Minnesota is among the first states to address the unintended consequence of CDC opioid guidance from 2016

Posted on August 7, 2022 by Pharmaciststeve


 

Minnesota is among the first states to address the unintended consequence of CDC opioid guidance from 2016

https://www.kare11.com/article/news/local/breaking-the-news/law-could-be-life-saving-for-chronic-pain-patients/89-b22f2aba-667d-42cb-877d-20c3eb70efd3

LAKEVILLE, Minn. — On August 1, a change to a Minnesota state statute regarding opioid prescribing quietly ushered in a change that could be life-saving for people who suffer of severe, chronic pain. 

The change addresses issues that arose from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. While the guideline was “intended to improve communication between providers and patients,” it had an unintended consequence for sufferers of intractable pain. It led to dosing restrictions and tapering of the only medication that worked for them.

“This is severe, unrelenting, incurable pain, where other medications have not worked as well or don’t work at all,” said Cammie LaValle, who suffers from complex regional pain syndrome. “It is an incurable, rare disease, rare condition. It is systemic, and at one point I was using a wheelchair, I was begging for amputation of my arm and my leg, because the pain is that severe.”

“It is considered one of the suicide pains,” said Dr. Todd Hess, who has worked in pain management for more than 30 years. “It is very difficult to treat, and it’s what I specialize in.”

Technically, Dr. Todd Hess is recently retired from that specialty, and says it’s a direct result of the impact the CDC guideline had on his ability to treat patients.

 “It felt like I couldn’t do my job any more,” Dr. Hess said. “The 2016 CDC guideline had good intentions, I believe, at the start, but it was not meant to be anything more than a guideline.”

The guideline featured specific numeric thresholds for opioid prescribing, which were later adopted widely and used in regulations and state laws to police opioid prescribing.

“Pain doctors were literally being investigated,” Dr. Hess said. “I mean, I’ve been investigated numerous times and luckily they’ve all come out in my favor because we’ve done the right thing, and that has sent a chilling effect to the medical community.”

And that left Cammie and many other patients out in the cold.

During a hearing in the Minnesota Senate this spring, Laura Johnson, a chronic pain patient, provided emotional testimony of her own struggles.

“I have suffered with chronic pain for over 20 years. I have MS and a deformed spine,” Johnson said. “I can no longer sit, I can’t sleep and I can’t walk. I don’t have a pain doctor anymore. I got dumped because he was so afraid of the fear of the DEA and the guidelines.”

Johnson said she represented just one of many patients who were no longer able to share their stories.

“Many have turned to the streets out of desperation,” she said. “Many more have ended their lives.” 

Both the Minnesota Medical Association and American Medical Association backed up that patient testimony, sending letters in support of the bill.

“For too many years, patients with pain have suffered because of inflexible, numeric thresholds on opioid therapy,” wrote Dr. James Madera, CEO of the AMA.

But thanks to the advocacy, led by Cammie, there is finally hope. The revised statute changes Minnesota law in several ways:

Provides new or updated definitions for intractable pain, drug diversion, palliative care, rare disease and establishes criteria for the evaluation and treatment of intractable pain when treating non-terminal and terminal patients.

  • No physician, advanced practice registered nurse, or physician assistant shall be subject to disciplinary action by the Board of Medical Practice or Board of Nursing for appropriately prescribing or administering a controlled substance in Schedules II to V of section 152.02 in the course of treatment of a patient for intractable pain, provided the physician, advanced practice registered nurse, or physician assistant keeps accurate records of the purpose, use, prescription, and disposal of controlled substances, writes accurate prescriptions, and prescribes medications in conformance with chapter 147 or 148 or in accordance with the current standard of care.
  • No physician, advanced practice registered nurse, or physician assistant, acting in good faith and based on the needs of the patient, shall be subject to disenrollment or termination by the commissioner of health solely for prescribing a dosage that equates to an upward deviation from morphine milligram equivalent dosage recommendations or thresholds specified in state or federal opioid prescribing guidelines or policies, including but not limited to the Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention and Minnesota Opioid Prescribing Guidelines.
  • Prohibits a prescriber from tapering a patient’s medication dosage solely to meet a predetermined dosage recommendation or threshold if the patient is stable; is experiencing no serious harm from the level of medication prescribed, and is in compliance with treatment plan and patient-provider agreement.
  • No pharmacist, health plan company or pharmacy benefit manager shall refuse to fill a prescription for an opiate issued by a licensed practitioner authorized to prescribe opiates solely based on the prescription exceeding a predetermined morphine milligram equivalent dosage recommendation or threshold.
  • Requires the prescriber and patient to enter into an agreement that includes the patient’s and prescriber’s expectations, responsibilities, and rights according to the best practices and current standard of care with agreement to be signed by the patient and the prescriber, and a copy of the agreement included with the patient’s medical record and a copy to the patient, to be reviewed at least annually and when there are any changes to treatment plan.
  • Absent clear evidence of drug diversion, nonadherence with the agreement must not be used as the sole reason to stop a patient’s treatment with scheduled drugs.

“Opioids are not for everybody, and this is not a pro-opioid bill at all,” Dr. Hess said. “It’s a doctor/patient relationship bill, where patients and doctors and nurse practitioners and PA’s will have a safe zone to do it properly. We know this is dangerous, but we also know not treating pain is dangerous too.”

“It will hopefully protect patients like me, and worse off than me,” Cammie said. “There are people actively dying right now that don’t have access to medications because their oncologist are afraid to prescribe.”

I did a word search of this text for “DEA” and it only appeared ONCE…  “It will hopefully protect patients like me, and worse off than me,” Cammie said. “There are people actively dying right now that don’t have access to medications because their oncologist are afraid to prescribe.”

Does this mean, that if any entity – like the DEA or VA system – decides to impose some daily MME system limit as to a pt’s daily dose.. will this law back the prescriber’s belief as to what the pt’s valid medical needs are. Could a insurance/PBM company does not impose a limit, just refuses to pay for a particular med or category of meds or refuse to pay for any Rx above a certain MME.

DEA Policy Reversal on Allowed Prescription Annotations for Schedule II Prescriptions

here is a post I did recently and I am not sure what the DEA is up to with information contained in the letter in this post,  but I suspect that it has something to do with prescribers sending out controlled med Rxs that is missing a “i” being dotted and/or a “t” being crossed.  Could the DEA start collecting data on such prescribers and could they determine that a particular prescriber is sending out controlled med Rx and track data on such prescribers and could they look to such a prescriber as providing “illegal Rxs” because of those “i’s” not dotted or “t’s” not crossed.  Here is a post : Supreme Court hearing for the Doctors Xiulu Ruan, MD and Shakeel Kahn, MD

Where the SCOTUS with a 9-0 vote decided that the DEA had been using OBJECTIVE CRITERIA to judge prescribers treating pts dealing with SUBJECTIVE DISEASES and it was ILLEGAL for the DEA to do so… Could this be what the DEA is going to use as “go around” to what they have used in the past to “take prescribers down” ?  Only time will tell, but this SCOTUS decision maybe a good example the path the chronic pain community needs take to get some better pain management… and that would mean using law firms.

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Insurance denies pt’s therapy: because the insurance company guidelines are out-of-date

Posted on August 7, 2022 by Pharmaciststeve

AITA for Pointing Out to the Insurance Company That I’m the Expert on My Patient?

https://www.medscape.com/viewarticle/976690

I (48, F) had to do one of those “peer-to-peer” calls with an insurance physician (undisclosed-age, M). I know, it’s a commonplace task now, what’s the big deal, etc., but let me explain.

From the start of the conversation, tons of red flags. First of all, he won’t tell me what specialty he is. And I’m like, “Okay, that’s kind of weird, but can you at least tell me if you’re an oncologist?” Then he asks, “Why does that matter?” So I say, “It matters a lot because I’m an oncologist and this is about a person with cancer. It’s literally a matter of life and death because your insurance company denied their cancer treatment.”

He finally says, “No,” he’s not an oncologist.

“So then, what’s your specialty?” I ask.

He clears his throat and says he isn’t allowed to say. Then he reminds me that this call is being recorded for quality assurance purposes.

“Excellent,” I say. “Then it’s being recorded that you’re the one obstructing my patient’s access to lifesaving treatment.”

Then he says there’s no reason to be rude and calls me “Miss.” I ask him to please refer to me by my title of “Dr,” and he drops the “Miss” but instead starts using my first name as if we’re old friends or something.

At this point, I’m not making any progress in getting my patient’s medication approved, so I let the first name/untitling go and ask him to explain why the insurance company denied the medication (let’s call it X).

I hear him shuffling papers, and then he says it’s because we didn’t try medication Y yet.

I tell him it’s correct that medication Y used to be the standard-of-care first-line therapy, but as of 6 months ago, the FDA approved medication X as the more effective therapy. I explain to him the insurance company guidelines are out-of-date. Any board-certified oncologist would know this. Which he, inconveniently, is not.

Then he tells me there’s often a lengthy delay in updates to company guidelines, which he can’t control. To which I respond, “That’s why I, as the patient’s doctor, should be in charge of what treatment is approved,” not him or the insurance company.

He says he doesn’t disagree with me, but it’s not in his power to approve it. Because the company hasn’t updated its guidelines, I’ll have to talk to an oncologist at the insurance company to get an override.

It seems obvious to me it would have made more sense to do that in the first place, but in the interest of time, I keep this comment to myself and tell him, “Fine, please transfer me to their oncologist.”

Then he says, “Oh no, I can’t do that. You’ll have to set up another phone call.”

At this point, I’ve had another patient in an exam room waiting for over 15 minutes so I ask him to please hurry and set that up.

I hear papers shuffling again, and he says they can set me up for that phone call at 4:42 AM the next day.

When I ask for a more reasonable time, he says because they’re in a different time zone, that’s all they can offer, and if I don’t take that time, then my patient’s case will be closed, and I’ll have to start all over with the appeal from the beginning — which means talking to someone like him again.

Because there’s no real choice, I take the offered time. The following morning, the insurance oncologist immediately approves medication X.

So AITA for pointing out that if the insurance company had trusted that I, as a board-certified oncologist, was doing the right thing for my patient from the get-go, we could have saved everyone a lot of time and frustration (and sleep)?

Their response? “This call is being recorded for quality assurance purposes.”

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Americans Have No Right to Healthcare

Posted on August 7, 2022 by Pharmaciststeve

Americans Have No Right to Healthcare

— It’s high time we change that

https://www.medpagetoday.com/opinion/second-opinions/96938

A photo of a woman outdoors with a sign which reads: Healthcare is a human right
The United Nations’ Universal Declaration of Human Rights, signed in 1948, set up the framework that healthcare is a human right. Article 25 of the document stated that, “everyone has a right to standard of living adequate for the health and well-being of himself and his family including…medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.”

President Franklin D. Roosevelt previewed these sentiments in his State of the Union Address where he described the four freedoms. The first two, freedom of speech and freedom of religion, are codified in our First Amendment. But the third and fourth, freedom from fear and freedom from want, remain nebulous in our view. And nowhere in our nation’s founding documents does it explicitly state that Americans are entitled to have access to a physician or any form of medical treatment.

Some people might interpret the values espoused in the Declaration of Independence, with its notion of inalienable rights to “Life, Liberty, and the pursuit of happiness,” as denoting that “life” equals an explicit right to healthcare. This is simply not a reality in America.

The preamble to the Constitution mentions providing for the “general welfare.” Could this be recognition enough that healthcare is a right for the individual? No, for one’s individual welfare does not necessarily equate to the general welfare. Although there have been Constitutional Amendments proposed in the past — most recently by Rep. Betty McCollum (D.-Minn.) — as yet, there is no enumerated U.S. right to healthcare.

But, you may ask, doesn’t a pregnant woman have the right to choose whether or not to have an abortion? Isn’t that a right to healthcare? Yes, the Roe v. Wade decision determined that this form of healthcare is legal. However, the Supreme Court based their decision on an individual’s right to privacy in their medical decision making. It did not stem from a right to healthcare.

But, others may say, the emergency department is open to all — doesn’t that mean Americans have a right to healthcare? Unfortunately, the 1986 Emergency Medical Treatment and Labor Act (EMTALA), which made access to emergency care a right for all Americans, is exceedingly limited in scope. It only guarantees treatment for life and limb threatening conditions and treatment of women in labor. It does not guarantee treatment for chronic conditions such as high blood pressure or heart disease. It does not cover cancer care. Moreover, one must ask if a single, limited law could be construed as a right.

Senior citizens have a right to healthcare once they age into the Medicare program. More recently, Americans with specific diseases, such as end stage renal disease and Lou Gehrig’s disease have this right to healthcare extended to them. But as simple laws, the right to emergency care, to care for seniors, and for those with certain deadly conditions could easily be ripped away. A future Congress could repeal these laws if it chose to do so.

It wouldn’t be the first time. We have seen that health laws, such as the Medicare Catastrophic Coverage Act of the late 1980s, can easily be repealed. Other laws, like the Affordable Care Act, show that a single law can be sabotaged whenever a political party has control of both Congress and the White House. And the will of the people can be ignored by dithering politicians who intransigently refuse to implement lawful extensions of healthcare. As just one example, this occurred in Maine in 2018, when the former Governor failed to execute a Medicaid expansion ballot initiative approved by the state’s citizens.

All our patients desire is a chance to be healthy and to keep their families healthy. Should they not be allowed to do this without squandering their life’s savings or risking bankruptcy? Since the 1940s, following the defeat of Nazi Germany, our country has made bold steps towards securing this human right to healthcare and making Americans free from want.

If nothing else, this last year showed us that moving toward the right to healthcare for all is possible. With the federal government ensuring access to COVID-19 testing and vaccinations, everyone in this country had a right to the most aggressively developed medical care the world has ever seen. The pandemic has shown us what we can do when we recognize that an individual’s welfare actually is dependent upon the general welfare. So, although an explicit right to healthcare does not formally exist in the U.S. for all people regardless of age or medical condition, the past 2 years have revealed why every American should be assured of that right.

America must make the healthcare of its citizens a protected right. As difficult as it may be in these polarized times, the U.S. needs a Constitutional Amendment to guarantee healthcare as a right. Anything less would fall short of the needs of everyday Americans. Until then, in America, healthcare is not a right. But its high time we change that.

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Democrats’ New Drug Pricing Bill Will Jack Up Prices For Americans, CBO Finds

Posted on August 6, 2022 by Pharmaciststeve

Democrats’ New Drug Pricing Bill Will Jack Up Prices For Americans, CBO Finds


below is a graphic of where the majority of the $$$ paid at the pharmacy register goes and here is what Congress has negotiated on the NUMBER OF MEDICATIONS that price negotiations can be done on  The number of negotiated drugs would be limited to 10 Part D drugs in 2026, 15 Part D drugs in 2027, 15 Part B and Part D drugs in 2028, and 20 Part B and Part D drugs in 2029 and later years.   More information is available in this hyperlink  https://dailycaller.com/2022/08/05/democrats-drug-pricing-cap-bill-cbo-manchin-sinema-schumer-medicare/     and NO ONE will see any savings for over THREE YEARS from now, and reaching a total of 20 meds AT THE END OF THE DECADE.  Since all Medicare meds are covered under Part D and/or Medicare-C and those are provided by FOR PROFIT insurance companies and these major insurance companies also own various PBM entities. Barb has been on Medicare Part D since it started in Jan 2006. So many promises over the years as to what was going to happen and never came to fruition, kind of reminds me of Charlie Brown and Lucy    

Democrats’ landmark new drug pricing legislation could actually result in an initial increase in drug prices, according to information released Thursday by the Congressional Budget Office (CBO).

The non-partisan CBO reported that the legislation, which places a cap on price increases so they cannot go up faster than inflation, could lead drug companies to raise launch prices of new drugs to make up the difference. The CBO also said that allowing Medicare to negotiate certain drug prices directly would contribute, albeit not as much, to higher prices.

 

The possibility that pharmaceutical companies will counteract the inflation-linked price cap by simply raising starting prices will undercut some messaging in favor of the bill, which Democrats argue will rein in major corporations allegedly price-gouging Americans for necessary medicine. (RELATED: ‘This Is An American Bill’: Joe Manchin Defends New Reconciliation Package)

The price cap provision of the bill has garnered bipartisan support in the past. The Medicare price negotiation is a far more contested aspect of the overall policy. Democrats are including the drug pricing reforms in the major reconciliation package slated to hit President Joe Biden’s desk in early August after it goes before the Senate on Saturday. The package also includes provisions aimed at addressing climate change and out-of-control inflation that has dogged the Biden administration and Democrats for months.

The bill had been stalled until Democratic West Virginia Sen. Joe Manchin recently gave his endorsement to move forward.

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Vanderbilt should lose Magnet status over RaDonda Vaught’s treatment, nurses say

Posted on August 5, 2022 by Pharmaciststeve

Vanderbilt should lose Magnet status over RaDonda Vaught’s treatment, nurses say

https://www.beckershospitalreview.com/nursing/vanderbilt-should-lose-magnet-status-over-radonda-vaught-s-treatment-nurses-say.html

Some nurses are urging the American Nurses Credentialing Center not to renew Vanderbilt University Medical Center’s Magnet designation, arguing that the hospital’s response to RaDonda Vaught’s fatal medication error and conviction do not align with the program’s mission to create an environment where nurses flourish.

Nashville, Tenn.-based Vanderbilt University Medical Center is applying for redesignation of its Magnet designation for Vanderbilt University Hospital’s adult enterprise and must undergo a site evaluation this month, according to a public notice posted on the organization’s website.

The credentialing center’s Magnet recognition program commends hospitals for their excellence in nursing services. Vanderbilt has received the designation in 2006, 2012 and 2017.

In 2017, Ms. Vaught made a fatal medication error while working as a nurse at Vanderbilt, for which she was sentenced to three years of probation in May after being found guilty of criminally negligent homicide and abuse of an impaired adult. 

Ms. Vaught immediately took responsibility for the error, which occurred after she overrode a medication cabinet, but contends that other factors and working conditions for nurses at the medical center contributed to the mistake. For example, she said that Vanderbilt directed nurses to use overrides to overcome cabinet delays and regular technical issues caused by an ongoing overhaul of the hospital’s EHR system. Vanderbilt fired Ms. Vaught in January 2018, and the Tennessee Board of Nursing stripped her of her license in 2021.

“So many things had to line up incorrectly for this error to have happened, and my actions were not alone in that,” Ms. Vaught told ABC News in May. In 2018, Vanderbilt shared a plan of correction with CMS to address deficiencies identified in a federal investigation after the fatal error.

Ms. Vaught’s case has spurred an outcry from nurses across the country, many of whom have expressed concerns about the likelihood of similar mistakes under increasingly difficult working conditions. 

Now, nurses from across the U.S. are penning letters to the credentialing center ahead of Vanderbilt’s site visit, saying the organization should not allow the hospital to keep its Magnet designation. 

“The mission of the Magnet Recognition Program is to ‘continually elevate patient care around the world in an environment where nurses flourish,'” Jenna Lukis, BSN, RN, wrote in emailed comments to the credentialing center, which she shared Aug. 2 in the Nurses March for RaDonda’s Law Facebook group. “With their actions in 2017 and their inaction in 2022, VUMC has demonstrated to the entire country that their hospital does not align with this mission.”

Ms. Lukis’ post garnered more than 30 comments, many from nurses who said they had also sent letters to the credentialing center about Vanderbilt’s Magnet status. The deadline to submit comments is Aug. 6. 

Vanderbilt did not immediately respond to Becker’s request for comment.

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EU Says Novavax COVID Shot Must Carry Heart Side Effect Warning

Posted on August 5, 2022 by Pharmaciststeve

EU Says Novavax COVID Shot Must Carry Heart Side Effect Warning

https://www.medscape.com/viewarticle/978527

LONDON (Reuters) -The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

The heart conditions – myocarditis and pericarditis – should be listed as new side effects in the product information for the vaccine, Nuvaxovid, based on a small number of reported cases, the EMA said on Wednesday.

Novavax said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid and that more data would be gathered, adding that the most common cause of myocarditis is viral infections.

“We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data,” U.S. vaccine developer Novavax added.

In June, the U.S. Food and Drug Administration flagged a risk of heart inflammation from the Novavax vaccine.

Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, from groundbreaking messenger RNA (mRNA) vaccines made by Moderna and the Pfizer and BioNTech alliance, with the vast majority of those affected recovering fully.

The EMA said on Wednesday it had asked Novavax to provide additional data on the risk of these side effects.

Last month, the EU agency identified severe allergic reactions as potential side effects of the vaccine.

Novavax was hoping that people who have opted not to take Pfizer and Moderna’s vaccines would favour its shot because it relies on technology that has been used for decades to combat diseases including hepatitis B and influenza.

However, only around 250,000 doses of Nuvaxovid have been administered in Europe since its launch in December, according to the European Centre for Disease Prevention and Control.

(Reporting by Natalie Grover in London and Ludwig Burger in Frankfurt, additional reporting by Michael Erman in New York; editing by Jason Neely, Emelia Sithole-Matarise and Alexander Smith)

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Did DEA Create “FAKE” Opioid “Crisis” to Screw doctors and patients?

Posted on August 5, 2022 by Pharmaciststeve

https://www.pharmaciststeve.com/supreme-court-hearing-for-the-doctors-xiulu-ruan-md-and-shakeel-kahn-md/

https://www.pharmaciststeve.com/dea-policy-reversal-on-allowed-prescription-annotations-for-schedule-ii-prescriptions/

If you listened to the above video and heard the retired pharmacist/chronic pain pt stating that all of his correspondence with bureaucrats/politicians seems to have “fallen on deft ears”.

Over 5 decades ago,  the feds/DEA declared that marijuana had NO VALID MEDICAL VALUE… yet 40 +/- states have legalized MJ in some form or another and Chuck Schumer (an attorney) is starting a “discussion” within Congress to get MJ taken off of the controlled substance act. https://nypost.com/2021/07/14/schumer-drafts-pot-legalization-bill-despite-biden-opposition/  but – of course – they are going to tax the crap out of every level in MJ distribution system from growing to sales…   but many states that had legalized MJ and taxed the crap out of it, have found that they have created a “good market” for the drug cartels to produce and sell non-approved MJ  https://nypost.com/2022/07/26/chuck-schumers-over-taxed-marijuana-bill-would-only-aid-illegal-dealers

Likewise, decades ago the FEDS/DEA declared that Psychedelic drugs had not valid medical necessity but now there is https://psychedelicspotlight.com/5-psychedelic-clinical-trials-2022-maps-mdma-psilocybin-ketamine-lsd-dmt/      No one has to look far to see how serious a mental health problem our country has.  Has this reality caused the FEDS/DEA to pull back on their “no valid medical use” on psychedelic drugs and remove it from being a C-I on the DEA’s controlled substance list.

Different states have passed and/or proposed some sort of tax on pharma Rx opiates  like NY, NJ, Delaware. & Minnesota.  In some states, as NY , which exempted Morphine, Methadone & buprenorphine from the tax.  Pts are finding pharmacies that no longer stock their opiate medications,  wholesalers not longer shipping opiates into NY and some manufacturers are no long shipping opiates into NY.  https://www.usnews.com/news/best-states/articles/2020-11-17/patients-struggle-to-find-prescription-opioids-after-new-york-tax-drives-out-suppliers  Senator Manchin has tried on several occasions to get a federal tax law on opiates passed and each time they have failed.

Will opiates eventually go down the same path as alcohol, tobacco, gambling… all having some potential for addiction, will become acceptable when the bureaucrats can find a way to put a excise/sin tax on opiates will make them socially acceptable and everyone will turn a blind eye/deft ear to whatever problems that results within our society ?

When is the chronic pain community figure it out that writing letters/emails and making phone calls to your member of Congress only to get – if you get a response  – that may or may not have anything to do with what you contacted your representative about ?  Lobbying Congress is probably not a viable idea, because collectively the lobbying industry spends 9+ million a day to lobby the 535 member of Congress to something that the businesses that hires lobbyists wants to be done.

If anyone notices, when any of the states are unhappy with what the Feds do, they end up filing a lawsuit. It is claimed that typically 40% of Congress is attorneys and the DEA is part of the DOJ – again with wall to wall attorneys.  If/when the CDC published the final document of their 2022 opiate dosing guidelines and many entities see the 50 MME lists dozens of times in the 211 page document and start implementing that as a new “standard of care and best practices” that all prescribers should follow on all chronic pain pts.  What is the community going to do… more letters/emails/phone calls to their member of Congress ?

Einstein defined insanity years ago… doing the same thing over and over and expecting a different outcome….

 

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FB/META: sued for acquiring private/personal medical data from Hospital’s pts’ portal

Posted on August 4, 2022 by Pharmaciststeve

Meta, Hospitals Sued for Sharing Private Medical Info

https://www.medpagetoday.com/special-reports/features/100050

The analytics tool “Meta Pixel” allegedly collected and shared medical conditions to target ads

Meta Platforms (formerly known as Facebook, Inc.), the University of California San Francisco (UCSF) Medical Center, and Dignity Health Medical Foundation are being targeted by a class action lawsuit centered on an anonymous patient whose lawyers allege her private medical information was unlawfully taken from her and used for profit.

The “Defendants’ action constitute an extreme invasion of Plaintiff and Class members’ right to privacy and violate federal and state statutory and common law,” her attorneys wrote in the complaint.

This case is part of a larger issue around data sharing and private medical information that’s become an increasing concern for patients and doctors alike.

The plaintiff, known as Jane Doe in the lawsuit, began receiving emails and seeing targeted ads on Facebook related to her medical conditions after she had scheduled appointments and contacted doctors using UCSF’s and Dignity’s patient portals. What she didn’t know was that they had a piece of software called “Meta Pixel” tucked into their code.

Meta Pixel, as Meta describes it to potential users, is a “snippet of JavaScript code that allows you to track visitor activity on your website.” UCSF Health does note in their website privacy statement that they gather personal medical information about its users for a number of reasons, including to send “product and service information” and to “improve the UCSF Health website user experience,” though the statement also says that the health system won’t share personal information “without your consent other than as required by laws.”

UCSF Health’s policy also acknowledges that they “may” use third parties including “Facebook Pixel” to collect information from the website, noting that “these companies collect information from across the internet and are not controlled or managed by UCSF.”

The only way to opt out of this data collection is to go to Facebook’s website and change the privacy settings.

Moreover, these policies only apply to the consumer-facing website, which is separate from the patient portal, MyChart, where more private data are stored, like health records, test results, and diagnoses. MyChart’s privacy policy states that “the information you provide on this web site is protected by federal laws,” but otherwise directs patients to customer service for more information.

According to the complaint, “when Plaintiff Doe logged into Healthcare Defendants’ patient portal, there was no indication that Meta Pixel was embedded or that it would collect her sensitive medical information.”

Meta has implied that they draw the line at accepting sensitive medical information from those that use their tool — and that this kind of data sharing goes against their own policies.

A Meta spokesperson sent MedPage Today links to its Meta Pixel policies in an email. According to its page on “Restricted Meta Business Tools Data” (Meta Pixel is one of their “business tools”), “advertisers should not share Business Tools Data with Meta that they know or reasonably should know is either from or about children under the age of 13, or includes health or financial information, or other categories of sensitive information.”

They define “sensitive health information” on another page, which includes information on diseases, medical conditions, and injuries — exactly what the lawsuit claims they did indeed access and use to send Doe ads on Facebook.

However, Meta’s policies specify that they can gather personal contact information from these sites and then match it with “Meta user accounts” — meaning whatever information Meta does gather can be used to then find the user’s Facebook account and tailor Facebook ads specifically to that user.

The lawsuit argues that Meta is violating its own policies, which “were not enforced or entirely ineffective.” They quote documents leaked from Meta in 2021 in which a Meta engineer acknowledged that “we do not have adequate level of control and explainability over how our systems use data.”

The ads the patient received after she used the portals to receive test results and diagnoses for her heart and knee conditions were specific enough to be from the patient portal itself: one from “Dr. Livingood” referenced “your heart condition.” Another for the “UpWellness Shop” announced “30-Sec. Joint Pain Trick ‘Greases’ Bone-on-Bone Knee Pain.” Emailed ads crept into her inbox, including one about treatments for cardiovascular disease.

“She has received so many of the targeted emails that she created a new email account separate from the one associated with her Facebook account to avoid the advertisements,” Melissa Nafash, JD, of Labaton Sucharow, one of the firms representing Doe, wrote in an email to MedPage Today. “This is an overwhelming invasion of Plaintiff Doe’s privacy and we look forward to representing her and the putative class in this important case.”

The lawsuit also argues that none of the defendants had a right to collect or use, let alone share, sensitive medical information that’s protected by various California laws and HIPAA, which they say “does not permit the use and disclosure of protected health information to Meta for use in targeted advertising.”

A spokesperson for UCSF told MedPage Today in an email that they can’t comment on pending litigation. Dignity Health Medical Foundation did not respond to requests for comment in time for publication.

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Biden Signs Executive Order: Ensure that healthcare providers follow federal non-discrimination laws

Posted on August 4, 2022 by Pharmaciststeve

Things are getting interesting with the Fed AG office and President Biden and his use of Executive Orders to impose his beliefs on states and trying to override and invalidate the SCOTUS recently ruling on the states have the authority to determine the issues around abortion.  It appear that AG Garland in trying to apply or enforce Biden’s Executive Order concerning the states’ rights to determine what is – or is not – allowed in their state in regards to abortion.

It would appear that the Biden’s EO and AG Garland is attempting to use Federal non-discriminating rules. The video below talks addresses the person experiencing harm for failure of a healthcare professional to provide appropriate care.  The paragraph below is from Biden’s EO. The chronic pain community has documentation that the failure of a prescriber to properly address a pt’s pain – resulting in under/untreated pain, can result in numerous complication of preexisting comorbidity issues and/or causing the pt to have new/additional comorbidity issues.

Could it be extrapolated that the existing CDC 2016 opiate dosing guidelines and the soon to be published 2022 CDC opiate dosing guidelines are violating the pt’s right to appropriate care ?  Could major healthcare corporations ( hospitals, insurance/PBM, chain pharmacies ) imposing some sort of limitation on what their policies and procedures that requires/forces their employees to force reduction and/or impose daily dosing limits.

The chart below elaborates on the health complications on pts because of under/untreated pain and the hyperlink below explains that the MME system has no science nor double blind studies supporting the appropriateness in pain management, especially for those pts suffering from chronic pain.

The Control Substance Act states that NO ONE can prescribe a controlled substances to a pt without doing a in person physical exam and one of the basics of the practice of medicine is the starting/changing/stopping a pt’s therapy.  Could one come to the conclusion that all of these entities are both violating the Controlled Substance Act and practicing medicine without a license.

Should all those chronic pain pts who have their pain meds reduced, limited or stopped, begin to file complaints with the AG Garland’s office, for failure to comply with FED non-discrimination rules ?  While Biden’s EO is primarily dealing with the abortion issue…  his EO talks about providers not complying with non-discrimination rules.

 

https://www.medpagetoday.com/obgyn/abortion/100053

Ensure that healthcare providers follow federal non-discrimination laws:

That could include helping providers who are unsure of their obligations now that the Supreme Court has overturned Roe v. Wade; meeting with providers to explain their obligations as well as the consequences of not complying with non-discrimination rules; and “issuing additional guidance or taking other appropriate action in response to any complaints or reports of non-compliance with federal non-discrimination laws.”

https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154

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Bureaucrats trying to get FDA to remove some/many/all opiates from the market ?

Posted on August 3, 2022 by Pharmaciststeve

Senator Manchin has tried a number of times to get a FEDERAL TAX ON PHARMA OPIATES and each time he has FAILED and WV just reached a settlement with the major drug wholesalers for 400 million dollars https://www.foxbusiness.com/economy/west-virginia-reaches-400-million-settlement-opioid-distributors

It is pathetic how they use the English Language…  they talk about less opiate Rxs and then in the next sentence they talk about DEATHS TIED TO THE MEDICATIONS – they didn’t say “deaths tied to opiate medications” and then they get to the next sentence with the statement that “STUDIES SUGGEST “.   I would bet that a study could be done that would SUGGEST that people that die in motorcycle accidents started out riding bicycles.

Should our government make decision that could affect the lives and quality of life of tens of millions of our citizens based on a study that SUGGESTS a particular outcome.  The CDC, has stated that there is an estimated 15,000/yr deaths from the use/abuse of NSAIDS…  Each year 100,000 die from the use/abuse of the drug alcohol and 450,000 die from the use/abuse of Nicotine and neither of these meds have a valid medicinal use. Maybe because there is a very healthy tax revenue stream attached to those two “drugs”.. is the reason that – as a society – we accept all those deaths ?

Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But deaths tied to the medications remain at 13,000 to 14,000 per year. And studies suggest people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally made fentanyl.

‘We still have a really huge problem’: FDA’s promised ‘sweeping’ opioid review faces skeptics in Congress and among patient advocates

https://www.marketwatch.com/story/we-still-have-a-really-huge-problem-fdas-promised-sweeping-opioid-review-faces-skeptics-in-congress-and-among-patient-advocates-01659135675

Senate Democrat Joe Manchin of West Virginia says he requested an update in April on the FDA’s progress toward policy recommendations but didn’t receive a response

As U.S. opioid deaths mounted in 2016, the then-incoming head of the Food and Drug Administration promised a “sweeping review” of prescription painkillers in hopes of reversing the worst overdose epidemic in American history.

Dr. Robert Califf even personally commissioned a report from the nation’s top medical advisers that recommended reforms, including potentially removing some drugs from the market. But six years later, opioids are claiming more lives than ever, and the FDA has not pulled a single drug from pharmacy shelves since the report’s publication. In fact, the agency continues putting new painkillers on the market — six in the last five years.

Now Califf is back in charge at the FDA, and he faces skepticism from lawmakers, patient advocates and others about his long-promised reckoning for drugs such as OxyContin and Vicodin, which are largely blamed for sparking a two-decade rise in opioid deaths.

“All the concerns that we had at the time on opioids are still there. We still have a really huge problem,” said Richard Bonnie, a University of Virginia public health expert who chaired the committee that wrote the report.

Bonnie and his co-authors say the FDA seems to have incorporated several of their recommendations into recent decisions, including a broader consideration of a drug’s public health risks. But they say there is more to be done.

In an interview with the Associated Press, Califf said a new internal review of opioids has been underway for months and that the public will soon “be hearing a lot more about this.” While the review will look at past FDA decisions, Califf suggested the focus will be on future policy.

“It seems like people love sort of looking back and fault-finding, but I’m much more interested in learning so we can go forward and make the best decisions for what we need to do today,” said Califf, who split his time between Duke University and working for Google after leaving the FDA in 2017 following President Donald Trump’s election.

The 453-page report issued five years ago this month by the National Academies of Sciences laid out a strategy for reducing overprescribing and misuse of opioids, with particular focus on the FDA.

From the archives (June 2017): Opioid addiction diagnoses rose nearly 500% in the last seven years

At the center of the recommendations was a proposal for the FDA to reassess the dozens of opioids being sold to determine whether their overall benefits in treating pain outweigh their risks of addiction and overdose. Those that don’t should be removed from the market, the group said.

The lack of swift action underscores the glacial pace of federal regulation and the legal obstacles to clawing back drugs previously deemed safe and effective.
“It’s really hard for the agency to get a drug taken off the market once it’s been approved,” said Margaret Riley, a University of Virginia food and drug law professor who consulted on the report.

Last year, U.S. overdose deaths soared to a record of 107,000, driven overwhelmingly by fentanyl and other illegal opioids.

‘The question to me is whether the agency will actually have the gumption to use those tools to start pulling drugs.’

— Margaret Riley, University of Virginia

Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But deaths tied to the medications remain at 13,000 to 14,000 per year. And studies suggest people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally made fentanyl.

Dr. Robert Califf gathers his documents at the adjournment of a committee hearing on his nomination as commissioner of the Food and Drug Administration. AP/Manuel Balce Ceneta/File

“If Dr. Califf is serious about addressing the drug epidemic, the FDA should immediately implement” the report’s recommendations, Sen. Joe Manchin of West Virginia said in a statement.

Manchin told the AP that he requested an update in April on the FDA’s progress on the recommendations but didn’t receive a response. He was one of five Democrats from hard-hit opioid states who voted against Califf’s confirmation in February.

In response to questions about the recommendations, the FDA provided a list of actions it has taken on opioids, some which predated the report. The agency said it has acted on “nearly all” of the recommendations, by enhancing prescriber education and labeling, convening meetings and improving data collection.

“I think what you’ve seen is the agency grabbing at some of the low-hanging fruit and only to a certain level,” Riley said.

Despite heightened scrutiny, the FDA continues putting new painkillers on the market. Many of the drugs have formulations designed to make them harder to misuse, such as hard-to-crush coatings that discourage snorting or injecting.

Califf has said the FDA is bound by its regulations: Companies need only show that their drugs work better than a placebo, and the agency can’t require new opioids to be safer or more effective than ones already on the market. He told Senate lawmakers in April that doing so might require legislation from Congress.

One of the report authors disagreed. “I think the FDA has a lot of flexibility at this point to say, ‘Look, given these circumstances we don’t think that a placebo-controlled trial would be adequate,’ ” said Dr. Aaron Kesselheim, a lawyer and professor of medicine at Harvard Medical School.

As for older opioids like OxyContin, Califf says that as the agency gets more evidence on opioids’ risks, it will “aggressively look at relabeling.”

But delays in getting that evidence illustrate just how slowly the FDA process moves. It’s been nearly 10 years since the agency required makers of long-acting opioids to conduct a dozen studies of their drugs’ risks and effectiveness.

The main clinical trial looking at opioids for chronic pain has been delayed since 2019, due to repeated changes to its design. And results from seven other studies released in 2020 don’t give a clear picture of whether the drugs are truly safe and effective for long-term use.

“We’ve got to have the data, and we can’t accept excuses that it’s hard to do,” Califf said. “That’s not going to be acceptable.”

Riley said the data the FDA is seeking will be critical to providing the evidence needed to remove opioids from the market, which would likely face years of industry pushback.

“The question to me is whether the agency will actually have the gumption to use those tools to start pulling drugs,” Riley said. “Do they have the will to do it?”

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