Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

This test could be a very slippery slope for this company and any practitioner who uses it and its results. Addiction has substantial underlying mental health issues. Mental health issues are all pretty much subjective health issues and can be various subsets of the total mental health spectrum.

What happens when a pt shows a “positive” test result and is not given or taken off their opioid pain meds, and the pt suffers health consequences for under/untreated pain?

On the other side, the pt shows a “negative” test result and is given opioids for their pain, and they end up becoming an addict because the negative ended up being a false negative.

I suspect that some entity is going to be sued for damages, will it be the pharma or the prescriber who ordered the test?

I hope that the FDA takes the recommendation of its committee of experts and withdraws this test from the marketplace. Of course, FDA is protected by sovereign immunity from being sued for any damages.

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

https://www.medpagetoday.com/neurology/opioids/109508

Methodology behind AvertD DNA test questioned

A group of 31 physicians and researchers called on the FDA to reverse its decision about AvertD, a test that uses DNA to identify whether adults may have an elevated risk of developing opioid use disorder (OUD).

In a letter to FDA Commissioner Robert Califf, MD, experts in genetics, addiction, psychiatry, public health, and device regulation asked the agency to revoke its recent approval of AvertD, based on research that doesn’t support the methodology used by the test’s sponsor.

The group also sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking CMS to deny coverage of AvertD.

The FDA approved AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon.

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.

The major risks associated with AvertD are false-negative and false-positive results, the FDA said. Before the agency approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.

“The FDA seems to believe the test isn’t a very good test but that it’s better than nothing. They’ve got it wrong,” said Andrew Kolodny, MD, an opioid policy expert at Brandeis University in Massachusetts, who signed the letters to the FDA and CMS.

“The problem isn’t that the test has weak specificity and sensitivity,” Kolodny told MedPage Today. “The problem is that it doesn’t work at all. It’s 100% bogus.”

The AvertD test will harm people, Kolodny emphasized. “Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction,” he said.

“Patients who test positive will be falsely branded as prone to a highly stigmatized condition,” he continued. “And they may become fearful of taking opioids, even in situations where use is beneficial.”

Genetic tests for opioid addiction have a checkered history. The FDA approval of AvertD last year was an industry first.

Like many genetic tests, confounding is part of the problem, Kolodny and colleagues said. An independent evaluation using methodology like the one used to test AvertD found that the algorithm gave the appearance of predicting genetic risk but was not a true measure of genetic risk, they noted.

“With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance,” they said in their letters to the FDA and CMS.

SOLVD Health said it was aware of the letters to FDA and CMS and is reviewing them.

“We believe the FDA approval of AvertD represents a significant step forward in helping clinicians and patients have informed discussions about opioid-sparing techniques or alternative pain management options, if medically appropriate,” the company said in an email to MedPage Today.

“Consistent with regulatory guidelines and standards, AvertD was clinically validated through a blinded, multicenter study evaluating participants at least 1 year after their initial exposure to prescription oral opioids,” SOLVD noted. “In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder.”

The company also said it is conducting prospective post-market studies to further evaluate the test’s performance in real-world settings.

Death because of GREED? Wisconsin family speaks out against PBMs after the loss of their son

I remember reading a story- many years ago – about a young man who was a brittle type-1 diabetic. He had called his refill into his pharmacy- mid-week- to get refilled and while the Rx had indicated two refills remaining, it was over 1 yr old and the refills had expired. The pharmacist requested for more additional refills for this guy’s insulin from the prescriber.  This young man came in on a Saturday or Sunday to pick up his refill, but the prescriber’s office had never followed thru on authorizing more refills.  The Pharmacist informed the guy this and the Pharmacist declined to refill the guy’s insulin Rx. A day or so later this fellow DIED, just because no one did their job.

The last contract that I worked under was to help turn around a large company that provided nursing homes with respiratory and other needs. The owner had suffered a serious brain clot/stroke and was incapacitated and eventually died. One of the older employees was a type-1 diabetic and was having trouble affording his Insulin. He was “rationing” his insulin. I printed out this website https://www.rxassist.org/ and gave it to him. He came back to my office a few days later, telling me that he had contacted this website and they were going to send him THREE BOTTLES OF HIS INSULIN, and they were going to continue providing him his insulin going forward. I don’t remember if it was going to be sent to him free of charge or for a very inexpensive cost, that he could afford. Needless to say, he was very happy.

 

Wisconsin family speaks out against PBMs after the loss of their son

https://www.wjfw.com/news/wisconsin-family-speaks-out-against-pbms-after-the-loss-of-thier-son/article_489e5590-e003-11ee-ae20-fb51d5ece985.html

Cole Schmidtknecht was a 22-year-old young man living in Appleton, Wisconsin who loved video games and sports. His parents Bil and Shanon described him as an inspirational free spirit with a love for being heard.

“He was definitely one of a kind,” said Shanon.

Cole was diagnosed with severe asthma at only a year old. He had just recently moved out on his own with opportunities to chase his dreams, until his life was cut short earlier this year.

“January 10th,, he went to the pharmacy to get his prescription and was told it was no longer covered by his insurance,” said Shanon.

He was told there was no alternative option and no generic drug would be covered. Cole didn’t know how to respond and couldn’t cover the extreme out-of-pocket cost of his Advair inhaler on a $19/hour income. An inhaler-dependent patient left the Walgreens Pharmacy with no medication. Five days later he suffered an extreme asthma attack and was taken to the hospital. He arrived at the Emergency Room lifeless and spent the next six days in the ICU on a ventilator.  

“We were told he’s never going to wake up again,” said Bil.   

A generic version of Advair only costs $15-$20. What happened to Cole is happening all over the country, according to Hometown Pharmacy co-founder Dan Strause.

“Unfortunately, we see even the state plan now no longer will allow for the generic, they force people into the brand. Why? It’s not hard to figure out it must be about the profit margin. Unfortunately, they’re making people decide between life-saving medicine [and paying bills, even though] the cost of the actual item is so low,” said Strause.

“We find this absolutely wrong, its infuriating we should all be angry, and we hope you tell your legislators this needs to be addressed sooner than later,” said Strause.

Hometown Pharmacy had to close a location in St. Germain partially due to the influence of PBMs. A pharmacy benefit manager acts as a middleman between drug manufacturers and pharmacies.

In the last state legislative session, the pharmacy benefit manager regulation bill wasn’t brought to a vote. The bill was designed to create transparency in the system and prohibit the PBMs’ control over the pharmaceutical industry as a whole.

“We’re very frustrated that it never got a chance to be voted upon,” said Strause.

Strause said there is a lot of speculation as to why the bill didn’t make it to the floor.

“In politics, there’s a lot of moving parts and we believe that the recent vote for Wisconsin mapping is part of it, because there’s a lot of energy and focus with what the next election is going to be and of course elections are very expensive, and you have to fund those elections.

Strause believes that money from lobbying groups associated with PBMs have a strong influence on lawmakers.

“Unfortunately, it means that money and influence is a significant factor in us passing bills especially ones that affect all of our lively hoods and our health,” said Strause.

Bil and Shanon said after learning of PBMs and the tactics that cost them their son they were angry and decided it was time to speak up.

“I don’t want you to ever have to imagine, I don’t want anyone to ever have to experience this,” said Shanon.

Their goal is to share Cole’s story and raise awareness.  

“We just kind of feel like this is now our fight to fight for him. If we can prevent it for one other person just that alone would be a little solace or a little something I know we can never have our son back, he’s gone,” said Bil.

Cole’s situation is not the only one, and this could happen anyone. Everyday life saving medications are becoming inaccessible to patients who need them.

“We need our senators and our congressmen to help this process that’s why they’re there in office for our complaints, our concerns our needs and the games that are played are just costing lives,” said Bil.    

HHS Cracks Down on Care Facilities for Failure to Turn Over Medical Records

HHS Cracks Down on Care Facilities for Failure to Turn Over Medical Records

https://www.medpagetoday.com/special-reports/features/109455

Office for Civil Rights fines two facilities that stalled on giving access for more than 100 days

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has settled two cases involving healthcare facilities that failed to provide timely access to medical records.

OCR announced settlements with Essex Residential Careopens in a new tab or window in New Jersey (doing business as Hackensack Meridian Health, West Caldwell Care Center) and Phoenix Healthcareopens in a new tab or window in Oklahoma (doing business as Green County Care Center).

Both care facilities failed to provide medical records to a patient’s personal representative within 30 days as mandated by the Health Insurance Portability and Accountability Act (HIPAA), OCR stated.

“It is unacceptable for a healthcare provider to delay or deny requests to release medical records for months, and we are calling on providers everywhere to be compliant to help empower patients,” OCR director Melanie Fontes Rainer, JD, said in a statement.

On Monday, OCR announcedopens in a new tab or window that West Caldwell Care Center (WCCC) — a skilled nursing facility that provides long-term care and rehabilitation services — would have to pay a $100,000 penalty for not providing timely access to patient records.

According to the agency’s notice of final determination, Peter Lindsay requested a copy of his mother’s medical records from WCCC via email. His request was denied on April 22, 2020, and an administrator asked for a copy of his power of attorney, medical proxy, or similar document signed by his mother, Lois Lindsay, establishing him as her representative.

Peter Lindsay sent the power of attorney via email on April 23, 2020, but still didn’t receive any records. He filed a complaint with OCR on May 19, 2020, alleging WCCC and its parent company failed to give him access to his mother’s medical records, even after providing proof of his status as her representative.

Peter Lindsay finally received a copy of the records on Dec. 1, 2020, as a result of an OCR investigation — 161 days after his initial request, the determination stated.

Late last week, OCR announced that Phoenix Healthcare in Oklahoma will pay $35,000 to settle claims that it didn’t provide access to patient medical records in a timely fashion.

In this case, a daughter who was not named filed a complaint with OCR alleging that Phoenix Healthcare wouldn’t give her access to medical records for her mother as her representative.

After attempts at “technical assistance” and “attempts to get the records by OCR,” the facility provided the records on Jan. 30, 2020 — 323 days after the initial request, according to an OCR press releaseopens in a new tab or window.

“The Office for Civil Rights continues to receive complaints from individuals and personal representatives on behalf of individuals who do not receive timely access to their health records,” Fontes Rainer said in a statement. “OCR will continue to vigorously enforce this essential right to ensure compliance by healthcare facilities across the country.”

Is your family in a financial death spiral?

Recently on one of the Financial TV shows, one of their “talking heads” stated that the USA is not using the same basket of goods to calculate our COLA/CPI as was used during the Jimmy Carter presidency. He stated that if we currently use the same basket  of goods as during the Carter Admin the peak increase in the CPI to 8.5% in March of 2022, would have been ~ 17%.https://www.newsweek.com/fact-check-has-inflation-gone-every-month-joe-bidens-presidency-1712159  

If you wish to use this comparison chart, you will have to go to this hyperlink to get it to make it function.  https://www.biden-mart.com/  The data is based on USDA data.

It is claimed that 60%+ of households are living paycheck to paycheck and the typical family cannot afford an unexpected $500 bill, and the total consumer debt on credit cards has passed ONE TRILLION DOLLARS for the first time. Some credit card companies are charging interest rates upwards of 30%. It seems that all too many families are in a financial death spiral.


Killing Them Quietly

Killing Them Quietly

https://www.daily-remedy.com/killing-them-quietly/

Government versus Medicine

A war is raging in America today, between physicians treating pain and addiction, and the United States federal government (mostly the DEA) on the proper practice of medicine. While the federal government is forbidden by law from trying to influence the practice of medicine, according to Lambert v. Yellowly, 1926, where the Supreme Court ruled that “direct control of medical practice in the States is beyond the power of the Federal Government.” Based on Linder v. United States, 268 U.S. 5, 18, where it was ruled that “Congress, therefore, cannot directly restrict the professional judgment of the physician or interfere with its free exercise in the treatment of disease. Whatever power exists in that respect belongs to the states exclusively.”

This was followed by a Medicare statute, 42 USC 1395, that expressly forbade the federal government from interfering with the practice of medicine, stating: “Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.”

These precepts were further affirmed by the US Supreme Court in Gonzales v. Oregon, where the US Supreme Court forbade the US Attorney General from enforcing the Controlled Substances Act against physicians who were prescribing medications in accordance with state law. In this case, the state of Oregon had passed legislation allowing physicians, in very narrow circumstances, to prescribe a medication for the express purpose of ending someone’s suffering by ending their lives. As of that lawsuit, 935 people had exercised their right under Oregon law, to end their suffering under their own terms, and the physicians had been protected from prosecution. The AG threatened to prosecute the doctors, and the physicians sued, eventually ending up in front of the Supreme Court and winning.

Then we had Xiulu Ruan v. United States. Where two physicians had been prosecuted for being “outside the usual practice of medicine” and prescribing controlled substances “without a legitimate medical purpose.” These ill-defined concepts heretofore being left to the government’s creation out of whole cloth. In this case the trial court b had instructed the jury that the doctors’ subjective belief that they were acting in good faith didn’t matter if the government was able to persuade the jury that the doctor’s practice deviated from “the norm.” According to one government expert in sworn testimony the norm exists only in the minds of government experts and cannot be found in any book or database. After the physicians were convicted their appeal ended up in front of the US Supreme Court.

The Court immediately saw the injustice in the government’s argument, stating that the law was ““ambiguous,” written in “generalit[ies], susceptible to more precise definition and open to varying constructions.” Further ruling that, without mens rea, a “vicious mind”, and clear knowledge of wrongdoing, a physician should not be declared criminal. This comports with a long held precept of American law that a serious crime requires proof the person knew what they were doing was wrong and did it anyway. The Court also ruled that the doctor should not have to prove that their mental state was that of a “hypothetical ‘reasonable’ doctor.” Finding that “…for purposes of a criminal conviction under §841, this requires proving that a defendant knew or intended that his or her conduct was unauthorized.”

That should have settled matters, but it did not. It is not common for the executive branch of the United States of America to refuse to follow the judicial branch’s interpretation of the law. In fact, I can find only two examples of this happening. The first of these was in 1832, in the case of Worcester v. Georgia. This case involved the Cherokee Nation, which had adapted better than most Native American tribes to life in the new American nation. They had developed a written language, and newspapers, and many had sent their children to universities and even law school. When the state of Georgia tried to control lands guaranteed to the Cherokee by treaty, they met fierce and eloquent opposition, and the US Supreme Court rule that the states did not have the right to impose regulations on Native American land. But the current president, Andrew Jackson, refused to enforce that ruling, saying of Chief Justice Marshall, “Now let him enforce it.” and refusing to protect the rights elucidated by the Supreme Court The states eventually seized most of the land set aside for Native Americans by treaty, leading eventually to the Trail of Tears.

The first Trail of Tears in 1838 had a 27% mortality rate, resulting in the deaths of 4,000 Native Peoples on that first death march. The states were so pleased with that result that they did it repeatedly over the next decade and a half. Eventually killing more than fifteen thousand and displacing over one hundred thousand. Today, there is a new Trail of Tears being created, by the DEA’s refusal to honor the ruling of the US Supreme Court in Ruan. Doctors are being prosecuted for the non-crimes of prescribing “dangerous medications in dangerous combinations,” (which is the very definition of what distinguishes a physician from every other profession…) to patients who “travel long distances for treatment.” Of the twelve listed “pill mill” descriptors pried from government records. None are crimes. In many cases, the government does not try to prove or even allege that the doctor had criminal intent, arguing only that he was “willfully blind” to the nebulous standard espoused by a medical expert witness of doubtful qualification, who has been paid to advance their opinion and convince the jury.

The government is pursuing a theory that the prescribing of opiate medications led to the current opioid epidemic. Nothing could be further from the truth. In the early 1990s it was recognized that untreated chronic pain reduced the quality and shortened the lives of those suffering from it. While pain itself is sometimes argued to not be fatal, this argument would instantly be recognized by any Civil War physician as inconsistent with evidence based medical practice. Without adequate analgesia, the simple amputation of a limb was found to cause death by shock if it took longer than fifteen minutes. Not from blood loss mind you. This was controlled by a tourniquet. But instead from the severe pain causing the heart to fail. It has been proven that even the psychological pain of a broken heart can have this effect. The proof that pain was causing death can be found in modern operating rooms, where, with the use of modern anesthetics, patients can survive hours of surgery without cardiac failure.

Severe chronic pain damages the heart by increasing sympathetic nervous system activation, increasing cardiac contractility and blood pressure, causing the heart to be overworked, predisposing it to arrhythmia and dysregulation of cardiac function. Chronic pain also increases stress hormone levels which increase the inflammatory response. Over time this leads to cardiac stress and arterial endothelial dysfunction and plaque formation, leading to coronary and arterial occlusion that causes heart attacks and strokes. A study in published by Harvard Health showed that people with chronic pain are 20% more likely to have a heart attack and 30% more likely to have a stroke, adjusting for factors like diabetes etc. These facts have long been well understood by the medical community, and treating chronic pain to make it tolerable was considered a basic function of primary care medicine.

By the early 2000s several states had passed pain treatment acts protecting physicians who treated pain from prosecution, recognizing that family and law enforcement may not understand the practice of medicine well enough not to blame a physician for any bad outcome. Leaving it to the state medical boards to police the practice of medicine, suspending or revoking a physician’s license under their state appointed authority. Opiate medication prescriptions peaked around 2012, as physicians sought to balance the need to control pain with the need to prevent overuse, addiction, and diversion. Then came the Fentanyl epidemic, where uncontrolled border checkpoints allowed a nonstop flow of this extremely potent opiate into the country. Since the early 1900s, heroin, invented as a “nonaddictive” treatment for morphine addiction, was the major opiate of abuse in America.

Heroin is bulky and hard to smuggle, but fentanyl, being much more potent, could have the same effect in milligrams that took kilograms of heroin. Hiding thirty pounds of something can be tough. Hiding three ounces is a lot easier. But fentanyl wasn’t well known on the black market, so the drug dealers used it to make fake heroin. If they had carefully calibrated the fake heroin to have the same potency as real heroin, the overdose rate would not have changed, but that’s asking too much of people who smuggle and deal drugs. Invariably they would put in too much, and people who thought they were taking there usual dose would die. This led to a sharp spike in fentanyl related deaths starting in 2013. Since fentanyl CAN be prescribed, every one of these deaths was initially reported as a prescription opiate related death. Even though comparing the rates of prescribed fentanyl to the death rate proves there is no correlation whatsoever. In 2018, the US Bureau of Vital Statistics was forced to correct its methods, reducing the number of deaths involving prescription drugs by at least half.

Fentanyl is very rarely prescribed to persons without cancer except in a patch form that is hard to abuse and not related to any significant overdose risk. As the deaths related to Fentanyl continued to climb, reaching 9,580 in 2015, the federal government saw an opportunity to intervene, and the CDC wrote the now somewhat infamous guidelines on prescription of opioids to adults with chronic pain. What started as a simple caution to primary care providers to be careful at certain levels of pain medication treatment, became a mandate to limit pain management, and finally, even a weapon to use against board certified pain specialists. With this cudgel in hand the DEA rapidly began prosecuting any physician who was perceived to be outside the limits of prescribing as defined by the CDC. States got in on the act, suing pharmaceutical companies for excessively promoting pain medications and creating laws in line with the CDCs guidelines.

As acknowledged publicly by the CDC in 2018, the problem was that these guidelines were never meant to become mandated limits on physicians. They were supposed to be just a reminder to be cautious. It is not that the guidelines were completely without merit, it’s that they were concocted without any real evidence and deeply influenced by anti-opioid bias. As some have acknowledged on video, there was not time for evidence, opinion would have to suffice. Opinion is fine when the professional is free to make exceptions. However, it becomes a government enforced ideology when they are not-which is precisely what the DEA has done. Physicians’ offices were raided, and the doctors paraded to the public as if they were Pablo Escobar. This witch hunt turned out to be a windfall for the federal government, as they seized physicians’ assets and made headlines, all the while avoiding the real drug dealers who might shoot back. For every doctor prosecuted, over a thousand patients were left stranded.

Following its unjustified persecutions of particular doctors, the DEA would then monitor these patients to see where they went, targeting doctors who accepted these medical refugees as patients. One needs only look at the tragic suicides of Daniel and Gretchen Elliot in 2022, when their doctor, Dr. Sachy, was targeted and shut down. Fleeing to Dr. Bockoff just set that doctor up for targeting. When Bockoff was shut down no one would treat them. Gretchen and Daniel took their lives together when his pain became intolerable, and his loss was more than she could bear. Now the formula for a perfect storm was complete. Heroin addicts overdosing on fentanyl which was then reported as a prescription medication death led to the targeting of doctors which in turn led to chronic pain patients having nowhere to go, sending them to the streets searching for medications. Which created the perfect opportunity for true “pill mills”.

A real pill mill is where fake pills made to look exactly like hydrocodone or oxycodone are made using pill presses that can be purchased online. These pills fooled the abandoned patients, who rapidly died of an overdose when the fentanyl level was too high. These were also reported as prescription related deaths. The DEA tried to shut these down with limited success, but this was hard and they were under pressure. So they started calling any practice that treated a lot of pain patients a “pill mill” something that judges routinely allowed them to repeat in court.

Let’s put some things in perspective. There were 336,997,624 people in the United States in 2021. During that same year 3,458,697 people died. That’s almost exactly 1%, 1.03% in fact. Of those deaths, 107,622 involved drug overdose. That’s 3.1% of all deaths. Stimulants like methamphetamine and cocaine accounted for another 26,806 deaths, sometimes overlapping deaths where opioids were involved. 88% of opioid involved deaths were due to illegal fentanyl-about 75% of all deaths involving a drug of any type. Almost NONE of this fentanyl comes from prescriptions. Fentanyl is used almost exclusively in the hospital, surgical, and emergency environments. It is extremely rare to get an outpatient fentanyl prescription, and these are usually reserved for cancer patients. Most remaining opiate related deaths are associated with heroin.

In that same year, from the DEA press release website, I can immediately find eighteen cases of doctors being shut down or sent to prison. Many of these were for prescriptions written years earlier, identified by data mining algorithms that target doctors based on the how busy their practice is, how much insurance companies have to pay for testing etc., how far their patients drive, and whether or not they own lake front or beach front property. In 2021 alone, just from these numbers, we’ll have at least eighteen healthcare providers shut down. That leaves about 36,000 people searching for a physician to help them. The DEA is actively tracking patients from a prosecuted doctor and targeting any physician who treats those patients for their pain. A study completed in 2021 found that about 36% of patients could not find any doctor willing to treat their pain, and that study was on patients whose doctor had NOT been targeted. Add all of these to the to that original more than one third of severe chronic pain sufferers that could already NOT find treatment before this madness started.

And what is the result? The DEA acts like cutting people off their treatment or not treating them at all with any effective medication is some kind of solution. It is not. Untreated and undertreated chronic pain sufferers are 20% more likely to have a heart attack and 30% more likely to have a stroke than the general population. They are also more likely to commit suicide. Ten percent of all suicides are linked to severe chronic pain. From my estimates we now have at least 6,156,000 people with severe life-limiting chronic pain that cannot find treatment. What is also not pointed out by the federal authorities, is how many of those patients suffering from untreated chronic pain in a world where it is no longer safe for doctors to treat them, will go to the streets. Finding fentanyl laced fake pills rather than their expected medication. The evidence is clear. In their misguided attempts to stop prescription opiate overdose, which accounts for less than five hundred deaths per year, the US federal government is killing tens of thousands. They may be killing them quietly and indirectly, but those patients are dead just the same.

Encourage patients to submit complaints to Medicare

Encourage patients to submit complaints to Medicare

https://ncpa.org/newsroom/qam/2024/03/27/encourage-patients-submit-complaints-medicare

Patients across the country are facing issues filling prescriptions due to patient steering and PBM network issues. Encourage your patients to reach out to Medicare directly through their online complaint form or call Medicare directly. We’ve added that contact information into a printer-friendly document that you can hand your patient at the pharmacy counter when they experience pharmacy access issues.

Healthcare is nothing more… nothing less than a FOR PROFIT BUSINESS

I have read stories, that these insurance/pbm companies hire retired physicians to review the prior authorization process. Those articles also stated that those physicians are paid a BONUS based on the percentage of what the insurance/pbm saves from denial of coverage of a specific product or service. These physicians are paid their BONUS weekly.

The physician reviewing a prior authorization may not be credentialed in the specific disease they are reviewing to decide to approve or deny coverage.

https://www.cmadocs.org/newsroom/news/view/ArticleId/50483/New-York-Times-video-on-prior-authorization-spotlights-CMA-physicians-and-california-patients-160

SB 516, authored by Senator Nancy Skinner and sponsored by the California Medical Association (CMA) will reform the prior authorization process in California to ensure patients get the treatment they need when they need it. 

The New York Times published an opinion video today, titled “What’s my life worth? The Big Business of Denying Medical Care” that clearly demonstrates how insurance companies use prior authorization to protect profits, putting patients at risk.

To produce the video, the New York Times interviewed more than 50 physicians and patients who have dealt with prior authorization delays firsthand, including Irvine-based pediatrician and CMA member, Eric Ball, M.D., who spoke about how the “peer-to-peer” process for appealing a prior authorization denial can involve speaking with a physician who does not have a relevant specialty.

“I’m a pediatrician and sometimes I’ll end up talking to a neurologist,” Dr. Ball said. “Often times it’s not even a physician.”

Also interviewed were California patients Vivian Gonzales and Ocean McIntryre, both of whom were harmed by prior authorization delays and had courageously shared their stories with the California Legislature last summer when prior authorization legislation was heard in the Assembly Health Committee.

Gonzales, a public health nurse, dealt with multiple denials while trying to obtain care for her father, whom she eventually lost to cancer. “I spent so much time on the phone, writing letters, faxing, that I didn’t get to spend that time with my father,” Gonzales said in the video.

And McIntyre, a space science communicator, lost her eyesight as the care she needed was delayed for months due to prior authorization. “I finally got the authorization to see the neuro-ophthalmologist after 12 weeks, and he said, ‘We’re going to do this surgery, but it’s only to preserve the vision you have left. If we had seen you earlier, that would have been a different story,’” McIntyre said in the video. “Maybe I’d be able to see now. Maybe I’d have a different life.”

This year, CMA is sponsoring SB 516 to reform the prior authorization system and ensure patients get treatments they urgently need without unnecessary delays. Over the course of this legislative session, be on the lookout for updates and further communications regarding SB 516.

Share Your Story

CMA physicians have staunchly advocated for prior authorization reform by sharing personal stories and stories from patients about harmful care delays and denials; speaking to local media about the need for prior authorization reform; and submitting video testimonies about the impact of prior authorization. Patient witnesses also shared harrowing testimony in legislative hearings and through media outlets about the devastating impacts prior authorization delays have had on their lives and their loved ones.

CMA urges physicians to continue to share stories about the harms of prior authorization delays – both from your own experiences and practices, as well as from your patients. Together, we can win this fight and create a better system that prioritizes patients over profits.

How Reporters Caught Payers Using Algorithms

How Reporters Caught Payers Using Algorithms

https://www.daily-remedy.com/how-reporters-caught-payers-using-algorithms/

In a call with a long-time source, what stood out most to STAT reporters Bob Herman and Casey Ross was just how viscerally frustrated and angry the source was about an algorithm used by insurance companies to decide how long patients should stay in a nursing home or rehab facility before being sent home.­

“The level of anger and discontent was a real signal here,” says Ross, STAT’s national technology correspondent. “The other part of it was a total lack of transparency” on how the algorithm worked.

The reporters’ monthslong investigation would result in a four-part series revealing that health insurance companies, including UnitedHealth Group, the nation’s largest health insurer, used a flawed computer algorithm and secret internal rules to improperly deny or limit rehab care for seriously ill older and disabled patients, overriding the advice of their own doctors. The investigation also showed that the federal government had failed to rein in those artificial-intelligence-fueled practices.

The STAT stories had a far-reaching impact:

  • The U.S. Senate Committee on Homeland Security and Government Affairs took a rare step of launching a formal investigation into the use of algorithms by the country’s three largest Medicare Advantage insurers.
  • Thirty-two House members urged the Centers for Medicare and Medicaid Services to increase the oversight of algorithms that health insurers use to make coverage decisions.
  • In a rare step, CMS launched its own investigation into UnitedHealth. It also stiffened its regulations on the use of proprietary algorithms and introduced plans to audit denials across Medicare Advantage plans in 2024.
  • Based on STAT’s reporting, Medicare Advantage beneficiaries filed two class-action lawsuits against UnitedHealth and its NaviHealth subsidiary, the maker of the algorithm, and against Humana, another major health insurance company that was also using the algorithm.
  • Amid scrutiny, UnitedHealth renamed NaviHealth.

The companies never allowed an on-the-record interview with their executives, but they acknowledged that STAT’s reporting was true, according to the news organization.

Ross and Herman spoke with The Journalist’s Resource about their project and shared the following eight tips.

1. Search public comments on proposed federal rules to find sources.

Herman and Ross knew that the Centers for Medicare and Medicaid Services had put out a request for public comments, asking stakeholders within the Medicare Advantage industry how the system could improve.

There are two main ways to get Medicare coverage: original Medicare, which is a fee-for-service health plan, and Medicare Advantage, which is a type of Medicare health plan offered by private insurance companies that contract with Medicare. Medicare Advantage plans have increasingly become popular in recent years.

Under the Social Security Act, the public has the opportunity to submit comments on Medicare’s proposed national coverage determinations. CMS uses public comments to inform its proposed and final decisions. It responds in detail to all public comments when issuing a final decision.

The reporters began combing through hundreds of public comments attached to a proposed Medicare Advantage rule that was undergoing federal review. NaviHealth, the UnitedHealth subsidiary and the maker of the algorithm, came up in many of the comments, which include the submitters’ information.

“These are screaming all-caps comments to federal regulators about YOU NEED TO SOMETHING ABOUT THIS BECAUSE IT’S DISGUSTING,” Ross says.

“The federal government is proposing rules and regulations all the time,” adds Herman, STAT’s business of health care reporter. “If someone’s going to take the time and effort to comment on them, they must have at least some knowledge of what’s going on. It’s just a great tool for any journalist to use to figure out more and who to contact.”

The reporters also found several attorneys who had complained in the comments. They began reaching out to them, eventually gaining access to confidential documents and intermediaries who put them in touch with patients to show the human impact of the algorithm.

2. Harness the power of the reader submission box.

At the suggestion of an editor, the reporters added a reader submission box at the bottom of their first story, asking them to share their own experiences with Medicare Advantage denials.

The floodgates opened. Hundreds of submissions arrived.

By the end of their first story, Herman and Ross had confidential records and some patients, but they had no internal sources in the companies they were investigating, including Navihealth. The submission box led them to their first internal source.

The journalists also combed through LinkedIn and reached out to former and current employees, but the response rate was much lower than what they received via the submission box.

The submission box “is just right there,” Herman says. “People who would want to reach out to us can do it right then and there after they read the story and it’s fresh in their minds.”

3. Mine podcasts relevant to your story.

The reporters weren’t sure if they could get interviews with some of the key figures in the story, including Tom Scully, the former head of the Centers for Medicare and Medicaid Services who drew up the initial plans for NaviHealth years before UnitedHealth acquired it.

But Herman and another colleague had written previously about Scully’s private equity firm and they had found a podcast where he talked about his work. So Herman went back to the podcast — where he discovered Scully had also discussed NaviHealth.

The reporters also used the podcast to get Scully on the phone for an interview.

“So we knew we had a good jumping off point there to be like, ‘OK, you’ve talked about NaviHealth on a podcast, let’s talk about this,’” Herman says. “I think that helped make him more willing to speak with us.”

4. When covering AI initiatives, proceed with caution.

“A source of mine once said to me, ‘AI is not magic,’” Ross says. “People need to just ask questions about it because AI has this aura about it that it’s objective, that it’s accurate, that it’s unquestionable, that it never fails. And that is not true.”

AI is not a neutral, objective machine, Ross says. “It’s based on data that’s fed into it and people need to ask questions about that data.”

He suggests several questions to ask about the data behind AI tools:

  • Where does the data come from?
  • Who does it represent?
  • How is this tool being applied?
  • Do the people to whom the tool is being applied match the data on which it was trained? “If racial groups or genders or age of economic situations are not adequately represented in the training set, then there can be an awful lot of bias in the output of the tool and how it’s applied,” Ross says.
  • How is the tool applied within the institution? Are people being forced to forsake their judgment and their own ability to do their jobs to follow the algorithm?

5. Localize the story.

More than half of all Medicare beneficiaries have Medicare Advantage and there’s a high likelihood that there are multiple Medicare Advantage plans in every county across the nation.

“So it’s worth looking to see how Medicare Advantage plans are growing in your area,” Herman says.

Finding out about AI use will most likely rely on shoe-leather reporting of speaking with providers, nursing homes and rehab facilities, attorneys and patients in your community, he says. Another source is home health agencies, which may be caring for patients who were kicked out of nursing homes and rehab facilities too soon because of a decision by an algorithm.

The anecdote that opens their first story involves a small regional health insurer in Wisconsin, which was using NaviHealth and a contractor to manage post-acute care services, Ross says.

“It’s happening to people in small communities who have no idea that this insurer they’ve signed up with is using this tool made by this other company that operates nationally,” Ross says.

There are also plenty of other companies like NaviHealth that are being used by Medicare Advantage plans, Herman says. “So it’s understanding which Medicare Advantage plans are being sold in your area and then which post-acute management companies they’re using,” he adds.

Some regional insurers have online documents that show which contractors they use to evaluate post-acute care services.

6. Get familiar with Medicare’s appeals databases

Medicare beneficiaries can contest Medicare Advantage denials through a five-stage process, which can last months to years. The appeals can be filed via the Office of Medicare Hearings and Appeals.

“Between 2020 and 2022, the number of appeals filed to contest Medicare Advantage denials shot up 58%, with nearly 150,000 requests to review a denial filed in 2022, according to a federal database,” Ross and Herman write in their first story. “Federal records show most denials for skilled nursing care are eventually overturned, either by the plan itself or an independent body that adjudicates Medicare appeals.”

There are several sources to find appeals data. Be mindful that the cases themselves are not public to protect patient privacy, but you can find the number of appeals filed and the rationale for decisions.

CMS has two quality improvement organizations, or QIOs, Livanta and Kepro, which are required to file free, publicly-available annual reports, about the cases they handle, Ross says.

Another company, Maximus, a Quality Improvement Contractor, also files reports on prior authorization cases it adjudicates for Medicare. The free annual reports include data on raw numbers of cases and basic information about the percentage denials either overturned or upheld on appeal, Ross explains.

CMS also maintains its own database on appeals for Medicare Part C (Medicare Advantage plans) and Part D, which covers prescription drugs, although the data is not complete, Ross explains.

7. Give your editor regular updates.

“Sprinkle the breadcrumbs in front of your editors,” Ross says.

“If you wrap your editors in the process, you’re more likely to be able to get to the end of [the story] before they say, ‘That’s it! Give me your copy,’” Ross says.

8. Get that first story out.

“You don’t have to know everything before you write that first story,” Ross says. “Because with that first story, if it has credibility and it resonates with people, sources will come forward and sources will continue to come forward.”

Read the stories

Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

How UnitedHealth’s acquisition of a popular Medicare Advantage algorithm sparked internal dissent over denied care

UnitedHealth pushed employees to follow an algorithm to cut off Medicare patients’ rehab care

UnitedHealth used secret rules to restrict rehab care for seriously ill Medicare Advantage patients

This article first appeared on The Journalist’s Resource and is republished here under a Creative Commons license.

FROM NEW YORK TIMES: “THE D.E.A. NEEDS TO STAY OUT OF MEDICINE” BY DR. SHRAVANI DURBHAKULA, MD, A PAIN MEDICINE PHYSICIAN FROM NASHVILLE

Shravani Durbhakula, MD, MPH, MBA | Department of Anesthesiology

FROM THE NEW YORK TIMES MARCH 22, 2024: “THE D.E.A. NEEDS TO STAY OUT OF MEDICINE” BY DR. SHRAVANI DURBHAKULA, MD, A PAIN MEDICINE PHYSICIAN FROM NASHVILLE & LYRICS FROM BIGGY SMALLS-NEW YORK IDENTIFYING D.E.A. -CORRUPTION

Congress strips out PBM reform at final hour, teeters toward shutdown with funding deadline

Our Congress passed a 1000+ page continued resolution to continue the funding of our government through the end of our fiscal year (09/30/2024). With 1.2 Trillion dollar patch to our federal spending, members of Congress had < 24 hrs to those 1,000+ pages BEFORE THEY HAD TO VOTE ON THIS BILL. Congress is required by law to have a budget passed for the next fiscal year before the fiscal year begins on Oct 1st of each year. With about 85% of the members of Congress up for re-election in Nov. I wonder how many millions of dollars from the insurance/PBM industry flowed into re-election campaign funds of those members of Congress up for re-election?

Here is a recent blog post about 30% of independent Pharmacist expect to close their doors by the end of 2024. That you be from 4,000- 6,000 independent pharmacies, mostly in rural areas. https://www.pharmaciststeve.com/cash-crunch-pushes-independents-to-the-brink-data-shows-pbms-the-cause/

Here is another post from today https://www.pharmaciststeve.com/medicare-advantage-is-under-fire-what-it-means-for-your-health-and-wallet/    Another example of how the insurance/pbm industry is putting profits over patient care/safety

Congress strips out PBM reform at the final hour, teeters toward shutdown with a funding deadline

https://ncpa.org/newsroom/qam/2024/03/20/congress-strips-out-pbm-reform-final-hour-teeters-toward-shutdown-funding

This week, Congress agreed to fund the government for the rest of fiscal year 2024, mere days before a looming government shutdown, with votes looking to happen this weekend. This agreement would fund nearly 70 percent of the government including the Departments of Defense, Homeland Security, Labor, Health and Human Services, and Education. NCPA is sad to share that PBM reform is not included in the final funding agreement, having been stripped out at the last moment. It was instead decided that a “skinny” health care package would replace the robust legislative package that committees had agreed upon late last week, which included several major NCPA legislative priority policies. The committees had finalized their package after Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) held a press conference with pharmacy leaders, pharmacists and patients — including NCPA CEO Douglas Hoey, pharmacy owner and former NCPA president Michele Belcher, and pharmacy owner Jack Holt — to discuss the urgent need for Congress to finalize bipartisan pharmacy benefit manager (PBM) reforms. Later that day Sens. Wyden and Crapo issued a letter to Finance Committee members reaffirming their commitment to enacting meaningful PBM reforms during this Congress. Additionally, last Friday, 21 Senators and 51 Representatives sent letters to their respective leadership calling for immediate action on PBM reform. The calls, led by Sens. Jon Tester (D-Mont.) and James Lankford (R-Okla.) in the Senate and Reps. Buddy Carter (R-Ga.) and Debbi Dingell (D-Mich.) in the House, highlighted the bipartisan support PBM reform has received in both chambers and the urgent need to act to preserve patient access to medications and pharmacies.

While PBM reform has been stripped out this time,

it made it to final negotiations a promising outlook and even more reason to fight for final passage. NCPA will continue to work with policy leaders to get PBM reform passed this year.