The Opioid Crisis Is Still a National Threat

Once again Congress is GIVEN A PASS over their contributions to the opiate crisis in the early 2000’s.  In 1999-2000 Congress passed the DECADE OF PAIN LAW… and The Joint Commission (JC) got involved and declared that pain was THE FIFTH VITAL SIGN – on par with the importance of  a pt’s Body Temperature, Pulse Rate, Respiration Rate, Blood Pressure.  JC made adequate pain management a MAJOR STANDARD for hospital to meet in order to attain certification by the JC.  Pt surveys given to pts on being discharged from the hospital were required to have questions about how their pain was treated while in the hospital. When the Decade of Pain Law expired, the politically party in the majority of Congress had FLIPPED and refused to renew the law.  Once that law was not renewed, JC disavowed any ownership of the 5th vital sign and pain was no longer a major standard for hospitals to meet when pts were in the hospital.  I guess that is no small coincidence that the number of opiate Rxs peaked a couple of years after the Decade of pain law expired and have continued to drop annual ever since.  Currently about 60% less from the earlier peak. While OD/poisoning from illegal fentanyl has increased around FOUR TIMES in a similar time frame. 

The Opioid Crisis Is Still a National Threat

https://www.medpagetoday.com/opinion/focusonpolicy/101502

Its shape is changing slightly, but we must continue to battle this scourge

Midterm election madness is in full swing and the incipient cold/flu/COVID season is looming. Our national opioid epidemic has largely disappeared from the headlines with the exception of local coverage when drugs are associated with a crime.

How are we faring in this longstanding battle?

First, a brief recap of what brought us to this point. Beginning in the late 1990s, pharmaceutical company misinformation about the addictive properties of opioid pain medications led providers to prescribe them at higher rates. This precipitated an alarming increase in the use and misuse of these highly addictive medications and, in 2017, prompted the Department of Health and Human Services to declare a public health emergency.

Since then, a great deal of effort and financial capital has gone into understanding the “upstream” conditions that fueled the crisis, and implementing interventions to resolve problems. However, the challenges are formidable; for instance –

  • Addressing social determinants such as poverty, joblessness, disparities, and crime
  • Changing long-established provider prescribing practices
  • Disrupting the supply chain for illegal manufacture and distribution of deadly opioid and synthetic preparations on a nationwide basis

On the “downstream” side, some interventions have been effective in preventing deaths and reducing recidivism. Consider the relative speed with which opioid antagonists (i.e., naloxone and naltrexone) have become an integral part of training for many police officers, emergency medical technicians, and non-emergency first responders. In fact, most states now permit people who are at risk — or who know someone at risk for an opioid overdose — to be trained in administering naloxone. There has also been a sizable uptick in the availability of mental health support services and medication assisted treatment options for people who have experienced a non-fatal opioid overdose.

So, back to my original question: are we any closer to winning the battle?

A quick scan of recent national statistics suggests that, rather than abating, the crisis may be undergoing a subtle transformation. A Substance Abuse and Mental Health Services Administration survey estimates that 9.5 million Americans age 12 and over misused opioids in 2020, down from 10.1 million the previous year. While this is encouraging, the survey data also show a disturbing increase in heroin use.

National hospitalization and mortality data provide a more robust assessment of the situation. From 2010-2018, opioid-involved overdose deaths rose from 21,088 to 46,802 in the U.S. Recent statistics paint an increasingly bleak picture. During the first year of the COVID pandemic, there was an increase of 30.6% in 12 months (68,630 overdose deaths through 2020). The increase was not confined to a few hot spots; statistically significant increases in drug overdose death rates were reported in 40 states.

Homing in on a specific locale, the Pennsylvania Health Care Cost Containment Council recently released its report on opioid overdose hospitalization trends in the state. In addition to differentiating between pain medication and heroin overdose hospitalizations, the report highlights trends across race/ethnicity and poverty levels from 2016 to 2021.

Over the 6-year period, there are indications that the crisis as we know it might be waning. For example, there was a 27% decrease in hospitalizations for opioid overdose (from 3,342 in 2016 to 2,429 in 2021), and the percentage of overdose hospitalizations associated with heroin also declined (from 47% of cases in 2016 to 30% of cases in 2021).

Analysis of demographic data suggests a worsening of “upstream” conditions. While hospitalization rates for opioid overdose decreased in the white, non-Hispanic population, they increased for both Black and Hispanic residents. Similarly, increased rates over time were observed for residents living in high-poverty areas (i.e., areas with a poverty rate >25%).

The statistics I find most alarming in this report relate to the drug fentanyl, a powerful and highly addictive synthetic opioid. In 2021, approximately 18% of all opioid overdose hospitalizations were for fentanyl overdose; and, of all opioid overdose hospitalizations that ended in death, 34% were for fentanyl overdose. National data reinforce these concerns; the CDC reports that overdose deaths from synthetic opioids (primarily fentanyl), psychostimulants (such as methamphetamine), and cocaine continued to increase in 2021 compared to 2020.

Inevitably, there is no simple answer to the question I raised. Although national- and state-level reports show hopeful declines in death rates from prescription opioids, the crisis appears to be evolving. We now face the prospect of rising deaths from fentanyl and other addictive substances.

The message is clear. Substance misuse is now –- and will likely remain — a serious threat to national and local population health. We cannot afford to avert our eyes!

If you sit on the sidelines… sitting on your hands… if nothing changes… if you are not part of the solution… you may be part of the problem

Just have to follow the $$$ trail

Posted by Steve Ariens on Sunday, October 30, 2022

‘Pill Mill’ Docs, You May Be in for a Big Scare

What has changed in the short time since the Ruan case faced the Supreme Court is that the opioid epidemic has gotten even worse. This puts pill mills and the doctors who fuel them firmly in the crosshairs of the media and the law.

Whether, if a physician’s good faith is a complete defense to a prosecution for prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.

The issue with “good faith” is that it’s simultaneously fact-based and subjective. Ten cases presenting 10 different fact sets are going to have some commonalities but also some critical differences. Of course, this is the case with Santos and Ruan.

The above statements from this article – are concerning -with recent CDC reports that AT LEAST 70%-75% of OD/poisoning involved illegal fentanyl yet in this article it is stated that “pill mills and doctors prescribing opiates has fueled this epidemic”. Rx opiate prescribing peaked in 2011-2012 and has been declining every year since and the DEA’s opiate productions quotas on the pharma have been cut abt 60% over the last 5 yrs +/-.  Are these attorneys that ill informed or the FACTS about opiate OD/poisoning no longer aligns with the agenda that the DEA created FIVE DECADES ago ?

maybe the details were in the transcript of the trial/testimony, but I have never any specifics from the DEA as to what they consider prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.  By and large when dealing with subjective diseases (pain,anxiety, depression, ADD/ADHD, various mental health issues) there is no real definitive tests that will signify the impact the particular disease issue is having on a pt’s QOL. Asking the pt is the only real indication that the prescriber has.  It is much like going to get your eyes tested for glasses.. the pt gets asked several times.. ” is one or two better ?”  Has anyone ever had a optometrist tell you.. this particular lens combination will let you see 20/20 and never put you thru the options of the optical variations  where the pt believes a particular combination is where they can see the best.

The same goes when a pt sees a psychiatrist about depression, anxiety or other various mental health issues. The psychiatrist prescribes one or more medications and sees the pt back in the office in a few weeks and asks the pt how their perception of  “how are you feeling”.. The Prescriber will increase, decrease the dose of the meds the pt is taking and/or change the medications the pt is taking and repeat the process every so many weeks or months.

When I first started working in a pharmacy all prescriptions were CASH. most stores had their own “store charge” and plastic charge cards were in their infancy, so were most physicians’ practices cash only or the practice had office charge account, but back then there was no PBM’s nor DEA.

Our Daughter, has a Masters in Psychology and when she decided to open her own private practice – for once in her life – she listened to me when I told her “if you can avoid it – don’t sign any insurance contracts – Her practice is now some 8 yrs old, she is only CASH up front and she will submit the pt’s insurance claims electronically – non assigned – the pt pays her up front and the pt’s insurance will send $$ to the pt for whatever the insurance allows for “talk therapy”.

Being a Psychologist, she has no prescriptive authority and there is some licensing board over Psychologists.  Bureaucratic oversight is minimal,  Does anyone else find it strange that there are certain healthcare professionals can have a CASH ONLY BUSINESS but others … because they are prescribing controlled substances… the law enforcement agency – THE DEA – can determine what is  a legal, valid activity of a medical practice ?

 

‘Pill Mill’ Docs, You May Be in for a Big Scare

https://www.medpagetoday.com/opinion/second-opinions/101457

Two recent Supreme Court cases have major implications for physician practice

Last week, in an otherwise unremarkable order list, the Supreme Court remanded a case involving a “pill mill” doctor to a lower court for further consideration, in a move that could impact previous precedent-setting decisions on prescribing liability.

The ultimate decision in the case, Santos, Medardo Q. v. United States (Santos), will have important implications for care.

Details of the Cases

Counsel for Medardo Queg Santos, MD, filed a writ of certiorari — a petition for review — with the Supreme Court earlier this year. The counsel argued that if the court were to decide that “pill mill” doctors could not be convicted absent a jury finding that they subjectively believed the doctor was wrongfully dispensing pills, then Santos should be cleared of his conviction.

I wrote about a similar case, Ruan v. United States, back in March, the day after the Supreme Court heard oral arguments.

In Ruan, the Supreme Court upheld a federal law making it illegal for doctors to prescribe opioids to patients without a legitimate medical purpose, but held, in a 9-0 ruling, that Xiulu Ruan, MD, the “pill mill” doctor in question, indeed had a good faith defense. He was, however, convicted for unauthorized distribution of controlled substances.

The historical context in which Ruan was charged was part of a push by the federal government to crack down on so-called “pill mills” or “opioid mills,” which are clinics where doctors prescribe opioids to patients without conducting any real examination, often with no regard for their long-term health or safety.

As for Santos, given that he had a pending application for certiorari in front of the Supreme Court and given the decision in Ruan, it should be a fait accompli that he and his conviction should have a similar fate.

Not so fast.

As I mentioned at the outset, last week the Supreme Court vacated the judgment against Santos and remanded the case to the 11th Circuit. I don’t believe that “further consideration” is going to result in the 11th Circuit simply aligning Santos with Ruan.

My theory is that Santos may again be considered by the Supreme Court after the 11th Circuit’s decision. This is because the Supreme Court might have seen something factually interesting in Santos that presents the Ruan issues in a different light. In other words, the settled law of Ruan might not be so settled, even after a 9-0 decision.

This could have serious implications for physician practice and care.

The Broader Context

What has changed in the short time since the Ruan case faced the Supreme Court is that the opioid epidemic has gotten even worse. This puts pill mills and the doctors who fuel them firmly in the crosshairs of the media and the law.

This zeitgeist speaks to the main issue presented to the Supreme Court in Santos, which mirrors that in Ruan:

Whether, if a physician’s good faith is a complete defense to a prosecution for prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.

The issue with “good faith” is that it’s simultaneously fact-based and subjective. Ten cases presenting 10 different fact sets are going to have some commonalities but also some critical differences. Of course, this is the case with Santos and Ruan.

In the recent ruling, the federal trial court found Santos (as well as a co-defendant) guilty of three counts of illegally distributing and dispensing controlled substances for no legitimate medical reason (similarly to Ruan’s conviction). However, unlike Ruan, Santos was also found guilty of conspiracy to distribute and dispense controlled substances outside the normal course of his professional practice.

Testimony at trial, which led to Santos’ conviction, spoke to his abuse of the system. Santos was director of a cash-only pain management clinic in Tampa, and over a 3-year period he and his co-defendant allegedly spent very little time with their patients and took little to no medical history or documentation. After this cursory medical attention, they allegedly prescribed what the trial court decided were excessive amounts of controlled substances, including morphine, oxycodone, hydrocodone, methadone, and more.

So, it was no surprise that the trial court found Santos guilty of these charges. This is not dissimilar to what happened at the trial court in Ruan’s case.

It’s critically important to understand that the 11th Circuit is a superb example of how a U.S. president can reshape a court. As Bloomberg Law recently highlighted, Trump nominees dominate the 11th Circuit Court of Appeals. Over half of these judges “got their posts through Trump’s aggressive remaking of the U.S. judiciary.”

Simply put, the 11th Circuit is a perfect venue to re-examine and realign Ruan.

As we examine this today, it’s worth considering whether the Supreme Court remanded this to the 11th Circuit because they see a factual basis for overturning Santos’ conviction (and aligning the decision with Ruan) or whether the Supreme Court sees a way for the 11th Circuit to distinguish this case from Ruan. In this latter instance, the 11th Circuit would, again, affirm the District Court’s decision and essentially take a bite out of Ruan.

Implications for Physician Practice

If the Santos decision holds, the implications for physician practice and care are immediate. Every bite that gets taken out of the Supreme Court’s decision in Ruan takes agency away from doctors to practice medicine as they see fit, using their best judgment and good faith as their north stars. But court decisions impact medical practice, and there is no denying that court decisions are influenced by the times we live in.

Ruan was one of Justice Stephen Breyer’s final decisions on the Supreme Court. While last term’s Supreme Court ruled that even doctors in a pill mill could be convicted only if a trial court jury found that they subjectively believed they were wrongfully dispensing pills, by the time Santos is decided by the 11th Circuit, close to a year will have passed since the Ruan decision.

As long as the U.S. government continues to crack down on illegal opioid production and distribution and opioid-related overdoses continue to rise, legislatures and courts will drive new regulation aimed at curbing opioid distribution and use.

In that context, doctors need to ask themselves whether they believe the scrutiny of their dispensing practices is the same, better, or worse than it was in March when the oral argument in Ruan was heard. They need to be responsive to the signals courts are sending about the good faith defense in Ruan and to keep a close eye on the impact of the upcoming Santos decision.

Joe Froetschel, JD, an experienced medical malpractice lawyer, observes that: “The Supreme Court’s decision in Ruan essentially established a rebuttable presumption that prescriptions from doctors are legitimate. The holding requires the government to prove, beyond a reasonable doubt, that an individual doctor ‘knowingly or intentionally’ acted in an unauthorized manner, which established an extremely high bar for prosecutors to meet in criminal cases.”

Ultimately, these cases present an ultimately more important question for doctors to consider:

Can it ever be good faith (and medically justifiable) for a physician to prescribe controlled substances without a legitimate medical purpose or outside the usual course of professional practice?

Reframing the question in this way makes the correct answer obvious, as it would to the 11th Circuit and the Supreme Court if they undertake a similar exercise.

The “good faith” standard is invariably subjective and a subjective standard should never operate as an absolute defense when assessing physician conduct. Why? Because a subjective good faith standard erodes patient safety.

For example, it’s not a valid defense in a traditional malpractice case for a doctor to say, “Well, I tried my best.” While that may be true, the real issue is whether the doctor’s care complied with the accepted standard of care. This is why objective standards are necessary to ensure safety, and allowing subjective defense will erode any culture of safety.

So, were I advising the Supreme Court in Santos, I would suggest that the standard of care remains the same: the care that a reasonably prudent physician would provide under the same or similar circumstances. By this logic, Santos should not be of much concern to physicians as it will not alter the standard of care in their practice area. Convictions should remain limited to the “pill mill” line of cases.

But, as last term’s Supreme Court reminded us again and again, nothing they do is predictable, and while not every decision defies logic, some of their more controversial ones clearly test its elasticity.

Aron Solomon, JD, is the chief legal analyst for Esquire Digital and the editor of Today’s Esquire. He has taught entrepreneurship at McGill University and the University of Pennsylvania, and was elected to Fastcase 50, recognizing the top 50 legal innovators in the world.

The Medicare Advantage Trade-Off: Saving Money, Losing Access

Medicare Advantage Prgms. (Medicare Part C) is provided by FOR PROFIT INSURANCE COMPANIES – who get so many $$/pt/month IF they spend less per pt per year they make money… if they spend more $$ per pt per year… they lose money…  the more expensive the cost to provide treatment to a pt’s particular health issue… more likely it will requrie a prior authorization and the pt just gets a denial… the most profittable thing that a Part-C can do is JUST SAY NO/Deny claims… hoping that the pt will just…GO AWAY

The Medicare Advantage Trade-Off: Saving Money, Losing Access

https://www.medpagetoday.com/special-reports/exclusives/101213

Beneficiaries may spend less on premiums, but care delays are common. Do worse outcomes follow?

From their ads, Medicare Advantage (MA) plans may seem like a low-cost, easy, and efficient way for America’s seniors to get healthcare. But Barry, a recently retired software executive, tells a cautionary tale.

When a gastric issue led the 65-year-old (his name has been changed to protect his privacy) to the hospital this summer, a CT and biopsy revealed pancreatic cancer. His oncologist came to his bedside to discuss next steps.

“We’ll need to do a PET scan to see if the tumor is localized, and that will determine whether we should do chemo or surgery,” he was told. With pancreatic cancer, the oncologist said, “the faster we move, the better.”

But the oncologist frowned. Unfortunately, the scan couldn’t be scheduled for 3 or 4 weeks.

“You’re the Cleveland Clinic,” Barry responded.

“We’re not the problem,” the oncologist replied. “We have to get approval from your insurance. We’ll submit it, they’ll reject it. There’s a lot of back and forth.”

Barry was puzzled. He had avoided signing up with an MA plan after his broker warned him that those enrollees often had to wait for prior authorization review, which delayed care for weeks to months.

“Just to be clear,” he said, “I’m not in Medicare Advantage. I have regular Medicare with a supplemental.”

The oncologist’s “whole demeanor changed,” he told MedPage Today. The frown became a smile.

“Well then, we can go a lot faster,” he was told.

He got his PET study 3 days later. Barry said a 4-week wait would be intolerable. More importantly, he said, “The sooner I could begin, the less chance the tumor would have to grow or spread elsewhere and become much more difficult to treat.”

With beneficiaries rapidly joining MA plans by the millions each year, more than half of those eligible will be in MA plans rather than traditional Medicare as soon as next year. By 2032, that number is projected to hit 61%, according to a Kaiser Family Foundation (KFF) analysis based on a Congressional Budget Office report.

They are wooed by ads promising low- or no-cost premiums, money added to their Social Security checks, free dentistry, home meals, prescriptions, and rides to the doctor. But those ads and marketing schemes don’t tell the whole story.

There is a greater, and less well-publicized, problem with MA plans — denial of physicians’ referrals for care. Even after appeals and approval, there are delays in scheduling. It’s a game that gobbles up huge amounts of staff time, clinicians complain. One physician said he expects all MA referral requests to be denied at least once.

“We hear about MA policies that seem to purposefully use all sorts of protocols to deny people care, or at least delay it, and we’ve seen more and more complaints,” said David Weil, program manager for the San Diego-based Health Insurance Counseling and Advocacy Program, a federally funded service that provides free, impartial insurance advice and education for Medicare beneficiaries.

Even when services are finally approved, Weil continued, “some MA beneficiaries go to schedule their test or procedure and find it’s nearly impossible.”

The advertisements on TV are particularly misleading and worrisome, he said. Featuring stars like Joe Namath, William Shatner, or Jimmie Walker, they urge beneficiaries to “call the number on your screen,” reassuring that “It’s free.”

“We’re seeing this all the time – people who have been taken in by advertising that changes their Medicare benefits to a Medicare Advantage plan to the detriment of their medical outcomes,” Weil said.

“They can’t see their doctors that they had been going to, and they have to work up all the tests and everything has to be redone with new providers. We continue to see clients who have been harmed by brokers who switch them to a plan that doesn’t work for them. They just sign them up for the highest commission that they’ll be paid.” (For a sidebar on incentives that lead brokers to steer new beneficiaries toward Medicare Advantage plans, click here.)

A Good Idea Gone Bad

The goal in creating the MA concept in 1997 appeared to be a noble one. As of 1999, new Medicare+Choice plan patients would get all their care from providers who talked with each other and coordinated services, thereby reducing waste and overuse. While absorbing risk of taking on sicker patients, they’d be incentivized to use resources judiciously, thus reducing harm from unnecessary care, and cost the Medicare program much less.

But that’s not how it’s worked out.

According to a KFF report, in 2019, Medicare spent an average of $321 more for an MA enrollee than if that enrollee was in traditional Medicare.

Subsequent to a flurry of Congressional hearings earlier this year, CMS recognized a problem with MA plans and in April acknowledged a growing number of complaints, some 15,497 in 2020 and 39,617 in 2021, excluding December.

On August 1, it asked for public input on some 46 potentially problematic aspects of MA plans. For example, it asked about the plans’ “specific prior authorization and utilization management techniques.” And on marketing, it asked, “How well do MA plans’ marketing efforts inform beneficiaries about the details of a given plan?” with specific examples of effective or ineffective techniques.

In a 42-page response, the Center for Medicare Advocacy said while there are barriers in traditional Medicare, those barriers are worse for MA enrollees.

In a nutshell, its attorneys David Lipschutz and Kata Kertesz wrote, MA plans seem to work well for the young and healthy, but not so well for many who are not.

“This is a population that is falling through the cracks when it comes to accessing medically necessary care in MA plans.” “Much more drastic changes are needed in order to adequately protect Medicare beneficiaries against an onslaught of overly aggressive and often misleading Medicare Advantage marketing performed by those who have significant financial stakes in steering people towards MA plans, regardless of whether such option is the best course for an individual,” they wrote.

Delays and Denial of Care

It is also of concern because of several reports suggesting that some MA plans deny care.

One Government Accountability Office analysis conveyed concern about the inordinate disenrollment of enrollees from MA plans, and into fee-for-service, in their last year of life. The report raised questions about whether they were able to get timely, needed care before they died.

Another report from the OIG in April found numerous examples of MA plans denying or delaying approval for enrollees’ recommended services, even though they were legitimately covered under Medicare benefits.

“We found that, among the prior authorization requests that MAOs [Medicare Advantage organizations] denied, 13% met Medicare coverage rules; in other words, these services likely would have been approved for these beneficiaries under” fee-for-service or traditional Medicare, the report said.

Mary Beth Donahue, President and CEO of Better Medicare Alliance, which represents more than 180 provider groups, health systems, and health plans, objected to the criticism of MA plans.

“More than 29 million seniors and individuals with disabilities make an active choice to enroll in Medicare Advantage because it provides a 94% consumer satisfaction rate, supplemental benefits that meaningfully improve beneficiaries’ health, fewer avoidable hospitalizations, and annual savings of nearly $2,000 per year – demonstrating an affordability that is particularly important for seniors on fixed incomes in a period of inflation on household costs,” she said.

She disputed the KFF report that MA enrollees cost more than those in traditional Medicare, saying that the plans receive “support from a record-setting bipartisan supermajority in Congress because it delivers lower per-beneficiary government spending while bringing coverage to a more diverse, lower-income, and more medically complex beneficiary population, all while taking important strides on policymakers’ health equity goals. These are the facts on Medicare Advantage conspicuously missing in recent misleading media reports.”

Three Years to a Diagnosis

Craig Rose, a 74-year-old San Diego man with a SCAN MA plan, started having recurring bouts of pneumonia just over 3 years ago. None of his doctors could identify the cause, and Rose wondered if the network’s pulmonologists were rigorously investigating his symptoms, or taking it slow, since Rose, a former runner, is trim and otherwise healthy.

While traveling in New York last June, Rose noted traces of blood in his sputum. He called his pulmonologist who advised him to stick with the plan, which meant undergoing a lung scan the following month but if he began coughing up blood, he should go to an ER.

Within 36 hours, Rose was coughing up blood. He spent four days at NYU Langone Health with pneumonia. Doctors there told him to get a bronchoscopy as soon as he got home. After another brief delay, that procedure revealed a rare case of nontuberculosis mycobacterial (NTM) infection.

Rose’s MA network did not have an NTM specialist but his internet search found one at UC San Diego Health, Wael El Maraachli, MD, just a few miles away. Rose’s MA plan denied him coverage since he was not in network, then rejected his appeal.

He scheduled anyway and paid nearly $900 out of pocket including labs, and will continue his care at UCSD. Now, he questions whether his diagnosis might have come months — if not years — sooner, and less costly had he been insured through traditional Medicare with a supplement.

Numerous beneficiaries told MedPage Today that they signed up for their MA plans when they were younger and healthier. Their premiums were zero or low. But after they needed care for newly diagnosed chronic conditions, they found themselves paying far more in co-pays and deductibles than a supplemental plan would have cost them. Now with pre-existing conditions they’re ineligible to sign up for a supplement. They’re stuck.

Saving Money, Losing Access

Paul Speckart, MD, a San Diego endocrinologist, told MedPage Today that prior authorization — the ritual of applying for approval, being denied, and reapplying — is a frustrating process he must endure for many of his patients regardless of their coverage. But it’s always worse when the patient has an MA plan, he said.

He tells those patients in or considering MA that “they’re trading money for access,” that is low or no premiums for a limited network, and they may not be able to see the best specialist for their problem. “I have to tell them, ‘Your plan does not offer that,'” he said.

And there are longer delays in scheduling when contracted providers are backed up, creating a logjam for those waiting to be seen. A recent patient complained to him that after waiting to see a dermatologist, he felt like “an object who got a cursory exam.”

The plans collect a per capita sum from Medicare, but can delay paying money out — “all to cut down on usage and save money,” Speckart said.

In recent months, several Congressional hearings and inquiries have focused on the dozens of Office of Inspector General reports that found MA companies submitted fraudulent diagnosis codes that were not supported in patients’ medical records. In less than two years, according to a MedPage Today search, the OIG accused some 20 MA companies that received overpayments from Medicare trust funds of at least $461 million, five of them last month.

Diagnosis codes exaggerated patients’ health status to make them appear sicker and more expensive than they were, and thus, they’d receive hundreds of dollars per enrollee more each month than audits of their health records justified.

On September 20, 2021, the OIG quantified their concern. “We found that 20 of the 162 MA companies drove a disproportionate share of the $9.2 billion in payments from diagnoses that were reported only on chart reviews and HRAs [health risk assessments], and on no other service records.”

“One company further stood out in its use of chart reviews and HRAs to drive risk adjusted payments without encounter records of any other services provided to the beneficiaries for those diagnoses,” the agency said.

A recent New York Times investigation quoted a former government official that estimated MA plans overbilled the government’s Medicare funds as high as $25 billion in 2020 alone.

Wendell Potter, former executive with two large health plan companies, Cigna and Humana, said on Democracy Now that MA plans “will be recognized in years to come as the biggest heist, the biggest fraud, and the biggest transfer of wealth from taxpayers, middle-income, low-income Americans” to corporate executives and shareholders.

TRICARE changes force 15,000 pharmacies out of network

TRICARE changes force 15,000 pharmacies out of network

https://www.legion.org/veteransbenefits/257335/tricare-changes-force-15000-pharmacies-out-network

Nearly 15,000 independent pharmacies are no longer in the TRICARE retail pharmacy network, as of Oct. 24. This is due to a change in the contract with Express Scripts, the Department of Defense TRICARE pharmacy contractor.

TRICARE says that over 90% of beneficiaries will still have an in-network pharmacy within 15 minutes from their home. However, the impact on veterans living in rural areas — who already face barriers in access to care — remains to be seen.

“The Defense Health Agency is confident that the new pharmacy contract maintains the quality of the TRICARE retail pharmacy network,” said Edward Norton, Jr., chief of the Pharmacy Operations Division at the Defense Health Agency. “Some independent pharmacies are leaving, but TRICARE families will continue to have access to an excellent network of pharmacies.”

Express Scripts sent letters to beneficiaries notifying them of the change.  If you have a prescription at one of the pharmacies leaving the network and would like to transfer it to a new retail network pharmacy, beneficiaries may use the Find a Pharmacy tool to find retail network pharmacies in your area.

Here are three easy ways to move your prescription:

– Take your medicine bottles to another participating network pharmacy. The pharmacy will inform you of their process.

– Call your doctor’s office. Ask them to send your prescription to your new in-network pharmacy.

– Call your new in-network pharmacy and ask them to transfer your prescription.

If you experience difficulties filling a prescription due to your pharmacy being removed from the TRICARE retail pharmacy network, The American Legion wants to hear from you by reaching out to the National Security Division email at  NationalSecurityDivision@legion.org.

Ketamine Linked to Reduced Suicidal Thoughts, Depression, Anxiety

While this study involved using Ketamine as a IV infusion with pts that state they are suicidial.  I know at least one pt that is using Ketamine that is being prescribed by a Psycharitist and a compounding pharmacy is making Ketamine Troche.  A Troche is like a cough drop and is designed to be put in the buccal area (between cheek and gums) and let it dissolve.   Doing this, the medication is aborbed by the body in a similar methodology like a pt getting a Sub-Q or IM injection.  The medication misses first pass of the liver metabolism and goes directly to the receptor site(s), also avoids the stomach acid which could be rather destructive on the Ketamine. The pt that I am aware of is getting a Troche that is FOUR TIMES what the pt is suppose to take – but the pt breaks the troche into quarters.  Studies have demonstrated that when a pt breaks a tablet in HALF that each HALF will be +/- 20% of what would be otherwise expected. When a pt starts breaking a tablet into QUARTERS – 4 pieces – the dose the pt is taking could be highly variable. There is no better way to get a very inconsistent therapy outcome from taking a particular medication.

What I would suggest is that a prescriber give the pt the Ketamine injectable and use a mini-nebulizer and enough normal saline to make a total volume of 2.5 to 3 ml in the nebulizer cup. Taking Ketamine this way, the dose that the pt is getting is pretty accurate, the onset of the medication would be fairly rapid, and the duration of the therapy should be in the 15 minute range.

The pt working with the prescriber, the Ketamine dose could be easily adjusted up or down, only thing that the pt should keep consistant is the total volume in the nebulizer should be around 15 minues. Less Ketamine would mean more Normal Saline. More Ketamine would mean less Normal Saline.

Ketamine Linked to Reduced Suicidal Thoughts, Depression, Anxiety

https://www.medscape.com/viewarticle/980814

Ketamine infusions can help reduce symptoms of suicidal ideation, depression, and anxiety in patients with treatment-resistant depression (TRD), new research suggests.

Results from a retrospective chart review analysis, which included more than 400 participants with TRD, illustrate that ketamine is a safe and rapid treatment in a real-world patient population, lead author Patrick A. Oliver, MD, founder and medical director, MindPeace Clinics, Richmond, Virginia, told Medscape Medical News.

The effect was perhaps most notable for reducing suicidal ideation, he said.

“In 2 weeks, we can take somebody from being suicidal to non-suicidal. It’s a total game changer,” Oliver added.

Every year in the United States, about 12 million individuals think about suicide, 3.2 million make a plan to kill themselves, and more than 46,000 succeed, the investigators note.

The findings were published online September 12 in The Journal of Clinical Psychiatry.

Molecule Mixture

Primarily used as an anesthetic in hospitals, ketamine is also taken illegally as a recreational drug. Users may aim for an intense high or feeling of dissociation, or an out-of-body–type experience.

Ketamine is a mixture of two mirror-image molecules. An intranasal version of one of these molecules (esketamine) is approved by the US Food and Drug Administration for TRD. Both esketamine and ketamine are believed to increase neurotrophic signalling that affects synaptic function.

The study included 424 patients (mean age, 41.7 years) with major depressive disorder or another mood disorder and who received at least one ketamine infusion at a specialty clinic. Most participants had failed prior medication trials.

Patients in the study were typically started on 0.5 mg/kg of ketamine, with the dose titrated to achieve symptoms of partial dissociation. The median dose administered after titration was 0.93 mg/kg over 40 minutes.

The main treatment course of at least six infusions within 21 days was completed by 70% of the patients.

At each clinic visit, all participants completed the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7).

The primary outcome was PHQ-9 total scores, for which researchers looked at seven time periods: 1 week, 2-3 weeks, 4-6 weeks, 7-12 weeks, 13-24 weeks, 25-51 weeks, and 52+ weeks.

“Blows It Out of the Water”

Results showed PHQ-9 total scores declined by 50% throughout the course of treatment, with much of the improvement gained within 4-6 weeks. There was a significant difference between week 1 and all later time periods (all P values < .001) and between weeks 2 and 3 and all later periods (all P values < .001).

Other measures included treatment response, defined as at least a 50% improvement on the PHQ-9, and depression remission, defined as a PHQ-9 score of less than 5. After three infusions, 14% of the patients responded and 7% were in remission. After 10 infusions, 72% responded and 38% were in remission.

 

Medical breaches accounted for 342 million leaked records from 2009 to 2022

Medical breaches accounted for 342 million leaked records from 2009 to 2022

Medical breaches accounted for 422.7 million leaked records from 5,478 data breaches

Since 2009, medical organizations in the US have suffered nearly 5,000 data breaches, affecting over 342 million medical records.

Our team of researchers analyzed data from 2009 to June 2022 to find out which US states suffer the most medical breaches and how many records have been affected each year. We also took an in-depth look at breaches from January 2021 to June 2022 to find the biggest cause of these breaches and the most-affected healthcare organizations.

Our study covered breaches that have crippled healthcare facilities, many of which led to the exploitation of personal medical data, putting patients’ health and, in some cases, lives, at risk. Breaches can often lead to healthcare systems going offline, meaning medical workers are left without critical information. Threat actors may also gain access to Social Security numbers, health insurance information, prescription information, medical history, and even financial data linked with medical billing.

2020 alone accounts for nearly one-fifth of all breaches since 2009, with 803 breaches and 46.6 million records affected. 2021 saw a minor decline of 11 percent (from 803 breaches to 711). So far, 2022 has only recorded 151 breaches and nearly 8 million records affected–a much smaller amount compared to previous years. However, with many breaches reported several months after they occurred, it is likely these figures will rise in the coming months.

Key findings:

  • 4,746 medical breaches recorded from 2009 to June 2022
  • 342,017,215 individual records were affected as a result of these breaches
  • 2020 was the biggest year for medical breaches with 803 reported (the second-highest was 2021 with 711)
  • 2015 saw the highest number of records affected with over 112 million in total
  • In 2021 and 2022 (so far), specialist clinics (clinics that specialize in a certain field of medicine–e.g. cardiology or radiology, etc.) account for the most data breaches (15 percent) with 130 breached entities in total, but hospital networks account for the most breached records with 8.8 million affected in total (16 percent of the overall records affected)
  • In 2021 and 2022 (so far), hacking was the most common type of breach, accounting for 40 percent of breaches (353 out of 862)

All 50 states are required to report medical breaches to the U.S. Department of Health and Human Services (HHS), with individual breaches filed if they affected over 500 records (those with fewer may be filed under a yearly report). Due to the tool only listing breaches that affect 500 or more patients, it is likely our figures underestimate the true scale of the problem.

The top 5 worst-hit states for medical data breaches and records impacted since 2009

If we look at the number of breaches by US states, we can see that California had the most by far, accounting for 474 (around 10 percent) of the 4,746 data breaches.

Texas (383), Florida (288), New York (287), and Illinois (217) are the other four worst-hit states. However, as all of these are among some of the most populous states in the US, this perhaps isn’t much of a surprise.

When it comes to the number of records affected, the picture changes slightly with Indiana making its way into the top.

Indiana recorded the highest number of records affected, with nearly 87.2 million records (more than 25 percent of all breached records). This is significantly higher than second-place New York with 25 million records affected. However, Indiana’s high figure stems primarily from one breach on Anthem, Inc. (reported in 2015) when 78.8 million records were affected.

The states that closely followed NY were Florida (23.1 million), California (19 million), and Texas (16.3 million).

South Dakota reported the lowest figures with just eight data breaches reported since 2009 and 36,900 medical records breached. However, it is important to note that data breaches that occur in medical institutions may affect residents in other states, particularly if the organization is located in more than one state.

When looking at the number of medical records affected per 100,000 people of each state’s population, the chart does change quite drastically with the exception of Indiana. Indiana comes out on top with 1.28 million records affected per 100,000 people in the population. However, as noted above, this is due to Anthem, Inc.’s breach, which would have affected residents from outside state lines, too.

Minnesota records the second-highest number of breached records per 100,000 people with 235,259 records. This is followed by Washington (210,632 records affected per 100,000 people), Tennessee (210,371 records affected per 100,000 people), and Iowa (175,848 records affected per 100,000 people).

As well as the above, there were eight more states listed as having more than 100,000 records per 100,000 people affected by medical breaches (MT, PR, NC, NY, NM, VA, AZ, and FL).

South Dakota reported just 4,121 records affected per 100,000 people of the population. Idaho (9,825 per 100,000) and Mississippi (9,843 per 100,000) were the only other two states to have less than 10,000 records per 100,000 people affected.

The top 5 medical data breaches with the most records affected since 2009

The top five biggest medical data breaches for the number of records affected are as follows:

  • Anthem Inc. = 78.8 million records affected: Reported in 2015, the OCR suggests this data breach is the largest US health data breach in history. An employee opened a malicious spear phishing email that in turn resulted in Anthem Inc.’s IT systems being accessed and the data of nearly 79 million people being extracted. Anthem agreed to pay $16 million to the OCR in order to settle potential violations.
  • Optum360, LLC = 11.5 million records affected: The private personal and financial information of 11.5 million lab patients at the American Medical Collection Agency were accessed by hackers from August 2018 to March 2019. Those who had overdue laboratory service bills were affected in the breach.
  • Premera Blue Cross = 11 million records affected: Premera Blue Cross was forced to pay $6.85 million to the OCR after it suffered a data breach whereby hackers used a phishing email to install malware that gave them access to its IT system. The hackers’ entry into the system went unnoticed from May 2014 until January 2015.
  • Laboratory Corporation of America Holdings dba LabCorp = 10.2 million records affected: In 2019, LabCorp reported an intruder accessed the payment website of a third party it used, the American Medical Collection Agency. The breach exposed the personal, financial, and medical data of more than 10.2 million people. LabCorp terminated its business relationship with the collection agency soon after the breach.
  • Excellus Health Plan, Inc. = 9.3 million records affected: Hackers gained unauthorized access to Excellus Health Plan Inc.’s IT systems from December 2013 until May 2015. Malware was installed that led to the disclosure of 9.3 million records of personal data.

The top-ranking medical breaches come from several years ago. So although we are seeing an uptick in the number of records affected on a yearly basis, this is due to a higher volume of attacks rather than larger, less frequent breaches. For example, the first time we see 2021 enter the top is in 16th place with the 20/20 Eye Care Network, Inc. It reported a hacking incident that affected 3.3 million individuals. Only one other breach for 2021 (Forefront Dermatology’s breach of 2.4 million records) enters the top 20, while the first entry for 2022 (Shields Health Care Group, Inc. breach of 2 million records in March 2022) comes in 22nd place.

The biggest years for medical data breaches

According to the chart below, 2020 was the biggest year for medical data breaches with 803 in total. 2021 also recorded a high number of breaches with 711, closely followed by 2019 with 520. This shows that in the last 3 full years, medical data breaches have grown exponentially.

2015 reported an extraordinarily high number of records affected compared to all other years with 112 million records breached. However, as we have already commented, this stems from the Anthem, Inc. breach.

If we analyze the median number of records affected for each year, between 2009 and 2018, the median number of records affected per breach remains around 2,000. From 2018 to 2019 there was a sharp increase (rising by 70 percent from 2,284 to 3,893). This continued into 2020 (with an increase of 26 percent from 3,893 to 4,916) and from 2020 to 2021 (rising by 4 percent up to 5,122).

What was the most common medical data breach type in 2021?

Hacking proved to be the most popular method of breaching medical organizations, accounting for 288 out of 711 breaches (41 percent) in 2021. The next largest category (excluding unknowns) was ransomware with 161 attacks (23 percent) recorded.

Breach definitions: Card (debit/credit card not via hacking, e.g. skimming), Hack (outside party or malware), Insd (insider–employee, third-party, or customer), Phys (paper documents), Port (portable devices, e.g. laptops, memory sticks, and hard drives), Rans (ransomware), Stat (stationary computer), Disc (unintended disclosure, e.g. sensitive information posted publicly), Unkn (unknown). While phishing attacks aren’t listed separately here, they may be the method used to initiate hacks and ransomware attacks.

The breach type that is least likely to occur for medical breaches is the use of credit or debit card skimming. This method only happened once in the TGH Urgent Care data breach in which an employee took pictures of patients’ credit cards and drivers’ licenses in order to steal information.

What was the most-affected medical organization type in 2021?

In order to see which organization suffered the most medical data breaches, we arranged all breaches into 23 categories of healthcare facilities types (please see the methodology for definitions).

The type of organization that suffered the highest number of breaches in 2021 was specialist clinics with 106 medical breaches, impacting 3 million records. As mentioned previously, specialist clinics are those that focus on a specific area of healthcare, e.g. cardiology or radiology. The other most affected organizations in 2021 by number of breaches were:

  • Clinic Networks (an organization consisting of several clinics offering general healthcare from multiple locations): 87 breached entities affecting 4.1 million records
  • Health Insurance Companies: 78 breaches affecting 2.4 million records
  • Hospitals: 72 breached entities affecting 3.2 million records
  • Clinics: 51 breached entities affecting 3 million records

When it comes to the number of records, hospital networks and clinic networks are the most affected with 6.8 million and 4.1 million records affected respectively. As both of these are “networks” of healthcare facilities, this isn’t too much of a surprise as they will likely have more records on file.

So far for 2022, health insurance companies are the most-affected type of organization with 26 breached entities affecting 1.2 million records. Specialist clinics closely follow with 24 breaches affecting nearly 620,000 records. Hospital networks and clinic networks have had the most records affected again (2 million and 1.9 million respectively).

What is 2022 looking like for medical data breaches?

During the first six months of 2022, there have been 151 reported medical data breaches with 7,997,739 records affected. While these figures may appear small now, it is likely that figures will rise in the coming months. Nevertheless, across our financial data breach and ransomware reports, we are noticing a dip in 2022. This is perhaps due to more targeted attacks being carried out. We can see this with the data breach on MCG Health. On June 10 of this year, the software company disclosed that there had been unauthorized access on its systems. So far, at least eight organizations affected by the breach on MCG Health have come forward and have submitted breach reports that affect nearly 800,000 records.

Methodology

In order to gather as much information as possible on medical data breaches, we collated a list of breaches from 2009 to June 2022 as reported on the OCR portal. To deep dive into the types of breaches and most-affected organizations, our team searched through industry resources, state data breach notification tools, and news sources to gather further data on breaches that occurred from 2021 to June 2022.

Where possible, the breach is assigned to the specific date it occurred. For example, a breach may have occurred in 2021 but may have only been disclosed in 2022. We would, therefore, allocate this to 2021’s figures, as this is when the breach happened.

Each breach was categorized into one of 23 medical organization types, which are defined as follows:

  • Academic hospital
  • Business: a general business (e.g. a marketing provider) that works solely with healthcare companies
  • Clinic: a clinic offering all-around healthcare services
  • Clinic network: a system of clinics operating from more than one location to offer all-around healthcare services
  • Dental: a practice offering dental healthcare services
  • Department of health: a government department of health
  • Education: a school/university that’s involved in a health-related data breach
  • Government: a general government department/entity that’s involved in a health-related data breach, e.g. the department of human services or a county government
  • Health insurance
  • Home/senior care
  • Hospital
  • Hospital network: a system of hospitals operating from more than one location to offer all-around healthcare services
  • Laboratory: a health-based laboratory business
  • Medical billing: a company that specializes primarily in medical billing solutions
  • Medical equipment: a company that specializes primarily in medical equipment
  • Medical technology: a company that specializes primarily in technology solutions for healthcare companies
  • Medical transport: a company that specializes primarily in transport solutions for healthcare companies
  • Optometry: a practice offering optical healthcare service
  • Other: any organization that has a health-related breach but isn’t a healthcare-based company
  • Pharmacy: an organization/network specializing in pharmaceuticals
  • Social services
  • Specialist clinic: a clinic that operates under a certain area of healthcare, e.g. physicians or rehabilitation centers
  • Specialist clinic network: as above but operating from multiple clinics/locations

Puerto Rico was included in this study, however, isn’t included in any maps.

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

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

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

Long-term antidepressant use is tied to an increased risk of adverse outcomes, including cardiovascular disease (CVD), cerebrovascular disease (CV), coronary heart disease (CHD), and all-cause mortality, new research suggests.

Investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.

After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost twofold higher risk of CVD as well as CVD mortality, a higher risk of CV, and more than double the risk of all-cause mortality.

On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.

The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although selective serotonin reuptake inhibitors (SSRIs) were also tied to increased risk.

“Our message for clinicians is that prescribing of antidepressions in the long- term may not be harm-free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol, United Kingdom, said in a news release.

“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.

The study was published online September 13 in the British Journal of Psychiatry Open.

Monitoring of CVD Risk “Critical”

Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators note. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”

Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”

Moreover, information about “a wide range of prospectively measured confounders…is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors note.

The researchers examined the association between antidepre

CV, and CHD. In addition, they assessed two mortality outcomes ― CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.

The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.

The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56–57 years). About half were women, and 96% were of White ethnicity.

Participants were excluded if they had been prescribed antidepressants ≤12 months before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.

Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.

Mechanism Unclear

By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80% – 82%), and citalopram was the most commonly prescribed SSRI (46% – 47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44% – 46%).

At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio [HR], 0.64; 95% CI, 0.49 – 0.83).

At 10 years, SSRIs were associated with an increased risk of CV, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.

Antidepressant class Risk (95% CI)
SSRIs CV: 1.34 (1.02 – 1.77)
CVD mortality: 1.87 (1.38 – 2.53)
All-cause mortality: 1.73 (1.48 – 2.03)
Other antidepressants CHD: 1.99 (1.31 – 3.01)
CVD: 1.86 (1.10 – 3.15)
All-cause mortality: 2.20 (1.71 – 2.84)

On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53 – .87; and HR, 0.77; 95% CI, 0.66 – 0.89, respectively).

“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Bansal.

“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she added.

ssant use and four cardiometabolic morbidity outcomes ― diabetes, hypertension,

Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.

Strengths, Limitations

Commenting for Medscape Medical News, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit, discussed the strengths and weaknesses of the study.

The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”

A “significant limitation” is the confounding that is inherent to the disorder itself — “people with depression have a much higher intrinsic risk of CVD, CV, and cardiovascular mortality,” McIntyre noted.

The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”

Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine, too, but then it’s important to make clear that there is no clear causative line, just an association.”

The research was funded by the National Institute of Health Research (NI) School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals,Viatris, AbbVie, and Atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

BJPsych Open. Published online September 13, 2022. Full text

Batya Swift Yasgur MA, LSW is a freelance writer with a counseling practice in Teaneck, NJ. She is a regular contributor to numerous medical publications, including Medscape and WebMD, and is the author of several consumer-oriented health books as well as Behind the Burqa: Our Lives in Afghanistan and How We Escaped to Freedom (the memoir of two brave Afghan sisters who told her their story).

 

DOJ sues Cigna for exaggerating patient illnesses

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.