Long-term Antidepressant Use Tied to an Increase in CVD, Mortality Risk

https://www.medscape.com/viewarticle/981951

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DOJ sues Cigna for exaggerating patient illnesses

https://www.healthcaredive.com/news/doj-sues-cigna-healthcare-fraud-patient-diagnoses/634340/

The Department of Justice is suing Cigna over allegations it defrauded the Medicare program out of tens of millions of dollars by exaggerating patient illnesses to obtain increased monthly payments.

The exaggerated diagnoses were based on in-home assessment forms — not the testing or imaging required to diagnosis the complex conditions in question like kidney disease, congestive heart failure, rheumatoid arthritis and diabetes with renal complications, the DOJ alleges.

Cigna paid outside vendors to conduct in-home visits with its plan members. The insurer pressured the vendors to record high-value diagnoses that would lead to higher payments for Cigna, the department alleges.

The Medicare Advantage program pays insurers a higher monthly payment to insure members with more serious medical conditions.

Cigna knew that under Medicare Advantage “it would be paid more if its plan members appeared to be sicker,” U.S. Attorney for the Southern District of New York Damian Williams said in a statement.

The DOJ alleges that Cigna certified annually that the diagnoses were “accurate, complete, and truthful,” according to the complaint.

“We reject these allegations and will vigorously defend our Medicare Advantage business against them,” Cigna said in a email statement provided to Healthcare Dive.

The DOJ is intervening in a federal lawsuit originally filed by a whistleblower in 2017 that is now in the Middle District Court of Tennessee.

Nurse practitioners typically conducted these home visits for Cigna’s so-called 360 comprehensive assessment program. Cigna paid multiple vendors to complete the assessments with members across the country from 2012 to 2019, according to the complaint.

The purpose of the visits were not treat medical conditions but to complete the 360 form, created by Cigna, to capture diagnosis codes that would generate revenue, the DOJ alleges. These vendors were prohibited from providing any treatment during the home visits.

Nearly 6,650 home visits resulted in an extra $14 million in payments during the first nine months of 2014, the DOJ alleges, citing a internal report from Cigna. Those additional payments “far dwarfed the approximately $2.13 million that Cigna paid to the vendor,” the DOJ said in its complaint.

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CMS Puts the Kibosh on Misleading Medicare Advantage Sales Pitches

https://www.medpagetoday.com/special-reports/exclusives/101348

“Secret shoppers” found that 80% of agent calls with clients were inaccurate or insufficient

After reviewing thousands of complaints about “confusing, misleading, and/or inaccurate” Medicare Advantage ads, and using “secret shoppers” to document deceptive telephone sales pitches, the Centers for Medicare & Medicaid Services (CMS) announced it is putting its foot down on Thursday.

Kathryn A. Coleman, director of the agency’s Medicare Drug and Health Plan Contract Administration Group, said in a three-page letter that CMS is immediately enhancing its review of marketing materials, which must be submitted under its regulatory “File and Use” authority for Medicare Advantage and Part D drug plans, and “may exercise its authority to prohibit” their use.

Currently, Medicare Advantage marketing materials may go live 5 days after submission, provided that the company submitting them “certifies the material complies with all applicable standards.”

However, starting January 1, Coleman said that no television advertisements will qualify to be submitted under its “File and Use” authority, meaning that the ads will not run until CMS approves them. MedPage Today reached out to CMS for a response but did not hear back by press time.

“They’re trying to find a way to put the brakes on misleading advertising,” said John Greene, vice president of Congressional Affairs for the National Association of Health Underwriters.

Christopher Westfall of Senior Savings Network, which is licensed to sell health plans in 47 states, noted that “we hope that finally the regulators will hold these plans and call centers accountable. We have clients call us all the time telling us they have no idea what they were signed up for, and were shocked that they were not on original Medicare any longer. Now they were in an Advantage plan, with all kinds of restrictions.”

In her letter, Coleman said that the agency is “particularly concerned with recent national television advertisements promoting MA [Medicare Advantage] plan benefits and cost savings, which may only be available in limited service areas or for limited groups of enrollees, overstate the available benefits, as well as use words and imagery that may confuse beneficiaries or cause them to believe the advertisement is coming directly from the government.”

CMS is also reviewing recordings of agent and broker calls with potential enrollees, and continuing its secret shopping of marketing events “by reviewing television, print, and internet marketing and calling related phone numbers and/or requesting information via online tools.”

The agency approved a final rule this spring that requires all Medicare Advantage agents, brokers, and third-party marketing organizations to record all their calls with potential enrollees “in their entirety, including the enrollment process.” In her letter, Coleman said reviews of recordings will continue.

“Our secret shopping activities have discovered that some agents were not complying with current regulation and unduly pressuring beneficiaries, as well as failing to provide accurate or enough information to assist a beneficiary in making an informed enrollment decision,” she wrote.

Coleman also noted that the agency will take “compliance action against plans for activities and materials that do not comply with CMS’ requirements.” However, the letter did not specify what form compliance action might take.

Furthermore, she wrote that “CMS may, at any time, determine an accepted material is not in compliance with our rules and require modification and resubmission.”

It also will review “all marketing complaints” received during the annual enrollment period, which runs from October 15 to December 7, and will target its “oversight and review on MA organizations and Part D sponsors with higher or increasing rates of complaints.”

Greene said CMS shared with his organization some of what they were finding through the secret shopper program, “and some of the stories they told us were just dreadful.”

One example of what he considered deceptive is any ad that tells targeted beneficiaries that they will get money back in their Social Security checks if they enroll in a Medicare Advantage plan.

“That [claim] applies to an extremely limited number of people in certain zip codes,” Greene explained. “The people who are the so-called agents or the call centers that receive calls from those ads have this expression, ‘turn ’em and burn ’em,'” meaning rapidly enrolling a beneficiary in a plan without spending the time to find out what their needs are.

“That is not the sort of behavior that independent agents who are not involved in these call centers or broadcast ads would do,” he emphasized. “No independent agent spends 20 minutes with a client, a beneficiary. It takes several hours to go through their drug history. What pharmacies do they use? Do they use mail order? Their health status? Do they travel? What’s their financial tolerance? There’s all sorts of considerations as to whether they recommend a Medicare Advantage plan or a medical supplement.”

In an accompanying FAQ, CMS noted that “agents failed to provide the beneficiary with the necessary information or provided inaccurate information to make an informed choice for more than 80% of the calls reviewed,” giving examples such as “beneficiaries being told that if their medication was not on the formulary, the doctor could tell the plan and the plan would simply add it; or incorrectly stating that ‘nothing would change’ when beneficiaries asked if their current health coverage would stay the same.”

Greene said that his organization and many consumer groups “have been complaining for years” about misleading claims and ads, like the one featuring Joe Namath.

“But what changed is that the pandemic allowed for special enrollment periods for COVID-infected individuals, and that allowed the ads to run year-round. So naturally, complaints escalated,” Greene said. “That got the attention of [CMS administrator] Chiquita Brooks-LaSure and her deputies that they had to do something to reduce the complaints.”

He noted that some plans may advertise that their “extra benefits” include rides to the doctor, dental coverage, hearing aids, and home meals. But after the beneficiary enrolls, they learn that only a small portion of those costs are covered, or they have to go to certain providers who aren’t near their home, or that there are co-pays and deductibles.

“Plans are recognizing that this is a problem that they need to be more transparent about,” said Greene. “Sometimes they’ll give you a card and you can use it in any of those buckets that you want to, but once you spend it, right, it’s gone. And then you’re on the hook for the rest. There’s now a recognition that they have to do a better job of explaining exactly what these benefits are, how far they go, and what they actually cover.”

The CMS letter is part of a wide-ranging effort by many federal agencies to crack down on myriad Medicare Advantage plan practices, including delays and denials of care through prior authorization requirements, and concerns that dozens of plans fraudulently inflated the severity of their enrollees’ illnesses to receive billions of dollars more from the Medicare Trust Fund that were not needed for their patients’ care.

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5 myths about using Suboxone to treat opiate addiction

https://www.health.harvard.edu/blog/5-myths-about-using-suboxone-to-treat-opiate-addiction-2018032014496

What is Suboxone and how does it work?

Suboxone, a combination medication containing buprenorphine and naloxone, is one of the main medications used to treat opioid addiction. Using ‘medications for opioid use disorder’ is known as MOUD. Use of MOUD has been shown to lower the risk of fatal overdoses by approximately 50%. It also reduces the risk of nonfatal overdoses which are traumatic and medically dangerous.

Suboxone works by tightly binding to the same receptors in the brain as other opiates, such as heroin, morphine, and oxycodone. By doing so, it blunts intoxication with these other drugs, it prevents cravings, and it allows many people to transition back from a life of addiction to a life of normalcy and safety.

A key goal of many advocates is to make access to Suboxone much more widely available, so that people who are addicted to opiates can readily access it. Good places to start are in the emergency department and in the primary care doctor’s office. More doctors need to become “waivered” to prescribe this medication, which requires some training and a special license.

The vast majority of physicians, addiction experts, and advocates agree: Suboxone saves lives. The U.S. Government has recently been lightening up on the requirements needed for doctors and nurses to “get waivered” in an urgent attempt to increase the availability of Suboxone prescribers, as the number of opioid deaths keeps rising.

Common myths about using Suboxone to treat addiction

Unfortunately, within the addiction community and among the public at large, certain myths about Suboxone persist, and these myths add a further barrier to treatment for people suffering from opiate addiction.

Myth #1: You aren’t really in recovery if you’re on Suboxone.

Reality: While it depends on how you define “recovery,” the circa 1930’s era AA-influenced abstinence-based models that have dominated the past century of addiction care are generally giving way to more modern conceptions of recovery that encompass the use of medications such as Suboxone that  help regulate your brain chemistry. As addiction is increasingly viewed as a medical condition. Suboxone is viewed as a medication for a chronic condition, similar to a person with type 1 diabetes needing to take insulin. To say that you aren’t really in recovery if you are on Suboxone is stigmatizing to people who take Suboxone, and it’s not the medical reality of effective addiction treatment.

Myth #2: People frequently misuse Suboxone.

Reality: Suboxone, like any opiate, and many other medications, can be misused. However, because it is only a “partial” agonist of the main opiate receptor (the “mu” receptor), it causes  much less euphoria than the other opiates such as heroin and oxycodone. In many cases, people may use Suboxone (or “misuse” it, if that is defined as using it illegally) to help themselves manage their withdrawal, or even to get themselves off heroin or fentanyl. If Suboxone were more available to those who need it, they wouldn’t have to self-treat. We are, in effect, blaming the victims here.

Myth #3: It’s as easy to overdose on Suboxone as it is to overdose with other opiates.

Reality: It is extremely difficult to overdose on Suboxone alone. It is much more difficult to overdose on Suboxone compared to other opiates, because Suboxone is only a partial opiate receptor agonist, so there is a built-in “ceiling” effect. This means there is a limit to how much the opioid receptors can be activated by Suboxone, so there isn’t as great a risk of slowed breathing compared with potent opiates such as heroin, oxycodone, or morphine. When people do overdose on Suboxone, it is almost always because they are mixing it with sedatives such as benzodiazepines, medicines that also slow breathing.

Myth #4: Suboxone isn’t treatment for addiction if you aren’t getting therapy along with it.

Reality: Ideally, addiction treatment should include MOUD as well as therapy, recovery coaching, support groups, housing assistance, and employment support. But that doesn’t mean that one component, in the absence of all of the others, doesn’t constitute valid treatment for addiction. Currently, about 10-20% of people with opioid use disorder are getting anything that qualifies as adequate treatment for their disease, due to flaws in our healthcare system and shortages in qualified providers. So, while combination treatment is an admirable goal, it is unrealistic to expect that everyone with an addiction will receive all the aspects of treatment that they need, especially if you add in that many people who suffer from addiction often also lack access to regular healthcare and  health insurance. Further, treatment with Suboxone alone, without therapy, has been proven to be effective. But it can be even more effective if combined with additional supports, such as therapy, recovery coaching, etc.

Myth #5: Suboxone should only be taken for a short period of time.

Reality: Expert practitioners have different theories on how long Suboxone treatment should last for, but there is no evidence to support the claim that Suboxone should be taken for a short period of time as opposed to being maintained on it for the long term, just as a person would manage their diabetes with insulin for the long term. Ultimately, this comes down to patient preference.

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Tricare is health insurance for  active/retired members of our armed services and many US government employees.  Tricare changed their PBM’s to Express Scripts and they sent out contracts that provided reimbursements to – at least – independent pharmacies that was BELOW THE COST OF WHAT PHARMACIES HAD TO PAY TO PURCHASE THE MEDICATION FROM THEIR DRUG WHOLESALER.   It is generally consider a necessary business fact that any business that sells a product or service for LESS THAN what the product or service costs them to provide – will most likely not survive very long as a functioning business.  The non-negotiable contract that is being offered, will mean that abt 15,000 of independent pharmacies will have little choice but to decline to accept this contract. That is about 25%  of all community pharmacies are independent pharmacies and > 50% of independent pharmacies are located in cities/towns of < 20,000 population, areas that will not financially support the typical 15,000-18,000 sq ft chain pharmacies.  It is claimed that some per-cent of Tricare folks will have to drive 30 minutes in each direction to find the closest Express Scripts in network pharmacy.  I have read that any pt with Tricare coverage will be mandated – after the original Rx fill and 2 refills – will be mandated to use Express Scripts mail order pharmacy services – or pay full price at the local pharmacy independent or chain.

FDA has required temp storage for all Rx meds and even many OTC meds – The majority of medications are recommended to be stored at room temperature, between 59 to 77 degrees Fahrenheit.  Any medication that is exposed to 10F +/- of its required temp storage >24 hrs.   Its potency may be compromised, but the FDA doesn’t bother to monitor or enforce this temp storage requirement.  How many has seen a Fed-X, USP, USPS delivery vehicle that is “temp controlled”.  How many have seen their Rxs meds sent from a mail order pharmacy was <24hr in the delivery system from the mail order pharmacy to a pt’s mailbox ? The standard “bubble mail envelope” or cardboard box provide little/no insulation from the ambient temp the Rx meds  is exposed to. Currently CVS is in a 3 yr time frame to close 900 pharmacies – abt 10% of their total store count.  One particular CVS store closure was on the news this week … that could create a pharmacy desert in a geographic area that had a high percent of the population being old/poor.  Not every newly created “pharmacy desert” is going to make the news.   Walgreen has closed nearly 24 pharmacies in the San Francisco area and this week Walgreens announced closing 4 stores – out of a total of 39 – in the Louisville, KY market.  This new Tricare pharmacy contract is going to create a lot of pharmacy deserts – especially in rural areas.

Probably those who are young/healthy/take few Rxs and/or live in large cities  will have little problems or inconvenienced by all of these changes in the Rx distribution system. But those who live in rural areas, areas without some sort of public transportation, poor/high acuity pts who needs a “boat load” of medications and wake up one morning in a pharmacy desert and mandating getting their Rxs from a mail order pharmacy.  Many who will end up being “collateral damage” and their health/QOL being compromises, because some of the Federal bureaucracies and for profit corporations place a “low priority” on the subset of our population.

Rep Buddy Cater, from Pooler, Georgia has been in the House since Jan 2015 and owns three independent pharmacies and has been the only pharmacist in Congress until a second pharmacist was elected from TN – Diana Harshbarger – who came to the House in 2021 and she and her husband own/run a independent pharmacy, Premier Pharmacy in Kingsport, TN.

There is a form on this hyperlink – https://buddycarter.house.gov/forms/form/?ID=133 – to share your comments and opinions in regards to the action of Dept of Defense moving all Tricare pharmacy business to Express Scripts.

Protecting Pharmacy Access for TRICARE Beneficiaries

https://buddycarter.house.gov/forms/form/?ID=133

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per the CDC:  Between 1999 and 2020, according to the CDC, more than 564,000 people in the U.S. fatally overdosed from prescription and illicit opioids… what we do know, that starting in abt 2012, opiate Rxs started to decline each year going forward.  Wouldn’t it be interesting if they put the PER-CENT of the OD’s from legal and illegal opiates ? During the same 21 yr time frame… abt 11 million deaths were contributed to the use/abuse of the two drugs ALCOHOL & NICOTINE…  so – on average during that time frame abt 27,000/yr people died from the use/abuse of legal & illegal opiate substances… so the deaths from the use/abuse of the two legal drugs ALCOHOL & NICOTINE in a SINGLE YEAR… was close to the number of people who died from the use/abuse of some legal or illegal opiate in 21 yrs.

The question has to asked… should the DEA have guidelines of dispensing controlled substances that may be in conflict of what the prescriber wanted for the pt and/or what the pts need to help them optimize their quality of life ?

I find the wording of this sentence very interesting The archive may be of use of families harmed by the opioid crisis   I wonder – but doubt it – if the “families harmed by the opioid crisis” – include those pts who have had their medication reduced or stopped and committed suicide or died a premature deaths because of the complication of the pts comorbidity issues ?  There are many, many days that I wished that the puritanical thread in our societal fabric was much, much smaller and/or didn’t exist at all.

pharmacies in driving opioid epidemic

https://hub.jhu.edu/2022/10/14/opioid-industry-documents-pharmacy-role/

The latest documents added to the Opioid Industry Documents Archive illustrate the repeated failure of retail pharmacies to heed warning signs and safety guidelines

Johns Hopkins University and the University of California, San Francisco, or UCSF, have added new documents to the Opioid Industry Documents Archive that detail the role of retail pharmacies in the opioid overdose epidemic.

The documents, based on litigation led by the Florida Attorney General, the Ohio counties of Lake and Trumbull, and the San Francisco City Attorney, show how companies including CVS, Rite-Aid, Target, Walgreens, and Walmart repeatedly failed to employ safeguards meant to prevent the over-dispensing and diversion of potentially dangerous controlled substances.

The court records show that pharmacies repeatedly ignored the strict policies and guidelines from the Drug Enforcement Administration, or DEA, designed to protect patients who receive controlled substances like prescription opioids. The records also show that many of these pharmacies repeatedly faced disciplinary action for failing to take corrective steps after breaking the rules. Examples include:

• Not following DEA guidelines on drug dispensing
• Failing to report suspicious drug sales to the DEA
• Not having (or not following) a plan to prevent the illegal diversion of drugs
• In the case of Walgreens, engaging in deceptive marketing by not informing patients about the dangers of opioids

The archive, launched by the two research universities in March 2021, is a digital repository of publicly disclosed documents arising from litigation brought against opioid manufacturers and consultants to the manufacturers, distributors, and pharmacies by local and state governments and tribal communities. For decades, as opioid addiction and deaths mounted, the public knew very little about the hidden business of making and selling prescription painkillers. Thousands of lawsuits have since shone a bright light on the industry’s practices. The archive is collecting as many documents as possible and sharing them freely.

“Much attention has been paid to the role of pharmaceutical manufacturers like Purdue in causing the opioid epidemic. But the archive’s documents are showing the public with great detail that drug makers did not create this tragedy by themselves,” said G. Caleb Alexander, professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health and co-founding director of its Center for Drug Safety and Effectiveness. Alexander, who has served as a paid plaintiff’s expert in federal and state opioid litigation, added, “There is a long path from the pill maker to the public, with multiple players including pharmacies in between.”

The addition of more than 2,200 pharmacy documents will expand the archive’s collection of more than 1.5 million opioid industry documents.

The archive may be of use to many different parties, including families harmed by the opioid crisis, as well as the media, health care practitioners, students, lawyers, and researchers.

Documents are full-text searchable and include an array of relevant materials, including company emails, memos, presentations, sales reports, budgets, audit reports, Drug Enforcement Administration briefings, meeting agendas and minutes, expert witness reports, and trial transcripts.

The opioid archive is modeled after UCSF’s pioneering Truth Tobacco Industry Documents archive, which has fostered scientific and public health discoveries shaping tobacco policy in the U.S. and around the world. Like its counterpart, the opioid archive is designed to accommodate new documents from future settlements or judgments as litigation continues.

It will allow researchers and historians to find and analyze negative patterns and practices of industry behavior that can lead to new policies and laws to protect the public from criminal, unethical and dangerous behavior.

According to the Centers for Disease Control and Prevention, the first wave of opioid overdose deaths in the U.S. began as early as 1999 with the increased opioid prescribing of the 1990s.

Between 1999 and 2020, according to the CDC, more than 564,000 people in the U.S. fatally overdosed from prescription and illicit opioids.

The White House Council of Economic Advisers’ most recent analysis estimates that the opioid epidemic cost $696 billion in 2018, and more than $2.5 trillion between 2015 and 2018.

“These documents are of huge importance, now and in the long term,” said Kate Tasker, UCSF Industry Documents Library’s managing archivist. “We are making them publicly available as soon as possible so that they can inform current public health investigation and action, but we are also working to preserve them for future generations of researchers, historians, policymakers, and others who want to prevent harms such as these from happening again.”

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what I find interesting in this court issue is…  what they are talking about is “off-label” prescribing… in which day in and day out… off label prescribing is a significant percent of all prescriptions filled. But “they” seemed to dance around and side-step around the very issue of off-label prescribing. Off labeling prescribing typically has NO SCIENTIFIC EVIDENCE for what the med is being prescribed for, but here our legal system … uses no scientific as a reason for siding with the defendants.  In reality, there is a growing mountain of scientific evidence that these mRNA vaccines, may not be a “vaccine” in the truest sense, and may only – at best – provide some passive immunity to a pt.   In fact, 100 of millions of vaccinations where administered under FDA’s EMERGENCY USE AUTHORIZATION and only having a very brief/abbreviated short term clinical trial.

This was just posted today: The CDC director just got COVID. She got the new bivalent booster a month ago      Pres Biden and Dr Fauci also was tested positive once or twice after getting all the recommended vaccinations…  Yet the CDC is getting ready, at a very minimum, to mandate COVID-19 vaccine for all kids in school.  It would seem that POLITICAL SCIENCE is dictating what our healthcare is doing/recommended.  Someone must be making a lot of money or has a vested interest in all of these mandated vaccinations.

Court addressed how and why a pharmacist may legally decline to honor a prescription

https://www.pharmacytoday.org/article/S1042-0991(22)00798-8/fulltext

Rationale

The judge first considered the plaintiffs’ claim that they were asserting their “common law right to self-determination.” The judge reasoned that the implications of recognizing “not just the right to do whatever you want with your own body, but the right to force others to help you (so much for their right of self-determination) would be mind-boggling.”

The judge stated that the recognition of such a right would “completely upend” the regulation of health care professionals.

The judge then reviewed the plaintiffs’ allegation that the pharmacists’ refusal to honor their prescriptions was “extreme and outrageous” conduct, noting that to meet this legal standard, the conduct must be “so atrocious that it passes the bounds of decency and is utterly intolerable to a civilized community.”

The judge acknowledged that “there might be circumstances under which a pharmacist’s refusal to dispense life-saving medicine to a severely ill person because of the pharmacist’s political beliefs (or because of a policy of the pharmacist’s employer) could be extreme and outrageous.” However, the judge concluded that “this case does not remotely approach those circumstances.”

Lastly, the judge reviewed the plaintiffs’ allegation that the pharmacists had interfered with the physician’s performance of her contract to treat the patients.

However, the plaintiffs conceded that the physician had not breached her contract with them. A person cannot have interfered with a contract between other persons if the contract was actually fulfilled. The judge ruled that the pharmacists had taken no affirmative action to interfere with the physician-patient relationship. They had merely declined to participate.

The case was dismissed.

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Pharmacist sued for confiscating patient’s prescription

https://www.pharmacytoday.org/article/S1042-0991(20)30963-4/fulltext#relatedArticles

Rationale

The court evaluated the four elements of a negligence claim (duty owed, breach of duty, causation, and damages) and concluded that the patient had alleged sufficient facts to support such a claim.

The court then turned to the conversion claim. A civil lawsuit for “conversion” is similar to a criminal prosecution for theft. The main difference is that a conversion lawsuit is filed by a person from whom property was taken against the person who allegedly took the property, while a theft case is filed by the government against the alleged perpetrator.

The court evaluated the three elements of a conversion claim (plaintiff’s right to possession of the property, defendant’s wrongful act or disposition of property rights, and damages). It concluded that the patient had alleged sufficient facts to support this claim also.

The pharmacy’s motion to dismiss was denied. This does not mean that the pharmacy will lose the lawsuit. It simply means the alleged facts, if proven by the patient, can support liability of the pharmacy.

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Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say

False positives, false negatives remain a concern

https://www.medpagetoday.com/painmanagement/opioids/101359

An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD).

In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of currently available alternative forms of detecting OUD risk.

AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

Currently, no FDA-cleared or -approved devices are indicated for identifying genetic risk for OUD. SOLVD, maker of the AvertD device, submitted an initial de novo classification request for AvertD, which the FDA declined in August 2021. In June 2022, the company resubmitted its request after collecting additional information to address the agency’s concerns.

But for many advisory committee members, questions about the device lingered. “My vote was really based on my concerns about the clinical validity of this test,” said Laura Bierut, MD, of Washington University School of Medicine in St. Louis, who voted no. “I am concerned about the validity of these 15 SNPs really being able to differentiate people with opiate use disorder.”

At the meeting, SOLVD presented results of an observational study that demonstrated an 82.76% sensitivity and a 79.23% specificity for detecting OUD among 385 adults exposed to prescription oral opioids for 4 to 30 days. Slightly more than half (57%) of the sample population were men, and 92% were white.

“There was no safety evaluation of this device, which I thought was a really odd omission,” noted panelist Adam Gordon, MD, MPH, of the University of Utah in Salt Lake City, who voted no.

“We have no idea what the prescribing patterns would be after the test was implemented,” Gordon pointed out. “We have no patient-level outcomes. We have no assessment of both providers and patients of how they would approach receiving results of this test. And I think that’s a really important point because I’m really worried about the false positives.”

“I believe 100% of the risk associated with this test is with false positives and false negatives — both people being untreated or poorly treated because somehow it came back as a positive result, or being given inappropriate treatment because it said negative,” observed Timothy Ness, MD, PhD, of the University of Alabama at Birmingham, who also voted no.

For some panelists, the demographic makeup and sample selection of the study helped sway their decision. “I have a lot of concerns about the demographic population that was sampled in the testing, that it’s not reflective of the population that would actually be treated out there,” noted Sherif Zaafran, MD, president of the Texas Medical Board, who voted no.

And at least one committee member who voted yes did so with reservations. “I voted in favor of approval clearance,” said Wilson Compton, MD, MPE, deputy director of the NIH’s National Institute on Drug Abuse. “I would have preferred not to be able to answer yes or no but to give sort of a balance, and I just barely kicked into the yes area.”

“I heard lots of concerns expressed today about potential risks,” Compton acknowledged. “I expressed a number of those myself.”

“But the part of the question that tipped the balance for me was the second half where it asked for risks and benefits in comparison to current available technology,” he noted. “And to my mind, I think genetic tests are likely to add benefit compared to the currently used risk profile test that clinicians have available at this time.”

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https://youtu.be/RFazRe7TMAk

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