Tuesday Tidbits

ACA

Tuesday Tidbits

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, No Surprises Act, OPM, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.

The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.

Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots. 

Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.

Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.

From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.

Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.

From the medical research front, BioPharma Dive reports

Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.

At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.

If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.

The article provides an overview of these RNA drug development efforts.

From the tidbits department —

  • MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
  • Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
  • The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
  • The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
  • The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.

Midweek Update

David Ermer–ACA, CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare, Wellness–
Photo by Manasvita S on Unsplash

From Capitol Hill, Roll Call reports

Democrats may need to make some changes to the tax portion of their budget reconciliation package to earn the support of Arizona Sen. Kyrsten Sinema, including possible removal of a tax increase on investment fund managers and softening a new minimum tax on the biggest corporations.

The bill could also undergo other tweaks as Senate Parliamentarian Elizabeth MacDonough continues her review of the bill. Changes to the prescription drug pricing provisions are already in the works, but many pieces of the package have yet to go through the formal “Byrd bath” to determine whether the language complies with budget rules.

Despite all the work still underway, several Democratic senators said they anticipated voting on the motion to proceed to the reconciliation package as soon as Thursday and beginning the “vote-a-rama” process, in which senators can offer unlimited amendments to the measure, as soon as this weekend. 

“As soon as possible, but don’t count on going home on the weekend,” Michigan Sen. Debbie Stabenow, a member of Democratic leadership, said. “We’re probably going to be here all weekend, so get lots of sleep.

From the OPM front, Federal News Digest tells us

The Office of Personnel Management is getting a second in command.

President Joe Biden nominated Rob Shriver to be the OPM deputy director on Aug. 3. * * *

Shriver is a political appointee already, having been the associate director for employee services since January 2021.

If confirmed by the Senate, Shriver would be OPM’s first deputy director since Michael Rigas, who held the job from March 2018 to January 2021, but worked in other administration positions from March 2020 until January 2021.

From the Omicron and siblings front —

Bloomberg informs us

[Israeli] Hospital workers who got a fourth dose of Pfizer Inc.’s messenger RNA vaccine were far less likely to get Covid than triple-vaccinated peers in a study. 

The findings published Tuesday in the American Medical Association’s open access journal are the latest to confirm the benefits of a second booster against breakthrough infections caused by omicron. The study’s authors pointed to an extra dose as a tool to prevent medical staff shortages and spare health systems in times of strain.  * * *

Doctors, nurses and other health-care workers who got a fourth mRNA shot in January showed a 7% rate of breakthrough infections. Those with three doses — the third having been administered by the end of September — saw an infection rate of 20%.  

The Department of Health and Human Services released two reports on long Covid to support patients and further research.

From the monkeypox front

  • Beckers Hospital Review explains that the Centers for Disease Control have released isolation guidance “as cases near 6,000.”

The New York Times delves into various aspects of the disease, including what people can do the stay safe.

From the U.S. healthcare business front

Healthcare Dive reports

CVS Health raised its full-year guidance in its second quarter earnings report despite a $77 million decrease in adjusted operating income primarily due to declines in its retail segment.

The company’s Aetna subsidiary boosted earnings with reported gains of 922,000 covered lives compared to the second quarter of last year and growth in all product lines contributing to a nearly 11% rise in revenues year over year.

Adjusted operating income was 9.1% lower in its retail division compared to the year prior due to a decrease in coronavirus vaccinations, “continued pharmacy reimbursement pressure” and the lack of an antitrust legal settlement gain that was recorded in the second quarter last year, according to the earnings report. * * *

In its race to add more primary care services, the executive team further teased acquisition plans, with [CVS Health CEO Karen] Lynch adding that the company could take the “next step on this journey” by the end of this year.

“We can’t be in … primary care without M&A. We’ve been very clear about that,” Lynch said.

[Larry] McGrath [CVS Health senior vice president of business development and investor relations] added that the company has been active in evaluating a wide range of assets around the care delivery space. CVS also signaled that it could potentially pursue multiple acquisitions, adding that there was “no one and done asset” in the market.

Biopharma Dive informs us

Gilead’s cell therapy business outperformed Wall Street expectations during the second quarter. The unit — which currently consists of two products, Yescarta and Tecartus, used to treat various blood cancers — generated $368 million in the three-month period, an increase of 68% year over year, earnings numbers released Tuesday show.

Key to that growth was a recent, first-of-its-kind approval from the Food and Drug Administration. In April, the agency cleared Yescarta as a so-called second line therapy for large B-cell lymphoma that resists or returns within a year of initial treatment with chemoimmunotherapy. Before, Yescarta was used only when patients either relapsed after or hadn’t responded to at least two other kinds of therapies.

Fierce Healthcare adds

CivicaScript’s first product is hitting the market.

The public benefits company and sister to Civica Rx is making its first generic available: 250-mg abiraterone acetate tablets. The drug is used in combination with the steroid medication prednisone as a treatment for prostate cancer that has spread to other parts in the body.

CivicaScript will make the drug available to pharmacies at $160 per bottle of 120 tablets, a typical one-month supply. The company suggests pharmacies sell it to patients at no more than $171 for each bottle. This price is about $3,000 less per month than the average cost for people enrolled in Medicare Part D, which is the largest portion of patients with this type of cancer.

Using CivicaScript’s abiraterone will lead to significant savings for patients both in the deductible phase and in the Part D “donut hole,” where they face the highest out-of-pocket costs, the company said in an announcement (PDF). * * *

“We’re proud the first lower-cost generic drug of our partnership with CivicaScript is entering the market,” said Kim Keck, president and CEO of BCBSA. “This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication.”

From the Affordable Care front, Prof. Katie Keith takes a deep dive into last week’s ACA FAQ 54 on mandated contraceptive coverage under that law.

From the research front —

Benefits Pro points to

A survey of nearly 2,500 U.S. healthcare consumers by PYMNTS.com offered more proof that this remains a barrier to consumer trust of the healthcareThe survey revealed that many consumers continue to under budget for their health care –probably because most have little idea about the cost of various procedures and appointments. * * *

For instance, nearly 20% of those surveyed said they “experienced financial distress due to health care costs because they spent more than they could afford in the past 12 months.” A quarter of respondents who said their advance notice cost estimates were accurate said they still spent more than they could really afford. Not surprisingly, 43% of those who received inaccurate cost estimates said they spent more than they could afford. system. PYMNTS.com, a provider of data, news and insights on innovation in payments and the payment-related, conducted the survey to learn how many respondents fell into the unexpectedly high and inaccurate estimate category, and what the outcome for them was in the aftermath. * * *

Medscape reports

Regular exercise, regardless of intensity level, appears to slow cognitive decline in sedentary older adults with mild cognitive impairment (MCI), new research from the largest study of its kind suggests.

Topline results from the EXERT trial showed patients with MCI who participated regularly in either aerobic exercise or stretching/balance/range-of-motion exercises maintained stable global cognitive function over 12 months of follow-up — with no differences between the two types of exercise.

“We’re excited about these findings, because these types of exercises that we’re seeing can protect against cognitive decline are accessible to everyone and therefore scalable to the public,” study investigator Laura Baker, PhD, Wake Forest University School of Medicine, Winston-Salem, North Carolina, said at a press briefing.

The topline results were presented at the Alzheimer’s Association International Conference (AAIC) 2022.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, Medicare, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.

The Hill adds that

A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.

Both articles discuss the flies remain in the reconciliation ointment.

Govexec informs us

The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.

Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.

From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.

The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.

On a related note, Healthcare Dive tells us

Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.

From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.

If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity.  * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.

From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.

From the monkeypox front, Reuters makes two reports

  • The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.
  • The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.

From the U.S. healthcare business front —

The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.

Healthcare Dive reports

Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.

But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.

STAT News chimes in

Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.

“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.

Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.

Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”

Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.

Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.

Monday Roundup

David Ermer–ACA, CDC, COVID-19, OPM, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and siblings front, STAT News reports

The Biden administration is preparing a sweeping initiative to develop a next generation of Covid-19 immunizations that would thwart future coronavirus variants and dramatically reduce rates of coronavirus infection or transmission, building on current shots whose impact has been mainly to prevent serious illness and death, the White House told STAT.

To kick off the effort, the White House is gathering key federal officials, top scientists, and pharmaceutical executives including representatives of Pfizer and Moderna for a Tuesday “summit” to discuss the new technologies and lay out a road map for developing them.

“These are vaccines that are going to be far more durable, that are going to provide far longer-lasting protection, no matter what the virus does or how it evolves,” Ashish Jha, the White House Covid-19 response coordinator, said in an interview. “If we can drive down infections by 90% … Covid really begins to fade into the background, and becomes just one more respiratory illness that we have to deal with.”

Here’s hoping. Curiously, the federal government did not start this effort last year when Delta was raging.

The Centers for Disease Control posted an information sheet on the Novovax vaccine. The FEHBlog was surprised to read “Novavax COVID-19 vaccine is not authorized for use as a booster dose.” The FEHBlog had read months ago that the Novovax vaccine would make a dandy booster to a series of mRNA shots.

Medscape discusses long Covid symptoms.

People who reported sore throats, headaches, and hair loss soon after testing positive for COVID-19 may be more likely to have lingering symptoms months later, according to a recent study published in Scientific Reports.

Researchers have been trying to determine who faces a higher risk for developing long COVID, with symptoms that can last for weeks, months, or years after the initial infection. So far, the condition has been reported in both children and adults, healthy people, those with preexisting conditions, and a range of patients with mild to severe COVID-19.

“These people are not able to do necessarily all the activities they would want to do, not able to fully work and take care of their families,” Eileen Crimmins, PhD, the senior study author and a demographer at the University of Southern California’s Leonard Davis School of Gerontology, told the Los Angeles Times.

“That’s an aspect of this disease that needs to be recognized because it’s not really as benign as some people think,” she said. “Even people who have relatively few symptoms to start with can end up with long COVID.”

From the Affordable Care Act front, the Department of Health and Human Services released today a proposed third version (Obama, Trump, Biden) version of a rule implementing Section 1557, the individual non-discrimination provision of the Affordable Care Act. Here are links to the proposed rule and the Department’s fact sheet. The law needs an implementing rule because its wording is garbled. The FEHBlog didn’t think he would ever see a more complicated rule than the Obama Administration’s 2016 rule, but at least at first glance, it appears that the Biden Administration has cleared that high bar. Later this week, the FEHBlog will offer his take on the extent of the rule’s application to the FEHBP. The public comment period will be 60 days long once the proposed rule is published in the Federal Register.

The Wall Street Journal has launched an investigative journalism campaign against certain large charitable hospitals.

Nonprofit hospitals get billions of dollars in tax breaks in exchange for providing support to their communities. A Wall Street Journal analysis shows they are often not particularly generous.

These charitable organizations, which comprise the majority of hospitals in the U.S., wrote off in aggregate 2.3% of their patient revenue on financial aid for patients’ medical bills. Their for-profit competitors, a category including publicly traded giants such as HCA Healthcare Inc., wrote off 3.4%, the Journal found in an analysis of the most-recent annual reports hospitals file with the federal government.

Among nonprofits with the smallest shares of patient revenue going toward charity care—well under 1%—were high-profile institutions including the biggest hospitals of California’s Stanford Medicine and Louisiana’s Ochsner Health systems. At Avera Health, a major hospital system in South Dakota, charity care was roughly half of 1% of patient revenue across all its 18 hospitals.

You get the gist. These Journal investigations usually attract attention on Capitol Hill.

From the public health front, the Washington Post discusses the meaning of a pre-diabetes diagnosis to the over 65 crowd.

More than 26 million people 65 and older have prediabetes, according to the Centers for Disease Control and Prevention. How concerned should they be about progressing to diabetes?

Not very, some experts say. Prediabetes — a term that refers to above-normal but not extremely high blood sugar levels — isn’t a disease, and it doesn’t imply that older adults who have it will inevitably develop Type 2 diabetes, they say.

“For most older patients, the chance of progressing from prediabetes to diabetes is not that high,” said Robert Lash, the chief medical officer of the Endocrine Society. “Yet labeling people with prediabetes may make them worried and anxious.”

Other experts believe it is important to identify prediabetes, especially if doing so inspires older adults to add more physical activity, lose weight and eat healthier diets to help bring their blood sugar under control.

Based on personal experience, the FEHBlog finds himself supporting “the other experts.”

From the OPM / FEHB front —

  • OPM today issues a fact sheet on the steps being taken to implement the President’s June 2021 Executive Order on increasing diversity, equity, and inclusion in the federal workforce.
  • FedSmith has an article encouraging federal annuitants to take look this Open Season at FEHB plans which offer an integrated Medicare Advantage. The number of those plans has been growing over the past two Open Seasons and the FEHBlog anticipates the number will continue to grow this coming Open Season.

From the telehealth front, mHealth Intelligence points out

The benefits of breastfeeding are well-documented. Breast milk is a comprehensive source of infant nutrition, can help stave off some short-and long-term illnesses, and enables babies to gain valuable antibodies from their mothers, according to the Centers for Disease Control and Prevention. Further, breastfeeding can reduce the mother’s risk of developing several conditions, including breast and ovarian cancer and type 2 diabetes.

Though a majority of babies are breastfed initially, there appears to be a drop-off at the six-month mark, and rates continue to decline from there. In total, about 84 percent of babies were breastfed in 2018, but only 57 percent were breastfed at six months and 35 percent at 12 months, according to CDC data.

To support breastfeeding, the five-hospital Trinity Health of New England system joined forces with Nest Collaborative last month to launch a telehealth program.

The telehealth-enabled breastfeeding support program, launched at the end of June, connects pregnant women and new mothers to a nationwide network of lactation consultants.

“Nest Collaborative’s [lactation consultants] help families reach their breastfeeding goals and assist them in making informed decisions about infant feeding options,” said Judith Nowlin, CEO of Nest Collaborative, in an email.

Weekend update

David Ermer–ACA, Congress, COVID-19, Medicare, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Capitol Hill, The House of Representatives and the Senate will be in session for Committee business and floor voting this week. This is the last week that the House is in session before the August recess. The Senate has one more week of legislative work before it heads off on its State work period for the eighth month of the year.

The Wall Street Journal adds

Congress nears the close of a packed legislative session this week, aiming to pass legislation providing about $54 billion to boost U.S. semiconductor manufacturing while also juggling a raft of other bills ahead of the monthlong August recess.

Along with the bipartisan bill subsidizing chips, Democrats are hoping to salvage a piece of President Biden’s once-ambitious domestic agenda, looking to advance a measure aimed at lowering some drug and healthcare costs. The party is also weighing whether to hold votes related to social issues and guns that could help rally the party’s base. * * *

In the Senate, Democrats are awaiting guidance from the Senate’s parliamentarian over whether a measure aimed at lowering drug costs by giving Medicare the right to negotiate prices for a narrow set of drugs will comport with the Senate’s procedures for passing bills through a budget-related process known as reconciliation. Democrats in the 50-50 Senate are using the special process because it allows the passage of bills with only a simple majority, instead of the 60 votes required for most legislation. The procedure is only available until Sept. 30, the end of the fiscal year.

Mr. Hoyer said that if Senate Democrats are able to soon pass the drug-pricing bill, which would also extend Affordable Care Act subsidies, then the House would return from its August recess to clear the measure in time for insurance companies to factor in the subsidies when they set prices for their plans.

From the Omicron and siblings front, the New York Times informs us

People with coronavirus infections of the Omicron variant often have significantly different viral levels in their noses, throats and saliva, and testing just a single type of sample is likely to miss a large share of infections, according to two new papers, which analyzed Omicron infections over time in a small number of people.

The papers, which have not yet been published in scientific journals, suggest that coronavirus tests that analyze both nasal and throat swabs would pick up more Omicron infections than those that rely on just a nasal swab. Although these combined tests are common in other countries, including Britain, none are yet authorized in the United States.

“You could get a lot more bang for your buck if you use these mixed specimen types,” said Rustem Ismagilov, a chemist at the California Institute of Technology and the senior author of both papers. But in the United States, he said, “we are stuck with nobody doing it.”

And yet the CDC has recorded nearly 90 million cases in our country.

From the unusual viruses front

STAT News reports

The World Health Organization on Saturday declared the unprecedented monkeypox outbreak that has spread around the world a public health emergency, a decision that will empower the agency to take additional measures to try to curb the virus’s spread.

In an unusual move, WHO Director-General Tedros Adhanom Ghebreyesus made the declaration even though a committee of experts he had convened to study the issue did not advise him to do so, having failed to reach a consensus. The same committee met just one month ago and declined to declare a public health emergency of international concern, or PHEIC [pronounced fake].

Secretary of Health and Human Services expressed his support for this decision.

Bloomberg Prognosis provides a quick take on monkeypox and its spread. Among other takes

The illness is usually mild and most patients will recover within a few weeks; treatment is mainly aimed at relieving symptoms. About 10-to-15% of cases have been hospitalized, mostly for pain and bacterial infections that can occur as a result of monkeypox lesions. The CDC says smallpox vaccine, antivirals, and vaccinia immune globulin can be used to treat monkeypox as well as control it.

The Wall Street Journal adds

Unusual for an emerging disease, there are already vaccines and treatments that can be used to counter monkeypox. That is because some governments have invested in developing defenses against the accidental or deliberate reintroduction of smallpox, a closely related but much more severe virus. Some countries hold these treatments and vaccines in national stockpiles, but they aren’t readily available everywhere.

In some places, including the U.S., U.K. and parts of Canada, broad groups of men who have sex with men are being offered vaccination in an effort to slow the spread, although vaccine supplies have so far been constrained. Public-health authorities also are working to raise awareness among men who have sex with men about the spread of monkeypox.

From the Medicare front, STAT News reports

The federal government is hashing out the details on a new type of rural hospital, and new developments suggest regulators want to make it an attractive option.

So-called Rural Emergency Hospitals (REH) will run emergency rooms, but won’t offer inpatient care. On top of bumped-up Medicare reimbursement, they’ll get facility payments north of $3 million annually, which is nothing to sneeze at for small hospitals. The new details were part of the government’s proposed Medicare payment rates for hospital outpatient services in 2023, released Friday [July 15].

For their part, hospitals aren’t yet sold on the idea.

From the Affordable Care Act front, we have Section 1557 news:

On Monday, July 25, 2022, [at 2:15 pm ET] the U.S. Department of Health and Human Services will announce a proposed rule to strengthen Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, and disability in certain health programs and activities. 

In regard to sex, which includes sexual orientation and gender identity, the proposed rule would solidify protections against discrimination consistent with the U.S. Supreme Court’s holding in Bostock v. Clayton County.  

Strengthening this rule is a significant achievement for the Biden-Harris Administration and promotes gender and health equity and civil rights for communities of color, women, LGBTQI+ individuals, people with disabilities, persons with limited English proficiency (LEP), and seniors.

From the reports and studies department

  • Fortune Well tells us “While two-thirds of Alzheimer’s cases are in women, an overwhelming majority don’t know they are at an increased risk for the disease, a new survey finds. A survey conducted by the Cleveland Clinic last month found that while 71% of women respondents saw a doctor for their health in the last year, 82% of them did not know that they are at increased risk for Alzheimer’s disease and 73% percent had not talked to their doctor about their brain health.”

Early physician follow-up with a comprehensive transitional care strategy and effective chronic disease management after discharge was associated with reduced 90-day readmissions among patients with COPD and other complex conditions.

“This population-based retrospective cohort study found that early follow-up with a [primary care] physician or relevant specialist was associated with fewer readmissions for patients with [congestive heart failure] or COPD, fewer COPD-related readmissions for patients with COPD and lower mortality for patients with [congestive heart failure], all within 90 days of discharge, but that there was no demonstrable benefit at 30 days or for patients with [acute myocardial infarction],” Farah E. Saxena, MPH,researcher at the Canadian Partnership Against Cancer in Toronto, and colleagues wrote in JAMA Network Open.

  • The CDC reports “Adults who receive diabetes education follow more recommended preventive care practices, such as getting regular physical activity.” Many FEHB plans offer diabetes education services.

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.”

Midweek update

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, SDOH, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported. 

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.

Weekend update

David Ermer–ACA, Congress, COVID-19, Rx coverage, U.S. Healthcare–

The House of Representatives and the Senate to continue to be engaged in Committee business and floor voting this coming week.

From the omicron and siblings front, Bloomberg Prognosis reports

People who are vaccinated and then get infected with omicron may be primed to overcome a broad range of coronavirus variants, early research suggests.  

A pair of studies showed that infection produced even better immune responses than a booster shot in vaccinated patients. Teams from Covid-19 vaccine maker BioNTech SE and the University of Washington posted the results on preprint server bioRxiv in recent weeks.

The researchers have found the silver lining in the Omicron cloud.

In other encouraging healthcare news, BioPharma Dive informs us

The Food and Drug Administration on Friday approved Eli Lilly’s diabetes drug Mounjaro, a first-of-its-kind treatment that can help control patients’ blood sugar and, potentially, help them lose weight as well.

Mounjaro, also known as tirzepatide, expands Lilly’s diabetes business, which includes insulins as well as other types of therapies. The company recorded $9 billion in diabetes drugs sales last year.

Mounjaro works by stimulating two hormones, called GLP-1 and GIP, that control insulin production. In clinical testing, the drug outperformed several other diabetes medicines, including one made by rival drugmaker Novo Nordisk that only acts on one hormone. Mounjaro was more effective in controlling blood sugar than two types of insulin as well. * * *

The drug’s approval will heighten competition between Lilly and Novo, which have battled for market share in the U.S. for years. Novo, for instance, has recently had success by launching a similar, once-weekly shot to Lilly’s top-selling drug Trulicity, as well as a daily pill that works the same way.

Novo is testing a dual-acting competitor to tirzepatide, but it’s only in Phase 2 testing, well behind Lilly’s drug. Both companies are also trying to develop a once-weekly insulin shot, with similar programs in Phase 3 development.

The next frontier for both companies is in obesity, where they are working to prove their drugs’ worth as weight loss treatments. Novo has already won approval for a drug called Wegovy, while Lilly reported promising data for Mounjaro last month.

The article adds that Lilly did not disclose pricing for its newly approved drug on Friday.

The FEHBlog also noticed that Katie Keith’s latest article on the Affordable Care Act delves into the recent guidance on posting three machine reading pricing files on health plan websites by July 1. The discussion may be found in the closing paragraphs of the article.

Tuesday’s Tidbits

David Ermer–ACA, CDC, CMS, COVID-19, No Surprises Act, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, Fortune Well explores earlier pandemics for similarities to our current one.

As U.S. COVID czar Dr. Anthony Fauci and colleagues pointed out in a 2009 New England Journal of Medicine article, “It is not generally appreciated that descendants of the H1N1 influenza A virus that caused the catastrophic and historic pandemic of 1918–1919 have persisted in humans for more than 90 [now 100] years and have continued to contribute their genes to new viruses, causing new pandemics,” including the 2009 H1N1 “swine flu.”

“We are living in a pandemic era that began around 1918,” they wrote 13 years ago—long before the advent of COVID-19.

Harald Brüssow, editor of Microbial Biotechnology, agrees with Fauci and his colleagues that “viruses do not simply disappear.”

“They change and hopefully they adapt and behave,” Brüssow said. “But there are still some escapes, and we might see a return with higher virulence. Vigilance is indicated.”

From the healthcare business front —

The Wall Street Journal reports

Pfizer Inc. expects demand for its Covid-19 antiviral drug to increase as governments return to replenish their supplies and seek to thwart surges as the pandemic virus continues to evolve.

The treatment, a pill called Paxlovid, brought in $1.5 billion in sales during Pfizer’s first quarter, while its vaccine totaled $13.2 billion, reflecting the need for tools to combat the virus despite a slowdown in cases and a growing sense of life trying to return to normal.

The company said Tuesday it is on track to deliver between $98 billion and $102 billion in revenue for the year, with $32 billion coming from its Covid-19 vaccine Comirnaty and $22 billion from Paxlovid. 

“We remain bullish on Paxlovid” said Chief Financial Officer Frank D’Amelio on a call discussing earnings with analysts. “The rhythm of that product looks very good.”

STAT New informs us

Biogen is replacing CEO Michel Vounatsos, the company said Tuesday, ending a five-year tenure in which he presided over the disastrous approval and rollout of its Alzheimer’s treatment, Aduhelm.

The company also said it is “substantially eliminating” all spending on Aduhelm just 10 months after securing U.S. approval — a concession from the struggling biotech that the drug had become a financial liability following a Medicare decision to restrict patient access and payment.

From the Affordable Care Act front, Health Affairs Forefront features the third and final part of Katie Keith’s series on the final 2023 notice of benefit and payment parameters. The third part discusses changes to the ACA marketplace’s risk adjustment program.

From the No Surprises Act, the FEHBlog had understood that the NSA regulators planned to release a final rule on the NSA’s arbitration process, replacing the interim final rule, this month. However, a Justice Department filing with the U.S. Court of Appeals for the Fifth Circuit submitted late last week states, “the Departments expect to issue a final rule early this summer that will supersede the portions of the interim final rule that Plaintiffs [in the Texas Medical Association case] challenged.” No wonder then that the final rule has not been presented yet to OMB’s Office of Information and Regulatory Affairs for its required review before publication in the Federal Register.

From the tidbits department —

  • Here is a link to the new CMS Strategic Plan.
  • Federal News Network tells us,

Agencies’ hiring efforts for the Bipartisan Infrastructure Law (IIJA) are “foot to the pedal,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

The surge includes filling 3,000 of those new positions over the first six months after President Joe Biden signed the bill into law.

Ahuja has frequently spoken about her goals to attract more early-career workers to federal service. The BIL gives OPM another chance to do just that.

  • FedSmith identifies four personal budget factors Federal retirees must anticipate. One of those factors is our beloved FEHBP.
  • The CDC offers ten tips for coping with diabetes distress.

Monday Roundup

David Ermer–ACA, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

The President has declared May 1 through May 7 to be Public Service Recognition Week. OPM explains

Celebrated annually during the first week of May since 1985, Public Service Recognition Week (PSRW) (external link) is time set aside to honor the men and women who serve our nation as federal, state, county and local government employees. 

Throughout the country, mayors, governors, agency leaders, communities and public service organizations participate in PSRW by issuing proclamations; hosting award ceremonies and special tribute events; and delivering messages about the value of public service.

To that end, Govexec reports the President took the time today to virtually award Presidential Rank Awards to 230 senior federal employees from 37 agencies.

Speaking directly to the career civil service, Biden said: “Over the last 15 months you’ve helped us deliver so much to the American people,” such as the getting Americans vaccinated against COVID-19, delivering economic relief checks, caring for veterans, implementing the infrastructure package and working to restore the public’s faith in government and democracy. He gave a big “thank you” to them as well as their families. 

The FEHBlog heartily agrees.

From the Omicron and siblings front, WebMd informs us

The FDA’s independent panel of advisors will meet in June to discuss the Pfizer and Moderna COVID-19 vaccines for children under age 5, as well as the Novavax vaccine for adults, according to an FDA announcement released Friday.

On June 7, the FDA’s vaccine committee will review the Novavax shot, which could become the first new COVID-19 vaccine to hit the U.S. market in more than a year. The shot is already authorized in more than three dozen countries, including across Europe.

The FDA has also selected three possible dates — June 8, 21, and 22 — to discuss the shots for kids under age 5. The dates are tentative because the companies haven’t completed their submissions, the agency said.

The FEHBlog is pleased to read about these developments because the Novovax shot which uses a traditional vaccination approach may be acceptable to the vaccine inquisitive and the country needs a vaccine for younger children.

STAT News adds

Pfizer released news late Friday that Paxlovid, the antiviral currently subject to a big push from the U.S. government, failed to prevent people living with Covid patients from catching the infection.

The news is one of several bad headlines for the new Covid pill, but one experts say doesn’t affect the medicine’s primary use: treating people who are already sick.

Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital, said he would “absolutely” prescribe Paxlovid to people at high risk of severe disease who have Covid. “Without hesitation,” he said. “Because the net benefit in the high risk study was extremely high.”

From the Affordable Care Act front, Health Affairs Forefront has posted the second part of Katie Keith’s three-part series on last week’s HHS final 2023 notice of ACA benefit and payment parameters. The second part concerns changes specific to the ACA marketplace or exchange plans.

From the Rx coverage front, Health Affairs informs us

UnitedHealthcare is restricting insurance coverage of Aduhelm across all of its health plans, saying the drug “is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to the company’s new policies.

Physicians who plan on giving Aduhelm to UnitedHealthcare patients will need to obtain prior approval from the insurance company, effective June 1. Patients also need to be in an approved clinical trial.

UnitedHealthcare’s decision follows Medicare, which said last month it would only pay for the costly infusion drug for patients who participate in a clinical trial. UnitedHealthcare is the largest Medicare Advantage insurer in the country, covering 8 million people older than 65 and people with disabilities, making this policy particularly important for older Americans on those private plans.

The FEHBlog expects UHC’s announcement to be the tip of the eventual iceberg of similar Aduhelm coverage decisions.

Following up on previous stories mentioned in the FEHBlog, the Wall Street Journal reports

Online pharmacy company Truepill Inc. said it is temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder, and partner Cerebral Inc. told its clinicians to direct those orders to patients’ local pharmacies.

Cerebral, an online mental-health company based in San Francisco that describes Truepill as its preferred pharmacy, informed its clinicians of Truepill’s decision in a Friday email viewed by The Wall Street Journal. The email said Truepill would no longer support mailing Schedule 2 controlled substances, including Adderall and Vyvanse, “to any of their customers.”

Truepill said that, “out of an abundance of caution,” it is temporarily pausing all fulfillment of Schedule 2 substances while it evaluates appropriate next steps. It said Schedule 2 substances such as Adderall make up less than 1% of its total prescription volume. Truepill didn’t provide a list of other partners affected by its decision.

Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the past year from clinicians working for telehealth startups that have sprung up to treat ADHD, according to pharmacies and people familiar with the issue.

The Journal reported last week that pharmacies including Walmart Inc., CVS Health Corp. and Walgreens Boots Alliance Inc. have blocked or delayed prescriptions for companies treating ADHD online or have blocked individual prescribers, according to people familiar with the issue.

That was the right outcome as far as the FEHBlog is concerned.

In U.S. Supreme Court news, Business Insurance reports “Private plaintiffs cannot be reimbursed for emotional distress damages under the 1973 Rehabilitation Act and the Patient Protection and Affordable Care Act, the U.S. Supreme Court ruled” last Thursday in the linked opinion. The Affordable Care Act provision at issue is the ACA’s convoluted individual non-discrimination provision, Section 1557.

From the healthcare business front, Fierce Healthcare tells us

Outpatient volumes and revenue for hospitals and health systems showed a robust rebound in March as expenses eased due to fewer extremely sick patients, a new report said. 

Consulting firm Kaufman Hall released its latest hospital flash report Monday (PDF) detailing the impact of system finances for the month of March. A key takeaway from the report is that while actual hospital margins were negative for the third month in a row, outpatient revenues had a massive bump.

“While the road to recovery remains long for many hospitals, these trends indicate some pressures of the pandemic may be lifting,” said Erik Swanson, senior vice president of data and analytics with Kaufman Hall, in a statement. 

From the mental healthcare front,

Fierce Healthcare reports

Mental health concerns are on the rise across the board, and especially among Blacks, seniors, young adults and LGBTQIA people, a new survey finds.

CVS Health and Morning Consult polled more than 2,200 adults in early April and found that 59% of respondents have experienced challenges with their mental health or that of a friend or family member. That is a 9% increase over 2020 survey data.

More than half (57%) of people surveyed who identify as LGBTQIA expressed concern about their own mental health, 20 percentage points higher than other groups included in the study. Nearly three-quarters (74%) of those aged 18 to 34 said they experienced such concerns either themselves or for a friend or family member, up 12 percentage points from 2020.

The survey also found an 11 percentage point increase in mental health concerns among Black respondents compared to pre-COVID levels. A double-digit increase was also found among people over age 65; about 40% reported mental health concerns for themselves or family and friends, up 10 percentage points from 2020.

AHIP describes ten ways that people can get the mental healthcare services that they need.