Insurers argue that they're not to blame for snags in COVID-19 vaccine rollout

 Major payers promised to iron out snags involved in the rollout of the newest COVID-19 vaccine booster when they met this week with Department of Health and Human Services (HHS) Secretary Xavier Becerra.

Some went even further, saying that many of the problems have already been solved or at least are well on their way to being solved. Experts told Fierce Healthcare that some of those snags were unavoidable and illustrated just how tricky handing off such an undertaking from the public to the private sector can be—and, as such, all the blame for these problems should not be laid at the feet of insurers.

Though stakeholders knew insurers would take over the process when the COVID-19 public health emergency ended May 11, the actual deadline turned out to be Sept. 11, when the Food and Drug Administration (FDA) approved the vaccine, which targets the new EG.5 and BA.2.86 COVID variants.

HHS said in a press release that at the meeting this week, participants discussed technical issues that made it difficult for some individuals to get the vaccine and cited reports that pharmacists have told some customers their insurance companies refused to cover the shot.

When the Centers for Medicare & Medicaid Services found out, the agency told plans to fix the problems and reminded them “that they must cover, without cost sharing, any COVID-19 vaccine authorized under an Emergency Use Authorization or approved under a Biologics License Application by the FDA immediately upon the vaccine becoming authorized or approved—a requirement that became binding on September 11, 2023,” an HHS spokesperson told Fierce Healthcare. The American Medical Association updated billing codes for the vaccines on Sept. 18.

Ceci Connolly, president and CEO of the Alliance of Community Health Plans (ACHP), told Fierce Healthcare that “if anybody suggested to you that an insurer is claiming they don’t cover it, that is just not true. It is not the case.”

Ceci Connolly, president and CEO (Alliance of Community Health Plans )

“You may need to go and ask pharmacies why they’re saying that to customers,” Connolly said. “Our member companies are not saying that and they’re not behaving that way. And I want to make sure that’s crystal clear on the record: Our members support the vaccines. They cover them, and they are encouraging people to get the shot.”

The National Association of Chain Drug Stores did not respond to Fierce Healthcare’s request for comment as of publication.

In the HHS announcement, Becerra “expressed his appreciation to insurance providers for taking immediate action to rectify these issues.”

“The group also discussed how providers could help their members to better navigate provider websites and other systems to make it even easier to receive their vaccine,” he said.

Among the more than 20 healthcare industry officials meeting with Becerra were representatives of AHIP, ACHP, the Association for Community Affiliated Plans and the Blue Cross Blue Shield Association. The top brass at major payers such as UnitedHealthcare, Aetna, Humana and Anthem were also present.

In a letter (PDF) dated Wednesday, the organizations stated that “at this time, we understand that systemic technical issues have been largely, if not completely, resolved and are not limiting patient access to vaccines. Should further issues arise, we stand ready to swiftly implement system improvements.”

F. Randy Vogenberg, Ph.D., a principal at the consultancy the Institute for Integrative Healthcare and a member of the board at the think tank the Employer-Provider Interface Council, told Fierce Healthcare the government didn’t “effectively communicate when and how this was going to happen.”

“As an administrator, you can’t do anything unless your client—which in this case is the federal government—tells you to do it and if there’s any mandate associated with getting the vaccine,” he said.

Unlike the original COVID-19 vaccines, the Centers for Disease Control and Prevention recommends, but does not mandate, that individuals get the new version.

Vogenberg described the problem as an operational issue perhaps made a bit more complicated by the fact that drug companies, health plans and pharmacies had to wait until the vaccine was approved Sept. 11.

“It’s all strictly a lag,” said Vogenberg. “And the other issue is a lot of people may not have the insurance policy that they think they have for coverage.”

Connelly said there will always be supply chain issues involving the rollout of any vaccine, and nothing “out of the ordinary” seems to be taking place with the COVID vaccine rollout.

“I’ve been around for enough flu seasons, and sometimes your flu shots are available one week in September and another time it’s not until October, and it’s a different batch. Sometimes your doctor has it,” she said. “Sometimes your pharmacy has it. I don’t think that’s unique to COVID-19.”

Michael Bagel, the associate vice president of public policy at ACHP, told Fierce Healthcare that alliance members have been working not only with HHS but with other stakeholders such as pharmaceutical manufacturers, consumer groups and other insurers to make the rollout as smooth as possible.

https://www.fiercehealthcare.com/payers/insurers-argue-theyre-not-blame-snags-covid-19-vaccine-rollout

Discounted drug purchases under 340B grew 22% to $54B across 2022, HRSA reports

Discounted prescription drugs purchased wholesale under the 340B program grew 22.3% to $53.7 billion from 2021 to 2022, according to data published by the Health Resources & Services Administration (HRSA).

The embattled program, in which roughly a third of the nation’s hospitals participate, requires manufacturer discounts on most drugs administered in the outpatient setting to help safety-net providers.

Drugmakers have amplified their arguments that providers have been taking advantage of the program more and more over the years, spurring a wave of manufacturer restrictions, back-and-forth legal challenges and lobbying efforts in recent months.

Per HRSA’s data (reported earlier this week by industry blog Drug Channels’ following a Freedom of Information Act request), disproportionate share hospitals (DSHs) made up the bulk of 2022’s spending with $41.8 billion in total purchases (77.9%).

Health center programs and children’s hospitals were the next largest buckets and accounted for $2.8 billion (5.2%) and $1.7 billion (3.1%), respectively. Hospitals of any type comprised 87% of the program’s total purchases.

The $53.7 billion total reflects indirect sales made through the 340B Prime Vendor Program, which is managed by Apexus and handles price negotiation, distribution facilitation and other supportive activities. In other words, the reported totals “do not capture the entire universe of 340B Program purchases,” HRSA wrote on its website.

Likely of interest to those with skin in the 340B debate was a note from HRSA estimating that at least $470 million of the $53.7 billion total was comprised of purchases above the upper limit of discounted pricing. That number reflects the savings lost by participating providers due to the restrictions imposed by at least 250 drugmakers amid the legal challenges.

The administration’s tallies land as Congressional scrutiny into the savings program has ramped up.

Earlier this week, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-La.) kicked off an investigation into “how certain hospital systems” may be spending the funds saved through the program. The senator’s announcement cited profits recorded by Bon Secours-owned Richmond Community Hospital and the participation of Cleveland Clinic’s flagship hospital in a program intended to support leaner safety-net facilities.

“[The Government Accountability Office (GAO)] has identified the troubling recent pattern of 340B covered entities increasingly serving wealthier communities with higher rates of insurance, which is far afield from the program’s intent,” Cassidy said this week in a release outlining the probe. “Additionally, GAO has found that covered entities often do not share 340B discounts directly with their patients.”

The Alliance to Save America’s 340B Program—a recently launched group comprised of community health centers, pharmaceutical industry group PhRMA and others—applauded Cassidy’s announcement.

“The 340B program was intended to help true safety-net providers increase access to affordable health care services and medications,” the group’s executive director, Thomas Johnson, said in a statement that also cited HRSA’s report. “However, some entities that participate in the program, have generated substantial profits without assurances the savings have been used to improve care and reduce costs for underserved patients.”

Cassidy’s investigation follows a request for information from program stakeholders issued back in June by six bipartisan senators. Replies to that call from hospital lobbying groups like the American Hospital Association outlined the program’s importance for hospital finances in light of “rising drug prices and chronic underpayments from Medicare and Medicaid.”  

https://www.fiercehealthcare.com/finance/discounted-drug-purchases-under-340b-grew-22-54b-across-2022-hrsa-reports

Hospitals push Congress to override HHS' crackdown on third-party web trackers

 The hospital lobby is calling on lawmakers to support their controversial use of third-party web tracking technologies that patients and the Department of Health and Human Services (HHS) view as a privacy breach.

Web traffic monitoring tools such as the Meta Pixel and Google Analytics are a mainstay on thousands of hospital websites, but since a June 2022 investigation from The Markup have become the focus of sometimes costly class action lawsuits.

In exchange for traffic monitoring metrics and insights for hospitals, the technologies gather and send identifiable information about users to outside parties, often without their knowledge. A recent study suggests that more than nine in 10 hospitals’ homepages have at least one third-party cookie.

In December 2022, HHS’ Office for Civil Rights (OCR) issued guidance to hospitals warning that the services are a likely Health Insurance Portability and Accountability Act (HIPAA) violation.

Since then OCR and the Federal Trade Commission have sent warning letters to more than a hundred hospital systems and telehealth providers that have integrated the tools into their websites or apps, which were made public in September (PDF).

Responding on Thursday to a Senate Committee on Health, Education, Labor and Pensions’ (HELP’s) Request for Information regarding health data privacy, the American Hospital Association (AHA) took the opportunity to paint the 2022 OCR guidance as “simply bad public policy.”

“Not only does this OCR rule violate HIPAA and its implementing regulations, but it inflicts meaningful harm on patients and public health,” AHA Executive Vice President Stacey Hughes wrote to HELP Ranking Member Bill Cassidy, M.D. (R-La.). “Congress should urge OCR to withdraw the rule immediately.”

From a legal perspective, AHA took issue with OCR’s “misguided view” that a technology’s connection of an individual’s IP address and a public webpage addressing specific health conditions or care providers meets the bar for HIPAA’s protections.

That stance extends the protections to users who may not actually be seeking care, users searching for services for another, users seeking general health information or those conducting academic research on a hospital’s website—all of which AHA said upends “the balance that HIPAA strikes” between patients’ privacy protections and allowing for the use of information.

“In fact, courts have already concluded that the interpretation of individually identifiable health information offered by HHS in its guidance ‘goes well beyond the meaning of what the statute can bear,’” Hughes wrote in reference to portions of court decisions in recent HIPAA lawsuits related to the technologies.

As written, OCR’s rule limits web traffic analytics tools that “allow hospitals to more effectively allocate resources and help community members more easily find the healthcare information that they are seeking,” the association wrote. It would also restrict other third-party tools related to embedded videos, which are used to inform the public, and map/location technologies when can offer directions to care services, AHA added.

Rather than bring the restrictions down on hospitals, AHA advised lawmakers to take a closer look at new privacy restrictions for vendors and other hospital tech partners that aren’t already covered by HIPAA—“especially those third-party entities that decline to sign business associate agreements to ensure patient privacy,” Hughes wrote.

Beyond the data tracker policy, AHA’s letter reiterated a request that Congress bolster HIPAA to override state-level privacy requirements that are “more stringent” than federal protections.

Though this would bring an effective net decline in the nation’s health data protections, the federal law “is more than sufficient to protect patient privacy,” AHA said. Maintaining a patchwork of state requirements, meanwhile, is costly to providers and presents a barrier to the electronic data sharing goals the industry is trying to achieve, the group said.

“Varying state laws only add costs and create complications for hospitals and health systems,” Hughes wrote. “As such, the AHA reiterates its long-standing recommendation that Congress strengthen HIPAA preemption.”

https://www.fiercehealthcare.com/providers/hospitals-push-congress-override-hhs-crackdown-third-party-web-trackers

COVID-19 Virus Infects Coronary Vasculature

 A new study finds SARS-CoV-2 directly infects the coronary vasculature and causes plaque inflammation, which could help explain why people with COVID-19 have an increased risk for ischemic cardiovascular complications up to 1 year after infection.

METHODOLOGY:

• Researchers obtained 27 coronary autopsy specimens from eight patients who died from COVID-19, mean age 70 years and 75% male. All had coronary artery disease and most had cardiovascular risk factors such as hypertension, were overweight or obese, and had hyperlipidemia and type 2 diabetes.

• All but one patient, who was pronounced dead before hospital admission, were hospitalized for an average of 17.6 days.

• To identify SARS-CoV-2 viral RNA (vRNA) in the autoptic coronary vasculature, researchers performed RNA fluorescence in situ hybridization (RNA-FISH) analysis for the vRNA encoding the spike (S) protein; they also probed the antisense strand of the S gene (S antisense), which is only produced during viral replication.

TAKEAWAY:

• The study found evidence of SARS-CoV-2 replication in all analyzed human autopsy coronaries regardless of their pathological classification, although viral replication was highest in early-stage lesions that progress to more advanced atherosclerotic plaques.

• Findings indicated that more than 79% of macrophages (white blood cells that help remove lipids) and over 90% of foam cells (lipid-laden macrophages that are a hallmark of atherosclerosis at all stages of the disease) are S+, and more than 40% of both cell types are S antisense+, indicating SARS-CoV-2 can infect macrophages at a high rate.

• SARS-CoV-2 induced a strong inflammatory response as evidenced by release of cytokines (including interleukin-1 beta and interluekin-6 that are linked to myocardial infarction) in both macrophages and foam cells, which may contribute to the ischemic cardiovascular complications in patients with COVID-19.

IN PRACTICE:

"Our data conclusively demonstrate that SARS-CoV-2 is capable of infecting and replicating in macrophages within the coronary vasculature of patients with COVID-19," write the authors, adding that SARS-CoV-2 preferentially replicates in foam cells compared to other macrophages, suggesting these cells "might act as a reservoir of SARS-CoV-2 viral debris in the atherosclerotic plaque."

SOURCE:

The study was led by Natalia Eberhardt, PhD, postdoctoral fellow, Department of Medicine, Division of Cardiology, New York University, New York City, and colleagues. It was published online September 28 in Nature Cardiovascular Research.

LIMITATIONS:

Findings are relevant only to the original strains of SARS-CoV-2 that circulated in New York City between May 2020 and May 2021, and are not generalizable to patients younger and healthier than those from whom samples were obtained for the study.

DISCLOSURES:

The study received support from the National Institutes of Health (NIH). The authors report no relevant financial relationships.

https://www.medscape.com/viewarticle/996964

Residential Move After a Heart Attack Raises Risk for Death

 Moving from one residence to another after an acute myocardial infarction (AMI) significantly increases the risk for death or transition to a long-term care facility as an end-of-life measure, data suggest.

In a prospective study that followed more than 3000 patients with AMI over two decades, each residential move was associated with a 12% higher rate of death.

Dr David Alter

"This study determined that residential mobility was more important than any other social factor that we studied," investigator David Alter, MD, PhD, chair of cardiovascular and metabolic research at the University Health Network–Toronto Rehabilitation Institute and associate professor of medicine at the University of Toronto, told Medscape Medical News.

The results were published online September 17 in the Canadian Journal of Cardiology.

Moving and Mortality

"There's been very little work, surprisingly, on what happens when individuals move from community to community," said Alter. "It is that movement from community to community that is a factor within the social context that needs to be explored better. To the best of our knowledge, up until our study, it has been studied very briefly in the literature."

The prospective cohort study sample included 3369 patients who had an AMI between December 1, 1999, and March 30, 2023. The investigators followed participants until death or the last available follow-up date of March 30, 2020. They defined a residential move as a relocation from one postal code region to another.

The investigators drew data from multiple sources, including the prospective, observational Socio-Economic Status and Acute Myocardial Infarction study, which encompassed more than 35,000 patient life-years following hospitalization for a first heart attack in Ontario. Mortality data were collected from the Ontario Registered Persons Data Base. Other sources included Statistics Canada for information on neighborhood income, the Canadian Institutes for Health Information for patients' clinical factors and comorbidities, and the Ontario Health Insurance Plan (OHIP) database for physician visits. Information on long-term care admissions came from the Continuous Care Reporting System-Long Term Care, OHIP, and the Ontario Drugs Benefit databases, the latter of which also provided information on medication prescriptions for individuals aged 65 years and older.

Patients' ages ranged from 19 to 101 years (median age, 65 years). Sixty-nine percent of patients were men. Of the study population, 1828 patients (54.3%) had at least one residential move during the study period. Approximately 87% died in the community or moved from home into a long-term care facility as an end-of-life destination. Overall, 84.8% of patients who were admitted to long-term care facilities died.

The study also tracked the socioeconomic status of persons living in the postal code regions from and to which patients moved. About 32% of patients moved to a neighborhood with a lower socioeconomic status, and 30.5% moved to an area with a higher socioeconomic status.

Each residential move was associated with a 12% higher rate of death and a 26% higher rate of long-term institutionalization for end-of-life care. In unadjusted analyses, the rate of death was almost double for those who moved more frequently: 44.3% for those who moved two or more times, vs 24.8% for those who moved once in 10 years.

Accounting for a multitude of variables, such as the socioeconomic status of areas that patients moved between, is a strength of the study, said Alter. But the study lacked information about why people moved.

"Where this study has a huge amount of strength is that it was designed specifically to really understand a patient's clinical and psychosocial profile at the start of their journey, their first AMI. But the fact that we took it from heart attack onward is also a strength because it characterizes and anchors a clinical context in which we were following patients out," said Alter.

"An Important Marker"

Commenting on the findings for Medscape, Paul Oh, MD, medical director of the cardiovascular disease prevention and rehabilitation program at University Health Network, said, "This is a very well-designed study and analysis from a cohort that has provided important insights about the role of socioeconomic factors and long-term outcomes post MI [myocardial infarction] over many years." Oh did not participate in the study.

Dr Paul Oh

"A few covariates that could impact on outcomes, like institutionalization, were not available to include in adjusted analyses — eg, functional status, frailty, mild cognitive changes, and availability of social supports in the home," he said.

The findings add another variable that cardiologists who care for post-MI patients need to be aware of, Oh added. "Clinicians need better awareness that the need to change residence is an important marker of changing health status and may portend end-of-life events in the near future. The need to change residence can signal an important change in physical, cognitive, and social circumstances that needs to be further explored during clinical encounters, with the goal of identifying and addressing any potentially reversible issues and identifying additional supports that may help that individual continue to live independently in their own home."

The study was supported by ICES, which receives funding from the Ontario Ministry of Health. The investigators have disclosed no relevant financial relationships. Oh serves on research boards for Lilly and Novartis and receives research funding from Apple.

Can J Cardiol. Published September 17, 2023. Abstract

https://www.medscape.com/viewarticle/996952

TikTok promotes illegal steroids to teens who want to look like Captain America, nonprofit warns

 TikTok has become a key marketing channel for promoting steroids and other bodybuilding drugs to millions of the video-sharing site’s users, according to a damning report.

The study by the nonprofit Center for Countering Digital Hate says popular videos encouraging the use of the products for aesthetic or athletic gain are being posted by influencers who often downplay the risks associated with them.

“They’re being marketed to young men by influencers who are deliberately saying, ‘If you want to be like Captain America, you’ve got to take these drugs’,” CCDH founder and CEO Imran Ahmed said after the study was released Thursday.

The Chinese-owned app — which has 87 million users in the US, many of them under age — has been accused of promoting a “toxic” diet culture, encouraging frivolous spending, and pushing Chinese propaganda.

The nonprofit’s study focused on TikTok videos which promoted a class of steroid-like drugs (SLDs) that include anabolic-androgenic steroids (AAS), peptides, and Selective Androgen Receptor Modulators (SARMs).

“Videos with hashtags promoting SLDs were viewed by US users up to 587 million times in the last three years, including up to 420 million views from US users aged under 24,” according to the CCDH.

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The Center for Countering Digital Hate claims that TikToks target young men by promoting steroid-like drugs that are illegal to sell over the counter. In one post, a user says that even Captain America needs the drugs to achieve his enviable physique.

TikTok/@christianand22

TikTok spokesperson Ben Rathe criticized the report, saying the group’s methodology doesn’t distinguish between harmful videos and positive content that talks about recovery from steroids or their side effects. It’s not possible for the CCDH to know that based on the type of data they’re presenting and the sheer volume of videos that are on TikTok, he said.

One video of a man working out displayed text that read: “Hear me out. Everyone always hating on steroids bro. You know who took steroids? Captain America. Bro literally is a morally grounded character and he injected super soldier serum.”

Another showed a young man deadlifting with text that said his mother asked: “First protein powder, now creatine. What’s next…steroids?” The clip then cuts to a clip of bodybuilder Ronnie Coleman saying “Yeah buddy!”

Adolescents who use protein powder supplements may have as much as a “five-fold higher risk of new use of steroids and other muscle-building products,” CCDH claimed.

One TikTok nodded to the link between protein powder and steroid use, showing a man discovering a vile of drugs in his whey protein powder container. “I found something in the whey,” the post said in a play on words.

A slew of comments called out that the mysterious bottle of drugs is “something called roids.”

And in a particularly disturbing post that has garnered over 2.4 million views, a teen who said he was 13 years old documented his “30-day steroids transformation” where a slideshow of images showed him becoming increasingly muscular.

Among the SARMs gaining popularity on the ByteDance-owned app is MK-2866. Though it’s an SLD that’s banned from being sold or purchased for humans, MK-2866 is still being sold for recreational use by third-party supplement companies.

@tomasobeid

Lightweight! #ronniecoleman #yeahbuddy #fyp #gymtok #steroids #protein #foryou #creatine #tren #motivation #relatable

♬ Part of me hardstyle remix – Raskal

Videos using the hashtag #MK-2866 have amassed nearly 3 million views on TikTok, and one popular post with 42,000-plus views promotes the supplement as a pill that can increase lean muscle, improve strength and endurance, and reduce recovery time.

Another SARM making its way into the limelight: Trenbolone, or simply “tren,” which is popular among bodybuilders, but has become even more sought after by non-weightlifters thanks to its promotion on TikTok, CCDH claims.

One account that posts under the username @teach_me_roids claims that the unnamed user’s workout and supplement-taking tips can help young boys bio-hack their body through puberty “in order to suppress their estrogen levels, which he claims will increase their height and genital size.”

The account holder also boasts a 10% discount code for Swiss Chems — a site that claims to be “a trusted source for high-quality research chemicals” — in their TikTok bio.

On Swiss Chems’ website, there’s an entire section dedicated to SARMs.

The hashtag #Tren was among the 30 tags that the CCDH found featured videos relating to the abuse or sale of SLDs, “contributing to a culture where abusing the drugs to alter body shape and size is normalized.”

For reference, 19.8 billion videos use the hashtag #Tren.

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Another gym rat shared a video that supported the CCDH’s findings that teens who use protein powder supplements may have as much as a “five-fold higher risk of new use of steroids and other muscle-building products.”

TikTok/@thekingdiet

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Accounts on TikTok claim that SLDs in the form of illegal supplements increase lean muscle, improve strength and endurance, and reduce recovery time.

TikTok/@thekingdiet

The CCDH report follows a warning issued by the Food and Drug Administration in April about performance-enhancing drugs being marketed to teenagers and young adults on social media platforms

The CCDH urged policymakers at the end of its report to “close loopholes through which sites selling SLDs can operate online.”

They’re also calling on TikTok to better enforce its ban on content that promotes the use of recreational drugs.

Rathe, the TikTok spokesperson, said content that sells or depicts SARMS will be removed by the company when it’s detected.

https://nypost.com/2023/09/29/tiktok-promotes-illegal-steroids-to-teens-nonprofit-warns/