October 10 is World Mental Health Day. The International Foundation of Employee Benefit Plans offers six steps toward addressing mental health in the workplace.
From Washington, DC,
The Foundation provides some basics on the final rule on imposing civil monetary penalties for violations of Medicare reporting requirements imposed on group health plans, including FEHB plans, and others. The new rule, which was released today, takes effect one year from its publication in the Federal Register.
“The Biden administration on Monday has begun the queue of new regions to add to the federal government’s map where federal workers are entitled to higher pay for 2025, approving a recommendation to add Clallam and Jefferson counties in Washington state to the existing Seattle-Tacoma, Washington, locality pay area.
“The Office of Personnel Management on Monday published the President’s Pay Agent’s annual report on locality pay, the practice by which the federal government supplements its compensation to employees under the General Schedule to address pay disparities between federal workers and their private sector counterparts in a given region.
“In this year’s report, the pay agent, which is made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and Acting Labor Secretary Julie Su and acts upon the recommendations of a panel of political appointees and labor leaders, approved one change to the map of locality pay regions in the form of adding Clallam and Jefferson counties to the Seattle-Tacoma locality pay area. But federal employees in line for an additional pay raise from the decision will have to wait; OPM first must craft and publish regulations implementing the pay agent’s decision, which won’t be in place until the 2025 pay raise at the earliest.”
From the public health and medical research front,
“A multilevel primary care intervention that included automated electronic health record (EHR) reminders and patient outreach/navigation improved timely follow-up of overdue abnormal cancer screening test results, a cluster randomized trial showed.
“Among nearly 12,000 patients with an abnormal screening test result for colorectal, cervical, breast, or lung cancer, completion of follow-up testing within 120 days of study enrollment was significantly higher with EHR reminders, patient outreach, and patient navigation (31.4%) and EHR reminders and patient outreach (31.0%) compared with only EHR reminders (22.7%), and usual care (22.9%), reported Steven J. Atlas, MD, MPH, of Massachusetts General Hospital in Boston, and colleagues.”
The NIH Director’s Blog discusses “Taking a Deep Dive into the Alzheimer’s Brain in Search of Understanding and New Targets.”
Getting tested for Alzheimer’s disease could one day be as easy as checking your eyesight.
RetiSpec has developed an artificial intelligence algorithm that it says can analyze results from an eye scanner and detect signs of Alzheimer’s 20 years before symptoms develop. The tool is part of broader work by startups and researchers to harness AI to unlock the mysteries of a disease that afflicts more than seven million Americans.
“Damaged mitochondrial DNA (mtDNA) initiates and spreads Parkinson’s disease (PD) pathology, potentially opening new avenues for early diagnosis, disease monitoring, and drug development.
“While defects in mitochondrial functions and in mitochondrial DNA have been implicated in PD in the past, the current study demonstrates “for the first time how damaged mitochondrial DNA can underlie the mechanisms of PD initiation and spread in brain,” lead investigator Shohreh Issazadeh-Navikas, PhD, with the University of Copenhagen, Denmark, told Medscape Medical News.
“This has direct implication for clinical diagnosis” ― if damaged mtDNA can be detected in blood, it could serve as an early biomarker for disease, she explained.
“The study was published online October 2 in Molecular Psychiatry.”
From the U.S. healthcare business front,
Healthcare Dive shares information from the HLTH conference in Las Vegas.
“Microsoft announced a slew of new data and artificial intelligence offerings in the healthcare sector on Tuesday, including new generative AI models meant to help ameliorate administrative burden on clinicians.
“Microsoft’s cloud division Azure is releasing new capabilities meant to free up information for clinicians. Those include patient timelines, which use generative AI to extract specific elements from unstructured data — like medication information in an electronic health record — and organize them chronologically to give a full view of a patient’s history. Another functionality, called clinical report simplification, uses generative AI to simplify clinical jargon so patients can better understand medical information.
“The launches tie in with Microsoft’s ethos of developing high-impact but low-risk use cases for AI in healthcare, said David Rhew, Microsoft’s global chief medical officer and vice president of healthcare, in an interview at the HLTH conference in Las Vegas, where the offerings were announced.”
“Walgreens plans to launch telehealth visits on its website later this month, as the retail pharmacy giant continues its strategic pivot to healthcare services.
“Walgreens Virtual Healthcare will offer on-demand virtual consultations with providers for common medical needs and medication prescriptions.
“Walgreens is adding direct-to-consumer virtual care because “our goal is to be the most convenient health and wellness destination, whether you’re physically in our stores or virtually in our stores,” said Tracey Brown, Walgreens’ chief customer officer and president of retail, while debuting the new offering at the HLTH conference in Las Vegas on Monday.”
“Cigna’s health services division Evernorth has acquired the technology and clinical capabilities of asynchronous telehealth provider Bright.md for an undisclosed amount, the company announced on Tuesday at the HLTH conference in Las Vegas.
“Evernorth’s telehealth business MDLive plans to start offering asynchronous care using the new capabilities within its virtual urgent care platform in 2024, and eventually expand asynchronous care to chronic disease management and wellness visits.
“A spokesperson for the company said it was too early to share a specific timeline for the launch in virtual urgent care and the expansion to more clinical areas. Currently, more than 43 million people have access to MDLive virtual urgent care through their health plans and employers, Cigna says.”
“Aetna is modifying its commercial policy to no longer cover certain telemedicine services starting on Dec. 1, the company said in a statement.
“This is for audio-only and asynchronous text-based visits that were expanded under the public health emergency, the CVS subsidiary said.
“The modifications are in line with the industry as a result of the expected PHE ending in May 2023,” Aetna said. “Telemedicine services that remain covered for Aetna Commercial plan sponsors are actually more extensive than what was provided pre-pandemic because of the access and value these services clearly bring to our members and providers.”
“According to Aetna, currently covered telehealth services include routine care, sick visits, urgent care through walk-in clinics, prescription refills and behavioral health services.”
“The number of U.S. employers who cover obesity medications, including Wegovy from Novo Nordisk that belongs to a class of GLP-1 drugs, could nearly double next year, according to a survey. The survey of 502 employers by Accolade, a company that provides healthcare programs for employers, and research firm Savanta said 43% of the employers it polled could cover GLP-1 drugs in 2024 compared to 25% that cover them now.”
It will be helpful to the FEHB if other employers join the FEHB in covering these drugs.
“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.”
“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.”
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.
House Republicans appeared to be moving closer to an agreement Wednesday on an opening bid for stopgap funding legislation that would keep the lights on at federal agencies beyond Sept. 30 and pave the way for their chamber to take up its full-year appropriations bills.
At least a handful of conservative holdouts still maintained their opposition as of Wednesday night, which would be enough to sink a revised bill unless GOP leaders are able to change some minds in the next few days. Speaker Kevin McCarthy, R-Calif., is expected to keep the chamber in session on Saturday if necessary.
Even if GOP leaders’ new effort is successful, however, it was starting to look more like a bid to reopen the government after a brief shutdown, given the deadline is 10 days away and the Senate is likely to ping-pong a much different bill back to the House.
The FEHBlog notes that it would not be unusual for Congress to pass a brief continuing resolution next week to allow for the passage of a longer continuing resolution, thereby side stepping the partial government shutdown.
Fierce Healthcare offers details on the House Ways and Means Committee’s No Surprises Act hearing, while Healthcare Dive shares details on the House Oversight and Accountability’s PBM reform hearing. Both hearings were held yesterday.
Speaking of the No Surprises Act, the ACA regulators released a proposed rule increasing the government’s NSA arbitration fee from $50 per party to $150 per party next year. The FEHBlog has no idea why the government doesn’t ladder the fee based on the amount in dispute. The government also increased the maximum fee independent dispute resolution entities can charge the parties.
“FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class
“FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.”
“FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
“ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.”
From the public health and medical research fronts,
“The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs and in part to stimulate a domestic testing industry that has struggled with cratering demand for rapid diagnostics.
“The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats. * * *
“Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.”
The FEHBlog thinks that the government is fighting the last pandemic. Why not incent the production of the FDA-approved (last February) at-home tests for Covid or the flu, not just Covid?
“Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. It may still be good.
“The Food and Drug Administration has been extending expiration dates for some authorized at-home, over-the-counter Covid test kits, meaning some unused tests may still be viable. The agency’s updated list of expiration dates may be useful to those reaching for their stash of Covid-19 tests amid new variants and a recent bump in cases and hospitalizations.”
“A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.”
“Is morning the best time of day to exercise? Research published Tuesday in the journal Obesity finds that early morning activity — between 7 a.m. and 9 a.m. — could help with weight loss.
“My cautious suggestion from this study is that if we choose to exercise in the early morning before we eat, we can potentially lose more weight compared to exercise at other times of the day,” said lead researcher Tongyu Ma, a research assistant professor at The Hong Kong Polytechnic University.”
“Ochsner Health is launching a pilot program this month that will use generative artificial intelligence to draft “simple” messages to patients.
“About a hundred clinicians across the New Orleans-based health system will participate in the first phase of the program, where AI will prepare responses to patient questions unrelated to diagnoses or clinical judgments. The messages will be reviewed and edited by providers before being sent to patients, according to a news release.
“Ochsner is part of an early adopter group of Microsoft’s Azure OpenAI Service, which integrates with the Epic electronic health record. The health system will test the messaging feature over three phases this fall, and Ochsner will collect patient feedback to improve the system.”
“Making sense of mountains of data continues to be an often elusive goal for most of the healthcare system, but Cambia Health Solutions said it hopes its latest effort will allow it to better corral useable information.
“Cambia and Abacus Insights, a data management company that tacklesthe challenge of making healthcare networks interoperable, launched a new data aggregating system that processes information for about 3.4 million members across four Blues plans.
“According to an Abacus case study (PDF), “Cambia recognized that to deliver care orchestrated around the unique needs of each individual, data must be actionable. To be actionable, case study data must be understandable, usable, timely, and have clinical utility.”
“House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
“The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
“The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
Politico discusses where we stand with the proposed mental health parity rule changes.
“The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
“Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
“For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
“The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
“The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
“Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order. On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations. The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
STAGE: Final Rule Economically Significant: No
RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
REVIEW EXTENDED
COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
The FEHBlog will be watching the Federal Register for this one.
CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”
From the public health and medical research fronts,
Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
“The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
“Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
“We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
Healio points out that based on a recent research study,
“Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
“Fructose from vegetables and fruits was not.”
The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
“Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
“A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
“Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
MedPage Today calls our attention to a different Swedish study,
“Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
“Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
“Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”
From the U.S. healthcare business and quality fronts,
The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
Commercial plans that received a five-star rating:
Independent Health Association (New York)
Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
“Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
“Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.
In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”
Key Senate panels have reached a bipartisan deal on a bill that aims to bolster primary care.
“The package would invest more than $26 billion into primary care programs as well as initiatives to grow the healthcare workforce. The bill is cosponsored by Sen. Bernie Sanders, I-Vermont, who chairs the Senate Health, Education, Labor and Pensions committee, and Sen. Roger Marshall, R-Kansas, the ranking member of the Subcommittee on Primary Health and Retirement Security.”
Under a policy statement that the commission approved Thursday, the Federal Trade Commission will “use its full legal authority” against drugmakers that impede competition by improperly listing patents in a government database that controls how generic manufacturers can enter the market.
According to FTC Chair Lina Khan, pharma companies can “weaponize” the database, called the Food and Drug Administration Orange Book, because any generic maker that applies for approval of a drug with a listed Orange Book patent can be sued by the branded manufacturer and blocked from entry for 30 months.
The policy statement highlights the antitrust regulator’s tightening scrutiny of drugmakers’ marketing, patent and acquisition practices. The FTC recently slowed Amgen’s $27.8 billion acquisition of Horizon Therapeutics until Amgen agreed to safeguards against the “bundling” of drugs in the combined company. The agency is also carefully reviewing Pfizer’s planned $43 billion takeout of Seagen.
“The CMS agency that tests value-based payment models hopes to announce two new behavioral health and maternal health models later this year, according to Liz Fowler, director of the Center for Medicare and Medicaid Innovation.
“Both upcoming models have “a heavy role” for the Medicaid program, Fowler said Thursday during a Health Affairs policy briefing. The behavioral health model, which is currently going through clearance, will also involve Medicare.
“The CMMI is also working on strategies to better integrate specialty care with primary care, a priority Fowler called “a hard nut to crack.”
“The research is the final trial conducted by MAPS Public Benefit Corporation, a company that is developing prescription psychedelics. It plans to submit the results to the Food and Drug Administration as part of an application for approval to market MDMA, the psychedelic drug, as a treatment for PTSD, when paired with talk therapy.
“If approved, “MDMA-assisted therapy would be the first novel treatment for PTSD in over two decades,” said Berra Yazar-Klosinski, the senior author of the study, which was published in Nature Medicine, and the chief scientific officer at the company. “PTSD patients can feel some hope.”
Healio interviews “Kevin C. Oeffinger, MD, professor in the department of medicine and a member of the Duke Cancer Institute (DCI), founding director of the DCI Center for Onco-Primary Care and director of the DCI Supportive Care and Survivorship Center.” Check it out.
AHIP discusses health insurers’ efforts to improve access to mental health care providers.
“A recent AHIP survey of health insurance providers offering commercial health insurance coverage found that there is meaningful access to a wide range of professionals who deliver mental health support within plan networks. This survey also showed that the number of in-network mental health providers has increased by 48% in three years among commercial health plans.”
From the U.S. healthcare business front,
Following up on the news about the FDA’s issues with certain over the counter decongestants, Reuters points out,
“Procter & Gamble (PG.N), Walgreens (WBA.O) and Johnson & Johnson’s (JNJ.N) former consumer business are among several companies accused in lawsuits of deceiving consumers about cold medicines containing an ingredient that a unanimous U.S. Food and Drug Administration advisory panel declared ineffective.
Proposed class actions were filed on Wednesday and Thursday, after the panel reviewed several studies and concluded this week that the ingredient phenylephrine marketed as a decongestant was essentially no better than a placebo.”
“Over a 6-year period 25 percent of U.S. health visits were conducted by a non-physician, according to Harvard Medical School researchers.
“Advanced care delivered by nurse practitioner and physician assistant roles first emerged in the 1960s, and now, in 2023, nurse practitioner is the fastest growing career nationwide, according to the Bureau of Labor Statistics. Physician assistants also landed on the list of the nation’s fastest-growing careers, taking the 17th spot.
“For the study, which was published Sept. 14 in the British Medical Journal, researchers analyzed data from 276 million patient visits between 2013 and 2019 and found that during this time frame, there was an 89 percent increase in visits conducted by nurse practitioners and a 60 percent increase in visits conducted by physician assistants.”
“Ascension closed out its 2023 fiscal year with a $2.66 billion net loss, according to financial disclosures for the period ended June 30.
“The St. Louis-based nonprofit health system’s tough year, which ended June 30, came from a combination of high expenses, “sustained revenue challenges” and a one-time non-cash impairment loss of almost $1.5 billion, management wrote in the filing.
“Ascension’s operating loss for the year came in at $3.04 billion, or $1.55 billion (-5.6% margin) without the impairment losses.
“The numbers follow what was a difficult fiscal 2022, in which Ascension logged an $879 million operating loss and a $1.84 billion net loss. * * *
“Ascension is among the country’s largest health systems with 140 hospitals and 40 senior living facilities. The Catholic giant employs roughly 134,000 people across 19 states and the District of Columbia and reported $28 billion in total revenue during its 2022 fiscal year.
“Higher volumes and expenses have been a recurring takeaway in other nonprofit systems’ recent quarterly financial statements. Providence, a fellow Catholic nonprofit aiming to dig its way out of last year’s losses, reported last month that it had managed to trim its six-month operating losses from $424 million to $202 million thanks to returning patients and operational restructuring.”
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.”
“As authorized yesterday by the Food and Drug Administration and recommended by its vaccine advisory committee, the Centers for Disease Control and Prevention today recommended a single dose of the updated Moderna and Pfizer COVID-19 vaccines for Americans aged 12 and older, and one or two doses of the updated vaccines for previously vaccinated children aged six months through 4, at least two months after receipt of their last dose. The agency also recommended three doses of the updated Pfizer vaccine and two doses of the updated Moderna vaccine for unvaccinated children under age 5, as authorized by the FDA and recommended by the committee. CDC anticipates the updated vaccines will be available later this week.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.
FEHBlog observation — The class action lawyers should be revving up the old turbobiller.
“The percentage of working-age adults ages 19 to 64 with health insurance coverage increased from 2021 to 2022, primarily driven by an increase in employment-based coverage. This resulted in uninsured rates dropping from 11.6% to 10.8% according to U.S. Census Bureau data released today [September 12].
CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.
“According to CMS’ price transparency website:
Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440.
Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
The hospitals have 30 days from the issuance date to appeal the fines.
CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.”
“To help improve the collection of the social determinants of health (SDoH) Z codes, the Centers for Medicare & Medicaid Services (CMS) Office of Minority Health last week released a new Z code infographic.
“CMS’s goal is to assist providers with understanding and using SDoH terminology in their documentation that will allow for greater alignment for ICD-10-CM Z code capture. As discussed, CMS believes that greater Z code capture will enhance quality improvement activities and provide further insights into the existing health inequities that hospitals and their community are facing.”
From the public health and medical research front,
The Wall Street Journal has updated its report on the fall vaccination season.
A prospective study published in the journal Lancet Digital Health found that an AI tool paired with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists, the current standard of care.
Researchers at the Capio Sankt Göran Hospital in Stockholm, Sweden, and the Karolinska Institute said the results suggest that AI “has potential for controlled implementation, which would include risk management and real-world follow-up of performance.”
The study used the Insight MMG system for breast cancer detection, made by Seoul, South Korea-based Lunit. The company helped fund the research, in addition to grants from the Swedish Research Council, the Swedish Cancer Society, and Region Stockholm.
“The U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2% to 19,928, the Centers for Disease Control and Prevention reported Sept. 12. The mortality rate increased for infants of Asian women and declined for infants of Dominican women. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight. Infant mortality rates by state ranged from a low of 2.77 in North Dakota to a high of 9.39 in Mississippi. The U.S. infant mortality rate has generally trended downward since 1995 and has declined 21% since 2005, the most recent high (6.86).”
STAT News is now offering a new generation weight loss drug tracker.
“STAT has created a new database to track the significant obesity drugs that are on the market and in development. The tracker, which will be updated with developments each quarter, gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.
“A related article details the strategies and challenges of some of these companies.”
Roughly seventy drugs are on the tracker currently.
From the U.S. healthcare business front,
Fierce Healthcare tells us, “Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.”
“Walgreens is partnering with startup Pearl Health to help primary care physicians manage value-based care, in a bid to expand its reach with community-based providers.
“The partnership announced Tuesday [September 12] marries Pearl’s provider enablement technology with Walgreens’ care delivery assets and pharmacy services in an attempt to make it easier for clinical teams to provide the personalized treatment necessary in value-based arrangements, according to the companies.
“Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
“Saving for retirement is a life-long challenge, and one that seems to be harder for women. While they live on average five years longer than men, they’re saving less.
“Bank of America analyzed 565,000 health savings accounts (HSAs), looking at utilization trends across genders and generations. Women’s HSA balances are 15% lower than men’s, with women more likely to spend their HSA savings before retirement and contribute less to their accounts. Overall, men’s average net HSA savings was $128 higher in 2022, and over the years that gap begins to add up.” * * *
“Lisa Margeson, managing director of retirement research and insights at Bank of America, advises employers to at the very least educate their employees on the power of HSAs and how they can use them as retirement savings vehicles. Employer HSA contributions, caregiving benefits and flexibility will also help ensure women can maintain successful careers and save for their future.
“As for women, Margeson encourages them to start their HSAs early, try to put at least a little aside each month and eventually invest that money according to their bank’s capabilities. For those who are uncomfortable with a high-deductible health plan, Margeson points to emergency savings accounts or an interest-bearing savings account as a companion to their retirement plans.”
The Society for Human Resource Management offers a breakdown of compensation expenses over the second quarter of this year.
“According to the latest Employer Costs for Employee Compensation report, released September 12 by the U.S. Bureau of Labor Statistics (BLS), employers spent just 0.59 percent more on wages and benefits in June 2023 compared to March 2023.
“Total employer compensation costs for private-industry workers averaged $41.03 per hour worked. Wages and salaries averaged $28.97 per hour worked, accounting for 70.6 percent of employer costs, while benefits costs averaged $12.06 per hour worked, accounting for the remaining 29.4 percent, according to the report.”
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