Lanton Law quoted in Bloomberg Law Article

We were quoted in Bloomberg Law’s article titled “States Risk Losing Power to Regulate Pharmacy Drug Middlemen” by Lydia Wheeler. The article discusses the pros and cons of Rutledge v. PCMA, which is currently being debated at the Supreme Court.

For those that have trouble accessing the article we have provided it below.

States are going to have a hard time controlling the cost of prescription drugs if the Supreme Court broadens a federal law prohibiting states from regulating employee benefit plans.

A challenge to an Arkansas law meant to protect independent pharmacies from abusive reimbursement practices of rate-setting pharmacy middlemen is testing the bounds of the Employee Retirement Income Security Act. A decision striking down Arkansas’s law could cripple state efforts to control the cost of prescription drugs and other health-care services. That could lead to a flood of litigation challenging dozens of similar laws in other states, health policy experts say.

“This is really the tip of the iceberg because states are trying to control drug costs in all kinds of different ways,” said Katherine Gudiksen, a senior health policy researcher at the Source on Healthcare Price and Competition, a project of the University of California Hastings College of Law.

The case could be one of the first decided by the Supreme Court this term. Arguments were heard Oct. 6.

Drawing the Line 

Arkansas’s fighting to save its law, which regulates the rates at which pharmacy benefit managers reimburse pharmacies for drugs and gives pharmacies a right to appeal the rates they set.

The U.S. Court of Appeals for the Eighth Circuit held the law was preempted by ERISA, which prohibits states from passing laws that reference an ERISA plan or have an impermissible connection to an ERISA plan. But Arkansas argues pharmacy reimbursement regulation is basic rate regulation, which the Supreme Court has ruled isn’t preempted by ERISA.

“It’s hard to see how a law that directly affects benefits claims processing isn’t central to ERISA plan administration,” said Stacey Cerrone, a principal in the New Orleans office of Jackson Lewis PC.

“The court is struggling on where to draw the line with preemption,” she said.

Patchwork of State Laws

A win for Pharmaceutical Care Management Association (PCMA)—the trade group for PBMs that’s aggressively fighting this law and others—would likely open the door for more legal challenges. Laws regulating PBMs have passed in 36 states.

“There’s no agency that oversees federally a pharmacy benefit manager,” said Ron Lanton, principal at Lanton Law, which helped lobby for some state PBM laws. “That’s the problem, so the states have had to come up with their own solution on how to regulate this problem.”

But PCMA argues Congress set out to create a uniform set of standards in administering ERISA plans, which include most private sector health plans. The trade group said employers will have to spend more money on administrative services and compliance, increasing the cost of care, if laws like the one in Arkansas remain.

“More than 266 million Americans rely on the prescription drug benefits PBMs administer, and now more than ever we’re committed to protecting accessible, affordable health care,” JC Scott, PCMA’s president and CEO, said in a statement after oral arguments in October.

In addition to Arkansas, PCMA has challenged laws in North Dakota, Oklahoma, and Iowa in recent years.

The trade group has been successful in winning challenges in the Eighth Circuit. The appeals court ruled Iowa’s law and two North Dakota lawsare preempted by ERISA. Iowa’s law regulates how PBMs establish generic drug pricing, and requires certain disclosures on their drug pricing methodology. North Dakota’s laws regulate the fees PBMs can charge pharmacies. North Dakota officials have appealed the court’s decision to the Supreme Court.

In July, a federal judge blocked part of Oklahoma’s law. PCMA filed an appeal to the U.S. Court of Appeals for the Tenth Circuit, which it later had dismissed. The case is still playing out in the district court.

Lanton, who represents independent pharmacies, said his clients hope the Supreme Court provides some uniformity to what’s become a patchwork of state laws. He’s also hoping for a clear definition of what a pharmacy benefit manager is and isn’t.

“It comes down to this split in the court of whether or not the court sees a pharmacy benefit manager as an insurer that provides benefits or as an administrator that simply regulates reimbursement and cost.”

Market Power 

The three largest PBM companies are OptumRx, a subsidiary of UnitedHealth Group; CVS Caremark, a subsidiary of CVS Health; and Express Scripts, a subsidiary of Cigna Corp. They control 85% of the market share for PBM services, according to the National Association of Specialty Pharmacy’s brief in support of Arkansas.

That market power gives health plans very little bargaining power, said Erin Fuse Brown, director of the Center for Law, Health and Society at Georgia State University College of Law.

PBMs say they use their size and power to negotiate discounts with the pharmaceutical manufacturers, but it’s not clear they’re passing along those savings to the health plans, she said.

The case is Rutledge v. Pharm. Care Mgmt. Ass’n, U.S., No. 18-540.

To contact the reporter on this story: Lydia Wheeler in Washington at lwheeler@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Brent Bierman at bbierman@bloomberglaw.com

Biosimilars Advocacy Group Outlines Congressional Wish List for 2021

The Association for Accessible Medicines sent letters to all members of Congress, which expressed what measures they would like them to take regarding access to biosimilars. 

Key legislation that they focused on was, 

1. Increasing Access to Biosimilars Act, incentivizes doctors to prescribe biosimilars through a Medicare demonstration project. 

2. BIOSIM Act, allows for an increase in biosimilar payments in Medicare for five years for biosimilars whose average sales price or wholesale price acquisitions cost is less than that of the reference product.

They also advised Congress on policies regarding brands suggesting that Congress provide a more certain date as to when generics and biosimilars enter the market and updating Medicare Part D. 

AAM stated that updating Part D should include these three key policies, 

1. Increasing the share that plans pay towards the catastrophic phase. 

2. Establishing an out-of-pocket cap.

3. Ensure that rebates and discounts do not disadvantage biosimilars and other lower-priced drugs. 

With a new Administration transitioning in, 2021 looks to be a major policy shaping year for healthcare and life sciences on the legislative and regulatory fronts. 

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Lanton Law & Private Equity

With increasing mergers and acquisitions in both the technology and healthcare sectors, investment opportunities abound for funds and interested stakeholders. In order for these stakeholders to be successful it is essential to know the limits and opportunities within a complex regulatory landscape. 

At Lanton Law not only do we understand the issues, but we provide you with timely solutions to help you make informed decisions about either an acquisition target or ways to maximize value. 

We counsel clients by performing corporate due diligence, provide strategic advice for growth and business strategies as well as structuring and executing M&A transactions.

If you are a financial stakeholder including a private equity firm, hedge fund, bank, etc. we have a suite of strategic services that can help. Contact us today to learn more.

Where Do Biden & Trump Stand On The Issues?

With election season underway many are wondering where the two Presidential candidates stand on the issues of importance to voters.

Reuters did a great summary found here that explains the major differences from the economy, trade, healthcare, etc.

The winner of this election will certainly have policies affecting your interests. Whether you are in technology, healthcare/lifesciences or finance, it is important to know what your organization’s priorities are and to have a plan for either candidate should they win.

Lanton Strategies; a division of Lanton Law is a is a full service federal and state lobbying and government affairs firm that has a menu of services to help you achieve your goals.

Contact us today to get started in understanding your range of options as the new legislative session approaches.

FDA Cannabis Draft Guidance Comment Period Closes

On September 21st the FDA closed its comment period related to cannabis. Back in July the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” 

This draft guidance outlined FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance had been developed to help support clinical research into development of cannabis and cannabis-derived products. 

Additional information on the draft guidance can be found here.  

Lanton Law is a national boutique law and government affairs 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!

New White House Drug Pricing Executive Order Released

On September 13, 2020, the Trump Administration released a new Executive Order (EO)  targeting drug pricing. The EO directs the Secretary of HHS to implement a “Most Favored Nation” drug pricing program for Medicare Parts B and D. This policy relies on international price competition and seeks to provide Americans with the same lower prices for prescriptions that we see in other countries.

Drug pricing has been a major point of contention as manufacturers and insurer/pharmacy benefit managers exchange blame over why drug prices are rising. Drug pricing has been a major issue that had been getting Congressional scrutiny until COVID-19. 

This issue will come back once a COVID-19 vaccine is available as there may be questions around the vaccine’s price. Additionally, once COVID-19 dies down, drug pricing for new therapies is expected to be front and center again.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare 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!

Lanton Law to Attend 9/14-9/18 2020 NASP Annual Meeting & Expo Virtual Experience

Lanton Law is proud to be attending the 9/14-9/18 2020 NASP Annual Meeting & Expo Virtual Experience.

We will be giving a presentation on the role of “State & Federal Regulations in Payer Contracting” and Ron Lanton will be serving as Vice Chair of Law Day! Additionally, we will be hosting a panel titled “Interoperability of Health Records: Providing Post-Market Data and Other Valuable Information.”

We are very much looking forward to interacting with our specialty colleagues including Sheila Arquette! Register today at https://lnkd.in/eU2VXaB

New Executive Order Aimed at Pharmacy Benefit Managers (PBMs)

The White House has released an Executive Order titled “Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen.” 

“One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process.  The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs.  Instead, these middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug.” 

This Executive Order advocates for HHS to complete its prior January 2019 proposed rule aimed at “revising the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them.”  

Not only does this Executive Order state that discounts offered on prescription drugs should be passed on to patients, but that HHS must confirm publicly prior to finalizing its proposed rule that “that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.”

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. 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. 

White House Issues Executive Order Advocating for Importation

The White House has issued an Executive Order titled “Executive Order on Increasing Drug Importation to Lower Prices for American Patients,” which seeks to advocate for having supply chain entities proceed with importation. 

“One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones.  Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs.  For example, in the European Union, a market characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for decades and has been estimated to reduce the price of certain drugs by up to 20 percent.  Accordingly, my Administration supports the goal of safe importation of prescription drugs.” 

The Executive Order gives stakeholders three methods to accomplish the goals of this order. Either allow reimportation of insulin products from Canada, finalize the December 2019 proposed rule addressing importation, or allow individuals to import drugs as long as the importation is designated by the Food & Drug Administration (FDA) as safe and results in lower costs to patients.  

• (a)  facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);

• (b)  authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and

• (c)  completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. 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 Administration Releases Executive Order Targeting Insulin and Injectable Epinephrine via 340B

The White House has announced a few Executive Orders targeting healthcare. One Executive Order titled Executive Order on Access to Affordable Life-saving Medications targets insulin and injectable epinephrine by requiring federally qualified community health centers to pass through 340B program discounts to patients using insulin and epinephrine auto-injectors. 

Specifically the Executive Order outlines the following: 

“It is the policy of the United States to enable Americans without access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs, such as Medicare and Medicaid, to purchase these pharmaceuticals from an FQHC at a price that aligns with the cost at which the FQHC acquired the medication.

To the extent permitted by law, the Secretary of Health and Human Services shall take action to ensure future grants available under section 330(e) of the Public Health Service Act, as amended, 42 U.S.C. 254b(e), are conditioned upon FQHCs’ having established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who:

(a)  have a high cost sharing requirement for either insulin or injectable epinephrine;

(b)  have a high unmet deductible; or

(c)  have no health care insurance.”

This will be interesting to see how this gets enforced. The 340B program which is where manufacturers provide outpatient drugs to eligible healthcare entities at a reduced price has been embroiled in controversy the last several years between manufacturers and hospitals over pricing. This Order does not address hospital practices. 

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. 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.

This Week in Washington D.C.

It is widely anticipated this week that negotiation on another stimulus bill will begin on Capitol Hill. The backdrop of these negotiations are that we are starting to see an alarming increase in the number of COVID-19 infections nationwide, along with the fact that enhanced unemployment benefits that were approved in March 2020 will expire this week for many states without Congressional action to extend these benefits. The question is will we see another COVID-19 relief package that is similar to the CARES Act?

The House has been discussing $3 trillion in possible aid while the Senate is positioning for a possible $1 trillion in economic aid. At this point it is unclear where the Administration is on this issue. Major issues within this discussion are whether to include more finding for COVID-19 testing, contact tracing, etc.

The House late this spring passed a $3 trillion Heroes Act but since then the bill has been stalled in the Senate. The Senate is looking to create its own bill where the plan is the Senate version would be the blueprint to negotiate any possible further aid. It looks as though this may be the last possible economic relief bill before the election, however; this situation remains fluid. 

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. 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.

EXIM Policies Impacting Biotechnology & Life Science Stakeholders

The Export-Import Bank of the United States (EXIM) has established some new policies that will impact several stakeholder groups, especially biotechnology, biomedical sciences and life sciences stakeholders. 

According to the EXIM’s release, the “EXIM’s historic seven-year reauthorization (P.L. 116-94), signed into law December 20, 2019, directs EXIM to establish a new “Program on China and Transformational Exports” (see Sec. 402). The Program’s purpose is to support the extension of loans, guarantees, and insurance, at rates and on terms and other conditions, to the extent practicable, that are fully competitive with rates, terms, and other conditions established by the People’s Republic of China or by other covered countries (as designated by the Secretary of the Treasury). The law charges EXIM with a goal of reserving not less than 20 percent of the agency’s total financing authority (i.e., $27 billion out of a total of $135 billion) for support made pursuant to the program, with a focus on specific industries.” 

To achieve full implementation, EXIM will hold a July 16th call with Biotechnology and Biomedical Sciences. Additional information on this call can be found here. 

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. 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.

Online Political Advertising Legislation to be Introduced

U.S. Congressman Cicilline (D-RI) has announced  his intent to introduce legislation “that tightly restricts the use of personal, online consumer data that is often used to ‘microtarget’ voters with misleading ads.” According to his release, the legislation will be titled the “Protecting Democracy from Disinformation Act” and has the following elements: 

• Restricts Microtargeting: Only allows advertisers and online platforms to use age, gender, and location when targeting political ads. 

• Improves Transparency: Requires disclosure and reporting on who paid for an ad, how much it cost, whom an ad is aimed at, and who saw the ad.

• Holds Online Platforms Accountable: Provides enforcement through the Federal Election Commission’s existing authority, a private right of action, and criminal penalties for online platforms and ad intermediaries that knowingly and willfully violate the Act.

Expect issues such as microtargeting and others to come to the forefront as we enter in the election season of 2020. 

Lanton Strategies; a segment of Lanton Law works to help advance our clients interests before both legislative and regulatory bodies on the state and federal levels. We use sources from the Hill, state houses, agencies, markets and trade associations, to inform our clients and achieve proactive results. Let us know how either our government affairs services or legal services can help you achieve your priorities. 

Apple and Google Announce Digital Contact Tracing Partnership Amid Privacy Concerns

Apple and Google have announced their partnership to enable Bluetooth technology to help interested stakeholders such as healthcare agencies and governments to fight COVID-19. The announcement describes the tech companies’ intent of “releasing draft documentation for an Exposure Notification system in service of privacy-preserving contact tracing.” The most important thing to note is that the companies will not be building contact tracing apps but will be providing tools around a unified programming interface that will allow these aforementioned stakeholders to create their own contact tracing applications. And while this partnership and others like it are a much needed resource during our fight against COVID-19, privacy concerns with how these companies are using our information loom in the background. 

So what is contact tracing? It can come in two forms. The first form is human to human tracing, which is described in the Centers for Disease Control and Prevention’s (CDC) list of core principles. 

• Contact tracing is part of the process of supporting patients with suspected or confirmed infection.

• In contact tracing, public health staff work with a patient to help them recall everyone with whom they have had close contact during the timeframe while they may have been infectious.

• Public health staff then warn these exposed individuals (contacts) of their potential exposure as rapidly and sensitively as possible.

• To protect patient privacy, contacts are only informed that they may have been exposed to a patient with the infection. They are not told the identity of the patient who may have exposed them.

• Contacts are provided with education, information, and support to understand their risk, what they should do to separate themselves from others who are not exposed, monitor themselves for illness, and the possibility that they could spread the infection to others even if they themselves do not feel ill.

• Contacts are encouraged to stay home and maintain social distance from others (at least 6 feet) until 14 days after their last exposure, in case they also become ill. 

As you can see this is a very specialized skill that needs to be timely executed to prevent further spread of disease. 

According to the CDC digital tracing on the other hand is another set of tools that can be used to “expand the reach and efficacy of contact tracers.” This is what we are seeing from the Apple-Google partnership, as well as other applications (apps) that we see flooding the market in an effort to provide additional tools to combat COVID-19. 

Digital contact tracing can theoretically be more efficient because it doesn’t rely on memory, but requires user cooperation where people would have to download the relevant apps on their phones. In order for something like this to have an almost “real time” effect, a large number of people would have to adapt to this technology. Are we as a society ready for this? While emergencies like this would seem like the answer would be a common sense “yes” there are a lot of other issues at play such as are positive alerts to a user accurate and will a user’s information be protected? A great example of user worry could come in the form of potential genetic discrimination of which we wrote a prior blog post.  

To date the skepticism of technology companies being able to use healthcare data has been rampant. For example, several industry stakeholders were surprised by the Wall Street Journal’s (WSJ) article  that Google has been working since 2018 on a "secret" project involving patient data with Ascension, the St. Louis-based nationwide health system. 

Project Nightingale would involve having Google be provided with millions of health records of U.S. citizens, which has prompted a recent follow up letter by three U.S. Senators to gain additional insight into the project’s specifics. Facebook has a new tool called Preventive Health that seeks to “connect people to health resources and checkup recommendations from leading health organizations.” And while Microsoft launched Microsoft Cloud for Healthcare; whose program applies “flexible capabilities to power individualized experiences, improve team collaboration, and unify data to unlock real-time insights,” demonstrates that while technology and healthcare are merging, the need for addressing privacy concerns remains at the forefront. 

We need all the tools we can get our hands on during this difficult struggle against COVID-19, especially when it comes to digital contact tracing. There is no doubt that we need the efficiencies that technology has to offer. The potential is there, but there has to be buy in from a majority of people in order for this to work. Not only do we have to continue to work to ensure that everyone has access to smartphone technology, but we have to put some additional “safety checks” in place to ensure that ‘anonymized’ aggregated data isn’t sold, that sensitive protected health information (PHI) is guarded and the proper laws/regulations are put in place so that we can learn from the painful lessons that COVID-19 has taught thus far. 

Lanton Law Interviews the Massachusetts Pharmacists Association on DIR & Provider Status

We are excited to have Lindsay De Santis; Executive Vice President of the Massachusetts Pharmacists Association (MPhA) do a blogcast with us. Our conversation covers pharmacy DIR (direct and indirect remuneration) fees, pharmacy provider status and COVID-19.

Click here to access the Lanton Law blogcast.

Will Immunity Passports Lead to Future Genetic Discrimination?

There is no need to rehash the harsh societal effects that COVID-19 has had not only on our psychological and financial wellbeing, but also on the vulnerable population’s immune system. Those having to deal with underlying health conditions such as diabetes, obesity, hypertension have been especially at risk, including some young and healthy individuals. As we race to understand the rationale behind why such an erratic disease impacts some but not others, the question that frequently comes up is whether a person’s genes has something to do with becoming infected?

While it seems like we have been discussing gene therapy for some time, understanding how to harness the potential of the human genome is still in the “early innings.” According to the National Human Genome Research it was found that there are about 20,500 genes in human DNA. This information had taken 13 years to find and was completed in 2003. There are so many things to learn about our genes in order to be precise enough to fully realize how we can get to the ultimate improvement in patient outcomes. Unfortunately, it seems as though time is not on our side when needing to understand how our genes play a key role in fighting this terrible disease. It seems like the best thing to mitigate our circumstances until we get a vaccine is how to contain it. From social distancing to contact tracing, one idea that has been gaining steam on re-opening the economy is the possibility of immunity passports. 

So what are immunity passports? The World Health Organization (WHO) states “Some governments have suggested that the detection of antibodies to the SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an ‘immunity passport’ or ‘risk-free certificate’ that would enable individuals to travel or to return to work assuming that they are protected against re-infection. There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”

Currently there is so much fear and mistrust regarding information on COVID-19 that in order for this to work in my opinion, we would have to have certainty in antibody testing, as well as a 100% understanding about how long immunity actually lasts. Aside from a vaccine, this would certainly move economies forward as a way to slowly start to recoup the financial losses we have witnessed worldwide. But could well intentioned things like immunity passports lead to something unintended such as genetic discrimination? 

According to the National Institutes of Health (NIH), genetic discrimination occurs when people are treated differently by their employer or insurance company because they have a genetic mutation that causes or increases the risk of an inherited disorder or they have a familial history of a specific health condition. Surprisingly, this issue could determine whether someone gets hired or fired and could mean the difference between receiving comprehensive coverage.

GINA does provide a solution to genetic discrimination. The Genetic Information Nondiscrimination Act (GINA) provides for protection against this type of discrimination. Title I of GINA prohibits genetic discrimination in health insurance, and Title II prohibits genetic discrimination in employment.

Under the first part of the act, it is illegal for health insurance providers to use or require genetic information to determine whether a person is eligible for coverage. The second part prohibits employers from using a person’s genetic information in making decisions about hiring, promotion, and various other terms of employment.

However, GINA and similar laws do not protect individuals from genetic discrimination under every circumstance, such as an instance in which an employer has fewer than 15 employees. The act also does not apply to those serving in the military or those insured under the Veterans Health Administration or Indian Health Service. Furthermore, the act does not protect against genetic discrimination in other forms of insurance, including life, disability, and long-term care, according to the NIH.

While GINA’s development was designed for genetic discrimination, I believe that we have not yet seen how this law could potentially evolve from its original intent, especially in this circumstance. Constantly looking through both a policy and legal lens, I see potential problems with an immunity passport. While I understand how this is designed to get the economy back on track, how will individuals be judged regarding obtaining an immunity passport. Is this something you will be required to have by an employer? Are there privacy issues that will evolve from having to declare whether you have an immunity passport? Will employees be looked at differently if they have a passport versus those that don’t? Will an employee’s cost of insurance increase because they happened to get COVID-19?

COVID-19 has changed our lives in ways that we cannot yet imagine. As we start transitioning back towards living with this complex disease until there is a cure, our minds are currently undergoing small yet lasting changes that will unconsciously shape the way we make decisions going forward. It is very foreseeable that society will try and mitigate risks to businesses, meaning that it is not unforeseeable that companies may try and understand any genetic risks that may exist to employees. Whether this is the new normal, a threat to privacy or something else remains to be seen. 

*Disclaimer: The information provided in this blog post is an opinion and is for informational purposes only and not for the purpose of providing legal advice. Access to this information does not create an attorney client relationship between Lanton Law and the viewer. You should contact your attorney to obtain advice with respect to any particular issue or problem.

PBM U.S. Supreme Court Case Rescheduled for this Fall

We at Lanton Law along with many other pharmacy stakeholders have been closely monitoring the events surrounding the pending U.S. Supreme Court case of Rutledge v. Pharmaceutical Care Management Association.

We released our first blog about this case in December 2019 and are proud to be quoted in the January 2020 Pharmacy Times article regarding Rutledge.

To refresh the U.S. Supreme Court has provided a brief summary of the facts: 

Thirty-six States have enacted legislation to curb abusive prescription drug reimbursement practices by claims-processing middlemen-known as pharmacy benefit managers (PBMs)-who make money on the spread between the rates at which they reimburse pharmacies and the drug prices they charge health plans. In response, Respondent Pharmaceutical Care Management Association (PCMA), a PBM trade association, has launched a barrage of litigation across the country arguing that state regulations of PBMs generally, and state drug-reimbursement regulations specifically, are categorically preempted by the Employee Retirement Income Security Act of 1974 (ERISA). Disregarding this Court's ERISA precedent (and contrary to the First Circuit's conclusion that PBM regulations are categorically not preempted by ERISA), the Eighth Circuit embraced that argument.

The question presented is “Whether the Eighth Circuit erred in holding that Arkansas's statute regulating PBMs' drug-reimbursement rates, which is similar to laws enacted by a substantial majority of States, is preempted by ERISA, in contravention of this Court's precedent that ERISA does not preempt rate regulation.”

Due to COVID-19 the U.S. Supreme Court has rescheduled arguments for this case to its October 2020 term. 

Lanton Law will continue to monitor the developments around Rutledge v. PCMA and will advise our clients accordingly. If you have an issue that we can assist you with please feel free to contact us.    

The New Concerns of a Digital Workplace

We are honored to have worked with STACK for Pharmacy on a great and timely webinar titled “The New Concerns of a Digital Workplace. COVID-19 has changed the way that we work, communicate and transfer information and finances. We discuss the early trends of what we are seeing from a transitioning marketplace.

Click here to access the webinar

Upcoming Webinar with STACK and Lanton Law

STACK will be teaming up with Lanton Law to do an April 22, 2020 webinar at 1:00 PM EST titled “The New Concerns of a Digital Workplace.” Join Jonathan Ogurchak, Founder & CEO of STACK and Ron Lanton III, Esq, Principle of Lanton Law to discuss the following:

Challenges facing healthcare organizations with a rapid deployment to “work from home” environments

Considerations to ensure ongoing compliance and ensure appropriate use

Future areas for advancement related to the “new normal” organizations are likely to face

Click here to register