Thursday Miscellany

COVID-19 vaccine

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.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Telehealth, U.S. Healthcare–

From Capitol Hill —

The Wall Street Journal reports

Sen. Joe Manchin (D., W.Va.) agreed to back a package aimed at lowering carbon emissions and curbing healthcare costs while raising corporate taxes, marking a stunning revival of core pieces of President Biden’s economic and climate agenda that the West Virginia Democrat had seemingly killed earlier this month. 

The deal, negotiated privately between Messrs. Manchin and Senate Majority Leader Chuck Schumer (D., N.Y.) since the start of last week, would raise roughly $739 billion, with much of the revenue coming from a 15% corporate minimum tax and enhanced tax enforcement efforts at the Internal Revenue Service, as well as projected savings from allowing Medicare to negotiate some prescription-drug prices.

Of that new revenue, roughly $369 billion would be spent on climate and energy programs, with another $64 billion dedicated to extending healthcare subsidies for three years for some Affordable Care Act users. The bill would dedicate the rest of the new revenue toward reducing the deficit, according to a summary provided by Messrs. Schumer and Manchin. * * *

The deal will still need the support of almost every other Democrat in Congress. Passing the agreement into law will test Mr. Schumer and the ability of House Speaker Nancy Pelosi (D., Calif.) to convince an ideologically diverse group of lawmakers to accept a deal announced by one of the party’s most conservative members. 

The announcement of a deal on Wednesday appeared to catch other Democrats off guard.

The Hill informs us

The House passed a bill Wednesday to expand telehealth services that were first introduced during the COVID-19 pandemic.

The legislation, titled the Advancing Telehealth Beyond COVID–19 Act, passed in a 416-12 vote. Eleven Republicans and one Democrat objected to the measure. Two Republicans did not vote.

The measure seeks to continue a number of telehealth policies established under Medicare that were first implemented at the beginning of the COVID-19 pandemic. If passed by the Senate and signed into law, the provisions would continue through 2024.

Fierce Healthcare adds

A key House panel advanced legislation to create an electronic prior authorization process for Medicare Advantage plans and several other reforms.

The House Ways and Means Committee unanimously advanced on Wednesday the Improving Seniors Timely Access to Care Act of 2022. The legislation has more than 300 co-sponsors and wide support across the healthcare industry.

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

While the Novavax shot is not yet authorized by the FDA as a booster, several experts told MedPage Today it could be headed that way.

“Probably the best niche now for Novavax’s purified protein vaccine is as a booster strategy for mRNA vaccines,” Paul Offit, MD, of Children’s Hospital of Philadelphia, who served on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Novavax, told MedPage Today.

Robert “Chip” Schooley, MD, an infectious disease expert at the University of California San Diego who has served on VRBPAC in the past, said since there “aren’t many people left who have been neither vaccinated nor infected … it will likely be mainly used as a booster.”

NPR Shots tells us

The Biden administration may scrap plans to let more younger adults get second COVID-19 boosters this summer. Instead, officials are trying to speed up availability of the next generation of boosters in the fall, NPR has learned.

The new strategy is aimed at trying to balance protecting people this summer with keeping people safe next winter, when the country will probably get hit by yet another surge.

But the possible shift is being met with mixed reactions. The Food and Drug Administration could make a final decision by the end of the week. 

The dilemma facing the FDA is that the immunity many people have gotten from getting vaccinated or infected has been wearing off. At the same time, the most contagious version of the virus to emerge yet — the omicron subvariant BA.5 — is making people even more vulnerable.

So as COVID is starting to become more serious than a cold or flu again, most people younger than age 50 aren’t eligible for fourth shots — second boosters — to protect themselves. In response, the FDA was considering opening up eligibility for second boosters for all adults.

But letting more people get boosted with the original vaccine now could interfere with plans to boost them with updated, hopefully more protective vaccines in the fall to blunt the toll of the winter surge. 

It’s quite a conundrum for the experts.

From the monkeypox front

  • NPR provides a helpful FAQ on the disease.

The Centers for Disease Control and Prevention (CDC) has expanded access to vaccines, tests, and treatments for monkeypox, agency officials said in a webinar Tuesday.

The CDC expects to release more than 750,000 doses of the JYNNEOS vaccine from its strategic stockpile within days, said panelists at the Clinician Outreach and Communication Activity (COCA) call.

In addition, by working with commercial labs, the agency has expanded US testing capacity and streamlined requirements for administering the antiviral tecovirimat, they said.

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

A 66-year-old man in Southern California and a woman in her 70s in Spain are the latest in a small group of people who appear to have beaten their HIV infections, providing researchers new clues to a possible cure at a time when Covid-19and other crises are slowing progress against the spreading virus.

Doctors caring for the man said they haven’t found any human immunodeficiency virus that can replicate in his body since he stopped antiretroviral drug therapy in March 2021 after a transplant of stem cells containing a rare genetic mutation that blocks HIV infection. He was given the transplant for leukemia, for which people with HIV are at increased risk. Details of his case were made public Wednesday and will be presented at a large international AIDS conference in Montreal that opens Friday.

“He saw many of his friends and loved ones become ill and ultimately succumb to the disease and had experienced some stigma associated with having HIV,” she said. His success “opens up the opportunity potentially for older patients to undergo this procedure and go into remission from both their blood cancer and HIV.

Also from the medical research front, STAT News informs us

[F]or several years, a small New Haven, Conn.-based startup has quietly been building technology to move the needle on suicide rates among the people at highest risk: those with a history of attempts or who have suicidal thoughts and have expressed a strong desire to die.

The company, called Oui Therapeutics, has raised roughly $26 million from high-profile investors like CVS Health Ventures and First Round Capital to develop and launch an app designed to train people how to quell their suicidal impulses. It pulls from in-person therapy methods that have shown dramatic reductions in suicide attempts — nearly 60% — in a randomized trial of soldiers at high risk. * * *

If the research bears out and the app secures buy-in from regulators, it could become a powerful tool in curbing suicide, which kills over 45,000 people in the U.S. each year. Oui is part of a broader constellation of efforts — including a new national suicide prevention hotline number and the development of prevention frameworks like Zero Suicide — in recent years that aim to address rates that have risen stubbornly high.

Fingers crossed for both worthy efforts.

From the Medicare front, Beckers Hospital Review reports

CMS updated its Overall Hospital Quality Star Ratings for 2022, giving 429 hospitals a rating of five stars.

CMS assigned star ratings to hospitals nationwide based on their performance across five quality categories. This year:

* 192 hospitals received a one-star rating

* 692 hospitals received a two-star rating

* 890 hospitals received a three-star rating

* 890 received a four-star rating

* 429 received a five-star rating

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

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

Humana raised its profit estimates for the full year after reporting lower than expected medical costs during the second quarter.

“The lower utilization trends and lack of COVID headwinds seen to date, give us confidence in raising our full year adjusted [earnings per share] guide,” Humana CFO Susan Diamond said Wednesday on a call with investors.

Humana’s net income increased 18% to $696 million for the second quarter as the Louisville-based insurer recorded increased revenues of $23.6 billion amid enrollment growth in both Medicare and Medicaid.

The insurer noted lower inpatient utilization among Medicare members for Q2.

But the lower-than-anticipated inpatient utilization has been partially offset by higher unit costs, Diamond said. * * *

The company’s total medical membership of 17.1 million was up 0.8% year over year.

As the company continues on its value creation plan to trim $1 billion in costs, Humana said it will restructure its organization into two distinct units as it looks to simplify the company’s overall organization.

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

There is substantial variation and low correlation in healthcare spending across Medicare, Medicaid, and private insurance plans within different US regions, a study published in JAMA Network Open found.

The US spends around $3.8 trillion per year on healthcare funded by Medicare, Medicaid, and private insurers. However, spending and healthcare utilization are rarely the same for all three payers. * * *

Healthcare spending per beneficiary varied across payers. The mean private insurance spending per beneficiary was $4,441, while the Medicare mean was $10,281, and the Medicaid mean was $6,127 per beneficiary. The overall mean for the three payers was $5,782 per beneficiary.

Medicaid had the most variation in spending per beneficiary across the [241 hospital referral regions] HRRs, with a coefficient of variation of 0.233, according to the study. Private insurance had a coefficient of variation of 0.160 and Medicare had a coefficient of variation of 0.126.

Medicaid and private insurance plans likely saw more variation in spending than Medicare because Medicare relies on regulated payments to hospitals, while Medicaid and privately insured prices are generally determined by the region’s market.

In addition to spending variation among the payers individually, there was low spending correlation within regions across all three payers.

For example, the correlation coefficient between HRR level spending was 0.020 for private insurance and Medicare, 0.213 for private insurance and Medicaid, and 0.162 for Medicare and Medicaid.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–
Mount Rushmore
Mt. Rushmore

From Capitol Hill, Govexec reports

The House [of Representatives on Wednesday voted 220-207 to pass the first minibus fiscal 2023 spending package, effectively endorsing President Biden’s plan to increase federal employees’ pay by an average of 4.6% next year.

The minibus contains six of the 12 annual appropriations bills, including transportation, housing and urban development; agriculture and rural development; energy and water development; military construction and veterans affairs; and financial services and general government, the last of which serves as the vehicle for provisions impacting federal employee compensation[, including the FEHBP].

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

The Biden administration is giving new powers to an office within the Health and Human Services Department to take a more prominent role in responding to public health crises, spanning from pandemics to natural disasters. 

HHS’s Office of the Assistant Secretary for Preparedness and Response will be renamed and enabled to “mobilize a coordinated national response more quickly and stably during future disasters and emergencies,” Dawn O’Connell, who heads the unit, said in a memo obtained by Bloomberg News. 

The office will be rebranded the Administration of Strategic Preparedness and Response and will be reclassified an operating division alongside other major health agencies like the Centers for Disease Control and Prevention and the Food and Drug Administration, according to the memo. Those agencies, along with the National Institutes of Health, have been criticized for their response and messaging since the outbreak of Covid-19 more than two years ago. 

In the memo, O’Connell wrote that the ASPR had taken on an increasingly important role during the pandemic and that the new designation would equip the unit with “greater hiring and contracting capabilities.”

From the Omicron and siblings front —

The American Hospital Association informs us

The Centers for Disease Control and Prevention last night endorsed the two-dose Novavax COVID-19 vaccine as a COVID-19 vaccine primary series for emergency use in adults, as recommended by its advisory committee. Authorized by the Food and Drug Administration last week, the protein-based vaccine offers an option to individuals who may have an allergic reaction to or prefer not to receive an mRNA vaccine.

CDC today updated its COVID-19 vaccine guidance to include the Novavax vaccine, and issued a chart summarizing the dosing schedules for all authorized or approved COVID-19 vaccines.

In other vaccine news, a new study by the National Institutes of Health comparing the effectiveness of COVID-19 vaccine boosters against the omicron variant found neutralizing antibody levels decreased substantially within three months, with the BA.4 and BA.5 sub-lineages up to 2.5 times less susceptible to neutralization. NIH said the results could help inform decisions regarding future vaccine schedule recommendations, including the need for variant vaccine boosting.

The Wall Street Journal reports

A serious inflammatory complication that strikes some children in the weeks following a Covid-19 infection has almost disappeared. A buildup of immunity and changes to the virus both likely play a part, pediatric infectious-disease doctors and researchers said.

Multisystem inflammatory syndrome is afflicting far fewer children as a proportion of known Covid-19 cases than during earlier waves of the pandemic, according to data from the Centers for Disease Control and Prevention. The condition, also known as MIS-C, is similar to Kawasaki disease, another rare pediatric inflammatory condition. Early in the pandemic, doctors believed they were seeing Kawasaki disease but soon recognized MIS-C as a distinct condition associated with an earlier Covid-19 infection.

MIS-C can cause inflammation two to six weeks after infection with Covid-19 in organ systems including the heart, lungs, kidneys and brain. Researchers haven’t determined why some children developed the condition but they have linked it to a hyperactive immune response. Treated with drugs such as intravenous immune globulin or corticosteroids, most children make a full recovery. Even so, the condition can be deadly. In the U.S., 70 children have died from MIS-C since the start of the pandemic, according to the CDC.

From the fraud, waste and abuse front —

Fierce Healthcare tells us

Federal prosecutors charged 36 defendants with committing a variety of alleged schemes to bilk Medicare using telehealth, as regulators continue to tinker with how to make the COVID-19 telehealth boom permanent.

The Department of Justice announced on Wednesday that the defendants allegedly engaged in a series of actions that led to $1.2 billion in medical fraud, with much of that coming from phony telehealth claims for advanced genetic testing and unnecessary medical equipment.

“Fraudsters and scammers take advantage of telemedicine and use it as a platform to orchestrate their criminal schemes,” said Luis Quesada, assistant director in the FBI’s Criminal Investigative Division, in a statement. “This collaborative law enforcement action shows our dedication to investigating and bringing to justice those who look to exploit our U.S. health care system at the expense of patients.”

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

The Justice Department also announced

Inform Diagnostics, Inc., (Inform) formerly known as Miraca Life Sciences, Inc. (Inform), has agreed to pay $16 million to resolve allegations that it submitted false claims for payment to Medicare and other federal health care programs. 

Inform is a clinical laboratory headquartered in Irving, Texas, that provides anatomic pathology services to physician practices throughout the United States. On April 27, 2022, Fulgent Genetics purchased Inform, and the company is now a wholly owned subsidiary of Fulgent Genetics.

According to the settlement, Inform admits that, between 2013 and 2018, it routinely and automatically conducted additional tests on biopsy specimens prior to a pathologist’s review and without an individualized determination regarding whether additional tests were medically necessary. The United States contends that Inform’s policy of conducting routine additional tests caused Inform to perform many tests that were medically unnecessary. Inform submitted these medically unnecessary tests for payment, causing federal health care programs to pay for false claims. * * *

“Submitting claims for medically unnecessary tests threatens the integrity of the federal health care programs and wastes taxpayer dollars,” said Amy K. Parker, Special Agent in Charge of the Office of Personnel Management’s Office of Inspector General. “Today’s settlement is a reminder to all providers that the OPM OIG will not tolerate fraud against the Federal Employees Health Benefits Program.”

From the U.S. healthcare business front —

Fierce Healthcare informs us

Elevance Health subsidiary myNEXUS recently launched a post-acute care program for Medicare members in Indiana, and the insurance giant is aiming to take it nationwide over the next year.

During the company’s earnings call Wednesday morning, CEO Gail Boudreaux said it plans to take the next six to 12 months to scale up the program, which uses a capitated risk-sharing arrangement. The platform arms docs with technology tools that aim to optimize patient care post-discharge. * * *

The company reported $1.7 billion in profit for the second quarter of this year, down from $1.8 billion in the second quarter of 2021 or by 7.8%. Revenues for the quarter were up, however, increasing by 14.1% to $38.6 billion.

Healthcare Dive tells us

JPMorgan Chase’s healthcare venture arm plans to invest $30 million in Centivo, a health plan for self-funded employers. It’s Morgan Health’s third major investment in a startup looking to lower the costs of employer-sponsored healthcare in the past year.

Three-year-old health plan administrator Centivo contracts with providers on behalf of large employers with the goal of improving quality and efficiency. The startup, which ties payments to patient outcomes, says it saves employers 15% to 30% annually compared to traditional health plans.

Morgan Health has shelled out at least $85 million in the past year, including the Centivo deal. The unit invested $50 million in value-based primary care company Vera Whole Health in August and $5 million in healthcare navigation startup Embold Health in March.

From the U.S. general healthcare front —

  • Forbes offers an interesting article about health insurance literacy in our country. The No Surprises Act has spurred people to look more carefully at their healthcare provider bills, but their analyses fall short because they need help understanding those bills and health insurance coverage.
  • Yale New Haven Hospital’s July newsletter provides good advice on avoiding skin cancer and stay safe in the summer. The FEHBlog was born at the facility’s predecessor Grace New Haven Hospital.
  • STAT News reports “Gestational diabetes is on the rise, climbing 30% between 2016 and 2020, according to a new study published Tuesday by the Centers for Disease Control and Prevention. “There is a growing maternal health crisis in the United States, and gestational diabetes is an important and common complication that requires new focus,” said Sadiya Khan, an assistant professor of medicine and preventive medicine at the Northwestern University Feinberg School of Medicine, who was not involved in the new study. “That inflection point there is really striking and something that we’re going to want to follow up [on].” * * * “This issue does not resolve with the pregnancy and is really one that we need to focus on before, during, and after pregnancy for those at risk.”
  • STAT News also explores the work of various mental health crisis centers in the days following the launch of the nationwide 988 suicide / mental health crisis hotline. Here’s a link to an HHS site that refers to the hotline more appropriately as a LifeLine.

Midweek Roundup

David Ermer–COVID-19, COVID-19 vaccine, NIH, Rx coverage, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From the Omicron and siblings front, MedPage Today informs us

As expected, the FDA has granted an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced on Wednesday.

The decision follows a near-unanimous FDA advisory committee recommendation more than a month ago, with the EUA reportedly delayed in order to allow regulators time to review recent changes to the vaccine’s manufacturing process.

Novavax’s product is a protein subunit vaccine that contains the SARS-CoV-2 spike protein plus an adjuvant to enhance the recipient’s immune response. The product is to be administered as a two-dose primary series given 3 weeks apart.

Becker’s Hospital Review discusses the White House’s latest Covid strategy.

From the No Surprises Act front, the U.S. Office of Personnel Management issued a carrier letter today on various NSA topics affecting FEHB carriers.

From the Rx coverage front

The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.

On July 26, 2022, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Medical Advisor Francesca Beaudoin, MD, PhD, MS will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.

From the Dobbs front, Healthcare Dive has created a state abortion law tracker and the Department of Human Resources announced the steps that its agencies have taken to protect reproductive rights.

From the research studies department, the National Institutes of Health announced today

The percentage of methadone-involved overdose deaths relative to all drug overdose deaths declined from January 2019 to August 2021, according to a new study. Access to methadone, a medication to treat opioid use disorder, was expanded at the start of the COVID-19 pandemic to allow more patients to take home doses, rather than visit a clinic daily. These data indicate that broader access to treatment was not associated with harms. While drug overdose deaths both with and without methadone increased in the month of March 2020, overdose deaths that did not involve methadone continued to increase in the months after the policy changes, while overdose deaths involving methadone held steady.

Published today in JAMA Psychiatry, this study was a collaborative effort led by researchers at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and the National Center for Injury Prevention and Control, part of the Centers for Disease Control and Prevention. 

Monday Roundup

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

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

From the Omicron and siblings front,

Becker’s Hospital Review reports

BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Time reported July 11. 

Two cases were detected in California and one in Washington as of July 8, according to data from Helix, which works with the CDC on viral surveillance. 

The subvariant is gaining traction in India and has also been detected in 10 other countries. 

Better start looking over your shoulders Omicron subvariants BA.4 and BA.5.

The Wall Street Journal informs us

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries.

The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week.

In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.

In the U.S., however, Moderna will develop a different dual-target booster, mRNA-1273.222, which goes after both the ancestral strain and the BA.4 and BA.5 subvariants of Omicron. These subvariants, which are nearly identical to each other for the purposes of a vaccine, now account for most new cases of Covid-19 in the U.S.

What about BA.2.75?

An announcement from HHS today points to an FDA emergency use authorization of the traditionally developed Novovax in the near future.

The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.

Medscape tells us

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.

Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.

The company has submitted an emergency use authorization request to the US Food and Drug Administration to use sabizabulin to treat COVID-19.

The analysis was published online July 6 in NEJM Evidence.

Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Benefits Pro calls to our attention health plan stop-loss insurer Sun Life’s top 10 high-cost claim conditions report.

Sun Life’s latest report saw a 354% increase in the number of COVID-19 claims from 2020 to 2021 [the Delta variant] —specifically, 107 claims to 486 claims. Total spend also rose from $30.4M to $114.0M, although the average cost for treatment went from $283.7K to $231.2K over the same period, amounting to an 18% decrease. Even so, COVID-19 landed (“somewhat ironically,” the study stated) at number 19 on Sun Life’s top 20 list of high-cost claim conditions over four years. This is significant, as every other condition on the list has amassed four years worth of claims to COVID’s two, underlining the severity of the pandemic.

From the Rx coverage front, Fierce Pharma reports

Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.

HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.

HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.

At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.

FDA approval of OTC contraceptives should have been approved years ago, in the FEHBlog’s opinion.

From the SDOH front, Health Payer Intelligence informs us

The Association for Community Affiliated Plans (ACAP) has initiated a center designed to spur new ideas about how to address social determinants of health, according to a press release that HealthPayerIntelligence received by email.

“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, chief executive officer of ACAP, shared in the press release. 

“Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades. This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment.”

Bravo.

The Wall Street Journal reminds us that the new three-digit 988 suicide hotline launches on Saturday, July 16.

Health officials preparing to broaden the reach of a national mental-health crisis line are working to strengthen an overstretched network of call centers that didn’t connect with about one in six callers in recent years, a Wall Street Journal data review showed. 

The National Suicide Prevention Lifeline will transition on July 16 to a three-digit number for calls and texts, 988, from a 10-digit number that has operated since 2005 in coordination with local crisis centers. The line’s operators, including the Substance Abuse and Mental Health Services Administration and the nonprofit Vibrant Emotional Health, said they expect an increase in calls to the shorter and more memorable 988 number during the next year. Stress, suffering and disruption of routines during the pandemic has worsened many people’s mental health, clinicians have said.

Fingers crossed for this important initiative.

Midweek Update

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

From Capitol Hill, Fierce Healthcare reports

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

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

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

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

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

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

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

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

Regrettably the Wall Street Journal adds

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

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

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

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

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

From the telehealth front

Healthcare Dive reports

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

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

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

Fierce Healthcare informs us

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

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

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

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

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

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

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

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

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

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

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

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

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

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–

Happy National Postal Workers Day!

Using the CDC’s Covid Data Tracker and Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 26th week of 2022:

The CDC did not produce its weekly review of Covid statistics today as it’s the beginning of the July 4th holiday weekend. The CDC’s daily averages of new cases, new deaths and new hospitalization for the past week has been 109,944 cases, 316 deaths and 4,947 hospitalizations.

Beckers Hospital Review informs us

Temporary loss of smell emerged as a common indicator of COVID-19 early in the pandemic. Research into the cause and treatment of the condition, known as anosmia, is ongoing, though recent studies have brought us one step closer to answers. 

Two latest findings on COVID-19-related anosmia:

1. Loss of smell and taste is becoming less common as the virus evolves, according to researchers.

2. Smell and taste hasn’t fully returned for many people who contracted COVID-19 early in the pandemic, research shows. 

In retrospect, the FEHBlog is pleased that he continued theses charts from the last six months of 2021 into the first half of 2022 because doing so captured the three important surges. Now the FEHBlog has to decide what to do next Friday as the charts present a years worth of data.

Here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era (the 51st week of 2020) through this week, the 26th week of 2022.

It’s worth adding that the CDC is currenly providing weekly, not daily, vaccination stats. The CDC is now offering on a colorful, adjustable chart on “Primary Series Completion, Booster Dose Eligibility, and Booster Dose Receipt by Age, United States.

Medscape adds

COVID-19 vaccines protected against severe disease and death in people with overweight or obesity, a large English study found.

Compared with the unvaccinated, vaccinated individuals in each BMI group experienced significantly lower likelihood of COVID-related hospitalization starting at 2 weeks from their second dose, reported Carmen Piernas, PhD, of the University of Oxford, and colleagues:

* Underweight: OR 0.51 (95% CI 0.41-0.63)

* Normal weight: OR 0.34 (95% CI 0.32-0.36)

* Overweight: OR 0.32 (95% CI 0.30-0.34)

* Obesity: OR 0.32 (95% CI 0.30-0.34)

In other vaccine news, Medscape reports

A new study provides more evidence that influenza vaccination may help protect older adults against Alzheimer’s disease (AD).

In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.

“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings ― that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years ― adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, with McGovern Medical School at the UTHealth, Houston, Texas, told Medscape Medical News.

Sign me up.

Also from the public health front, Medscape tells us

About 80% of US adults have low to moderate cardiovascular (CV) health based on the American Heart Association (AHA) checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health. With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist. * * *

The AHA Presidential Advisory — Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health — was published online June 29 in the journal Circulation.

A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.

Overall, the results show that CV health of the US population is “suboptimal, and we see important differences across age and sociodemographic groups,” [Dr. Donald] Lloyd-Jones [chair of the department of preventive medicine at Northwestern University’s Feinberg School of Medicine in Chicago] said.

Medpage offers a detailed Q&A on monkeypox. Among them

Could monkeypox be spread easily from person to person, similar to COVID-19? 

“Monkeypox is certainly not COVID-19,” stressed [Capt. Agam] Rao [, MD, a medical officer at the U.S. Public Health Service at the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)]. Based on prior outbreaks and the current outbreak, monkeypox appears to spread through “direct close contact. So, intimate contact that might happen during sex, but also any other close contact that might occur — for example, if you live with someone who has monkeypox and you are sleeping on the same bedding and using the same towels.”

“It really is not something that you will just pass on to someone walking down the street,” she said.

While agency researchers are “keeping an open mind” about the possibility that the virus could be more easily transmitted, “at this time, there’s no indication that it would spread the way that COVID spread and spread to as many people, [and] at this time, the risk for the worldwide population … is low,” she added.

From the prior authorization front, Healthcare Dive reports

Aetna is no longer requiring prior authorization for cataract surgeries, a controversial policy the payer adopted a year ago, according to a new provider notice.

Aetna is also rolling back prior authorization requirements for video EEGs and home infusion for some drugs. It’s adding two new-to-market drugs to the precertification list.

The payer said in a statement that it came to its decision after analyzing real-time data from the year the requirement was in place. “Going forward, we will focus on retrospective reviews of procedures and providers where questions of medical necessity exist,” Aetna said.

From the Rx coverage front, Fierce Pharma offers an article on how payers are planning to avoid cost shocks associated with gene therapy.

Kelley Miller, senior director of managed markets for the specialty pharmacy Optum Frontier Therapies, said there are three major considerations for his team during coverage talks. One is the clinical landscape, while another is the “human” element of what the patients and their families are going through. Thirdly, the team looks at the “economic impact” of the treatment.

Once Miller’s team has that information, the “conversations should come fast and furious,” he said.

Despite the biopharma industry’s advances in gene therapies, ICER president Steven Pearson, M.D., M.Sc., said it’s still a “fairly dicey business proposition” for companies in this field, especially outside the U.S. He pointed to bluebird bio’s decision to pull beta thalassemia gene therapy Zynteglo from the European market last year.

From the U.S. healthcare front, Beckers Hospital Review reports

IBM Watson Health, in partnership with Fortune, has released its top 15 health systems, which they find set an example for health systems and hospitals across the nation. With its data, the report will continue to stand as a resource for these groups to improve their quality of care and efficiency. 

In its 14th year of publishing this study, IBM Watson Health found that the top 15 health systems had better survival rates, fewer patient complications, fewer healthcare-associated infections, better long-term outcomes, better 30-day mortality/revisitation rates and more. The study also found that patients revered the top 15 hospitals more than peer system hospitals. 

For 2022, Allina Health of Minneapolis, MN, sits on top of the large health systems division. Cone Health of Greensboro, NC, sits on top of the medium health systems division. Asante of Medford Oregon sits on top of the small health system division.

From the Medicare Advantage front, Health Payer Intelligence discusses AHIP’s statement on the Medicare Advantage program which places various attacks against the MA program in perspective.

In addition to defending prior authorizations and spotlighting certain facets of OIG reporting, AHIP also offered evidence for Medicare Advantage plans’ efficacy overall.

The health plans have been proven to excel on quality measures and on overall efficiency, surpassing original Medicare’s quality level. They also have to ascribe to certain network adequacy standards.

Medicare Advantage plans produce savings for the Medicare program and offer higher value for members and taxpayers. In particular, Medicare Advantage plans offer strong value to members who are lower-income and underserved.

Lastly, AHIP pointed out that these plans have bipartisan support.

Finally federal employee benefits consultant Tammy Flanagan follows the retirement process of a federal employee in a three-part article in Govexec.

Thursday Miscellany

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

Wishing everyone a happy end of the second quarter 2022.

From Capitol Hill, the American Hospital Association informs us

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

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

* * *

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

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

STAT News reports

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

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

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

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

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

From the Omicron and siblings front, MedPage Today tells us

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

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

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

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

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

* Identify hotspots in real-time 

* Track vaccination rates by region or county 

* Locate areas that will soon be affected by the virus  

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

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

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

HHS adds

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

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

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

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

From the transparency front, STAT News reminds us

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

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

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

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

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.

Tuesday’s Tidbits

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

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

Nevertheless, from the Omnicron and siblings front

The Wall Street Journal reports

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

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

What’s more also per the Journal

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

From the medical research front —

The National Institutes of Health announced

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

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

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

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

MedTech Dive tells us

If a knee talks, who’s listening? 

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

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

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

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

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

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

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

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