Shortage of albuterol is about to get worse, especially in hospitals

Posted on March 3, 2023 by Pharmaciststeve

About 10-15 yrs ago, many of the generic pharmas were merging to create some economy of scale,  because the PBM’s were reimbursing pharmacies less and less for the medications they were dispensing and the generic pharmas were competing to be the lowest price on a particular generic. So that more pharmacies would buy their products, to be able to make a extra $0.50 to $1.00 per Rx filled.

Apparently Akorn Operating Company LLC, couldn’t be price competitive in the market place and apparently Akorn couldn’t sell enough units to pay their overhead operational costs and has went bankrupt and closed their operations.  We have had some serious shortage of various meds over the last number of years…  this situation is just getting worse,  how many people

Shortage of albuterol is about to get worse, especially in hospitals

https://www.abc12.com/news/health/shortage-of-albuterol-is-about-to-get-worse-especially-in-hospitals/article_a03f500d-2ac3-5d41-9295-954a57ce5da1.html

An ongoing shortage of a medicine commonly used to treat people with breathing problems is expected to get worse after a major supplier to U.S. hospitals shut down last week.

Liquid albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists. It has been on the U.S. Food and Drug Administration’s shortages list since October.

The news of the plant shutdown worries some doctors who work with patients with breathing problems such as asthma.

“This is definitely concerning, especially as we are coming out of the respiratory season where we had a big demand with RSV, COVID-19 and flu, and are now heading into spring allergy season when a lot of kids and adults experience asthma symptoms,” said Dr. Juanita Mora, a national volunteer medical spokesperson for the American Lung Association and an allergist/immunologist based in Chicago. “This is a life-saving drug and being able to breathe is vital for everyone.”

The manufacturer that recently shut down, Akorn Operating Company LLC, had filed for Chapter 11 bankruptcy in May 2020.

It was the only company to make certain albuterol products used for continuous nebulizer treatment. It’s a staple in children’s hospitals, but had been out of stock since last fall. Without that particular form of the product, hospitals have had to scramble to find alternatives.

“Members are either forced to compound it themselves to make the product or go to an outside third party source who is compounding the product,” said Paula Gurz, senior director of pharmacy contracting with Premier Inc., a major group purchasing company for hospitals.

With the Akorn shutdown, Gurz said products from the one remaining major domestic source of liquid albuterol, Nephron Pharmacuticals, have been on back order. Nephron just started shipping albuterol last Friday, Gurz said, but to get back on track, “it’s going to be an uphill climb.”

Hospitals work around shortages

Hospitals around the country said they’re watching the supply chain — and their current stock — closely. There’s concern they might have to delay discharging patients because they don’t have enough medicine, or that they may see more ER visits for people with breathing problems who don’t have access to medicine.

Dr. Eryn Piper, a clinical pharmacist at Children’s Hospital of New Orleans, said her hospital has been largely unaffected so far, but for months she has heard about retail pharmacies and other health systems that have had issues with albuterol shortages.

“The big problem we’ve been hearing about is inhalation solutions, not really the inhalers, it’s more like the solutions that go into the nebulizer machines for inhalation that the patients breath in,” said Piper.

Without the larger Akorn product, staff at Lurie Children’s Hospital in Chicago had to squeeze out the albuterol contents from smaller packages.

It’s “time-consuming and labor-intensive as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 syringes per day),” said hospital spokesperson Julianne Bardele in an email.

When Nephron was unable to meet demand due to manufacturing issues, Bardele said Lurie had to make another temporary switch to a different concentration and use an alternative liquid bronchodilator, levalbuterol.

Most hospital pharmacies are aware of supply issues for many medicines, particularly pediatric medicines, said T.J. Grimm, the director of retail and ambulatory services at University Hospitals Cleveland Medical Center, and they try to keep a higher stock — especially of the less expensive medicines like albuterol.

“Just so we can cover situations like this,” Grimm said.

Grimm said his system has albuterol supply for a couple of months still, but he’s frustrated and concerned about the supply chain.

“When you have supply chains that are just-in-time, it can create some issues with when something goes off,” Grimm added. “There’s the short-term crisis we all have to get through and then there’s a longer term. We need to think about these things a little more strategically, especially with our kids.”

Dr. Jerrod Milton, the chief clinical officer at Children’s Hospital Colorado, said they’ve been paying close attention to the albuterol shortages for many months. The hospital has experienced shortages in the past, and has continued to implement protocols to conserve doses.

“Challenges are what we deal with when it comes to pediatric medicine. We consider most of the kids that we take care of as somewhat therapeutic orphans,” Milton said. “It’s just another one of the myriad of shortages that we have to deal with, I guess.”

Supply chain concerns

Jessica Daley, the group vice president of strategic sourcing for Premier, said that she doesn’t anticipate that the albuterol shortage will be an ongoing problem for years, but when the market has only a handful of suppliers, “it makes for a very tight market, a very concerning market right now.”

Daley said there are things hospitals can do to help, such as protocol changes, making products on site and finding different suppliers.

The Children’s Hospital Association stepped in to help when it heard from members having difficulty finding enough supply. The association worked with STAQ Pharma, a facility that provides compounded pediatric medication, to start production on batches of albuterol for children’s hospitals in the sizes they needed.

“We’ve been creative and trying to work proactively. So when we think there’s going to be a problem, we’re trying to plan ahead,” said Terri Lyle Wilson, director of supply chain services for the Children’s Hospital Association.

STAQ should be at full production by May, so hospitals will have a steady, stable supply ahead of the next season in which respiratory viruses are in wide circulation, the association says.

Daley at Premier said that in an ideal world, there would be more suppliers of these products, particularly with generic drugs, so that when there is a problem with one, the market could handle it. When there is a concentration of manufacturing with a small number of suppliers, it is very hard to recover, she said.

“We really advocate for diversity and supply to prevent types these types of issues,” Daley said. “Meaning at least three globally, geographically diverse suppliers that are supplying the market with sufficient products.”

Guidance for patients

For patients, Piper at Children’s Hospital of New Orleans said they are encouraging patients with breathing problems to take precautions and avoid asthma triggers if possible. She said if a patient’s usual pharmacy runs out, it’s also good to check with a doctor to see if there is another medication that’s available.

Inhalers don’t seem to be impacted by the shortage so far, but Daley said if people panic about the lack of albuterol for hospitals, that could change.

“Albuterol is one of those things that if there’s a patient who needs it, you want to have it all the time. So there’s always that potential for the market to respond and react in a way that that will then create downstream shortages of other sizes or presentations of a product,” Daley said.

To avoid that problem, Milton at Children’s Hospital Colorado said it’s simple: “Talk to a provider and see if there are alternatives,” Milton said. “And please don’t hoard.”

Filed under: General Problems | Leave a Comment »

Cardinal Health, McKesson prevail in Georgia families’ opioid trial

Posted on March 3, 2023 by Pharmaciststeve

Cardinal Health, McKesson prevail in Georgia families’ opioid trial

https://www.reuters.com/legal/cardinal-health-mckesson-prevail-georgia-families-opioid-trial-2023-03-01/

March 1 (Reuters) – Drug distributors Cardinal Health Inc (CAH.N), McKesson Corp (MCK.N) and JM Smith Corp on Wednesday prevailed at trial in Georgia in a case brought by families of opioid addicts accusing the companies of acting as drug dealers.

A jury in Glynn County Superior Court handed down the verdict after two days of deliberations, according to Courtroom View Network, which carried live video of the trial. It was the first trial of opioid claims brought by individual plaintiffs, rather than government entities.

“We are pleased with the jury’s decision, which confirms that a law meant to apply to street dealers of illegal drugs cannot be used in a misguided attack” on distributors of federally licensed drugs, Cardinal said in a statement.

McKesson called the verdict “the right outcome based on the law and evidence.”

A lawyer for the plaintiffs did not immediately respond to a request for comment.

The 21 plaintiffs include children whose parents died of overdoses, a woman whose grandson was born with opioid addiction symptoms and died at one month old, and a woman who was raped as a teenager but received no help from her opioid-addicted mother.

Plaintiffs said the distributors fueled illegal opioid use by filling illegitimate pharmacy orders and failing to report suspicious opioid purchases to law enforcement, as required by the federal Controlled Substances Act.

Litigation by more than 3,300 state, local and tribal governments against opioid manufacturers, distributors and pharmacies has resulted in more than $50 billion in settlements.

Unlike those lawsuits, which accused companies of creating a public nuisance by failing to stem the flow of illegal opioids, the Georgia plaintiffs brought their claims under the state’s Drug Dealer Liability Act, which allows people injured by illegal drug use to sue dealers.

More than half a million people died from overdoses in the United States in the period from 1999 to 2020, according to the U.S. Centers for Disease Control and Prevention. The agency has said opioid overdoses surged further during the COVID-19 pandemic, increasing 38% in 2020 over the previous year and another 15% in 2021.

Filed under: General Problems | 3 Comments »

Government agent’s fake testimony

Posted on March 3, 2023 by Pharmaciststeve


what is the definition of police entrapment

Police entrapment refers to a situation in which law enforcement officers use coercive or deceptive tactics to induce a person to commit a crime that they would not have otherwise committed. This may involve encouraging or enticing someone to engage in illegal activity, and then arresting them for that activity.

Entrapment is considered a defense in criminal law, and it can be used to argue that the defendant was not responsible for their actions because they were induced by the police. However, it is important to note that not all police behavior that leads to a person’s arrest constitutes entrapment. The key factor is whether the police used tactics that overcame the defendant’s free will and caused them to commit a crime that they would not have otherwise committed.

The above text is what I got back from asking CHATGPT… what is the definition of police entrapment

My understanding of the CSA, it is illegal to try obtain a controlled substance without a legit medical issue. Since pain is subjective, so there is really no way to determine if a pt has pain nor the intensity of the pt’s pain. Apparently this “investigator” chose to investigate Dr Pompy’s practice because of some “fishing ” and data mining in some medical databases.. to find that Dr. Pompey has some “out-lying” numbers. I guess this Blue Cross has never heard of a BELL CURVE.  No random segment of our population is going to produce a FLAT LINE, homo sapiens are not homogeneous. Isn’t it amazing the lengths law enforcement will go to to entrap a prescriber.  Send in a person with fake driver’s license, fake home address, fake insurance card, and fake referral from another practitioner.

https://doctorsofcourage.org/government-agents-fake-testimony/

When doctors are attacked in the United States, one of the techniques used by the government is to send in an agent as a patient. They complain of pain, get treated appropriately for their complaint, and then later testify that the treatment was medically unnecessary because they really don’t have pain and the doctor broke the law.  Here is the testimony of one such CS (confidential source) in the trial of Lesly Pompy, MD.

The government witness is James Stewart Howell.  The direct examination is by US Attorney Andrew J. Lievense.  Questions (Q) are by Mr. Lievense and answers (A) are by Mr. Howell

Q. And what role did you have in this case?
A. I was an employee of Blue Cross doing undercover visits.

Q. And what type of patient were you posing as when you went to see Dr. Pompy?
A. I was posing as an undercover patient seeking drugs or pills or medication.
Q. And did Dr. Pompy prescribe those pills to you?
A. Yes.
Q. what did he prescribe to you?
A. Norco.

Q. Now, in your role with Blue Cross Blue Shield, how do you identify people to investigate?
A. We have a variety of ways that we get our Case. One of them is we have an antifraud hotline. We get cases from law enforcement. We get cases from other areas within the company. We get cases from former employees of providers, doctors’ offices, things like that.

Q. And does Blue Cross Blue Shield have people who are engaged in — in data mining?  What does that mean?
A. Data mining is when you search for particular things within data that you have possession of. We receive cases that are created by data mining.
Q. And so you would see the results of their work?
A. Yes.
Q. And based on your review of the results of that work, do the people that are referred to you, are they just randomly drawn out of the databases?
A. No.

Q. Based on the results of work that you received from them, are the people referred to you kind of outliers in some way?
A. Yes.
Q. In what ways might a health care provider be an outlier?
A. They could be an outlier based on the fact they compare them against peers of similar practice size, et cetera. If somebody’s outside of the peer comparisons, they would be considered an outlier.

Q. What types of methods do you employ as a health care fraud investigator for Blue Cross?
A. We use undercover techniques, record review techniques, audits, and there’s other ways.

Q. Why does Blue Cross or why do you as an investigator for Blue Cross use undercover work as one of your techniques?
A. The reason I like to use them is that it gives you an inside view of actually what’s going on at a particular place such as the time spent or like what transpires, the number of employees, exactly how the practice works.

Q. Now, do you use your normal driver’s license that’s issued by the Secretary of State that you’ve had since you turned 16 years old? A. No.
Q. Are you able to get an undercover driver’s license?
A. Yes.
Q. Now would you need an insurance card that matched your undercover driver’s license?
A. Yes.
Q. And why do you use an undercover driver’s license and undercover Blue Cross Blue Shield insurance card instead of your personal ones?
A. You don’t want to give your own personal information out.

Q. How did you come to learn about Dr. Lesly Pompy?
A. He came to my attention from another investigator within the area where I work.
Q. And do you know how your colleague learned of Dr. Pompy?
A. Yes.
Q. And how did essentially you and Blue Cross learn about Dr. Pompy? Did Dr. Pompy getting on your radar came from law enforcement?
A. Yes.

Q. All right. And I’d like to direct your attention to January 5th, 2016. Do you recall what happened that day with respect to your investigation of Dr. Pompy?
A. So on January 5th, 2016 I did go to Dr. Pompy’s office to inquire about becoming a new patient there in an undercover capacity.
Q. And can you describe what you did when you entered the office?
A. I spoke with the person on the desk.
Q. And did the person there ask you whether you had any insurance?
A. Yes.
Q. And did they provide you a new patient questionnaire and paperwork?
A. Yes.
Q. In addition, did the person there at the reception area say anything else that you needed to fill out or have with you besides the new patient questionnaire?
A. Yes. Told me I needed a referral from a doctor for pain management. The explanation I remember was to fill out the new patient paperwork and return it when it was completed fully and bring that referral from another doctor back when I had it all filled out.

Q. Do you recall when the next time you went to Dr. Pompy’s office was?
A. That was on January 26th of 2016.
Q. I’d like to show you a clip from Government’s Exhibit 91. We’re going to be showing you a series of videos from the undercover investigation. Were you the person who made those video recordings?
A. Yes.
Q. And where is the camera?
A. It’s in my hand recording, handheld or it can be set down, but it’s portable. It’s hidden in the top of a coffee mug.
Q. Is this a special coffee mug that has this equipped?
A. It’s a camera mug, yes.

He discussed the protocol used to accept a new patient.

Q. And did you also turn in the new patient questionnaire?
A. Yes.
Q. And what does it say underneath “New Patient Information Packet”?
A. “Please be advised that during your initial evaluation for pain management narcotic medications will not be prescribed. Testing and evaluations will be performed to determine the best treatment for your condition.”

Q. When you filled it out, what was your goal, what was your purpose?
A. My goal was to get in as a new patient.
Q. Was your goal to present as a new patient who was completely healthy?
A. No. My goal is to get in as a pain patient and be seen as a normal patient that was being seen there.
Q. So did you know you had to present as someone who had some level of discomfort?
A. Yes.

Q. What address did you put down as your address?
A. It’s Dearborn, Michigan.
Q. And if you know, approximately how far away is that from Monroe, Michigan?
A. I’m going to estimate 25 miles.

THE Judge: Why did you say Dearborn instead of Monroe?
THE WITNESS: Just to give an address that wasn’t too close to Monroe or was in Monroe because I was trying to appear to be a drug-seeking patient not from the area.

And under “Referring Physician,” did you write in Dr. Robertson, which is consistent with the referral?
A. Yes.
Q. And what did you write for Dr. Robertson’s city in which he lived in?
A. I listed Eastpointe because that’s where his practice is.
Q. And is that a farther distance from Monroe?
A. Yes.

Q. What’s the title of this page of the document?
A. Title of the page is “Review of Symptoms-Circle All that Apply to your current condition.”
Q. And the fourth one down is — you circled “Musculoskeletal,” is that correct?
A. It is, yes.
Q. And next to — of that list of musculoskeletal symptoms, which one did you circle?
A. I circled “stiffness.”
Q. Why did you circle “stiffness”?
A. I was indicating stiffness, not really pain.
Q. All right. And it looks like underneath “Musculoskeletal” there’s “Neurological.” What did you circle next to “Neurological”?
A. Back, back problems.
Q. And below that under “Psychiatric,” did you circle one of the symptoms under “Psychiatric”?
A. “Personality changes.” I don’t remember the purpose of circling that.
Q. And if you go further down, right at the bottom, did you circle “Addiction”?
A. Yes. I wrote “Booze weekends.” I was giving indications of not only drug seeking but alcohol abuse or use.
Q. the next page under “Review of Symptoms.” Did you write anything on this page?
A. I did. Under “List Past-Current Medical Diagnosis” I wrote “Back and Nerves.” I was indicating stiff back, so I was directing it towards back.

Q. All right. And what did you write on this page in terms of your wishes
A. I indicated “help with back” in two different spots.
Q. So on these two pages you did report some symptoms consistent with discomfort, is that right? A. Yes.
Q. And you also — and you also mentioned the alcohol abuse, is that right?
A. I did, yes.
Q. And under Question 4 it says, “Use the Following Scales to Indicate How Severe Your Pain is.” Did you circle anything?
A. No.
Q. What did you write?
A. I wrote “stiffness mostly.”
Q. And under number 5, “Which Statement Best Describes Your Pain?,” what did you check?
A. I checked “Always Present, Always Same Intensity,” and wrote “stiffness” next to it.
Q. And on page 16 what were you asked to circle?
A. On that form I was asked to “Indicate on the Diagram Where Your Pain Occurs by Shading the Painful Areas,” and which I circled low back.
Q. And under Question 8 is the question “What Makes Your Pain Feel Worse?” And what did you check?
A. I checked “Other: driving.”
Q. And driving, did you report that you had a particular occupation in your undercover capacity?
A. Yes. I indicated that I was a driver.
Q. And under Question Number 9, when it says, “What makes your pain feel better?” what did you check there?
A. I checked “alcoholic drinks” and “medicines.”
Q. Now, the questionnaire asks you to “List All Pain Medication You’re Currently Taking.” What did you write?
A. I wrote “Norco 7.5, Soma 350 and Ativan .5.”
Q. And do you understand Norco to be a — an opioid, a narcotic?
A. Yes.
Q. Do you know what Soma is?
A. Yes. It’s a muscle relaxer.
Q. And do you know what Ativan is?
A. It’s a benzodiazepine.
Q. And had anybody, any physician been prescribing those three medications for you? A. No, not those three together, no.
Q. And you are aware of something called MAPS, right?
A. I am.
Q. And so when you listed those, were you aware whether Dr. Pompy or anyone else could check to see whether that was accurate?
A. Yes.

Lievense: I’d like to go back to page 26
Q. What did paragraph 6 of this document advise you?
A. Paragraph 6 says that “I agree to disclose all pain medications that I receive. I agree to receive my pain medications from one doctor only. I agree not to misrepresent my pain medication intake or my physical status to any of my health care providers.”
Q. And what is the first sentence of paragraph 10.
A. It says, “I will not share, sell or trade my medication for money, goods or services.”
Q. And the next one says what?
A. It says, “I agree not to doctor shop, street shop, conceal or divert prescribed medications for additional drugs.”
Q. And what about the next sentence?
A. “Any illegal diversion or questionable use of opioids will result in weaning and discontinuance of narcotics with the potential for clinic discharge.”
Q. As part of this agreement, did you also sign saying you agreed to take your medications as directed by Dr. Pompy?
A. Yes.
Q. Given that these paragraphs were part of the narcotics contract that you were provided, were these things that you were looking to see whether Dr. Pompy enforced them?
A. Yes.
Q. And if you didn’t comply with these requirements, what did you expect him to do?
A. I expected to be either questioned, called out or discharged.
Q. After turning in the questionnaire, did you then leave the office? And as you were leaving, did you talk to other people who were in the hallway?
A. Yes.
Q. Did you learn anything during those conversations that impacted your investigation?

MR. CHAPMAN: Your Honor, I’m going to object to the relevance of these statements. They’re from patients out in the hallway. There’s no indication Dr. Pompy knew these things were said.
THE JUDGE: Right, but I think he can testify as to how they affected his next steps in the investigation,
THE WITNESS: What I learned in the hallway from talking to some people was that it would take multiple visits to get medications and also that you may be required to submit to some testing.

 

So a 26+ page patient questionnaire is amazing! And all of the procedures are appropriate. So how does the government get away with sending fake patients in like this, who complain of pain, lying about their history but saying enough to get the appropriate medication, and then use these fakers to get a doctor convicted?  It’s purely because of the prejudice in the juror’s minds against opioids that the government has planted in our minds since 1999.

Does anyone know what happened to the Benedict Arnold physician—J Alan Robertson, MD—that helped the government by writing a referral to Dr. Pompy? Googling him states that his office is permanently closed. But other offices say he is practicing addiction medicine and working as a chiropractor.  Let me know what he is doing. Patients need to boycott him.

The only way to end this is to end government immunity and learn the REAL cause of addiction–and it isn’t the drugs!. Did you know that the government can lie to you and nothing happens?  But if you lie, you commit a crime. Lying to achieve a conviction in court should be a punishable offense. Prosecutorial misconduct is rampant now, simply because they can. There is no morality or virtue anymore in the legal profession.  “Do whatever it takes to get a conviction” is the rule. People don’t understand this until it happens to them. Do something before it happens to you. Join the communication campaign and let’s get some laws changed.

 

Filed under: General Problems | 2 Comments »

Medicare Plan Commissions May Steer Beneficiaries to Wrong Coverage

Posted on March 1, 2023 by Pharmaciststeve

Medicare Plan Commissions May Steer Beneficiaries to Wrong Coverage

https://www.medpagetoday.com/special-reports/features/103306

Commonwealth Fund report: opaque, misaligned agent incentives influence enrollment choices

Agents and brokers who sell Medicare plan coverage often steer their clients to a Medicare Advantage (MA) plan because it earns them a higher commission compared with a Medigap supplemental plan with traditional Medicare that might better serve the beneficiary’s needs.

That’s the finding from a new Commonwealth Fund reportopens in a new tab or window that was based on responses from more than two dozen sellers of MA, Medigap supplemental, and Part D plans who participated in focus groups the fund organized in September 2022.

For example, one California broker was extremely candid: “A lot of times … you’re pushing an Advantage plan when someone wants a freedom of choice [of doctor], which would be a supplement plan,” the report said.

Incentives that are misaligned with that of the beneficiary “have financial consequences for beneficiaries, can affect beneficiaries’ coverage options down the road, and can affect Medicare spending,” Gretchen Jacobson, vice president of the Commonwealth Fund’s Medicare program and an author of the report, told MedPage Today.

“Ideally, [the system] should be more transparent on how brokers and agents winnow down choices,” she said.

The report is a timely one as nearly halfopens in a new tab or window of Medicare beneficiaries are now enrolled in MA plans, and as federal regulators try to tamp down MA fraudopens in a new tab or window and denials of care, as well as higher per beneficiary spendingopens in a new tab or window for MA enrollees compared with those in traditional Medicare.

While brokers are required by a 2022 federal policy to inform clients that they don’t sell all plans in their area, they’re not required to reveal how many plans they sell or which ones, the report noted. There is no minimum number of plans they must search for a client nor is there a requirement that they disclose the names of the plans they searched.

Brokers said that in addition to commissions, another factor that influences their decision on what plans they offer clients is whether the plan made it “easy for me to work with.”

Along with a lack of information about how brokers narrow down plan options, beneficiaries lack information on “what role financial incentives might play in the advice they give,” the report said.

Among the report’s findings:

  • Most brokers and agents in the focus groups said they received higher commissions for enrolling beneficiaries in MA plans compared with Medigap supplemental plans with traditional Medicare, and one said the commissions could be three times higher. They receive more from selling MA than they do selling a Medigap, even when adding in the commission they get from selling a Part D drug plan.
  • Agents said many plans offer bonus commissions as high as $100 per policy when an agent sells a benchmark number of a certain plan — say 20 policies in a 3-month period — and that can “create an incentive for a broker or agent to steer clients to a plan regardless of whether it’s the best one for their clients,” the report said.
  • For themselves, most brokers and agents said they would reject MA plans in favor of traditional Medicare with a Medigap, “believing that combination offers better coverage and choices than Medicare Advantage, particularly as people age.” Said one broker, “If I ever have a medical issue, I’d want to be able to go to any physician I want.”
  • Some in the focus groups remarked that based on the commission rates and information from the Centers for Medicare & Medicaid Services, it seemed “obvious” that the federal government wanted more people in MA plans rather than in traditional Medicare.
  • Commissions for sales of Part D prescription drug plans are so low, agents said, that many neglect to enroll their clients in them and that the plans were “not worth the time.” Then, after having been enrolled in Medicare for years, beneficiaries may need a Part D for their medications. By then, however, they have to pay a federally required Part D late-enrollment penalty each month, amounting to about $1 for every 3 months that they didn’t have Part D or other creditable coverage after becoming Medicare eligible. Additionally, they can’t enroll in a Part D plan until the next open enrollment period. These low Part D commissions also don’t incentivize brokers and agents to encourage their clients to reevaluate their Part D plan each year, even though coverage and premiums can change and vary greatly among plans, participants said.
  • Focus group members said they are concerned about deceptive MA marketing. These ads, one participant said, mislead clients into believing “they can just switch to a Medicare supplement anytime that they want” when supplement plans in most states require beneficiaries to pass an extensive underwriting questionnaire before they can be approved. Most focus group participants said that for many of these clients with health conditions, there are few options, although they may enroll beneficiaries in an MA preferred provider organization, which offers more provider choice. Focus group participants characterized the advertising as “relentless,” “overwhelming,” and “misleading,” and said it has led some clients to enroll in plans that excluded their doctors, and other clients to unknowingly change plans. “I’ve had clients call me up in tears not realizing that their plan had been switched,” one said. In some cases, agents have even lost clients who didn’t believe them and wanted everything the ad promised.
  • Focus group participants said they tend to sell MA plans to beneficiaries with lower incomes, and Medigap policies with traditional Medicare to those with higher incomes.
  • For Medigap supplemental coverage, commission structure pays more to sell plans with higher premiums and low or no deductible, such as a G or an F plan, rather than plans with lower monthly premiums and higher deductibles, such as K or L. But for beneficiaries with limited financial resources, a plan with a higher deductible but lower premiums and out-of-pocket payment limits “may make more sense,” the report said. “The [Medigap] commission structure may result in some beneficiaries paying more than they need to.”
  • Health plan sellers can earn extra money — $75 to $100 — for 5 minutes of work if they complete a “health risk assessment” for clients who enroll in a new MA plan. The report noted that it is unclear if these assessments are sent to the enrollees’ primary care physicians, whether it informs their care management, “or helps to expedite additional resources and benefits to them.”
  • One reason for the rapid recent increase in beneficiaries choosing MA plans over traditional Medicare with supplemental plans is the rising cost of Medigap premiums. One Arizona broker said, “They’re getting these price increases year in and year out on those supplement plans. And yeah, you bet, it has definitely shifted my focus.”

David Lipschutz, JD, associate director of the Center for Medicare Advocacy, who reviewed a pre-release copy of the Commonwealth Fund report, said it struck him that many brokers believe the Medicare program itself is steering beneficiaries toward MA plans rather than Medigap plans.

“This speaks to the growing imbalance between MA and traditional Medicare, and while there have been improvements in Medicare materials over the last couple of years, there is still a bias toward MA that must be addressed,” he said.

Lipschutz added that the commission imbalance “leads many agents and brokers to steer people towards MA plans and neglect Part D.”

The four focus groups were held by PerryUndem, a public opinion research firm, in partnership with the Commonwealth Fund.

Filed under: General Problems | 2 Comments »

Family Builds Empire Off ‘Christian’ Insurance

Posted on March 1, 2023 by Pharmaciststeve

Family Builds Empire Off ‘Christian’ Insurance; Narcolepsy Drug Patent Games

https://www.medpagetoday.com/special-reports/features/103329

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Family Builds Empire Off ‘Christian’ Insurance

Liberty HealthShare, a nonprofit known as a health care sharing ministry, billed itself as a religious alternative to Obamacare. In reality, the family running it funneled money from members into various shell companies and businesses owned by other family members, leaving medical bills unpaid and patients in debt, a ProPublica investigation foundopens in a new tab or window.

One member spent her last months begging Liberty to pay her bills that went to collections. But the company has largely escaped consequences because insurance regulators can’t investigate the nonprofit, and federal agencies haven’t acted.

Through Liberty, Daniel Beers, with family members and a colleague, helped create what ProPublica calls a “dizzying array of businesses, real estate holding companies and shell companies — entities that conduct no business but hold assets and move money,” and spend it on land, a wedding venue, a horse stable, a hunting and fishing camp, and even a vineyard.

At the same time, Liberty didn’t pay many patients’ bills: 70 members interviewed for the investigation described “extended periods of stress, harassment by bill collectors and financial ruin” over bills Liberty promised to reimburse but never did.

Health care sharing ministries work like health insurers, but have roots in Mennonite and Amish communities, pooling money from a community to send aid directly to families with medical expenses. Beers was part of an early operation that started out with a similar model, charging members a small fee to be a part of a network, which would then cover medical expenses for people in need. This eventually grew into an insurance-like business, using marketers to recruit new subscribers, and a second company to negotiate with hospitals and doctors. Eventually, medical bills went unpaid because leaders were hiding money and siphoning it to leaders and family members, ProPublica reported.

Beers started Liberty in 2014 with family and ran it the same way, contracting out services like bill negotiations to companies owned by his family members. He insisted to ProPublica he doesn’t work for Liberty. Between 2015 and 2021, Liberty recruited members and made nearly $2 billion in revenue, but didn’t report half of it to tax agencies, claiming this pool of money belonged to its members, although in reality Liberty had control of the money, the article stated.

 

Filed under: General Problems | Leave a Comment »

Biden’s $125 billion investment in a comprehensive response to the opioid epidemic and substance use disorders is paid for by raising taxes on the profits of pharmaceutical corporations

Posted on February 28, 2023 by Pharmaciststeve

Biden is going to stop the opioid crisis and the addiction problem… spending 12.5 billion/yr over the next TEN YEARS…  The war on drugs is currently costing us 100+ billion/yr. So Biden expects to succeed where FIVE DECADES and TWO + TRILLION spent has not only FAILED  but seemingly MADE THINGS WORSE ! Last year the number of opioid OD/poisonings was abt SEVEN TIMES the number from TEN YEARS AGO.

This is so typical of a mid 20th century mindset … when you had a problem… you threw $$ and man hours at it.

https://joebiden.com/opioidcrisis/#

The Biden Plan to End the Opioid Crisis

THE BIDEN PLAN TO END THE OPIOID CRISIS AND ENSURE ACCESS TO EFFECTIVE TREATMENT AND RECOVERY FOR SUBSTANCE USE DISORDERS

Millions of families are impacted by the opioid crisis. It’s ravaging communities coast to coast, from New Hampshire to California. The challenge of substance use disorders is not limited to opioids. Millions of individuals are affected by misuse of other substances such as alcohol or methamphetamine. Latest estimates indicate that, in 2018, almost 68,000 Americans died from a drug overdose – almost 47,000 of which involved an opioid. And, the impacts of this crisis reverberate in our classrooms and neighborhoods, in small towns and big cities.

Biden will tackle this crisis by making sure people have access to high quality health care – including substance use disorder treatment and mental health services. That’s what Obamacare did by designating substance use disorder treatment and mental health services as essential benefits that insurers must cover, and by expanding Medicaid, the nation’s largest payer for mental health services which also plays an increasingly growing role as a payer for substance use disorder services.

But President Trump wants to repeal Obamacare, including its Medicaid expansion. Repeal would be disastrous for communities and families combating the opioid crisis. It is not realistic to think that grant money will fill the hole that eliminating Obamacare and its Medicaid expansion would create.

Step one of Biden’s plan to tackle the opioid epidemic and substance use disorders is to defeat Trump and then protect and build on Obamacare. And, Biden will pursue a comprehensive, public health approach to deal with opioid and other substance use disorders. His plan will:

  • Hold accountable big pharmaceutical companies, executives, and others responsible for their role in triggering the opioid crisis.
  • Make effective prevention, treatment, and recovery services available to all, including through a $125 billion federal investment.
  • Stop overprescribing while improving access to effective and needed pain management.
  • Reform the criminal justice system so that no one is incarcerated for drug use alone.
  • Stem the flow of illicit drugs, like fentanyl and heroin, into the United States – especially from China and Mexico.

HOLD ACCOUNTABLE BIG PHARMA COMPANIES, EXECUTIVES, AND OTHERS RESPONSIBLE FOR THEIR ROLE IN TRIGGERING THE OPIOID CRISIS 

Biden will demand accountability from pharmaceutical companies and others responsible for the opioid crisis, including manufacturers, distributors, and “pill mill operators.” Pharmaceutical executives should be held personally responsible, including criminally liable where appropriate. Specifically, Biden will:

Direct the U.S. Justice Department to make actions that spurred this crisis a top investigative and, where appropriate, civil and criminal enforcement priority. Biden will make sure the Department has all the necessary resources to complete this work. Building on the efforts of the Obama-Biden Administration, Biden will also ensure the Food and Drug Administration takes action when new information reveals harms from previously approved drugs (including the risk of diversion, or the use of drugs by an individual other than the one to whom the drug was prescribed), ensures compliance with risk mitigation strategies, and punishes drug companies for deceptive practices. And, he will appoint an Opioid Crisis Accountability Coordinator to coordinate efforts across federal agencies and support the enforcement efforts of state and local partners.

Direct the Drug Enforcement Administration (DEA) to step up its efforts to identify suspicious shipments and protect communities. Opioids distributors knowingly shipped millions of pills to towns with hundreds of residents, helping trigger the opioid epidemic. Biden will empower the DEA to stop drug shipments from pharmaceutical companies and their distributors that create risks of diversion and misuse. Biden will work with Congress to allow the DEA to act expeditiously when a pharmaceutical distributor fails to adequately monitor shipments that could pose an “imminent danger” to vulnerable communities and increase penalties for companies that fail to take action to stop suspicious shipments. In addition, Biden will direct the DEA to improve data collection on wholesalers and pharmacies, including prescribing patterns and suspicious order reports, and to disseminate its analysis to distributors to prevent problems before they become disasters. 

Ban drug manufacturers from providing payments or incentives to physicians and other prescribers. Pharmaceutical companies work hard to persuade doctors and other medical personnel to prescribe their products. These companies essentially pay providers to prescribe opioids and other drugs by, for example, paying providers to speak at or attend conferences, or consult for their companies. By banning these practices, Biden will ensure that patients’ lives do not take a backseat to doctors’ bottom lines.

Terminating pharmaceutical corporations’ tax break for advertisement spending. Drug corporations spent an estimated $6 billion in 2016 alone on prescription drug advertisements to increase their sales, a more than four-fold increase from just $1.3 billion in 1997. The American Medical Association has even expressed “concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices.” Currently, drug corporations may count spending on these ads as a deduction to reduce the amount of taxes they owe. But taxpayers should not have to foot the bill for these ads. As President, Biden will end this tax deduction for all prescription drug ads, as proposed by Senator Jeanne Shaheen.

MAKE EFFECTIVE PREVENTION, TREATMENT, AND RECOVERY SERVICES AVAILABLE TO ALL WHO NEED THEM

Biden has long recognized and led on efforts to make clear that substance use disorders are diseases, not a lifestyle choice, and that we need to change how we talk about and treat substance use disorders to align with this fact. 

He knows that the most important step we can take to address substance use disorders is to ensure that Americans have access to affordable, high-quality health care, including treatment for mental illnesses and substance use disorder. That’s why Biden has a plan to build on the Affordable Care Act and achieve universal coverage. In addition, Biden will redouble efforts to ensure insurance companies stop discriminating against people with behavioral health conditions and instead provide the coverage for treatment of mental illness and substance use disorders that patients and families need. Congress passed a bipartisan parity law 12 years ago requiring that this discrimination stop, but the enforcement of parity has been insufficient. As Vice President, Biden championed efforts to implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act. As President, he will finish the job by appointing officials who will hold insurers accountable, enforcing our parity laws to the fullest extent. He will also direct federal agencies to issue guidance making clear how state officials and the public can file a complaint when their insurers – or Medicaid – are not living up to their parity obligations.

In addition, Biden will work to make sure that people experiencing substance use disorders have access to quality facilities and providers. As President, he will ensure that the new public option, Medicare, Medicaid, the Indian Health Service, the Military Health System, and the Veterans Health Administration accelerate integration of substance use disorder care into standard health care practice. Biden will double funding for community health centers and expand the supply of health care providers, for example by growing the National Health Service Corps. And, he will protect rural hospitals from payment cuts, give them the flexibility they need to remain open, and invest in telehealth so people in remote areas can still have access to mental health and substance use disorder specialists.

Finally, Biden will make sure federal funds are specifically targeted at improving access to treatment and recovery for opioid and other substance use disorders, and at preventing these disorders in the first place. As Vice President, Biden championed passage of the 21st Century Cures Act, which included $1 billion in funding for states to address the opioid epidemic. That was a down payment. To deal with the immense scope of the opioid and substance use disorder crisis, Biden will dramatically scale up the resources available, with an unprecedented investment of $125 billion over ten years. Funds will be used to:

Pursue comprehensive strategies to expand access to treatment, particularly in rural and urban communities with high rates of substance use disorders and a lack of access to substance use disorder treatment services. Biden will invest $75 billion in flexible grants to states and localities for prevention, treatment, and recovery efforts. State and local agencies will also be able to use funds to enhance data systems allowing them to better target resources to individuals and communities most in need of support. As a condition for receiving funding, grant recipients will have to provide long-term, comprehensive strategic plans that address the multifaceted nature of the substance use disorder crisis. Funds may be used to:

  • Invest in evidence-based, cost-effective prevention programs in schools and communities to reduce the development of substance use disorders.
  • Mitigate harms from opioid and other drug use, including overdoses. Local communities will be able to use the funds to implement evidence-based programs designed to stop the spread of diseases like hepatitis C and HIV, including syringe service programs, or to scale up innovative programs like the safe station initiative started in Manchester, New Hampshire, which allows those seeking help to go to fire stations in order to be connected to treatment and recovery services. 
  • Expand access to ongoing treatment and recovery services. Communities will be able to use funds to increase access to substance use disorder and mental health treatment and other services to support long-term recovery, including peer support networks and recovery coaches, and better integrate primary care and behavioral health. Recognizing the strong evidence that social supports, including family support, may have a positive impact on the treatment of HIV, Biden will support the development of family-centered models for substance use disorder treatment and recovery. 

Make Medication Assisted Treatment (MAT) available to all who need it, reaching universal access no later than 2025. MAT (also referred to as MOUD or Medications for Opioid Use Disorder) is regarded as the gold standard of care for individuals with opioid use disorder. Yet, less than 50% of substance use disorder facilities around the country offer even one of the FDA-approved medications. The 21st Century Cures Act, legislation Biden championed as Vice President, provided resources to states designed to expand access to MAT.  Biden will build on this in order to ensure universal access to MAT for all who need it, including by:

  • Providing $20 billion for grants to dramatically expand capacity to administer MAT across the country, especially in underserved areas, including establishing new facilities and developing training programs to increase the number of professionals able to administer MAT.
  • Stopping insurance companies from erecting barriers to coverage of MAT. For example, insurers have imposed “fail first” protocols which require prescribers to certify that other therapies were tried before covering MAT. Insurers also may require that physicians obtain “prior authorization” for MAT before prescribing it.   
  • Removing undue restrictions on prescribing medications for substance use disorder. For example, drugs containing buprenorphine were approved by the FDA in 2002 but a relatively small number of doctors or medical personnel are certified to prescribe them. Biden will ensure that any undue restrictions on prescribing are lifted and review methadone treatment regulations. 

Help first responders and community health providers respond to overdoses. Biden will invest $10 billion to provide local communities with the tools needed to prevent overdoses and respond to emergencies emanating from this crisis.  

  • Ensure local communities have a sufficient supply of overdose prevention drugs. Naloxone (also known as Narcan) is a medication that can reverse an opioid overdose, making it a critical tool in the fight to save lives. Biden will expand grants to states for the purchase of Naloxone to be distributed to local community actors called upon to respond to overdoses, including first responders, public health providers, and the staff at homeless shelters and public libraries. 
  • Demand that drug companies charge a fair price for overdose drugs, including Naloxone. The Biden Administration will aggressively negotiate a reduction in the drug’s price, on behalf of the federal government, and state and local communities. 
  • Support first responders. Police officers and firefighters are often the first on the scene of an overdose. Biden will ensure they are equipped not just with naloxone, but also with the mental health and resilience support anyone would need after being exposed again and again to such trauma.
  • Invest in community-based prevention programs and a major public education effort to eliminate the stigma surrounding substance use disorder treatment. Biden will invest $5 billion in community-based prevention efforts and public education initiatives including training educators to recognize the signs of mental health problems and substance use disorders and refer them to appropriate services. Funds will also support evidence-based education programs for young people on mental health and substance use disorders.

Expand the pipeline of medical personnel to treat substance use disorders. Building on legislation like the Opioid Workforce Act of 2019, Biden will work with Congress to invest $5 billion to expand medical residencies and access to education and training for medical personnel in substance use disorder diagnosis and treatment. Funding will support training for primary care providers, as well as other members of the health care team, to build an integrated system of care.

Invest in research by doubling funding for the NIH HEAL (Helping to End Addiction Long-Term) Initiative. This $10 billion investment will support efforts to improve treatments for chronic pain.

Provide targeted interventions for particular populations. Biden will invest $10 billion in efforts specifically designed to support populations with unique situations or needs. Biden will ensure a portion of this funding for state and local governments is set aside for Tribal governments. In addition to expanding veterans’ access to substance use disorder and mental health treatment, Biden will direct his Secretary of Veterans Affairs to ensure VA medical personnel are sufficiently trained in safe prescribing practices and pain treatment. Biden will call upon the public health and criminal justice systems to provide evidence-based substance use disorder treatment, including MAT, for people during their incarceration and after their release. Finally, Biden will expand investments to help children suffering from Neonatal Abstinence Syndrome or Neonatal Opioid Withdrawal Syndrome, and to ensure their mothers have access to effective treatment and care.

STOP OVERPRESCRIBING WHILE IMPROVING ACCESS TO EFFECTIVE AND NEEDED PAIN MANAGEMENT

An essential part of our national strategy to address the opioid epidemic must be stopping pharmaceutical companies’ practices that lead to overprescribing. Yet at the same time, physicians still must effectively treat pain. Chronic pain is a growing public health challenge with wide-ranging impacts: keeping individuals out of the workforce, negatively affecting their mental and physical health, contributing to suicidal ideation, and otherwise limiting their quality of life. Biden believes we need to pursue two joint goals: eliminate overprescribing of prescription opioids for pain, and improve the effectiveness of and access to alternative treatment for pain. Biden will:

Support development of less addictive pain medications and alternative pain treatments, and improve standards of quality for treatment. We need pain medications that are less addictive and more effective. Biden will invest in NIH research to develop these new medications. By doubling funding for NIH’s HEAL program, Biden will accelerate research regarding alternative treatments and therapies and help providers and patients better understand the options and access alternatives. And, he will direct the FDA to give priority to new pain medications with a documented reduced risk of addiction.  

Expand coverage for alternative pain treatments. As documented in a recent study related to back pain, some non-pharmacological pain interventions (e.g., psychological counseling, acupuncture, physical therapy, or occupational therapy) are not consistently covered or have administrative barriers to coverage (e.g., pre-authorization, visit limits). In accordance with evidence-based medicine, Biden will call for a requirement that Medicare, Medicaid, his proposed new public option, and private insurance companies consistently and transparently cover alternatives to opioids for chronic pain, without barriers such as prior authorization or high levels of cost-sharing. 

Crack down on misleading advertising regarding substance use disorder treatment facilities with no basis in evidence. Biden will ensure that the Federal Trade Commission and the FDA act when companies try to mislead. He will appoint leaders of both agencies who will make this a key priority. 

Provide training to medical personnel in pain management and substance use disorder treatment. Building on the Obama-Biden Administration’s prior efforts, Biden will direct the U.S. Department of Health and Human Services to work with the medical community to support research and the development of curricula and training regarding pain management. He will ensure that the systematic study of pain management and substance use disorder is a mandatory part of the curricula and material on which doctors and other medical personnel are tested. Those seeking a federal DEA license to prescribe controlled substances will be required to receive training on proper prescribing guidelines and pain management.

Expand the effectiveness of monitoring programs designed to prevent inappropriate overprescribing of opioids. Prescription Drug Monitoring Programs (PDMPs) are electronic databases designed to prevent drug abuse. For example, a provider can check the database before prescribing in order to determine whether his or her patient has been getting the same prescription from multiple providers. In order to receive any of the $125 billion in new grants under the Biden Administration, states will have to institute a requirement that every prescriber checks the database every time they write a new opioid prescription. Biden will also set aside some of these grant dollars to ensure states improve Prescription Drug Monitoring Programs data-sharing across state lines.

Ensure regular updating of the Centers for Disease the Control and Prevention (CDC) prescriber guideline based on the best available evidence. The CDC has issued a guideline to help prescribers make evidence-based decisions regarding when and how to prescribe opioids in order to minimize the risk of abuse while also effectively treating pain. Biden will ask the CDC to commit to regularly updating these guidelines as new evidence emerges regarding opioid abuse risk factors and alternative pain treatments. And, he will partner with health care providers and states to maximize providers’ awareness and use of the guideline.

REFORM THE CRIMINAL JUSTICE SYSTEM SO THAT NO ONE IS INCARCERATED FOR DRUG USE ALONE

Biden has released a criminal justice plan that will strengthen America’s commitment to justice and reform our criminal justice system by building a system focused on redemption and rehabilitation. Biden believes that no one should be incarcerated for drug use alone, and as President he will treat drug use as a disease rather than a crime. Specifically, Biden will:

End all incarceration for drug use alone and instead divert individuals to drug courts and treatment. Biden will require federal courts to divert these individuals to drug courts so they receive appropriate treatment and services. He’ll incentivize states to put the same requirements in place. And, he’ll expand funding for federal, state, and local drug courts and other programs that divert individuals who commit crimes as a result of or in furtherance of substance use disorders to treatment rather than incarceration.  

Get people who should be supported with social services – instead of in our prisons  – connected to the help they need. Too often, those in need of mental health care or treatment for a substance use disorder do not get the care that they need. Instead, they end up having interactions with law enforcement that lead to incarceration. To change the nature of these interactions, the Biden Administration will fund initiatives to partner mental health and substance use disorder experts, social workers, and disability advocates with police departments. These service providers will respond to calls with police officers so individuals who should not be in the criminal justice system are diverted to treatment for substance use disorder or mental illness, when appropriate, or are provided with the housing or other social services they may need.

Read more about Biden’s plan to reform the criminal justice system at https://joebiden.com/justice/.

STEM THE FLOW OF ILLICIT DRUGS LIKE FENTANYL, ESPECIALLY FROM CHINA AND MEXICO

As part of a comprehensive agenda that prioritizes prevention, treatment, recovery, and harm reduction, Biden believes that part of the solution to the opioid crisis involves preventing bad actors from smuggling opioids and other illicit drugs into our country. Specifically, Biden will:

Make fentanyl a top priority in our dealings with China. The Treasury Department has already sanctioned a small number of Chinese nationals in connection with fentanyl – it’s a good start, but going after individuals will not alter Beijing’s thinking long-term. Biden will pressure Beijing to crack down on illicit fentanyl production in China and stem the flow of the drug into the United States. Biden will also develop regional strategies in the Asia-Pacific and the Americas to deal with shifts in the routes and sources of fentanyl in response to a Chinese crackdown.

Enhance cooperation with Mexican authorities to disrupt the movement of heroin and fentanyl across the U.S.-Mexico border.  Chinese fentanyl is frequently transshipped through Mexico, and then smuggled across the border in pure form or combined with heroin. As China takes steps to police fentanyl and its precursors, production and distribution will increasingly shift to Mexico. Biden will pursue strong, sustained cooperation with Mexican authorities to disrupt suppliers and supply routes, including the importation of precursor chemicals from China. The Biden Administration will also provide technical assistance to enhance the Mexican Post Service’s (SEPOMEX) ability to detect and electronically track shipments of fentanyl and precursors that come through Mexico. As President, Biden will repair the damage to U.S.-Mexico ties inflicted by Donald Trump and develop a common agenda with Mexico that looks beyond our shared border to promote our shared prosperity and protect U.S. national security interests. 

Enforce sanctions on international actors engaged in the trafficking of illicit drugs like heroin and fentanyl. Biden’s Treasury Department sanctions team will map the financial institutions and networks that facilitate the distribution of fentanyl and key precursors and develop sanctions packages based on that evidence and task the Office of the Director of National Intelligence to support these efforts with a focus on illicit finance.

Increase cooperation among global law enforcement agencies. Biden will direct U.S. law enforcement agencies to work closely with foreign counterparts, share threat information, and use technology to assist in tracking and seizing illicit shipments.

Ensure federal agencies have the tools and resources they need to stop the flow of fentanyl from abroad. Fentanyl producers have exploited gaps in monitoring through the U.S. Postal Service (USPS) to flood the U.S. with the deadly product. Biden will give the USPS the tools and resources it needs to carry out that mandate and disrupt the large supplies of fentanyl that are sent through the mail system, working with U.S. Customs and Border Protection. In addition, the vast majority of opioids and fentanyl are shipped through legal ports of entry—not in between them. Rather than waste resources building a wall or tearing families apart, Biden will direct resources to the ports of entry to interdict opioid shipments there.

Combating the Opioid Epidemic and Substance Use Disorders, Paid for By Making Sure Pharma Pays Its Fair Share

Biden’s $125 billion investment in a comprehensive response to the opioid epidemic and substance use disorders is paid for by raising taxes on the profits of pharmaceutical corporations.

Filed under: General Problems | 1 Comment »

They are dropping like flies… but no one is really keeping stats

Posted on February 27, 2023 by Pharmaciststeve

A fairly visible chronic pain advocate just re-posted a video she did abt four years ago about another chronic painer who had her pain management reduced, given the date on the video would suggest that happened sometime after the 2016 CDC guidelines published and the 2019 posted date on the video.  Apparently this pt over that 2-3 yr period had suffered FIVE HEART ATTACKS with the 5th one being FATAL.

The CSA was signed into law in 1970, the same year I was first licensed as a Pharmacist. So I  have had a front row seat to its evolution over the years. That created the BNDD ( Bureau of Narcotics & Dangerous Drugs) which created the bureaucratic foundation for when in 1973 Congress created the DEA with 1200 employees and a 42-43 million/yr budget.

Most of the active Heroin addicts was in the NY area and the mafia was the primary supplier of Heroin. During the 80’s the DEA/law enforcement got more and more creative with Civil Asset Forfeiture seizure and since the mafia and their assets were USA based and a good target for the DEA/law enforcement.

It would appear that the mafia gave up on the illegal Heroin distribution and apparently the Mexican cartels moved in to pick up the distribution of Heroin.  Since the Cartels’ assets were outside of the DEA jurisdiction, confiscating the Cartel’s assets proved a challenge. All the assets the DEA had previously confiscated, they were able to put them into the DEA’s coffers… to spend as they wished.

In 2000, our Congress passed the DECADE OF PAIN LAW, that encouraged ALL DOCTORS to treat pain.  the FIFTH VITAL SIGN was created and the Joint Commission made it a MAJOR STANDARD for hospitals to meet.  Pt discharge questionnaires included if/how the pt’s pain was treated. The number of Rx prescribed during the decade and when the bill was up for renewal, the political party in charge of Congress when it was passed was no longer in the majority and the law was not renewed.

Rx opiates filled peaked in 2011-2012.  In Jan 2009, we have a new President (Obama) in office and in 2011 FL gets a new Governor Rich Scott and a new state AG Pam Bondy.  Florida had become a major source of opiate prescribing, mostly because they had a “loose licensing system” and they did not have a state wide PDMP.

The Decade of pain law – in essence – created a lot of “low hanging fruit” for the DEA to go after – prescribers who were following the Decade of Pain law and as DEA was losing MJ as states were making MJ legal in many states. which was a “cash cow” for the DEA.  The Decade  of pain law disappeared and FL implemented a PDMP and AG Bondy what she called “oxy docs” and according to her re-election campaign ads she chased out 200 oxy docs from FL in her first 4 years.

The first blog post on my blog was June 2012. In the ensuing 10 yrs, yes chronic pain pts have died. Especially after the 2016 CDC guidelines were published. What was put on their death certificate ?  Opiate related death because there was some record of them receiving a Rx opiate, or they committed suicide using their own meds ?  Was it because of “natural causes”, because their blood pressure spiked and they had a stroke, heart attack, ruptured aortic aneurysm.  Maybe a GI bleed or kidney failure because of the excessive use of a NSAID  or excessive use of Tylenol/Acetaminophen and liver failure.

How many petitions have been published ? Has anyone see any action because of those petitions ?  How many letters, phone calls, faxes, emails, in person meetings has there been with members of Congress ?  How many responses/letters focused on the problems with the war on drugs and little/nothing about the context of the original communication ?

The 2016 CDC guidelines, they tried to have them created behind closed doors, with anonymous committee members and no public comment.  They didn’t follow the statutory requirements – any consequences to CDC/anyone ?

The 2022 CDC guidelines, how many comments from the community, how many comments were read, some claim that many comments “disappeared”.  Was there any changes from the proposed 2022 guidelines and those that were published as FINAL ?

Recently, Walgreen, CVS, Walmart agreed/settled to a combined 13.8 billion settlement for contributing to the opioid crisis and as I remember within the settlement they are agreed to FILL FEWER OPIOID Rxs.

J&J was found guilty of being a “PUBLIC NUISANCE” and a 572 million settlement for being the wholesaler of raw opioid powder to the pharma industry to produce FDA approved Rx meds – it was overturn later.  Teva agreed to a 4.25 billion settlement to untold number of “wronged parties” and contributed to the opioid crisis.

I has not been until the last year or so that it has came to light some of the shenanigans that federal prosecutors and federal judges will pull to help assure a conviction. I now understand why I have numerous attorneys have claimed that 90%+ of those taken to federal court – are found GUILTY !

Here is a letter from Kaiser from 2019 from their “medical clinic team” that they are limiting opioid Rx to < 50 MME, most/all below the FDA’s recommended max daily dosing.  The MME system that  has no science nor double blind clinical studies supporting its conclusion.  https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154  they are also using a “broad brush” to prohibit the concurrent prescribing of 4 different categories of FDA approved meds as safe for human use. ( Opioids, benzos, muscle relaxants & sleeping meds)

Since the letter by “medical clinic team”  and it is on Kaiser’s letter head, one can only presume that this committee’s decision is supported by the BOD of Kaiser.

One of the core functions of the practice of medicine is the starting, changing, stopping a pt’s therapy. So is Kaiser limiting/restricting the professional discretion and prescriptive authority that is granted each prescriber by their state medical license.

In 2021 https://www.statista.com/statistics/401547/kaiser-permanente-members/ it is reported that Kaiser had 12.6 million members. If one uses the low end figure of 20% chronic painers in our general populations.  That would suggest that this policy could impact up top 2.5 million pts.

This is just one of a unknown number of large heath care corp doing the same/similar thing and that is not counting the number of chain pharmacies and insurance/PBM corporations doing same/similar thing.

Law firms like to find large corporations – with deep pockets – that has harmed people and the more “bodies” the better. To start a class action by a law firm only needs 1-2 lead plaintiffs.  All it is going to take is 1 or 2 chronic pain pt reaching out to a law firm that deals with civil rights violations that a interest to investigate

To date, all those chronic pain pts that are suffering from under/untreated pain or have died is doing so because of laws & illegal guidelines that have been used against them. The only way that the chronic pain has a chance to get their appropriate pain management back is using the laws that these corporations are using against them and/or laws they are breaking.

Filed under: General Problems | 11 Comments »

From Eugenics to Genocide

Posted on February 26, 2023 by Pharmaciststeve

There has been all too many dictators/groups- over many centuries – that have targeted certain groups because they were deemed unequal, unholy or doesn’t “fit in” with what some believe is representative of what a particular societal population should be.

Annually, there is a huge meeting in DAVOS, https://news.yahoo.com/davos-2023-key-takeaways-world-153551754.html where financially and politically important people fly their fuel guzzling jet planes and discuss how our plant is going to hell in a hand basket and how they can help save our planet. I heard that one of those “big shots” made a comment that our planet  is grossly populated and we need to get rid of 50% of the planet’s population. Current world’s population is abt 8 BILLION and each time each of exhales we are adding CO2 to our atmosphere, that is suppose to be harming our plant.

Here is a bureaucrat in MASS made the suggestion that “defective fetus in the womb” should be aborted because they are will be a financial burden on the various school systems. The vary definition of eugenics.

His mindset seem to mirror the mind set of certain other segment of other bureaucrats… when they seem to be “targeting” high acuity disabled pts that are consider a financial burden  on our healthcare system.

Congress has passed at least two laws – Americans with Disability Act & Civil Rights Act – that is supposed to prevent disabled people from being discriminated against. Unfortunately, the agency – within the DOJ – that is suppose to enforce those laws has mostly chosen to tell those to attempt to file a civil rights discrimination complaint, are told that they don’t have the resources to pursue such complaints.

While another agency under the DOJ – is the primary source of causing those civil rights discrimination to happen with their FIVE DECADE war on drugs.  In many minds, the DEA actions in fighting the war on drugs is a direct/indirect cause of a COVERT GENOCIDE. Opioid Rxs peaked in 2011-2012 and today pharma opioid production is down abt 60% as is the filled Opioid Rxs. The number  of Opioid OD’s is UP abt SEVEN TIMES – mostly from illegal fentanyl coming from China & Mexico and yet we keep funneling over 100 billion/yr into the DEA to fight the war on drugs.

I guess the only people who would think that after FIVE DECADES and over TWO TRILLION spent on our war on drugs has been a success is those whose paycheck comes from that TWO TRILLION we have spent. Isn’t the House of Representatives suppose to be in charge of the “federal purse stings” ? there is 435 members in the House, is there NO ADULTS IN THE HOUSE ?

Massachusetts Democrat told to step down after abortion comments leave parents irate

https://www.foxnews.com/politics/massachusetts-democrat-told-step-down-abortion-comments-leave-parents-irate

‘This is eugenics in 2023 America,’ says Students for Life President Kristan Hawkins

FRAMINGHAM, Mass. – A local Democrat official in Massachusetts is facing calls to step down after complaining about the cost of special education for children with disabilities who are not aborted.

Michael Hugo, the chair of the Framingham Democratic Committee, made the remarks during a city council meeting when discussing a proclamation about access to abortion and crisis pregnancy centers in the city. He said crisis pregnancy centers could misdiagnose a defect in a baby in the womb, leading to them being born and becoming a strain on a school budget. He issued a public apology after 10 days of backlash from members of his own party and parents of special needs children.

“I saw what Michael had said as a personal attack against my own children,” said Sheryl Goldstein, the chair of the Framingham Disabilities Commission. “That my children who had special needs were not worth the expense in the school system.”

MASSACHUSETTS DEMOCRAT TOLD TO RESIGN AFTER ABORTION REMARKS LEAVE PARENTS IRATE

Massachusetts Democrat told to resign after abortion remarks leave parents irate Video

In his public apology letter, Hugo called his comments “offensive and hurtful.”

“I am writing to offer my most sincere and humble apology to members of the Framingham Democratic Committee, but more especially my fellow members of Framingham’s disability family community, for comments that I made at the last City Council meeting which were offensive and hurtful,” he wrote. 

He said members of the committee did not “see or review” his remarks despite being sent out the night before the meeting. 

“Our fear is that if an unqualified sonographer misdiagnoses a heart defect, an organ defect, spina bifida or an encephalopathic defect that becomes a very local issue because our school budget will have to absorb the cost of a child in special education, supplying lots and lots of special services to children, who were born with the defect,” Hugo said at the Feb. 7 meeting.

Laura Green, a disability advocate in Framingham told Fox News that she does not accept his apology.

“I feel that it was generic and lackluster. I feel like after a statement like that is made, you can’t just pretend that it didn’t happen or take it back because it’s damaging to a community of people,” she said. “The disability community is the only minority group that you can become a part of at any time.” 

Crisis pregnancy centers provide ultrasounds to pregnant women for little to no cost.

Crisis pregnancy centers provide ultrasounds to pregnant women for little to no cost. (iStock)

According to his LinkedIn, Hugo is also the director of policy and government affairs for the Massachusetts Association of Health Boards. 

MA REPUBLICAN GOVERNOR CHARLES BAKER SIGNS BILL PROTECTING ABORTION RIGHTS

Jon Fetherston, a special needs advocate and registered Republican said he was in disbelief when he heard the comments. 

“As a parent of an autistic child, I read those comments and go ‘what?’” he said. “A peer of mine thinks that I should’ve aborted my child because he was going to be a burden to a school budget?”

Kristan Hawkins, the mother of two children with cystic fibrosis and the president of Students for Life told Fox News she was deeply offended by Hugo’s comments. 

“This is discrimination plain and simple,” she said. “I think people who say that the sick cost too much for our society better find the fountain of youth real quick because someday that’s going to be them, it’s going to be their family members.”

“This is eugenics, this is eugenics in 2023 America, this is an argument that sadly we’ve heard before and throughout American history, just regurgitated using a bunch of fancy lingo or support for abortion,” Hawkins added.

Laura Green says her best friend with down syndrome inspired her to be a disability advocate.

Laura Green says her best friend with down syndrome inspired her to be a disability advocate. (Laura Green)

In his speech, Hugo said he was “speaking on behalf of the Framingham Democratic Committee,” adding that it’s their mission to “work for the common good by promoting racial, ethnic, social, and economic equality for the people of Framingham.”

NATIONAL ARCHIVES CUTS TIES WITH GUARD WHO TOLD VISITORS TO REMOVE CLOTHING WITH PRO-LIFE MESSAGES: REPORT

“It’s astounding to see such a heartless statement, especially coming from 2023 America where we’re supposed to be this progressive inclusive society that celebrates diversity, come out and say ‘well yeah certain people shouldn’t be born because they’re going to cost us too much money,” Hawkins said.

A speaker that came shortly after Hugo at the meeting denounced him and said he went “off the rails.”

“I’m a lifetime member of the Democratic Committee, and the person who wanted to represent us went off the rails on a different direction that was never brought before the Democratic Committee,” said Pat Dunne, a former Framingham School Committee member, according to Framingham Source. “We’re not talking about eliminating special education students and the like. We’re talking about getting out good information to the people in Framingham. And he’s casting a bit too wide for me and that’s why I did want to say something.”

In a letter sent to city council members several hours before the meeting and obtained by Fox News, Hugo provided a preview of his remarks reported to the Source, asking if the state will “cover the medical costs for a fetus that had sound medical reason to be terminated.”

He questioned if the state would “cover the costs of special education for a down syndrome affected child” and “pay for the extraordinary medical expense of a child with an atrial septal defect?”

“How much does Framingham’s Public School Department pay for unreimbursed special needs school transportation, specialized education and durable supplies?” he asked. 

Hugo also claimed crisis pregnancy centers’ sonographers would likely misdiagnose defects “while proclaiming that it is a beautiful child living inside the mother and handing her an ultrasound photo that nobody can figure out without training, some diapers and a couple of ‘onesies’ for her new baby.” 

Hugo said he and others are working to prevent pro-life crisis pregnancy centers from opening up in Framingham.

Michael Hugo, a local democratic official in Framingham, MA questioned the costs of children with down syndrome on his city who are not aborted.

Michael Hugo, a local democratic official in Framingham, MA questioned the costs of children with down syndrome on his city who are not aborted. (BSIP/Universal Images Group via Getty Images)

Hawkins disputed Hugo’s complaints about crisis pregnancy centers.

PRO-LIFE GROUPS SOUND ALARM ON OHIO ABORTION BALLOT PROPOSAL THEY SAY WILL ‘CANCEL THE RIGHTS OF PARENTS’

“Pregnancy care centers offer such excellent free services that even the abortion-supporting community has taken note,” she said. “Preventing young mothers from getting free services is a sign that the abortion mindset has poisoned far too many in our culture.” 

Goldstein added that due to her leadership position with the disabilities commission, she has received many calls and texts from families with special needs children in the community.

“People are quite frankly very upset,” she said “They want action.”

"I saw what Michael had said as a personal attack against my own children," said Sheryl Goldstein, the chair of the Framingham Disabilities Commission. 

“I saw what Michael had said as a personal attack against my own children,” said Sheryl Goldstein, the chair of the Framingham Disabilities Commission.  (Sheryl Goldstein)

The Framingham Democratic Committee echoed Hugo’s apology in a statement issued last week, claiming his remarks did not reflect the full committee, adding “we fully disavow and denounce them.”

“If they disavow and do not support those comments, how do you leave him in charge of your organization?” Fetherston who has a child with autism asked. “He has an influential position inside the party and if he even thinks that, much less says it in a public meeting, then he shouldn’t be in a leadership position.”

“I think he should immediately step down,” Fetherston added.

Hawkins said that while she believes Hugo should be removed, his blunt comments “hopefully woke up a lot of people to their support of abortion.”

Neither Hugo nor the Framingham Democratic Committee responded to Fox News’ request for comment.

To learn more about the backlash to Hugo, click here.

Kassy Dillon is a reporter for Digital Originals. You can reach her at kassy.dillon@fox.com and follow her on Twitter at @kassydillon.

Filed under: General Problems | 2 Comments »

Reportedly Kaiser has discharged all chronic pain pts unless cancer or palliative care

Posted on February 25, 2023 by Pharmaciststeve

Apparently by the date on this letter Kaiser JUMPED THE GUN on the CDC 2022 guidelines and they are referencing the MME system which has no science nor double blind clinical studies supporting its conclusions https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154 Looks like Kaiser is practicing medicine by COMMITTEE. I know that the Controlled Substance Act states that no one can prescribe a controlled substance without doing in person exam. And from the second picture, it appears that they have created a “corporate “cookie cutter” treating pain ” book.

I am sure that most of their employee prescribers are ecstatic that Kaiser has taken away their prescriptive authority and professional discretion that they were granted by the state medical license.

Obviously, Kaiser is following the DEA’s opinion of how many subjective diseases should be treated, based on DEA’s observations and opinions of how those people with mental health issues and are considered addicts and the “medical expertise” that the DEA has come to the conclusion by those observations of what drugs addicts take/consume.. disregarding how many tabs/caps/mgs of each are taken at one time.  Which has nothing to do with how they would be prescribed to a pt with valid medical necessity.

It has been my experience that many high acuity pain pts are dealing with multiple pain generating medical issues and often will benefit from having one or all four of meds that Kaiser has declared cannot be prescribed concurrently.  Most of these pts are probably considered DISABLED. Isn’t disabled people protected under the Americans with Disability Act & Civil Rights from being discriminated against ?  Could a corporate edict that certain categories of medications cannot be concurrently be prescribed to a pt that has multiple high acuity health issues whose QOL could be improved … if they were appropriately prescribed one or more of  meds in those categories and any person or entity denying the appropriate medications concurrently… actually be discriminating against them and a civil rights violation of those laws that protect disabled pts.  Kaiser has to have tens of thousands of such pts.  I guess that it would take a law firm that deals with civil rights discrimination issues to figure that out.

Here are a few posts from past post on my blog concerning Kaiser and how they are treating chronic pain pts..these are for 2018 & 2019

Yesterday Kaiser Permanente signed my death warrant

Dying Cancer patient denied Opioids by Kaiser

Kaiser Permanente and the End of Compassionate Care

 

 

 

 

https://preview.redd.it/wr11sf8eq5ka1.jpg?width=3072&format=pjpg&auto=webp&v=enabled&s=95e093f4b922fcf8bfcdd3951aa6796ef4c0f10c

Filed under: General Problems | 4 Comments »

Canadian panel pushes assisted suicide for minors without parental consent

Posted on February 24, 2023 by Pharmaciststeve

Canadian panel pushes assisted suicide for minors without parental consent

https://www.foxnews.com/media/canadian-panel-pushes-assisted-suicide-minors-parental-consent

Canada’s Special Joint Committee on Medical Assistance in Dying recommending allowing euthanasia for some minors

Canada’s Special Joint Committee on Medical Assistance in Dying (MAID) recommended assisted suicide for minors without parental consent in mid-February.

A 138-page Canadian Parliament document was shared online called, “Medical Assistance In Dying In Canada: Choices or Canadians.” One part of the report addressed assisted suicide options for “mature” minors in Canada. They considered two tracks, one for whom there is “reasonably foreseeable” death, the second track for those for whom “mental disorder is the sole underlying medical condition.”

The government document explained the debate among government witnesses about expanding assisted suicide to those who are not yet legal adults.

“For MAID and mature minors, the committee heard a mix of views about whether MAID should be available to those under the age of 18. Many witnesses believed that age alone does not determine whether someone is capable of consenting to MAID,” the document’s authors wrote. “At the same time, a cautious approach was recommended, especially since there is little evidence from youth themselves on this topic.”

In 2014, Quebec reported enacted legislation for "end-of-life care," which includes rules relating to "medical aid in dying."

In 2014, Quebec reported enacted legislation for “end-of-life care,” which includes rules relating to “medical aid in dying.” (iStock)

CANADIAN SOLDIER SUFFERING WITH PTSD OFFERED EUTHANASIA BY VETERANS AFFAIRS

While the paper ultimately did not recommend MAID for children who are mentally ill, “The committee agrees with the many witnesses who opined that MAID for mature minors should be limited to track one [reasonably foreseeable natural death] at this stage, especially given the lack of youth perspectives on the topic.”

Among a list of recommendations was a suggestion that “That the Government of Canada restrict MAID for mature minors to those whose natural death is reasonably foreseeable.”

One critical aspect was that while the government committee supported the concept of consulting parents about administering euthanasia, children would have the final say: “The committee agrees with those witnesses who supported a requirement for parental consultation, but not consent, in the context of MAID for mature minors.”

Judging assisted suicide.

Judging assisted suicide. (iStock)

One recommendation the committee gave was to formalize this idea into law.

“That the Government of Canada establish a requirement that, where appropriate, the parents or guardians of a mature minor be consulted in the course of the assessment process for MAID, but that the will of a minor who is found to have the requisite decision-making capacity ultimately take priority,” the committee advised.

The Daily Mail, after noting children would be “joining the roughly 10,000 adults who end their lives each year by state-sanctioned euthanasia in Canada, quoted multiple critics of the proposal.

“I think it’s horrible,” Amy Hasbrouck, of the anti-MAID group, Not Dead Yet, told the outlet. “Teenagers are not in a good position to judge whether to commit suicide or not. Any teenagers with a disability, who’s constantly told their life is useless and pitiful, will be depressed, and of course they’re going to want to die.”

Multiple activists from organizations concerned about government-assisted suicide condemned the committee's recommendations for minors.

Multiple activists from organizations concerned about government-assisted suicide condemned the committee’s recommendations for minors. (iStock)

Executive director of the Euthanasia Prevention Coalition Alex Schadenberg told the Daily Mail, “We said we were going to have safeguards and guardrails, but the next government can simply open it up further by making a decision — and that’s exactly what’s happening.”

Filed under: General Problems | 1 Comment »

« Previous Page — Next Page »