FEHBlog

Midweek Update

David Ermer–COVID-19, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Omicron and unusual viruses front —

BioPharma Dive reports

Moderna has joined Pfizer in asking the Food and Drug Administration for emergency authorization of a new COVID-19 booster shot adapted to the virus strains now dominant in the U.S.

The biotech’s reformulated shot targets both the original coronavirus strain and the BA.4/BA.5 omicron subvariants. BA.5 now accounts for almost 90% of cases in the U.S., with versions of BA.4 making up almost all of the rest, according to estimates from the Centers for Disease Control and Prevention.

Moderna and Pfizer have been working closely with the FDA to design boosters that can better fend off COVID-19, particularly as immunity wanes in people who were last vaccinated many months ago. On Monday, Pfizer announced it had finished its application. Moderna followed a day later.

The Wall Street Journal discusses monkeypox’s symptoms, vaccines and how it spreads:

[I]nfectious-disease experts say patterns of transmission in this outbreak have been consistent with the need for close contact, rather than airborne spread. If the virus could easily spread through airborne transmission, they say many more cases outside the LGBT community would be expected. * * *

Most monkeypox cases in the U.S. have been mild, though some patients have experienced moderate to severe disease with symptoms such as extreme pain and high fevers and have had to be hospitalized. * * *

Most monkeypox cases in the U.S. and globally have, to date, been among men who have sex with men. The CDC released data finding the outbreak is concentrated among men who have had sex with several men. Public-health experts say the current risk to the general population is low.

“At this moment in terms of acquiring monkeypox, I wouldn’t change my behavior,” said Dr. Chin-Hong, noting that the calculation would be markedly different for someone in an at-risk group.

Though a handful of children in the U.S. have contracted monkeypox, infectious-disease experts say the risk to most children is very low.

In other public health news

  • Becker’s Payer Issues tells us “Cancer has overtaken musculoskeletal conditions as large employers’ biggest driver of healthcare costs, according to Business Group on Health’s ‘2023 Large Employers’ Health Care Strategy and Plan Design Survey.’ Business Group on Health surveyed 135 employers across various sectors that together cover more than 18 million people between May 31 and July 13, according to the August 23 report.”
  • Becker’s Hospital Review ranks the states by average life expectancy.

In judicial news —

  • The FEHBlog checked the court docket in the Change Healthcare antitrust case today, and he discovered that the defense rested in the bench trial on August 15, and the Court has scheduled closing arguments for September 8. The bench trial, in this case, pending in the U.S. District Court for the District of Columbia, began on August 1.
  • The Wall Street Journal reports this evening.

A federal judge blocked Idaho from enforcing its near-total abortion ban in certain emergency situations, an early victory for the Justice Department in a case it filed this month.

U.S. District Judge B. Lynn Winmill on Wednesday issued a preliminary injunction that prevents the state from enforcing its ban in emergency circumstances where doctors and hospitals deem an abortion is necessary to avoid placing the health of a pregnant patient in serious jeopardy. * * *

The ruling was one of two initial tests for Biden administration efforts to require abortion access for emergencies in states that have moved to heavily restrict the procedure. A separate ruling from Texas, issued late Tuesday, went against the administration.

In that case, a federal judge in Lubbock ruled that hospitals and doctors for now aren’t required to abide by the administration’s guidance requiring emergency abortion care.

The next stop is the federal appellate courts in both cases.

In U.S. healthcare business news —

Fierce Healthcare informs us

Three years after it began piloting a primary care service for its employees that blended telehealth and in-person medical services, Amazon plans to cease operations of its Amazon Care service.

Amazon announced Wednesday afternoon that it would end Amazon Care operations after December 31. In an email to Amazon Health Services employees, Neil Lindsay, senior vice president of Amazon Health Services, said Amazon Care wasn’t a sustainable, long-term solution for its enterprise customers.

Amazon provided a copy of the email to Fierce Healthcare.

The decision only impacts Amazon Care and Care Medical teams and not Amazon’s other healthcare services. 

CEO Andy Jassy has made health care a priority, naming Amazon Care as an example of “iterative innovation” in his first letter to shareholders earlier this year. In July, the company announced plans to buy concierge primary care provider One Medical in a deal valued at approximately $3.9 billion.

If the One Medical deal goes through, it would significantly expand Amazon’s foothold in the nearly $4 trillion healthcare market, specifically in the competitive primary care market.

One Medical markets itself as a membership-based, tech-integrated, consumer-focused primary care platform. The company operates 188 offices in 29 markets. At the end of March, One Medical had 767,000 members.

The deal also gives Amazon rapid access to the lucrative employer market as One Medical works with 8,000 companies.

This news suggests to the FEHBlog that Amazon is confident that the One Medical acquisition will close.

Kaiser Health News offers an enlightening story on unregulated dietary supplements.

Dietary supplements, which include a broad range of vitamins, herbs, and minerals, are regulated by the FDA. However, they are classified as food and don’t undergo the rigorous scientific and safety testing the government requires of prescription drugs and over-the-counter medicines.

Lawmakers aren’t proposing to put supplements into the same category as pharmaceuticals, but some say they are alarmed that neither the FDA nor the industry knows how many dietary supplements are out there — making it almost impossible for the government to oversee them and punish bad actors.

The FDA estimates 40,000 to 80,000 supplement products are on the market in the U.S., and industry surveys estimate 80% of Americans use them.

Tuesday Tidbits

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, No Surprises Act, OPM, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.

The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.

Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots. 

Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.

Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.

From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.

Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.

From the medical research front, BioPharma Dive reports

Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.

At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.

If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.

The article provides an overview of these RNA drug development efforts.

From the tidbits department —

  • MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
  • Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
  • The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
  • The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
  • The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.

Monday Roundup

David Ermer–CDC, COVID-19, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and unusual viruses front —

STAT News reports

Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots.

Notably, in the same press release, the companies said that a clinical study investigating the safety, tolerability, and immunogenicity of the vaccine, which also includes the original Covid strain, is expected to start this month, meaning data would not be available for the FDA to consider.

The application to authorize the vaccine without new clinical trial data is part of a bold and potentially controversial gambit by the U.S. and its advisers to try and get ahead of the fast-mutating coronavirus, SARS-CoV-2. But it’s one that could also have a big payoff.

The Pharmacy Times tells us

Officials with the FDA have granted an expanded Emergency Use Authorization (EUA) to Novavax for its COVID-19 vaccine, adjuvanted for adolescents 12 through 17 years of age, according to a press release. The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.

The expanded EUA allows for a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents. Doses are now available and primary series immunizations for adolescents can begin once the CDC releases a policy recommendation.

Will the next Novovax approval from the FDA be for a booster?

Medpage Today points to a study suggesting a connection between myocarditis in children and long Covid.

The Wall Street Journal adds

Officials in New York are urging pediatricians and parents to bring patients up to date on polio shots, as evidence suggests the infectious and potentially debilitating poliovirus was present in the state as early as April. 

Health officials said they have sent alerts to healthcare providers, hung fliers in houses of worship, grocery stores and summer camps, and talked with community leaders to boost polio vaccination rates in the greater New York City area. Some places including Rockland and Orange counties have polio vaccination rates around 60% among eligible children, compared with a national rate of around 93%, according to federal data. 

Polio is particularly insidious, health officials and other public-health experts said, because the majority of cases occur in people who never develop symptoms but can still spread the virus. That silent spread can cause meningitis or paralysis in someone unvaccinated against the disease. 

In other public health news, STAT News informs us

Anthony Fauci, the top U.S. infectious diseases official for decades and a leading researcher on crises from HIV to Covid-19, announced Monday that he would be stepping down from his positions in December.

Fauci, 81, has led the National Institute of Allergy and Infectious Diseases for 38 years, serving a line of presidents from both parties since the Reagan administration. He has also served as President Biden’s chief medical adviser since Biden took office. While Fauci has telegraphed that he was planning on leaving those roles in a matter of months, Monday’s announcement makes it official.

But Fauci, known as a tireless workhorse, said he would not be retiring. “After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field,” he said. “I want to use what I have learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.”

From the U.S. healthcare business front, Bloomberg reports

Signify Health Inc. soared the most since its shares started trading last year as UnitedHealth Group Inc., Amazon.com Inc., CVS Health Corp. and Option Care Health Inc. competed to acquire the home-health technology and services provider, according to people familiar with the matter. 

UnitedHealth has submitted the highest bid in excess of $30 a share, while Amazon’s offer is close behind, the people said, asking not to be identified as the discussions are private. Signify is holding a board meeting Monday to discuss the bids, the people said. * * *

Final bids are expected Sept. 6, but a deal could come earlier if any of the parties preempt the sales process, the people said.  * * *

Through its software and services, Signify aims to help clients — payers like health plans, government programs and employers — shift to value-based payment plans. It’s backed by private equity firm New Mountain Capital, which formed the company in 2017, according to the firm’s website. 

That is quite a big business rumble.

From the No Surprises Act front, Prof. Katie Keith and her colleagues wrote two articles on last Friday’s “final, final” independent dispute resolution rule — one concerns its impact on IDR arbitrations and the other on miscellaneous topics.

From the mental healthcare front, Health Payer Intelligence lets us know that “Payers are working toward achieving broader access to mental healthcare and behavioral healthcare services by reimbursing at higher rates and supporting primary care” according to a recent AHIP survey.

Nearly eight in ten health plans had boosted behavioral healthcare workers’ reimbursement rates (78 percent). Additionally, 83 percent of payers had attracted and retained a diverse population of behavioral healthcare providers.

Substance abuse care is becoming more accessible, the survey found. Specifically, more providers have become eligible to offer medication-assisted therapy (MAT). This population has expended 114 percent over the course of three years.

Nearly three-quarters of health plans (72 percent) support behavioral healthcare training for primary care providers. The same share supported primary care providers by helping them find behavioral healthcare specialist referral partners.

Payers have also offered primary care providers the opportunity to call behavioral healthcare specialists via telehealth or telephone in order to consult them on a patient’s condition. More than half of the health plans (56 percent) provide this option. This method has been used in pediatric psychiatry to solve members’ challenges in connecting with specialists.

Health plans reported a couple of main ways that they try to connect members with mental healthcare services. Many plans do this by supporting patient navigation (83 percent). For example, health plans might connect members with community-based organizations that can address their social determinants of health needs. 

Additionally, more than eight in ten health plans said they help members secure behavioral healthcare visits. Follow-up on inpatient care and emergency room visits is often part of health plans’ efforts to connect members with mental health services as well. Seventy-eight percent of the plans leveraged specialized case managers to perform this function.

From the medical research and development front —

Biopharma Dive informs us

Gilead’s long-acting HIV shot Sunlenca is now cleared for sale in Europe, marking the first marketing authorization for a treatment the California biotechnology company hopes can be used broadly as a standard therapy and preventive regimen.

The decision by the European Commission, announced Monday, authorizes Sunlenca for patients whose current treatment regimen can no longer keep their infection at bay. Sunlenca, previously called lenacapavir, will be added to other antiviral drugs to boost patients’ immune response and reduce levels of virus in the body.

Gilead is still waiting on a regulatory decision in the U.S., where it has been delayed by manufacturing issues. An approval by the Food and Drug Administration’s December deadline could put the drug on track to reach sales that RBC Capital Markets analysts estimate will climb as high as $4 billion a year.

The Wall Street Journal reports

Zapping the brain with weak electrical currents that mimic normal neural activity can boost memory in healthy older adults, at least over the short term, researchers said in a study published Monday in the journal Nature Neuroscience.

Electrical stimulation of the brain as a potential tool for enhancing memory is a growing field of research, with experiments showing that the ability to recall memories depends upon synchronized activity between different brain regions.

The new research, conducted on people over age 65, “adds to the growing evidence that noninvasive stimulation mimicking the rhythmic brain activity that supports cognition can improve memory” in this population, said Joel Voss, a University of Chicago professor of neurology who wasn’t involved in the research.

Weekend update

David Ermer–Congress, COVID-19, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Congress is on a State / District work break again this week.

The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.

Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.

Here’s a link to a Fierce Healthcare article on the new rules.

From the omicron and unusual viruses front —

The Wall Street Journal reports

The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.

But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.

As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S. 

This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.

The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce. 

The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.

Fingers crossed.

On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.

NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes

Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.

A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.

The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox. 

The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.

The Wall Street Journal offers articles on “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York” and “Am I Protected Against Polio? Here’s What to Know About the Vaccine.”

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.

The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.

Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.

Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.

STAT News adds

Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.

Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.

Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.

CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.

There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.

From the miscellany front

  • Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization.  The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
  • Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cyber policy front —

Cybersecurity Dive reports

Cybersecurity and Infrastructure Security Agency Director Jen Easterly praised the efforts of the Joint Cyber Defense Collaborative (JCDC) following its one-year anniversary, saying in a blog post the public-private partnership has helped limit cyber risk at scale. 

JCDC helped federal agencies and private sector partners mitigate some major cybersecurity threats, Easterly said, including the Log4Shell crisis from December 2021; the development of the Shields Up campaign related to the Russia invasion of Ukraine; and the Daxin malware discovery from February. 

JCDC recently expanded to include industrial control partners. The change comes at a time when sophisticated malware threatens major critical infrastructure targets in the U.S. JCDC is also working to protect the nation’s election infrastructure from nation-state threats ahead of the November midterm elections.

and

U.S. executives now consider cyberattacks the No. 1 risk companies are confronting, according to a PwC Pulse survey released Thursday. The study shows 40% of top business executives consider cyberattack risk their top concern, followed by talent acquisition at 38%. 

Cybersecurity concerns have moved well beyond the office of the CISO or cyber risk officer, as the entire C-suite and corporate boards are focused on the risks of cyberattack. 

Almost half of all corporate executives said they are making additional investments in cybersecurity, while slightly more than half of executives said they are increasing investments in digital transformation.

Health IT Security adds

US Senator Angus King (I-ME) and Representative Mike Gallagher (R-WI), both co-chairs of the Cyberspace Solarium Commission (CSC), wrote a letter to HHS Secretary Xavier Becerra asking about the current status of HHS’ healthcare cybersecurity efforts.

King and Gallagher, who also authored the Sector Risk Management Agency (SRMA) legislation, urged HHS and the Biden administration to bolster cybersecurity efforts and called on HHS to hold an urgent briefing on the administration’s current cybersecurity posture and plans for improvement.

From the cyber vulnerabilities front —

The Wall Street Journal reports

All companies should be using two-factor authentication at least to secure their systems, but relying on text messages alone is foolish, cybersecurity experts say.

The process, known as 2FA, adds another level of protection to systems by requiring users to verify their identity through more than just a password. Often, this takes the form of a verification code sent by text message—or SMS—or voice calls, but experts warn that these systems are becoming increasingly out of date.

“SMS was never designed to be a 2FA method,” said Jamie Boote, associate principal consultant at cybersecurity company Synopsys Software Integrity Group. “Originally, it was a maintenance communication channel between cell towers and phones. It only became a consumer-centric communications channel after users discovered they could send text messages to one another.”

The widespread use of SMS as a security mechanism has also increased hackers’ focus on compromising the technology, Mr. Boote said. Hackers also use SMS as an avenue to launch other attacks, he said. Common methods include phishing attacks by text message, known as smishing, and SIM-swapping, in which a cellphone is cloned, meaning attackers can read messages sent to a device. * * *

Mobile security specialists say the best forms of protection for 2FA are security tokens such as those developed by the Fast Identity Online Alliance, or FIDO, a consortium including Apple Inc., MicrosoftCorp. and Alphabet Inc.’s Google that is creating open security standards. The general lack of security in mobile phones means they are often easy targets for hackers without the added protection that more advanced security technologies such as those developed by FIDO provide, said Hank Schless, senior manager of security solutions at cyber company Lookout Inc.

ZDNet adds

Using [Multi factor authorization] MFA protects against the vast majority of attempted account takeovers, but recently there’s been a surge in cyber attacks which aim to dodge past multi-factor authentication security. According to Microsoft, in just one campaign 10,000 organizations have been targeted in this way during the last year. 

One option to for hackers who want to get around MFA is to use so-called adversary-in-the-middle (AiTM) attack which combined a phishing attack with a proxy server between the victim and the website they’re trying to login to. This allows the attackers to steal the password and session cookie which provides the additional level of authentication they can exploit – in this case to steal email. The user simply thinks they have logged into their account as usual.

“Note that this is not a vulnerability in MFA; since AiTM phishing steals the session cookie, the attacker gets authenticated to a session on the user’s behalf, regardless of the sign-in method the latter uses,” as Microsoft notes of that particular campaign. * * *

While it isn’t totally infallible, using multi-factor authentication is still a must as it stops a significant amount of attempted account takeover attempts. But as cybercriminals get smarter they’re increasingly going to go after it – and that requires extra levels of defense, particularly from those responsible for securing networks. 

“It’s good it’s recommended because you won’t be the lower hanging fruit. But you definitely need to augment it with additional layers of security because, just like any other siloed security solution, it can be circumvented and you can’t think everything is secure, just because of one security layer,” says Etay Maor, senior director of security strategy at Cato Networks.  

and

There’s been a big rise in cybercriminals combining fraudulent emails and telephone calls to trick victims into disclosing sensitive information like passwords and bank details.

Known as vishing attacks, criminals and scammers telephone victims and attempt to use social engineering to trick them into giving up personal data.  

Researchers warn that vishing and other email-based phishing attacks will continue to be a problem – but there are steps with organisations can take to help prevent attacks. 

“Capabilities to automatically detect and remove threats from all infected employee inboxes before users can interact with them also plays a critical role, as well as a proper security training regimen, to prepare users to be on the lookout for such threats,” said John Wilson, the senior fellow responsible for threat research at Agari. 

The Health Sector Cybersecurity Coordination Center (HC3) issued an analysts note on vishing this week.

This week

  • CISA “and the Multi-State Information Sharing & Analysis Center (MS-ISAC) published a joint Cybersecurity Advisory (CSA) in response to active exploitation of multiple Common Vulnerabilities and Exposures (CVEs) against Zimbra Collaboration Suite (ZCS), an enterprise cloud-hosted collaboration software and email platform.
  • CISA also added seven known exploited vulnerabilities to its catalog.
  • HC3 issued a Sector Alert on Apple fixes to two Zero Day Exploits.
  • HC3 also released its vulnerability bulletin concerning “July Vulnerabilities of Interest to the Health Sector.”

HC3 posted a PowerPoint presentation on the impact of social engineering on healthcare.

From the ransomware front, here is a link to the latest Bleeping Computer’s Week in Ransomware.

From the Cyber defenses front —

Cybersecurity Dive reports

A fundamental shift in information security practices is underway, as 55% of organizations now have a zero trust initiative in place, more than double the 24% totals from a year ago, according to the State of Zero Trust report from Okta released Tuesday. 

The report shows almost universal adoption of zero-trust principles, as 97% of businesses either have a zero trust initiative in place or will adopt one in the next 12-18 months. 

“Today we’ve seen that zero trust is no longer a theoretical idea — it’s an active initiative that almost every organization across [every] industry is implementing,” Christopher Niggel, regional chief security officer for the Americas at Okta, said via email.

Security Week offers expert opinions on prevention being the future of cybersecurity and the future of endpoint management.

Friday Stats and More

David Ermer–COVID-19, No Surprises Act–

Based on the Centers for Disease Control’s (“CDC”) Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases for 2022.

Omicron reigned from before Week 1 through Week 15. Its siblings began to take over in week 15 and still reign.

The CDC’s weekly review of its Covid statistics adds

As of August 17, 2022, the current 7-day moving average of daily new cases (95,652) decreased 9.9% compared with the previous 7-day moving average (106,116).

CDC Nowcast projections* for the week ending August 20, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 88.9% (95% PI 87.6-90.1%).

Here’s the CDC’s latest daily trends chart of new Covid admissions

The CDC’s weekly review adds, “The current 7-day daily average for August 10–16, 2022, was 5,690. This is a 6.1% decrease from the prior 7-day average (6,059) from August 3–9, 2022.”

Here is the FEHBlog’s weekly chart of new Covid deaths, which like new Covid cases, has plateaued for months but is trending down somewhat.

The CDC’s weekly review adds, “The current 7-day moving average of new deaths (394) has decreased 10.7% compared with the previous 7-day moving average (442).”

Here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered over the Covid vaccination era, which began in the 51st week of 2022.

The CDC’s weekly review adds,

As of August 17, 2022, 607.6 million vaccine doses have been administered in the United States. Overall, about 262.3 million people, or 79.0% of the total U.S. population, have received at least one dose of vaccine. About 223.7 million people, or 67.4% of the total U.S. population, have been fully vaccinated.

The CDC’s weekly chart includes this charts on the administration of the first and second boosters:

Medpage Today offers Physicians Address Parents’ Concerns on COVID Vaccines in Young Kids, and the New York Times provides expert medical opinions on whether to delay the fourth dose of vaccine for the bivalent vaccine in the fall.

To sum up, the CDC’s weekly review leads off with a discussion of how to stay safe from Covid in school and reminds us the check the Communities tracker, which honestly has not turned out to be that informative in the aggregate:

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

Friday’s big, late-breaking news is the Affordable Care Act’s regulators’ release of the final No Surprises Act Independent Dispute Resolution rule following provider and court objections to the interim final rule with comments.

The departments continue to work to implement and put into effect the Jan. 1, 2022, consumer protection law to help curb surprise billing for medical care. Today’s final rules will make certain medical claims payment processes more transparent for providers and clarify the process for providers and health insurance companies to resolve their disputes. * * *

In addition to issuing the final rules, the departments are issuing [28 pages of Frequently Asked Questions Part 55 with guidance on implementing the requirements of the No Surprises Act, including those related to surprise billing protections, open negotiation and the federal IDR process.

Also available:

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, NIH, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Federal News Network identifies five federal workforce items on Congress’s to-do list.

From the omicron and siblings front, the Wall Street Journal reports

The Biden administration is planning for an end to its practice of paying for Covid-19 shots and treatments, shifting more control of pricing and coverage to the healthcare industry in ways that could generate sales for companies—and costs for consumers—for years to come. * * *

Shifting payments for Covid-19 drugs and vaccines to the commercial market is expected to take months, an HHS spokesman said.  * * *

Switching vaccine purchasing to the commercial market would mean that each insurer and pharmacy benefit manager would be negotiating with drug manufacturers and prices would likely be higher than what the federal government has paid, said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. Insurers would have to start paying for the vaccines, he said, likely raising premiums.

MedPage Today informs us

More than 2 years after patients started reporting long-lasting symptoms after acute SARS-CoV-2 infection, the U.S. announced its national long COVID plan.

The National Research Action Plan on Long COVID aims to improve prevention, diagnosis, and treatment for long COVID, which currently affects up to 23 million people in the U.S., about 1 million of whom may be out of the workforce at any given time because of the condition, according to Admiral Rachel Levine, MD, HHS assistant secretary for health. * * *

Long COVID advocates expressed mixed opinions. Hannah Davis, co-founder of the Patient-Led Research Collaborative, noted the fact that “there’s going to be an [Office of Long COVID Research and Practice] is pretty amazing.”

But Davis voiced concerns about the scarcity of prevention efforts addressed by the plan. “I think there’s still a feeling like we can get through this without minimizing cases, but we really need to be focused on prevention as well,” she said.

Diana Berrent, founder of Survivor Corps, told MedPage Today that the administration “nailed the institutional challenge of long COVID” but also thought the plan was insufficient.

“Millions of Americans, young and old, are suffering the aftermath of COVID and need immediate relief from their pain,” Berrent said. “An established office in HHS is a welcome step but nothing short of actual treatments and therapeutics will do the trick.”

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of monkeypox cases, and MedPage Today reports

The Biden administration is making an additional 1.8 million doses of the Jynneos monkeypox vaccine available beginning Monday, and will be targeting certain large events — such as gay pride marches that attract many LGBTQIA participants — as sites for monkeypox vaccination and outreach, administration officials said Thursday.

From the healthcare costs front, Healthcare Dive reports

U.S. employers will pay 6.5% more on average for employee healthcare coverage in 2023 compared to this year, according to an Aon report out Thursday.

The latest predicted rise, while a jump from the 3.7% growth in employer costs between 2021 and 2022, is still far below the 9.1% Consumer Price Index, a figure reflecting inflation. 

Inflation typically hits healthcare costs later than other goods and services due to the multi-year nature of contracts between providers and insurers, but impacts will become more prevalent over the year, according to the report.

Speaking of higher costs, Fierce Healthcare discusses Moody’s report on how an economic downturn would impact health plans.

From the post-Dobbs front, the FEHBlog ran across this Congressional Research Service FAQs on Federal Resources for Reproductive Health.

From the No Surprises Act front, the American Hospital Association informs us “The Centers for Medicare & Medicaid Services has launched a new webpage with resources and guidance related to the dispute resolution process under the No Surprises Act, including guidance for disputing parties and a walkthrough of the federal portal. CMS also has added functionality to the portal for initiating disputes, including a button to upload supporting documents at initiation.”

From the miscellany department —

  • Fierce Healthcare discusses J.D. Powers’ annual study of Medicare Advantage plans. “[T]he analysts found members’ general satisfaction is up from 2021 and is higher than satisfaction reported by people in employer-sponsored plans. However, while members said they’re happy with access to preventive and routine care, coverage of mental health and substance abuse treatment is lacking.”
  • STAT News calls our attention to “a new Pew-funded report, by researchers at George Washington University, the federal government can expand methadone access without approval from Congress.” According to the article, “When it comes to fighting opioid addiction, there’s no tool more effective than methadone. Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose.”

Midweek update

David Ermer–CDC, Government Contracting, Rx coverage, U.S. Healthcare–

From inside the Beltway, Roll Call tells us

Centers for Disease Control and Prevention Director Rochelle Walensky is looking to reorganize the agency in the wake of an external review of the CDC’s COVID-19 response. * * *

“For 75 years, CDC and public health have been preparing for COVID-19,” Walensky said, “and in our big moment, our performance did not reliably meet expectations.” 

The plan aims to achieve a “more cohesive and customer centric structure,” by implementing new programs and procedures to work more quickly and ensure more accountability. Walensky plans to establish an executive council to oversee the CDC’s progress on specific goals, consolidate various points of access for external stakeholders and establish a new equity office.

STAT News adds

Outside experts expressed enthusiasm — though some of it tempered — for the changes Walensky is proposing.

Jay Varma, who spent 20 years at CDC before becoming director of the Cornell Center for Pandemic Prevention and Response at Weill Cornell Medicine, applauded many of the points Walensky stressed, particularly her promise to reform the culture of the agency and build up the capacity of its staff to respond to emergencies. Over the past two decades or so, Varma told STAT, public health agencies like the CDC have become increasingly bureaucratic.

“If your culture is not aligned entirely with what your mission is, it doesn’t matter how good the strategy is. It doesn’t matter what your org charts are. It is all about the workforce culture,” he said.

But Varma warned effecting change in the agency’s culture will be challenging.

Speaking of change, Fierce Healthcare informs us

A dramatic pickup in the pace of change for payers in the last year has created new priorities for health plan leaders, a new survey has found. 

The survey, conducted by payment integrity solution HealthEdge, reached more than 300 health plan leaders. Common themes, per a report of the survey results, included the move to newer systems amid a digital transformation, rising demand for real-time data access and the promise of interoperability. 

Some of the biggest threats facing health plans are new regulations, growing consumer expectations, competition and the transition to value-based payment strategies. The top two challenges are managing costs and driving operational efficiencies, which were lower on the list of priorities just last year. Tied in third place are member satisfaction and alignment of IT and business needs. 

There are several drivers of these hurdles. Post-pandemic, there are notably more claims. Long delays in care have also led to rising costs, and outdated systems have required significant investment to keep up with demand. Having a solid digital baseline can help payers eliminate manual, repetitive processes, the report suggested. Payers also believe increasing interoperability and improving claims accuracy helps alleviate administrative costs. 

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Wednesday approved a powerful new treatment for people with an inherited blood condition called beta thalassemia, clearing a personalized gene therapy developed by the biotechnology company Bluebird bio. * * *

Its approval is a milestone in a number of other respects, too. Beta thalassemia, a disease that in severe cases requires regular blood transfusions for life, has for years been marked as a target for gene therapy. Bluebird’s treatment, which will be sold as Zynteglo, is the first of several in development to reach market in the U.S., giving patients an option that could free them from those transfusions and their associated side effects.

STAT News adds

Bluebird has set the price of Zynteglo at $2.8 million per patient, making it one of the most expensive medicines ever sold in the U.S. And that price tag doesn’t include the cost of the lengthy hospitalization for patients getting the therapy.

A person with beta thalassemia incurs total health care costs that average $6.5 million over their lifetime, or 23 times higher than the general population, said Obenshain, making the case for Zynteglo’s cost effectiveness. Earlier this year, the Institute for Clinical and Economic Review, an independent drug-pricing analysis group, said Zynteglo would be cost effective up to a price of $3 million.

Bluebird will be asking insurers to pay for Zynteglo entirely up front, but the company will also return up to 80% of the cost if patients need to restart blood transfusions before two years.

“All the commercial insurers we’ve engaged with have expressed a really strong interest in this,” said [Bluebird CEO Andrew] Obenshain, of Bluebird’s outcome-based payment proposal.

From the research and studies front —

  • “Infectious disease expert Dave Wessner reports for Forbes from the 24th International AIDS Conference, where researchers shared ways that Covid vaccine development might help the development of a vaccine for AIDS.”
  • The National Institutes of Health announced “Scientists funded by the National Institutes of Health have developed a same-day test to identify abnormal fetal chromosomes. The Short-read Transpore Rapid Karyotyping (STORK) test can detect extra or missing chromosomes (i.e., aneuploidy) using samples collected from prenatal tests, such as amniocentesis and chorionic villus sampling, as well as tissue obtained from miscarriage and biopsies from pre-implantation embryos produced using in vitro fertilization (IVF). * * * Overall, the study shows that STORK is comparable to standard clinical tests and has many advantages. STORK is faster, providing results within hours versus several days. It is also cheaper, with the study team estimating STORK to cost less than $50 per sample, if 10 samples are run at the same time, or up to $200 if a sample is run on its own. STORK can also be done at the point-of-care for a patient, eliminating the need to ship a sample to a clinical laboratory.  According to the study authors, STORK may be particularly useful in identifying genetic causes of miscarriage. Currently, professional societies only recommend genetic testing if a person has had multiple miscarriages, but an easy, cost-effective test like STORK can potentially be offered after the first miscarriage. STORK can also be used to streamline the IVF process. Currently, embryos must be frozen while genetic tests are run and analyzed before implantation. STORK’s ability to provide results within hours can presumably eliminate this freezing step, which saves time and cost. More work is needed to validate STORK, but if results continue to show promise, STORK could improve the quality of reproductive healthcare.”
  • The National Cancer Institute announced “For people with advanced cancer, severe side effects from treatment often force them to the hospital or the emergency room. Although these time-consuming and, quite often, expensive hospital trips potentially could be prevented by better communication about symptoms between patients and their doctors, the reality is that such discussions don’t typically happen as frequently as they should.   Now, a new study shows that community health workers (CHWs) may help bridge this communication gap in cancer care. In the study, having a CHW directly consult with people newly diagnosed with advanced cancer or cancer recurrence, including assessing their symptoms and helping them with advance care planning, substantially decreased hospitalizations and emergency room visits.”
  • Fierce Healthcare reports “Musculoskeletal conditions are a massive source of health spending—accounting for $420 billion in 2018—and a new report from [Cigna’s] Evernorth aims to pinpoint where health plans could cut down on costs.”
  • Health IT Analytics tells us “New research published in JAMA Internal Medicine shows that an artificial intelligence (AI)-based cognitive behavioral therapy intervention for chronic pain (AI-CBT-CP) had similar outcomes to standard CBT-CP, which could result in increased access and reduced costs.”

From the government contract front, Federal News Network reports that

As the travel industry — and prices — recover from COVID-19, the General Services Administration is giving federal employees a little more leeway on hotel costs for official travel.

The base daily traveling allowances will rise slightly from $155 per day in 2021 to $157 per day in 2022. Per diem lodging rates will account for that rise, increasing from $96 per night to $98. Meals and incidental expenses will not change from their current range of $59-$79 per day.

For feds who already have an idea of their travel plans for fiscal 2023, GSA included a new calculator tool that will allow them to search by city, state, zip code or a map to determine the exact amount of their per diem.

Experience-rated FEHB plan carriers must subject employee lodging and miscellaneous expenses to the GSA’s per diem caps when seeking government contract reimburses for those expenses.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog is back inside the Capital Beltway this week so let’s kick it off with a link to the President’s remarks at his signing of the budget reconciliation act (H.R. 5376) into law.

Because the new law’s drug pricing changes will impact the FEHB Program most, here is a link to STAT New’s article unpacking those provisions.

From the omicron and siblings front, Federal News Network reports that the Safer Federal Workforce Task Force is following the CDC’s lead by easing restrictions to stop the Covid spread.

From the monkeypox front, check out Fierce Healthcare’s monkeypox news tracker.

MedPage Today offers a fascinating article in which a Johns Hopkins epidemiologist assesses the current case of polio paralysis in New York through a historical lens.

Polio is a fecal-oral pathogen and the Sabin vaccine, as an oral vaccine, more naturally mimicked the natural route of infection and therefore triggers different and more potent immune responses than the injectable Salk vaccine. Also, because it is a “live” vaccine, the vaccine virus is shed and can passively immunize close contacts of vaccinated individuals. For these reasons, the Sabin vaccine eventually came to be a more dominant and preferred vaccine than the [original, injected] Salk version.

However, as polio receded as a public health threat, rare complications elicited by the Sabin vaccine became intolerable in many Western countries. The “live” nature of Sabin’s vaccine, in rare instances, could lead to vaccine-associated paralytic polio. In even rarer circumstances, the virus could mutate or recombine with other viruses to become a circulating vaccine-derived poliovirus (cVDPV) that could be capable of infecting others, and in some cases, causing paralysis. This is why 2 decades ago — with polio no longer an issue domestically — the U.S. switched to an all-Salk injectable polio vaccine regimen for children, away from a combination that used the Sabin oral polio vaccine (OPV) and the injectable polio vaccine. But many countries, especially those in which wild polio still circulates, still use OPV. * * *

In response, [U.S.] healthcare professionals and policymakers need to encourage widespread immunization in areas in which cVDPVs have been found. It is not surprising that this problem has been detected in the same locales in which a very large measles outbreak recently occurred. I suspect other areas likely have cVDPVs circulating as well, and broader wastewater surveillance coupled with targeted catch up immunization will be critical. I can’t stress this point enough: high vaccination rates are required for resiliency. 

In related virus news, the Centers for Disease Control released a report titled “Hepatitis C Treatment Among Insured Adults — the United States, 2019–2020.”

What is already known about this topic?

Direct-acting antiviral (DAA) treatment is recommended for nearly all persons with hepatitis C and cures ≥95% of cases. Treatment saves lives, prevents transmission, and is cost saving.

What is added by this report?

Treatment rates are low overall and vary by age and insurance payor. DAA treatment is lowest among young adults aged 18–29 years and Medicaid recipients, and within Medicaid, among persons reporting Black or other race and persons in states with treatment restrictions.

What are the implications for public health practice?

Timely initiation of DAA treatment, regardless of insurance type, is critical to reducing viral hepatitis–related mortality, disparities, and transmission.

Also of note,

Across insurance types, ≥75% of persons treated initiated treatment within 180 days after diagnosis. The smaller percentage of persons treated within 180 days after diagnosis might indicate lack of access to a hepatitis C treatment provider, insurance denial, or loss to follow-up. Treatment coverage can be increased by providing integrated care, patient navigation, and care coordination (15). The introduction of simplified hepatitis C treatment algorithms reducing the number of laboratory tests and in-person visits can facilitate patient-centered treatment (20).

From the U.S. Healthcare business front

  • The Food and Drug Administration issued “a final rule to improve access to hearing aids which may, in turn, lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without needing a medical exam, prescription or a fitting adjustment by an audiologist.” The rule will take effect in 60 days / mid-October.
  • STAT News reports Merck has cut a deal to enter the mRNA market.

On Tuesday, the company announced a deal to develop mRNA-based vaccines and therapies with Orna Therapeutics, a Cambridge-based startup that launchedduring the pandemic with a slightly different take on mRNA technology. Merck will pay Orna a $150 million upfront fee, invest $100 million in a new funding round for the company, and offer $3.5 billion in longer-term milestones.

  • The American Hospital Association tells us.

Hospital patients are sicker and more medically complex than they were before the COVID-19 pandemic, driving up hospital costs for labor, drugs and supplies, according to a new AHA report.

“Combined with rapidly rising economy-wide inflation and reimbursement shortfalls, these mounting costs are threatening the financial stability of hospitals around the country,” the report notes.

Hospital patient acuity as measured by average length of stay (ALOS) rose almost 10% between 2019 and 2021, including a 6% increase for non-COVID-19 Medicare patients as the pandemic contributed to delayed and avoided care, the report notes. For example, ALOS rose 89% for patients with rheumatoid arthritis and 65% for patients with neuroblastoma and adrenal cancer. In 2022, patient acuity as reflected in the case mix index rose 11.1% for mastectomy patients, 15% for appendectomy patients and 7% for hysterectomy patients.

These increases have occurred at a time of significant financial challenges for hospitals and health systems, which have still not received support to address the delta and omicron surges that have comprised the majority of all COVID-19 admissions. As a result, AHA is asking Congress to halt its Medicare payment cuts to hospitals and other providers; extend or make permanent certain waivers that improve efficiency and access to care; extend expiring health insurance subsidies for millions of patients; and hold commercial insurers accountable for improper and burdensome business practices.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the federal policy front, Fierce Health tells us about four healthcare policy changes beyond government negotiation of a subset of Medicare-covered drugs and extension of ACA subsidies found in the budget reconciliation bill that Congress approved last week. The President is scheduled to sign the bill into law tomorrow.

Here are four other health policy changes to look for in the bill:

  • First, expands eligibility for the full amount of low-income Part D subsidies from 135% of the federal poverty line to 150% of the FPL.
  • Gets rid of the cost-sharing for adult vaccines for Medicare Part D. The FEHBlog has personal experience with this one. In 2020 he received the new Shingrix vaccine under Medicare Part D. The vaccine was eligible for no cost sharing when administered in-network under the Affordable Care Act. However, under Part D, the FEHBlog was charged $200 for each of the two doses. This big bowl of wrong will be remedied in 2023.
  • Delays the controversial Part D rebate rule, again. “The Trump-era rule would eliminate the safe harbor for Part D rebates, leaving them open to prosecution under federal anti-kickback laws. The rule passed at the tail end of Trump’s term but has never gone into effect. The law would delay the rule from going into effect again into 2032.”
  • Limits the premium growth on Medicare Part D to no more than six percent a year from 2024 through 2029. “The cap on premium growth is intended to mitigate the impact of other changes to Part D, said Ryan Urgo, managing director of the policy practice at consulting firm Avalere Health. The legislation includes a $2,000 out-of-pocket cost cap on Part D drugs, spread out in installments for the beneficiary over a calendar year. Part D plans will also have to pick up more of the costs for spending in the catastrophic coverage phase, which a beneficiary reaches when their drug costs reach a certain level.”

From the Omicron and siblings front, BioPharma Dive informs us

British drug regulators on Monday approved a two-pronged vaccine from Moderna that’s designed to fight both the original version of the coronavirus and the omicron variant.

The decision makes the U.K. the first country to clear a COVID-19 booster that’s been specifically tailored to a newer form of the virus. While the original shots, like Moderna’s Spikevax, remain strongly effective at preventing hospitalization and death, they’ve had a harder time warding off infections from omicron and its subvariants. * * *

Speaking to a [U.S.] advisory committee in June, executives from Moderna and Pfizer said dual-acting boosters with a BA.4 or BA.5 could be available in large volumes in October and November, although they would first need to undergo regulatory review before they could be administered.

Separately, Novavax on Monday asked the FDA to authorize its COVID-19 vaccine as a booster shot in people 18 and older. The shot is only available as a primary series to those who haven’t yet been vaccinated.

The Centers for Disease Control released updated guidance on what to do if exposed to Covid.

The Wall Street Journal reports on assessing Covid-19 risks after easing CDC guidelines, which began last week. The headline notes, “More decision-making is shifting to individuals, and here is what doctors recommend.”

From the monkeypox front, the Journal discusses “What to Know About Symptoms, Vaccines and How It Spreads,” and Beckers Hospital Review offers five monkeypox updates, including a complete explanation of how the World Health Organization is going about changing the disease’s name.

From the mental healthcare front, about ten years ago, the FEHB Program under OPM’s leadership was the first large employer-sponsored program to cover a form of autism therapy called “applied behavior analysis” (ABA). A STAT News investigation discloses

ABA has long been viewed as the gold standard for kids with autism, so much so that every state mandates insurance coverage. For some families, it is the only option that insurance will cover at all. 

But like other pockets of the health care industry, this one has been transformed over the past decade by a flood of investments from private equity firms, drawn by the promise of insurance reimbursement and the rising rate of autism in children across the U.S., now estimated at 1 in 44 kids. 

Families and clinicians who once believed fully in the promise of ABA say the financial investors’ fixation on profit has degraded the quality of services kids receive, turning it into the equivalent of fast food therapy. They’ve grown disillusioned with the industry, they told STAT.

The HHS Inspector General is auditing Medicaid claims for ABA. The final audit report is expected later this year.

From the Rx coverage front, the Drug Channel blog discloses

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type. 

The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion—an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart. Hospitals accounted for 87% of these skyrocketing 340B purchases.

What’s more, the difference between list prices and discounted 340B purchases also grew, to $49.7 billion (+$7.0 billion). This figure approximates the money collected by 340B covered entities.

340B advocates have been screaming that “drug companies are cutting 340B,” but the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut. 

From the U.S. healthcare business front, Beckers Payer Issues provides an interview with “Kyu Rhee, MD, a senior vice president at CVS Health and chief medical officer at Aetna. He sat down with Becker’s to discuss ongoing trends across the healthcare industry and how he is working to create a “values-based” care system through opportunities offered by a global pandemic.”