Law Firm Wants Transparency in Medicare Opioid Policy

www.painnewsnetwork.org/stories/2017/5/24/legal-group-calls-for-transparency-in-medicare-opioid-policy#

CMS wants to set a daily ceiling on opioid pain medication at 90mg morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers would be expected to impose a “soft edit” that would automatically block the prescription from being filled until the edit is overridden by a pharmacist. Pharmacies would have to check with the prescribing physician to make sure the higher dose is warranted.

Meanwhile, the new commissioner of the Food and Drug Administration is calling on the agency to “take whatever steps we can” to ensure that opioids are only prescribed under “appropriate clinical circumstances.”

In a blog post on the FDA website, Scott Gottlieb, MD, announced the formation of an Opioid Policy Steering Committee to develop additional tools and strategies the FDA can use to prevent opioid abuse.

“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” he wrote.

Gottlieb wants the committee to focus on three areas:

scott gottlieb, MD

One needs to read the warnings in some of  these conversion programs… that by and large.. they are AT BEST… FUZZY MATH… unless you are talking about Methadone conversions… then they are FUZZIER MATH.  Any healthcare professional that believes that opiate conversions are BLACK & WHITE… is – IMO – a healthcare professional that should not be trusted in dosing opiates.
And these tables don’t even consider the CYP450 enzyme system .. which can cause a person to metabolize opiates fast/slower that “normal”.. it is estimated that 20%-30% of pts are fast/ultra fast opiate metabolizers.. They also ignore pts with GI issues that will affect absorption.. like IBS with/without diarrhea, short gut, crohn’s disease and others issues.
IMO, this is just another example of our healthcare system moving toward treating pts/disease(s) by a simple check lists and/or “cookie cutter methodology”.. which means that those pts that are at 10%-20% at each end of the “bell curve” will end up getting medically “screwed” by the system.  Remember, nearly all health insurance companies are publicly held FOR PROFIT companies…  their primary interest is to the stock market and their stock holders.  Policy holders are just a means to generate revenue and if they can place obstacles – prior authorization, declaring treatment is experimental, first fail step therapy and other tactics to “deny care that should be covered”. Pts need to be made aware that everything denied by a insurance companies can be APPEALED and the majority of pts that go thru their entire appeal process will get their treatment approved. They don’t have to tell you about their appeal process, unless you ask, then they have to provide their appeal process is some form of printed format – could be a website.

http://clincalc.com/opioids/

    Single-dose studies: Early studies determining equianalgesia were based on single doses, not chronic administation.8 Due to drug accumulation, half-life, tolerance, and active metabolites, subsequent chronic administration studies often vary greatly from the original single-dose data.
    Bidirectional conversions: When converting between certain opioids, the direction of conversion (eg, morphine to hydromorphone versus hydromorphone to morphine) will produce a different conversion ratio. These bidirectional differences are not captured in a traditional equianalgesic table.5,7
    Dose-dependent conversions: The conversion ratio of certain opioids can be dependent on the dose of the original opioid. In the case of converting morphine to methadone, methadone has a relative potency of 4:1 at lower morphine doses, but becomes much more potent (12:1) in patients converting from very high morphine doses.5,7
    Cross-tolerance: Many references recommend a cross-tolerance reduction between 25-50% when converting between unlike opioids.9 In patients with very high opioid requirements, the difference between 25% and 50% can be a very significant discrepancy.
    Equianalgesic Discrepancies: There are significant discrepancies in equianalgesic dosing tables, with even FDA-approved drug labels not demonstrating agreement.10 These discrepancies are a factor of both references using old data (single-dose studies) and an overall paucity of data in chronic dosing studies.
    Patient-specific factors: No equianalgesic table is able to take into account patient-specific factors — primarily hepatic function, renal function, and age. Opioid metabolism and excretion do differ among the opioids; therefore, alterations in drug disposition will alter the relative potencies of different opioids.

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On May 24th I received the following email

To which I made this post on my blog:

 Dr. IBSEN – WINS COURT BATTLE – Dismissal With Prejudice

Order Dismissing Charge – Ibsen

Dismissal With Prejudice: When a lawsuit is dismissed with prejudice, the court is saying that it has made a final determination on the merits of the case, and that the plaintiff is therefore forbidden from filing another lawsuit based on the same grounds.

Yesterday afternoon I received this email:

to me, mark

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Opioid epidemic: Can it be stopped at the source?

http://www.wfmj.com/story/35506202/heroin-epidemic-can-it-be-stopped-at-the-source

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DEA misled Congress about Honduras shootings

https://www.msn.com/en-us/news/us/dea-misled-congress-about-honduras-shootings/ar-BBBuIi2

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The ACLU is concerned that the repeal of Obamacare will cause millions to go without healthcare, but try to get the ACLU to express any concern about the untold millions that are being denied pain management and mental health care because of the CDC guidelines, the DEA regulations, many of the state legislatures have decided to “practice medicine without a license” and without any medical knowledge/background and many healthcare corporations and insurance companies that have instituted some sort of opiate dosing limitations… without regard of the real medical need of the pt.

Healthcare is quickly become a “by the numbers” process.. “cookie cutter medicine”… and those who hold the pocket book strings… tend to believe that they can dictate the type or limit of healthcare that a person can receive.

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Why Some Hospitals Are Allowing Unnecessary Suffering

http://www.alternet.org/story/85637/why_some_hospitals_are_allowing_unnecessary_suffering

“His heart filled virtually his whole chest,” recalls Dr. Diane Meier describing her very first patient, an 89-year-old suffering from end-stage congestive heart failure. 

It was the first day of Meier’s internship at a hospital in Portland Oregon, and after being assigned 23 patients, she was suddenly told that one of her patients, who had been in the Intensive Care Unit for months, was “coding.” She raced to the ICU where the resident told her to put in a “central line.”

“I didn’t know how,” Meier admits.  “I felt overwhelmed and inadequate. Then, the patient died …

“Everyone just walked out of the room,” she remembers.  I stood there. I still sometimes flash back on that scene: the patient, naked, lying on the table, strips of paper everywhere, the room empty. This was my patient. I felt I was supposed to do something — but I didn’t know what.”

Meier left the room and, in the hallway, saw the patient’s wife. “I walked right past her,” she recalls, nearly shuddering at her own cowardice.  I didn’t know what to say. I didn’t even say ‘I’m sorry.’ As a physician, I didn’t think that I was supposed to do that. “

I heard Dr. Diane Meier tell this story at a conference for medical students at  Manhattan’s Mt. Sinai School of Medicine last week. When she finished, she asked her audience, “What is the hidden curriculum here? What does this story tell you?’

“Once the patient dies, he no longer matters,” said one student.

“If we can’t save the patient, the patient doesn’t matter,” added another.

Meier drew a third lesson: “Before he died, this patient had spent two months in the ICU. We had done everything possible to prolong the dying process.”  As a doctor, you have to step back and say, ‘What is this experience telling me, and is this right?'”

As a palliative care specialist, Meier spends much of her time with dying patients.  For many, “palliative care” offers a middle road between pulling out all the stops and simply giving up hope. Like traditional “hospice” care, palliative care focuses on “comfort” rather than “cure,” emphasizing pain management and easing the emotional trauma of facing death, both for the patient and for the family.  But palliative care also includes procedures aimed at treating the symptoms of the disease.

In the past, Meier explains, physicians have seen caring for a terminally ill patient as an “either/or” situation: “Either we are doing everything possible to try to prolong your life — or when there is ‘nothing more that we can do,’ only then do we make the switch to providing comfort measures. This dichotomous notion — that you can do one thing alone and then the other thing alone later — has nothing to do with the reality of what patients and their families go through.”

In her talk last week, Meier explained that her first patient was one of three who marked turning points on her life as a physician. Originally, she trained to become a geriatrician, a doctor who cares for people over 65.  “I think because I was very close to my grandfather,” she explained, “and because I’m a ‘lumper’ not a ‘splitter’,” she added, referring to the distinction between doctors who prefer to treat the whole patient, head to toe, and those who prefer to specialize in a body part: the foot, for example, or the eye.’

Her interest in treating the elderly brought her to Mt. Sinai, which, at the time, had the only Department of Geriatrics in the country.  But as her career unfolded, she found herself “become more and more alienated from medicine. Here, in the hospital, everyone was running around, ostensibly trying to help the patient, but actually often hurting the patient. I thought about quitting. I had a fantasy of opening a bakery/book shop where I could read and eat brownies …” she told the med students.

“Then I met a patient I will call Mr. Santanaya.”

Meier first encountered Santanaya when she was walking down a hospital hallway and  heard a man screaming and moaning in pain. She looked into his room and there he was, pinioned to his bed, hand and foot, in “four-point restraint.”

“I went to the nurse and asked, ‘Why is this man in a four-point restraint?”  The nurse called for the intern.

“I’ll never forget this kid’s face,” Meier recalled “To me, he looked about twelve years old. And terrified.

Meier asked the question again,  and the intern explained: “He has lung cancer that spread to his brain and he’s delirious. We put a feeding tube up into his nose and down to his stomach, and he pulled it out. So we tied his hands. Then he pulled it out with his knees and feet — so we tied his knees and feet.”

“The feeding tube is very uncomfortable,” Meier told the students. “It makes the nose and esophagus raw. I asked the intern, ‘Why do we have to do this?'”

“He looked at me with tremendous distress in his eyes: ‘Because if we don’t, he’ll die.”

“I realized he didn’t know any better,” said Meier.  “Neither did the resident or the attending physician. I realized that this was an educational problem.

“They cared about the patient. This wasn’t callousness or indifference or venality.  They just didn’t know when too much is too little.” So Mr. Santayana spent 33 days tied hand and foot to his bed before he died. He spoke no English, but during that time, he kept screaming “Ayudeme! Ayudeme!” (Help Me! Help Me!)

Why didn’t Mr. Santayana’s physician intervene to do something to help him? “He didn’t have a primary care physician because he was on Medicaid,” Meier explained. So it was left to the hospital staff, and not knowing what else to do, they simply followed procedure.

“This was the early 1990s, and that is when I decided to shift my career to try to make up for what happened to Mr. Santayana,” said Meier.  Then she got lucky.

Dr. Robert Butler, founder of gerontology at Mount Sinai, and  a friend of George Soros, urged her to apply for funding from Soros’s newly formed Project on Death in America. Meier and three colleagues won the funding and in 1995, with help from Soros and the United Hospital Fund, launched the Hertzberg Palliative Care Institute at Mount Sinai School of Medicine. The Robert Wood Johnson Foundation also invested in developing content.  In 1999 Meier and Dr. Christine Cassel founded the Center to Advance Palliative Care (CAPC) .  As a result of CAPC’s program, by 2005, the number of hospital-based palliative care programs in the U.S. had roughly doubled to 1,240, and some 3,100 health care professionals had been taught CAPC’s methods and ethics.

The third patient who Meier told the students about last week  is a 24-year-old who she called “Kate.” Kate had just graduated from college and had worked and saved enough money to go to Australia. There she developed the worst headache of her life. “She called her mother from Sydney and her mother came to get her,” Meier told her audience. “In retrospect, she might have been better off if she had stayed in Australia.”

The problem was that Kate had no health insurance.  She was only 24 and she thought she didn’t need insurance.

Her mother brought her directly from the airport to Mt. Sinai, “where she was admitted directly to the oncology service, not to a doctor,” Meier explains. Like Mr. Santayana, she would be on Medicaid and so wouldn’t have her own doctor. Kate was diagnosed with leukemia.

“I met Kate on day 7 when a consult called me to say that they had a manipulative drug-seeking patient with acute myeloid leukemia,” Meier recalled. “By then, Kate had earned the contempt and hostility of the house staff because she was constantly screaming for pain-killers.

“It turned out that no one knew the half-life of the opiate they were giving her — not the attending physician, not the resident, not the intern.”

Meier then turned to her audience, made up largely of second-year medical students. “Does anyone here know the half-life,” she asked, naming the pain-killer.

No one did. (The half-life of a pain-killer tells you how long it will be before it wears off.)

“What they were giving her provided relief for only 90 minutes,” said Meier, “and they were giving it to her every six hours.”  After 90 minutes , Kate would begin ringing for nurse. Then, after a half hour, when no one came, she would begin ringing more and more frantically, and finally begin screaming. “Between four and six hours, she would just be screaming,” said Meier.

This had been going on for seven days.  “The pain specialists wouldn’t see her because she had no insurance.”

“I doubled the dose and ordered that it be given to Kate every three hours, around the clock,” said Meyer. “And before long, she was transformed into the sweet, charming intelligent person she always had been.”

“Kate had become the victim of iatrogenic pseudo-addiction,” Meier added. She wasn’t an addict, but she was behaving like an addict and seemed like an addict — a pseudo-addiction created by her doctors, which makes it an “iatrogenic disease,” an illness caused, inadvertently, by medical care. 

Why hadn’t her mother tried to persuade the doctors to give her more pain-killers? “Kate was the middle child in an Irish family of seven kids and one of her brothers had become addicted to drugs. As a result, the mother was terrified of opiates,”  said Meier. “The palliative care team had to spend time with the parent, explaining that pain kills.

The only possible hope for Kate was a bone marrow transplant. Because she was on Medicaid, this would be very hard to get. “It took six weeks of begging to get someone to take her,” Meier recalled. “And then the transplant failed.

“While she was dying, Kate told us that the worst part of the experience had been those first six days when she was labeled a ‘manipulative drug addict.’ She was marginalized because her doctors did not know how to administer the opiates.

“Untreated pain is a medical emergency,” Meier told the students. “The reason no one here knew the half-life of that opiate is because learning about pain-killers is not a priority in medical curriculums.” In fairness, this is the sort of thing that doctors on the ward often look up. But in this case, no one even tried to look it up.

“The relief of suffering is a fundamental part of medicine,” Meier concluded. “In this country there is a tremendous amount of stigma associated with opiates. When you are caring for patients, and you leave an order for the  nurse to administer the pain-killers, remember, there’s a real chance that she’ll think, ‘This is dangerous. I don’t want something bad to happen on my shift.  Okay, I’ll give it to you — but I won’t give you enough.’

“This is why pain is so poorly managed in this country.”

In Italy, by contrast, a patient dying of cancer is often sent home, with morphine, to die in his own bed. His wife administers the morphine and she is given enough to keep him as much as he wants — when he wants it.   In the U.K., where hospice care was invented in the 1960s, there are many more palliative care specialists than in the U.S. 

Here, medicine is all about “cure,” not about “care.” “Defeating death at any cost: that is the priority,” Meier told me. “It comes ahead of reducing suffering or considering the quality of the patient’s life. If you look at NIH funding,” she pointed out, “you see that this is where the money goes — to cure cancer, to prevent all heart disease and stroke.”

This is not to say that Meier favors cutting back on end-of-life care because it is so expensive and so much money is “squandered” during the final year of a patient’s life. “The problem is, of course, that we don’t know who is in their last year — or their final three months,” Meier observed.  “The fact that we spend so much on these patients in their final months of life is not necessarily a bad thing,” she added. “These are the sickest people in the hospital, who need the most care. We shouldn’t say: ‘We’re wasting money on the dying.’ But,” she added , “we should be asking, ‘Is this the best care? Is it appropriate care?”

Clearly, we need more palliative care specialists like Meier. But this is another case where we don’t pay enough for “thinking medicine” — which involves talking to and listening to the patient — rather than cutting him or radiating him.

“When a three-person palliative care team made up of a doctor, a nurse and a psychologist spends 90 minutes in a meeting with a family, Medicare would probably pay $130 to $140 — for all three people,” Meier told me. “And Medicare is one of the better payers. This explains why Meier earns $100 for every several thousand dollars that her husband, an invasive cardiologist, takes home. “Though,” Meier said mildly, “it would be hard to say that one of us is practicing more sophisticated medicine.”

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The Deepening Opioid Crisis Among Native Americans

thecrimereport.org/2017/05/24/the-deepening-opioid-crisis-among-native-americans/

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VA hospital in Marion abruptly cutting opiate prescriptions

fox59.com/2017/05/23/fox59-investigates-va-hospital-in-marion-abruptly-cutting-opiate-prescriptions/

VIDEO ON LINK

MARION, Ind. – A VA hospital once investigated for giving out too many opioids, is now cracking down hard on opiate prescriptions.

But are they going too far?

According to a number of veterans, the answer is yes. They say their opiate prescriptions were cut off, with no warning and no communication from doctors. Many of them rely on the Marion VA.

Three, who agreed to be identified on camera—Josh Keller, Rae Ann Panther and John Nelson—call the VA’s response to the opioid abuse epidemic “irresponsible” and “dangerous.”

“They’re treating us like we’re addicts, selling our prescriptions on the street,” said Nelson.

Nelson, along with the three others, acknowledges that some of their fellow veterans are addicts and may be selling their opiate prescriptions or otherwise abusing them. Their concern is that providers are now assuming everyone is an addict and treating them poorly because of that.

“None of us wants the drugs for the high,” said Panther. “We just want to live again.”

All three were left to struggle with pain and some even withdrawal symptoms, after they say their daily doses of Oxycontin, Lortab and Tramadol were suddenly cut off.

“I called back several times and finally got a nurse to say, ‘They’re not giving you any of your medication. I am extremely sorry,’” said Keller as he recounted the day he found out his prescription would not be refilled.  “And she was very upset on the line and it sounded like she was in tears. She said, ‘They’ve done it to not just you, but everybody. They’ve done this to everybody.’”

Panther had a similar experience. As a former nurse herself, she says the most unnerving part was not getting any prior communication from her doctor.

“They never contacted me to say, ‘Hey, we’re thinking about doing something, what’s your idea?’” recalled Rae Ann. “No plan of action. Cut you off, never talk with you about it.”

They say the cutoffs came just a day or two before their prescriptions ran out. They say they received no help tapering off the heavy-duty narcotics and no relief for chronic back and knee pain they spent years trying to leave behind.

For Nelson, who’s self-employed, that meant sometimes not being able to work and falling behind. For Keller, it meant using his vacation days because he was in too much pain to even get out of bed.

“I have to weigh my options,” said Keller. “Am I going to be sick? Can I call in sick today or is it going to be worse tomorrow?”

For Rae Ann, whose husband had to quit his job to care for her due to numerous illnesses years ago, the pain made her bad situation much worse.

“There’s no quality of life for people like us!” exclaimed Panther. “When they say, your pain level from 1-10. Dear God, what’s a one? We live, probably at a 4.”

They claim the doctors not only brushed off their concerns at being so abruptly cut off, but were quick to point the finger at one person, Dr. Lori Drumm, they say is making the decisions.

Dr. Drumm is not these vets’ primary physician. In fact, they say she never treated them at all.

Drumm wouldn’t speak on camera with FOX59, but her boss, Chief of Staff, Dr. Wayne McBride did.

“Dr. Drumm is a very experienced primary care provider and she is our service chief for the primary care service line,” said McBride.

He says part of Drumm’s job is to make sure providers are aligning their care with the national VA Opioid Safety Initiative. She’s also responsible for recommending changes to prescriptions.

There are two main reasons Drumm might suggest a change.

Sometimes, Dr. McBride says she might be looking through records and find that a veteran has violated what is known as a “pain contract” by taking opiates improperly. A veterans’ urinalysis that comes back negative when they’re supposed to be on an opiate might indicate they’re diverting their drugs and giving or selling them to someone else.

Dr. Drumm can also recommend changes when she believes the prescribed dose is too high.

“There have been times, I believe, when some of the providers and physicians have sought her assistance and she has then indicated to them, a certain course of action,” said Dr. McBride.

When asked why veterans are hearing these recommendations or orders from Dr. Drumm and not their own provider, McBride sympathized with the vets.

“I’m concerned, when the veteran has not received the communication from the assigned provider and Dr. Drumm is scripting this care or making those determinations,” said Dr. McBride.

With Panther’s permission, we showed Dr. McBride two My HealthyVet messages from the two times doctors said they were taking her Tramadol away.

In June of last year, a nurse tells Panther, “Dr. Drumm is not going to order additional opiates” and “Dr. Drumm is concerned about unintentional overdose.”

Panther replies, stating she’s “never been seen by Dr. Drumm.”

At the time, Dr. Drumm was covering for Panthers’ normal provider who was out on leave. But still, McBride says that doesn’t absolve her of all responsibility for what he considers proper communication with a patient.

“In this particular case, she was covering for another provider, but as I’ve acknowledged, I think it could’ve been handled better,” said McBride.

After Panther gets a nurse to help intervene, her prescription is renewed. But then in October, her nurse practitioner tries to cut her off this time.

Dr. McBride read where Panther relays to a nurse that she was told by a third party that her nurse practitioner would not refill her script.

That is not the way McBride wants these conversations to happen.

“It’s disturbing that she wouldn’t say, ‘Come in let`s talk about this,’” said Dr. McBride. “I don’t think you need this, why and have a conversation. So it’s concerning.”

Dr. McBride says his intent is for opiate reductions at the Marion VA hospital to always comply with the Opioid Safety Initiative.

“In many chronic pain conditions, opioid medications are now not thought to be the standard of care,” said McBride. “It is our intent, before we reduce the medication or even start to lower it or discontinue it, our intent is to make sure they have pain management from other sources, non-narcotic sources, where they will have access to chiropractic or physical therapy.”

Those alternative pain management sources can also include an acupuncturist or even a psychiatrist, as they’re slowly taken off opiates. But that doesn’t match the accounts from these three veterans or the many others.

“I’ve spent almost $1,200 of my own money using a doctor for acupuncture and chiropractic,” said Panther. “We ask them about it and they say, ‘Oh no you don’t need that.’ I’ve had a doctor say to me, I don’t believe in that stuff. I would believe in anything that helps me!”

McBride says he doesn’t want to see veterans spending their own money on care they should be able to receive through the VA or CHOICE program. Yet he admitted alternative pain care appointments aren’t always available quickly.

He also acknowledged that some doctors haven’t been following orders to wean veterans off their opiates.

“We have had accounts that have arisen in our healthcare system, where veterans have been removed from their opioid medications, perhaps a little bit aggressively,” said McBride.

McBride believes fear may be motivating some providers to move too swiftly.

“Concern is growing, that they may be subject to a review or their license, if they’re giving too many opioids, may be in some jeopardy,” said McBride.

But the veterans feel some primary care providers are putting their and other veterans’ lives in jeopardy.

“That’s why there’s 22 veterans committing suicide every single day,” said Panther. “Chronic pain is a killer. And in my opinion, these programs where they`re just abruptly taking medication from patients that absolutely need it, this is the cause.”

Dr. McBride’s point about the pressure doctors are feeling to cut the number of opiates they prescribe is key to why some doctors may be acting the way they are.

Under the new Comprehensive Addiction Recovery Act authored by Indiana representative Jackie Walorski, the number of opiate prescriptions provided by doctors and at VA facilities will be under review each year, starting with a report set to be filed this summer. These doctors’ prescription numbers will be under a microscope, in an attempt to keep veterans from getting hooked on the drugs in the first place.

The law clearly requires safe weaning from opiates, no matter the reason for stopping the prescription.

Her office says they’re concerned about reports of abrupt cutoffs throughout the Northern Indiana VA system. They plan to make sure a recently requested report from the system addresses potential issues at the Marion facility, as well as the Peru clinic also now under scrutiny since this investigation started.

They say they will also take into consideration that FOX59 received complaints from all over Indiana, as well as across the country, to make sure this isn’t a nationwide problem.

They volunteer to serve our country… we use/abuse them… we send them back home “broken”  and then the VA system abuses them even more.  The 535 members of Congress just sit up there on “the Hill” on their pompous asses and turn a “blind eye” to what is going on.

What a disgrace !!!

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