DarshanTalks Podcast

Narrator: This is the DarshanTalks Podcast, before this week's interview with Stephanie Noblit and Dale Cooke on promotional compliance and lab testing with COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, May 7th 2020.

Darshan: So here are some interesting bits of information that have occurred in the last week that might be relevant. Number one, Health and Human Services issued a notification about enforcement discretion for provision of telehealth services during the COVID-19 pandemic. What does that really mean? It means that, number one, a lot of companies have come out and said, oh, they've legalized telehealth using FaceTime and they're like, "That's not what they've done." What they've done is they've simply said, we will use enforcement discretion which means, we will choose not to enforce at least during this one period of time. There are significant limitations.

Darshan: They actually said that they will not impose fines for non compliance with the regulatory requirements like not having the appropriate business associate agreement in place, but certain steps do need to be taken. That includes, enabling all available encryption and privacy modes, notifying the patient that third party applications, pose a potential privacy risk. So keep that in mind as you continue. The second bit of information that's popped up is that a lot of individuals and companies believe that the FDA has stopped doing audits during this time. It seemed that that's not true.

Darshan: The FDA just warned an Indian testing company, two device makers and a university lab for running a non clinical trial for a medical device. If you need more information, feel free to reach out about that. Do you believe that the FDA should be doing this testing? If you disagree with that, feel free to reach out. Feel free to comment on Twitter. You can reach me on twitter @DarshanTalks. The other bits of information is that, the PPP loans just came into play. And people have been wondering what this means, because PPP loans, what happens if the employee doesn't want to come back?

Darshan: Do you have to give those PPP loans back? So the EEOC provided some interesting information about that, and so did the Treasury. And off that, the question that was asked was, will a borrower's PPP loan forgiveness amount, be reduced if the borrower laid off an employee, and offer to rehire the same employee, but the employee declined the offer? And the short answer is no. That would not be the case. If you need more details, feel free to reach out about that as well. There is another interesting bit of information happening. Specifically, the question of clinical trials versus the right to try, and people are wondering what does this mean? What is the difference?

Darshan: So clinical trial is working on the proposition that both arms of a clinical study are equivalent, and the right to try works with the proposition that you have a preferred option. So with clinical trials, if you look at it, the subject enters into the clinical study with what's known as equipoise. And that means that they do not believe that there is any difference between the two arms of the randomized trial, for the randomization to be ethical. However, that analysis does not consider if while the individual patient may be indifferent, the researchers themselves may not be, so they may be actually aiming for a specific result.

Darshan: So, that becomes more complicated in the context of a pandemic, where patients just want to get better, while the actual individual researchers are hoping for one line of treatment, so that they can help other people. So, where a patient has a rational preference for the treatment,

Darshan: As a person of Indian origin, I figured this list was interesting to me. So these are the top five Desi doctors to learn about COVID-19. The first one is Dr. Nisha Metha who is a physician, a radiologist, she works in health policy, and she can be followed @nishamethamd.

Darshan: The second one is Dr. Neil Lall who's a radiologist. He is also one of those people who talks about hacks and technology and music, et cetera, and he can be followed at @NULall.

Darshan: The third person is an infectious disease doctor working on pandemic policy, emerging infections, and preventing bio-terrorism and that's Dr. Amesh Adalja. That's at @AmeshAA.

Darshan: The third one, well, the fourth one, I guess, is Dr. Raagini Jawa who is an infectious disease fellow and is a big follower in humanism in medicine, is a former Delhiite, and she can be followed at @Raaginizzle.

Darshan: And the last person that I have on my list is Dr. Krutika Kuppali who is a infectious disease and global health physician. She follows infectious diseases, Ebola, HIV, biosecurity, pandemic preparedness, and she can be followed at @KrutikaKuppalli.

Darshan: I should clarify, I don't actually know if they're actually of Indian origin or of Southeast Asian origin, but that was my best guess and you know what? I'm going to go with close enough, we're all the same people in the end. Anyways, this is just something to highlight some other individuals that I hope to follow in time.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni.

Narrator: You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

In the wake of COVID-19, health care workers are on the front lines of the crisis--navigating keeping patients safe, while also keeping themselves healthy. As the pandemic progresses, health care workers become exposed to more risks. Darshan talks with Paul B., a clinician who has worked in multiple hospital departments, about how the disease is affecting essential workers. We'll also ask him about what precautions patients are taking to protect themselves.Screen reader support enabled.

Narrator: This is the DarshanTalks Podcast. Before this week's interview with Paul B. on healthcare practitioner reactions to COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, April 30th, 2020.

Darshan: This has been a slower news week. It's interesting, and we'll sort of explore in greater detail, some of the conversations that are happening out there. One of the ones to keep in mind is a North Carolina testing lab just settled a whistleblower allegation for up to 43 million and those were primarily for claims that it billed for medically unnecessary lab tests. The settlement allegations suggest that the company improperly submitted claims to Medicare, TRICARE, and federal employee health programs for several different lab tests that were not medically necessary, they engaged in improper billing techniques, and they paid a compensation to three phlebotomy vendors that violated the physician self-referral prohibition, known as Stark Law. Under the settlement, the company agreed to pay $17 million.

It also was the week in which people are starting to look at their companies themselves and in that vein, the EEOC basically came up with some general rules, the EEOC being the Equal Employment Opportunity Commission, and they came up with some rules and suggestions and guidelines. So as you may already know, they issued a guidance permitting employers to conduct temperature checks of employees to help prevent the spread of COVID-19. They've gone ahead and actually expanded that and the guidance now says that you have to make sure that the COVID-19 tests are accurate and reliable, you have to stay abreast of the latest public health information from the FDA, you must consider false positives or false negatives and understand that the accurate testing only reveals if the virus is currently present. A negative test does not mean that the employee will not acquire a virus later.

However, there are some additional takeaways. Number one, if you are going to be doing these tests, you should have a policy and procedure to administer the test uniformly. If you are going to be performing the tests, they should be administered by a trained person or a trained third-party professional, you need to try to administer the test in the least invasive way possible and ensure that the appropriate disclosures are being made to the employees, including CCPA Disclosures, to the extent necessary. If you [inaudible 00:02:33], and CCPA for those of you who don't know, is the California Privacy Law. If using a third party to administer the medical tests, ensure that the appropriate consent and disclosures are obtained to share the data between the medical provider and the business. And the information that is received should be treated as confidential medical records.

This was also the week in which people started looking forward. They came up with 10 new inventions that might help crush future pandemics. One of them is a digital tattoo for monitoring blood so that you could get real time measurements and do analytical assessments of a person's blood. Ideally, graphene might be useful [inaudible 00:03:17]. There are conversations about odorometers for monitoring smells.

Darshan: Here are the top five individuals to follow to learn about COVID-19. Number one, Dr. David Juurlink. Dr. Juurlink is an internal medicine, clinical pharmacology and toxicologist and works in drug safety research at the University of Texas Medicine. He talks about his own experiences in the field, treating coronavirus and gives advice for the best ways individuals can act to stop its spread. His Twitter handle is @davidjuurlink. That's D-A-V-I-D-J-U-U-R-L-I-N-K.

Darshan: The second person to follow is Max Roser. He actually is a data scientist and uses data to understand the big global problems and shares helpful visuals and graphics that explain the spread of the virus across continents. His Twitter account is Max C. Roser, R-O-S-E-R. Then there's Timothy Caulfield who actually tends to refute the spread of misinformation and pseudoscience. He's a professor of health, law and science policy and he's a speaker, TV host and author. He can be found on Twitter, @caulfieldtim. C-A-U-F-I-E-L-D, Tim.

Darshan: Then you've got Isaac Bogoch who is a clinical investigator and is at the Toronto General Hospital Research Institute. He can be found @bogo, B-O-G-O-C-H-I-S-A-A-C.

Darshan: And then the last person is the former CEO of the Bill and Melinda Gates Foundation, Sue Desmond-Hellman, and she can be found @suedhellmann, H-E-L-L-M-A-N-N, and she rounds out the list of the top five individuals to follow to learn about COVID-19.

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.

Narrator: This is the DarshanTalks Podcast. Before this episode's interview with Christina D'arcangelo on clinical research with COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, April 23rd, 2020.

Darshan: It's been a really interesting week again and COVID has done everything to make it more interesting. For example, there are some articles out there talking about how COVID is now stalling clinical trials for everything except COVID. There have been some discussions that patients themselves aren't even coming to the hospital because they're afraid of getting COVID, so the question is where are these patients going that don't have COVID-like symptoms. A lot of people are saying that they're actually either just passing away at home. Others are saying that this is impacting the actual clinical trials, so that's an interesting, unexpected result of COVID. So keep that in mind as you continue.

Darshan: This was also the week in which the Department of Justice announced that Logan Laboratories, Logan Labs, in Tampa, Florida, and Tampa Pain Relief Centers, Inc., a pain clinic also based in Tampa, agreed to pay, along with former executives, a total of $41 million to resolve alleged violation of the False Claims Act for billing Medicare, Medicaid, and Tricare for medically unnecessary urine drug testing. So again, keep in mind that performing a service is not enough. Was there a good reason for the service itself?

Darshan: This week, the EEOC, the Equal Employment Opportunity Commission, also put out some rules and put out some information around what they consider important for the purpose of the Coronavirus. So if you have some questions about that, feel free to reach out. I'd be happy to send you the link to that.

Darshan: This was also one of those weird weeks where they announced unusual things. In Nebraska, a pharmacist was arrested for an alleged conspiracy to use explosives, specifically Molotov cocktails, to firebomb and destroy a competitor pharmacy. That just seems unusual. That's sort of not the point of this. So I just thought that was interesting to note.

Darshan: Also, on April 16th, Novartis lost its bid to toss a former employee's revised False Claims Act suit after New York, sorry, a New Jersey federal judge said that the ex-worker's alleged conversation with his boss supported claims that he was fired for objecting to a potential kickback scheme involving express scripts. So stay tuned. This should get interesting. Is Novartis in trouble again is something we need to look out for.

Darshan: As usual, COVID-19 is keeping us interested. The FDA has taken the unusual step of allowing compounding of necessary hospital drugs for COVID-19 and this includes drugs like Cisatracurium and Precedex. There are a bunch of them, including Fentanyl and Furosemide, et cetera, so keep that in mind. That should be interesting as the days come through.

Darshan: Again, the FDA is also taking other unusual steps. They've said that developers can release digital products for psychiatric disorders without a 510 K Submission during COVID-19. That's going to be interesting because that changes the expectation of requirements around COVID-19. The guidance that came out and it says that this device availability may increase patient access to digital therapeutics while individuals are following stay-at-home orders orpracticing social distancing without the need for in-clinic business during the COVID-19 public health emergency. Remember, this basically is for a limited period. You may still need to go back, so stay tuned. You might be able to reach out if that's something you have, feel free to call us.

Darshan: April is also the National Minority Health Month and that actually talks...

Narrator: This is the DarshanTalks Podcast. Before this week's episode, COVID-19's impact on patient centricity, an interview with Deborah Collyar, Darshan will introduce this episode with the recap for the week of Thursday, April 16, 2020.

Darshan: So as usual, this has been a very busy week. COVID has kept its control over the news for the most part. But that's not to say that it hasn't been busy for other things. So we're going to discuss some of the conversations that are happening in other areas but that seem to have COVID ramifications or that COVID seems to be influencing in some ways. One of them is the idea of false promotion. The FDA basically came out on April 8th, and they sent out an update saying that there was a seller who was marketing chlorine dioxide products to prevent or treat COVID-19 and that there was no proof to this. That was actually hugely problematic. They were marketing it as miracle mineral solution for prevention and treatment of novel coronavirus disease 2019. Obviously that became problematic.

Darshan: The other thing that was sort of interesting, similarly, is Dr. Stephen Hahn, who is a current director of the FDA, the commissioner of the FDA basically. He's the 24th commissioner. They issued a warning letter to Free Speech Systems LLC, doing business as InfoWars, for offering products fraudulently claiming to prevent, cure, diagnose, treat COVID-19, obviously hugely problematic. They were selling things like Super Blue Silver Immune Gargle, Super Silver Whitening Toothpaste, Super Silver Wound Dressing Gel, and Super Blue Fluoride-free Toothpaste, saying that they might help with the treatment or prevention of COVID-19. The FDA took the position that it's within their discretionary authority to stop this, so that was obviously a step in the right direction.

Darshan: Interestingly enough, there are concerns that it's not just companies that have their own agendas but also people. And on an April 9th article, Jill Adams, who's a freelance contributor, says that physicians who are self-promoting are hawking unproven COVID-19 pandemic treatments. As usual, it usually starts off with Dr. Oz, but there is some argument that a Dr. Vladimir Zelenko is also doing something similar, which I think is interesting. You probably want to be careful if people who are saying that they have a treatment for COVID-19, because the truth is anyone who had a treatment for COVID-19 would probably be making a lot of money. It's not that the government's just trying to hold off on treatments. If anything, they're promoting off-label things that even haven't been proven yet. So I would caution people and take such statements with a grain of salt.

Darshan: To change away a little bit, there have been other changes that are coming on. A lot of marketing changes obviously in general, one of which is the FDA put out a notice on the Prescription Drug Marketing Act. They put out a guidance document saying that they have some guidance on the donation of prescription drug samples to free clinics. That's going to be sort of interesting in the coming weeks to see how this gets incorporated. How should these free clinics that receive donated prescription drug samples be managed, if you will? And the FDA has a guidance on that.

Darshan: On April 6th, the Department of Justice announced that Georgia-based MiMedx Group will pay a $6.5 million penalty... I guess it's not a penalty, but to settle civil allegation that the company submitted false pricing data, defective pricing for its human tissue grafts. The settlement involved allegations that MiMedx knowingly submitted false statements and disclosures to the VA regarding their commercial pricing practices, and that enabled MiMedx to charge the VA inflated prices for its human ...

Darshan: Hey, everyone. Welcome to another episode of Darshan Talks. We have a frequent guest of ours. We have Tim Youkhana. Tim, do I say your last name correctly?

Tim: You got it. You got it, Darshan. There's multiple ... It's like tomato, tomato. Youkhana, Youkhana, it doesn't matter.

Darshan: Youkhana, okay.

Tim: I'll still answer.

Darshan: Fair enough. Tim is a frequent guest. I've known him for a while. He is the person to talk to when it comes to telepharmacy.

Darshan: As some of you may know, depending on when you're listening to this, we're in the middle of the COVID-19 outbreak. Everyone's working from home as much as they can to avoid spreading, and as they say, to avoid flattening the curve.

Darshan: The perfect person to talk to right now is someone who actually has helped flatten the curve before there was a curve. In many ways, Tim is the telepharmacy hipster. He was cool before it was cool to be cool.

Tim: Yeah.

Darshan: Tim, let's ask a really basic question, which is, we've spoken about this before, but what is telepharmacy, and how is that different from telehealth or telemedicine?

Tim: I appreciate all the accolades that you gave me, Darshan. I'm blushing right now, if you can't see it.

Tim: What telepharmacy is, it's similar, in regards to the pharmacy aspect, of how telemedicine works for physicians; outpatient, inpatient treatment; psychiatric care. It's just taking that model from the telemedicine side, and integrating it into a dispensing role from a pharmacy perspective. What it allows community retail pharmacies to accomplish is essentially being able to serve a larger amount of the population in areas that might not be conducive if they were operating in a traditional setting.

Tim: Right now, as you had mentioned, depending on when anybody's listening to this, we're in the middle of a COVID-19 crisis, the pandemic that's going on all over the world really. Businesses have been scrambling, because they've been shutting down all over the place, to find ways to still not only remain important in front of their clients' perspectives, but if they're an essential business, still be able to deliver the products and services that their clients need on a day to day basis.

Tim: That's one area that telepharmacy, if you hadn't adopted it before this whole thing came up, and you're trying to find a way to be able to still stay relevant, if you're not looking into it right now, I really don't know what else would bring you to the table to start thinking, "Oh man, maybe I need to start looking into doing something like this."

Tim: God forbid something happens like this again in the future, at least you can be prepared, and your clients will be reassured that you're still going to be able to deliver them the same amount of care, if not better, because you've already been adjusted, and there's not those growing pain that kick in any time that you adopt a new process or system into your workplace.

Tim: I hope that answers, in the grand scheme, what you had asked, Darshan.

Darshan: Well, I think you're answering at a grand scheme, but one of the questions I get is that just sounds like mail order. How is this different from mail order?

Tim: You've got the brick and mortar aspect still. Telepharmacies still operate out of a physical location. It's considered an outpatient pharmacy. It's a community based pharmacy where patients can come in and out. You can have a storefront. You can do all those same things that you do in a traditional pharmacy setting. You just don't need to have a pharmacist on site.

Tim: By being able to remove that, the largest part of your payroll, you're enabled to have a couple different pharmacies in different geograp...

Darshan: Everyone's been recently talking about GDPR. People have been talking about CCPA. Those are the people in the know, right? Everyone's talked a lot about HIPAA, but if you are a health tech company that is working at a global level, what you really need to recognize, and what you really need to understand, is that this is going to be complicated. That you are subject to laws and privacy considerations that you have haven't even thought of. The most recent one of these is the proposed Indian Data Protection Bill.

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

Darshan: So in 2017 the Supreme Court of India rule that privacy is a constitutional right of an Indian citizen. Great. That sounds great. This data protection bill intends to protect and safeguard citizens privacy rights, and they intend to do that by controlling the collection, security, storage, sale and exploitation of this data. What this bill goes out and does, and this is kind of interesting to me, they now try to make these digital companies data fiduciaries instead of mere data collectors. And that means that they're responsible for obtaining user permission, and therefore, they need to get the permission for initial collection, and for subsequent processing off that user data.

Darshan: It goes out, and unlike GDPR, even CCPA, I believe, they go out and propose the data provider is the owner of their own data, but, and this is kind of interesting, the data provider, which in this case is the individual, has the right to access this locally stored data. And that's kind of interesting to me. This kind of changes the cost benefit analysis for a lot of digital companies that obviously you lose money in the provision of free services, but theoretically you could earn the money from the sale and exploitation of the actual personal data itself.

Darshan: So that takes us to the next piece, right? And the next piece is what is consent and what do you need consent for? So what you need under this new proposed law, is you need to get explicit consent from the user, and it must be obtained that each stage of subsequent data processing. So think about collection, and then when again, you need collection. So companies often collect the personal data, and then you'll often be modifying that and using that, updating that to create new information that may not belong to the original user. So do you have to go back to the user each time and go, well, what does it mean now?

Darshan: The next thing is not just the processing of the consent, but the data classes. And this is kind of interesting as well. Under this new proposed law, they create three categories of information. The first is the general category. They don't really define it, and there are no limitations on where the data must be either processed or stored. Then there's sensitive data, sensitive data, or first to financial data, health data, sexual orientation, genetics, transgender status, caste, and religious belief. The data must be stored in servers in India, but it can be processed out of India. So you can do the processing outside, bring it back in.

Darshan: So if you are a health tech company, this becomes extremely important for you. If you are a pharmaceutical company, that's doing research, that becomes extremely important for you. Where is your data going to be stored? The data has to be stored in India. And then there's critical data, that typically refers to things like military or national security data, and it must be stored in servers and cannot be taken out of India.

Darshan: So how is this different from HIPAA?