Lanton Law Speaks at Summit & Reverse Expo

We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.

Congressional Bill Advocating for Biosimilars and Generics Introduced

U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) have introduced the Affordable Prescriptions for Patients Act. The bill seen here seeks to lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market. The bill addresses two important issues such as product hopping and the patent dance.  

Product hopping: As far as product hopping, “the bill puts an end to this practice. It prohibits branded drug manufacturers from engaging in anticompetitive product hopping and facilitates entry to the market for generics and biosimilars, driving down drug costs.”

Patent dance: “This bill places a reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket.” This will help deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place.”

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.

DEA Announces Proposed Rules for Telemedicine

The Drug Enforcement Administration has announced “proposed permanent rules for the prescribing of controlled medications via telemedicine, expanding patient access to critical therapies beyond the scheduled end of the COVID-19 public health emergency. The public will be able to comment for 30 days on the proposed rules.”

Additionally, the “proposed rules would provide safeguards for a narrow subset of telemedicine consultations—those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a controlled medication. For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe:

• a 30-day supply of Schedule III-V non-narcotic controlled medications; 

• a 30-day supply of buprenorphine for the treatment of opioid use disorder

without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. The proposed rules are explained in further detail for patients and medical practitioners on DEA.gov.”

The proposed rule can be found here. 

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our firm helps various stakeholders with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help entities nationwide grow business opportunities 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.

What is Remote Patient Monitoring (RPM)?

What is Remote Patient Monitoring (RPM)?

Remote patient monitoring is an innovative way that healthcare providers are using to treat chronic and acute conditions. With COVID-19 spurring faster adoption of telehealth and RPM, the subject of RPM involves the connection of digital tools that record healthcare data that is reviewed by an off-site provider. According to HHS, new treatment methods like RPM can help with the following conditions:

• High blood pressure

• Diabetes

• Weight loss or gain

• Heart conditions

• Chronic obstructive pulmonary disease

• Sleep apnea

• Asthma

Many of the devices that patients will use may be familiar to them, including:

• Weight scales

• Pulse oximeters

• Blood glucose meters

• Blood pressure monitors Telehealth.hhs.gov

At Lanton Law we have been monitoring the both exciting and emerging field of RPM. We fully anticipate the conversation to continue to evolve into further regulatory definitions as well as appropriate reimbursement schemes. 

Lanton Law is a national healthcare and technology 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 RPM, RTM and digital therapeutics so that we can help our valued clients. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

FDA REMS Change for Abortion Pill Creates Opportunities, Questions for Pharmacists

Although the FDA has now allowed retail pharmacies to dispense mifepristone, a drug used for medicated abortions, questions still remain about the requirements for pharmacies and the availability of the drug. Lanton Law talks to Pharmacy Times in an interview about a post Dobbs world with mifepristone. Click here for the interview.

Prescription Digital Therapeutics Bill Introduced in Congress

The Medicaid and CHIP Access to Prescription Digital Therapeutics Act also known as S. 5238 seen here was introduced on December 12, 2022 by Senator Capito (R-WV). The bill seeks to “require the Administrator of the Centers for Medicare & Medicaid Services to provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children's Health Insurance Program.” While this bill is a step forward for digital therapeutics, questions remain about this bill such as whether this bill will get introduced in the new Congress, will this bill create more access, reduce costs and is the correct reimbursement model?

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. 

Lanton Law is a national healthcare and technology 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.

Lanton Law Talks Provider Status With Don Downing; Clinical Professor at the UW School of Pharmacy

We have a new podcast with Professor Downing of the University of Washington School of Pharmacy. We discuss pharmacy provider status and the opportunities within pharmacy. Listen here.

U.S. House passes legislation to extend telehealth waivers through 2024

The U.S. House of Representatives has passed passed the Advancing Telehealth Beyond COVID-19 Act of 2022 (H.R. 4040). The bill proposes to extend telehealth flexibilities under Medicare that were initially authorized during the public health emergency of COVID-19. The bill heads to the U.S. Senate. 

Specifics of the proposal are as follows:

• Provides that certain flexibilities continue to apply until December 31, 2024, if the emergency period ends before that date. 

• Beneficiaries to continue to receive telehealth services at any site, regardless of type or location (e.g., the beneficiary's home); 

• Occupational therapists, physical therapists, speech-language pathologists, and audiologists to continue to furnish telehealth services;

• Federally qualified health centers and rural health clinics to continue to serve as the distant site (i.e., the location of the health care practitioner);

• Evaluation and management and behavioral health services to continue to be provided via audio-only technology; and

• Hospice physicians and nurse practitioners to continue to complete certain requirements relating to patient recertifications via telehealth.

The bill also delays implementation of certain in-person evaluation requirements for mental health telehealth services until January 1, 2025, or the first day after the end of the emergency period, whichever is later.

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.

American Data Privacy and Protection Act Introduced

In late June 2022 H.R. 8152 was introduced which seeks to provide consumers with foundational data privacy rights, create strong oversight mechanisms, and establish meaningful enforcement. 

What are some of the important aspects of the bill?

According to the Congressional Research Service the bill proposes the following:

Covered Entities. It would apply to most entities, including nonprofits and common carriers. Some entities, such as those defined as large data holders that meet certain thresholds or service providers that use data on behalf of other covered entities, would face different or additional requirements.

Covered Data. It would apply to information that “identifies or is linked or reasonably linkable” to an individual.

Duties of Loyalty. It would impose several duties on covered entities, including requirements to abide by data minimization principles and special protections for certain types of data, such as geolocation information, biometric information, and nonconsensual intimate images.

Transparency. It would require covered entities to disclose, among other things, the type of data they collect, what they use it for, how long they retain it, and whether they make the data accessible to the People’s Republic of China, Russia, Iran, or North Korea.

Consumer Control and Consent. It would give consumers various rights over covered data, including the right to access, correct, and delete their data held by a particular covered entity. It would require covered entities to get a consumer’s affirmative, express consent before using their “sensitive covered data” (defined by a list of sixteen different categories of data). It would further require covered entities to give consumers an opportunity to object before the entity transfers their data to a third party or targets advertising toward them.

Youth Protections. It would create additional data protections for individuals under the age of 17, including a prohibition on targeted advertising, and it would establish a Youth Privacy and Marketing Division at the Federal Trade Commission (FTC).

Third-Party Collecting Entities. It would create specific obligations for third-party collecting entities, which are entities whose main source of revenue comes from processing or transferring data that it does not directly collect from consumers (e.g., data brokers). These entities would have to comply with FTC auditing regulations and, if they collect data above the threshold amount of individuals or devices, would have to register with the FTC.

Civil Rights and Algorithms. It would prohibit most covered entities from using covered data in a way that discriminates on the basis of protected characteristics (such as race, gender, or sexual orientation). It would also require large data holders to conduct algorithm impact assessments. These assessments would need to describe the entity’s steps to mitigate potential harms resulting from its algorithms, among other requirements. Large data holders would be required to submit these assessments to the FTC and make them available to Congress on request.

Data Security: It would require covered entities to adopt data security practices and procedures that are reasonable in light of their size and activities. It would authorize the FTC to issue regulations elaborating on these data security requirements.

Small- and Medium-size Businesses: It would also relieve small- and medium-size businesses from complying with several requirements; for instance, these businesses may respond to a consumer’s request to correct their data by deleting the data, rather than correcting it.

Enforcement. It would be enforceable by the FTC, under that agency’s existing enforcement authorities, and by state attorneys general in civil actions.

Private right of action. It would create a delayed private right of action starting four years after the law’s enactment. Injured individuals would be able to sue covered entities in federal court for damages, injunctions, litigation costs, and attorneys’ fees. Individuals would have to notify the FTC or their state attorney general before bringing suit. Before bringing a suit for injunctive relief or a suit against a small- or medium-size business, individuals would be required to give the violator an opportunity to address the violation.

Preemption. It would generally preempt any state laws that are “covered by the provisions” of the ADPPA or its regulations, although it would expressly preserve sixteen different categories of state laws, including consumer protection laws of general applicability and data breach notification laws. It would also preserve several specific state laws, such as Illinois’ Biometric Information Privacy Act and Genetic Information Privacy Act and California’s private right of action for victims of data breaches.

Section by section specifics can be found here. 

We are going to see more privacy proposals on the state and federal level. 

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.

Lanton Law Talks with Savages Drug About The Business of Pharmacy

We speak with Deb Rockwell; Business Manager at Savages’ Drug in Fairfield, Maine about the importance of understanding pharmacy accounts receivable. Listen the the interview here.

U.S. House Sends Chips and Science Act & Sends to the President For Signature

The U.S. House has passed the bipartisan Chips and Science Act of 2022. The bill can be viewed here. The bill aims to strengthen U.S. competitiveness with China by providing more than $52 billion for U.S. companies producing computer chips, as well as billions more in tax credits to encourage investment in chip manufacturing. It also provides tens of billions of dollars to fund scientific research, and to spur the innovation and development of other U.S. technologies.

This legislation will provide several opportunities for both technology companies and technology stakeholders to expand and thrive. 

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

Amazon to Acquire Primary Health Care Provider

Amazon has decided to take another step forward in healthcare by acquiring One Medical.

According to the press release “One Medical is a human-centered, technology-powered national primary care organization on a mission to make quality care more affordable, accessible, and enjoyable through a seamless combination of in-person, digital, and virtual care services that are convenient to where people work, shop, and live.”

Amazon will acquire One Medical for $18 per share in an all-cash transaction valued at approximately $3.9 billion, including One Medical’s net debt.

We have been monitoring Amazon’s healthcare moves for a while. In 2017 we forecasted our thoughts in a blog post with Victor Morrison on whether the company would wade into healthcare. We posted when Amazon Launched its U.S. Pharmacy Business and followed their moves into biometrics. This is definitely not the last move the company will make in healthcare. The only issue is whether there will be antitrust scrutiny.

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.

Expert Discusses Long-Term Implications of Roe V. Wade Decision for Pharmacists, Contraception Access

In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.

The interview can be viewed here. We have also provided the text from Aislinn Antrim’s interview at Pharmacy Times below:

In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times,and I'm here with Ron Lanton, partner at Lanton Law, to discuss the recent Supreme Court decision in Dobbs v. Jackson Women's Health and what this means for pharmacists, contraception access, and all of these other questions. So to get started, can you explain the Supreme Court reasoning in this case?

Ron Lanton III, Esq: Absolutely. And before I get started, let me just put a disclaimer out there that while I'm not going to be discussing my personal views about the Supreme Court decision, I'm just going to talk like a lot of health care providers are probably talking right now, where they're just trying to figure out what happened, and what does this mean for them. So, with that out of the way, I'll quickly explained Dobb.

So basically, what happened in this case is that Roe v. Wade and Casey v. Planned Parenthood were both actually overturned by the Supreme Court on the basis that abortion at any time was not protected by the constitution. So basically, what they've done is that they didn't really put any standards around what they thought abortion was, or you know, how many weeks there should be at, because they felt that the state should actually control the outcome. So, the facts within Dobbs is that the state of Mississippi banned abortions at 15 weeks, which is pre-viability (viability referring to if the fetus can survive outside of the womb). And what Justice Alito said, writing for the majority opinion, is a quote that I wanted to make sure that everybody has heard in case they have not read the opinion. And the quote talks about this, it says, “The inescapable conclusion is that a right to abortion is not deeply rooted in the nation's history and traditions. On the contrary, an unbroken tradition of prohibiting abortion, on pain of criminal punishment, persisted from the earliest days of the common law until 1973.” So, this is definitely a landmark decision. You know, my entire life has been post-Roe. So, this is going to be very, very different for a lot of people and we'll see what happens.

Aislinn Antrim: Definitely. Where do states stand currently in terms of abortion access? And where do you see this headed in the coming weeks and months?

Ron Lanton III, Esq: I see a lot of litigation coming in the next weeks and months. Right now, it's kind of weird how we say this, because right now, there are 5 states where abortion is either illegal or banned. Those states are Texas, South Dakota, Oklahoma, Louisiana, and Kentucky. Soon there will be 16. And the reason I say that is because of what's called trigger laws. So basically, if Roe was ever overturned, which it was in this case, there were some states that have laws in the books that said, should this happen, then, you know, within 30 days abortions will be banned in that state.There is also another thing called zombie lawsthat are out there, in addition to the trigger laws, and what zombie laws are, is that these are pre-Roe abortion laws that may come back, they were never officially taken off of the books. So, they're just kind of there and a lot of states really don't know what to do with these and businesses that are operating there don't know what to do with these, or if they'll ever come back. So that number, while it may go up to 16 with the trigger laws, it may be more with these zombie laws. So, we really have to do a close scrutiny of what's on the books. And I think that if health care providers are wondering what that might be, I would just suggest that they look and see if their states do in fact have these laws on the books. There have been some states, though, that have taken the stance that they will be arresting medical providers that actually attempt to do these services. So, my prediction is just like I mentioned earlier, is that we're probably going to see a lot of different lawsuits, just for people that are trying to understand their rights and what they can and can't do, especially the health care providers.

Aislinn Antrim: Absolutely. There are many things that are still really unclear. One of the major things that's come into play is access to mail-order abortion pills, and from my understanding, the FDA has permanently allowed these pills to be accessible by mail. But some governors are still looking to ban them. Can you explain this, what this means, and where it stands?

Ron Lanton III, Esq: Yeah, of course. Well, the FDA has been using the pill since 2000, and in December of 2021 what they did was they had some labeling and some evidence-based medicine requirements that they put in and finalized in December of 2021. I can't really speak to specifics about what those are. I know they did them, but if people are interested, I would just go to the FDA and just look. They have that stuff there on their site. The FDA does allow the pill to be prescribed by mail or by telehealth and it's authorized for use during the first 10 weeks of pregnancy. And what was interesting was that when I was looking at this is that more than half of the abortions in the United States are actually medication abortions, which I did not know.

You have mentioned some of the anti-abortion policies that tend to happen with this. So, there have been some anti-abortion states that have laws on the books that stipulate that this pill either has to be given in-person or it has to be prescribed, instead of done through telehealth or by mail. And also, they're saying it's only allowed through the seventh week, whereby the FDA says that it's the tenth week. So that's different. So, what we're seeing here, and what we're also hearing, is that some states may even try to ban the pill. And there's questions legally on whether they can do this. It's really a Tenth Amendment versus Supremacy Clause question. You know, I don't think the FDA, this is just me personally, I think you should check this out. But you know, just for me, I'm not sure you could do that as a state, just legally, with something that the FDA has already approved. It's also going to come down to what the Board of Medicine in your particular state is allowing a physician to do. So, these are just other things that a health care provider would have to check out.

I do think it is interesting to bring up what the Department of Justice has said about this very issue. So, here's a quote I’d like to share with you. So, in what the Department of Justice has said, has stated, “…and we stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care. In particular, the FDA has approved the use of medication (Mifeprex). States may not ban this based on disagreement with the FDA’s expert judgment about safety and efficacy.” So, if a state has a policy where it's just challenging the safety of it, that's not going to stand. So, what really remains to be seen is if states are going to continue to do this regardless, we'll have to see.

Aislinn Antrim: Very interesting. And there are also states where legislators are attempting to interpret IUDs as abortion to restrict their access. What is the legal basis for this? And what are the implications if they are successful?

Ron Lanton III, Esq: Yeah, so let's go back to the Supreme Court majority opinion. In this case, they said that other rights, like the rights to contraception and marriage, do not discuss the ending of human life as abortion does. So, they tried to make a distinction in this ruling. Now, with what you just brought up, I started thinking about Plan B and copper IUDs because those stop an already fertilized egg or an embryo from implanting and thus creating the pregnancy. Right? So, the argument Dobbs was they sided with Mississippi in that Mississippi could deny an abortion at pre-viability, which they already ruled that they can. So, therefore, a state could potentially rule with regards to Plan B or the copper IUD, that these are not contraception and that they are a form of abortion. I mean, theoretically it could happen, as they stop an embryo from implanting, thus stopping human life. So especially if the state believes that human life starts at fertilization, and not implantation. So, many health care providers are definitely likely to be concerned about this because it could also affect IVF treatments. Basically, this ruling has allowed states to ban abortion but kind of has left the door open because they were ambiguous on, you know, they didn't say anything about weeks or what abortion was, there was no definition about it. So, this could potentially bleed over into contraception. So honestly, a legal basis for this could be a new law that describes when human life starts, such as fertilization instead of implantation. So, Dobbs opened the door to that and, you know, that's another one of those things we just don't know.

Aislinn Antrim: Definitely. Many people are urging the Biden administration and Congress to codify a right to abortion. Do you have a sense of whether this could happen or where this stands?

Ron Lanton III, Esq: Well, let's just talk about the Senate makeup right now. So, to get anything passed in Congress has been very difficult to do lately because of just the hyper-partisanship stuff that's been going on. And the Senate, it's almost like forget about it. You know, if you don't have those 60 votes to satisfy the threshold, then you're just not getting anything done. So right now, with an issue this divisive—and really, I mean, anything can be hyper-partisan but, you know, this is definitely one of those issues. I don't know if they can get anything passed in the Senate that could codify Roe.

Now, I like to go back to whether it's accurate when we say codify Roe, because Roe v. Wade hasn't been in place since 1992. And the reason I say that is because the Supreme Court had the Casey v. Planned Parenthood case that I referenced earlier, which was also overturned with Roe in the Dobbs decision. Now, in Casey, the court upheld Roe’s decision holding that a woman has the right to choose to terminate a pregnancy up until the point of fetal viability, and that states could restrict abortion after that point, subject to exceptions such as, you know, protecting the life and health of the pregnant woman. But in Casey the court said that Roe too severely limited state regulation prior to fetal viability and held that states can impose restrictions on abortion throughout pregnancy to protect potential life, as well as the maternal health, which, you know, which has been status quo up until just recently. What was also interesting about Casey is that had had the undue burden test, which basically said that states can't make a law that makes it too hard for someone that wants to seek an abortion. So again, that's been status quo until now. And now we're really not sure what's going to happen.

Aislinn Antrim: Definitely. Going back to what you were saying a few minutes ago, there are also discussions of whether a future Supreme Court case could impact contraception access. What could this look like from a policy or legal standpoint?

Ron Lanton III, Esq: I think [policy and legality] these are 2 related issues, but when we're looking at legalities, I mean, you know, we can split hairs all day but those legally are 2 different issues. So, for contraception that prevents fertilization, you know, such as the pill, that would require a state to draft an entirely new law that outlawed contraception. And that would have to be pushed through several states, and then in order to get to the Supreme Court, someone would have to challenge that and make it all the way up through the ladder. So, these cases are coming faster than they used to before, but that's the process that would have to happen. The rights of contraception is a bit different than what we were talking about in Dobbs because the contraception was actually a different case based on Griswold v. Connecticut. And that basically held that married couples have a protected right to privacy, and that this is being violated by states banning contraception. So, Griswold was not overturned or even mentioned in the majority opinion. Now, I think what has people talking is the Justice Thomas concurring opinion, which basically said that we ought to look at cases like Griswold. Well, that's different from the majority opinion. So, the majority opinion is what we base everything off of now. Concurring opinions happen, judges put their opinions in there all the time. Whether someone later may look at that concurring opinion and shape a different policy, legally or whatnot, that remains to be seen. But the majority opinion did not talk about Griswold. I just want to make sure that was very clear.

Aislinn Antrim: Definitely. Thank you. Could this Dobbs ruling potentially impact the legality of scientific research and innovation in the area of women's health and contraception?

Ron Lanton III, Esq: Yes. So, any current or future research that is connected to the use of an already fertilized egg or an embryo may be deemed unlawful by a state, depending on what their abortion laws actually are. So, as we talked about earlier, Dobbs opens the door for states to determine when human life actually begins. And they're now able to put in their own standards about how they feel about abortion. So, I think in order to answer your question, it really depends on how the state is going to regulate the practice of medicine. So, it’s going to come down to where you live and how medicine is regulated.

Aislinn Antrim: With a wide range of restrictions varying state-to-state, do you have any resources or suggestions for pharmacists who may not know exactly how to handle things in their state, what's legal what they can and can't do? Where can they look?

Ron Lanton III, Esq: That's a good question. I think if I were a pharmacist in this environment, I would definitely look at the Board of Pharmacy to see if there's any guidance about that. I think the second thing that you have to do is really understand how Plan B is going to be regulated. And I think if that's the case, you might want to call an attorney—I'd hate to even get to that kind of level, but you want to make sure that you're complying with what is going on. But I think an issue that most people miss is privacy and HIPAA. And, you know, if you have someone that's coming to a pharmacy that is in a state like the Northeast, where it's pretty much status quo with how they're going to rule or regulate this issue, you know, you can't be telling another state what's going on based on that. So, you really should understand your privacy laws and just look at that in your state. And just make sure you have a good understanding of HIPAA, which will help you in your practice going forward. So, I think those are the 3 places that I would look at first, to make sure. So, make sure that you understand your privacy, get a lawyer if you have questions about things, and just make sure that you're familiar with Board of Pharmacy and their policies and procedures.

Aislinn Antrim: Absolutely. Well, we've covered a lot. Is there anything that you wanted to add?

Ron Lanton III, Esq: I wish I could, I wish I had a crystal ball to kind of figure out how all this is going to go. Like I said, I think with this decision it's going to be a lot of litigation. So, this is not going to be over by, you know, any short imagination. This is going to go on for quite a while. And the only thing that could change things again, back to the way things were, is either an act by Congress, which would invalidate a court decision, or this comes back up through the Supreme Court again and they rule a different way. So that's a long way of me saying that we just have to wait and see what happens.

Aislinn Antrim: Absolutely. Well, thank you so much for diving into this with me.

Ron Lanton III, Esq: You’re welcome, thank you for the time.

Pharmacy Times Speaks with Lanton Law About "Vanity Drugs"

In an interview by Aislinn Antrim of Pharmacy Times called “Calling Them ‘Vanity Drugs,’ Some Insurers Refuse to Cover New Anti-Obesity Drugs,” Ron Lanton III, Esq., Partner at Lanton Law, discussed why insurers are refusing to cover new, highly effective anti-obesity drugs and how some prescribers are getting around the issue. Lanton said that this is a common issue across many different disease spaces and drug types, but some policy changes may be able to help.

The interview can be seen here.

We have taken the text that appears on Pharmacy Times.com from the interview and placed it below in case you have trouble accessing the video.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times, and I'm here with Ron Lanton, principal at Lanton Law, to discuss how and why some insurers are considering new weight loss and anti-diabetes drugs to be “vanity drugs.” So, there are several new drugs on the market, and they've shown significant weight loss in clinical trials. But some insurers are calling these “vanity drugs” and are not covering them. Do you have a sense of what this term, vanity drugs, means?

Ron Lanton III, Esq.: No, I don't. I think whenever somebody askd me, like, “What does that mean?” I’m always like, okay, let's go to the legal definition. And I don't think there really is a legal definition of vanity drugs, which is something that we say. But to me, whenever I hear something like that characterized as vanity drugs, it's just another excuse. We're not going to pay for it. Right? So, I got a couple of ideas about what I think is going on behind that terminology, but I just wanted to talk a little bit about what this drug is and kind of the history about why it got here and where we are.

So, the brand name drug is Wegovy, because it's just too complex for me to say the generic form of the name of it, but it was approved last year in June by the FDA. And apparently, this is a new generation of highly effective hormone-based obesity medications. And specifically, what it does is that it targets a hormone, GLP-1, which is secreted in the gut, and then targets receptors throughout the body. And it makes it so that there is some kind of positive response, where you do lose the weight. And for this drug, it was prescribed for patients that are obese, who have a BMI or body mass index of greater than 30, or a BMI greater than 27 accompanied by weight-related medical problems, such as high blood pressure and type 2 diabetes and cholesterol, things like that. It’s definitely something that I believe would be beneficial to the patient because if you do take it, if it works as it says, we're not going to jump to those other more expensive disease states that cost a lot of money to treat.

But, going back to like the whole vanity drug classification of it, yes, this isn't a proven curative drug, I think they were saying like up to 13% of individuals don't lose any weight that take this drug. But, you know, insurance companies have for a while used thing called step therapy, where they're like, try drug A first before you go to drug B, and a lot of time is wasted. And a lot of dollars can be wasted too, because that's that kind of one-size-fits-all approach to everything. Whereas, you know, if we're doing more curative, something that just kind of goes right to your specific biological makeup, that could have a lot better of an outcome for a patient and at a lower cost. So, I think they're coming at it from a step therapy mindset.

And, too, there is a policy that's been weakened a little bit ago by the court, but the copay accumulator, where they're stopping you from having the rebates from a manufacturer go to the deductible and the patient's maximum allowable cost. So, it's like you have those mindsets of let's try not to pay it. But I think, you know, with our medicine and science getting a lot better, we're going to have to think past that old traditional reimbursement system.

Aislinn Antrim: Yeah, absolutely. This seems to be kind of a widespread issue—you talked about Wegovy, and it's been applied to a couple of these other similar new drugs. What are pharmaceutical lobbyists really doing to kind of get insurers to pay for these?

Ron Lanton III, Esq: That's an interesting question. So, I can't speak for pharma, I don't know what they're doing. I talked to pharma interests, I did look at their website, and one of their policy issues is called “Build a better patient-centered agenda.” And I like where they're going with that, because essentially, what it's saying is we want insurance to work like insurance is supposed to work. Which is, if we have something that's wrong with us, we go see the doctor, the doctor prescribes. And the doctor says, “This is what we think is good for that patient to have a good outcome.” And the insurance is supposed to just pay for it. Now, you know, there's all kinds of things, and I know why there's rules about it and there's all kinds of special circumstances. But you know, more times than not, we're fighting the insurance company to pay for things that seem to be common sense. So, I think there is a bill, which I'll talk about in a little bit, on the obesity issue that we're talking about here. But instead of it being what I call a hard lobbying issue, which is I'm going to go directly to my congressman, or my senator and we'll go lobby about how we need this particular drug. It seems to be more of a soft lobbying issue to me, where the pharmaceutical industry would have to reach out to the payers to have that conversation about why the manufacturers think this is a good thing with the patients today. They have to talk to the patient themselves and educate the patient. So, if the patient feels comfortable enough, what you're dealing with is years of stigma and everything about this. Again, this is getting out of traditional health care and going to the root of the problem. And instead of just treating a symptom, you know, we're really trying to figure out what's going on here. So that's the other thing. And then really, the last thing that I see as kind of the soft lobbying by pharma is educating the doctors about this drug and why this is here, and why they should start to utilize this in their weapons system of fighting whatever it is that they're dealing with patients. So that's what I call more of a soft lobbying issue.

Aislinn Antrim: Interesting. Are there policy changes that could address this issue?

Ron Lanton III, Esq: The court system is weakening the copay accumulators, which I mentioned earlier, and there have been several state and state efforts. And, definitely, there's a federal bill right now on step therapy, where they're trying to get rid of that, because again, it's like, why are we doing all these things that may not work, and it's wasting time and it's causing a lot of money. And we could just get right to the heart of the problem, especially when the doctors are saying, you really shouldn't get in between my relationship with my patient, because I know the patient. And, you know, I'm the closest that's here. So, this is what I think.

There is an interesting bill that I want to bring up about policy changes that you had asked about. So, there is a bill, HR 1577, and there's also a senate version of this—SB 596 is a companion bill. So it’s basically the same bill that's in the house is also in the Senate, same language, and everything. It’s called the Treat and Reduce Obesity Act and let me tell you just really quick what this is. The bill would allow for coverage for therapy that is provided by a physician who's not a primary care physician, or other health care providers and approved counseling programs, if you have a referral from your PCP. Currently, the therapy is covered only if provided by a PCP. The bill would also allow coverage under Medicare's prescription drug benefit, so under Part D, for the treatment of obesity, or weight loss management for individuals who are overweight. So, this really targets what we're talking about right now. And if we actually have this bill go through, I think this conversation will be a lot easier, because we already have the regulatory scheme for it, instead of having to build it from scratch and just kind of convince people that this is a good thing for patients to take. Again, when we're coming at it from the traditional mindset of “Let's try not to pay for things and if we do, let's try the cheaper stuff first, before we get to something that might actually help,” I think that's just backwards.

Aislinn Antrim: Yeah, absolutely. Do you see similar issues in other drug classes or treatment areas?

Ron Lanton III, Esq: A long while ago—well, it's about 2013, so seems like a long while ago, with everything that's happened between then—[we had] Sovaldi with hepatitis C, you know, at $4,000. For the treatment, I think it was 12 course treatment, and people were like, “Oh, my God.” I know there's still an issue but, you know, if 9 out of 10 times a patient takes this, they get better, those are pretty decent odds. So why not try it for a little bit? So, that would be my kind of form of step therapy, which is let's just try, and if it's not working, then okay, we can get off of it. But this kind of seems to be what I call a best-in-breed prescription out there. So, like, if this is the best thing, let's take it and see what happens. And I think, again, with drugs that are curative and more expensive, because the upfront cost has to be there, because you're not going to have the repeat customer because they're getting cured. But at the same time, I think somebody has to do a cost analysis at the payer by saying, if we put patient on drug A and it costs this, but if we put them on drug B, it's going to cost all this other stuff and the patient's going to get sicker. It's just that's just not really what we should be doing. I do know that there's this balance of, you know, we have to have something that's affordable for patients to take. So it's $84,000. And I hate to bring up old wounds, but it's at $4,000, something that is reasonable or not. And I think that's, you know, something that the pharma and the insurance just still haven't quite worked out yet, especially since we keep seeing this thing about drug price from congress, and why is this stuff so high? But I think now there's a lot more scrutiny starting to come into the picture with the Federal Trade Commission, and how they're now saying, okay, well, high drug prices and what are these PBMs doing and let's find out a little bit more about this. So, that's something we should continue to watch. But those are the policies. You know, if we get bills like this, we have an FTC that is really scrutinizing both pharma and the PBM industry, I think we'll start to slowly but surely get to an answer that's tolerable for everybody.

Aislinn Antrim: Well, that's good to hear. Some companies have found kind of an interesting workaround by marketing these drugs as diabetes treatments, rather than weight loss drugs. And in some cases that seems to have worked. Does this seem like an effective solution? Or what are your thoughts on this?

Ron Lanton III, Esq: I think it obviously depends on what the doctor is seeing from the patient. I mean, if you're pre-diabetic, then you know, if you don't do anything, you're going to get over into type 2 diabetes, potentially. So, I can understand the rationale behind it. But I don't think it's really that different than off labeling. I mean, you know, if you have a drug and it's supposed to be used for cancer A but also works for cancer B, it’s not approved for cancer B, but, you know, there may be times as a patient where your condition doesn't have something that is FDA approved, but the doctor is looking at these studies and trying to see what can help you. Again, that's that patient-doctor relationship that you just have to trust. And that's what the patient is looking for. So, I think it's really no different than off labeling and if that really goes to the result that we're getting to, I'm all for it.

Aislinn Antrim: Absolutely. Why do list prices vary for the same drug with different indications? So, with diabetes versus for obesity?

Ron Lanton III, Esq: Yeah, that's the million-dollar question. Literally, if you live with these high-priced drugs, right? I don't know if I can give you an answer. I think the best people to ask this question to would be the pharmacy benefit managers, because the more and more they've gotten involved, the more and more prices have gone up. And that is because the manufacturer has to hire the higher price because they have to compensate for the rebate that they're giving to the pharmacy benefit manager. So why is that? And I think that, you know, like I was telling you earlier, the scrutiny with the Federal Trade Commission going in and just seeing exactly what PBMs are doing with these drug prices, and then, you know, either getting some federal standards around it, and what they can and can't do or be giving the PBM a federal regulator. They don't have one, you know, and it's just this piecemeal stuff that they're doing by state. I think those days are numbered, as far as just having a PDMP and unregulated entity. But I think the more layers that start to get peeled back, the more attention that's coming. Again, this stuff doesn't happen overnight. None of this happened overnight at all. I mean, PBMs really didn't grow until the ‘90s. So, we're talking from the ‘90s until now, there's been some changes, gradual changes, but there's been a shift. And I think we're starting to start to shift that backwards to where we can get an answer. We'll find out these things.

Aislinn Antrim: Wonderful. Is there anything else you wanted to add on this topic?

Ron Lanton III, Esq: No. I think this is definitely not the last thing that we're going to see. I just think it's, I hate to say it, I know it's a different disease state, but it's just Sovaldi in a different form. I mean, we have these drugs that are promising to do things, and if 13%—and I know that's one study, but I mean, if somebody tells me “Okay, 13% of people this may not do anything for them.” I'm at least willing to give it a shot, because it's better than what we have now. And it's definitely better than some of the step therapy protocols that patients are going to have to go through.

Aislinn Antrim: Definitely, thank you for talking to me about this.

Ron Lanton III, Esq: Definitely. Thank you for asking.

Pharmacy Transactions- The Buying and Selling of a Pharmacy

There are many things to consider when you are deciding to either purchase or sell a pharmacy. Hence the need for an experienced firm to address these matters. 

Lanton Law has helped various stakeholders ranging from private equity to retail pharmacies who are looking to either acquire or divest either a retail, specialty or chain pharmacy.   

Issues within this type of transaction typically include: 

• Drafting corporate formation and relevant governance documents

• Lease negotiation

• Regulatory filings

• Preparing shareholder and if necessary employment agreements

• Drafting relevant contracts

• Strategic planning 

• Ensuring the pharmacy has the appropriate operating policies and procedures

• Assisting with appropriate accreditations 

There is also the issue of whether to do a stock purchase or an asset purchase. Each has their respective pros and cons. Additionally, each board of pharmacy has different standards and procedures regarding change of ownership. 

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 as well as counseling clients on responding to relevant proposed rules.  

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 Podcast speaks with the Vermont Office of the Health Care Advocate

For this episode of the Lanton Law Podcast we interview Sam Peisch of the Vermont Office of the Health Care Advocate. We discuss the new Office of the Health Care Advocate within Vermont Legal Aid, healthcare challenges in the state as well as efforts to address healthcare inequity within at risk communities in Vermont.

Listen to the podcast here

FTC Takes Aggressive Policy Stance Against Drug Manufacturers and Pharmacy Benefit Managers (PBMs)

The Federal Trade Commission (FTC) has come out aggressively against both pharmaceutical manufacturers and pharmacy benefit managers (PBMs). The agency has released its policy statement seen here, announcing that the agency “will ramp up enforcement against any illegal bribes and rebate schemes that block patients’ access to competing lower-cost drugs.”  

Here is what the FTC is specifically targeting in its policy statement: 

• Exclusionary rebates that foreclose competition from lower-cost medicines may constitute unreasonable agreements in restraint of trade under Section 1 of the Sherman Act; unlawful monopolization under Section 2 of the Sherman Act; or exclusive dealing under Section 3 of the Clayton Act.

• Inducing prescription drug middlemen to place higher-priced drugs on formularies instead of lower-cost alternatives in a manner that shifts costs to payers and patients may violate the prohibition against unfair methods of competition or unfair acts or practices under Section 5 of the FTC Act. 

• Paying or accepting rebates or fees in exchange for excluding lower cost drugs may constitute commercial bribery under Section 2(c) of the Robinson-Patman Act, which prohibits compensating an intermediary to act against the interests of the party it represents in the transaction.

This follows the recently revealed PBM study by the FTC will officially examine the impact of vertically integrated PBMs on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. 

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.

U.S. Supreme Court Rejects Medicare’s $1.6 Billion Reimbursement Reduction for Hospitals

The U.S. Supreme Court today has overturned the D.C. Circuit ruling that upheld the U.S.Department of Health and Human Services (HHS’) $1.6 billion annual reduction within the 340B program. In an opinion drafted by Justice Kavanaugh, the Court believed that HHS failed to gather a survey of hospital acquisition costs before deciding on the payment reductions at issue. 

Absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful. The text and structure of the statute make this a straightforward case. Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals. HHS maintains that even when it does not conduct a sur- vey, the agency still may “adjus[t]” the average price “as necessary.” §1395l(t)(14)(A)(iii)(II). But HHS’ power to increase or decrease the price is distinct from its power to set different rates for different groups of hospitals. Moreover, HHS’s interpretation would make little sense given the statute’s overall structure. Under HHS’s interpretation, the agency would never need to conduct a survey of acquisition costs if it could proceed under option 2 and then do everything under option 2 that it could do under option 1. That not only would render irrelevant the survey prerequisite for varying reimbursement rates by hospital group, but also would render largely irrelevant the provision of the statute that precisely details the requirements for surveys of hospitals’ acquisition costs. See §1395l(t)(14)(D). Finally, HHS’s argument that Congress could not have intended for the agency to “overpay” 340B hospitals for prescription drugs ignores the fact that Congress, when enacting the statute, was well aware that 340B hospitals paid less for covered prescription drugs. It may be that the reimbursement pay- ments were intended to offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities. Regardless, this Court is not the forum to resolve that policy debate.

The Court did not entertain the possibility of overturning Chevron v. Natural Resources Defense Council, which requires judicial deference to reasonable agency readings of ambiguous statutes, as the Court did not address this legal theory. 

The Court decision can be found here.

This is a big development for 340B stakeholders. 

Lanton Law is a national boutique healthcare and technology 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.    

Biden Administration Proposes New National Electric Vehicle Charging Network Standards

On June 9th, the  Biden Administration announced new steps to meet the Administration’s goal to build out the first-ever national network of 500,000 electric vehicle chargers along America’s highways and in communities. This initiative is a part of the enacted Bipartisan Infrastructure Law.

In a proposed rulemaking, the Department of Transportation is “proposing to establish regulations setting minimum standards and requirements for projects funded under the National Electric Vehicle Infrastructure (NEVI) Formula Program and projects for the construction of publicly accessible electric vehicle (EV) chargers funded under title 23, United States Code. The standards and requirements proposed would apply to the installation, operation, or maintenance of EV charging infrastructure; the interoperability of EV charging infrastructure; traffic control device or on-premises signage acquired, installed, or operated in concert with EV charging infrastructure; data, including the format and schedule for the submission of such data; network connectivity of EV charging infrastructure; and information on publicly available EV charging infrastructure locations, pricing, real-time availability, and accessibility through mapping applications.” 

Stakeholders in this emerging space should continue to monitor new regulations and plan strategies accordingly. If you need help, let us know. 

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.

California Privacy Regulator Releases Draft Regulations

The California Privacy Protection Agency, the regulator established by the California Privacy Rights Act in November 2020 has posted draft regulations for its upcoming June 8 Board meeting. The draft CPRA regulations can be viewed here. 

The draft regulations do need work to clarify several issues. The draft does address privacy notice requirements, as well as how companies must notify its contractors and vendors to delete personal information as well as how to respond to opt out preference signals. The rules are forecasted to take effect on January 1, 2023. 

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.