DarshanTalks Podcast

 

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February 25, 2020

Darshan: So we have previously talked about promotional review committees. We've talked about what happened in 2019 that will change the landscape for promotional review committees in 2020. Well, let's actually look at 2020 and what those findings of what happened in 2019 actually means for companies, and how that changes how we engage.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: What's interesting to me is, again, we talked about [LESE 00:00:36] summaries and this is actually outside what a lot of companies are looking at because they see that as something that's happening in clinical, it's not happening in promotional, so that's okay for them. However, I have actually had people with clinical push back at me and companies say, "You know what? We need to run this by our PRC." And how do you handle LESE summaries in the context of clinical trials?

Darshan: If you are a company that's engaged in global clinical studies, you may be subject to the EMA's clinical trial transparency requirements. You need to actually have been looking at the plain language summary requirement and how does that actually apply. I expect that if you are in one of those states or if you are in one of those countries and/or you are engaged in those studies, your promotional review committee needs to start coming up with a plan on what they will accept and what they will allow to be patient-centric and patient-facing. Unfortunately from the FDA I would be surprised if you see much guidance. They are saying that they want to be more patient-centric. However, this has not been a priority for them previously. But who knows, that might change. But at least at this moment I'm not expecting much to happen.

Darshan: As it relates to patient groups getting targeted, we've talked about Jazz Pharmaceuticals and we've talked about Lundbeck and talked about a couple of others all being targeted for illegally paying [inaudible 00:02:02] basically copays for their own products using patient groups. I would expect these patient groups will continue to be targeted under [EKL 00:02:10]. As we've talked about previously, there's been a decrease in enforcement under off-label marketing. However, that doesn't necessarily mean that DOJ and FDA have really just given up on the space. They have refocused there. First they are looking at some of these other issues, and I expect that patient groups need to be appropriately targeted. You need to have appropriate policies and procedures in place. If you are engaged in social media, I expect... Okay, you will be updating your policies but nothing crazy is going to change around social media. There was the Amerind decision that came up.

Darshan: Payments of doctors. I expect that to again continue to be an area of focus. There have been, as you know, in 2019, several lawsuits and settlements associated with for example, Insys, where there were settlements associated with payments to doctors. I expect that the DOJ and the FDA will continue to review and prosecute the types of engagements that are being had there.

Darshan: And then we previously talked about Outcome Health and we talked about how there was a $1 billion fraud scheme there. I expect that fraud will continue to be targeted, as we discussed before. But what I think is going to be interesting is that in 2020,

 

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February 20, 2020

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have a really, really exciting conversation for you. Today what we're going to talk about, is the idea of PRC review or Promotional Regulatory Committee review, which sometimes is also called the MLR or the LMR, which is the Legal Medical Regulatory review. The Kulkarni Law firm provides services reviewing these types of promotional pieces. So what are some issues that have popped up in 2019 that are different, or worth mentioning as you go into 2020?

Narrator: This is the DarshanTalks Podcast, Regulatory Guy, Irregular Podcast, with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks, or the show's website at darshantalks.com

Darshan: The number one issue, lay summaries. If you are engaged in any type of clinical research, the EMA has put out certain requirements saying that you need to put up plain language summaries, so that patients can understand this information. However, that's more for the EMA. The moment you do that in the US, that would be considered potentially promotional. Is that information being... And a lot of companies are saying, "You know what? What do we want to do is we want to have a global standard that reviews these pieces." So plain language summaries. Are they being reviewed in your company? What rules are they being reviewed as? Scientific discussion may not be subject to PRC review. On the other hand, medical stuff, doesn't necessarily always go through PRC review. However, if it's patient-facing, maybe it does. What are your rules around this information?

Darshan: Number two, patient groups. Everyone's been talking about using patient groups and patient advocacy, and that's great. However, there have been several instances where patient groups are getting prosecuted. It's often because these patient groups, end up being four methods in which copays for these companies, copays towards these products, are being paid for. Copays are used as a system by the government to ensure that moneys are appropriately being used towards the cost of drugs. However, these patient advocacy groups often come out and pay the copay, and the result of that is, allegedly, that drugs are being inappropriately prescribed. At least three different companies have agreed to pay a total of $122.6 million to resolve claims that they violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program copays for their own products. And, Jazz and Lundbeck each entered five-year corporate integrity agreements with the OIG as part of the respect of settlements. So, stay tuned. Just because it's a patient group doesn't mean you're home free. You need to make sure it's being reviewed appropriately.

Darshan: Then the next question we'll look at is social media. And when we talk about social media, we're really talking about the Amarin vs... The Amarin case. And essentially what had was, Amarin accused DSM Pharmavite and Nordic Naturals of importing dietary supplements, and making claims. And essentially, their argument was that these are new drugs that have not received approval from the FDA. They went to the ITC and they said that you need to launch an investigation, because the FDCA, the Food, Drug, and Cosmetics Act, bars private enforcement, the ITC tossed the claim in 2017. The Federal Circuit held that the ITC can refuse to probe allegations. So, Amarin's claims are based on alleged violation of the Fo...

 

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February 18, 2020

Darshan: We're going to be discussing a few different issues. We're going to start focusing and talking about just a recap of how 2019 went. And we're going to start by talking a little bit about should we think about the typical general counsel. Think about the typical lawyer. What are the big legal issues that happened in 2019?

Narrator: This is the Darshan Talks Podcast, Regulatory Guy, Irregular Podcast, with host Darshan Kulkarni. You can find the show on twitter @darshantalks or the show's website at darshantalks.com.

Darshan: So, let's start with the basics. One of the big things that happened if you are a US attorney, is how you engage with contractors. And this was unusual and unexpected because if you're a startup, if you're a mid-sized company, or even if you're a large company, you probably use a lot of consultants. Now, there was a April 2018 California Supreme Court decision, that has implications that kick in mostly starting 2019. And essentially, it changed the rules. What it came out and said is that there's a new test for employers. So if you're an independent contractor, the independent contractor must be free to perform their work as they wish. And they must be in a different line of work from the company contracting them, and must operate their own business.

Darshan: So, what they really were initially going after were the Airbnb's of the world, and the Ubers of the world. But, it obviously has major implications on companies that aren't those types of companies. So, if you are a car driving company, the idea that all your drivers are consultants or contractors may not work as well. However, if you are a biotech, or if you are a medical device company, or you are some kind of health company, recognize that if you're in a startup phase, you're often using people as consultants and contractors, and that may not necessarily fly.

Darshan: The impact of this is an additional 20 to 30% in labor costs, when you include Social Security and Medicare taxes, and unemployment and disability insurance. All of this suddenly adds up. Again, remember you're now suddenly exposed to all kinds of liability, including discrimination, sexual harassment. If you are using consultants out of California, if you are a business based in California, consider these issues.

Darshan: The other thing that came into play is GDPR. As we know, that really started occurring more in 2018; however, the impact of that is really coming out in 2019. The overall awareness levels are high; however, how this actually impacts the life sciences sector is a little bit up in the air. It seems to vary from company-to-company. There are companies aware of it, there are companies who are not, and I'm not necessarily talking about small companies. I've heard through the grapevine that CROs are telling sponsors to stay outside the European Union because of the implications of that, and because of the methods that have to be taken to protect personal data that belongs to individuals.

Darshan: Essentially, if you are a company that's processing personal data in relation to the offering of goods or services to individuals in the EU. Or, if you monitor the behavior of individuals in the EU, you probably need to comply with GDPR. Obviously, if you're doing clinical trials in the EU, that very much falls under the ambit of what GDPR includes. As we said that there are a lot of the European companies are aware of this.

 

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February 13, 2020

Darshan: We have previously talked about pharmacy and we've talked about what happened in 2019 and what was the many, many issues that pharmacists should be aware of in 2019. Well, let's talk about what this actually means for 2020.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: We talked about the cannabis issue and we talked about CBD versus THC. I would expect that more states will actually land up passing more cannabis supportive laws. There are already, the majority of states have some version of cannabis supportive laws. However, I expect that there will be more. On the other hand, I do not expect that we will see a law at the federal level which legalizes cannabis. It's an election year. I simply don't see Congress taking that step right now. It would make a lot more sense for them to do it in 2021 or later. Interestingly enough though, I do expect that the FDA will take this opportunity to comment and provide some clarity around what to expect around cannabis. So stay tuned. I expect that as a pharmacist, you might find this to be really, really interesting in how you integrate cannabis into your practice.

Darshan: In the context of Telepharmacy, I expect that we've talked about how, for the most part, Telepharmacy has really taken root in the West coast and in the Midwest. I expect it will continue to expand. You'll see some of the Eastern states continuing to consider Telepharmacy more aggressively. On the other hand, when it comes to TCPA and unwanted, unsolicited auto dial phone calls, I expect that there will continue to be prosecutions, but I don't expect it to be a major issue as we continue, especially for smaller players in the pharmacy space. I expect that they will, to the extent that they do... when I say they, I mean the government, uses the TCPA as a option. I expect that it will primarily be used against the larger companies in 2020. Again, they might pivot but I would be more surprised than not.

Darshan: In terms of privacy, we've talked about how California has gone live with its own version of GDPR, its own privacy law. However, I expect that more states will actually come out. There are various bills across the many states that are going to have privacy implications and significant focus on privacy. However, I would be very surprised if in 2020 you would see a federal privacy law. I expect that to actually happen in 2022 maybe or later than that. I don't see that being a primary goal for any presidential candidate or either a new or an existing president to do in their first year.

Darshan: On the other hand, as it relates to executive movement and non-competes being enforced, we talked about the Rhode Island federal judge who actually scolded a CVS drug middleman basically for moving. However, non-competes have become a area in which a lot of companies are continuing to fight and the government has started pushing back.

Darshan: For example, New York and California generally tend to hate non-competes. However, I expect that, I don't expect non-competes to go away. I think we're going to land up having more of a step back where you need to do a state-by-state analysis and non-competes will continue to be argued in the short term to the longer term.

Darshan: So let's talk about fraud in the context of pharmacies. Now I'm going to actually do this one slightly differently. I'm going to talk and start from the punchline and then go in deeper. So those of you who really just want to know what are the quick takeaways, you're going to get that in the first minute and a half. But then we're going to talk about exactly why those takeaways matter and what happened.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's a website at darshantalks.com.

Darshan: There have been six major trends in 2019 around pharmacy fraud, and that means that you as a pharmacist need to be aware of these issues. You as a pharmacist need to be taking the appropriate steps so that you are not being caught up in these problems. So the six major issues. Number one, compounding pharmacies are being targeted especially in Florida. Number two, there's an uptick in opioid review. Number three, kickback reviews are being consistently reviewed, shall we say, especially in the context of telehealth. So if you are using telehealth as a pharmacy and that may actually become a problem in the context of kickbacks. That's not to say that telehealth is inappropriate, that's not to say that without it you wouldn't have a kickback problem. But that combination seems to be grabbing people's attention.

Darshan: The idea of in manufacturing and compounding, this is the course of care. That's what I was being told. This is okay to do as a pharmacist because just this is what people taught me. That argument is not being accepted anymore. So if you are a pharmacist and you've always gone, "You know what, this is what I was taught. This is okay." Yeah, that's not going to fly anymore. In New York, larger pharmacies are being targeted, and I'd say overall, and this has been happening for several years, if you are a pharmacy using a marketing company, be very, very careful and be sure to audit them. Because marketing companies have the goal of marketing and they will do whatever they can to optimize their sales.

Darshan: The problem is that you are left holding the bag and these marketing companies are being sued independently, but you as a pharmacist are being sued and are potentially paying millions of dollars in fines as well. So that's my takeaway. It took me about two and a half minutes to give you that. So if you want to walk away at this time, shut off this podcast, that's fine. But if you want to know why I said what I said, stay tuned. So let's start with the compounding kickbacks.

Darshan: The first one I would talk about is in the context of Alabama, those Global Compounding Pharmacy, there were 10 defendants being charged in 103 count indictment, including a nurse practitioner, the owners, a pharmacist, managers, sales representatives and billers. Global describe itself as one of the three largest compounding pharmacies in the US and it primarily shipped compounded drugs from its Haleyville facility, but they did most of that prescription processing, billing and customer service in its call center in Clearwater, Florida. The company hired sales reps who were located in various States and were responsible for generating prescriptions from physicians and other prescribers.

Darshan: The company also worked with affiliate pharmacies. The indictment charges essentially said that they were fraudulent in billing healthcare insurers and prescription drug administrators for over $200 million in prescription drugs. In one instance, the defendants' fraudulent conduct caused a prescription plan administrator to pay over $29,000 for one tube of a cream advertised as treating general wounds. Aspects of the scheme included paying prescribers to issue prescriptions. So number one, from a fraud perspective,

 

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February 6, 2020

Darshan: In the last podcast on pharmacogenomics, we talked about what happened in 2019, the different settlements that happened with the DOJ and what that means for pharmacogenomics companies and for providers in this space.

Speaker 2: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks, or the show's website at darshantalks.com.

Darshan: We talked about things like kickbacks. We talked about Stark violations. We talked about payments for services not rendered, upcoding. We talked about Primex and GenomeDx. We talked about UTC Lab settlements and Operation Double Helix, and that's all great. And we talked about the LCD, the local coverage decisions, and we talked about the national coverage decisions. And this is all excellent, but what does this mean for 2020? How should a company that's engaged in pharmacogenomics think about what 2020 looks like for them? And what I would expect.

Darshan: So I would think that looking forward, the big thing to think about is you're going to continue to see more enforcement from the Department of Justice, because the Department of Justice is really looking at payments being made by CMS or the various government providers basically, the various government payers. And I don't expect that to slow down because you're going to be looking at are payments being inappropriately made? So that's going to continue.

Darshan: What I think is going to be actually more interesting is I think that the FDA will actually start getting into the fray and you might start seeing claims around misbranding, and I think that's going to be interesting. I don't expect a deluge of that, but I expect that there will be some claims around fraud that you might start seeing, which will land up guiding the industry a little bit more. The FDA has come out and said that they've practiced enforcement discretion for the most part, but I expected that they will land up guiding companies through enforcement. And there have already been some initial forays into this by the FDA.

Darshan: The next thing to look at is what else is the FDA going to do? The FDA, I expect, is actually going to take this opportunity to provide more guidance, so stay tuned. The FDA may actually land up putting on guidance's that say, "Here's the type of evidence you need to be able to make claims. Here's how much evidence is normally expected, here's how much you actually have. How do you meet that gap? And which companies primed to provide that type of evidence."

Darshan: So there are, I expect that in the short term, there will be some winners and losers in that space. So you might see some attrition in 2020 and 2021. If you have questions about what that looks like for you, are you going to be one of the winners or the losers? Feel free to reach out to me. You can find me @DarshanTalks on twitter, or you can find me on my website at darshantalks.com. That's D-A-R-S-H-A-N-T-A-L-K-S dot com. Great talking to you guys.

Speaker 2: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks, or the show's website at darshantalks.com.

February 4, 2020

Darshan: Welcome again to another episode of Darshan Talks. We've previously talked about clinical trial transparency, but it's important to recognize that clinical trial transparency exists as a part of a whole, and that whole is patient centricity. And if you don't understand the different levers that affect clinical trial transparency, then you are actually shortchanging yourself.

Speaker 2: This is the DarshanTalks podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks or the show's website darshantalks.com.

Darshan: Let's look at patient centricity. And as I see it, patient centricity is at least four major arms. You've got innovation, you've got clinical trial transparency, the balance to clinical trial transparency, which is patient privacy, and then more importantly then all of this is access, because what's the point of doing all this if patients can't actually get access to the medications that they need?

Darshan: So we've previously talked about each of these factors and we've talked about what happened in 2019 that lends pause in each of these areas. Let's talk about what the implications are now in 2020 in each of these areas.

Darshan: So let's talk about first innovation. We previously talked about march-in rights and we talked about things like Bayh–Dole and we talked about how pharma companies are being pushed so that patient advocates are basically coming in and lawmakers are coming in and they're saying that the Federal Government must deploy the legal provision that allows the government to suspended drugmakers patent and license someone else to produce the drug.

Darshan: That's often under the Bayh–Dole Act and there are a few other versions, but IP experts have disagreed on its applicability and I think that in the short-term there's unlikely to be any actual impact in this specific area. Obviously things might change, but at this moment I would be surprised if anything happens.

Darshan: GDPR. We've talked about 2018 being the year when GDPR actually was live. 2019 interestingly was when you started seeing the first set of fines, and I think 2020 is going to be when you actually continue seeing more fines. In December there was actually a pharmacy that landed up paying fines. There have been boarding schools that have paid fines and I would not be surprised if other deeper pockets start paying fines as well.

Darshan: If you are a health IT company, I would expect to see some prosecution or some reach-outs from the government in that context. If you are a pharma company, this becomes especially problematic because member states don't actually know what should be expected from you, the US itself is confused and concerned about what this means. I know CROs have actually ended up pushing companies away from Europe because of GDPR and the implications, so we will continue to see fines.

Darshan: There is this black hole of information that's required for companies to make important decisions on how they should engage with Europe, so I would expect that the CROs would actually see a pullback in terms of the engagement into Europe.

Darshan: So what are the implications on patient centricity? Patients in Europe would actually end up suffering because you will actually end up having a loss of innovation as a result of the increase in privacy requirements. And again, I'm not saying that privacy is a bad thing, I think privacy is a really good thing actually, but lack of clarity on the expectations around privacy is a bad thing. And I think that that has to be solved quickly.

Darshan: For those of you who are saying, "Well lucky me, I don't actually have any problems in the US," well no, no, no.

 

 

Looking Back: Pharmacy Issues in 2019

January 30, 2020

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Darshan: This conversation is going to be really, really interesting. I'm looking forward to having this conversation because of my own background as a pharmacist and because of my own background as a lawyer. Today's talk is going to be about the top eight issues that happened in pharmacy in 2019 that are going to affect how pharmacy occurs in the next decade, shall we say, and what has been happening that will change the impact of pharmacy.

Intro: This is the Darshan Talks Podcast, Regulatory Guy, Irregular Podcast with host Darshan Kulkarni. You can find the show on twitter @DarshanTalks or the show's website at darshantalks.com.

Darshan: So the number one issue I would talk about is the rise of cannabis. And as you may know, and there are numerous talks that I've put out there already. There have been several states that actually have legalized the use of medical cannabis. There have also been States that have legalized the use of recreational cannabis.

Darshan: However, you should also consider that simultaneously there is a federal law that makes the general use of what we call medical cannabis to be illegal. On the other hand, there are concerns, well there are some advantages in that you have the Farm Bill which goes out there and actually says that in specific situations you can actually wind up using CBD in specific scenarios. It's important to recognize what that means.

Darshan: For example, if you're making claims, medical claims using CBD, you're probably going to have problems. There have been numerous citations for companies that are making medical claims. If you're a pharmacist either selling them or making medical claims for CBD, stay tuned, be careful, there may be issues. There have been in the last year. The FDA itself has actually taken a more proactive role. They've gone after CBD companies and THC companies for misbranding and adulteration issues, so stay tuned, look out for those as we continue.

Darshan: The next issue that's popped up over time has been the issue of telepharmacy. Telepharmacy is, as some of you may know, is the use of, I think I'm going to call it Skype, or call it some of these web conferencing services. Obviously it's not as simple as that because you have some protection issues that have to kick in. But using a tools like Epic, people are using ways to virtually consult and connect with patients, with other pharmacists, to provide better care to their patients. There has been a rise of this primarily in the West Coast and in the Midwest. I would expect that you would see the East Coast starting to join this more and more. The East Coast tends to be a little bit more conservative, so we'll see how that plays itself out, but there has been a rise in uptake for telepharmacy as well.

Darshan: The next thing to think about is the TCP and unwanted calls. So essentially if you're using unsolicited auto dial calls, you may have concerns under the TCPA. CVS Pharmacy agreed to pay $50 million to resolve 8 class action claims that had made unsolicited auto dial flu shot reminder calls to consumers. This went out to about 230,000 individuals and they were called with a message offering a CVS Pharmacy shopping pass during this flu shot reminder calling campaign. So again, when big players like CVS are being targeted,

 

 

Looking Back: Pharmacogenomics in 2019

January 28, 2020

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Darshan: Hey everyone. Welcome to another episode of Darshan Talks. Today's episode is going to be about pharmacogenomics. So the first thing to ask is what exactly is pharmacogenomics?

Intro: This is the Darshan Talks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter, @Darshantalks or the show's website at Darshantalks.com.

Darshan: So pharmacogenomic tests are aimed at identifying genetic variations that suggest that a patient may have an unusual reaction to a specific medication. A pharmacogenomic test may therefore be useful if a patient has shown an unexplained or otherwise unexplainable reaction to a certain medication. However, the scientific evidence supporting pharmacogenomic testing in the vast majority of cases remains relatively slim. There are obviously exceptions to this. So coverage wise, between 2015 and 2018, Medicare payments for genetic test more than doubled. They went to well over $1 billion in 2018. So obviously these genetic tests have become a lot more common and there are financial incentives behind this.

Darshan: To date, Medicare has generally recognize that pharmacogenomic testing and other genetic tests are medically necessary in only a very narrow set of cases. Some Medicare contractors have issued numerous local coverage decisions making that clear. However, where no local coverage decision is at issue, a test must still be medically necessary and thus the absence of a local coverage decision may mean that it may raise the question of whether something is reimbursable. However, just because it's not written out there doesn't mean that it doesn't meet the medical necessity standard.

Darshan: The Medicare claims processing manual explains the screening tests, genetic or otherwise, are generally not covered by Medicare. A practitioner who routinely performed genetic tests on patients regardless of each patient's clinical history and presentation would therefore potentially fall foul of Medicare requirements. Now, having said all of this, the US Department of Justice announced criminal charges against 35 individuals across various jurisdictions allegedly involving genetic testing fraud and this went to over $2.1 billion, and the government asserted that these individuals had engaged in targeting seniors and disabled through various cancer screenings. So these cancer genetic tests were performed to screen patients for genes that may show whether a patient is predisposed to developing certain cancers.

Darshan: The federal government has launched over 300 investigations into alleged fraud in genetic testing, many of which are actually probably ongoing. Having said all this, let's look at a couple of different examples. Outside the actual Operation Double Helix, there's the UTC lab settlements. On October 9th, pharmacogenetic pet lab test, UTC labs and three of its principles, the lab agreed to pay for $41.6 million with three separate individuals being responsible for another $1 million. The case resolved allegations brought by whistle blowers that the lab paid kickbacks to doctors as well as marketers for medically unnecessary tests. The physician kickbacks were, as the government described them, thinly disguised as seemingly legitimate payments for work done by UTC led clinical study.