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Lanton Law Speaks with Drug Topics on Its Over the Counter Podcast on MFN

Lanton Law speaks with Drug Topics on their podcast episode of Over the Counter. Ron discusses developing policy expected to enact significant change in the pharmacy industry and beyond titled “Most Favored Nation: Global Benchmarking to Reimagine US Drug Distribution.”

Ron Lanton of Lanton Law speaks with Drug Topics on their podcast episode of Over the Counter. Ron discusses developing policy expected to enact significant change in the pharmacy industry and beyond titled “Most Favored Nation: Global Benchmarking to Reimagine US Drug Distribution.” Click here to access the podcast.

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

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

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

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Effects of the Federal Trade Commission's Repeal of Non-Compete Agreements on the Pharma Industry

In an interview with Associate Editor Donald Tracy, MA, Ron Lanton III, Esq., Partner, Lanton Law offers his thoughts on the recent Federal Trade Commission (FTC) repeal of non-compete agreements, and how it could effect the #pharma industry.

In an interview with Associate Editor Donald Tracy, MA, Ron Lanton III, Esq., Partner, Lanton Law offers his thoughts on the recent Federal Trade Commission (FTC) repeal of non-compete agreements, and how it could effect the #pharma industry.

The interview can be viewedhere.

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California Passes First-in-Nation Law to Reduce Medication Errors, Address Pharmacy Staffing Concerns

Lanton Law speaks with Pharmacy Times on California's new Stop Dangerous Pharmacies Act (AB 1286). This new law aims to address understaffed chain pharmacies and reduce medication errors. Key aspects of the law included giving pharmacists more autonomy over staffing decisions, requiring reporting of unsafe conditions, and establishing a confidential medication error reporting system.

Lanton Law speaks with Pharmacy Times on California's new Stop Dangerous Pharmacies Act (AB 1286). This new law aims to address understaffed chain pharmacies and reduce medication errors. Key aspects of the law included giving pharmacists more autonomy over staffing decisions, requiring reporting of unsafe conditions, and establishing a confidential medication error reporting system. Listen here for the interview.

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Pharmaceutical Commerce Speaks with Lanton Law about New Drug Pricing Models

Pharmaceutical Commerce interviews Ron Lanton; Partner at Lanton Law on newly emerging pricing models such as the cost plus drug model.

Pharmaceutical Commerce interviews Ron Lanton; Partner at Lanton Law on newly emerging pricing models such as the cost plus drug model. Ron gives his insight on what impacts these emerging models will have on the pharmaceutical industry. The interview can be seen here.

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Lanton Law Speaks With Pharmacy Times About Provider Status

Below is the description from Pharmacy Times about our discussion with them on pharmacy provider status. You can listen to the interview here.

Below is the description from Pharmacy Times about our discussion with them on pharmacy provider status. You can listen to the interview here.

In this episode of Pharmacy Focus: Policy Edition, we delve into the intricacies of provider status for pharmacists, including challenges that have hindered pharmacists from attaining this recognition, the recent legislative strides, and the far-reaching implications for the field. Our guest, Ron Lanton III, Esq from Lanton Law, lends his expertise to shed light on the financial impacts and effective advocacy strategies.

Key Topics

  • Unpacking the concept of provider status for pharmacists and its significance

  • Recent legislative advancements that have propelled the provider status movement forward

  • Implications of achieving provider status: expanded clinical roles, reimbursement opportunities, and patient care improvements

  • Financial considerations for pharmacists and the broader healthcare landscape

  • Strategies for effective advocacy to accelerate provider status adoption

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New York Proposes New PBM Regulations

The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.

The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.

This rulemaking is one to monitor especially with the recent events from the 10th Circuit. We have written a recent blog post on this developments surrounding this decision. 

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.

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Pharmacy Congressional Bills to Watch

Two pro-pharmacy bills continue to make their way through Congress.

Two pro-pharmacy bills continue to make their way through Congress.

S.1038 titled Drug Price Transparency in Medicaid Act of 2023 sponsored by Senator Welch (D-VT) requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with pharmacy benefit managers under Medicaid. The bill also extends funding for retail pharmacy surveys and requires additional information with respect to price concessions and survey participation to be made publicly available.

S2052 titled Protect Patient Access to Pharmacies Act proposes to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare Part D.

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.

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Tenth Circuit Deals Pharmacy a Set Back Regarding Oklahoma PBM Law

This week The U.S. Court of Appeals for the Tenth Circuit issued a decision agreeing with the Pharmaceutical Care Management Association (PCMA) that Oklahoma's Patient's Right to Pharmacy Choice Act (the Act) is preempted by ERISA because it interferes with central matters of plan administration by restricting ERISA plans from structuring their pharmacy networks in a particular manner.

In 2020 the pharmacy industry witnessed much needed relief with the U.S. Supreme Court ruling on behalf of pharmacy in the unanimous Rutledge v. PCMA case. That decision held that a federal law, the Employee Retirement Income Security Act of 1974 (ERISA), does not prevent states from enacting laws regulating the abusive payment practices of PBMs. 

However; this week The U.S. Court of Appeals for the Tenth Circuit issued a decision agreeing with the Pharmaceutical Care Management Association (PCMA) that Oklahoma's Patient's Right to Pharmacy Choice Act (the Act) is preempted by ERISA because it interferes with central matters of plan administration by restricting ERISA plans from structuring their pharmacy networks in a particular manner. The court also held that ERISA preempted the Act's provision that would bar pharmacy benefit managers (PBMs) from denying, limiting, or terminating a pharmacy's contract because one of its pharmacists is on probation with the state pharmacy board.

This is definitely an inconsistent decision from Rutledge and should be overturned due to recent U.S. Supreme Court precedent. 

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.

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Lanton Law Lobbies on Beacon Hill in Boston, Massachusetts for Pharmacy Issues

Lanton Law was on Beacon Hill this week advocating for pharmacy issues.

Lanton Law was on Beacon Hill this week advocating for pharmacy issues. We are happy to be working with several pharmacy allies within the legislature on meaningful issues around health promotion screening and pharmacy benefit manager transparency.

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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.

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.

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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.

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.

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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.

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.

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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.

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.

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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 or specialty 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.

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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.”

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.

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Vermont Enacts New PBM Law

Vermont Gov. Phil Scott (R) signed H. 353, a bill that several issues including patient steering, reimbursement transparency, spread pricing, and other PBM practices.

Vermont Gov. Phil Scott (R) signed H. 353, a bill that several issues including patient steering, reimbursement transparency, spread pricing, and other PBM practices.

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

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

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The Pharmacy Benefit Manager Transparency Act of 2022 Introduced in Congress

The Pharmacy Benefit Manager Transparency Act of 2022 was introduced by Senate Commerce Science, and Transportation Committee Chair Maria Cantwell and Senate Judiciary Committee Ranking Member Chuck Grassley.

The Pharmacy Benefit Manager Transparency Act of 2022 was introduced by Senate Commerce Science, and Transportation Committee Chair Maria Cantwell and Senate Judiciary Committee Ranking Member Chuck Grassley. 

The bill which can be viewed here, seeks to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. 

According to the Senate Commerce Committee’s announcement the proposed bill seeks to specifically do the following: 

PROHIBITS UNFAIR OR DECEPTIVE PRICING PRACTICES

The legislation would make it illegal for PBMs to engage in “spread pricing” in which they charge health plans and payers more for a prescription drug than what they reimburse to the pharmacy, and then pocket the difference – the “spread” – as profit.

The bill would also prohibit PBMs from arbitrarily, unfairly, or deceptively clawing back payments made to pharmacies, or arbitrarily, unfairly, or deceptively increasing fees or lowering reimbursements to offset reimbursement changes in federally-funded health plans.

INCENTIVIZES FAIR AND TRANSPARENT PBM PRACTICES

The bill would encourage fair and transparent PBM practices that benefit local pharmacies and consumers by making clear that a PBM would not be in violation of the Act if it:

Passes along 100 percent of any rebate to the health plan or payer; and

Provide full and complete disclosure of:

  • The cost, price, and reimbursement of prescription drugs to the health plans and pharmacies;

  • All fees,markups, and discounts the PBM charges or imposes on health plans and pharmacies; or

  • The aggregate remuneration fees it receives from drugmakers to health plans, payers, and any federal agency.

MANDATES TRANSPARENCY

The bill would require PBMs to file an annual report with the FTC, shining a brighter light on how they charge health plans and pharmacies for prescription drugs. Specifically, it would require PBMs to disclose:

  • The aggregate amount of the difference between how much each health plan paid the PBM for prescription drugs, and how much the PBM paid each pharmacy on behalf of health plans for such drugs;

  • The aggregate total amount of fees the PBM charged to pharmacies and the total amount of reimbursements the PBM clawed back from pharmacies;

  • Why the cost, copay, coinsurance, or deductible for a consumer increased, or why the reimbursement rate to a pharmacy decreased for a prescription drug; and

  • For PBMs that control or are affiliated with a pharmacy, a description of any differences between what they reimburse or charge affiliated and nonaffiliated pharmacies.

ENFORCEMENT

The bill would authorize the FTC and state attorneys general to enforce its mandates, including by seeking civil penalties from PBM companies for each violation, plus an additional penalty of up to $1 million.

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

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

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Lanton Law Interviews Famlee Founder & CEO Shelley Bailey

Ron Lanton of Lanton Law interviews Shelley Bailey of Famlee. They discuss fertility, entrepreneurship and the benefits of technology for the advancement of women's health.

Ron Lanton of Lanton Law interviews Shelley Bailey of Famlee. They discuss fertility, entrepreneurship and the benefits of technology for the advancement of women's health. The interview can be heard here.

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

Check out our micro webinar on the upcoming FTC comment and period on pharmacy benefit managers.

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

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