Lanton Law Quoted in Pharmacy Times Interview on Drug Pricing Reforms Amid the Repeal of Executive Order 14087

Lanton Law was quoted in the Pharmacy Times Article titled "Reversal of Executive Order (EO) 14087 Raises Questions About Future Drug Pricing Reforms.” We discuss the EO and how pharmacists are impacted. The article can be viewed here.

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.

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.

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. 

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.  

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.

Illumina Acquires Grail

According to the press release, Illumina announced that it has “acquired GRAIL, a healthcare company focused on life-saving early detection of multiple cancers, but will hold GRAIL as a separate company during the European Commission's ongoing regulatory review. 

Illumina, the global leader in DNA sequencing, first announced its intention to acquire GRAIL nearly a year ago, reuniting Illumina with GRAIL four years after it was spun off. GRAIL's Galleri blood test detects 50 different cancers before they are symptomatic. Illumina's acquisition of GRAIL will accelerate access and adoption of this life-saving test worldwide.”  

This acquisition has been announced despite the fact that it faces a legal challenge from the FTC as well as European antitrust scrutiny. 

Here are the reasons Illumnia gave for the deal according to the press release:

• The deal will save lives. Cancer kills around 10 million people annually worldwide and 600,000 people in the US alone. Cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening, and most cancers are detected when chances of survival are lower. Illumina feels there is a moral obligation to have the deal decided by a thoughtful and full review by the EU regulators and the US courts. This can only be done if Illumina acquires GRAIL now. Otherwise, the company is locked into a situation where the deal terms will expire before there is a chance for full review; the clock will just run out.

• Right now, the Galleri test is available but costs $950 because it is not covered by insurance. Reuniting the two companies is the fastest way to make the test broadly available and affordable. Illumina's expertise in market development and access has resulted in coverage of genomic testing for over 1 billion people around the world already. This experience will help lead to coverage and reimbursement for the Galleri test.

• GRAIL and Illumina have a long history. Illumina formed GRAIL and spun it out in 2016. GRAIL's first employees were part of Illumina, which still owns 12 percent of the company. GRAIL and Illumina are not competitors—this is a vertical acquisition.

• Based on past experience, when Illumina enters a market, the market expands. When Illumina entered the non-invasive prenatal testing space, prices dropped, reimbursement expanded, the number of providers increased, and more expectant parents had access to testing.

• Illumina's acquisition of GRAIL is driven by the belief that this test should be available to as many people as possible as quickly as possible. From fighting the COVID-19 pandemic to matching cancer patients to therapies, Illumina's mandate is to save lives and transform healthcare. The first COVID-19 viral sequence was on an Illumina machine and now genomic surveillance has emerged as a critical tool in the global fight against the pandemic, with over 70 countries now using Illumina platforms for COVID-19 variant tracking.

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.

New Louisiana Law Bans White Bagging

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

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

Update on FTC Administrative Complaint Against Illumina

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

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

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

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

FTC Files Administrative Complaint Against Illumina on Market Competition Concerns

This week the Federal Trade Commission filed an administrative complaint to “block Illumina’s $7.1 billion proposed acquisition of Grail—a maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. Illumina is the only provider of DNA sequencing that is a viable option for these multi-cancer early detection, or MCED, tests in the United States.

The complaint alleges the proposed acquisition will diminish innovation in the U.S. market for MCED tests. MCED tests could be used to detect up to 50 types of cancer, most of which are not screened for at all today, saving millions of lives around the world. Grail is one of several competitors racing to develop these liquid biopsy tests, which analyze a sample of a patient’s blood or other fluid through DNA sequencing.”

Furthermore the complaint addressed the effect on the marketplace. The FTC alleged “that even if a viable substitute to Illumina’s NGS platform entered the market, it would take years for MCED test developers to switch to a platform other than Illumina’s because they would have to reconfigure their tests to work with the new NGS platform, and in some situations, conduct new clinical trials.”

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

New Lanton Law Specialty Drug Blogcast with Ken Kaitin of Tufts University

We are excited to interview Kenneth Kaitin; Professor and Director for the Tufts Center for the Study of Drug Development at Tufts University School of Medicine in Boston, Massachusetts.

Our conversation touches on a wide variety of specialty drug issues such as oncology, orphan drugs, value based care, innovative payment models and Boston’s pharmaceutical R&D expansion.

Click here for the interview.

Private Equity Presence Grows in Physician Practices As Well As Congressional Scrutiny

The Changing Market

As the consolidation of independent physician practices continues, one finds that there is a new player in the corporatization of medicine. While hospitals, health systems and insurers continue to make physician practice acquisitions, these entities suddenly find themselves competing against private equity firms.

Several physicians are finding themselves struggling in today’s reimbursement landscape. Whether you are in orthopedics, oncology, dermatology, urology, women’s health and gastroenterology for example, not only are reimbursement pressures much worse than in prior years, but transitioning to value based care has caused these and other physician practices to struggle with acquiring specialized personnel, new workflows and innovative technology.

What is Private Equity?

Private equity firms are backed by money from high net worth individuals, sovereign wealth funds, pensions funds, etc. that seek to invest in specialized sectors for an average return of 20% within 5-7 years. Once these firms take a majority stake in these practices and scale down costs to make the practice efficient, these same firms exit their positions after a short period while the remaining physician owners profit from the resale. The goal is to target a market, region or to create a multi-specialty practice. Besides the goal of financial returns, these firms can use their market clout to negotiate better rates and compete for more contracts with payers. 

To date, there are many questions surrounding private equity firms purchasing physician practices. Do they improve patient outcomes? Do all employees within these new scaled practices work for the private equity firm? What legal liabilities exist for the physicians? Are physicians considered owners or employees in these newly acquired entities? 

Private Equity Transactions Debated by Congress

Transactions such as the ones described above are now being debated by Congress. The House Ways and Means Committee is debating whether transparency is warranted by private equity firm ownership of physician practices. Should these firms have to file disclosures with the Internal Revenue Services (IRS) on Medicare payments, as well as provider rents and mortgages? Additionally, the question of whether an increase in patient surprise billing is the result of private equity ownership is also currently being examined.    

How Can Lanton Law Help?

Lanton Law’s advocacy and legal services  can help physician practices think about your options in this changing marketplace. If your position is not to sell your firm, we can help you with both legal and advocacy options that will assist with better reimbursement and network access. If you are thinking of selling your practice we can help walk you through your strategies. Once you sell, your practice will transition not only operationally, but also how you care for your patients. Not having complete managerial control will likely occur after the transaction so making sure that you sell to the right stakeholder is crucial. Contact us today for more information.