Friday Stats and More

Rx coverage

Friday Stats and More

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

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 chart of weekly new Covid cases 2022:

The bulge on the left side of the chart is the original Omicron. The CDC’s weekly interpretation of its Covid stats adds

As of September 21, 2022, the current 7-day moving average of daily new cases (54,186) decreased 10.6% compared with the previous 7-day moving average (60,593).

CDC Nowcast projections* for the week ending September 24, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five lineages designated as Omicron: BA.5, BA.4.6, BA.4, BF.7, and BA.2.75. The predominant Omicron lineage is BA.5, projected at 83.1% (95% PI 81.3-84.7%).

The New York Times asks

Where is Pi?

Last year, the World Health Organization began assigning Greek letters to worrying new variants of the coronavirus. The organization started with Alpha and swiftly worked its way through the Greek alphabet in the months that followed. When Omicron arrived in November, it was the 13th named variant in less than a year.

But 10 months have passed since Omicron’s debut, and the next letter in line, Pi, has yet to arrive.

That does not mean SARS-CoV-2, the coronavirus that causes Covid-19, has stopped evolving. But it may have entered a new stage. Last year, more than a dozen ordinary viruses independently transformed into major new public health threats. But now, all of the virus’s most significant variations are descending from a single lineage: Omicron.

“Based on what’s being detected at the moment, it’s looking like future SARS-CoV-2 will evolve from Omicron,” said David Robertson, a virologist at the University of Glasgow.

Here is the CDC’s latest chart of daily new Covid hospitalization trends:

The weekly CDC review adds

The current 7-day daily average for September 14–20, 2022, was 3,971. This is a 9.9% decrease from the prior 7-day average (4,410) from September 7–13, 2022.

CDC’s Coronavirus Disease 2019-Associated Hospitalization Surveillance Network (COVID-NET) shows that COVID-19-associated hospitalizations continue to affect adults ages 65 years and older. Since early April 2022, more than 50% of all COVID-19-associated hospitalizations occurring every week are among adults ages 65 years and older. Before April 2022, adults ages 65 years and older had not comprised more than half of all COVID-19-associated hospitalizations since January 2021.

Here’s the FEHBlog latest chart of new weekly Covid deaths

The weekly CDC review adds “The current 7-day moving average of new deaths (347) decreased 12.2% compared with the previous 7-day moving average (396).”

Here is the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era, the 51st week of 2020, and the recently end 38th week of 2022.

The weekly CDC review adds

As of September 21, 2022, 616.2 million vaccine doses have been administered in the United States. Overall, about 263.8 million people, or 79.5% of the total U.S. population, have received at least one dose of vaccine. About 225.0 million people, or 67.8% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 109.6 million people have received a booster dose,* and 4.4 million people have received an updated (bivalent) booster dose. But 49.9% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.

It’s worth noting that according to the CDC’s Covid Data Tracker 92.3% of Americans 65 and older have received the first two vaccination doses; 71% of this cadre as received one booster dose, and 43% of this cadre, including the FEHBlog, has received two booster doses. Given the COVID-NET news above, these are the most important statistics.

In CDC Communities Level news, the weekly CDC review points out

As of September 22, 2022, there are 226 (7.0%) counties, districts, or territories with a high COVID-19 Community Level, 1,005 (31.2%) counties with a medium Community Level, and 1,986 (61.7%) counties with a low Community Level. Compared with last week, this represents a large decrease (−6.3 percentage points) in the number of high-level counties, a moderate decrease (-4.7 percentage points) in the number of medium-level counties, and a large increase (+11.0 percentage points) in the number of low-level counties. 

In other virus news, the New York Times reports

With monkeypox cases on the decline nationally, federal health officials expressed optimism on Thursday that the virus could be eliminated in the United States, though they cautioned that unless it was wiped out globally, Americans would remain at risk.

“Our goal is to eradicate; that’s what we’re working toward,” Dr. Demetre Daskalakis, the deputy coordinator of the White House monkeypox response team, said during a visit to a monkeypox vaccination clinic in Washington. He added, “The prediction is, we’re going to get very close.”

From the Rx coverage front, EndPoint News informs us

Drug pricing experts generally agree that bluebird bio’s two recently approved gene therapies and their multimillion-dollar price tags aren’t going to be one-offs as a wave of new cell and gene therapies makes its way to the market.

The FDA’s recent approvals for bluebird’s $2.8 million Zynteglo — with ICER supporting the price and an 80% rebate if patients don’t achieve transfusion independence — and the $3 million Skysona, approved under accelerated approval, are likely to be the norm for gene therapy prices moving forward, particularly if they can reduce costs elsewhere in the health care ecosystem, experts said.

Daniel Ollendorf, director of value measurement & global health initiatives at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, told Endpoints News in a phone interview that the trend behind multimillion-plus gene therapies is an extension of what began with Novartis’ $2.1 million spinal muscular atrophy gene therapy Zolgensma, which is still priced at about half of the 10-year current cost of chronic SMA therapy, and became a blockbuster for Novartis last year with more than $1.35 billion in annual sales.

But the expectation is that these high list prices will come with risk-sharing agreements and refunds if the products don’t work so payers don’t have to bear the full brunt of the financial risk, Ollendorf said. And he noted that some gene therapies don’t lend themselves as well to tracking milestones, but that isn’t the case for observing transfusion independence in those receiving Zynteglo.

From the maternity care front, Health Payer Intelligence tells us

Payers are implementing new programs that capitalize on telehealth and partnerships with technology companies to better engage pregnant members and improve maternal health outcomes. * * *

AHIP encouraged payers to integrate health technologies like telehealth into perinatal and maternal health to close access gaps to obstetric care in rural and underserved communities.

Perinatal telehealth interventions to improve outcomes can include videoconferences to replace or supplement in-person visits and enable consultation with specialists remotely, AHIP mentioned.

In the postpartum period, telehealth and other tools can be implemented to drive earlier postpartum follow-up visits and provide access to lactation consultants (tele-lactation).

Within the last year, Capital District Physicians’ Health Plan and Harvard Pilgrim Health Care partnered with digital family health platform Ovia to help members navigate fertility, pregnancy, and early parenting.

Through this partnership, members will gain access to three mobile apps – Ovia Fertility, Ovia Pregnancy, and Ovia Parenting in an effort to reduce maternity costs and improve maternal outcomes such as lowering c-section rates, preterm delivery, and neonatal intensive care unit (NICU) stays.

From the human interest front, Forbes explains “Why Billionaire Eric Schmidt Is Backing A High School Senior Making A Cancer-Detecting Toothbrush And Other Brilliant Teens.”

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Govexec lays out what appears to be an unnecessarily complicated path to a continuing resolution funding the federal government for 10 weeks into the new federal fiscal year beginning October 1. The Senate majority leadership crafted the rocky path that stems from the compromise which lead to Congressional passage of the budget reconciliation act earlier this summer.

From the No Surprises Act front, the American Medical Association informs us

The AHA and American Medical Association today moved to dismiss their challenge to the federal government’s September 2021 interim final rule governing the No Surprises Act’s independent dispute resolution process.

The groups challenged the rule in a District of Columbia court last December, but the lawsuit became moot when the Administration released a revised final rule on Aug. 26. However, the AHA and AMA remain concerned that the final rule continues to favor insurers and does not line up with what Congress intended when it passed the law.

In a joint statement the AHA and AMA said, “No patient should fear receiving a surprise medical bill. That is why the AHA and AMA strongly supported the No Surprises Act to protect patients from unexpected medical bills and keep them out of the middle of any billing disputes between providers and commercial health insurance companies. Congress enacted the law with a balanced, patient-friendly approach, and it should be implemented that way. We have serious concerns that the August 2022 final rule departs from Congressional intent just as the September 2021 interim final rule did. Hospitals and doctors intend to make our voices heard in the courts very soon about these continued problems.”

The AHA and AMA’s suit did not seek to prevent the law’s core patient protections from moving forward. It sought only to force the Administration to bring the regulations in line with the law before the dispute negotiations begin.

The AHA / AMA lawsuit is consolidated with a suit filed by an air ambulance association which may explain why these two large provider associations are dismissing its case rather than amending their complaint. The FEHBlog does not understand why the provider associations refuse to give the new rule a chance before bringing another expensive lawsuit.

From the U.S. healthcare business front —

Fierce Healthcare reports

Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.

Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.

The transaction is expected to be completed by the end of the year. * * *

As a specialty pharmacy, Shields offers medications with unique handling, administration and monitoring requirements. Specialty drugs are used to treat complex or rare conditions such as cancer, hepatitis and transplants. Shields currently names 30 health systems as partners, including 1,000 hospitals.

and

Employer health startup Transcarent is making its next move with the launch of its new pharmacy program.

Transcarent’s Pharmacy Care offering is designed to be fully transparent and integrate with its other platforms. The goal, executives said, is to break through the noise for members and make it easier for them to understand their pharmacy benefits while offering employers full control over formulary, benefit design and data.

The platform is available to self-funded employers as well as health systems, Transcarent said in an announcement. Snezana Mahon, Transcarent’s chief operating officer, told Fierce Healthcare that the company’s employer clients have felt the market changes and are seeking a way to “coexist” in a world where there are traditional pharmacy benefits, cash pay and coupon cards all working together.

From the healthcare quality front, Beckers Hospital Review calls attention to

A new data visualizer shows the 10 most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists like those from U.S. News & World Report.

SimilarityIndex | Hospitals comes from Trilliant Health Labs, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 

Users can compare hospitals to find peers in either quality alone or aggregate — the latter reflects an equally weighted combination of measurements in the categories of hospital quality (including 30-day mortality and readmission rates), outpatient service line, financial (including operating margin and average inpatient service costs), patient mix and market share.

Nifty.

From the public health front —

The US Preventive Services Task Force (USPSTF) today posted for public comment draft recommendations on screening for anxiety, depression, and suicide risk in adults.

For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety — including pregnant and postpartum women.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.

The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.

The public comment deadline is October 17.

  • The Wall Street Journal offers advice on timing the annual flu shot and the upcoming flu season in general.
  • The CDC released a vital signs report warning that rates of screening and treatment of children with sickle cell anemia for life-threatening problems are far too low.

Two recommended healthcare measures to prevent complications in children with sickle cell anemia are:

* Transcranial doppler (TCD) ultrasound screening, which identifies children with increased risk for stroke.

* Hydroxyurea therapy, which reduces the occurrence of several complications, including severe acute pain episodes and acute chest syndrome, which can result in lung injury and trouble breathing.

Far too few patients are receiving these potentially lifesaving prevention measures, recommended by an expert panel in 2014. 

  • The CDC also called attention to its website about gestational diabetes.

From the Rx coverage front, Bio Pharma Dive relates

The Food and Drug Administration on Friday [September 16] granted accelerated approval to a personalized gene therapy for an ultra-rare childhood brain disease, called cerebral adrenoleukodystrophy or CALD.

Built from a patient’s own stem cells, the therapy is the first medicine to be made available in the U.S. for CALD, which affects young boys and typically results in severe disability or death. It was developed by the biotechnology company Bluebird bio and will be sold as Skysona.

Its approval is Bluebird’s second in four weeks, following an Aug. 17 FDA decision on another gene therapy from the company for the blood disorder beta thalassemia. * * *

In the U.S., an estimated 50 boys are born each year who will go on to develop CALD. Bluebird expects to treat about 10 annually.

Meant to be a one-time infusion, Skysona will cost $3 million. The price tag makes the therapy one of the most expensive ever launched on a single-use basis, exceeding the $2.8 million cost of Bluebird’s other gene therapy. * * *

Bluebird expects Skysona to be available by the end of the year, and is planning to work with a “limited number” of centers that are experienced in treating CALD and in stem cell transplantation, including Boston Children’s Hospital and CHOP [Children’s Hospital of Philadelphia].

[Due to the small number of patients, t]he company is not putting in place “outcomes-based” coverage agreements with insurers for Skysona as it did with its other gene therapy, for which it’s offering to reimburse part of the cost if patients don’t continue to benefit.

From the surveys department —

A majority of healthcare executives think value-based-care has replaced fee-for-service billing, a new survey found. 

Of 160 C-suite executives and other high-level staff surveyed, just 4 percent said they think payers use traditional fee-for-service billing with no connection to quality and value. The majority of executives think payers use FFS models with connections to the quality and value of care taken into account. 

The survey, conducted by business intelligence firm Morning Consult and health tech company Innovaccer, found just 1 percent of executives think FFS billing with no connection to value will be in use in 2025. 

According to a Sept.14 news release, payers report that FFS billing with no account for value makes up more than 10 percent of billing, higher than providers estimated. 

“So, providers think the transition to value has substantially occurred, when in fact we’re only at the very beginning,” Brian Silverstein, MD, Innovaccer’s chief population health officer, said in the release. “The amount of financial risk providers have is going to increase significantly in the next few years.”

  • Beckers Hospital Review tells us “Patients who are publicly insured or uninsured are more likely to be treated unfairly in healthcare settings compared to patients with private insurance, according to a report from the Urban Institute with support from the Robert Wood Johnson Foundation.”

In closing Federal News Network shares the list of deserving federal employees receiving the 2022 Partnership for Public Service’s Samuel J. Heyman Service to America Medals — affectionately known as the Sammies. These awards “often dubbed the “Oscars” of federal service” will be presented at a gala tonight. Hearty congratulations to the award winners and the other nominees.

Monday Roundup

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

From Capitol Hill, Govexec informs us that

Congress is looking to fund federal agencies at their current spending levels through mid-December, with momentum growing for a 10-week stopgap bill to avoid a government shutdown on Oct. 1. 

Lawmakers must clear several hurdles before voting on a continuing resolution to kick off fiscal 2023, but they could act as soon as this week. Senate Majority Leader Chuck Schumer, D-N.Y., said last week he would work with Republicans to “avoid even a hint of a shutdown,” though several disagreements remain. Negotiations appear to have settled on a CR that would fund agencies through approximately Dec. 16, but lawmakers have yet to determine exactly which provisions will be added to it. 

From the federal appointment front, STAT News reports

President Joe Biden on Monday appointed longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health.

Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized. The president officially launched the agency in March with $1 billion in initial funding allotted by Congress, but the search for its inaugural director has taken months.

Wegrzyn, 45, currently works at Boston-based Ginkgo Bioworks, a company focused on biological engineering, but has prior experience in two government agencies Biden has said he hopes to emulate with ARPA-H — the Pentagon’s Defense Advanced Research Projects Agency and the Intelligence Advanced Research Projects Activity.

Good luck, Dr. Wegryzn.

From the omicron and siblings front

The American Hospital Association tells us

Insured and uninsured Americans can receive the new bivalent Pfizer or Moderna COVID-19 booster and other COVID-19 vaccines at no cost as long as the federal government continues to purchase and distribute them, the Centers for Medicare & Medicaid Services announced today.

The Centers for Disease Control and Prevention this month recommended Pfizer’s updated COVID-19 vaccine booster for Americans aged 12 and older and Moderna’s updated COVID-19 vaccine booster for Americans aged 18 and older at least two months after completing a primary COVID-19 vaccine series or booster. Authorized by the Food and Drug Administration, the updated boosters are bivalent, meaning they help protect against the most recently circulating omicron variants as well as the original virus strain.

Americans can find local sites administering the new COVID-19 vaccine booster here. For more on provider requirements and payment, visit the CDC COVID-19 Vaccination Program and CMS toolkit.

The Wall Street Journal reports

Illness caused by Covid-19 shrank the U.S. labor force by around 500,000 people, a hit that is likely to continue if the virus continues to sicken workers at current rates, according to a new study released Monday.

Millions of people left the labor force—the number of people working or looking for work—during the pandemic for various reasons, including retirement, lack of child care and fear of Covid. The total size of the labor force reached 164.7 million people in August, exceeding the February 2020 prepandemic level for the first time. The labor force would have 500,000 more members if not for the people sickened by Covid, according to the study’s authors, economists Gopi Shah Goda of Stanford University and Evan J. Soltas, at the Massachusetts Institute of Technology.

“If we stay where we are with Covid infection rates going forward, we expect that 500,000-person loss to persist until either exposure goes down or severity goes down,” said Mr. Soltas. That assumes that some of those previously sickened eventually return to work.

The authors “provide the most credible evidence to date about labor-market impacts for a large set of workers,” said Aaron Sojourner, an economist at the W.E. Upjohn Institute for Employment Research, who wasn’t involved in the study.

From the U.S. healthcare business front —

Healthcare Dive relates

Escalating costs for labor, drugs, supplies and equipment are adding to the long-term pressures facing rural hospitals, raising the risk of more closures that could jeopardize patient access to care, the American Hospital Association warned in a new report. 

Many hospitals were already in difficult financial positions before the COVID-19 pandemic began, due to challenges including low patient volume and reimbursement, geographic isolation, staffing shortages and aging infrastructure, the AHA said. From 2010 through 2021, 136 rural hospitals closed, according to data from the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. In 2020, when the pandemic hit, a record 19 rural hospitals closed.

The public health emergency put additional pressure on margins and patient volumes. “While rural hospitals were partially buoyed by the Provider Relief Fund and other sources of COVID-19 assistance that limited closures in 2021, the financial outlook for many rural hospitals moving forward is precarious,” the AHA said.

Revcycle Intelligence reports

Private equity acquisition of physician practices in dermatology, gastroenterology, and ophthalmology was associated with increased healthcare spending and utilization, according to a study published in JAMA Health Forum. * * *

Following a private equity acquisition, physician practices saw consistent growth in spending during the next eight quarters. Acquired practices saw a mean increase of $71 in charges per claim or a 20.2 percent increase. In addition, practices saw an increase of $23 in the allowed amount per claim—an 11 percent increase.

Patient utilization of healthcare services grew as well after practices underwent acquisitions.

Across the eight post-acquisition quarters, the mean number of unique patients increased by 25.8 percent. This increase was mainly driven by more new patient visits, which rose by 37.9 percent. The number of encounters grew by 16.3 percent and the number of evaluation and management (E/M) visits increased by 37.1 percent.

The increase in patient visits may reflect changes in management and practice operations or overutilization of profitable services and low-value care, the study suggested. This could lead to higher healthcare spending without corresponding benefits.

Additionally, researchers said the growing number of visits was consistent with private equity firms’ common strategy to maximize revenue through a fee-for-service delivery system.

Ruh roh on both counts.

Healthcare Finance adds

Quality can go a long way in determining if a consumer is willing to pay more for their healthcare, as indicated by new survey responses published by revenue cycle company AKASA.

Out of more than 2,000 respondents, the survey found that 57% would pay more for a higher quality of care. Out of all categories in the survey, care quality was the only area in which a majority said they would be willing to pay more.

Forty-seven percent said they would pay more for the ability to work with the care team of their choice. Forty-one percent said they would pay more for the ability to work with hospitals of their choice, while the same percentage said they’d pony up more cash for better location proximity or convenience.

In public health news, the American Hospital Association celebrates the fact that

The United Network for Organ Sharing, which serves as the nation’s transplant system under contract with the federal government, Friday reported its millionth U.S. organ transplant. UNOS and the Organ Donation and Transplantation Alliance credited the organ donation and transplantation community, including transplant hospitals, with making the historic milestone possible. The first successful transplant took place at Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston in 1954.

UNOS and the Alliance encourage the transplant community to join Living It Forward, a national initiative to commemorate the achievement and accelerate the path forward to the next million transplants. They also encourage members of the public to register as organ donors, noting that each donor can save up to eight lives and help up to 75 people through tissue donation. Over 100,000 people remain on the transplant waitlist.

From the Rx coverage front, BioPharma Dive tells us that

The Food and Drug Administration on Friday approved Bristol Myers Squibb’s psoriasis pill Sotyktu, the first medicine of its type and the last of three potential blockbuster drugs the company sought to bring to market this year.

Sotyktu will compete with biologic drugs like AbbVie’s Humira and Amgen’s Enbrel, but as a pill could be more attractive to patients who don’t want to inject themselves regularly. Importantly, Sotyktu’s labeling doesn’t require patients to first try biologic drugs, giving doctors an opportunity to prescribe it widely.

Approval came after Phase 3 testing in which the pill, also known as deucravacitinib, was tested against a placebo as well as another oral therapy, Amgen’s Otezla. In patients with moderate-to-severe plaque psoriasis, Sotyktu outperformed both on two commonly used measures for assessing skin clearing: PASI and sPGA.

“All in all, the overall efficacy and safety profile as a new first-in-class agent for plaque psoriasis bodes well for it becoming the standard of care,” said Samit Hirawat, Bristol Myers Squibb’s chief medical officer, setting a high bar for his company’s commercial expectations.

In wellness news, Healio informs us that

Widespread adoption of simple lifestyle changes, including switching to a well-known eating plan, could reduce risk for CV events and death for millions of adults with stage 1 hypertension, researchers reported.

“Millions of working-age people are walking around with elevated BP, which is symptomless but is also a leading preventable cause of disability and death,” Kendra D. Sims, PhD, MPH, a postdoctoral fellow at the University of California, San Francisco (UCSF) School of Medicine who presented the findings at the American Heart Association Hypertension Scientific Sessions, told Healio. “Our study found that 27,000 CVD events and 2,800 deaths could be prevented during the next 10 years if people with elevated BP follow through with recommended lifestyle changes. We would then save $1.6 billion in associated health care costs. The largest benefit comes from eating more fruits and vegetables and less salt, as outlined in the Dietary Approaches to Stop Hypertension (DASH) diet.

Midweek Update

David Ermer–CDC, COVID-19, HSA, Mental health care, Rx coverage, U.S. Healthcare–

OPM announced today that the next Federal Benefits Open Season will be held from November 14 through December 12, 2022. The announcement tells us that OPM expects to post 2023 FEHB and FEDVIP premiums on its website in “late September.”

From the Omicron and siblings front, the Wall Street Journal offers a helpful set of FAQs on the new bivalent mRNA boosters that are currently rolling out for administration.

From the monkeypox front, the Food and Drug Administration announced action to expand testing for the disease.

From the public health front, McKinsey and Company released its

United States of Health Dashboard. [McKinsey describes the tool as] an easy-to-use data visualization tool that enables users to explore the impact of disease and ill health within individual states, the dashboard is informed by key metrics encompassing maternal and neonatal health, behavioral health, communicable disease, chronic disease, and environmental health. It measures the total loss of healthy years of life, assuming full health (also known as “the burden of disease”), that affect a state’s population over the course of one year.

The dashboard is designed to help current and newly tapped state leaders, public-health agencies, and other stakeholders identify the highest-priority areas for investment by offering insights into key questions such as: How do behavioral health challenges affect a state’s population? How well is chronic disease managed and infectious disease controlled? How do mothers and their newborn infants fare? How well are health risks in the environment managed? And which populations are most significantly impacted by these metrics?

For example, here is a link to the Texas dashboard.

In other public health news, the American Hospital Association informs us

September is Suicide Prevention Awareness Month, with National Suicide Prevention Week running Sept. 4-10. In recognition of the effort to reduce the occurrence of suicide and destigmatize the conversation around it, AHA is proud to highlight resources available to our members and the public at large.

HR Director offers an interesting article about how HR professionals can approach this issue.

In the roughly dozen years since [he dealth with an employee suicide], [Matthew] Burr has advised every one of his clients (which include schools, financial firms and manufacturers, among other companies) to establish an EAP. Aside from a couple smaller companies, which have anywhere from five to 10 employees, every client has taken his advice. They were truly grateful to have done so ahead of the COVID-19 pandemic, so their employees had support systems already in place during the unprecedented time.

From the U.S. healthcare business front

  • Healthcare Dive reports that Walmart and UnitedHealthcare have teamed up to offer a Medicare Advantage plan under a ten-year-long contract. “Ultimately, the goal is to serve hundreds of thousands of seniors and Medicare beneficiaries in value-based arrangements through multiple Medicare Advantage plans.
  • Beckers Hospital Review tells us “Cost Plus Drug Co. founder Mark Cuban expects his online pharmacy to soon grow past 1 million customers, the billionaire of Shark Tank fame said Sept. 6 during Vox‘s Code Conference.  ‘By the time I get back, we should, hopefully, be past a million patients in seven months,’ Mr. Cuban told Vox‘s Recode, referring to the late-January launch of Cost Plus Drug Co., according to CNET.”
  • Reuters reports, not surprisingly, that “CVS Health Corp’s (CVS.N) plan to buy healthcare services company Signify Health for about $8 billion will face a tough U.S. antitrust review even though the two companies do not compete directly in any markets, three experts said Tuesday.”

From the Rx coverage, BioPharma Dive discusses the near term future of biosimilar drugs.

From the health savings account front, Voya Financial discusses “five HSA funding strategies companies [or FEHB plans’ can employ to help boost employee saving.”

Tuesday’s Tibits

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

From Capitol Hill, Fierce Healthcare points out four legislative items that providers should be tracking for the remainder of this year.

From the Omicron and siblings front, the Washington Post reports

Cold weather favors the coronavirus. But as summer gives way to fall, infectious-disease experts are guardedly optimistic that the spread of covid-19 this autumn and winter won’t be as brutal as in the previous two years of the pandemic.

Coronavirus scenarios from multiple research teams, shared in recent weeks with federal officials, foresee stable or declining hospitalizations in early fall. The scenarios show the possibility of a late-fall surge. A new variant remains the biggest wild card. But several factors — including the approval this week of reformulated boosters and the buildup of immunity against the latest strain of the virus — could suppress some of the cold-season spread, experts say.

In related news, the Wall Street Journal informs us

U.S. health authorities plan to recommend that people get Covid-19 boosters once a year, starting with the new shots now rolling out, a shift from their current practice of issuing new advice every several months.

The annual cadence would be similar to that of flu shots, White House officials said Tuesday, though elderly people and those with weakened immune systems may need more frequent inoculations. 

A shift to annual Covid-19 boosters would be a departure from current practice and comes after many people in the U.S. have ignored calls to get a first or second booster, partly due to fatigue with repeat inoculations. 

“Barring any new variant curveball,” said White House coronavirus coordinator Ashish Jha, “for a large majority of Americans, we are moving to a point where a single annual Covid shot should provide a high degree of protection all year.”

A very sensible approach, indeed!

From the healthcare business front, Healthcare Dive tells us

Amazon and One Medical said Friday that antitrust regulators want more information about the online retailer’s proposed $3.9 billion acquisition of the primary care group. 

The Federal Trade Commission sent a second request for information on Friday, One Medical said in a filing with the U.S. Securities and Exchange Commission.

A second request from the FTC means the two cannot move forward with the deal “until the companies have substantially complied with the additional investigatory request,” according to the FTC.

Amazon and One Medical will “promptly respond” to the second request, the primary care group said in the SEC filing.

In July, Amazon agreed to purchase One Medical for $3.9 billion in an all-cash deal.

From the tidbits department

  • Drug Channels surveys the upcoming Humira price war as biosimilar competitors take the field.
  • CMS posted new information about available group health plan defenses to CMS contractor assertions that the GHP has failed to properly coordinate its benefits with Medicare.
  • Beckers Payer Issues offers expert opinions on the impact of the transparency in coverage rule on consumerism now that the three machine-readable files of health plan pricing data have been posted for two months. For example, “Neil Mayle is the founder and president of Visible Charges, a Cambridge, Mass.-based company that provides clients with curated datasets of both payer- and provider-negotiated service prices. * * * ‘I think we’ve gone from nothing to a lot,’ Mr. Mayle said. ‘We haven’t gone to perfect.'” Of course, it was only the first of three stages in transparency in coverage rule disclosures.
  • The FEHBlog noticed today these CMS and DOL fact sheets on the No Surprises Act which are worth a gander.

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Friday Stats and More

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

Because it’s the beginning of the three day weekend, the Centers for Disease Control did not publish its weekly review of CDC Covid statistics. The FEHBlog values that weekly review because it complements the FEHBlog’s own Covid charts which are based on the CDC’s Covid Data Tracker and use Thursday as the first day of the week. So without further ado, here are the FEHBlog’s three Covid charts for this week, the 35th week of 2022:

It’s always worth noting that the peaks on the left sides of the top two charts reflect the grand daddy of surges, the first Omicron wave. With respect to Covid vaccines, Revcycle Intelligence reports that the American Medical Association has added eight new CPT-4 codes to its procedures manual to cover physician services for the new Covid bivalent boosters.

From the U.S. healthcare business front, the Wall Street Journal reports this evening

CVS Health Corp. is in advanced talks to acquire the home-healthcare company Signify Health Inc. for around $8 billion, according to people familiar with the matter.

CVS appears to have beat out other heavy hitters including Amazon.com Inc. and UnitedHealth Group Inc., which had been circling Signify for a deal that could be announced soon. UnitedHealth never submitted an official bid, one of the people said.

There is still no guarantee that CVS will reach a deal for Signify, which has been exploring strategic alternatives since earlier this summer.

While Signify’s deadline for bids is Tuesday, September 6, Signify could strike a deal before then.

UHC is not sitting on its hands though. According to MedPage Today

UnitedHealth Group’s healthcare services division, Optum, will reportedly acquire Kelsey-Seybold for approximately $2 billion, according to the Star Tribune.

The acquisition of Kelsey-Seybold, a physician group based in Houston that includes cancer and women’s health centers, two ambulatory surgery centers, and a sleep center, was first announced in April, but few details have emerged since, the Star Tribunereported.

However, Optum, based in Eden Prairie, Minnesota, did provide a statement to MedPage Today about incorporating Kelsey-Seybold’s operations and staff into the Optum network.

From the rather quiet monkeypox front, STAT News raises a new concern.

A new study is raising concerns about the effectiveness of the monkeypox vaccine being used in the United States and other parts of the world.

The work, which has not yet been peer-reviewed, found that two doses of the vaccine induced relatively low levels of neutralizing antibodies against the monkeypox virus, and those antibodies had poor neutralizing capacity.

The researchers noted the so-called correlates of protection — what is needed, in terms of immune system weaponry, to be protected against monkeypox — are not known. Still, the evidence of low levels of neutralizing antibodies raises questions about how much protection is generated by two doses of the vaccine, marketed as Jynneos in the U.S. and made by the Danish manufacturer Bavarian Nordic. * * *

The study also casts a shadow over the recent decision by the U.S. government and others to stretch vaccine supplies by giving people one-fifth of a regular dose — and to do so by intradermal (into the skin) rather than subcutaneous (under the skin) injection. Intradermal administration, which requires smaller doses to be protective, has been shown to be effective in other disease outbreaks with other types of vaccine.

From the opioid epidemic front, STAT News features an interview with Rahul Gupta, M.D., “the director of the White House Office of National Drug Control Policy and the first doctor to hold that position.”

Gupta’s selection as director of the White House Office of National Drug Control Policy, however, has ushered in a new era of federal drug policy. As the first doctor to hold the position, he says he will embrace new strategies, including harm reduction tactics, which aim to reduce drug users’ risk of overdose, death, and disease in lieu of a hardline, abstinence-only attitude.

Still, though, addiction treatment is dogged by stigma, underuse of existing medications, and ongoing debate about certain harm-reduction techniques. The debate came to a head last week in California, where Gov. Gavin Newsom vetoed a bill to allow supervised injection sites — essentially clinics where people can use illicit drugs under medical supervision so as to prevent overdose.

Gupta sat down with STAT this week to discuss the ongoing crisis and the Biden administration’s efforts to address it. While circumspect about Newsom’s decision, Gupta did take several positions that are far more aggressive than any of his predecessors: Calling out doctors for their role in poor treatment outcomes; arguing that the addiction medication buprenorphine is widely misunderstood; and advocating for contingency management, a new addiction intervention that offers rewards — often cash — in exchange for cessation of drug use.

From the public health front, the Food and Drug Administrations discusses “Using A Whole-Of-Governments Approach to Combating Illicit Health Products.” Among other steps, “the agency has partnered with the Organisation of Economic Co-Operation and Development (OECD) Task Force on Countering Illicit Trade, which has been studying the problem of illicit trade for 15 years.” 

From the Rx coverage front, Endpoints News informs us

Last July, the cost-effectiveness drug watchdog ICER released a preliminary draft report that Vivus’ Qsymia was the most cost-effective option for weight loss. That decision has now been validated.

ICER made its final determination Wednesday [August 31] that Qsymia, the brand name for the appetite suppressant phentermine combined with anticonvulsant topiramate, was more cost-effective for weight loss than other competitors such as Novo Nordisk’s Saxenda (liraglutide) and Wegovy (semaglutide) or Currax Pharmaceuticals’ Contrave (bupropion/naltrexone). * * *

ICER reviewers also added that if Qsymia wasn’t performing well in certain patients, Contrave may be the next best cost-effective option. The reviewers noted in their report that there were a few limitations to analysis, including the full impact of the drugs in patients with chronic kidney diseases or conditions where weight loss may be beneficial.

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19, COVID-19 vaccine, Government Contracting, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, Regulatory Focus reports

[Last week,] both Pfizer and Moderna are seeking FDA authorization for their bivalent COVID-19 vaccines containing components of both the prototype virus and Omicron BA.4/5. 

“The FDA is working tirelessly to evaluate the submissions to ensure the data meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality so that these new boosters are available as soon as possible,” Califf tweeted on Thursday, noting that the agency would base its decision on “the totality of available evidence,” including clinical trial data from other bivalent mRNA vaccines, real-world evidence from current vaccines and non-clinical data on the two BA.4/5-containing vaccines.
 
Califf also said that the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) would not be convened to review the submissions. “FDA will not hold a VRBPAC meeting about these submissions, as the agency feels confident in the extensive discussion that was held in June. VRBPAC voted overwhelmingly to include an omicron component in COVID-19 boosters. FDA has no new questions that warrant committee input,” he wrote.

From the monkeypox front, the Wall Street Journal informs us

A person in Texas who was diagnosed with monkeypox and had a weak immune system has died, Texas state health officials said Tuesday, in what could be the first-known fatality from the virus in the U.S.

The Texas Department of State Health Services said this was the first death of a person diagnosed with monkeypox in Texas. Officials are investigating what role monkeypox played in the death. They said the patient, who was an adult and a resident of Harris County, Texas, was “severely immunocompromised” but didn’t offer additional details. 

In a statement, Texas health commissioner Dr. John Hellerstedt said that “monkeypox is a serious disease, particularly for those with weakened immune systems.” He urged those who have been exposed or have symptoms to seek treatment.

Healthcare Dive adds

Concerns over monkeypox vaccine supplies appear to be softening after federal public health agencies initially scrambled to acquire enough doses of the shot.

The Biden administration has been working to boost its supply of vaccines in recent weeks, and so far has made over 1 million vials available to jurisdictions, “which is nearly enough to reach the entire population that’s most at risk,” HHS Secretary Xavier Becerra said during a call with reporters Tuesday.

The HHS also announced on Monday that it will provide about $11 million to support the first U.S.-based productioneffort for manufacturing the Jynneos vaccine at a facility in Grand Rapids, Michigan.

The FDA authorized administering the Jynneos shot intradermally — a method that requires only one-fifth of the usual dose but is just as effective, according to the agency.

However, the vaccine’s developer, Bavarian Nordic, has raised concerns about the method, citing a lack of data and evidence related to its efficacy.

About 75% of jurisdictions that have received the vaccine are administering it intradermally now, Bob Fenton, the White House’s monkeypox response coordinator, said on Tuesday’s call.

From the public health front, CNN Health discloses

CDC Director Dr. Rochelle Walensky has tapped Mary Wakefield — an Obama administration veteran and former nurse — to helm a major revamp of the sprawling agency and its multibillion-dollar budget. Making the changes will require winning over wary career CDC scientists, combative members of Congress, and a general public that in many cases has stopped looking to the agency for guidance.

“If she can’t fix it, she’ll say, ‘It’s not fixable, here’s why, and here’s what needs to be done next,'” said Eileen Sullivan-Marx, dean of the New York University Rory Meyers College of Nursing, who’s known Wakefield professionally for decades.

Also, Specialty Pharmacy Continuum points out

Less than 20% of providers submitted claims using a type of payment code [ICD 10 Z codes] that could help identify and address health disparities that adversely affect patient outcomes, according to a new ICON Market Access report.

The results come amid a growing call for payors and pharmaceutical manufacturers to work together to better address racial and ethnic health inequalities, speakers said during the AMCP 2022 annual meeting.

Such health disparities exist in nearly all U.S. states, said Jessica Cherian, PharmD, RPh, the vice president of content and strategic services for ICON Market Access, citing a 2021 Commonwealth Report, In 2021, her company surveyed 32 payor executives for their perceptions regarding health disparities in racial and ethnic groups, with a targeted focus on medication access and utilization.

Payors typically review data from claims, case manager screenings and more, and use that information to match members to programs that meet their SDOH needs, such as access to care, housing or transportation help, Ms. Fleming said. Payors also track needs through Z codes: additional codes provided in the International Classification of Diseases, Tenth Revision to report nonmedical factors influencing health status. For example, code Z63 would indicate difficulty with a patient’s family/support, such as alcoholism or drug addiction. Approximately 71% of payors in the ICON report used Z codes to monitor SDOH; however, they said less than 20% of submitted claims included these codes.

In payor personnel news, Healthcare Dive informs us

Name: David Brailer

New title: Executive vice president and chief health officer, Cigna

Brailer will assume his new role in early September, and will be Cigna’s first chief health officer.

In his role, he will focus on bringing together Cigna products, technologies and services in new ways in an attempt to drive more value and help improve overall health, according to the release.

He will report to Cigna Chairman and CEO David Cordani and will serve on the company’s enterprise leadership team.

From the healthcare costs front, the HHS Agency for Healthcare Quality and Research released “STATISTICAL BRIEF #543: Trends in Health Insurance at Private Employers, 2008-2021.”

“Highlights

  • “Employment-sponsored health insurance at private-sector employers was characterized by increases in premiums and cost-sharing for covered workers in 2021.
    • In 2021, average health insurance premiums were $7,380 for single coverage, $14,634 for employee-plus-one coverage, and $21,381 for family coverage, representing increases of 3.2, 3.1 and 3.0 percent, respectively, from their 2020 levels.
    • In 2021, the average employee contribution was $1,643 for single coverage, a 7.2 percent increase from the 2020 level. Single premium contributions increased at small (12.3 percent), medium (14.1 percent), and large firms (5.6 percent).
    • From 2020 to 2021, average deductible levels for single coverage increased by 3.0 percent to $2,004, and family coverage deductibles increased 3.9 percent to $3,868.
  • “From 2020 to 2021, there were no statistically significant changes in enrollment rates or offer rates for small, medium, or large firms. 
  • “Overall enrollment and offer rates decreased from 2020 to 2021. These decreases are due to an increase in employment among small employers, and a corresponding decrease in the proportion of employees in medium and large firms, which have higher rates for both measures.
  • “In 2021, overall eligibility and take-up rates were not significantly different from 2020 levels.”

From the Rx coverage front, HealthDay tells us

Cholesterol-lowering statins are proven lifesavers, but they’ve also gained a reputation for causing muscle aches and pains in a good number of patients.

That reputation is undeserved, according to a new large-scale analysis of data from nearly two dozen clinical trials of statins.

There’s a less than 10% chance that muscle symptoms reported by patients are caused by the statin they are taking, researchers report.

“Our analysis showed that over 90% of muscle symptoms were not attributable to the statin, and those cases that were due to statins occurred mainly within the first year of treatment,” said joint lead researcher Colin Baigent, director of the Medical Research Council Population Health Research Unit at the University of Oxford, in England.

Statins have simply gotten a bad rap when it comes to muscle side effects, Baigent said.

In government contract reporting news, the Society for Human Resource Management reports

The Office of Federal Contract Compliance Programs (OFCCP) has issued a revised directive on compensation compliance, addressing concerns federal contractors had about a previous directive issued earlier this year. Some contractors were concerned that the prior version of the directive intruded upon communications protected by attorney-client privilege.

On the same day the revised directive was issued, OFCCP Director Jenny Yang wrote in a blog post that a top priority for the OFCCP is combating agency pay discrimination.

“Contractors therefore should review the directive and ensure they are engaging in compensation analyses as required by the regulations and be prepared to respond to questions regarding those analyses that are detailed in the directive,” said Guy Brenner, an attorney with Proskauer in Washington, D.C.

“Federal regulations require contractors periodically—or OFCCP interprets now as annually—[to] review their compensation systems to determine whether there are gender, race or ethnicity-based disparities in compensation,” said Sheila Willis, an attorney with Fisher Phillips in Columbia, S.C.

Thursday Miscellany

David Ermer–COVID treatment, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

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.

Midweek update

David Ermer–CDC, Government Contracting, Rx coverage, U.S. Healthcare–

From inside the Beltway, Roll Call tells us

Centers for Disease Control and Prevention Director Rochelle Walensky is looking to reorganize the agency in the wake of an external review of the CDC’s COVID-19 response. * * *

“For 75 years, CDC and public health have been preparing for COVID-19,” Walensky said, “and in our big moment, our performance did not reliably meet expectations.” 

The plan aims to achieve a “more cohesive and customer centric structure,” by implementing new programs and procedures to work more quickly and ensure more accountability. Walensky plans to establish an executive council to oversee the CDC’s progress on specific goals, consolidate various points of access for external stakeholders and establish a new equity office.

STAT News adds

Outside experts expressed enthusiasm — though some of it tempered — for the changes Walensky is proposing.

Jay Varma, who spent 20 years at CDC before becoming director of the Cornell Center for Pandemic Prevention and Response at Weill Cornell Medicine, applauded many of the points Walensky stressed, particularly her promise to reform the culture of the agency and build up the capacity of its staff to respond to emergencies. Over the past two decades or so, Varma told STAT, public health agencies like the CDC have become increasingly bureaucratic.

“If your culture is not aligned entirely with what your mission is, it doesn’t matter how good the strategy is. It doesn’t matter what your org charts are. It is all about the workforce culture,” he said.

But Varma warned effecting change in the agency’s culture will be challenging.

Speaking of change, Fierce Healthcare informs us

A dramatic pickup in the pace of change for payers in the last year has created new priorities for health plan leaders, a new survey has found. 

The survey, conducted by payment integrity solution HealthEdge, reached more than 300 health plan leaders. Common themes, per a report of the survey results, included the move to newer systems amid a digital transformation, rising demand for real-time data access and the promise of interoperability. 

Some of the biggest threats facing health plans are new regulations, growing consumer expectations, competition and the transition to value-based payment strategies. The top two challenges are managing costs and driving operational efficiencies, which were lower on the list of priorities just last year. Tied in third place are member satisfaction and alignment of IT and business needs. 

There are several drivers of these hurdles. Post-pandemic, there are notably more claims. Long delays in care have also led to rising costs, and outdated systems have required significant investment to keep up with demand. Having a solid digital baseline can help payers eliminate manual, repetitive processes, the report suggested. Payers also believe increasing interoperability and improving claims accuracy helps alleviate administrative costs. 

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Wednesday approved a powerful new treatment for people with an inherited blood condition called beta thalassemia, clearing a personalized gene therapy developed by the biotechnology company Bluebird bio. * * *

Its approval is a milestone in a number of other respects, too. Beta thalassemia, a disease that in severe cases requires regular blood transfusions for life, has for years been marked as a target for gene therapy. Bluebird’s treatment, which will be sold as Zynteglo, is the first of several in development to reach market in the U.S., giving patients an option that could free them from those transfusions and their associated side effects.

STAT News adds

Bluebird has set the price of Zynteglo at $2.8 million per patient, making it one of the most expensive medicines ever sold in the U.S. And that price tag doesn’t include the cost of the lengthy hospitalization for patients getting the therapy.

A person with beta thalassemia incurs total health care costs that average $6.5 million over their lifetime, or 23 times higher than the general population, said Obenshain, making the case for Zynteglo’s cost effectiveness. Earlier this year, the Institute for Clinical and Economic Review, an independent drug-pricing analysis group, said Zynteglo would be cost effective up to a price of $3 million.

Bluebird will be asking insurers to pay for Zynteglo entirely up front, but the company will also return up to 80% of the cost if patients need to restart blood transfusions before two years.

“All the commercial insurers we’ve engaged with have expressed a really strong interest in this,” said [Bluebird CEO Andrew] Obenshain, of Bluebird’s outcome-based payment proposal.

From the research and studies front —

  • “Infectious disease expert Dave Wessner reports for Forbes from the 24th International AIDS Conference, where researchers shared ways that Covid vaccine development might help the development of a vaccine for AIDS.”
  • The National Institutes of Health announced “Scientists funded by the National Institutes of Health have developed a same-day test to identify abnormal fetal chromosomes. The Short-read Transpore Rapid Karyotyping (STORK) test can detect extra or missing chromosomes (i.e., aneuploidy) using samples collected from prenatal tests, such as amniocentesis and chorionic villus sampling, as well as tissue obtained from miscarriage and biopsies from pre-implantation embryos produced using in vitro fertilization (IVF). * * * Overall, the study shows that STORK is comparable to standard clinical tests and has many advantages. STORK is faster, providing results within hours versus several days. It is also cheaper, with the study team estimating STORK to cost less than $50 per sample, if 10 samples are run at the same time, or up to $200 if a sample is run on its own. STORK can also be done at the point-of-care for a patient, eliminating the need to ship a sample to a clinical laboratory.  According to the study authors, STORK may be particularly useful in identifying genetic causes of miscarriage. Currently, professional societies only recommend genetic testing if a person has had multiple miscarriages, but an easy, cost-effective test like STORK can potentially be offered after the first miscarriage. STORK can also be used to streamline the IVF process. Currently, embryos must be frozen while genetic tests are run and analyzed before implantation. STORK’s ability to provide results within hours can presumably eliminate this freezing step, which saves time and cost. More work is needed to validate STORK, but if results continue to show promise, STORK could improve the quality of reproductive healthcare.”
  • The National Cancer Institute announced “For people with advanced cancer, severe side effects from treatment often force them to the hospital or the emergency room. Although these time-consuming and, quite often, expensive hospital trips potentially could be prevented by better communication about symptoms between patients and their doctors, the reality is that such discussions don’t typically happen as frequently as they should.   Now, a new study shows that community health workers (CHWs) may help bridge this communication gap in cancer care. In the study, having a CHW directly consult with people newly diagnosed with advanced cancer or cancer recurrence, including assessing their symptoms and helping them with advance care planning, substantially decreased hospitalizations and emergency room visits.”
  • Fierce Healthcare reports “Musculoskeletal conditions are a massive source of health spending—accounting for $420 billion in 2018—and a new report from [Cigna’s] Evernorth aims to pinpoint where health plans could cut down on costs.”
  • Health IT Analytics tells us “New research published in JAMA Internal Medicine shows that an artificial intelligence (AI)-based cognitive behavioral therapy intervention for chronic pain (AI-CBT-CP) had similar outcomes to standard CBT-CP, which could result in increased access and reduced costs.”

From the government contract front, Federal News Network reports that

As the travel industry — and prices — recover from COVID-19, the General Services Administration is giving federal employees a little more leeway on hotel costs for official travel.

The base daily traveling allowances will rise slightly from $155 per day in 2021 to $157 per day in 2022. Per diem lodging rates will account for that rise, increasing from $96 per night to $98. Meals and incidental expenses will not change from their current range of $59-$79 per day.

For feds who already have an idea of their travel plans for fiscal 2023, GSA included a new calculator tool that will allow them to search by city, state, zip code or a map to determine the exact amount of their per diem.

Experience-rated FEHB plan carriers must subject employee lodging and miscellaneous expenses to the GSA’s per diem caps when seeking government contract reimburses for those expenses.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

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.”