Hospital and health system merger and acquisition activity remained consistent in the first quarter of 2023 with 15 healthcare industry transactions, a slight drop from 17 in the fourth quarter of 2022, according to a new report from hospital consultancy Kaufman Hall. The 15 transactions comprised $12.4 billion in total transacted revenue, down from the high of $12.7 billion in 2018.
Mergers and acquisitions are trending toward cross-regional partnerships, and the size of the smaller party in mergers is increasing to between $250 million and $750 million in annual revenue, according to the report.
Realignment of for-profit health system portfolios continued in the first quarter of 2023, particularly for high financial and operational performing health systems.
AHIP issued a report finding that hospital markups on specialty drugs cost patients thousands of dollars.
Beckers Hospital CFO Reports identifies 22 US hospitals that are cutting care.
UnitedHealthcare’s plans to implement a gold-card program in 2024 might cut another 10 percent of its prior authorization volumes on top of a 20 percent reduction that will roll out this summer, UnitedHealthcare CEO Brian Thompson said during UnitedHealth Group’s April 14 earnings call, which was transcribed by Seeking Alpha.
The payer plans to implement the national gold-card program in early 2024 for care provider groups that meet eligibility requirements, according to a March 29 company news release. The gold-card status applies for most UnitedHealthcare members across commercial, Medicare Advantage and Medicaid.
Qualifying care provider groups “will follow a simple notification process for most procedure codes rather than the prior authorization process,” according to the release.
From the public health front, Medpage Today reports
Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.
During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.
Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Report.
From the Rx coverage front, the Institute for Clincical and Economic Research released a Final Evidence Report on Lecanemab for Alzheimer’s Disease.
— Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —
— Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
— Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes
Lecanemab is an FDA approved drug that the CDC is considering for Medicare coverage beyond clinical testing. The VA has agreed to cover FDA marketing label uses for the drug in its patient population which overlaps with FEHBP.
From the medical research front, a National Institutes of Health study outlines “opportunities to achieve President Biden’s Cancer Moonshot goal of reducing cancer death rates in the United States. Accelerated progress is needed to achieve Cancer Moonshot goal of cutting the age-adjusted cancer death rate by at least 50% over 25 years, NIH study says.”
The study was conducted by researchers in NCI’s Division of Cancer Epidemiology and Genetics, the Center for Cancer Research, and their collaborators, using data from NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention’s National Center for Health Statistics. The researchers examined trends in age-standardized cancer incidence, survival, and mortality rates from 2000 to 2019 for all cancers combined, as well as for the six cancers that together account for 57% of cancer deaths: lung, colorectal, pancreatic, breast, prostate, and liver. They then projected the overall cancer death rate in 2047 based on the assumption that current trends would continue.
According to their analysis, because of decreasing cancer incidence and improvements in survival, age-adjusted death rates from all cancers combined declined by 1.4% per year from 2000 to 2015 and by 2.3% per year from 2016 to 2019. These declines reflect substantial reductions in deaths from lung cancer (-4.7% per year during 2014–2019), as well as colorectal cancer (-2.0% per year during 2010–2019) and breast cancer (-1.2% per year during 2013–2019).
Trends in prostate, pancreatic, and liver cancer death rates have been less promising. Death rates from prostate cancer had declined strongly (-3.4% per year during 2000–2013), but the decline has slowed (to -0.6% per year during 2013–2019). Death rates from pancreatic cancer have been increasing (0.2% per year during 2006–2019). Death rates from liver cancer, which had been increasing for decades, recently began to decline (-0.5% per year during 2016–2019). Death rates from all other cancer types combined have declined (-1.7% per year during 2016–2019).
Dear FEHBlog readers — The FEHBlog wrote a quick blog post for Thursday but overlooked hitting the publish button, so here are the two items from Thursday and the remainder from Friday.
Wednesday afternoon, the Affordable Care Act regulators issued ACA FAQ 59 about the Braidwood Management decision. The FAQs expressly endorsed OPM’s informal administration action last Friday using FEHB Act Section 8902(d) to endorse the U.S. Preventive Services Task Force recommendations that the decision rejected because they had no federal government endorsement. The FEHBlog wonders why HHS hasn’t pulled this page out of OPM’s playbook.
Wednesday night, the U.S. Court of Appeals for the Fifth Circuit (2-1 decision) stayed a portion of the abortion pill injunction on statute of limitations grounds in a 42-page opinion. The Fifth Circuit opinion allows the abortion pill to stay on the market with reinstated in-person medical visit prerequisites and without delivery by mail. The Attorney General has stated that he will ask the Supreme Court to weigh in. Axios reports that the Supreme Court would decide quickly.
Axios was correct because the Wall Street Journal reported that today
The Supreme Court temporarily blocked lower court orders that would have limited access to the abortion drug mifepristone beginning Saturday, preserving the pill’s availability while the justices weigh the Biden administration’s emergency request to leave current Food and Drug Administration approvals in place during a continuing legal battle with antiabortion groups.
In a pair of orders Friday, Justice Samuel Alito, who oversees emergency matters for the lower courts that limited or suspended approval of the widely used abortion pill, gave the antiabortion groups until noon Tuesday to file briefs in response to appeals by the FDA and Danco Laboratories LLC, which makes the branded version Mifeprex.
The temporary orders expire at 11:59 p.m. Wednesday, suggesting a high court decision on whether and to what extent mifepristone will remain available during litigation may come by then.
In other judicial news, the American Hospital Association informs us
The U.S. Supreme Court today unanimously reversed a 9th Circuit decision that impliedly stripped federal district courts of jurisdiction over constitutional challenges to the Federal Trade Commission structure, procedures and existence. Ruling in the FTC case and another case involving the Securities and Exchange Commission, the Supreme Court said, “The statutory review schemes set out in the Securities Exchange Act and Federal Trade Commission Act do not displace a district court’s federal-question jurisdiction over claims challenging as unconstitutional the structure or existence of the SEC or FTC.”
As a result of this decision, parties may bring claims in federal court alleging that “the structure, or even existence, of an agency violates the Constitution” without having to first go through costly and time-consuming administrative proceedings before the SEC or FTC.
Office of Management and Budget guidance released Thursday tasks agencies with developing a new system to monitor their “organizational health and organizational performance” on an ongoing basis. With the new system comes an expectation that federal agencies will rely less on telework and remote work, although that must be balanced with the need to compete for talent with private sector employers who continue to offer similar workplace flexibilities, wrote OMB Deputy Director for Management Jason Miller in a blog post accompanying the memo.
Federal News Network reports OPM’s implementation of the Postal Service Health Benefits Program.
From the public health front
The Centers for Disease Control begins to bring down the curtain on its now bi-weekly review of its Covid statistics and updates us on the bird flu situation.
The Food and Drug Administration announced granting emergency use authorization to an improved Covid test.
The Robert Wood Johnson Foundation offers various perspectives on achieving joyful, healthy births for all, a worthy goal.
Medscape identifies troubling trends in colorectal cancer data recently released by the American Cancer Society.
From the regulatory front —
Mercer Consulting offers advice on the recent instructions concerning RxDC reporting for the 2022 reference year due June 1.
The Office of Civil Rights is providing a 90-day transition period for healthcare providers to come into compliance with the HIPAA Rules regarding telehealth, according to the Department of Health and Human Services OCR.
The transition period will be in effect beginning on May 12 and will expire at 11:59 p.m. on August 9.
OCR said it would continue to exercise its enforcement discretion and not impose penalties on covered providers for noncompliance during the 90- day transition period.
During the public health emergency, providers did not have to be licensed in the state where the patient was located. They were allowed to treat patients in other states.
Also, under the PHE, non-HIPAA-compliant platforms were allowed as long as they were not public facing.
Both of these flexibilities are coming to an end with the PHE on May 11, with providers now getting a 90-day grace period.
Other telehealth provisions expire at the end of 2023 and 2024
From the Rx coverage front —
Fierce Healthcare informs us that Cigna’s Express Scripts unveiled two new programs on Thursday, Copay Assurance and ClearCare Rx, which reminds the FEHBlog of OPM’s transparent pharmacy pricing program.
The Institute for Clinical and Economic Research (ICER) published an
Evidence Report on Treatments for Non-Alcoholic Steatohepatitis [liver inflammation]
— Evidence suggests that both resmetirom and obeticholic acid improve liver histology without evidence yet demonstrating improved long-term outcomes; obeticholic acid has more concerning side effects —
— Current evidence suggests that resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year, while obeticholic acid would achieve these thresholds if priced between $32,800-$40,700 per year —
— At the April 28 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money —
From the U.S. healthcare business front
Beckers Payer Issues reports, “UnitedHealth Group posted revenues of $91.9 billion in the first quarter of 2023, up 15 percent from $80.1 billion over the same period last year, according to the company’s earnings report released April 14.”
Beckers Hospital Review ranks 29 physician specialties by annual compensation.
Congress remains on a District / State work break which concludes next Monday following the Easter and Passover holidays.
OPM has rescheduled the second day of the 2023 OPM AHIIP carrier conference for April 20, 2023 from 11 am to 4:15 pm ET.
From the public health front —
NPR Shots discusses the simple intervention that may keep Black moms healthier — daily home-administered blood pressure readings.
Blood pressure is just one way to measure a person’s health, but during pregnancy and soon after, it’s a critical metric. Unchecked, high blood pressure can contribute to serious complications for the pregnant woman and baby, and increase the risk of death.
Politico tells about new efforts underway to solve the crisis in mental health problems among children and adolescents that accompanied the Covid pandemic.
Sen. Bob Casey (D-Pa.) plans to introduce three bills aimed at improving mental health care for kids, one of his aides told POLITICO. One bill, set to be reintroduced soon, would create grants for children’s mental health services and make them more accessible. Another would help gather more accurate national data on mental health and children, and the third would focus on the mental health of kids in foster care.
And children’s health providers tell government leaders it’s now critical that the federal government step up support for an overburdened system, arguing for increased funding for graduate medical education programs and boosted government reimbursement rates for mental health services.
From the Rx coverage front —
USA Today discusses challenges related to using the new generation of weight loss drugs. “Drugmakers are working hard to convince Americans they need their next-generation weight loss medications. But many come with side effects – and the fact we don’t really know what happens long-term.”
The Wall Street Journal offers an essay about potential uses for inhalable therapies beyond asthma.
“We’re pushing the boundaries of delivery,” said Philip Santangelo, a professor of biomedical engineering at Emory University.
Respiratory diseases that spread through the air are a key target. Dr. Santangelo and colleagues are developing inhalable drugs that use an RNA-editing tool known as CRISPR-Cas13 and messenger RNA to kill viruses such as Covid-19, influenza and respiratory syncytial virus or RSV. Using nebulizers that dispense medicine as mist via a mask, they have tested the delivery of some of the medicines on rhesus monkeys, cows, horses and pigs. The tests in pigs showed that getting the drugs to the lungs reduces the severity and spread of infections, Dr. Santangelo said.
From the medical research front —
Forbes reports, “Researchers have uncovered an unusual way some cancer cells make nutrients they need to grow, a discovery that could hold the key to starving one of America’s deadliest cancers [pancreatic] with a drug we already possess and raising hopes for a powerful new treatment against a disease that is often caught late and has one of the lowest survival rates of any cancer.”
Fortune Well discusses new developments in cancer testing via blood studies.
Voice of America’s Asian American Changemakers series premiered its final episode recently, featuring the work of the U.S. Office of Personnel Management and the leadership of Director Kiran Ahuja. Asian American Changemakers is a character-driven docuseries highlighting the lives and experiences of Asian Americans in the political and public arena. * * *
Watch the full Asian American Changemakers episode here and learn more about opportunities to serve at opm.gov.
OPM also informed FEHB carriers that “The recent opinion in Braidwood Management, Inc. v. Becerra, — F. Supp. 3d —, 2023 WL 2703229 (N.D. Tex.), in the U.S. District Court for the Northern District of Texas, pertains to the preventive services requirement under the Affordable Care Act; it does not impact the preventive services requirements for FEHB Carriers.” Regardless, and as the FEHBlog anticipated, writers in Health Affairs suggest sensible administrative law approaches to repairing the Braidwood management problem. For example, “the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force’s recommendations, which the CDC director now does before ACIP’s immunization recommendations become effective.” No wonder HHS appealed Braidwood Management to the Fifth Circuit without requesting a stay of the district court’s decision.
In other judicial news, the Washington Post reports
“A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
“The highly anticipated ruling puts on hold the Food and Drug Administration’s approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days to give the government time to appeal.”
Later today, per the AP, “A federal judge in Washington state on Friday ordered U.S. authorities not to make any changes that would restrict access to the abortion medication mifepristone in 17 Democratic-led states that sued over the issue, countering a ruling by a judge in Texas on the same day that ordered a hold on federal approval of the drug.”
From the healthcare of the near future front —
Medscape relates
“US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.
“Most recently, Guardant Health, Inc., announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test.
“Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
I”f these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.”
A Wall Street Journal essay digs into why “doctors are turning to artificial intelligence to help them make the best decisions for patients.
From the public health front –
Fierce Healthcare informs us “Black mothers living in the least vulnerable areas of the U.S. are more likely to die or have worse birth outcomes compared to white mothers living in the most vulnerable areas, a sweeping new study has found.”
Fierce Healthcare tells us “Reports of serious patient safety events among healthcare facilities in 2022 rose 19% from 2021 with falls, the most common such event, rising nearly 27%, according to data reported to The Joint Commission and released Tuesday.”
From the Omicron and siblings front, Kaiser Family News reports
More than three years into the COVID-19 pandemic, about half (53%) the public says they would likely get an annual COVID-19 vaccine if offered similar to an annual flu shot, the latest KFF COVID-19 Vaccine Monitor finds. This includes about a third (32%) who would be “very likely” to do so. The findings provide a window into the potential uptake of an annual COVID-19 vaccine, which the Food and Drug Administration has raised as a potential option to provide future protection from the virus.
* * *
Nearly a quarter (23%) of adults say they’ve gotten the latest bivalent COVID-19 booster, which has been available since September. Similar shares say they have received an earlier booster shot (25%) or have gotten their initial course of vaccinations but no booster (25%). That leaves slightly more than a quarter (27%) who say that they are either partially vaccinated or not vaccinated at all.
Half (49%) of adults say they’ve heard at least something about the Biden administration’s plan to end the COVID-19 public health emergency on May 11.
* * *
Nearly a third (32%) of all adults nationally say they have never tested positive for COVID-19 or never thought they’ve had the virus, and the new survey examines their experiences. This never-had-it group includes nearly half (46%) of adults ages 65 and older, who generally had earlier access to the vaccines due to their high risks.
In other public health news
“The U.S. Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The plan provides a framework for everyone—across the federal government and all of society—to collaborate in ending cancer as we know it, and to realize the vision laid out by President Joe Biden and First Lady Jill Biden’s Cancer Moonshot.”
“The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights on the brain-wasting disease.
“The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.”
Bloomberg Prognosis looks back at the perfect storm of serious ailments that afflicted children worldwide last year. The culprit was socially distancing the kids.
In FDA and drug development news
BioPharma Dive points out five FDA drug decisions to watch for in this quarter. “By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy, two vaccines for RSV and a closely watched ALS drug.”
“The U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”
The Wall Street Journal offers a fascinating look at how Lilly reengineered its drug development business. The article explained that in the last decade, Lilly focused on non-interference with the patent status of existing blockbuster drugs, e.g., squeezing the last egg out of the golden goose. Late last decade, Lilly redirected its focus to bringing new drugs to market regardless of patent concerns. As a result, Lilly is close to receiving FDA market approval for the “King Kong” of obesity drugs Mounjaro.
The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months.
No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose.
The advance of Mounjaro, which is already on the market to treat Type 2 diabetes, has excited doctors and patients who have been waiting decades for effective treatments, while helping turn its maker, Eli Lilly & Co., into themost valuable standalone pharmaceutical company in the U.S. with a market value of more than $300 billion.
The Senate Finance Committee held a hearing today on “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.” Fierce Healthcare reports
Sen. Ron Johnson, R-Wisconsin, said during the hearing that “this whole area is ripe for gamesmanship.” He then asked Matthew Gibbs, PharmD and Capital Rx President, what Capital Rx’s model would bring to the table that sets it apart from other players like Amazon or Mark Cuban Cost Plus Drug that are aiming to shake up the traditional PBM space.
Gibbs emphasized Capital Rx’s focus on transparency, something that sets it apart in the broader market.
“Using a price index like NADAC, which is published by CMS, they actually do the survey of the pharmacies, and getting it more robust so that it’s not voluntary—today it’s a voluntary survey—and getting responses to that will lead us to the actual drug costs,” Gibbs said. “And then you can have your nuances of Costco, Mark Cuban. And the person can actually go in and look and actually be informed about the real prices once and for all. The only way is to level set.”
“We have the tools already,” he said. “We just need to employ them.”
Meanwhile, the National Council of State Legislatures discusses the wide variety of state laws being imposed on PBMs, which only complicates matters.
In Affordable Care Act New, MedPage Today reports, “A federal judge on Thursday struck down the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law’s supporters.” The FEHBlog won’t delve into this case now because he expects the U.S. Court of Appeals for the Fifth Circuit to promptly stay this decision.
From the Omicron and siblings front, WebMD tells us
The CDC has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time.
“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website now explains.
16.4% of people in the U.S. have gotten the latest booster that was released in September, CDC data shows.
MedPage Today opines on a World Health Organization “Booster Update: Here’s What They Got Right and Wrong.”
On May 9 and May 10, an FDA advisory panel will discuss whether to recommend the agency approve what could be the first over-the-counter birth control pill.
The pill, a 0.075-milligram norgestrel tablet [manufactured by French drugmaker Laboratoire HRA Pharma], “is proposed for nonprescription use as a once-daily oral contraceptive to prevent pregnancy,” according to a document published March 29 on the Federal Register.
“Johnson & Johnson will stop developing its experimental vaccine for respiratory syncytial virus in an unexpected retreat from a high-profile research effort that had put the pharmaceutical giant among the leading companies seeking to win the first approval of a preventive shot.
“The company said Wednesday it will discontinue a 23,000-person Phase 3 trial, called Evergreen, of its RSV vaccine in adults following a review of its drug pipeline. The company does not plan to develop the shot for pregnant women or infants, a spokesperson confirmed.
“J&J’s pullback comes amid a restructuring of its infectious disease division, which was reported by Fierce Pharma in February. Its decision also thins the RSV vaccine competition, leaving GSK and Pfizer in the lead with shots that are currently under review by the Food and Drug Administration. Moderna is also developing an RSV vaccine and could file for approval this year.”
Walgreens’ growing U.S. healthcare segment is continuing to bolster the retail health chain’s financial performance. The business, which includes value-based provider VillageMD, recorded $1.6 billion in sales in the second quarter, an increase of $1.1 billion from last year.
VillageMD sales were up 30%, including a boost from its recent acquisition of medical group Summit Health. Specialty pharmacy Shields Health Solutions grew sales 41%, while at-home care provider CareCentrix’s sales were up 25%.
Thanks in part to a jump in revenue in its healthcare segment, Walgreens’ results beat Wall Street expectations even as profit declined more than 20% amid lower COVID-19 vaccine volumes and test sales, higher salary costs, opioid litigation charges and costs associated with its $3.5 billion investment in its Summit acquisition.
Oak Street Health disclosed on Thursday that the antitrust waiting period for its planned sale to CVS Health has expired.
CVS and Oak Street filed the required notification forms under the Hart-Scott-Rodino Act with the Department of Justice and Federal Trade Commission on Feb. 24. The waiting period under the HSR Act ended Monday, according to a new proxy filing from Oak Street.
The disclosure means the $10.6 billion deal has cleared one regulatory hurdle — companies can’t consummate mergers until the HSR waiting period expires — but regulators could still challenge the acquisition on antitrust grounds in the future.
From the healthcare studies front —
Bloomberg tells us the story behind a breast cancer scare. Last week, I noticed a breast cancer study report that struck the FEHBlog as overblown, and it turns out that this report is the breast cancer scare that Bloomberg discusses.
“Losing weight — even if some pounds are gained back — may help your heart over the long term, according to a study published Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes.
“The findings may be welcome news to those who have found it difficult to keep weight off and feared the risks thought to be associated with gaining weight back.
“In the new study, researchers analyzed data from 124 clinical trials with a total of more than 50,000 participants. They found that risk factors for heart disease and Type 2 diabetes decreased for people who lost weight through intensive behavioral programs. The diminished risk persisted for years after they were done with the programs, even if some, but not all, of the weight came back.”
“The whole time your weight is less than it would otherwise have been, your risk factors for heart disease are lower than they would have been,” co-author Susan Jebb, a professor of diet and population health at the University of Oxford in the United Kingdom, said in an email.
The Centers for Disease Control announced
The expanded availability of opioid use disorder-related telehealth services and medications during the COVID-19 pandemic was associated with a lowered likelihood of fatal drug overdose among Medicare beneficiaries, according to a new study.
“The results of this study add to the growing research documenting the benefits of expanding the use of telehealth services for people with opioid use disorder, as well as the need to improve retention and access to medication treatment for opioid use disorder,” said lead author Christopher M. Jones, PharmD, DrPH, Director of the National Center for Injury Prevention and Control, CDC. “The findings from this collaborative study also highlight the importance of working across agencies to identify successful strategies to address and get ahead of the constantly evolving overdose crisis.”
From the healthcare quality front, Beckers Hospital Review relates
CVS and Optum have struggled to integrate behavioral health into their payer-provider models, Behavioral Health Business reported.
For Optum, the challenges lie in integrating all the different IT systems from the providers the company has bought, Trip Hofer, the CEO of Optum Behavioral Health Solutions, said at the news outlet’s VALUE conference. For example, Optum in 2022 acquired Kelsey Seybold Clinic, a medical group in Houston with 500 healthcare professionals.
“Kelsey Seybold says, ‘Trip, here’s my issue. I have access problems for depression, stress and anxiety for adults.’ And I’m like, ‘Well, we have a ton of solutions for you,'” Mr. Hofer said, according to the March 27 story. “Six months later, we still can’t get it implemented because it’s like, ‘Well, how do I get data back to them?'”
Deborah Fernandez-Turner, DO, deputy chief psychiatric officer of CVS payer subsidiary Aetna, said at the conference that it’s time-consuming and complex to build behavioral health into payer-provider companies.
CVS, for instance, has started bringing mental health providers and virtual behavioral health access into its MinuteClinics, according to the story.
Keep on truckin’
The FEHBlog had planned to discuss the OPM-AHIP carrier conference in this post. However, the second day of the conference was postponed today due to a power outage affecting the webinar operations. The second day will be rescheduled, and the FEHBlog will bring readers up to date then.
Roll Call reports on the state of the debt ceiling negotiations and Senator Bernie Sanders’s encounter today with the Moderna CEO Stéphane Bancel at a Senate hearing that Senate Sanders chaired. The FEHBlog can’t understand why Senator Sanders and his majority colleagues are flipping their lids over a $100 price per vial increase on a low-cost vaccine.
The Medicare Payment Advisory Commission’s recent breakdown of the hospital sector’s financial viability largely struck a different tone from the doom and gloom industry groups have voiced as of late.
The independent commission advises Congress on year-to-year Medicare policy adjustments, which are largely based on data from 2020 and 2021, preliminary data for 2022 and trend projections for upcoming years. It released its annual report to Congress last week.
With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals (AEH) has already criticizedfor “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) rules.
“The Commission anticipates that a 2024 update to hospital payment rates of current law plus 1% would generally be adequate to maintain FFS beneficiaries’ access to hospital inpatient and outpatient care and keep IPPS and OPPS payment rates close to the cost of delivering high-quality care efficiently,” the group wrote in its report (PDF).
This decision must have the American Hospital Association flipping its lid.
The Department of Health and Human Services announced an organ procurement and transplantation network modernization initiative that “includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act.” More background on his announcement is available at Roll Call.
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.
By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.
The FDA is not required to follow the recommendation of its outside advisors, but often does. The mixed votes suggest the FDA will likely grant Biogen accelerated approval for tofersen based on preliminary evidence. This would allow the company to market the drug while it collects additional data to confirm its benefit.
Benefits Pro offers guidance on employer-sponsored health plan coverage of the new weight loss drugs, Mounjaro, Saxenda, and Wegovy. OPM has already decided that FEHB carriers will oprovidecoverage of one or more of these drugs in their 2024 formularies. Currently, carriers are developing their 2024 benefit and rate proposals.
The FEHBlog has flipped his lid because he discovered that OPM hhadrefreshed its FEHB carrier website. This merits further investigation.
Federal health regulators are nearing a decision on whether to authorize a second round of the Omicron-targeted booster shots for the elderly and other people at high-risk of severe Covid-19, people familiar with the agency’s deliberations said.
Food and Drug Administration officials could make the decision within a few weeks, the people said.
The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said.
The Centers for Disease Control and Prevention would then have to recommend the shots for them to become widely available.
From the primary care front, Healthcare Finance informs us
People are shifting away from traditional primary care providers, with about three in 10 foregoing primary care altogether between 2016 and 2022, according to FAIR Health’s new analysis of private claims data.
That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians. * * *
The analysis pointed to evidence showing that primary care improves health regardless of age, sex, race, ethnicity, education, employment, income, health insurance and smoking status. It has also been reported that a gain of 10 additional primary care physicians per 100,000 people is associated with an increase in life expectancy by 51.5 days.
Guiding members to primary care providers is a vital health plan task, in the FEHBlog’s opinion.
From the miscellany department —
Health IT Analytics highlights, “Researchers from Utica University recently leveraged socioeconomic data to gain insights into generational poverty and other health equity barriers that impact patients’ ability to prioritize their health to improve clinical outcomes.”Hela
Health Payer Intelligence relates, “The National Alliance of Healthcare Purchaser Coalitions (National Alliance) has announced the publication of its playbook which aims to encourage biosimilar adoption among employers.”
EHR Intelligence informs us, “Nuance Communications, a Microsoft company, has announced Dragon Ambient eXperience (DAX) Express, the first clinical documentation application to combine conversational and ambient artificial intelligence (AI) with OpenAI’s newest model, ChatGPT-4.:
The FEHBlog’s Friday Insights did not publish as scheduled on Saturday morning. To get the email distribution back on schedule the FEHBlog is combining the Weekend Update and the Cybersecurity Saturday posts below.
Recently, the Centers for Medicare and Medicaid Services confirmed that the No Surprises Act air ambulance reporting will not occur in 2023.
Under section 106 of the No Surprises Act, air ambulance providers, insurance companies, and employer-based health plans must submit to federal regulators information about air ambulance services provided to consumers. The Centers for Medicare & Medicaid Services (CMS) in the Department of Health & Human Services (HHS) is conducting this Air Ambulance data collection (AADC), which will be used to develop a public report on air ambulance services. The proposed rules describing the proposed form and manner of the data collection can be found at this link. The final rules will specify the final reporting requirements, including the data elements and the deadlines for the data collection. The data collection will not begin until after the final rules are published. This page will be updated when the rules are finalized and more information on data collection is available.
From the value added care front, Behavioral Health Business discusses how Aetna and Optum are collaborating with a large mental health provider, Universal Health Services, to develop reliable outcome measurements for mental health services.
When the FDA approved bempedoic acid, marketed under the brand name Nexletol, back in 2020, it was clear that the drug helped lower LDL — “bad”cholesterol. The drug was intended for people who can’t tolerate statin medications due to muscle pain, which is a side effect reported by up to 29% of people who take statins.
What was unknown until now, is whether bempedoic acid also reduced the risk of cardiovascular events. Now, the results of a randomized, controlled trial published in TheNew England Journal of Medicine point to significant benefit. The study included about 14,000 people, all of whom were statin intolerant.
“The big effect was on heart attacks,” says study author Dr. Steven Nissen of Cleveland Clinic.
People who took daily doses of bempedoic acid for more than three years had about a 23% lower risk of having a heart attack, in that period, compared to those taking a placebo.There was also a 19% reduction in coronary revascularizations, which are procedures that restore blood flow to the heart, such as a bypass operation or stenting to open arteries.
A common chemical that is used in correction fluid, paint removers, gun cleaners, aerosol cleaning products, and dry cleaning may be the key culprit behind the dramatic increase in Parkinson’s disease (PD), researchers say.
An international team of researchers reviewed previous research and cited data that suggest the chemical trichloroethylene (TCE) is associated with as much as a 500% increased risk for Parkinson’s disease (PD).
Lead investigator Ray Dorsey, MD, professor of neurology, University of Rochester, New York, called PD “the world’s fastest-growing brain disease,” and told Medscape Medical News that it “may be largely preventable.”
“Countless people have died over generations from cancer and other disease linked to TCE [and] Parkinson’s may be the latest,” he said. “Banning these chemicals, containing contaminated sites, and protecting homes, schools, and buildings at risk may all create a world where Parkinson’s is increasingly rare, not common.”
The paper was published online March 14 in the Journal of Parkinson’s Disease.
The FEHBlog has several friends with Parkinson’s Disease.
From the Medicare front, Health Payer Intelligence relates
Beneficiaries with end-stage renal disease (ESRD) are increasingly shifting from Medicare fee-for-service (FFS) to Medicare Advantage, leading more Medicare Advantage plans to form value-based arrangements with kidney care management companies, according to Avalere.
Beneficiaries with ESRD have typically received coverage through Medicare FFS because only those already enrolled in a Medicare Advantage plan before initiating dialysis were eligible for the private program through 2020.
A provision under the 21st Century Cures Act that went into effect on January 1, 2021, made all Medicare beneficiaries with ESRD eligible to enroll in Medicare Advantage plans.
Although patient safety awareness week is over, the Wall Street Journal makes us aware that
Black boxes on airplanes record detailed information about flights. Now, a technology that goes by the same name and captures just about everything that goes on in an operating room during a surgery is making its way into hospitals.
The OR Black Box, a system of sensors and software, is being used in operating rooms in 24 hospitals in the U.S., Canada and Western Europe. Video, audio, patient vital signs and data from surgical devices are among the information being captured.
The technology is being used primarily to analyze operating-room practices in hopes of reducing medical errors, improving patient safety and making operating rooms more efficient. It can also help hospitals figure out what happened if an operation goes wrong. * * *
Duke University Hospital, where two operating rooms are equipped with black boxes, is using the technology to study and improve on patient positioning for surgery to reduce the possibility of skin-tissue and nerve injuries. It is also studying and using the technology to improve communication among nursing personnel throughout a surgical procedure to ensure that key tasks—such as confirming that surgical instruments and medical devices are available for a procedure—are being completed promptly, effectively and efficiently.
Cybersecurity Saturday
From the cybersecurity policy front, the American Hospital Association informs us that
The Senate Homeland Security and Governmental Affairs Committee held a full Committee hearing examining cybersecurity risks to the healthcare sector on March 16. Witnesses included Scott Dresen, chief information security officer for Corewell Health, a large integrated health system in Michigan.
“The increasing frequency of attack from nation state actors and organized crime has created a sense of urgency within the healthcare sector and we need help from the United States government to respond to these threats more effectively,” Dresen said.
Specifically, he called for enhancing existing partnerships with and between federal agencies, expanding the sharing of actionable threat intelligence, incentivizing access to affordable technology to defend against advanced threats, ensuring there is an adequate cyber workforce, and reforming legislation to encourage the adoption of best practices while not penalizing the victims of cyberattacks.
STAT News reveals why an HHS rule amending the HIPAA Privacy Rule will wreak financial havoc on health systems. The proposed rule was issued in January 2021, so the final rule has been pending for a long time.
The Cybersecurity and Infrastructure Security Agency (CISA) is looking to position a new “Cyber Analytics and Data System” at the center of national cyber defenses, as the agency’s post-EINSTEIN plans come into focus in its fiscal 2024 budget request.
CISA is seeking $424.9 million in the 2024 budget for “CADS.” The program is envisioned as a “system of systems,” budget documents explain, that provides “a robust and scalable analytic environment capable of integrating mission visibility data sets and providing visualization tools and advanced analytic capabilities to CISA cyber operators.”
The new program is part of the “restructuring” of the National Cybersecurity Protection System, according to the documents. More commonly known as “EINSTEIN,” the NCPS has been in place to defend federal agency networks since the Department of Homeland Security’s inception in 2003.
From the cyber breaches front, Tech Target brings us up to date on the DC Health Link breach.
An additional wrinkle to the breach came Monday [March 13] when another user on the same dark web forum using the alias Denfur, who had previously published sample data from the breach, created a thread supposedly aiming to clear up misinformation surrounding the breach.
Claiming to be a friend of IntelBroker, Denfur said the attack vector for the breach was an exposed, insecure database belonging to DC Health Link. Moreover, the poster said the database was likely exposed “for over a year and a half” before the breach occurred. TechTarget Editorial contacted DC Health Link in order to verify Denfur’s claims, but a spokesperson declined to comment.
At least two hacking groups were able to gain access to at least one federal agency’s servers through an old vulnerability in a software development and design product, according to a cybersecurity advisory issued Wednesday.
According to an alert issued by the Cybersecurity and Infrastructure Security Agency, or CISA, hackers were able to gain access to and run unauthorized code on a federal agency’s server, though they were not able to gain privileged access or move deeper into the network. The malicious activity was observed between November 2022 and early January, though the initial compromise goes as far back as August 2021.
Hackers used a vulnerability in old versions of Telerik UI, a software developer kit for designing apps, which, when exploited, allows hackers with access to execute code. The vulnerability was discovered in 2019 and builds on previous vulnerabilities discovered in 2017 that allow bad actors to gain privileged access and “successfully execute remote code on the vulnerable web server.”
The National Vulnerability Database—managed by the National Institute of Standards and Technology—rates this a critical vulnerability, with a score of 9.8 out of 10.
From the cyber vulnerabilities front, HHS’s Healthcare Cybersecurity Coordination Center (HC3) released its February 2023 list of vulnerabilities of interest to the health sector.
In February 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for this month are from Microsoft, Google/Android, Apple, Mozilla, SAP, Citrix, Intel, Cisco, VMWare, Fortinet, and Adobe. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.
Researchers are warning that state-linked and financially motivated threat actors may try to exploit a critical zero-day vulnerability in Microsoft Outlook to launch new attacks against unpatched systems.
Microsoft urged customers to patch their systems against CVE-2023-23397 to address the critical escalation of privilege vulnerability in Microsoft Outlook for Windows, the company said Tuesday. Microsoft Threat Intelligence warned that a Russia-based threat actor launched attacks against targeted victims in several European countries.
Mandiant researchers warned that other criminal and cyber-espionage actors will race to find new victims vulnerable to the zero day before organizations can apply patches.
CISA added three and then one more known exploited vulnerability to its catalog this week.
Security Week highlights that “Deepfakes are becoming increasingly popular with cybercriminals, and as these technologies become even easier to use, organizations must become even more vigilant.”
Deepfakes are part of the ongoing trend of weaponized AI. They’re extremely effective in the context of social engineering because they use AI to mimic human communications so well. With tools like these, malicious actors can easily hoodwink people into giving them credentials or other sensitive information, or even transfer money for instant financial gain. Deepfakes represent the next generation of fraud, by enabling bad actors to impersonate people more accurately and thus trick employees, friends, customers, etc., into doing things like turning over sensitive credentials or wiring money.
Here’s one real-world example: Bad actors used deepfake voice technology to defraud a company by using AI to mimic the voice of a CEO to persuade an employee to transfer nearly $250,000 to a Hungarian supplier. Earlier this year, the FBI also warned of an uptick in the use of deepfakes and stolen PII to apply for remote work jobs – especially for positions with access to a lot of sensitive customer data.
The Security Week article also discusses defenses to deepfake tactics.
From the ransomware date infiltration front –
The Federal Bureau of Investigation (FBI), CISA, and the Multi-State Information Sharing and Analysis Center (MS-ISAC) has released a joint cybersecurity advisory (CSA), #StopRansomware: LockBit 3.0. This joint advisory details known indicators of compromise (IOCs) and tactics, techniques, and procedures (TTPs) that FBI investigations correlatedwith LockBit 3.0 ransomware as recently as March 2023. LockBit 3.0 functions as an affiliate-based ransomware variant and is a continuation of LockBit 2.0 and LockBit. CISA encourages network defenders to review and apply the recommendations in the Mitigations section of this CSA.
“Black Basta was initially spotted in early 2022, known for its double extortion attack, the Russian-speaking group not only executes ransomware but also exfiltrates sensitive data, operating a cybercrime marketplace to publicly release it, should a victim fail to pay a ransom. The threat group’s prolific targeting of at least 20 victims in its first two weeks of operation indicates that it is experienced in ransomware and has a steady source of initial access. The level of sophistication by its proficient ransomware operators, and reluctance to recruit or advertise on Dark Web forums, supports why many suspect the nascent Black Basta may even be a rebrand of the Russian-speaking RaaS threat group Conti, or also linked to other Russian-speaking cyber threat groups. Previous HC3 Analyst Notes on Conti and BlackMatter even reinforce the similar tactics, techniques, and procedures (TTPs) shared with Black Basta. Nevertheless, as ransomware attacks continue to increase, this Threat Profile highlights the emerging group and its seasoned cybercriminals and provides best practices to lower risks of being victimized.”
Here is a link to the always interesting Bleeping Computer Week in Ransomware.
the creation of the Ransomware Vulnerability Warning Pilot (RVWP). Through the RVWP, CISA:
Proactively identifies information systems—belonging to critical infrastructure entities—that contain vulnerabilities commonly associated with ransomware intrusions.
Notifies the owners of the affected information systems, which enables the owners to mitigate the vulnerabilities before damaging intrusions occur.
Review the RVWP webpage for details, including information on the authorities and services CISA leverages to enable RVWP notifications.
HelpNetSecurity tells us how to use ChatGPT to improve cyber defenses.
The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state. The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana. The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.
The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:
October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.
Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.
The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.
I also located the CDC’s website on keeping new mothers alive.
This evening the Journal discussed why our country’s maternal mortality rate is so high.
Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.
Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.
More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.
The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.
Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.
In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.
What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”
The FEHBlog’s goal is to provide perspective on this vital issue.
From the Omicron and siblings front, MedPage Today informs us
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.
By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.
“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.
The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.
Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants.
We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will not make any change when the PHE ends: 22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost. Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.
Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.
From the Rx coverage front
STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.
For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.
Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.
In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.
From the No Surprises Act front, Fierce Healthcare reports
An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.
Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.
“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C.
The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider.
These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said.
The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.
The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.
The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.
The FEHBlog doubts that this MedPAC report made anyone happy.
From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.
In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives.
Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects.
Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
“A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Instituteof MIT and Harvard, a biomedical researchcenter in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
“Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.
The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.
From the Rx coverage front —
Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024.
In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.
The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
What is already known about this topic?
The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
What is added by this report?
By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
What are the implications for public health practice?
To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.
Beckers Hospital Review tells us that drug shortages in U.S. emergency departments are increasing. “Standard antibiotics such as amoxicillin continue to be in short supply, as do dextrose 50, dextrose 25, dexamethasone and betamethasone. Even over-the-counter medications such as Tylenol and Motrin are short in some areas due to increased demand, according to Southern Standard.”
In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights
Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards.
The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals.
From the medical research front,
NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
“The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
“This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.”
Thanks, research mice.
From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”
The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.
Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.
Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”
Additional findings from Nomi Health’s Trends in Spend Tracker research include:
Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.
This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year
From the post-Dobbs front, Healthcare Dive relates
Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.
On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.
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