“President Biden signed into law bipartisan legislation that suspends the $31.4 trillion debt ceiling, narrowly avoiding an unprecedented U.S. default that could have pushed the economy into a recession and touched off a financial crisis.
“The president signed the bill on Saturday afternoon, just two days before the government was set to run out of money to pay all of its bills, according to Treasury Department estimates.
“The legislation’s enactment caps weeks of tense negotiations between the White House and House Republicans that were spurred by GOP lawmakers’ demands to cut spending in exchange for raising the nation’s borrowing limit.
“The Fiscal Responsibility Act suspends the debt ceiling through Jan. 1, 2025, pushing the issue beyond the 2024 elections, in exchange for cuts in unspecified domestic programs and a 3% cap on increases for military spending in fiscal 2024.
“It provides $45 billion for a recently created program expanding coverage for veterans exposed to toxic burn pits, formally ends a three-year freeze on student-loan payments, expedites large-scale energy and infrastructure projects and raises to 54 the age at which able-bodied, low-income adults without dependents must work to receive food aid.”
The Supreme Court will continue to issue opinions from its October 2022 term. The Supreme Court now releases opinions on Thursdays, instead of Mondays.
From the miscellany front —
NPR Shots reports that “Vaccination and awareness could help keep mpox in check this summer.”
“After engaging in a free program provided by Capital Blue Cross (Capital), type 2 diabetes patients experienced a variety of health improvements along with noticeable financial benefits, according to a press release that HealthPayerIntelligence received by email.
“According to the Centers for Disease Control and Prevention (CDC), about 37 million people in the US have diabetes, accounting for 11 percent of the population. The CDC also noted that about 1 in 3 Americans will develop diabetes at some point during life.
“However, in 2021, Capital [which serves central Pennsylvania] began providing a program that aimed to lessen the effects of type 2 diabetes. Along with this, the insurer launched a program that aimed to lessen the risk of developing the disease, while helping those with the disease handle its effects.
“According to a Capital update released earlier this month, the program has led to various positive effects.”
“Employees who take Family and Medical Leave Act leave in partial or intermittent increments during a week may not have holidays that fall during the same week counted against their FMLA leave, U.S. Department of Labor Principal Deputy Administrator Jessica Looman wrote in an opinion letter May 30.
“On the other hand, if an employee uses a full workweek of FMLA leave during a week that includes a holiday, that holiday counts against their FMLA leave allotment, she said.
“This method of counting holidays is not a change from past provisions, Looman clarified, saying the department has used the same approach since the first publication of its FMLA regulations in 1995.”
“Companies shouldn’t wait for new rules around cybersecurity, privacy and emerging technologies to be finalized before preparing for them, lawyers say, particularly as senior executives with the right experience can be hard to come by.
“Proposed cybersecurity rules from the Securities and Exchange Commission would require public companies to disclose which board members have security knowledge or experience, along with details about the board’s approach to cyber oversight. The SEC published draft rules in March 2022 and is expected to finalize them in the coming months.”
A federal council tasked with harmonizing future cyber incident reporting requirements is set to release proposed recommendations on how to develop an incident-reporting framework across key agencies and regulatory bodies, according to the chair of the council.
Department of Homeland Security Under Secretary for Policy Robert Silvers said the Cyber Incident Reporting Council is expecting to submit its report to Congress “in the next month or two” during a panel discussion Thursday at the Center for Strategic and International Studies, a nonprofit think tank.
The council was established under the Cyber Incident Reporting for Critical Infrastructure Act last year with the goal of minimizing industry burden while ensuring timely awareness of cyber incidents impacting critical infrastructure sectors across all required federal components.
The Cybersecurity and Infrastructure Security Agency is currently developing regulations as required under the law for critical infrastructure owners and operators to report cyber incidents within 72 hours and has led a series of listening sessions with sector-specific industries to aid its rule-making process.
“CISA is considering the inputs received through these consultations as we develop the proposed regulations and look for ways to harmonize CIRCIA’s requirements with other existing cyber incident reporting regulatory requirements,” CISA’s Executive Director Brandon Wales wrote in a March blog post reflecting on his agency’s implementation of the bill a year after it was signed into law.
CISA also issued a request for information from key stakeholders on the proposed regulations and said it was specifically interested in “definitions for and interpretations of the terminology to be used in the proposed regulations, as well as the form, manner, content and procedures for submission of reports required under CIRCIA.”
From the cybersecurity reports front —
The OPM Inspector General released its latest semi-annual report to Congress. That report includes a section on cybersecurity audits of FEHB plans.
The National Institutes of Standards and Technology issued its Fiscal Year 2022 Cybersecurity and Privacy Annual Report.
“The sizable time gap between the first known active exploitation of CVE-2023-2868 in October and Barracuda’s disclosure increases the potential for widespread compromise for customers using the security vendor’s email security gateway appliances.
“Malware was identified on a subset of appliances allowing for persistent backdoor access,” the company said. Data exfiltration was also identified on a subset of impacted appliances.
“Barracuda did not respond to questions about how many customers use its ESG appliances nor how many customers are potentially compromised and had data stolen.”
On June 2, 2023, HHS’s health sector Cybersecurity Coordination Center issued a sector alert titled “Healthcare Sector Potentially at Risk from Critical Vulnerability in MOVEit Transfer Software.”
“On May 31, 2023, Progress Software (formerly IPSwitch) published a notification disclosing that a critical vulnerability exists in their MOVEit Transfer software, which could result in unauthorized access and privilege escalation. The vulnerability is a SQL injection flaw that allows for escalated privileges and potential unauthorized access. As of May 31, 2023, the vulnerability does not have a CVE. File transfer solutions are frequently targeted by multiple threat actors, including ransomware groups. Progress Software has yet to report any attempts of extortion due to exposure to the vulnerability, nor is there any attribution to any specific threat actors. However, the exploitation is very similar to the January 2023 mass exploitation of a GoAnywhere MFT zero-day and the December 2020 zero-day exploitation of Accellion FTA servers. Both of these products are managed on file transfer platforms that were heavily exploited by the Clop ransomware gang to steal data and extort organizations.”
The Cybersecurity and Infrastructure Security Agency (CISA) released a corollary alert.
“Progress Software has released a security advisory for a SQL injection vulnerability (CVE-2023-34362) in MOVEit Transfer—a Managed File Transfer Software. A cyber threat actor could exploit this vulnerability to take over an affected system.
“CISA urges users and organizations to review the MOVEit Transfer Advisory, follow the mitigation steps, apply the necessary updates, and hunt for any malicious activity.”
CISA announced on May 31, 2023, adding one more known exploited vulnerability to its catalog and another on June 2, 2023.
“There have been rumors for weeks that Royal ransomware was rebranding to a new ransomware operation called BlackSuit. This week, Trend Micro analyzed encryptors from both operations and said they share very strong similarities.
“While this is not a strong enough link, the attack on Dallas may have put the Royal ransomware operation in the crosshairs, scaring them into a rebrand.
“Retail giant Walmart said artificial intelligence is helping it to make sense of the data its security systems generate and to spot patterns that its analysts might miss. Generative AI systems like ChatGPT might enhance that ability further.
“Rob Duhart, Walmart’s deputy chief information security officer, said the sheer amount of information the company handles means that some form of automation is essential.
“There’s scale, and then there’s Walmart scale,” he said, speaking at the WSJ Pro Cybersecurity Forum held virtually Wednesday.
“With around 10,500 stores globally and 2.3 million employees, the company scans around 11 billion lines of code each year, Duhart said. Its cybersecurity tools generate around 6 trillion data points annually, and it blocks 8.5 billion malicious bots a month.
“Walmart has developed a number of AI tools in-house, given that off-the-shelf products typically can’t handle the vast body of data it needs to analyze, Duhart said. It’s also a problem for human analysts, who can’t comb through the information they need quickly enough.”
“With recent economic trends pointing toward a recession, companies are bracing for the downturn and slashing resources in anticipation of financial turmoil.
“Yet, cybersecurity budgets remain resilient. A recent survey revealed that most IT security decision-makers, including those in healthcare, have ramped up their 2023 cybersecurity spending to strengthen programs.
“Nuspire’s Second Annual CISO Research Report on Challenges and Buying Trends surveyed 200 CISOs across various sectors. The results showed that 58 percent had increased their budgets in 2023, with 42 percent planning to pour more even funding into cybersecurity within the following year.
“This uptick in budget allocation speaks volumes as leaders recognize the importance of a strong landscape.
“As we’ve seen in previous years, the current economic conditions have shown how resilient cybersecurity budgets are in the face of business cost reductions,” said Lewie Dunsworth, CEO of Nuspire.”
“The FDA today told AHA that is has worked with Qilu Pharmaceuticals and Apotex Corp. to temporarily import cisplatin, a drug used in chemotherapy, after a national shortage. FDA said it is carefully assessing the overseas product for quality to ensure it is safe for U.S. patients. The agency issued a “Dear Health Care Provider” letter with details and updated its drug shortage database with more information.”
“Almost all Americans have some level of immunity against COVID-19 through vaccination, previous infection or both, suggests new research from the Centers for Disease Control and Prevention.
“The study, which was published Thursday, tested blood donations from people ages 16 years and older for antibodies against the coronavirus from July through September 2022.
“It found that 96% of people had antibodies by last fall. About 23% were from infection alone and 26% were from vaccination alone. Nearly 48% had hybrid immunity – a number that’s only expected to grow as the coronavirus continues to circulate.
“Hybrid immunity, or the combination of protection from vaccination and infection, is believed to be higher and longer lasting than protection from either source on its own.
“This increase in seroprevalence, including hybrid immunity, is likely contributing to lower rates of severe disease and death from COVID-19 in 2022–2023 than during the early pandemic,” the authors wrote.”
“The Centers for Disease Control and Prevention is following up on a previous alert of an outbreak of suspected fungal meningitis in Texas, which is now significantly expanded to multiple states. A total of 212 residents in 25 U.S. states and jurisdictions have been identified who might be at risk of fungal meningitis because they received epidural anesthesia at clinics in Matamoros, Mexico, during cosmetic procedures.
The CDC is urging all patients, including those without symptoms, who underwent medical or surgical procedures under epidural anesthesia at River Side Surgical Center or Clinica K-3 in Matamoros, Mexico, since Jan. 1, 2023, should be evaluated for fungal meningitis as soon as possible. Health care providers should immediately report possible fungal meningitis cases possibly related to this outbreak to their state or local health department.”
“The number of American women who have diabetes when they become pregnant has increased dramatically over five years, health officials reported Wednesday.
“Between 2016 and 2021, the rate of pregnancy among diabetic women has risen 27%, from about 9 per 1,000 births to 11 per 1,000 births, according to the report from the U.S. Centers for Disease Control and Prevention.
“Primary reasons for this increase are most likely the ongoing obesity epidemic and the fact that more older women are having children.”
The Wall Street Journal offers an essay discussing why are our knees are so easy to injure.
A targeted drug from Novartis reduced the risk of breast cancer returning by 25% versus standard treatment when used after surgery in people vulnerable to a relapse, according to clinical trial data released Friday.
The findings, which will be presented at the American Society of Clinical Oncology’s annual meeting in Chicago, give Novartis a chance at Food and Drug Administration approval for its drug in this so-called adjuvant setting. A competing therapy from Eli Lilly won a similar OK a year and a half ago.
Novartis announced in March that the trial, called NATALEE, had succeeded, but didn’t disclose details. The full findings now released give breast cancer doctors an opportunity to evaluate how the drug, known as ribociclib and sold as Kisqali, might fit in treatment.
From Washington, DC –The Wall Street Journal reports
“The Senate passed wide-ranging legislation Thursday [night] that suspends the $31.4 trillion debt ceiling [until January 1, 2025] while cutting federal spending, backing a bipartisan deal struck by President Biden and House Speaker Kevin McCarthy to avert an unprecedented U.S. default.
“The 63-36 vote reflected support from both Democrats and Republicans, with backers saying the need to raise the nation’s borrowing limit outweighed concern about provisions related to military and domestic spending and energy policy, among other contentious issues.
“The measure now goes to the president for his signature with several days to spare before Monday, when the Treasury Department has said that the government will run out of money to pay all of its bills.”
“President Biden plans to pick former North Carolina Health Secretary Dr. Mandy Cohen to lead the Centers for Disease Control and Prevention, according to people familiar with the planning. * * *
“Cohen, a medical doctor like Walensky, served in the Obama administration as chief of staff at the Centers for Medicare and Medicaid Services. She helped implement the Affordable Care Act and new payment models at the agency.
“She also served as North Carolina’s health secretary for nearly five years into 2021, helping lead the state through the Covid-19 pandemic. She is an executive at Aledade, a network of independent primary-care practices. * * *
“The White House and the CDC declined to comment. Cohen’s selection for the role was earlier reported by The Washington Post. The role doesn’t require Senate confirmation.”
“The CMS on Wednesday issued a final rule lifting the COVID-19 vaccine mandate for workers in healthcare facilities that receive federal funding as soon as early August. The rule, which will go into effect 60 days after being published in the Federal Register, would withdraw regulations requiring the vaccines for healthcare workers that went into effect last year following a number of legal challenges.
“The CMS said it will not be enforcing the provisions between now and August.”
“There is a test that could diminish the toll of the nation’s top cancer killer—if people would use it. Doctors are pushing harder to make that happen.
“Lung cancer kills upward of 127,000 people in the U.S. each year. The toll has waned in recent years thanks to declining smoking rates and new treatments, but it remains the deadliest cancer for Americans by far.
“A CT scan can catch the disease early to help save lives. The five-year survival rate when lung cancer is caught early is about 60%, compared with around 7% if it is caught after disease has spread, according to the American Lung Association. Medical groups recommend annual, low-dose scans starting at 50 for people who smoke heavily or recently quit. Insurers often cover the test.
“It’s low-hanging fruit for the country,” said Dr. Patrick Hwu, president and chief executive of the Moffitt Cancer Center in Tampa, Fla. “It would save the most lives immediately.”
“About 3.66 million babies were born in the U.S. in 2022, essentially unchanged from 2021 and 15% below the peak hit in 2007, according to new federal figures released Thursday.
“The provisional total—3,661,220 births—is about 3,000 below 2021’s final count, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics. Final government data expected later this year could turn that small deficit positive. * * *
“Absent increases in immigration, fewer births combined with ongoing baby boomer retirements will likely weigh on the labor force supply within the next 10 years, said Kathy Bostjancic, chief economist at Nationwide, an insurance and financial-services company.
“You’re going to have a real shortage of workers unless we have technology somehow to fill the gap,” Bostjancic said.”
The U.S. Preventive Services Task Force released a final research plan for its Perinatal Depression: Preventive Interventions project.
[Last week,] “the White House released the first-ever U.S. National Plan to End Gender-Based Violence. The plan lays out a roadmap for a whole-of-government effort to prevent and address gender-based violence in the United States. One of the groundbreaking aspects of this plan is that it reflects principles from the International Labor Organization’s Convention on Violence and Harassment in the World of Work, recognizing gender-based violence and harassment in the “world of work,” which includes not only traditional workplaces but anywhere workers are paid, in places workers take rest breaks, in work-related training, and through work-related communications.”
“The percentage of employees in the general U.S. workforce who tested positive for marijuana after a job accident reached a 25-year high in 2022, according to data released May 18 by Quest Diagnostics.
“In 2022, 7.3% of the general workforce (private sector employees in non-safety-sensitive jobs) tested positive for marijuana in a post-accident urine test, up from 6.7% in 2021, according to Quest’s latest Drug Testing Index. After rising steadily each year for the past 10 years, the 2022 positivity rate reflected a 204% jump since 2012, Quest said.
“The increase in post-accident marijuana positivity rates corresponds with the legalization of marijuana for recreational use in certain states, starting in 2012 with Colorado and Washington, Quest noted in a news release. The DTI data “provide compelling evidence that increased use of cannabis products can contribute to greater risk for injuries in the workplace,” Katie Mueller, a National Safety Council senior program manager, stated.”
From the U.S. healthcare business front —
Beckers Hospital Review shares Newsweek’s list of top-ranked maternity hospitals in the U.S.
“Following discussions between the American Hospital Association (AHA) and United Healthcare (UHC), the insurer late yesterday announced a refocused gastroenterology (GI) policy that relies on additional provider education rather than prior authorizations to address the insurer’s concerns about possible overutilization. The refocused policy avoids potential care denials for patients, particularly vulnerable patients, and will not impact the coverage and payment of claims for these services. The GI policy, which pertains to certain non-screening endoscopy and colonoscopy services, goes into effect today, June 1.
“UHC will instead implement a 7-month, or potentially longer, pilot program to collect data that substitutes notification and submission of standard clinical data when services are delivered for prior authorization, removing the risk of potential care delays and claim denials. This data will be applied to UHC’s gold-carding program, beginning sometime in 2024, in order to exempt physicians that are routinely aligned with the insurer’s guidelines. The insurer has yet to determine any additional controls that will be placed on non-gold-carded clinicians at the end of the pilot.”
“BJC HealthCare and Saint Luke’s Health System announced Wednesday they had signed a non-binding agreement to merge, creating a $10 billion health system serving patients in Missouri, Kansas and Illinois.
“The 28-hospital system would keep their current brands and operate from two headquarters, with the St. Louis base focusing on eastern Missouri and southern Illinois, while the Kansas City, Missouri, headquarters serves western Missouri and parts of Kansas.
“BJC and Saint Luke’s said they’re planning to reach a definitive agreement “in the coming months,” assuming no regulatory hurdles. They expect the deal to close by the end of the year.”
“Oak Street Health plans to enter Arkansas, Iowa, Kansas and Virginia beginning this summer, the value-based primary care chain for seniors announced Tuesday.
“Oak Street also plans to open additional centers in Arizona, Colorado, Georgia, Illinois, Indiana, Louisiana, New York, Ohio and Pennsylvania this year, according to a release.”
“In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.
“Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthritis and other conditions. At the same time, Coherus will sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which will market the treatment for about $579.
“The lowball pricing for the drug, which will become available in July, has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years. After enjoying a monopoly that yielded billions of dollars in annual sales, AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.”
“Medicare on Thursday affirmed plans to limit coverage for certain Alzheimer’s disease drugs, but signaled it’s taking steps to ensure broader access should one of the medicines receive full Food and Drug Administration approval.
“In a statement, the Centers for Medicare and Medicaid Services said they would cover drugs like Eisai and Biogen’s Leqembi when patients and their doctors participate in a registry for collecting data on how the treatments work in the real world. The stance is in line with the agency’s current policy, but describes a process that analysts viewed as relatively straightforward to fulfill.
“However, the nonprofit Alzheimer’s Association, which has previously attacked Medicare’s policy, criticized the registry requirement and said it “will create unnecessary hurdles to coverage.” The agency’s plan will soon be tested as Leqembi — currently cleared on a conditional basis in the U.S. — is up for full FDA approval, with a decision expected by July.”
“The House passed a sweeping bill that suspends the federal government’s $31.4 trillion debt ceiling in exchange for spending cuts, as Republican Speaker Kevin McCarthy muscled through a deal struck with President Biden to avert a looming government default.
“The 314-117 vote relied on support from both Republicans and Democrats. Passage of the deal sends the measure to the Senate, where leaders have promised quick action, and Biden has said he is eager to sign the measure into law. Treasury Secretary Janet Yellen has said the government could run out of the cash it needs on June 5 to pay its bills on time and warned of severe economic damage and market disruptions unless Congress acts.
“The House vote marks the culmination of a hard-fought debate in the chamber, where Republicans were intent on using the debt ceiling as leverage to deeply cut deficit spending and roll back many of Biden’s signature initiatives—but ended up settling for more modest changes.
“The outcome showed, for now, that McCarthy has the power to deliver high-stakes deals with Democrats while still keeping his job, and bolstered Biden’s reputation as a deal maker who was willing to find a middle ground with Republicans.”
Healthcare Dive provides details on the healthcare provisions in the bill (HR 3746).
“As Congress considers wide-ranging reforms to pharmacy benefit managers, a top executive at CVS Health, which owns one of the largest PBMs in the country, said the company would find ways to maintain its level of profit if those reforms to things like drug rebates went into effect.
“There’s other ways in the economic model that we can adjust to if one of those things changes,” Shawn Guertin, CVS’ chief financial officer, said at an industry conference Wednesday. “The other important part of this, if some of these things change, it could lead to higher costs for employers and health plans.”
If the FEHBP’s experience with transparent prescription drug pricing is any guide, the reforms under consideration will not lower costs for employers and health plans. For example, OPM mandated full transparency of manufacturer rebates and 100% distribution of those rebates to the health plans, causing higher administrative expenses for FEHB plans. Presumably, the larger rebates and higher administrative expenses wash. OPM also mandates triennial RFP processes for PBM contracts which do produce savings.
Speaking of FEHBP, Govexec brings us up to date on Postal Service Health Benefits Program implementation. The article illustrates the support that carriers and the Postal Services, among other agencies, are providing OPM with this project. All of the major Postal unions are FEHB carriers.
Today is the deadline for FEHB carriers to submit their 2024 benefit and rate proposals to OPM. Fierce Healthcare discusses a Mercer survey of employer expectations for 2024 premiums.
From the public health front —
Kaiser Family Foundation News points out that medical debt is materially higher in the Diabetes Belt found in the southeastern U.S. “The CDC says the Diabetes Belt consists of 644 mostly Southern counties where rates of the disease are high. NPR found that more than half of the counties have high levels of medical debt in collections — meaning at least 1 in 5 people are affected.”
Compared with reoffering colonoscopy and fecal immunochemical test alone, offering a blood test as a secondary option resulted in a nearly twofold increase in colorectal cancer screening in veterans who had declined first-line screening.
“We know screening prevents colorectal cancer, but participation in screening is suboptimal,” Peter S. Liang, MD, MPH, assistant professor of medicine and population health at NYU Langone Health, told Healio. “Compared to widely used screening modalities such as colonoscopy and stool-based testing, a blood test has certain advantages: It is noninvasive, can be done at point of care and does not require self-collection.”
Leapfrog Group calls attention to its newly released 2023 maternity care report.
STAT News explains why new cancer patients need navigation support
[P]eople * * * in this suspected peri-diagnostic period (the time between a positive finding on a screening test and leading up to a formal diagnosis and treatment) are not looking for specific answers so much as they are seeking general support.
Patients want a trusted person to help provide a general overview of the journey ahead. They want someone to help them through the structural and logistical challenges of our cumbersome and sometimes unresponsive health systems. They would like triage on whether their case is common enough that they can access high-quality, convenient, and accessible community care, or whether their diagnosis warrants the specialized care available at large academic medical centers. They want guidance on what sorts of questions to ask their care team. They want to know if they should pursue second opinions, and if so, how to go about getting insurance approval or the mechanics of how to actually secure an appointment.
Medscape reports
“About 10% of people infected with Omicron reported having long COVID, a lower percentage than estimated for people infected with earlier strains of the coronavirus, says a study published in The Journal of the American Medical Association.”
“The Food and Drug Administration (FDA) on Wednesday approved Pfizer’s vaccine to prevent the respiratory disease RSV in older adults, the company announced.
The approval of Pfizer’s Abrysvo marks the second authorized RSV shot for older adults in the U.S. this month, after GlaxoSmithKline won approval for its rival shot, Arexvy. “
Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 as well as SGLT2, received marketing approval from the US Food and Drug Administration (FDA) on May 26 for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.
This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.
Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect US sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.
Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.
“The median year-to-date operating margin index for hospitals slightly improved in April to 0 percent, according to Kaufman Hall.
“The neutral margin marks a slight improvement from the -0.3 percent recorded in March, according to Kaufman Hall’s latest “National Flash Hospital Report” — based on data from more than 900 hospitals.
“Hospitals saw increased bad debt and charity care and decreased inpatient and outpatient volumes in April, which Kaufman Hall experts correlate to the winding down of the COVID-19 Public Health Emergency, which ended May 11.”
“Nonprofit hospital and health plan operator Kaiser Permanente announced Tuesday that it was committing $10 million to safety-net hospital and regional operator Denver Health, as the facility struggles with “unprecedented financial challenges” including increased expenses and a rise in uninsured patients.
“Denver Health provides care for around 30% of the city’s population — including the largest percentage of uninsured patients. The system has struggled with a rise in costs and a surge in sicker patients, with expenses totaling $1.3 billion for Denver Health in fiscal year 2022.
“The announcement comes as both nonprofit and for-profit hospitals across the country struggle with negative margins and pent-up financial challenges stemming from the COVID-19 pandemic, including persistent heightened contract labor costs, inflationary pressures and unfavorable payer mixes.”
From the miscellany department —
Bloomberg updates us on the promising hunt for a breast cancer vaccine.
About 65% of Americans believe that employer-sponsored insurance provides them with “financial peace of mind,” a new survey shows.
The AHIP report, published Wednesday, was conducted by Locust Street Group from April 17 to April 25 as part of AHIP’s Coverage@Work campaign, which aims to gather insights on Americans’ thoughts on employer-sponsored coverage. It included responses from 1,000 U.S. consumers with employer-sponsored coverage.
Beckers Payer Issues ranks the States by Medicare Advantage enrollment.
“In a memo released May 30, National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo announced that noncompete agreements violate the National Labor Relations Act (NLRA). The announcement, which applies to nonunionized and unionized employers, may result in unfair labor practice charges for any employer that uses noncompetes, said Thomas Payne, an attorney with Barnes & Thornburg in Indianapolis.
“However, a manager’s or supervisor’s noncompete would seemingly be unaffected by the memo because the NLRA applies only to nonmanagerial, nonsupervisory staff, said James Redeker, an attorney with Duane Morris in Philadelphia. Managers and supervisors are the most likely to have noncompetes, he noted.”
From Washington, DC, the House Rules Committee held a four-hour hearing on the debt ceiling compromise bill (HR 3746) this afternoon. The Wall Street Journal adds
“House Republican leaders projected confidence Tuesday that the debt-ceiling deal struck with President Biden would draw enough support to pass, while some conservative lawmakers angrily denounced the agreement.
“The bill advanced (7-6 vote) past a closely watched procedural hurdle in the Rules Committee late Tuesday, and a final House vote is expected as soon as Wednesday night. While the bill appears on track to gain sufficient Republican and Democratic votes to pass the House and then the Senate by the June 5 deadline, it could still run into procedural obstacles, complicating the race to avoid an unprecedented default.”
“[As of last Friday] the two main metrics that the Centers for Disease Control and Prevention (CDC) uses to track US COVID-19 activity—hospitalizations and deaths—continue to decline, according to the latest data. Hospitalizations for COVID are down 11% compared to a week ago, and deaths from the virus are down 13.3%.
“The hospitalization map, which reflects activity by county, replaces the CDC’s earlier community levels, and there are currently only a few hot spots, some in Texas and in small portions of Nebraska and Louisiana.
“Early indicators—regional test positivity and emergency department (ED) visits—also show no signs of increase. Test positivity at the national level is 4.3%, down 0.7% from a week ago. The only region showing a slight increase is the part of the Southwest that includes California, Nevada, and Arizona. Only 0.5% of ED visits last week were due to COVID, down 10.8% from the previous week. There are no major rises in COVID positivity in wastewater surveillance.”
HHS’s Agency for Healthcare Quality and Research issued a report on “Treated Prevalence of Commonly Reported Health Conditions, 2016 to 2020.”
“The United States grew older, faster, last decade.
“The share of residents 65 or older grew by more than a third from 2010 to 2020 and at the fastest rate of any decade in 130 years, while the share of children declined, according to new figures from the most recent census.
“The declining percentage of children under age 5 was particularly noteworthy in the figures from the 2020 headcount released Thursday. Combined, the trends mean the median age in the U.S. jumped from 37.2 to 38.8 over the decade.
“America’s two largest age groups propelled the changes: more baby boomers turning 65 or older and millennials who became adults or pushed further into their 20s and early 30s. Also, fewer children were born between 2010 and 2020, according to numbers from the once-a-decade head count of every U.S. resident. The decline stems from women delaying having babies until later in life, in many cases to focus on education and careers, according to experts, who noted that birth rates never recovered following the Great Recession of 2007-2009.”
From the Rx coverage front —
Fierce Healthcare updates us on the soaring employee demand for anti-obesity drugs.
“Optum Rx is rolling out new programs aimed at supporting independent and rural pharmacies in closing care gaps beginning in June.
“The pharmacy benefit manager said Tuesday that the new initiatives will focus on three key areas: helping patients in underserved areas connect to community resources, improving maternal and fetal health by boosting access to key supplies and deploying community pharmacies to address healthcare deserts.
:The new initiatives kick off what Optum said is a “broader, industry-leading commitment to bridge resource gaps in the community.”
“These initiatives provide opportunities not only to help patients but also to offer appropriate compensation that recognizes the clinical expertise and unique capabilities our community and independent pharmacy partners have to meet the needs of their patients,” said Heather Cianfrocco, CEO of Optum Rx, in the release.”
From the medical and prescription drug research front
“Biomedical breakthroughs most often involve slow and steady research in studies involving large numbers of people. But sometimes careful study of even just one truly remarkable person can lead the way to fascinating discoveries with far-reaching implications.
“An NIH-funded case study published recently in the journal Nature Medicine falls into this far-reaching category [1]. The report highlights the world’s second person known to have an extreme resilience to a rare genetic form of early-onset Alzheimer’s disease. These latest findings in a single man follow a 2019 report of a woman with similar resilience to developing symptoms of Alzheimer’s despite having the same strong genetic predisposition for the disease [2].
“The new findings raise important new ideas about the series of steps that may lead to Alzheimer’s and its dementia. They’re also pointing the way to key parts of the brain for cognitive resilience—and potentially new treatment targets—that may one day help to delay or even stop the progression of Alzheimer’s.”
“An experimental hemophilia drug developed by Pfizer significantly reduced bleeding frequency compared to on-demand or preventive clotting factor proteins, the drugmaker said Tuesday. Called marstacimab, the drug was not associated with the kind of dangerous blood clotting that has delayed or sidelined similarly acting drugs from Novo Nordisk and Bayer.
“If approved, marstacimab would compete with established medicines like Roche’s Hemlibra as well as newer treatments like CSL Behring’s gene therapy Hemgenix and Sanofi’s long-acting drug Altuviiio. These therapies offer options for patients beyond regular infusions of engineered clotting factor proteins.
“Marstacimab requires a weekly subcutaneous shot, while Hemlibra can be administered subcutaneously as infrequently as once every four weeks after an initial dosing phase. Gene therapies like Hemgenix, or another from BioMarin Pharmaceutical that’s now under review, are intended to be a one-and-done treatment, although their long-term durability has not been proven.”
“Nonprofit hospital operator Ascension Healthcare reported a loss from operations of $1.8 billion on revenue of $21.3 billion for the nine months ending March 31, as it struggled with higher operating costs and sustained revenue challenges driven by continued impacts of the COVID-19 pandemic and inflationary pressures.
“An improvement in total surgical volumes, especially outpatient surgeries and emergency room visits, didn’t outpace growing expenses for Ascension, which increased by $804 million year over year in the nine-month period.”
“Advocate Health, the newly formed marriage of major nonprofits Advocate Aurora Health and Atrium Health, reported a $10.4 million operating income (0.1% operating margin) and $578.7 million net gain in its first-ever Q1 earnings report, released Tuesday.
“The 67-hospital entity tallied more than $7.54 billion in total revenue during the three months ended March 1 thanks to year-over-year increases across each of its major divisions—Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist.”
From the litigation front, STAT News reports, “A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. * * * The U.S. Court of Appeals for Second Circuit, though, ruled a U.S. bankruptcy court was correct in approving the immunity and, moreover, that it was “equitable and appropriate under the specific factual circumstances of this case.” The decision reverses a ruling made last December by a federal judge had sided with the U.S. Trustee. The case now goes back to U.S. bankruptcy court to approve the settlement, although the U.S. Trustee could ask the U.S. Supreme Court to review the appeals court ruling.”
Today we honor our service members who died for our Country. While many of my forebearers served, it was the son of one of the FEHBlog’s first cousins, Army Capt. Eric T. Paliwoda, who died in combat. Next January 2 will mark the 20th anniversary of his death in Iraq. Rest in peace. Never forget.
The Senate is in session this week for floor voting and Committee business, while the House of Representatives, which had planned to take a District work break, will resume floor voting and hold a Rules Committee meeting tomorrow.
“The path to a tentative agreement to raise the debt limit started in January with the election of Kevin McCarthy as House speaker on the 15th ballot, after he made conservatives a host of promises to cut spending and gave them the ability to oust him if he wavered.
“The agreement represents a compromise, which means not everyone gets what they want,” Biden said. “That’s the responsibility of governing.” McCarthy called the deal an “agreement in principle” and warned: “We still have a lot of work to do.”
The agreement has been reduced to legislative language that the House of Representatives will consider on Wednesday. Roll Call describes the deal in English. The Senate is expected to take up the bill on Friday if all goes well. The FEHBlog at least expects it will.
From the miscellany department —
Last week, the Centers for Medicare and Medicaid Services proposed a rule to improve prescription drug price transparency in Medicaid.
The Wall Street Journal explains why “Early detection of dementia can help people make important decisions and weigh possible treatments. But getting a diagnosis can be difficult.”
“Getting an early and correct diagnosis for dementia gives those with the condition time to make financial and legal plans while they still can. A timely diagnosis could become even more important with new drugs, such as Biogenand Eisai’s Leqembi and Eli Lilly’s donanemab that help slow decline in early stages of Alzheimer’s. The drugs wouldn’t be used to treat frontotemporal dementia, or FTD, but they hold promise for future treatments across a broader spectrum of dementia.” * * *
“Yet, dementia remains difficult to diagnose. About half of those affected go undiagnosed, according to studies on dementia diagnosis and prevalence.
“Doctors who specialize in dementia cite several reasons for high undiagnosed rates, including a shortage of specialists such as cognitive neurologists, geriatric psychiatrists and gerontologists, and limited access to tests, including certain PET scans that help reveal specific abnormalities in the brain but may not be covered by insurance. Blood tests to detect Alzheimer’s risk aren’t widely used.
“Many individuals, family members and primary-care doctors are reluctant to talk about dementia because they are afraid, embarrassed or think nothing can be done. Early symptoms are often attributed to stress, lack of sleep and forgetfulness.”
NPR Shots reports on the “intriguing” results of a study of multivitamin use by older Americans.
Back, hip, and/or pelvis pain that doesn’t go away
Painful ejaculation
Patients diagnosed in early stages of the condition can have a “high expectation of cure,” Knudsen says, and “can continue to have a wonderful quality of life.” In fact, the five-year survival rate for prostate cancer detected early is virtually 100%, Siddiqui says.
The outlook for late-diagnosed patients, however, is not nearly as rosy. There is no “durable cure” for such cancer, Knudsen points out. The five-year survival rate for advanced prostate cancer is only 31%, according to Siddiqui.
When it comes to prostate cancer prevention, “what’s good for your heart is good for your prostate,” Oh advises. He encourages men to pack their diets full of leafy green veggies and colorful fruits, and to limit dairy and barbecued meat, which are associated with a higher risk of prostate cancer and aggressive prostate cancer.
The Department of Defense sent its new classified cyber strategy to Congress this week, the Pentagon said Friday.
The highly anticipated strategy is the first since 2018 and follows the release of the National Cybersecurity Strategy in March.
The DOD also publicly released an unclassified “fact sheet” on Friday, and said an unclassified “summary” will be provided in the “coming months.”
Of note, the fact sheet explains that the updated strategy is based upon real-world operations. Prior to 2018, the Pentagon had only conducted a limited number of cyber ops due to a variety of factors such as stringent authorities and a high-risk calculous.
The 2018 National Defense Authorization Act combined with changes to executive policy streamlined authorities and made it easier for the DOD to approve and conduct operations.\
“President Joe Biden has nominated U.S. Air Force Lt. Gen. Timothy Haugh, the no. 2 at U.S. Cyber Command, to serve as the new head of both Cyber Command and the National Security Agency, according to an Air Force notice.
“The notice, obtained by POLITICO, was sent out on Monday and is titled “General Officer Nomination.” It announces that the president has nominated Haugh to the Senate for promotion to four-star general and assignment in the dual-hatted role. * * *
“If confirmed, Haugh will replace Gen. Paul Nakasone, who has led both NSA and Cyber Command since 2018. Nakasone is planning to step down sometime this year.”
“In remarks before a Washington, D.C. audience on Thursday, Microsoft President Brad Smith proposed a five-point plan for governing AI: implementing and building upon existing frameworks, requiring effective brakes on AI deployments, developing a broader legal and regulatory framework, promoting transparency and pursuing new public-private partnerships.”
From the cybersecurity breaches and vulnerabilities front —
“PillPack, an online pharmacy owned by Amazon, has reported a data breach affecting more than 19,000 customers.
“The cyberattack exposed users’ email addresses, prescription information and their providers’ contact details. Social Security numbers and credit card information weren’t involved. PillPack said more than 3,600 affected accounts included prescription data.
“The online pharmacy said it discovered the breach on April 3, and it determined an unauthorized person used users’ email addresses and passwords to sign into their accounts between April 2 and April 6.”
“China-sponsored threat actors have managed to establish persistent access within telecom networks and other critical infrastructure targets in the US, with the observed purpose of espionage — and, potentially, the ability down the line to disrupt communications in the event of military conflict in the South China Sea and broader Pacific.
“That’s according to a breaking investigation from Microsoft, which dubs the advanced persistent threat (APT) “Volt Typhoon.” It’s a known state-sponsored group that has been observed carrying out cyber espionage activity in the past, by researchers at Microsoft, Mandiant, and elsewhere.”
“A rare form of malicious software designed to infiltrate and disrupt critical systems that run industrial facilities such as power plants has been uncovered and linked to a Russian telecom firm, according to a report released Thursday from the cybersecurity firm Mandiant.
“The discovery of the malware dubbed “CosmicEnergy” is somewhat unusual since it was uploaded to VirusTotal — a service that Google owns that scans URLs and files for malware — in December 2021 by a user with a Russian IP address and was found through threat hunting and not following an attack on a critical infrastructure system.
“Whatever the motivation for developing it and uploading the code to VirusTotal, CosmicEnegy joins an highly specialized group of malware such as Stuxnet, Industroyer and Trisis that are purpose built for industrial systems. Furthermore, the discovery adds another layer of concern for critical infrastructure operators and organizations that are increasingly targeted by criminal and nation-backed hackers.
“Researchers at Mandiant, which is part of Google Cloud, noted that its highly unusual for this type of code to be discovered or even disclosed to the public. Yet, it’s not clear if the malware was intended for use in a cyberattack or it could have been developed for internal red-teaming exercises before the code was released into the wild.”
“The Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Australian Cyber Security Centre (ACSC) released a joint cybersecurity advisory (CSA) regarding BianLian ransomware group.
“The group has been observed targeting a variety of United States critical infrastructure sectors since June 2022, as well as Australian critical infrastructure sectors. BianLian typically gains access via valid Remote Desktop Protocol (RDP) credentials and uses open-source tools for credential harvesting. In 2023, BianLian has threatened negative financial, legal, and business impacts if victims refuse to pay the ransom.
“BianLian group actors then extort money by threatening to release data if payment is not made,” the advisory stated. “BianLian group originally employed a double-extortion model in which they encrypted victims’ systems after exfiltrating the data; however, around January 2023, they shifted to primarily exfiltration-based extortion.”
CISA warned of hurricane/typhoon-related scams and identified three and then one more known vulnerabilities to its catalog.
From the ransomware front —
Cybersecurity Dive informs us, “A trio of [recent] ransomware attacks targeting the Dallas metro area have the hallmarks of a targeted campaign. They also underscore a very real problem: society is becoming desensitized to disruption.”
Here’s a link to the latest issue of Bleeping Computer’s The Week in Ransomware.
“The Cybersecurity and Infrastructure Security Agency for the first time since 2020 released an updated version of #StopRansomware, in partnership with the FBI, National Security Agency and the Multi-State Information Sharing and Analysis Center.
“The updated guide, developed through the Joint Ransomware Task Force, reflects lessons learned over the last few years, adding the FBI and NSA as co-authors for the first time. It offers recommendations to prevent initial intrusion as well as steps to protect data using cloud backups. * * *
“It includes a comprehensive list of best practices to defend against attacks, including:
“Maintain offline, encrypted backups of critical data and regularly test those backups in a simulation of disaster recovery. This should include “golden images” of critical systems, including preconfigured operating systems and associated applications.
“Develop, maintain and practice a basic cyber incident response plan for ransomware and data breaches. This should include a communications plan, including disclosure notifications to government authorities.
“The guide also includes a comprehensive set of measures to prevent and mitigate ransomware and data extortion, including:
“Conduct regular scanning to identify and address vulnerabilities, particularly on internet facing devices.
“Regularly patch and update software and operating systems to the latest versions.
“Make sure all on premises, cloud services, mobile and bring your own devices are properly configured and security features are enabled.
“Enforce lockout policies after a certain number of failed login attempts.
“The guide suggests creating illustrated guides that provide detailed information about data flows inside an organization. This will help incident responders understand which systems to focus on during an attack.”
“Cyber insurance prices in the United States rose 11% year over year on average in the first quarter of 2023 according to insurance broker Marsh. This was a noticeably smaller increase than the 28% rise in Q4 2022 and was the fifth straight quarter that prices rose by less than the previous quarter. Additionally, rate increases moderated during 2022, with an average increase of 17% in December 2022, which was down significantly from a December 2021 high average increase of 133%.
“Marsh said increased competition, improved cybersecurity controls, and a reduction in ransomware attacks in 2022 were factors that affected the continued moderation in pricing, while noting there has been an upturn in ransomware incidents and claims since Q4 2022.”
Tom’s Guide updates us on best VPN logging practices.
The Harvard Business Review offers ideas on creating effective cybersecurity training programs.
“President Biden said negotiators were closing in on a deal to cut spending and raise the $31.4 trillion debt limit, seeking to overcome final hurdles on issues regarding the budget as well as requiring more people to work to receive federal benefits.
“He said talks are “very close” to reaching an agreement and that he was hopeful that there could be a breakthrough as soon as later on Friday. “I hope we’ll have some clear evidence tonight, before the clock strikes 12, that we have a deal,” he said as he departed the White House for Camp David on Friday evening.
“Negotiators are hoping to strike a deal soon in order to set up votes on the legislation next week. The Treasury Department, which is currently using extraordinary measures to avoid exceeding the debt ceiling, estimated Friday that the government could run out of money to pay its bills if Congress doesn’t act by June 5.
“Treasury had previously put the deadline as early June, saying it could come as soon as June 1. Any legislation would likely take at least several days to pass both the House and Senate.
“The federal government’s HR agency on Wednesday unveiled new guidance aimed at standardizing and revitalizing employee assistance programs across the federal government, an effort officials said would prioritize employee wellness and improve productivity.
“Like many private sector employers, federal agencies often offer employees access to employee assistance programs, which provide services related to maintaining one’s mental and physical health, as well as resources related to substance use issues.
“The Office of Personnel Management, spurred by a provision of President Biden’s management agenda tasking agencies with promoting “awareness of employee well-being and [supporting] initiatives that extend beyond the workplace,” underwent a year-long effort to design a “standardized approach” to employee wellness programs, consulting with focus groups, health experts and vendors who provide assistance programs to employers.
“The result is a 19-page guidance document for agencies to reassess their assistance program offerings and, if necessary, expand them.
The FEHBlog wonders why OPM silos its various benefit programs rather than integrate them to get more bang for the buck.
From the healthcare costs front —
Milliman has released its 2023 Medical Index. Milliman estimates the healthcare cost for a hypothetical family of four enrolled in a hypothetical PPO plan is $31,065, a 5.6% increase over 2022.
The Medical Group Management Association issued its 2023 Physician Compensation and Productivity Benchmarks.
“Productivity remained relatively flat or only slightly increased relative to pre-pandemic benchmarks, with the biggest change in work RVUs posted in dermatology, hematology/oncology, and family medicine (without OB).
“The growth in median total compensation for primary care physicians (PCPs) doubled from 2021 (2.13%) to 2022 (4.41%), but was outpaced by inflation at 7% and 6.5%, respectively.
“Surgical and nonsurgical specialists saw their change in median total compensation cool slightly in 2022, dropping from 3.89% for surgical specialists in 2021 to 2.54% in 2022, and from 3.12% for nonsurgical physicians in 2021 to 2.36% in 2022.
“APPs [advanced practice providers]— who saw the biggest change in median total compensation from pre-pandemic levels — saw their 2022 growth ebb slightly to 3.70%, down from 3.98% growth in 2021.”
“There are 293 rural hospitals at immediate risk of closure due to inflation, staffing shortages and other financial stress, according to the Center for Healthcare Quality & Payment Reform.
“Hospitals at immediate risk of closure have lost money on patient services for multiple years, excluding 2020 during the pandemic, and aren’t likely to receive sufficient funds to cover the losses with public assistance ending, according to the report. These hospitals also have low reserves and more debt than assets.”
“The pandemic prompted a great need for technology-enabled care delivery, so the regulations surrounding reimbursement for these services were tossed out the window in 2020. Now that the public health emergency has ended, the healthcare industry has to figure out how it is going to pay for digital health services going forward.
“It’s clear that services like telehealth and remote patient monitoring have potential to provide value, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce, panelists argued during a Wednesday session at MedCity News’ INVEST conference in Chicago.”
STAT News adds market perspective on the Food and Drug Administration’s full approval of Paxlovid, announced yesterday.
“The full approval for treating adults at high risk of progression to severe disease will help Pfizer expand its marketing campaign. U.S. officials plan to work through much of the government’s Paxlovid inventory, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug. Pfizer has sold the U.S. government nearly 24 million courses at around $530 a course, but it is not clear yet what price the company will charge.”
“Integrating Immunization Information Systems (IIS) vaccination records into claims data (collected by health insurers) increased the number of people identified as being vaccinated against COVID-19, according to the results of a study published in JAMA Network Open. Having accurate COVID-19 vaccination data is important for future COVID-19 vaccine studies that capture efficacy and safety, according to the study.
“When claims data were supplemented with IIS vaccination records, the proportion of participants with at least one vaccine dose rose from 32.8% to 48.1%. And when IIS vaccine records were included with claims data, the percentage of people who completed a vaccine series increased from 24.4% to 41.9%, varying by state.”
The Food and Drug Administration is looking to develop standardized “supersets of data” and improve data interoperability, analysis and management across the agency, an official said on Wednesday.
The agency is planning to gather information and seek public input on the use of real-world data in its decision-making processes, according to Jose Galvez, deputy director for the office of strategic programs of the FDA’s Center for Drug Evaluation and Research.
Galvez said at the Professional Services Council 2023 FedHealth Summit that the FDA is set to release a Federal Register notice “very shortly” to gain industry input on evaluating new types of data analysis.
“Top White House officials and Republican lawmakers were closing in on Thursday on a deal that would raise the debt limit for two years while capping federal spending on everything but the military and veterans for the same period. Officials were racing to cement an agreement in time to avert a federal default that is projected in just one week.
“The deal taking shape would allow Republicans to say that they were reducing some federal spending — even as spending on the military and veterans’ programs would continue to grow — and allow Democrats to say they had spared most domestic programs from significant cuts.
“Negotiators from both sides were talking into the evening and beginning to draft legislative text, though some details remained in flux.”
“The Treasury Department is preparing to change how the U.S. processes federal agencies’ payments if the debt ceiling is breached, dusting off a contingency plan crafted after the 2011 borrowing-limit standoff, people familiar with the matter said.
“Just days away from becoming unable to pay all of the government’s bills on time unless Congress raises the debt limit, Treasury officials have been quietly laying the groundwork for potentially delaying some payments after June 1.
“Under the backup plan created for a debt-limit breach, federal agencies would submit payments to the Treasury Department no sooner than the day before they are due, the people familiar with the talks said. That would represent a change from the current system, in which agencies may submit payment files well before their due dates. The Treasury Department processes them on a rolling basis, often ahead of the deadlines. Some payments are already sent to the department one day early, one person said.
“The plan would enable the Treasury to make daily decisions about whether it can pay all of the government’s bills the next day.”
“The [U.S.] House of Representatives passed legislation on Thursday that would make permanent harsh criminal penalties and strict controls on fentanyl-related drugs, with scores of Democrats joining nearly all Republicans in a vote that reflected the political challenges of tackling what both parties consider America’s most pressing drug crisis.
“The bill, approved by a vote of 289 to 133, would permanently list fentanyl-related drugs as Schedule I controlled substances, a designation that mandates severe prison sentences for highly addictive, nonmedicinal chemicals, and which is now set to expire at the end of 2024.
“The bipartisan vote reflected agreement among Republicans and a solid bloc of Democrats that stiffening penalties for fentanyl-related drugs is a necessary component of the federal response to the crisis. According to the Centers for Disease Control and Prevention, there were roughly 75,000 synthetic opioid overdose deaths in 2022, with fentanyl being a main culprit.”
“With many agencies’ return-to-office plans still uncertain, Republicans on the House Oversight and Accountability Committee want to take matters into their own hands.
“GOP committee leaders changed their strategy for trying to get more federal telework data, now reaching out directly to agency heads. In a series of 25 letters, the lawmakers asked for up-to-date numbers of teleworking federal employees, after saying the Biden administration was “not adequately tracking the specific levels of telework.”
“The Biden administration “has not provided current data about the specific amount of telework occurring within federal agencies or across the entire federal workforce. Furthermore, it has provided no objective evidence concerning the impact of elevated telework on agency performance — including any deleterious impacts,” lawmakers said in the letters, published May 18.”
From the Rx coverage front —
Today the Food and Drug Administration granted full marketing approval to Paxlovid, the Covid treatment pill, which in the FEHBlog’s opinion, brought us to the end of the pandemic. Here’s a link to a MedPage Today report on this FDA action
The Institute for Clinical and Economic Research released “a Final Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH).”
“Independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit —
“ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
“Payers should develop coverage criteria based on non-invasive testing to foster equitable access to early detection and treatment across diverse communities.
“Apellis Pharmaceuticals on Thursday became the latest drugmaker to give up on a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative disorder that has frustrated researchers for decades.
“The decision came after a Phase 2 trial showed no benefit for the drug, known as systemic pegcetacoplan, compared with a placebo. It failed to meet the primary endpoint, measured by a statistical tool called the Combined Assessment of Function and Survival, as well as secondary goals assessing overall function, survival, lung function and muscle strength.
“The final results weren’t a total surprise; an independent board monitoring the study had already advised the company not to start a second, “open-label” part of the trial that would have offered the medicine to all participants after the initial 52-week research period. Apellis executives had also signaled to analysts that the trial had a low chance of success.”
“Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant.
The study, published in JAMA, is coordinated through the NIH’s Researching COVID to Enhance Recovery initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward potential treatments for long COVID, which affects the health and well-being of millions of Americans.
The New York Times discusses the miraculous case of a paralyzed man who has begun to walk again thanks to brain and spine “implants that provided a “digital bridge” between his brain and his spinal cord, bypassing injured sections” of his body.
“Older Americans are increasingly likely to log into “patient portals” to access their health care information — but confidence levels vary.
“About 78% of people aged 50 to 80 now use at least one patient portal, according to the new University of Michigan (U-M) National Poll on Healthy Aging.
“Five years ago, just 51% in this age range used patient portals, the researchers said.
“The poll also found that 55% of those who used patient portals had done so in the past month. About 49% had accounts on more than one portal.
“This surge is partly due to the increase in use of telehealth visits, said Denise Anthony, the U-M School of Public Health professor who worked on the poll.
“This change makes access to secure portals even more important for older adults who want to see their doctors and other health care providers virtually. It also makes the disparities we found in our poll even more troubling,” Anthony said in a Michigan Medicine news release.
“Older adults with annual household incomes below $60,000, and those who were Black or Hispanic, had lower rates of portal use. These groups were also less likely to say they’re comfortable using a portal.”
“U.S. authorities have seized increasing quantities of illegal ketamine, according to new research, a trend that coincides with the psychedelic drug’s rising popularity as a treatment for mental health ailments.
“The number of ketamine seizures by federal, state and local law enforcement in the United States increased from 55 in 2017 to 247 in 2022, while the total weight increased by more than 1,000 percent over that time, according to a letter published Wednesday in JAMA Psychiatry. Most of the ketamine was in powder form, which could raise the risk of being adulterated with deadly drugs such as fentanyl.”
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