From the Omicron and siblings front, the Wall Street Journal reports
The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.
The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.
Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots.
Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.
Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.
From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.
Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.
From the medical research front, BioPharma Dive reports
Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.
At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.
If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.
The article provides an overview of these RNA drug development efforts.
From the tidbits department —
MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.
Thanks to Aaron Burden for sharing their work on Unsplash.
Congress is on a State / District work break again this week.
The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.
Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.
Here’s a link to a Fierce Healthcare article on the new rules.
The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.
But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.
As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S.
This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.
The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce.
The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.
Fingers crossed.
On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.
NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes
Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.
A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.
The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox.
The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.
From the Rx coverage front, BioPharma Dive reports
The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.
The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.
Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.
Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.
Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.
Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.
From the U.S. healthcare business front, the Wall Street Journal reports
Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.
Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.
CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.
There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.
Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization. The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”
MedPage Today reports “Second COVID booster shot boosted antibodies in Seniors — but small Israeli study did not determine how quickly response will wane.”
At least 18 cases of the newest omicron subvariant BA.2.75 have been confirmed in seven U.S. states as of July 20, early disease surveillance data shows.
Globally, researchers have identified 201 cases in more than a dozen countries as of July 12, according to data from outbreak.info, a platform that tracks data on coronavirus variants and is supported by the CDC and other national research groups.
The subvariant has a large number of mutations that may make it more adept than BA.5 — the nation’s current dominant strain — at spreading quickly and evading immune protection. Experts say it’s still unclear whether BA.2.75 will compete against BA.5 or cause more severe illness, according to CNN.
This leads us to the Wall Street Journal’s editorial board comments
The President’s [Omicron] infection [disclosed today] demonstrates how hard it is to avoid the new and highly transmissible Covid variants. The White House has gone to great lengths to protect Mr. Biden, but there’s only so much staff can do if the President is going to do his job.
Despite continuing pleas from the White House and public-health elite, vaccination by now provides little protection against transmission. * * * The evidence is that the vaccines do reduce the chances of getting serious Covid and being hospitalized, though many elderly patients who have been vaccinated are still dying from the virus.
While this quote is an opinion, not a news report, it struck a chord with the FEHBlog. The FEHBlog wishes the President a speedy recovery.
From the unusual viruses front, the Department of Health and Human Services offers a fact sheet on its response to the monkeypox outbreak.
In mergers and acquisitions news, Healthcare Dive informs us
Amazon has agreed to acquire primary care network One Medical for $18 a share, valuing the company at $3.9 billion.
The all-cash deal for San Francisco-based One Medical comes after months of speculation about a potential acquisition, reportedly drawing interest from companies including CVS Health, according to Bloomberg.
Analysts said a potential buyout for One Medical, which has grown rapidly since it was founded in 2007, could come at a significant premium. Amazon’s price of $18 a share represents a premium of 43% over its closing price of $10.18 a share on Wednesday.
STAT News explains why Amazon pursued adding One Medical to its healthcare portfolio.
With One Medical, Amazon is also tapping deeper into the vein of health care’s payment system. One Medical gets paid through two main avenues: commercial health insurers and Medicare. The Medicare side came from Iora, which One Medical bought for $1.4 billion last year.
Commercially insured patients, or those who get coverage through their jobs, are by far the most profitable within health care and overlap with a large chunk of Amazon’s subscription base. Even though One Medical focuses on less expensive primary care, there’s evidence One Medical charges some of the highest rates for those routine office visits and services, and that’s largely assisted by One Medical’s hospital partners.
Hospitals pay fixed sums to One Medical to care for patients, but they also “extend their health insurance contracts” to One Medical, the company said when it went public in 2020. The result: Hospitals that ink deals with One Medical get the most profitable patients in their market referred to them for more intensive services, and One Medical gets to piggyback off the lucrative payments that those dominant hospitals wring out of insurers.
Amazon’s success — and how disruptive it might prove to be to telehealth competitors — will depend in part on how well it integrates One Medical into its existing in-person and virtual offerings through Amazon Care. Analysts said that will become clear over the next year.
Whether it does draw patients away from traditional health care providers depends on their partnership with payers and their fees, said Aaron Neinstein, vice president of digital health for UCSF Health. “There’s no question that the One Medical annual fee is out of reach for most people in the U.S. Might Amazon change that or bundle it with Prime? Who knows.”F
Health Leaders Media reports that, notwithstanding the Federal Trade Commission’s nascent efforts,
Hospital and health system mergers and acquisitions in Q2 of 2022 have returned to trendlines that Kaufman Hall has been following since the beginning of the pandemic, the consulting firm said in its recently released M&A quarterly report.
During the second quarter of 2022, there were 13 hospital and health system M&A transactions, on-trend and only one transaction less than the 14 transactions reached in Q2 of 2021 and 2020. However, the total transacted revenue in the second quarter reached a “historic high” of $19.2 billion, more than doubling the $8.5 billion transacted revenue in the same quarter in 2021.
From the reports department and via Axios, the FEHBlog ran across this comprehensive McKinsey and Company report on the future of U.S. healthcare: what’s next for the industry post-Covid. Check it out.
From the Rx coverage front, DrugChannels calls our attention to this Amgen preview of 2022 trends in the biosimilars market. Adam Fein observes
As I predicted two years ago, the biosimilar boom is finally here. Prices are dropping while adoption accelerates. Prices are now declining by 9% to 22% annually. For therapeutic areas with biosimilars launched in the last three years, biosimilars’ market share averages 74%. See Amgen slides 8 and 9.
Fierce Healthcare discusses a recent Fitch report on non-profit hospitals.
Labor, supply and capital cost increases have been rampant across the industry this year thanks to broader inflation pressures and other pandemic factors, the ratings agency wrote.
Reversing the margin trends will likely require nonprofit hospitals to take on a combination of rate hikes in the short term, “relentless” cost-cutting and productivity initiatives for the medium term and “transformational changes to the business model” for the long term, Fitch wrote.
Fortunately for those hospitals, many organizations already have the means to weather the storm as they overhaul their operations.
“The vast majority of our rated credits have strong balance sheets that will offset lower margins for a period of time and allow for operational improvements,” Fitch wrote. “Without more substantial changes to the current business model, or with additional coronavirus surges this fall or winter, this balance sheet cushion could eventually erode.”
Rate negotiations with payers will likely be an upward battle, the group wrote.
Healthcare Forefront points out the value of underutilized fentanyl test strips
Fentanyl test strips (FTS) are a simple, inexpensive, and evidence-based method of averting drug overdose. FTS are small strips of paper that can detect the presence of fentanyl in any drug batch—pills, powder, or injectables. This tool might be lifesaving for the teenager experimenting for the first time, the individual in the throes of a severe opioid use disorder, the concert-goer looking for a trip, the person using a preferred substance obtained from a new source, or the individual years into recovery. FTS also support the dignity and well-being of people who use drugs (PWUD), enabling them to make educated decisions about their safety.
And yet after yearsofpress and discussions of the strips’ utility, FTS aren’t as widely available as one would expect them to be. It is time to take a more critical look at the importance of destigmatizing this tool and increasing its distribution and availability, while highlighting the grave risks in not doing so.
U.S. hospitals became much safer places for patients over the past decade, with medical errors and adverse events declining significantly across the nation, federal government data show.
Between 2010 and 2019, patient safety dramatically improved among the four types of conditions for which people are most often hospitalized: heart attacks, heart failure, pneumonia and major surgical procedures.
“There has been a precipitous, very important drop in the number of these events, which to me validates the idea that these were preventable,” said senior researcher Dr. Harlan Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Education in New Haven, Conn. “The status quo wasn’t written in stone. We have been able to actually make hospitals safer for those conditions.”
The new study relied on data gathered by the Medicare Patient Safety Monitoring Program, an effort created in the wake of a landmark 1999 Institute of Medicine report that drew national attention to patient safety in hospitals, the study authors said in background notes.
Fedweek reviews the steps that federal employees should take to position themselves for retirement.
Senate leadership said they reached a deal with centrist Sen. Joe Manchin, D-W.Va., to give Medicare narrow authority to negotiate lower drug prices and extend key Affordable Care Act subsides for another two years.
“We are excited about doing something on prescription drugs,” Schumer said during a press conference Tuesday. “This is something we have waited for.”
Centrist Sen. Joe Manchin, D-W.Va., had reached a narrow deal to give Medicare the power to negotiate for lower prices on up to 10 drugs in 2026 and up to 20 drugs starting in 2029. The package includes a host of other reforms that include a $2,000 cap on out-of-pocket drug costs.
The deal released earlier this month would also repeal a controversial Trump-era rule that stripped Part D rebates of their safe harbor from prosecution under federal anti-kickback laws.
It now includes a two-year extension of a boost to ACA subsidies that has helped fuel record-breaking enrollment of more than 14 million people.
The Senate majority leader plans to move this legislation via the reconciliation process which means the Senate Parliamentarian must confirm that the bill meets the standards for the reconciliation approach.
STAT News adds that the Senate majority leadership has encountered problems from across the aisle in obtaining passage of the must-pass Food and Drug Administration users fee bill which helps fund the thousands of FDA experts who process drug review requests. Absent the necessary user fee funding, these folks will be furloughed.
From the Omicron and siblings front
AHIP tells us
Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommended the use of the Novavax two-dose COVID-19 vaccine as a primary vaccine series for adults 18 years and older. The two dose series is recommended to be administered by intramuscular injection with 3-8 weeks between doses depending on the patient risk and immunocompetency status.
The Committee reviewed data showing the vaccine is approximately 90.4% effective in preventing mild, moderate or severe COVID-19 and 79% effective in a subset of people aged 65 years or older. Additionally, the vaccine had favorable safety data that showed mild side effects. Committee members noted the hope that Novavax’s traditional protein-based vaccine will help to convince the 10-13% of adults who remain unvaccinated to receive a COVID-19 vaccine.
Members also expressed concerns about vial size, potential discard waste, and lack of an expiration date on the vial or carton, with clinicians needing to go to NovavaxCovidVaccine.com to get expiration date. The committee clearly stated that the vaccine is not recommended to be used in combination with other COVID-19 vaccines for primary or booster series completion at this time.
The FDA granted the Novavax vaccine an emergency use authorization on July 14. CDC Director Walensky is expected to make an official recommendation statement on Novavax in the coming day.
The Wall Street Journal reports that natural immunity from contracting Covid, typically has lasts 90 days. However, the highly contagious and current king of Covid infections, Omicron BA.5, can bear natural immunity based on an earlier strain of Omicron. Rest assured that your natural immunity can be expected to last 90 days when you contracted Omicron BA.5.
Also from the public health front,
The New York Times reports on the difficulties that New Yorkers infected with monkeypox have encountered when they seek treatment for that disease.
“What many of us learned in medical schools is that monkeypox is a mild, self-limiting illness,” said Dr. Mary Foote, medical director of the office of emergency preparedness and response at the city’s Department of Health, speaking at a Thursday briefing hosted by the Infectious Diseases Society of America. “But the reality on the ground is that a lot of people with this infection are really suffering.”
What’s also striking, she said, about this outbreak, is “how many of these patients have had difficulty getting the care they need to treat these symptoms.”
[E]ven as global health officials race to curb spread of the virus, most experts polled by STAT said they don’t believe it will be possible to contain it.
Not everyone is categorical — or pessimistic.
Rochelle Walensky, director of the Centers for Disease Control and Prevention, and Rosamund Lewis, the World Health Organization’s technical lead on monkeypox, expressed the belief that with a lot of effort, transmission in the population of men who have sex with men can be stopped.
Walensky’s optimism in this case derives from the fact that, to date, the virus appears to be spreading mainly within a defined community — one that has mobilized to get out the word of the risk its members face.
“Within this community there was a lot of high-risk [exposures] before we were able to test enough, educate enough, both on the provider side and the patient side. And there’s a lot of that happening right now,” Walensky said.
In June, HHS began shipping orthopoxvirus tests to five commercial laboratory companies — Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare — to increase monkeypox testing capacity and access. As of Monday, they all have begun testing, the most recent being Sonic Healthcare. * * *
In addition to increased testing, the CDC has issued travel alerts and expanded access to vaccines in response to the outbreak. HHS also ordered an additional 2.5 million doses of Bavarian Nordic’s Jynneos vaccine to strengthen preparedness. This followed an earlier order made for 2.5 million doses that will begin arriving over the next year and will bring the federal stockpile of vaccine to treat monkeypox to nearly 7 million doses by mid-2023.
Overdose deaths continued increasing in 2019-2020, especially among Black and American Indian/Alaskan Native (AI/AN) individuals, the CDC reported Tuesday.
Overdose deaths in the U.S. increased by about 30% during that period, said Mbabazi Kariisa, PhD, MPH, a health scientist in the CDC’s Division of Overdose Prevention, during a phone briefing with reporters. “We know that health disparities play a key role in overdose death rates among people in certain racial and ethnic minority groups. In just 1 year, overdose death rates increased 44% for Black people and 39% for American Indian and Alaskan Native people.”
STAT News tells us “The deaths were broadly driven by illicit fentanyl, CDC officials said, though deaths attributed to other drug types, including stimulants like methamphetamine, have also been rising in recent years.”
In advocacy news, MedPage Today discusses the American Medical Association President Jack Resneck’s campaign to tie physician burnout to prior authorization and other health insurer hassles. It’s unfortunate that the various health care professional and trade associations can’t work together to reduce healthcare spending while improving quality.
Fresh off the Federal Trade Commission’s successful challenges to four hospital mergers, the Biden administration’s new majority on the commission is primed to more aggressively combat consolidation in the health care industry than it has in past years.
Although hospital mergers were supposed to improve cost efficiency, experts agree that the creation of huge conglomerates and hospital networks has driven up U.S. medical costs, which are by far the highest in the world. Many enjoy near-monopoly pricing power. * * *
Extensive research has found that prices rise when hospital systems acquire or merge with their competitors or when they buy a significant percentage of physician practices in their market. Highly consolidated markets, such as Northern California (dominated by Sutter Health) and western Pennsylvania (dominated by UPMC) tend to have higher prices.
The FTC has a long history, under both Democratic and Republican administrations, of antitrust enforcement actions to block so-called horizontal mergers between hospitals that could stifle competition in a market.
BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Timereported July 11.
Two cases were detected in California and one in Washington as of July 8, according to data from Helix, which works with the CDC on viral surveillance.
The subvariant is gaining traction in India and has also been detected in 10 other countries.
Better start looking over your shoulders Omicron subvariants BA.4 and BA.5.
Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries.
The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week.
In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.
In the U.S., however, Moderna will develop a different dual-target booster, mRNA-1273.222, which goes after both the ancestral strain and the BA.4 and BA.5 subvariants of Omicron. These subvariants, which are nearly identical to each other for the purposes of a vaccine, now account for most new cases of Covid-19 in the U.S.
What about BA.2.75?
An announcement from HHS today points to an FDA emergency use authorization of the traditionally developed Novovax in the near future.
The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.
Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.
Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.
The company has submitted an emergency use authorization request to the US Food and Drug Administration to use sabizabulin to treat COVID-19.
Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.
Benefits Pro calls to our attention health plan stop-loss insurer Sun Life’s top 10 high-cost claim conditions report.
Sun Life’s latest report saw a 354% increase in the number of COVID-19 claims from 2020 to 2021 [the Delta variant] —specifically, 107 claims to 486 claims. Total spend also rose from $30.4M to $114.0M, although the average cost for treatment went from $283.7K to $231.2K over the same period, amounting to an 18% decrease. Even so, COVID-19 landed (“somewhat ironically,” the study stated) at number 19 on Sun Life’s top 20 list of high-cost claim conditions over four years. This is significant, as every other condition on the list has amassed four years worth of claims to COVID’s two, underlining the severity of the pandemic.
Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.
HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.
HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.
At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.
FDA approval of OTC contraceptives should have been approved years ago, in the FEHBlog’s opinion.
From the SDOH front, Health Payer Intelligence informs us
The Association for Community Affiliated Plans (ACAP) has initiated a center designed to spur new ideas about how to address social determinants of health, according to a press release that HealthPayerIntelligence received by email.
“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, chief executive officer of ACAP, shared in the press release.
“Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades. This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment.”
Bravo.
The Wall Street Journal reminds us that the new three-digit 988 suicide hotline launches on Saturday, July 16.
Health officials preparing to broaden the reach of a national mental-health crisis line are working to strengthen an overstretched network of call centers that didn’t connect with about one in six callers in recent years, a Wall Street Journal data review showed.
The National Suicide Prevention Lifeline will transition on July 16 to a three-digit number for calls and texts, 988, from a 10-digit number that has operated since 2005 in coordination with local crisis centers. The line’s operators, including the Substance Abuse and Mental Health Services Administration and the nonprofit Vibrant Emotional Health, said they expect an increase in calls to the shorter and more memorable 988 number during the next year. Stress, suffering and disruption of routines during the pandemic has worsened many people’s mental health, clinicians have said.
Congress returns on Monday with Democrats aiming to revive central pieces of President Biden’s stalled economic agenda while trying to keep on track a separate, bipartisan bill targeted at boosting competitiveness with China that top Republicans are threatening to block.
House Democrats also are set to roll out legislation responding to the Supreme Court ruling ending federal abortion protections. The push could include legislation to write into law the right to an abortion before fetal viability, as well as a bill intended to block any state attempts to criminalize travel for the purpose of getting an abortion. The bills wouldn’t have enough support to pass the Senate.
The three-week work period may be the last chance lawmakers have for a legislative victory before campaigning begins in earnest for midterm election races across the country. Republicans are heavily favored to win back control of the House this fall, while the Senate is seen as a tossup.
From the Omicron and siblings front, MedTecHDive Dive informs us
A single antigen test may only be able to correctly identify the virus 60% of the time in patients who have the omicron variant and who display symptoms of the disease, Tim Stenzel, director of the Food and Drug Administration’s Office of In Vitro Diagnostics and Radiological Health, said during a [recent[ meeting on testing.
The FDA is seeing an increase in samples with the omicron variant that have a relatively low viral load, also referred to as a low positive. “Instead of seeing the usual 10% to 20% low positives in clinical studies last year, we saw a jump to 30% to 40% low positives,” Stenzel said. “When you have 40% low positives… you’re going to see a really big hit in sensitivity.”
The lower sensitivity means people testing for Covid should use multiple antigen tests to rule out a negative result, with 24 to 48 hours between tests, according to the regulator.
From the unusual viruses front, Medpage Today discusses the ties between cases of monkeypox and syphillis.
Syphilis is a known sexually transmitted infection (STI) that can manifest in lesions in the groin area and can transmit through bodily fluid. The genital sores associated with syphilis can make it easier to transmit other diseases such as HIV — and especially pressing at the current moment, genital sores or lesions are also common transmission pathways for the current B1 monkeypox outbreak. While monkeypox has not technically been categorized as an STI, there have been reports of some monkeypox patients also having STIs.
By scaling up testing and treatment for syphilis, we can better identify people who may be more likely to get and transmit monkeypox. Additionally, because the lesions in the genital region can be difficult to distinguish from those associated with syphilis, testing for both conditions is important.
The incidence of syphilis has been increasing in the U.S. In 2020 alone, there were more than 130,000 new cases of syphilis. While 43% of the new infections occur in men who have sex with men, cases have also been rising in heterosexual men and women, and over 50% of the new infections were in people ages 15 to 24.
From the U.S. healthcare front, Fierce Healthcare tells us
Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday. * * *
HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.
Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.
UnitedHealth Group [Optum’s parent] is aiming to address 600 million gaps in care for its members by 2025.
The healthcare and insurance giant released its annual Sustainability Report last week, where it outlined three strategic goals to improve health outcomes and affordability.
Alongside addressing care gaps, the company said it wants to ensure at least 85% of its members receive preventive care each year by 2030 as well as to make sure 55% of outpatient surgeries and radiology services are provided in high-quality, cost-efficient sites of care by 2030.
The CMS’ innovation center has found evidence of implicit bias in three payment models as the agency takes an harder internal look at how its policies might perpetuate health disparities.
The use of certain risk assessment and screening tools, provider processes and payment design algorithms caused some beneficiaries to be unintentionally excluded from the Kidney Care Choices Model, Comprehensive Care for Joint Replacement Model and Million Hearts Cardiovascular Risk Reduction Model, according to a new article published in Health Affairs from Center for Medicare and Medicaid Innovation researchers.
“These findings are troubling” due to limiting access to model participation and stymied efforts to evaluate the models, researchers wrote. CMMI has taken initial steps to address existing bias, and has begun developing a guide to screen and mitigate bias in existing and future models prior to launch, according to the article.
The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.
The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.
Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.
The American Hospital Administration informs us
The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.
Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”
Also, from the SDOH front, MedPage Today informs us
Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.
After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.
The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *
The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).
From the monkeypox front, the Department of Health and Human Services announced
an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox. The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.
Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone. * * *
The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.
The American Hospital Association adds
CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported.
From the Dobbs case front
CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”
In general, the guidance does two things:
1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and
2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.
According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *
From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.
From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.
The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services. * * *
Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.
Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out
Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.
The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.
The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.
Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.
So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?
Probably not, infectious disease experts say.
“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.
The American Hospital Association tells us
More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”
Speaking of hospitals, Beckers Hospital Review reports
Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience. * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience. * * * View the full list of recipients here.
From the Rx coverage front —
The Food and Drug Administration released one of its news roundups today.
Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”
From the interoperability and telehealth fronts
Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
AHRQ offers research on telehealth for women’s preventive healthcare services.
President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.
The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.
The Senate on Thursday took a major step toward broadening America’s commitment to take care of sick veterans, passing a bill to offer new health care and tax-free disability benefits to as many as 3.5 million veterans on an 84-14 vote.
Under the legislation written by Veterans’ Affairs Chairman Jon Tester, D-Mont., and ranking member Jerry Moran, R-Kan., the Department of Veterans Affairs would consider a veteran with any of 23 conditions, ranging from brain cancer to hypertension, who was deployed to a combat zone during the wars in Iraq or in Afghanistan automatically eligible for care at government cost, based on the presumption that exposure to toxic chemicals in the war zone caused the ailments.
The House must now pass the revised bill before President Joe Biden can sign it, which seems likely. The legislation largely mirrors, and slightly expands on, a House bill by Veterans’ Affairs Chairman Mark Takano, D-Calif., that passed 256-174 in March. Biden issued a statement at the time saying he supported the measure.
Under current law, veterans who believe toxic exposure during their service caused them to develop a disease can have trouble proving it, even when the linkage is known. So it’s likely that many veterans are denied care and disability benefits they deserve, advocates say. The new law, at a projected cost of $278.5 billion over 10 years, shifts the calculus, meaning the government will now pay for the care of veterans whose sickness is tied to their service, as well as others whose ailments might not be.
Because the federal government employs many veterans, this bill will reduce benefits costs for the FEHB Program once it becomes law.
From the Omicron and siblings front, the Wall Street Journal informs us
Many people are embarking on a summer of vacations, concerts and weddings put off during the height of the pandemic. Covid-19 is still finding ways to disrupt some of those plans.
Covid-19 isn’t causing acute illness and death on the scale it once did, thanks in part to protection built up by vaccines and prior infections. * * *
The U.S. is logging some 100,000 known cases a day, and many more are being detected via at-home tests health departments don’t track. This is a stark difference from a year ago, when U.S. cases sank below 12,000 a day, the lowest level since the first surge, as vaccinations rose and many hoped the virus was in retreat.
The era of 12,000 cases a day was over when Delta and then Omicron arrived and will remain around until Omicron departs.
In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines.
The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices.
“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan in a statement. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”
While the end of Omicron is not in the offing, the end of prescription drug rebates appears to be getting closer. However, the federal government should not put the kibosh on rebates unless the drug manufacturers agree to maintain the economic equities by offering price reductions equivalent to the rebates.
Drugmaker acquisitions of all sizes could receive closer scrutiny in the future if the Federal Trade Commission follows the advice of experts who spoke at a two-day agency meeting on market concentration and anticompetitive conduct.
The experts, mostly economists and other antitrust regulators, warned that some drugmakers have gained unfair market power due to the breadth of their product portfolios, allowing them to negotiate for preferred or even exclusive status on insurers’ coverage lists and thereby squeeze out competitors.
Taken together with the FTC’s plans to investigate the practices of pharmacy benefit managers, the meeting signals the Biden administration may take a tougher line on monopolistic practices in an effort to spark competition and target drug pricing.
From the Food and Drug Administration front, BioPharma Dive notes that
An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that affects millions of people.
The drug’s developer, Roche, along with Banner Alzheimer’s Institute, the Phoenix-based organization helping lead the study, announced the negative results Thursday. After years following a family believed to be genetically predisposed to the disease, researchers found no significant difference in cognition or the ability to store and retrieve new memories between participants who received the drug and those who got placebo.
The failure is an upset not only to Roche, which hopes to follow its rival Biogen in getting an Alzheimer’s therapy approved for market, but also to the wider Alzheimer’s research field. For years, a protein called beta amyloid has been at the center of efforts to treat the disease. But every drug designed to block this protein, including Biogen’s, has faced setbacks. Roche’s announcement may therefore add to concerns that this protein isn’t the best research target.
In other drug research news, Walgreens announced “the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreen’s flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.”
In U.S healthcare news, the American Medical Association completed its annual meeting. The AMA offers highlights from the session here.
Also, the Commonwealth Fund released its 2022 Scorecard on State Health System Performance.
Hawaii and Massachusetts top the 2022 State Scorecard rankings, based on overall performance across 56 measures of health care access and quality, service use and cost, health disparities, and health outcomes during the COVID-19 pandemic in 2020. The lowest-performing states were Mississippi, Oklahoma, and West Virginia.
From 2000-2019 overall life expectancy in the United States increased by 2.3 years, but the increase was not consistent among racial and ethnic groups and by geographic area. In addition, most of these gains were prior to 2010. This is according to a new study funded by the National Institutes of Health that examined trends in life expectancy at the county level. The study was led by researchers at the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, Seattle, in collaboration with researchers from NIH and published on June 16th in The Lancet.
MedCity News reports “Online healthcare marketplace Sesame closed a $27 million Series B funding round on Tuesday, bringing its total funding to $75 million. David Goldhill, CEO of the New York City-based startup, said the company is ‘an Expedia for medical care’ because patients can buy the care they want directly online, without the middleman of an insurance company.”
From the federal employee benefits front, Govexec delves into the impact of cost of living adjustments on federal employee retirement benefits.
From our Nation’s capital, the New York Times reports,
White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.
Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.
Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out
Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.
The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look.
From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”
From the maternal health front, the American Hospital Association informs us
The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.
From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.
Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.
From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.
From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.
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