Pain Clinic Chain to Pay $11M to Settle Fraud Claims

By Don Thompson, KFF Health News

The owner of one of California’s largest chains of pain management clinics has agreed to pay nearly $11.4 million to California, Oregon, and the federal government to settle allegations of Medicare and Medicaid fraud.

The U.S. Department of Justice and the states’ attorneys general say Francis Lagattuta, a physician, and his Lags Medical Centers performed — and billed for — medically unnecessary tests and procedures on thousands of patients over more than five years.

It was “a brazen scheme to defraud Medicare and Medicaid of millions of dollars by inflicting unnecessary and painful procedures on patients whom they were supposed to be relieving of pain,” Phillip Talbert, U.S. attorney for the Eastern District of California, said in a statement this month.

The federal Medicare program suspended reimbursements to Lags Medical in June 2020, and Medi-Cal, California’s Medicaid program, followed in May 2021. Lags Medical shut down the same day the state suspended reimbursements. The company, based in Lompoc, California, had more than 30 pain clinics, most of them in the Central Valley and the Central Coast.

A KFF Health News review last year found the abrupt closure left more than 20,000 California patients — mostly working-class people on government-funded insurance — struggling to obtain their medical records or continue receiving pain prescriptions, which often included opioids.

Lagattuta and Lags Medical did not admit liability under the settlement. Lagattuta denied the governments’ claims, saying in a statement he was “pleased” to announce the settlement of a “long-standing billing dispute.” As part of the agreement, Lagattuta will be barred for at least five years from receiving Medicare and Medicaid reimbursements.

“Since the Centers have been closed for a couple of years, it made sense for Dr. Lagattuta to settle the dispute and continue to move forward with his other business interests and practice,” Malcolm Segal, an attorney for Lagattuta and the centers, said in the statement.

According to state officials, the federal government will receive the bulk of the money, about $8.5 million. California will receive about $2.7 million, and an additional $130,000 will go to Oregon. The settlement amount is based in part on Lagattuta’s and Lags Medical’s “ability to pay.” It does not cover the governments’ full losses, which the U.S. attorney’s office in Sacramento said are not public record.

Blanket Orders for Unnecessary Tests

A nearly four-year investigation by federal officials and the California Department of Justice found that from March 2016 through August 2021, Lagattuta and his company submitted reimbursement claims for unneeded skin biopsies, spinal cord stimulation procedures, urine drug tests, and other tests and procedures.

Lagattuta began requiring all his clinics to perform various medical procedures on every patient, the officials said, no matter if they were needed or requested by patients’ medical providers. Patients who refused were told they would have their pain medication reduced and could suffer adverse medical consequences.

U.S. and California investigators piggybacked on a federal claim filed in late 2018 by a whistleblower, Steven Capeder, Lags Medical’s former operations and marketing director, who will receive more than $2 million of the settlement.

As part of the settlement, Lagattuta and his company acknowledged that in mid-2016 he began requiring his providers to do at least two to three skin biopsies on Medicare patients each day and told providers to quit if they wouldn’t comply. Such biopsies are used to measure small-fiber neuropathy, which causes burning pain with numbness and tingling in the feet and lower extremities.

According to the settlement, a monthly report in early 2018 set a goal of performing 250 biopsies a week. Lagattuta created a separate team that was required to order at least 150 biopsies weekly, often overruling providers. And the company’s chief executive officer in late 2019 texted Lagattuta to report a particularly high number of biopsies, illustrating the text with emojis of a money bag and a smiley face.

Authorities said Lagattuta violated regulations requiring that skin biopsy results be interpreted by a trained pathologist or neurologist. Instead, they say, Lagattuta had the biopsies read by a family member who had no formal medical training and by a former clinic executive’s spouse, who was trained as a respiratory therapist.

Lags Medical clinics performed more than 22,000 biopsies on Medi-Cal patients from 2016 through 2019.

The settlement also alleges Lagattuta encouraged unsuitable patients to undergo spinal cord stimulation. It describes the procedure as “an invasive surgery of last resort,” in which implants placed near the spinal cord apply low-voltage electrical pulses to nerve fibers.

Lagattuta paid a psychiatrist $3,000 each month to falsely certify that every Lags Medical candidate for the procedure had no psychological or substance use disorders that would negatively affect the outcome, according to the settlement. For instance, the settlement says the psychiatrist overruled a Lags Medical social worker to OK the procedure for a young woman who had bipolar disorder with hallucinations that included hearing a man’s voice ordering her out of bed.

He also issued blanket orders for every patient to have urine drug testing, a policy the company’s CEO said “should be a big money maker.”

KFF Health News found that from 2017 through 2019 nearly 60,000 of the most extensive urine drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for those tests.

The clinics “carefully examined, tested, and treated” more than 60,000 patients during the time covered by the settlement, “when others might have been content to prescribe medication to mask pain,” said Lagattuta’s statement. 

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

Few Fatal Overdoses Found in Rx Opioid Study

By Pat Anson, PNN Editor

The odds of having an overdose are relatively small for most people after getting their first opioid prescription, but are significantly higher if patients are over age 75, insured by Medicaid or Medicare, and have a history of depression or substance use disorders, according to a large new study.

Researchers analyzed health claims for nearly 237,000 opioid “naïve” patients in Oregon from 2013 to 2018, and found that about 3 in 1,000 (0.3%) experienced an overdose within three years of their first prescription. The vast majority of the 667 reported overdoses were non-fatal, and researchers could not determine if they involved illicit opioids or the opioids that patients were prescribed.  

“There were relative few fatal overdoses - I believe it was less than 100. So we didn't look further than that because there wasn't statistical power,” said lead author Scott Weiner, MD, an emergency physician at Brigham and Women’s Hospital in Boston. “Unfortunately, it is not possible to ascertain if the overdose was from illicit or prescribed opioids from the data.”  

One of the more surprising aspects of the study is that there was little association found between overdoses and high dose prescriptions. The CDC says opioids prescribed at daily doses that exceed 90 MME (morphine milligram equivalent) raise the risk of overdose, but Weiner and his colleagues found little evidence to support that.  

“Incidence of overdose was not associated with varying levels of MME that were received in the first 6 months, which may indicate that patient factors may be more important than the strength of the opioids prescribed. These are both novel findings,” researchers reported in in JAMA Network Open.

The research team did find a higher risk of overdose when patients were prescribed long-acting opioids such as oxycodone, or used opioids concurrently with benzodiazepines, a class of anti-anxiety medication.  

Patients in the study who refilled an opioid prescription 6 or more times also had a higher overdose risk, as did those who got refills from three or more pharmacies. 

Patients with alcohol or substance use disorders had the highest risk of overdose, as did those with a history of depression or psychosis. 

Medicaid, Medicare and Elderly Patients at High Risk

Another high risk factor associated with overdose is insurance coverage. Patients covered by Medicaid had an overdose risk almost four times higher than those covered by a private insurer, while those insured by Medicare Advantage had an overdose risk nearly 8 times higher than commercially insured patients. 

The finding that patients over age 75 had an overdose risk nearly three times higher than other age groups is not surprising, according to one pain management expert.

“Obviously, this older age group has more comorbidities which is also associated with increased risk,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “What we don’t know is why opioids were prescribed and if severity of pain or suicidality or denial to prescribe opioids for severe pain could be contributing factors for the higher risk of overdose with elderly patients.”

Weiner cautioned doctors against taking the findings too literally. For example, although African-Americans were found to have a higher risk of overdose compared to white patients, they make up only a small percentage of Oregon’s population, making the data for them statistically weak.

“I absolutely do not advocate for suboptimal pain control for any patient, regardless of their risk profile. However, I do want prescribers to be careful when prescribing opioids to any previously naive patient, and to be extra careful when prescribing to the higher risk groups,” Weiner told PNN in an email.

“For patients in the higher risk groups, particularly those with diagnosis of substance use disorders, I would counsel the patient and inform them of their elevated risk and come up with a game plan for safety. I am only unwilling to prescribe to anyone when I don't believe an opioid is indicated for their condition.”  

Obamacare Prevented Thousands of Opioid Overdose Deaths

By Pat Anson, PNN Editor

The expansion of Medicaid under the Affordable Care Act – widely known as Obamacare -- was associated with a six percent lower rate of opioid overdose deaths, according to a new study that estimates thousands of overdoses may have been prevented by expanding access to healthcare for millions of Americans.

Researchers also found a significant and unexpected increase in overdoses involving methadone, an addiction treatment drug sometimes used to treat chronic pain.

Thirty-two states and the District of Columbia opted to expand Medicaid eligibility under the Affordable Care Act (ACA), providing healthcare coverage to uninsured low-income adults. ACA requires that individuals who receive coverage be provided with mental health and substance use disorder treatment.

Researchers at the NYU Grossman School of Medicine and University of California, Davis looked at death certificate data from 49 states and the District of Columbia between 2001 and 2017— looking for changes in overdose rates in counties that expanded Medicaid under ACA compared to those that did not.

Their findings, published online in JAMA Network Open, suggest that Medicaid expansion prevented between 1,678 and 8,132 opioid overdose deaths from 2015 to 2017.

Overall, there was a 6% lower rate of opioid overdose deaths, an 11% lower rate of heroin overdoses, and a 10% lower rate of death involving fentanyl and synthetic opioids other than methadone in states that adopted the ACA.

"The findings of this study suggest that providing expanded access to health care may be a key policy lever to address the opioid overdose crisis," said senior author Magdalena Cerdá, DrPH, director of the Center for Opioid Epidemiology and Policy in the Department of Population Health at NYU Langone Health.

Methadone Overdoses Rose

Cerdá and her colleagues also found a concerning 11% increase in methadone overdose rates in states that expanded Medicaid under the ACA. Methadone is an opioid that has long been used to treat addiction, but it is also prescribed by some doctors to treat chronic pain.

“Although the rate of methadone-related mortality is relatively low compared with other opioid classes, our finding that Medicaid expansion was associated with increased methadone overdose deaths deserves further investigation,” researchers said.

“Past research has found high rates of methadone use to treat pain among Medicaid beneficiaries and that the drug is disproportionately associated with overdose deaths among individuals in this population, underscoring the importance of ongoing local, state, and federal actions to address safety concerns associated with methadone for pain in tandem with Medicaid expansion.”

In 2014, the methadone prescribing rate among Medicaid patients was nearly twice that of commercially insured patients. Medicaid patients were also slightly more likely to be prescribed methadone for pain (1.1% vs. 0.85%) as opposed to addiction.

Expansion Reduced Opioid Deaths

The ACA became law at a time when opioid overdose deaths were rising sharply. Some critics of Obamacare claimed that expanding access to low-cost opioid pain relievers would create an incentive for low-income Medicaid beneficiaries to sell their drugs.

“It stands to reason that expanding the program — particularly to people most susceptible to abuse — could worsen the problem,” a 2018 report by Sen. Ron Johnson (R-WI) claimed. “The epidemic has indeed spiraled into a national crisis since the Obamacare Medicaid expansion took effect in 2014. Drug overdose deaths have risen rapidly, at a much faster pace than before expansion.”

The NYU and UC Davis study found that theory to be false.

"Past research has found Medicaid expansion is associated with not only large decreases in the number of uninsured Americans, but also considerable increases in access to opioid use disorder treatment and the opioid overdose reversal medication naloxone," said lead author Nicole Kravitz-Wirtz, PhD, an assistant professor in the Department of Emergency Medicine at UC Davis.

"Ours was the first study to investigate the natural follow-up question: Is the expansion associated with reductions in local opioid overdose deaths? On balance, the answer appears to be yes." 

Many Alternative Therapies for Back Pain Not Covered

By Pat Anson, PNN Editor

A new study by the Johns Hopkins Bloomberg School of Public Health has confirmed what many back pain sufferers already know: Public and private health insurance plans often do not cover non-drug alternative pain therapies.

Bloomberg researchers looked at dozens of Medicaid, Medicare and commercial insurance coverage policies for chronic lower back pain and found that while most plans covered physical therapy and chiropractic care, there was little or no coverage for acupuncture, massage or counseling.

"This study reveals an important opportunity for insurers to broaden and standardize their coverage of non-drug pain treatments to encourage their use as safer alternatives to opioids," says senior author Caleb Alexander, MD, a professor of epidemiology at the Bloomberg School.  

Alexander and his colleagues examined 15 Medicaid, 15 Medicare Advantage and 15 major commercial insurer plans that were available in 16 states in 2017.

Most payers covered physical therapy (98%), occupational therapy (96%), and chiropractic care (89%), but coverage was inconsistent for many of the other therapies.

Acupuncture was covered by only five of the 45 insurance plans and only one plan covered therapeutic massage.

Nine of the Medicaid plans covered steroid injections, but only three covered psychological counseling.

"We were perplexed by the absence of coverage language on psychological interventions," Alexander says. "It's hard to imagine that insurers wouldn't cover that."  

Even for physical therapy, a well-established method for relieving lower back pain, insurance coverage was inconsistent.

"Some plans covered two visits, some six, some 12; some allowed you to refer yourself for treatment, while others required referral by a doctor," Alexander says. "That variation indicates a lack of consensus among insurers regarding what model coverage should be, or a lack of willingness to pay for it.”  

The Bloomberg study is being published online in the journal JAMA Network Open.  It was funded by the U.S. Department of Health and Human Services, National Institutes of Health and the Centers for Disease Control and Prevention.  

Lower back pain is the world’s leading cause of disability, but there is surprisingly little consensus on the best way to treat it. A recent series of reviews by an international team of experts in The Lancet medical journal found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Rachelle Buchbinder, PhD, a professor at Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

The authors recommend counseling, exercise and cognitive behavioral therapy as first-line treatments for short-term low back pain, followed by spinal manipulation, massage, acupuncture, meditation and yoga as second line treatments. They found limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) are not recommended at all.

Medicaid Expansion Did Not Fuel Opioid Crisis

By Pat Anson, PNN Editor

A new study is debunking claims that increased access to healthcare and pain management helped to fuel the opioid crisis. If anything, the opposite appears to be the case.

The study, published in the Journal of General Internal Medicine, found that early Medicaid expansions in Arizona, Maine and New York may have led to lower overdose rates in those states.

"These findings suggest that Medicaid expansions were unlikely to have contributed to the subsequent rise in drug overdose deaths, and may even have been protective," said lead author Atheendar Venkataramani, MD, PhD, an assistant professor of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania.

Venkataramani and co-author Paula Chatterjee, MD, looked at state-level data on drug overdoses from 1999 to 2008, comparing overdose mortality rates in the three Medicaid-expansion states to those in other states.

By 2008, Arizona, Maine and New York had about 7 fewer overdose deaths per 100,000 people compared to the other 47 states.

The differences were even greater when the three states were only compared to adjacent states: They had 17 fewer deaths per 100,000 people.

Overall, the study suggests that drug overdose deaths were nearly 20 percent lower in the early expansion states.

"The results should provide reassurance to policymakers who are concerned that state Medicaid expansions, including the recent expansions implemented as part of the Affordable Care Act, promote rises in drug overdose mortality," said Venkataramani.

The Affordable Care Act (ACA) – widely known as Obamacare – greatly expanded Medicaid coverage for millions of poor Americans, starting in 2014. But some critics have claimed the ACA made the opioid crisis worse by giving patients easier access to opioids.

“The Medicaid expansion may be fueling the opioid epidemic in communities across the country,” Wisconsin Sen. Ron Johnson (R) wrote in a 2017 letter to the Health and Human Services inspector general. “Because opioids are so available and inexpensive through Medicaid, it appears that the program has created a perverse incentive for people to use opioids, sell them for large profits and stay hooked.”

The Penn Medicine study wasn't designed to determine why Medicaid expansion appeared to lower overdose death rates in New York, Arizona and Maine. But it does suggest that better access to healthcare was a factor.

“Improving people’s access to health care could have a number of effects. It may be that people had better access to substance use disorder treatment or better access to mental health or pain management. Or it may be that providing health insurance reduced the risk of financial ruin, which helped downward socioeconomic spirals that could lead to substance use disorder,” Venkataramani wrote in an email to PNN.

“If Medicaid expansions did increase access to opioids, then the effect of doing so was far outweighed by other forces that actually reduced mortality rates from drug use order. The mechanisms again are not known because of data limitations in this study, but access to regular health care, access to substance use disorder treatment, and improved socioeconomic circumstances all may have contributed to the slower growth in drug overdose mortality in Medicaid expansion states.”

The Affordable Care Act expanded Medicaid coverage to about 12 million Americans in the 31 states and the District of Columbia that opted to receive it. A recent study found that opioid prescriptions decreased slightly in those states, while prescriptions for addiction treatment drugs like Suboxone rose significantly.

Oregon Health Official Defends Opioid Plan

By Pat Anson, Editor

The head of Oregon’s Health Authority is defending a controversial plan that would force many of the state’s Medicaid patients off opioids.

In an op/ed this week in the Wall Street Journal, Patrick Allen wrote that patients deserve “safe, effective choices to relieve pain -- not just a pill.” He suggested physical therapy, exercise and massage would be better alternatives.

At issue is a task force recommendation to limit Medicaid coverage of opioids to just 90-days for five broad chronic pain conditions – including fibromyalgia and chronic pain caused by trauma.  Patients already on opioids longer than 90 days would be given one year to taper off the medications and switch to alternative therapies that would be covered by Medicaid.

The plan has drawn criticism nationwide from chronic pain patients, advocates and pain management experts. Drs. Sally Satel and Stefan Kertesz wrote in another WSJ op/ed that the plan would “exacerbate suffering for thousands of patients.”

Allen disagrees, saying opioids are too risky to use long-term.

“This new proposal would expand evidence-based options for chronic pain management, allowing Oregonians to find a care plan that works for them,” Allen wrote.  “Evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function.

“Offering only one pain-management option that continues to kill Americans at alarming rates is a tragedy we can’t accept.”

According to his LinkedIn profile, Allen does not hold a medical degree and has spent most of his career working in the banking industry and as a state regulator in consumer and business affiars. He was appointed last year as director of the Oregon Health Authority, which operates the state’s Medicaid program and purchases health insurance for over 400,000 public employees and teachers.

PATRICK ALLEN

Oregon’s Health Evidence Review Commission held a public hearing on the opioid proposal earlier this month, but has not given final approval. If adopted, the opioid restrictions would not go into effect until 2020.

Opioid prescribing in Oregon has been declining for years – as it has nationwide – but the state has the highest rate of non-medical use of prescription opioids in the country. About three Oregonians die every week from an opioid overdose.

Oregon Opioid Plan Would Do 'Substantially More Harm'

By Pat Anson, Editor

A proposed change in Oregon’s Medicaid program would result in the forced tapering of many pain patients off opioid medication and do “substantially more harm than good,” according to a group of pain physicians, academics and patient advocates.

At issue is a recommendation by a task force to limit Oregon Health Plan coverage of opioids to just 90-days for five broad chronic pain conditions – including fibromyalgia and chronic pain caused by trauma.  Medicaid patients with those conditions taking opioids beyond 90 days would lose coverage for the pain relievers and be encouraged to use alternative pain therapies such as yoga, acupuncture and physical therapy, which would be covered under the plan.

“We recently learned of efforts by the Oregon Medicaid Pain Task Force to deny coverage of opioids beyond 90 days for most chronic pain conditions and, effectively, to mandate the taper of current patients receiving opioid therapy. We believe that such efforts risk doing substantially more harm than good,” wrote Kate Nicholson, a civil rights attorney and pain patient, in a letter to Oregon health officials. The letter was co-signed by over a dozen  physicians, academics and advocates.

“An across-the-board denial of opioid therapy for the huge umbrella category of chronic pain is as destructive as is liberally prescribing opioids for all types of chronic pain,” the letter warns. “The denial of coverage to the Medicaid population, in particular, is likely to have a disproportionate impact on individuals with disabilities, on the sickest patients and those with multiple chronic conditions.”

Oregon’s Health Evidence Review Commission will review the proposal at its August 9th meeting. The commission could give final approval as early as October, but the opioid restrictions would not go into effect until 2020, according to the Bend Bulletin.

“Individuals with chronic pain really face debilitating conditions that impact quality of life, yet we’re faced with this significant opioid epidemic where we know there’s a lot of misuse and overprescribing,” Dr. Dana Hargunani, chief medical officer for the Oregon Health Authority, told the Bulletin. “We’re trying to use evidence to guide us, but we really welcome public input into the process. I know it’s a really significant issue for many individuals.” 

Opioid prescribing in Oregon has been declining for years – as it has nationwide – yet the state has “one of the highest rates of prescription opioid abuse in the nation,” according to the Oregon Health Authority. An average of three Oregonians die every week from an opioid overdose. However, many of those deaths involve the “non-medical” use of opioid pain relievers by drug abusers, not patients.

The 2013 National Survey on Drug Use and Health found Oregon to have the highest rate of non-medical use of prescription pain relievers in the country.

“I’m very sad for the people who OD’d,” pain patient Steve Hix told the Bulletin. “But what’s that got to do with me?”

Fewer Opioids Prescribed in Medical Marijuana States

By Pat Anson, Editor

The availability of medical marijuana has significantly reduced opioid prescribing for Medicaid and Medicare patients, according to two large studies published in the Journal of the American Medical Association (JAMA).

In one study, researchers at the University of Georgia looked at Medicare Part D prescription drug data from 2010 to 2015. They found that the number of daily doses prescribed for morphine (-14%), hydrocodone (-10.5%) and fentanyl (-8.5%) declined in states with medical marijuana laws. However, daily doses for oxycodone increased (+4.4%) in those same states.

The drop in opioid prescribing was most pronounced in states that have medical marijuana dispensaries, as opposed to those that only allow home cultivation of cannabis for medical purposes.

“We found that prescriptions for hydrocodone and morphine had statistically significant negative associations with medical cannabis access via dispensaries,” wrote lead author W. David Bradford, PhD, Department of Public Administration and Policy at the University of Georgia.

“Combined with previously published studies suggesting cannabis laws are associated with lower opioid mortality, these findings further strengthen arguments in favor of considering medical applications of cannabis as one tool in the policy arsenal that can be used to diminish the harm of prescription opioids.”

The second study, by researchers at the University of Kentucky, looked at Medicaid prescriptions from 2011 to 2016, and found a 5.88% decline in opioid prescribing in states with medical marijuana laws.  Opioid prescribing for Medicaid patients fell even more -- by 6.38% -- in states where the recreational use of marijuana is legal.

“These findings suggest that medical and adult-use marijuana laws have the potential to reduce opioid prescribing for Medicaid enrollees, a segment of population with disproportionately high risk for chronic pain, opioid use disorder, and opioid overdose,” wrote lead author Hefei Wen, PhD, University of Kentucky College of Public Health.

One weakness of both studies is that they did not determine if Medicaid and Medicare patients reduced their use of opioid medication because they were using cannabis.  They also only included patients that were elderly, poor or disabled. And they were conducted during a period when nationwide opioid prescribing was in decline.

A recent study by the RAND corporation found little evidence that states with medical marijuana laws experience reductions in the volume of legally prescribed opioid medication. RAND researchers believe some pain patients may be experimenting with marijuana, but their numbers are not large enough to have a significant impact on prescribing. 

"If anything, states that adopt medical marijuana laws... experience a relative increase in the legal distribution of prescription opioids," the RAND study found. "Either the patients are continuing to use their opioid pain medications in addition to marijuana, or this patient group represents a small share of the overall medical opioid using population." 

Although 29 states and the District of Columbia have legalized medical marijuana and a handful of states allow its recreational use, marijuana remains illegal under federal law.

Prescriptions Plummet in Medical Marijuana States

By Pat Anson, Editor

Medical marijuana is giving some serious competition to the prescription drug industry. A new analysis of Medicaid claims found that prescriptions to treat pain, nausea, seizures, psychosis and depression plummeted in the 23 states and District of Columbia where medical marijuana was legal in 2014.

If all 50 states had medical marijuana laws that year, researchers say the potential savings to Medicaid and taxpayers would have been over a billion dollars.

“We found statistically and economically meaningful reductions in prescription drug use associated with the laws. This finding suggested that patients in states with such laws were substituting medical marijuana for prescription drugs,” W. David Bradford and Ashley Bradford, a father-daughter team of researchers at the University of Georgia, reported in the journal Health Affairs.

Previous studies have shown that prescriptions for opioid pain medication have fallen in states where medical marijuana is legal.

The new study was more comprehensive and included nine clinical areas that cannabis could be used to treat: anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders, and spasticity (muscle spasms).

Five of the nine clinical areas had significant drops in prescribing where medical marijuana was legal:

• 17% decline in anti-nausea medication
• 13% decline in antidepressants
• 12% decline in psychosis medication
• 12% decline in anti-seizure drugs
• 11% decline in pain medication

The study found no significant association between medical marijuana laws and drugs used to treat anxiety, glaucoma, sleep disorders or spasticity.

“There is no question that we see patients constantly turning to cannabis, to get off their other medications, mainly to eliminate the side effects they are experiencing.  At this time, this is a huge advantage to us all -- we get a healthier solution to help us with our medical issues and Medicare and Medicaid are seeing a reduction of costs,” said Ellen Lenox Smith, a PNN columnist, medical marijuana user and caretaker in Rhode Island.

“However, until we are able to receive insurance reimbursement like Germany started providing in March, we have to still pay out of pocket. So until we are treated fairly like this in the U.S., we will continue to be paying more for this safer help than if we went to the pharmacy to purchase medication with our co-pays. For me, however, the cost is worth the quality of life I have been able to achieve using cannabis.”

In the current study, researchers cautioned that using fewer prescription drugs is not necessarily a good thing for every marijuana user.

“Our findings do raise important questions about individual behavior. For example, it is plausible that forgoing medications with known safety, efficacy, and dosing profiles in favor of marijuana could be harmful under some circumstances,” said the Bradfords. “In addition, patients who switch from a prescription drug that requires regular physician monitoring to marijuana may interact with their doctor less often, and their adherence to other important treatment regimens could suffer.”

Previous studies have found a significant decline in use of opioid medication by patients who use marijuana and that marijuana users are not at greater risk of alcohol and drug abuse.

Currently medical marijuana is legal in 29 states and the District of Columbia.

Insurers Behind Medicare’s ‘Big Brother’ Opioid Policy

By Pat Anson, Editor

The insurance industry appears to have played a major role in the development of a new strategy by the federal government to combat the abuse of opioid pain medication.

As Pain News Network has reported, the plan calls on pharmacists to report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients (see “Medicare Takes ‘Big Brother’ Approach to Opioid Abuse”). Individual profiles of patients, their behavior, and opioid use would also be created and shared among insurance providers.

The plan was outlined earlier this month by the Centers for Medicare & Medicaid Services (CMS) in the agency’s proposed “Opioid Misuse Strategy.” 

The CMS plan closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  It states that all physicians should follow the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, even though the guidelines are voluntary and explicitly state they are not intended for all prescribers.

The white paper was drafted largely by insurance companies – called “Partner Champions” -- including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

“These HFPP Partner Champions have committed themselves to the creation of an HFPP White Paper that describes the best practices for serious consideration by all healthcare payers and other relevant stakeholders to effectively address and minimize the harms of opioids,”  the white paper states.

“Through coordinated action, payers, including members of the HFPP, have the opportunity to dramatically influence and reduce opioid misuse in the U.S. Simple actions performed systematically across a large group of stakeholders can considerably decrease the toll of prescription opioid misuse and OUD (opioid use disorder) in the U.S.”

Physicians and Patients Left Out

No other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were involved in a “special session” of the HFPP last October that led to the drafting of the white paper.

“It’s concerning that CMS appears to have developed a policy proposal regarding opioid prescribing solely on the basis of advice from a group dominated by the insurance industry, without asking for input from affected healthcare professional groups,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of physicians who specialize in pain care.

“We have to be mindful of the vested interests of insurance companies in this issue. Some advocates have argued that pharmaceutical manufacturers have wielded outsized influence in previous policy decisions, but there has been precious little focus on the influence of payers, which seems obvious in this case.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs.

“Who exactly are the individuals who put this information together for CMS… and what is their true aim?” asks Ingrid Hollis, the mother of a chronic pain patient. “It looks to me like collusion between insurance companies and federal agencies to cut costs.

“Senior citizens and those disabled with progressive painful diseases or injuries deserve better treatment than this. To single this community out for draconian policies based on what looks like purely profit motives in the name of ‘harm reduction’ is inhumane. Who is truly being harmed here?”

“When they describe insurance companies involved in their efforts as ‘Champions,’ it calls to mind comic book and movie heroes like Superman.  Superman was noble, his motives pure.  I don't think of profit-conscious insurers as being noble or pure in motive,” said Anne Fuqua, a disabled nurse, pain patient and patient advocate. 

“Involving insurance companies in setting policies that directly or indirectly impact prescribing and/or reimbursement presents a conflict of interest.”

Stewards, Stockers and Demanders

Under the proposed CMS policy, information about doctors and patients who’ve been red flagged by pharmacists for suspicious prescribing would be shared through a CMS database with all insurers. The companies would then be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

The HFPP white paper goes further, recommending that insurers develop profiles of each patient and classify them in one of three groups based on their behavior:

1. “Stewards” (patients who follow guidelines)
2. “Stockers” (patients who stockpile unused medications)
3. “Demanders” (patients who ask for medication)

“Segmenting patients by intentions/behaviors with regards to opioid prescriptions could help payers better target messages and disseminate tailored communications that are most salient to the recipient,” the white paper states.

“For example, stewards may be those who are more likely to adhere to the CDC guideline and seek non-pharmacologic or non-opioid pharmacologic therapies for chronic pain and stockers may be those who are likely to ask for an opioid prescription/have received an opioid prescription for chronic pain in the past.”

A data analysis of patients and doctors, according to the white paper, could also be used by insurers to develop computer models to identify “problematic actors and schemes” and “deny payments for prescriptions that do not conform to general prescribing practices.”

“The HFPP strongly encour­ages collaborative efforts to develop and widely disseminate effective strategies to identify: patients at risk of opioid misuse or OUD, providers whose opioid prescribing patterns fail to comply with quality indicators (such as the CDC Guideline for Prescribing Opioids for Chronic Pain), and methods that are particularly ef­fective at preventing or treating OUD,” the white paper states.

But critics say the profiling of patients and doctors, as well as the sharing of data from prescription drug monitoring programs (PDMPs), amounts to an invasion of privacy.

“PDMP data contains some of the most sensitive health information that is produced.  When PDMPs were introduced, confidentiality protections were stressed and prescribers and pharmacists could review the information,” says Anne Fuqua.

“Now, CMS is discussing their plan to provide open access to insurers participating in their database.  They flip between arguments that this will help insurers make sure people get needed treatments for addiction and fraud detection.  It's clear that detection of fraud and conserving on drug costs is the primary focus.”

Non-Opioid Treatments Encouraged

Like the CDC guidelines, the white paper discourages the use of opioid pain medication, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as an alternatives, as well as “non-pharmacological” treatments like cognitive behavioral therapy and chiropractic care. Addiction treatment drugs such as buprenorphine and methadone are strongly recommended for anyone showing signs of opioid use disorder.

“Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy,” the paper states.

Critics say the recommendations – and threats of sanctions against those who don’t follow them -- could interfere with the doctor-patient relationship.

"Proposals, like CMS' Opioid Misuse Strategy, aimed at combatting the prescription drug abuse crisis, while important, must be careful to not leave patients with a legitimate medical need without access to the treatments they and their doctors have determined are the best course of care,” the Alliance for Patient Access, a national network of physicians, said in a statement to PNN.

“Patient access can be impeded when physicians and patients feel threatened that they are being watched, may be reported, or their personal information shared by pharmacists and insurers. When that happens patients suffer and the physician-patient relationship, one based on trust, is strained.” 

“It should not be a surprise that insurance companies have been aggressively opposing the use of branded opioids. Their fiduciary responsibility is to their shareholders, not to patients,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Decisions by insurance companies are causing many patients to suffer. This is not right.”

“Patients and doctors don’t want insurance companies and other parties determining what is best for them.  Doctors have a medical degree, the experience, the knowledge and treatment plans are determined by the medical condition they are treating,” says Ingrid Hollis.

“They act in the best interest of the patient, and have pledged the Hippocratic Oath of ‘Do no harm.’ Can the same be said of the bean counters in the insurance industry? Insurance is interested in cost cutting and maximizing profits.  Doctors are trying to save lives.”

CMS has not said when it plans to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency has only said that in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

The HFPP white paper was released publicly for the first time Tuesday on the CMS website, without any explanation of its broader meaning or impact on Medicare and Medicaid policies.

An HFPP infographic urging people "to fight healthcare fraud, waste and abuse" was also released on the government-run website, without any indication that it was largely developed by the insurance industry.

Pain Community Reacts to ‘Big Brother’ Medicare Policy

By Pat Anson, Editor

Here we go again.

That’s seems to be the reaction from many in the pain community to plans by the federal government to have pharmacists report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients. (See “Medicare Takes Big Brother Approach to Opioid Abuse”)

The Centers for Medicare & Medicaid Services (CMS) says its new strategy to fight opioid abuse is aimed at “incentivizing prescribing behavior” by having pharmacists identify and report doctors who may be overprescribing opioids and patients who may be abusing them. 

“It is a terrible idea to pit pharmacist against physicians. It is an unbelievably perverse way to solve a serious healthcare problem that requires trust and collaboration among all the stakeholders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Many, many people with pain and addiction are going to be harmed by this decision.”

“This will only serve to further increase stigma and increase distrust between patients, their prescribers, and pharmacists,” says Anne Fuqua, a former nurse, chronic pain sufferer and patient advocate.

“Just the words ‘incentivized prescribing’ makes me shudder.  It may well help root out a limited number of substance abusers and decrease pharmacy claims for Medicare Part D and Medicaid, but this is neither an effective manner to intervene when substance abuse does exist nor an ethical way to decrease prescription drug benefit claims.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs. Under the new policy, information about doctors and patients who’ve been red flagged by pharmacists would be shared through a database with all insurers. The companies would be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

“A policy like this, that encourages pharmacists to report the prescriber or patient to the insurer for investigation, is dubious enough.  It's even more serious that the allegations would be entered in a database whether or not they are proven,” said Fuqua. “This would be like your doctor saying they think it's possible a patient is misusing medication and then emailing this to all the doctors in your state.  Every element of this reeks of big brother and directly contradicts treating addiction as a health issue.”

“It appears that CMS is dictating that pharmacists perform activities that are both outside of their training and the legal authority granted to them under the state's practice act,” said Steve Ariens, a retired pharmacist and patient advocate. “Pharmacists don't have access to the patient's entire medical records. They are being told by CMS to both diagnose and prescribe what is right for a patient.”

“Many of the pharmacists I know are already overworked with other regulations to the point of PDMP’s not being updated in a timely manner. I know of patients who have been affected by this personally,” said Barby Ingle, president of the International Pain Foundation and a PNN columnist.   

“What a pharmacist believes about a medication’s appropriateness should not come into play when they are not trained on the medical aspects of chronic conditions. Pharmacists know about medication, but not in-depth information on diseases we are living with and therefore should not be making the call on what they deem suspicious on behalf of a prescriber.”

Medicare Policy Based on CDC Guidelines

CMS is basing many of its policy decisions on opioid prescribing guidelines released last year by the Centers for Disease Control and Prevention. The guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and meant only for primary care physicians. But they are being widely adopted by insurers and doctors throughout the country as a “standard of care,” even though the scientific evidence supporting many of the guidelines is weak.

CMS seems unconcerned by that lack of evidence.

“Where sufficient evidence was not available, the CDC guidelines are based on expert opinion, as noted by the CDC,” the agency said in a 30-page briefing paper on its Opioid Misuse Strategy.

“The guidelines were formed by consensus of mostly people with agendas, biased against opioids, and totally insensitive to the needs of people in pain. The dose limits suggested by the CDC guidelines are arbitrary, not evidence based,” said Dr. Webster. “

“Let's be clear about the CDC guidelines.  A major reason the guidelines were developed was to reduce cost of drugs for payers.  If Medicare and Medicaid patients have an increasing incidence of opioid use disorder it is because these people do not have any alternative treatments for their pain other than an opioid. 

“If CMS is going to endorse the guidelines that have little to no science basis, then they should mandate all of the alternative therapies to opioids have unlimited coverage and that payers be mandated to provide adequate coverage for the underlying reasons that lead to opioid use and mental health disorders.  This would more likely reduce the incidence of an opioid use disorder.”

CMS is not requiring insurers to cover alternative pain therapies, such as massage and acupuncture, but says it is a prioritizing efforts to develop more evidence to support their use.

Public Not Informed

CMS convened a “cross-agency working group” to develop its opioid misuse strategy, and says it is “working closely” with other federal agencies such as the CDC, Food and Drug Administration, National Institutes of Health, and the White House Office of National Drug Control Policy. Members of the working group were not identified.

“CMS sought representatives from every component of the agency to ensure a broad range of expertise and perspectives. This diverse group assessed the benefits, limitations, and improvement opportunities within CMS’s current policies and programs. The group then defined desired outcomes from the perspective of CMS’s unique role as a leading payer of health care and identified key actions to achieve those outcomes,” the agency said in a statement on its website.

But CMS never held a public hearing or sought public comment prior to the strategy’s release last week. Several medical organizations and patient advocacy groups contacted by Pain News Network were unaware the policies were even being developed. 

“I was not even aware that these new CMS policies were being created and as a patient on Medicare, I think that we should have been notified at minimum,” said Barby Ingle. “Our opinion as patients in the program should have been a part of the voice of something that will affect proper and timely access to care.”

“Society would never tolerate any other patient group being treated in this manner,” said Anne Fuqua. “It's no accident that this provision has been given so little attention.”

On its website, CMS says it now welcomes “input from clinicians, patients, consumers, caregivers, manufacturers, researchers and others.” But it never makes clear how interested parties can comment or participate, such as a notice or public comment period published in the Federal Register.

The secretive actions of the agency – so far – are similar to those used by the CDC in developing its opioid prescribing guidelines. For several months, the CDC refused to identify members of a “core expert group” that helped draft the guidelines, which were released in September 2015 to a small and mostly selected online audience.

Initially, the public was given only 48 hours to comment on the CDC guidelines -- a decision that was reversed after a public outcry and threats of a lawsuit. Over 4,300 public comments were later received online, most of them in opposition to the guidelines, which were released virtually unchanged in March 2016.

CMS has not responded to repeated requests for an interview about its opioid misuse policies. It is not clear when the policies will be initiated, who was involved in drafting them, or where the idea came from.

CMS caved into political pressure last year when it agreed to drop pain related questions from patient satisfaction surveys. Politicians, hospitals, the American Medical Association, and other health organizations all claimed the questions encouraged the overprescribing of opioids. CMS officials said there was no evidence that was true, but agreed to eliminate the questions in 2017 patient surveys. The agency is still working on a future set of questions to replace them.

Medicare Takes 'Big Brother' Approach to Opioid Abuse

By Pat Anson, Editor

A new strategy being developed by Medicare to combat the abuse of opioid pain medication will encourage pharmacists to report physicians who may be prescribing opioids inappropriately. Patients that a pharmacist believes are abusing opioids could also be referred for investigation.

The strategy, which has yet to be finalized, was outlined by the Centers for Medicare & Medicaid Services (CMS) last week in a 30-page report on the agency’s “Opioid Misuse Strategy.”  It has not been widely publicized by CMS or reported in the news media.

“Many Medicare and Medicaid beneficiaries and their families have experienced opioid use disorder, commonly referred to as addiction,” the agency says in the report’s executive summary.

“Given the growing body of evidence on the risks of misuse… CMS is outlining our agency’s strategy and the array of actions underway to address the national opioid misuse epidemic.”

One strategy CMS will explore is “incentivizing prescribing behavior” by encouraging physicians and pharmacists to consult with prescription drug monitoring programs (PDMPs) to review each patient’s prescription drug history. The use of PDMPs is fairly widespread already, but CMS would take it a step further by encouraging pharmacists to report suspicious activity by prescribers and patients.

“Pharmacies would be able to identify prescribers with potentially illicit prescribing practices or beneficiaries (patients) who may be overusing opioids. This information can be referred to health plans to investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.”

Investigations of abuse or inappropriate prescribing would be shared with insurers enrolled in the giant Medicare/Medicaid system, even if the allegations are never proven. CMS contracts with dozens of private insurance companies to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“Part D plans can use CMS’s information sharing platform to identify leads for their own internal investigations and can report actions they have taken. For example, if one plan sponsor suspects a provider of inappropriate prescribing behavior, it can alert other plans to that possibility so that those plans can conduct their own evaluations and take coordinated action if warranted.

“The results of these projects are provided to plan sponsors so that additional actions can be taken, including initiating new investigations, conducting audits, or terminating physicians and pharmacies from their network.”

“It looks like ‘Big Brother’ is going to watch everyone,” says Rick Martin, a retired Las Vegas pharmacist who suffers from chronic back pain.

“Pharmacists are going to be even more paranoid than they already are," Martin wrote in an email. “Retail pharmacists don't have time for this. They aren't the police. Nevada has a PDMP. It already shows a significant decrease in prescribing patterns over the last several years, so it is working.  With the CMS, just who decides what are appropriate quantities and proper prescribing habits?”

CMS Using CDC’s Prescribing Guidelines

In developing its strategy, CMS is relying heavily on prescribing guidelines released in 2016 by the Centers for Disease Control and Prevention, which discourage doctors from prescribing opioids for chronic pain. CMS says it will use the “evidence-based guidelines” to determine what constitutes inappropriate prescribing. The guidelines include a recommendation that opioids be limited to no more than 90 mg of morphine equivalent milligrams a day, a dose that many patients in severe chronic pain consider inadequate. 

The CDC maintains the guidelines are “voluntary” and intended only for primary care physicians. However, under the CMS strategy, the guidelines would apply to all prescribers, except those treating cancer or patients in palliative care.

“I just hate to see something that CDC itself said was voluntary, was a recommendation, and really isn’t all that specific if you really read it, get turned into something that creates bright red lines. And if you step across the line, you’re going to get yourself in trouble. I don’t think that’s right,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, the nation's largest pain management organization.

CMS says the additional scrutiny of doctors and patients is needed because “the Medicare population has among the highest and fastest-growing rates of diagnosed opioid use disorder,” which the agency estimates at 6 out of every 1,000 beneficiaries. Addiction rates are higher among Medicaid beneficiaries, at 8.7 patients for every 1,000, a figure 10 times higher than patients covered by private insurance plans.

“Because there is no systematic policy of screening for opioid use disorder and patients are unlikely to volunteer that they are misusing their medication or are using opioids like heroin because of discrimination and stigma, these rates are likely underestimates,” CMS says.

Rick Martin believes the Medicare policies will make physicians even less likely to prescribe opioids and pharmacists less likely to fill legitimate prescriptions.

“Pharmacists, like the docs, are just plain scared. If they don't know you, many are reluctant to fill,” said Martin, who is enrolled in Medicare's Part D prescription drug plan.

“One pharmacy I went to refused to fill my bona fide legitimate prescription because it exceeded an arbitrary amount. The manager didn't want any extra scrutiny from DEA, the home office, the PDMP, the board of pharmacy, or the (drug) wholesaler. Even though I was in the system for over 2 years and had previously had even higher amounts filled.

“One of the pain docs I am working with told me he has gotten numerous letters from Humana and one other (insurer) because he is in the upper 1% of dispensing opioids. Well, duh!  He is an exclusive pain management doctor. They didn't compare him with other pain doctors, just ALL doctors. Stupid. What will the CMS do on top of what goes on already?”

Bob Twillman worries the CMS strategy will create distrust between physicians and pharmacists.

“We’ve been trying to make efforts over the last few years to get pharmacists and physicians to work more closely together. I’m concerned this could increase suspicion between the two and be counter to that effort,” said Twillman. “Getting prescribers and pharmacists to work together is an important thing in enhancing patient safety and if we do something like this and short circuit that effort we’re doing more harm than we are good.”

CMS did not say when it planned to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency only said in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

Also unclear is why CMS and the Department of Health and Human Services would take a major step affecting the healthcare of tens of millions of patients and their doctors in the final days of the Obama administration.

“The fact that this is coming out a couple of weeks before the new administration comes in does make it a little bit odd. It makes me wonder how many legs it has or whether it will carry over into the next administration,” said Twillman.