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.

Massachusetts Discussing Data Privacy Protection

Senator Creem and Senator Lesser have introduced S.46 titled “An Act Establishing the Massachusetts Information Privacy Act.” The bill can be found here. The Act applies to Massachusetts businesses that earn $10,000 or more annual revenue through 300 or more transactions or that process or maintain the personal information of 10,000 or more unique individuals during the course of a calendar year. The bill has protections on the collection of biometric or location information and seeks to prevent companies from discriminating based on consumer personal information. The MA Information Privacy Commission would also be created by this proposal to oversee this bill’s regulatory scheme. 

This bill mirrors the efforts unleashed by the landmark General Data Protection Regulation (GDPR) in Europe which has been followed by efforts in California. Massachusetts did have a predecessor to S.46 in 2019 which stalled in the legislature.

The bill is currently in the Advanced Information Technology, the Internet and Cybersecurity Committee.  If you are a technology, healthcare or commerce stakeholder then this is something to keep a watch on.  

Lanton Law is a national healthcare & technology law and government affairs firm. Our technology practice has been monitoring privacy developments nationwide. If you are a commerce, 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.

Prescription Digital Therapeutics (PDTs) Legislation Introduced

The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by  Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV). 

“According to the bill’s release, it would expand Medicare coverage to include PDTs, which are software-based treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software.” 

The bill sponsors released a one page fact sheet about the bill and PDTs itself.

“Prescription Digital Therapeutics (PDTs) are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. These therapies are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software.

The COVID-19 pandemic and public health emergency rapidly accelerated the pace of innovation to address some of the most pressing challenges in health care. New tools are being rapidly deployed and adopted, particularly in the case of digital health, which are increasingly being used, PDTs provide clinicians and patients with evidence-based remote treatment modalities to treat substance and opioid use disorders, mental health, diabetes and other diseases and conditions. However, there is no clear statutory benefit category to allow for Medicare and Medicaid coverage for PDTs.”

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.

Cancer Moonshot Initiative Returns

In 2017 we wrote an article that previewed the Cancer Moonshot Initiative (CMI). It was a widespread belief that with Joe Biden becoming President that the CMI would return in some capacity. Today, the White House issued a Fact Sheet that has reignited this policy effort.    

According to the White House’s announcement on the reignited CMI, here is what the Initiative is going to focus on:

• Re-establish White House Leadership, with a White House Cancer Moonshot coordinator in the Executive Office of the President, to demonstrate the President and First Lady’s personal commitment to making progress and to leverage the whole-of-government approach and national response that the challenge of cancer demands.

• Form a Cancer Cabinet, which will be convened by the White House, bringing together departments and agencies across government to address cancer on multiple fronts. These include the Department of Health and Human Services (HHS), Department of Veterans Affairs (VA), Department of Defense (DOD), Department of Energy (DOE), Department of Agriculture (USDA), Environmental Protection Agency (EPA), National Institutes of Health (NIH), National Cancer Institute (NCI), Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), Office of Science and Technology Policy (OSTP), Domestic Policy Council (DPC), Gender Policy Council (GPC), Office of the First Lady (OFL), Office of the Vice President (OVP), Office of Management and Budget (OMB), Office of Legislative Affairs (OLA), Office of Public Engagement (OPE), along with additional members, as needed, to help establish and make progress on Cancer Moonshot goals. 

• Issue a Call to Action on Cancer Screening and Early Detection:

• Build on a White House Cancer Roundtable Conversation Series hosted over the last six months, with experts, including people living with cancer, caregivers, and survivors. 

As the industry starts to refocus on initiatives prior to COVID-19, we fully expect issues like precision based medicine, gene therapy, biologics and other cutting edge policy solutions to return front and center as we continue our transition towards a world of value based payment models for improved patient outcomes. This means that many private market initiatives will be implemented in state and federal policies. 

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. 

Lanton Law Speaks with Pharmacy Times About the Mark Cuban Cost Plus Drug Company

Lanton Law spoke with Pharmacy Times about the possible market implications of the new Mark Cuban Cost Plus Drug Company.

“In an interview with Pharmacy Times, Ron Lanton III, Esq, principal at Lanton Law, said entrepreneur Mark Cuban's new venture into the pharmacy field is very interesting, although it maybe just another player in the mail-order pharmacy market.

In the interview, Lanton discussed the company's steep discounts on drugs in a myriad of disease states, as well as the company's pharmacy benefits manager, which is expected to be operational in 2023. Ultimately, Lanton said the company's broader impacts on the pharmacy field and drug pricing remain to be seen, although several other legislative efforts to lower drug prices have been discussed in recent years.”

The interview can be seen by clicking here.

Major Tech Legislation Passes U.S. Senate Judiciary Committee

The Senate Judiciary Committee voted 16-6 to advance the American Innovation and Choice Online Act. The legislation seeks to provide that certain discriminatory conduct by covered platforms shall be unlawful. Essentially this bill stops large tech platform companies from the practice of “self-preferencing” meaning these platforms will not be able to discriminate against other businesses that rely on the platform companies’ services. With momentum gaining in the Senate for passage along with similar language in the House via H.R. 3816, this bill definitely seems to be going places these days.  

For a while now we have been forecasting greater policy and regulatory oversight when it comes to technology stakeholders. We believe that we will see more scrutiny this year, as technology oversight is an issue that crosses party lines. Don’t wait to form your strategic plan for 2022.

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.

New York Enacts New Pharmacy Benefit Manager Law

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

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

Why is this important?

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

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation.  

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

CMS Ends Most Favored Nation Drug Price Model Proposal

According to the Centers for Medicare and Medicaid Services (CMS), the agency has published a final rule in the Federal Register on December 27, 2021, that rescinds the November 27, 2020, MFN Model interim final rule with comment period.​​ The final rule rescinding the Most Favored Nation Model interim final rule with comment period can be found here.

Proposed Rule Background:  

CMS included the following background to the issue in its announcement:

“In the August 10, 2021 Federal Register (86 FR 43620), we published a proposed rule (86 FR 43618, hereafter, referred to as “the August 2021 proposed rule”) that would rescind the Most Favored Nation (MFN) Model interim final rule with comment period (85 FR 76180) that appeared in the November 27, 2020 Federal Register (hereafter, referred to as “the November 2020 MFN Model interim final rule”). The November 2020 MFN Model interim final rule established a 7-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act), with the model performance period beginning on January 1, 2021. The MFN Model was not implemented on January 1, 2021 as contemplated following four lawsuits and a nationwide preliminary injunction. On December 28, 2020, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction in California Life Sciences Ass'n v. CMS, No. 3:20-cv-08603, which preliminarily enjoined HHS from implementing the MFN Model and the November 2020 interim final rule. For additional information on the MFN Model and the related lawsuits, see the August 2021 proposed rule, the November 2020 MFN Model interim final rule, and the MFN Model website.[1]”

Why does this matter?

Drug price continues to be an issue and it is essential for stakeholders to monitor how reimbursement will be for your operations. 

How Lanton Law Can Help

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.

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.”

“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.

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. 

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.

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.

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.

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

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.

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.” 

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.