Lanton Law Podcast Episode 1

On Episode 1 Lanton Law speaks with STACK CEO Jonathan Ogurchak about privacy trends, healthcare efficiencies using SAAS and whether healthcare is ready for tech disruption. Click here to listen to the podcast.

Arizona passes new law requiring insurers to cover cancer biomarker tests

Arizona has enacted HB 2144 seen here which requires health care insurers, the Arizona Health Care Cost Containment System (AHCCCS) and its contractors to provide coverage for biomarker testing. Prescribes processes and requirements for the usage and coverage of biomarker testing.

Bills like these are needed as they improve physicians’ abilities to target cancers more accurately which could lead to improved patient outcomes and less healthcare financial waste.

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 healthcare 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 priorities.   

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

UnitedHealthcare (UHC) Announces Virtual Physical Therapy Program

UHC has announced a partnership with Kaia Health on a new virtual physical therapy program. The program is aimed at shoulder or knee problems and other musculoskeletal issues. 

How does it work? 

According to the announcement  “The app uses a front-facing smartphone camera and artificial intelligence technology to analyze a user’s movement patterns while performing PT exercises. The program gives real-time tips for carrying out safe, effective exercise sessions that typically last between 10-25 minutes. If, at any point, a certified health coach is needed, one can be accessed using an in-app chat feature.

The app is part of a broader set of in-person and virtual musculoskeletal support tools available to eligible UnitedHealthcare members recovering from surgery or injury, including knee, back or shoulder problems. The programs are designed to help improve health, reduce costs and avoid often unnecessary invasive treatments, including imaging, surgery or opioid prescriptions.”

We continue to see emerging innovation within healthcare around digital healthcare and digital therapeutics. Opportunities abound for those looking for new ways to care for patients. 

Lanton Law is an innovative firm at the center of tomorrow’s legal, policy and market trends. We continue to monitor the developments of emerging sectors such as digital healthcare and give counsel to stakeholders accordingly. Contact Lanton Law to discuss your lobbying and legal strategies.     

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

Biden Administration to Invest $3.1 Billion to Manufacture Electric Car Batteries

The U.S. Department of Energy (DOE) has announced “$3.1 billion in funding from President Biden’s Bipartisan Infrastructure Law to make more batteries and components in America, bolster domestic supply chains, create good-paying jobs, and help lower costs for families. The infrastructure investments will support the creation of new, retrofitted, and expanded commercial facilities as well as manufacturing demonstrations and battery recycling. DOE is also announcing a separate $60 million to support second-life applications for batteries once used to power EVs, as well as new processes for recycling materials back into the battery supply chain. Both funding opportunities are key components of the Administration’s whole-of-government supply chain strategy to strengthen America’s energy independence to reduce our reliance on competing nations and support the President’s goal to have electric vehicles make up half of all vehicles sales in America by 2030.”    

Clean energy continues its push forward as the U.S. explores alternatives to fossil fuels. As the debate around climate change starts to take shape, many manufacturing companies have already started thinking about green energy as a next step in their evolution plans.

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. We help stakeholders understand what’s at issue so that we can help our valued clients achieve their priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

FDA Releases Draft Guidance To Encourage Enhancing Clinical Trial Diversity

The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity. 

The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.3 Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.

The draft guidance can be found here.  

Lanton Law is a national healthcare and life science boutiquelaw andgovernment 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 ourlegal orlobbying services can help you attain your goals.

CFPB Will Invoke Dormant Authority to Scrutinize Nonbank Companies

The Consumer Financial Protection Bureau (CFPB) issued an announcement that it is “invoking a largely unused legal provision to examine nonbank financial companies that pose risks to consumers. The CFPB believes that utilizing this dormant authority will help protect consumers and level the playing field between banks and nonbanks. The CFPB is also seeking public comments on a procedural rule to make this process more transparent.” 

Additionally, “Under the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the CFPB has authority to use traditional law enforcement to stop companies from engaging in conduct that pose risk to consumers; this can involve adversarial litigation. However, the law also gives the CFPB authority to conduct supervisory examinations to review the books and records of regulated entities. CFPB examiners typically provide a report to entities with problems that need to be addressed, and responsible institutions typically take prompt corrective action.”

Fintech has been an area that has been ahead of regulatory changes, but as we have been forecasting to industry stakeholders this may be about to change. It is imperative that you have a strategic plan going forward. 

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.

Massachusetts Attorney General Agrees to Optum Atrius Health Merger

Massachusetts Attorney General Healey has agreed to Optum’s Atrius Health acquisition for a price of $236 million. With this Optum has taken another step in its acquisition of Massachusetts’ largest independent physician organization. 

The Massachusetts Health Policy Commission has also been reviewing this transaction. The Commission’s preliminary review on the transaction can be found here. 

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare, technology and clean energy. Our mergers and acquisitions practice focuses on helping stakeholders acquire targets as well as helping clients transfer assets.

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.

Lanton Law Talks with Pharmacy Times about Pending Opioid Litigation

In an interview with Pharmacy Times, Ron Lanton, JD, principal at Lanton Law, discussed the recent Johnson & Johnson legal settlement in Texas to resolve opioid claims. Lanton said this decision could be significant but working with prescribers is an essential step to shifting the opioid epidemic.

To access the video and the entire text of the interview click here.

Lanton Law Micro Webinar on the Corporate Practice of Medicine

We have a new micro webinar on the corporate practice of medicine. Click here to view the presentation.

Lanton Law Micro Webinar on the Upcoming FTC Comment Period on PBMs

We have a micro webinar on the upcoming FTC comment period on pharmacy benefit managers. Click here to view the micro webinar.

FDA Releases Draft Cybersecurity Guidance

The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” The draft guidance can be viewed here. Comments are due July 7, 2022. 

What is the FDA proposing? 

In 2018, the FDA proposed updates to the final guidance, ‘‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,’’ and issued a draft guidance of the same name.”

This draft guidance replaces the aforementioned 2018 guidance and is “intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns.” 

Why is the FDA doing this? 

According to the draft guidance as “more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system.”

How Lanton Law can help

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

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. If you are a tech or healthIT industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Pharmacy Focus: Oncology Edition - A Conversation About Biden's Cancer Moonshot Program

In the first episode of Pharmacy Focus: Oncology Edition, the Times spoke with Ron Lanton, JD, principal at Lanton Law. Although it is still too early to know how the program differs from private-sector efforts to improve cancer treatments, Lanton said the program has some interesting goals and approaches.

The podcast can be heard here.

CMS is Proposing to Delay the Radiation Oncology (RO) Model

Last week the Centers for Medicare & Medicaid Services (CMS) announced its proposal to delay the start of the Radiation Oncology Model. The announcement can be found here. No reason was given but the proposed reimbursement structure was undoubtedly the major reason behind this delay. 

So what is the RO Model? According to CMS “The Radiation Oncology (RO) Model aims to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether prospective, site neutral, modality agnostic, episode-based payments to physician group practices (PGPs), hospital outpatient departments (HOPD), and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries.”

Below are some key elements of the RO Model:

Alternative Payment:

• Episode Payments: CMS makes prospective, episode-based (i.e., bundled) payments, based on a patient's cancer diagnosis, that cover RT services furnished in a 90-day episode for the included  cancer types meeting the included cancer type criteria described in the final rule;

• Site-neutrality: The Model uses site-neutral payment by establishing a common, adjusted national base payment amount for the episode, regardless of the setting where it is furnished;

• Professional and Technical Payment Components: Episode payments are split into professional and technical components to allow the current claims systems for the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) to be used to adjudicate RO Model claims and for consistency with existing business relationships.

• Linking Payment to Quality: The Model links payment to quality using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to RO participants. The Model meets the requirements to qualify as an Advanced Alternative Payment Model (APM) and a Merit-Based Incentive Payment System (MIPS) APM under QPP starting in performance year (PY) 1.

• RO Participants in a Mandatory Model: The RO Model requires participation from RT providers and RT suppliers that furnish RT services within randomly selected CBSAs.

If you are a radiation oncology stakeholder, this is something to continue to watch. 

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 healthcare 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 priorities.   

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

House Passes Insulin Bill

The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here. According to the bill’s summary this bill does the following: 

• Limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit.

• Caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023.

• Caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at $35 beginning in 2023.

• Currently, the Centers for Medicare & Medicaid Services is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.

• The bill also (1) further delays implementation of regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws, and (2) increases funding for the Medicare Improvement Fund.

The bill now goes to the Senate where 60 votes are needed to send it to the President. 

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 healthcare 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.   

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

U.S. Houses Passes the MORE Act Helping Cannabis Stakeholders

The U.S. House has passed the Marijuana Opportunity Reinvestment and Expungement Act otherwise known as the MORE Act. The proposed bill removes marijuana from the list of scheduled substances under the Controlled Substances Act and eliminates criminal penalties for an individual who manufactures, distributes, or possesses marijuana.

Sepcifically the bill:

• requires the Bureau of Labor Statistics to regularly publish demographic data on cannabis business owners and employees, 

• establishes a trust fund to support various programs and services for individuals and businesses in communities impacted by the war on drugs, 

• imposes an excise tax on cannabis products produced in or imported into the United States and an occupational tax on cannabis production facilities and export warehouses, 

• makes Small Business Administration loans and services available to entities that are cannabis-related legitimate businesses or service providers, 

• prohibits the denial of federal public benefits to a person on the basis of certain cannabis-related conduct or convictions, 

• prohibits the denial of benefits and protections under immigration laws on the basis of a cannabis-related event (e.g., conduct or a conviction), 

• establishes a process to expunge convictions and conduct sentencing review hearings related to federal cannabis offenses, 

• directs the Government Accountability Office to study the societal impact of state legalization of recreational cannabis,

• directs the National Highway Traffic Safety Administration to study methods for determining whether a driver is impaired by marijuana, 

• directs the National Institute for Occupational Safety and Health to study the impact of state legalization of recreational cannabis on the workplace, and 

• directs the Department of Education to study the impact of state legalization of recreational cannabis on schools and school-aged children.

The bill H.R. 3617 can be viewed here. The bill faces an unknown future in the U.S. Senate. 

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.

President Biden Invokes Defense Production Act to Help Issues Related to EV Battery Materials

President Biden has invoked the Defense Production Act as a means to increase mineral production that is used to manufacture electric vehicle batteries. The document titled “Memorandum on Presidential Determination Pursuant to Section 303 of the Defense Production Act of 1950” seen here, seeks to:

“To promote the national defense, the United States must secure a reliable and sustainable supply of such strategic and critical materials.  The United States shall, to the extent consistent with the promotion of the national defense, secure the supply of such materials through environmentally responsible domestic mining and processing; recycling and reuse; and recovery from unconventional and secondary sources, such as mine waste.” 

As the world transitions to clean energy, the minerals targeted by this Order will be lithium, nickel, cobalt, graphite, and manganese for large capacity batteries. 

The transition to clean energy is being felt now. With soaring energy prices due to the war in Ukraine we foresee plenty of change happening with supply chain security. 

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. We help stakeholders understand what’s at issue so that we can help our valued clients achieve their priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

What to Know about CURES 2.0

In November 2021, U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) today introduced their bipartisan Cures 2.0 legislation. The bill which is aimed at helping patients of innovative companies within healthcare and life sciences can be viewed here.

According to Congressman Upton’s press release the bill:

• Creates an entirely new agency aimed at ending some of the world’s most difficult diseases – such as cancer, diabetes, ALS, Alzheimer’s and more. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country. 

• 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.

We have featured this bill in a previous November 23, 2021 blog post. We believe that this is a great opportunity if you are a manufacturer, telehealth provider or clinical trial stakeholder. CURES 2.0 is something that we have been forceasting since 2020 as a way to make our system better. 

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.

FDA Proposes Rule Impacting Wholesale Drug Distributors & 3rd Party Logistics Providers

According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”

The rule can be found here. The comment period ends June 6, 2022. 

Lanton Law has personal experience in the wholesale distribution industry. 

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 healthcare practice can help distribution 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.   

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

Prescription Digital Therapeutics Presses Ahead for Behavioral Health

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

A recent CMS meeting illustrates this point. CMS released a document titled “Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations” for the Second Biannual, 2021 HCPCS Coding Cycle. The document can be viewed here. The document describes Pear Therapeutics’ reSET-O which is a “12-week interval prescription digital therapeutic for opioid use disorder (OUD).” CMS’ examination ended with its decision effective April 1, 2022 to establish a HCPCS Code to “facilitate options for non-Medicare payers to provide access to this therapy in the home setting,” so that CMS can continue its marketplace monitoring. This on top of the AMA’s CPT Editorial Panel’s actions (seen here) to establish a new CPT code for Cognitive Behavioral Therapy Monitoring effective January 2023 shows that there will definitely be more certainty in this field in the next coming years. 

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

President Biden Signs the Consolidated Appropriations Act of 2022 Impacting Telehealth and Health System Stakeholders

On March 15, 2022 President Biden signed the Consolidated Appropriations Act of 2022 into law. The announcement can be viewed here. This $1.5 trillion omnibus appropriations bill is important as there are several provisions applicable to hospitals and health systems contained within; namely touching on issues such as 340B eligibility and telehealth. 

Specifically regarding 340B the bill allows for limited protections for certain 340B hospitals that lost their eligibility due to a drop in their disproportionate share hospitals (DSH) adjustment percentage below the required threshold for 340B eligibility to gain limited access to the program. Access to the 340B drug discounts would be available only from the date of the bill’s enactment through the end of 2022 and not retrospectively.

For telehealth stakeholders, the new law would extend several telehealth flexibilities for 151 days after the end of the COVID-19 public health emergency. Additionally, the Medicare Payment Advisory Commission (MedPAC) shall “conduct a study on the expansions of telehealth services” and report their findings to Congress no later than June 2023.

Stakeholders in these groups have a lot of uncertainty in their specific industries. 

Lanton Law is a national boutique healthcare and technology law and government affairs firm.  We closely monitor legislative, regulatory and legal developments for our clients. Contact us to learn about how either our legal or lobbying services can help you attain your goals.