Busy Thursday

Electronic health records

Busy Thursday

David Ermer–CDC, Congress, COVID-19, Electronic health records, FDA, Federal employment benefits, HSA, OPM, Patient safety, Rx coverage–
Photo by Manasvita S on Unsplash

From Capitol Hill Roll Call reports

House Republicans are mulling an attempt to buy time for further negotiations on federal spending and deficits by passing one or more short-term suspensions of the statutory debt ceiling this summer, including potentially lining up the deadline with the end of the fiscal year Sept. 30.

No decisions on a cutoff date have been made, and it’s not yet clear when the Treasury Department will run out of cash to meet all U.S. financial obligations. But most analysts agree Congress will need to act at some point between early June and September, and lawmakers likely won’t want to leave the matter unaddressed before the August recess.

and

The Senate is taking its time getting to work for 2023.

Back in Washington after a two-and-a-half week recess, the chamber adjourned Thursday afternoon without adopting an organizing resolution, meaning committees will remain in their holdover state until at least next week.

Senate Majority Leader Charles E. Schumer announced the Democratic committee assignments for the new Congress, with Michigan Democratic Sen. Gary Peters, the Democratic Senatorial Campaign Committee chair, earning a coveted seat on the Appropriations Committee.

From the Omicron and sibligns front, The American Hospital Association tells us

A Food and Drug Administration Vaccines and Related Biological Products Advisory Committee [VRBAC] unanimously voted today to recommend harmonizing the composition of all primary series and booster doses administered in the U.S. For example, the composition of all vaccines administered going forward might be bivalent.

STAT News offers a complete report on today’s meeting. For example, STAT News explains

The FDA is also asking the members of VRBPAC their thoughts on its proposal that Americans get an annual Covid shot, in the way they get a flu shot, one that is reconstituted regularly to try to target the strains in circulation at the time. In documents the FDA made public before the meeting, it proposed choosing new vaccine strains in June for a vaccine campaign that would begin in September.

Covid is clearly here to stay, so this may sound sensible. But there are concerns some of this is still based on a leap of faith rather than a data-led process. For example, the idea that everyone might need an annual Covid booster will not earn a unanimous “yea” vote out of this expert panel.

The VRBAC recommendation is subject to FDA and CDC approval.

STAT News adds

The FDA on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to be rendered ineffective by the mutations the virus has picked up. Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems.

In other FDA news

  • The FDA announced, “Given the growing cannabidiol (CBD) products market, the FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
  • Fierce BioTech informs us “More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.”

From the obesity treatment front —

HealthDay discusses findings made by “Utah researchers who followed patients for up to 40 years after they had one of four types of weight-loss (bariatric) surgery.” 

Weight-loss surgery can literally be a lifesaver, cutting death rates significantly during the course of a decades-long study

Death from all causes was 16% lower, while it was 29% lower for heart disease, 43% lower for cancer and 72% lower for diabetes

But there were some troubling findings: These patients were 83% more likely to die of liver disease and 2.4 times more likely to die by suicide, mostly seen in younger patients

STAT News provides a two minute long video explaining how the new obesity drugs work.

STAT News also describes an unusual alliance that has banded together to lobby Congress to repeal a provision in the Medicare Modernization Act of 2023 that prohibits Part D from covering obesity drugs. “Recent scientific advances, media coverage, and advocacy have helped raise the profile of the issue on Capitol Hill, said Jeanne Blankenship, the vice president for policy initiatives and advocacy at the Academy of Nutrition and Dietetics. ‘It’s becoming front and center. I think we can’t turn our backs on it any longer,’ Blankenship said.”

From the Rx coverage front, Beckers Hospital Review introduces us to the three PBMs that have partnered with the Mark Cuban Pharmacy.

From the HIPAA / electronic health records front —

  • MedPage Today reports, “Unique Patient Identifier Funding Once Again Barred by Congress— Biden administration working on better patient matching instead.” The FEHBlog will never understand Congress’s intransigence here.
  • Healthcare Dive tell us “Interoperability continues to improve among U.S. hospitals, but there’s still a ways to go, according to new government data. More than six in 10 hospitals electronically shared health information and integrated it into their electronic health records in 2021, up 51% since 2017, the Office of the National Coordinator released in a Thursday data brief. The availability and usage of electronic data received from outside sources at the point of care has also increased over the last four years, reaching 62% and 71% respectively in 2021.”

From the NIH research front, NIH calls attention to its research studies on the role of the placebo effect in healthcare treatments and the link between hydration and better aging.

From the miscellany department —

  • Mercer Consulting “projects the 2024 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will rise significantly from 2023 levels.”
  • Benefits Consultant Tammy Flanagan, writing in Govexec, discusses the categories of family members who are eligible and ineligible for FEHB coverage.
  • HR Dive identifies five trends that will share HR this year.

 

Monday Roundup

David Ermer–CMS, Congress, Electronic health records, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, the Wall Street Journal reports

House Republicans passed a rules package Monday dictating the terms of the next session of Congress, the first test for House Speaker Kevin McCarthy (R., Calif.) in keeping his raucous conference united.  

The rules package, a required step before moving on to legislation, is typically passed on the first day of a new Congress. But it was delayed by the GOP fight to elect a new speaker. Mr. McCarthy prevailed early Saturday morning on the 15th ballot over four days, after making a series of concessions to holdouts. 

The package passed 220 to 213, with all Democrats and one Republican, Rep. Tony Gonzales of Texas, opposing the measure. It is customary for the minority party to oppose the legislation. 

The package, which includes standard rules on decorum, also restores what is known as the motion to vacate the chair, a procedure that would allow one Republican member to ask for a vote to remove the speaker. It also outlines several Republican priorities around spending, such as banning consideration of any bill that has the net effect of increasing mandatory spending. 

The Journal adds

House Republican leaders chose Rep. Jason Smith (R., Mo.) to run the House Ways and Means Committee, giving him a prime perch to shape the party’s approach to tax, trade and health policy. 

As chairman, Mr. Smith will lead a committee with broad power over economic policy and healthcare that is poised to receive an influx of new Republican members.

From the other side of Capitol Hill, Healthcare Dive informs us

Longtime Congressman Sen. Bernie Sanders, I-Vt., is expected next month to take the helm of the Senate’s Health, Education, Labor and Pensions Committee, bringing the Medicare-for-All proponent center stage in one of the nation’s most broadly influential health policy forums.

The anticipated appointment comes after the current committee chair Sen. Patty Murray, D-Wash., announced that she was stepping down to head the Senate Committee on Appropriations. Sanders has been on the Senate’s Health, Education, Labor and Pensions Committee, or HELP, since 2007, but the chance to lead the committee will give Sanders sway on some of his most prominent healthcare policy positions.

High healthcare costs — including prescription drugs like insulin —nursing education and elder care are issues Sanders anticipates focusing on, calling the national healthcare system dysfunctional, unsustainable and disgraceful in a Jan. 1 video.

From the FEHB front —

OMB’s Office of Information and Regulatory Affairs (OIRA) posted the federal government’s fall 2022 regulatory agenda on January 4. Here are the three FEHB rulemakings:

  • OPM proposes to modify its FEHB enrollment regulations regarding the effective date of coverage. The regulatory changes would allow, at an employing agency’s discretion, FEHB Coverage to become effective upon a new employee’s start date if their election is received before that date. The regulatory changes would promote the recruitment of new Federal employees and align with the best practices of the private sector. Publication of the proposed rule is scheduled for March 2023.
  • OPM and the three other No Surprises Act regulators plan to release a proposed rule on the law’s complicated good faith estimate and advance explanation of benefits provisions in August 2023.
  • As previously noted in the FEHBlog, OPM has passed along its interim final rule to implement the Postal Service Health Benefits Program to OIRA for final regulatory review. The statutory deadline for promulgating the rule is April 6, 2023. OPM clearly will meet that deadline.
  • Here is the complete list of OPM rule-makings in process or recently completed.

The Government Accountability Office released a report titled “Federal Employees Health Benefits Program: Additional Monitoring Mechanisms and Fraud Risk Assessment Needed to Better Ensure Member Eligibility.” The report summary tells us

More than 8 million federal employees and their families receive health insurance benefits under the Federal Employees Health Benefits program.

In 2021, the Office of Personnel Management began requiring some new program enrollees to verify that their family members are eligible. But OPM doesn’t have a process to identify and remove ineligible family members who are already enrolled in the program. As a result, the program may be spending almost $1 billion per year on payments for ineligible members.

We recommended that OPM take steps to remove ineligible family members and assess fraud risks associated with ineligible program members.

In the middle of the last decade, OPM added an FEHB contract provision requiring carriers to share OPM’s expenses to arrange for a family member eligibility audit, which is a common practice among employers. This struck the FEHBlog as a proven approach to identifying ineligible family members. Why not give it a go?

The Centers for Medicare and Medicaid Services released updated guidance for its Section 111 reporting program, which applies to FEHB carriers and other employer-sponsored health plans.

From the public health front —

Medpage Today tells us

In contrast to previous recommendations, pediatricians and other pediatric healthcare providers are advised to provide “immediate, intensive obesity treatment to each patient” as soon as they receive a diagnosis, according to new guidance from the American Academy of Pediatrics (AAP).

The guidance, published in Pediatrics, marks the AAP’s first clinical practice guideline outlining evidence-based evaluation and treatment for children and adolescents with overweight (defined as a body mass index [BMI] at or above the 85th percentile and below the 95th percentile) or obesity (defined as a BMI at or above the 95th percentile), though the organization previously published recommendations on prevention and treatment in 2007.

“This is one of the most important messages that differentiates our current clinical practice guidelines from the prior recommendations, and that is to say 15 years of data have taught us that ‘watchful waiting’ only leads to greater increase in child BMI, accumulation of comorbidities, and more challenges in trying to reverse some of this,” author Sarah Armstrong, MD, co-director of the Duke Center for Childhood Obesity Research in Durham, North Carolina, told MedPage Today.

In a number of key action statements, the guideline authors state that pediatricians and other providers should refer children ages 6 years and older — and potentially those ages 2 to 5 years — with overweight or obesity to intensive health behavior and lifestyle treatment.

Additionally, healthcare providers should offer weight-loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment to adolescents ages 12 and older, Armstrong and colleagues noted. They should also offer referrals for evaluation for metabolic and bariatric surgery to adolescents ages 13 and older with severe obesity (BMI ≥35 or 120% of the 95th percentile for age and sex, whichever is lower).

The Wall Street Journal reports

This flu season hit earlier and harder than those of the past couple of years, doctors say. The reason is likely because of the cyclical nature of the flu and the lifting of Covid precautions such as working from home, wearing masks and having smaller social gatherings, says Robert Frenck, a pediatrician in the division of infectious diseases at Cincinnati Children’s hospital in Ohio. 

We asked doctors what to expect this year if the influenza virus causes illness in your household.

Check out the Q&A.

Politico Pulse calls attention to the fact that

Doctors are frustrated that patients are getting test results before they can explain them, POLITICO’s Ben Leonard reports.

A recently implemented federal [information blocking] rule requires HHS to ensure that patients receive test results as soon as they become available, but doctors argue that they often need to add context and support to results before patients view them — even as technology has made the results easier to share.

The disagreement, with doctors on one side and HHS and patient advocates on the other, has raised a key question: How should patients get bad news, especially in the rapidly evolving world of telehealth?

Before this rule was in effect, a member of the FEHBlog’s family received an email on a Sunday morning suggesting that she log into the patient portal. She promptly did so and was faced with confusing test results. See Seinfeld. Can’t doctors give patients a choice at the time of portal registration to get the log on email or wait to hear the results from a medical professional in non-emergency circumstances?

From the U.S. healthcare business front —

STAT News tells us

Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts.

The timing was not offered, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 shot. The Moderna pricing was first reported by The Wall Street Journal and confirmed by a company spokesperson.

The 41st JP Morgan healthcare conference is being held this week in San Francisco. “Fierce Healthcare will be covering the day’s biggest news as it happens. Check back here for updates, and catch Fierce Biotech’s reporting here and Fierce Pharma’s reporting here.”

Tuesday’s Tidbits

David Ermer–CMS, Electronic health records, FDA, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.

From the medical research and development front,

STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”

The National Institutes of Health announced

The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.

The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *

[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.

A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.

The Wall Street Journal reports

New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.

Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.

The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.

“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”

. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.

“Causality is a bit up in the air,” he said. 

From the mental healthcare front, Fierce Healthcare tells us

While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.

The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.

In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.

At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.

The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.

However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.

There are now 305 mental health providers per 100,000, according to the report.

Health Payer Intelligence adds

Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.

Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.

From the Rx coverage front, STAT News tells us

During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.

The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.

Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.

Of course, PBM formularies are designed to correct these issues.

The Wall Street Journal adds

Emergent BioSolutions Inc., maker of Narcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.

The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market. 

The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.

Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.

From the fraud, waste, and abuse front, mHealth Intelligence reports

As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.

They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.  

In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.

Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.

But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.

From the plan design front, Fierce Healthcare relates

The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026. 

The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.

“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement. 

It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans. 

Midweek update

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, NCQA, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Capitol Hill, the Wall Street Journal reports

Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.

The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.

Healthcare Dive adds

With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.

“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,

Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.

Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.

In other HLTH 2022 conference news,

  • Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
  • MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”

From the federal employee benefits front,

  • Govexec collected all of its current Open Season articles for convenient access.
  • Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
  • Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.

From the Affordable Care Act front —

  • The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
  • The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”

From the public health front —

  • Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
  • CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
  • The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”

From the miscellany department —

  • Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
  • MedTech Dive discusses how Labcorp, Abbott, BD, and Siemens plan to expand the home testing market
  • NCQA looks back at its recent Health Innovation Summit.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, Electronic health records, Federal employment benefits, Medicare, Mental health care, OPM, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, OPM released its Open Season press announcement today. Its lede is

Thousands of Enrollees Are Leaving Valuable Savings on the Table During Open Season
Enrollees should use Open Season as a period to conduct a wellness or financial check-up and reassess their health needs and coverage

Among other guidance, OPM recommends

Below we’ve provided sample questions to help you assess how you can utilize Open Season to review your benefits and needs to make an informed decision on coverage:

What are my and/or my family’s expected health care needs for 2023? 

* Questions while reviewing your FEHB plan: Am I expecting a new baby? Do I need surgery? Will my medication need change? Does my plan provide a pharmacy mail order option for prescriptions?

* Questions while reviewing FEDVIP: Do I want coverage for my routine dental care? Will I need a crown or root canal? Does my child need braces? Do I need glasses and/or contact lenses? Am I considering laser vision correction surgery?

* Questions while reviewing FSAFEDS: Do I have out-of-pocket expenses I need to consider, such as deductibles, copays, day care, elder care, or over-the-counter drugs and medicines? Do I have medical expenses that may not be covered by my FEHB plan? Do I plan to send my children (under 13) to in-home care or summer camp? 

OPM does not mention the availability of the FEHB plan’s summary of benefits and coverage (“SBC”), an Affordable Care Act requirement. The FEHBlog recalls visiting friends in Denver who were preparing for their employers’ open season by comparing these short but comprehensive SBCs. For example, the SBCs include a broken-out estimate of the plan’s cost-sharing for having a baby, receiving diabetes treatment for a year, and fixing a broken bone. In addition, the federal government consumer tested the SBCs.

FEHB plans update their SBCs annually in advance of Open Season and post them on their websites, usually on the page with forms and brochures.

The Washington Post has an article on the 2023 Open Season, and Federal News Network offers “a few” other expert views on the 2023 Open Season. Fierce Healthcare adds

Open enrollment is coming soon, and foremost on everybody’s mind as these windows draw nearer is just how much health insurance will cost, according to a survey by Gravie and Wakefield Research.

“Consumers are concerned about the high costs of health coverage impacting their access to healthcare, increasing medical debt and the lack of mental health coverage,” according to a press release from the two companies.

From the Omicron and siblings’ front —

  • Beckers Hospital Review tells us

The CDC revised its “up to date” COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.  * * *

The CDC’s website still deems people who are not immunocompromised as “fully vaccinated” two weeks after their second dose of Moderna or Pfizer’s series or two weeks after receiving J&J’s COVID-19 vaccine. 

[However, last Friday’s] decision could update the “fully vaccinated” term that experts have urged regulators to update.

  • HealthLeaders Media reports “Treating COVID-19 patients with Paxlovid significantly reduces hospitalizations and deaths, according to a recent large-scale study by Epic Research.”

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Nationally, BA.4.6 currently makes up about 13% of new cases, compared to just 1% of cases at the beginning of July, according to the CDC. But in some regions, like in Iowa, Missouri, Kansas and Nebraska, the BA.4.6 subvariant makes up more than 20% of all Covid-19 cases.

  • David Leonhardt writing in the New York Times Morning column discusses “A Public Health Success Story; We revisit the subject of Covid and racial inequities”. Check it out.
  • The NIH Directors Blog considers “Understanding Long-Term COVID-19 Symptoms and Enhancing Recovery.”

From the mental healthcare front, MedPage Today reports

Suicide risk was higher in people recently diagnosed with dementia, especially younger patients, a case-control study in England showed.

Compared with people who didn’t have dementia, suicides rose in people who received a dementia diagnosis in the past 3 months (adjusted OR 2.47, 95% CI 1.49-4.09), according to Danah Alothman, BMBCh, MPH, of the University of Nottingham in England, and colleagues.

For people under age 65, suicide risk within 3 months of diagnosis was 6.69 times (95% CI 1.49-30.12) higher than in patients without dementia, the researchers reported in JAMA Neurology

From the U.S. healthcare business front, Bloomberg reports on giant drug manufacturer Pfizer’s future

Pfizer Inc. emerged from the Covid-19 pandemic as the world’s most visible drugmaker, but its success has left investors impatient for an encore.

The windfall from the pharmaceutical giant’s Covid vaccine almost doubled its revenue in just one year. And now the shot, coupled with Pfizer’s Covid antiviral pill, is poised to make up more than half of its expected $100 billion of sales in 2022. That’s left Pfizer flush with cash — $28 billion it could spend on the kinds of deals that for decades fueled its growth into an American colossus.

The pressure is clearly on for Pfizer to show that the muscle it built during the pandemic won’t atrophy. Big Pharma companies don’t normally double revenue so quickly, and nobody expects that kind of growth to continue. But one thing’s clear: Pfizer can’t go back to the sluggish path it was on for years.

The American Hospital Association informs us

Operating margins for U.S. hospitals and health systems were down 24% in August compared to a year ago, driven in large part by a 7.2% increase in labor expenses, according to data from over 900 hospitals reported yesterday by Kaufman Hall.

“Nine months into a challenging year, margins have fluctuated wildly,” the report notes. “Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.”

From the Medicare front, the American Hospital Association adds

Effective Oct. 1 for five years, the Centers for Medicare & Medicaid Services will pay average sales price plus 8%, rather than ASP plus 6%, for biosimilars whose average sales price does not exceed the price of the reference biological product. The payment increase was included in the Inflation Reduction Act of 2022. For new biosimilars that qualify, the five-year period will begin on the first day of the calendar quarter for which ASP payment for that biosimilar begins under Medicare Part B.

From the electronic health records front, STAT News reports

Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition.

Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats. The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition.

The changes follow the publication of a series of investigations by STAT that found an earlier version of Epic’s tool resulted in high rates of false alarms at some hospitals and failed to reliably flag sepsis in advance. One of the investigations found that the model’s use of antibiotics as a prediction variable was particularly problematic, resulting in late alarms to physicians who had already recognized the condition and taken action to treat it.

Fierce Healthcare looks into “How Google, Mayo Clinic and Kaiser Permanente tackle AI bias and thorny data privacy problems.”

From the telehealth front, Healthcare Dive reports

Telehealth utilization varied by region from June to July of 2022 and rose 1.9% nationally, according to Fair Health’s monthly tracker data out Monday. 

In the West, Midwest and South, telehealth utilization rose 5.7%, 2.5% and 4.9%, respectively, from June to July. In the Northeast, telehealth use fell 3.3% during that period.

Mental health conditions remained the top diagnoses nationally, and psychiatrists also delivered more virtual care in some regions.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Government Contracting, Mental health care, SDOH–

As we wrap up the last weekend of summer, we can look forward to the House of Representatives and the Senate holding Committee business and floor voting. Yahoo Finance adds

Once again, the threat of a government shutdown looms at the end of the fiscal year, which arrives on September 30. Lawmakers have two weeks to provide funding to keep large swaths of the federal government open and functioning, and the most likely result at this point is a short-term bill called a continuing resolution that funds the government for about 10 weeks, or until mid-December. Lawmakers would then look to pass an omnibus spending package to cover the rest of the 2023 fiscal year.

From the Omicron and siblings front, the Wall Street Journal offers an engaging interview with Moderna’s CEO Stéphane Bancel who “discusses the company’s latest Covid shot and research on using mRNA in seasonal flu vaccines and personalized treatments for cancer.”

From the social determinants of health front, Health Affairs discusses best practices to improve the collection and distribution of race, ethnicity, and language data for use by health care providers and payers. Healthcare payers, in particular, cannot address SDOH issues strategically without having REL data. The FEHBlog’s idea, which he has floated unsuccessfully to date, is to add REL codes to the AMA’s CPT 4 code system, thereby allowing the ready distribution of that data via reliable coders.

Speaking of the distribution of healthcare data, EHR Intelligence reports that “Large Health IT Networks Unveil Plans to Become Qualified Health Information Network (“QHIN”) Under TEFCA.” TEFCA will act as the Electronic Health Records “backbone” to vastly improve health record interoperability, which has long been a national EHR goal.

From the mental healthcare front, last Friday, “the U.S. Department of Health and Human Services (HHS) released the HHS Roadmap for Behavioral Health Integration (Roadmap), which details policy solutions that would help to better integrate mental health and substance use care into the larger health care system and other systems. The Roadmap is based on feedback Secretary Becerra received from patients and providers during more than two dozen stops on his National Tour to Strengthen Mental Health.”

Finally, a government contract expert discusses in Federal News Network why the 1994 federal acquisition reform law (actually the related 1994 and 1996 laws) aiming to simplify the federal procurement process needs a reboot. The FEHBlog heartily agrees.

Tuesday Tidbits

David Ermer–AHRQ, COVID vaccine mandate, Electronic health records, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the omicron and siblings front, Govexec and Federal News Network recount today’s oral argument before the Fifth Circuit U.S. Court of Appeals over the legality of the Administration’s Covid vaccine mandate on federal employees.

The en banc ruling, expected in the next few weeks, could be the last step after a lengthy court battle that has played out through many fits and starts over the last year. Feds for Medical Freedom has previously said it will take its case to the Supreme Court if the Fifth Circuit rules against it, though the high court may be less inclined to weigh in on the case after it already ruled on two vaccine mandate cases in January. If the mandate is ultimately permitted to stand, individual employees could still wind up in the federal circuit if they take their cases to MSPB and appeal further after an initial decision. The mandate has not been enforced since a U.S. district judge in Texas first enjoined it in January.

In other virus news, the Wall Street Journal offers one of its helpful overview articles titled “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York.”

From the healthcare cost front, HHS’s Agency for Healthcare Quality and Research called attention to a recent agency report about the characteristic “high spenders”:

• In 2019, the top 1 percent of persons ranked by their healthcare expenditures accounted for about 21 percent of total healthcare expenditures, while the bottom 50 percent accounted for only 3 percent.
• Hypertension and osteoarthritis/other non-traumatic joint disorders were the most commonly treated conditions among the top 5 percent of spenders.
• Persons ages 65 and older and Whites were disproportionately represented in the top spending tiers.
• Inpatient hospital care accounted for about 37 percent of spending for persons in the top 5 percent of spenders.
• Over three-quarters of aggregate expenses for persons in the top 5 percent of spenders were paid for by private insurance or Medicare.

From the SDOH front, MedCity News reports about “Information as a social determinant: Three ways Google is addressing health inequity: Google announced three updates at the Google Health Equity Summit, including a new video series partnership, improved search features and an expanded program with Fitbit.”

In coding news, Healthcare Dive tells us

The American Medical Association said its 2023 Current Procedural Terminology code set, released Friday, contains burden-reducing revisions to the codes and guidelines for providers.

The updates to the data-sharing terminology for medical procedures and services are intended to make coding and documentation easier and more flexible, freeing providers from time-wasting administrative tasks that are clinically irrelevant to providing high-quality care to patients, the AMA said.

The modifications follow the 2021 revisions made to the evaluation and management codes for office visit services. They extend to inpatient and observation care services, consultations, emergency department services, nursing facility services, home and residence services and prolonged services.

HHS regulations implementing HIPAA electronic transaction standards require that the CPT be used to code outpatient services.

Monday Round-up

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 testing, Electronic health records, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

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

Govexec adds today that

The executive order is still enjoined in Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Carolina, South Dakota, Tennessee, Utah, West Virginia and Wyoming as a result of the Friday opinion and the injunctions in the other cases, members of the law firm McGuireWoods noted in a post. 

A spokesperson for the Office of Management and Budget told Government Executive on Monday morning the Justice Department is currently reviewing the decision. “At this time, the nationwide injunction remains in effect, and thus agencies should continue not to take any steps to enforce Executive Order 14042.” 

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

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

The federal government is putting a pause on sending free COVID-19 testing kits to Americans starting in September, due to a lack of funding. 

“Ordering through this program will be suspended on Friday, September 2 because Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” the ordering website says. 

However, the program is still accepting orders before [next Saturday] Sep. 2. 

From the No Surprises Act front, Mercer Consulting announced

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

Download PDF of this article

Click here

Download the 21-page print-friendly article for details on the prescription drug reporting rules and the compliance challenges facing group health plans. This GRIST has been updated to reflect the updated submission instructions.

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

From the FEHB plan design front, Federal News Network reports

Democratic lawmakers are urging the Office of Personnel Management to follow through on its plans to expand federal employees’ medical coverage to cover infertility diagnoses and treatments.

Sen. Tammy Duckworth (D-Ill.) and Government Operations Subcommittee Chairman Gerry Connolly (D-Va.) urged OPM on Monday to ensure all Federal Employee Health Benefits (FEHB) program carriers provide coverage for assistive reproductive technology (ART), which includes in vitro fertilization (IVF), starting in 2023.

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

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

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

Seven strategic themes emerged from the list of ways that payers have helped members manage their mental health needs:

* Helping members find the right providers

* Creating opportunities for care through telehealth, online platforms

* Designing new payment models

* Expanding and educating the mental healthcare workforce

* Offering population-based services

* Supporting caregivers

* Expanding research and awareness

The article expounds on each of these themes.

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

Months of inching performance gains were upended in July as the nation’s hospitals logged “some of the worst margins since the beginning of the COVID-19 pandemic,” Kaufman Hall wrote in its latest industry report. * * *

What’s more, seven straight months of negative margins “reversed any gains hospitals saw this year” and has the advisory group forecasting a brutal year for the industry.

“July was a disappointing month for hospitals and put 2022 on pace to be the worst financial year hospitals have experienced in a long time,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a statement. “Over the past few years, hospitals and health systems have been able to offset some financial hardship with federal support, but those funding sources have dried up, and hospitals’ bottom lines remain in the red.” * * *

The silver lining in Kaufman Hall’s report were total expenses that, although up 7.6% from July 2021, saw a modest 0.4% decline since June. Those savings came squarely among supply and drug expenses as total labor costs and labor expense per adjusted discharge still grew 0.8% and 3.5%, respectively, since June. Increases in full-time employees per adjusted occupied bed “possibly” suggest increased hiring, the group wrote in the report.

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

Judy Faulkner, CEO of Epic, discussed the company’s vision to build a nationwide health IT infrastructure last week at the annual Users Group Meeting while dressed as Amelia Earhart, according to The Cap Times. 

Ms. Faulkner has a history of dressing as characters and historical figures for her highly anticipated keynote address at the meeting every year, and this year she chose Ms. Earhart, the iconic female pilot, as a nod to the meeting’s theme: A Night at the Museum. She talked about new technologies and expectations for Epic and its data platform, Cosmos. * * *

“We are building a nationwide health IT infrastructure to connect the different parts of healthcare,” Ms. Faulkner told the crowd.

Epic’s largest competitor in the hospital market, Oracle Cerner, is also on a mission to digitally connect the U.S. healthcare system. Larry Ellison, chair, co-founder and chief technology officer of Oracle, revealed in June the company’s plans to build a unified national healthcare database after acquiring Cerner earlier this year for $28.4 billion. His vision of a national healthcare database includes anonymized data from hospitals, clinics and providers to give real-time information about patients’ health as well as public health statistics.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill —

The Federal Times seeks to project the timeline for implementing the new law requiring the Veterans’ Administration to cover illnesses contracted by Iraq and Afghanistan veterans who were exposed to burn pit smoke while overseas.

The Republicans on the House Ways and Means Committee offer their perspective on the budget reconciliation bill that Senate passed yesterday and the House will take up this Friday.

From the OPM front, the FEHBlog noticed today that its Office of Inspector General (OIG) has posted on its revamped website the OIG’s semi-annual report to Congress for the period ended March 31, 2022. This report is always worth a gander to those who are interested in the FEHB Program.

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

Parents are having their say about the Covid-19 vaccines for children under 5, and for most, the answer so far is no.

More than a month after the U.S. Centers for Disease Control and Prevention recommended shots for about 17.4 million children ages 6 months through 4 years, about 4% to 5% of them have received a shot, according to the most recent agency data and population estimates from the American Academy of Pediatrics. 

By contrast, the vaccination rate for children 5 to 11 years reached about 18% a month after the CDC first recommended shots last November. The rate now stands at about 38%. * * *

Uptake has varied by state, recent counts from around the U.S. show. In Massachusetts, roughly 40,541 children under 5, about 11% of the state’s population in that age group, have received one dose. In New Jersey, more than 21,000 young children, or 4.6% of the children under 5 in that state, have received one dose. 

A lawyer writing on the Society for Human Resource Management advises “employers with workers who test positive for COVID-19 should follow guidance from the Centers for Disease Control and Prevention (CDC), including its guidelines on quarantining and isolation, to minimize safety and legal risks, even though the guidance is somewhat complex.”

From the public health front, the Department of Health and Human Services announced today its Health Resources and Services Administration (HRSA) is

awarding nearly $90 million in American Rescue Plan funding to nearly 1,400 community health centers across the country to advance health equity through better data collection and reporting. On Friday, August 5, President Biden issued a proclamation on National Health Center Week to recognize the vital role health centers play in safeguarding the well-being of Americans and honor the heroic staff who keep these facilities running.

What’s more, the American Hospital Association tells us

[HRSA] today awarded $45.7 million from the American Rescue Plan Act [ARPA]to develop the public health workforce in rural and tribal communities. The grants will help train dental hygienists, medical and dental assistants, doulas and other community health workers; health information technology and telehealth technical support staff; community paramedical workers; and respiratory therapists and care coordinators for patients with long-term COVID-19 effects and chronic medical conditions.

In addition to the ARPA grants, the agency awarded $9.7 million to help hospitals and others establish new medical residency programs in rural communities; $2.9 million to improve health outcomes in rural counties; and nearly $1 million to improve access to care for rural veterans. 

From the No Surprises Act front, Healthcare Dive informs us

The Medical Group Management Association, which represents physician practices, is urging the HHS and the CMS to delay enforcing certain requirements of the No Surprises Act to allow providers time to understand and implement the mandates.

In a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks La-Sure, MGMA asked that medical group practices be given six months’ notice before enforcement of additional surprise billing requirements.

The provider group requested the enforcement delay following publication of more anticipated rulemaking including an advanced explanation of benefits, continuity of care protections and provider directory requirements. 

The FEHBlog supports the MGMA’s position because Congress goofed in the NSA by not treating the good faith estimate and advance EOB as HIPAA electronic transaction standards.

STAT News discusses the stress that providers and payers are experiencing as they wait for the Labor Department to issue its final rule (following receipt of public comments on its interim final rule) about the NSA’s independent dispute resolution process.

From the Rx coverage front, STAT News reports

Karuna Therapeutics said Monday that a novel combination pill reduced psychosis and related symptoms experienced by patients with schizophrenia, achieving the main goals of a late-stage clinical trial.

With positive study results in hand, the Boston-based biotech intends to submit a marketing application with the Food and Drug Administration by the middle of next year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.

Called KarXT, the Karuna drug targets muscarinic acetylcholine receptors in the brain to reduce psychotic symptoms. Current antipsychotics — which mostly block dopamine receptors — have become blockbuster schizophrenia medicines despite causing troubling side effects like weight gain and somnolence. Peak sales for KarXT could also reach into the billions of dollars, analysts forecast.

That’s certainly encouraging.

From the U.S. healthcare business front —

Fierce Healthcare reports

Kaiser Permanente posted a thinned operating margin and nearly $1.3 billion net loss during its second quarter “driven largely by investment market conditions,” according to topline financials for the quarter ended June 30 reported Friday evening.

The massive integrated nonprofit health system notched $23.47 billion in total operating revenues, representing a minor 0.9% dip from the second quarter of last year. Total operating expenses inched nearly 0.2% upward year over year, to $23.38 billion.

The result was an operating income of $89 million (0.4% operating margin) during the most recent quarter, down from the prior year’s $349 million (1.5% operating margin).

“Much like the entire health care industry, we continue to address deferred care while navigating COVID-19 surges and associated expenses. Kaiser Permanente’s integrated model of providing both care and coverage enables us to meet these challenges as demonstrated by our moderate increase in year-over-year operating expenses for the second quarter,” EVP and Chief Financial Officer Kathy Lancaster said in a statement accompanying the filing.

BioPharma Dive informs us

Pfizer on Monday said it has agreed to acquire Global Blood Therapeutics for $5.4 billion in a deal that will hand it a recently approved drug for sickle cell disease, as well as two other experimental medicines for the rare blood condition. Under terms of the deal, Pfizer will pay $68.50 in cash per Global Blood share * * *. * * * Pfizer and Global Blood expect the deal, which has been approved by the boards of directors at both companies, to close as early as the fourth quarter, pending the sign off regulators and Global Blood shareholders. 

Becker’s Hospital Review is running a series on health information interoperability:

Health data interoperability has long been a goal of health IT executives and policy experts. But it’s 2022 — and the healthcare system doesn’t appear all that close to getting there.

Becker’s spoke to experts from health systems, industry and academia on what it will take to create an open exchange of healthcare information in the U.S.

The first entry in the series is a Q&A with Donna Roach, CIO of University of Utah Health in Salt Lake City

Check it out.

Weekend update

David Ermer–CDC, Congress, COVID-19, Electronic health records, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Capitol Hill —

The Senate is on a State work break for the next two weeks which encompasses Independence Day. The House of Representatives will be engaged in Committee business this week through Thursday. Then the House will be on District work break through the end of the following week.

The House Oversight and Reform Committee is holding a hearing tomorrow on an important topic: “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis.”

On Friday, the House Appropriations Committee approved

the fiscal year 2023 Financial Services and General Government bill on a 31 to 22 vote. * * *

The following amendments to the bill were adopted by the full Committee:

Rep. Quigley – The manager’s amendment makes technical and noncontroversial changes to the bill and report. The amendment was adopted by voice vote.

Rep. Stewart #3 – This amendment prohibits the government’s use of cloud computing platforms unless they prevent child exploitation images. The amendment was adopted by voice vote.

A summary of the bill is here. The text of the draft bill is here. The bill report, before the adoption of amendments in full Committee, is here. 

This bill includes FEHB and OPM funding.

It occurred to the FEHBlog over the weekend that on Friday he did not explain how the Supreme Court’s Dobbs decision overruling Roe v. Wade impacts the FEHB Program. The short answer in the FEHBlog’s opinion is that it has no impact.

Under the Hyde Amendment whose requirements have been applied to the FEHB via annual appropriations bills for decades, FEHB Program coverage of abortions is limited to abortions in cases of rape, incest, or endangerment of the mother’s life. Federal courts of appeals uniformly have held that the Hyde Amendment preempts more restrictive State abortion limitations. E.g., Planned Parenthood Affiliates v. Engler, 73 F.3d 654 (6th Cir. 1996) (citing precedential authorities).

From the Omicron and siblings front —

Nature reports

The BA.4 and BA.5 subvariants are spiking globally because they can spread faster than other circulating variants — mostly BA.2, which caused a surge in cases at the beginning of the year. But so far, the latest Omicron variants seem to be causing fewer deaths and hospitalizations than their older cousins — a sign that growing population immunity is tempering the immediate consequences of COVID-19 surges.

Nature explores what the rise of BA.4 and BA.5 means for the pandemic.

The FEHB agrees that the complete Nature article is worth reading.

The Wall Street Journal informs us

Pfizer Inc. and BioNTech SE vaccines modified to target the Omicron variant produced a significantly larger immune response than the companies’ currently available vaccine in a study, they said.

A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday. * * *

The results, coming after Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggest possible benefit to modifying the shots to improve protection against an evolving virus.

The Journal adds that the Food and Drug Administration is considering whether to give emergency use authorization to the Omicron-oriented boosters for fall 2022. Based on the Nature article, it appears that Omicron will still be with us then.

Fortune identifies seven things doctors who treat long Covid want people to know.

From the Monkeypox front, Bloomberg Prognosis tells us

The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern.

The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak.

“What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.”

NPR Shots expresses concern that U.S. testing program for this disease is inadequate.

For many of the [201] confirmed cases, health officials don’t know how the person caught the virus. Those infected haven’t traveled or come into contact with another infected person. That means the virus is spreading in some communities and cities, cryptically. 

“The fact that we can’t reconstruct the transmission chain means that we are likely missing a lot of links in that chain,” Jennifer Nuzzo, an epidemiologist at Brown University, says. “And that means that those infected people haven’t had the opportunity to receive medicines to help them recover faster and not develop severe symptoms. 

“But it also means that they’re possibly spreading the virus without knowledge of the fact that they’re infected,” she adds.

In other words: “We have no concept of the scale of the monkeypox outbreak in the U.S.,” says biologist Joseph Osmundson at New York University. “

NPR explains that the monkeypox testing process is much too cumbersome and the CDC hopes to have the process streamlined “sometime in July.”

Meanwhile, Precision Vaccines reports

New influenza vaccine effectiveness data presented at the U.S. CDC’s June 22, 2022 meeting of the Advisory Committee on Immunization Practices (ACIP) show flu shots worked better during 2021 – 2022 than initially reported.

Published on June 23, 2022, this ACIP data shows flu shots reduced the risk of influenza illness by about 35% among vaccinated people.

Data from October 4, 2021, through April 30, 2022, showed that flu vaccines reduced people’s risk of mild to moderate flu illness caused by H3N2 flu viruses—the most common flu viruses this season—by about one-third overall. * * *

Also, at the meeting, ACIP voted in favor of a preferential recommendation for certain flu vaccines over others for adults 65 years and older in the United States. 

The ACIP voted to preferentially recommend higher-dose flu vaccines (Fluzone High-Dose vaccine and Flublok recombinant vaccine) or adjuvanted flu vaccine (Fluad vaccine) over standard-dose unadjuvanted flu vaccines.

And if one of these vaccines is unavailable at the time of administration, people in this age group should get a standard-dose flu vaccine instead. 

From the health information technology front, Health Data Management calls out attention to the following

  • “In a [very sensible] letter to Department of Health and Human Services Secretary Xavier Becerra, several healthcare standards organizations are calling for streamlining and making more predictable the process for submitting attachments as well as modernizing existing rules to improve patient care and reduce burdens on clinicians.”
  • “New legal requirements for providers to give an estimated cost of patients’ medical services will be difficult to meet, particularly when multiple organizations are involved in a patient’s care, according to WEDI, the Workgroup on Electronic Data Interchange. Meeting the requirements of the No Surprises Act, which was included as part of a Consolidated Appropriations Act passed late in 2020, will be challenging because there is no standardized process to enable the exchange of cost information among facilities, WEDI notes.”
  • “While healthcare organizations see the prevailing trend of increasing patient consumerism, the ability to give patients opportunities to schedule their own appointments is lagging. Many organizations have adopted some capabilities for self-scheduling, according to new research from the Center for Connected Medicine (CCM), yet the use of these tools remains low [because] scheduling solutions lack the right algorithms and that organizations lack standardized scheduling templates across appointment types.”

In particular the second bullet strikes a chord with the FEHBlog as he has pointed out that Congress made a huge mistake by failing add the provider’s good faith estimate and the health plan’s advance explanation of benefits to the list of HIPAA standard transactions.