HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Artificial Intelligence May Decide Whether You Get Rx Opioids

By Andy Miller and Sam Whitehead, KFF Health News

Elizabeth Amirault never heard of NarxCare until last year, when she learned its software was tracking her medication use. During a visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain and received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like NarxCare are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. NarxCare’s overdose risk ratings – known Narx Scores -- are produced by health care technology company Bamboo Health (formerly Appriss Health).

NarxCare’s software uses artificial intelligence to analyze data about prescriptions for controlled substances to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind their algorithm formulas are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work. Lacking the ability to see inside these systems leaves only clues to their potential impact.

Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened.

Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

We’re concerned that it’s not working as intended, and it’s harming patients.
— Jason Gibbons, Health Economist

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. Amirault had been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

(Editor’s note: A citizen’s petition filed with FDA earlier this year alleged that NarxCare software “altered the practice of medicine in the U.S. to the detriment of patients,” and sought to have the software declared a misbranded medical device and recalled. The petition by the Center for U.S. Policy was rejected by FDA on technical grounds because it was “not within the scope” of the agency’s petition process.)

Impact on Patients

Bamboo Health says NarxCare’s rating system should never replace decisions made by physicians. But some patients say the risk scores have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

New DEA Rule Allows Pharmacies to Transfer Opioid Prescriptions

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has adopted a new rule that allows patients, doctors and pharmacists to transfer initial prescriptions for opioids and other controlled substances from one pharmacy to another.  

The rule became effective August 28, but has been in the works for several years. It revises DEA regulations to allow prescribers, hospitals and pharmacists the ability to write, dispense and transfer electronic prescriptions for controlled substances “upon request of the patient.” Under the old rule, prescriptions could not be transferred if a pharmacy is unwilling or unable to fill them – forcing doctors to write a second prescription for another pharmacy and creating delays for patients in need of treatment.

“The final rule amends DEA regulations to explicitly state that an electronic prescription for a controlled substance in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient, and clarifies that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription,” DEA said in a lengthy notice published in the Federal Register.

In recent years, many patients have experienced delays or outright refusals getting prescriptions filled for opioids, stimulants, sedatives, steroids and other medications classified as controlled substances.  The problem has grown worse in recent months, due to chronic shortages of oxycodone, hydrocodone and stimulants.

It would be nice to say the DEA changed the rule to make it easier for patients to get their prescriptions filled, but the agency’s primary goal is to reduce drug diversion. Having doctors write duplicate prescriptions for the same patient is not only a waste of time, in the eyes of the DEA it raises the risk of the original prescription being misused.

“DEA realizes that this scenario creates the potential for duplication of prescriptions, if the practitioner transmits a new prescription to a different pharmacy and does not cancel or void the original prescription that was sent to the first pharmacy. It also recognizes that this scenario creates additional burden for patients, who have to get back in touch with the prescribing practitioner to request a new prescription,” the agency said.

“DEA believes that allowing the electronic transfer of controlled substance prescriptions will decrease the potential for duplicate prescriptions and thus reduce the opportunity for diversion or misuse.”

The diversion of prescription opioids is actually rare. According to the DEA, less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

The DEA estimates the new prescription transfer rule will cost pharmacies over $91 million annually due to additional record-keeping and time spent transferring prescriptions, but will reduce overall costs to the healthcare system by $22 million a year.  

FDA Approves First Biosimilar for Multiple Sclerosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Tyruko (natalizumab-sztn) as the first biosimilar for adults with relapsing forms of multiple sclerosis (MS), a move that could substantially reduce treatment costs for MS patients. Biosimilars are “highly similar” to brand-name biologic medicines, but about 30% cheaper.

"Approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA's longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost," said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars.

Like Tysabri (natalizumab), the biologic it is modeled after, Tyruko is administered by infusion every four weeks to patients with MS, a chronic disease that attacks the body’s central nervous system, causing numbness, paralysis, loss of vision, fatigue and pain. Many MS patients experience periods of remission, followed by relapses.  

The listed cash price for a single vial of Tysabri is over $17,000, although the discounted price for insured patients is about $8,500 or $102,000 a year. Sandoz, a pharmaceutical company that specializes in biosimilars and generics, has not revealed its pricing plans for Tyruko or said when it will become available. Sandoz is a division of Novartis.

“Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market,” Keren Haruvi, President North America, Sandoz Inc., said in a news release.

Like Tysabri, Tyruko may also be used to treat adults with moderate to severe symptoms from Crohn's disease who have not responded well to other treatments. Crohn’s causes chronic inflammation in the digestive tract.

The FDA says patients using natalizumab products (including Tyruko and Tysabri) are at higher risk of developing progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that can lead to death or severe disability. Because of that risk, prescribers must evaluate patients three and six months after their first infusion, every six months thereafter, and even after they discontinue treatment.

Growing Market for Biosimilars

Patients have long complained about the high price of MS drugs in the US, which cost two to three times more than the same drugs in Canada, Australia or the UK. One reason biologics are so expensive is that they derived from living organisms such as animal cells or bacteria, making them costly to develop.

Drug patents also last a long time – usually five years – before a “copycat” version can be introduced. Patent holders often take their competitors to court to further delay the introduction of generics or biosimilars, as was the case with AbbVie’s Humira, a biologic widely used to treat rheumatoid arthritis and other chronic inflammatory diseases. At least 9 new Humira biosimilars are finally entering the U.S. market this year.

Last week, CVS Health announced that it was launching a wholly owned subsidiary called Cordavis, which will work with drug manufacturers to commercialize biosimilars. The first biosimilar CVS plans to market in early 2024 is Hyrimoz (adalimumab-adaz), a biosimilar for Humira produced by Sandoz. CVS says the list price of the Hyrimoz will be over 80% lower than the current list price of Humira.

"Biosimilars are crucial to creating competition and reducing costs for specialty pharmaceuticals where drug prices are rising the fastest," said Prem Shah, PharmD, Executive Vice President and Chief Pharmacy Officer for CVS. "Through our direct involvement, we will expand the supply chain and ensure biosimilar availability in the market.”

As more patents expire, the biosimilars market in the U.S. is projected to grow from $6.7 billion in 2021 to more than $100 billion in 2029, according to one market forecast..

What Is End-of-Life Care?

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California’s new Guidelines for Prescribing Controlled Substances for Pain are futuristic and practical.  They recognize that persons who need intractable pain or “end-of-life” care may often require a non-standard medical program, so the board made these two conditions exempt from any limitations on dosage or treatment.

In our recent column on the guidelines, we clarified the meaning of intractable pain and suggested criteria for identification of the intractable pain patient who requires non-standard drugs and dosages. This column does the same for “end-of-life” care. 

The California guidelines define end-of-life care as “for persons with a terminal illness or at risk of dying in the near future whether in hospice care, hospitals, long-term care or at home.”  Note that this definition does not include palliative care, whose definition is frankly now in limbo, because medical textbooks define it as “symptomatic rather than curative care.” Third party payers only recognize palliative care as being in the last few months of life.

How does one identify a person who needs “end-of-life” care?  California actually has a law which helps identify the person who needs end-of-life care.  Such a person “is suffering from an incurable and irreversible illness that will bring about death within one year if the illness takes its normal course and the treatment is for pain control and/or symptom management rather than to cure the illness.” 

In effect, this definition includes intractable pain patients who are not expected to live more than a year without treatment.  Severe intractable pain, regardless of cause, if left untreated will result in malnutrition, immune deficiency, cardiac or adrenal failure, and a shorter life. 

To our knowledge there are no formal criteria published for clinicians to determine when there exists high risk of death within a year.  Here are criteria used and suggested by us: 

  1. Patient has a known disease that may shorten life, such as cancer, adhesive arachnoiditis, head trauma, and Ehlers-Danlos syndromes.

  2. Pain is constant and interferes with activities of daily living as reported by a close family member.  Examples are inability to eat, toileting, mobility, hygiene, and dressing.

  3. Bed bound and immobile for many hours of each day.

  4. Malnutrition, evidence of tissue loss, poor skin turgor (rigidity), and/or weight loss.

  5. Family reports inability to normally read, answer questions, or socially respond.

  6. Some alterations in normal physiologic functions such as blood pressure, pulse, and hormone levels.

We encourage clinicians to use our criteria for “end-of-life” care or develop some specific alternative criteria.  Too many seriously ill intractable pain patients have been denied care until it was too late.  An “end-of-life” case may begin at any age, be it 14, 40 or 80 years old. 

Many, if not most “end-of-life” patients meet terminus within a year. But some persons turn things around with adequate intractable pain care and live much longer.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state.

Tramadol Banned by Anti-Doping Agency

By Pat Anson, PNN Editor

When it comes to treating pain, tramadol (Ultram) is widely seen as a weak synthetic opioid that provides little relief to patients with severe or chronic pain.

“I get a lot more relief from aspirin” and “this stuff does nothing but make you dizzy and sleep,” are some of the comments PNN readers have made about tramadol.  

But some professional athletes, particularly those in cycling, have a completely different take on tramadol. They use it as a performance enhancing drug that can help them run, skate or peddle faster, and for longer periods of time. That’s why the World Anti-Doping Agency (WADA) is adding tramadol to its list of prohibited drugs, starting in 2024.

“Tramadol has been on the WADA Monitoring Program for some years. Monitoring data has indicated significant use in sports including cycling, rugby and football,” WADA said in a statement. “Research studies funded by WADA have confirmed the potential for tramadol to enhance physical performance in sports.”

Results from one of those studies, recently published in the Journal of Applied Physiology, confirm many of WADA’s concerns. UK researchers enrolled 27 cyclists in a double-blind randomized study, in which they were given either 100mg tramadol or a placebo before engaging in 30 minutes of high intensity cycling, followed by a 25-mile time trial.

On average, the cyclists who took tramadol were 1.3% faster in the time trial (TT) than those given a placebo. That doesn’t sound like much, but in the highly competitive world of professional cycling, even a few seconds can be the difference between finishing first or second.

Interestingly, the researchers found there were “no differences in pain intensity” between the cyclists on tramadol and those who took the placebo.

“This study demonstrates that highly trained cyclists can maintain a significantly higher power output and complete a competitive TT in a significantly faster time following acute ingestion of 100 mg of fast-acting soluble tramadol. Tramadol reduced the perception of effort for a given power output but had no discernible impact on pain intensity whilst cycling,” wrote lead author Alexis Mauger, PhD, a professor in the School of Sport and Exercise Sciences at the University of Kent.

“The findings from this study suggest that tramadol elicits a significant performance-enhancing effect in highly trained cyclists, such that it can change the outcomes of a race. Given the evidence of the historical prevalence of use of tramadol in sport with the intention of improving performance, and the risks pertaining its use, this study provides strong evidence to justify its inclusion on the 2024 Prohibited Substance List.”

To be clear, no one is taking tramadol away from pain patients. But professional athletes who test positive for tramadol — without a medical reason for taking it — run the risk of suspension or disqualification if their sport follows the WADA guidelines..

Previous studies by Mauger found that acetaminophen (Tylenol) gave a 2% boost in performance for cyclists, suggesting that even a mild analgesic can be helpful in making endurance exercise seem easier. Conversely, it also lends weight to pain sufferers who say tramadol works no better than Tylenol or aspirin.      

“Now we have a conundrum. Tramadol, an opioid painkiller, appears to have had no effect whatsoever on the pain experienced during cycling. On the other hand, it significantly lowered the perception of effort, which in turn…  improved performance,” journalist Alex Hutchinson wrote in Outside. “I’m not sure what to make of this finding, but it reaffirms my sense that we still have a lot to learn about how pain and effort and other related constructs like mental fatigue influence our performance.”

The U.S. Food and Drug Administration classifies tramadol as a Schedule IV controlled substance, meaning it has less potential for abuse and addiction compared to opioids like oxycodone or hydrocodone, which are Schedule II drugs.

In recent years, prescriptions for tramadol have soared in the U.S. because it is considered “safer” than other opioids. In many third world countries, however, tramadol is widely misused. In 2019, Public Citizen filed an unsuccessful petition with the FDA to have tramadol reclassified as a Schedule II drug, saying there was “overwhelming evidence” that tramadol was a public health risk.

Doctors and Patients Shame Insurers to Reverse Treatment Denials

By Lauren Sausser, KFF Health News

Sally Nix was furious when her health insurance company refused to pay for the infusions she needs to ease her chronic pain and fatigue.

Nix has struggled with a combination of autoimmune diseases since 2011. Brain and spinal surgeries didn’t ease her symptoms. Nothing worked, she said, until she started intravenous immunoglobulin infusions late last year. Commonly called IVIG, the treatment bolsters her compromised immune system with healthy antibodies from other people’s blood plasma.

“IVIG turned out to be my great hope,” she said.

That’s why, when Nix’s health insurer started denying payment for the treatment, she turned to Facebook and Instagram to vent her outrage.

“I was raising Cain about it,” said Nix, 53, of Statesville, North Carolina, who said she was forced to pause treatment because she couldn’t afford to pay more than $13,000 out of pocket every four weeks.

“There are times when you simply must call out wrongdoings,” she wrote on Instagram. “This is one of those times.”

Prior authorization is a common cost-cutting tool used by health insurers that requires patients and doctors to secure approval before moving forward with many tests, procedures, and prescription medications.

SALLY NIX

Insurers say the process helps them control costs by preventing medically unnecessary care. But patients say the often time-consuming and frustrating rules create hurdles that delay or deny access to the treatments they need. In some cases, delays and denials equal death, doctors say.

That’s why desperate patients like Nix — and even some physicians — say they have turned to publicly shaming insurance companies on social media to get tests, drugs, and treatments approved.

“Unfortunately, this has become a routine practice for us to resort to if we don’t get any headway,” said Shehzad Saeed, a pediatric gastroenterologist at Dayton’s Children’s Hospital in Ohio. In March, he tweeted a photo of an oozing skin rash, blaming Anthem for denying the biologic treatment his patient needed to ease her Crohn’s disease symptoms.

In July, Eunice Stallman, a psychiatrist based in Idaho, joined X, formerly known as Twitter, for the first time to share how her 9-month-old daughter, Zoey, had been denied prior authorization for a $225 pill she needs to take twice a day to shrink a large brain tumor. “This should not be how it’s done,” Stallman said.

Prior Authorization Reform

The federal government has proposed ways to reform prior authorization that would require insurance companies to provide more transparency about denials and to speed up their response times. If finalized, those federal changes would be implemented in 2026.

But even then, the rules would apply only to some categories of health insurance, including Medicare, Medicare Advantage, and Medicaid plans, but not employer-sponsored health plans. That means roughly half of all Americans wouldn’t benefit from the changes.

The 2010 Patient Protection and Affordable Care Act prohibits health insurance plans from denying or canceling coverage to patients due to their preexisting conditions.

AHIP, an industry trade group formerly called America’s Health Insurance Plans, did not respond to a request for comment.

They just delay and delay and delay until you die. And you’re absolutely helpless as a patient.
— Linda Peeno, Healthcare Consultant

But some patient advocates and health policy experts question whether insurers are using prior authorization as “a possible loophole” to this prohibition, as a way of denying care to patients with the highest health care costs, explained Kaye Pestaina, a KFF vice president and the co-director of its Program on Patient and Consumer Protections.

“They take in premiums and don’t pay claims. That’s how they make money,” said Linda Peeno, a health care consultant and retired Kentucky physician who was employed as a medical reviewer by Humana in the 1980s and later became a whistleblower. “They just delay and delay and delay until you die. And you’re absolutely helpless as a patient.”

But there’s reason to hope things may get marginally better. Some major insurers are voluntarily revamping their prior authorization rules to ease preapproval mandates for doctors and patients. And many states are passing laws to rein in the use of prior authorization.

“Nobody is saying we should get rid of it entirely,” said Todd Askew, senior vice president for advocacy at the American Medical Association, in advance of the group’s annual meeting in June. “But it needs to be right-sized, it needs to be simplified, it needs to be less friction between the patient and accessing their benefits.”

Online Venting

Customers are increasingly using social media to air their complaints across all industries, and companies are paying attention. Nearly two-thirds of complainants reported receiving some sort of response to their online post, according to the 2023 “National Consumer Rage Survey,” conducted by Customer Care Measurement & Consulting in collaboration with Arizona State University.

Some research suggests companies are better off engaging with unhappy customers offline, rather than responding to public social media posts. But many patients and doctors believe venting online is an effective strategy, though it remains unclear how often this tactic works in reversing prior authorization denials.

“It’s not even a joke. The fact that that’s how we’re trying to get these medications is just sad,” said Brad Constant, an inflammatory bowel disease specialist who has published research on prior authorization. His work found that prior authorizations are associated with an increased likelihood that children with inflammatory bowel disease will be hospitalized.

Saeed said the day after he posted the picture of the skin rash, the case was marked for a peer-to-peer review, meaning the prior authorization denial would get a closer look by someone at the insurance company with a medical background. Eventually, the biologic medicine Saeed’s patient needed was approved.

Stallman, who is insured through her employer, said she and her husband were prepared to pay out of pocket if Blue Cross of Idaho didn’t reverse the denial for the drug Zoey needed.

Bret Rumbeck, a spokesperson for the insurer, said Zoey’s medication was approved on July 14 after the company consulted an outside specialist and obtained more information from Zoey’s doctor.

Stallman posted details about the ordeal online only after the insurer approved the drug, in part, she said, to prevent them from denying the treatment again when it comes up for a 90-day insurance review in October. “The power of the social media has been huge,” she said.

Nix had been insured by Blue Cross Blue Shield of Illinois through her husband’s employer for almost two decades. Dave Van de Walle, a spokesperson for the company, did not specifically address Nix’s case. But in a prepared statement, the company said it provides administrative services for many large employers who design and fund their own health insurance plans.

Nix said an “escalation specialist” from the insurance company reached out after she posted her complaints on social media, but the specialist couldn’t help.

Then, in July, after KFF Health News contacted Blue Cross Blue Shield of Illinois, Nix logged in to the insurer’s online portal and found that $36,000 of her outstanding claims had been marked “paid.” No one from the company had contacted her to explain why or what had changed. She also said she was informed by her hospital that the insurer will no longer require her to obtain prior authorization before her infusions, which she restarted in late July.

“I’m thrilled,” she said. But “it just should never have happened this way.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.  

The Way Forward: California’s New Opioid Guidelines

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California recently published new guidelines for prescribing opioids and other controlled substances for pain, which emphasize “individualized care” that is customized for each patient. 

The guidelines are a remarkable, positive and practical way forward in pain care. All persons concerned about chronic pain treatment with opioids, benzodiazepines and other controlled drugs need to know the basic concepts embedded in them.    

As the medical board was updating its guidelines, we had great concern that they would bury California’s Pain Patient's Bill of Rights and Intractable Pain Treatment Act. When these laws were passed in the 1990’s, they were a godsend to patients with chronic intractable pain, who were given the right to “request or reject the use of any or all modalities in order to relieve his or her pain.”

That means patients, with the support of their doctors, could get opiate medication without first having to submit to surgery, medical devices and other forms of pain treatment.  

To our great pleasure, the medical board’s new guidelines recognize, define and support these worthy laws.  Importantly, the guidelines also state that they are “not in any way intended to limit treatment” of patients in hospice or palliative care. And they allow for doctors to prescribe high dose opioids, provided they keep good medical records that document a need for them.

Defining Intractable Pain

The California guidelines provide a classic definition of intractable pain as “a state in which the cause cannot be removed or otherwise treated and no relief or cure has been found after reasonable efforts.” 

The problem with this definition is that intractable pain may be mild or intermittent and not curable, but may still be treated with non-opioid modalities. To require and receive treatment with opioids and other controlled drugs, one really needs a specific causative diagnosis of the unremitting “high impact” pain that produces physiologic complications such as hypertension, tachycardia, and endocrine deficiencies. 

Put another way, is intractable pain an incurable but treatable problem? Or is it constant and incurable with potentially life-threatening complications? 

Physicians, as a group, are often mystified, confused and unaware of how to determine which patients have an incurable, but readily treatable problem, and which patients have the constant and incurable pain that causes complications and require opioid therapy.

Physicians need help to make sound, defensible treatment decisions in the face of this quandary.  Some patients with complex intractable pain are greatly impacted and require non-standard treatment, which may include high-dose opioids, benzodiazepines and stimulant drugs. 

Here are the recommended criteria to identify such patients and support non-standard treatment plans.

  1. A specific medical cause of intractable pain has been identified.

  2. Constant pain has impacted some physiological and/or mental functions such as sleep, eating, hygiene, reading, concentration, and mobility.

  3. Trials of standard medications and dosages with such agents as anti-depressants, muscle relaxants, anti-inflammatories, stimulants, anti-seizure medications, and low-dose opioids have not controlled pain or normalized functions.

  4. There is objective physical evidence of the causative disease or complications of the pain, such as hypertension, tachycardia, neurologic deficits, or anatomic structural abnormalities.

  5. There is an objective, diagnostic test result that documents an abnormality of the cause of pain or its complications, such as a magnetic resonance imaging (MRI), hormone deficiency, elevated autoimmune or inflammatory marker, or an abnormal electrodiagnostic test.

It is the lack of adequate treatment of complex intractable pain that is really the crux of the suffering and deaths that have emerged due to overzealous and misinformed opioid regulations and guidelines.  These legitimate, complex patients comprise about 3 to 5% of chronic pain patients.

The California medical board’s new guidelines provide clinicians the opportunity to implement individualized and effective treatments for these unfortunate and deserving intractable pain patients. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. Dr. Tennant was the lead physician in crafting California’s Intractable Pain Law and Pain Patient Bill of Rights, and worked with the legislature to get them passed. 

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state. Kristen testified during public hearings on the California guidelines and closely followed their development. 

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

A Pained Life: Let the Words Flow

By Carol Levy, PNN Columnist

I ended my last column with my favorite saying: “You don't know what you don't know. And if you don't know what you don't know, you don't know what to ask. Our doctors need to ask.”

A couple of days later, I thought about the column and my second appointment with a neuro ophthalmologist, a specialist in nerve disorders that affect the eye.

I didn’t know that my parents were still carrying insurance on me, so I was going to a low-fee clinic in New York City, where I lived at the time.  It took almost a year, but finally one of the residents there decided I had trigeminal neuralgia. Even with a name for my condition, they still didn't have a clue what to do for it. Or with me.

When I realized that I could afford to see a private doctor, I returned to one I had seen years ago.  He referred me to the specialist.

The first appointment did not go well. He told me the disabling, horrendous facial and eye pain I had were caused by anxiety. At the end of the appointment, he patted me on the head, handed me a prescription for an anti-anxiety drug, and sent me home.

I was mad. Another "I dunno" exam that ends with a doctor saying, "It's psychosomatic." I debated if I even wanted to keep the second appointment, but what else could I do?  A feeling I think many of us have.

At the next appointment, I repeated my story of how the pain started, what it felt like, and what it was doing to me.  Again, he was unimpressed. He turned away from me, saying nothing.

Then, just to fill the silence, I said "You know, the other day, for a few seconds, I thought the pain was done and gone."

He abruptly turned back towards me. “What made you think that?” he said, the vehemence in his voice surprising me.

“Well, a lady on the bus inadvertently touched the left side of my face, where the pain is,” I explained. “And the pain didn't start. I was so, so happy. Until about 20 seconds later, when the lightning bolts came.”

The doctor walked over to me, and without missing a beat said, “I think it's time we brought you into the hospital.” I was startled and dumbfounded. In the span of a minute, he went from nonchalant to alarmed. I didn't think to ask why.

I was in the hospital for 52 days. After many tests and workups, they decided I should have brain surgery. The surgeon would cut away the numerous tiny little blood vessels that were wrapped around the part of my trigeminal nerve that gives sensation. The surgery only worked for three months, but it was a glorious three months.

Sometimes, it's the minor things: a change in the way pain feels, a new area of pain, or a change in how and when it happens. We may think, why bother the doctor with this? He won't care anyway. It's unimportant. If I tell him, he may think I'm a dolt or making things up. I’ll keep it to myself.

Which brings me to my second favorite saying: “You don't know what you don't know. And if you don't know what you don't know, how will you know if it matters?” 

Sometimes our deciding what a doctor doesn't need to know may be the one thing he needs to know the most. It may really matter. So let the words flow.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Medicare May Cover Training for Family Caregivers

By Judith Graham, KFF Health News

Even with extensive caregiving experience, Patti LaFleur was unprepared for the crisis that hit in April 2021, when her mother, Linda LaTurner, fell out of a chair and broke her hip.

LaTurner, 71, had been diagnosed with early-onset dementia seven years before. For two years, she’d been living with LaFleur, who managed insulin injections for her mother’s Type 1 diabetes, helped her shower and dress, dealt with her incontinence, and made sure she was eating well.

In the hospital after her mother’s hip replacement, LaFleur was told her mother would never walk again. When LaTurner came home, two emergency medical technicians brought her on a stretcher into the living room, put her on the bed LaFleur had set up, and wished LaFleur well.

That was the extent of help LaFleur received upon her mother’s discharge.

She didn’t know how to change her mother’s diapers or dress her since at that point LaTurner could barely move. She didn’t know how to turn her mother, who was spending all day in bed, to avoid bedsores.

Even after an occupational therapist visited several days later, LaFleur continued to face caretaking tasks she wasn’t sure how to handle.

“It’s already extremely challenging to be a caregiver for someone living with dementia. The lack of training in how to care for my mother just made an impossible job even more impossible,” said LaFleur, who lives in Auburn, Washington, a Seattle suburb. Her mother passed away in March 2022.

LINDA AND PATTI LAFLEUR

A new proposal from the Centers for Medicare & Medicaid Services addresses this often-lamented failure to support family, friends, and neighbors who care for frail, ill, and disabled older adults. For the first time, it would authorize Medicare payments to health care professionals to train informal caregivers who manage medications, assist loved ones with activities such as toileting and dressing, and oversee the use of medical equipment.

The proposal, which covers both individual and group training, is a long-overdue recognition of the role informal caregivers — also known as family caregivers — play in protecting the health and well-being of older adults. About 42 million Americans provided unpaid care to people 50 and older in 2020, according to a much-cited report.

“We know from our research that nearly 6 in 10 family caregivers assist with medical and nursing tasks such as injections, tube feedings, and changing catheters,” said Jason Resendez, president and CEO of the National Alliance for Caregiving. But fewer than 30% of caregivers have conversations with health professionals about how to help loved ones, he said.

Even fewer caregivers for older adults — only 7% — report receiving training related to tasks they perform, according to a June 2019 report in JAMA Internal Medicine.

Nancy LeaMond, chief advocacy and engagement officer for AARP, experienced this gap firsthand when she spent six years at home caring for her husband, who had amyotrophic lateral sclerosis, a neurological condition also known as Lou Gehrig’s disease. Although she hired health aides, they weren’t certified to operate the feeding tube her husband needed at the end of his life and couldn’t show LeaMond how to use it. Instead, she and her sons turned to the internet and trained themselves by watching videos.

“Until very recently, there’s been very little attention to the role of family caregivers and the need to support caregivers so they can be an effective part of the health delivery system,” she told me.

Training Coverage Could Begin Next Year

Several details of CMS’ proposal have yet to be finalized. Notably, CMS has asked for public comments on who should be considered a family caregiver for the purposes of training and how often training should be delivered.

If you’d like to let CMS know what you think about its caregiving training proposal, you can comment on the CMS site until 5 p.m. ET on Sept. 11. The expectation is that Medicare will start paying for caregiver training next year, and caregivers should start asking for it then.

Advocates said they favor a broad definition of caregiver. Since often several people perform these tasks, training should be available to more than one person, Resendez suggested. And since people are sometimes reimbursed by family members for their assistance, being unpaid shouldn’t be a requirement, suggested Anne Tumlinson, founder and chief executive officer of ATI Advisory, a consulting firm in aging and disability policy.

As for the frequency of training, a one-size-fits-all approach isn’t appropriate given the varied needs of older adults and the varied skills of people who assist them, said Sharmila Sandhu, vice president of regulatory affairs at the American Occupational Therapy Association.

Some caregivers may need a single session when a loved one is discharged from a hospital or a rehabilitation facility. Others may need ongoing training as conditions such as heart failure or dementia progress and new complications occur, said Kim Karr, who manages payment policy for AOTA.

When possible, training should be delivered in a person’s home rather than at a health care institution, suggested Donna Benton, director of the University of Southern California’s Family Caregiver Support Center and the Los Angeles Caregiver Resource Center. All too often, recommendations that caregivers get from health professionals aren’t easy to implement at home and need to be adjusted, she noted.

Nancy Gross, 72, of Mendham, New Jersey, experienced this when her husband, Jim Kotcho, 77, received a stem cell transplant for leukemia in May 2015.

Once Kotcho came home, Gross was responsible for flushing the port that had been implanted in his chest, administering medications through that site, and making sure all the equipment she was using was sterile.

Although a visiting nurse came out and offered education, it wasn’t adequate for the challenges Gross confronted.

“I’m not prone to crying, but when you think your loved one’s life is in your hands and you don’t know what to do, that’s unbelievably stressful,” she told me.

NANCY AND JIM KOTCHO

For her part, Cheryl Brown, 79, of San Bernardino, California — a caregiver for her husband, Hardy Brown Sr., 80, since he was diagnosed with ALS in 2002 — is skeptical about paying professionals for training. At the time of his diagnosis, doctors gave Hardy five years, at most, to live. But he didn’t accept that prognosis and ended up defying expectations.

HARDY AND CHERYL BROWN

Today, Hardy’s mind is fully intact, and he can move his hands and his arms but not the rest of his body. Looking after him is a full-time job for Cheryl, who is also chair of the executive committee of California’s Commission on Aging and a former member of the California State Assembly.

She said hiring paid help isn’t an option, given the expense. And that’s what irritates Cheryl about Medicare’s training proposal.

“What I need is someone who can come into my home and help me,” she told me. “I don’t see how someone like me, who’s been doing this a very long time, would benefit from this. We caregivers do all the work, and the professionals get the money? That makes no sense to me.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

America’s Biggest Fear: Fentanyl and Opioid Addiction

By Pat Anson, PNN Editor

The fentanyl crisis is the biggest public health problem in the US, according to two new surveys that highlight Americans’ growing fears about opioid addiction and the toxicity of street drugs.

The first survey, conducted by Axios-Ipsos, found that opioids and fentanyl have surpassed Covid-19, firearms, obesity and cancer as the nation’s #1 public health threat. Over one in four Americans (26%) ranked opioids and fentanyl first, replacing gun violence as the top threat to public health.  

Top U.S. Public Health Threats

Fentanyl is a synthetic opioid that is 100 times more potent than morphine. It has been used safely for decades as an analgesic during surgery and to treat severe pain, but in recent years illicit versions of fentanyl have come to dominate the black market, where they are used in counterfeit medication or mixed with substances like heroin. Most fatal overdoses in the U.S. involve illicit fentanyl, not prescription opioids.

The Axios-Ipsos survey found that about four in ten adults (44%) are aware that U.S. overdose deaths reached a record high last year. Americans who live in rural areas, which have some of the highest overdose rates, are even more familiar (51%) with the rising number of drug deaths. 

Over half the respondents (51%) said they cared a lot about overdoses and think the government should be doing more to reduce drug deaths (79%). Most also believe that government does not make the health and well-being of citizens a priority (62%).  

While most Americans trust the health information they get from federal agencies like the CDC (64%) and FDA (62%), there is more trust placed in health information from personal doctors (89%) and family members/close friends (75%). 

Other key findings about respondents’ drug use in the last three months:

  • 26% used a pain medication for which they had a prescription or knew someone who did

  • 3% used a pain medication for which they did not have a prescription or knew someone who did

  • 20% used cannabis or knew someone who did

  • 2% used hallucinogenic drugs or new someone who did

  • 2% used “other illegal drugs” or knew someone who did

“Pain medication” was not defined in the survey questions, so the responses may include some non-opioid analgesics.

The recently updated Axios-Ipsos American Health Index is based on a nationally representative sample of 1,162 adults, who were surveyed on a wide array of health topics from August 11-14.

Most Families Impacted by Addiction

The second survey, conducted by the non-profit KFF, asked a representative sample of 1,327 adults online and over the phone in July about a variety of drug and substance use issues.

Two-thirds of respondents said either they or a family member were addicted to alcohol or drugs, experienced homelessness due to addiction, or had a drug overdose resulting in hospitalization or death.  

Nearly three in ten (29%) said they or someone in their family were addicted to opioids, either prescription opioids or illicit ones like fentanyl and heroin. Opioid addiction was most common among rural residents (42%) and White adults (33%). Among those who experienced addiction firsthand, most said it had a negative impact on their family’s relationships and finances. 

Only 5% felt they themselves might be addicted to opioid painkillers, far less than those who believe they might be addicted to alcohol (13%). 

Fear about addiction is common. Over half (51%) of adults are worried that someone in their family will experience a substance use disorder and one-third (32%) are worried that someone in their family will overdose on opioids.  

About four in ten adults (39%) are worried that someone in their family will unintentionally consume illicit fentanyl, a fear that looms largest in rural areas (48%). 

SOURCE: KFF

Nearly three in ten respondents (29%) said they had been prescribed opioid pain medication in the past five years. Of those, most said their doctors had warned them about the risks of opioid addiction and dependence (57%), side effects from opioids (69%), other ways to manage pain (60%), and about keeping their medications in a safe place (58%).  

While fears about addiction to opioid pain medication are common, it doesn’t happen nearly as often as many people believe. A recent study in Australia found that 92% of patients prescribed opioids for the first time never progressed to long-term use. Less than 3% became persistent users or needed higher doses — and they were mostly seniors with chronic health problems.

Neither the KFF or Axios-Ipsos polls asked respondents about growing shortages of opioid pain medication or how the reduced supply was impacting legitimate pain patients.   

‘Unintended Victims’

The patient side of the story was shared this week in an opinion video by The New York Times. Video producers Vishakha Darbha, Lucy King and Adam Westbrook spoke with chronic pain patients who are the “unintended victims” of the national crackdown on opioid prescribing.

“America’s doctors have been put in a difficult position. But it doesn’t need to be this way. It is possible to stop overprescribing yet ensure that pain sufferers get the relief they deserve. The patients in our video have one message: Listen to us,” the producers said.

Chronic Pain Riskier Than Smoking for Heart Attack Survivors

By Pat Anson, PNN Editor

People recovering from a heart attack who have moderate or severe pain are significantly more likely to die -- even when the pain is not associated with heart disease – according to a large new study that highlights the deadly toll that chronic pain can have on health.

“Pain causes significant loss of function and may lead to disability, all of which contribute to major, global public health issues. Research indicates that pain is linked to higher risk of cardiovascular disease and overall death; however, the impact of pain on death after a heart attack has not yet been examined in large studies,” said lead author Linda Vixner, PhD, an associate professor of medical science at Dalarna University in Sweden.

Vixner and her colleagues analyzed 8.5 years of health data for over 18,300 Swedish adults who had a myocardial infarction (MI) – more commonly known as a heart attack. Their findings, published in the Journal of the American Heart Association, show that pain was common a year after the heart attack, with nearly 45% of participants reporting moderate or extreme pain. About two-thirds of them had persistent or long-term pain.

The effect of pain on mortality was even more pronounced than smoking, a well-known risk factor for cardiovascular disease, cancer and other health problems. Heart attack survivors who reported extreme pain were more than twice as likely to die from any cause during the study period, compared to those who had no pain. Those with moderate pain were 35% more likely to die.

Researchers say the study demonstrates that chronic pain is a major risk factor for health providers to consider when treating a patient recovering from a heart attack.

“Pain severity seems to be an important factor, because mortality among patients with chronic pain is higher than in the general population, especially when chronic pain is severe. In addition, we found that patients with extreme pain were less physically active,” they reported.

“Pain and cardiovascular diseases share many lifestyle‐related risk factors and risk factors related to socioeconomic status, which could be one explanation as to why mortality among patients with pain 1 year after MI was significantly higher than mortality in patients without pain. Pharmaceuticals commonly used in pain treatment (both opioids and nonsteroidal anti‐inflammatory agents) are associated with increased cardiovascular risk, which could also be a part of the explanation.”

Previous studies have found that long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) significantly raises the risk of a heart attack or stroke. The FDA says people with a history of cardiovascular disease are at the greatest risk. But the risk is also present for those who don't have heart problems.

A 2016 Vanderbilt University study found that long-term opioid users are more likely to die from cardiovascular and respiratory problems than they are from accidental overdoses.

Kaiser Permanente’s Expansion Faces Skepticism

By Harris Meyer, KFF Health News

As regulators review Kaiser Permanente’s proposed acquisition of a respected health system based in Pennsylvania, health care experts are still puzzling over how the surprise deal, announced in April, could fulfill the managed care giant’s promise of improving care and reducing costs for patients, including in its home state of California.

KP said it would acquire Danville, Pennsylvania-based Geisinger — which has 10 hospitals, 1,700 employed physicians, and a 600,000-member health plan in three states — as the first step in the creation of a new national health care organization called Risant Health. Oakland-based Kaiser Permanente said it expects to invest $5 billion in Risant over the next five years, and to add as many as six more nonprofit health systems during that period.

Industry experts believe KP’s aim is to build a big enough presence across the country to effectively compete with players like Amazon, Aetna CVS Health, Walmart Health, and UnitedHealth Group in providing health care for large corporate customers. Kaiser Permanente executives touted the potential for spreading the group’s vaunted brand of quality, lower-cost care around the country.

But it’s not clear how KP will be able to bring its model, in which facilities and doctors receive a monthly per-member fee for all care, to markets where it doesn’t own an integrated system of physicians, hospitals, and health plans, as it does in California. Critics note that KP’s efforts to expand failed in a number of states in the 1980s and 1990s.

In addition, the physician-led Permanente Medical Groups, which lead KP’s patient care, were not involved in the Risant deal, raising questions about how their expertise would be shared.

“I don’t know how Kaiser will bring its knowledge and best practices to improve health care delivery without the involvement of the medical group, which does all the care delivery,” said Robert Pearl, a former CEO of the Permanente Medical Group who’s now a lecturer at the Stanford Graduate School of Business.

Is Bigger Better?

There are also questions about how the expansion will benefit current KP customers. The tax-exempt, nonprofit organization has 39 hospitals, 24,000 physicians, and 12.7 million health plan members in eight states and Washington, D.C., though about three-quarters of its members are in California, where it controls nearly half of the private insurance market. KP reported $95 billion in revenue last year.

“We’ve asked Kaiser Permanente management questions about the deal’s advantages to employees and customers, but we haven’t heard back,” said Caroline Lucas, the executive director of the Coalition of Kaiser Permanente Unions, several of which are in contentious contract talks with the company. “Where is the money coming from? Are the citizens of California and other states subsidizing this expansion? How are they benefiting?”

Kaiser Permanente CEO Greg Adams declined to comment. A KP spokesperson, Steve Shivinsky, said the group’s physicians would be involved in developing a “platform” to offer other health systems its value-based care expertise, including in design of care models, pharmacy practices, consumer digital engagement, development of health insurance products, and best practices for supply chains. Shivinsky said work on the platform was just beginning.

“Risant Health’s success will firmly establish value-based care as a better model for health care in this country,” said Shivinsky, KP’s director of national media relations.

“If there is a commitment to truly delivering higher-quality and lower-cost care, it will take time and hard work,” said John Toussaint, chair of Catalysis, a nonprofit that trains executives in health care and other industries in quality improvement. “But frankly I’m skeptical that’s the reason for these types of mergers. Bigger may be better for increasing prices, but not necessarily for improving care.”

The deal may be a sign that KP, founded in 1945, is hearing the alluring call of lucrative fee-for-service medicine. “This gets Kaiser into the much bigger part of the market — commercial insurance — and expands beyond their traditional model of owning all the pieces and selling their own insurance,” said Glenn Melnick, a health economics professor at the University of Southern California.

The Geisinger acquisition is being reviewed by the Pennsylvania Insurance Department, with a 30-day public comment period ending Aug. 7, 2023. The Federal Trade Commission and the California attorney general’s office declined to say whether they were reviewing the deal. KP expects the deal to close sometime in 2024. There was no purchase price, but KP said Risant would make a minimum of $2 billion available to Geisinger through 2028, including income that Geisinger generates itself.

Federal and state antitrust regulators have expressed growing concern about consolidation of hospitals and physician groups into ever-larger organizations with the power to drive up prices. But antitrust experts say it’s unlikely regulators will challenge the deal since KP does not currently have a presence in Pennsylvania, Delaware, or Maine, where Geisinger operates.

Indeed, the deal could boost competition if KP’s investment enables Geisinger to expand beyond central and eastern Pennsylvania and take on the University of Pittsburgh Medical Center and Highmark, the state’s two dominant integrated health systems.

Around the country, Risant could be appealing to businesses that offer health plans to their employees.

“If Kaiser can become an effective player in more markets through Risant and that leads to greater price competition, that will be very attractive to large employers,” said Bill Kramer, senior adviser for health policy at the Purchaser Business Group on Health, which represents large employer health plans.

Smaller health systems and physician groups that are struggling financially may also see joining Risant as a more palatable option than being acquired by more profit-hungry entities, such as private equity firms, Melnick noted.

Through tight coordination between its physicians, hospitals, and health plans, KP has a strong track record of producing good health outcomes, particularly for plan members with chronic conditions such as high blood pressure and diabetes. In recent years, Kaiser doctors have also significantly reduced opioid prescribing.

KP hospitals and doctors are paid a monthly per-member fee for all care — called capitated payment. That gives KP a powerful financial incentive to keep members healthy and prevent costly hospital admissions and emergency room visits.

In contrast, Geisinger and most other health systems across the country generally are paid for each separate procedure — known as fee-for-service payment — giving them less incentive to keep patients healthy and reduce overall costs. Because of that, it’s not clear how KP’s value-based care model will work at Geisinger and other health systems acquired through Risant.

Adams has said Risant won’t try to fully replicate Kaiser Permanente’s model. Instead, Risant will help other health systems achieve the same kind of outcomes and cost savings while working with multiple insurers and providers.

KP also could potentially learn lessons from Geisinger and other health systems about producing better health outcomes at lower cost for members. Geisinger has won acclaim for its ProvenCare model, in which it accepts a fixed fee for providing an entire episode of care, such as heart bypass surgery, with no extra charge if the outcome isn’t satisfactory and the patient needs additional care.

But Kramer, a former KP executive, is skeptical. “It’s hard if not impossible to transform a medical group that’s reliant on fee-for-service payment into something like the Kaiser Permanente Medical Group,” he said.

Critics of the deal, citing KP’s failed expansion moves in the 1980s and 1990s, also worry that building Risant Health could distract KP executives from cost-control and quality improvement efforts in their home state and draw down the organization’s financial reserves, potentially leading to premium hikes.

In 1999, for example, KP sold a money-losing medical group it had established in North Carolina in the mid-’80s. It faced opposition from the local medical community and challenges with employer health plans, among other factors. Kramer also pointed to its withdrawal from other markets including Connecticut, Missouri, Ohio, and Texas.

Still, KP did succeed in establishing a significant presence in the mid-Atlantic states, Washington, D.C., and Georgia, though it doesn’t own hospitals in those markets. It also has long-standing operations in Hawaii, Colorado, and Oregon.

With Risant, KP will be up against very large, sophisticated managed care competitors including UnitedHealth’s Optum, which employs about 70,000 physicians across the country.

“Hopefully Kaiser’s senior leadership will be smarter this time around and avoid the kinds of problems they had when they expanded in the past,” Kramer said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues. It is not affiliated with Kaiser Permanente.

Expanded Insurance Coverage ‘Urgent Priority’ for Chronic Pain Patients

By Pat Anson, PNN Editor

A panel of experts convened by the University of Michigan is recommending expanded insurance coverage and better training of providers to address problems faced by millions of chronic pain patients on long-term opioid therapy. Although improving access to pain care is an “urgent priority,” it took nearly three years for the panel’s recommendations to be developed and released.

“Patients who take opioids for chronic pain face unique challenges in the present opioid policy landscape, including reduced access to care,” wrote lead author Adrianne Kehne, a former researcher at Michigan Medicine who is now a Research Project Manager at U.S. Department of Veterans Affairs.

“While there have been substantial efforts to improve access to care for OUD (opioid use disorder), the needs of this patient population have gone largely unrecognized and unaddressed.  Limited access to high-quality care has caused significant distress among both patients and providers, and increasing access is an urgent priority.”

In a paper recently published in the Journal of Pain Research, Kehne and her colleagues said recent efforts to improve access, such as a revised CDC guideline that takes a more flexible approach to opioid prescribing, may not be adequate.

“It remains to be seen how providers and policymakers respond to these new recommendations. The non-binding guideline may not be sufficient to reverse prescribing rules at the state and health system level or significantly change provider behaviors,” they wrote.

A Michigan-based panel of 24 experts, including providers, researchers, regulators, insurers and patients, first met online in September, 2020 to discuss ways to improve access to pain care. Their long-delayed recommendations -- which are only being made public now -- stop well short of reversing policies that discourage opioid prescribing.

Instead, they focus on changing insurance reimbursement policies, to allow providers to spend more time with patients and to offer multimodal, non-pharmacological treatments. Multimodal therapy includes acupuncture, chiropractic care, cognitive behavioral therapy, injected pain therapies and “collaborative care” techniques that are often not covered by insurance.

“In order to encourage more clinics to offer multimodal pain care and increase access for patients who currently don’t receive it, insurance companies and government health coverage programs such as Medicaid need to change how they pay for it,” said senior author Pooja Lagisetty, MD, an assistant professor of internal medicine at Michigan Medicine and the VA Ann Arbor Healthcare System.

“We are starting to see some change, most notably at the VA and in insurance coverage of physical therapy, but more is needed in order for patients and providers to have time to develop individualized approaches, overcome stigma around providing opioid-related care, and for clinics to begin offering non-medication services.”

Other key recommendations of the panel:

  • Make providers aware of how Michigan’s Prescription Drug Monitoring Program (PDMP) is “used in investigating and disciplining providers”

  • To reduce stigma, educate providers on the differences between addiction and dependency in patients on long-term opioid therapy

  • Improve provider education about chronic pain, as well as multimodal and non-pharmacological therapies

  • Train social workers in biopsychosocial factors involved in chronic pain treatment

  • Improve provider education and practices to address racial barriers and biases in pain care

  • Increase recruitment of providers from racial and ethnic minorities

The expert panel study was funded by the Michigan Health Endowment Fund, the National Institute on Drug Abuse and the National Institute on Aging.

Researchers say between 5 and 8 million U.S. patients currently take opioids long-term. That’s down from about 11 million a few years ago. Opioid prescribing in the U.S. has decline by 64% since its peak, and now stands at levels last seen in the year 2000. Despite that historic decline, fatal overdoses have climbed to record levels, fueled primarily by illicit fentanyl and other street drugs.

Illicit Drug Users Turn to Cannabis as ‘Safe Supply’ Option  

By Pat Anson, PNN Editor

The cannabis industry and its advocates have long said that medical marijuana could help solve the opioid crisis by reducing demand for prescription opioids. While the evidence for that claim is somewhat mixed, a new study suggests that cannabis may be useful in reducing demand for illicit opioids, such as fentanyl.

Researchers at UCLA and the British Columbia Centre on Substance Use surveyed 205 people in Vancouver, BC who use cannabis and “unregulated opioids” obtained on the black market. In recent years, Vancouver has become a laboratory for harm reduction programs aimed at reducing overdoses, such as “safe supply” sites that offer prescription opioids and injectable heroin to drug users.  

The survey findings, published in the International Journal of Drug Policy, found that almost half the participants used cannabis to manage their opioid cravings and nearly 58% reported decreasing their opioid use. Researchers say the association between cannabis and harm reduction was “mainly driven by those living with moderate to severe pain.”

“These findings indicate that cannabis use to manage opioid cravings is a prevalent motivation for cannabis use among PWUO (people who use unregulated opioids) and is associated with self-assessed reductions in opioid use during periods of cannabis use,” wrote lead author Hudson Reddon, PhD, a Postdoctoral Fellow at the BC Centre on Substance Use.

The study is believed to be the first to investigate if illicit drug users can successfully manage their opioid cravings with cannabis. If the findings are confirmed, it could broaden access to cannabis as a harm reduction measure.

A previous survey of illicit drug users by the BC Centre on Substance Use found that about 1 in 4 used cannabis for harm reduction. About half used cannabis as a substitute for cocaine, methamphetamine and other stimulants (50%) and nearly a third used it as a substitute for illicit opioids (31%). Other reasons for using cannabis include coming off of other drugs (25%), substitution for a legal substance (15%), and as a treatment for withdrawal (15%).

“Given the increasing harm of the drug toxicity crisis and ongoing maturation of the regulated cannabis market in Canada, evaluating how cannabis use patterns, such as substitution, impact opioid use behaviours will be important to inform public health and policy responses to mitigate the harms of opioid use and evolving cannabis access,” Reddon wrote.

“Increasing the accessibility of cannabis products for therapeutic use may be a useful supplementary strategy to mitigate exposure to unregulated opioids and associated harm during the ongoing drug toxicity crisis.”