Weekend update

Congress

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, HIPAA Privacy and Security Rules, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The House of Representatives and the Senate are in session this week for Committee business and floor voting. This is the House’s last week of scheduled floor voting before the August recess.

The Wall Street Journal reported last Friday evening

President Biden signaled he was prepared to support a narrow bill that lowered prescription drug costs and extended Affordable Care Act subsidies but left out climate provisions, as Senate Democrats grappled with whether to abandon their broader economic agenda after intraparty talks hit an impasse.

Mr. Biden said that if the Senate didn’t move forward with climate legislation, he would turn to executive action, calling clean energy and combating climate change urgent matters. On the prescription drug portion of the agenda, he said the Senate “should move forward, pass it before the August recess, and get it to my desk so I can sign it,” characterizing it as a major victory for American households.

The statement came a day after talks between Sen. Joe Manchin (D., W.Va.) and Senate Majority Leader Chuck Schumer (D., N.Y.) broke down. Mr. Manchin told Mr. Schumer that he would back a prescription-drug proposal but couldn’t yet commit to backing tax increases or climate provisions, citing inflation worries.

From the Omicron and siblings front, NPR tells us

The BA.5 omicron subvariant, which is now the most prevalent coronavirus strain in the United States, is four times more resistant to COVID-19 vaccines, according to a new study.

The strain, which is considered “hypercontagious,” according to the Mayo Clinic, is more defiant against messenger RNA vaccines, which include Pfizer and Moderna.

The BA.5 strain represented 65% of cases from July 3 to 9, according to data from the Centers of Disease Control and Prevention. 

It is contributing to increases in COVID-19 hospitalizations and admissions to intensive care units across the country. 

But vaccines still provide much better protection than going without the safeguards.

Bloomberg Prognosis adds

Bertha Hidalgo, a University of Alabama epidemiologist, was faked out by a variant that never truly got off the launchpad.

“A few weeks ago, I thought BA2.12.1 would drive the summer wave and it would be a small wave, with not too many infections, to be followed by a BA.5 wave when schools reopened,” she says.

Instead, the BA.5 omicron variant decided that the summer of 2022 was its time to shine. The variant is now dominant in the US, according to the Centers for Disease Control and Prevention. Combined with BA.4, it is also powering a surge of the virus in Europe. 

This week, World Health Organization chief Tedros Adhanom Ghebreyesus warned that “new waves of the virus demonstrate again that Covid-19 is nowhere near over.”

The good news is that we now know much more about what strategies are effective for reducing spread of the virus as we go about our lives in these very odd times.

Hidalgo shared her list of best practices:

* Get vaccinated and get all available boosters

* Wear a mask indoors (and outdoors if in crowded spaces)

* Make sure to get a good quality, good fitting mask, like a KN95 

* Use rapid tests before gathering with others, or at the sign of any questionable symptoms

* If gathering indoors, consider improving ventilation through measures like opening windows or running a central HVAC system

“All of these are layers of protection we can take advantage of that are preventive and can help reduce chances of infection and transmission,” she says.

Quite honestly, the FEHBlog relies on vaccines, including boosters, and rapid tests along with common sense.

HR Dive informs us

Employers must now justify mandatory coronavirus testing for workers, the U.S. Equal Employment Opportunity Commission said in a July 12 update to its technical assistance manual.

Until now, the commission took the position that the Americans with Disabilities Act standard for medical examinations always permitted employer worksite COVID-19 testing. 

Going forward, employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify testing to prevent workplace transmission, the agency said. Specifically, an employer must show that testing is job-related and consistent with business necessity, as defined by the ADA.

From the unusual viruses front, Govexec brings us a CDC update on monkeypox. Here are links to

From the U.S. healthcare business front, Fierce Healthcare offers 21st Century advice on improving health plan call centers.

From the mental healthcare front, NPR takes a deep dive into the new 988 suicide and mental health crisis number.

From the HIPAA privacy and security rule enforcement front, HHS’s Office for Civil Rights announced “the resolution of eleven investigations in its Health Insurance Portability and Accountability Act (HIPAA) Right of Access Initiative, bringing the total number of these enforcement actions to thirty-eight since the initiative began.  OCR created this initiative to support individuals’ right to timely access their health records at a reasonable cost under the HIPAA Privacy Rule.” All of the chastised parties were healthcare providers.

This morning the FEHBlog was doing his weekly quality review of the FEHBlog. He noticed that last Thursday, he mentioned a new Kaiser Family Foundation report without providing a topic or a link for his readers. Lo siento. Here is the missing information:

Pregnancy is one of the most common reasons for a hospitalization among non-elderly people. In addition to the cost of the birth itself, pregnancy care also involves costs associated with prenatal visits and often includes care to treat psychological and medical conditions associated with pregnancy, birth, and the post-partum period.

This analysis examines the health costs associated with pregnancy, childbirth, and post-partum care using a subset of claims from the IBM MarketScan Encounter Database from 2018 through 2020 for enrollees in large employer private health plans. It finds that health costs associated with pregnancy, childbirth, and post-partum care average a total of $18,865 and the average out-of-pocket payments total $2,854. The analysis also examine how pregnancy, childbirth, and post-partum health spending among large group enrollees varies by the type of delivery.

The analysis can be found on the Peterson-KFF Health System Tracker, an information hub dedicated to monitoring and assessing the performance of the U.S. health system.

Childbirth also is one of the required out-of-pocket cost requirements for a health plan’s ACA summary of benefits and coverage template.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

West Virginia Democrat Joe Manchin III is yet again upending his party’s priority economic package, jettisoning climate measures and tax increases he previously favored and leaving only provisions focused on lowering health care costs.

Manchin communicated the decision to his negotiating partner, Senate Majority Leader Charles E. Schumer, on Thursday, according to two Democratic sources familiar with the situation.

The move came one day after Manchin expressed heightened anxiety about inflation, after the June consumer price index data released that morning showed inflation climbed 9.1 percent on an annualized basis over the previous year.

and

The House on Thursday passed, 329-101, its version of the fiscal 2023 National Defense Authorization Act, which would authorize $840.2 billion in national defense spending, after sifting through hundreds of amendments and hours of debate.

The sprawling Pentagon policy bill, which has been enacted into law every year for the past 61 years, would authorize funds for the Defense Department and national security programs within the Department of Energy. * * *

In the coming months, the Senate will take up its own version of the annual defense policy bill.

This must-pass bill typically includes significant federal procurement changes that can impact FEHB contracts.

From the Omicron and siblings front, MedPage Today offers an expert opinion on whether to get a second Covid booster or wait until the fall for potentially improved Covid shots?

For those still deciding, the CDC’s booster calculator provides guidance for anyone unsure about their eligibility. Generally speaking, for people age 60 and older, a first booster is recommended for those who received primary immunization more than 5 months previously, and a second booster is recommended for those who received their first booster more than 4 months ago.

James Grisolia, MD, a San Diego neurologist, described it as a physician’s dilemma. “While we were between surges, I would have given similar advice (to wait before getting the second booster) but as of several weeks ago, it was obvious we were going into another surge. I began encouraging older folks to get their second booster.”

From the FEHB front —

  • Fedweek discusses the differences in levels of FEHB coverage.
  • Benefits consultant Tammy Flanagan wraps up her three-part series on one federal employee’s journey into retirement with an article on FEHB issues.

From the telehealth front, Healthcare Dive offers an interview with Teladoc’s chief medical officer, Vidya Raman-Tangella.

From the mental healthcare front, here is a link to SAMHSA’s 988 nationwide suicide/mental healthcare crisis hotline which becomes available on Saturday, July 16.

From the reports department

  • CVS Health released its Health Care Insights 2022 report.
  • The Kaiser Family Foundation issued a report on the cost of delivering a baby in the U.S. “This analysis examines the health costs associated with pregnancy, childbirth, and post-partum care using a subset of claims from the IBM MarketScan Encounter Database from 2018 through 2020 for enrollees in large employer private health plans. It finds that health costs associated with pregnancy, childbirth, and post-partum care average a total of $18,865 and the average out-of-pocket payments total $2,854.”

From the U.S. healthcare business front, MedPage Today identifies the largest physician groups in our country.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare informs us

House Rep. Lloyd Doggett, D-Texas, introduced the Assuring Medicare’s Promise Act on Monday aimed at redirecting income tax revenue as a solution to Medicare’s hospital fund that will run out of money in 2028. * * *

The legislation aims to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. * * *

If the bill is implemented, Doggett expects Medicare Trust Fund solvency to be extended through 2040.

The legislation comes as Congress is taking a sharper eye at ways to shore up Medicare’s finances. The Senate, for instance, is eyeing closing similar loopholes for NIIT and would extend Medicare solvency for another three years, according to a CNN report.

Senate Democrats are working on a deal to give Medicare the power to negotiate lower drug prices, and the tax provisions could be included. 

From the Omicron and siblings front, we have mixed bag Covid news from the Wall Street Journal.

Covid-19 is circulating widely as the BA.5 Omicron subvariant elevates the risk of reinfections and rising case counts, spoiling chances for a summer reprieve from the pandemic across much of the U.S.

Covid-19 levels are high in a fifth of U.S. counties, according to the Centers for Disease Control and Prevention’s metric based on case and hospital data, a share that has been mostly rising since mid-April. BA.5 is estimated to represent nearly two in three recent U.S. cases that are averaging just more than 100,000 a day, CDC data show. The true number of infections may be roughly six times as high, some virus experts said, in part because so many people are using at-home tests that state health departments largely don’t track.  * * *

The pace of hospital admissions for Covid-19-positive patients has recently sped up, federal data indicate. The seven-day moving average for confirmed Covid-19 patients in hospitals has topped 34,000, federal data show, up from a low near 10,000 in April but far below January’s record peak topping 150,000.

Many of the hospitalizations are cases where patients test positive after being admitted for other reasons. Deaths are hovering around 300 to 350 a day, Dr. Jha said Tuesday. This is much closer to historic lows than highs, though he called the current level unacceptable.

The reduced threat is one reason a pandemic-fatigued populace is less likely to change behavior when cases are high, said Robert Wachter, chairman of the department of medicine at the University of California, San Francisco. * * * “Part of what motivated people to be super careful for a long time was the fear that I’m going to die of this thing,” Dr. Wachter said. “I think people have less fear of that, and that’s not inappropriate.”

From the U.S. healthcare business front

  • MedPage Today identifies the heavy hitters in Healthcare who topped the recently announced Fortune 500.
  • Insurance News Net reports that “Commercial health insurers suffered a 90% decrease in underwriting income last year as fewer people signed onto group health and instead moved into individual coverage on an exchange or a Medicaid program, and COVID care requirements far exceeded expectations. * * * Large, diversified carriers fared best, according to Antonietta Iachetta, AM Best senior financial analyst. “Smaller carriers with concentrations in the commercial business found themselves in an especially difficult position — more than half of insurers with capital and surplus under $50 million posted underwriting losses in 2021, the highest share of companies with losses for that group since 2012,” Iachetta said.”
  • Beckers Payer Issues reviews the history of Mark Cuban’s PBM Cost Plus Drug Co. to identity barriers to competing in that market.
  • Fierce Healthcare tells us, “Optum has quietly teamed with Red Ventures on a new joint venture focused on consumer health. The venture, called RVO Health, covers a mix of assets from both parties, including Optum’s Store and Perks and Red Ventures’ Healthline Media and Healthgrades. Virtual coaching platforms Real Appeal, Wellness Coaching and QuitForLife, news first reported by Axios. Through these elements, RVO includes a slew of consumer offerings, including doctor ratings through Healthgrades, medical information and communications from Healthline, Optum Perks’ prescription savings card and home delivery of health and wellness products through Optum Store.”

From the U.S. healthcare front

The American Hospital Association reports

After declining in recent years, antimicrobial-resistant infections starting during hospitalization grew 15% from 2019 to 2020, the Centers for Disease Control and Prevention reported today, based on limited data for 2020.

“During the pandemic, hospitals experienced personal protective equipment supply challenges, staffing shortages, and longer patient stays,” the agency notes. “Hospitals also treated sicker patients who required more frequent and longer use of medical devices like catheters and ventilators. The impact of the pandemic likely resulted in an increase of healthcare-associated, antimicrobial-resistant infections.”

More than 90% of U.S. hospitals in 2020 had an antibiotic stewardship program aligned with CDC’s Core Elements of Hospital Antibiotic Stewardship, CDC said. The AHA released an antibiotic stewardship toolkit in 2014 to help hospitals and health systems enhance their antimicrobial stewardship programs based on the CDC’s core elements, and in 2017 partnered with CDC on guidance to help small and critical access hospitals implement programs to improve antibiotic prescribing and use and reduce the threat of antibiotic-resistant infections. For more AHA resources to promote the appropriate use of medical resources, click here.

The CDC’s July 2022 Diabetes Insider called attention to its Diabetes and Your Skin website.

From the mental healthcare front, an expert contributor to HR Morning expresses his views on what employees want in mental health coverage from their employer-sponsored health plans.

From the artificial intelligence front, the Journal of AHIMA looks at the administrative cost savings potential of artificial intelligence.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, SDOH–
Photo by Sven Read on Unsplash

From Capitol Hill, the Hill provides a useful outline of scheduled Congressional activities for this week.

From the Omicron and siblings front,

Becker’s Hospital Review reports

BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Time reported 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.

The Wall Street Journal informs us

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.

Medscape tells us

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.

The analysis was published online July 6 in NEJM Evidence.

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.

From the Rx coverage front, Fierce Pharma reports

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.

Fingers crossed for this important initiative.

Weekend Update

David Ermer–Congress, COVID-19, SDOH, U.S. Healthcare, Wellness–
Photo by Tomasz Filipek on Unsplash

Congress returns to Capitol Hill this week following a two-week-long break. Both the House of Representatives and the Senate will be engaged in Committee business and floor voting.

The Wall Street Journal adds

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.

and

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.

From the SDOH front, Healthcare Dive reports

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.

From the nutrition front, Fortune Well offers “7 expert-backed strategies to avoid overeating when you’re working from home” and “4 expert-backed foods for a good night’s sleep.”

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Federal employment benefits, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Capitol Hill front, STAT News provides more information on the Senate Democrats’ drug pricing proposal

The text released Wednesday is similar to a sweeping package that passed the House last year — it would allow Medicare to negotiate prices with drugmakers, it would protect seniors from especially exorbitant drug costs, and it would discourage drugmakers from raising their prices dramatically.

There are some notable changes that will affect when patients see savings, how the drug development pipeline works, how certain patients will pay for insulin, and how the new prices would affect safety-net programs and Medicaid.

The Washington Examiner emphasizes The proposal * * * lacks language included in the lower chamber’s bill that would cap insulin prices for people with diabetes at $35 a month.”

The STAT News article adds

Senate Democrats are taking a gamble and removing all of the provisions that would have lowered patients’ insulin prices out of the bill, to allow a separate, bipartisan effort led by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) to advance.

Now, the HHS secretary would still be allowed to negotiate insulin prices, but only within the parameters and limits of the regular process. Shaheen and Collins’ bill relies on drugmakers voluntarily lowering their prices in exchange for banning rebates for the products.

The brand drug lobby PhRMA blasted the out-of-pocket cost changes, claiming that “Democrats weakened protections for patient costs included in previous versions, while doubling down on sweeping government price-setting policies.”

From the Omicron and siblings’ front

STAT News reports

Six months after regulators issued an emergency use authorization for Paxlovid, physicians say they still have significant questions about prescribing guidelines for the leading treatment for high-risk Covid patients.

STAT spoke with providers who said they and their colleagues aren’t on the same page about when to prescribe Paxlovid or the criteria that separates those who need it from those who do not. They also said it is unclear whether they can give a second course when patients test positive again after taking Paxlovid, a phenomenon known as a rebound. And nearly all the experts who spoke with STAT said that they are clamoring for more data on rebounds, which is complicating and sometimes changing their calculus about when to give the drug.

“There is a real dearth of evidence right now out there, and obviously there’s a lot of confusion,” said Jonathan Li, a physician at Brigham and Women’s Hospital and virology researcher at Harvard Medical School who is also a member of the Covid-19 Treatment Guidelines Panel. “And even amongst people who are immersed in the literature, and who are infectious disease experts, you’ll see actually a fairly wide range in opinions.” * * *

“Pretty much everybody meets the EUA criteria. They made it very, very, very broad,” said David Smith, a professor, physician, and virology researcher at the University of California, San Diego. In a single week in May, over 160,000 Paxlovid prescriptions were filled.

Physicians generally agree that certain high-risk patients — including people who are unvaccinated or those over 65 with multiple comorbidities — should always be prescribed the drug. But the broader eligibility makes it difficult for some physicians to decide who should or should not receive Paxlovid. A child is not likely to need it, but what about a healthy 50-year-old man? A 65-year-old woman? The experts STAT spoke with didn’t agree.

MedPage Today informs us

According to Lawrence Kleinman, MD, MPH, of the department of pediatrics at Rutgers Robert Wood Johnson Medical School in New Jersey, we need to take our time in defining long COVID, whether it’s with a checklist, an algorithm, or an entry for the medical dictionary.

“If we defined it a certain way and we missed something in that initial definition, then there will be silence on that until someone comes around and does a postmortem on our analysis,” Kleinman, who is also the lead researcher in the Rutgers pediatric hub of the NIH’s nationwide RECOVER study, told MedPage Today. “We want to avoid that to the extent that’s possible.”

He said more research and data collection are needed before the work of defining long COVID is possible in a clinically meaningful way. At the moment, he noted, there isn’t even clear criteria for where to start.

For example, should researchers focus on setting a specific number of days a person experiences fatigue after an acute COVID infection? If so, what should those ranges look like — fatigue after 30 days? As he pointed out, there are not enough data to develop the foundational elements needed for researchers to piece together a practical definition just yet.

Nothing is simple.

From the Medicare front, the American Hospital Association reports

The Centers for Medicare & Medicaid Services today released its calendar year 2023 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor to $33.08 in CY 2023, as compared to $34.61 in CY 2022, which reflects the following: the expiration of the 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment. In addition, CMS proposes to delay for one year (until Jan. 1, 2024) the implementation of its policy to define the substantive portion of a split (or shared) visit based on the amount of time spent by the billing practitioner. Under this policy, if a non-physician practitioner performed at least half of an E/M visit and billed for it, Medicare would only pay 85% of the PFS rate.

CMS proposes numerous policy changes to the Medicare Shared Savings Program. For example, it would modify the manner in which accountable care organizations’ benchmarks are calculated to help sustain long-term participation and reduce costs. It also would provide increased flexibility for certain smaller ACOs to share in savings. The rule also proposes updates to MSSP quality-measurement policies, including a new health equity adjustment that would award bonus points to ACOs serving higher proportions of underserved or dually-eligible beneficiaries.

For the Quality Payment Program, CMS proposes five new, optional Merit-based Incentive Payment System Value Pathways that would be available beginning in 2023. These MVPs align the reporting requirements of the four MIPS performance categories around specific clinical specialties, medical conditions or episodes of care. CMS also proposes refinements to the MIPS subgroup reporting process, an increase to the quality data completeness threshold, and changes to the requirements and scoring of the Promoting Interoperability category. The proposed rule also includes requests for input on policy ideas for advancing health equity and transitioning to digital quality measurement.

Comments are due Sept. 7. 

CMS adds

For a fact sheet on the CY 2023 Physician Fee Schedule proposed rule, please visit:https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule

For a fact sheet on the CY 2023 Quality Payment Program proposed changes, please visit (clicking link downloads zip file): https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1972/2023%20Quality%20Payment%20Program%20Proposed%20Rule%20Resources.zip

For a fact sheet on the proposed Medicare Shared Savings Program changes, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule-medicare-shared-savings-program

For a CMS blog on the proposed behavioral health changes, please visit: https://www.cms.gov/blog/strengthening-behavioral-health-care-people-medicare

To view the CY 2023 Physician Fee Schedule and Quality Payment Program proposed rule, please visit: https://www.federalregister.gov/public-inspection/2022-14562/medicare-and-medicaid-programs-calendar-year-2023-payment-policies-under-the-physician-fee-schedule  

From the nicotine front, STAT News tells us

The FDA suddenly reversed course this week on its efforts to ban Juul e-cigarette sales, an embarrassing about-face that calls into question the reasoning behind the agency’s initial decision, experts said.

Tuesday evening, the Food and Drug Administration announced it was giving Juul’s application for its vaping products a second look because of “scientific issues … that warrant additional review.” The move came less than two weeks after the FDA made international headlines for ordering all of the vaping giant’s products off the market, prompting praise from lawmakers and advocates alike.

The FDA previously said that Juul “did not provide [sufficient] evidence and instead left us with significant questions,” which prevented the agency from granting its application. But now, it seems, the FDA is acknowledging there is additional information in Juul’s application that regulators didn’t adequately consider.

Ruh-roh.

From the women’s healthcare front —

Employee Benefit News reports

Fertility benefits and family-building programs have become table stakes for employers looking to support their workforce, but an increasing number of providers and employees are working to offer care during the next stage of reproductive health: menopause. 

Nine out of 10 working women said menopause affects their work performance, according to a survey by AARP, which estimates that companies lose $150 billion a year in lost productivity as a result. Yet, 99% of women in the U.S. don’t have access to an employer-sponsored menopause care benefit. 

“This is an area that nobody has really focused on, and there isn’t much out there available for employees,” says Maya Bodinger, vice president of business development at P.volve. “The menopause transition can be anywhere from four years to 12. This is not just a year or two like how we traditionally think about reproductive health.” 

MedPage reports

Cesarean deliveries have increased in the U.S. over the last few years, driven by a rise in patients who underwent first-time C-sections, according to a CDC report.

While the rate of primary C-sections fluctuated from 2016 to 2019, it increased from 2019 to 2021 among women in all age groups, reported Michelle Osterman, MHS, of the CDC’s National Center for Health Statistics.

The primary cesarean rate reached 22.4% in 2021, Osterman wrote in Vital Statistics Rapid Release.

The repeat cesarean rate, however, which captures patients who have multiple procedures, steadily decreased by around 1% each year from 2016 to 2021 (87.6% to 85.9%), Osterman noted. Repeat cesarean delivery rates decreased specifically for women ages 25 to 39, those who identified as white or Hispanic, and those with full- or late-term pregnancies.

The increase in overall C-sections likely would have been higher if not for the decrease in repeat procedures, she said.

“Because 7 to 9 out of 10 pregnant folks with a prior cesarean will have a repeat cesarean, we can anticipate an overall climb in the overall cesarean delivery rate for the years ahead,” Kjersti Aagaard, MD, PhD, an ob/gyn at Baylor College of Medicine and Texas Children’s Hospital in Houston, told MedPage Today.

Finally, the FEHBlog notes that benefits consultant Tammy Flanagan has released the second part of her three-part story on a typical federal employee’s experience with the federal government’s retirement process. The report appears in Govexec.

Midweek Update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, Telehealth, U.S. Healthcare–

From Capitol Hill, Fierce Healthcare reports

Senate Democrats have narrowly reached a deal on legislation to give Medicare the power to negotiate for lower drug prices.

The Senate released text Wednesday (PDF) on the deal that also repeals the controversial Part D rebate rule and installs a cap on monthly cost-sharing payments for Part D and Medicare Advantage plans. 

The legislative text shows that starting in 2026, the Department of Health and Human Services will choose 10 drugs eligible for negotiation. The next year, the number of eligible drugs will increase to 15, and in 2029 and every year after by 20. 

The sole-source drugs subject to negotiation will be chosen based in part on their total spending under Medicare Parts B and D. There is an exception for small biotech drugs from 2026 through 2028 such as vaccines and excludes certain orphan drugs as well.

Roll Call adds “Congress is fast approaching its scheduled August recess, followed by peak campaign season, so Democratic lawmakers only have a few more weeks in session to push their legislative priorities before they could lose control of either chamber in November.”

From the Omicron and siblings front, the American Hospital Association tells us

The Food and Drug Administration today authorized state-licensed pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) to patients as a treatment for those at high risk of severe COVID-19. Because Paxlovid must be taken within five days of symptom onset, the change could spur expanded access and more-timely treatment of eligible patients. The change was made through an amended emergency use authorization. 

This standing order approach should accelerate the continuing rollout of test to treat locations.

Regrettably the Wall Street Journal adds

Governments, drugmakers and vaccination sites are discarding tens of millions of unused Covid-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce. * * *

In the U.S., about 90.6 million Covid-19 doses have been wasted, or 11.9% of the more than 762 million Covid-19 vaccine doses delivered since the shots became available in late 2020, according to the Centers for Disease Control and Prevention.

The wastage rate has accelerated recently: Some 12 million of the discarded doses have been thrown out since late May.

The disposals come during a significant drop in demand for Covid-19 vaccines, even with young children recently becoming eligible. The seven-day moving average of doses administered daily in the U.S. was about 155,000 as of June 21, down from about 1.1 million on Jan. 1 and the peak of about 3.5 million daily in April 2021.

Partly driving the wastage, health experts said, is the way the Covid-19 vaccines are packaged in multiuse vials containing from five to 20 doses. Once opened, the vials generally must be used within about 12 hours of opening or the remaining doses discarded.

From the telehealth front

Healthcare Dive reports

COVID-19 made its way back into the top five telehealth diagnoses nationally on Fair Health’s monthly tracker in April for the first time since January, according to the report out Wednesday.

Every U.S. census region except the South saw COVID-19 return to the top five diagnoses list, and the uptick is in line with rising cases reported in April by the Centers for Disease Control and Prevention.

Telehealth use overall also rose nationally and in every region after two months of decline, the report found.

Fierce Healthcare informs us

Teladoc is further building out its primary care offering, Primary360, with new services that enhance care coordination and grow in-home options.

Primary360 will now provide care coordination support and health plan in-network referrals alongside free same-day medication delivery from Capsule and in-home, on-demand phlebotomy services backed by Scarlet Health, according to an announcement Wednesday from Teladoc.

The new care coordination capabilities will allow Primary360’s care team to take a “holistic” view of the patient’s coverage and make streamlined referrals to Teladoc services they can access. The care team can also then ensure a patient is referred to an in-network provider when in-person services are necessary.

mHealth Intelligence reports “The burgeoning mental health epidemic in America is widespread across age groups, but the youth have faced a particularly challenging time amid the COVID-19 pandemic. As the youth mental health crisis reaches new heights, providers are increasingly turning to telehealth to help expand access to behavioral healthcare.”

In the same spirit, Health Data Management discusses best practices for hospitals interested in providing acute care at home services.

From the U.S healthcare front, Beckers Hospital Review calls our attention to the fact that “Money, formerly Money Magazine, and Leapfrog Group collaborated for their first shared ranking of “best hospitals” to help consumers make decisions about which healthcare institutions are best for their money. The inaugural list was released July 6 and can be found in full here.” Check it out.

From the fraud, waste and abuse front, Healthcare Dive reports

The federal government won or negotiated more than $5 billion in healthcare fraud judgments and settlements in its 2021 fiscal year, the largest amount ever in the history of the HHS and Department of Justice’s fraud and abuse enforcement program.

Due to those and other efforts from previous years, the government clawed back almost $1.9 billion, according to a new report from the departments.

Of that $1.9 billion, about $1.2 billion went to the Medicare trust funds, which are on increasingly precarious financial footing due to growing stress on the insurance program. In addition, roughly $99 million in federal Medicaid money was transferred back to the CMS.

 Finally, Govexec brings us up to date on projections for 2023 annual raises for federal employees.

President Biden and House appropriators seem thus far to be in agreement that federal employees should receive an average 4.6% pay raise next year, but there are still several steps officials must take before it can be implemented at the end of the year. * * *

On Capitol Hill, there are still a few opportunities for federal employee groups and some lawmakers to try to increase the raise to the average 5.1% figure they have been advocating for.

Happy Independence Day

David Ermer–Congress, COVID-19, SCOTUS–

Congress is on a State / District work break this week.

The Supreme Court ended its October 2021 Term last week by recognizing retiring Justice Stephen Breyer and Judge Ketanji Brown Jackson was sworn in as the 104th Associate Justice of the Supreme Court last Thursday, June 30.

From the Omicron and siblings front –

Bloomberg Prognosis reports on New York City’s significant improvements to its test to treat program.

New York City will start offering Pfizer Inc.’s Covid antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus.

Initially [last Thursday June 30], mobile sites will be stationed outside of pharmacies in Inwood, South Ozone Park and the East Bronx, and will expand to 30 locations by the end of July, Manhattan’s Borough President Mark Levine said on Twitter Thursday. People who test positive for Covid and qualify for Paxlovid will be able to get a prescription on-the-spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.

“We were the epicenter of the Covid pandemic at the start, but we’re leading the way in prevention and mitigation,” [NYC Mayor Eric] Adams said during the press conference. “What we’re doing here other cities can look at to make a determination of how they want to address Covid.”

Bloomberg adds “Earlier on Thursday, Pfizer asked US regulators for full approval of Paxlovid for people at high risk of developing severe disease, bringing the drugmaker one step closer to securing a formal clearance that would allow it to sell and market the antiviral outside of the public health emergency.”  

The Wall Street Journal helpfully tells us

Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. According to an updated list of expiration dates, it may still be good. 

The Food and Drug Administration has extended the expiration dates for some authorized at-home, over-the-counter Covid test kits in recent months, meaning some unused tests may still be viable. 

Many Americans received free tests from the federal government this year. They also bought their own tests, especially at the height of the first Omicron wave that hit much of the country over the winter.

While the FDA initially marked many at-home Covid-19 kits with a fairly short shelf life, additional data gathered since then from manufacturers has given the agency more insight into how long the tests can be used accurately. 

The article also includes a Q&A.

Precision Vaccines wonders when the FDA will consider granting emergency use authorization to the traditionally developed Covid vaccine from Novovax.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Wishing everyone a happy end of the second quarter 2022.

From Capitol Hill, the American Hospital Association informs us

The House Appropriations Committee today voted 32-24 to approve legislation that would provide $242.1 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2023, a 13% increase over the prior fiscal year.

According to a committee summary, the bill would provide $124.2 billion for HHS, $15.6 billion more than the FY 2022 enacted level but slightly below the president’s request.

* * *

Notably, the HHS report language would urge the Centers for Medicare & Medicaid Services to evaluate several aspects of the Medicare Advantage program that are important to hospitals and health systems. Specifically, Congress would urge CMS to assess MA enrollees’ access to long-term acute care hospitals, inpatient rehabilitation facilities and substance use services, including by looking at MA plan prior authorization policies and network adequacy. In addition, the report encourages CMS to examine potential MA plan overpayments with a particular focus on risk adjustment.

The full House is expected to consider the bill in July. 

STAT News reports

Senate Democrats are vetting a new, tweaked version of a drug pricing package as they hurtle toward a September deadline to pass any major reforms.

It’s by no means certain that Congress will pass prescription drug pricing reform as part of a broader domestic policy package being hammered out between Senate Majority Leader Chuck Schumer and moderate Sen. Joe Manchin (D-W.V.), but this week, the chances are looking better than ever. * * *

The new plan looks a lot like the one Democrats settled on last fall — a sweeping overhaul of how the government pays for prescription drugs [which fell short of passage]. There are a few main differences, according to a summary obtained by STAT. The Washington Post first reported the summary. * * *

In the coming days, Senate leadership is planning to ask the Senate’s rules referee to review the policy to see whether it could be passed using a fast-track process known as reconciliation. The original drug pricing plan was never actually vetted by the referee last year, after negotiations soured between the White House and Manchin in December.

Senate Democrats are hoping to finalize tax and climate provisions and put a full bill on the floor as soon as late July, according to a source familiar with the talks. Democrats would have to advance a bill by Sept. 30 to use the reconciliation mechanism, which allows them to advance policy without Republican support.

From the Omicron and siblings front, MedPage Today tells us

The FDA on Thursday called on COVID-19 vaccine manufacturers to include components targeting the latest Omicron strains in bivalent booster shots for the fall and winter 2022 season.

“We have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19.”

If all goes according to plan, the modified vaccines could potentially be available in “early to mid-fall,” he said.

The Robert Wood Johnson Foundation calls our attention to the following resource:

The US COVID Atlas, led by University of Chicago with support from RWJF, is a near real-time visualization tool that helps you access current, validated county-level data and spatial analysis to better understand the spread in communities and to bolster planning efforts.

* Identify hotspots in real-time 

* Track vaccination rates by region or county 

* Locate areas that will soon be affected by the virus  

* Connect social, economic, and health indicators for meaningful community context

From the rural health care front, the American Hospital Association informs us

The Centers for Medicare & Medicaid Services today released a proposed rule establishing the conditions of participation for Rural Emergency Hospitals and updating a few requirements for Critical Access Hospitals. The Consolidated Appropriations Act of 2021 established REHs to preserve an emergency presence in communities where rural hospitals could no longer be sustained. By law, REHs can provide emergency services, observation care, and additional medical and health outpatient services. CMS has proposed standards for REHs based largely on the current CAH CoPs and, where appropriate, on outpatient services’ requirements. CMS is seeking input from the rural community on specific proposed REH standards, including the ability of an REH to provide low-risk labor and delivery services and the minimum qualifications for professionals who will provide on call emergency services.

HHS adds

For today’s rule, the comment period closes on August 29, 2022.

For more information on the Rural Emergency Hospital and Critical Access Hospital Conditions of Participation, visit: https://www.federalregister.gov/public-inspection/current

To read the Fact Sheet on the Rural Emergency Hospital and Critical Access Hospital Conditions of Participation, visit: https://www.cms.gov/newsroom/fact-sheets/conditions-participation-rural-emergency-hospitals-and-critical-access-hospital-cop-updates-cms-3419.

To read the Fact Sheet on HHS actions to strengthen rural health, click here:  https://www.hhs.gov/sites/default/files/rural-health-fact-sheet.pdf

From the transparency front, STAT News reminds us

The federal government’s latest push for more health care price transparency starts July 1, and it is focused on those who are writing the checks: Health insurance companies and employers that directly pay for their workers’ medical care will have to start posting data on what they pay hospitals, doctors, and other providers.

The law requires all health insurers and self-insured employers (also known as self-funded) to publish machine-readable files with two sets of information: the negotiated prices paid to in-network hospitals and doctors, and the allowed rates paid to out-of-network hospitals and doctors. This data — which has to be on a public website, just like hospitals’ prices — does not reflect what workers pay out-of-pocket for care, but does reflect the premiums that employers and workers pay.

The law also says insurers and employers have to disclose what they pay for prescription drugs. However, that has been punted for now while the federal government mulls “whether this requirement remains appropriate,” according to an April notice.

From the second-quarter earnings front, the Wall Street Journal reports “Walgreens Boots Alliance Inc. is bracing for a recession and life after Covid.  The second-biggest U.S. drugstore chain by stores said Thursday that quarterly sales fell and earnings plunged as revenue from Covid-19 vaccinations dried up. The pharmacy chain also paid out a $683 million opioid settlement.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, MedPage Today reports on yesterday’s House Oversight and Reform Committee hearing on the federal response to the drug overdose crisis. Both parties flogged the government agency witnesses. It’s worth reading. This epidemic merits more attention that Covid at this point in the FEHBlog’s view.

Nevertheless, from the Omnicron and siblings front

The Wall Street Journal reports

The easily spread Omicron BA.4 and BA.5 subvariants represent more than half of all U.S. Covid-19 cases, federal estimates showed, ramping up pressure as a spring surge stretches into summer. 

The two variants represented a combined 52% of cases for the week ended June 25, according to estimates the Centers for Disease Control and Prevention released on Tuesday. The variants were most prevalent—an estimated 60% of cases—in a five-state region that includes Texas, Oklahoma, Louisiana, Arkansas and New Mexico.

What’s more also per the Journal

Federal health authorities moved a step closer to authorizing modified Covid-19 booster shots that better target the Omicron variant and could be rolled out by the fall.

Vaccine advisers to the Food and Drug Administration, which includes doctors and public-health specialists, voted 19 to 2 to recommend updating Covid-19 vaccines to target the Omicron variant.

The recommendation, which the FDA doesn’t have to follow but often does, suggests the agency may go ahead and direct vaccine makers Pfizer Inc., its partner BioNTech SE and Moderna Inc. to proceed with plans to roll out modified boosters.

The vote didn’t specify whether the modified boosters should only target Omicron, or target both Omicron and the ancestral strain of the coronavirus, though several committee members said they preferred a dual-target approach. 

The vote also didn’t specify whether the modified shots should target more recent subvariants of Omicron now dominant in the U.S. * * *

Many members of the committee said they thought it should target the recent subvariants of Omicron, known as BA.4 and BA.5.

After the vote, Dr. Peter Marks, who heads the FDA’s vaccines division, said he took away from the meeting support for shots that target the ancestral strain as well as BA.4 and BA.5.

The options for a fall booster shot include sticking with current vaccines or using updated, Omicron-targeted vaccines that have shown promise in clinical studies. Another option: Use boosters that target more recent Omicron subvariants, including BA.4 and BA.5, but that haven’t been tested in people.

From the hospital systems front, the American Hospital Association informs us

U.S. hospitals and health systems continued to face difficult financial and operational headwinds in May, according to the latest report by Kaufman Hall, based on data from more than 900 hospitals.

“Nearly halfway through 2022, margins are cumulatively negative,” the report notes. “While some metrics have normalized, hospitals continue to perform below pre-pandemic levels, and there is an uncertain outlook for the rest of the year.”

Hospitals continue to see higher labor costs and fewer hours worked, “a sign of inflation and an indicator that long-standing labor shortages are likely worsened by increased turnover,” the authors said.

In addition, the Lown Institute has released its 2022 rankings of socially responsible hospital systems in the U.S. According to the Institute’s press release,

Sixty-six U.S. hospitals earned the distinction of “most socially responsible” by the Lown Institute, a think tank known for its evidence-based assessments of America’s healthcare providers. To achieve this designation, hospitals earned “A” grades across measures of health equity, value, and outcomes. 

Launched in 2020, the Lown Institute Hospitals Index for Social Responsibility draws attention to leading and lagging institutions nationwide, and provides benchmarks for hospitals to measure how well they serve their patients and communities. 

From the medical research front —

The National Institutes of Health announced

A Phase 1 clinical trial of a novel influenza vaccine has begun inoculating healthy adult volunteers at the National Institutes of Health Clinical Center in Bethesda, Maryland. The placebo-controlled trial will test the safety of a candidate vaccine, BPL-1357, and its ability to prompt immune responses. The vaccine candidate was developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID). The single-site trial can enroll up to 100 people aged 18 to 55 years and is led by NIAID investigator Matthew J. Memoli, M.D. * * *

“With the BPL-1357 vaccine, especially when given intranasally, we are attempting to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection,” said Dr. Memoli. “This is very different than nearly all other vaccines for influenza or other respiratory viruses, which focus on inducing immunity to a single viral antigen and often do not induce mucosal immunity.”

“Our study will examine the safety of BPL-1357 and also will allow us to assess the importance of mucosal immunity against flu and whether a strategy of inducing both the cellular and antibody arms of the immune system can provide broader protection against the ever-changing influenza virus,” he added.

For additional information about the trial, visit clinicaltrials.gov and search on the trial identifier NCT05027932.

MedTech Dive tells us

If a knee talks, who’s listening? 

That’s the question facing orthopedic surgeons and rehab physicians as they learn to work with a new knee replacement that incorporates sensors and processors to send data about how the joint works from deep inside the patient’s body. 

It’s one of a growing number of devices sending data to physicians to help them monitor their patients, including continuous glucose monitors and wearables to monitor for heart arrhythmia. With this influx of information, medtech companies are still ironing out how to make the data useful for doctors. * * *

“The talking knee is a reality,” Indiana-based Zimmer Biomet announced at the American Academy of Orthopaedic Surgeons’ conference last year. The company was presenting its new knee-implant extension with an embedded sensor just days after receiving de novo clearance from the Food and Drug Administration. 

Now, Zimmer, which developed the device along with California-based Canary Medical, Inc., a company that creates sensors for medical devices, has begun selling the smart knee implant, called Persona IQ. It can measure a patient’s range of motion, step count, stride length, and walking distance from inside the human body. Still, physicians don’t yet know how to use this data to help patients [due to lack of time currently]. * * *

Eventually, sensors will detect problems with implants, help patients adjust their gait or provide data to predict patient outcomes. Meanwhile, competitors are creating systems that use wearable sensors to track patient recovery and hinting at their own plans for sensor-embedded implants. 

Bill Hunter, Canary’s founder and chief executive, said in an interview that medical technology companies are already unleashing a wave of sensor-loaded devices in other sectors.

“Having this ability for the device to provide the clinician with actual feedback from inside the body has implications in most every major medical device,” he said. “So I do believe that you will see this showing up in all kinds of different ways.”

Time will tell but the FEHBlog’s money is on the sensor companies. Fascinating article.