Looking Back: Pharmacy Issues in 2019

 
 

Looking Back: Pharmacy Issues in 2019

January 30, 2020

Read Transcript

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, if you are using auto dialing if you will, as part of your marketing campaign, be very careful as a pharmacist.

Darshan: Next comes the issue of privacy. California has passed its own version of what’s called GDPR. That was a European privacy law and it’s called CCPA. If you are a California pharmacy, you should be careful with patient information anyways for HIPAA, but again, you may want to be careful with it under CCPA as well. I recognize CCPA has certain exceptions for HIPAA, but whether your use is contained within that exception is still up for grabs. So again, if you have questions about what that means for you as a pharmacist, feel free to reach out. I’d be happy to talk t

Darshan: Another issue that pops up is if you are a large conglomerate of pharmacies, one of the big things that you need to start thinking about is how are you going to keep your executives from moving? Because again, as a pharmacist, one of the things you want to do is go after the best place you can get paid. There was a CVS executive who tried to do that and essentially what they were told, a Rhode Island federal court judge actually pushed back because this individual was moving over to Amazon’s mail order service and apparently violated his non-compete.

Darshan: Again, if you have individuals like this, you might get the sense of, “Oh you know what that means? That I can actually protect my intellectual property. This is going to be great.” However, there have been numerous other situations where the courts have pushed back against non-competes for being over broad. So what does it mean in your specific state? You need to be aware of it. You need to make sure that your contract controls it. What a lot of lawyers do in these specific situations is they’ll say, “You know what? If you as a judge decide that you don’t like it, just delete that one part and everything else remains enforceable.” There have been states where the judge basically said, “You can’t put it on me to decide what your contract should be. You need to do your own work.” So, you’ve got to sort of balance this all out. How are you going to play it as you continue?

Darshan: What’s going to also be interesting is that in December in 2019, HHS for the first time unveiled proposed regulations at letting states import prescription drugs from Canada. You actually have to submit a proposal to the FDA for authorization to import and then be given a new NDC code. And group of governors from Maine, Colorado, Vermont, and New Hampshire, have already expressed interest in this new pathway. And again this sort of goes in simultaneously with some of the other ideas that President Trump has around drug costs. That specifically talks about things like most favored nation status where you can cap the cost of drugs based on the lowest one paid in certain other countries.

Darshan: The administration was also looking to finalize a international pricing index that would slash reimbursement by pegging it to prices offered in other developed countries as well. So stay tuned. There’s going to be a lot of work around both drug importation and drug pricing, so that should be interesting as we continue as well.

Darshan: If you are a pharmacist another thing that’s … well let’s sort of catch up. We’ve got cannabis, the rise of cannabis. You have telepharmacy. You’ve got TCPA and unwanted calls. You have the issue of privacy and what that means in California for example, and again, if you’re not in California, don’t think that you’re actually on Easy Street There are I think about seven other states that are considering various versions of laws that look at patient and individual privacy. The idea of non-competes and how that should be written into your contracts with either your pharmacists, your marketing people or your executives. The idea of drug importation, what that means for you as a pharmacist because pharmacies are going to have a lot more control in the context of drug importation.

Darshan: Then let’s talk about another one which is a bipartisan bill was introduced in December requiring that drug manufacturers and distributors and pharmacies actually, well pharmacists, would more frequently report on the use of controlled substances from drug manufacturers and distributors. This would actually impose additional requirements of pharmacies. I believe we used to do it quarterly, it might become monthly. Again, this has broad bipartisan support, so we’ll see how that goes, as well. So stay tuned for that piece.

Darshan: And again, if you are following Surescripts saga, the FTC actually sued Surescripts in DC Federal Court. It alleged the company used contract terms and other tactics to illegally maintain a monopoly on electronic prescription services. The result of that was there was a riot. Surescripts was trying to allegedly preserve it’s 95% market share to markets and this resulted in what the FTC called vertical and horizontal restraints to preserve its monopoly position.

Darshan: FTC alleges that Surescripts did this in four ways. One is the use of loyalty contracts, preventing competitors from attaining the critical mass that would be necessary to be a viable competitor in either routing or eligibility. The use of alleged threats and other non-merit based competition to further ensure no competitors could emerge, this was some of their own executives, referred to them as nuclear missiles. The third prong was the use of anti-competitive methods such as inking a deal with Relay Health, subsidiary of McKesson that resells Sure scripts writing transactions to pharmacies and this provided, really helped with incentives to convince its customers to be loyal to Surescripts. And again, this was another problem. Surescripts obviously asserted that it was reducing the price. It had reduced the price of electronic prescribing by 70% since 2009 but they were removing these loyalty provisions in their contracts with pharmacies. Falconer Pharmacy also proposed a class action lawsuit based on this issue, as well. So stay tuned, we’ll see how Sure scripts goes. I think it’s going to be really interesting as we continue.

Darshan: So we had Surescripts, the drama around Surescripts if you will. The DEA proposed bill, drug importation, the use of non-competes, the California privacy law. There was TCPA and unwanted calls. Then there was telepharmacy and what that means and how that’s being adopted. Then the rise of cannabis.

Darshan: As a final issue, this is really not within the US, but a UK pharmacy. We talk about GDPR and we talked about privacy. UK pharmacy got it’s first GDPR fine as well for leaving 500,000 documents in unlocked lockers, unlocked containers at the back of its premises. That obviously means … and they paid a fine for about 275,000 pounds for careless storage of patient data. Now, what does this have to do with us in the US, GDPR perspective? Probably not too much. However, from a HIPPA perspective that is basically the same exact issue.

Darshan: So as I’m sure you guys know, OCR has been looking at fines in the context of not appropriately maintained privacy. What does this mean for you as a pharmacist? What controls do you have? Start looking into those as well. That’s probably a good idea as you continue.

Darshan: If you have questions about what the practice of pharmacy is starting to look like, what does this mean for you? What are some of the issues you might be facing? How do you actually maintain patient privacy? Are you right for cannabis? Is your marketing up to plan or are you going to have other issues? Stay tuned.

Darshan: I’m also going to do another talk on some of the fraud issues that pharmacies have been getting into. There was so much information out there for them for fraud, that I had to do a separate podcast on it. So stay tuned for that as well.

Intro: This is the DarshanTalks Podcast, Regulatory Guy, Irregular Podcast with host Darshan Kulkarni, but you can find the show on Twitter at DarshanTalks or the show’s website at darshantalks.com.

 

Looking Back: Pharmacogenomics in 2019

 
 

Looking Back: Pharmacogenomics in 2019

January 28, 2020

Read Transcript

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. The payments were used to leverage referrals from the physicians and the clinical study work was basically unnecessary.

Darshan: Similarly, there was Primex and Primex Clinical Labs LLC concealed kickbacks to doctors for providing clinical data to the lab, and then there was a remuneration arrangement. So again, if you think about it, this is another situation again using this concept of kickbacks so just keep that in mind as we continue. Then there was Pathway Genomics and they agreed to pay $4.1 million to the federal government, the 20th states and Washington, D.C. That’s Pathway Genomics. Then there was GenomeDx, or Genome Disease Biosciences, and they agreed to pay almost $2 million to resolve allegations that they billed Medicare from medically unnecessary tests.

Darshan: So if you look at this, there are two major formats that problems seem to be occurring in. One is kickbacks to physicians. The second one being medically unnecessary tests. But there are other methods in which the DOJ is actually going after these types of companies. The first being obviously the fact that there was the kickbacks, that physicians are being bribed to order these very expensive DNA tests, and that’s actually not necessary. The second one being a Stark violations and medically unnecessary tests. So these practices, particularly those with financial incentives, may institute policies [inaudible 00:05:30] principals and practitioners. So sometimes you actually have physicians who actually own these labs and therefore then land up sending and referring patients to these labs. So they’ll land up double dipping, if you will.

Darshan: One from as a physician writing the order and one as the owner of the genetic lab tests who actually fulfills the order. This was exactly what the Stark Law was intended to prevent. These policies therefore issued under the standard of care, guys, landed up providing cutting edge personalized or precision medicine services to their patients, but these were actually unnecessary. There were two other versions of claims that actually came about. One was payment for services not rendered, and those situations, physicians didn’t even land a printing patients or only saw them by a cursory telemedicine consult. So again, this brings in the concept of telemedicine and how that’s being used in inappropriate ways. So telemedicine should be able to augment or even sometimes replace. However, it has to be done the same way as any normal consult would be taken. A simple cursory telemedicine consult is likely to not meet the standards.

Darshan: Another situation in which these pharmacogenomics tests were being abused was that labs may be upcoding, which means billing payers for more expensive tests than those that were actually performed. So again, since this is relatively new, the Medicare and other insurance auditors have found it difficult to actually crack down since this information is simply not available. So we’ve got four typical methods in which the DOJ is alleging that there’s fraud occurring. One is kickbacks, one is Stark violations and medically unnecessary tests. One is payments for services not rendered. Finally, there’s upcoding. So keep each of these in mind as you continue.

Darshan: If you are a pharmacist providing pharmacogenomic testing and assisting in interpretation of what this means to your drugs or to the types of services being used, keep that in mind because again, just because you’re a pharmacist doesn’t mean you wouldn’t be targeted. In fact, there might be other claims that come in as well. Another thing to think about is where is this going? Again, for the most part, the FDA has performed what’s referred to as prosecution discretion where they basically say that, “You know what? We want to see the industry develop before we actually go after people unless there’s some serious effects of safety or efficacy.” So we might start seeing more information around that as we continue. I would also expect that in the coming months and years, we’ll see the DOJ continue to prosecute in this format. So keep aware of what’s going on here.

Darshan: If you have any questions, feel free to reach out to me. Again, you can reach out to me on Twitter, @Darshantalks. You can also reach out to me via my website, Darshantalks.com and I would love to hear from you. If you think that pharmacogenomics has been especially useful for you, feel free to leave a message, feel free to contact me. If you think that pharmacogenomics has actually harmed you, feel free to reach out to me and feel free to talk to me. I’d be happy to help in any way I can. If you actually are a practitioner and you find that there have been concerns where you don’t fully know how to integrate this into your practice and how do you market this, feel free to reach out to me, I’d be happy to help. If you are a pharmacist and you’re trying to understand, do you have a role to play in pharmacogenomics, feel free to reach out to me.

Intro: 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.

 

The Role of Patient Advocacy in Informed Consent

 
 

The Role of Patient Advocacy in Informed Consent

January 23, 2020

Read Transcript

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. The payments were used to leverage referrals from the physicians and the clinical study work was basically unnecessary.

Darshan: Similarly, there was Primex and Primex Clinical Labs LLC concealed kickbacks to doctors for providing clinical data to the lab, and then there was a remuneration arrangement. So again, if you think about it, this is another situation again using this concept of kickbacks so just keep that in mind as we continue. Then there was Pathway Genomics and they agreed to pay $4.1 million to the federal government, the 20th states and Washington, D.C. That’s Pathway Genomics. Then there was GenomeDx, or Genome Disease Biosciences, and they agreed to pay almost $2 million to resolve allegations that they billed Medicare from medically unnecessary tests.

Darshan: So if you look at this, there are two major formats that problems seem to be occurring in. One is kickbacks to physicians. The second one being medically unnecessary tests. But there are other methods in which the DOJ is actually going after these types of companies. The first being obviously the fact that there was the kickbacks, that physicians are being bribed to order these very expensive DNA tests, and that’s actually not necessary. The second one being a Stark violations and medically unnecessary tests. So these practices, particularly those with financial incentives, may institute policies [inaudible 00:05:30] principals and practitioners. So sometimes you actually have physicians who actually own these labs and therefore then land up sending and referring patients to these labs. So they’ll land up double dipping, if you will.

Darshan: One from as a physician writing the order and one as the owner of the genetic lab tests who actually fulfills the order. This was exactly what the Stark Law was intended to prevent. These policies therefore issued under the standard of care, guys, landed up providing cutting edge personalized or precision medicine services to their patients, but these were actually unnecessary. There were two other versions of claims that actually came about. One was payment for services not rendered, and those situations, physicians didn’t even land a printing patients or only saw them by a cursory telemedicine consult. So again, this brings in the concept of telemedicine and how that’s being used in inappropriate ways. So telemedicine should be able to augment or even sometimes replace. However, it has to be done the same way as any normal consult would be taken. A simple cursory telemedicine consult is likely to not meet the standards.

Darshan: Another situation in which these pharmacogenomics tests were being abused was that labs may be upcoding, which means billing payers for more expensive tests than those that were actually performed. So again, since this is relatively new, the Medicare and other insurance auditors have found it difficult to actually crack down since this information is simply not available. So we’ve got four typical methods in which the DOJ is alleging that there’s fraud occurring. One is kickbacks, one is Stark violations and medically unnecessary tests. One is payments for services not rendered. Finally, there’s upcoding. So keep each of these in mind as you continue.

Darshan: If you are a pharmacist providing pharmacogenomic testing and assisting in interpretation of what this means to your drugs or to the types of services being used, keep that in mind because again, just because you’re a pharmacist doesn’t mean you wouldn’t be targeted. In fact, there might be other claims that come in as well. Another thing to think about is where is this going? Again, for the most part, the FDA has performed what’s referred to as prosecution discretion where they basically say that, “You know what? We want to see the industry develop before we actually go after people unless there’s some serious effects of safety or efficacy.” So we might start seeing more information around that as we continue. I would also expect that in the coming months and years, we’ll see the DOJ continue to prosecute in this format. So keep aware of what’s going on here.

Darshan: If you have any questions, feel free to reach out to me. Again, you can reach out to me on Twitter, @Darshantalks. You can also reach out to me via my website, Darshantalks.com and I would love to hear from you. If you think that pharmacogenomics has been especially useful for you, feel free to leave a message, feel free to contact me. If you think that pharmacogenomics has actually harmed you, feel free to reach out to me and feel free to talk to me. I’d be happy to help in any way I can. If you actually are a practitioner and you find that there have been concerns where you don’t fully know how to integrate this into your practice and how do you market this, feel free to reach out to me, I’d be happy to help. If you are a pharmacist and you’re trying to understand, do you have a role to play in pharmacogenomics, feel free to reach out to me.

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.

 

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.