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Clinicians must “uncomfortably” examine bias in life-and-death decisions, says expert

https://www.medpagetoday.com/criticalcare/generalcriticalcare/111230

Critically injured trauma patients without insurance had a higher risk of being taken off life-saving care sooner than their insured counterparts, according to findings from a retrospective cohort study of more than 300,000 U.S. adults.

After adjustment for patient and hospital characteristics, those without insurance had significantly earlier withdrawal of life-sustaining therapy (WLST) when compared with Medicaid recipients (HR 1.53, 95% CI 1.45-1.62) or the privately insured (HR 1.57, 95% CI 1.49-1.65), reported researchers led by Graeme Hoit, MD, of the University of Toronto.

In contrast, no such difference in time to WLST was observed between the Medicaid and privately insured groups (HR 1.03, 95% CI 0.98-1.08). Unadjusted numbers showed mean times to WLST of 6.5 days in the uninsured group, 8.9 days in the Medicaid group, and 7.8 days for the privately insured group.

“Our study suggests that a patient’s ability to pay may be associated with a shift in decision-making for WLST,” the group wrote in JAMA Network Openopens in a new tab or window.

This would appear to go against the Emergency Medical Treatment and Labor Act, which requires that all critically ill patients in hospitals receive optimal care regardless of insurance status or financial means.

But more than two-thirds of uninsured trauma patients are at risk of catastrophic health expenditures, noted Hoit and colleagues, and if these patients are unable to pay, the financial responsibility may shift to the institutions caring for them. One study from 2013opens in a new tab or window estimated a $2.8 billion annual tab for uninsured trauma care in the U.S.

Under ideal circumstances, the decision to WLST involves a shared decision between clinicians and a patient’s surrogate or substitute decision-maker (SDM), the researchers pointed out.

“However, the nature of severe traumatic injury means that trauma patients are typically younger, less likely to have preexisting care directives, more likely to be estranged from their families and SDMs, and more likely to belong to marginalized social populations compared with the general critical care population,” they wrote. “These factors complicate WLST decisions and may increase the likelihood of practitioner, caregiver, or institutional biases impacting decisions and timing.”

The new findings, said Hoit and colleagues, build on prior trauma studies linking uninsured status with increased mortality.

“When presented with decisions about whether or not to proceed with tests, procedures, or care continuation, institutions and/or SDMs may both have concerns with the cost of care and be less likely to pursue extensive measures, resulting in earlier mortality,” they wrote.

In an accompanying commentaryopens in a new tab or window, Zara Cooper, MD, MSc, a trauma surgeon at Brigham and Women’s Hospital and Harvard Medical School in Boston, said “it is incumbent upon individual clinicians and health systems to closely and uncomfortably examine how bias either creeps or marches into the life-and-death decisions we make for everyone under our care.”

In fact, she suggested, meaningful differences between the study groups — namely alcohol or substance use and mental health disorders — may have influenced WLST decisions. Self-inflicted injuries, for example, were associated with a greater risk of earlier WLST (HR 1.54, 95% CI 1.36-1.73), “suggesting that even though depression is a treatable disorder, comorbid depression may have biased clinicians and surrogates toward WLST.”

But Cooper added that “one of the more important findings in this study is that having any insurance vs no insurance is more important than having public vs private insurance in terms of risk of treatment withdrawal.”

An estimated 12% of American adults ages 18 to 64 do not have insurance, according to recent CDC dataopens in a new tab or window, with the highest rates among Hispanics, those of lower income, and people living in non-Medicaid expansion states (all but 10 states — mostly in the south — have expanded Medicaid accessopens in a new tab or window under the Affordable Care Act).

Compared with injured adults in non-expansion states, noted Cooper, people in expansion states “are more likely to survive hospitalization, have shorter hospitalizations, and are more likely to receive rehabilitation postdischarge.”

The study from Hoit’s team included 307,731 critically ill trauma patients ages 18 to 64 admitted to an intensive care unit (ICU) in the U.S. from 2017 to 2020. Data were captured from level I and level II trauma centers participating in the American College of Surgeons Trauma Quality Improvement Program (TQIP) registry. Analyses excluded patients who died on arrival or in the emergency department, as well as individuals with a “do not resuscitate” order.

Mean age was 40 years, three-fourths were male, about two-thirds were white, and 19% were Black. The most common mechanism of injury was motor vehicle collision (35%), followed by falls (22%), firearms (12%), and motorcycle (10%) or pedestrian (9%) accidents. More than three-fourths of the injuries were unintentional, while 15.8% were related to assaults and 2.8% were self-inflicted.

A majority (52%) of the cohort had private insurance, while 19% were uninsured, and the rest were insured through Medicaid.

Uninsured patients tended to be younger than those with private insurance (37.8 vs 41.7 years); were more likely to be male (82.6% vs 73.2%), have a history of substance abuse (12.5% vs 0.8%), and be victims of assault (24.2% vs 7%); they were less likely to be white (56.1% vs 73.8%) and generally had lower rates of chronic illness. The uninsured population was more similar to the Medicaid group.

Hoit’s team noted that TQIP defined life-supporting interventions as ventilator support (with or without extubation), kidney replacement therapy, medications to support blood pressure or cardiac function, and surgical, interventional, or radiological procedures.

Overall, 12,962 patients (4.2% of the total cohort) underwent WLST during their ICU admission, including 5% of those without insurance, 4.2% of those with Medicaid, and 3.9% of those with private insurance. Overall, the average time to WLST was 7.8 days.

Besides self-inflicted injuries, another variable associated with earlier withdrawal of care was firearm injuries (HR 2.01, 95% CI 1.79-2.27). WLST was less common in Asian, Black, and Hispanic patients (as compared with whites) and for those treated at teaching or for-profit hospitals.

Study limitations cited by the authors included a lack of variables captured in the TQIP registry — including income, religious/spiritual beliefs, marital status, language ability, and education level — that may have influenced decisions related to WLST. Also, researchers did not assess the types of care that had been provided before it was withdrawn.

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Texas Lawsuit to Stop Optum PBM Audit Termination

https://www.healthlawalliance.com/blog/health-law-alliance-files-emergency-texas-lawsuit-against-optum-pbm-audit-termination

When is the last time you took a stand on something that you believed in? Here, at HLA, we stand up everyday for clients across the country who we believe in and who are in serious need of help, whether that be against PBMs, payors, the federal government, or some other industry giant looking to crush them and their livelihood. It’s not easy, and anyone who promises specific results should not be taken at their world. With us, however, you can be assured that we will represent you fiercely at every turn. It’s just who we are and what we do based on decades of experience at the highest levels of industry. Today’s lawsuit is one example of that commitment.

Texas Lawsuit to Stop Optum PBM Audit Termination

PBMs like Optum have motivations behind their audits that are not always apparent. However, our founding partner, Anthony Mahajan, previously served as the Chief Compliance Officer of United Health, with oversight over both Optum and United Healthcare. We used to work for them, now we fight for you.

You can read HLA’s complaint HERE, a summary of the relief requested HERE, and our legal arguments HERE. Among other claims, we allege that our client was selected for termination because Optum wanted to reverse or transfer to its internal, mail-order pharmacy claims for beneficiaries of United Healthcare plans. The lawsuit alleges that United Health is losing money on its Part C Medicare Advantage capitated plans given rising medical loss ratio, and therefore is particularly incentivized to audit and recoup on prescription claims using its corporate affiliate, Optum Rx.

Alleged Violations of Texas PBM Audit Reform Laws

We have many clients in the great State of Texas who have been targeted by Optum and other PBMs as a result of their relationship with telemedicine providers. In our client’s case, the pharmacy was targeted for termination due to “mailing on a retail contract.” Nonetheless, in addition to the waiver on mailing arising from the pandemic, Texas has specific PBM reform laws, enacted under Governor Abbott, that expressly prohibit payors and PBMs from barring mail-order delivery in their provider contracts.

With HLA, providers can hold PBMs like Optum accountable to their legal obligations because our PBM audit lawyers have decades of experience litigating federal and state laws.

Alleged Violations of Federal and Texas “Prompt Pay” Laws

PBMs often refuse to reimburse providers for claims that are submitted during the pendency of an audit. This results in a difficult choice for many: should you continue serving patients in good faith, or should you change course to avoid the possibility of the PBM recouping on everything owed.

However, Texas and federal laws prohibit PBMs from refusing to reimburse “clean claims” within certain time periods. These laws may also prohibit PBMs from extending the “look-back” period for claims audits. In addition, certain laws impose significant monetary penalties on PBMs who do not comply.

HLA’s lawsuit alleges that Optum refused to timely reimburse the pharmacy for hundreds of thousands of dollars in clean claims even though Optum’s final audit findings were far lower. If a PBM is refusing to pay reimbursement due and owing, you should understand your rights under these “prompt pay” laws.

Texas PBM Audit Attorneys Fighting for You

If your pharmacy is facing unjust termination from a PBM’s network, or other PBM audit abuses, HLA can help you level the playing field. Our PBM audit defense team has successfully resolved PBM audits across the country because we have a reputation as trial lawyers with the dedication to win.

Contact us today to learn more about how we can advocate for your rights and fight for your continued ability to serve your pharmacy patients.

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Thank you everyone!! Via email (above) contact Maria Higginbotham for details

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Presidential candidate VP Kamala Harris brings to DC the experience of a PROSECUTOR for THREE DECADES. The above video is her first campaign stop where she states that she is going to get women to be allowed to make their own decisions about their bodies and medical decisions and keep the government out of medical decisions- but apparently when it only involves abortion!

Does this mean that no pts- especially those who are dealing with medical disabilities – do not have the right to be involved in their medical care – especially subjective diseases – like pain, depression, and anxiety?

Just ask chronic pain pts in Florida, where they elected a state Attorney General who is married to a DEA AGENT!

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House criticizes PBMs for pushing patients to higher-priced drugs

https://www.beckershospitalreview.com/pharmacy/house-criticizes-pbms-for-pushing-patients-to-higher-priced-drugs.html

An investigation by federal lawmakers found that pharmacy-benefit managers promised to control costs but have instead steered patients toward higher-priced medicines and affiliated pharmacies that reduce patient choice, The Wall Street Journal reported July 23.

A House Committee on Oversight and Accountability investigation found PBMs devised formulas for preferred medications that encouraged use of higher-priced drugs. It also found that Express Scripts sent messages to patients saying they would pay more to fill at their local pharmacy, but less for a three-month supply by using the affiliated mail-order pharmacy.

“While this is made to appear to benefit the patient, what it is instead doing in practice is limiting a patient’s ability to choose their own pharmacy,” the committee wrote.

The report followed a 32-month investigation. Leaders from three large PBMs are set to testify before the House committee this week.

A Pharmaceutical Care Management Association spokesperson told the Journal the firms help reduce costs to patients and health plans. He declined to comment on the report because the organization had not seen it.

“The critically important role of PBMs in our healthcare system in driving affordable access to prescription drugs is undeniable, saving patients and health plans $1,040 per person per year on drug costs,” the spokesperson said.

The three largest PBMs — CVS Caremark, Cigna’s Express Scripts and UnitedHealth’s OptumRx — handle 79% of U.S. medical prescriptions for approximately 270 million people. Integrating further with health insurers allows even more control over medication prices and access, according to a Federal Trade Commission report issued in July. On top of that, PBMs contributed to a 10% closure rate of independent pharmacies in rural locations between 2013 and 2022.

An investigation by the FTC into pharmacy benefit managers revealed PBM favoritism toward their own pharmacies and vast market control, which affects both medication access and affordability, according to the agency’s report.

The House committee also criticized the largest PBMs for lack of transparency and said they sent House investigators only a handful of pages about the groups they established to buy drugs, the Journal reported.

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15 health systems dropping Medicare Advantage plans | 2024

https://www.beckershospitalreview.com/finance/15-health-systems-dropping-medicare-advantage-plans-2024.html

Medicare Advantage provides health coverage to more than half of the nation’s seniors, but some hospitals and health systems are opting to end their contracts with MA plans over administrative challenges.

Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers.

In 2023, Becker’s began reporting on hospitals and health systems nationwide that dropped some or all of their Medicare Advantage contracts.

In January, the Healthcare Financial Management Association released a survey of 135 health system CFOs, which found that 16% of systems are planning to stop accepting one or more MA plans in the next two years. Another 45% said they are considering the same but have not made a final decision. The report also found that 62% of CFOs believe collecting from MA is “significantly more difficult” than it was two years ago.

Fifteen health systems dropping Medicare Advantage plans in 2024:
Editor’s note: This is not an exhaustive list. It will continue to be updated this year

1. Canton, Ohio-based Aultman Health System‘s hospitals will no longer be in network with Humana Medicare Advantage after July 1, and its physicians will no longer be in network after Aug. 1.

2. Albany (N.Y.) Med Health System stopped accepting Humana Medicare Advantage on July 1.

3. Munster, Ind.-based Powers Health (formerly Community Healthcare System) went out of network with Humana and Aetna’s Medicare Advantage plans on June 1.

4. Lawton, Okla.-based Comanche County Memorial Hospital stopped accepting UnitedHealthcare Medicare Advantage plans on May 1.

5. Houston-based Memorial Hermann Health System stopped contracting with Humana Medicare Advantage on Jan. 1.

6. York, Pa.-based WellSpan Health stopped accepting Humana Medicare Advantage and UnitedHealthcare Medicare Advantage plans on Jan. 1. UnitedHealthcare D-SNP plans in some locations are still accepted.

7. Newark, Del.-based ChristianaCare is out of network with Humana’s Medicare Advantage plans as of Jan. 1, with the exception of home health services.

8. Greenville, N.C.-based ECU Health stopped accepting Humana’s Medicare Advantage plans in January.

9. Zanesville, Ohio-based Genesis Healthcare System dropped Anthem BCBS and Humana Medicare Advantage plans in January.

10. Corvallis, Ore.-based Samaritan Health Services’ hospitals went out of network with UnitedHealthcare’s Medicare Advantage plans on Jan. 9. Samaritan’s physicians and provider services will be out of network on Nov. 1.

11. Cameron (Mo.) Regional Medical Center stopped accepting Aetna and Humana Medicare Advantage in 2024.

12. Bend, Ore.-based St. Charles Health System stopped accepting Humana Medicare Advantage on Jan. 1 and Centene MA on Feb. 1. 

13. Brookings (S.D.) Health System stopped accepting all Medicare Advantage plans in 2024.

14. Louisville, Ky.-based Baptist Health went out of network with UnitedHealthcare Medicare Advantage and Centene’s WellCare on Jan. 1.

15. San Diego-based Scripps Health ended all Medicare Advantage contracts for its integrated medical groups, effective Jan. 1.

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Warren Blasts United Health CEO for Monopolistic Practices that Harm Patients

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WHO Warns of Counterfeit Ozempic in the Global Supply Chain—Here’s What to Know

https://jamanetwork.com/journals/jama/fullarticle/2821502

The World Health Organization (WHO) is warning of counterfeit Ozempic discovered in 2023 in regulated supply chains in Brazil, the UK, and the US, amid an uptick in similar reports worldwide. Besides potentially being ineffective, fake versions of the drug pose a serious, perhaps life-threatening risk because they are injected under the skin, according to the alert.

An authentic Ozempic needle, left, and a counterfeit needle, right.

Food and Drug Administration/AP Images

Ozempic, a branded version of the drug semaglutide, is a once-weekly injection to treat type 2 diabetes and cardiovascular disease; it’s also prescribed for weight management off-label or at a different dose under the brand name Wegovy. Demand for these hugely popular glucagon-like peptide 1 (GLP-1) receptor agonists has often exceeded supply—at least 25 000 patients are starting Wegovy every week in the US, according to drug maker Novo Nordisk—and earlier this year, the WHO linked shortages of drugs like Ozempic to a rise in counterfeit versions sold though unregulated outlets including social media platforms.

The recent WHO warning is the first public alert to verify falsified Ozempic’s infiltration into legitimate drug supply chains in 3 different countries. It asks health care professionals, regulatory authorities, and the public worldwide to be on the lookout for suspicious medicines and to report any irregularities.

“WHO has received reports of falsified Ozempic detected in at least 14 countries across 4 different WHO regions,” Rutendo Kuwana wrote in an email to JAMA Medical News. Kuwana is the team lead for substandard and falsified medical products at WHO, which has been actively monitoring and responding to reports of counterfeit Ozempic since September 2022. WHO does not know how many people were affected or how many units were counterfeit in Brazil, the UK, or the US, he said.

According to Kuwana, no serious or uncommon adverse reactions were noted in the incidents reported to WHO. “WHO is however aware of media reports of adverse effects, especially when the incorrect active substance is used,” he added.

“Counterfeit drugs are illegal, and they could contain the wrong ingredients, other harmful ingredients, or contain too little, too much or no active ingredient at all,” Sangeeta Chatterjee, PharmD, deputy director of the US Food and Drug Administration (FDA) Office of Drug Security, Integrity, and Response, wrote in an email.

The WHO’s medical alert is a roundup and verification of previously reported fakes, which Ozempic manufacturer Novo Nordisk confirmed were falsified.

In December, the FDA reported:

• Thousands of units of counterfeit Ozempic (1 mg) with serial number 430834149057, lot NAR0074—a combination that does not correspond to genuine manufacturing records

• Needles from the lot were also counterfeit and of unknown sterility and read “NovoFine” rather than the authentic “NovoFine Plus.”

• Packaging and prescribing information were also falsified.

• Some of these counterfeit products may still have been available for purchase in December 2023.

In October, the UK Medicines and Healthcare products Regulatory Agency (MHRA) reported:

• Counterfeit prefilled Ozempic pens (1 mg) identified at 2 UK wholesalers that were bought from legitimate suppliers in Austria and Germany.

• Batch number MP5E511 of the pens is genuine but the product is counterfeit.

• Dose selectors protrude beyond the counterfeit pens when setting doses, unlike authentic Ozempic pens.

• None of the falsified pens were dispensed to patients, and there were no reports of harm.

Also, in October, Novo Nordisk informed Brazil’s national health surveillance agency about counterfeit Ozempic batch number LP6F832.

In the US, the regulated supply chain for drugs starts with a manufacturer like Novo Nordisk, and includes repackagers, wholesale distributors, third-party logistic providers, and pharmacies.

“The US has a very safe drug market, but it’s not unheard of that [counterfeits] happen,” said Kristina Acri, PhD, an economist at Colorado College who studies counterfeit medications.

A buyer at a midsize pharmaceutical distributor warehouse in New York purportedly found the fake batch, according to a Vanity Fair article, and the New York Times quoted a Novo Nordisk representative who said the falsified products were found in warehouses outside the company’s authorized supply chain. The FDA recommends that pharmacies only buy Ozempic through distributors authorized by Novo Nordisk.

As of March 2024, the FDA is aware of 9 adverse event reports for products with the lot number of the counterfeit Ozempic, Chatterjee wrote.

“The agency continues to monitor adverse event reports through MedWatch. However, we are not able to provide additional details about an ongoing investigation,” Chatterjee wrote in response to a request for information about the counterfeit products’ quality and safety and how they came into the legitimate supply chain.

The UK has a similarly regulated drug market to the US, Acri said, adding that some developing countries with less sophisticated markets can present more opportunities for counterfeit drugs to slip in.

“Producing counterfeit drugs and inserting them into the legitimate supply chain is an illegal activity and puts patients at considerable risk,” a spokesperson for Novo Nordisk said in an email.

In June 2023, Novo Nordisk reported that a counterfeit Ozempic pen, reportedly bought at a retail pharmacy in the US, actually contained insulin and led to an adverse reaction.

Novo Nordisk has filed 21 lawsuits as of May 2024 against businesses such as medical spas, weight loss clinics, and pharmacies selling compounded versions of semaglutide that could be harmful and deceptively marketed. A compounded version of a drug may be allowed when a commercially available drug appears on the FDA’s drug shortage list. Compounded drugs are not approved by the FDA, and the agency cannot verify their safety or effectiveness. Novo Nordisk said it does not directly or indirectly sell bulk semaglutide to compounding pharmacies.

A search of the FDA’s site showed that between last October and early July of this year, the agency sent warning letters to 6 online retailers selling unapproved or misbranded semaglutide or tirzepatide. The latter is a GLP-1 and glucose-dependent insulinotropic polypeptide agonist drug that works similarly to semaglutide to suppress appetite and delay gastric emptying. It’s sold by Lilly under the name Mounjaro for diabetes and as Zepbound for weight management.

Lilly has filed lawsuits against business purporting to sell products containing tirzepatide and in an open letter said it “is deeply concerned about the proliferation of online sales and posts on social media involving counterfeit, fake, compounded, and any other unsafe or untested versions of what they say is tirzepatide.”

John Buse, MD, PhD, a professor of medicine at University of North Carolina School of Medicine, said his patients with diabetes and obesity continue to intermittently struggle to fill prescriptions for semaglutide and tirzaptide, often calling dozens of pharmacies to find inventory. “It is driving doctors and patients crazy.”

Wegovy, Mounjaro, and Zepbound continue to be in short supply, according to the FDA. These shortages coupled with increasing demand has fueled the market for counterfeit Ozempic, Acri noted.

“It comes down to economics,” she said. “There is a tremendous amount of money that can be made in making and passing along counterfeit drugs, and that’s a great incentive for some really evil people.”

In addition to fighting counterfeits, drug manufacturers are trying to relieve shortages fueling the market for fakes. In late June, Novo Nordisk announced it plans to invest $4.1 billion in a North Carolina manufacturing facility to expand production of its obesity drugs and other medications, but the construction is not expected to be complete until between 2027 and 2029.

To avoid purchasing falsified medications, the FDA recommends that consumers only buy Ozempic from state-licensed pharmacies that require a valid prescription and that they check the packaging for signs of counterfeiting. Clinicians and consumers should report adverse effects to FDA’s MedWatch program by submitting an online report or downloading a report that they can fax to 1-800-FDA-0178.

Acri and Buse said consumers may never know if they used a counterfeit version of a drug unless they have an adverse reaction.

Buse said, “If someone is good at creating counterfeit material, unfortunately, I think it’s going to be very difficult for patients and pharmacists to know when they might have these bootleg products.”

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