Weekend update

ACA

Weekend update

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

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

The Wall Street Journal adds

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

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

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

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

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

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

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

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

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

From the unusual viruses front

STAT News reports

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

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

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

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

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

The Wall Street Journal adds

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

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

From the Medicare front, STAT News reports

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

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

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

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

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

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

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

From the reports and studies department

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

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

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

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

Weekend Update

David Ermer–Congress, COVID-19, SDOH, U.S. Healthcare, Wellness–
Photo by Tomasz Filipek on Unsplash

Congress returns to Capitol Hill this week following a two-week-long break. Both the House of Representatives and the Senate will be engaged in Committee business and floor voting.

The Wall Street Journal adds

Congress returns on Monday with Democrats aiming to revive central pieces of President Biden’s stalled economic agenda while trying to keep on track a separate, bipartisan bill targeted at boosting competitiveness with China that top Republicans are threatening to block.

House Democrats also are set to roll out legislation responding to the Supreme Court ruling ending federal abortion protections. The push could include legislation to write into law the right to an abortion before fetal viability, as well as a bill intended to block any state attempts to criminalize travel for the purpose of getting an abortion. The bills wouldn’t have enough support to pass the Senate.

The three-week work period may be the last chance lawmakers have for a legislative victory before campaigning begins in earnest for midterm election races across the country. Republicans are heavily favored to win back control of the House this fall, while the Senate is seen as a tossup.

From the Omicron and siblings front, MedTecHDive Dive informs us

A single antigen test may only be able to correctly identify the virus 60% of the time in patients who have the omicron variant and who display symptoms of the disease, Tim Stenzel, director of the Food and Drug Administration’s Office of In Vitro Diagnostics and Radiological Health, said during a [recent[ meeting on testing. 

The FDA is seeing an increase in samples with the omicron variant that have a relatively low viral load, also referred to as a low positive. “Instead of seeing the usual 10% to 20% low positives in clinical studies last year, we saw a jump to 30% to 40% low positives,” Stenzel said. “When you have 40% low positives… you’re going to see a really big hit in sensitivity.”

The lower sensitivity means people testing for Covid should use multiple antigen tests to rule out a negative result, with 24 to 48 hours between tests, according to the regulator.

From the unusual viruses front, Medpage Today discusses the ties between cases of monkeypox and syphillis.

Syphilis is a known sexually transmitted infection (STI) that can manifest in lesions in the groin area and can transmit through bodily fluid. The genital sores associated with syphilis can make it easier to transmit other diseases such as HIV — and especially pressing at the current moment, genital sores or lesions are also common transmission pathways for the current B1 monkeypox outbreak. While monkeypox has not technically been categorized as an STI, there have been reports of some monkeypox patients also having STIs.

By scaling up testing and treatment for syphilis, we can better identify people who may be more likely to get and transmit monkeypox. Additionally, because the lesions in the genital region can be difficult to distinguish from those associated with syphilis, testing for both conditions is important.

The incidence of syphilis has been increasing in the U.S. In 2020 alone, there were more than 130,000 new cases of syphilis. While 43% of the new infections occur in men who have sex with men, cases have also been rising in heterosexual men and women, and over 50% of the new infections were in people ages 15 to 24. 

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

Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday. * * *

HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.

Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.

and

UnitedHealth Group [Optum’s parent] is aiming to address 600 million gaps in care for its members by 2025.

The healthcare and insurance giant released its annual Sustainability Report last week, where it outlined three strategic goals to improve health outcomes and affordability.

Alongside addressing care gaps, the company said it wants to ensure at least 85% of its members receive preventive care each year by 2030 as well as to make sure 55% of outpatient surgeries and radiology services are provided in high-quality, cost-efficient sites of care by 2030.

From the SDOH front, Healthcare Dive reports

The CMS’ innovation center has found evidence of implicit bias in three payment models as the agency takes an harder internal look at how its policies might perpetuate health disparities.

The use of certain risk assessment and screening tools, provider processes and payment design algorithms caused some beneficiaries to be unintentionally excluded from the Kidney Care Choices Model, Comprehensive Care for Joint Replacement Model and Million Hearts Cardiovascular Risk Reduction Model, according to a new article published in Health Affairs from Center for Medicare and Medicaid Innovation researchers.

“These findings are troubling” due to limiting access to model participation and stymied efforts to evaluate the models, researchers wrote. CMMI has taken initial steps to address existing bias, and has begun developing a guide to screen and mitigate bias in existing and future models prior to launch, according to the article.

From the nutrition front, Fortune Well offers “7 expert-backed strategies to avoid overeating when you’re working from home” and “4 expert-backed foods for a good night’s sleep.”

Midweek update

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

From the Omicron and siblings front —

The Wall Street Journal reports

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

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

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

The American Hospital Administration informs us

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

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

Also, from the SDOH front, MedPage Today informs us

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

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

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

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

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

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

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

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

The American Hospital Association adds

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

From the Dobbs case front

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

In general, the guidance does two things:

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

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

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

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

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

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

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

Weekend update

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

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

From the omicron and siblings front, Bloomberg Prognosis reports

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

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

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

In other encouraging healthcare news, BioPharma Dive informs us

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

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

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

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

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

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

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

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

Tuesday’s Tidbits

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

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

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

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

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

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

From the healthcare business front —

The Wall Street Journal reports

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

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

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

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

STAT New informs us

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

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

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

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

From the tidbits department —

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

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

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

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

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

Monday Roundup

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

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

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

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

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

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

The FEHBlog heartily agrees.

From the Omicron and siblings front, WebMd informs us

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

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

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

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

STAT News adds

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

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

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

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

From the Rx coverage front, Health Affairs informs us

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

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

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

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

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

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

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

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

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

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

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

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

From the healthcare business front, Fierce Healthcare tells us

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

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

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

From the mental healthcare front,

Fierce Healthcare reports

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

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

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

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

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

Weekend update

David Ermer–ACA, Congress, COVID-19, Rx coverage, Telehealth–

Happy Law Day 2022!

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

From the Omicron and siblings front

The Wall Street Journal informs us

As new Omicron variants further infiltrate the U.S., a jumble of signals suggest the latest increase in Covid-19 infections hasn’t sparked a commensurate surge in severe illness even as risks remain.

Covid-19 virus levels detected in wastewater in the Northeast, the first region to see significant concentrations of the easily transmitted Omicron BA.2 variant, appear to have flattened out in the past two weeks. Covid-19 hospital admissions have risen in the region, but they remain far below levels during earlier surges that indicated widespread severe illness and taxed healthcare facilities. 

“This wave of Covid in the United States, in the places where it is, is not dangerous in a way that prior waves of Covid were,” said Megan Ranney, an emergency physician and academic dean at Brown University’s School of Public Health.

The fast-mutating virus still poses risks, she said. 

The new Fortune Well website offers timely guidance on the symptomatic differences between Covid and allergies.

Bloomberg Prognosis posted its late April Word Covid resilience rankings. Norway rides atop the rankings for the second month in a row The U.S. dropped six rankings to 30th. The article notes that the U.S. and the U.K are “weighed down by ongoing fatalities—their Covid Mortality Rate scores are among the worst of developed economies.

From the Affordable Care Act front, Health Affairs Forefront posted the ever-reliable Katie Keith’s first of three articles on the final 2023 ACA notice of benefit and payment parameters that was issued last week. This article’s section on Essential Health Benefits is relevant to FEHB carriers as each of them must select an EHB benchmark in order to apply the ACA’s restriction on annual dollar limits. The article’s section on Medical Loss Ratio is relevant to community-rated FEHB plans who generally use that benchmark to determine the reasonableness of their prices.

From the Rx coverage front, Medcity News reports “Bristol Myers Squibb drug Camzyos has received FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller, and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.”

From the telehealth front, mHealth Intelligence informs us

A majority of clinics (79 percent) used telemedicine to provide contraceptive services during the COVID-19 pandemic, according to a recent study published in the journal Reproductive Health.

For the study, researchers surveyed 907 US providers and clinic staff between April 10, 2020, and Jan. 29, 2021. They collected data on contraceptive service delivery challenges and strategies, including telehealth. The sample of respondents included physicians (17 percent), advanced practice clinicians (41 percent), registered nurses (16 percent), and health educators and social workers (11 percent).

The respondents practiced in a wide array of care settings, including youth clinics/school-based health centers or college health centers (36 percent), primary care clinics or health departments (29 percent), family planning clinics (22 percent), and independent abortion care clinics (4 percent). They saw, on average, 3,184 contraceptive patients annually.

Though only 11 percent of the clinics offered telemedicine for contraceptive services before the pandemic, this figure shot up to 79 percent after March 2020.

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, HSA, Medicare, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 17th week of 2022:

In addition, here’s the CDC’s Chart of Daily Trends in the Number of New COVID-19 Hospital Admissions in the United States:

Can you say endemic?

Below you will find the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 to the current week 17.

The CDC’s Covid Data Tracker Weekly Review points out, “This week, the U.S. COVID-19 Vaccination Program marks two milestones: 500 days since the first COVID-19 vaccine was approved for use in the United States, and 100 million first booster doses administered.”

In the New York Times, David Leonhardt reports that the FDA is waiting to receive additional data from Pfizer and Modera [likely next month] to support their emergency use authorizations for Covid vaccines for children between six months and five years. Although the FDA’s preference is to give EUAs to both vaccines simultaneously to provide parents a choice, the agency will not delay a EUA decision on one or the other unnecessarily.

The CDC’s weekly review adds,

Currently, there are 54 (1.68%) counties, districts, or territories with a high COVID-19 Community Level, 256 (7.95%) counties with a medium Community Level, and 2,910 (90.37%) counties with a low Community Level. This represents a slight (0.59%) increase in the number of high-level counties, a small (+1.43%) increase in the number of medium-level counties, and a corresponding (−2.02%) decrease in the number of low-level counties. Seventeen (30.36%) of 56 jurisdictions had no high- or medium-level counties this week.

To check your COVID-19 community level, visit COVID Data Tracker.

From the health savings account front, the Society for Human Resource Management reports

Health savings account (HSA) contribution limits for 2023 are going up significantly in response to the recent inflation surge, the IRS announced April 29, giving employers that sponsor high-deductible health plans (HDHPs) plenty of time to prepare for open enrollment season later this year.

The annual inflation-adjusted limit on HSA contributions for self-only coverage will be $3,850, up from $3,650 in 2022. The HSA contribution limit for family coverage will be $7,750, up from $7,300. The adjustments represent approximately a 5.5 percent increase over 2022 contribution limits, whereas these limits rose by about 1.4 percent between 2021 and 2022.

In Revenue Procedure 2022-24, the IRS confirmed HSA contribution limits effective for calendar year 2023, along with minimum deductible and maximum out-of-pocket expenses for the HDHPs with which HSAs are paired.

Here is that 2023 deductible and OOP max information:

For calendar year 2023, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,500 for self-only coverage or $3,000 for family coverage [Self-only: +$100 Family: +200 from 2022], and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $7,500 for self-only coverage or $15,000 for family coverage [Self-only: +$450 Family: +$900 from 2022].

From the Medicare Part D front, Fierce Healthcare reports

CMS is giving Part D plans a little extra time to prepare to funnel price concessions to the member at the point of sale.

The Centers for Medicare & Medicaid Services on Friday finalized a rule with the price concession changes as well as a slew of updates for Medicare Advantage plans.

The agency said in a fact sheet on the regulation that beginning Jan. 1, 2024, it will define the negotiated price for a drug in Part D as the baseline, or lowest possible, payment to a pharmacy to ensure that price concessions are felt at the point of sale by beneficiaries.

“This policy reduces beneficiary out-of-pocket costs and improves price transparency and market competition in the Part D program,” CMS said.

The bell for prescription drug rebates is beginning to toll.

From the healthcare business front, Healthcare Dive tells us

Molina Healthcare in the first quarter recorded its highest COVID-19 costs since the start of the pandemic, CEO Joe Zubretsky said Thursday.

However, those costs were almost entirely offset by members cutting back on healthcare visits, a common trend throughout the pandemic, he said on a call with investors.

After costs peaked in January, they quickly declined in the subsequent months. “When I say [COVID-19 costs] subsided during the quarter, it did so dramatically,” Zubretsky added.   

HR Morning discusses a recent Willis Towers Watson survey on how employers are dealing with rising health care costs. To make healthcare more affordable for employees.

Fifty-five percent said their plan is to improve quality and outcomes to lower overall cost. Adding or enhancing low- or no-cost coverage for specific benefits is the plan for 41%. And 32% will be making changes to employees’ out-of-pocket costs, while 21% said they’ll alter their health plan payroll contributions.

From the preventive services front, the U.S. Preventive Services Task Force made a final grade D recommendation against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older. “For adults aged 40 to 59 years with an estimated 10% or greater 10-year cardiovascular disease (CVD) risk:  The decision to initiate low-dose aspirin use for the primary prevention of CVD in this group should be an individual one.” This is a Grade C recommendation.

Thursday Miscellany

David Ermer–ACA, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron and siblings front —

MedPage Today brings us up to date on the whereabouts of Omicron BA 2.12.1.

“What we’re seeing right now is a version of the virus that is much more transmissible than previous versions of the virus, perhaps, but also less likely to cause severe disease,” Perry Halkitis, PhD, MPH, dean of the Rutgers School of Public Health, told MedPage Today.

The FEHBlog heard a fascinating talk about the Long Covid or PASC on the second and final day of the 2022 OPM AHIP Carrier Conference. Dr. Micheal Brode explained that PASC usually is evidenced by fatigue, brain fog, or exertional fatigue more than 12 weeks after the first symptoms of Covid. People afflicted by PASC typically, but not always, were hospitalized when Covid was in its acute opening phase. Covid vaccinations reduce the risk of contracting PASC by at least 50%, but they don’t prevent PASC. Although it’s premature for evidenced-based treatment guidelines to exist, Dr. Brode complimented the work of the PASC Collaborative to get to that point expeditiously. Most PASC patients recover slowly with medical care, although some PASC patients have permanent disabilities. Dr. Brode reminded the audience that Covid is a multi-system disease, not only a lung disease. PASC’s recently added ICD-10 code is U09.9.

The American Hospital Association adds, “Moderna today asked the Food and Drug Administration to authorize for emergency use its COVID-19 vaccine in children aged six months through 5 years, citing previously released data estimating the vaccine’s efficacy against the omicron variant in this age group was similar to that in adults, with a favorable safety profile.”

From the Affordable Care Act front, the ACA regulators released the final 2023 notice of benefit and payment parameters and the Final 2023 Actuarial Value Calculator and Methodology. Fierce Healthcare highlights the significant changes facing ACA qualified health plans in 2023.

From the healthcare business front —

Humana has released its 1st Quarter 2022 earnings. Fierce Healthcare provides background on the favorable report.

Fierce Healthcare informs us, “Walmart’s telehealth provider, MeMD, is rolling out the virtual diabetes program as a standalone service or as part of a comprehensive medical and behavioral telehealth program for enterprise customers and health plans. The retail giant collaborated with the American Diabetes Association on the virtual program, which was developed to help employees and members close gaps in diabetes management through early intervention, Walmart Health executives said.”

From the drug research front, BioPharma Dive tells us

Eli Lilly’s experimental diabetes shot tirzepatide helped obese people who have an underlying medical condition lose more than 15% of their body weight in a late-stage clinical trial. At the highest dose tested, patients receiving the weekly injection lost, on average, 21% of their body weight, Lilly said in a press release Thursday.

The data suggests tirzepatide could challenge similar drugs marketed by Danish drugmaker Novo Nordisk, which earned about $1.2 billion when prescribed for obesity in 2021. Novo’s weekly weight-loss shot Wegovy helped patients with medical complications lose an average of 15% of their body weight in clinical testing.

Wall Street analysts forecast swift growth for obesity drugs in coming years as patients, doctors and insurers acknowledge the effectiveness of newer agents like Wegovy and tirzepatide. Wegovy sales alone are expected to reach $5.5 billion in 2026, according to consensus estimates highlighted by Cantor Fitzgerald analyst Louise Chen in January.

From the federal employment front —

The U.S. Office of Personnel Management (OPM) released government-wide results of the 2021 OPM Federal Employee Viewpoint Survey (OPM FEVS). Federal News Network summarizes the results as follows:

Change is the biggest constant for the federal workforce after two years in a pandemic that capsized government operations. Despite the upheaval, employee engagement remained relatively steady over the last year, dropping just one point between 2020 and 2021, from 72% down to 71%.

But other factors, like employees’ job and pay satisfaction, declined in 2021 compared to 2020. The overall index points for global satisfaction dropped as well, from 69% down to 64%.

Govexec notes

As part of his fiscal 2023 budget proposal, [President] Biden proposed an average pay increase of 4.6% for civilian federal workers and members of the military, which, if implemented, would mark the biggest raise the federal workforce has seen in 20 years. Although it is unclear how that raise would be broken up between across-the-board increases to basic pay and an average boost to locality pay, traditionally, 0.5% of the pay raise has been set aside for locality pay increases.

In a letter, [62] House Democrats led by Rep. Gerry Connolly, D-Va., pressed the leadership of the House Appropriations Committee to go further than the president and endorse a 5.1% average pay increase for feds, reflecting legislation introduced by Connolly and Sen. Brian Schatz, D-Hawaii, that would grant federal employees a 4.1% across-the-board boost to basic pay and a 1.0% average increase in locality pay.

And don’t forget that this Saturday, April 30, is National Prescription Drug Take-Back Day.

Friday Stats and More

David Ermer–ACA, Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage–

Based on the Centers for Disease Control’s Covid Data Tracker and using 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, a low points of cases and death, and the 14th week of 2022, another lull but not quite as low.

The CDC’s Weekly Review of its COVID statistics issued today notes “The current 7-day daily average for March 30–April 5, 2022, was 1,406. This is a 10.3% decrease from the prior 7-day average (1,567) from March 23–29, 2022.”

Here’s the FEHBlog’s weekly chart of Covid vaccinations administered and distributed since the beginning of the Covid vaccination era through this week, again using Thursday as the first day of the week.

The administration of Covid vaccines popped us this week. Over 75% of the U.S. population aged 18 and older are fully vaccinated. Nearly half (48.6%) of that cadre is boostered. The Weekly Review’s commentary discusses the importance of vaccinating children.

COVID-19 vaccines have undergone—and continue to undergo—the most intensive safety monitoring in U.S. history, and adverse events are rare. Vaccinating children is the single best way to protect them from severe illness associated with COVID-19. 

From Capitol Hill, the Wall Street Journal reports

Senators had also hoped to move forward on the coronavirus vaccines and treatments package, but progress quickly bogged down over Republican efforts to amend the bill to extend a pandemic-era immigration policy called Title 42—which allows Border Patrol agents to quickly turn away migrants at the southern border—with some Democrats siding with the GOP. Senators said they ran out of time, and the break could help end the logjam, even if it means the aid will need to wait at least several weeks.

“We’ll see where the discussions go, but my assumption is during the course of the break they’ll be some conversations between people who are interested in advancing it and see if we can make any headway on coming up with a process,” said Sen. John Thune (R., S.D.) on the Covid aid.

“I don’t think we’re leaving anything hanging up in the air that we’re not going to be able to continue to work with afterwards,” said Sen. Angus King (I., Maine), who caucuses with Democrats.

Congress is on State / District work periods for the next two weeks.

From the Rx coverage front, Health Affairs offers a fascinating article leading with an HHS Inspector General report on biosimilar drug use in the Medicare Part D program. The article blossoms into a broader look at biosimilar use in America. For example,

Last fall, two academics from the USC Schaeffer Center for Health Policy & Economics and the University of Chicago Harris School of Public Policy analyzed the available biosimiliars and found these were, on average, 30% less expensive than the underlying brand-name biologics. This represented a savings of about $665 off the average price.

Perhaps the biggest boost, though, will occur when biosimilar versions of Humira begin entering the U.S. market next year. This is expected to kick-start a wave of increased biosimilar usage between now and 2027, by which time the worldwide market should roughly double to $20 billion, according to Bernstein analyst Ronny Gal.

“The savings we identified with increased biosimilar use, while modest, could be significant once biosimiliar versions of Humira come on the market,” said [Melissa] Baker [from the HHS Office of Inspector Genera]. “Part D spending for Humira is in the billions of dollars.” The HHS OIG report noted that Humira and Enbrel accounted for more than $5 billion in Part D spending and nearly half of Part D spending on biologics in 2019.

From the Aduhelm front, Fierce Healthcare tells us

Leaders of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) sought to present a united front a day after CMS approved narrow Medicare coverage of the Alzheimer’s disease drug Aduhelm.

FDA Commissioner Robert Califf, M.D., and CMS Administrator Chiquita Brooks-LaSure issued a joint statement Friday to address criticism of CMS’ decision that Medicare only cover Aduhelm and similar products for beneficiaries in a qualifying clinical trial. Critics have charged CMS is trying to undermine the FDA’s approval decisions as the agency cleared the drug last year via accelerated approval.

“The work of both of our agencies is critical to ensure that medical products are available to people across the country,” the agency leaders said in a statement.

From the mental healthcare front, Health Payer Intelligence informs us

CVS Health and its payer arm, Aetna, aimed to make strides in the healthcare industry in 2021 by delivering affordable healthcare services to members, increasing access to virtual and mental healthcare, and implementing initiatives to advance health equity, according to the payer’s 2021 Environmental, Social, and Governance (ESG) report. The report reflects data from January 1 to December 31, 2021.

Well done.

Finally, the FEHBlog ran across this helpful Kaiser Family Foundation preventive services tracker website.

The Affordable Care Act (ACA) requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. For adults, the required services are recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Institute of Medicine Committee on Women’s Clinical Preventive Services.  As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date.

This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.

For more information, see the fact sheet Preventive Services Covered by Private Health Plans under the Affordable Care Act.

This tracker also applies to FEHB plans. Thanks, KFF.