Podcasts about public health service act

Deb (00:03.606)Within the next seven months, up to 1.5 million Americans could lose access to a medication that they’ve relied on for decades. Not because it’s dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you’re one of them, your doctor may already have told you about this issue and stopped prescribing it.This isn’t a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they’re the same ones manufacturing the only product that might survive.Today on Let’s Talk Wellness Now, we’re exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I’m about to share what could save your access to the medication keeping you alive.Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I’m Dr. Deb, naturopathic doctor, your medical detective, and today we’re diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,for hypothyroidism or if you’ve struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I’m about to reveal will make your blood boil. Now grab your cup of coffee, don’t forget your notebook and settle in because what’s happening to this medication right now is a masterclass in how pharmaceutical companies use regular Deb (02:06.544)agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts. Deb (02:20.982)Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.Now let’s really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn’t some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn’t have to Deb (04:08.112)go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here’s what matters. Some patients…a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval. Deb (06:04.654)a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA’s official statement, FDA’s actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.This wasn’t a guideline. This wasn’t a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it’s an estimation of 1.5 million patients receiving prescriptions for these medications.could potentially lose their thyroid access. Now, here’s where it gets interesting. The FDA didn’t wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what’s really happening in this industry.The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding. Deb (08:13.972)This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.Then two months later, in November of 2022, the FDA’s Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?I honestly don’t know of any other drug that’s been around this long that’s used by this many people. Now granted, I haven’t done the research on it either, which I can do for you guys, but I’m just thinking if a drug is on the market today and it causes harm, it doesn’t make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?Hmm, just thought. But here’s the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down. Deb (10:09.806)August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.The FDA cited, and I’m quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.Second, the agency expressed concern about batch inconsistency. According to the FDA’s official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let’s back up. I want you to remember I said that Deb (12:11.216)because further down in this podcast, we’re going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material, including potential for viral contamination due to the animal source and supraphysiological levels of T3.the FDA statement on impurities, viral contamination and super physiological T3 levels. Now I will tell you, I’ve been prescribing armarithograde for 20 years. I’ve rarely seen a super physiological dose given of T3 in lab results, unless the patient takes their medication like four or five hours before you do the blood test, then you’ll see a false rise because you’re actually seeing the medication. You’re not seeing people walking aroundsuperphysiological T3 levels. Nobody would like that feeling. So anyway, I digress. Now let me pause here because this is where I need to give you some context that the FDA hasn’t quite emphasized yet. Of course, we have another connection and it is the China connection.So the FDA’s concerns about contaminated drugs and quality issues don’t exist in a vacuum. In 2024, the U.S. over 828,000 metric tons of pharmaceuticals, seven times the level from 2000. And here’s the kicker. China and India supply the majority of active pharmaceutical ingredients. APIs for U.S. generics accounting for 70 to 80 % of the total genericdrug supply. According to Reuters industry report in 2024, they state that China supplies 82 % of the APIs for critical drugs. Deb (14:08.204)Got to question that, right? Why are we giving all of our drug formulas to China and allowing them to import them into our country? In fact, roughly 20 % of the critical drugs have APIs exclusively sourced from China. And China controls 80 to 90 % of the global production for antibiotics and other key compounds. This was also cited by Reuters industry data thatcontrols 80 to 90 percent of the global production for antibiotics and other key compounds. Now just think about this. They control 80 to 90 percent of our medication. They control 20 percent of our critical drugs and we just put what kind of tariff on them? Hmm.In 2025 alone, the FDA issued multiple warning letters to foreign manufacturers for contamination issues and failure to follow good manufacturing practices. This is also cited by the FDA warning letters 2024 through 2025 and multiple citations to foreign manufacturing facilities. This is a systematic problem affecting the entire US drug supply, not just desiccated thyroid.So when the FDA suddenly became concerned about DTE quality and contamination, part of that concern was legitimate. But this is crucial. The same inconsistencies and contamination issues exist across the entire generic drug supply. And the FDA has not taken the same enforcement action against them. Let that sink in.They have not taken the same enforcement action against the other drug companies. So what’s behind all of this? Where is this all coming from? Hmm. Let’s address something directly, because you deserve to know it. And I’m going to cite my sources precisely so that when the medical boards have something to say about this, and they might, I have a documentation for every single word that I am about to speak. Deb (16:24.878)According to the court documents filed in October 2025, in the case ofa urine, a urine. I’m going to say that wrong. Pharmaceuticals versus Dr. George Tidmarsh from ABBV, the multinational pharmaceutical company that manufactures armor thyroid, reportedly petitioned the FDA in 2024, asking the agency to reclassify DTE as a biologic and to prohibit other manufacturers from selling unlicensed DTE products unless they havehad an investigational new drug application, we call this an IND, and a clinical development program aimed at eventual approval. This is cited in the court filing a Urena pharmaceuticals lawsuit versus Dr. George Tidmarsh, October 2025, reported by Fierce Pharma. Now let me explain why this matters and why this is one of the most brazen examples of regulatory capture I’ve ever seen in my career.AbbeVee is one of the world’s largest pharmaceutical companies. In 2024, they reported over $54 billion in revenue. Drop the mic on that one.They have the resources, the regulatory expertise, the legal teams, and the financial capacity to navigate a biologics license application process that costs between $500 million and $1 billion. Let that sink in. Deb (18:07.882)A drug that’s been on the market since the 1800s that was grandfathered in 1938 that’s making plenty of money right now. They’re going to spend 500 million to $1 billion to get a biologics license application. Why would they do that? Well, we’re about to find out. Most otherDTE manufacturers, smaller companies like Acela Pharmaceuticals, which makes NP-thyroid, and RLC Labs, which made WP-thyroid, do not have those same resources. And this is cited in Pharma Voice in 2025. Why a treatment older than the FDA is getting new regulatory scrutiny. So when you petition the FDA to reclassify a drug in a way that requires this type of expensivetime-consuming biological approval, you’re not just asking for safety. You’re asking to eliminate your competitors from the marketplace. Now, I want to be very precise here. These allegations are documented in federal court filings, and it hasn’t been approved in court. It’s also been reported by multiple industry sources, including Fierce Pharma. But I’m telling you,what has been reported in legal proceedings, not stating it as an absolute fact because you deserve to know the difference and because I have to protect my license. Now, what do we know for certain?AbbeVee is working on a biologics license application for Armour thyroid through clinical trials called Avantia. This is cited by the AbbeVee corporate statement 2025 Avantia clinical trial for Armour thyroid. A cell of pharmaceuticals has been pursuing BLA approval for NP thyroid for seven years since 2017 and it completed its phase two trials successfully in 2025. They’re now moving Deb (20:15.448)into Phase 3 trials. This is also cited by the Acela Pharmaceuticals CEO statement 2025 seven-year pursuit for BLA approval completed Phase 2 trials moving to Phase 3.RLC Labs, which manufactured WP thyroid, has made no public announcement about pursuing BLA approval and really probably don’t have a plan to do this since they’ve been off the market for some time now. About five years, I think maybe a little longer. Here’s the market manipulation.If only ABBV is successful and obtains a BLA approval for Armour thyroid, that company would effectively have a monopoly on the DDT market. And in pharmaceutical markets, monopolies historically lead to price increases.We’ve seen this pattern over and over again when turning pharmaceuticals acquired Daraprim and raised their price from $13.50 to $750 per tablet overnight. When Myelin raised EpiPen increased prices by 400 % when insulin manufacturers colluded to raise prices in lockstep. This is the playbook.use regulatory barriers to eliminate your competition and then exploit pricing power. For a drug that’s been on the market since the 1800s, guess corporate greed is everywhere. They’re not making enough money on this product already and they’re taking advantage of the rules that they can manipulate their competition by. And here’s what really makes me furious. The American Thyroid Association, the professional organization Deb (22:06.672)representing endocrinologists sent letters to the FDA commissioner on October 8th of 2025 and September 18th of 2025.advocating for continued patient access to DTEs. This is cited in the American Thyroid Association statement and letter to the FDA commissioner dated October 8th, 2025 and September 18th, 2025. The American Association of Clinical Endocrinologists issued a statement on September 9th of 2025 supporting equitable access and personalized medicine for DTE. This was also cited in the American AssociationAssociation of Clinical Endocrinologists, AACE, statement dated September 9th, 2025. Even the medical establishment, which has historically favored levothyroxine, is saying, wait, this is going too far. Patients need access to this medication. But the FDA is moving forward anyway. Why? Well, where does it always lead us? Follow the money trail.Okay, so I need to explain what a biologics license application actually is because this is where the rubber meets the road for what’s going to happen to pricing and availability. What is a BLA?A BLA is a biologics license application. It’s a formal request submitted to the FDA to market a biologic product in the United States. A biologic is defined under the Public Health Service Act section 351 as a product derived from or made using living material, in this case, animal thyroid glands. And this is cited in the FDA definition for biologic products. So they’re putting armor thyroid right Deb (23:57.377)right up with stem cells and exosomes. Think about that. Stem cells and exosomes cost thousands of dollars per application because of how they have to be harvested, stored, freezed, all of that. But we’re talking about a thyroid gland. Good Lord, people.Unlike regular drug applications for synthetic medications which follow a simpler pathway, the BLA process is designed for complex biological products like monoclonal antibodies, vaccines, and gene therapy products. It’s a much more expensive, much more time-consuming process. The BLA processis what manufacturers have to do. And we’re going to talk about that. So according to Reprocell and Forge Biologics analysis of the FDA’s BLA process, here’s what companies need to submit. First, they need to complete a clinical trial data, phase one, two, and three trials, proving safety and efficacy for desiccated thyroid. Haven’t we done that since it’s been on the market since the 1800s? Just saying.This means they have to conduct large randomized controlled trials comparing it to levothyroxine, measuring safety outcomes, efficacy outcomes, and quality of life metrics. Second,Chemistry, Manufacturing and Controls, CMC’s data. Detailed information about how the product is manufactured, quality control measures, stability testing and specifications that must be met for every batch. Third, preclinical and animal safety data. Fourth, labeling and product information. Now, I think we have labeling and product information. Deb (25:53.717)since the 1800s? But just saying. Fifth, they need Pharma Covigilance Plan, a detailed plan for monitoring safety after the product is on the market. Haven’t they had to do that since the 1800s? And they have to have a timeline. And this is the critical part. The FDA’s standard review time for a BLA is 10 months.That’s after the application is deemed complete and accepted for filing. So this is cited by the FDA standard review timeline, BLA submission, and FDA review.Now, before you even get to filing, you need to conduct the clinical trials and compile all the data that’s typically several years of work. How are you going to prove safety and effectiveness in a large clinical trial long term? What do they consider? What do they deem long term? Three months, six months, a year, two years. These companies had 10 months.Well, maybe 12. They did it a year in advance. But unless you knew this was coming, how are you going to put together a trial, enroll the people, have all the trial components set up and ready to go in less than 12 months unless you knew it was coming beforehand? Even ifhad started all their clinical trials in 2024, completing them, compiling the data, and getting a complete application ready for submission, this would likely take you through mid-2026, then add another 10 months for FDA review. We’re looking at 2027 at the earliest for most of these companies to receive a BLA application. Deb (27:54.319)But the FDA gave the manufacturers until August of 2026. That’s approximately 19 months from when the August 2025 letters were sent. Most companies cannot reasonably complete the BLA approval in that timeframe. And when I’m talking about the 19 months, I’m talking about the information they would have had earlier. Now the cost.This gets me even more frustrated. Why are we spending this kind of money? The BLL process is extraordinarily expensive. The current FDA user fee for a BLA submission is approximately $483,560 just for the filing fee. And this is cited at the FDA user fees prescription drug user fee rates for 2025.The full cost of conducting clinical trials, CMC studies, and all the supporting documentation typically ranges from $500 million to over $1 billion, depending on the scope of the trials and the complexity. And this is cited in JAMA’s network, Open2023. A cell of pharmaceuticals has been pursuing the BLA approval since 2017. That’s eight years. And it’s just now.moving into phase three trials with a planned enrollment of approximately 300 patients. This is cited by the Acela Pharmacies CEO statement of 2025. Now that’s unusual. That’s typical for this process. This is not unusual. This is typical for this process to take seven, 10 years to get approval for this. So if Abby’s the one that requested this,Abby V. And Acela started this in 2017. Was Abby V threatened by Acela that Acela might get this approval and it would be quietly done without anybody seeing it? And maybe Abby V would be left out of the market after a century? Who knows? It’s possible. Deb (30:13.112)But for smaller manufacturers without billions in revenue, this cost is completely prohibitive. And this is why this matters. When you push an old established medication through an extraordinary, expensive approval process with a compromised timeline, one of three things happen. First, only the largest companies can afford it, creating a monopoly. And when that happens, the company that holds the only approved product can set pricing withminimal competitive pressures. Two, smaller manufacturers can’t afford it and their products disappear and the market shrinks and access decreases. Three, we see a combination of both and who pays the price? Literally, patients do. Now here’s whereThere’s something I want you to really think about because this is where the regulatory argument falls apart when you look at it carefully. The FDA’s concern about DTE is that, and I’m quoting their official statement, tablets from the same manufacturing batches may not always provide the same thyroid hormone levels. This is from their FDA statement.And that’s a legitimate quality concern, right? It is. Thyroid medications have a narrow therapeutic window like any other hormone, meaning the difference between an effective dose and the dose that causes problems can be quite small. But here’s what the FDA doesn’t emphasize. Generic drugs have the exact same dosing inconsistency issue, and it’s considered acceptable and has been since we allowed generics on the market.So how does a generic drug dose work anyway? Well, for generic drugs to be approved as bioequivalent to a brand name medication, the FDA requires that the generic drugs bioavailability fall within 80 to 125 % of the brand name product. Isn’t that a dose inconsistency? Deb (32:22.894)from the brand name medication? 800 or sorry, 80 to 125%. According to the pharmacy times analysis of the FDA’s bioequivalent standards, the 80 to 125 % bioequivalence rule means that a generic drug can have 20 to 45 % variability compared to the original brand product.Now, most generics are much closer than that. The FDA study data shows that the mean difference for an AUC value between generic and reference products is about three and a half percent in the two year post-Waxman hatch period, and 80 % of the generics fall within a five percent range. But the FDA’s regulations allow for that much higher variability. And this is cited in an FDA study data mean difference for AUC.Now, let me put this in plain language. A patient could take a generic levothyroxine tablet where one batch provides, say, 75 micrograms of an active thyroid hormone. And the next batch from a different manufacturer, a different generic manufacturer, could provide up to 93.75 micrograms, 125 % of that 75. That’s an 18 microgram difference.in the same prescribed dose. Now, this is considered acceptable and patients tolerate it and this system works.Yet the FDA’s argument against DTE is that batch-to-batch inconsistency is unacceptable and requires this expensive biologic approval? That’s a double standard. So why is batch inconsistency acceptable for generic levothyroxine, but supposedly unacceptable for desiccated thyroid? I’ll give you the regulatory answer. Deb (34:29.366)because DDT is a biological product derived from an animal tissue and the FDA considers biological products to require more rigorous control. That’s the regulatory answer, but I’ll give you the real answer.because there’s no billion dollar pharmaceutical company with a patent pending on generic levothyroxine who petitioned the FDA to regulate their competitors more strictly. The inconsistency argument is legitimate, but it’s selectively applied. And that matters when you’re trying to understand whether this is really about patient safety or whether it’s about market control.Now I want to talk about something that hasn’t gotten nearly enough attention in this discussion and it’s something that makes me absolutely furious. What is Armour Thyroid? According to the official prescribing information published by AbbeV and available through rxabbev.com and the FDA’s daily med database, Armour Thyroid contains the following inactive ingredients. Calcium steroid,dextrose derived from corn, mycocrystalline cellulose,sodium starch glycolate and a opadri white coating. Now let’s talk about dextrose. Dextrose is a sugar derived from corn and while manufacturers claim that the corn derived dextrose in armor thyroid is gluten free, here’s the problem. Cross contamination during corn processing can introduce gluten proteins especially if the corn is processed in facilities that also handle Deb (36:18.808)wheat, barley, or rye. Corn sensitivity is extremely common in patients with celiac disease and non-celiac gluten sensitivity, and studies show that up to 50 % of the celiac patients react to corn proteins due to molecular mimicry, and the corn proteins look similar enough to gluten that the immune system attacks them. And this is cited by RestartMD.com.And here’s what’s documented in peer-reviewed medical literature in a 2023 case report published in Case Reports in Endocrinology. These researchers documented five patients with gluten intolerance or celiac who were taking natural desiccated thyroid. Three of those patients also reported lactose intolerance. Now these patients had to switch from DTE to liquid levothyroxine formulations to avoid the inactiveSo here’s my question. If AbbeV becomes the only manufacturer with an approved DTE product and their formulations contain corn-derived dextrose that triggers reactions in celiac patients, what are those patients supposed to do? They can’t take armor because of the corn. They can’t take compounded DTE because the FDA is banning compounding of these biologics. They can’t take NPKsor WP thyroid because those companies may not survive the BLA process. So they’re left with a synthetic version of levothyroxine which may not work for them.Now the NP thyroid and WP thyroid difference. Now here’s what’s interesting according to drugs.com comparison of inactive ingredients and P thyroid and P thyroid has calcium steroid dextrose also derived from corn, mineral oil, multi-crystalline cellulose. Deb (38:19.31)cross carmelicin sodium and a opadri to white. So NP thyroid also has corn-derived dextrose. WP thyroid on the other hand was specifically formulated to be hypoallergenic according to ROC labs, but it’s no longer available and its ingredients were inulin from chicory root and medium chain triglycerides. No corn, no gluten, no common allergies. So todayWe do not have a glandular thyroid, a DTE, that is not potentially contaminated with gluten. Yet, patients with autoimmune thyroid disease are supposed to avoid gluten.Now, some of these people can handle a DTE and many cannot, so that argument could be a mute point. But at the end of the day, the one product that we had that was designated for patients with multiple chemical sensitivities, celiac disease and coron allergies, has been off the market for a long time already.We have a monopoly problem. So if ABBV becomes the only approved manufacturer, patients with these celiac diseases and corn allergies will either be forced to take a medicine that makes them sick and triggers their immune reaction or switch to a synthetic that doesn’t adequately treat their hypothyroidism or choose to go without treatment. This is not hypothetical. This is real patients with real medical needs who are about to lose accessto the only formulation that works for their body. And the FDA’s response is silence. Deb (40:07.69)Now I want to highlight something that hasn’t gotten nearly enough attention in this discussion. Compounding pharmacies. What is a compounding pharmacy? Compounded medications are custom made by licensed pharmacists to meet a patient’s specific needs. Maybe you need a different strength that was commercially available, but you have an allergy to a filler or a dye in the commercial product. Maybe you need a liquid formulation or instead of a tablet or you need a capsule. That’s when compoundingin. And the FDA’s, this is the FDA’s definition of compounding. And for decades, compounding pharmacies have been making desiccated thyroid extract for patients who needed customization. Some patients couldn’t take the commercial products because of the dyes and the fillers, and some needed strengths that were not available. And these compounding pharmacies filled the gap.But reclassification changes everything. When the FDA reclassified DTE as a biologic in 2022 and reinforced that decision in August of 2025, explicitly stated, and I’m quoting directly from the FDA’s official statement, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biologic products under the Public Health Service Act.How can that be? These products have been approved since 1938 and the Biologics Act didn’t go into effect or doesn’t go into effect until August of 2026.So how in 2022 were they able to say that the compounding pharmacies could not make these products? Anyway, what this means is after August 2026, compounding pharmacies will no longer be permitted to compound a desiccated thyroid extract, even for patients with specific medical needs. Now, compounding pharmacies can still compound T4 and T3 separately, synthetic versions of levothyroxine and liothyronine, according to Deb (42:12.728)healing dose compounding pharmacy. These pharmacists can create custom ratios of these two synthetic hormones to approximate what a patient was receiving from a DTE. But that’s not the same thing. Some patients respond better to the whole DTE preparation than to a compounded synthetic combination. And for patients with specific allergies to standard fillers like your celiac patients that I just talked about, losing the ability to get a compounded DTE alternative isreal hardship. This is going to be a ripple effect. For a subset of patients, maybe 5 to 10 percent of those on DTE compounding was their lifeline and it was their way to get a medication formulation that worked for their unique body. When compounding goes away, these patients lose that option as well and for some it will be a significant problem. Now let’s talk about what this likely means for your wallet.The current pricing right now, according to SingleCare and GoodRx, Armour Thyroid costs approximately $150 to $157 for a 90-day supply of 60-milligram tablets, about $1.67 per tablet. With discount cards, some patients can get it down to $101 to $152 for a 90-day supply.Generic levon thyroxine costs about $70 for a 90 day supply, less than half that price. And p-thyroid costs approximately $133 for a 90 day supply of 60 milligrams with a discount card about $83 to $101.What happens after we get BLA approval? Well, here’s the pharmaceuticals pricing model. When a company spends 500 million to $1 billion to bring a product to market, including conducting massive clinical trials, the cost tens of millions of dollars they recoup in that investment through pricing power. And this is cited in the pharmaceutical pricing models. If ABBIEV is the only company with an approved BLA of DTE, Deb (44:18.248)They have pricing power. They don’t have competitors. They can set their price, whatever they want. And historically, when drugs transition from grandfather status, which is basically unregulated to formal formally approved status, prices often increase significantly, not always, but often. And typically they have to get re-approval for insurance. SoTouring Pharmaceuticals acquired DARPM and raised the price again from $1,350 to $750 overnight, a 5,000 % increase. This is the playbook.Let’s talk about insurance coverage. This is the other consideration. Insurance companies sometimes have different coverage policies for approved versions versus unapproved drugs. And right now, many insurance plans cover armor thyroid or NP thyroid, even though they’re technically unapproved because they’ve been on the market for decades and patients are on them. Once a drug becomes formally approved, insurance companies may have new contractual relationships, prior authorization requirements, or preferred drugs.list that could affect your coverage. If 1.5 million people have to get a prior auth for their insurance to cover this new medication, this is going to drive the doctor’s offices crazy. We do not have the staff to man this. We do not have the manpower. We do not have the time. This is going to interrupt people’s ability to get their medications. This is going to create chaos within the system. And some patients might see better coverage, but manymost likely are going to see worse coverage and some might find themselves in a situation where they need to try to get the drug approved first or get an approval for something else like levothyroxine and they’re going to have to document that it didn’t work and the documentation that they had from 20 years ago is probably not going to be enough because it’s not documented anywhere. It’s lost in the system after 10 years. So for patients the practical takeaway is expect Deb (46:25.774)a price increase. I would say possible, but I don’t think that’s true. think you’re going to see a price increase if they get approved. Expect possible insurance complexities, budget accordingly, talk to your insurance company now about what your coverage is going to look like in 2027 if they even know. And if you want my honest assessment of what is likely to happen,I’ll give you a scenario, 30 % likelihood. The FDA enforces the August 26 deadline and DTE products not approved by then are pulled from the market. Patients will have 30 to 90 days to transition to other medications. Some patients suffer significant symptom relapse. Compounding for DTE becomes illegal and this disruptiveness of the system creates a real hardship. Scenario two.which is 50 % likely. This is actually what the FDA commissioner, Marty McCreary suggested on August 13th of 2025 when he posted on social media. The FDA is committed to pursuing the first ever approval of desiccated thyroid access pending results of the ongoing clinical trials. In the meantime, we’ll ensure access for all Americans. Hopefully that continues. What this likely means is the FDA uses enforcement discretion to allow continuedsales while approvals are being pursued and the deadline gets extended. Maybe patients get access for another two to three years while companies work on a BLA approval. This would be the least disruptive scenario, but it’s also legally uncertain because the enforcement letters have been formally rescinded. And scenario three, which is 20 % likelihood, one or two companies get BLA approval. Those products stay on the market at higher product prices and companies, products, other companiescompanies, products are pulled, the market shrinks, availability is limited, prices are higher, but patients can still get something. This is likely if a seller successfully completes phase three trials for NP-thyroid. And my assessment is based on the regulatory language and the enforcement letters that have not been rescinded yet, that the pattern of FDA enforcement, I believe scenario two enforcement discretion with an extended time frame is most likely what we’re going to see. Deb (48:49.488)doesn’t mean patients should sit back and do nothing. It means you should be prepared for change while advocating for access. If you want to keep Arm or Thigh Right on the market, 1.5 million people need to start talking about this publicly and flooding our Congress people, Bobby Kennedy, the FDA, with what you want to see happen. We have the ability to shape this and to change this with our voice. But if we sit back on our laurels and we do absolutelynothing. What is going to happen is what the FDA wants to have happen and ABV wants to have happen because they’re going to simply think people don’t give a shit. And if the American people are going to be lazy and not want to step forward and actually start using their voice for some good and instead of just going to social media and bitching and hoping something is going to happen, well, then we’re going to get what we deserve. But if you start taking someaction and you start advocating for the things that you want. Contacting your representatives, contacting your U.S. tell them the FDA has done this. Many of them may not know this, may not be on their radar. Tell them what you want. Start going after this. Start writing to the FDA Commissioner’s Office. They have a website. They have a Commissioner’s Office at fda.hhs.gov. Be responsible.respectful, but be firm. Explain your scenario. How long you’ve been on DTE. Why levothyroxine doesn’t work. What symptoms you experience when not adequately treated. How this decision will affect your quality of life and your pocketbook. Let’s do something proactive. So let’s consider this. Moving forward, work with your provider who understands the regulatory landscape around DTE. You can discuss the evidence for and against combination therapy.You can monitor for thyroid function with free T3 and free T4 testing, not just TSH. If you’re willing to try individualized approaches, you can do that. If you need help finding a functional medicine provider who understands this issue, come to serenityhealthcarecenter.com or explorethevanari.com. It’s a self-directed functional medicine support group. And right now what is happening is going to shape how history Deb (51:19.024)is made with not just armor thyroid, but many drugs to come. And it is important for you to take action. So I want to thank you for joining me today on Let’s Talk Wellness Now. This episode is about far more than thyroid medication. It’s about your right to personalized medical treatment. It’s about your regulatory capture and corporate influence. And it’s about what happens when billion dollar companies shape healthcare policy in ways that reduce patient choice and increase their profits.this episode resonates with you or you know somebody who’s going to be affected by desiccated thyroid, please share it. Post it on social media, send it to your doctor, email it to your representatives, tag AbbeVee, tag FDA. Make noise because the only way we stop this is if we make it too politically costly for them to continue. Your voice truly matters. Your health truly matters and you deserve access to treatments that work best for your unique body.If you’re ready to explore comprehensive personalized health care that puts you in control, visit us at SerenityHealthCareCenter.com. Learn more about functional medicine approaches to thyroid and beyond and explore my new platform, Venari.com, which is a self-directed functional medicine tool. Thank you for joining me today. Until next time, I’m Dr. Deb reminding you, your health is your responsibility, your choice, and your right. Be well, stay informed, fight back.and I’ll see you in the next episode. And if you’re looking for a full citation list of this episode, you can head over to letstalkwellnessnow.com and I will post all the citations for you so you have them in your arsenal as well. Thank you again.The post Episode 259 – The Desiccated Thyroid Crisis: FDA's Unseen Impact & Corporate Manipulation first appeared on Let's Talk Wellness Now.

On September 7, 2022, Wisconsin Senator Tammy Baldwin introduced bill S.4794 - Naloxone Education and Access Act (NEAA). This bill reauthorizes through FY2027, expands eligibility for, and otherwise makes changes to a grant program that supports access to medications that reverse opioid overdoses (e.g., naloxone). What might this mean for K-12 schools? WHAT IS AN OPIOID? Opioids are a class of drug prescribed by doctors to treat moderate to severe pain. Common types of opioids are oxycodone (Oxycontin), hydrocodone (Vicodin), morphine, and methadone (REMS, 2022). OPIOID USE DATA. According to the 2017 Final Report of the President's Commission on Combating Drug Addiction and Opioid Crisis: In 2016, an estimated 239,000 adolescents aged 12 to 17 were current misusers of pain relievers (1.0% of adolescents), and 631,000 young adults aged 18 to 25 misused pain relievers in the past month (1.8% of young adults) … Among adolescents aged 12 to 17, 152,000 (0.6%) had a pain reliever use disorder in the past year, and 291,000 young adults aged 18 to 25 (0.8%) and 1.3 million adults aged 26 or older in 2016 (0.6%) had a pain reliever use disorder in the past year (p. 24). OPIOIDS IN SCHOOLS. Opioid use and overdoses are increasing in schools. In addition to user-exposure, second-hand exposure also poses risks, especially with fentanyl, a synthetic opioid, which is 50 to 100 times more potent than morphine (REMS, 2022). Per EducationWeek, “Citing concerns about student opioid use—and fentanyl specifically—a growing number of districts have equipped schools with naloxone, a drug that temporarily reduces the harmful effects of overdoses. The Los Angeles Unified School District became the latest to do so last month when it said it would stock the drug, and train qualified staff to use it, as part of a multiprong response to a “devastating epidemic of overdoses that are all too common in Los Angeles. [Other] districts—from Des Moines, Iowa, to Denver— have also stocked naloxone in recent years, some empowered by changes in state laws that make it easier to do so.” (Blad, 2022). SENATOR BALDWIN'S BILL. The bill would amend Section 545 of the Public Health Service Act and bring federal-level clarity and guidance to states regarding who can dispense reversal medication, where it can be placed, training, and immunity for using it in an attempt to benefit a suspected overdose person. Specifically, the NEAA would strike “for pharmacists to dispense a drug or device approved and cleared” and insert “that increase access to drugs and devices approved, cleared, or otherwise legally-marketed.” In other words, reversal drugs would be available to community-based distribution programs and there would be some type of “standing order” allowing for non-medical personnel to administer the reversal drug. CONSIDERATIONS FOR SCHOOLS. For some educators and community members, Naloxone on campus will signal a defeat against the invasiveness of opioids. Once Naloxone is stashed in AED cabinets - it's there forever. Others will have more favorable perceptions that might center on saving lives. How will schools integrate opioid awareness and overdose prevention along with other alcohol and other drug (AOD) programs? Naloxone availability has been impacted by supply chain disruptions, but it's typically about $25 per dose and there's little incentive for someone to steal or misuse it. Naloxone could be placed in the AED cabinet, for example. A top concern for school officials will be legal ramifications of administering Naloxone. Would a student be permitted to administer it to another student? Who has discretion to use it? A guidance document from REMS (2022) states, “Identify, with general counsel, and inform the campus community about state Good Samaritan laws that provide immunity from arrest, charge, or prosecution for certain drug offenses for a person experiencing an overdose — or witnessing another person experiencing an overdose — who seeks medical attention.” So, it's ultimately placing the risk upon the local board of education and the school's insurer. Hopefully, Senator Baldwin's proposed bill, or others like it, will align Naloxone with the standard for a non-trained person to be able to use a publicly-available AED to attempt to benefit a person encountering a heart attack. SOURCES: Blad, E. (2022, October 10). Why Districts Are Stocking Naloxone in Response to the Opioid Crisis. Education Week.; Preparing for Opioid-Related Emergencies for K-12 Schools and Institutions of Higher Education. Readiness and Emergency Management for Schools (REMS) Technical Assistance (TA). (Retrieved 2022) SAFETY DOC WEBSITE, BLOG & BOOKS: www.safetyphd.com. The Safety Doc Podcast is hosted & produced by David P. Perrodin, PhD. This podcast and blog post represent the opinions of David P. Perrodin and his guests to the show. This is episode 199 of The Safety Doc Podcast published on 12-20-2022. Purchase Dr. Perrodin's Books: School of Errors – Rethinking School Safety in America. www.schooloferrors.com Velocity of Information - Human Thinking During Chaotic Times. www.velocityofinformation.com

H.R.4693 — 117th Congress (2021-2022)Global Malnutrition Prevention and Treatment Act of 2021Sponsor: McCaul, Michael T. [Rep.-R-TX-10] (Introduced 07/26/2021) Cosponsors: (102)Committees: House - Foreign Affairs | Senate - Foreign RelationsLatest Action: 10/19/2022 Became Public Law No: 117-214. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed HousePassed SenateTo PresidentBecame Law S.4791 — 117th Congress (2021-2022)A bill to amend section 301 of title 44, United States Code, to establish a term for the appointment of the Director of the Government Publishing Office.Sponsor: Blunt, Roy [Sen.-R-MO] (Introduced 09/06/2022) Cosponsors: (0)Latest Action: 10/17/2022 Became Public Law No: 117-213. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame LawS.4205 — 117th Congress (2021-2022)PAW ActSponsor: Peters, Gary C. [Sen.-D-MI] (Introduced 05/12/2022) Cosponsors: (2)Committees: Senate - Homeland Security and Governmental AffairsCommittee Report: S. Rept. 117-140Latest Action: 10/17/2022 Became Public Law No: 117-212. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame LawS.3470 — 117th Congress (2021-2022)End Human Trafficking in Government Contracts Act of 2022Sponsor: Lankford, James [Sen.-R-OK] (Introduced 01/11/2022) Cosponsors: (1)Committees: Senate - Homeland Security and Governmental AffairsCommittee Report: S. Rept. 117-116Latest Action: 10/17/2022 Became Public Law No: 117-211. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame LawS.3157 — 117th Congress (2021-2022)Bridging the Gap for New Americans ActSponsor: Klobuchar, Amy [Sen.-D-MN] (Introduced 11/03/2021) Cosponsors: (5)Committees: Senate - Health, Education, Labor, and PensionsLatest Action: 10/17/2022 Became Public Law No: 117-210. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame Law S.2794 — 117th Congress (2021-2022)Supporting Families of the Fallen ActSponsor: Tuberville, Tommy [Sen.-R-AL] (Introduced 09/22/2021) Cosponsors: (8)Committees: Senate - Veterans' AffairsLatest Action: 10/17/2022 Became Public Law No: 117-209. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame Law S.2771 — 117th Congress (2021-2022)A bill to designate the community-based outpatient clinic of the Department of Veterans Affairs in San Angelo, Texas, as the "Colonel Charles and JoAnne Powell Department of Veterans Affairs Clinic".Sponsor: Cornyn, John [Sen.-R-TX] (Introduced 09/21/2021) Cosponsors: (1)Committees: Senate - Veterans' AffairsLatest Action: 10/17/2022 Became Public Law No: 117-208. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame Law S.2551 — 117th Congress (2021-2022)AI Training ActSponsor: Peters, Gary C. [Sen.-D-MI] (Introduced 07/29/2021) Cosponsors: (1)Committees: Senate - Homeland Security and Governmental AffairsCommittee Report: S. Rept. 117-40Latest Action: 10/17/2022 Became Public Law No: 117-207. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame Law S.2490 — 117th Congress (2021-2022)Blackwell School National Historic Site ActSponsor: Cornyn, John [Sen.-R-TX] (Introduced 07/27/2021) Cosponsors: (1)Committees: Senate - Energy and Natural ResourcesCommittee Report: S. Rept. 117-92Latest Action: 10/17/2022 Became Public Law No: 117-206. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame Law S.1198 — 117th Congress (2021-2022)Solid Start Act of 2022Sponsor: Hassan, Margaret Wood [Sen.-D-NH] (Introduced 04/15/2021) Cosponsors: (5)Committees: Senate - Veterans' AffairsLatest Action: 10/17/2022 Became Public Law No: 117-205. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame LawS.958 — 117th Congress (2021-2022)Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care ActSponsor: Rosen, Jacky [Sen.-D-NV] (Introduced 03/24/2021) Cosponsors: (6)Committees: Senate - Health, Education, Labor, and PensionsLatest Action: 10/17/2022 Became Public Law No: 117-204. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame LawS.516 — 117th Congress (2021-2022)Advanced Air Mobility Coordination and Leadership ActSponsor: Moran, Jerry [Sen.-R-KS] (Introduced 03/01/2021) Cosponsors: (1)Committees: Senate - Commerce, Science, and TransportationCommittee Report: S. Rept. 117-53Latest Action: 10/17/2022 Became Public Law No: 117-203. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseResolving DifferencesTo PresidentBecame LawS.442 — 117th Congress (2021-2022)BRIGHT ActSponsor: Peters, Gary C. [Sen.-D-MI] (Introduced 02/25/2021) Cosponsors: (1)Committees: Senate - Homeland Security and Governmental AffairsCommittee Report: S. Rept. 117-80Latest Action: 10/17/2022 Became Public Law No: 117-202. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame LawS.169 — 117th Congress (2021-2022)ARTS ActSponsor: Tillis, Thomas [Sen.-R-NC] (Introduced 02/02/2021) Cosponsors: (3)Committees: Senate - JudiciaryLatest Action: 10/17/2022 Became Public Law No: 117-201. (All Actions)Tracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedPassed SenatePassed HouseTo PresidentBecame Law H.R.3531 — 117th Congress (2021-2022)Women Who Worked on the Home Front World War II Memorial ActSponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large] (Introduced 05/25/2021) Cosponsors: (12)Committees: House - Natural Resources | Senate - Energy and Natural ResourcesCommittee Reports: S. Rept. 117-189, H. Rept. 117-197Latest Action: Senate - 10/18/2022 Placed on Senate Legislative Calendar under General Orders. Calendar No. 540. (All Actions)Tracker:This bill has the status Passed HouseHere are the steps for Status of Legislation:IntroducedPassed HousePassed SenateTo PresidentBecame Law H.R.9223 — 117th Congress (2021-2022)To require analyses of the impact of Government rules, programs, and policies on poverty and racial inequity, including the racial wealth gap, and for other purposes.Sponsor: Williams, Nikema [Rep.-D-GA-5] (Introduced 10/21/2022) Cosponsors: (4)Committees: House - Oversight and Reform; JudiciaryLatest Action: House - 10/21/2022 Referred to the Committee on Oversight and Reform, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee... (All Actions)Tracker:This bill has the status IntroducedHere are the steps for Status of Legislation:IntroducedPassed HousePassed SenateTo PresidentBecame Law2. H.R.9222 — 117th Congress (2021-2022)To amend title XXVII of the Public Health Service Act to increase health insurance access for individuals placing their newborns up for adoption.Sponsor: Van Duyne, Beth [Rep.-R-TX-24] (Introduced 10/21/2022) Cosponsors: (2)Committees: House - Energy and CommerceLatest Action: House - 10/21/2022 Referred to the House Committee on Energy and Commerce. (All Actions)Tracker:This bill has the status IntroducedHere are the steps for Status of Legislation:IntroducedPassed HousePassed SenateTo PresidentBecame Law3. H.R.9221 — 117th Congress (2021-2022)To establish an awareness campaign related to the lethality of fentanyl and fentanyl-contaminated drugs, to establish a Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs, and to provide community-based coalition enhancement grants to mitigate the effects of drug use.Sponsor: Trone, David J. [Rep.-D-MD-6] (Introduced 10/21/2022) Cosponsors: (3)Committees: House - Energy and CommerceLatest Action: House - 10/21/2022 Referred to the House Committee on Energy and Commerce. (All Actions)Tracker:This bill has the status IntroducedHere are the steps for Status of Legislation:IntroducedPassed HousePassed SenateTo PresidentBecame Law4. H.R.9220 — 117th Congress (2021-2022)To amend the Public Health Service Act to provide for a national public awareness campaign to inform health care professionals and health care professional students on how to help patients navigate the legal landscape in the United States with respect to abortion and other reproductive health care services following the Supreme Court's decision to overturn Roe v. Wade, and for other purposes.Sponsor: Trahan, Lori [Rep.-D-MA-3] (Introduced 10/21/2022) Cosponsors: (14)Committees: House - Energy and CommerceLatest Action: House - 10/21/2022 Referred to the House Committee on Energy and Commerce. (All Actions)Tracker:This bill has the status IntroducedHere are the steps for Status of Legislation:IntroducedPassed HousePassed SenateTo PresidentBecame Law5. H.R.9219 — 117th Congress (2021-2022)To amend the Civil Rights Act of 1964 to clari

This is Garrison Hardie with your CrossPolitic Daily News Brief for Wednesday, October 12th, 2022. I just got back from our Fight Laugh Feast Conference in Knoxville TN, and we announced while we were out there, where our next conference will be at the Ark Encounter next year! So stay tuned for when registration will open up, and we hope to see you and your family out in Kentucky, October of next year. Also, FLF Magazine: We are on a mission to make magazines great again. So, subscribe to our Fight Laugh Feast magazine. This is a quarterly mini-book like experience, packed full of a variety of authors that includes theologically-driven cultural commentary, a Psalm of the quarter, recipes for feasting, laughter sprinkled throughout the glossy pages, and more. Sign your church up, sign your grumpy uncle up, and while you are at it…sign up the Pope, Elon Musks, and Russel Moore. Disclaimer: This magazine will guarantee various responses and CrossPolitic is not held liable for any of them. Reading the whole magazine may cause theological maturation, possibly encourage your kids to take the Lord’s Supper with you, and will likely cause you to randomly chuckle in joy at God’s wondrous world. Sign up today! Four issues and $60 per year, that is it. Go to fightlaughfeast.com right now to sign up!. Now, here’s what you may have missed over the weekend. https://www.dailywire.com/news/colorado-officials-incorrectly-sent-out-30000-voter-registration-postcards-to-noncitizens Colorado Officials ‘Incorrectly’ Sent Out 30,000 Voter Registration Postcards To Noncitizens Colorado officials claim they accidentally sent approximately 30,000 postcards last month to noncitizens instructing them how they could register to vote. First reported by Colorado Public Radio News, Democratic Secretary of State Jena Griswold’s office said department employees had sent the postcards on Sept. 27 after comparing a list of 102,000 names provided by the Electronic Registration Information Center, a nonprofit organization aiming to improve U.S. voter rolls and advocating residents to vote. “The Department has become aware that approximately 30,000 EBU [Eligible But Unregistered] postcard mailers were incorrectly sent to ineligible Coloradans,” a spokesperson for the Colorado Secretary of State’s Office told local media. “The office is undertaking an internal review of the incident and will take any corrective action that is warranted.” Griswold insisted noncitizens would not be allowed to register to vote. The postcards, which the office printed in English and Spanish, read, “A message from Colorado Secretary of State Jena Griswold . . . Our records indicate that you or your household may be eligible to vote, but do not appear to be registered at your current address.” The mailers did include that to vote that residents must be 18 years old by Election Day, a United States citizen, and a Colorado resident for at least 22 days before the upcoming election, according to Colorado Public Radio News. Griswold’s office said they plan on sending out correction mailers to the noncitizens, “reminding them that only those that meet the above requirements are eligible to register.” According to local media, while the office had compared the list of potential unregistered voters to local DMV records, the data had included noncitizen drivers with Colorado driver’s licenses which the state issues for noncitizens to drive legally. The National Council on State Legislatures website shows Colorado as one of at least 17 states, along with the District of Columbia, that issue driver’s licenses to non-U.S. citizens. However, the system did not distinguish their eligibility to vote. Sean Morales-Doyle, director of the Voting Rights Program at the Brennan Center for Justice, told The Journal that the system making a mistake indicates it works. Griswold is up for reelection in the November midterms, where she will face Republican Pam Anderson, the head of the state’s county clerks association. https://www.theepochtimes.com/exclusive-cdc-wont-release-review-of-post-vaccination-heart-inflammation_4786038.html?utm_source=partner&utm_campaign=BonginoReport&src_src=partner&src_cmp=BonginoReport CDC Won’t Release Review of Post-Vaccination Heart Inflammation The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation. The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System. But the agency is saying that federal law prevents it from releasing the results. The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request. One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.” The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person. The information sought is available through the CDC website without details that would identify patients, the agency also said. The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email. Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center. “The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email. Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers. Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.” In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021. The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time. A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal. Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear. The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data. The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act. Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal. https://www.breitbart.com/politics/2022/10/10/nike-co-founder-phil-knight-donates-1-million-to-republican-oregon-gov-candidate-christine-drazan/ Nike Co-Founder Phil Knight Donates $1 Million to Republican Oregon Gov. Candidate Christine Drazan Knight’s donation to Drazan’s campaign comes after he donated $3.75 million to Independent candidate Betsy Johnson, signaling his strong dislike for Tina Kotek. Republican strategist Rebecca Tweed told KGW Knight’s donation said the two donations are not meant as an endorsement of either candidate but rather an attack against the Democrat candidate. The donation comes as Christine Drazan stands within striking distance of unseating Kotek in a deep blue state that has not elected a Republican governor since Vic Atiyeh in 1982. As Breitbart News reported last week, a recent Emerson College poll showed the Oregon House Republican leader actually leading Koteck by two points – 36 percent to 34 percent. A new Emerson College Polling survey shows former Oregon House Republican leader Drazan ahead of former state House Speaker Tina Kotek (D)–36 percent to 34 percent. Nineteen percent of those polled plan to vote for former Democrat state senator-turned independent Betsy Johnson. The poll was conducted between Sept. 30 – Oct. 1 with 796 very likely Oregon voters. The survey’s Credibility Interval (CI), similar to a margin of error, is ±3.4 percentage points. KGW political analyst Len Bergstein concurred with Rebecca Tweed that Phil Knight’s donation should be seen as a knock against Kotek by potentially putting Drazan on the path to victory. “As soon as he sees some polls that say ‘wait a minute, there’s a chance that Drazan could win,’ he’s saying well maybe my money could make the difference to push her over the top,” said Bergstein. “This is not a normal election. We’re having fun watching it because we have three original candidates for governor and a lot of interesting twists and turns in the race already,” Bergstein added. Armored Republic The Mission of Armored Republic is to Honor Christ by equipping Free Men with Tools of Liberty necessary to preserve God-given rights. In the Armored Republic there is no King but Christ. We are Free Craftsmen. Body Armor is a Tool of Liberty. We create Tools of Liberty. Free men must remain ever vigilant against tyranny wherever it appears. God has given us the tools of liberty needed to defend the rights He bestowed to us. Armored Republic is honored to offer you those Tools. Visit them, at ar500armor.com https://thepostmillennial.com/bidens-railway-deal-to-avert-strike-spiked-by-union?utm_campaign=64487 Biden's railway deal to avert strike spiked by union Nearly a month after President Biden announced that a deal had been reached between railroad companies and their unions, the deal has fallen apart, raising concerns for a possible strike. The Brotherhood of Maintenance of Way Employees Division of the Teamsters, one of the nation’s largest railroad unions, rejected the deal on Monday, expressing discontent with the number of paid sick days, according to the Washington Post. Officials said that members of the third-largest union rejected the proposed five-year contract in a 56 to 43 percent split. Both sides have agreed to continue with negotiations until at least November 19. Railroads are currently expected to continue operating normally. The deal included a 24 percent increase in pay by 2024, as well as $1,000 annual bonuses for employees over five years. The plan ensured that healthcare co-pays would not increase in price, but included only one paid sick day compared to the 15 days union leaders pushed for. The deal followed two years of negotiations between the rail carriers and unions, which prompted the White House to appoint an emergency board in July to mediate between the two groups. In September, Biden applauded the tentative deal reached, calling it "an important win for our economy and the American people." Now, it’s time for my favorite topic, sports! Let’s catch up with what’s happening in the world of football shall we? First in the college ranks: #3 Alabama 24 Texas A&M 20 #2 Ohio State 49 Michigan State 20 #1 Georgia 42 Auburn 10 #15 NC State 19 Florida State 17 Texas 49 OU 0 #13 TCU 38 #19 Kansas 31 #7 USC 30 WSU 14 NFL: Giants 27 Packers 22 Chargers 30 Browns 28 Jets 40 Dolphins 17 Bills 38 Steelers 3 Cowboys 22 Rams 10 Chiefs 30 Raiders 29 So that’s what you may have missed over the weekend: This has been your CrossPolitic Daily News Brief. If you liked the show, hit that share button for me down below. If you want to come to our conference next year, if you want to sign up for a club membership, or sign up for a magazine subscription, you can do all of that at fightlaughfeast.com. As always, if you’d like to email me a news story, ask about our conference, or become a corporate partner of CrossPolitic, email me, at garrison@fightlaughfeast.com. For CrossPolitic News, I’m Garrison Hardie. Have a great day, and Lord bless.

This is Garrison Hardie with your CrossPolitic Daily News Brief for Wednesday, October 12th, 2022. I just got back from our Fight Laugh Feast Conference in Knoxville TN, and we announced while we were out there, where our next conference will be at the Ark Encounter next year! So stay tuned for when registration will open up, and we hope to see you and your family out in Kentucky, October of next year. Also, FLF Magazine: We are on a mission to make magazines great again. So, subscribe to our Fight Laugh Feast magazine. This is a quarterly mini-book like experience, packed full of a variety of authors that includes theologically-driven cultural commentary, a Psalm of the quarter, recipes for feasting, laughter sprinkled throughout the glossy pages, and more. Sign your church up, sign your grumpy uncle up, and while you are at it…sign up the Pope, Elon Musks, and Russel Moore. Disclaimer: This magazine will guarantee various responses and CrossPolitic is not held liable for any of them. Reading the whole magazine may cause theological maturation, possibly encourage your kids to take the Lord’s Supper with you, and will likely cause you to randomly chuckle in joy at God’s wondrous world. Sign up today! Four issues and $60 per year, that is it. Go to fightlaughfeast.com right now to sign up!. Now, here’s what you may have missed over the weekend. https://www.dailywire.com/news/colorado-officials-incorrectly-sent-out-30000-voter-registration-postcards-to-noncitizens Colorado Officials ‘Incorrectly’ Sent Out 30,000 Voter Registration Postcards To Noncitizens Colorado officials claim they accidentally sent approximately 30,000 postcards last month to noncitizens instructing them how they could register to vote. First reported by Colorado Public Radio News, Democratic Secretary of State Jena Griswold’s office said department employees had sent the postcards on Sept. 27 after comparing a list of 102,000 names provided by the Electronic Registration Information Center, a nonprofit organization aiming to improve U.S. voter rolls and advocating residents to vote. “The Department has become aware that approximately 30,000 EBU [Eligible But Unregistered] postcard mailers were incorrectly sent to ineligible Coloradans,” a spokesperson for the Colorado Secretary of State’s Office told local media. “The office is undertaking an internal review of the incident and will take any corrective action that is warranted.” Griswold insisted noncitizens would not be allowed to register to vote. The postcards, which the office printed in English and Spanish, read, “A message from Colorado Secretary of State Jena Griswold . . . Our records indicate that you or your household may be eligible to vote, but do not appear to be registered at your current address.” The mailers did include that to vote that residents must be 18 years old by Election Day, a United States citizen, and a Colorado resident for at least 22 days before the upcoming election, according to Colorado Public Radio News. Griswold’s office said they plan on sending out correction mailers to the noncitizens, “reminding them that only those that meet the above requirements are eligible to register.” According to local media, while the office had compared the list of potential unregistered voters to local DMV records, the data had included noncitizen drivers with Colorado driver’s licenses which the state issues for noncitizens to drive legally. The National Council on State Legislatures website shows Colorado as one of at least 17 states, along with the District of Columbia, that issue driver’s licenses to non-U.S. citizens. However, the system did not distinguish their eligibility to vote. Sean Morales-Doyle, director of the Voting Rights Program at the Brennan Center for Justice, told The Journal that the system making a mistake indicates it works. Griswold is up for reelection in the November midterms, where she will face Republican Pam Anderson, the head of the state’s county clerks association. https://www.theepochtimes.com/exclusive-cdc-wont-release-review-of-post-vaccination-heart-inflammation_4786038.html?utm_source=partner&utm_campaign=BonginoReport&src_src=partner&src_cmp=BonginoReport CDC Won’t Release Review of Post-Vaccination Heart Inflammation The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation. The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System. But the agency is saying that federal law prevents it from releasing the results. The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request. One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.” The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person. The information sought is available through the CDC website without details that would identify patients, the agency also said. The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email. Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center. “The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email. Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers. Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.” In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021. The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time. A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal. Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear. The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data. The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act. Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal. https://www.breitbart.com/politics/2022/10/10/nike-co-founder-phil-knight-donates-1-million-to-republican-oregon-gov-candidate-christine-drazan/ Nike Co-Founder Phil Knight Donates $1 Million to Republican Oregon Gov. Candidate Christine Drazan Knight’s donation to Drazan’s campaign comes after he donated $3.75 million to Independent candidate Betsy Johnson, signaling his strong dislike for Tina Kotek. Republican strategist Rebecca Tweed told KGW Knight’s donation said the two donations are not meant as an endorsement of either candidate but rather an attack against the Democrat candidate. The donation comes as Christine Drazan stands within striking distance of unseating Kotek in a deep blue state that has not elected a Republican governor since Vic Atiyeh in 1982. As Breitbart News reported last week, a recent Emerson College poll showed the Oregon House Republican leader actually leading Koteck by two points – 36 percent to 34 percent. A new Emerson College Polling survey shows former Oregon House Republican leader Drazan ahead of former state House Speaker Tina Kotek (D)–36 percent to 34 percent. Nineteen percent of those polled plan to vote for former Democrat state senator-turned independent Betsy Johnson. The poll was conducted between Sept. 30 – Oct. 1 with 796 very likely Oregon voters. The survey’s Credibility Interval (CI), similar to a margin of error, is ±3.4 percentage points. KGW political analyst Len Bergstein concurred with Rebecca Tweed that Phil Knight’s donation should be seen as a knock against Kotek by potentially putting Drazan on the path to victory. “As soon as he sees some polls that say ‘wait a minute, there’s a chance that Drazan could win,’ he’s saying well maybe my money could make the difference to push her over the top,” said Bergstein. “This is not a normal election. We’re having fun watching it because we have three original candidates for governor and a lot of interesting twists and turns in the race already,” Bergstein added. Armored Republic The Mission of Armored Republic is to Honor Christ by equipping Free Men with Tools of Liberty necessary to preserve God-given rights. In the Armored Republic there is no King but Christ. We are Free Craftsmen. Body Armor is a Tool of Liberty. We create Tools of Liberty. Free men must remain ever vigilant against tyranny wherever it appears. God has given us the tools of liberty needed to defend the rights He bestowed to us. Armored Republic is honored to offer you those Tools. Visit them, at ar500armor.com https://thepostmillennial.com/bidens-railway-deal-to-avert-strike-spiked-by-union?utm_campaign=64487 Biden's railway deal to avert strike spiked by union Nearly a month after President Biden announced that a deal had been reached between railroad companies and their unions, the deal has fallen apart, raising concerns for a possible strike. The Brotherhood of Maintenance of Way Employees Division of the Teamsters, one of the nation’s largest railroad unions, rejected the deal on Monday, expressing discontent with the number of paid sick days, according to the Washington Post. Officials said that members of the third-largest union rejected the proposed five-year contract in a 56 to 43 percent split. Both sides have agreed to continue with negotiations until at least November 19. Railroads are currently expected to continue operating normally. The deal included a 24 percent increase in pay by 2024, as well as $1,000 annual bonuses for employees over five years. The plan ensured that healthcare co-pays would not increase in price, but included only one paid sick day compared to the 15 days union leaders pushed for. The deal followed two years of negotiations between the rail carriers and unions, which prompted the White House to appoint an emergency board in July to mediate between the two groups. In September, Biden applauded the tentative deal reached, calling it "an important win for our economy and the American people." Now, it’s time for my favorite topic, sports! Let’s catch up with what’s happening in the world of football shall we? First in the college ranks: #3 Alabama 24 Texas A&M 20 #2 Ohio State 49 Michigan State 20 #1 Georgia 42 Auburn 10 #15 NC State 19 Florida State 17 Texas 49 OU 0 #13 TCU 38 #19 Kansas 31 #7 USC 30 WSU 14 NFL: Giants 27 Packers 22 Chargers 30 Browns 28 Jets 40 Dolphins 17 Bills 38 Steelers 3 Cowboys 22 Rams 10 Chiefs 30 Raiders 29 So that’s what you may have missed over the weekend: This has been your CrossPolitic Daily News Brief. If you liked the show, hit that share button for me down below. If you want to come to our conference next year, if you want to sign up for a club membership, or sign up for a magazine subscription, you can do all of that at fightlaughfeast.com. As always, if you’d like to email me a news story, ask about our conference, or become a corporate partner of CrossPolitic, email me, at garrison@fightlaughfeast.com. For CrossPolitic News, I’m Garrison Hardie. Have a great day, and Lord bless.

This is Garrison Hardie with your CrossPolitic Daily News Brief for Wednesday, October 12th, 2022. I just got back from our Fight Laugh Feast Conference in Knoxville TN, and we announced while we were out there, where our next conference will be at the Ark Encounter next year! So stay tuned for when registration will open up, and we hope to see you and your family out in Kentucky, October of next year. Also, FLF Magazine: We are on a mission to make magazines great again. So, subscribe to our Fight Laugh Feast magazine. This is a quarterly mini-book like experience, packed full of a variety of authors that includes theologically-driven cultural commentary, a Psalm of the quarter, recipes for feasting, laughter sprinkled throughout the glossy pages, and more. Sign your church up, sign your grumpy uncle up, and while you are at it…sign up the Pope, Elon Musks, and Russel Moore. Disclaimer: This magazine will guarantee various responses and CrossPolitic is not held liable for any of them. Reading the whole magazine may cause theological maturation, possibly encourage your kids to take the Lord’s Supper with you, and will likely cause you to randomly chuckle in joy at God’s wondrous world. Sign up today! Four issues and $60 per year, that is it. Go to fightlaughfeast.com right now to sign up!. Now, here’s what you may have missed over the weekend. https://www.dailywire.com/news/colorado-officials-incorrectly-sent-out-30000-voter-registration-postcards-to-noncitizens Colorado Officials ‘Incorrectly’ Sent Out 30,000 Voter Registration Postcards To Noncitizens Colorado officials claim they accidentally sent approximately 30,000 postcards last month to noncitizens instructing them how they could register to vote. First reported by Colorado Public Radio News, Democratic Secretary of State Jena Griswold’s office said department employees had sent the postcards on Sept. 27 after comparing a list of 102,000 names provided by the Electronic Registration Information Center, a nonprofit organization aiming to improve U.S. voter rolls and advocating residents to vote. “The Department has become aware that approximately 30,000 EBU [Eligible But Unregistered] postcard mailers were incorrectly sent to ineligible Coloradans,” a spokesperson for the Colorado Secretary of State’s Office told local media. “The office is undertaking an internal review of the incident and will take any corrective action that is warranted.” Griswold insisted noncitizens would not be allowed to register to vote. The postcards, which the office printed in English and Spanish, read, “A message from Colorado Secretary of State Jena Griswold . . . Our records indicate that you or your household may be eligible to vote, but do not appear to be registered at your current address.” The mailers did include that to vote that residents must be 18 years old by Election Day, a United States citizen, and a Colorado resident for at least 22 days before the upcoming election, according to Colorado Public Radio News. Griswold’s office said they plan on sending out correction mailers to the noncitizens, “reminding them that only those that meet the above requirements are eligible to register.” According to local media, while the office had compared the list of potential unregistered voters to local DMV records, the data had included noncitizen drivers with Colorado driver’s licenses which the state issues for noncitizens to drive legally. The National Council on State Legislatures website shows Colorado as one of at least 17 states, along with the District of Columbia, that issue driver’s licenses to non-U.S. citizens. However, the system did not distinguish their eligibility to vote. Sean Morales-Doyle, director of the Voting Rights Program at the Brennan Center for Justice, told The Journal that the system making a mistake indicates it works. Griswold is up for reelection in the November midterms, where she will face Republican Pam Anderson, the head of the state’s county clerks association. https://www.theepochtimes.com/exclusive-cdc-wont-release-review-of-post-vaccination-heart-inflammation_4786038.html?utm_source=partner&utm_campaign=BonginoReport&src_src=partner&src_cmp=BonginoReport CDC Won’t Release Review of Post-Vaccination Heart Inflammation The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation. The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System. But the agency is saying that federal law prevents it from releasing the results. The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request. One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.” The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person. The information sought is available through the CDC website without details that would identify patients, the agency also said. The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email. Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center. “The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email. Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers. Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.” In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021. The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time. A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal. Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear. The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data. The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act. Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal. https://www.breitbart.com/politics/2022/10/10/nike-co-founder-phil-knight-donates-1-million-to-republican-oregon-gov-candidate-christine-drazan/ Nike Co-Founder Phil Knight Donates $1 Million to Republican Oregon Gov. Candidate Christine Drazan Knight’s donation to Drazan’s campaign comes after he donated $3.75 million to Independent candidate Betsy Johnson, signaling his strong dislike for Tina Kotek. Republican strategist Rebecca Tweed told KGW Knight’s donation said the two donations are not meant as an endorsement of either candidate but rather an attack against the Democrat candidate. The donation comes as Christine Drazan stands within striking distance of unseating Kotek in a deep blue state that has not elected a Republican governor since Vic Atiyeh in 1982. As Breitbart News reported last week, a recent Emerson College poll showed the Oregon House Republican leader actually leading Koteck by two points – 36 percent to 34 percent. A new Emerson College Polling survey shows former Oregon House Republican leader Drazan ahead of former state House Speaker Tina Kotek (D)–36 percent to 34 percent. Nineteen percent of those polled plan to vote for former Democrat state senator-turned independent Betsy Johnson. The poll was conducted between Sept. 30 – Oct. 1 with 796 very likely Oregon voters. The survey’s Credibility Interval (CI), similar to a margin of error, is ±3.4 percentage points. KGW political analyst Len Bergstein concurred with Rebecca Tweed that Phil Knight’s donation should be seen as a knock against Kotek by potentially putting Drazan on the path to victory. “As soon as he sees some polls that say ‘wait a minute, there’s a chance that Drazan could win,’ he’s saying well maybe my money could make the difference to push her over the top,” said Bergstein. “This is not a normal election. We’re having fun watching it because we have three original candidates for governor and a lot of interesting twists and turns in the race already,” Bergstein added. Armored Republic The Mission of Armored Republic is to Honor Christ by equipping Free Men with Tools of Liberty necessary to preserve God-given rights. In the Armored Republic there is no King but Christ. We are Free Craftsmen. Body Armor is a Tool of Liberty. We create Tools of Liberty. Free men must remain ever vigilant against tyranny wherever it appears. God has given us the tools of liberty needed to defend the rights He bestowed to us. Armored Republic is honored to offer you those Tools. Visit them, at ar500armor.com https://thepostmillennial.com/bidens-railway-deal-to-avert-strike-spiked-by-union?utm_campaign=64487 Biden's railway deal to avert strike spiked by union Nearly a month after President Biden announced that a deal had been reached between railroad companies and their unions, the deal has fallen apart, raising concerns for a possible strike. The Brotherhood of Maintenance of Way Employees Division of the Teamsters, one of the nation’s largest railroad unions, rejected the deal on Monday, expressing discontent with the number of paid sick days, according to the Washington Post. Officials said that members of the third-largest union rejected the proposed five-year contract in a 56 to 43 percent split. Both sides have agreed to continue with negotiations until at least November 19. Railroads are currently expected to continue operating normally. The deal included a 24 percent increase in pay by 2024, as well as $1,000 annual bonuses for employees over five years. The plan ensured that healthcare co-pays would not increase in price, but included only one paid sick day compared to the 15 days union leaders pushed for. The deal followed two years of negotiations between the rail carriers and unions, which prompted the White House to appoint an emergency board in July to mediate between the two groups. In September, Biden applauded the tentative deal reached, calling it "an important win for our economy and the American people." Now, it’s time for my favorite topic, sports! Let’s catch up with what’s happening in the world of football shall we? First in the college ranks: #3 Alabama 24 Texas A&M 20 #2 Ohio State 49 Michigan State 20 #1 Georgia 42 Auburn 10 #15 NC State 19 Florida State 17 Texas 49 OU 0 #13 TCU 38 #19 Kansas 31 #7 USC 30 WSU 14 NFL: Giants 27 Packers 22 Chargers 30 Browns 28 Jets 40 Dolphins 17 Bills 38 Steelers 3 Cowboys 22 Rams 10 Chiefs 30 Raiders 29 So that’s what you may have missed over the weekend: This has been your CrossPolitic Daily News Brief. If you liked the show, hit that share button for me down below. If you want to come to our conference next year, if you want to sign up for a club membership, or sign up for a magazine subscription, you can do all of that at fightlaughfeast.com. As always, if you’d like to email me a news story, ask about our conference, or become a corporate partner of CrossPolitic, email me, at garrison@fightlaughfeast.com. For CrossPolitic News, I’m Garrison Hardie. Have a great day, and Lord bless.

Is Executive Order 14067 actually communism in its purest form.!? Well, today's episode is a great place to start. Clay Clark, CEO of Thrive15.com and host of the Thrivetime Show, returns to the program to explain how Executive Order is essentially copying one right out of the Chinese social credit system. Strap in... — there's more than just that going on here! This episode also covers: What exactly is EO 14067? How does it work? Why should we care? Clay's BOMBS: Is Biden Planning On Removing the Cash In America Beginning On December 13th 2022? https://www.presidency.ucsb.edu/documents/executive-order-14067-ensuring-responsible-development-digital-assets - Sec. 4. Policy and Actions Related to United States Central Bank Digital Currencies. (a) The policy of my Administration on a United States CBDC is as follows: https://www.wnd.com/2022/08/biden-planning-protect-us-cash-beginning-dec-13/ What Is Executive Order 14067? | Does the Central Bank Digital C Read Section 4 of Executive Order 14067 | Will Freedom Die On December 13th 2022? | Read Executive Order 14067 - https://rumble.com/v1g81nx-executive-order-14067-will-freedom-die-on-december-13th-2022-read-executive.html Why is the World Economic Forum logo 666? - See the World Economic Forum Logo - https://www.weforum.org/ Why is the CERN Logo 666? - See their logo - https://www.home.cern/ “11 And they had a king over them, which is the angel of the bottomless pit, whose name in the Hebrew tongue is Abaddon, but in the Greek tongue hath his name Apollyon.” - Revelation 9:11 WATCH - https://rumble.com/v1b9d3z-cern-why-does-cern-have-a-666-logo.html Why did CERN name the internet “WWW” which is “666” in Hebrew? - https://rumble.com/v1cpml9-666-.html Why is the Word Corona 666? Why does Microsoft have a patent with a WO-2020-060606 publication number? - https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2020060606 Why Is the Google Chrome Logo 666? - https://www.quora.com/What-is-the-Google-Chrome-logo-supposed-to-be Why is Congress working on legislation HR 666? - Read - https://www.congress.gov/bill/117th-congress/house-bill/666?q=%7B%22search%22%3A%5B%22A+bill+to+amend+the+Public+Health+Service+Act+to+provide+for+public+health+research+and+investment+into+understanding+and+eliminating+structural+racism+and+police+violence.%22%5D%7D&r=2&s=6 Why is Congress working on legislation HR 6666? - Read https://www.congress.gov/bill/116th-congress/house-bill/6666/tex The United Nations Placed the “Guardian of Nations” Statue In Front of the United Nations Building Located At 405 East 42nd Street New York, New York 10017 **See https://twitter.com/un_photo/status/1458178013082816513?lang=en **Watch - United Nations "Guardian of Nations" Statue | Why Does the United National Sculpture Look Like the Beast Described In Daniel 7 and Revelation 13? https://rumble.com/v1clxtv-united-nations-guardian-of-nations-statue.html Why is Putin seeking to Cement Ties With Iran, Turkey in Rare Trip Abroad? https://www.wsj.com/articles/putin-seeks-to-cement-ties-with-iran-turkey-in-rare-trip-abroad-11658055769 Ezekiel Chapter 38: 1-6 GOG = Prince, Ruler or The Head Magog = Modern Russian “38 And the word of the Lord came unto me, saying, 2 Son of man, set thy face against Gog, the land of Magog, the chief prince of Meshech and Tubal, and prophesy against him, 3 And say, Thus saith the Lord God; Behold, I am against thee, O Why is Putin seeking to Cement Ties With Iran, Turkey in Rare Trip Abroad? https://www.wsj.com/articles/putin-seeks-to-cement-ties-with-iran-turkey-in-rare-trip-abroad-11658055769 Ezekiel Chapter 38: 1-6 GOG = Prince, Ruler or The Head Magog = Modern Russian Learn more about your ad choices. Visit megaphone.fm/adchoices

In 1973, not long after the Supreme Court decided Roe v. Wade, Congress amended the Public Health Service Act to allow medical professionals to refuse to provide abortion care on the basis of their moral or religious beliefs. But if healthcare workers can be “conscientious objectors” to abortion care, couldn't “conscientious providers” of abortion be legally protected, too? That's the question University of San Diego law professor and bioethicist Dov Fox asks in his recent New York Times op-ed “What Will Happen if Doctors Defy the Law to Provide Abortions?” We'll talk to Fox and other experts about the medical and moral dilemmas abortion providers face in the post-Roe world.  Guests: Dov Fox, professor of law and director, Center for Health Law Policy and Bioethics, University of San Diego School of Law Dr. Jennifer Conti, adjunct clinical assistant professor of obstetrics and gynecology, Stanford University Sonja Sharp, metro reporter, LA Times Dr. David Eisenberg , associate director, Division of Family Planning, Department of Obstetrics & Gynecology, Washington University in St. Louis School of Medicine

The Centers for Disease Control and Prevention's mask mandate on planes, trains and buses ended earlier this month, and it came down, in part, to a judge's interpretation of the word "sanitation." U.S. District Judge Kathryn Kimball Mizelle voided the mask requirement, citing a 1944 law that gives the CDC power to stop the spread of communicable diseases through measures like inspection, fumigation, disinfection and sanitation.Lawrence Gostin is a professor of public health law at Georgetown University. He explains what the 1944 Public Health Service Act did and why he thinks the judge's interpretation could have an impact on the United States' ability to respond to future health crises. Additional reporting by NPR's Pien Huang also appeared in this episode.In participating regions, you'll also hear a local news segment to help you make sense of what's going on in your community.Email us at considerthis@npr.org.

Kim points out that unpredictable and excessive taxation along with government induced inflation affect everyone, especially those on a fixed income.  Florida Governor Ron DeSantis proposes $8 million in the state budget to fund the move of illegal immigrants, flown in the middle of the night into Florida by the Biden administration, to Delaware (Biden's home state) and Marth's Vineyard (Obama's residence).  On Friday Jared Polis, in an CPR interview, stated that the COVID-19/Wuhan-China virus emergency is over.  He adds that he will not implement a state mask mandate since he shouldn't tell people what to wear.  And the very next day, he walks his comments back.  A recent poll has Polis at a 49% favorable rating, and he is vulnerable in the 2022 election.  Kim examines HR 550, Immunization Infrastructure Modernization Act of 2021, introduced in late January and passed in the U.S. House of Representatives on November 30th.  All republicans who voted for this legislation should be primaried.  HR 550 is titled “To amend the Public Health Service Act with respect to immunization system data modernization and expansion, and for other purposes.”  Kim encourages all listeners to contact the their senators and congressmen, especially Hickenlooper who sits on the Senate Committee on Health, Education, Labor and Pensions, and tell them to vote “NO” for this bill.  This legislation is unconstitutional as it is a direct affront to the 4th Amendment. Danielle Greene with Kirsch Insurance Group discusses the next open enrollment period, January 1-March 31, 2022, for Medicare.  This upcoming period is for all Medicare Advantage plans.  The Part B portion price is increasing to $170.10 from $148.50, the largest increase in many years.  Many Medicare recipients will be affected and now is the time to talk to an expert.  You can visit their website Kirsch Insurance Group or contact them at 303-397-7830.  Knowledge is power. Guest and sponsor of the show Roger Hays, owner of Premier Employer Services, a back office professional firm that helps companies navigate payroll, insurance, employee benefits and other HR management duties, informs Kim and listeners that the name of the firm changes January 1, 2022, to PASSIO HR.  Premier Employer Services/PASSIO HR frees up business owners so they can concentrate on their product or service.  Roger and Kim discuss current policy issues that are on the horizon as 2021 comes to a close.  The labor shortage impacts businesses, especially small and mid-size, as they struggle with the “Great Resignation.”  All the government handouts this past year have taught many people they do not have to work to get money.  Inflation is another hit on businesses.  The Colorado Supreme Court recently ruled that employers must pay all accrued “PTO,” Paid Time Off, when someone leaves the company.  “Big Business,” with the aid of the U.S. Chamber of Commerce, are pushing immigration policies that provide cheap labor.  This is just one reason we are seeing non-enforcement of border laws.  Government is expanding the H1-B Visa program for additional “cheap labor.”  Colorado is looking at legislation that will void employee arbitration and all lawsuits against an employer, many of them frivolous, will be heard in court.  The Colorado Democrats are also looking at allowing an employee to choose any doctor in workman compensation claims. This opens up opportunity for fraud in workman comp claims.  The Democrats have a “trifecta” with the Colorado House, Senate and Governorship and are able to get their policies through with little resistance

Kim recognizes the deep divide happening with law enforcement focus in the Denver metro area.  JeffCO police are on hand to make sure attendees at a Christmas event have masks on.  Meanwhile, Denver's Union Station has become a crime ridden area with risks to RTD passengers, vendors and property values.  The recent FBI raid on America's Mom Sherronna Bishop is another travesty regarding protection of personal rights.  The America's Veteran's Stories featuring Marine Veteran Marty Letellier who served in the Korean War, the “Forgotten War,” and fought at the Battle of Chosin Reservoir, November 27-December 13, 1940, airs this Sunday.  The show broadcasts 3-4pm on KLZ 560 FM, KLZ 100.7 FM, the KLZ website, and the KLZ app.  Additional shows air on Saturday and Sunday night at 10pm featuring other veterans.  Kim asks listeners to read HR 550, a bill “To amend the Public Health Service Act with respect to immunization system data modernization and expansion, and for other purposes.”  Then call your Senators and Congressional representatives to voice your concern and stop this terrible piece of legislation.  This is yet another assault by the federal government and bureaucratic agencies to take away your freedom. Mary Alpers, co-owner of Three Points Financial, agrees with Kim that failure is part of life and we must teach this to our children along with humility.  Mary's firm is a fee-only firm.  Three Points Financial services include investments, tax planning and financial estate planning.  Mary is now helping clients strategize as the tax year is coming to a close.  Mary explains the advantage of “Donor Advanced Funds.”  Contact Three Points Financial to set a meeting and strategize for year-end finances. America is under attack, specifically Caucasian Americans through the manipulation of blacks, with our children as the prize.  Cain has set up a task force and can be reached at TaskForceFreedom@aol.com.  His group is assisting parents who need help and has three main objectives:  hear complaints of people regarding CRT, address schools on a monthly basis and co-ordinate with parents who want to homeschool their children.  Today his group is holding a rally outside Loveland High School.  He also seeks a law firm to represent families fighting CRT in their schools and communities. Guest Lauren Fix, the Car Coach, discusses the “kill switch” that will be in all cars by 2026 per the Build Back Better bill unless we fight back and contact our Senators and Congressional representatives to have this eliminated.  The kill switch will have the capability to monitor your movements and automatically turn your car off if the AI (artificial intelligence) deems you not able to drive.  Additionally, it will have the cap

(Washington, DC) Judicial Watch announced today that it received 2,469 pages of new documents from the Centers for Disease Control and Prevention (CDC), which reveal that Facebook coordinated closely with the CDC to control the COVID narrative and “misinformation” and that over $3.5 million in free advertising given to the CDC by social media companies. These new documents were received in response to a Freedom of Information Act (FOIA) (Judicial Watch v. U.S. Department of Health of Human Services (No. 1:21-cv-00625)) lawsuit for: Any and all records of communication between CDC officials and/or employees and employees, agents, and/or representatives of Google, Facebook, Twitter, Instagram, LinkedIn, and YouTube concerning, regarding, or relating to COVID-19 related content on company platforms. Such records include, but are not limited to, any advice or instructions issued on disinformation re COVID-19. The documents show collusion between the CDC and Big Tech on Covid-19 message and misinformation: In an email exchange beginning on January 26, 2020 with the subject, “Data for Good | CDC intros,” a Facebook representative sends the “FB coronavirus narrative” to the CDC. It states the following: Facebook is taking a three pronged approached to the global response for the coronavirus: Limit misinformation and other harmful content on our platforms. Our third-party fact-checkers have been rating information on this topic as false, including the AP, Politifact, AFP Hong Kong, Rapple IQ in the Philippines. As a result, we show people who come across that false content accurate information from our fact-checking partners and strong warning labels. We also send notifications to people who already shared this content alerting them that it's been fact checked. Provide accurate and helpful information on our platforms t our partners. Partners are already using our platforms to share accurate information about the situation, including ono Pages. We have also provided ad credits to the World Health Organization and the Philippines' Department of Health to enable them to run coronavirus education campaigns on Facebook in-region, which we will continue to do. We're continuing to explore additional steps we can take, including dedicated information modules on relevant search queries and improved search ranking. Empower partners with data tools. We're sharing aggregated mobility data and high resolution density maps with various partners (e.g., National Tsinghua University (Taiwan); Harvard School oof Public Health) to help inform forecasting models for the spread of the virus as part of our broader Data for Good program. We're exploring doing this with a broader set of partners (e.g., WHO, US CDC) and also helping partners understand how people are talking about the issue online through tools like Crowdtangle to inform their efforts. This email exchange continues on showing more coordination on messaging between the CDC and Facebook. The CDC was given over $3.5 million of free advertising on Facebook, Twitter, and YouTube. In a March 8, 2020 email, a Facebook representative sends four ad credits totaling $2 million to the CDC for the purpose of supporting “messaging related to coronavirus.” On March 14, 2020, then-CDC Chief Operating Officer and Chief Strategy Officer Sherri Berger emails Facebook to thank them for the $2 million. “On behalf of the Centers for Disease Control and Prevention (CDC) and by the authority delegated to me through Section 231 of the Public Health Service Act (42 U.S.C. Section 238), as amended, thank you for Facebook's non-monetary gift of advertising credited with an estimated value of $2,000,000. The gift will be used by CDC's COVID-19 response to support dissemination of critical public health messaging. Thank you!” In an email exchange between August 10-11, 2020, the CDC's Sherri Berger emails Facebook again to thank them for another $1 million in ad credits with a similar message to that on March 14, except she adds: “This gift will be used by the CDC's COVID-19 response to distribute scientifically accurate data, guidance and risk communication information on COVID-19 to a broader audience.” In an email exchange on August 25, 2020, Facebook makes CDC officials aware that of their recent gift of $1 million in ad credits, $529,207.42 remain. In a heavily redacted email exchange on March 17, 2020, a Twitter official offers the CDC advertising in the form of Twitter's Promoted Trend and Promoted Spotlight Trend, which have approximate values given as $75,000 and $150,000.In an email exchange beginning March 16, 2020, a Google representative offers the CDC free video advertising on YouTube. In the exchange, they claim to not be able to assign a dollar value to this advertising.The CDC's official acceptance document for this advertising, which they value at $0, Sherri Berger states:I understand that Google LLC may be a vendor and/or lobbyist employed and that Google LLC's employees may be registered lobbyists. Providing the gift will not prevent Google LLC or its affiliates from supplying products of services to CDC in the future; CDC, however, is under no obligation to accept future services from Google LLC or its affiliates.In a February 27, 2020 email, a Facebook representative offers to put CDC officials in contact with WhatsApp in order to establish auto-responses to FAQs about coronavirus in that communications platform. “These documents show that Facebook and the CDC are joined at the hip on managing the ever-changing Covid-19 ‘narrative' – which includes censorship of alleged ‘misinformation',” stated Judicial Watch President Tom Fitton.

You're listening to the voice of Dr. Amy Brower, the co-host of the Newborn Screening SPOTlight Podcast. This episode focuses on the common question, What does it take to get on the "list"? The list refers to the Recommended Uniform Screening Panel (RUSP) which is a national guideline for newborn screening (NBS).   Dr. Amy Brower was an inaugural member of a Federal Advisory Committee created during the administration of President George W. Bush. In 2004, the Advisory Committee on Heritable Disorders in Newborns and Children was established under the Public Health Service Act and was charged with advising the Secretary of Health and Human Services about aspects of newborn and childhood screening. Their charter includes recommending improvements in the national newborn and childhood screening programs. This includes making systematic evidence-based and peer-reviewed recommendations on which disorders should be included in newborn screening. During Dr. Brower's tenure on the Committee, they developed a system of nomination and review that was open to all stakeholders. The idea was to encourage not only researchers and clinicians to nominate a condition but also parents, patients, families, and advocacy groups. Listen to this episode to learn the: history of Recommended Uniform Screening Panel (RUSP). nomination process on getting a condition added to the RUSP list. importance of pilot study in advancing newborn screening research. how NBSTRN helps with NBS pilot study.    Here are ways you can get involved with NBS research:  Attend a meeting organized by the Advisory Committee on Heritable Disorders in Newborns and Children. Find the meeting dates and time at https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html Support the Newborn Screening Saves Lives Reauthorization Act of 2021. Learn more at https://www.congress.gov/bill/117th-congress/house-bill/482/text Become a member of NBSTRN to connect with communities of researchers, health professionals, families, advocacy groups and state newborn screening programs. Learn more about membership, visit www.nbstrn.org  

A federal judge on Wednesday invalidated a national eviction moratorium after finding that the COVID-19 pandemic policy exceeded the authority of the Centers for Disease Control and Prevention.U.S. District Court for the District of Columbia Judge Dabney Friedrich threw out the measure, which was enacted by Congress in March 2020 as part of the CARES Act and later extended by President Biden until June 30, 2021. Lawmakers cited the Public Health Service Act of 1944, which grants the federal government the authority to impose quarantines and other measures to handle health emergencies, as justification for the provision.Join your host Sean Reynolds, owner of Summit Properties NW and Reynolds & Kline Appraisal as he takes a look at this developing topic.Support the show (https://buymeacoff.ee/seattlepodcast)

The Latest Case to Overrule the CDC's Eviction Moratorium A federal judge on May 5th struck down the nationwide halt on evictions, reasoning that the CDC overstepped its authority.  “It is the role of the political branches, and not the courts, to assess the merits of policy measures designed to combat the spread of disease, even during a global pandemic,” U.S. District Judge Dabney Friedrich wrote. “The question for the Court is a narrow one: Does the Public Health Service Act grant the CDC the legal authority to impose a nationwide eviction moratorium? It does not.” Mark and Vec discuss this decision and the impact it could have on NCLA's litigation against the CDC's unlawful eviction moratorium.    CFPB Doubles Down on CDC Order Later in the episode, Vec explains his new case, The Property Management Connection, LLC, et al. v. Dave Uejio, Consumer Financial Protection Bureau, et al. The Consumer Financial Protection Bureau (CFPB) is requiring that anyone who seeks to collect unpaid residential rent, including property management companies, real estate attorneys, or housing providers, must now lie to tenants who have been sued for unpaid rent and are subject to eviction. NCLA filed a lawsuit and motion for temporary restraining order against CFPB in the U.S. District Court for the Middle District of Tennessee for doubling down on the unlawful Halt Order issued by the Centers for Disease Control and Prevention (CDC) last September. NCLA represents The Property Management Connection LLC, attorney Gordon Schoeffler, and the National Association of Residential Property Managers. Each Plaintiff suffered significant economic damages after CDC issued its Order, which forced property owners to provide habitable housing for tenants while continuing to pay maintenance, utilities, and other expenses, but prevented them from requiring tenants to pay their rent. Read more about the case here. See omnystudio.com/listener for privacy information.

The Federal Eviction Moratorium What: The Centers for Disease Control and Prevention (CDC) announced the issuance of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19. When: September 4, 2020 through June 30, 2021. Who is covered: All properties, except vacant and abandoned. Any resident who certifies they meet the below criteria may not be evicted for failure to pay. The CDC's order requires residents to declare (under penalty of perjury) that they: Have used best efforts to obtain all available government assistance for rent or housing; Expect to earn no more than $99k (individual) or $198k (joint) in 2020; OR was not required to report income in 2019; OR received an Economic Impact Payment from the CARES Act; Are unable to pay the full rent or housing payment due to substantial loss of household income, loss of hours, lay-off, or extraordinary medical expenses; Are using best efforts to make timely partial payments; Eviction would likely render them homeless or force to move into close quarters in congregate or shared living settings due to no other housing options. Has, was exposed to, or might have been exposed to COVID-19 and is taking reasonable precautions no to spread the disease. What eviction is allowed? Landlords may still evict tenants due to criminal activity, threatening health/safety, damaging property, violating codes/ordinances, or other contractual obligations. Is the rent still due? Yes, rental payments are still due. This order does not relieve anyone of the obligation to pay rent or make a housing payment and follow other terms of the lease. In addition, landlords may charge late fees, penalties and interest for any missed payments. However, they cannot evict any tenants until after the expiration of the notice (June 30, 2021). How is this enforced? This is to be enforced jointly by Federal authorities and cooperating State and local authorities. The Department of Justice may also take independent action. The order is enforceable through criminal penalties to individuals of up to $100,000 - $500,000 per event and one year in jail. and Organizations of no more than $200,000 per event if the violation does not result in a death or $500,000 per event if the violation results in the death of an evicted person from COVID-19. What else? Allows more restrictive state and local protections, but overrides anything less restrictive. photo David Martiroso Quadruple Gold / Director of Operations DNA Realty Group - Keller Williams Success O: 617-340-9135 C: 617-939-7138 dmdna1@gmail.com - davidm@dna-realtygroup.com www.dna-realty.com $122,209,038.81 in REAL ESTATE SOLD #BUY --- https://www.dna-realty.com/buy/ #SELL --- https://www.dna-realty.com/sell/ --- Support this podcast: https://anchor.fm/dnarealtygroup/support

This is an excerpt of the October 12, 2020 episode of What's Up With Water. Two Democrats on the House Committee on Oversight and Reform asked the CDC to suspend water service disconnections nationwide as a way to slow the spread of Covid-19. Representatives Harley Rouda of and Rashida Tlaib want the federal government’s top public health agency to use its authority under the Public Health Service Act. To protect public health, they want the CDC to prohibit water utilities from shutting off service to customers who are behind on their bills.

Senate Committee on Indian Affairs Legislative Hearing to receive testimony on S. 3126, S. 3264, S. 3937, S. 4079 & S. 4556 Wednesday, September 23 2020 - 02:30 PM Location: Dirksen Room Number: 628 S. 3126, A bill to amend the Public Health Service Act to authorize a special behavioral health program for Indians. S. 3264, A bill to expedite and streamline the deployment of affordable broadband service on Tribal land, and for other purposes. S. 3937, A bill to amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes. S. 4079, A bill to authorize the Seminole Tribe of Florida to lease or transfer certain land, and for other purposes. ​​​​​​​ S. 4556, A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California, and for other purposes. PANEL 1 The Honorable Rear Admiral Michael D. Weahkee Director Indian Health Service, Rockville, MD https://www.indian.senate.gov/sites/default/files/FINAL_HHS%20testimony%20IHS%20legislative%20hearing_SCIA%209.23.20%20Hearing.pdf The Honorable Marcellus Osceola, Jr. Chairman Seminole Nation of Florida, Hollywood, FL https://www.indian.senate.gov/sites/default/files/Chairman%20Osceola%20Statement.pdf The Honorable Timothy Nuvangyaoma Chairman Hopi Nation, Kykotsmovi, AZ https://www.indian.senate.gov/sites/default/files/Hopi%20Testimony%20-%20SDPI%20Senate%20Hearing.pdf The Honorable Michael Chavarria Chairman All Pueblo Council of Governors, Albuquerque, NM https://www.indian.senate.gov/sites/default/files/Gov.%20Chavarria%2C%20Santa%20Clara%20Pueblo%20-%20Written%20Testimony%20on%20S.%203126%20and%20S.%203264%20%2809.21.2020%29.pdf Committee Notice: https://www.indian.senate.gov/hearing/legislative-hearing-receive-testimony-s-3126-s-3264-s-3937-s-4079-s-4556

Senate Committee on Indian Affairs Legislative Hearing to receive testimony on S. 3126, S. 3264, S. 3937, S. 4079 & S. 4556 Wednesday, September 23 2020 - 02:30 PM Location: Dirksen Room Number: 628 S. 3126, A bill to amend the Public Health Service Act to authorize a special behavioral health program for Indians. S. 3264, A bill to expedite and streamline the deployment of affordable broadband service on Tribal land, and for other purposes. S. 3937, A bill to amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes. S. 4079, A bill to authorize the Seminole Tribe of Florida to lease or transfer certain land, and for other purposes. ​​​​​​​ S. 4556, A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California, and for other purposes. PANEL 1 The Honorable Rear Admiral Michael D. Weahkee Director Indian Health Service, Rockville, MD https://www.indian.senate.gov/sites/default/files/FINAL_HHS%20testimony%20IHS%20legislative%20hearing_SCIA%209.23.20%20Hearing.pdf The Honorable Marcellus Osceola, Jr. Chairman Seminole Nation of Florida, Hollywood, FL https://www.indian.senate.gov/sites/default/files/Chairman%20Osceola%20Statement.pdf The Honorable Timothy Nuvangyaoma Chairman Hopi Nation, Kykotsmovi, AZ https://www.indian.senate.gov/sites/default/files/Hopi%20Testimony%20-%20SDPI%20Senate%20Hearing.pdf The Honorable Michael Chavarria Chairman All Pueblo Council of Governors, Albuquerque, NM https://www.indian.senate.gov/sites/default/files/Gov.%20Chavarria%2C%20Santa%20Clara%20Pueblo%20-%20Written%20Testimony%20on%20S.%203126%20and%20S.%203264%20%2809.21.2020%29.pdf Committee Notice: https://www.indian.senate.gov/hearing/legislative-hearing-receive-testimony-s-3126-s-3264-s-3937-s-4079-s-4556

Senate Committee on Indian Affairs Legislative Hearing to receive testimony on S. 3126, S. 3264, S. 3937, S. 4079 & S. 4556 Wednesday, September 23 2020 - 02:30 PM Location: Dirksen Room Number: 628 S. 3126, A bill to amend the Public Health Service Act to authorize a special behavioral health program for Indians. S. 3264, A bill to expedite and streamline the deployment of affordable broadband service on Tribal land, and for other purposes. S. 3937, A bill to amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes. S. 4079, A bill to authorize the Seminole Tribe of Florida to lease or transfer certain land, and for other purposes. ​​​​​​​ S. 4556, A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California, and for other purposes. PANEL 1 The Honorable Rear Admiral Michael D. Weahkee Director Indian Health Service, Rockville, MD https://www.indian.senate.gov/sites/default/files/FINAL_HHS%20testimony%20IHS%20legislative%20hearing_SCIA%209.23.20%20Hearing.pdf The Honorable Marcellus Osceola, Jr. Chairman Seminole Nation of Florida, Hollywood, FL https://www.indian.senate.gov/sites/default/files/Chairman%20Osceola%20Statement.pdf The Honorable Timothy Nuvangyaoma Chairman Hopi Nation, Kykotsmovi, AZ https://www.indian.senate.gov/sites/default/files/Hopi%20Testimony%20-%20SDPI%20Senate%20Hearing.pdf The Honorable Michael Chavarria Chairman All Pueblo Council of Governors, Albuquerque, NM https://www.indian.senate.gov/sites/default/files/Gov.%20Chavarria%2C%20Santa%20Clara%20Pueblo%20-%20Written%20Testimony%20on%20S.%203126%20and%20S.%203264%20%2809.21.2020%29.pdf Committee Notice: https://www.indian.senate.gov/hearing/legislative-hearing-receive-testimony-s-3126-s-3264-s-3937-s-4079-s-4556

Senate Committee on Indian Affairs Legislative Hearing to receive testimony on S. 3126, S. 3264, S. 3937, S. 4079 & S. 4556 Wednesday, September 23 2020 - 02:30 PM Location: Dirksen Room Number: 628 S. 3126, A bill to amend the Public Health Service Act to authorize a special behavioral health program for Indians. S. 3264, A bill to expedite and streamline the deployment of affordable broadband service on Tribal land, and for other purposes. S. 3937, A bill to amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes. S. 4079, A bill to authorize the Seminole Tribe of Florida to lease or transfer certain land, and for other purposes. ​​​​​​​ S. 4556, A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California, and for other purposes. PANEL 1 The Honorable Rear Admiral Michael D. Weahkee Director Indian Health Service, Rockville, MD https://www.indian.senate.gov/sites/default/files/FINAL_HHS%20testimony%20IHS%20legislative%20hearing_SCIA%209.23.20%20Hearing.pdf The Honorable Marcellus Osceola, Jr. Chairman Seminole Nation of Florida, Hollywood, FL https://www.indian.senate.gov/sites/default/files/Chairman%20Osceola%20Statement.pdf The Honorable Timothy Nuvangyaoma Chairman Hopi Nation, Kykotsmovi, AZ https://www.indian.senate.gov/sites/default/files/Hopi%20Testimony%20-%20SDPI%20Senate%20Hearing.pdf The Honorable Michael Chavarria Chairman All Pueblo Council of Governors, Albuquerque, NM https://www.indian.senate.gov/sites/default/files/Gov.%20Chavarria%2C%20Santa%20Clara%20Pueblo%20-%20Written%20Testimony%20on%20S.%203126%20and%20S.%203264%20%2809.21.2020%29.pdf Committee Notice: https://www.indian.senate.gov/hearing/legislative-hearing-receive-testimony-s-3126-s-3264-s-3937-s-4079-s-4556

Senate Committee on Indian Affairs Legislative Hearing to receive testimony on S. 3126, S. 3264, S. 3937, S. 4079 & S. 4556 Wednesday, September 23 2020 - 02:30 PM Location: Dirksen Room Number: 628 S. 3126, A bill to amend the Public Health Service Act to authorize a special behavioral health program for Indians. S. 3264, A bill to expedite and streamline the deployment of affordable broadband service on Tribal land, and for other purposes. S. 3937, A bill to amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes. S. 4079, A bill to authorize the Seminole Tribe of Florida to lease or transfer certain land, and for other purposes. ​​​​​​​ S. 4556, A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California, and for other purposes. PANEL 1 The Honorable Rear Admiral Michael D. Weahkee Director Indian Health Service, Rockville, MD https://www.indian.senate.gov/sites/default/files/FINAL_HHS%20testimony%20IHS%20legislative%20hearing_SCIA%209.23.20%20Hearing.pdf The Honorable Marcellus Osceola, Jr. Chairman Seminole Nation of Florida, Hollywood, FL https://www.indian.senate.gov/sites/default/files/Chairman%20Osceola%20Statement.pdf The Honorable Timothy Nuvangyaoma Chairman Hopi Nation, Kykotsmovi, AZ https://www.indian.senate.gov/sites/default/files/Hopi%20Testimony%20-%20SDPI%20Senate%20Hearing.pdf The Honorable Michael Chavarria Chairman All Pueblo Council of Governors, Albuquerque, NM https://www.indian.senate.gov/sites/default/files/Gov.%20Chavarria%2C%20Santa%20Clara%20Pueblo%20-%20Written%20Testimony%20on%20S.%203126%20and%20S.%203264%20%2809.21.2020%29.pdf Committee Notice: https://www.indian.senate.gov/hearing/legislative-hearing-receive-testimony-s-3126-s-3264-s-3937-s-4079-s-4556

Senate Committee on Indian Affairs Legislative Hearing to receive testimony on S. 3126, S. 3264, S. 3937, S. 4079 & S. 4556 Wednesday, September 23 2020 - 02:30 PM Location: Dirksen Room Number: 628 S. 3126, A bill to amend the Public Health Service Act to authorize a special behavioral health program for Indians. S. 3264, A bill to expedite and streamline the deployment of affordable broadband service on Tribal land, and for other purposes. S. 3937, A bill to amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes. S. 4079, A bill to authorize the Seminole Tribe of Florida to lease or transfer certain land, and for other purposes. ​​​​​​​ S. 4556, A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Indian Health Service, to acquire private land to facilitate access to the Desert Sage Youth Wellness Center in Hemet, California, and for other purposes. PANEL 1 The Honorable Rear Admiral Michael D. Weahkee Director Indian Health Service, Rockville, MD https://www.indian.senate.gov/sites/default/files/FINAL_HHS%20testimony%20IHS%20legislative%20hearing_SCIA%209.23.20%20Hearing.pdf The Honorable Marcellus Osceola, Jr. Chairman Seminole Nation of Florida, Hollywood, FL https://www.indian.senate.gov/sites/default/files/Chairman%20Osceola%20Statement.pdf The Honorable Timothy Nuvangyaoma Chairman Hopi Nation, Kykotsmovi, AZ https://www.indian.senate.gov/sites/default/files/Hopi%20Testimony%20-%20SDPI%20Senate%20Hearing.pdf The Honorable Michael Chavarria Chairman All Pueblo Council of Governors, Albuquerque, NM https://www.indian.senate.gov/sites/default/files/Gov.%20Chavarria%2C%20Santa%20Clara%20Pueblo%20-%20Written%20Testimony%20on%20S.%203126%20and%20S.%203264%20%2809.21.2020%29.pdf Committee Notice: https://www.indian.senate.gov/hearing/legislative-hearing-receive-testimony-s-3126-s-3264-s-3937-s-4079-s-4556

Today, we're going to talk about legal issues in the COVID-19 vaccine development arena. A big challenge from a legal perspective is how can these companies get the vaccine to us? Typically when you're developing a new vaccine or anything for use inside of a human being, the FDA under the FD and C Act, the Federal Food, Drug and Cosmetics act, and the Public Health Service Act regulates the development of vaccines and anything that gets injected into your body. And there's a good reason for that and typically it takes a long time. These companies have to go through a series of clinical trials and they have to produce results to the FDA and the FDA has to come back, but there is a provision of the FD and C Act called an EUA, Emergency Use Authorization, and let's see if this happens. For the FDA to issue this EUA, which basically allows temporarily the use of an unapproved product, or an approved product for unapproved uses, the FDA has to go through the secretary of Health and Human Services. And the secretary of Health and Human Services have to first determine that there's a qualifying emergency caused by biological, chemical, radiological or nuclear. And here we've got, I think number one, biological emergency, COVID clearly. Two, the secretary of Health and Human Services has to find out that this agent can cause serious life threatening disease and the secretary then has to determine that for each product it's reasonable to believe that based on the totality of all the evidence available, that the product can treat or prevent the disease caused by this agent, in this case COVID, and that the known potential benefits outweigh the risk. Finally, that there are no other adequate and approved alternatives. So, in short, if COVID-19 is a biological qualifying emergency and the secretary of Health and Human Services finds that a company has produced something that it reasonably believes can help people, then it can issue this Emergency Use Authorization and we will get our vaccine. Let's wait and see what companies come up with, and the FDA comes up with. Hopefully they come up with it quickly. For more information check out this blog: https://www.dbllawyers.com/covid-19-progress-pfizer-inc-s-u-s-trials-for-coronavirus-vaccine/

Recorded May 27, 2020https://walkinverse.buzzsprout.com/In episode #12, "HR 6666, the Overview," I show the dangers in this bill and share some insight.  This is a multi-part podcast that will dive into 4th Amendment violations and privacy issues surrounding contact tracing.   OverviewH.R. 66661This bill authorizes the Centers for Disease Control and Prevention (CDC) to award grants for testing, contact tracing, monitoring, and other activities to address COVID-19 (i.e., coronavirus disease 2019). Entities such as federally qualified health centers, nonprofit organizations…By the ambiguous words used in this bill we are at risk.  When they say nonprofit organizations, we the people need to know who they are.  One of the organizations used for tracing is Partners in Health 2, which I will dive into later.As we continue to read the overview is states… awarding the grants, the CDC shall prioritize applicants that (1) operate in hot spots and medically underserved communities, and (2) agree to hire individuals from the communities where grant activities occur.Another concern is how they will hire. We have seen with Census workers they have hired felons and child sex offenders for workers under their programs.  And in 2020 3 they did it again to help with the Census count.  I cannot even imagine who they will find for H.R. 6666.SEC. 2. COVID–19 TESTING AND CONTACT TRACING USING MOBILE HEALTH UNITS.This section, “COVID-19 Testing, Reaching, And Contacting Everyone (TRACE) Act 1”, it's interesting as it sets the basis for fourth amendment and additional privacy rights violations. It will allow for entry into a home, to potentially quarantine and collect identifiable data by workers who may not be so qualified especially due to the individuals they hire from the communities of underserved and hot spot areas.2 (a) GeneralIn this section 2a – General;The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may award grants to eligible entities to conduct diagnostic testing for COVID–19, to trace and monitor the contacts of infected individuals, and to support the quarantine of such contacts, through—And the vehicles in which they will pursue is via mobile health units and residential quarantine & testing. Again, it's loosely defined leaving for interpretation.2 (b) FundingA grant recipient under this section may use the grant funds, in support of the activities described in subsection(1)  to hire, train, compensate, and pay the expenses of individuals; and(2)  to purchase personal protective equipment and other supplies.This section I found interesting.  To hire someone is to pay and with it comes training. And with training comes compensation. But for what?Many online schools are offering free training4 with certificates. But, the issue with these courses is the misinformation throughout.  And what is even more bothersome is John Hopkins, the same University behind Event 201 5, funded by the Bill and Melinda Gates foundation is offering these classes.Some of the topics include the history of SARS-CoV-2, interventions through contact tracing, identify common barriers and how to overcome and my favorite, ethical consideration around tracing, isolation and quarantine. Next is they will compensate and pay expenses which is starting to sound a lot like contractors or mercenaries.compensateCompensate is a verb and it means;1 [with object] give (someone) something, typically money, in recognition of loss, suffering, or injury incurred;Why I bring this to the forefront is in the bill it mentions to pay, and the word compensate.  You would not pay and compensate if you did not expect some kind of loss.pay expensesNext is to pay expenses.  And again, it has the feeling of a contractors who must reimburse themselves and well as a mercenary who is hired to pay without thought of consequences in whom they engage.2 (c) PriorityThey will hire anyone from hot spot communities, or any individual areas that lack access to primary care.In selecting grant recipients under this section, the Secretary shall give priority to—(1)  applicants proposing to conduct activities funded under this section in hot spots and medically underserved communities; andMedically Underserved Areas6An example of who they will target is the Homeless. In Austin Texas they are testing ID20207 to track medical and criminal records of these individuals using blockchain technology to digital identity and 5G to scale.  Other types of individuals on are those who are Medicaid-eligible, Native American and Migrant farmworkers. There is always an exception to the rule.  If they wish to go after other areas, the requesting person must explain the reason along with written consent to the person in charge.  Such as a state's governor or representative and the local health official. Again, vague usage of who they must submit the request to as it leaves them room for working with third parties.2 (e) Federal privacy requirementsThis section quotes a few interesting laws in which they must adhere to while performing their tracing tasks.Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c)8 of the Health Insurance Portability and Accountability (HIPPA) Act of 1996 (Public Law 104–191; 110 Stat. 2033) and section 543 of the Public Health Service Act (42 U.S.C. 290dd–2).Section 264(c) RegulationsThese regulations center on a person's identifiable health data connected with electronic data exchange, as stated in section1173(a) 9 of the Social Security Act, as referenced in section 262 from the HIIPA Act of 1996 dealing with data administration.  Also, a time limit, not exceed 42 months (4 years), is stated for compliance. An interesting point is a presidential term is four years.  To pull off digital identity at scale, a president would need to fast track the implementation.  It means 5G nationwide coupled with blockchain to create an immutable system of record for wide-scale digital identities.In an earlier podcast10, I discussed how the FCC approved SpaceX11 on March 29, 2018, to launch 4,425 5G satellites into low orbit around the Earth. The total number of satellites expected will range from 20K up to 42K by 202712, making digital id a reality. section 54313 of the Public Health Service Act (42 U.S.C. 290dd–2)section (a) RequirementRecords of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance use disorder education (sickness, illness), prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b).section (b) Permitted disclosure(1) ConsentThe following shall apply with respect to the contents of any record referred to in subsection (a):(A) Such contents may be used or disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained.Subsection (B, C) states that once you have given your consent, then anyone defined in this section can use your data now and in the future.  This will include treatments, payments, health care operations, until the patient revokes consent in writing.  But the bill does not define where you send your letter to.(2) Method for DisclosureIn section (2) titled Method for Disclosure, defines how the data can be used when consent is not given.Section 2a allows medical personnel only to use the data to meet the need of the medical emergency.  Then in section 2b in addresses what qualified personnel can do.  These individuals are only allowed to use non-identifiable information for scientific research, financial and management audits, and evaluation of the program.  They are not allowed to use any of this data to identify a person directly or indirectly.  Section 2c continues to address the court's power for access in extreme cases for a good cause in the public interest.  This is where the Katz test14 comes into play as well as other privacy tests established by the supreme court case law.   I will cover this in more detail when I discuss the fourth amendment.Section 2d focuses on the role of a public health authority as defined under section 164.514(b) of title 45, Code of Federal Regulations15 for creating de-identified information.section 164.514(b) of title 45, Code of Federal Regulations1545 CFR § 164.514 - Other requirements relating to uses and disclosures of protected health information.(a) Standard: De-identification of protected health informationMean that the data cannot be used in any way to identify the individual's health information.(b) Implementation specifications: Requirements for de-identificationThis section is pretty in depth, but in a nutshell the only information they are allowed to use is the year of birth, admission, discharge or date of death. No month or day allowed. Nothing other information can be used that is considered identifiable in this section. The list of comprehensive on what they cannot collect.                               (c) Implementation specifications: Re-identificationNow to re-identify, a covered entity will use a generated code.  They cannot create the code from data that can identify the individual. In addition, they are not allowed to share how they created the code nor disclose it to anyone.  This is now starting to sound like digital identity plus myPass via blockchain, backed and funded by Bill Gates ID20207 initiative.section (c) Use of records in criminal, civil, or administrative contextsExcept as otherwise authorized by a court order under subsection (b)(2)(C) or by the consent of the patient, a record referred to in subsection (a), or testimony relaying the information contained therein, may not be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority, against a patient, including with respect to the following activities:(1) Such record or testimony shall not be entered into evidence in any criminal prosecution or civil action before a Federal or State court.(2) Such record or testimony shall not form part of the record for decision or otherwise be taken into account in any proceeding before a Federal, State, or local agency.(3) Such record or testimony shall not be used by any Federal, State, or local agency for a law enforcement purpose or to conduct any law enforcement investigation.(4) Such record or testimony shall not be used in any application for a warrant.WIV Reports — Uncensored is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.References1.         Bobby L. Rush. H.R.6666. (2020).2.         Massachusetts Contact Tracing Program Handed to Clinton-Linked NGO with Questionable Past. MintPress News https://www.mintpressnews.com/massachusetts-contact-tracing-partners-in-health-clinton/267534/ (2020).3.         WATCH, J. Census Bureau Still Hiring Felons, Child Sex Offenders Pass Background Check. Judicial Watch https://www.judicialwatch.org/corruption-chronicles/census-bureau-still-hiring-felons-child-sex-offenders-pass-background-check/ (2019).4.         COVID-19 Contact Tracing. Coursera https://www.coursera.org/learn/covid-19-contact-tracing?edocomorp=covid-19-contact-tracing.5.         Event 201. Center for Health Security https://www.centerforhealthsecurity.org/event201/ (2019).6.         Medically Underserved Areas and Populations (MUA/Ps). Bureau of Health Workforce https://bhw.hrsa.gov/shortage-designation/muap (2016).7.         ID2020. Welcome the City of Austin to the ID2020 Alliance! Medium https://medium.com/id2020/welcome-the-city-of-austin-to-the-id2020-alliance-76b0ebe6776 (2019).8.         STATUTE-110-Pg1936.pdf.9.         SSA, O. Standards for information transactions and data elements. https://www.ssa.gov/OP_Home/ssact/title11/1173.htm#ft246.10.       5G: A Blessing or a Curse. https://www.buzzsprout.com/906265/3254200-5g-a-blessing-or-a-curse.11.       THOMAS, J. P. 5G From Space: 20,000 Satellites To Blanket The Earth. Technocracy News https://www.technocracy.news/5g-from-space-20000-satellites-to-blanket-the-earth/ (2019).12.       McFall-Johnsen, M. SpaceX's license to launch hundreds of internet satellites may have violated the law, experts say. Astronomers could sue the FCC. Business Insider https://www.businessinsider.com/spacex-starlink-satellite-license-fcc-environmental-law-2020-1 (2020).13.       [USC02] 42 USC 290dd-2: Confidentiality of records. vol. 42 (2020).14.       Katz v. United States, 389 U.S. 347 | Casetext Search + Citator. https://casetext.com/case/katz-v-united-states-2.15.       45 CFR § 164.514 - Other requirements relating to uses and disclosures of protected health information. 164.514. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit walkinverse.substack.com/subscribe

In this episode we discuss the newly signed Cares Act aimed at providing aid to businesses and individuals that have been impacted by the Coronavirus and the resulting economic shut-down. The application process for the Cares Act loans will take the form of a modified 7a SBA loan and will be processed through SBA approved lenders. On this episode, we have bank representatives, employment attorney, FSU Economics professor and business leaders in the restaurant industry. A recent post re: the summary of the Cares Act:Senate Passes the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”)26 March 2020  Coronavirus Resource Center  BlogAuthors: Frank S. Murray Jr Jared B. Rifis Leah R. Imbrogno Jamie N. Class Matthew E. Sierawski Julia Di Vito Kaitlyn M. Foley As the coronavirus outbreak continues to wreak havoc on markets and industries in the United States and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges will require thoughtful and comprehensive planning. Foley has created a multi-disciplinary and multi-jurisdictional team, which has prepared a wealth of topical client resources (see Foley’s Coronavirus Resource Center) and is prepared to help our clients meet the legal and business challenges that the coronavirus outbreak is creating for stakeholders across a range of industries, including manufacturing, technology, solar, hospitality and travel, healthcare, food, fashion and apparel, and sports and entertainment. The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) – Summary of Bill Language and Key TakeawaysOn March 25, 2020, the Senate unanimously passed (96-0) the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), commonly known as “Phase Three” of coronavirus economic relief. The CARES Act provides much needed stimulus to individuals, businesses, and hospitals in response to the economic distress caused by the coronavirus (COVID-19) pandemic. The bill passed on March 25 is not yet law. Until the CARES Act is passed by the House of Representatives and signed into law by the President, it is subject to revisions. The bill will now go to the House, which is currently not in session. The House may reconvene to address the bill or pass the bill by unanimous consent agreement. The House is expected to pass the bill without changes on March 27, and it will then be presented to the President for his signature.Additional information, updates, and analysis regarding the CARES Act will be posted on Foley’s Coronavirus Resource Center. Please check back frequently for updates. Foley is available to assist in interpretation of the CARES Act for your business and can help you find ways to claim and/or use available funding for your company. The CARES ActTop 10 Takeaways:Provides stimulus to individuals, businesses, and hospitals in response to the economic distress caused by the coronavirus (COVID-19) pandemic.Creates a $349 billion loan program for small businesses, including 501(c)(3) non-profits and physician practices. These loans can be forgiven through a process that incentivizes companies to retain employees.Allocates $500 billion for assistance to businesses, states, and municipalities, with no more than $25 billion designated for passenger air carriers, $4 billion for air cargo carriers, and $17 billion for businesses critical to maintaining national security. The remaining $454 billion may be used to support lending to eligible businesses, states, and municipalities.Allocates $130 billion in relief to the medical and hospital industries, including for medical supplies and drug and device shortages.Expands telehealth services in Medicare, including services unrelated to COVID-19 treatments.Provides $1,200 to Americans making $75,000 or less ($150,000 in the case of joint returns and $112,500 for head of household) and $500 for each child, to be paid “as rapidly as possible.”Expands eligibility for unemployment insurance and provides people with an additional $600 per week on top of the unemployment amount determined by each state.Expands the Defense Production Act, allowing for a period of two years when the government may correct any shortfall in resources without regard to the current expenditure limit of $50 million.Provides the Secretary of the Treasury with the authority to make loans or loan guarantees to states, municipalities, and eligible businesses and loosens a variety of regulations prior legislation imposed through the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Economic Stabilization Act of 2008, and others.Accompanied by supplemental appropriations to help the government respond to this pandemic.Summary of the CARES Act:Division A - Keeping American Workers Paid and Employed, Healthcare System Enhancements, and Economic Stabilization   Title I – Keeping American Workers Paid and Employed Act     Foley Title I Contacts: Jamie Class, Erin Toomey, Jessica Glatzer Mason, and Frank MurrayPaycheck Protection ProgramThe Paycheck Protection Loan Program, at a price tag of $349 billion, covers the period February 15, 2020 through June 30, 2020 and greatly expands SBA loan eligibility.  The loan program will allow businesses suffering due to the coronavirus outbreak to borrow money for a variety of qualified costs related to employee compensation and benefits, including (i) payroll costs, (ii) continuation of health care benefits, (iii) employee compensation (of those making less than $100K), (iv) mortgage interest obligations, (v) rent, (vi) utilities and (vii) interest on debt incurred before the covered period.The legislation greatly expands the number of businesses (including non-profits) that are eligible for SBA loans and raises the maximum amount for such a loan by 2.5 x the average total monthly payroll costs, or up to $10 million.  The interest rate may not to exceed 4%.Companies that employ no more than 500 employees are (or a greater number based on the size standard applicable to the industry) may be eligible.  Certain companies in the Accommodation and Food Services Industry (NAICS Code 72) may be eligible if they have no more than 500 employees per physical location. In most cases, the number of employees is counted together with all affiliates.Waives affiliation rules under 13 C.F.R.  121.103 for any business with less than 500 employees in the Accommodation and Food Services Industry, certain franchise businesses and small businesses that receive financing through the Small Business Investment Company Act.  Affiliation rules otherwise apply to determine eligibility.Waives the credit available elsewhere, personal guaranty and collateral requirements.For eligibility purposes, requires lenders to determine whether a business was operational on February 15, 2020, and had employees for whom it paid salaries and payroll taxes, or a paid independent contractor. (This is likely to be interpreted to replace the determination of repayment ability which is not possible during the crisis.)All or a portion of the loan may be forgivable and debt service payments may be deferred for up to 1 year.Entrepreneurial DevelopmentProvides funding to educate small businesses and their employees regarding (i) Federal resources available during this time, (ii) Hazards of COVID-19 and (iii) best practices around teleworking to prevent the spread of COVID-19.iii.  State Trade Expansion ProgramAllows for federal grant funds appropriated to support the State Trade Expansion Program (STEP) in FY 2018 and FY 2019 to remain available for use through FY 2021.Waiver of Matching Funds Requirement under the Women’s Business Center ProgramEliminates the non-federal match requirement for Women’s Business Centers for a period of three months. Loan Forgiveness Establishes that the borrower under the Paycheck Protection Program shall be eligible for loan forgiveness equal to the amount spent by the borrower during an 8-week period after the origination date on (i) rent, (ii) payroll costs for workers making less than $100K, (iii) interest on a mortgage, and (iv) utility payments. The amount forgiven may not exceed the principal of the loan. Incentivizes companies to retain employees by reducing the amount forgiven proportionally by any reduction in employees retained compared to the prior year.To encourage employers to rehire any employees who have already been laid off due to the COVID-19 crisis, borrowers that re-hire workers previously laid off will not be penalized for having a reduced payroll at the beginning of the period.Minority Business Development Agency Empowers the Department of Commerce, through the Minority Business Development Agency, to provide grants to minority business centers and minority chambers of commerce to provide education, training and advising related to accessing federal resources.vii. United States Treasury Program Management Authority The Department of the Treasury, consulting with the Small Business Administration and the Chairman of the Farm Credit Administration shall establish criteria to allow other lenders to participate in the Paycheck Protection Program, so long as such participation does not threaten the safety and soundness of the lender, as determined in consultation with the relevant federal banking agencies.viii.  Emergency Economic Injury Disaster Loans (“EIDLs”) For the period between January 31, 2020 and December 31, 2020 (the “covered period”) EIDL eligibility is greatly expanded to include any business with not more than 500 employees operating under a sole proprietorship or as an independent contractor, and any cooperative, ESOP and tribal small business concern with not more than 500 employees. The number of employees is determined together with affiliates.Furthermore, EIDLs may be approved solely on the bases of an applicant’s credit score or by use of alternative methods to gauge the applicant’s ability to repay. Additionally, applicants may request an advance of up to $10,000 within three days after the Administrator receives the application, subject to verification that the entity is eligible under this program. The advance may be used for any allowable purposes under §7(b)(2) of the Small Business Act and is not subject to repayment, even if the loan request is ultimately denied.Importantly, the CARES Act waives: (1) the requirement of personal guarantees for loans up to $200,000, (2) the requirement that the applicant must be in business for a year (but must be in operation on January 31, 2020), and (3) the credit elsewhere test.Establishes that an emergency involving Federal primary responsibility determined to exist by the President under Section 501(b) of the Stafford Disaster Relief and Emergency Assistance Act qualifies as a new trigger for EIDLs.Importantly, the CARES Act waives: (1) the requirement of personal guarantees for loans up to $200,000, (2) the requirement that the applicant must be in business for a year (but must be in operation on January 31, 2020), and (3) the credit elsewhere test.Subsidy for Certain Loan PaymentsFor loans under §7(a) of the Small Business Act, Title V of the Small Business Investment Act, and for loans made by an intermediary using §7(m) loans or grants, the Administrator shall pay the principal, interest, and fees owed for loans in regular servicing status for any such loans, whether on deferment or not, that were made before the enactment of the Act for the following 6-month period, and for any such loans that were made between the date of enactment of the Act and six months from such date. This does not apply to Payroll Protection loans or EIDL loans which have separate subsidy and repayment requirements.The payments shall be made not later than 30 days from when the first payment is due and shall be applied such that the borrower is relieved of any obligation to pay that amount. The Administrator shall coordinate with relevant banking agencies to request that lenders not be required to increase reserves because of these payments.The Administrator will waive limits on the maximum loan maturities for loans given deferral and extended maturity during the year following enactment. The Administrator will extend lender site visit requirement timelines as necessary because of COVID-19, to within 60 days of a non-default adverse event, and 90 days of a default. $17 billion is appropriated for the foregoing.BankruptcySection 1182(1) of Title 11 is amended to define “debtor” as persons engaged in commercial or business activities and their affiliates (excluding persons who primarily own single asset real estate) that have aggregate, noncontingent, liquidated secured and unsecured debts (at the date of petition filing or the order for relief) of $7,500,000 or less (excluding debts owed to affiliates or insiders), half or more of which arose from those activities.  Exempt from this new definition are any members of a group of affiliated debtors that has aggregate, noncontingent, liquidated secured and unsecured debts over $7,500,000 (excluding debt owed to affiliates or insiders); corporations subject to 1934 Act reporting requirements; and affiliates of an issuer under the 1934 Act.  National Emergency Act payments for COVID-19 by the President are exempted from “current monthly income” and “disposable income” when determining the power of courts to approve debtor plans rejected by trustees or claim holders. Debtors that have experienced material financial hardship due to COVID-19 can modify a plan confirmed prior to this Act’s enactment date if approved after notice and hearing, but only if that plan doesn’t provide payments more than seven years after the first payment was due under the original plan, and follows requirements of 1322(a)-(c) and 1325(a). This modification terminates one year after the enactment of this Act.Title II – Assistance for American Workers, Families, and Businesses      Foley Title II Contacts: Julie Lutfi, Ashley May, and Dick RileySubtitle A: Unemployment Insurance ProvisionsEligibilityThe law expands the scope of individuals who are eligible for unemployment benefits, including those who are furloughed or out of work as a direct result of COVID-19, self-employed or gig workers, and those who have exhausted existing state and federal unemployment benefit provisions.The only individuals expressly excluded from coverage are those who have the ability to telework with pay and those who are receiving paid sick leave or other paid benefits (even if they otherwise satisfy the criteria for unemployment under the new law).Administration of BenefitThe benefits are administered by each state and upon the state’s written agreement with the Secretary of Labor to provide the specific benefits.  States that enter into such an agreement with the Secretary of Labor will be reimbursed in whole or in part for the cost of the benefits plus administrative expensesTypes of Benefits ProvideThe law provides an increase of $600 per week in the amounts customarily available for unemployment under state law.  This increase applies for unemployment payments made from the date of the law’s enactment through July 31, 2020 (approximately four months).States can agree to provide pandemic emergency unemployment compensation to individuals who have either exhausted all of the benefits available to them under existing state and federal law or who are not otherwise eligible for benefits under existing state and federal law.  Individuals must be able and available to work and actively seeking work, unless they are unable to do so as a result of COVID-19 illness, quarantine, or movement restriction.States can agree to waive the waiting period for receipt of benefits so that individuals do not experience gaps in income.The federal government will temporarily fund short-time compensation under existing state plans.  States that do not yet have short-time compensation plans in place may agree to implement a plan, provided that employers who enter into short-time compensation plans must be required to pay to the state half of the short-time compensation paid under the planTime Periods for Expanded BenefitsThe law provides unemployment benefit assistance to covered individuals who are not otherwise entitled to benefits under existing state or federal law for weeks of unemployment, partial unemployment, or inability to work caused by COVID-19 during the period January 27, 2020 through December 31, 2020.  This includes any waiting periods for benefits under applicable state law.The total benefit may not extend beyond 39 weeks (including any unemployment benefits or extended benefits received under existing state or federal law), unless, after the law is enacted, the duration of extended benefits is extended, in which case the total benefit may extend beyond 39 weeks by that same additional period of extended benefits.The $600 weekly benefit increase will be applicable to weekly payments made through the end of July 2020.Protections Against Fraud and OverpaymentAny fraudulent intent or misrepresentations to obtain payments to which an individual is not entitled will result in ineligibility for any other unemployment compensation benefits under the new law as well as criminal prosecution. Overpayments may be clawed back by the state agencies.Social Security TreatmentThe additional unemployment compensation provided is not considered “income” for purposes of Medicaid and CHIP.Subtitle B: Rebates and Other Individual ProvisionsTax CreditsBeginning in 2020, "eligible individual" taxpayers can benefit from a tax credit equal to the sum of: (i) $1,200 for single filers ($2,400 for those filing a joint return) plus (ii) an amount equal to th eproduct of (a) $500 multiplied by (b) the number of qualifying children. However, the aforementioned tax credits will be “phased-out” by 5% (but not below 0) when such eligible taxpayer’s adjusted gross income exceeds: (i) $150,000 for joint-filers, (ii) $112,500 for heads of household, and (iii) $75,000 for all other types of filers.This means, for example, the tax credit will phase out entirely at $198,000 for joint-filers with no children.“Coronavirus-Related Distribution”A “coronavirus-related distribution,” as defined under the CARES Act, is generally defined as any distribution from an eligible retirement plan made: (i) on or after January 1, 2020 and before December 31, 2020, (ii) to an individual (a) who is diagnosed with COVID-19, (b) whose spouse or dependent is diagnosed with COVID-19, or (c) who experiences adverse financial consequences as a result of being quarantined, furloughed, laid off, had hours reduced, or other factors as determined by the Secretary of the Treasury during the COVID-19 pandemic.Tax Treatment of Coronavirus-Related DistributionsIndividuals who elect to receive a “coronavirus-related distribution” will not be subject to the traditional 10% tax penalty imposed under the Internal Revenue Code of 1986, as amended (the “Code”) for early withdrawals from eligible retirement accounts,unless the aggregate amount of such distributions from all plans maintained by the employer (and any member of any “controlled group” which includes the employer) to such individual exceeds $100,000. Coronavirus-related distributions made from both traditional eligible employer sponsored retirement plans and individual retirement accounts (“IRAs”) may be excluded from gross income.Repayments of Coronavirus-Related DistributionsAny individual who receives a coronavirus-related distribution may generally, at any time during the three (3) year period beginning on the day after the date such coronavirus-related distribution was received, make one (1) or more contributions in an aggregate amount not to exceed the amount of such distribution to an eligible retirement plan of which such individual is a beneficiary . The aforementioned repayments of coronavirus-related distributions for eligible retirement plans, will, to the extent of the amount of the contribution, be treated as having received the coronavirus-related distribution in an eligible rollover distribution,” and as having transferred the amount to the eligible retirement plan in a direct trustee to trustee transfer within sixty (60) days of distribution.Effects on the Limits on Loans from Qualified Employer PlansThe limitation on loans from any qualified employer plan made to qualified individuals will be increased from $50,000 to $100,000, and should the due date of any such loan occur between the date of enactment of the CARES Act and December 31, 2020, it will be delayed for one (1) year.Effects on Minimum Distribution ThresholdThe CARES Act temporarily waives the minimum distribution requirements for all “eligible deferred compensation plans.” This includes: (i) certain contribution plans (e.g. an employer purchased annuity contract), (ii) deferred compensation plans that are maintained by an eligible employer, or (iii) IRAs.  This applies for all distributions made on or after January 1, 2020.However, if this section applies to any pension plan or contract amendments, such pension plan or contract amendments will not fail to be treated as being operated in accordance with the terms of the plan during such period, solely because the plan operates in accordance with the CARES Act, so long as the amendment or contract in question has been in effect from its effective date until December 31, 2020.Any plan or contract amendments to which Section 2203 of the CARES Act (the section on temporary waiver of required minimum distribution rules) applies will not fail to meet the requirements of either the Internal Revenue Code or the Employee Retirement Income Security Act as a result of making such an amendment. However, this provision only applies to those amendments which are in effect during the period beginning on the effective date of the amendment until December 31, 2020.Tax Treatment of Charitable DonationThe CARES Act allows taxpayers to take an above-the-line tax deduction for charitable contributions of up to $300 for the tax year beginning in 2020.Additionally, except for certain exclusions specified below, the percentage and excess carryover restrictions on charitable and other “qualified contributions” (e.g. a contribution to a corporation, trust, a state, or an organization of war veterans, etc.) are disregarded.Exceptions to the CARES Act General Disregard of the Percentage and Excess Carryover Restrictions on Qualified ContributionsThe CARES Act treats individuals and corporations differently regarding the aforementioned exceptions, and such different treatments are described below.Qualified contributions for individuals will be allowed as deductions to the extent that the combined contributions do not exceed (i) the excess of the taxpayer’s adjusted gross income over (ii) the amount of the charitable contributions made by the individual under certain other provisions of the CARES Act (e.g., donations to a church, educational organization, private foundation, etc.). If such contributions exceed the foregoing limitation, they will be added to the qualified contribution excess, which is eligible to be treated as charitable deductions for up to the next five (5) successive tax years. Any qualified contributions made by corporations will be allowed as deductions only if these contributions do not exceed 25% of the taxable income of the corporation over the amount of all other charitable contributions allowed under the CARES Act. To the extent a corporation exceeds this limit, it will carry over the excess which will be eligible to be applied as charitable contribution deductions for the subsequent five tax years. This is provided that the excess qualified contribution amounts in question meet certain other restrictions, specifically, they must not exceed the lesser of: (i) 10% of the corporation’s taxable income or the total charitable deductions taken by the corporation during the taxable year over the sum of the contributions made in such year plus the aggregate of the excess contributions which were made in taxable years before the contribution year and which are deductible under this subparagraph for such succeeding taxable year; or (ii) in the case of the first succeeding taxable year, the amount of such excess contribution, and in the case of the second, third, fourth, or fifth succeeding taxable year, the portion of such excess contribution not deductible under this subparagraph for any taxable year intervening between the contribution year and such succeeding taxable year.iii.  Subtitle C: Business ProvisionsEmployee Retention Credit for Employer Subject to Closure Due to COVID-19Eligible employers will receive a credit against applicable employment taxes for each calendar quarter in an amount equal to 50% of the qualified wages with respect to each employee. The amount of qualified wages taken into account for each eligible employee, however, will not exceed $10,000 per calendar quarter and the credit will not exceed the applicable employment taxes owed for such calendar quarter. The aforementioned credit is not applicable if the employer is alto taking advantage of the small business interruption loan. An eligible employer is defined as any employer: (i) which was carrying on a trade or business during calendar year 2020, and (ii) with respect to any calendar quarter for which, (a) the operation of their trade or business was fully or partially suspended due to governmental order as a result of COVID-19, or (b) the  calendar quarter is within the period beginning with (1) the calendar quarter after December 31, 2019 for which gross receipts for the calendar quarter are less than 50% of the gross receipts for the same calendar quarter of the prior year and the ending with (2) the calendar quarter following the first calendar quarter beginning after the calendar quarter described in (1) for which gross receipts of the employer are greater than 80% gross receipts for the same calendar quarter in the prior year.Delay of Payment of Employer Payroll TaxesThe CARES Act will allow for most employers to defer paying their share of applicable employment taxes from the time the CARES Act is signed into law through December 31, 2020. Half of this deferred amount would be due on December 31, 2021 and the other half by December 31, 2022.Modifications for Net Operating Losses (“NOL”)There will generally be a temporary repeal of taxable income limitation including (i) in the case of a taxable year beginning before January 1, 2021, the aggregate of the net operating loss (“NOL”) carryovers to such year, plus the NOL carrybacks to such year, and (ii) in the case of a taxable year beginning after December 31, 2020, the sum of (a) the aggregate amount of NOLs arising in taxable years beginning before January 1, 2018, carried to such taxable year, plus (b) the lesser of (1) the aggregate amount of NOLs beginning after December 31, 2017, carried to such taxable year, or (2) 80% of the excess of certain taxable income.In the case of any NOL arising in a taxable year beginning after December 31, 2017, and before January 1, 2021, whereby (i) such NOL will be a net operating loss carryback to each of the five (5) taxable years preceding the taxable year of such loss and (ii) certain rules applicable to farming losses and insurance companies shall not apply.  There are additional rules that apply specifically to “real estate investment trusts” and life insurance companies.Modification of Limitation on Losses for Taxpayers Other Than CorporationsFor any taxpayer other than a corporation:For a taxable year beginning after December 31, 2017 and before January 1, 2026, subsection (j) (relating to a limitation on excess farm losses of certain taxpayers) would not apply; and ii.  For any taxable year beginning after December 31, 2020 and before January 1, 2026, any excess business loss of the taxpayer for the taxable year will not be allowed.In regard to treatment of capital gains and losses for purposes of calculating “excess business losses”: Deductions for losses from sales or exchanges of capital assets will not be taken into account.The amount of gains from sales or exchanges of capital assets taken into account will not exceed the lesser of (1) the capital gain net income determined by taking into account only gains and losses attributable to a trade or business, or (2) the capital gain net income.The amendments made in the aforementioned section shall apply to taxable years beginning after December 31, 2017.Modification of Credit for Prior Year Minimum Tax Liability of CorporationsThe corporate alternative minimum tax (AMT) was repealed as part of the Tax Cuts and Jobs Act, but corporate AMT credits were made available as refundable credits over several years, ending in 2021.  The CARE Act accelerates the ability of companies to recover those AMT credits, permitting companies to claim a refund now and obtain additional cash flow during the COVID-19 emergency.  Modification of Limitation on Business InterestThe CARES Act temporarily increases the amount of interest expense businesses are allowed to deduct on their tax returns, by increasing the 30-percent limitation (as imposed under the Tax Cuts and Jobs Act) to 50 percent of taxable income (with adjustments) for 2019 and 2020.  As businesses look to weather the storm of the current crisis, this provision will allow them to increase liquidity with a reduced cost of capital, so that they are able to continue operations and keep employees on payroll.Qualified Improvement PropertyThe CARES Act enables businesses, especially in the hospitality industry, to write off immediately costs associated with improving facilities instead of having to depreciate those improvements over the 39-year life of the building. The provision, which corrects an error in the Tax Cuts and Jobs Act, not only increases companies’ access to cash flow by allowing them to amend a prior year return, but also incentivizes them to continue to invest in improvements as the country recovers from the COVID-19 emergency. Temporary Exception from Excise Tax for Alcohol Used to Produce Hand SanitizerFor distilled spirits removed after December 31, 2019 and before January 1, 2021, such distilled spirits will be free of tax for use in or contained in hand sanitizer produced and distributed in a manner consistent with any guidance issued by the FDA related to the outbreak of COVID-19.Title III – Supporting America’s Health Care System in the Fight Against the Coronavirus      Foley Title III Contacts: Rachel O’Neil, Erin Horton, Anil Shankar, and Paul JosephSubtitle A, Part I:  Addressing Supply ShortagesProvides for the National Academies to examine and report on the security of the U.S. medical product supply chain in order to assess U.S. dependence on critical drugs and devices sourced outside of the U.S., and to develop recommendations to improve resiliency of the U.S. supply chain for critical drug and devices.Requires the Strategic National Stockpile to include certain types of medical supplies, including personal protective equipment (PPEs), and identifies respiratory protective devices as covered countermeasures for use during a public health emergency.Prioritizes the review of drug applications to mitigate emergency drug shortages.Creates additional reporting requirements for drug manufacturers to report a discontinuation and disruption of the sourcing of active pharmaceutical ingredients.Requires manufacturers of certain drugs and medical devices critical to public health during a public emergency to develop, maintain, and implement risk management plans related to shortages, creating an annual notification requirement of the same. Such manufacturers are also subject to shortage-related inspections by the Secretary of Health and Human Services (HHS).Subtitle A, Part II: Access to Health Care for COVID-19 Patients Permits group health plans and insurers to cover and reimburse providers of diagnostic testing relating to COVID-19 at pre-emergency-period negotiated rates, and sets reimbursement rates in instances without previously negotiated rates equal to the cash price for services listed on a publicly-available website or the plan or insurer can negotiate with a provider for a rate lower than such cash price. All providers of a diagnostic test for COVID-19 are required to publicize cash price for such tests. Failure to comply with these requirements could result in HHS assessing a civil monetary penalty of up to $300 per day.Requires health plans and issuers to provide for rapid coverage of “qualifying coronavirus preventative services” – an item, service, or immunization intended to prevent or mitigate coronavirus—and vaccines for coronavirus.Appropriates $1.3 billion for FY 2020 for supplemental awards to health care centers for the prevention, diagnosis, and treatment of COVID-19.Amends Section 330I of the Public Health Service Act, relating to Telehealth Network and Telehealth Resource Centers Grant Programs, and Section 330A of the Public Health Service Act, relating to the Rural Health Care Services Outreach, Rural Health Network Development, and Small Healthcare Provider Quality Improvement Grant Programs—an individual or entity affected by these grant programs should seek out an attorney to examine the effect of such amendments.Limits potential state and federal liability for volunteer health care professionals—who provide services without compensation or other thing of value—for harm caused to patients relating to the diagnosis, prevention, or treatment of COVID-19. This provision expressly preempts more restrictive state or local law.Amends certain federal regulations governing the confidentiality and disclosure of substance use disorder patient records (Part 2), including allowing certain re-disclosures to covered entities, business associates, or other programs subject to HIPAA after obtaining the patient’s prior written consent.Permits a state agency or area agency on aging to transfer, without prior approval, not more than 100% of the funds received by the agency to meet the needs of the state or area served, and provides that the same meaning shall be given to an individual unable to obtain nutrition due to social distancing as one who is homebound due to illness.Provides that within 180 days of the passage of the Act, the Secretary of HHS shall issue guidance on the sharing of patients’ protected health information (PHI) related to COVID-19, including guidance on compliance with HIPAA regulations and applicable policies.Provides that the Secretary of HHS shall carry out a national awareness campaign relating to the importance and safety of blood donation, and the need of for donations for the blood supply during a public health emergency.iii.  Subtitle A, Part III:  Innovation Provides for using competitive procedures to enter into transactions to carry out public-health emergency health related projects and prohibits canceling those contracts solely because the emergency ends.Includes new provisions to expedite the development and approval of drugs to prevent or treat diseases in animals that are could have significant adverse consequences for humans.Subtitle A, Part IV:  Health Care WorkforceApproves appropriations for a variety of health professions-related programs, with particular focus on programs serving medically underserved populations (rural and geriatric).Subtitle B:  Education ProvisionsWaives requirement for certain higher education institutions to match federal funding and allows certain institutions to transfer unexpended allotment.Permits certain higher education institutions to use their allocations of Supplemental Educational Opportunity Grants for emergency financial aid for students.Permits certain higher education loan borrowers flexibility in repaying loans or returning grants during a qualified emergency.Permits certain students to complete distance education and certain students of foreign institutions to take classes in the United States.Allows the Secretary of Education to issue waivers upon request relating to assessments, accountability, and related reporting requirements, and requirements for state and local educational agencies and Indian Tribes to receive funding.Allows the Secretary of Education to grant a deferment to an institution that received a loan under Part D of Title III of the Higher Education Act.Payments on student loans held by the Department of Education are suspended for 6 months, and the Secretary of Education shall suspend all involuntary collection activities during the period of payment suspension.The Corporation for National and Community Service can allow individuals to accrue service hours and may permit certain grants funds.Not more than 20% of the total amount allocated to a local area under 29 U.S.C. 3151 et seq. may be used for administrative costs.For the program year 2019, not more than 20% of the total amount allocated to a local area under 29 U.S.C. 3151 et seq., may be used for administrative costs of carrying out certain local workforce investment activities, if the portion of the total amount that exceeds 10% of the total amount is used to respond to qualifying emergency.  For the program year 2019, certain unobligated funds reserved by a governor for statewide activities under the Workforce Innovation Opportunity Act may be used for statewide rapid response activities, or in certain circumstances, released to local boards impacted by the coronavirus.Gives the Secretary of Education authority to waive certain eligibility requirements, wait periods, and allotment requirements under the Higher Education Act for a period of time.Authorizes the Secretary of Education to modify the required and allowable uses of funds for grants and to modify any federal share or other financial matching requirement for a grant awarded under certain provisions of the Higher Education Act to an institution of higher education or other grant recipient (not including an individual recipient of Federal student financial assistance) as a result of a qualifying emergency.Allows the Secretary of Education to modify the categories of extenuating circumstances under which a grant recipient may be excused from fulfilling a portion of a service obligation under title IV of the Higher Education Act and must consider teaching service that is part-time or temporarily interrupted due to the emergency to be full-time service.  Requires the Secretary of Education to waive certain years of teaching service requirements under the Higher Education Act in certain circumstances.Subtitle C: Labor ProvisionsPaid Public Health Emergency Leave MinimumsEmployers may, but are not required to, pay any more than $200 per day and $10,000 in the aggregate for each employee for public health emergency leave under section 110(b)(2)(B) of the Family & Medical Leave Act of 1993 as amended by the Emergency Family and Medical Leave Expansion Act.Rehire Eligibility for Paid Public Health Emergency Leave EmployersFor purposes of public health emergency leave under the Emergency Family and Medical Leave Expansion Act, an eligible employee is an employee who has been employed for at least 30 calendar days by an employer with respect to whom leave is requested. The employee must be employed for at least 30 calendar days, which includes an employee who was laid off by that employer on or after March 1, 2020, had worked for employer for not less than 30 of the last 60 calendar days prior to the employees layoff, and was rehired by the employer.Emergency Paid Sick Leave MinimumsEmployers may, but are not required to, pay any more than:$511 per day or $5,110 in the aggregate for each employee when taking emergency paid sick leave if the employee is subject to a federal, state or local quarantine or isolation order related to COVID-19, the employee has been advised by a health care provider to self-quarantine due to concerns related to COVID-19, or the employee is experiencing symptoms of COVID-19 and seeking medical diagnosis; or $200 per day or $2,000 in the aggregate for each employee when taking emergency paid sick leave if the employee is caring for an individual who is subject to a federal, state or local quarantine order, or is caring for an individual who has been advised to self-quarantine due to concerns related to COVID-19, the employee is caring for the employee's son or daughter, if the child’s school or childcare facility has been closed or the child’s care provider is unavailable due to COVID-19 precautions, or the employee is experiencing any other substantially similar condition specified by HHS in consultation with the Department of the Treasury and the Department of Labor.Advance Refunding of Payroll Credits for Required Paid Sick Leave and Required Paid Family LeaveEmployers can apply a credit in the amount calculated under subsection (a) of section 7001 or 7003 of the Family First Coronavirus Response Act, subject to the limitations placed by subsection (b) of section 7001 and 7003, both calculated through the end of the most recent payroll period in the quarter. In anticipation of a credit, the credit may be advanced according to forms and instructions to be provided by the Secretary of Labor. The Act ensures employers that the Secretary of Treasury shall waive any penalty under section 6656 of the Internal Revenue Code of 1986 for failure to make a deposit of the tax imposed under section 3111 (a) or 3221(a) of such Code if failure was due to anticipation of credit allowed.vii. Subtitle D: Finance CommitteeAn additional safe harbor provision is added to section 223(c)(2) of the Internal Revenue Code, providing that a plan shall not fail to be treated as a high deductible health plan (HDHP) by reason of failing to have a deductible for telehealth and other remote care services.  Section 223(c)(1)(B) of the Internal Revenue Code is adjusted to include “telehealth and other remote care.” This addition allows an individual to have an insurance plan (for plan years beginning on or before December 31, 2021) that includes telehealth and other remote care without disqualifying the individual from owning an HDHP.Inclusion of Certain Over-the-Counter Medical Products as Qualified Medical ExpensesMenstrual care products are now included under the term “qualified medical expenses.” Increasing Medicare Telehealth Flexibilities During Emergency Period The amendment removes some limiting qualifications to section 1320b-5(b)(8), which allows for the Secretary of HHS to temporarily waive or modify the application of portions of the Social Security Act in the case of a telehealth service furnished in any emergency area during an emergency period.  The provision that sets out the defined term “qualified provider,” which limited 1320b-5(b)(8), is removed in its entirety. Enhancing Medicare Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics During Emergency PeriodA new provision is added under Section 1834(m) of the Social Security Act (42 USC 1395m(m)), enhancing payment for telehealth services furnished via a telecommunications system by a federally qualified health center (FQHC) or rural health clinic (RHC) during an “emergency period” notwithstanding that the FQHC or the RHC providing the telehealth service is not at the same location as the beneficiary.  Payment methods for FQHCs or RHCs that serve as distant sites shall be based on payment rates similar to the national average payment rates for comparable telehealth services under the physician fee schedule under section 1848.Temporary Waiver of Requirement for Face-to-Face Visits Between Home Dialysis Patients and PhysiciansAmended section 1395rr(b)(3)(B) to allow the Secretary of HHS to waive the requirement that individuals with end stage renal disease receiving home dialysis must receive certain periodic face-to-face (non-telehealth) clinical assessments in order to be eligible to receive end stage disease-related clinical assessments via telehealth. Use of Telehealth to Conduct Face-to-Face Encounter Prior to Recertification of Eligibility for Hospice Care During Emergency PeriodSection 1395f(a)(7)(D)(i) is amended to allow a hospice physician or hospice nurse practitioner during an “emergency period” to conduct a face-to-face encounter via telehealth to determine recertification for continued eligibility for hospice care.Encouraging Use of Telecommunications Systems for Home Health Services Furnished During Emergency PeriodDuring an emergency period, the Secretary of HHS shall consider ways to encourage the use of telecommunications systems.Improving Care Planning for Medicare Home Health ServicesCertain Medicare sections are expanded from being limited to the services of a physician to include services of nurse practitioners, clinical nurse specialists, and physician assistants that provide home health services.Adjustment of SequestrationA temporary suspension of Medicare sequestration put into effect during the period of May 1, 2020 through December 31, 2020. The Medicare programs under title XVIII of the Social Security Act shall be exempt from reduction under any sequestration order during the period.Medicare Hospital Inpatient Prospective Payment System Add-On Payment for COVID-19 Patients During Emergency PeriodThe Secretary of HHS will increase the weighting factor for coronavirus-diagnosed patients discharged during the emergency period. The weighting factor is used by the Secretary of HHS to reflect the relative hospital resources used with respect to discharges for a particular group compared to discharges within other groups.Increasing Access to Post-Acute Care During Emergency PeriodDuring the emergency period, the Secretary of HHS will waive the requirement that patients of inpatient rehabilitation facilities receive at least 15 hours of therapy per week.  For long-term care hospitals furnishing services during the emergency period, the Secretary of HHS will further waive discharge percent requirements and the general application of site neutral payment rates.Revising Payment Rates for Durable Medical Equipment Under the Medicare Program Through Duration of Emergency PeriodThe Secretary of HHS shall apply the transition rule, described in 42 C.F.R. § 414.210(g)(9)(iii), to items and services furnished in rural areas and noncontiguous areas as planned through December 31, 2020, and through the duration of the emergency period.  For areas other than rural and noncontiguous areas, the Secretary of HHS shall apply the transition rule described in 42 C.F.R. § 414.210(g)(9)(iv) through the remainder of the emergency period.Coverage of the COVID-19 Vaccine Under Part B of the Medicare Program Without Any Cost-SharingThe term “medical and other health services” is expanded to include “COVID-19 vaccine and administration.”  The deductible described in section 1395l(b) shall not apply with respect to a COVID-19 vaccine and its administration.Requiring Medicare Prescription Drug Plans and MA-PD Plans to Allow for Fills and Refills of Covered Part D Drugs for up to a 3-Month SupplyDuring the emergency period, a prescription drug plan or MA-PD plan shall permit a part D eligible individual reenrolled in such plan to obtain a single fill or refill the total day supply prescribed for such individual for a covered part D drug.Providing Home and Community-Based Services in Acute Care HospitalsThe prohibition that nothing in section 1395a allows the Secretary of HHS authorization to limit the amount of payment that may be made under a plan for home-and-community care is expanded to include home and community-based services, self-directed personal assistance services, or home and community-based attendant services.  The provision is also expanded to clarify that the section shall not be construed to prohibit receipt of any care or services specified in paragraph (1) in an acute care hospital, provided certain requirements are met.Clarification Regrading Uninsured Individuals The Families First Coronavirus Response Act, enacted last week, added subsection (ss) to section 1396a, which defined “uninsured individual” as those not described in section 1396a(a)(10)(A)(i) and not enrolled in certain health care programs. The CARES Act amends this definition to exclude subsection VIII if the individual is a resident of a state that does not furnish medical assistance as described.    Clarification Regarding Coverage of COVID-19 Testing ProductsThe Families First Coronavirus Response Act, enacted last week, added COVID-19 testing to section 1396d, which provides medical assistance payments under certain conditions. The CARES Act amends this section by removing the requirement that the in-vitro diagnostic products administered are approved, cleared, or authorized under sections 510(k), 513, 514, or 564 of the Federal Food, Drug, and Cosmetic Act.Amendment Relating to Reporting Requirements with Respect to Clinical Diagnostic Laboratory TestsThe CARES Act extends the dates by one year for the reporting periods in section 1395m-1(a)(1)(B).  The applicable prohibition that payment amounts determined under section 1395m-1 shall not result in a reduction in payments, as defined by the subsection, for a clinical diagnostic laboratory test is expanded to 2017 through 2024.   The applicable percentages used to determine the limits on reductions in payment defined in 1395m-1(b)(3)(A) are adjusted to include a new clause for 2021, which makes the new applicable percentage zero (0) for 2021.Expansion of Medicare Hospital Accelerated Payment Program During the COVID-19 Public Health EmergencyMandates that the Secretary of HHS expand the accelerated payment program to hospitals experiencing significant cash flow problems during the “emergency period.” Exception for Certain States from Enhanced FMAP Requirements Provides that states may receive the temporary increase of Medicaid Federal Medical Assistance Percentage (FMAP) (authorized under the Families First Act enacted last week) notwithstanding the requirement to not impose premiums on beneficiaries, for a period of 30 days.viii.  Subtitle E, Part I: Medicare ProvisionsExtension of Funding for Quality Measure Endorsement, Input, and SelectionThe Social Security Act is amended to increase the amount allotted for this fiscal year ending on October 1, 2020 from $4,830,000 to $20,000,000 and for the period beginning on October 1, 2020 and ending on November 30, 2020, the amount equal to the pro rata portion of $20,000,000. Extension of Funding Outreach and Assistance for Low-Income ProgramsThe amount allocated for state health insurance programs shall be $13,000,000 for this fiscal year. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $13,000,000.The amount allocated for area agencies on aging shall be $7,500,000 for the fiscal year of 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $7,500,000.The amount allocated for aging and disability resource centers shall be $5,000,000 for fiscal year 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $5,000,000.The amount allocated for grant or contract with national center for benefits and outreach enrollment is now $12,000,000 for the 2020 fiscal year ending on October 1, 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $12,000,000.Subtitle E, Part II: Medicaid ProvisionsExtension of the Money Follows the Person Rebalancing Demonstration ProgramThe Deficit Reduction Act of 2005 section 6071(h)(1)(G) is amended to allocate $337,500,000 for the period beginning on January 1, 2020 and ending on September 30, 2020. For the period beginning on October 1, 2020 and ending on November 30, 2020, the amount available will be equal to the pro rata portion of $337,500,000.Extension of Spousal Impoverishment ProtectionsExtends the protections through November 30, 2020.Allows the State to disregard the income of a spouse and conduct an analysis solely on an individual’s eligibility for medical assistance on the basis of reduction of income.Delay of DSH ReductionsThis section removes the $4 billion DSH reductions for federal fiscal year 2020 and delays the cuts from taking effect December 1, 2020. Extension and Expansion of Community Mental Health Services Demonstration ProgramExpands the Protecting Access to Medicare Act of 2014.According to this section not later than 6 months after the date of enactment, the Secretary shall select two states, in addition to the eight States already listed, to participate in two-year demonstration programs that meet the requirements of this subsection.The requirements are states that:Were awarded planning grants, Applied to participate in the demonstration programs under this subsection but were not selectedThe Secretary shall use the results of its evaluation of the state’s original application and shall not require the submission of any additional application.If a state is selected it is required to: Submit a plan to monitor certified community behavioral health clinics under the demonstration program to ensure compliance with certified community behavioral health criteria during the demonstration period; and Commit to collecting data, notifying the Secretary of any planned changes that would deviate from the prospective payment system methodology outlined in the state’s demonstration application, and obtaining approval from the Secretary of any such change before implementing change.The Federal matching percentage applicable to amounts expended by states participating in the demonstration program under this subsection shall apply to amounts expended by the state during the fiscal period that begins on January 1, 2020 if the state was participating in the demonstration program as of January 1, 2020 and shall apply to amount expensed by the state during the first fiscal period the state participates if the state was selected pursuant to the expansion. Subtitle E, Part III: Human Services and Other Health ProgramsExtension of Sexual Risk Avoidance Education ProgramSection 510 of the Social Security Act is amended to extend the time through 2020 instead of ending in May 22, 2020 and to change the fiscal year to 2021. Extension of Demonstration Projects to Address Health Professions Work-Force NeedsActivities authorized by section 2008 of the Social Security Act shall continue through November 30, 2020. Extension of the Temporary Assistance for Needy Families Program and Related ProgramsActivities authorized by part 1 of title IV and section 1108(b) of the Social Security Act shall continue through November 30, 2020. Subtitle E, Part IV: Public Health ProvisionsExtension for Community Health Centers, the National Health Service Corps, and Teaching Health Centers that Operate GME ProgramsThe amount allocated for community health centers under the Patient Protection and Affordable Care Act is increased to $4,000,000,000 for fiscal year 2020 and $668,493,151 for the period beginning on October 1, 2020 and ending on November 30, 2020.The amount allocated for the National Health Service Corps is now $310,000,000 for fiscal year 2020 and $51,808,219 for the period beginning on October 1, 2020 and ending in November 30, 2020.The amount allocated for teaching health centers that operate graduate medical education programs now extends through fiscal year 2020 and $21,141,096 is allocated for the period beginning on October 1, 2020 and ending on November 30, 2020.Diabetes ProgramsThe amount allocated under the Public Health Service Act for Type I will extend through the fiscal year of 2020 and $25,068,493 will be allocated for the period beginning on October 1, 2020 and ending on November 30, 2020.The amount allocated under the Public Health Services Act for Indians will extend through the 2020 fiscal year and $25,068,493 will be allocated for the period beginning on October 1, 2020 and ending on November 30, 2020.xii. Subtitle F, Part I: Over-the-Counter DrugsAmends Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to insert a new section regulating certain nonprescription drugs that are marketed without an approved drug application under section 505 of the FD&C Act.  This new section primarily achieves two goals: (1) reforms the regulatory process for over-the-counter (OTC) drug approvals permitting the FDA more flexibility to make changes administratively, rather than through the time-consuming full notice and comment rulemaking process; and (2) incentivizes pharmaceutical companies to research and manufacture innovative drug products by providing an 18-month market-exclusivity period to reward investments for new OTC drugs.Amends Section 502 of the FD&C Act, to clarify that an OTC drug which does not comply with the requirements of its OTC monograph, which is essentially an approved recipe for a drug product, is considered misbranded.  The FD&C Act prohibits the introduction of misbranded drugs into interstate commerce.Clarifies that nothing in the CARES Act will apply to drugs previously excluded by the FDA from the Over-the-Counter Drug Review under the original 1972 Federal Register document.Clarifies that sponsors of sunscreen ingredients with pending orders have the option to see review in accordance with the Sunscreen Innovation Act (SIA) or to see review under the new monograph review process.  The election must be made within 180 calendar days of the date of enactment of the CARES Act. Provides an annual procedure to update Congress on the appropriate pediatric indication for certain OTC cough and cold drugs for children under the age of six.  The evaluation consists of conditions under which nonprescription drugs are generally recognized as safe and effective.Makes technical corrections to the FDA Reauthorization Act of 2017 (Public Law 115-52).xiii. Subtitle F, Part II: User FeesDeclares that the fees paid pursuant to this section will be dedicated to FDA review of over-the-counter monograph drugs as set forth in the goals section and in letters from the Secretary of HHS to certain congressional committees.Establishes a new FDA user fee to allow the agency to hire additional staff members to ensure there is adequate agency oversight to approve changes to OTC drugs.Title IV – Economic Stabilization and Assistance to Severely Distressed Sectors of the United States Economy      Foley Title IV Contact: Christopher SwiftTitle IV of the Coronavirus Aid, Relief, and Economic Securities Act provides the Secretary of the Treasury with the authority to make loans or loan guarantees to states, municipalities, and eligible businesses and loosens a variety of regulations created in the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Economic Stabilization Act of 2008, and others.ii.Subtitle A – Coronavirus Stabilization Act of 2020Emergency Relief and Taxpayer ProtectionsThe Act authorizes the Treasury Secretary to make up to $500 billion worth of loans and loan guarantees to eligible businesses, states, and municipalities. The term “eligible business” includes passenger air carriers or any other business that has not already received adequate economic relief in the form of loans or loan guarantees under other provisions of the Act. The Act reserves $46 billion to support passenger air carriers, air cargo carriers, and businesses important to maintaining national security. The Act establishes a $454 billion credit facility for Federal Reserve programs designed to support lending to eligible businesses, states, and municipalities. This program contemplates various loans and loan guarantees for distressed businesses.Businesses that receive loans through these Federal Reserve programs are prohibited from paying dividends or repurchasing stock (or other outstanding equity interests) while the loan or loan guarantee is outstanding, as well as for the 12 months following repayment. These businesses are subject to the same employee compensation restrictions as listed for air carriers, air cargo carriers, and businesses deemed important to maintaining national security. Although the Treasury Secretary can waive these restrictions, he must identify and explain the rationale for such waivers in testimony before Congress.Businesses that receive loans or loan guarantees through these Federal Reserve programs can only make loans (or other advances) to business that are incorporated in the United States. Transfers to subsidiaries and affiliates incorporated outside the United States are prohibited.The Act directs the Treasury Secretary to establish a program to provide low-interest loans for eligible businesses (including nonprofit organizations) with between 500 and 10,000 employees. Although these loans will require no repayment for at least six months, businesses and non-profit organizations seeking this support must provide a good-faith certification that they meet the following criteria:The company intends to maintain at least 90 percent of their current workforce;The company will not pay dividends or repurchase stock (or other equity securities);The company will not outsource or offshore jobs during the loan period or two years thereafter;The company will not abrogate existing collective bargaining agreements with labor unions; and The company will remain neutral regarding current or future union organizing activity.Limitation on Certain Employee CompensationThe Act also imposes certain compensation caps for officers and employees at companies  receiving loans or loan guarantees.  Under these caps, officers or employees that received $425,000 or more in total compensation in 2019 will have their future compensation capped at the amount they received that year.  This cap applies while the loan or loan guarantee is in effect, as well as to the 12 consecutive months after the loan or loan guarantee is no longer outstanding. The same restriction also applies to severance payments or other compensation received upon termination from businesses participating on the loan and loan guarantee programs.Additional caps apply for officers and employees whose total compensation exceeded $3,000,000 in 2019.  Under the Act, these individuals may receive compensation up to $3,000,000 plus 50 percent of the excess over $3,000,000 of the total compensation received by the officer or employee in 2019. For example, an officer or employee whose total 2019 compensation was $3,000,010 would be restricted to total compensation of $3,000,005 in subsequent years. Like the lower cap discussed above, this restriction applies while the loan or loan guarantee is in effect, as well as to the 12 consecutive months after the loan or loan guarantee is no longer outstanding.Continuation of Certain Air ServicesThe Secretary of Transportation may require any air carrier receiving loans or loan guarantees under Section 4003 to maintain scheduled air transportation services as the Secretary deems necessary to maintain service to any destination the carrier served before March 1, 2020. The Secretary of Transportation is to consider the needs of “small and remote communities” and “health care and pharmaceutical supply chains” when enforcing this portion of the Act.Suspension of Certain Aviation Excise TaxesThe Act suspends the imposition of aviation excise taxes as otherwise required under the Internal Revenue Code through December 31, 2020.Debt Guarantee AuthorityIn order to backstop solvent depository institutions, it appears that the CARES ACT allows the FDIC to establish a program to insure these institutions without regard to a maximum amount.  All such guarantees are to last at least until December 31, 2020.Temporary Government in the Sunshine Act ReliefIn the event that unusual and exigent circumstances continue to exist, the Board of Governors of the Federal Reserve System may conduct meetings with less restrictive and formal meeting notification and record-keeping requirements until December 31, 2020.  Temporary Hiring FlexibilityWithout regard to certain statutory hiring requirements, the Secretary of Housing and Urban Development and the Securities Exchange Commission are given flexibility to recruit and appoint candidates for temporary and term appointments as necessary to prevent, prepare for, or respond to COVID-19 during the “covered period” of the CARES Act.Temporary Lending Limit WaiverEnlarges exception to requirement on the maximum amount of loans and extensions of credit by a national banking association to include a nonbank financial company (as defined in Section 102 of the Financial Stability Act of 2010) and allows the Comptroller o

The Centers for Medicare and Medicaid services uses the terms telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health.  Telehealth applications include: Live (synchronous) videoconferencing: a two-way audiovisual link between a patient and a care provider Store-and-forward (asynchronous) videoconferencing: transmission of a recorded health history to a health practitioner, usually a specialist. Remote patient monitoring (RPM): the use of connected electronic tools to record personal health and medical data in one location for review by a provider in another location, usually at a different time. Mobile health (mHealth): health care and public health information provided through mobile devices. The information may include general educational information, targeted texts, and notifications about disease outbreaks. The Coronavirus Preparedness and Response Supplemental Appropriations Act, was signed into law by the President on March 6, 2020, declared an 1135 waiver on telehealth services during the covid- 19 crisis. Essentially this allows for clinic visits to be done via videoconferencing between patient and physician during the crisis, allowing the physician to bill for the services at the same level that they would an in-office clinic visit. This allows for both the delivery of services to patients in need but also allows physician offices, many of them small independent business to maintain a revenue stream during the crisis. I welcome this change because I have long thought that many of the services we deliver to patients should not require them to drive to the office, check in at the front desk, wait in the waiting room, and then sitting in an exam room for multiple minutes prior to a short visit to follow up on labs, or an x-ray review, or get some education, or discuss a medical problem that does not require a physical exam. When the President expanded the use of telehealth he used what is called an 1135 waiver. When the President declares a disaster or emergency under the Stafford Act or National Emergencies Act and the HHS Secretary declares a public health emergency under Section 319 of the Public Health Service Act, the Secretary is authorized to take certain actions. For example, under section 1135 of the Social Security Act, a secretary, or in this case the President, may temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs. These 1135 waivers typically are time limited, ending no later than the termination of the emergency period, or 60 days from the date the waiver. The current 1135 waiver for covid-19 allows Medicare to pay for office, hospital, and other visits furnished via telehealth across the country and including in patient's places of residence starting March 6, 2020. Connect with me at whyurologypodcast.com.  

Due to the coronavirus pandemic, a State of Emergency has been declared at the city, state, and federal level.  These declarations have far-reaching impact and consequences and, frankly, we are in uncharted waters. Here to help us walk through everything that has happened in the past 48 to 72 hours for my cohosts, Bailey Perkins and Scott Melson.  Last Friday President Trump declared a national state of emergency, which was followed by a similar declaration on Sunday from the mayors of Oklahoma City and Stillwater, as well as Governor Stitt. We are recording this on Monday evening, and so far today I have seen that the mayors of Yukon and Tulsa have also declared state of emergency in those jurisdictions. Additionally, the Oklahoma state Department of Education has canceled school throughout the state until April 6, the Cherokee in Chickasaw tribes are clothes in their casinos, (Most of the casinos in Las Vegas are also closed, for what it's worth), and the Oklahoma legislature announced they are making significant changes to their operations to expedite passage of the budget and other constitutionally required duties. Yesterday the CDC said that all public events with 50 or more people for the next 8 weeks should be canceled, and today they updated that to be all public events with more than 10 people should be canceled.  How about we start by talking about what a state of emergency declaration is, and why there are different ones, walk through what a state of emergency means at each level. So,  why do we have different ones?  [discussion] So, a when the president declares a national state of emergency (https://www.nytimes.com/2020/03/13/us/politics/coronavirus-national-emergency.html) for a public health emergency, it basically enacts three laws: the Public Health Service Act, Stafford Act, Social Security Act, as well as some other laws. The Stafford Act is the government’s main mechanism for responding to major disasters and emergencies. It permits tapping into an account that currently has more than $40 billion, which it could use to do things like buy medical supplies and equipment. Often used with natural disasters, previously also used by President Clinton to respond to  the West Nile outbreak   It frees up federal funds and other resources to help when “federal assistance is needed to supplement state and local efforts and capabilities to save lives and to protect property and public health and safety.”  also empowers the president to direct any federal agency to use its personnel, facilities and equipment to support state and local emergency efforts, disseminate public health and safety information, provide public health and safety measures, and distribute supplies like medicine and food. unlocks extra powers under Section 1135 of the Social Security Act aimed at making it easier to get medical supplies and doctors and nurses where they are needed most. (Prev used by by Obama to address H1N1 aka Swine Flu. Okay, let’s move down to the state level (http://www.sos.ok.gov/documents/executive/1913.pdf?fbclid=IwAR3b9a5RrTJ4vkDbMTnroOe6pPur5Ge4FVxw2muKJW3nYdL57SC2eq5CShY) . [discussion] And finally, down to the city level. (https://www.okc.gov/Home/Components/News/News/3287/5296) [discussion] Resources cdc.gov (http://cdc.gov) Coronavirus.health.ok.gov (http://coronavirus.health.ok.gov) Regionalfoodbank.org/covid19  (http://regionalfoodbank.org/covid19) Okfoodbank.org (http://okfoodbank.org)   Good news coverage: The Frontier (https://www.readfrontier.org/) NonDoc (http://nondoc.com) Support this podcast

The Health Resources and Services Administration (HRSA), which administers Section 340B of the Public Health Service Act, has published a proposal to delay for another year the ceiling price and civil monetary penalties regulation that was originally issued by the outgoing Obama Administration in January 2017. It was formally published on Monday. National Correspondent Timothy Powell reported our lead story on this episode of Monitor Mondays on 340B. The broadcast rundown also will include: Monday Focus: Nationally recognized whistleblower attorney Mary A. Inman, partner at Constantine Cannon’s London office, reported on a whistleblower case that is attracting unprecedented media coverage—the nurse who knew too much. Monday Rounds: Ronald Hirsch, MD, vice president of R1 Physician Advisory Services, made his Monday Rounds with another installment of his popular segment. Hot Topics: Monitor Mondays senior correspondent Nancy Beckley, president and CEO for Nancy Beckley and Associates, reported on all the latest hot topics and present the Monitor Mondays Listener Survey. Risky Business: Healthcare attorney David Glaser with Fredrikson & Byron reported on another example of a potentially troublesome issue that could pose a risk to your facility. Medicare Advantage Report: Monitor Mondays National Correspondent J. Paul Spencer, a senior healthcare consultant for DoctorsManagement, continued to report on the vexing issue of Medicare Advantage. Monitor with us.™

The American Health Care Act, the Republican plan for a new health care system, passed the House of Representatives at lightning speed. In this episode, get the backstory on the reckless process used to pass the bill, learn how it changed from the original version, and find out how the Congressional Budget Office expects the bill would affect you. Please support Congressional Dish: Click here to contribute using credit card, debit card, PayPal, or Bitcoin Click here to support Congressional Dish for each episode via Patreon Mail Contributions to: 5753 Hwy 85 North #4576 Crestview, FL 32536 Thank you for supporting truly independent media! Recommended Congressional Dish Episodes CD146: Repeal & Replace Bill Outline H.R. 1628: American Health Care Act of 2017 Bill Outline Title I: Energy and Commerce Subtitle A: Patient Access to Public Health Programs Section 101: Repeals the Prevention and Public Health Fund at the end of 2018 Section 103: Prohibits any Federal funding for any non-profit that performs abortions for a year Subtitle B: Medicaid Program Enhancement Section 111 : Reduces Medicaid funding Section 112: Ends the Medicaid expansion... For people under 65 years old whose income is less than 133% of the poverty line at the end of 2019 Ends the States' option to cover these people's families at the end of 2017 People in this category who have Medicaid on December 31, 2019 will be grandfathered in and will keep their insurance as long as they never go off of Medicaid for more than one month The Federal funding increase for states covering grandfathered individuals will only apply for people enrolled as of March 1, 2017 and is capped at 80% reimbursement rate Repeals the requirement that Medicaid cover “essential health benefits” as of January 1, 2020. Section 114: Prevents Medicaid for lottery winners Section 115: Gives $10 billion extra over five years to the “non-expansion States” Section 116: Forces States to verify Medicaid eligibility every six months and gives them more enforcement money Section 117: Allows States deny people Medicaid if they are not participating in "work activities" The State decides how long the person has to work for in order to get Medicaid The State can't deny Medicaid to... Pregnant women or to women who have had a baby within the last 60 days Kids under age 19 Only parents with kids under the age of 6 or a disabled child Gives the States more money for enforcement Subtitle C – Per Capita Allotment for Medical Assistance Section 121: Caps Medicaid funding on a per capita basis. States that spend too much one year will have their Medicaid cut the following year States will be allowed to get 10 year block grants instead Subtitle D: Patient Relief and Health Insurance Market Stability Section 131: Repeals the lower out-of-pocket limits for low-income people effective in 2020 Section 132: Creates a "Patient and State Stability Fund" to be administered by the Secretary of Health and Human Services to give money to the States until the end of 2026. Funds can be used for: Helping "high-risk individuals" buy insurance if they don't get coverage through their employer Giving money to insurance companies ("incentives") so they will lower premiums Taxpayers will pay insurance companies 75% of the claims made between $50,000 and $350,000 "Promoting access" to preventative care, including dental and vision Maternity & newborn care Mental health care and substance abuse treatment Reduction of out-of-pocket costs for people enrolled in health insurance in the State The fund is appropriated with $15 billion per year until 2020 and $10 billion per year until 2026. There will be an extra $8 billion a year put into the fund from 2018-2023 to pay for increased premiums and out-of-pocket costs of people in States that get a waiver In order to receive money from the Federal fund, States will have to match an increasing percentage, starting with 7% in 2020 increasing to 50% by 2026 An extra $15 billion "Federal Invisible Risk Sharing Program" will go directly to health insurance companies. The rules in terms of whose claims will be paid for, the percentage of their premiums that would be paid, and the dollar amount at which the government will starting covering the insurance companies' costs will be determined by the Secretary of Health and Human Services Section 133: Starting in 2019, people who purchase insurance after a coverage gap of 63 days will be charged a 30% penalty for a year. The insurance companies get to keep all the extra money. Section 134: The requirements that bronze, silver, gold, platinum level plans exist and must cover certain percentages of expenses and “essential health benefits” are repealed effective January 1, 2020. Section 135: Allows insurance companies to charge older people five times more than younger people (they’re currently allowed to charge three times more) Section 136: Starting in 2018, States can apply for a waiver for the individual and small group insurance plans from the national “essential health benefits” requirements and instead allow States to determine what essential health benefits need to be covered by insurance companies. Waiver applications from States are automatically approved after 60 days Waivers will be granted if the State says that doing so would do at least one of the following: Reduce premiums Increase enrollment Stabilize the insurance market Increase the number of health plans offered. Waivers will be valid for 10 years and continuation requests will be automatically approved Starting in 2019, states can also get waivers that would allow insurers to charge different rates based on people's health status ("pre-existing conditions") if they did not have coverage for at least 63 days in lieu of the 30% surcharge. States can get this waiver as long as that state participates in the high-risk funds to help pay for individuals and insurance companies' costs. Insurance companies could limit coverage during the "enforcement period", not permanently. Section 137: Health insurers can't set rates based on gender and "Nothing in this act shall be construed as permitting health insurance issuers to limit access to health coverage for individuals with preexisting conditions." Title I: Committee on Ways and Means Subtitle A: Repeal and Replace of Health-Related Tax Policy Section 201: Starting in 2018, the limits on the amount of advanced-paid tax credits that can be taken back from low income people will be repealed. Section 202: Allows tax credits to be used on “catastrophic-only” health insurance plans that are not listed on the exchanges and prohibits tax credits for any plan that covers abortions. Section 203: Repeals the tax credit for employers with fewer than 25 employees who want to provide health benefits to their employees starting in 2020 and prohibits tax credits for any health plan that covers abortion. Section 204: Reduces the tax penalties for failing to purchase insurance to $0 and back dates it to be effective in 2016. Section 205: Reduces the tax penalties for employers who fail to provide health benefits to their employees to $0 and back dates it to be effective in 2016. Section 206: Delays the start of a tax on insurance companies which charges a 40% excise tax on “Cadillac plans”, which charge premiums more than $10,200/year ($850/month) for individuals until 2026. The 40% is only on the extra premiums charges above the cap. Section 207: Starting in 2017, over-the-counter drugs can be purchased with Health Savings Accounts (HSA). Section 208: Starting in 2017, taxes on money from health savings accounts that is not used for medical expenses will be cut in half (from 20% to 10%) Section 209: Starting in 2017, the $2,500 limit on the amount that can be taken out of an employee’s paycheck for employer health plans that use “flexible savings accounts” is repealed. Section 210: Starting in 2017, repeals a 2.3% tax, paid by manufacturers or importer, on sales of medical devices that are not generally purchased by the general public at retail stores. Section 211: Beginning in 2017, businesses who provide retiree prescription drug benefits that are at least as valuable as Medicare Part D can get a federal drug subsidy. This provision will allow those businesses to deduct the entire cost of providing that coverage even though a portion of the drug coverage is offset by the subsidy they receive. Section 212: People can get a tax deduction for medical care that is not paid for by insurance if those expenses exceed 10% of their gross income; this provision reduces that to 5.8 % starting in 2017. Section 213: No changes are actually made because the text of the new paragraphs are exactly the same as current law. Section 214: Starting in 2020, this bill creates a new tax credit structure tied to age instead of income for people making under $75,000 per year (the credits gradually reduce the more you make over $75,000) Credit amounts: Under age 30: $2,000/yr Ages 30-40: $2,500/yr Ages 40-49: $3,000/yr Ages 50-59: $3,500/yr Over age 60: $4,000/yr The credits are capped at $14,000 per family for the five oldest individuals People can only get the tax credits if they are ineligible for employer-provided plans Credits can't be used to buy insurance that covers abortions Married couples are forced to file jointly if they want the health coverage tax credits There are exceptions for couples who don't live together & domestic abuse victims Section 215: Starting in 2018, increases the amount than can be put in Health Savings Accounts Individual contribution limit raised from $2,250 to $5,000 per year. Family contribution limit raised from $4,500 to $10,000. Section 216: Starting in 2018, married couples over the age of 55 with high deductible plans will be able to contribute more to joint health savings accounts Section 217: Starting in 2018, if a health savings account is opened within 60 days of a person getting coverage with a high deductible, medical expenses for those 60 days will be eligible for payment from the HSA Subtitle B: Repeal of Certain Consumer Taxes Section 221: "Repeal of tax on prescription medications" Starting in 2017, a fee paid by pharmaceutical manufacturers and distributors will be repealed Section 222: "Repeal of health insurance tax" Starting in 2017, a fee on large health insurance companies, which is tied to and increases with premium growth rates, would be repealed. Subtitle C: Repeal of Tanning Tax Section 231: Starting on July 1, 2017, the 10% tax on indoor tanning is repealed. Subtitle D: Remuneration from Certain Insurers Section 241: Starting in 2017, insurance companies can get tax deductions on employee pay between $500,000 and $1 million. Subtitle E: Repeal of Net Investment Income Tax Section 251: Starting in 2017, a 3.8% tax on net income from stock market investments over $200,000 will be repealed. H.R. 2192 - To amend the Public Health Service Act to eliminate the non-application of certain State waiver Additional Reading Article: The most important part of the Republican health bill is mostly getting ignored by Matthew Yglesias, Vox, May 9, 2017. Article: GOP Health Bill Leaves Many 'Pre-Existing Condition' Protections Up To States by Bram Sable-Smith, NPR, May 8, 2017. Article: The 4 Big Changes To Health Care In The Latest GOP Bill by Anna Maria Barry-Jester, FiveThirtyEight, May 2, 2017. Article: The MacArthur Amendment Language Race in the Federal Exchange and Risk Adjustment Coefficients, Health Affairs, April 25, 2017. Article: Gripes About Obamacare Aside, Health Insurers Are in a Profit Spiral by Jeff Sommer, The New York Times, March 18, 2017. Article: Health insurance industry rakes in billions while blaming Obamacare for losses by Amy Martyn, Consumer Affairs, November 1, 2016. Report: Health Care Legislation Eliminates Tax Deduction Related to Medicare Part D Subsidy - Potential Accounting Impact This Quarter, Deloitte, March 31, 2010. Article: More Americans Went Uninsured in 2009 Than in 2008 by Elizabeth Mendes, Gallup, January 8, 2010. References CBO Cost Estimate: H.R. 1628 American Health Care Act of 2017 Life of the bill in the Rules Committee: H.R. 1628 - American Health Care Act of 2017 HealthCare.gov: Federal Poverty Level GovTrack: American Health Care Act of 2017 Votes OpenSecrets: Thomas MacArthur OpenSecrets: Rep. David Schweikert - Top Industries OpenSecrets: Rep. Gary Palmer Sound Clip Sources Hearing: House Rules Committee Meeting on Republican Health Care Bill Amendment, House of Representatives, April 6, 2017. Timestamps & Transcripts 03:48 Rep Jim McGovern: We’re meeting on an amendment affecting millions of people’s healthcare, that came out of a backroom about an hour ago, with no vetting at all. I think the amendment, it was—the text was stamped, I think at 11:24 a.m. We were noticed for this meeting at 11:52. We waived the traditional hour so we can kind of move on with it, but there was no vetting at all, no process whatsoever, just a couple of good old boys with a typewriter, saying maybe this will work. 8:00 Rep Jim McGovern: If you guys want to deal with healthcare, introduce a bill; get co-sponsors on the bill; have the relevant committees—committees like Ways and Means, and Energy and Commerce—do hearings, that’s a radical idea; invite people who know something about this issue—invite patients and patient-advocate groups and doctors and heads of hospitals, and invite some of your friends in the insurance industry—to come up and weigh in on your proposal; then you could do markups. Then get a CBO estimate, and after you get a CBO estimate and it’s marked up, then you come to Rules Committee, and you advance a bill to the floor. 13:40 Rep David Schweikert: If we were to actually have just sort of the top-line math question and say, let’s strip away some of the rhetoric and ideology and just sort of say “math,” when we look at our healthcare-utilization data, it’s functionally a hockey stick. Fifty percent of our population, the healthiest 50 percent, only use about three percent of healthcare costs, but our least healthy—our folks with chronic conditions, our brothers and sisters who really do suffer out there or have multiple issues laddered up—they represent five percent of that population, represents 50 percent of our spending. So you have this situation where we as a society, as a community, we’ve decided that guaranteed issue is out there, so now how do we find premium efficiency, rate efficiency? And as long as we’ve made this decision over here as a society, the fastest, most efficient thing we could do is actually sort of laddering some of that risk at that very top end. Last thing, and this may require a little more diving into it, and looking around, this is a smart committee, so you understand these things, if you were the actuaries building your rate profile, the ability to say we believe providing coverage for this population is going to cost this, you always have to design in a shock absorber because you wake up tomorrow and some people sign up for this coverage who have a chronic condition. The beauty of this type of risk-sharing model is that shock absorber that you have to build into your rate model can be substantially less because your top-end exposure is actually mitigated. So this was an occasion of, was there something we could do for lowering and making much more predictable the rate environment for that individual market, and this, I think, was the most elegant, simple way to get there. 38:55 Rep Alcee Hastings: In the brief time I’ve had to review it, the measure will provide $15 billion for the high-risk pools. Is that correct? All right. The language, specifically, setting it for is, “For the purpose of providing funding for the program there is appropriated, out of any money in the Treasury not otherwise appropriated, $15 billion for the period beginning January 1, 2018”—am I right?—“and ending on December 31, 2026.” So that’s $15 billion over a 10-year period of time. Get it straight, America. If this measure were to become law—there was a conservative gentleman, I can’t pull his name up right now, that said in the great scheme of things, it’s chump change because it simply would not provide the necessary money over the nine-year period of time. Hearing: Rules Committee Hearing H.R. 1628 and H.R. 2192, House of Representatives, May 3, 2017. Timestamps & Transcripts 24:05 Rep Jim McGovern: As you mentioned in your testimony, we found out last week that the MacArthur amendment mysteriously exempted Congress from the damaging effects of this bill, and I say mysteriously because nobody seems to know who put the provision in. And as the Vox reporter who uncovered the exemption put it, and I quote, “No one will fess up to putting the Congress exemption in the AHCA amendment.” Apparently, Representative MacArthur, your office told her that the Senate Budget added it, and the Senate Budget said no, in fact they didn’t. So, I guess I’m just curious. My first question is, where precisely did this exemption come from, and who thought that this bill was good enough for American families but not good enough for Congress? Mr. MacArthur, you wrote the amendment; did you put the provision in? Or Mrs. McSally, your bill tries to fix it; do you know anything about how the exemption got in there in the first place? Rep Martha McSally: Want to go? This budget-reconciliation process is not intuitive to really anyone. I mean, this is very arcane, and so as we’ve been going through this process in the House, trying to comply with Senate rules, content can only apply if it’s referred to specific Senate committees. And— McGovern: So somebody consciously knowing that—someone consciously moved the legislation forward without — McSally: So, again, my understanding is in order to comply with these arcane Senate rules of budget reconciliation, where if a matter is going to be referred to some other committee other than the ones that are listed in the original budget resolution, then it’ll no longer be applicable and the budget-reconciliation process doesn’t go forward. So, all I know is I heard it didn’t apply, and I said let’s fix it. McGovern: Who put it in? Who put the exemption in the first place? McSally: Yeah, and it specifically—just to be clear, it specifically related to his amendment. It’s not related to other provisions in the middle. So… McGovern: Yeah, so who put this exemption in in the beginning? Rep Tom MacArthur: Well, first, I don’t believe that members of Congress or our staffs should receive any special treatment, and I don’t think anybody believes that. McGovern: But Mrs. McSally’s bill— MacArthur: Well, as— McGovern: It’s not an amendment, it’s a bill; but it’s just to fix the fact that, is it a drafting error, or did somebody intentionally try to exempt Congress? MacArthur: It’s not an error, but the challenge, as Mrs. McSally has said, the challenge is getting House policy, drafting House policy, to conform with Senate rules. And I had every intention in drafting my amendment that there would be no special exception for Congress. Senate rules required us to accomplish this— McGovern: What Senate rules? Did you talk to the Senate parliamentarian? Who did…? MacArthur: I didn’t personally, but the requirement is because exempting us would require to go to a different committee that we needed to accomplish this through a stand-alone bill, which we have. Mrs. McSally has introduced it. I’m an original co-sponsor. I hope you’ll support the bill. I think it’s worthy of support, and none of us should want to exempt Congress— McGovern: None of us do, but from where we’re sitting, it looks like you guys get your hands caught in the cookie jar and then get exposed and then decided to fix it after a reporter uncovered it. MacArthur: Well, that’s your interpretation. I wouldn’t describe it that way. I think we fixed the issue in the only way that the Senate suggested that we could and that was through a stand-alone bill that was introduced around the same time. 28:56 Rep Jim McGovern: I think anybody who’s watching this is scratching their head, wondering how in the world can Congress be dealing with healthcare issues in a way where we don’t have hearings, where fixes are being worked out in a back room, and we’re just seeing the language for the first time right now, that their input is being pushed aside—American people don’t matter—all so that it could be a vote before we go in recess because the president wants us to. I mean, I think healthcare’s a very personal issue, it’s very important, and people want us to get it right, and I don’t think anybody here believes that we’re getting this right, even those of us with different opinions, in the process that we’re utilizing here. I’ve got to be honest with you, this process, to put it bluntly, is a goddamn mess. I mean, it really is. And I don’t know how anyone can defend it. Fixes upon fixes to fix the fixes to fix the fixes—and it’s going to be brought to the floor tomorrow, and we’re going to have a debate, and that’s how we’re going to serve our constituents? You guys can defend it, and you’ll have to defend it, but I think you’re going to be surprised how upset the American people are going to be. 37:30 Rep Fred Upton: My—our amendment, I should say, is carefully targeted at those states that may seek a waiver. Obviously, there are none today. I don’t know what Governor Scott or the future governor will do. Unknown Speaker: I’ll get to him in a minute. Upton: All right. Well, I know I talked to my governor this morning. He’s not interested in seeking a waiver. Unknown Speaker: Mm-hmm. Upton: I would guess that most governors—maybe all, I don’t know—will not seek a waiver, and in that case, my amendment just covers something if maybe it happens. And one of the reasons why we targeted the money—so it’s $8 billion: it’s a billion the first year; a billion the second year; and two billion, years, each, three, four, and five—because chances are if a governor does take this course, you’ll have fewer at the beginning than at the end. I ask the question, is five billion enough to cover those that might need some help if a governor sought a waiver in that first year, because remember, after the first year they have continuous coverage. Unknown Speaker: That's right. Upton: The answer, not a lot of facts behind it, but the answer was, five billion should probably cover that, in which case a number of us said, well, we want to make sure that it is covered. And that’s why it is eight billion and not five. 40:54 Rep Jim McGovern: Who did you ask? I mean, that’s the whole point of a CBO is because we want to get a nonpartisan— Rep Fred Upton: We don’t have a CBO score. McGovern: Right. So who? Who did you—who gave you these figures? Rep Alcee Hastings: Eight billion. Upton: Who? I'm sorry, who? McGovern: You said you asked— Upton: No, no. I know Mr. Hastings’ had an answer. I didn’t hear what he said. Hastings: No. You asked for the five billion, was that enough. Who? Upton: I asked, I asked— Hastings: And he asked who. Upton: I asked some of the drafters—so I made this proposal—I’m not a lawyer, like you—I asked legislative counsel, I asked a number of staff very tied into the—what is the estimate. They thought five billion would cover it. 51:25 Rep Alcee Hastings: And to predict for you what I think is going to happen in the Senate: I think they take health security a little more seriously and is a more moderate body than we are, and so you can reasonably expect that when you pass this tomorrow on the slimmest of margins that you may never see it again, and you will not see it in the form that it’s in. So let’s just have at it. I’ve had my fun. I hope you continue to have yours, and some of you ain’t going to be here the next time that we meet after 2018. Tell your body I said so. Music Presented in This Episode Intro & Exit: Tired of Being Lied To by David Ippolito (found on Music Alley by mevio) Cover Art Design by Only Child Imaginations

It’s our ebola episode. You know, I think that’s description enough. This show’s links: Fazal Khan’s profile and his writing Our U.S. News rankings episode, Heart of Darkness More on the debate about state courts’ following federal circuit courts (relevant to the gay marriage rulings) that arose during our episodes with Michael Dorf and with Steve Vladeck: (1) a post by Michael Dorf, (2) a post by Steve Vladeck, and (3) a post by Christian Turner About Ebola virus diseased and about Ebola in the United States The CDC’s information page on Ebola transmission and Review of Human-to-Human Transmission of Ebola Virus Michael Dorf, Is There Any Risk of Ebola Transmission from an Asymptomatic Person? EM Leroy et al., Human Asymptomatic Ebola Infection and Strong Inflammatory Response Gostin, Hodge, and Burris, Is the United States Prepared for Ebola Tavernise, Shear, and Cooper (for the NY Times), Seeking Unity, U.S. Revises Ebola Monitoring Rules Laura Donohue, Biodefense and Constitutional Constraints (an excellent history of US and UK quarantine law) Josh Hicks, A Brief History of Quarantines in the United States (a very short timeline in the Washington Post) and Peter Tyson, A Short History of Quarantine (a more detailed and global timeline) Jacobson v. Massachusetts; see also James Colgrove and Ronald Bayer, Manifold Restraints: Liberty, Public Health, and the Legacy of Jacobson v Massachusetts Tara Ragone, State Quarantines: Balancing Public Health with Liberty Interests (a very helpful blog post discussing issues and authorities relevant to the Kaci Hickox case) Jared Cole (for the Congressional Research Service), Federal and State Quarantine and Isolation Authority Gostin, Burris, and Lazzarini, The Law and the Public's Health: A Study of Infectious Disease Law in the United States About Philadelphia’s Yellow Fever epidemic of 1793 The text of the Public Health Service Act (containing the authority for federal quarantine and isolation) Jew Ho v. Williamson Norimitsu Onishi (for the NY Times), Quarantine for Ebola Lifted in Liberia Slum Michael Dorf, Containing Ebola: Quarantine and the Constitution Arjun Jaikumar, Red Flags in Quarantine: The Questionable Constitutionality of Federal Quarantine After NFIB v. Sebelius Mark Rothstein, From SARS to Ebola: Legal and Ethical Considerations for Modern Quarantine Morgan’s Steamship Co. v. Louisiana Board of Health (upholding the constitutionality of state quarantine) CDC, Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola Virus Exposure See section 604 of the The Model State Emergency Health Powers Act Fazal Khan, Ensuring Government Accountability During Public Health Emergencies City of Newark v. J.S. (analyzing the Due Process and statutory rights of a “non-compliant,” TB-infected, homeless man) Greene v. Edwards (awarding a state writ of habeas corpus in a TB isolation case) About the 2007 tuberculosis scare caused by the travel of Andrew Speaker Fidler, Gostin, and Markel, Through the Quarantine Looking Glass: Drug-Resistant Tuberculosis and Public Health Governance, Law, and Ethics (also discussing the Andrew Speaker incident) Compagnie Francaise de Navigation a Vapeur v. Louisiana State Board of Health Wendy Parmet, AIDS and Quarantine: The Revival of an Archaic Doctrine (interesting, among other reasons, for the fact it was written in 1985 in the midst of the relative early days of the AIDS crisis) City of New York v. New Saint Mark’s Baths Randy Shilts, And the Band Played On About the John Warner National Defense Authorization Act of 2007, the Posse Comitatus Act, and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 Mathews v. Eldridge (and, yes, there are only three factors) Daniel Markovits, Quarantines and Distributive Justice Helene Cooper and Michael Shear, Joint Chiefs Chairman Urges 21-Day Quarantine for Troops Working in Ebola Zone Special Guest: Fazal Khan.