“The Centers for Medicare & Medicaid Services Oct. 6 reopened the No Surprises Act’s Independent Dispute Resolution [IDR] portal to out-of-network providers and group health plans initiating new single payment disputes under the No Surprises Act’s independent dispute resolution process, including single disputes involving bundled payment arrangements. The agency also released new guidance for processing these disputes.
“New and in-progress batched disputes and new air ambulance disputes remain temporarily suspended while the Departments of Health and Human Services, Labor and the Treasury update their guidance and operations to align with recent court orders, including an Aug. 24 ruling that set aside certain regulations implementing the IDR process and an Aug. 3 ruling that vacated nationwide a federal fee increase and batching rule for the process.”
In that regard, the federal regulators issued ACA FAQ 62 today, which focuses on No Surprises Act issues.
What’s more, a No Surprises Act IDR operations proposed rule is still undergoing review at OMB’s Office of Information and Regulatory Affairs.
“The National Institutes of Health on Thursday said it will provide funding for three clinical trials of experimental ALS drugs, part of a broader push by the federal government to support the development of treatments for rare neurodegenerative diseases. * * *
“Until recently, the FDA had approved just two main medicines for the disease. Clinical testing had shown the drugs respectively offered modest benefits on function and survival.
“But in the last year or so, two more treatment options received nods from the FDA. Amylyx Pharmaceuticals’ Relyvrio is now cleared for the broad ALS population, while Biogen’s Qalsody is specifically for the small portion of patients who have mutations in a gene called SOD1.”
“The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders. * * *
“FDA Center for Drug Evaluation and Research Substance Use and Behavioral Health deputy center director Marta Sokolowska said: “Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps.
“The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as the development of evidence-based treatments for stimulant use disorder.”
“The Office of Personnel Management’s retirement claims backlog saw some improvement in September. OPM cut its backlog by 2,111 claims, hitting a new six-year low point in its overall inventory. OPM received 6,768 claims in September, and managed to process 8,879, shrinking the backlog to the lowest it has been in six years: 15,852.”
“The U.S. Postal Service wants to raise the price of a stamp in what would be the third increase in a year.
“The postal service proposed a price of 68 cents, up 3% from the current price of 66 cents. If approved by the Postal Regulatory Commission, the price increase would go into effect on Jan. 21.
“The agency raised stamp prices to 63 cents from 60 centsin January 2023. Six months later, the price of a stamp went up again, by 3 cents.”
“Around 4 million Americans received the updated COVID-19 shots in September, according to the U.S. Department of Health and Human Services (HHS), even as some people have found it difficult to book vaccination appointments or find the vaccines at no cost.”
“The brief report is the first study of its kind, the researchers say, to establish a link between the use of such drugs, called GLP-1 agonists, for weight loss and the risk of such gastrointestinal conditions. GLP-1 agonists include semaglutide — the drug found in Ozempic and Wegovy — and liraglutide, the drug used in Saxenda. Both drugs are made by Novo Nordisk.
“Although rare, the incidence of these adverse events can happen. I’ve seen it happen,” said lead author Mohit Sodhi, a medical student at the University of British Columbia Faculty of Medicine in Vancouver. “People should know what they’re getting into.”
“World Mental Health Day is right around the corner and this year, there’s good news to share. The mental health of U.S. employees is finally on the rise nearly three years after the pandemic. A new study shared by Leapsome, a people enablement platform based in Germany, found that 88% of U.S. employees rate their mental health as being good or very good.
“The massive improvements in mental health took place largely over the past year, with 47% of U.S. workers reporting that their mental health had improved within the last 12 months, according to the study.”
“The grand plan for Moderna’s future in respiratory viruses is to market a single shot that would protect against Covid-19, influenza, and RSV, using the scalability of mRNA to craft a first-of-its-kind product. And the first step — establishing the promise of its combination flu and Covid vaccine — is moving on as planned.
“Yesterday Moderna said its combo shot measured up to established flu and Covid vaccines in generating immune responses against each virus. The next step is to take that combination to Phase 3, which could lead to approval by 2025. At the same time, Moderna is awaiting FDA approval for its RSV vaccine and testing a combination that would protect against all three viruses.”
“Amgen on Friday closed its $27.8 billion acquisition of Horizon Therapeutics, about one month after securing clearance from U.S. antitrust regulators who had challenged the deal.
“With the acquisition’s completion, Amgen gains access to 12 drugs that had combined sales of $1.8 billion over the first six months of 2023. The company said it will update its sales guidance for the rest of the year when it reports third-quarter earnings.
“The deal is the largest in Amgen’s history, surpassing in dollar terms the 2001 buyout of Immunex. That acquisition gave Amgen Enbrel, a long-lasting blockbuster that, like several of its other major drugs, could lose market exclusivity in the coming years. That looming patent cliff has pushed the company to restock its pipeline via dealmaking.”
“UnitedHealthcare’s Surest, which axes deductibles and provides upfront pricing data to members, is the fastest growing product among its commercial plan lineup. And a new analysis offers a look as to why.
“The insurance giant released Thursday an Impact Study examining some of the results Surest has seen to date and notes that members enrolled in these plans had 6% fewer emergency department visits and 13% fewer inpatient hospital admissions compared to those who were not enrolled in a Surest plan at the same employer.
“In addition, members enrolled in Surest plans had a 20% increase in visits to a physician and a 9% jump in preventive physical exams compared to those in other commercial plans.”
“Cigna’s Evernorth is launching a new, value-based care management program for its behavioral health network.
“The company said in an announcement that this marks a key step in collaboration with providers as the industry pushes for standardized benchmarks in behavioral health. About 44,000 providers will participate in the program at launch, according to Evernorth.
“Ultimately, if payers and providers align on how to measure success in treatment, it will drive better care, lower costs, and lead to improvements in collaboration. It should also ease administrative burdens for providers, according to the announcement, as at present they use a wide array of measures across multiple payers.”
The shortage of cancer drugs is not going away, but it may be easing slightly, a new national survey suggests. Based on questions posed to 29 of its 33 member hospitals, the National Comprehensive Cancer Network said Thursday that 86% of those cancer centers are experiencing a shortage of at least one type of generic chemotherapy drug, down from 90% in May.
One of the top health care committees in the Senate is assembling ideas for bipartisan legislation to address drug shortages, three Senate aides and three lobbyists told STAT.
The talks, led by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) are in the early days, but they could move the debate over drug shortage reforms into a new phase. The committee has jurisdiction over Medicare and Medicaid payment policies for hospitals. Other committees that have tried tackling the issue have jurisdiction mostly over the Food and Drug Administration.
Two law firms dive into regulatory issues that have puzzled the FEHBlog recently:
Miller and Chevalier makes the following observation about the recent federal court decision vacating an HHS rule permitting health plans to use manufacturer copay assistance accumulators. These accumulators prevent the manufacturer coupons from being counted toward out-of-pocket maximums.
“Following this ruling, it is unclear what rules will govern the use of co-pay accumulator programs. The prior agency rule, under which plans and issuers were allowed to exclude manufacturer co-pay assistance payments from deductible and out-of-pocket maximum calculations only if a generic drug was available and only to the extent permitted by state law, may be reinstated, but it suffers from the same issues that led the court to vacate the 2020 rule. The government may move for reconsideration of the court’s ruling or for a stay of the ruling, pending an appeal, and an appeal is expected. Further guidance from HHS and CMS is likely forthcoming in the interim. It should be noted that state laws prohibiting co-pay accumulator programs could be susceptible to ERISA pre-emption challenges, and the related guidance may spawn collateral litigation.”
Proskauer explains how the ACA regulators used FAQ 61 to “press play” on the Transparency in Coverage Rule’s Prescription Drug Machine-Readable File Requirement.
“Prescription drug machine-readable file: Having concluded that the prescription drug machine-readable file requirement is sufficiently different from the separate CAA prescription drug reporting obligation, the Departments rescinded their prior delayed enforcement policy. The Departments state they intend to release future technical guidance with an implementation timeline that “sufficiently accounts” for prior reliance by plan sponsors on the deferred enforcement policy, suggesting that plan sponsors may have some lead time to gather the necessary information to post the file.
“In-network rate machine-readable file: Going forward, the Departments state they intend to exercise enforcement discretion on a case-by-case basis with respect to the requirement that in-network rates be expressed as dollar amounts for items and services covered by arrangements that make it difficult to express the cost as a dollar amount prior to receipt of the item or service. Because the Departments do not mention future guidance or an implementation guideline, it appears that the revocation of this enforcement safe harbor is immediate.”
The Congressional Budget Office issued a call for new research in the area of obesity. In this regard, the Wall Street Journal observes
“Big food companies and investors are watching as Ozempic and other similar weight-loss drugs flow to millions of people, upending America’s diet industry and raising new questions about how consumers will eat.
“Executives at food manufacturers from Campbell Soup to Conagra Brands said they are fielding questions from investors about the drugs’ potential impact as internal teams start to assess consumer behavior and brainstorm ways to respond.
“The drugs, which suppress patients’ appetites, have exploded in popularity in the U.S., straining manufacturing capacity.
“Morgan Stanley has projected that 24 million people, or nearly 7% of the U.S. population, will be taking such medications in 2035.
“Those people could cut their daily calorie consumption by as much as 30%, according to the firm, which surveyed over 300 patients. For a person on a 2,000-calorie diet, that could mean eliminating a one-ounce bag of salted potato chips, a bottle of soda and more each day.”
“The Office of Personnel Management on Wednesday reminded federal agencies of recent changes to how to monitor and collect data on the usage of workplace flexibilities like telework and remote work, as the Biden administration prepares to increase in-person work across the federal government this fall.”
“So-called “good” HDL cholesterol may not be as healthy as experts once thought, a new study suggests.
“The new study, published Wednesday in Neurology, found that having either high or low levels of high-density lipoprotein, or HDL, cholesterol, may increase the risk of dementia in older adults. It’s more evidence showing that keeping HDL cholesterol within a certain range is important for cardiovascular and brain health.
“The relationship between HDL cholesterol and dementia is more complex than we previously thought,” said the study’s lead author, Erin Ferguson, a doctoral student studying epidemiology at the University of California San Francisco. “While the magnitude of this relationship is relatively small, it’s important,”
“The results show a correlation between HDL cholesterol and dementia, but do not prove that low or high levels of the lipid directly caused dementia.”
“Using a host of high-tech tools to simulate brain development in a lab dish, Stanford University researchers have discovered several dozen genes that interfere with crucial steps in the process and may lead to autism, a spectrum of disorders that affects about one inevery 36 Americans, impairing their ability to communicate and interact with others.
“The results of a decade of work, the findings published in the journal Nature may one day pave the way for scientists to design treatments that allow these phases of brain development to proceed unimpaired.”
“Mortality rates among women and children grew between 2018 and 2021, emphasizing the importance of prioritizing preventive care and public health interventions, a report from the United Health Foundation shared.
“The America’s Health Rankings 2023 Women and Children Report analyzed data on 122 healthcare measures from 34 data sources. The findings reflect outcomes among women between 18 and 44 and children across the United States.”
“Froedtert Health plans to acquire full ownership of insurer Network Health from Ascension Wisconsin, the Milwaukee-based health system announced Tuesday.
“The system agreed to buy the remaining 50% stake in the payer, which offers commercial and Medicare plans in 23 counties throughout the state, from Ascension Wisconsin. Froedtert originally acquired its stake in the company in 2014.
“Terms of the deal weren’t disclosed, and the health systems said a closing date will be determined after regulatory review and approval.”
and
“U.S.-based digital health startups raised $2.5 billion across 119 deals in the third quarter this year, marking the second-lowest quarter of funding since the fourth quarter in 2019, according to a report by consultancy and venture capital firm Rock Health. “Digital health startups have raised $8.6 billion in 365 deals so far this year, a little more than half of 2022’s total. The results cement a move toward decreased funding compared with pandemic boom years, the report found. “While funding and deal count has fallen significantly, trends have now stabilized for several quarters in a new normal for the digital health sector
“Several prominent Republicans jumped into the race for House speaker and pledged to unite their splintered party, a day after Kevin McCarthy was ousted in a vote orchestrated by hard-line conservatives, setting up a crowded race for the gavel.
“House Majority Leader Steve Scalise, the No. 2 House Republican, announced his candidacy, as did Ohio Rep. Jim Jordan, chairman of the House Judiciary Committee and a founding member of the conservative House Freedom Caucus. A third member, Oklahoma Rep. Kevin Hern, told the Texas delegation that he planned to run as well as he laid the groundwork for a campaign.
“The House is effectively paralyzed until it picks a new speaker, raising the stakes for a successful vote next week. Members are hoping to avoid a replay of the 15 rounds of ballots in January to elect McCarthy. Major legislative fights, including Ukraine aid and border security, remain unresolved, and the next speaker will control the floor on both of those hot-button issues as well as a spending showdown with Democrats in mid-November.”
The Assistant Secretary of Labor for Employee Benefits Security created a blog post on mental health parity.
“We’re proposing new regulations, committing unprecedented resources to bringing plans into compliance with the law, and reaching out to communities across the United States to ensure that more of America’s workers and families understand their rights and are better able to exercise them, including by contacting us for help when they need it.
“We are determined to make sure these workers and beneficiaries get their due. For example, our enforcement program has required plans to address discriminatory practices by:
“eliminating blanket pre-authorization requirements for mental health benefits;
“ensuring comparable coverage of nutrition counseling for people with eating disorders applied behavioral analysis therapy to treat autism, and medication-assisted treatment for opioid use disorders, and
“eliminating special gatekeepers for mental health and substance use disorder treatment.
The FEHBlog is on board with mental health parity. However, he would prefer a proposed rule that sets forth clear requirements like the ones stated above rather than a convoluted process for confirming parity status.
“In an effort to expand new personnel vetting procedures well beyond national security positions, agencies will soon have to begin implementing “continuous vetting” requirements for a larger subset of the federal workforce.
“The Office of Personnel Management is now directing agencies to ramp up preparations to start continuous vetting (CV) procedures for employees in “non-sensitive public trust positions,” beginning in fiscal 2024.
“OPM defines this section of the workforce as positions in both high and moderate risk levels. These include jobs involving, for instance, policymaking, public safety and health, law enforcement, fiduciary responsibilities or “other duties demanding a significant degree of public trust,” OPM said.”
From the FEHB front,
Govexec offers a closer look at 2024 FEHB premiums.
The FEHBlog has noticed that GEHA and the National Association of Letter Carriers, among other popular FEHB plans, have posted information about their 2024 FEHB benefit offerings.
“Moderna on Wednesday announced what it described as positive data from an early-stage study of its experimental messenger RNA-based combination vaccine for COVID-19 and influenza.
“Moderna said the vaccine spurred similar or stronger immune responses against all four influenza strains compared to one of two flu vaccines and to its Spikevax COVID booster in older adults. Most side effects were mild in severity, the company said.
“The company plans to begin a Phase 3 study of the vaccine candidate later this year, and is targeting regulatory approval in 2025.”
“The Hermitage, Pennsylvania resident has vasculitis, a genetic disease that inflames the blood vessels and stops blood from flowing to the legs. She had already lost her left leg below the knee after a sunburn on the tip of her toe got progressively worse. She was determined to keep her right one. * * *
“She went to Mehdi Shishehbor, an interventional cardiologist at University Hospitals in Cleveland, for help. Traditional surgical methods had failed to save her left leg, so he offered her an investigational treatment from a company called LimFlow. The device employed an old surgical technique: using a stent to connect the blocked artery to an open vein, thus allowing blood to flow through and heal injuries. Previously, that type of surgery was risky and invasive, as it involved cutting a patient’s leg open. LimFlow allows doctors to perform the surgery percutaneously via a catheter inserted in the bottom of the foot.
“The procedure, performed around three years ago, ultimately saved Elford’s leg. LimFlow hopes to save many more after the Food and Drug Administration approved its device last month. * * *
“It’s a tool in the fight to end the amputation epidemic, which disproportionately impacts Black patients — though experts cautioned to STAT that this is limited to a small subset of people with PAD and that expanding screenings to catch the disease early is the most important measure. It’s also unclear whether the most vulnerable patients will be able to access this procedure and whether it will be able to help patients retain legs in the long-term.”
From the U.S. healthcare business front,
BioPharma Dive reports,
“Eli Lilly’s diabetes division head, Mike Mason, will retire at the end of 2023 after four years in the position. The company veteran will be replaced by immunology chief Patrik Jonsson in one of several executive changes the Indianapolis-based drugmaker announced Wednesday.
“The shake-ups, which also affect leadership in research, corporate affairs and customer service, come as Lilly’s newest diabetes drug, Mounjaro, is set for rapid growth with an expected Food and Drug Administration approval as a weight loss treatment.”
Per the American Hospital Association News,
“Median operating margins for nonprofit hospitals declined to 0.2% in fiscal year 2022 as labor costs and staffing shortages drive a “labordemic” expected to persist into 2024, according to the latest Fitch Ratings report, adding to a growing body of evidence that describes hospitals’ rocky recovery.”
“Efforts to pass a stopgap funding measure before Saturday night’s deadline were sputtering in both chambers Friday, with lawmakers openly predicting a partial government shutdown was inevitable. The only question appeared to be how long the funding lapse would last.”Efforts to pass a stopgap funding measure before Saturday night’s deadline were sputtering in both chambers Friday, with lawmakers openly predicting a partial government shutdown was inevitable. The only question appeared to be how long the funding lapse would last.
“Border security talks in the Senate stalled Friday ahead of a key procedural vote Saturday, casting doubt on whether there would be the required 60 votes to end debate on a seven-week stopgap bill.
“Meanwhile, House Republicans huddled to discuss remaining options after their last shot at a 31-day continuing resolution chock full of spending cuts and restrictive border policies fell flat on the floor earlier Friday.
“None of the options — taking up a Senate bill that hasn’t even passed yet, or a “clean” CR extending current funding levels for a week or two, appeared to be gaining much steam, at least yet.”
“After a two-hour meeting with the Republican caucus, House Speaker Kevin McCarthy (R-Calif.) said he would support a clean continuing resolution without major funding cuts if it did not include either the $12 billion in Ukraine and disaster relief funding that has bipartisan Senate support or the border security legislation that House Republicans have demanded.”
Today, OPM issued a press release about 2024 FEHB premiums and a white paper with 2024 Open Season highlights. The highlights include a list of the plans terminating their participation in the FEHB for 2024. The Compass Rose Benefits Group added a standard option. The FEHBlog noticed that Blue Cross FEP and Kaiser Permanente have unveiled their 2024 FEHB benefits on their websites.
“OPM has said it will soon administer its Federal Employee Benefits Survey to some 100,000 federal employees who will be notified by email and will have up to six weeks to respond.
“The purpose of the FEBS is to measure the importance, adequacy and value of employee benefits to assess if employees believe the available benefits meet their needs. The FEBS will also help us to evaluate whether federal employees understand the flexibilities and benefits available to them,” OPM said in a memo to agencies on chcoc.gov.”
“A proposed rule issued on Friday by the Food and Drug Administration would bring laboratory-developed tests under the agency’s purview, closing a regulatory loophole.
“Laboratory-developed tests are designed, manufactured and used within a single clinical laboratory. The FDA has exempted these tests from some regulatory requirements, such as premarket review, but it now seeks to bring all tests under one regulatory framework.
“The agency said the changes should better protect public health by ensuring the safety and effectiveness of tests. But it is “unclear if and when the FDA will finalize the rule as it will likely face opposition,” analysts with TD Cowen wrote in a research note on Friday.”
“The Center for Medicare and Medicaid Innovation, which aims to reduce spending or improve quality of care, increased net federal spending during its first 10 years of operation, and it will likely continue to boost spending over its next decade, according to a report by the Congressional Budget Office.
“The CBO estimated that CMMI’s activities increased direct spending by $5.4 billion, or about 0.1% of the net spending on Medicare, between 2011 and 2020.
“CMMI’s work is projected to increase net federal spending by $1.3 billion, or 0.01% of net spending on Medicare from 2021 to 2030, according to the report.”
The IRS posted draft instructions and forms of 1095-B and 1095-C forms for 2023
HHS requests comments on mandating health plan coverage with no-cost sharing and no prescription requirements for low-cost preventive supplies, most of which OPM already mandates for FEHBP. The public comment period will likely expand the list. The public comment deadline will be in early December.
From the public health and medical research fronts,
“granting de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.”
“Shares in Structure Therapeutics jumped Friday after the San Francisco-based biotechnology company released results from a small study of an experimental weight loss drug that appear competitive to rival programs from Eli Lilly and Pfizer.
“Over the 28-day Phase 1 trial, people taking the highest doses of Structure’s drug lost about 5% of their weight compared to the study’s start, up to around 10 pounds. There were side effects, most commonly mild nausea and vomiting, but no participants stopped treatment as a result, the company said.
“Dubbed GSBR-1290, Structure’s drug is a GLP-1 agonist, similar to the much in-demand diabetes and obesity medicines Ozempic and Wegovy. Unlike those, however, GSBR-1290 is taken orally rather than by injection, potentially meaning greater convenience.”
“A cancer drug combination developed by Johnson & Johnson succeeded in an important late-stage trial testing the new regimen against a widely used medicine from AstraZeneca.
“According to J&J, treatment with its approved drug Rybrevant and an experimental therapy called lazertinib kept a common type of metastatic lung tumor at bay for longer than AstraZeneca’s Tagrisso alone. The results were from an interim analysis of the study, which is continuing to study patient survival.
“J&J’s trial, called Mariposa, has been followed closely by analysts as it could offer J&J a chance to compete with AstraZeneca in a large cancer drug market. J&J didn’t share any specific data in its statement Thursday, but said it plans to submit the study results for presentation at an upcoming medical conference.”
“Transport accidents are the leading cause of death for most children while opioids and major cardiovascular disease are the most common leading cause of death for adults, according to a report from USA Facts, a nonprofit organization that conducts data analysis.
“The “America in Facts 2023″ report, published in September, used CDC data to calculate the leading causes of death by age for the time periods 2001 to 2002 and 2020 to 2021.”
From the Econtalk Podcast
“We spend too much of our health care focus on lifespan and not enough on healthspan–the quality of our life as we get older. So argues Dr. Peter Attia, author of Outlive: The Science and Art of Longevity. Attia speaks with EconTalk’s Russ Roberts about what kills us, what slows us down as we age, and the weapons we have to allow us to live better and longer.”
“A federal judge on Friday denied business groups’ move to halt Medicare’s new drug price negotiation program while multiple lawsuits challenging its constitutionality wind through the courts.
“The decision by Judge Michael J. Newman, a Trump appointee, in Ohio’s Southern District preserves the Biden administration’s power to begin haggling with drug companies over the prices of 10 medications. Manufacturers of products that CMS chose for the first tranche of negotiations have until Oct. 1 to agree to the talks.
“The Court is not convinced that granting Plaintiffs preliminary injunctive relief will protect them from imminent and irreparable harm,” Newman wrote in his opinion. “Any economic harm — which, on its own, is insufficient to satisfy this prong of a preliminary injunction analysis — will not occur for years in the future.” * * *
“Newman denied DOJ’s motion to dismiss to give the chambers the chance to address his concerns, though the government can refile.”
“Speaking to reporters on Thursday morning, McCarthy said concerns among both Democrats and Republicans about the pace of migrants crossing the U.S.-Mexican border could provide enough common ground for them to work out a short-term deal to keep the government open past Sept. 30, when the fiscal year ends.
“He said he had spoken with some Democratic senators about border enforcement as recently as Thursday morning.“They want something on the border. They’re working on it,” he said of Democrat senators. “And so I think there’s an opportunity here. We know we have to keep the government funded. We know we have a concern about the border—both sides.” Asked directly by a reporter if he expects a shutdown, McCarthy said: “No, I’m saying we work through this and get it done.”
Following a Senate Finance Committee markup hearing in July, where members voted 26-1 in favor of the Modernizing and Ensuring PBM Accountability (MEPA) Act, Senators Ron Wyden, D-Oregon, and Mike Crapo, R-Idaho, formally introduced the bill on Thursday.
Designed to curb the power of pharmacy benefit managers, the bill would prohibit PBM compensation in Medicare from being tied to the price, increase audit and enforcement measures and aid independent community pharmacies that have struggled because of PBM practices, according to a news release.
Following reports of some patients having difficulties accessing new COVID-19 boosters without cost sharing, Alliance of Community Health Plans, Association for Community Affiliated Plans, AHIP, and Blue Cross Blue Shield Association came together in a letter to Xavier Becerra, Secretary of the Department of Health & Human Services, to reiterate their commitment to providing access, swiftly addressing any challenges, and continuing to partner with HHS and others across the health care system.”
Good to hear.
STAT News offers six approaches to resolving the drug shortages confronting our country.
“A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval.
“After a day-long meeting that included impassioned testimony from ALS patients, the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence.”
“The label for Novo Nordisk’s weight loss drug Ozempic now acknowledges some users’ reports of ileus or intestinal blockage.
“In its update, however, the FDA said it’s difficult to confirm a causal relationship between the side effect and the drug.
“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label says.
“Wegovy and Mounjaro, also GLP-1 agonist medications, already acknowledge reports of ileus on their labels. Novo Nordisk is the maker of both Ozempic and Wegovy, which both use an injection of semaglutide.”
The Affordable Care Act regulators released ACA FAQ 61, which updates interested parties on transparency in coverage and RxDc reporting issues.
The U.S. Office of Personnel Management announced “issuing an interim final rule today to extend the eligibility date for noncompetitive appointment of military spouses married to a member of the armed forces on active duty through December 31, 2028, as called for by enactment of the Fiscal Year (FY) 2023 National Defense Authorization Act (NDAA) (P.L. 117-263).”
“[A 36-year-old woman living in San Francisco was told her kidneys would heal. But they didn’t; dialysis became a regular routine. She moved to UCSF Medical Center, seeking better care and a place that would allow her parents to visit. There, she met Chi-yuan Hsu, UCSF’s chief of nephrology, who was looking to study patients who might be successfully weaned from dialysis. He believed many patients with acute kidney injury like Lawson stayed on dialysis for longer than they needed.
“The results of a new study by Hsu, published Thursday in the Journal of the American Society of Nephrology, validate his suspicions. The study of nearly 8,000 patients, nearly 2,000 with acute kidney injury, found 40% of patients with acute kidney injury recovered their kidney function. But of these patients, just 18% were weaned from dialysis through having fewer sessions, and 9% by having shorter sessions.
“More than 70% of these patients ended up eventually stopping dialysis without any weaning — “cold turkey” as Hsu puts it — suggesting they could have been having fewer, or shorter treatments earlier. This is important, he said, because dialysis not only impacts quality of life, as it did for Lawson, it can also lead to infection and heart damage, and possibly — this is still under debate — to additional kidney injury that could inhibit recovery and lead to a need for permanent dialysis.”
Health Leaders Media explains how to address the relationship between patient safety and health equity.
Employee Benefit News points out the need for mental health benefits to cover suicide prevention.
From the U.S. healthcare business front,
Forbes reports that CVS, Walgreens And Rite Aid are closing nearly 1,500 stores across the U.S.
“All three drug chains have different reasons for closing stores, but the downsizing prescription is the same. Chain drugstores cost a lot to operate, and they don’t have sufficient differentiation to attract customers feeling the economic pinch.”
Ophthalmologists who accepted payments from drug companies were less likely to prescribe a cheaper medicine to treat an eye disease that causes blindness in older people, rather than a pair of more expensive alternatives, according to a new study. This led Medicare to spend an additional $643 million during a recent six-year period.
Specifically, physicians who received money prescribed Avastin, an older cancer medicine, 28% of the time for combating age-related macular degeneration. And they prescribed two costlier treatments, which have approved specifically to treat the eye disease, 72% of the time. Physicians who did not accept payments prescribed Avastin 46% of the time, nearly twice as often as those who accepted payments.
“As a result, Medicare shelled out an estimated $642.8 million from 2013 to 2019, presumably due to the company payments, according to the study, which was published in JAMA Health Forum. The researchers examined Medicare Part B data that encompassed nearly 21,600 ophthalmologists who accepted money from Roche and Regeneron Pharmaceuticals, which sell the pricier eye treatments.”
“Members of Generation Y, who were born between 1977 and 1994, and Generation Z, born between 1995 and 2004, report a satisfaction score of 714 out of 1,000. But Baby Boomers, born between 1946 and and 1964, and people born earlier had a significantly lower score of 671.
“The satisfaction gap between older and younger generations is widest when it comes to digital channels and appointment scheduling, which could mean older users are struggling to use telehealth providers’ digital interfaces, the study argues.”
“Medicare Advantage provides health coverage to more than half of the nation’s seniors, but a growing number of hospitals and health systems nationwide are pushing back and dropping the private plans altogether.
“Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers. Some systems have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.
“It’s become a game of delay, deny and not pay,” Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s. “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed.”
“In late September, Scripps began notifying patients that it is terminating Medicare Advantage contracts for its integrated medical groups, a move that will affect more than 30,000 seniors in the region. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners.”
interviews an Aetna executive about successful value based care.
The Wall Street Journal reports about employer groups that are successfully advocating for lower hospital prices in their states. The flagbearer is Gloria Sachdev, who is chief executive officer of the Employers’ Forum of Indiana. Good luck.
Here are the highlights from the related Federal News Network article:
“Starting in January, federal employees and retirees will pay an average of 7.7% more toward their health premiums, according to data the Office of Personnel Management released Wednesday. * * *
“The government will contribute 5% more toward FEHB premiums in 2024.”
The government contribution is 72% of the enrollment weighted average premium capped at 75% of the selected plan’s premium per 5 U.S.C. Sec. 8906.
OPM always emphasizes that the average increase can be lowered by enrollees selecting lower-priced plans during the Open Season, which runs from November 13 to December 11, 2023.
This is the last Open Season before the Postal Service Health Service Health Benefits Program launches on January 1, 2025/
The surprising number to the FEHBlog is the following:
“FEHB participants will see a total of 159 plan options in 2024, offered across 69 health carriers. That’s far fewer than this year’s total of 271 plan options.
“The roughly 41% decrease in plan options is mainly due to the exit of health carrier Humana from the FEHB program. Humana is exiting the program over the next two years.”
OPM also posted 2024 FEDVIP premiums today. Per Federal News Network, “Premiums will rise for FEDVIP dental plans by 1.4% on average, while vision plans will go up by 1.1%, OPM said.”
Here are links to the Govexec and Federal Times articles on this OPM announcement.
The Department of Health and Human Services provided a readout from HHS Secretary Xavier Becerra’s meeting with national health insurance leaders about the current Covid vaccine campaign.
“House Speaker Kevin McCarthy (R., Calif.) rebuffed a bipartisan short-term funding bill from the Senate in favor of a House Republican plan driven by conservatives, as dim prospects for a deal raised the likelihood of a partial government shutdown starting this weekend.
“Many lawmakers now anticipate that Congress will fail to fund the government past Sept. 30, a lapse that will partially close federal agencies and temporarily withhold pay for federal workers and active duty-military personnel.”
From the public health front,
Here is a link to the National Cancer Institute’s latest bulletin of research highlights.
The National Institutes of Health informs us about its decision to fund
“a first-of-its-kind community-led research program to study ways to address the underlying structural factors within communities that affect health, such as access to safe spaces, healthy food, employment opportunities, transportation, and quality health care. Through the NIH Common Fund Community Partnerships to Advance Science for Society (ComPASS) program, NIH made 26 awards to community organizations and a coordinating center, totaling approximately $171 million over five years, pending the availability of funds. Through these awards, ComPASS will enable research into sustainable solutions that promote health equity to create lasting change in communities across the nation.”
“Yet another retailer is making moves in healthcare. This time it’s Costco, which announced Monday that it is partnering with virtual health marketplace Sesameto provide Costco members with discount pricing for medical care. But its move is a little different from other retailers like Walgreens and CVS Health, one expert said.
“Sesame’s platform provides access to thousands of independent clinicians across all 50 states. Through the partnership, Costco members will have access to $29 per virtual primary care visit and $79 per virtual mental health therapy visit. They’ll also have access to health checkups — which include a standard lab panel and a virtual follow-up consultation — for $72. In addition, they’ll receive 10% off on other Sesame services, including in-person care. Sesame’s usual prices (for those accessing the company outside of Costco) vary, but a primary care visit can often be around $45, said Michael Botta, co-founder and president of Sesame.
“Sesame does not accept insurance, so all of the services are offered via cash pay, meaning the partnership will mostly benefit patients who are uninsured or enrolled in high-deductible health plans.”
Amazon announced this week that it would invest up to $4 billion in artificial intelligence company Anthropic as the AI arms race heats up.
The two companies are forming a strategic collaboration to advance generative AI, and the startup selected AWS as its primary cloud provider. Along with the hefty investment, Amazon also took minority ownership in the two-year-old start-up.
“As new primary care models, including retail health clinics, continue to scale, the national supply of clinical providers will become even more constrained. For health systems, hospitals and medical groups, competition for the shrinking pool of nurses and doctors will intensify, according to a new analysis.
“Patients have more choices than before with the increasing supply of new entrants like CVS, Amazon and Walmart, and this is also leading to care becoming more fragmented and disintermediated from the traditional care journey, said Sanjula Jain, Ph.D., chief research officer and senior vice president of market strategy at healthcare analytics company Trilliant Health.
“Patient panel sizes for new primary care entrants—like Walgreens’ VillageMD, CVS’ Oak Street Health and Amazon’s One Medical —average 584 patients per provider, which is far lower than the current patient-to-provider ratio of 944. These ratios suggest that the U.S. would need an additional 218,000 primary care providers to meet the needs of every American under the new entrant primary care model, according to Trilliant Health’s “2023 Trends Shaping the Health Economy” report.”
“Centene is laying off 2,000 employees — a little over 3% of its workforce — as the health insurer struggles with headwinds from Medicaid redeterminations and Medicare Advantage star ratings.
“The layoffs were confirmed to Healthcare Dive by a company spokesperson. Centene has recently sold off assets, including AI platform Apixio and UK
The FEHBlog failed to hit publish last night, so Thursday Miscellany was not emailed Friday morning. To correct the problem, Friday Factoids will follow Thursday September 21’s post. Lo siento
“Faced with the House stalemate over a government stopgap funding bill, Senate Majority Leader Chuck Schumer (D-N.Y.) on Thursday set up a path for the Senate to move first on a bill to fund the government beyond Sept. 30.
“Schumer filed cloture on a motion to proceed to H.R. 3935, the House-passed bill to reauthorize the Federal Aviation Administration (FAA), which could serve as a legislative vehicle to pass a continuing resolution to fund the government through the Senate. * * *
“Senators will spend next week debating and voting on the legislation in hopes of sending it to the House by Wednesday or Thursday of next week.”
“The [new] plan [from the House of Representatives] is to ready more of the chamber’s 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a firm negotiating position for talks with the bigger-spending Senate.”
Yesterday, the Affordable Care Act regulators extended the public comment deadline for the proposed mental health parity rule revisions from October 2 to October 17, 2023.
Today, the Centers for Medicare and Medicaid Services posted a new announcement on its No Surprises Act website:
“Effective September 21, 2023, the Departments have directed certified IDR entities to resume processing all single and bundled disputes already submitted to the IDR portal and assigned to a certified IDR entity. The ability to initiate new disputes involving air ambulance items or services as well as batched disputes for air ambulance and non-air ambulance items and services is currently unavailable. IDR portal functionalities related to previously initiated batched disputes are also unavailable. Disputing parties should continue to engage in open negotiation according to the required timeframes.”
CMS also updated its website with No Surprises Act rules and fact sheets.
“The FWCI competencies provide a common language for 214 occupational series. OPM has published 80 occupation-specific competency models representing work governmentwide that may be used for selection, evaluation, and training activities. The FWCI is a resource for agencies to leverage in their skills-based hiring practices.
“OPM will continue to support agencies and collect critical data that strengthens our workforce and enables us to deliver services for the American people,” said OPM Director Kiran Ahuja. “This update to the Federal Workforce Competency Initiative will help agencies hire the talent they need and expand opportunities for positions that do not require certain degrees.”
The Equal Employment Opportunity Commission posted its new strategic enforcement plan for 2024 through 2028.
From the public health front,
The American Medical Association identifies eight things doctors wish their patients knew about the flu shot.
“Poor oral hygiene is associated with an increased risk for myriad health problems, including heart disease, diabetes, cancer, rheumatoid arthritis and early death. The state of our teeth and gums, though, may be vital for our well-being beyond the mouth and body.
“Emerging evidence suggests that what goes on in our mouth can affect what goes on in our brain — and may even potentially affect our risk for dementia.
“People should really be aware that oral health is really important,” said Anita Visser, professor in geriatric dentistry at the University of Groningen in the Netherlands.”
“A recent CVS Health®/Harris Poll survey of Americans 18 years and older found that nearly one in five (18%) U.S. adults say they were plagued with suicidal thoughts in the past year.
“Other key findings from the survey include:
“More than a third of younger adults aged 18-34 (36%) say they had moments in the past year where they contemplated suicide.
“An overwhelming nine in ten (89%) U.S. adults deem suicide prevention efforts a major priority in our society.
“However, less than a third (32%) strongly agree they can recognize the warning signs of someone potentially at risk, and only four in ten (43%) are strongly aware of resources that offer support and information on suicide prevention.
“Nearly eight in ten (77%) U.S. adults believe healthcare providers have a crucial role in suicide prevention, and there is an opportunity for providers to have more discussions about suicide with patients.”
“The Federal Trade Commission is suing anesthesia provider U.S. Anesthesia Partners and private equity firm Welsh, Carson, Anderson and Stowe, alleging the two colluded to consolidate anesthesiology practices in Texas, driving up prices to boost their profits.
“Welsh Carson created USAP in 2012 before acquiring over a dozen anesthesia providers over the next decade to create a single dominant provider in the state, regulators allege. The PE firm and USAP also made price-setting agreements with independent anesthesiology practices while sidelining a potential competitor by striking a deal to keep them out of USAP’s market, the FTC said.
“The complaint filed Thursday in federal district court says the actions have cost Texans “tens of millions of dollars” more each year in anesthesiology services.”
MedCity News offers insights on value-based care from an executive at the HealthPartners HMO in Minnesota. “The commercial market has struggled to adopt value-based care, but HealthPartners has had some success, according to Mark Hansberry, senior vice president and chief marketing officer of the company. During a conference, he shared five rules for scaling value-based care, including creating trust and providing real-time data.”
“Nearly 1,900 U.S. physicians have applied to become certified in obesity medicine — a record number — according to data from the American Board of Obesity Medicine.
“In October, 1,889 physicians will take the exam to become certified in the specialty area. That’s up from 1,001 exam candidates in 2020, marking an 88.7 percent jump. Physicians’ growing interest in the certification comes amid booming patient demand for GLP-1 receptor agonist drugs such as Ozempic and Wegovy. As of August, 2023, sales for Ozempic in the U.S. topped $3 billion.
“More than 6,700 physicians are certified in obesity medicine, a certification that first became available in 2012. For the upcoming exam in October, 38 percent of exam candidates are internal medicine physicians and 30 percent family medicine. To sit for the exam, physicians must have completed a minimum of 60 continuing medical education credits on the topic of obesity.”
The FEHBlog notes that if you build it, they will come.
Fierce Healthcare looks inside Walgreens’ pharmacy and primary care model.
“Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal.
“The Food and Drug Administration inspected the Clayton, N.C., plant in July and issued a report saying that Novo Nordisk had failed to investigate the cause thoroughly and that the plant’s microbial controls were deficient.
“The plant makes the drug ingredient semaglutide, which is used in the diabetes pill Rybelsus. Semaglutide is also the main ingredient in Novo Nordisk’s popular injections Ozempic and Wegovy, but the company said the semaglutide for those products isn’t made at the same plant.
“The Danish company said the Clayton plant is still running and producing for the market and wouldn’t share details of its interactions with the FDA.
“The agency said Thursday that based on Novo’s responses to its inspection findings, the FDA isn’t aware of ongoing compliance issues that raise any concerns about the quality of drugs made at the plant.”
“A bipartisan bill led by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to improve access to lifesaving organ donations became law today. The Securing the U.S. Organ Procurement and Transplantation Network Act will improve the management of the U.S. organ donation system by breaking up the contract for the Organ Procurement and Transplantation Network (OPTN) and encouraging participation from competent and transparent contractors. U.S. Sens. Ben Cardin (D-Md.), Todd Young (R-Ind.) and Bill Cassidy (R-La.) are original cosponsors of the legislation.”
“The lawmakers’ novel approach would aim to ensure Congress completes its work on all 12 appropriations bills needed to fund the government, without the threat of a shutdown that would furlough hundreds of thousands of federal workers and leave government contractors unpaid. Major government functions will stop on Oct. 1 at 12:01 a.m. unless Congress acts.
“The bill, co-sponsored by Sens. James Lankford (R., Okla.) and Maggie Hassan (D., N.H.), would set in motion 14-day continuing resolutions, which keep the government funded at the prior year’s levels, while Congress works exclusively on passing appropriations bills.”
“The threat of a massive tax is enough to push drugmakers such as Boehringer Ingelheim Pharmaceuticals, Inc. and Novartis AG to comply with the Biden administration’s landmark drug pricing law and negotiate with Medicare.
“Companies who manufacture the first 10 drugs selected to negotiate prices with Medicare have until Oct. 1 to officially agree to enter price talks. Under the Inflation Reduction Act, those who refuse to comply with the negotiations must pay a tax starting at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.”
That’s a lot of leverage.
The Consumer Financial Protection Bureau has “announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals under consideration that would help families financially recover from medical crises, stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often plagued with inaccuracies and mistakes.” In the FEHBlog’s view, this approach is bound to backfire as lenders lose faith in credit reports.
From the public health and medical research front,
“Nearly half of U.S. states had an adult obesity prevalence at or above 35% in 2022, according to CDC.
“The 22 states that met this mark — a small jump from the 19 states just the year prior — included Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin.”
By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks gestation to prevent lower respiratory tract RSV infection in infants.
After decades without an option for protecting most infants against the annual respiratory scourge, providers now have two options: the maternal vaccine and the monoclonal antibody nirsevimab (Beyfortus), which the ACIP last month recommended for all infants younger than 8 months born during or entering their first RSV season.
STAT News adds, “The recommendation was accepted by CDC Director Mandy Cohen shortly after the conclusion of the panel’s meeting.”
“A new cancer drug developed by Daiichi Sankyo and AstraZeneca met one of its two main goals in a breast cancer trial, helping patients who had progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, the companies said Friday.
“The trial tested the drug, known as datopotamab deruxtecan, in HER2-low or -negative patients whose tumors were sensitive to hormone treatments before their cancer returned. AstraZeneca and Daiichi didn’t release detailed data and stated that the trial hadn’t gone on long enough to tell if patients given their treatment lived longer overall, the trial’s other main goal.
“The data suggest the companies’ drug could present a threat to Gilead’s similarly acting medicine Trodelvy, which gained approval in a similar setting earlier this year. HR-positive, HER2-negative breast cancer is the most common form of the disease.”
“A combination of cancer drugs from Seagen and Merck & Co. has shown early success in a large clinical trial, results that help confirm the pairing’s ability to treat a wide range of bladder cancer patients.”
“A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 people at research sites around the world. It is supported by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in partnership with NIH’s National Center for Advancing Translational Sciences (NCATS).
“Immune modulators—treatments for modifying the immune system to better respond to disease or illness—are lifesaving for certain hospitalized COVID-19 patients. However, the optimal timing for administering the medicines to achieve the best outcomes has not been defined.”
The Wall Street Journal poses ten questions about experimental drugs that can be made available to seriously ill patients.
“Catholic healthcare giant CommonSpirit Health has reported a $1.4 billion operating loss (-4.1% operating margin) and a net loss of $259 million for its 2023 fiscal year, which ended June 30, according to financial statements released Thursday.
“The nonprofit, which currently operates 145 hospitals across 24 states, had logged a $1.3 billion operating loss (-3.8% operating margin) and a $1.8 billion deficit of revenues over expenses during its prior fiscal year.
“This time around, the organization enjoyed patient volumes that “reached pre-pandemic levels in many of the health system’s markets” but was dragged by “private and government reimbursements [that] did not keep pace with increased costs of providing care to patients,” CommonSpirit said in a release accompanying the latest financial filings. The most recent year’s operating performance also included a $160 million adverse impact from a fall 2022 cybersecurity breach that affected numerous locations.”
The CMS is poised to crack down further on health insurers in the Medicare Advantage program, according to new comments from a top agency official.
MA plans — which now cover more than half of Medicare beneficiaries — have faced rising criticism over care denials and access, along with improper coding practices that inflate the program’s cost.
“You will see CMS in the future be a much tougher payer and much tougher regulator to ensure that, for every beneficiary and taxpayer who pay more for it, the value is there, the service is there and beneficiaries have full information for the choices that they’re making,” CMS Deputy Administrator Jon Blum said Thursday at the National Association of ACOs’ fall conference in Washington, D.C.
“Speaker Kevin McCarthy said on Sunday that he intended to resurrect a stalled Pentagon spending measure and try to push it to the House floor this week despite pledges by members of the far-right Freedom Caucus to oppose the move unless their sweeping demands on spending were met. * * *
“Other House Republican leaders joined Mr. McCarthy in saying that some progress had been made in weekend talks toward resolving their internal differences over their spending strategy, and that they hoped to break the logjam this week.
“We are working through this, and I’m optimistic that we will continue to move the appropriations process forward,” Representative Elise Stefanik, Republican of New York and a member of the leadership team, said in a separate interview on “Fox News Sunday.”
“The Office of Personnel Management on Friday announced that it is proposing new regulations aimed at hamstringing future administrations from reviving a controversial plan to strip tens of thousands of federal workers of their civil service protections, potentially accelerating a long-simmering battle between good government groups and conservative Republican activists. ***
“OPM’s newly proposed regulations, which will be published Monday in the Federal Register, seek to at least slow down a future administration from reviving Schedule F. It stipulates that when a federal employee’s job is converted from the competitive service to the excepted service, the employee retains “the status and civil service protections they had already accrued,” unless they voluntarily transfer into an excepted service position.”
“Women who live to age 90, 95 or even 100 experience what’s known as “exceptional longevity.” An analysis published last month found one factor linking those long lives: maintaining a stable body weight over decades.
“The study, published in the Journals of Gerontology: Series A, looked at data about 54,437 women from the Women’s Health Initiative, a long-term study that began in the 1990s. The women studied were born on or before Feb. 19, 1932, and the researchers looked at their weight when they began the program, in Year 3, and in Year 10 of the program, then followed up on their survival status as of Feb. 19, 2022.
“They found that the women whose body weight stayed stable over the years had 1.2 and 2 times the odds of surviving to 90 and beyond than those who lost weight.
“Women who lost 5 percent or more of their body weight over the first three years studied had 33 percent lower odds of surviving to 90, 35 percent lower odds of surviving to 95 and 38 percent lower odds of surviving to 100 than their counterparts whose weight remained stable.”
The new Covid shots and the flu vaccines will be available this week. The New York Times observes, and the FEHBlog agrees,
“Some experts believe that spreading out your shots might make sense if you can time them to just before each virus peaks. So while you may get the Covid vaccine this month, as cases rise in parts of the United States, you could consider waiting until later in the fall to get the flu shot. Flu cases typically peak between December and February; you can monitor flu activity in your state through the Centers for Disease Control and Prevention’s influenza surveillance reports for more detailed information. A doctor can also help you decide the best strategy, especially if you have a high risk of severe disease or are immunocompromised.”
“Does M&A work? The latest research says it’s a tossup.
“Business-school students are often taught that successful mergers and acquisitions are a long shot. One influential Harvard Business Review article, dating from 2011, says a range of studies show roughly 70% to 90% of deals fail to create value for the buyer.
And many investors worry that takeovers are more reliably lucrative for investment banks—which LSEG says earned some $13.1 billion in M&A fees in the first half of this year—than for the acquiring companies and their shareholders.
But more recent research from academics and consultants puts the success rate closer to even. Companies that do frequent smaller deals, as well as making bigger bets, tend to outperform, advisers say. That is because they hone their ability to identify targets, integrate those businesses and reap the intended financial benefits.
Companies should always weigh up deal making against alternative uses of funds, said Barry Weir, Citigroup’s co-head of European mergers and acquisitions.
“If the risk-adjusted return from M&A is higher than the benefits from returning cash to shareholders or some other lower-risk alternative, then it makes sense,” Weir said. “If it doesn’t meet this hurdle then you shouldn’t be doing M&A.”
HR Dive considers the occasions on which employees subject to the Fair Labor Standards Act are entitled to be paid for commuting to the office.
The Wall Street Journal reports, “House Speaker Kevin McCarthy laid out a map for passing legislation to keep the government funded past Oct. 1, but immediately ran into new roadblocks from spending hawks and fresh grumbling that he should be ousted from his post.” The FEHBlog anticipates that Congress will pass a continuing resolution before the end of the month.
The Centers for Medicare and Medicaid Services announced,
“the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Some people with Medicare who take these drugs may save between $1 and $618 per average dose starting October 1, 2023, depending on their individual coverage. * * *
“CMS has released information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.”
“Healthcare legislation being hashed out on the Hill is taking aim at pharmacy benefit managers, but the policies — while potentially worthwhile — are unlikely to have more than modest effects on the cost of prescription drugs in the U.S., experts say. us,
“Eliminating all PBM profits would only reduce total drug-related spending by “several percentage points,” since operating margins for the three biggest PBMs averaged roughly 4% of revenues last year, according to a new report from the Brookings Schaeffer Initiative on Health Policy.
“Lowering spending further would require “fundamental market changes” like changing drug patent protections or the way drug prices are regulated, the report says — measures sure to face heavy opposition from pharmaceutical companies.”
“Cisplatin, a drug used for multiple types of cancer that’s been in a severe shortage for months, is close to returning to 100 percent of pre-shortage supply levels, the White House said Sept. 12. * * *
“In June and July, the FDA allowed China-based Qilu Pharmaceutical to temporarily import cisplatin. These lots have already been distributed, according to the FDA. The agency also worked with domestic drugmakers to increase their manufacturing capacity.
“These actions brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels and are greatly alleviating the shortages of carboplatin,” according to a post from the White House’s Office of Science and Technology Policy.”
The Federal Times writes about the impending premium increases in the Federal Long Term Care Insurance Program.
From the public health and research front,
The American Medical Association released a letter supporting the CDC’s “universal recommendation for the 2023-2024 COVID-19, XBB.1.5 containing vaccine.”
“Testing for the presence of cancer-causing types of the human papillomavirus (HPV) is now a standard part of screening for cervical cancer, sometimes with simultaneous Pap tests (known as co-testing). But cervical cancer screening is recommended to stop at age 65 in many places and, for a variety of reasons, many older adults stop getting screened for cervical cancer well before that age.
“In the new study, about 62% of women who were invited to undergo this “catch-up” testing for HPV (intervention group) had a test within the next year. In a comparison group of women not invited for catch-up testing, only about 2% had either a Pap test or an HPV test over the next year.”
“The first artificial womb to gestate a human baby is fast approaching reality.
“Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. * * *
“Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S.groups known to be testing the technology on lambs. The otherU.S.group says it is still a few years off from human trials.”
Forbes notes, “The Marcus Autism Center in Atlanta has launched its biomarker-based device that has been authorized by the FDA to aid in the diagnosis of autism in children between 16 and 30 months of age.”
“After pulling off a biomedical triumph with its COVID-19 vaccine, Moderna on Wednesday put out a roadmap for investors that promises billions of dollars from new medicines.
“The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028.”
“Humana, Aetna and Molina are not renewing their contracts with senior companionship company Papa following allegations of abuse against patients or company employees, Bloomberg reported Sept. 11.
“In May, Bloomberg Businessweek published a report detailing allegations of abuse against seniors and Papa employees based on 1,200 complaints submitted to the company. The complaints included allegations of sexual abuse and assault, harassment, or unsafe living conditions.
“A spokesperson for Papa declined to provide a comment to Bloomberg about specific contracts, but said the company has grown its client base this year and is selling programs for next year.”
The Office of Personnel Management issued a Benefit Administration Letter providing guidance about an Enrollee Decision Period for Federal Long Term Care Insurance Program enrollees. The Enrollee Decision Period started today and ends on November 9, 2023.
“approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
“Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter.
“Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.”
STAT News tells us, “Sen. Bernie Sanders (I-Vt.) will hold a confirmation hearing next month for Dr. Monica Bertagnolli, President Biden’s nominee to run the National Institutes of Health, he said Friday.”
“Anesthesiologists are sharply divided over how to handle the growing number of surgical patients on GLP-1 receptor agonists, given that the drugs can raise the risk of aspiration during surgery.
“While the leading U.S. anesthesiology society suggests that patients stop taking injectable versions of the medications for 7 days ahead of surgeryopens in a new tab or window, some anesthesiologists are turning to alternative strategies such as intubating all at-risk patients, even for minor procedures.
“Other anesthesiologists are calling for patients to stay off the drugs for weeks, not days, or titrate down to lower doses.
“This topic is being heavily discussed in the anesthesia community right now, and it’s very polarizing,” Michael Gulak, MD, a resident anesthesiologist at the University of Toronto, told MedPage Today.”
“Nonprofit hospital expenses continued to grow last year while liquidity fell to pre-pandemic levels, according to Moody’s Investor Services.
“In a Sept. 7 report, Moody’s outlined 2022 fiscal year trends based on data from 218 health systems. The report noted operating margins fell to”unsustainable levels” as median operating cash flow margin was 4.9 percent and median operating margin was -0.3 percent amid labor shortages and inconsistent patient volumes.
“While the industry shows signs of stabilizing in 2023, the labor environment will remain challenging,” the report states.”
“Hospitals in the United States faced unprecedented challenges during the COVID-19 pandemic, and those challenges have left them floundering in the face of increased costs and workforce shortages. According to the most recent Costs of Caring report from the American Hospital Association, this combination of factors has resulted in a 17.5% increase in overall hospital expenses between 2019 and 2022. “Further exacerbating the situation is the fact that the staggering expense increases have been met with woefully inadequate increases in government reimbursement,” the report states, leading to consistently negative margins and over half of hospitals ending 2022 at a financial loss.
“Even so, hospital expenses per inpatient day have been steadily trending upwards for years in the U.S., whether for-profit, non-profit, or state/local government. Research from KFF shows that in 1999, the average adjusted expenses per inpatient day for state/local government hospitals was $1,004. Non-profits were at $1,139, and for-profits were at $999. As of 2021, state/local government stands at $2,742—a 173% increase. Non-profits are at $3,013 (164.5%) and for-profits at $2,296 (129.8%).”
While there are fewer rural residents enrolled in Medicare Advantage plans than micropolitan or metropolitan residents, MA enrollment in rural areas is growing much more rapidly, new research shows.
The KFF report, published Thursday [September 7], defines rural areas as having less than 10,000 people, micropolitan areas as having 10,000 to 50,000 people and metropolitan areas as having at least 50,000 people. The findings come when Medicare Advantage growth overall is on the rise, accounting for more than half of eligible Medicare beneficiaries in 2023.
Walmart is considering buying a majority stake in value-based medical chain ChenMed, according to a Bloomberg report published Friday.
The retail giant is in discussions with ChenMed regarding a transaction that would value the Miami-based primary care clinic operator at several billion dollars, Bloomberg reported, citing sources familiar.
Terms of the deal aren’t finalized, and talks could fall through or a different buyer could emerge, Bloomberg’s sources said.
If a deal is announced, Walmart would become the latest retail operator to bag a primary care operator, following in the footsteps of rivals including CVS, Amazon and Walgreens.
ChenMed operates a network of more than 125 clinics for Medicare-eligible seniors in 15 states, according to the company’s website.
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This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
