FEHBlog

Weekend update

David Ermer–CDC, Congress, Medical / Rx research, Mental health care, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The lede item necessarily is this Fortune Well warning dated August 13

  • “Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia. This summer’s guidance to halt the medication for up to a week may not go far enough, either.
  • “Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on the weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance.”
  • The drugs can slow digestion so much that it puts patients at increased risk for the problem called pulmonary aspiration, which can cause dangerous lung damage, infections and even death, said Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston.
  • “This is such a serious sort of potential complication that everybody who takes this drug should know about it,” said Hobai, who was among the first to flag the issue.

From the healthcare policy front —

  • Congress is on a State/District work break this week. There are no out-of-town hearings scheduled.
  • NPR Shots predicts that a recently proposed rule will improve hospital price transparency. Fingers crossed.

From the public health front –

  • Fortune Well identifies and explains the four daily habits of “truly happy” people.
  • The Drug Enforcement Administration’s public education website explains the dangers of
    • “Xylazine – often called “tranq” – is a drug adulterant that DEA has detected in a growing number of overdose deaths, despite the FDA authorizing it only for veterinary use.
    • “Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.”
  • Cardiovascular Business points out that,
    • “The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling certain Cardiosave intra-aortic balloon pumps (IABPs) due to a risk that the devices could stop working unexpectedly. This is a Class I recall, which means the FDA believes using one of these IABPs “may cause serious injuries or death.” 
    • “These devices are designed to provide temporary support to a patient’s left ventricle. Electrical failures have caused some of them to turn off with no warning, however, putting the patient’s health at immediate risk. 
    • “Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA’s advisory.”
    • This is the fourth cardiac care device to be recalled in 2023.
  • mHealth Intelligence says that “Using survey data on patient attitudes toward mental health services and depression screening, a new study indicated that Black American Women are comfortable with using voice or video calls to communicate with mental health providers.”
  • Patient Engagement HIT informs us,
    • Only a fifth of the nearly 2.5 million adults with opioid use disorder received medication for the disease 2021, leaving millions without access to addiction treatment, according to new data from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).
    • The report, published as a research note in JAMA Network Open, also showed sociodemographic health disparities in opioid use disorder treatment access, with Black people, women, individuals who were unemployed, and those in non-metropolitan areas being less likely to receive treatment.
    • The study looked particularly at medication-assisted treatment, or MAT, which is considered the gold standard in OUD therapy. Drugs like buprenorphine, methadone, and naltrexone have all proven effective for OUD treatment.

In early medical/drug research news,

  • Precision Vaccinations reports
    • While the U.S. government has recently licensed monoclonal antibody therapies (LEQEMBI®), anti-amyloid vaccines may offer a convenient, affordable, and accessible means of preventing and treating Alzheimer’s Disease (AD).
    • The Lancet’s eBioMedicine recently published a paper that concludes that an immunotherapeutic vaccine candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent AD.
    • Published on July 29, 2023, this research paper concludes Vaxxinity, Inc. UB-311 is an active immunotherapy, “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).
    • And UB-311 could offer multiple competitive advantages over licensed passive immunotherapies, including less frequent dosing, a more convenient mode of administration, improved accessibility, and cost-effectiveness.

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “Federal spending on Medicare Advantage bonus payments has risen every year since 2015, and will reach at least $12.8 billion this year — an increase of nearly 30% from 2022, according a new KFF analysis.
    • “Rapid growth in bonus payments has implications for Medicare spending and beneficiary premiums, especially since spending on the bonuses has grown faster than MA enrollment overall, researchers said.
    • “UnitedHealthcare — the biggest MA insurer — will receive the largest total payments at $3.9 billion. Kaiser Permanente has the highest per-enrollee bonuses at $523.”
  • and
    • “The Department of Justice is requesting more data from Amedisys regarding its proposed $3.3 billion acquisition by UnitedHealth, a move that will push back the timeline of the deal.
    • “The home health and hospice provider disclosed in a filing with the SEC on Thursday that it received a second request for information from regulators on August 4 regarding the merger.
    • “UnitedHealth announced plans to acquire Amedisys in June, after the Louisiana-based provider reneged on an existing merger agreement with Option Care Health.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Cybersecurity Dive informs us,
    • “The National Institute of Standards and Technology released a long-anticipated draft version of the Cybersecurity Framework 2.0 Tuesday,  the first major update of the agency’s risk guidance since 2014. 
    • “After originally focusing risk guidance on critical infrastructure, the updated framework includes a wider array of organizations, including small- and medium-sized businesses, local schools and other entities. 
    • “The revised framework also addresses the role of corporate governance and the growing risks to digital networks via third-party relationships. * * *
    • “NIST will release a CSF 2.0 reference tool in a few weeks to help users browse, search and export data in a format that is machine-readable. It will also hold a workshop in the fall for additional public comments. 
    • “The deadline for public comments is Nov. 4, and NIST plans to publish a final version of CSF 2.0 in early 2024.”
  • Health IT Security adds,
    • As previously reported, the NIST CSF can be an asset to healthcare organizations looking to bolster their cybersecurity programs. Alongside other voluntary frameworks and HIPAA compliance actions, healthcare organizations can leverage the NIST framework to enhance privacy and security protections.
  • Politico updates us on the Federal Trade Commission’s proposed health data breach rule.
    •  In May, the Federal Trade Commission proposed a sweeping expansion of health data privacy rules, and now, the period for the public to weigh in has ended.
    • “While many comments were supportive, others were concerned that the FTC was overstepping its authority, opening itself up to litigation, and urged more clarity.” * * *
    • “The proposal would clarify that health app developers would be subject to regulations requiring them to notify customers if their identifiable data is accessed by hackers or business partners or shared for marketing without patient approval. The rule would include those offering health services and supplies — broadly defined to include fitness, sleep, diet and mental health products and services, among a laundry list of categories.”
  • The Wall Street Journal summarizes the Security and Exchange Commission’s final cyber rule:
    • The U.S. Securities and Exchange Commission has approved new regulations requiring public companies to disclose cybersecurity breaches within four business days of becoming aware of a material impact resulting from the incident.
    • The regulations dropped the requirement for companies to disclose the names of cybersecurity experts on company boards and the nature of their expertise..
    • Companies are now required to report information regarding their cybersecurity risk management, strategy and governance annually.
    • Despite the SEC not requiring cyber expertise, experts believe having cyber oversight on the board is still beneficial and a priority.

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive informs us,
    • “The mass exploit of a zero-day vulnerability in MOVEit has compromised more than 600 organizations and 40 million individuals to date, but the numbers mask a more disastrous outcome that’s still unfolding.
    • “The victim pool represents some of the most entrenched institutions in highly sensitive — and regulated — sectors, including healthcare, education, finance, insurance, government, pension funds and manufacturing.
    • “The subsequent reach and potential exposure caused by the Clop ransomware group’s spree of attacks against these organizations is vast, and the number of downstream victims is not yet fully realized. * * *
    • “The widespread attack against MOVEit and its customers was “highly creative, well-planned, organized by multiple groups and executed well since they were able to poach records at scale,” independent analyst Michael Diamond said via email.
    • “Without a doubt, they hit one of the juicy parts of the orchard from an information perspective that they’ll continue to monetize and use for attacks in the future,” Diamond said. “My impression is that this is only going to get worse over time.”
    • “Diamond isn’t alone in forecasting the worst is yet to come.”
  • The Cybersecurity and Infrastructure Security Agency added one known exploited vulnerability to its catalog on August 7 and another one on August 9.
  • The Wall Street Journal reports that “AI Is Generating Security Risks Faster Than Companies Can Keep Up: Rapid growth of generative AI-based software is challenging business technology leaders to keep potential cybersecurity issues in check.”
  • The Healthcare Sector Cybersecurity Coordination Center released a threat analysis on multifactor authentication (good) and smishing (bad).

From the ransomware front,

  • Cybersecurity Dive pointed out on August 7, 2023,
    • “A ransomware attack against Prospect Medical Holdings disrupted healthcare services across multiple states last week, prompting multiple hospital closures as response and recovery efforts are underway.
    • “Prospect Medical Holdings recently experienced a data security incident that has disrupted our operations,” the healthcare provider said Friday in a statement. The California-based company operates 16 hospitals and more than 165 clinics and outpatient facilities in California, Connecticut, Pennsylvania and Rhode Island.”

From the cybersecurity defenses front,

  • FedScoop reports
    • “The White House on Wednesday [August 9] announced a competition for cybersecurity researchers that is intended to spur the use of artificial intelligence to identify and fix software vulnerabilities.
    • “Teams that compete in the “AI Cyber Challenge,” which the Defense Advanced Research Projects Agency will lead, can win prizes worth up to $18.5 million. The agency has also allocated an additional $7 million in prize money for small businesses that participate.
    • “As part of the competition, researchers will use AI technology to fix software vulnerabilities, with a particular focus on open-source software. Leading AI companies Anthropic, Google, Microsoft and OpenAI will make their technology available for the challenge, according to the Biden administration.
    • “The White House’s announcement comes amid continued concern over rising cyber supply-chain risk across the federal government and the private sector. Last September, the Office of Management and Budget stipulated that all software providers would have to self-attest to the security of their products before deploying them on federal agency systems.”

Friday Factoids

David Ermer–No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The AMA News says,
    • “The Centers for Medicare & Medicaid Services today released a FAQ explaining how it will handle the administrative fee for out-of-network providers and group health plans that initiate payment disputes under the No Surprises Act’s independent dispute resolution process on or after Aug. 3, when a federal judge vacated nationwide a six-fold increase in the fee. According to the FAQ, the fee for disputes initiated on or after Aug. 3 or unpaid before Aug. 3 will return to $50 per party until the Departments of Health and Human Services [HHS}, Labor, and the Treasury set a new fee amount.
    • “The judge also vacated nationwide the department’s restrictions on batching related claims in a single payment dispute. In response to the ruling, CMS has suspended the IDR process, including the ability to initiate new disputes. The agency said the departments intend to reopen the portal for new disputes soon and will notify interested parties at that time.”
  • Bear in mind that the independent dispute resolution entities will continue to charge $400 to $500 per party on top of the government’s fee.

From the Rx coverage front —

  • KFF Health News notes
    • Basics — “Leqembi [the recently approved Alzheimer’s Disease infused drug] is very effective at removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it doesn’t reverse cognitive decline or prevent future deterioration.”
    • Benefits — Research suggests that patients notice a “clinically meaningful” change in cognitive performance — a noticeable alteration in their ability to think, remember, and perform daily tasks — when scores rise at least 1 point on an 18-point scale used to measure Leqembi’s impact. But the change detected after 18 months for patients taking this medication was only 0.45%.
    • Side Effects — The drugmaker reported 17% of patients taking Leqembi experienced swelling in the brain and 13% had brain bleeds. Most of these side effects occurred during the first three months of treatment and were resolved without serious consequences four months later. In slightly more than 1 in 4 cases, there were also infusion-related side effects — chills, aches, nausea, vomiting, a spike or drop in blood pressure, and more. A little-discussed side effect is a reduction in brain volume associated with Leqembi and other anti-amyloid therapies. “We don’t know what this will mean to patients long term, and that’s concerning,” Alberto Espay, a professor of neurology at the University of Cincinnati College of Medicine said.
    • Not all patients will qualify. “I’m very carefully selecting the patients I think will be appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” said Erik Musiek, an associate professor of neurology at the Washington University School of Medicine in St. Louis.
    • Costs could be considerable. Costs for Leqembi are difficult to calculate since Medicare officials haven’t announced what the government [Part B] will pay for services. But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of the medication, could total about $90,000, according to Schneider. A separate analysis by the Institute for Clinical and Economic Review suggests that all the medical services necessary to administer the drug, monitor patients, and undertake needed testing could total an average of $82,500 yearly on top of Leqembi’s direct cost.
  • Medscape informs us,
    • “A novel triple agonist to receptors for three nutrient-stimulated hormones led to weight loss as high as 24% among people with overweight or obesity but who did not have type 2 diabetes when used at the highest tested dose for 48 weeks. The results are from a phase 2 study of retatrutide that was published in The New England Journal of Medicine on August 9.
    • “This level of weight loss is “unprecedented” for a medication administered for 48 weeks, commented Mary-Elizabeth Patti, MD in an editorial that accompanied the report.
    • “The findings “offer further optimism…that effective pharmacologic management of obesity and related disorders is possible,” writes Patti, a principal investigator at the Joslin Diabetes Center in Boston.”
  • BioPharma Dive reports,
    • The Food and Drug Administration has conditionally approved a new medicine for multiple myeloma, offering patients with hard-to-treat forms of the blood cancer another therapy option.
    • “The medicine, which was developed by Johnson & Johnson and will be sold under the brand name Talvey, is what’s known as a bispecific antibody. A first of its kind, Talvey binds to both “CD3,” a protein found on T cells, and “GPRC5D,” a protein found on malignant blood plasma cells, bringing the two together so the immune system has a better shot at identifying and fighting cancer.
    • “The FDA based its decision on a clinical trial that enrolled multiple myeloma patients whose disease persisted after at least four other therapies. The trial found just under three-quarters of participants responded in some way to J&J’s drug, with roughly a third going into remission. Regulators have requested additional testing to confirm the benefits of Talvey and to keep it on the market.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare merger and acquisition activity hit a three-year low in the second quarter of this year, according to a report by accounting firm and consultancy KPMG. 
    • “The analysis tallied 245 deals in the second quarter of 2023, a decrease of 7% compared to the same period last year and a 41% decline from the second quarter in 2021. 
    • “Ongoing financial pressures — like potential interest rate hikes, political divisions and uncertainty about valuations of acquisition targets — could keep M&A low in the second half of the year. But some of those headwinds are expected to lighten up as sell-side valuations continue to contract and companies look to divest non-core assets, giving deal-making a boost during the first half of 2024, the report noted.”
  • Fierce Healthcare tells us
    • “While major payers issued warnings to investors ahead of second-quarter earnings about rising utilization rates, patients returning to deferred services did not prevent these companies from turning a profit.
    • “UnitedHealth Group led the way yet again in profitability for the second quarter as well as the first half of 2023, according to company earnings reports. The healthcare giant posted $5.5 billion in profit for the quarter and $11.1 billion through the first six months of the year.
    • “By comparison, the next-highest company for second-quarter profit was CVS Health at $1.9 billion. CVS also reported the second-highest profit for the first half of 2023 with $4 billion, according to the filings.
    • “UnitedHealth also tops the list for revenue in the second quarter and first sixth months of the year. The company reported $92.9 billion in second-quarter revenue and $184.8 billion in midyear revenue.”
  • The AHA News reports on its President Rick Pollack’s views on controlling medical consumer debt. Of course, Mr. Pollack does not mention lowering healthcare prices which is a straight line to debt reduction. Rather, he focuses on adding administrative burdens to health insurers and plans and reducing consumer choice of health plans.

Thursday Miscellany

David Ermer–Uncategorized–
Photo by Josh Mills on Unsplash

From Washington DC,

  • The Wall Street Journal reports
    • “The [U.S.] Supreme Court blocked Purdue Pharma’s $6 billion settlement of opioid lawsuits against its Sackler family owners, agreeing to hear the Justice Department’s claim that the drugmaker’s bankruptcy plan improperly wipes out potential liability to additional parties for allegedly fueling the opioid addiction crisis.”
  • and
    • “Social Security recipients are on track to pocket a significantly smaller raise in 2024 because of a slowdown in inflation.
    • “If inflation climbs in line with its recent trend over the next two months, recipients’ monthly checks will rise by about 3% in 2024, according to estimates from analysts and nonprofits. The estimates follow an 8.7% cost-of-living increase in 2023 as inflation soared.”
  • The Centers for Medicare and Medicaid Services updated its recent No Surprises Act website notice to read,
    • “Effective August 8, 2023, the Departments have directed certified IDR entities to resume processing single and bundled disputes initiated in 2022, as well as single and bundled disputes initiated in 2023 where the administrative fees have been paid (or the deadline for collecting fees expired) before August 3, 2023. Additionally, the Departments have directed certified IDR entities to resume processing batched disputes where the IDR entity determined that the batched dispute was eligible and administrative fees have been paid (or the deadline for collecting fees expired) before August 3, 2023. Processing of other disputes remains temporarily suspended.“
  • The FEHBlog checked the status of the August 3, 2023, decision in the Texas Medical Association versus HHS case, filed in the Eastern District of Texas, and he found that as of today, the Justice Department has not noticed an appeal from that final decision.
  • The Department of Health and Human Services announced,
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, announced awards of more than $100 million to train more nurses and grow the nursing workforce. These investments will address the increasing demand for registered nurses, nurse practitioners, certified nurse midwives, and nurse faculty.
    • “Nurses are an essential part of our nation’s health care system,” said HHS Secretary Xavier Becerra. “Now more than ever, we need to double down on our investments in nurses who care for communities across the country.”

From the public health and Rx coverage fronts,

  • The Wall Street Journal reports
    • “Health officials, vaccine makers and doctors are gearing up for a fall vaccination campaign that will look different from previous ones: Vaccines will be distributed to pharmacies and doctors’ offices through the commercial market, not government purchases. The vaccines are targeting the recently dominant XBB.1.5 strain in line with instructions the Food and Drug Administration set earlier this year. 
    • “Boosters updated to target XBB.1.5 should retain good protection against EG.5, because the Omicron subvariants are similar, Kanter said. It is difficult to predict how long the protection might last, he said.
    • “Pfizer expects its new shots to win approval this month, with vaccinations likely starting in September, Chief Executive Albert Bourla said this month. Pfizer expects the booster to work against EG.5 because it is an offshoot of Omicron—but is conducting laboratory tests to be sure, a spokeswoman said. Pfizer and partner BioNTech presented animal testing to FDA advisers at a June meeting about how to update the vaccine. * * *
    • “Moderna has ample supply of its updated vaccine and is waiting for FDA signoff to distribute doses, a spokesman said. He said that preliminary testing shows the shot works against EG.5 and that more testing is under way.
    • “Novavax, whose Covid-19 vaccine uses a different technology, is submitting data to regulators to authorize its booster and expects to win clearance and ship doses in September, a spokeswoman said.”
  • Cost curve up for health plans.
  • Fierce Healthcare says,
    • “Medicare Part D drug prices have increased by an average of 226% since market entry. These 25 drugs are responsible for $80.9 billion in total Part D spending in 2021.
    • “The new report (PDF) from AARP’s Public Policy Institute shows that high pharmaceutical drug prices are placing an unwelcome burden on customers. Overall, lifetime price increases among 25 name-brand drugs have increased by 20% to 739%, with just one drug exceeding the annual rate of inflation over the same period of time.”
  • The Wall Street Journal adds,
    • “Weight-loss drugs such as Wegovy will continue to be tough to find for the foreseeable future, as demand outpaces drugmakers’ ability to make enough.
    • “Denmark-based Novo Nordisk said Thursday it will continue to reduce the availability of lower doses of Wegovy that are meant for new patients starting out on the drug in the U.S. Capacity limitations at some manufacturing sites will cause continued periodic supply constraints across a number of products and geographies.
    • “Novo Nordisk started this rationing in May as a way to conserve supplies for existing patients who take higher doses of the drug to lose weight and keep it off. The company had said previously the reduction in starting doses would last through September, but Novo Nordisk executives said Thursday that they expect to continue to manage the starting dose supply after September.”

From the healthcare business front,

  • BioPharma Dive informs us
    • “Novo Nordisk agreed to buy metabolic disorder specialist Inversago Pharma in a deal worth as much as about $1.1 billion as the Danish company works to strengthen its leading position in the obesity drug market.
    • “Inversago’s lead experimental drug has shown promise for weight loss in a Phase 1b trial and is being tested in Phase 2 for diabetic kidney disease, Novo said Thursday. The privately held Canadian company is also developing treatments for other metabolic and fibrotic disorders.
    • “Novo didn’t release further financial details of the transaction, which includes potential payments for reaching certain developmental and commercial goals. The companies expect the acquisition to close by the end of the year, after which Novo intends to investigate the potential of Inversago’s lead drug in “obesity and obesity-related complications.”
  • Per Healthcare Dive,
    • “America’s largest for-profit health systems reported higher-than-anticipated revenues this quarter, driven by rebounding admissions and increased demand for elective surgeries.
    • “HCA and Tenet, which both posted revenues that surpassed Wall Street estimates, raised their full revenue forecasts for the year in light of their second quarter performance, and UHS raised its lower-bound revenue guidance. CHS was an outlier, posting a net income loss of $38 million, which analysts said was still an improvement compared to the health system’s net loss of $326 million in the same period last year.
    • “Hospitals said normalizing labor conditions post-pandemic and proactive cost-cutting initiatives helped keep operating margins stable, even as expenses rose year over year.
    • “The reported revenues and cost-cutting initiatives for for-profit hospitals is a contrast to last year, when operators struggled to meet targets during the second quarter amid lower admissions and challenging labor market conditions.”
  • Per Fierce Healthcare
    • “Cigna is teaming up with Virgin Pulse to launch a new, personalized digital health program for its members.
    • “The new platform will be available through the myCigna portal and allows users to set their personal health goals and track daily progress. They can then receive real-time feedback and guidance that’s based on the data they’ve submitted, according to an announcement.
    • “The tool will be offered to nearly 11 million members, Cigna said.
    • “Cigna said it will make the platform available beginning Jan. 1 to people enrolled in its employer plans. It intends to expand further over time.”

Midweek update

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

From the public health and Rx coverage front —

  • Think Advisor informs us
    • “Executives from life insurance, health insurance and annuity issuers have spent their second-quarter earnings calls telling securities analysts about an open secret: The U.S. death rate is still noticeably higher than it was before 2020, when the COVID-19 pandemic began.
    • “Some executives emphasized that COVID-19 had little effect on earnings because their companies had prepared for COVID-19 to linger, not because the effects have gone away.
    • “But John Gallina, Elevance CFO, said costs related to COVID-19 and the pandemic’s impact are a headwind.
    • “When you combine COVID and non-COVID cost, the overall cost of the health care system is more expensive than if COVID had never occurred,” Gallina said. “We’ve seen it, we’ve priced for it and we’ve factored it into our expectations. But COVID is not gone. It still exists. It’s just no longer the big significant driving force that it had been for the past several years.”
  • KFF Health News says,
    • “[M]ultiple studies show that firefighters, both military and civilian, have been diagnosed with testicular cancer at higher rates than people in most other occupations, often pointing to the presence of perfluoroalkyl and polyfluoroalkyl substances, or PFAS, in the foam.
    • “But the link between PFAS and testicular cancer among service members was never directly proven — until now.
    • “A new federal study for the first time shows a direct association between PFOS, a PFAS chemical, found in the blood of thousands of military personnel and testicular cancer. * * *
    • “The Department of Veterans Affairs does not recommend blood testing for PFAS, stating on its website that “blood tests cannot be linked to current or future health conditions or guide medical treatment decisions.”
    • “But that could change soon. Rep. Dan Kildee (D-Mich.), co-chair of the congressional PFAS Task Force, in June introduced the Veterans Exposed to Toxic PFAS Act, which would require the VA to treat conditions linked to exposure and provide disability benefits for those affected, including for testicular cancer.
    • “The last thing [veterans] and their families need to go through is to fight with VA to get access to benefits we promised them when they put that uniform on,” Kildee said.”
  • Reuters reports,
    • “U.S. psychiatrists are increasingly prescribing the popular weight-loss drug Wegovy to patients who gain weight from medicines used to treat mental disorders, such as schizophrenia or bipolar disorder, according to Reuters interviews with ten prescribers across the country.
    • “Many antipsychotic drugs and mood stabilizers can cause patients to gain significant weight and contribute to diabetes and heart disease, the leading cause of death among adults with schizophrenia.”
  • The New York Times provides us with information about who should get the flu, Covid and R.S.V. vaccines, and when this fall.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “The average U.S. physician earns $350,000 a year. Top doctors pull in 10 times that.
    • “When those simple data points were first presented in 2020, a small subset of physicians came unglued on the microblogging site formerly known as Twitter, slinging personal insults and at least one deeply unflattering photo illustration of an economist.
    • “We couldn’t understand why. The figures are nigh-on unimpeachable. They come from a working paper, newly updated, that analyzes more than 10 million tax records from 965,000 physicians over 13 years. The talented economist-authors also went to extreme lengths to protect filers’ privacy, as is standard for this type of research.
    • “By accounting for all streams of income, they revealed that doctors make more than anyone thought — and more than any other occupation we’ve measured. In the prime earning years of 40 to 55, the average physician made $405,000in 2017 — almost all of it (94 percent) from wages. Doctors in the top 10 percent averaged $1.3 million. And those in the top 1 percent averaged an astounding $4 million, though most of that (85 percent) came from business income or capital gains.”
  • Fierce Healthcare relates,
    • “Hospitals nationwide charge payers more than double for healthcare services covered under commercial plans than they do for the same insurer’s Medicare Advantage (MA) plans, according to a recent Johns Hopkins analysis of hospitals’ published pricing data.
    • “The work, published this week in Health Affairs, reviewed more than 200,000 unique combinations of hospitals, insurers, settings and services for which a commercial and an MA price were available for direct comparison. In total, it included pricing data from 2,434 hospitals and 118 insurers collected in September 2022.
    • “Commercial prices were, on average, between $600 and $707 more expensive than MA prices, or 2.1 to 2.2 times more expensive.
    • “The dollar gap for prices was widest within the surgery and medicine service category where median commercial prices were nearly $800 more expensive than the charges for MA plans ($1,702 versus $928), 1.8 times higher. The median price increases were consistent across the other three reviewed service categories: imaging ($490 versus $191, 2.6 times higher), lab tests ($32 versus $12, 2.7 times higher) and ED visits ($519 versus $262, 2.0 times higher).”
  • Beckers Hospital Review points out the payer mix of largest for profit health systems based on their second-quarter earnings reports.
  • BioPharma Dive reports on the latest biotech M&A deals as the market begins to pick up.

From the miscellany department,

  • AHA News reminds us that “Health care providers must comply with the HIPAA rules with respect to telehealth effective Aug. 9 at 11:59 p.m., when the 90-day enforcement discretion period announced in April expires.” 
  • MedPage Today notes
    • “A new blood test from Quest Diagnostics has Alzheimer’s experts concerned.
    • “The Quest AD-Detect test, which consumers can now purchase from home without visiting a doctor, measures amyloid-beta 42 and amyloid-beta 40 in blood to provide an amyloid-beta 42/40 ratio. In theory, the ratio may help identify the risk of developing Alzheimer’s disease. In practice, the value of the Quest test is unknown.
    • “The test has not been cleared or approved by FDA.”

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington DC —

  • FedScoop reports
    • “Amid scrutiny of the retirement services division within the Office of Personnel Management, congressional inquiries to the agency have grown drastically, according to a February letter sent by Retirement Services Associate Director Margaret Pearson.
    • “According to the missive, which was sent in response to questions from House lawmakers, OPM’s Congressional, Legislative, and Intergovernmental Affairs branch received more than 9,000 congressional inquiries in 2022, compared with more than 3,000 in 2020. In other words, the number of inquiries from Congress to the agency has approximately tripled in three years.”
  • Fedsmith adds
    • “The latest data from the Office of Personnel Management (OPM) show that the backlog of outstanding retirement claims now stands at 17,047, 4.1% higher than at the end of June. The number of incoming claims was much higher in July than in June, 7,261 versus 4,854, respectively, a difference of 50%. Although OPM still processed nearly the same number of claims in July (6,584) as in June (6,609), this served to drive the backlog higher.
    • “Another contributing factor was that the monthly average processing time was higher in July than in June. It took OPM 85 days on average in July to process retirement applications versus 74 days in June. July was the second-highest monthly average processing time so far in 2023, second only to January (93 days).”
  • The Labor Department’s Assistant Secretary for Employee Benefits Security, Lisa Gomez, blogs about the ACA regulator’s proposed amendments to the federal mental health and substance use disorder rule. Why must all of the pressure to improve mental health care be placed on health plans?
  • Federal News Network says,
    • “The Postal Service is falling short of its goal to turn around its financial losses this year, but is pointing to an ongoing shakeup of its nationwide delivery network as a critical part of its plan to break even by the end of the decade.
    • “Postmaster General Louis DeJoy said Tuesday that “more aggressive cost reductions to operations” are needed to keep USPS’ long-term financial goals within reach — and that USPS reshaping its nationwide delivery network is key to those savings.
    • “This undertaking is massive and long overdue, and time is of the essence if we wish to enjoy the benefits of this cherished institution for years to come,” DeJoy told the USPS Board of Governors.
    • “USPS reported a $1.7 billion net loss for the third quarter of fiscal 2023, and is expected to see a net loss for the entire fiscal year.”

From the public health and Rx coverage fronts–

  • STAT News informs us
    • “The momentum around weight loss drugs is about to get even bigger in the wake of Novo Nordisk’s announcement that its semaglutide drug Wegovy cut the risk of cardiovascular disease by 20% in its large SELECT trial.
    • “The full results of the study, funded by Novo, will be presented at the American Heart Association meeting in November. Doctors and researchers say they expect the findings to have a big impact on how clinicians approach the treatment of both obesity and cardiovascular disease, as well as increase the likelihood that prescriptions for obesity drugs will be covered by insurance.
    • “But experts who spoke with STAT also cautioned that the long-term safety and efficacy of Wegovy and other weight loss drugs remain unknown. The SELECT study has yet to be peer-reviewed, and not enough information is yet available to make independent assessments of the results.”
  • The Wall Street Journal adds,
    • “The surging demand for GLP-1s has prompted analysts to raise their forecasts for the global obesity market, with Morgan Stanley recently revising its estimate to $77 billion in annual sales by 2030, up from $54 billion.
    • “For now, doctors are prescribing more of Mounjaro and Wegovy than the companies can make, with a lack of manufacturing capacity frequently leading to shortages. Eli Lilly on Tuesday reported $980 million in Mounjaro sales in the second quarter, trouncing analyst estimates of $740 million on FactSet. The Mounjaro beat allowed the company to raise its annual guidance as well. Mounjaro is approved for diabetes and is expected to receive Food and Drug Administration approval for obesity treatment this year, though doctors are already prescribing it off-label.”
  • The Wall Street Journal also lets us know,
    • “Women are closing a gender gap, but it isn’t a good one: They’re catching up to men when it comes to problem drinking.
    • “Women’s drinking, on the rise for the past two decades, jumped during the pandemic as women reported more stress. Although men still drink more alcohol than women and have higher alcohol-related mortality rates, doctors and public health experts say women are narrowing that divide.
    • “Alcohol-related emergency department visits, hospitalizations and deaths are increasing faster for women than for men. And studies suggest that women are more susceptible to alcohol-related liver inflammation, heart disease and certain cancers.”
  • Independence Blue Cross announced,
    • ” Independence Blue Cross (Independence) and the Colorectal Cancer Alliance (the Alliance) announced the launch of 45+ Reasons, a campaign to get more than 5,000 Black Philadelphians ages 45-75 screened for colorectal cancer to reduce the significantly higher incidence and mortality rates of Black Americans. The campaign supports the Cycles of Impact initiative launched by Independence and the Alliance in 2022.
    • T”he campaign is a flagship program of Philadelphia’s Accelerate Health Equity, a city-wide initiative to produce tangible improvement in health inequities, and ultimately achieve measurable, positive changes in health outcomes in Philadelphia. Colorectal cancer screening and treatment is a priority area for Accelerate Health Equity.”
  • The All of Us Program released its August 2023 newsletter.
  • Fierce Healthcare tells us,
    • “There has been a 2% rise in maternity care deserts since 2020—meaning 1,119 additional counties, a new analysis suggests.
    • “The latest 2022 report on maternity care deserts, put together by nonprofit March of Dimes (PDF), relied mostly on 2019-20 data for its analysis.
    • “It classified more than a third of all U.S. counties as maternity care deserts in the report. These were defined as counties with no hospitals or birth centers offering obstetric care and no obstetric providers. 
    • “Nationwide, 5% of counties have less maternity access than two years ago while 3% shifted to higher access. Florida had the most women impacted by improvements to maternity care access, while Ohio had the most women impacted by overall reductions in access to care.” 

From the U.S. healthcare business front —

  • BioPharma Dive relates
    • “Eli Lilly became the most valuable healthcare company in the U.S. after a stock price surge Tuesday morning propelled the Indianapolis drugmaker’s market value above $500 billion for the first time in its 147-year history.
    • “Shares jumped 15% on second-quarter earnings that showed the company’s revenue rose by 28%, driven by fast sales of its diabetes medicine Mounjaro. The drug has attracted intense interest for its potential as an obesity treatment, a use for which it’s expected to earn Food and Drug Administration approval later this year.”
  • STAT News reports that Sage Therapeutics finds itself under financial pressure due to the FDA’s decision to approve its new drug for postpartum depression but not other types of depression.
    • “Sage’s chief business officer, Chris Benecchi, declined to name a price or a price range for Zurzuvae, saying that the company is working together with its partner Biogen to “determine adjustments for thinking on price given the PPD label.” Sage expects the drug to be available in the fourth quarter following its scheduling by the Drug Enforcement Administration because of the drug’s low potential for misuse.
    • “Sage hosted the pre-market call without Biogen, raising analysts’ eyebrows as the two companies signed a commercialization deal in 2020 valued at over $1.5 billion, predicated on the hope that zuranolone would become a blockbuster drug for major depression. Despite many questions about what exactly would be needed for the drug to get FDA approval for major depression and whether Biogen would continue its partnership with Sage, Greene declined to give any insight into how committed Sage and Biogen are to pursuing the MDD indication, or whether Biogen was going to vacate the partnership.”
  • Healthcare Dive offers five takeaways from the health insurers’ second-quarter earnings.
    • “Major health insurers saw their shares dip coming into the second quarter, as investors prepared themselves for skyrocketing medical costs due to seniors returning for outpatient care.
    • “But health insurers generally outperformed market expectations in the quarter, helped by cost control measures.”
  • Meanwhile, the American Hospital Association’s President takes these health insurers to task in U.S. News and World Report for imposing cost control measures.

Monday Roundup

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

From Washington, DC —

  • Fedscoop reports
    • “The Office of Personnel Management is expecting to conduct a four-month trial of a new online retirement application platform for federal employees later this year, FedScoop has learned.
    • “In a letter to lawmakers, which was obtained by this publication through a Freedom of Information Act request, agency director Kiran Ahuja said OPM will conduct an approximately 120-day pilot in coordination with the National Finance Center, which is a federal agency division under the United States Department of Agriculture.
    • “Responding to questions from lawmakers, including Sen. Dick Durbin, D-Il., Ahuja wrote: “Between the electronic employee data received from the payroll center and the online retirement application, RS will receive all the information necessary to process a retirement application electronically.”
    • “She added: “The pilot will likely last 120 days, at which point RS will evaluate the results and determine the appropriate next steps to expand the program.” 
  • The Federal Times says that “Unions representing more than 900,000 federal workers are pushing back against President Joe Biden’s plan to bring back more in-person work for federal employees, citing contract terms and the benefits of a hybrid workforce.”
  • The FEHBlog had time today to redline the proposed amendments to the mental health parity rule in the existing rule, 45 C.F.R. Sec. 146.136. The FEHBlog thought that the proposed amendment would downplay the complicated non-quantitative treatment limitation (NQTL) provisions in favor of more direct requirements to improve access to, and lower costs for, mental health and substance use disorder care. Au contraire, the regulators seek to achieve these goals via the NQTL rules, which will become hyper-complicated. It’s disappointing, considering that parity could be achieved much more efficiently by covering medical/surgical and mental health/substance use disorder care under a unified set of rules.

From the public health front —

  • U.S. News and World Report informs us
    • A new coronavirus strain has taken over as the top variant circulating in the U.S.
    • EG.5 was responsible for more than 17% of new coronavirus cases over the past two weeks, according to data from the Centers for Disease Control and Prevention. That’s the highest prevalence of any strain circulating, rising above the so-called “arcturus” variant, which caused nearly 16% of infections. * * *
    • XBB.1.5, which will be the target of the updated COVID-19 vaccines coming in the fall, is decreasing in the U.S. Still, health experts say that the shot should work on other omicron subvariants as well.
    • Health officials hope that the upcoming fall booster campaign will increase protection against the coronavirus ahead of a potential fall and winter wave.
  • Reuters points out
    • “Five major U.S. health systems said they would offer Eisai and Biogen’s promising new Alzheimer’s drug Leqembi after working out payment and administrative policies, and how to assess and monitor patients, most likely in the next month or two.
    • “Leqembi, which won full U.S. regulatory approval last month, is the first treatment proven to slow progression of the mind-robbing disease for people in the earliest stages of Alzheimer’s.
    • “The disease affects an estimated 6.5 million people, most of whom are part of the U.S. government’s Medicare plan for people 65 and older.
    • “The patients are lining up. They want to be treated, but it’s difficult to rush right into it,” said Dr. James Galvin, who heads the Alzheimer’s research program at the University of Miami Miller School of Medicine.
    • “Neurologists at the Mayo Clinic in Rochester, Minnesota, Chicago’s Northwestern Memorial and Los Angeles’ Cedars-Sinai all said they plan to roll out the drug in the next few months. Cleveland Clinic and Utah’s Intermountain health system said they have not started offering it.”
  • Per Health Day,
    • “By age 75 years, approximately half the global population can expect to develop a mental disorder, according to a study published online July 30 in The Lancet Psychiatry.
    • “John J. McGrath, Ph.D., from Queensland Centre for Mental Health Research in Brisbane, Australia, and colleagues used data from 156,331 adult participants in the World Mental Health surveys (2001 to 2022; 29 countries) to estimate age-of-onset distributions, lifetime prevalence, and morbid risk for mental disorders.
    • “The researchers found that the lifetime prevalence of any mental disorder was 28.6 percent for male respondents and 29.8 percent for female respondents. By age 75 years, the morbid risk for any mental disorder was 46.4 percent for male respondents and 53.1 percent for female respondents. At 15 years, the conditional probabilities of first onset peaked, with a median age of onset of 19 years for male respondents and 20 years for female respondents. Alcohol use disorder and major depressive disorder were the two most prevalent disorders for male respondents, while major depressive disorder and specific phobia were most prevalent for female respondents.”

From the No Surprises Act front

  • According to Healthcare Dive,
    • “A Texas judge has vacated portions of the No Surprises Act dispute resolution process after the state’s medical group argued it was illegal and overly favorable to health insurers, leading the HHS to once again suspend arbitrations until further notice.
    • “Judge Jeremy Kernodle for the Eastern District of Texas on Thursday vacated regulators’ increase of the dispute resolution administrative fee to $350 and the “batching rule,” which allowed arbitration processes only on claims with the same service code.
    • “The judgment removes barriers for providers to file dispute resolution claims and will likely increase the volume of claims, especially from physician groups and hospital outpatient departments, according to a health lawyer.”
  • CMS adds
    • Effective August 7, 2023, the Departments have directed certified IDR entities to resume processing single and bundled disputes where the administrative fees have been collected (or the deadline for collecting fees expired) before August 3, 2023. Additionally, the Departments have directed certified IDR entities to resume processing batched disputes where the IDR entity determined that the batched dispute was eligible and collected administrative fees (or the deadline for collecting fees expired) before August 3, 2023. Processing of other disputes remains temporarily suspended.
  • The federal government appealed one of Judge Kernodle’s decisions in favor of the Texas Medical Association and may appeal this one too. The FEHBlog has no problem with Judge Kernodle’s batching rule. He thinks that the regulators should ladder the administrative fee based on the sum of the QPAs in dispute. The higher the sum; the higher the fee. By the way, the government’s administrative fee is on top of the independent dispute entity’s fee, which runs from $400 to $500 fee per party.

In other U.S. healthcare business news —

  • Fierce Healthcare relates
    • “Large health systems are scooping up independent hospitals, and that consolidation negatively affects employers, insurers and patients, according to a new analysis backed by Blues giant Elevance Health.
    • However, the American Hospital Association was quick to dispute the findings, with CEO Rick Pollack telling Fierce Healthcare in an email that the analysis “draws absurd conclusions about the impact of healthcare systems on access to care, cost and quality.”
  • Beckers Payer Issues ranks health insurers by commercial membership here.
  • Beckers Hospital Review names three U.S. hospitals that announced shutdown plans last week.

Weekend update

David Ermer–Congress, FDA, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • While on August recess, Congress is holding four out-of-town hearings.
  • The recently proposed mental health parity rule was published in the Federal Register last Thursday. The deadline for public comments is October 2, 2023.
  • WTOP reports,
    • “President Joe Biden has asked Cabinet officials to “aggressively execute” plans to bring federal employees back to their offices, ending a precedent of remote work that started during the COVID-19 pandemic three years ago, according to multiple sources.
    • “Axios first reported that White House Chief of Staff Jeff Zients sent an email on Friday to every member of the Cabinet saying federal agencies must return to in-person work “because it is critical to the well-being of our teams and will enable us to deliver better results for the American people.”
    • “Zients said remote work won’t be completely eliminated, but that in-person time will be prioritized to “build a strong culture, trust, and interpersonal connections” within agencies, according to The Washington Post.”

From the public health front —

  • Fortune Well provides more background on the new Sage Therapeutics drug that the Food and Drug Administration approved to treat post-partum depression last Friday.
    • “In trials, zuranolone [trade name Zurzuvae] showed a “rapid reduction of depressive symptoms starting as early as day three—after two doses of medicine—and showed continued improvement through day 15,” Deligiannidis said, adding that the drug continues to work even after patients stop taking it, for 45 days in all.
    • “The fast-acting, temporary nature of the drug stands in contrast to standard-of-care antidepressants that might otherwise be prescribed. Such medications—typically SSRIs, or selective serotonin reuptake inhibitors, which increase serotonin levels in the brain—usually take four to six weeks to begin to work, and two to three months to fully kick in, according to Deligiannidis. * * *
    • “Because zuranolone is a controlled substance, the U.S. Drug Enforcement Administration now has 90 days to assign a schedule to it. Earlier this week, Chepke predicted it would be designated a Schedule IV drug or one with a low potential for abuse and dependence like Xanax, Valium, Ativan, and Ambien.
    • “From there, he anticipated it would soon be in the hands of prescribers and patients, where it’s sorely needed. * * *
    • “Sage Therapeutics and co-developer Biogen had also applied for approval to use the drug in cases of major depressive disorder. The federal agency on Friday did not issue a ruling on such use.”
  • NPR Shot tells us “Testing your genes for cancer risk is way cheaper now — and it could save your life.”

From the Rx coverage front —

  • The FEHBlog wants to point out the Center for Biosimilars website, which is chock-a-block full of useful articles on this important topic.
  • BioPharma Dive reports
    • “The Food and Drug Administration on Friday approved a second medicine for a common type of vision loss, clearing a drug developed by biotechnology company Iveric Bio for geographic atrophy.
    • “The monthly eye injection, which will be sold as Izervay, is meant to slow the progression of the condition, which Iveric and its new owner, Japanese drugmaker Astellas Pharma, estimate affects 1.5 million people in the U.S.
    • “The FDA’s decision on Izervay follows about six months after the agency greenlighted the first geographic atrophy treatment, Apellis Pharmaceuticals’ Syfovre. Both drugs work by blocking a part of the immune system, slowing the growth of eye lesions and, in theory, preserving vision. Such a benefit on visual function hasn’t been proven yet, however.
    • “The medicines are expected to become blockbuster sellers.”

From the U.S. healthcare business front —

  • KFF News offers “An Early Look at What is Driving Health Costs in 2024 ACA Markets.”
    • “This updated analysis of marketplace insurers’ early rate filings are requesting a median premium increase of 6% for 2024, which they say is largely due to price increases for medical care and prescription drugs. Insurers’ rate requests are preliminary and may change during the review process before being finalized in late summer.
    • “In addition to inflation’s impact on medical costs, insurers say the higher premiums are a result of growth in the utilization of health care, which fell in 2020 but has since returned to more normal levels.
    • “The analysis is available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Although the FEHB is affected by the same cost drivers, OPM’s wise decision to approve the use of Part D EGWPs in the FEHB for 2024 will offset these cost drivers to a substantial extent.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front —

  • Cybersecurity Scoop reports,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] released its strategic plan for fiscal year 2024 through 2026 on Friday, following a plethora of strategies and implementation plans released over the past several months by the White House aimed at improving the nation’s overall cybersecurity preparedness. 
    • “Within CISA, this Plan will serve as a keystone for implementation, resource, and operational planning, as further executed through our Annual Operating Plans. Externally, it will help stakeholders understand and participate in our long-term cybersecurity planning and prioritization,” the document reads.
    • “CISA’s strategic plan will focus on three goals: address immediate threats, harden the terrain and drive security at scale. Additionally, the strategy has nine objectives, three for each goal, outlining the agency’s scope for the next three years.
    • “The release comes shortly after the Office of the National Cyber Director released a National Cyber Workforce and Education Strategy, as well as the National Cybersecurity Strategy in March and subsequent Implementation Plan in July.”
  • and
    • “The Biden administration’s strategy for building the U.S. cybersecurity workforce calls for government, industry and civil society groups to collaborate in increasing the number of cybersecurity workers and also urges an overhaul of the U.S. immigration system. 
    • “To address a dire shortage of cybersecurity workers, Monday’s strategy document takes a broad approach in overhauling the cybersecurity workforce. “The national cyber director’s office can only really task federal departments and agencies because, realistically, we need all of society. We need them to be feel supported and heard and seen as we approach these ecosystem models,” Acting National Cyber Director Kemba Walden told CyberScoop.”

From the cybersecurity breaches and vulnerabilities front —

  • Health IT Security brings us up to date on MOVEit breaches affecting healthcare organizations.
  • Health IT Security adds, “The healthcare sector continued to face a high volume of cyberattacks in the past few months as infostealing malware rose in popularity, BlackBerry stated in its latest Global Threat Intelligence Report.”
  • Cybersecurity Dive reports
    • “Half of the 12 most-commonly exploited vulnerabilities in 2022 were discovered the previous year, cyber authorities from the Five Eyes said in a joint advisory released Thursday. One of the top 12 vulnerabilities was discovered in 2018.
    • “Flaws in Microsoft products accounted for 1 in 3 of the most-routinely exploited vulnerabilities, including three Exchange Server CVEs from 2021. Two-thirds of the most-exploited vulnerabilities were found in products from three vendors: Atlassian, Microsoft and VMware.
    • “Other vendors that made the list include Apache’s Log4j, F5 Networks, Fortinet and Zoho.
    • * * * “Delayed or inconsistent vulnerability patching remains an underlying problem. This, combined with the unmet need for vendors, designers and developers to adhere to secure-by-design and secure-by-default principles, is aggravating the risk of compromise by malicious cyber actors.
    • “The Five Eyes intelligence alliance, which includes authorities from the U.S., Australia, Canada, New Zealand and the U.K., reiterated the need for vendors to follow secure design practices throughout the software development lifecycle.”
  • Security Week tells us
    • The US government’s cybersecurity agency CISA is calling attention to under-researched attack surfaces in UEFI [Unified Extensible Firmware Interface], warning that the dominant firmware standard presents a juicy target for malicious hackers.
    • “UEFI is a critical attack surface. Attackers have a clear value proposition for targeting UEFI software,” the agency said in a call-to-action penned by CISA technical advisor Jonathan Spring and vulnerability management director Sandra Radesky. 
  • CISA’s Director Jen Easterly blogs about the importance of securing the Border Gateway Protocol, which she describes as being the most important part of the internet you have never heard of.
  • On July 31, CISA added another known exploited vulnerability to its catalog.

From the ransomware front —

  • HHS’s Health Sector Cybersecurity Coordination Center released a sector alert on August 4, 2023.
    • “Rhysida is a new ransomware-as-a-service (RaaS) group that has emerged since May 2023. The group drops an eponymous ransomware via phishing attacks and Cobalt Strike to breach targets’ networks and deploy their payloads. The group threatens to publicly distribute the exfiltrated data if the ransom is not paid. Rhysida is still in early stages of development, as indicated by the lack of advanced features and the program name Rhysida-0.1. The ransomware also leaves PDF notes on the affected folders, instructing the victims to contact the group via their portal and pay in Bitcoin. Its victims are distributed throughout several countries across Western Europe, North and South America, and Australia. They primarily attack education, government, manufacturing, and technology and managed service provider sectors; however, there have been recent attacks against the Healthcare and Public Health (HPH) sector.”
  • Bleeping Computer informs us that “Clop ransomware now uses torrents to leak data and evade takedowns” and it offers its Week in Ransomware.
    • “Ransomware gangs continue to prioritize targeting VMware ESXi servers, with almost every active ransomware gang creating custom Linux encryptors for this purpose.
    • “This week, BleepingComputer analyzed the Linux encryptor for Abyss Locker and illustrated how it was specifically designed to encrypt ESXi virtual machines.”

From the cybersecurity defenses front —

  • Per Forbes
    • “Traditional passwords have proven to be an increasingly problematic authentication strategy in the evolving face of cybersecurity. Biometrics, such as fingerprints, facial recognition and iris scanning, are ushering in a new era of safe authentication.
    • “Biometrics provide distinct advantages over passwords in terms of security, convenience and user experience. But why exactly are biometrics more secure, and how can businesses successfully implement this technology into their existing strategies?
    • Forbes article explains how.
  • HelpNet offers advice on building cybersecurity defenses.
  • Security Intelligence explains how artificial intelligence can reduce data breach life cycles and costs.

Friday Factoids

David Ermer–COVID-19, FDA, HSA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The Food and Drug Administration announced today
    • “approv[ing Sage Therapeutic’s] Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.
  • STAT News informs us
    • “A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.
    • “The meeting at the Eisenhower Executive Office Building focused on immediate steps that could help alleviate shortages, such as allowing temporary importation of drugs from other countries, according to an attendee and three others with knowledge of the discussion. It also touched on purchasing issues.”
  • HR Dive relates
    • “The National Labor Relations Board on Wednesday reversed its Trump-era stance that allowed employers to maintain certain handbook policies, such as those mandating a respectful workplace (Stericycle, Inc. and Teamsters Local 628).
    • “The shift means all policies that restrict employee speech and actions must be reviewed — “and very likely rewritten,” according to Peter Spanos, a partner at law firm Taylor English.”

From the public health front —

  • The Leapfrog Group now offers ratings on maternity care services.
  • Health Day relates,
    • “A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health.
    • “Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas.
    • “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer.
    • “Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.”
  • STAT News lets us know,
    • “Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.
    • “This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States. The starkest decline was observed after the initial shutdowns, with the regular 70,000 monthly cancer diagnoses (captured by the study’s inclusion criteria) being cut in half in April 2020.”
  • KFF News offers polling data on consumer interest in the new injectable weight loss drugs and their attitudes toward pharmaceutical companies and “A Look at the Latest Suicide Data and Change Over the Last Decade” in our country.

From the U.S. healthcare business front —

  • The Kaiser Foundation announced
    • “For the quarter ending June 30, 2023, Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported operating revenues of $25.2 billion and operating expenses of $24.4 billion compared to operating revenues of $23.5 billion and operating expenses of $23.4 billion in the same period of the prior year. Operating income was $741 million for the second quarter of the year compared to operating income of $89 million in the second quarter of 2022.
    • “Like all health systems, Kaiser Permanente is experiencing ongoing cost headwinds and volatility driven by inflation, labor shortages, and the lingering effects of the pandemic on access to care and service.
    • “Due to favorable financial market conditions, Kaiser Permanente benefited from strong investment income with other income (net of other expenses) of $1.3 billion for the second quarter, compared to a $1.4 billion loss in the second quarter of 2022. For the second quarter, net income was $2.1 billion compared to a net loss of $1.3 billion in the same period of 2022.”
  • Healthcare Dive points out
    • “Patrick Conway is stepping up as CEO of UnitedHealth pharmacy benefit manager OptumRx effective immediately, according to a Thursday post on the executive’s LinkedIn, as part of a leadership shakeup at the healthcare giant.
    • “Conway is replacing Heather Cianfrocco, who is pivoting to president of Optum. Cianfrocco will lead the division’s pharmacy and care delivery capabilities, per UnitedHealth’s website.
    • “Cianfrocco replaces John Prince as Optum president. Prince has departed the company to serve as a senior advisor to private equity firm TPG, according to his LinkedIn.”
  • EBRI announced
    • “A new research report published today by the Employee Benefit Research Institute (EBRI) found that cost-sharing shifted from deductibles to copayments and coinsurance among enrollees in HSA-eligible health plans for a number of services impacted by IRS Notice 2019-45. The report, “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Employee Choice of Health Plan and Cost Sharing,” analyzed claims data to quantify the effect of expanding pre-deductible coverage on enrollee choice of health plan and cost-sharing.
    • “In response to IRS Notice 2019-45, three-quarters of large employers and health plans offering HSA-eligible health plans expanded pre-deductible coverage for medications and services that prevent the exacerbation of chronic conditions. As a result, it is not surprising that when examining medical claims, cost-sharing shifted from deductibles to copayments and coinsurance for enrollees in HSA-eligible health plans,” explained Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI. “The percentage of cost sharing paid through deductibles fell for antidepressants, insulin and other glucose-lowering agents, statins, beta blockers and inhaled corticosteroids.”
  • Health Payer Intelligence updates us on the status of provider challenges to the No Surprises Act’s arbitration rules.
    • “The legal challenges highlight the difficulties of prioritizing affordable healthcare for consumers. With payers and providers holding opposing views, federal policymakers must reach a conclusion that benefits both sides and improves costs for consumers.
    • “If federal agencies cannot establish reasonable guidelines for the IDR process, Americans may face an inflationary federal IDR process that results in higher premiums and healthcare costs, according to Georgetown University’s O’Neill Institute.
    • “There is a strong urgency to determine concrete guidelines, given the high amount of disputes that payers and providers have submitted through September 2022, a CMS report indicated.”
  • Behavioral Health Business reports
    • “The Cigna Group (NYSE: CI) has seen a historic but expected rise in behavioral health benefits utilization in recent years. 
    • “These insights, presented by the health care insurance and service conglomerate’s executives, echo others made by UnitedHealth Group (NYSE: UNH) executives on their second-quarter earnings call. 
    • “As it relates to what we’re seeing in terms of trends in terms of utilization, behavioral health has certainly been growing at a strong clip, not just this year, but for the past few years,” Brian Evanko, The Cigna Group’s CFO said Thursday on the company’s second-quarter earnings call. “Part of that is by design as we engage with our customers. And over time, that’s a good thing because the more utilization we see in behavioral health services, [the more] it helps to defray core medical costs.”