Are implants for opioid addicts a new hope or a new scam?

Are implants for opioid addicts a new hope or a new scam?

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If a stake could be driven through the vampire heart of the nation’s opioid epidemic, it might look something like this: Four tiny spines, each smaller than a matchstick, sunk into a drug addict’s upper arm.

These implants remain beneath the skin for months, delivering a continuous dose of a drug called buprenorphine, which blunts the euphoria of an opioid high. Ideally, its manufacturer says, patients will get the implants replaced every six months, helping achieve the lasting sobriety that currently eludes an estimated 2.5 million Americans who are addicted to heroin or other opioids.

As the addiction crisis grows, implants that deliver buprenorphine, naltrexone and opioid-blocking drugs like them might offer light in an otherwise oppressive darkness. One recent study found that nearly 86 percent of the people who used the buprenorphine implant refrained from using opioids during a six-month window. And in Russia, more than half of heroin-addicted patients who got a naltrexone implant were abstinent over a six-month clinical trial.

But here in Southern California — a region known as Rehab Riviera because there are so many drug and alcohol recovery centers — implants might also be a new way to turn an illicit buck.

In one of the latest twists on the profit-before-patient mindset so common in the addiction treatment industry, addicts are demanding to be paid for agreeing to get implants, knowing that rehab centers and the doctors who surgically insert the devices can bill insurance providers thousands of dollars per patient, according to professionals in the rehab industry.

“Hey Bud. I have at least me and 3 other people looking to come … and all 4 of us want the implant,” said a text from an addict to an executive with New Existence Treatment Center in Fountain Valley, according to screen shots of a text exchange reviewed by the Southern California News Group.

“If I can get others with the same insurance any chance I could possible (sic) make little something, I got nothing… ”

Requested payouts for agreeing to the treatment, according to an apparently unsent text on the addict’s phone, were $700 for his implant plus $300 for each additional person he recruited to get implants.

Dylan Walker, one of New Existence’s owner-operators, was trading texts with the addict, and said he did nothing irregular. “If you actually read them, nowhere in there does it say I’m paying clients to get the implant,” Walker said when contacted about the exchange.

Later, in a prepared statement, the company said Walker simply offered encouragement and support to a former client, nothing more.

“New Existence has not and will not engage in any unlawful or unethical treatment or business practice such as payments to clients or other organizations for procedures or treatments,” it said by email.

“Unfortunately, the addiction treatment industry is fraught with questionable practices, and we have encountered similar requests or demands in the past—which have all been rejected.”

New Existence — a non-medical enterprise — also said it is carefully reviewing its own policies and procedures “to ensure that our communication with clients regarding treatment are clear, making sure that they understand their treatment plan as it relates to their own recovery process.”

Other addiction professionals say such demands aren’t unusual. Paying addicts to get implants – and other forms of insurer-covered treatments – is at least widespread enough to prompt some addicts to make the request.

“Does it surprise me? No. That’s part of toxic behavior.,” said Cynthia Moreno Tuohy, executive director of the National Association for Alcoholism and Drug Abuse Counselors.

The requests amount to, “Give me money to help me help you get money,” she said, and they constitute a basic corruption of how the industry should work.

“In our code of ethics, you can’t do that.”

Probuphine — the brand name of the implant that delivers buprenorphine — was developed by Braeburn Pharmaceuticals of New Jersey with partner Titan Pharmaceuticals in San Francisco. Company officials didn’t say if they’ve heard of the shakedown proposed by the addict, but promised to probe further.

“We take all reports of potential misconduct, violations of internal Braeburn policy or applicable laws, very seriously,” said Braeburn spokeswoman Nancy Leone by email.

Officials with BioCorRx, the Anaheim company that’s working on FDA approval for implants delivering naltrexone, said they have received demands for money directly from addicts.

“We have an 800 number and people just flat-out ask, ‘How much will you pay me to get your implant?’ ” said Brady Granier, the company’s chief executive. “We tell them we don’t treat people, and the people we work with don’t do that. It shouldn’t be happening.

“It’s a form of patient-brokering,” he added. “And it gives what we do a bad name.”

Naltrexone implants are inserted into the abdomen and last several months. They’ve been widely used in Europe for years and have been prescribed in the U.S. as well, even without the FDA’s official stamp of approval – which is usually required before health insurers will agree to pay for them.

The chatter is that some illicit implants are imported from overseas, Granier said.

“There’s a black market for them. Patients who are considering this should always ask their doctor, ‘Where are you getting your implants?’”

Billing opportunity

Probuphine is, for now, the only long-acting FDA-approved implant for opioid addiction. It got the green light last year, hit the market in January, and lasts six months.

A single Probuphine implant costs $5,000, and billings for follow-up care can run thousands more. It’s covered by most private and public health insurance plans and, in a recent statement, the FDA backed such coverage, saying “expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic.”

Since most insurance companies don’t cover naltrexone implants yet, those are often billed as surgeries, insiders said.

Health insurance officials confirmed that they’ve heard of irregularities connected to anti-opioid implants. Many insurers and treatment providers are embroiled in lawsuits over alleged billing fraud on other fronts, and insurers claim they’ve seen all manner of creative billings in the addiction treatment industry.

“We have heard anecdotally of a California facility that makes its own implants…  for use with its clients,” said Mark Slitt, spokesman for Cigna. “We would not cover that.”

Ashton Abernethy of AVA medical billing, a Costa Mesa company that works with behavioral health centers, said she started hearing about pay-for-implants scams over the last 18 months or so.

Abernethy, who said she works with rehab operators to help them understand the law, said the implant situation reminds her of the “sweaty palms” surgeries of about a decade ago. In those operations, doctors paid people with generous insurance policies to undergo unnecessary surgeries. Authorities later said the schemes generated $154 million in fraudulent billing.

The Southern California News Group recently investigated the addiction industry and found it peppered with financial abuses that bleed untold millions from public and private pockets, can upend neighborhoods and often fails to set addicts on a path to sobriety. The revolving door between detox centers, treatment facilities, sober living homes and, often, the streets generates huge money for operators who know how to game the system. And even obvious fixes prohibiting patient brokering can be hard to enact.

Some professionals in the industry, frustrated by what they see as abuses, are trying to force change from within.

David Skonezny created “It’s Time for Ethics in Addiction Treatment,” a closed Facebook group for industry professionals that has more than 2,000 members. It’s a destination for people to challenge themselves and have honest dialogue about ethics in the industry, he said, and where people are calling out what they deem as questionable behavior.

News of the pay-for-implant texts recently created a social media firestorm.

“Changing the face of addiction treatment needs to happen, and I’ve jumped on the grenade to do that,” said Skonezny, a certified drug and alcohol counselor who has served on the board of directors for California Consortium of Addiction Programs and Professionals.

“I’m ether in the process of doing really good work, or committing career suicide.”

Why implants?

Walter Ling, professor of psychiatry and founding director of the integrated Substance Abuse Programs at UCLA, says most people don’t really understand how much time drug addicts think about getting drugs.

It’s on their minds constantly.

When the freeway collapsed during the 1994 Northridge quake, he said, the panic for some addicts wasn’t about houses falling; it was about being unable to get to the local methadone clinic, where they could get at least a substitute for heroin.

The power of long-acting anti-opioid implants, he said, is that they can interrupt that pattern.

“Anything that can free (addicts) from the constant preoccupation with (their drug of choice) allows them to think about getting a life,” said Ling.

Implants can offer a consistency that’s lacking in other medications aimed at preventing relapse, he said. Methadone, the best known anti-opioid drug, must be taken daily and essentially marries an addict to a methadone clinic. Naltrexone blocks the effects of opioids by turning off pleasure receptors, and patients often hate it. Buprenorphine, Ling said, strikes something of a middle ground.

The current delivery systems for most of these drugs are pills or under-the-tongue film strips that a patient must keep in the mouth for 15 minutes, one or more times a day, to get the full dose. Addicts often grow weary of the routine and drop out. Pills and strips also become a commodity on the street, bought and sold from one addict to another.

Injectable drugs taken weekly or monthly, and implants, offer potential solutions to those problems. The addict isn’t making a daily decision about taking the anti-opioid, reducing the odds of relapse though not entirely wiping it out. Also, injections and implants can be invisible, meaning sobriety doesn’t include the stigma of visiting a methadone center or popping pills every day.

The manufacturers claim this helps addicts keep jobs, take care of their families and lead productive lives.

Ling is inclined to agree. He was the lead researcher on a study published in the Journal of the American Medical Association in 2010, which found that buprenorphine implants were indeed effective in treating opioid dependence over the six months following implantation.

“Of particular clinical importance are the favorable urinalysis toxicology results and the good patient retention—with 65.7% of patients who received the active implants completing 24 weeks of treatment without experiencing craving or withdrawal symptoms that necessitated withdrawal from the study,” the study said.

Naltrexone implants worked wonders as well. “The implant device, which releases a steady dose of naltrexone continuously for two months, averted relapse to heroin use three times as effectively as daily oral doses of the medication,” said the National Institute on Drug Abuse.

Drug abusers are notoriously ambivalent, said study co-leader Dr. George Woody, a professor of psychiatry at the University of Pennsylvania, in a NIDA statement. Just because they decide to quit using heroin one week doesn’t mean they’ll be motivated to quit a week later. The rationale for extended-release implants is to protect against that ambivalence.

The implants’ success in preventing relapse cuts a marked contrast to traditional social-based treatment approaches. Addicts have a relapse rate between 40 and 60 percent, according to the U.S. Surgeon General’s most recent probe, and it can take as long as 8 or 9 years to achieve sustained recovery.

Taking medication is the best guarantee that you don’t die from an overdose and actually stay off drugs, Ling said. “You can’t get a life if you can’t stay off drugs. And you can’t stay off drugs for long if you can’t get a life.”

Michael M. Miller, past president of the American Society of Addiction Medicine and medical director of the Herrington Recovery Center at Rogers Memorial Hospital in Wisconsin, also likes the idea of making it easier for an addict to get medicine for treatment, but says implants are only one way to do that.  He is on the manufacturer’s physicians advisory committee for Probuphine, a paid position, but  has not yet prescribed it.

“Implants probably have a role, but probably a fairly small role,” Miller said. “The 30-day injectables are going to have tremendous impact.”

On the street, stories about addicts who’ve cut implants out of their skin so they can get high are not uncommon, and some physicians worry about potential complications.  

Both Miller and Ling said many in the addiction field resist the idea of using drugs as a long-term treatment. That patients might need to be on medication for the rest of their lives to manage their addiction makes physicians and patients uncomfortable; Ling chalks it up to a strain of Puritanism that runs through American culture.

Moreno Tuohy, executive director of the NAADAC, the Association for Addiction Professionals, believes that medication is one piece of the treatment puzzle, but that counseling is essential to address the psychological, social and spiritual aspects of an addict’s behavior.

Medications may make patients more available to do the work they need to do in counseling to fully recover, she said. She also predicted that the number of medications designed to fight opioid and other addictions is going grow considerably over the next few years.

“The hope is it will help people to reduce cravings for marijuana and cocaine and other drugs, and become more available to comprehensive treatment,” Moreno Tuohy said. “That’s the goal, not just (short-term) recovery.”

Moody’s: Proposed changes to 340B program will hurt the finances of nonprofit hospitals

http://www.fiercehealthcare.com/finance/moody-s-proposed-changes-to-340b-program-will-hurt-finances-nonprofit-hospitals?utm_medium=nl&utm_source=internal&mrkid=959610&mkt_tok=eyJpIjoiTURSbU5qazJZbU5sWlRKayIsInQiOiJJTnUxcUsyUm42Y3FjKzBZZXkzQytVR09NYzB0TzNZXC9rXC9YNnBFNXowa0duZGM1SU4yRGJYM2EraXk2TitOa3lwODlWVFNEXC9rc001WUJvcXNjc1U5ZDlYb3FWclNEUjBwbnNlNHc4RVwvc3dGWDVQclJtMDYyZXU4ZmJBNU1lcVkifQ%3D%3D

drugs

Inpatient drug costs will continue to rise for nonprofit and public U.S. hospitals, but the pace of drug price increases will likely slow down amid growing scrutiny of drug manufacturers’ pricing practices.

But even with the slowing rate of price increases, the rising drug costs and potential changes to Medicare 340B payments for outpatient drugs would further reduce hospital margins, according to a new report from Moody’s Investors Service.

Pharmaceutical costs have outpaced hospital revenue growth in recent years, contributing to weaker operating margins, Moody’s finds. “Price increases in recent years were extraordinarily high for certain branded hospital inpatient drugs, but drug manufacturers are pulling back on these increases,” said Diana Lee, a Moody’s vice president. “On the generic drug side, we expect that some of the pressure will ease as the U.S. Food and Drug Administration approves more generic drugs for the first time.”

However, the government’s proposed reduction of Medicare Part B outpatient drug reimbursement to 340B hospitals by roughly 30% would hurt hospital margins.

“Hospitals and health systems of varying size and across the rating spectrum have noted anecdotally that they have benefited from cost savings from this discount drug program,” Lee says. “In some instances, the savings and income gained from this program can be meaningful relative to total operating cash flow. While about half of hospitals in the nation are 340B providers, those that have limited financial flexibility would be most exposed to possible changes to the 340B program.”

Hospitals and industry trade groups have urged the Centers for Medicare & Medicaid Services to withdraw its proposal to cut the drug payments to hospitals in the federal drug discount program. Hospitals use the savings to waive copays and provide drugs and other services for free or reduced costs to low-income patients.

Last week a bipartisan group of more than 220 members of the House of Representatives also told CMS in a letter (PDF) they oppose the proposal.

“This program is a lifeline for the hospitals that serve our most vulnerable patients. These arbitrary cuts will do nothing to improve patient care, or address rising costs in the Medicare program. Instead they simply jeopardize access to the treatments and services that 340B hospitals provide,” said Rep. Mike Thompson (D-Calif.) in an announcement. “There is robust bipartisan agreement that CMS should go back to the drawing board to prevent harm to patients across the country.”

Rep. David P. McKinley (R-W.Va.) said CMS’ proposal was “misguided.” “Our letter shows strong bipartisan opposition to this proposed rule, and hopefully will convince CMS to change course. We must address the high costs of drugs, but this is not the way to do it,” he said.

Meanwhile, the Health Resources and Services Administration has once again delayed (PDF) the effective date of a different 340B final rule that would set drug price ceilings and penalties for drug manufacturers that knowingly overcharge hospitals for drugs purchased under the program. The Department of Health and Human Services said it has delayed the effective date to July 1, 2018, to give more time to make changes to facilitate compliance. “After reviewing the comments received from stakeholders regarding objections on the timing of the effective date and challenges associated with the complying with the final rule, HHS has determined that delaying the effective date to July 1, 2018, is necessary to consider some of the issues raised.”

Doctors want to give their cancer patients every chance. But are they pushing off hard talks too long?

Doctors want to give their cancer patients every chance. But are they pushing off hard talks too long?

A new generation of immune-boosting therapies has been hailed as nothing short of revolutionary, shrinking tumors and extending lives. When late-stage cancer patients run out of other options, some doctors are increasingly nudging them to give immunotherapy a try.

But that advice is now coming with unintended consequences. Doctors who counsel immunotherapy, experts say, are postponing conversations about palliative care and end-of-life wishes with their patients — sometimes, until it’s too late.

“In the oncology community, there’s this concept of ‘no one should die without a dose of immunotherapy,’” said Dr. Eric Roeland, an oncologist and palliative care specialist at University of California, San Diego. “And it’s almost in lieu of having discussions about advance-care planning, so they’re kicking the can down the street.”

Can Patrick Soon-Shiong silence his many critics?

Can Patrick Soon-Shiong silence his many critics?

LOS ANGELES, CA - MARCH 22: CEO of Abraxis Health Institute Patrick Soon-Shiong during a Urban Economic Forum co-hosted by White House Business Council and U.S. Small Business Administration at Loyola Marymount University on March 22, 2012 in Los Angeles, California. Topics discussed at the forum included the Obama administration's support for policies that create private sector-jobs and future entrepreneurs. (Photo by Kevork Djansezian/Getty Images)

On the phone, Patrick Soon-Shiong speaks slowly and deliberately. He clearly trusts himself, but he doesn’t trust journalists anymore.

A series of scathing articles by STAT News and Politico sent stocks in his publicly-traded companies tumbling earlier this year. On Monday, he has an opportunity to change that narrative somewhat, with the unveiling of data from human trials of his cancer vaccine at a major oncology conference.

The stories allege that despite his bold claims, Soon-Shiong’s NantWorks subsidiaries are underperforming and reliant on contracts from other companies in the group. Reporters have also claimed that one of his companies, NantHealth, has received contracts from institutions that had received donations from his nonprofit foundation — a major conflict of interest. This was not adequately disclosed prior to the massive initial public offering of NantHealth, they argue, which may violate SEC laws.

For his part, Soon-Shiong, dismisses the allegations noting that part of the motivation behind those stories was political: “They had never written about me until they saw this picture of me with Trump.”

Speaking to MedCity on Wednesday after his recent appointment to a national health IT advisory committee, Soon-Shiong detailed how the various threads of his career are converging toward a pivotal moment. A solution for healthcare is almost within reach and he’s poised to unveil what he believes is a disruptive cancer therapy – the Nant vaccine – at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Monday.

This story clearly clashes with many other viewpoints in the industry.

Healthcare Triage: Orphan Drugs: An Introduction

Healthcare Triage: Orphan Drugs: An Introduction

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We at Healthcare Triage couldn’t be more excited about this month. We’re doing a whole month on orphan drugs, with the help of Nick Bagley. He wrote a lot about them, and we begged him to let us adapt his work into a series. This is the Introduction. Over the next few weeks, there will be three more. Enjoy!

 

How Pharma Companies Game the System to Keep Drugs Expensive

https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive?utm_campaign=hbr&utm_source=facebook&utm_medium=social

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I help the University of Utah hospital system manage its drug budgets and medication use policies, and in 2015 I got sticker shock. Our annual inpatient pharmacy cost for a single drug skyrocketed from $300,000 to $1.9 million. That’s because the drug maker Valeant suddenly increased the price of isoproterenol from $440 to roughly $2,700 a dose.

Isoproterenol is a heart drug. It helps with heart attacks and shock and works to keep up a patient’s blood pressure. With the sudden price increase, we were forced to remove isoproterenol from our 100 emergency crash carts. Instead, we stocked our pharmacy backup boxes, located on each floor of our hospitals, to have the vital drug on hand if needed. We had to minimize costs without impacting patient care.

This type of arbitrary and unpredictable inflation is not sustainable. And it’s not the way things are supposed to work in the United States. Isoproterenol is a drug that is no longer protected by a patent. Theoretically, any drug company should be able to make a generic version and sell it at a competitive cost. We should have had other options to buy a competitors’ copy for $440 or less. But that’s not happening like it should. The promise of generic medications is getting further from reality each day. As the U.S. Senate considers President Donald Trump’s choice to head the Food and Drug Administration, now is the time refocus efforts on generic drugs.

 

Artificial Intelligence In Healthcare Will Make Decisions For Doctors

https://techdigg.com/2017/03/25/artificial-intelligence-in-healthcare-will-make-decisions-for-doctors/

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Artificial intelligence could soon make tough medical choices

Patients are often willing to put themselves in the hands of healthcare professionals when they need to see a doctor, and this includes accepting the technological devices that help physicians. But, artificial intelligence making vital decisions for doctors is another story.

AI is already playing a significant role in healthcare. The healthcare organization, MedyMatch says it is, “creating a new category of AI-driven diagnostic tools” and “leveraging the richness of 3D imaging, the breadth of patient-specific data, and other relevant data… to deliver precise clinical decision support directly to the physician.”

MedyMatch recently announced a major collaboration with IBM Watson Health. The aim is for artificial intelligence applications to work alongside doctors in emergency rooms and other acute care settings.

AI can use deep learning to help physicians by highlighting regions of interest that could “indicate the potential presence of cerebral bleeds in suspected head trauma and strokes.”

Better decisions from better information

So what would AI decision making in a hospital setting look like?

“Clinical Decision Support (CDS) is where the greatest opportunity exists to make an impact,” MedyMatch CFO Michael Rosenberg told TechDigg.

While it’s well known that better decision making comes from having better information, it’s also well known that healthcare professionals are constantly short of time, making it difficult to process a lot of information.

“CDS in its classical sense has been about decision trees, if this then do that… when it comes to AI, we take it to a whole other level,” Rosenberg said.

“When looking at decision support, we aren’t looking at a set of rules, but a set of considerations highlighted for the physician, whether they be statistical data looking at similar patients across a population or highlighting regions of interest.”

This also has a positive financial impact, because: “better decisions lead to better outcomes, and better outcomes mean the reduction of costly errors, which means cost savings for the healthcare system from the Provider, Patient, and Payer.”

Speaking on the relationship between artificial intelligence and doctors, and the stage that relationship is now at, Rosenberg said:

“I think we are seeing the very early stages of an evolution where the definition of a doctor changes. AI will never replace the physician, at least not in our lifetime. The physician will always be the ultimate decision maker, however that decision will be influenced by recommendations that an AI platform recommends.”

“We think of AI as a capability that can be used to enhance the work of a physician… the final diagnosis will always be the responsibility of the doctor, but it will rapidly increase the number of physicians that can perform at an expert level.”

Can we be sure artificial intelligence decisions are safe?

There are many areas of life where people are both excited and cautious about the role that AI can play. Healthcare is perhaps the number one area where the public needs to know it can trust the technology.

“The great thing in healthcare is the regulator,” Rosenberg said. “The FDA is looking out for the patient, and close collaboration between the healthcare industry and the AI provider will result in the best quality for the marketplace.”

Even the best doctors get tired and short of time, and artificial intelligence could be on hand to do the work they simply can’t do themselves.

An infographic of healthcare cuts in Trump’s draft budget

An infographic of healthcare cuts in Trump’s draft budget

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