Mental health care Archives - Page 19 of 28

Monday Round-up

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 testing, Electronic health records, Mental health care, No Surprises Act, U.S. Healthcare–August 29, 2022October 10, 2022

Yesterday, the FEHBlog discussed a U.S. Court of Appeals for the 11th Circuit opinion issued last Friday narrowing the scope of a nationwide injunction that a federal district court had imposed on the Biden Administration’s federal government contractor mandate.

Govexec adds today that

The executive order is still enjoined in Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Carolina, South Dakota, Tennessee, Utah, West Virginia and Wyoming as a result of the Friday opinion and the injunctions in the other cases, members of the law firm McGuireWoods noted in a post.
A spokesperson for the Office of Management and Budget told Government Executive on Monday morning the Justice Department is currently reviewing the decision. “At this time, the nationwide injunction remains in effect, and thus agencies should continue not to take any steps to enforce Executive Order 14042.”

The nationwide injunction remains in effect at least until the appellate court issues its mandate to the lower court which typically happens in two weeks.

Also from the Omicron and siblings front, the Wall Street Journal discusses best practices for Covid testing while NPR tells us

The federal government is putting a pause on sending free COVID-19 testing kits to Americans starting in September, due to a lack of funding.
“Ordering through this program will be suspended on Friday, September 2 because Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” the ordering website says.
However, the program is still accepting orders before [next Saturday] Sep. 2.

From the No Surprises Act front, Mercer Consulting announced

A new prescription drug reporting mandate, adopted as part of the 2021 Consolidated Appropriations Act (CAA) (Pub. L. No. 116-260), requires group health plans and health insurers to report detailed data about prescription drug pricing (including rebates) and healthcare spending. The first reports are due by Dec. 27, 2022, and annually thereafter. The departments of Labor, Treasury, and Health and Human Services will use the information to prepare a biannual, publicly available report. The departments have issued interim final rules (IFR) detailing the data to report and recently updated submission instructions describing the mechanics of the reporting process. The updated instructions provide important information about reporting wellness services, prescription drug expenses that are covered by the pharmacy benefit manager and more.
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Download the 21-page print-friendly article for details on the prescription drug reporting rules and the compliance challenges facing group health plans. This GRIST has been updated to reflect the updated submission instructions.

OPM added FEHB plans to the list of reporting plans and insurers. The initial report on the 2020 plan year is due no later than December 27, 2022.

From the FEHB plan design front, Federal News Network reports

Democratic lawmakers are urging the Office of Personnel Management to follow through on its plans to expand federal employees’ medical coverage to cover infertility diagnoses and treatments.
Sen. Tammy Duckworth (D-Ill.) and Government Operations Subcommittee Chairman Gerry Connolly (D-Va.) urged OPM on Monday to ensure all Federal Employee Health Benefits (FEHB) program carriers provide coverage for assistive reproductive technology (ART), which includes in vitro fertilization (IVF), starting in 2023.

The legislators’ demand strikes the FEHBlog as a day late and a dollar short because FEHB carriers and OPM closed their benefit and rate negotiations earlier this month. OPM did ask carriers in the agency’s 2023 call letter to plan on expanding ART coverage or offering a discounted ART network, among other options.

From the maternal health front, the Department of Health and Human Services announced “investments of over $20 million to improve maternal and infant health and implement the White House Blueprint for Addressing the Maternal Health Crisis – PDF. Funding aims to help reduce disparities in maternal and birth outcomes, expand and diversify the workforce caring for pregnant and postpartum individuals, increase access to obstetrics care in rural communities, and support states in tackling inequities in maternal and infant health.”

From the mental healthcare front, Health Payer Intelligence delves into the resources that AHIP has made available.

Seven strategic themes emerged from the list of ways that payers have helped members manage their mental health needs:
* Helping members find the right providers
* Creating opportunities for care through telehealth, online platforms
* Designing new payment models
* Expanding and educating the mental healthcare workforce
* Offering population-based services
* Supporting caregivers
* Expanding research and awareness

The article expounds on each of these themes.

From the U.S. healthcare business front, Fierce Healthcare reports

Months of inching performance gains were upended in July as the nation’s hospitals logged “some of the worst margins since the beginning of the COVID-19 pandemic,” Kaufman Hall wrote in its latest industry report. * * *
What’s more, seven straight months of negative margins “reversed any gains hospitals saw this year” and has the advisory group forecasting a brutal year for the industry.
“July was a disappointing month for hospitals and put 2022 on pace to be the worst financial year hospitals have experienced in a long time,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a statement. “Over the past few years, hospitals and health systems have been able to offset some financial hardship with federal support, but those funding sources have dried up, and hospitals’ bottom lines remain in the red.” * * *
The silver lining in Kaufman Hall’s report were total expenses that, although up 7.6% from July 2021, saw a modest 0.4% decline since June. Those savings came squarely among supply and drug expenses as total labor costs and labor expense per adjusted discharge still grew 0.8% and 3.5%, respectively, since June. Increases in full-time employees per adjusted occupied bed “possibly” suggest increased hiring, the group wrote in the report.

From the electronic health record interoperability front, Becker’s Health IT informs us

Judy Faulkner, CEO of Epic, discussed the company’s vision to build a nationwide health IT infrastructure last week at the annual Users Group Meeting while dressed as Amelia Earhart, according to The Cap Times.
Ms. Faulkner has a history of dressing as characters and historical figures for her highly anticipated keynote address at the meeting every year, and this year she chose Ms. Earhart, the iconic female pilot, as a nod to the meeting’s theme: A Night at the Museum. She talked about new technologies and expectations for Epic and its data platform, Cosmos. * * *
“We are building a nationwide health IT infrastructure to connect the different parts of healthcare,” Ms. Faulkner told the crowd.
Epic’s largest competitor in the hospital market, Oracle Cerner, is also on a mission to digitally connect the U.S. healthcare system. Larry Ellison, chair, co-founder and chief technology officer of Oracle, revealed in June the company’s plans to build a unified national healthcare database after acquiring Cerner earlier this year for $28.4 billion. His vision of a national healthcare database includes anonymized data from hospitals, clinics and providers to give real-time information about patients’ health as well as public health statistics.

Weekend Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, Mental health care, U.S. Healthcare–August 28, 2022October 10, 2022

Congress’s State / District work break ends next Monday Labor Day.

From the Omicron and siblings front, Federal News Network tells us that last Friday the U.S. Court of Appeals for the Eleventh Circuit, which is based in Atlanta, issued a ruling on the federal government’s appeal of a district court preliminary injunction of the Biden Administration’s Covid vaccination mandate on federal government contractors.

The three-judge panel’s majority found that a narrower injunction to block the mandate would have been warranted, and that once the case is fully litigated, the plaintiffs are at least “reasonably” likely to win their claim that the president can’t use his authority under procurement law to mandate vaccines for contractors.
But the court found Georgia District Court Judge Stan Baker went too far by applying the injunction nationwide during the case’s earliest stages last December. Instead, the court ruled, the injunction can only apply to the handful of parties who actually sued. * * *
In this case, that means the government is barred from enforcing the mandate against members of the Associated Builders and Contractors (ABC), and state agencies from seven states that were part of the same suit: Georgia, Alabama, Idaho, Kansas, South Carolina, Utah and West Virginia. * * *
The administration completely suspended enforcement of the contractor mandate right after Judge Baker’s decision last December, and hasn’t yet said how it will respond to the new ruling partially lifting his injunction. A spokesman for the Office of Management and Budget did not immediately respond to an inquiry Friday evening.

From the healthcare cost front, Fierce Healthcare informs us

Healthcare price increases during the past year pale in comparison to those seen across the rest of the economy, suggesting that the healthcare sector has so far been spared from the full impact of 2022’s rapid inflation.
Healthcare’s upward price movement has so far been led by hospitals and nursing homes as opposed to other medical care spend, per an analysis of Bureau of Labor Statistics data released Wednesday.
Policy analysts affiliated with the Kaiser Family Foundation and the Peterson Center on Healthcare wrote that those quicker increases are likely a reflection of staff shortages and rising average wages and are likely to continue “unless hospitals can find ways to operate with fewer staff.”
With health prices often set in advance by the Centers for Medicare & Medicaid Services or private insurance contracting, however, the analysts wrote that “the relatively high rate of inflation seen in the rest of the economy may eventually translate to higher prices for medical care. This may lead to steeper premium increases in the coming years.”

In post-Dobb’s news, the Department of Health and Human Services brings us up to date on the steps that the Biden Administration has taken to protect access to abortion services. Most recently,

Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are under attack and women may be denied medical care. The letter also underscored that current or proposed abortion restriction laws do not negate providers’ responsibilities to comply with federal laws protecting access to emergency health care. Also today, HHS issued a report and plan of action in response to the Dobbs v. Jackson Women’s Health Organization Supreme Court decision.

From the mental healthcare front, NPR brings us inside the operations of 988 call centers in Pennsylvania.

The 2020 law enacting the 988 number also allows states to pass legislation to add a small fee to cell phone bills as a permanent source of funds for 988 and associated mental health services. So far, only four states have done so, and only two more have proposed legislation.
Pennsylvania is not one of those states, and doesn’t have any other funding plan implemented. That worries Kevin Boozel, who heads the County Commissioners Association of Pennsylvania.
“This is life or death,” Boozel says. “And you can’t halfway do it.”
He pointed out that Pennsylvania has decided to hold back on publicizing the new 988 number until next year. The fear is that too many calls could flood the system, and counties need more time to set up funding, hire workers and build capacity for things like those mobile crisis teams.
Challenges aside, In Centre County, Herr McCann emphasizes that calling the hotline works. In most cases, just talking with someone is enough to defuse a crisis.
“When they have someone who is empathetic and who listens, that connection helps them,” she said. That lets people know that “it isn’t hopeless. There is hope out there. There is help out there.”

From the health benefit plan design front, Fierce Healthcare reports

Bicycle Health, a virtual provider for opioid use disorder treatment, has announced it is now part of Cigna Evernorth’s behavioral health network.
The startup’s services will now be available to all Evernorth and Cigna health plan customers in the 24 states where Bicycle Health operates. The potential reach is millions of patients, the company told Fierce Healthcare without disclosing additional details.

In Postal Service news, Govexec reports

More than 200 post offices and other U.S. Postal Service facilities are set to shed some of their operations as soon as this year as the mailing agency seeks to consolidate those functions at larger buildings, according to documents shared by management.
The changes will mean letter carriers no longer go to their local facility to pick up mail for their route, instead traveling farther distances after starting at a consolidated location. The impacted post offices will still conduct their retail operations, but many of the back-end functions will be stripped away and relocated. They are connected to an initial 10 buildings that USPS previously announced it was standing up in previously closed facilities, as well as an additional 11 centers.
Most post offices around the country operate as delivery units, meaning mail carriers go to them to pick up mail and packages for their routes before bringing them to homes and businesses. Postmaster General Louis DeJoy has repeatedly decried this model, saying it is inefficient and can lead to as many as dozens of such units in one metropolitan area. Instead, he is looking to open “sorting and delivery centers” around the country, as well as larger mega-centers, that can take on more work in less space. Letter carriers will have to travel farther to take mail to its final destination, but DeJoy said it will save costs on the contracted trucks that USPS hires to bring mail between various facilities.
The impacted sites are located in Georgia, New York, Texas, Florida, Michigan, Pennsylvania, Ohio, Kansas, Maryland, Massachusetts, West Virginia, Kentucky, Washington, North Carolina, Indiana and Arkansas. The initial consolidations are expected to begin as soon as next month.

Friday Stats and More

David Ermer–COVID-19, Medicare, Mental health care, SDOH–August 26, 2022October 10, 2022

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases for this year.

On the left side of the chart are the peak and downslope of the original Omincron strain, and what a peak it was. On the right side of the chart is the Omicron sibling’s plateau.

The CDC’s weekly review of its Covid statistics adds

As of August 24, 2022, the current 7-day moving average of daily new cases (90,676) decreased 6.7% compared with the previous 7-day moving average (97,184). * * *
CDC Nowcast projections* for the week ending August 27, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 88.7% (95% PI 87.3-89.8%).

Here’s the CDC’s latest chart of daily trends in new Covid hospitalizations:

The CDC’s weekly review adds “The current 7-day daily average for August 17–23, 2022, was 5,314. This is a 6.6% decrease from the prior 7-day average (5,687) from August 10–16, 2022.” That converts to a very low percentage of new Covid cases.

Here is the FEHBlog latest weekly chart of new Covid deaths for 2022:

Omicron is on the left, and Omicron’s siblings are on the right. The CDC’s weekly review adds “The current 7-day moving average of new deaths (390) has decreased 11.6% compared with the previous 7-day moving average (441).”

Contributing to the current low Covid death rate are the Covid vaccines, and here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in the 51st week of 2020 through the 34th week of 2022:

The CDC’s weekly review adds

As of August 24, 2022, 608.9 million vaccine doses have been administered in the United States. Overall, about 262.6 million people, or 79.1% of the total U.S. population, have received at least one dose of vaccine. About 223.9 million people, or 67.4% of the total U.S. population, have been fully vaccinated.

In other Covid news

Medscape reports “Long COVID Mimics Other Post-Viral Conditions.” That’s reassuring.

Medscape also tells us that a major weak spot on the Omicron variants which could lead to effective treatments.

In Covid-related legal news, STAT News informs us

It’s the stuff that headline writers’ dreams are made of: Moderna is suing Pfizer and BioNTech over their Covid vaccines.
As someone who has written dozens of catchy headlines about patent suits and read hundreds more, let me offer a bit of advice: Take several deep breaths. Most likely, this is less dramatic than it seems.
The reality of patent litigation in the pharmaceutical industry is that it proceeds at a glacial pace. And it rarely results in products being pulled from the market (Moderna isn’t even asking for that!) or for payments or royalties so significant that they dramatically change the profitability of a product. These lawsuits, though, can involve sums large enough that they make a financial difference to investors.

Time will tell.

From the monkeypox front, the New York Times reports

Monkeypox cases are declining in New York City and globally as more people get vaccinated and as they change their sexual behavior in response to the outbreak, health officials said this week.
New York City on Thursday reported that 2,885 monkeypox cases had been identified in the city since the first case in the city was identified in May. In mid-August, about 50 new monkeypox cases were being detected each day, a drop from the 70 or so new daily cases emerging in late July and early August, according to city data. * * *
Monkeypox infections are also declining in parts of California and in Europe, which at one point had 90 percent of the world’s cases. The World Health Organization on Thursday reported that monkeypox cases globally dropped 21 percent last week. But the overall trend masked rising cases in other parts of the world, including Latin America and Africa.
In New York, Dr. Vasan attributed the decline to the city’s efforts to get tens of thousands of people vaccinated; the city has administered 69,311 doses of the vaccine, according to city data.

In Medicare news, Fierce Healthcare tells us

More than 28 million people are in a Medicare Advantage (MA) plan in 2022, with the program accounting for nearly half of all Medicare beneficiaries, a new analysis finds.
The analysis, released Thursday by the Kaiser Family Foundation, also showed how spending on MA, especially on quality bonuses, has surged to take up more than half of all federal Medicare spending. The findings underscore the widespread interest in the insurance industry on the MA marketplace, which has grown more lucrative in recent years.
Kaiser found that the share of eligible Medicare beneficiaries who chose an MA plan has more than doubled since 2007, growing from 19% that year to 48% in 2022. An earlier projection from the Congressional Budget Office projected that the percentage of Medicare beneficiaries in MA will swell to 61% by 2032.

From the substance use disorder front, Health IT Analytics reports

A new study by Epic Research and the University of Maryland’s Center for Substance Abuse Research (CESAR) shows that only 5 percent of drug overdose patients admitted to the emergency department are tested for fentanyl and synthetic opioids, despite these drugs being the leading cause of death for Americans 18 to 45 years.
The Centers for Disease Control and Prevention (CDC) report that synthetic opioids are currently the main driver of drug overdose deaths, which increased by 31 percent from 2019 to 2020. Opioids were involved in 75 percent of all drug overdose deaths in 2020, and 82.3 percent of all opioid overdose deaths involved synthetic opioids.

That is confounding.

From the coding front, Becker’s Hospital CFO Review points out the top 10 states with the highest coding rates for social determinants of health diagnoses. The FEHBlog suspects that these states have the most reliable coders.

Thursday Miscellany

David Ermer–COVID treatment, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–August 25, 2022October 10, 2022

From the omicron and siblings front, MedPage Today provides us with good news.

Older patients treated with nirmatrelvir boosted by ritonavir (Paxlovid) for COVID-19 had lower rates of hospitalization and death compared with those not treated with the antiviral during the Omicron wave, according to an observational retrospective cohort study from Israel.
Among patients ages 65 and older, the rate of hospitalization due to COVID was 14.7 cases per 100,000 person-days for the 2,484 patients who received nirmatrelvir compared with 58.9 cases per 100,000 person-days for the 40,337 untreated patients (adjusted HR 0.27, 95% CI 0.15-0.49), reported Ronen Arbel, PhD, of Clalit Health Services in Tel Aviv, and colleagues.
Death occurred in two nirmatrelvir-treated patients and in 158 untreated patients (aHR 0.21, 95% CI 0.05-0.82), they said in the New England Journal of Medicine.

Herd safety, indeed.

From the Rx research and development front, NBC News reports

Two doses of psilocybin pills, along with psychotherapy, helped people with alcohol use disorder reduce drinking for at least eight months after their first treatments, results from the largest clinical trial of its kind show.
During the eight-month trial, 93 men and women ages 25 to 65 were chosen to receive either two psilocybin doses or antihistamine pills, which the researchers used as a placebo. They all also participated in 12 psychotherapy sessions.
All of the volunteers were averaging seven alcoholic drinks at a time before the trial.
More than 80% of those who were given the psychedelic treatment had drastically reduced their drinking eight months after the study started, compared to just over 50% in the antihistamine control group, according to results published Wednesday in JAMA Psychiatry. At the end of the trial, half of those who received psilocybin had quit drinking altogether, compared to about one-quarter of those who were given the antihistamine.

STAT News reports

A vaccine Pfizer is developing protected older adults against the respiratory syncytial virus, or RSV, which is a common cause of hospitalization and death in the U.S., the company said Thursday.
The experimental vaccine, known as RSVpreF, is considered a key product in Pfizer’s pipeline of experimental drugs. Right now drug companies are close to launching several different products against RSV, focused on protecting both older adults and infants.

BioPharma Dive tells us

BioMarin, a California-based biotechnology company, said Wednesday that its gene therapy for hemophilia has been cleared for market by European regulators, marking a first-of-its-kind approval.
The therapy, known as Roctavian, was given conditional marketing authorization as a treatment for certain patients with hemophilia A, the more common version of the rare bleeding disorder. Specifically, Roctavian is to be used in adults with “severe” disease — hallmarked by exceedingly low levels of a blood-clotting protein called Factor VIII — who don’t have a history of developing antibodies that attack this protein.
With approval in hand, BioMarin is now working to secure reimbursement across the European Commission’s various member states. Jeff Ajer, the company’s chief commercial officer, said on a conference call Thursday that the plan is to immediately launch Roctavian in Germany, followed by France. The company expects Roctavian’s list price in Europe to be “around” 1.5 million euros, or roughly $1.5 million, net of all discounts, he said.
Ajer added that BioMarin expects to disclose the specific European list price in October, a number that will be in-line but lower than the comparable net price in the U.S.

From the mental healthcare front —

Fierce Healthcare tells us

Employers view long-term mental health as the key healthcare issue coming out of COVID-19, according to a new survey.
Nearly half (44%) of employers surveyed by the Business Group on Health said they have seen this trend in their workforces, and another 44% expect to see worsening mental health in the future. Most (85%) said they anticipate enhanced mental health benefits launched under the pandemic to continue.
Mental health conditions also ranked sixth on the survey’s list of conditions driving healthcare costs, with 17% of those surveyed saying it was a major driver. This is a marked increase from 9% in 2020 and 14% in 2021.
Brenna Shebel, vice president of the Business Group on Health, said during a briefing with reports Tuesday that many employers are tackling mental health challenges “at all different angles.”

Forbes adds

AHIP, which stands for America’s Health Insurance Plans, issued a statement and “advocacy vision” at a time its member health plans are looking beyond paying and coordinating just medical care but also integrating behavioral health care into benefit plans for their government, commercial and employer clients. * * * Further details of the policy proposals and commitments can be found here.

From the U.S. healthcare business front, we learn about financial results for two health systems involved with the FEHB Program.

Becker’s Hospital Review reports that ” Intermountain Healthcare [based in Utah and serves surrounding states] saw its revenues increase in the first half of this year, and its merger with SCL Health fueled a significant increase in net income, according to recently released financial documents. The financial documents are the first Intermountain has filed since completing a merger with Broomfield, Colo.-based SCL Health in April.

Beckers Hospital CFO Report tells us, “UPMC reported higher revenue in the first half of this year than in the same period of 2021, but the Pittsburgh-based health system’s operating income declined year over year, according to financial documents released Aug. 23. * * * “Throughout 2022, the continued effect of COVID-19, along with conditions in the labor and supply markets have resulted in cost growth in employment, staffing and other operating expenses in excess of revenue growth,” UPMC management wrote in the financial filing.”

Finally STAT News delves into why so many large healthcare companies are interested in Signify Health. Quite simply,

The bidding war over Signify Health — a health technology business that could fetch multibillion-dollar offers from Amazon, CVS, and UnitedHealth Group — is not about its dazzling software or a blockbuster AI algorithm.
The crush of corporate interest, experts said, stems from something much bigger: the opportunity to move medical services back into the home. In-home care is quickly becoming the biggest battlefield in America’s biggest business, with a huge array of companies seeking to move health care outside the institutional walls that have confined it for much of the last century.
Signify Health is among those at the forefront of the quest. The Texas-based company, founded in 2017 as the result of a merger, has built its business around delivering highly detailed assessments of patients by visiting with them in their bedrooms and living rooms, creating better visibility — and clearer data — about their lives and health status.

Monday Roundup

David Ermer–CDC, COVID-19, Mental health care, No Surprises Act, U.S. Healthcare–August 22, 2022October 10, 2022

From the Omicron and unusual viruses front —

STAT News reports

Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots.
Notably, in the same press release, the companies said that a clinical study investigating the safety, tolerability, and immunogenicity of the vaccine, which also includes the original Covid strain, is expected to start this month, meaning data would not be available for the FDA to consider.
The application to authorize the vaccine without new clinical trial data is part of a bold and potentially controversial gambit by the U.S. and its advisers to try and get ahead of the fast-mutating coronavirus, SARS-CoV-2. But it’s one that could also have a big payoff.

The Pharmacy Times tells us

Officials with the FDA have granted an expanded Emergency Use Authorization (EUA) to Novavax for its COVID-19 vaccine, adjuvanted for adolescents 12 through 17 years of age, according to a press release. The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.
The expanded EUA allows for a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents. Doses are now available and primary series immunizations for adolescents can begin once the CDC releases a policy recommendation.

Will the next Novovax approval from the FDA be for a booster?

Medpage Today points to a study suggesting a connection between myocarditis in children and long Covid.

The Wall Street Journal adds

Officials in New York are urging pediatricians and parents to bring patients up to date on polio shots, as evidence suggests the infectious and potentially debilitating poliovirus was present in the state as early as April.
Health officials said they have sent alerts to healthcare providers, hung fliers in houses of worship, grocery stores and summer camps, and talked with community leaders to boost polio vaccination rates in the greater New York City area. Some places including Rockland and Orange counties have polio vaccination rates around 60% among eligible children, compared with a national rate of around 93%, according to federal data.
Polio is particularly insidious, health officials and other public-health experts said, because the majority of cases occur in people who never develop symptoms but can still spread the virus. That silent spread can cause meningitis or paralysis in someone unvaccinated against the disease.

In other public health news, STAT News informs us

Anthony Fauci, the top U.S. infectious diseases official for decades and a leading researcher on crises from HIV to Covid-19, announced Monday that he would be stepping down from his positions in December.
Fauci, 81, has led the National Institute of Allergy and Infectious Diseases for 38 years, serving a line of presidents from both parties since the Reagan administration. He has also served as President Biden’s chief medical adviser since Biden took office. While Fauci has telegraphed that he was planning on leaving those roles in a matter of months, Monday’s announcement makes it official.
But Fauci, known as a tireless workhorse, said he would not be retiring. “After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field,” he said. “I want to use what I have learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.”

From the U.S. healthcare business front, Bloomberg reports

Signify Health Inc. soared the most since its shares started trading last year as UnitedHealth Group Inc., Amazon.com Inc., CVS Health Corp. and Option Care Health Inc. competed to acquire the home-health technology and services provider, according to people familiar with the matter.
UnitedHealth has submitted the highest bid in excess of $30 a share, while Amazon’s offer is close behind, the people said, asking not to be identified as the discussions are private. Signify is holding a board meeting Monday to discuss the bids, the people said. * * *
Final bids are expected Sept. 6, but a deal could come earlier if any of the parties preempt the sales process, the people said. * * *
Through its software and services, Signify aims to help clients — payers like health plans, government programs and employers — shift to value-based payment plans. It’s backed by private equity firm New Mountain Capital, which formed the company in 2017, according to the firm’s website.

That is quite a big business rumble.

From the No Surprises Act front, Prof. Katie Keith and her colleagues wrote two articles on last Friday’s “final, final” independent dispute resolution rule — one concerns its impact on IDR arbitrations and the other on miscellaneous topics.

From the mental healthcare front, Health Payer Intelligence lets us know that “Payers are working toward achieving broader access to mental healthcare and behavioral healthcare services by reimbursing at higher rates and supporting primary care” according to a recent AHIP survey.

Nearly eight in ten health plans had boosted behavioral healthcare workers’ reimbursement rates (78 percent). Additionally, 83 percent of payers had attracted and retained a diverse population of behavioral healthcare providers.
Substance abuse care is becoming more accessible, the survey found. Specifically, more providers have become eligible to offer medication-assisted therapy (MAT). This population has expended 114 percent over the course of three years.
Nearly three-quarters of health plans (72 percent) support behavioral healthcare training for primary care providers. The same share supported primary care providers by helping them find behavioral healthcare specialist referral partners.
Payers have also offered primary care providers the opportunity to call behavioral healthcare specialists via telehealth or telephone in order to consult them on a patient’s condition. More than half of the health plans (56 percent) provide this option. This method has been used in pediatric psychiatry to solve members’ challenges in connecting with specialists.
Health plans reported a couple of main ways that they try to connect members with mental healthcare services. Many plans do this by supporting patient navigation (83 percent). For example, health plans might connect members with community-based organizations that can address their social determinants of health needs.
Additionally, more than eight in ten health plans said they help members secure behavioral healthcare visits. Follow-up on inpatient care and emergency room visits is often part of health plans’ efforts to connect members with mental health services as well. Seventy-eight percent of the plans leveraged specialized case managers to perform this function.

From the medical research and development front —

Biopharma Dive informs us

Gilead’s long-acting HIV shot Sunlenca is now cleared for sale in Europe, marking the first marketing authorization for a treatment the California biotechnology company hopes can be used broadly as a standard therapy and preventive regimen.
The decision by the European Commission, announced Monday, authorizes Sunlenca for patients whose current treatment regimen can no longer keep their infection at bay. Sunlenca, previously called lenacapavir, will be added to other antiviral drugs to boost patients’ immune response and reduce levels of virus in the body.
Gilead is still waiting on a regulatory decision in the U.S., where it has been delayed by manufacturing issues. An approval by the Food and Drug Administration’s December deadline could put the drug on track to reach sales that RBC Capital Markets analysts estimate will climb as high as $4 billion a year.

The Wall Street Journal reports

Zapping the brain with weak electrical currents that mimic normal neural activity can boost memory in healthy older adults, at least over the short term, researchers said in a study published Monday in the journal Nature Neuroscience.
Electrical stimulation of the brain as a potential tool for enhancing memory is a growing field of research, with experiments showing that the ability to recall memories depends upon synchronized activity between different brain regions.
The new research, conducted on people over age 65, “adds to the growing evidence that noninvasive stimulation mimicking the rhythmic brain activity that supports cognition can improve memory” in this population, said Joel Voss, a University of Chicago professor of neurology who wasn’t involved in the research.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–August 15, 2022October 10, 2022

From the federal policy front, Fierce Health tells us about four healthcare policy changes beyond government negotiation of a subset of Medicare-covered drugs and extension of ACA subsidies found in the budget reconciliation bill that Congress approved last week. The President is scheduled to sign the bill into law tomorrow.

Here are four other health policy changes to look for in the bill:

First, expands eligibility for the full amount of low-income Part D subsidies from 135% of the federal poverty line to 150% of the FPL.
Gets rid of the cost-sharing for adult vaccines for Medicare Part D. The FEHBlog has personal experience with this one. In 2020 he received the new Shingrix vaccine under Medicare Part D. The vaccine was eligible for no cost sharing when administered in-network under the Affordable Care Act. However, under Part D, the FEHBlog was charged $200 for each of the two doses. This big bowl of wrong will be remedied in 2023.
Delays the controversial Part D rebate rule, again. “The Trump-era rule would eliminate the safe harbor for Part D rebates, leaving them open to prosecution under federal anti-kickback laws. The rule passed at the tail end of Trump’s term but has never gone into effect. The law would delay the rule from going into effect again into 2032.”
Limits the premium growth on Medicare Part D to no more than six percent a year from 2024 through 2029. “The cap on premium growth is intended to mitigate the impact of other changes to Part D, said Ryan Urgo, managing director of the policy practice at consulting firm Avalere Health. The legislation includes a $2,000 out-of-pocket cost cap on Part D drugs, spread out in installments for the beneficiary over a calendar year. Part D plans will also have to pick up more of the costs for spending in the catastrophic coverage phase, which a beneficiary reaches when their drug costs reach a certain level.”

From the Omicron and siblings front, BioPharma Dive informs us

British drug regulators on Monday approved a two-pronged vaccine from Moderna that’s designed to fight both the original version of the coronavirus and the omicron variant.
The decision makes the U.K. the first country to clear a COVID-19 booster that’s been specifically tailored to a newer form of the virus. While the original shots, like Moderna’s Spikevax, remain strongly effective at preventing hospitalization and death, they’ve had a harder time warding off infections from omicron and its subvariants. * * *
Speaking to a [U.S.] advisory committee in June, executives from Moderna and Pfizer said dual-acting boosters with a BA.4 or BA.5 could be available in large volumes in October and November, although they would first need to undergo regulatory review before they could be administered.
Separately, Novavax on Monday asked the FDA to authorize its COVID-19 vaccine as a booster shot in people 18 and older. The shot is only available as a primary series to those who haven’t yet been vaccinated.

The Centers for Disease Control released updated guidance on what to do if exposed to Covid.

The Wall Street Journal reports on assessing Covid-19 risks after easing CDC guidelines, which began last week. The headline notes, “More decision-making is shifting to individuals, and here is what doctors recommend.”

From the monkeypox front, the Journal discusses “What to Know About Symptoms, Vaccines and How It Spreads,” and Beckers Hospital Review offers five monkeypox updates, including a complete explanation of how the World Health Organization is going about changing the disease’s name.

From the mental healthcare front, about ten years ago, the FEHB Program under OPM’s leadership was the first large employer-sponsored program to cover a form of autism therapy called “applied behavior analysis” (ABA). A STAT News investigation discloses

ABA has long been viewed as the gold standard for kids with autism, so much so that every state mandates insurance coverage. For some families, it is the only option that insurance will cover at all.
But like other pockets of the health care industry, this one has been transformed over the past decade by a flood of investments from private equity firms, drawn by the promise of insurance reimbursement and the rising rate of autism in children across the U.S., now estimated at 1 in 44 kids.
Families and clinicians who once believed fully in the promise of ABA say the financial investors’ fixation on profit has degraded the quality of services kids receive, turning it into the equivalent of fast food therapy. They’ve grown disillusioned with the industry, they told STAT.

The HHS Inspector General is auditing Medicaid claims for ABA. The final audit report is expected later this year.

From the Rx coverage front, the Drug Channel blog discloses

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type.
The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion—an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart. Hospitals accounted for 87% of these skyrocketing 340B purchases.
What’s more, the difference between list prices and discounted 340B purchases also grew, to $49.7 billion (+$7.0 billion). This figure approximates the money collected by 340B covered entities.
340B advocates have been screaming that “drug companies are cutting 340B,” but the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.

From the U.S. healthcare business front, Beckers Payer Issues provides an interview with “Kyu Rhee, MD, a senior vice president at CVS Health and chief medical officer at Aetna. He sat down with Becker’s to discuss ongoing trends across the healthcare industry and how he is working to create a “values-based” care system through opportunities offered by a global pandemic.”

Weekend update

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–August 14, 2022October 10, 2022

Congress is on a State / District work break until after Labor Day.

The Change Healthcare antitrust trial is ongoing. The judge Hon. Carl J. Nichols will be deciding the case without a jury. He was heard evidence for ten days already. The case is U.S. v UnitedHealth Group et al., 22-cv-481, U.S. District Court for the District of Columbia.

From the Omicron and siblings front, Bloomberg Prognosis informs us

Scientists fear that the omicron shots coming this fall won’t be all that much better at keeping people from getting Covid than the shots we already have. That’s pushing drugmakers to start working on next-generation vaccines that don’t have to be updated that often, if at all, writes Bloomberg’s Madison Muller, Riley Griffin and Fiona Rutherford.
“Even with the highly flexible platform of mRNA, which is more flexible than virtually anything we’ve had before, it’s going to be very difficult to keep up with the pace of newly evolving variants,” Anthony Fauci, President Joe Biden’s chief medical adviser told Bloomberg. “Which gets us to the question: What about a pan-coronavirus vaccine?”

Aim high.

From the monkeypox front, the World Health Organization has renamed the disease that is quite bland.

Consensus was reached to now refer to the former Congo Basin (Central African) clade as Clade one (I) and the former West African clade as Clade two (II). Additionally, it was agreed that the Clade II consists of two subclades.

A clade means “a group of organisms believed to have evolved from a common ancestor, according to the principles of cladistics, e.g., “the great ape and human clade.” How will WHO distinguish between the monkeypox clade and the chickenpox clade? Time will tell.

From the U.S. healthcare business front, Fierce Healthcare tells us

Humana will acquire a Wisconsin managed care plan in a bid to bulk up its Medicaid services, the insurer announced Friday.
Inclusa, Inc. offers long-term care coverage as well as supporting 16,600 older adults and adults with disabilities in Wisconsin’s Family Care program. The managed care organization has worked with local providers and community resources for more than 20 years to connect members with necessary support and services.
Inclusa partners with more than 6,000 service providers across about 40 service categories, as well as contracts with the state to provide family care services in 68 of Wisconsin’s 72 counties, according to the announcement.

The Wall Street Journal offers two expert interviews on mental health issues:

When We Eat Can Affect Our Mental Health

How Can the U.S. Solve a Shortage of Mental-Health Professionals?

Check them out.

Speaking of eating, Forbes offers the five best diets for people with diabetes in 2022.

NPR reports on initial experience with the 988 lifelines.

The 988 hotline is the nation’s most comprehensive mental health crisis service and can provide crucial help to those in emotional distress. If you’re thinking about suicide but not taking steps to act on it, 988 is unlikely to call law enforcement without your consent. Instead, 988 counselors can provide resources, referrals and a kind ear. However, if you’re at imminent risk and could act on a plan to kill yourself, police may be called, and you could be taken to a hospital involuntarily.
Sonyia Richardson, a licensed clinical social worker who owns a counseling agency that serves mostly Black and brown clients in Charlotte, N.C., said she didn’t immediately tell her clients about 988 when it launched. Even though she’s a member of her state’s 988 planning committee, she said she needed time to develop trust in the service herself. When she learned at a recent committee meeting that fewer than 5% of 988 calls in North Carolina led to a law enforcement response, she felt reassured.

Thursday Miscellany

David Ermer–Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–August 4, 2022October 10, 2022

From Capitol Hill, Roll Call reports

The Senate is expected to begin consideration of Democrats’ climate, tax and health care package on Saturday, leaving about two days for the party to shore up support for the bill.
Senate Majority Leader Charles E. Schumer said Thursday that he’s expecting a vote on the motion to proceed Saturday afternoon, which would follow a nomination vote he scheduled for 12:30 p.m.
The motion to proceed is a simple majority threshold; no Republicans are expected to back it.
If Democrats can secure the votes to move forward, it would trigger up to 20 hours of debate before a “vote-a-rama,” when senators can offer unlimited amendments and motions to delay the process. The debate time is equally divided between the parties and senators on either side can choose to yield back time in order to get to the vote-a-rama quicker.
It remained unclear Thursday afternoon whether party leaders had secured crucial backing from Sen. Kyrsten Sinema. * * *
Democrats are also working to wrap up the “Byrd bath,” in which the Senate parliamentarian hears arguments from both parties and issues opinions on whether provisions meet conditions of the budget reconciliation rules. Reconciliation allows the bill to avoid a filibuster and pass with only Democrats’ votes in the 50-50 Senate. * * * [Sen.] Sinema is expected to wait for the process to play out before making her position on the package known.

While the FEHBlog was writing this post, Politico reports

Sen. Kyrsten Sinema announced on Thursday night that she’s signed off on Democrats’ climate, tax and health care legislation after securing a handful of changes.
The Arizona Democrat was not consulted during July’s dealmaking between Senate Majority Leader Chuck Schumer and Sen. Joe Manchin, but after changes to several tax provisions she okayed the agreement on Thursday. “We have agreed to remove the carried interest tax provision, protect advanced manufacturing, and boost our clean energy economy in the Senate’s budget reconciliation legislation. Subject to the Parliamentarian’s review, I’ll move forward,” Sinema said.

From the Omicron and siblings front

The New York Times explores the question “Is This What Endemicity Looks Like?” The article points out “The basic footprint of the disease has been consistent for a few months.”

We’ve been at roughly the same number of hospitalizations and deaths in the country since the end of the initial Omicron wave in the winter. And because so much of that has to do with how much better our immune systems are working against Covid than in the past, there’s probably no reason to think that those dynamics are going to dramatically change unless there’s an out-of-left-field new variant like the original Omicron.
And I think that fits the layperson’s understanding of what an endemic disease is: It’s circulating, but it’s sort of in the background, and while there are some little peaks and some little valleys, they aren’t so dramatic that they threaten to really upend life at a community level, let alone at a national level. That’s a pretty fair description of where we are right now.

While Omicron remains a dangerous virus, particularly for the elderly, which of course is where we started, we now have vaccines against severe illness and treatments for the virus.

It’s worth reading the article.

MedPage Today tells us

Most patients with smell or taste dysfunction related to COVID-19 reported complete recovery of their senses at 2 years, according to a cross-sectional survey conducted in Italy.
Among 119 patients with smell or taste dysfunction within 4 weeks of COVID onset, 88.2% reported complete resolution at 2 years, 9.2% reported a decline in symptom severity, and 2.5% reported unchanged or worsening symptoms, said Paolo Boscolo-Rizzo, MD, of the University of Trieste, and colleagues.

MedPage also offers us some Omicron miscellany

The CDC may relax guidance for COVID-19 control, including for schools, possibly as early as this week. (CNN)
And Los Angeles schools plan on updating COVID-19 protocols for the upcoming school year by dropping “overly aggressive” testing, masking, and vaccination requirements. (KTLA).

From the monkeypox front,

NPR reports

The White House today declared monkeypox a public health emergency.
“We are prepared to take our response to the next level in addressing this virus and we urge every American to take monkeypox seriously,” Health and Human Services Secretary Xavier Becerra said to reporters during a briefing on Thursday.
A public health emergency can trigger grant funding and open up more resources for various aspects of a federal response. It also allows the Secretary to enter into contracts for treatments and other necessary medical supplies and equipment, as well as support emergency hospital services, among other things. Public health emergencies last for 90 days but can be extended by the Secretary.
CDC Director Rochelle Walensky, said the declaration will provide resources and increase access to care. She also said it will expand the CDC’s ability to share data.

STAT News adds

Also Thursday, FDA Commissioner Robert Califf announced the agency was considering allowing Bavarian Nordic’s Jynneos, the only vaccine licensed in the United States to prevent monkeypox, to be given in two doses that are one-fifth the size of the licensed doses, via intradermal administration. Doing so could allow five times as many people to be vaccinated with existing supplies than if the licensed dosage was employed.
The vaccine is licensed as a two-dose product, with the doses administered via intramuscular injection 28 days apart.
“We believe this could be a promising approach,” Califf said.

In other public health news, the Department of Health and Human Services announced

Our nation’s blood and plasma supply dropped to historic lows during the COVID-19 pandemic. While some areas of the country have seen improvement, other areas are still struggling to meet the demand. Blood and plasma are needed on an ongoing basis to treat a variety of life-threatening conditions, which is why the U.S. Department of Health and Human Services (HHS), is launching a new campaign, Giving = Living. * * *
Visit hhs.gov/givingequalsliving to learn more about the importance of donation and make an appointment at a donation location near you.

From the U.S. healthcare business front —

Healthcare Dive tells us

Cigna reported net income increased 6% year over year to $1.6 billion during the second quarter as fewer people were admitted to the hospital, had fewer surgeries and visited the emergency room less.
The Connecticut-based insurer said medical costs for both COVID-19 and non-COVID-19 care were lower than projected. The insurer’s medical loss ratio, an important measure of how much is spent on medical care, fell to 80.7% for the second quarter. Analysts said price hikes helped the MLR, too.
As a result of the quarterly performance, Cigna raised financial targets for the year for revenue and income from operations.

Fierce Healthcare informs us

Telehealth company Amwell is working with CVS Health to roll out the retail drugstore giant’s new virtual primary care service.
CVS announced at the end of May plans to launch a virtual care service that gives consumers access to primary care, on-demand care, chronic condition management and mental health services. Eligible Aetna and CVS Caremark members will be able to use the virtual primary care service to access healthcare services on demand, whether at home or in a retail or community-based setting, the drug store company said.
CVS’ virtual care platform is a “consumer-centric offering designed to bring together the many elements of CVS Health ecosystem services into a single integrated experience with a unified digital front door,” Dr. Ido Schoenberg, chairman and co-chief executive officer of Amwell, said during the company’s second-quarter earnings call Thursday.

and

Elevance Health is betting big on primary care with a new nationwide partnership with Aledade.
The team-up will focus on assisting primary care practices in transitioning to value-based care, to boost health outcomes and lower costs. Independent primary care practices that are within the insurer’s network will be able to access Aledade’s suite of technology and local, in-person services.
Aledade’s platform provides the tools, support and resources that PCPs need to roll out value-based care, the companies said.

Bloomberg reports

Pfizer Inc. will spend $470 million to expand its vaccine research facilities 25 miles northwest of New York City, where the company hopes to maintain its edge in the booming field of messenger RNA, the technology behind its blockbuster Covid-19 shot.
The drugmaker will construct a new building and renovate existing facilities on its campus in Pearl River, New York, which has been the nexus of laboratory research driving its vaccine programs, including the one for Covid in partnership with BioNTech SE.

From the substance use disorder front, NPR explains

Music festivals once frowned upon naloxone, and some banned it. But even though what’s known as harm reduction — the concept of minimizing the negative effects of illicit drug use without trying to stop it altogether — has gained acceptance, it’s far from embraced. Less accepted than naloxone among concert promoters is helping people test their drugs for fentanyl. Companies don’t want to be seen as condoning drug use. They’re also navigating a legal gray area and battling public perceptions. * * *
Overdose deaths continue to climb in the U.S. Drug fatalities topped 100,000nationwide in 2021, with two-thirds caused by synthetic opioids. This has prompted federal and state governments to try to think of new ways to combat the crisis, with the Biden administration giving $30 million to support programs that have often operated in the shadows. In the past few years, the Substance Abuse and Mental Health Services Administration also has fully embraced fentanyl test kits.
Still, many communities far beyond music festival grounds are resistant to harm-reduction strategies, especially fentanyl-testing tools. Dr. Yngvild Olsen, director of SAMHSA’s Center for Substance Abuse Treatment, said harm reduction requires an evolution in thinking, and she encourages organizations to consider harm reduction a lifesaving tool — especially when mass overdoses are possible.

From the telehealth front, Health Payer Intelligence reports

Telehealth flexibilities during the coronavirus pandemic contributed to a 26 percent spike in overall utilization of in-network outpatient behavioral health, according to a report from UnitedHealth Group.
“Prior to the COVID pandemic, telehealth was broadly viewed as a potential strategy for improving access to behavioral health care,” the report explained.
“During the pandemic—which saw increased rates of depression, anxiety, and substance use disorder—federal and state policymakers and commercial health plans established temporary flexibilities to increase access to care, and patients and providers increased their use of virtual visits as an alternative to in-person office-based care.”

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Telehealth, U.S. Healthcare–July 27, 2022October 10, 2022

From Capitol Hill —

The Wall Street Journal reports

Sen. Joe Manchin (D., W.Va.) agreed to back a package aimed at lowering carbon emissions and curbing healthcare costs while raising corporate taxes, marking a stunning revival of core pieces of President Biden’s economic and climate agenda that the West Virginia Democrat had seemingly killed earlier this month.
The deal, negotiated privately between Messrs. Manchin and Senate Majority Leader Chuck Schumer (D., N.Y.) since the start of last week, would raise roughly $739 billion, with much of the revenue coming from a 15% corporate minimum tax and enhanced tax enforcement efforts at the Internal Revenue Service, as well as projected savings from allowing Medicare to negotiate some prescription-drug prices.
Of that new revenue, roughly $369 billion would be spent on climate and energy programs, with another $64 billion dedicated to extending healthcare subsidies for three years for some Affordable Care Act users. The bill would dedicate the rest of the new revenue toward reducing the deficit, according to a summary provided by Messrs. Schumer and Manchin. * * *
The deal will still need the support of almost every other Democrat in Congress. Passing the agreement into law will test Mr. Schumer and the ability of House Speaker Nancy Pelosi (D., Calif.) to convince an ideologically diverse group of lawmakers to accept a deal announced by one of the party’s most conservative members.
The announcement of a deal on Wednesday appeared to catch other Democrats off guard.

The Hill informs us

The House passed a bill Wednesday to expand telehealth services that were first introduced during the COVID-19 pandemic.
The legislation, titled the Advancing Telehealth Beyond COVID–19 Act, passed in a 416-12 vote. Eleven Republicans and one Democrat objected to the measure. Two Republicans did not vote.
The measure seeks to continue a number of telehealth policies established under Medicare that were first implemented at the beginning of the COVID-19 pandemic. If passed by the Senate and signed into law, the provisions would continue through 2024.

Fierce Healthcare adds

A key House panel advanced legislation to create an electronic prior authorization process for Medicare Advantage plans and several other reforms.
The House Ways and Means Committee unanimously advanced on Wednesday the Improving Seniors Timely Access to Care Act of 2022. The legislation has more than 300 co-sponsors and wide support across the healthcare industry.

From the Omicron and siblings front, Medpage Today asks “Can I boost with Novovax?”

While the Novavax shot is not yet authorized by the FDA as a booster, several experts told MedPage Today it could be headed that way.
“Probably the best niche now for Novavax’s purified protein vaccine is as a booster strategy for mRNA vaccines,” Paul Offit, MD, of Children’s Hospital of Philadelphia, who served on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Novavax, told MedPage Today.
Robert “Chip” Schooley, MD, an infectious disease expert at the University of California San Diego who has served on VRBPAC in the past, said since there “aren’t many people left who have been neither vaccinated nor infected … it will likely be mainly used as a booster.”

NPR Shots tells us

The Biden administration may scrap plans to let more younger adults get second COVID-19 boosters this summer. Instead, officials are trying to speed up availability of the next generation of boosters in the fall, NPR has learned.
The new strategy is aimed at trying to balance protecting people this summer with keeping people safe next winter, when the country will probably get hit by yet another surge.
But the possible shift is being met with mixed reactions. The Food and Drug Administration could make a final decision by the end of the week.
The dilemma facing the FDA is that the immunity many people have gotten from getting vaccinated or infected has been wearing off. At the same time, the most contagious version of the virus to emerge yet — the omicron subvariant BA.5 — is making people even more vulnerable.
So as COVID is starting to become more serious than a cold or flu again, most people younger than age 50 aren’t eligible for fourth shots — second boosters — to protect themselves. In response, the FDA was considering opening up eligibility for second boosters for all adults.
But letting more people get boosted with the original vaccine now could interfere with plans to boost them with updated, hopefully more protective vaccines in the fall to blunt the toll of the winter surge.

It’s quite a conundrum for the experts.

From the monkeypox front

NPR provides a helpful FAQ on the disease.

Medscape adds

The Centers for Disease Control and Prevention (CDC) has expanded access to vaccines, tests, and treatments for monkeypox, agency officials said in a webinar Tuesday.
The CDC expects to release more than 750,000 doses of the JYNNEOS vaccine from its strategic stockpile within days, said panelists at the Clinician Outreach and Communication Activity (COCA) call.
In addition, by working with commercial labs, the agency has expanded US testing capacity and streamlined requirements for administering the antiviral tecovirimat, they said.

Encouraging news from the HIV front. The Wall Street Journal reports

A 66-year-old man in Southern California and a woman in her 70s in Spain are the latest in a small group of people who appear to have beaten their HIV infections, providing researchers new clues to a possible cure at a time when Covid-19and other crises are slowing progress against the spreading virus.
Doctors caring for the man said they haven’t found any human immunodeficiency virus that can replicate in his body since he stopped antiretroviral drug therapy in March 2021 after a transplant of stem cells containing a rare genetic mutation that blocks HIV infection. He was given the transplant for leukemia, for which people with HIV are at increased risk. Details of his case were made public Wednesday and will be presented at a large international AIDS conference in Montreal that opens Friday.
“He saw many of his friends and loved ones become ill and ultimately succumb to the disease and had experienced some stigma associated with having HIV,” she said. His success “opens up the opportunity potentially for older patients to undergo this procedure and go into remission from both their blood cancer and HIV.

Also from the medical research front, STAT News informs us

[F]or several years, a small New Haven, Conn.-based startup has quietly been building technology to move the needle on suicide rates among the people at highest risk: those with a history of attempts or who have suicidal thoughts and have expressed a strong desire to die.
The company, called Oui Therapeutics, has raised roughly $26 million from high-profile investors like CVS Health Ventures and First Round Capital to develop and launch an app designed to train people how to quell their suicidal impulses. It pulls from in-person therapy methods that have shown dramatic reductions in suicide attempts — nearly 60% — in a randomized trial of soldiers at high risk. * * *
If the research bears out and the app secures buy-in from regulators, it could become a powerful tool in curbing suicide, which kills over 45,000 people in the U.S. each year. Oui is part of a broader constellation of efforts — including a new national suicide prevention hotline number and the development of prevention frameworks like Zero Suicide — in recent years that aim to address rates that have risen stubbornly high.

Fingers crossed for both worthy efforts.

From the Medicare front, Beckers Hospital Review reports

CMS updated its Overall Hospital Quality Star Ratings for 2022, giving 429 hospitals a rating of five stars.
CMS assigned star ratings to hospitals nationwide based on their performance across five quality categories. This year:
* 192 hospitals received a one-star rating
* 692 hospitals received a two-star rating
* 890 hospitals received a three-star rating
* 890 received a four-star rating
* 429 received a five-star rating

The article lists all of the five star hospitals by state.

From the U.S. healthcare business front, Healthcare Dive tells us

Humana raised its profit estimates for the full year after reporting lower than expected medical costs during the second quarter.
“The lower utilization trends and lack of COVID headwinds seen to date, give us confidence in raising our full year adjusted [earnings per share] guide,” Humana CFO Susan Diamond said Wednesday on a call with investors.
Humana’s net income increased 18% to $696 million for the second quarter as the Louisville-based insurer recorded increased revenues of $23.6 billion amid enrollment growth in both Medicare and Medicaid.
The insurer noted lower inpatient utilization among Medicare members for Q2.
But the lower-than-anticipated inpatient utilization has been partially offset by higher unit costs, Diamond said. * * *
The company’s total medical membership of 17.1 million was up 0.8% year over year.
As the company continues on its value creation plan to trim $1 billion in costs, Humana said it will restructure its organization into two distinct units as it looks to simplify the company’s overall organization.

Revcycle Intelligence reports on how healthcare spending varies by region and payer type.

There is substantial variation and low correlation in healthcare spending across Medicare, Medicaid, and private insurance plans within different US regions, a study published in JAMA Network Open found.
The US spends around $3.8 trillion per year on healthcare funded by Medicare, Medicaid, and private insurers. However, spending and healthcare utilization are rarely the same for all three payers. * * *
Healthcare spending per beneficiary varied across payers. The mean private insurance spending per beneficiary was $4,441, while the Medicare mean was $10,281, and the Medicaid mean was $6,127 per beneficiary. The overall mean for the three payers was $5,782 per beneficiary.
Medicaid had the most variation in spending per beneficiary across the [241 hospital referral regions] HRRs, with a coefficient of variation of 0.233, according to the study. Private insurance had a coefficient of variation of 0.160 and Medicare had a coefficient of variation of 0.126.
Medicaid and private insurance plans likely saw more variation in spending than Medicare because Medicare relies on regulated payments to hospitals, while Medicaid and privately insured prices are generally determined by the region’s market.
In addition to spending variation among the payers individually, there was low spending correlation within regions across all three payers.
For example, the correlation coefficient between HRR level spending was 0.020 for private insurance and Medicare, 0.213 for private insurance and Medicaid, and 0.162 for Medicare and Medicaid.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–July 20, 2022October 10, 2022

From Capitol Hill, Govexec reports

The House [of Representatives on Wednesday voted 220-207 to pass the first minibus fiscal 2023 spending package, effectively endorsing President Biden’s plan to increase federal employees’ pay by an average of 4.6% next year.
The minibus contains six of the 12 annual appropriations bills, including transportation, housing and urban development; agriculture and rural development; energy and water development; military construction and veterans affairs; and financial services and general government, the last of which serves as the vehicle for provisions impacting federal employee compensation[, including the FEHBP].

In other news from our Nation’s Capital, Bloomberg tells us

The Biden administration is giving new powers to an office within the Health and Human Services Department to take a more prominent role in responding to public health crises, spanning from pandemics to natural disasters.
HHS’s Office of the Assistant Secretary for Preparedness and Response will be renamed and enabled to “mobilize a coordinated national response more quickly and stably during future disasters and emergencies,” Dawn O’Connell, who heads the unit, said in a memo obtained by Bloomberg News.
The office will be rebranded the Administration of Strategic Preparedness and Response and will be reclassified an operating division alongside other major health agencies like the Centers for Disease Control and Prevention and the Food and Drug Administration, according to the memo. Those agencies, along with the National Institutes of Health, have been criticized for their response and messaging since the outbreak of Covid-19 more than two years ago.
In the memo, O’Connell wrote that the ASPR had taken on an increasingly important role during the pandemic and that the new designation would equip the unit with “greater hiring and contracting capabilities.”

From the Omicron and siblings front —

The American Hospital Association informs us

The Centers for Disease Control and Prevention last night endorsed the two-dose Novavax COVID-19 vaccine as a COVID-19 vaccine primary series for emergency use in adults, as recommended by its advisory committee. Authorized by the Food and Drug Administration last week, the protein-based vaccine offers an option to individuals who may have an allergic reaction to or prefer not to receive an mRNA vaccine.
CDC today updated its COVID-19 vaccine guidance to include the Novavax vaccine, and issued a chart summarizing the dosing schedules for all authorized or approved COVID-19 vaccines.
In other vaccine news, a new study by the National Institutes of Health comparing the effectiveness of COVID-19 vaccine boosters against the omicron variant found neutralizing antibody levels decreased substantially within three months, with the BA.4 and BA.5 sub-lineages up to 2.5 times less susceptible to neutralization. NIH said the results could help inform decisions regarding future vaccine schedule recommendations, including the need for variant vaccine boosting.

The Wall Street Journal reports

A serious inflammatory complication that strikes some children in the weeks following a Covid-19 infection has almost disappeared. A buildup of immunity and changes to the virus both likely play a part, pediatric infectious-disease doctors and researchers said.
Multisystem inflammatory syndrome is afflicting far fewer children as a proportion of known Covid-19 cases than during earlier waves of the pandemic, according to data from the Centers for Disease Control and Prevention. The condition, also known as MIS-C, is similar to Kawasaki disease, another rare pediatric inflammatory condition. Early in the pandemic, doctors believed they were seeing Kawasaki disease but soon recognized MIS-C as a distinct condition associated with an earlier Covid-19 infection.
MIS-C can cause inflammation two to six weeks after infection with Covid-19 in organ systems including the heart, lungs, kidneys and brain. Researchers haven’t determined why some children developed the condition but they have linked it to a hyperactive immune response. Treated with drugs such as intravenous immune globulin or corticosteroids, most children make a full recovery. Even so, the condition can be deadly. In the U.S., 70 children have died from MIS-C since the start of the pandemic, according to the CDC.

From the fraud, waste and abuse front —

Fierce Healthcare tells us

Federal prosecutors charged 36 defendants with committing a variety of alleged schemes to bilk Medicare using telehealth, as regulators continue to tinker with how to make the COVID-19 telehealth boom permanent.
The Department of Justice announced on Wednesday that the defendants allegedly engaged in a series of actions that led to $1.2 billion in medical fraud, with much of that coming from phony telehealth claims for advanced genetic testing and unnecessary medical equipment.
“Fraudsters and scammers take advantage of telemedicine and use it as a platform to orchestrate their criminal schemes,” said Luis Quesada, assistant director in the FBI’s Criminal Investigative Division, in a statement. “This collaborative law enforcement action shows our dedication to investigating and bringing to justice those who look to exploit our U.S. health care system at the expense of patients.”

Here’s a link to the HHS Office of Inspector General fraud alert which provides background on these telehealth schemes.

The Justice Department also announced

Inform Diagnostics, Inc., (Inform) formerly known as Miraca Life Sciences, Inc. (Inform), has agreed to pay $16 million to resolve allegations that it submitted false claims for payment to Medicare and other federal health care programs.
Inform is a clinical laboratory headquartered in Irving, Texas, that provides anatomic pathology services to physician practices throughout the United States. On April 27, 2022, Fulgent Genetics purchased Inform, and the company is now a wholly owned subsidiary of Fulgent Genetics.
According to the settlement, Inform admits that, between 2013 and 2018, it routinely and automatically conducted additional tests on biopsy specimens prior to a pathologist’s review and without an individualized determination regarding whether additional tests were medically necessary. The United States contends that Inform’s policy of conducting routine additional tests caused Inform to perform many tests that were medically unnecessary. Inform submitted these medically unnecessary tests for payment, causing federal health care programs to pay for false claims. * * *
“Submitting claims for medically unnecessary tests threatens the integrity of the federal health care programs and wastes taxpayer dollars,” said Amy K. Parker, Special Agent in Charge of the Office of Personnel Management’s Office of Inspector General. “Today’s settlement is a reminder to all providers that the OPM OIG will not tolerate fraud against the Federal Employees Health Benefits Program.”

From the U.S. healthcare business front —

Fierce Healthcare informs us

Elevance Health subsidiary myNEXUS recently launched a post-acute care program for Medicare members in Indiana, and the insurance giant is aiming to take it nationwide over the next year.
During the company’s earnings call Wednesday morning, CEO Gail Boudreaux said it plans to take the next six to 12 months to scale up the program, which uses a capitated risk-sharing arrangement. The platform arms docs with technology tools that aim to optimize patient care post-discharge. * * *
The company reported $1.7 billion in profit for the second quarter of this year, down from $1.8 billion in the second quarter of 2021 or by 7.8%. Revenues for the quarter were up, however, increasing by 14.1% to $38.6 billion.

Healthcare Dive tells us

JPMorgan Chase’s healthcare venture arm plans to invest $30 million in Centivo, a health plan for self-funded employers. It’s Morgan Health’s third major investment in a startup looking to lower the costs of employer-sponsored healthcare in the past year.
Three-year-old health plan administrator Centivo contracts with providers on behalf of large employers with the goal of improving quality and efficiency. The startup, which ties payments to patient outcomes, says it saves employers 15% to 30% annually compared to traditional health plans.
Morgan Health has shelled out at least $85 million in the past year, including the Centivo deal. The unit invested $50 million in value-based primary care company Vera Whole Health in August and $5 million in healthcare navigation startup Embold Health in March.

From the U.S. general healthcare front —

Forbes offers an interesting article about health insurance literacy in our country. The No Surprises Act has spurred people to look more carefully at their healthcare provider bills, but their analyses fall short because they need help understanding those bills and health insurance coverage.

Yale New Haven Hospital’s July newsletter provides good advice on avoiding skin cancer and stay safe in the summer. The FEHBlog was born at the facility’s predecessor Grace New Haven Hospital.

STAT News reports “Gestational diabetes is on the rise, climbing 30% between 2016 and 2020, according to a new study published Tuesday by the Centers for Disease Control and Prevention. “There is a growing maternal health crisis in the United States, and gestational diabetes is an important and common complication that requires new focus,” said Sadiya Khan, an assistant professor of medicine and preventive medicine at the Northwestern University Feinberg School of Medicine, who was not involved in the new study. “That inflection point there is really striking and something that we’re going to want to follow up [on].” * * * “This issue does not resolve with the pregnancy and is really one that we need to focus on before, during, and after pregnancy for those at risk.”

STAT News also explores the work of various mental health crisis centers in the days following the launch of the nationwide 988 suicide / mental health crisis hotline. Here’s a link to an HHS site that refers to the hotline more appropriately as a LifeLine.

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