“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“The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders.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.”
“After days of warnings, [Rep. Matt] Gaetz [(R FL)] rose Monday evening [on the floor of the House of Representatives] to bring up a resolution declaring the speakership vacant. That started a process that would force a vote within days on whether to keep Mr. McCarthy in his post. * * *
“Under House rules, Mr. McCarthy and his leadership team will need to address the motion within two legislative days — though they could do so sooner.”
“The Senate will adjourn earlier than planned this week, with no session on Thursday, to allow members to travel to California and pay their respects to the late Sen. Dianne Feinstein. * * *
“On Sunday, California Gov. Gavin Newsom appointed Laphonza Butler to fill the remainder of Feinstein’s term. Butler recently led the abortion rights campaign group EMILY’s List and spent 20 years as president of SEIU Local 2015, a home care workers union in California.
“Butler will serve until a replacement is elected in a still-unscheduled special election. Three House Democrats — Barbara Lee, Katie Porter and Adam B. Schiff — are running in the March primary for the full, six-year term and can also run in the special election.
“Butler is scheduled to be sworn in by Harris on Tuesday. She will become the first openly gay Black woman to serve in the Senate.”
Last Thursday, U.S. District Judge John Bates vacated a Trump-era Affordable Care Act rule permitting health plans, including FEHB plans, to use copay assistance accumulators. These accumulators prevent manufacturer assistance used to pay cost-sharing for expensive drugs from counting towards out-of-pocket maximums. While that outcome seems reasonable to the FEHBlog, Judge Bates takes the opposite view in his opinion. The federal government, which is the defendant in the case, has the right to appeal this final judgment.
The Institute for Clinical and Economic Research publisheda “Special Report on Eliquis and Xarelto Submitted to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations.” The report “evaluate[es] the evidence on apixaban (Eliquis®, Bristol-Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF).”
BioPharma Dive identifies five Food and Drug Administration to watch for in the fourth quarter of 2023. “By the end of the year, the regulator will decide on new genetic treatments for sickle cell, expanded use of Alnylam’s Onpattro and an inflammatory disease drug from Pfizer.”
“Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC.
“At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-68) against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness of 35% (95% CI 15-51) for infants younger than 6 months, reported researchers led by Regina Simeone, Ph.D., of CDC’s National Center for Immunization and Respiratory Diseases in Atlanta, in the Morbidity and Mortality Weekly Report. * * *
“Looking at the COVID shot specifically, women were nine times more likely to receive a bivalent booster if a provider recommended it (63.2% vs 6.8% when a provider did not).”
The American Medical Association offers “What doctors wish patients knew about managing anxiety disorders.”
“In a guidance document published Monday in the Federal Register, the CDC is seeking input on its proposal that health providers offer gay and bisexual men who have sex with men, as well as transgendered women, access to a common antibiotic, doxycycline, that they could take after having had unprotected sex to lower their risk of acquiring chlamydia, gonorrhea, or syphilis. Doxycycline is in the tetracycline family of antibiotics.
“Studies have show the so-called “doxy PEP” regime — a single, 200-milligram dose taken no later than 72 hours after unprotected sex — can reduce acquisition of chlamydia and syphilis by nearly 80%, and gonorrhea by about 50%. PEP is short for post-exposure prophylaxis.
“Doxy PEP is moving STI prevention efforts into the 21st century,” Jonathan Mermin, director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in a statement. “We need game-changing innovations to turn the STI epidemic around, and this is a major step in the right direction.”
“Katalin Karikó and Drew Weissman won the Nobel Prize in medicine on Monday for an idea that pushed them to the fringes of the scientific establishment before it saved millions of lives during the pandemic.
“Karikó, a molecular biologist, and Weissman, an immunologist, realized during a chance encounter at a University of Pennsylvania a photocopy machine in the 1990s that they could combine their work exploring messenger RNA’s potential in drugs or vaccines.
“Their collaboration was met with skepticism by their colleagues and indifference in the scientific community. Karikó struggled to secure funding for her work. Penn demoted her and sent her to work in an office on the outskirts of campus.
“People wondered, ‘What the hell is wrong with her,’ there must be some reason she’s not on the faculty,” Karikó has said.
“The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the committee said in awarding Karikó, 68, and Weissman, 64, the annual prize in physiology or medicine. Karikó is the 13th woman among 227 people to win the prize.”
“The Fierce 50 goes beyond surface-level accolades to delve deep into the monumental impact 50 exceptional individuals and organizations have on the lives of patients. It shines a spotlight on the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in biopharma and healthcare.”
“Hospital margins are moving in the right direction, as the median year-to-date operating margin improved in August to 1.1 percent, according to Kaufman Hall.
“August’s median of 1.1 percent marked an upswing from the 0.9 percent median margin recorded in July, according to Kaufman Hall’s latest “National Hospital Flash Report” — based on data from more than 1,300 hospitals.
“Increased revenue offset hospitals’ increased supply and drug expenses in August. Decreased reliance on contract labor helped labor expenses decline on a volume-adjusted basis, while average lengths of stay also fell, by 4 percent month over month.”
“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.
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 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 House Energy and Commerce Committee today held a hearing on legislative proposals to prevent and respond to generic drug shortages. In comments submitted last month, AHA urged the committee to reject provisions in its draft legislation proposals that would limit patient access to 340B drugs and consider additional proposals that would protect the supply chain for essential medications.
“Witnesses at today’s hearing included representatives from Civica, the American Society for Health System Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance, and Association for Accessible Medicines.”
“Although shortages are not new, the number of drugs in short supply has grown steadily for about two years. Shortages also have become more difficult to predict and are affecting drugs that are more critical.
“Most concerning are the shortages of cancer drugs, which until recently hadn’t been much of a problem for at least a decade. There are 15 cancer drugs currently in short supply, according to the Food and Drug Administration, though the White House this week said one of the key shortage chemotherapies, cisplatin, is nearly back to pre-shortage levels.
“Civica Rx members choose which drugs it brings to market. So far, the nonprofit contracts for cyclophosphamide, a chemotherapy that helps treat multiple cancers, and there’s a heightened urgency to determine whether to add more cancer drugs to the list.
“Given the drug shortage situation for cancer drugs, we have a working group now,” said Allan Coukell, senior vice president of public policy at Civica Rx. “We’re looking at what would a portfolio of those drugs be.”
“Despite misleading headlines, such as “Sudafed, Benadryl and most decongestants don’t work,” * * * [t]here are branded products that include the names Sudafed and Benadryl that do work as nasal decongestants. These contain the active ingredient pseudoephedrine. But because the dangerous illicit substance methamphetamine can be made in illegal laboratories with pseudoephedrine these products were placed behind the counter years ago. In 2005, Congress passed the Combat Methamphetamine Epidemic Act, which requires that pharmacies and other retail stores maintain purchase logs for products that include pseudoephedrine, and it limits the amount of those products an individual can purchase per day. Pseudoephedrine-based drugs are not affected by the FDA panel’s vote. They will remain available behind the counter.”
“GoodRx has notched a third partnership with a pharmacy benefit manager to integrate its drug coupons at the point of sale, further expanding GoodRx’s access to the commercially insured PBM market.
“For eligible members filling a generic medication starting in 2024, the new program will compare GoodRx’s discount price with their price through insurance and apply the lowest cost. The payment will be automatically applied to consumers’ deductibles.
“With MedImpact and existing deals with CVS Caremark and Cigna-owned Express Scripts, GoodRx now reaches more than 60% of insured lives through the partnerships, the company said Wednesday.”
The Institute for Clinical and Economic Research published an evidence report for gene therapy to treat Metachromatic Leukodystrophy.
“Currently available evidence provides greater certainty of substantial net health benefit in pre-symptomatic MLD; evidence also suggests that individuals with early symptomatic disease benefit from treatment —
“Using weighted analyses across all patient subpopulations, arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M – $3.9M —
“At the September 29 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money.”
Results from the American Association for Cancer Research’s annual Cancer Progress Report revealed that the age-adjusted overall cancer death rate in the U.S. fell by 33% between 1991 and 2020.
The report also detailed FDA approvals related to anticancer therapeutics over the past year, the impact of immunotherapy on cancer care in the 21st century and key challenges needed to overcome obstacles patients with cancer still face moving forward.
McKinsey notes” “Orthopedic care is among the largest categories in US healthcare; improvements could have far-reaching positive effects. We analyze care pathways to spot opportunities for better coordination.” Check it out.
“Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis.
“The analysis was conducted by national drug testing lab Millennium Health, looking at more than 160,000 de-identified urine drug test results from more than 73,000 unique patients collected between mid-April and mid-July 2023.
“Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs. The Biden administration designated fentanyl combined with xylazine an emerging threat in April. “
“Loneliness can have major impacts on seniors’ health, worsening comorbidies and even driving mortality, according to a white paper by the Elevance Health Public Policy Institute.
“Loneliness in older adults increases the likelihood of depression and dementia as well as worsening outcomes for individuals with hypertension, heart disease and stroke, according to the white paper.
“In a survey, the researchers researchers found that:
About 28% of respondents had a mental health condition.
About 1 in 4 reported having both depression and another mental health condition.
Individuals with a mental health diagnosis were more likely to live alone.
Individuals with a mental health diagnosis cited limitations to social activities in the past month because of poor health.
“Elevance Health hired research and consulting company Health Management Associates to describe the characteristics of 16,000 Medicare beneficiaries with a mental health diagnosis using the 2018 Medicare Current Beneficiary Survey. Some beneficiaries were covered by traditional fee-for-service Medicare, others by Medicare Advantage (MA).”
“Medical services provided in outpatient settings are notably pricier when delivered in hospital-owned departments compared with ambulatory surgery centers or physicians’ offices, according to a new analysis from a Blue Cross Blue Shield Association subsidiary.
“The report, based on data for 133 million Blues members found from 2017 to 2022, also found prices generally grew more rapidly at hospital outpatient departments than at non-hospital outpatient settings.
“Researchers said their data supports site-neutral proposals to make care costs the same regardless of where it’s provided. Momentum is building in Congress around the policies, but they face fierce opposition from hospital groups.”
“Out-of-network ground ambulance rides made up a larger percentage of total claim lines than in-network rides between 2018 to 2022, exposing patients to a higher risk of surprise bills, according to an analysis by Fair Health.
“Out-of-network rides made up almost 64% of all ground ambulance claim lines in 2018, decreasing slightly to over 59% in 2022.
“Advanced life support (ALS) services, which provide a higher level of care than basic life support (BLS), comprised a larger share of ground ambulance claims than basic life support services from 2018 to 2022 — another factor that could drive up costs, the research found. About 51% to 52% of ground ambulance claim lines were associated with ALS during the study period.”
“The odds moved up, based on the latest inflation data, that Social Security benefitscould see a 3.2% cost-of-living adjustment next year. Not sky high but a bit better than average.
“To be sure, we’ll need to see one more month of data before the exact inflation adjustment will be known. The next round of Consumer Price Index data for September will be released by the U.S. Bureau of Labor Statistics on Oct. 12.”
“Starting in 2024, Medicare Premium costs will be changing — Medicare Part B costs are expected to get more expensive, while Medicare Part D prices are projected to decrease. We’ll tell you how much below. * * *
“Due to a new Alzheimer’s treatment coming to the market (Leqembi, from pharmaceutical companies Eisai and Biogen), Medicare beneficiaries are expected to pick up the cost. Therefore, Medicare Part B prices are expected to increase in 2024. The costs are projected to go up from the current $164.90 to $174.80, a nearly $10 increase per month.
“While you may not see a huge difference in the amount you’re paying for Medicare Part D, it still could be slightly lower. The average total monthly Part D premium is projected to decrease from $56.49 in 2023 to $55.50 in 2024, according to the Centers for Medicare & Medicaid Services (CMS). That’s nearly $1 each month.”
Way back in the day, OPM routinely would announce the next year’s FEHB premiums around Labor Day. The announcement was known as OPM’s Labor Day press release. Currently, the announcement is made in the last week of September.
Tammy Flanagan writes in Govexec about federal employee benefit issues confronting couples who both work for Uncle Sam, specifically
“Should we carry two self only plans under the Federal Employees Health Benefits program or one self plus one plan if we don’t need to cover children?
“Do we need to provide survivor annuities for each other?”
Check it out.
The Senate returns from its August State work break tomorrow for a shortened week of Committee business and floor voting. The House of Representatives returns to the Nation’s Capital next Tuesday.
From the public health front,
The Washington Post reports
“The Centers for Disease Control and Prevention on Friday [September 1] issued a national alert warning health-care professionals to watch out for infections of Vibrio vulnificus, a rare flesh-eating bacteria that has killed at least 13 people on the Eastern Seaboard this year.
“Although infections from the bacteria have been mostly reported in the Gulf Coast, infections in the eastern United States rose eightfold from 1988 to 2018, the CDC said. In the same period, the northern geographic range of infections has increased by 30 miles every year. This year’s infections came during a period of above-average coastal sea surface temperatures, the agency said.
“Up to 200 people in the United States every year report Vibrio vulnificus infections to the CDC. A fifth of the cases are fatal, sometimes within one or two days of the onset of illness, according to the agency.”
“We’re finding them with disease not contained in the prostate but also in the bones, in the lymph nodes,” said Dr. James Porter, a urological surgeon in Seattle. “That’s a recent phenomenon.”
“Groups including the American Cancer Society are reviewing their own guidance for prostate-cancer screening. Many doctors want to better target the test, limiting screening for some men while encouraginghigh-risk groups including Black men or those with a strong family history to get testing earlier.
“PSA recommendations have been ping-ponging back and forth, and what’s been lost in that is the high-risk people,” said Dr. Heather Cheng, director of the Prostate Cancer Genetics Clinic at Fred Hutchinson Cancer Center in Seattle. She is helping to review the American Cancer Society’s prostate-cancer screening guidelines.
“Cheng and other doctors working to better calibrate screening said the risks of overdiagnosis have declined. More doctors now monitor low-risk tumors for growth before rushing a man into surgery or radiation. Better imaging tools have reduced biopsies.”
In other words, the problem is not necessarily the screening test; rather the problem may be the reaction of the medical community to screening results.
“The idea of food as medicine dates back to the ancient Greek doctor Hippocrates, and a new study adds to the evidence that a diet full of fruits and vegetables can help improve heart health. The research comes amid an epidemic of diet-related disease, which competes with smoking as a leading cause of death.
“Researchers evaluated the impact of “produce prescriptions,” which provide free fruits and vegetables to people with diet related diseases including diabetes, obesity and hypertension. The study included nearly 4,000 people in 12 states who struggle to afford healthy food. They received vouchers, averaging $63 a month, for up to 10 months, which could be redeemed for produce at retail stores or farmers markets, depending on the location.
“Health care providers tracked changes in weight, blood pressure and blood sugar among the participants. “We were excited to see improvements,” says study author Kurt Hager, an instructor at UMass Chan Medical School.
“Among adults with hypertension, we saw that systolic blood pressure decreased by 8 mm Hg and diastolic blood pressure decreased by about 5 mm Hg, which could have a meaningful impact on health outcomes,” Hager says.
“Among people with uncontrolled diabetes, their A1C levels, which is a 2-3 month average of their blood sugar, also declined significantly, by about .6 percent. “The reductions we saw in blood sugar were roughly half of that of commonly prescribed medications, which is really encouraging for just a simple change in diet,” Hager says.”
Fortune Well explains how to deal with the uncertainty that serves as the root of anxiety.
“Uncertainty is life’s promise to us all. For more than twenty years, I have watched people rise from unspeakable pain to venture again into a future that withholds all certainty. I work with people who have endured shocking traumas and, predictably, our early conversations are filled with interrogative pleas for a certain safety: “How can I be absolutely sure nothing like this will ever happen again?” they ask me.
“The answer is: they cannot.
“After many years, the thing that still takes my breath away is the grace and courage of people who accept this truth and say: I rise again not because I know for sure, but because I hope anyway.”
The New York Times offers a reminder about how to use at home COVID tests effectively. Bear in mind that Paxlovid should be taken within five day after showing Covid symptoms.
“Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia. This summer’s guidance to halt the medication for up to a week may not go far enough, either.
“Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on the weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance.”
The drugs can slow digestion so much that it puts patients at increased risk for the problem called pulmonary aspiration, which can cause dangerous lung damage, infections and even death, said Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston.
“This is such a serious sort of potential complication that everybody who takes this drug should know about it,” said Hobai, who was among the first to flag the issue.
From the healthcare policy front —
Congress is on a State/District work break this week. There are no out-of-town hearings scheduled.
NPR Shots predicts that a recently proposed rule will improve hospital price transparency. Fingers crossed.
From the public health front –
Fortune Well identifies and explains the four daily habits of “truly happy” people.
The Drug Enforcement Administration’s public education website explains the dangers of
“Xylazine – often called “tranq” – is a drug adulterant that DEA has detected in a growing number of overdose deaths, despite the FDA authorizing it only for veterinary use.
“Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.”
“The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling certain Cardiosave intra-aortic balloon pumps (IABPs) due to a risk that the devices could stop working unexpectedly. This is a Class I recall, which means the FDA believes using one of these IABPs “may cause serious injuries or death.”
“These devices are designed to provide temporary support to a patient’s left ventricle. Electrical failures have caused some of them to turn off with no warning, however, putting the patient’s health at immediate risk.
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA’s advisory.”
This is the fourth cardiac care device to be recalled in 2023.
mHealth Intelligence says that “Using survey data on patient attitudes toward mental health services and depression screening, a new study indicated that Black American Women are comfortable with using voice or video calls to communicate with mental health providers.”
Only a fifth of the nearly 2.5 million adults with opioid use disorder received medication for the disease 2021, leaving millions without access to addiction treatment, according to new data from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).
The report, published as a research note in JAMA Network Open, also showed sociodemographic health disparities in opioid use disorder treatment access, with Black people, women, individuals who were unemployed, and those in non-metropolitan areas being less likely to receive treatment.
The study looked particularly at medication-assisted treatment, or MAT, which is considered the gold standard in OUD therapy. Drugs like buprenorphine, methadone, and naltrexone have all proven effective for OUD treatment.
While the U.S. government has recently licensed monoclonal antibody therapies (LEQEMBI®), anti-amyloid vaccines may offer a convenient, affordable, and accessible means of preventing and treating Alzheimer’s Disease (AD).
The Lancet’s eBioMedicine recently published a paper that concludes that an immunotherapeutic vaccine candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent AD.
Published on July 29, 2023, this research paper concludes Vaxxinity, Inc. UB-311 is an active immunotherapy, “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).
And UB-311 could offer multiple competitive advantages over licensed passive immunotherapies, including less frequent dosing, a more convenient mode of administration, improved accessibility, and cost-effectiveness.
“Federal spending on Medicare Advantage bonus payments has risen every year since 2015, and will reach at least $12.8 billion this year — an increase of nearly 30% from 2022, according a new KFF analysis.
“Rapid growth in bonus payments has implications for Medicare spending and beneficiary premiums, especially since spending on the bonuses has grown faster than MA enrollment overall, researchers said.
“UnitedHealthcare — the biggest MA insurer — will receive the largest total payments at $3.9 billion. Kaiser Permanente has the highest per-enrollee bonuses at $523.”
“The Department of Justice is requesting more data from Amedisys regarding its proposed $3.3 billion acquisition by UnitedHealth, a move that will push back the timeline of the deal.
“The home health and hospice provider disclosed in a filing with the SEC on Thursday that it received a second request for information from regulators on August 4 regarding the merger.
“UnitedHealth announced plans to acquire Amedisys in June, after the Louisiana-based provider reneged on an existing merger agreement with Option Care Health.”
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