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It would seems that the Federal bureaucracy gets more and more contradictory… a number of years ago our Supreme Court ruled that the 8th Amendment only applies to prisoners

Treatment for opioid addiction often brings discrimination

https://apnews.com/article/covid-business-health-opioids-discrimination-5462560a707d7c27b71ed4773d9ba82c

PHILADELPHIA (AP) — Danielle Russell was in the emergency department at an Arizona hospital last fall, sick with COVID-19, when she made the mistake of answering completely when she was asked what medications she was on.

“I said yes, I was taking methadone,” said Russell, a doctoral student who also was in recovery from heroin use. “The smart thing to do, if I wanted to be treated like a human, would be to say no.”

Even though her primary doctor had sent her to the ER, she said she was discharged swiftly without being treated and given a stack of papers about the hospital’s policies for prescribing pain medications — drugs she was not asking for.

“It becomes so absurd and the stigma against methadone especially is so strong,” she said, noting that other people in recovery have had it worse. “You’re getting blocked out from housing resources, employment.”

It’s a problem people in the addiction recovery community have dealt with for decades: On top of the stigma surrounding addiction, people who are in medical treatment for substance abuse can face additional discrimination — including in medical and legal settings that are supposed to help.

This week, the U.S. Department of Justice published new guidelines aimed at dealing with the problem: They assert that it’s illegal under the Americans with Disabilities Act to discriminate against people because they are using prescribed methadone or other medications to treat opioid use disorder.

The guidelines don’t change federal government policy, but they do offer clarification and signal that authorities are watching for discrimination in a wide range of settings. The Justice Department’s actions this year also show it’s taken an interest in the issue, reaching multiple legal settlements, filing a lawsuit and sending a warning letter alleging other violations.

One of the government’s recent settlements was with a Colorado program that helps house and employ people who are homeless. A potential client filed a complaint claiming she was denied admission because she uses buprenorphine to treat her addiction. As part of the settlement, Ready to Work is paying the woman $7,500. Stan Garnett, a lawyer for the organization, said Thursday that the organization’s staff is being trained to comply with the law.

FILE – In this Nov. 14, 2019, photo, Jon Combes holds his bottle of buprenorphine, a medicine that prevents withdrawal sickness in people trying to stop using opiates, as he prepares to take a dose in a clinic in Olympia, Wash. The U.S. Department of Justice made clear, Tuesday, April 2, 2022, that barring the use of medication treatment for opioid abuse is a violation of federal law. (AP Photo/Ted S. Warren, File)

PHILADELPHIA (AP) — Danielle Russell was in the emergency department at an Arizona hospital last fall, sick with COVID-19, when she made the mistake of answering completely when she was asked what medications she was on.

“I said yes, I was taking methadone,” said Russell, a doctoral student who also was in recovery from heroin use. “The smart thing to do, if I wanted to be treated like a human, would be to say no.”

Even though her primary doctor had sent her to the ER, she said she was discharged swiftly without being treated and given a stack of papers about the hospital’s policies for prescribing pain medications — drugs she was not asking for.

“It becomes so absurd and the stigma against methadone especially is so strong,” she said, noting that other people in recovery have had it worse. “You’re getting blocked out from housing resources, employment.”

It’s a problem people in the addiction recovery community have dealt with for decades: On top of the stigma surrounding addiction, people who are in medical treatment for substance abuse can face additional discrimination — including in medical and legal settings that are supposed to help.

This week, the U.S. Department of Justice published new guidelines aimed at dealing with the problem: They assert that it’s illegal under the Americans with Disabilities Act to discriminate against people because they are using prescribed methadone or other medications to treat opioid use disorder.

The guidelines don’t change federal government policy, but they do offer clarification and signal that authorities are watching for discrimination in a wide range of settings. The Justice Department’s actions this year also show it’s taken an interest in the issue, reaching multiple legal settlements, filing a lawsuit and sending a warning letter alleging other violations.

One of the government’s recent settlements was with a Colorado program that helps house and employ people who are homeless. A potential client filed a complaint claiming she was denied admission because she uses buprenorphine to treat her addiction. As part of the settlement, Ready to Work is paying the woman $7,500. Stan Garnett, a lawyer for the organization, said Thursday that the organization’s staff is being trained to comply with the law.

“It’s terrifying to be told by some authority — whether it’s a judge, or a child welfare official, or a skilled nursing facility — someone who has something you need is telling you you have to get off the medication that is saving your life,” said Sally Friedman, senior vice president of legal advocacy at the Legal Action Center, which uses legal challenges to try to end punitive measures for people with health conditions, including addiction.

Friedman said advocates and lawyers will cite the new guidelines when they’re making discrimination claims.

Dan Haight, president of The LCADA Way, which runs addiction treatment programs in the Cleveland area, said a suburb where they wanted to put a clinic at one point nixed the idea because of a moratorium in place on new drug counseling centers.

“We’re not looked at as another medical facility or counseling office,” Haight said. “We’re looked at because we do addiction.”

The new guidelines suggest that such broad denials could be violations of the ADA.

Overdoses from all opioids, including prescription drugs containing oxycodone, heroin and illicit laboratory-made varieties including fentanyl, have killed more than 500,000 Americans in the last two decades, and the problem has been growing only worse. That has frustrated advocates, treatment providers and public health experts who see the deaths as preventable with treatment.

Even as the crisis has deepened, there have been glimmers of hope. Drugmakers, distribution companies and pharmacy chains have announced settlements since last year to pay government entities about $35 billion over time plus provide drugs to treat addictions and reverse overdoses. Most of the money is required to be used to fight the epidemic.

It’s still to be determined how the money will be deployed, but one priority for many public health experts is expanding access to medication-based treatments, which are seen as essential to helping people recover.

But there’s still a stigma associated with the treatment programs, which use the medication naltrexone or drugs that themselves are opioids, such as methadone and buprenorphine.

Marcus Buchanan used methadone from 2016 through 2018 to help end a decadelong heroin habit. During that time, he was looking for work near his home in Chouteau, Oklahoma — mostly at factories — and could never land one.

“I can nail an interview. It would be the drug-screen process” when he’d explain why the results showed he was using methadone, said Buchanan, who is now an outreach coordinator for an opioid prevention program. “Every job, more than 20 probably, during those two years, was a door shut in the face.”

Dr. Susan Bissett, president of the nonprofit West Virginia Drug Intervention Institute, said people who are in treatment programs often hide it out of fear that they could lose their jobs.

She said she wants to reach out to business leaders and encourage them to hire and retain people who are using the medications.

“The next step is helping employers understand this is a disease instead of a moral failing,” Bissett said. “We don’t think about substance abuse disorder the way we think about diabetes, for example.”

One of the places where medication-assisted treatment is sometimes restricted or banned is in state drug diversion court programs, which are intended to get people help for addiction rather than incarcerate them.

Fewer than half the states have specific language that prohibits judges from excluding people who are taking the medications from participating in diversion programs or requires that they allow its use as part of the programs. That finding is based on an Associated Press review of legislation, administrative court orders and drug court handbooks that guide state drug diversion court programs.

Some states allow individual courts to make their own rules, while others only include language saying people can’t be excluded. Judges in some states still require defendants to taper off the medications and allow the diversion programs to decide whether the medications are appropriate for each person enrolled.

The Center for Court Innovation is trying to steer the drug courts into creating policies and programs that support people taking those medications instead of incentivizing them to stop.

“It can be frustrating, because nobody needs to tell a judge they need to allow someone to take blood pressure medication,” said Sheila McCarthy, a senior program manager for the Center for Court Innovation. “But for some, there is just a disconnect about the real effect these medications have on a person’s daily life.”

Veronica Pacheco has been off methadone for nearly a year after being on it for more than six years to treat an addiction to pain pills.

She said some people in the medical field — a physician, a dentist, a pharmacist — seemed to treat her differently after they learned she was on methadone treatment. They sometimes assume she was going to ask for new prescriptions for pain medications.

“I felt like I had a sign on my forehead saying, ‘I am a methadone person.’ The minute someone has your medical record, everything changes,” said Pacheco, who lives in the Minneapolis suburb of Dayton. “Now that I’ve been off it, I can see the night-and-day difference.”

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Some kids in pain need opioids. For doctors, that means walking a tightrope

https://www.statnews.com/2019/11/04/kids-pain-opioids-pediatricians-tightrope/

As a physician who works in a pediatric emergency department, I see the downsides of trampolines, monkey bars, coffee tables with sharp corners, and even hot soup — all common sources of children’s injuries. No matter what the trauma, many of my patients are in pain. And with all of the publicity around opioids, treating injured children’s pain has become a complicated, and often emotional, issue.

Pain can often be eased with acetaminophen or ibuprofen. But broken bones, burns, and other severe injuries that cause excruciating pain usually require something stronger, like an opioid.

In the era of opioid abuse and the overdose crisis, conversations around using medications such as morphine and fentanyl to control pain can be difficult to have with patients and parents. No one wants to become part of the grim statistics, such the 70,000 Americans dying from drug overdoses in a year or the nearly 9,000 children and adolescents who died from prescription and illicit opioid poisoning in the United States between 1999 and 2016.

Yet untreated or inadequately treated pain can harm children, both immediately and in the long term. It can also affect their development, their reactions to future painful experiences, and may cause post-traumatic stress disorder.

Since pain is a subjective experience, the best way to gauge it is by asking the person experiencing it how he or she feels. That usually works with older children, but doesn’t with infants and young children who can’t verbalize what they are feeling. For them, several behavioral scales can be used to assess and estimate pain.

Opioids work by binding to receptors in the brain that control pain and emotions. Taking opioids many times diminishes the brain’s sensitivity to the drug, making it hard to feel pleasure from anything besides the drug. That can lead to dependence and addiction. Taking a single dose to immediately control severe pain in the emergency room, and then quickly moving on to non-opioid pain control, does not cause dependence. It can temporarily depress breathing, which is why doctors determine the dose based on a child’s weight and carefully monitor his or her breathing.

My colleagues and I must walk a fine line between alleviating a patient’s pain while allaying fears and concerns of parents regarding the side effects and unclear potential for addiction from one or two doses of an opioid.

When I begin treating a child with a severe burn or broken bone, I start gearing up for the conversation about pain control, knowing I might get a response from his or her parents like, “I don’t want my child getting hooked on those drugs,” or, “Are you trying to make my child an addict by giving her those drugs?”

I usually start slowly, and say to parents something like, “It’s great you gave your child ibuprofen or acetaminophen at home, but I think she needs more than that.” Most parents know what opioids are and have opinions about them. I can see worry on their faces the second I mention the word.

Some say, “I trust your judgment.” Others immediately say no. When that happens, I suggest trying more ibuprofen or acetaminophen and seeing if that helps. If it doesn’t, I’ll once again recommend an opioid.

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As a pain specialist, I may have caused more harm by under prescribing opioids+

https://www.statnews.com/2022/04/12/underprescribing-opioids-can-also-cause-harm/

A reporter recently asked me about what harm I may have caused as a pain management physician who prescribes opioids. As I reflected on my last 10 years in this field, my response was that the harms I may have caused were because I underprescribed these drugs, not overprescribed them.

I thought of a 25-year-old patient, I’ll call him John, whose sciatic nerve was crushed in a motor vehicle accident, causing excruciating pain in his leg. We knew this would be a life-long injury, and that he would likely have to live with chronic pain.

We tried everything I could think of — nerve medications, mindfulness techniques, desensitization, rehabilitation techniques, cognitive therapy, nerve blocks, and spinal cord stimulation — except opioids. John continued to suffer immensely from the debilitating pain, and eventually died by suicide.

Did he die because I undertreated his pain due to my own fear of prescribing chronic, potentially high-dose opioids in a young patient? I cannot know, but I worry and fear that this may be true.

In 2016, the Centers for Disease Control and Prevention published prescribing guidelines for opioids. Though intended to encourage best practices in opioid prescribing, these guidelines fueled providers’ fears of opioids and led to many clinicians abandoning patients who relied on opioids for pain relief. Although even pain specialists like me share fears and doubts about what role these medications play in managing chronic pain, so-called legacy patients are not the same as those who have never taken opioids before, as a colleague and I explained in The New England Journal of Medicine.

Despite a precipitous drop in opioid prescribing since the guidelines were published, drug overdose deaths have surpassed 100,000 in the U.S. in 2020-2021. In response to the unintended consequences of its 2016 guidelines for legacy patients with chronic pain, in February 2022 the CDC proposed revised guidelines that are currently open for public comment.

To be sure, there are many ways to manage pain, and opioids should not be the first approach offered. Pain care can include exercise, physical and occupational therapy, mind-body techniques, coping skills, group support, mental health care, surgical treatment, dietary modifications, and other alternative approaches such as acupuncture and chiropractic care.

Opioids do have a place in pain control and can be safely prescribed, even at high doses, by following best practices while monitoring for risks and side effects. There is no one-size-fits-all approach to opioid therapy or pain management. The revised CDC prescribing guidelines provide a framework for these best practices and alternatives to pain care. It is now up to doctors and other prescribers, along with educators of health care students, to advance the concept of a personalized toolbox to improve the quality of life and function of people living with pain.

People with pain need to know that not treating it — especially chronic pain — is bad for the brain. The brain on pain shrinks in volume over time, but this is reversible when pain is treated.

I sometimes wonder if John would still be alive if I had prescribed opioids earlier for him. I’ll never know. But I do know that although opioids are not my first-line treatment in managing chronic pain, pain care is individualized. There is so much more to managing pain than just the drugs I can prescribe. Understandably, we may fear opioids. But doctors and patients must not be afraid of managing pain.

Antje M. Barreveld is a pain medicine physician, medical director of pain management services at Newton-Wellesley Hospital in Newton, Mass., an assistant professor of anesthesiology at Tufts University School of Medicine, and advisor for Lin Health, an online program for mind-body approaches to managing pain. The opinions expressed here are those of the author and do not necessarily reflect those of her institutions.

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This is a little 12 y/o (Jennie) that Bob Sheerin started  advocating for at Vanderbilt Hospital in Nashville… a few months ago, unfortunately she recently died from her Leukemia.  Vanderbilt is one of those DAMN  NON-OPIATE hospital corporation.  After Bob got involved, Jennie started getting some opiates to help her deal with her pain.  Here is a page from her dairy

10-2-2021 Today I met Bob. Finally my mom got one right. He got me medication that actually worked. He’s such a dork and tried making me laugh all day with dorky faces. He even went into the hospital with me and you can tell he’s in a lot of pain. He’s kind and funny and he got the doctor to do everything he said. The way he did it was funny. Mom used to ask and they would say no because it was dangerous. Bob made them believe it was their idea in such a way they thought it was. Doctors aren’t as smart as I thought. Meds are making me feel better and I was invited to Bob’s to play with his daughter. Can’t wait. Bob gave me his daughter Millys text number and she invited me to trick or treat, hope mom lets me go.

Bob is the “front man” when it comes to advocating…  I think that the doctor got a little intimidated that when Bob got a little over his head when the doctor started talking about medication therapy and Bob said that he would have to reach out to APDF’s Pharmacist…  the doc apparently asked  “you have a Pharmacist ?” and Bob replied “we have a doctor also..” So Jennie got her pain med prescription that the doc had been refusing the parents for some time.

Bob posted:  She was thrilled that Steve was on the actual phone telling doc what meds she needed lol it was like a movie star helped her

Bob shared:  her mom made me laugh as she was @Steve Ariens. Biggest fan lol She would read his blog at breakfast and wrote the government over Steve getting kicked off FB lol she messaged me 10 times to make sure he was gonna keep doing them Sweet little thing got no shot to live a full life and even got ripped off because she died in the wrong era … wow I will return with a fu#### vengeance

The really sad thing is that Bob is just now sharing this with me 🙁  I wish Bob would have shared that info with me earlier, I could have done one or more “shout outs” directed to her, might have brightened her day.

She was big into writing poems… and here is one that is undated, but given the tone .. she realized that “the end ” was near

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

The True Story of Morphine Milligram Equivalents (MME)

By Chuck Dinerstein, MD, MBA — March 1, 2022

They are the foundation of the CDC’s 2016 opioid guidelines, resulting in legislation that limits opioid prescribing in 36 states. Morphine milligram equivalents, or MMEs, are used to set arbitrary prescribing limits for opioids by physicians, since many state legislators fail to understand – and translate into policy and law – the ‘16 guidelines. If we had all known the history of MMEs, perhaps we would not have been so eager to embrace them.

Image courtesy of qimono on Pixabay

What exactly is a Morphine Milligram Equivalent (MME)? The CDC defines it as

“The amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength.” [emphasis added]

MMEs are used in pain management. Clinically, to help transition patients from an ineffective treatment choice to a more effective dosage, form, or medication. Researchers have also used MMEs in attempting to standardize data on medications and prescribing habits when using varying datasets.

The Source of MMEs – Not at all what you’d think

The origin of MMEs seems to be shrouded in the mists of history. The earliest reference to comparing one opioid to another was in a 1974 JAMA article treating the acute pain of myocardial infarction, “Meperidine hydrochloride in parenterally administered doses of 75 mg provides effective analgesia of the same duration as does 10 mg of morphine sulfate.” Two months later, that view of equivalence was rebutted as

“… counter to that of standard texts and journals of pharmacology and is not consistent with our own experience. While it is accepted that the meperidine dose equivalent to 10 mg of morphine is 75 to 100 mg, duration of analgesia by meperidine may be as little as 50% that of morphine. …in chronic or sustained pain, such as occurs in malignant invasion of bones or in sickle cell crisis, the difference is readily apparent to the alert physician and nurse. It has been suggested that physicians are undertreating patients in pain.” [emphasis added]

All the hallmarks of today’s concerns were there.

• Clinical experience
• Equianalgesic dosage (the amount to provide the same level and duration of pain relief)
• The distinction between acute and chronic pain
• Undertreatment of patients in pain

The next reference I found was published in 1984, coming from a study of 38 patients receiving opioids for chronic, non-malignant pain at Memorial Sloan Kettering’s pain clinic.

“A 25-year-old man developed severe left calf pain associated with swelling and tenderness. He was admitted to hospital in June 1975, taking approximately 28 morphine equivalent mg/24 h for pain.” [emphasis added]

There was no citation. The authors relied on their expertise or some unreferenced work to draw that equivalence.

A paper in the journal Pain from 1996 begins to unravel the underlying scientific studies performed in 1936.

“The morphine dose equivalents for hydromorphone and other opioids derive from single dose studies, all of which involved intramuscular or oral administration and measured pain reduction as the therapeutic endpoint.”

But the authors settle for an even more unsettling definition, based on a 1975 paper in the journal Anaesthesiology. The use of this paper to define MMEs is nothing short of astounding:

“Subjective responses to nurse-observer questions were used to quantitate analgesia for postoperative pain. Hydromorphone is more potent than commonly believed: approximately 0.9 to 1.2 mg is equianalgesic with 10 mg of morphine, with a similar incidence of side effects.”  [emphasis added]

It is scientifically illiterate to use this subjective casual observation to form the basis of policy. Yet, this paper is used as a reference by the CDC in its 2016 Opioid Prescribing Guide.

The CDC’s MMEs – Lost in Translation

The CDC explanation of their MME conversions references this paper, Defacto Long-term Opioid Therapy for Non-Cancer Pain, so let’s take a brief look at this study.

It looked at opioid use of adults in two healthcare plans, between 1997 to 2005, reflective of their regional demographics. There is exactly one sentence in the paper that you need to pay attention to:

“The conversion factors were based on information from multiple sources. After reviewing published conversion factors, consensus was reached among two physicians with clinical experience in pain management and a pharmacist pharmacoepidemiologist.” [emphasis added]

The basis of the CDC recommendations comes down to two physicians and a pharmacoepidemiologist. Not overwhelmingly “established” science. Let’s leave those subjective MME conversions to the side for a moment and consider the researchers’ quest to identify a “threshold” to long-term opioid therapy.

In their study, the overwhelming majority of patients took them for less than a month; 80% used opioids for less than a week, 14% took opioids, on average, for only a month. Only 5.5% of the patients receiving opioids took them for longer than a year; they became the focus. In searching for even longer-term use, a possible marker of “addiction,” the researchers found that half of those patients continued therapy into the next year – they were those most likely “to continue frequent use of opioids in future years.” [1] They identified a boundary or signal that an individual’s opioid use might be problematic.

“By setting a clear boundary between acute and episodic use on the one hand, and long-term use on the other, it may be possible for physicians and health plans to establish a check point ….”

There is no mention of MMEs. The variation in the amount of MMEs prescribed or taken among that 6% was too variable [2] to be a threshold; not surprising, given the subjective nature of their calculation. The researcher’s boundary line was the duration of prescribing – a year, the point that would identify that half of the 5.5% they felt to be “at risk.” Most importantly, their boundary was a call to reconsider therapy, not a limit on MME.

Other researchers with similar studies sought their bright line defining those at risk. But quietly, the risk changed from a concern over addiction, as a threshold based on length of treatment would suggest, to a concern over the risk of “overdose.” See the difference in the focus of a 2016 review which concluded

“A clear cut-point in opioid dosage to distinguish between overdose cases and controls was not found. However, lowering the recommended dosage threshold below the 100 MME used in many recent guidelines would affect proportionately few patients not at risk for overdose while potentially benefitting many of those at risk for overdose.”

Somewhere along the way, lost in translation, the concern of addiction morphed to concern over overdose. Despite a lack of “a clear cut-point in opioid dosage,” MMEs replaced fuzziness with pseudo-certainty.

If the ambiguity of what a threshold MME means is insufficient, MME suffers from two additional problems: its calculation and what is being measured. Topics we will address another day.

[1] This does not answer the question of whether their chronic pain had been adequately managed or whether some form of “addiction” or misuse was present.

[2] Among that 6%, there was a greater than 2-fold difference in prescribed amounts and a nearly 4-fold difference in amounts consumed.

Have you ever noticed that “they” always state that non-opiates are “very effective” in treating just about any/all pain, but NO ONE has seemed to use the processes that was originally used to develop the MME’s for all opiates… the basics behind the MME system is – in theory – to compare different “pain meds” ..  but .. apparently no one bothered to include non-opiates when making the MME system comparisons.  Motrin was first marketed in 1975 & Naprosyn was first marketed in 1976 and Aspirin & Tylenol has been around “forever”..

Does anyone, other than me, find it strange that NO ONE has bothered to include these “pain meds ” in the MME system, unless “they” know that the MME ratios would be so pathetic that no medical professional would even consider “prescribing” or recommend a pt taking them for pain.  Not to mention the potential liver and kidney damage that these non-opiates can cause.

Tomorrow is the last day to make a comment on the proposed 2022 CDC opiate dosing guidelines. Should everyone be concerned that the “experts” behind the 2016 & 2022 CDC opiate dosing guidelines were based on and around the MME system that those experts knew or should have known that the MME system was based on NOTHING IN SCIENCE nor any double blind clinical studies.

Here is the link to CDC comment page on the proposed 2022 opiate dosing guidelines https://www.regulations.gov/commenton/CDC-2022-0024-0001  all everyone needs to do is copy the hyperlink to the article  https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154 and I suggest that you copy/paste the text of the article as well..  Just request that the CDC rescind/revoke the 2016 guideline and withdrawal the 2022 guidelines…  because both are based on a MME system that has no science and/or double blind clinical studies behind them and in support of them.  You can make comments anonymously !

 

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HHS Secretary Xavier Becerra : Americans are entitled to receive healthcare services

https://www.foxnews.com/politics/biden-hhs-becerra-suggests-support-taxpayer-funded-gender-altering-procedures-children

“Well, Americans are entitled to receive healthcare services. They are entitled to receive any of the case you just mentioned,” Becerra responded.

Later in the exchange, Boebert asked Becerra about a document suggesting removing children from homes is “on the table” if the parents withhold gender-affirming care from their children.

 “Mr. Secretary, do you think that parents who believe in two genders only should have their children removed from them?” Boebert asked?

Becerra responded, “I can respond very quickly. Congresswoman, I believe in supporting and protecting transgender youth. I believe that they, along with their parents and their caregivers, will make the best decisions, and I would really urge that politicians, like you, stay out of their business.”

Last week, the Biden administration released a series of documents encouraging gender-reassignment surgery and hormone treatments for minors.

The Department of Health and Human Services’ Office of Population Affairs released a document titled “Gender Affirming Care and Young People.” The same day, the Substance Abuse and Mental Health Services Administration’s National Child Traumatic Stress Network – another subset of the HHS – released a parallel document titled, “Gender-Affirming Care Is Trauma-Informed Care.”

The HHS documents describe what it calls appropriate treatments for transgender adolescents, including: “‘Top’ surgery – to create male-typical chest shape or enhance breasts;” and “‘Bottom’ surgery – surgery on genitals or reproductive organs, facial feminization or other procedures.”

“Medical and psychosocial gender affirming healthcare practices have been demonstrated to yield lower rates of adverse mental health outcomes, build self-esteem, and improve overall quality of life for transgender and gender diverse youth,” the OPA release states.

The White House released a video to coincide with the new policies featuring President Biden speaking on the issue of transgender children.

HHS did not immediately respond to a request for comment from Fox News Digital.

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A Victory for “Off-Label” Prescription Drug Coverage

https://medicareadvocacy.org/a-victory-for-off-label-prescription-drug-coverage/

On February 11, 2022, the U.S. Court of Appeals for the 11^th Circuit reversed a lower-court decision and found that Medicare must provide coverage for a beneficiary’s off-label use of a medication in Dobson v. Secretary of Health & Human Services, No. 20-11996, 2022 WL 424813 (11^th Cir. Feb. 11, 2022). Florida resident Donald Dobson contacted the Center for Medicare Advocacy because his Medicare Part D plan denied coverage for dronabinol. He could not afford the medication without coverage, but he needed it critically. Since he suffered a spinal cord injury and underwent related surgeries, Mr. Dobson has experienced intractable, severe nausea and vomiting that interfere with his ability to function and other aspects of his health. After standard anti-nausea medications failed to alleviate his symptoms, Mr. Dobson’s physicians prescribed dronabinol (brand name Marinol), which worked immediately.

However, when Mr. Dobson became eligible for Medicare based on his disability, his Part D plan denied coverage of dronabinol. The denial was based on the prescription being “off-label,” meaning it was for a non-FDA approved use. Off-label prescribing is a routine, legal practice, frequently used when medications are needed to treat less-common conditions. But Medicare Part D requires more than a doctor’s prescription for off-label coverage. The program allows for coverage only if there is “support” for a particular off-label use in one of the “drug compendia” specified by Medicare law. The drug compendia are essentially reference books that summarize information on prescription medications, including chemical ingredients, potential side effects, clinical studies, and different uses for the drugs. (The compendia are also commercial publications, available only to paid subscribers, so it can be very difficult for Medicare beneficiaries to access the information they need to argue for off-label coverage of needed medications.)

Medicare agreed that dronabinol was medically necessary for Mr. Dobson. There is also a compendium entry indicating dronabinol’s off-label use for intractable nausea and vomiting that is disease-related – his very condition. Yet Medicare denied coverage on the grounds that his use was not “supported by” that compendium entry because Mr. Dobson did not share exactly the same underlying diagnosis as the patient described in the entry’s cited case study.

Conducting a thorough analysis of the Medicare Part D statute, the 11^th Circuit decided that Congress’s intent was clear. For an off-label use to be “supported by” a compendium citation, the citation “must tend to show or help prove the efficacy and safety of the prescribed medication.” Furthermore, “[n]othing about the common meaning of ‘support’ means that a compendium citation must hyperspecifically identify a prescribed off-label use to tend to show or help prove its efficacy and safety.” Using this commonsense meaning of the word “support,” the court concluded that the listing in question requires Medicare to cover Mr. Dobson’s off-label use of dronabinol.

The Center for Medicare Advocacy plans to issue additional material with further details and practice tips for advocates in light of the decision, assuming it stands. The Center is grateful to co-counsel Florida Health Justice Project and Akin Gump Strauss Hauer & Feld.

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Pushed to Their Limits, 1 in 5 Physicians Intends to Leave Practice

https://jamanetwork.com/journals/jama/fullarticle/2790791

On the same day in March 2020 that President Donald Trump declared the COVID-19 pandemic a national emergency, researchers at the Larry A. Green Center in Virginia launched an ongoing survey of COVID-19’s effects on primary care practices. Over the past 2 years, more than 36 000 survey responses from clinicians across the country have painted an alarming picture of a workforce that’s increasingly burned out, traumatized, anxious, and depressed. As Green Center codirector Rebecca S. Etz, PhD, summed up her survey’s findings in a recent interview with JAMA, “It’s been bad for primary care over the pandemic and it’s getting worse.”

iStock.com/Armand Burger

Another national health care worker survey, the Coping With COVID study, found that burnout approached 50% in 2020 among 9266 physicians across medical disciplines. Last year’s survey results, which haven’t been published yet, are more dire still, according to study coauthor Mark Linzer, MD, a professor of medicine at the University of Minnesota whose research focuses on burnout. His takeaway: burnout has increased considerably as the pandemic has dragged on.

“It has been a very, very trying 2 years for the clinician workforce, and the health care workforce in general,” Linzer said in an interview. “Particularly over the last 6 months, I think people have really just needed to process what they’ve been through and have time to recuperate. But there really has not been time, given all the pent-up demand for care and the continuing pandemic and the Omicron surge.”

Meanwhile, Lotte Dyrbye, MD, MHPE, chief well-being officer for the University of Colorado School of Medicine, said that some physicians have had the opposite experience during the pandemic—too little work. “An important thing to realize is that how the pandemic has affected physicians is incredibly heterogeneous,” she said in an interview.

Many medical specialties saw the workload decrease in the pandemic’s first year and even during subsequent surges, when demand for non–COVID-19–related visits and elective procedures evaporated. Some practices watched their business and finances dry up.

Experts warn that the COVID-19 pandemic, now entering its third year, has pushed an already fragile workforce to the brink. For many clinicians the workplace challenges—ranging from high stress and burnout to understaffing and reduced income, often in combination—have become insurmountable.

Worsening staffing issues are now the biggest stressor for clinicians. Health care worker shortages, especially in rural and otherwise underserved areas of the country, have reached critical and unsustainable levels, according to the National Institute for Occupational Safety and Health (NIOSH).

“The evidence shows that health workers have been leaving the workforce at an alarming rate over the past 2 years,” Thomas R. Cunningham, PhD, a senior behavioral scientist at NIOSH, wrote in a statement emailed to JAMA.

In the absence of national data, Etz says the Green Center data point to a meaningful reduction in the primary care workforce during the pandemic. In the February 2022 survey, 62% of 847 clinicians had personal knowledge of other primary care clinicians who retired early or quit during the pandemic and 29% knew of practices that had closed up shop. That’s on top of a preexisting shortage of general and family medicine physicians. “I think we have a platform that is collapsed, and we haven’t recognized it yet,” Etz said.

In fact, surveys indicate that a “great clinician resignation” lies ahead. A quarter of clinicians said they planned to leave primary care within 3 years in Etz’s February survey. The Coping With COVID study predicts a more widespread clinician exodus: in the pandemic’s first year, 23.8% of the more than 9000 physicians from various disciplines in the study and 40% of 2301 nurses planned to exit their practice in the next 2 years. (The Coping With COVID study was funded by the American Medical Association, the publisher of JAMA.)

A lesson that’s been underscored during the pandemic is that physician wellness has a lot to do with other health workers’ satisfaction. “The ‘great resignation’ is affecting a lot of our staff, who don’t feel necessarily cared for by their organizations,” Linzer said. “The staff are leaving, which leaves the physicians to do more nonphysician work. So really, in order to solve this, we need to pay attention to all of our health care workers.”

Nurses who said they intended to leave their positions within 6 months cited 3 main drivers in an American Nurses Foundation survey: work negatively affecting their health and well-being, insufficient staffing, and a lack of employer support during the pandemic.

“Health care is a team sport,” L. Casey Chosewood, MD, MPH, director of the NIOSH Office for Total Worker Health, wrote in the agency’s emailed statement. “When nurses and other support personnel are under tremendous strain or not able to perform at optimal levels, or when staffing is inadequate, the impact flows both upstream to physicians who then face a heavier workload and loss of efficiency, and downstream impacting patient care and treatment outcomes.”

The pandemic began to take its toll on primary care clinicians early on, says Etz, who is a professor in the department of family medicine and population health at Virginia Commonwealth University. Although primary care offices typically handle the vast majority of respiratory infections in the community, they weren’t prioritized for personal protective equipment (PPE) and other crucial supplies when COVID-19 struck. “Our survey showed, going as far as 6 months into the pandemic, half the [clinicians] still didn’t have PPE,” Etz said. “People were wearing coffee filters and garbage bags to take care of their patients.”

The Green Center survey showed that primary care clinicians’ stress levels improved last summer as vaccines became widely available in the US, but the Delta variant surge reversed this. Since then, physician mental and physical exhaustion has returned to prevaccine levels.

As of this February, only about a fifth of Green Center survey respondents were fully staffed, and 44% had open clinician positions they could not fill. Still, 40% of respondents said they had taken on an influx of new patients whose previous practices closed. The pandemic also required primary care practices to provide new or expanded services—telehealth, home monitoring of patients with COVID-19, and more mental health care, to name a few.

They’ve done all this with limited resources. Throughout the public health crisis, primary care physician practices have struggled with low reimbursement for telehealth and long-overdue payments from insurers, Etz says. Applying for aid, such as Paycheck Protection Program (PPP) or Small Business Association (SBA) loans, was onerous and itself often costly. “The primary care practices that I know that were able to get money from PPP and the SBA loans that were available had to hire accountants to help them figure out how to do it,” Etz said. Unpublished data from various states and task forces suggest that less than 5% of health care sector financial assistance may have gone to primary care, she noted.Trying to do more for patients while dealing with shrinking staff and resources—all during an unprecedented infectious disease crisis—has left some clinicians traumatized. “In our qualitative comments,” Etz said of the Green Survey, “we still get people sharing suicidal ideation. Talking about panic attacks in their sleep and pulling over on their way to work to puke because they’re under so much stress.” Recent survey responses reflect the ongoing distress:

“I cannot continue to work at this pace and retire at 65. I am 50. I am chronically exhausted. There is no relief in sight.”

“I’m burned out. The patients have so much anxiety and it has affected me. I see 21 patients daily for relatively low pay. I’m on my way out of this position—I can’t remain healthy and stay here.”

“I am emotionally traumatized and experiencing severe burnout. I would quit if I was able.”

“I had planned to work for at least 10 more years, now I’m thinking about ways to retire as soon as possible.”

“I have been in practice for over 30 years and have never felt so emotionally and physically drained as I have this year. I have given up trying to correct COVID misinformation and this is so very discouraging.”

“I’ve exited practice. Pray I don’t ever need to go back. It’s miserable with no positive indicators for improvement.”

Etz, who trained as a cultural anthropologist, sees a troubling pattern in the responses: lack of hope. Hopelessness was also apparent in a mid-2021 survey by the nonprofit Physicians Foundation. About 20% of 2504 physicians said they knew a physician who had either considered, attempted, or died by suicide during the COVID-19 pandemic.

Today, frontline clinicians are experiencing high rates of depression, anxiety, sleep disturbance, and posttraumatic stress disorder, according to Dyrbye, who is a member of the National Academies of Medicine’s Clinician Well-being Collaborative. “Many of them are running on the very last steam,” she said. She noted that compassion fatigue, a result of high levels of work stress, has also set in for some: “They’re getting tired of taking care of patients who are incredibly sick and aren’t vaccinated.”

“There’s clearly still widespread burnout, fatigue, and frustration not only related to the earlier phases of the pandemic, but also the aftermath related to shortage of staffing,” Lou Baptista, MD, MPH, executive vice chair of the department of psychiatry at Columbia University Medical Center (CUMC), said in an interview.

As a result, some physicians are cutting their clinical hours for the first time or jumping ship to different institutions where they feel they’ll be better cared for. Baptista says that many mental health professionals at CUMC are leaving for private practice, where they can work fewer days, make more money, and practice telemedicine from the comfort of their own home.

An important mitigator of health care burnout and intention to leave, it turns out, is feeling valued by one’s organization, which Linzer says requires more from employers than simply expressing the sentiment. Dyrbye says health care organizations must undertake systemic steps to improve the work environment. That means finding ways to reduce workload, improve work efficiency, maximize teamwork, and promote a culture of wellness.

Linzer, who directs the Hennepin Healthcare Institute for Professional Worklife, offered a workload solution: if resources allow, float physicians can be hired for periodic coverage, or locum tenens clinicians could be brought in to cover shifts during critical times. “I’m hoping that our health system has learned that as we go through these crises, not unlike in the military, one needs to plan how many times you deploy someone, how long you deploy them for, when you give them a rest to put somebody else in place,” he said.

Early in the pandemic, when time off wasn’t a reality for New York City’s frontline health workers, Baptista helped organize a group of CUMC psychologists and psychiatrists who began volunteering their services to other clinicians in the health system. The program, called CopeColumbia, offered 30-minute peer-to-peer telehealth support sessions, small group sessions customized for different clinical departments, and larger webinars and town halls devoted to topics like stress, trauma, and grief.

“Our thinking was, can we create these brief spaces of just half an hour to give them support,” said Baptista, who last year was named chief well-being officer at ColumbiaDoctors. About a third of the early peer-to-peer sessions led to referrals for clinical care. Over the past 24 months, CopeColumbia has expanded to become the main platform that provides well-being resources and peer support to all medical center employees, not just clinicians.

Last year, NIOSH launched a campaign to address health worker stress, burnout, depression, anxiety, substance use disorders, and suicidal behavior—long-standing problems exacerbated by the pandemic. A goal of the Health Worker Mental Health Initiative is system-wide, organizational-level improvements. The program’s research, funded by the American Rescue Plan Act, could help inform fundamental changes to health care worker shifts, workloads, benefits, time off, and more.

NIOSH’s Chosewood acknowledged the challenge ahead: “The design of work in healthcare needs an overhaul,” he wrote. “Ideally, health worker jobs are so well-designed that doctors, nurses and technicians go home at the end of a fulfilling work day even healthier than when they arrived. I don’t think that’s a pipe dream.”

Linzer agrees that changes are overdue to reduce burnout. “I think there’s a lot of ways that things could be done differently—a lot of work that could be done by others, that would give a chance for physicians to grieve, debrief, heal, and then continue again,” he said. “But the idea of just rushing to start again is, I think, not going to work.”

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