New Data on Disordered Sleep After COVID

 Moderate to severe sleep disturbances and severe fatigue affect up to 40% of patients with long COVID, or post-acute sequelae of SARS-CoV-2 infection (PASC). Such disturbances are especially common among Black people, new research shows.

The "high" prevalence of moderate to severe sleep disturbances is "alarming," study investigator Cinthya Pena Orbea, MD, sleep specialist at the Cleveland Clinic, told Medscape Medical News.

The findings were presented at SLEEP 2022: 36th Annual Meeting of the Associated Professional Sleep Societies.

Pena and colleagues analyzed data on 962 patients with PASC seen at the Cleveland Clinic ReCOVer Clinic between February 2021 and April 2022.

More than two thirds of patients (67.2%) reported at least moderate fatigue, while 21.8% reported severe fatigue, Pena reported.

In addition, 41.3% reported at least moderate sleep disturbances, while 8% of patients reported severe sleep disturbances, including insomnia, "which may impair quality of life," Pena said.

Obesity, mood disorders, and Black race emerged as contributors to problems with sleep and fatigue after COVID.

Notably, after adjusting for demographics, Black race conferred threefold higher odds of moderate to severe sleep disturbances.

"We don't know why this is, and one of our next steps is to better understand race-specific determinants of sleep disturbances after COVID and create targeted interventions," Pena said.

How long after COVID the fatigue and sleep problems last "remains uncertain," Pena acknowledged. However, she added, in her clinical experience with therapy, patients' sleep and fatigue may improve after 6 or 8 months.

Ruth Benca, MD, PhD, co-chair of the Alliance for Sleep, is not surprised by the Cleveland Clinic findings.

"Sleep disturbances and fatigue are part of the sequelae of COVID," Benca, who was not involved in the study, told Medscape Medical News.

"We know that people who have had COVID have more trouble sleeping afterwards. There is the COVID insomnia created in all of us just out of our worries, fears, isolation, and stress. And then there's an actual impact of having the infection itself on worsening sleep," said Benca, with Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina.

The study had no specific funding. The authors have disclosed no relevant financial relationships. Benca is a consultant for Idorsia Pharmaceuticals.

SLEEP 2022: 36th Annual Meeting of the Associated Professional Sleep Societies: Abstract 0735. Presented June 6, 2022.

https://www.medscape.com/viewarticle/975185

Supreme Court overturns 340B pay cut to hospitals

 The Supreme Court on Wednesday unanimously rejected massive payment cuts to hospitals under the contentious 340B drug discount program.

In the ruling (PDF), the justices noted that the Department of Health and Human Services did not survey hospital costs before adjusting payments for 340B in a 2018 rule, which cut payments to hospitals in the program by nearly 30%.

The agency repeated that approach in 2019 rulemaking, and attorneys for HHS argued before the court that the surveys were not required. SCOTUS disagreed.

"The text and structure of the statute make this a straightforward case," the opinion says. "Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals."

The American Hospital Association sued to challenge the payment cuts, and a federal district court sided with them and struck down the rule. However, an appeals court later reversed the decision, leading to the SCOTUS showdown.

HHS also argued that in designing the 340B program, Congress would not have intended for the agency to "overpay" hospitals for 340B drugs. However, the justices said that legislators would have been "well aware" that 340B hospitals paid less for prescription drugs.

"It may be that the reimbursement payments were intended to offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities," they said. "Regardless, this Court is not the forum to resolve that policy debate."

In a joint statement, AHA, AAMC and America's Essential Hospitals called the ruling "a decisive victory for vulnerable communities and the hospitals on which so many patients depend."

"340B discounts help hospitals devote more resources to services and programs for vulnerable communities and increase access to prescription drugs for low-income patients," the organizations said.

"Now that the Supreme Court has ruled, we look forward to working with the Administration and the courts to develop a plan to reimburse 340B hospitals affected by these unlawful cuts while ensuring the remainder of the hospital field is not disadvantaged as they also continue to serve their communities," they said.

While the Supreme Court has resolved this prong of the 340B debate, more legal battles around the program are ongoing. The Biden administration has fined multiple pharmaceutical companies for restricting contract pharmacies' access to 340B drugs, which has prompted a slew of lawsuits from drugmakers.

https://www.fiercehealthcare.com/regulatory/supreme-court-overturns-340b-pay-cut-hospitals

Suit: CVS prevented Part D members from accessing generics

 A newly unsealed whistleblower suit claims that multiple CVS Health subsidiaries coordinated to prevent members from accessing generic drugs in a bid to boost the bottom line.

The suit, first obtained by Stat, was filed by Alexandra Miller, who worked at CVS for nearly two decades before leaving the company three years ago. Miller says that when she reported the behavior to a superior, she was told that the company had decided the benefits of the alleged scheme outweighed the likelihood of being caught.

Miller claims that CVS' SilverScripts Part D subsidiary as well as its Caremark pharmacy benefit manager and retail pharmacies worked together to prevent access to generics, which allowed it to pocket higher rebates because members were pushed to buy branded medications rather than lower-cost options.

Members were also often kept in the dark about potential authorized generic medications or identical drugs that are produced by the same manufacturer but offered at a lower cost.

The company violated Medicare regulations by failing to disclose this formulary distinction and felt that SilverScripts Part D customers were less likely to complain about the potential costs because many receive subsidies to cover their medication expenses, according to the lawsuit.

The Department of Justice declined to join the suit. CVS told Stat said it intends to "vigorously defend" itself.

The lawsuit was made public as policymakers put the pharmacy supply chain, and pharmacy benefit managers in particular, under the microscope. The Federal Trade Commission said last week that it would dig into the business practices of six major PBMs, including Caremark, as the industry becomes increasingly consolidated.

The PBM market is dominated by three companies, all of which are also integrated with a major health plan and other industry segments: Caremark, a sister company to Aetna; Express Scripts, which is owned by Cigna; and OptumRx, which is a sister company to UnitedHealthcare.

A recent Supreme Court decision granted states greater power to regulate PBMs, and with that have come multiple investigations into their role in Medicaid, including millions in settlements paid out by Centene in six states.

https://www.fiercehealthcare.com/payers/whistleblower-suit-cvs-prevented-part-d-members-accessing-generics

Third of top hospitals' websites collecting patient data for Facebook

 Facebook has been collecting potentially sensitive health data through a tracker that, until recently, was included in the online scheduling tools of roughly a third of the country’s top hospitals, according to a new report from nonprofit investigative newsroom The Markup.

Called the Meta Pixel, the tracker is an analytics tool Facebook’s parent company offers website owners. In exchange for social media advertising information, the tracker sends the tech company data on users’ IP addresses and webpage activity.

The Markup reviewed the appointment scheduling webpages of 100 leading hospitals and found the Meta Pixel on 33, according to the report. These hospitals collectively saw over 26 million patient admissions and outpatient visits in 2020, per American Hospital Association survey data cited by the publication.

The group also found the tracker within the password-protected patient portals of seven major health systems, five of which they were able to document sending the personal data of real volunteer patients.

IP addresses, doctor names, appointment times, medication information, search terms and connections to users’ Facebook accounts were all among the data being collected and sent to the tech company, according to the report, which was co-published with digital publication Stat. There were reportedly no specific contracts or other evidence that patients were providing consent to these data being collected.

Health privacy consultants and advocates cited in the report said they were troubled by the data collection practices but stopped short of definitively declaring the tracker to be a HIPAA violation.

The organization reached out to the hospitals and health systems that had the Meta Pixel on their webpages. As of the time of the report’s publication, seven hospitals and five health systems had removed the Meta Pixel from their webpage after being contacted.

Some reportedly replied to inquiries by referencing safeguards installed by Facebook to filter out sensitive health data prior to transmission. Some of these organizations still removed the tracker from their webpages.

The Markup noted a February investigation from the New York Department of Financial Services reporting the poor accuracy of Facebook’s sensitive data filtering system.

Facebook parent company Meta did not respond to questions from The Markup regarding how the data were being used but referenced its policy to remove potentially sensitive health data via the filtering tool.

Facebook also acknowledges that the Meta Pixel and other tracking tools collect users’ personally identifiable information in its business tools terms of service.

https://www.fiercehealthcare.com/health-tech/report-third-top-hospitals-websites-collecting-patient-data-facebook

Rhythm's Imcivree Scores FDA Approval in Bardet-Biedl Syndrome

 The U.S. Food and Drug Administration has approved Boston-based Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome (BBS), a rare genetic disease with a wide range of symptoms, including severe obesity.

Imcivree is already approved by the European Commission (EC) and Great Britain’s Medicines & Healthcare Products Regulatory Agency (MHRA) for obesity and control of hunger linked with genetically confirmed loss-of-function biallelic proopiomelanocortin (POMC), including PCSK1, deficiency or biallelic LEPR deficiency in adults and children six years of age and older. The drug is a melanocortin-4 receptor (MC4R) agonist. MC4R plays a key role in the biological pathway that regulates hunger, caloric intake and energy expenditure.

“This FDA approval represents a significant milestone for Rhythm, validating our strategy of developing Imcivree for people with hyperphagia and severe obesity caused by rare MC4R-pathway diseases and allowing us to provide our precision therapy to an established community of patients living with BBS and their families who are eagerly awaiting a new treatment option,” Dr. David Meeker, M.D., chair, president and chief executive officer of Rhythm, said in a statement.

“Leveraging the robust infrastructure we put in place following the initial approval of Imcivree for obesity due to biallelic POMC, PCSK1 or LEPR deficiency and our new high-touch patient support services to assist patients throughout the journey from diagnosis to ongoing treatment, we are able to make Imcivree available for BBS immediately," he added. 

On Monday, the company presented data from its long-term extension study of the drug in BBS syndrome, or POMC or LEPR deficiency obesity receiving the therapy between 18 months and three years. The presentation took place at the Endocrine Society Annual Meeting & Expo (ENDO) held in Atlanta. Forty-two patients with BBS treated with setmelanotide in Phase II or Phase III continued into the long-term extension. As of the data cutoff, 30 and 19 patients received at least 18 and 24 months of the drug, respectively. The mean percent change in body mass index (BMI) across all patients was -9.5% and -14.3% at 18 and 24 months, respectively.

BBS affects about 1,500 to 2,500 people in the U.S. They may experience insatiable hunger (hyperphagia), with severe obesity starting early in life. Other symptoms include retinal degeneration, decreased kidney function, extra fingers or toes (polydactyly), hypogonadism and learning disabilities.

The approval was based on data from the company’s pivotal Phase III trial. The drug demonstrated early, significant and sustained weight reduction, hitting its primary endpoint and all key secondary endpoints. The mean percentage change in BMI was -7.9% without diet and exercise. There was a statistically significant mean change in hunger score of -2.1 at 52 weeks in patients 12 years of age and older who could self-report their hunger.

Dropped toward the end of the announcement, the company indicated the FDA had issued a complete response letter (CRL) for the sNDA for setmelanotide in Alström syndrome.

Alström syndrome is also a rare disease affecting a broad range of body systems. It is marked by a progressive loss of vision and hearing, a type of heart disease that enlarges and weakens the heart muscle called dilated cardiomyopathy, obesity, type 2 diabetes and short stature. It ranges greatly in severity. It is caused by mutations in the ALMS1 gene.

Meeker said, “We appreciate the FDA’s careful review of our sNDA for Imcivree for the treatment of Alström syndrome but are disappointed in this outcome. We are tremendously grateful to the Alström syndrome patients, caregivers and physicians who participated in our clinical development efforts and look forward to providing an update regarding our path forward.”

The company also announced it had entered into a Revenue Interest Financing Agreement with HealthCare Royalty Partners for an investment of up to $100 million. Rhythm plans to use the proceeds and its cash on hand to support worldwide commercialization activities for Imcivree and ongoing clinical programs. Under the deal, it will receive an initial investment of $37.5 million due to Thursday’s approval.

https://www.biospace.com/article/fda-approves-rhythm-s-drug-for-bardet-biedl-syndrome/

Bausch Health suspends plans for Solta IPO

 Bausch Health Companies Inc said on Thursday that it is suspending its plans for the initial public offering of its unit Solta Medical, citing challenging market conditions.

Bausch said it will revisit alternative paths for the medical aesthetics company in future.

In August, Bausch announced plans to pursue an IPO of Solta in a bid to shed non-core assets and cut down debt. 

https://finance.yahoo.com/news/1-bausch-health-suspends-plans-214820962.html

U.S. FTC fires warning shot at drug middlemen over rebates, fees

 The Federal Trade Commission (FTC) voted unanimously Thursday to increase scrutiny of pharmacy benefit managers that act as middlemen between drug companies and consumers in a renewed effort to combat soaring healthcare costs and drug prices.

The five-member commission, including two Republican commissioners, voted to increase scrutiny of discounts that pharmaceutical middlemen seek from drug companies to ensure their products are covered by the pharmacy benefit manager (PBM).

FTC Chair Lina Khan said in an open meeting the FTC would study to see if rebates sought by middlemen reduced competition, ultimately leading to higher drug prices.

"The FTC has also determined that commercial bribery practices, commonly referred to as kickbacks, constitute an unfair method of competition," she added.

The three biggest PBMs are UnitedHealth Group Inc's Optum unit, CVS Health Corp's CVS Caremark and Cigna Corp's Express Scripts. PBMs decide what drugs will be covered by health insurance plans and negotiate prices with manufacturers.

An official with the PBM industry said the goal of the companies was to "control costs and lower costs," and pointed to the drug companies as the cause of sometimes spectacular price rises for insulin and other medicines.

The FTC expressed particular concern about insulin, which was first produced synthetically in the 1970s and which some 8 million American diabetics rely on. The price of insulin had risen 300% in the past two decades, with the list price of a one-year supply now costing nearly $6,000.

https://news.yahoo.com/u-ftc-fires-warning-shot-213044651.html