatory Statement accompanying the Consolidated Appropriations Act, 2021, P.L. 116-260, directing the Federal Trade Commission (“Commission” or “FTC”) to “conduct a comprehensive internal assessment measuring the agency’s current efforts related to data privacy and security while separately identifying all resource-based needs of the FTC to improve in these areas. The agreement also urges the FTC to provide a report describing the assessment’s findings to the Committees [on Appropriations of the House and Senate] within 180 days of enactment of this Act.”

Additionally, “The report first provides an overview of the FTC’s authority related to privacy and security, highlighting certain recent efforts in those areas. Second, it discusses priorities for improving the effectiveness of our efforts to protect Americans’ privacy. Third, it identifies areas in which we could use additional resources to further ensure Americans’ privacy is protected. Finally, it discusses the need for Congressional action on the FTC’s authority.”

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. We continue to monitor the policy and legal developments around the FTC.

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.

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Pharmacy Times Interviews Lanton Law On How COVID-19 May Lead to the Expansion of Practice Laws for Pharmacists Across the Country

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

Lanton Law PLLC was honored to speak with Medical World News’ Second Opinion on emerging COVID-19 vaccine mandates. It was great sharing this program with Ned Milenkovich of Much Shelist, P.C.

Episode 2 can be viewed here.

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SAFE Banking Act Passes House in Defense Legislation

The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation.

The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation.  The bill would give safe harbors to financial institutions servicing cannabis industry stakeholders. The text of the SAFE Banking Act can be found here

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.

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