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Thursday, October 20, 2022

Mayo Warns It Won't Take Most Medicare Advantage Plans

 The Mayo Clinic sent letters this fall to all eligible Medicare beneficiaries who received care at its Arizona and Florida facilities in the last 3 years, warning them that it is out-of-network "with most Medicare Advantage plans."

The letter sent to Florida beneficiaries said that "marketing for Medicare Advantage Plans may indicate that you can be seen at any facility that accepts Medicare, however Mayo Clinic in Florida is out of network on these plans."

Asked about the reasoning behind the letters, Mayo communications manager Kevin Punsky replied that they are intended to serve as "a courtesy reminder" at the start of the annual Medicare re-enrollment window that began Oct. 15. They are intended to notify those eligible for Medicare that if they want coverage for non-emergency care at the Mayo Clinic in those two states, they should enroll in "Original Medicare (Parts A, B and D) as well as Medicare supplements."

"This notice allows the patient to make an informed selection of coverage if the patient would like to seek a plan that has Mayo Clinic in network. Out-of-network care is not in the best interest of patients and does not support Mayo's model of care."

The letter also advises recipients that the Mayo Clinic "will not schedule appointments for patients with out-of-network Medicare Advantage Plans."

Medicare Advantage plans have been under increasing scrutiny and investigation because so many of them have been accused by federal agencies of denying care, exaggerating the severity of illnesses to pull billions more from Medicare, and delaying care with lengthy prior authorization requirements.

Additionally, unhappy enrollees who want to disenroll often find they can't sign up for a supplemental plan without underwriting, which can result in rejection of beneficiaries with certain common underlying health conditions.

Asked whether the Mayo Clinic was aware of any specific Medicare Advantage marketing ads that provided misleading information suggesting that MA enrollees can make appointments for care at the Mayo Clinic, Punsky sent this reply in an email to MedPage Today:

"Respectfully, we disagree that the letter insinuates deceptive marketing practices. When a patient enrolls in a narrow network plan, non-emergency medical services are only covered when obtained at certain network providers. We support a patient's ability to make an informed decision on their plan and preferred providers."

Mayo Clinic in Minnesota did not send out a similar letter, Punsky said.

In February, according to a story in the Star Tribune in Minnesota, Mayo had stopped scheduling out-of-network Medicare Advantage patients enrolled in UnitedHealthcare plans. "Seniors in UnitedHealthcare plans are among those no longer getting clinic appointments due to capacity concerns," the story said. "But the change also hints at a financial dispute over payment rates between Mayo and UnitedHealthcare, the health insurance giant based in Minnetonka."

However, the Minnesota-based Mayo Clinic lists that it accepts Humana Medicare Advantage plans. In June, it agreed to a multi-year commercial relationship with UnitedHealthcare, the largest Medicare Advantage company in the country.

It could not be determined from the Mayo Clinic website of contracted providers which, if any, Medicare Advantage plans have contracts with Mayo Clinic in Arizona or Florida.

Perry Davis, who just turned 65, received the same letter from the Florida Mayo Clinic earlier this month and handed it to his wife, Michele Davis, a broker in Ormond Beach who sells Medicare health plans in Florida, New Jersey, and Alabama.

"He just handed the letter to me and said, 'Looks like I'm signing up for Original Medicare and a supplement.'"

She told MedPage Today that to her, the letter "suggests that customers of Medicare Advantage plans have been given other information," although she is not aware of any ads that have said that.

As a broker, she noted, "It's important for anyone marketing Medicare Advantage plans to be aware of the network, including hospitals. The network information needs to be made clear to the consumer."

"While you can and should be able to be seen at any hospital for emergency services, Medicare Advantage marketers and agents need to make it clear that in non-emergent situations, MA plan customers cannot be seen at any facility that accepts Medicare, but only those that are within the plan's network. Otherwise, the customer would pay for those out-of-network services," she said.

Known for its specialization in many conditions and its coordinated system of care, the Mayo Clinic's website says it "cares for 1.4 million people each year with serious or complex illnesses from all 50 U.S. states and 140 countries."

https://www.medpagetoday.com/special-reports/exclusives/101320

AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity

 


Background & Aims

Pharmacological management of obesity improves outcomes and decreases the risk of obesity-related complications. This American Gastroenterological Association guideline is intended to support practitioners in decisions about pharmacological interventions for overweight and obesity.

Methods

A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis of the following agents: semaglutide 2.4 mg, liraglutide 3.0 mg, phentermine-topiramate extended-release (ER), naltrexone-bupropion ER, orlistat, phentermine, diethylpropion, and Gelesis100 oral superabsorbent hydrogel. The guideline panel used the evidence-to-decision framework to develop recommendations for the pharmacological management of obesity and provided implementation considerations for clinical practice.

Results

The guideline panel made 9 recommendations. The panel strongly recommended the use of pharmacotherapy in addition to lifestyle intervention in adults with overweight and obesity (body mass index ≥30 kg/m2, or ≥27 kg/m2 with weight-related complications) who have an inadequate response to lifestyle interventions. The panel suggested the use of semaglutide 2.4 mg, liraglutide 3.0 mg, phentermine-topiramate ER, and naltrexone-bupropion ER (based on moderate certainty evidence), and phentermine and diethylpropion (based on low certainty evidence), for long-term management of overweight and obesity. The guideline panel suggested against the use of orlistat. The panel identified the use of Gelesis100 oral superabsorbent hydrogel as a knowledge gap.

Conclusions

In adults with overweight and obesity who have an inadequate response to lifestyle interventions alone, long-term pharmacological therapy is recommended, with multiple effective and safe treatment options.

Quest Raises Guidance for Full Year 2022

 

  • Third quarter revenues of $2.49 billion, down 10.4% from 2021
  • Third quarter reported diluted earnings per share ("EPS") of $2.17, down 46.0% from 2021; and adjusted diluted EPS of $2.36, down 40.4% from 2021
  • Third quarter base business revenues of $2.17 billion, up 5.1% from 2021
  • Full year 2022 reported diluted EPS now expected to be between $8.52 and $8.72; and adjusted diluted EPS expected to be between $9.75 and $9.95

Axsome Announces Availability of 1st and Only Oral NMDA Receptor Antagonist for Major Depressive Disorder

 AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week1-4

Auvelity On My Side offers comprehensive patient support services including access and prescription drug support    

Axsome Therapeutics Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that AUVELITY™ (dextromethorphan HBr-bupropion HCl) is now available by prescription in the United States for the treatment of major depressive disorder (MDD) in adults.1 AUVELITY is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD, and the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.1-4 AUVELITY was developed with FDA Breakthrough Therapy designation for the treatment of MDD.

https://www.biospace.com/article/releases/axsome-therapeutics-announces-availability-of-auvelity-the-first-and-only-oral-nmda-receptor-antagonist-for-the-treatment-of-major-depressive-disorder-in-adults/

Pfizer and Erasca Target Pancreatic, Colorectal Cancer with "Synergistic" Pairing

 California-based Erasca announced Thursday it is expanding its existing partnership with Pfizer to assess ERAS-007 in combination with Pfizer's Ibrance (palbociclib).

The extended clinical trial collaboration and supply agreement will see both biopharmas embark on a clinical proof-of-concept study. They will test their drug combo in pancreatic ductal adenocarcinoma patients harboring mutations in the KRAS gene, and in colorectal cancer patients with mutations in the NRAS and KRAS genes. 

Erasca will sponsor the trial, while Pfizer will provide Ibrance for free.

In a statement, Jonathan E. Lim, M.D., chairman, CEO and co-founder of Erasca, said the drug combo can be highly effective in these indications because the two medicines act through complementary pathways.

“Preclinical evidence supports synergistic anti-tumor effects when downstream RAS/MAPK pathway inhibition is combined with cell cycle inhibition in CRC and PDAC,” he said. “Based on their respective mechanisms of action, ERAS-007 and palbociclib offer a promising combination to overcome adaptive resistance in patients with these highly prevalent oncogenic drivers.”

Designed as an oral medication, ERAS-007 exerts its anti-cancer effect by targeting and inhibiting the ERK1 and ERK2 signaling proteins, which disables the RAS/MAPK pathway, a central cascade in cancer. 

Erasca’s candidate is being assessed in the HERKULES series of clinical trials, both as a monotherapy or in combination with other drugs, and has shown potential best-in-class activity and wide inhibitory effects across several RAS mutations.

Meanwhile, Ibrance is a cell cycle inhibitor that targets CDK4 and CDK6, both important enzymes involved in cell division. This action allows Ibrance to arrest the frenzied growth and multiplication of tumor cells, preventing the malignancy from progressing.

The combination of Ibrance and ERAS-007 is currently in a Phase Ib/II study under the HERKULES master protocol trial and is being investigated as a treatment for gastrointestinal malignancies.

Erasca and Pfizer first entered into a clinical trial collaboration and supply agreement in September last year, when both companies agreed on a Phase Ib/II study, also under the HERKULES trial series, to assess ERAS-007 with Pfizer’s Braftovi (encorafenib) in metastatic colorectal cancer with the BRAF V600E mutation.

The initial alliance between Erasca and Pfizer also sought to attack cancer on many different fronts.

“Combining upstream EGFR inhibition, midstream BRAF inhibition and downstream ERK inhibition fits squarely within Erasca’s strategies to erase cancer and has potential to limit pathway reactivation, offering the therapeutic potential to comprehensively shut down the RAS/MAPK pathway in this tumor type,” Lim noted at the time.

In April, at the annual meeting of the American Association for Cancer Research, Erasca presented promising preclinical data supporting the strong anti-cancer activity of ERAS-007 as a monotherapy and in combination with Braftovi or established cancer drugs such as cetuximab.

Erasca plans to share Phase Ib combination data for ERAS-007 plus various combination agents in lung cancer (HERKULES-2) in 2023 and in GI malignancies (HERKULES-3) in the first half of the year, David Chacko, CFOtold BioSpace

Once Erasca has defined the dose for ERAS-007 in these combinations and established preliminary safety and efficacy, the company will then move to dose expansion studies, Chacko said. 

Depending on the outcome of those studies, Erasca will "speak with the FDA and other health authorities to discuss regulatory timelines, including potential accelerated approval where warranted," he added. 

Earlier this year, Erasca announced a clinical trial collaboration and supply agreement with Eli Lilly to evaluate another asset, ERAS-601, an oral SHP2 inhibitor, with Lilly's anti-EGFR antibody cetuximab. 

https://www.biospace.com/article/pfizer-inks-expanded-partnership-with-erasca-target-pancreatic-colorectal-cancer/

Police Issue Warning Ahead Of Halloween After Fentanyl Pills Found In Candy Bags At LAX

 by Lorenz Duscamps via The Epoch Times,

Authorities in California have issued a warning to parents ahead of Halloween celebrations after approximately 12,000 fentanyl pills packaged in several popular candy boxes were seized at Los Angeles International Airport.

“With Halloween approaching, parents need to make sure they are checking their kids’ candy and not allowing them to eat anything until it has been inspected by them,” the Los Angeles County Sheriff’s Department said in a press release.

“If you find anything in candy boxes that you believe might be narcotics, do not touch it and immediately notify your local law enforcement agency,” the agency added.

The giant seizure of the deadly synthetic opioid happened on Oct. 19 after narcotic detectives and agents with the Drug Enforcement Agency (DEA) stopped a suspect who was attempting to pass the airport’s security screening with several bags of candy and miscellaneous snacks.

Upon investigating the packages, authorities “discovered that inside the ‘Sweetarts,’ ‘Skittles,’ and ‘Whoppers’ candy boxes were fentanyl pills,” the release said.

The suspected drug trafficker managed to flee the scene before being detained by law enforcement, officials said, noting that the suspect has been identified and the investigation is ongoing.

Anyone with additional information about the incident is asked to contact the Los Angeles Sheriff’s Department’s narcotics bureau at (562) 946-7125.

Narcotic detectives seized about 12,000 suspected fentanyl pills that were packaged in bags of candy at Los Angeles International Airport in California on Oct. 19, 2022. (Courtesy of Los Angeles County Sheriff’s Department)

Fentanyl Deaths on the Rise

Fentanyl is a potent synthetic opioid that is 50 times stronger than heroin and 100 times more potent than morphine. As little as two milligrams is potentially enough to be lethal.

An increasing number of Mexican cartels have been importing fentanyl from China before pressing it into pills or mixing it into other counterfeit pills made to look like Xanax, Adderall, or oxycodone. The drugs are then sold to unaware buyers in the United States.

https://www.zerohedge.com/medical/police-issue-warning-ahead-halloween-after-fentanyl-pills-found-candy-bags-lax

Tenet Healthcare stock drops more than 20% on poor outlook

 Tenet Healthcare Corp. shares dropped in the extended session Thursday after the hospital operator forecast an outlook that came up short of Wall Street expectations while announcing a share buyback program. Tenet shares fell 21% after hours, following a 0.2% decline in the regular session to close at $54.32. Tenet forecast adjusted earnings of $1 to $1.54 a share on revenue of $4.82 billion to $5.02 billion for the fourth quarter, and $5.88 to $6.42 a share on revenue of $19 billion to $19.2 billion for the year. Analysts surveyed by FactSet had estimated $1.80 a share on revenue of $5.04 billion for the fourth quarter, and $6.38 a share on revenue of $19.27 billion for the year. The company reported third-quarter net income of $131 million, or $1.16 a share, compared with $449 million, or $4.13 a share, in the year-ago period. Adjusted earnings, which exclude stock-based compensation expenses and other items, were $1.44 a share, compared with $1.99 a share in the year-ago period. Revenue declined to $4.8 billion from $4.89 billion in the year-ago quarter. Analysts had forecast $1.24 a share on revenue of $4.81 billion. Tenet also announced a $1 billion share-buyback program.

https://www.morningstar.com/news/marketwatch/20221020746/tenet-healthcare-stock-drops-more-than-20-on-poor-outlook