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.
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.
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.”
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.
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.
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.
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.
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.
“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 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
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.
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.
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 givingPartD 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.
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.”
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.
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%.
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,  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.
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.
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.
Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 4th week of 2022.
The Omicron surge clearly has peaked. However, the weekly new Covid deaths chart continues to rise as deaths are a lagging indicator.
Here’s the FEHBlog’s chart of Covid vacciniations, including boosters, distributed and administered from the 51st week of 2020 through the 4th week of 2022.
The CDC’s Covid Data Tracker Weekly Review sums it up as follows:
COVID-19 cases and hospitalizations are starting to decline across the United States. However, deaths are still rising, and community transmission is still high nationwide. As of January 27, 2022, more than 211 million people in the United States have received a primary series of a COVID-19 vaccine and are considered fully vaccinated. More than 86 million people are up to date with their COVID-19 vaccines, which means they have received all recommended COVID-19 vaccine doses, including boosters.
Two new CDC reports show that people who are up to date with their COVID-19 vaccines have the highest amount of protection against both the Delta and Omicron variants.
New data show that vaccines still protect against a spinoff of the Omicron variant, a welcome sign as the world keeps a close eye on the latest coronavirus iteration.
BA.2, as the sublineage is known, is part of the broader Omicron umbrella. Scientists are paying more attention to it as it begins to eat into the dominance of the more common Omicron strain, which is technically called BA.1.
Here’s a link to the CDC’s latest Fluview whose key update is as follows:
The percent of specimens testing positive for influenza remains stable, indicating that influenza virus circulation has remained at similar levels during the past two weeks, even while overall levels of respiratory illness have declined.
WIRED Magazine informs us that the goverment’ covidtests.com has been working smoothly to distribute sixty million rapid antigen tests to American thanks to sound planning from the U.S. Digital Service supported by the U.S. Postal Service.
At one time, a presidential announcement like that would have caused a mad scramble in the agencies involved. But hard and bloody experience has changed the way the executive branch works. This time, even before Biden made his public promise, the people charged with actually building the site had, as Hsiang says, “a seat at the table” and were able to shape expectations from the beginning. “We did a bunch of work to make sure that it was technically feasible before we decided how we were going to implement it,” says Natalie Kates, who is the Covid lead for USDS.
They decided that the project should be sited and built at the United States Postal Service, which not only had the national database of valid addresses, but would ultimately deliver the packages. When the Postal Service’s CIO, Pritha Mehra, learned about the project in December, she was given estimates that demand might peak at a million users an hour. Mehra, a 31-year veteran of the service, concluded that was a lowball prediction and multiplied the number by 20, striving for a fail-safe capability. “Think about it—free Covid tests,” she says. “Look at the numbers of people that are trying to buy them. And so we read 20 times the demand that had been projected, and I told my team that’s what we’re going to build to.” She had no problem recruiting that team. “This is a technologist’s dream, to be able to do this,” she says.
Mehra knew it would be a challenge to the service’s architecture, which involved a combination of its own data centers and outside cloud providers. Her team set up a system with triple redundancy, beefing up the architecture, separating the customer experience process from the order fulfillment, and caching data multiple times in the process. And doing endless load testing. “Believe me, there was a lot of work behind what seemed like a very simple site,” she says.
Health Payer Intelligence reviews insurer association comments on the HHS proposed 2023 Notice of Benefit and Payment Parameters which principally focuses on the ACA marketplace.
The proposed rule addressed a broad range of issues on the individual health insurance marketplace, from medical loss ratios to health equity data.
AHIP and the Alliance for Community Affiliated Plans (ACAP) have both responded to the proposed rule with mixed reactions. Some elements they strongly applauded, such as the return to pre-2020 language around discrimination, web-broker display requirements, standards of conduct for brokers and agents, special enrollment period verification, and quality improvement strategy (QIS).
AHIP and ACAP highlighted a couple of key areas of the proposed rule that they would like to see changed in the finalized version [including risk adjustment, offering standardized plans, network adequacy, and medical loss ratio.
On the hand, the American Hospital Association also submitted comments on the proposed Notice.
The AHA yesterday voiced support for many of the policies proposed in the Centers for Medicare & Medicaid Services’ Notice of Benefit and Payment Parameters for 2023, including clarifications to the Medical Loss Ratio calculations, reestablishment of standardized health plan option requirements, changes to the essential health benefit nondiscrimination policy, and new requirements and standards of conduct for agents, brokers and web-brokers.
“In particular, we commend CMS on the proposed updates to the network adequacy standards, which are critical to ensuring that patients have access to the care they need,” AHA wrote. “We also strongly support CMS’ attention to advancing health equity throughout the proposed polices.”
From the Omicron front, MedPage Today reports that
While a large meta-analysis of studies on convalescent plasma use early in the pandemic turned up no survival advantage for the typical patient hospitalized for COVID-19, researchers have mined the dataset to predict who may benefit.
Eva Petkova, PhD, of NYU Grossman School of Medicine in New York City, and colleagues devised a simple and freely available tool called the Convalescent Plasma Benefit Index Calculator that allows doctors to input certain patient criteria to determine if their patient may benefit from convalescent plasma (age, oxygen need, blood type, and history of either diabetes, heart disease, or pulmonary disease).
Note: The FEHBlog has been intrigued by convalescent plasma treatments since reading John Barry’s The Great Influenza in early 2020. The FEHBlog currently is reading Gregory Zuckerman’s A Shot to Save the World which is equally fascinating.
The Wall Street Journal’s personal technology reporter Joanna Stern reviews the latest in at home Covid testing.
It’s Friday and you’ve got a scratchy throat and a mild headache. Time to play “Cold? Covid? Or Just Crazy?”—the only game more popular than Wordle.
Or you could open up your medicine cabinet and power-on a small white box. Swab your nose with a Lego-like stick, then slide that into the illuminated gadget. About 20 minutes later, your iPhone buzzes: “COVID-19 Positive.”
The future? Nope, it’s already here. For the past few weeks, I’ve been testing the Cue Health Monitoring system and the Detect Covid-19 Test, two systems from health-tech startups that put lab-like molecular testing right on your bathroom counter. No driving to the testing center. No waiting in line. No anticipating the results for days.
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Molecular tests’ biggest benefit: They can spot Covid earlier—anywhere from 6 hours to two days, depending on the variant and other factors. Dr. Mina, who previously served as an adviser to Detect, said they’re good “if you’re really symptomatic and you definitely want to know, ‘Is this Covid?’ ”
However, if you’re using a test to determine whether you can safely go out into the world—back to work, back to school—the cheaper rapid antigen test would be best. “The problem with a molecular test is that it’s so sensitive that it may detect dead fragments and not live virus,” said Peter Chin-Hong, an infectious-disease specialist at the University of California, San Francisco.
Ms. Stern also explains in the article that the molecular test cost singificantly more than the rapid antigen tests.
Bloomberg released its latest Covid resilence ranking for 53 countries around the world.
The Covid Resilience Ranking is a monthly snapshot of where the virus is being handled the most effectively with the least social and economic upheaval. Drawing on 12 data indicators spanning virus containment, quality of healthcare, vaccination coverage, overall mortality and progress toward restarting travel, it captures how the world’s biggest 53 economies are responding to the same once-in-a-generation threat.
The United Arab Emirates and Saudi Arabia rank one and two. The U.S. ranks 23 down 11 ranks since last month. The FEHBlog recalls that last Spring before Delta hit us, the U.S. ranked number 1 in this index. How the mighty have fallen.
From the No Suprises front
The Affordable Care Act regulators today released 37 pages of helpful guidance about the No Suprises Act’s new federal independent dispute resolution process.
Healthcare Leaders tells us that “The U.S. Department of Health and Human Services (HHS), Office of Inspector General, plans to conduct a nationwide audit to determine whether hospitals that received Provider Relief Funding complied with the billing requirements for COVID patients. This requirement stipulates that those hospitals must not pursue out-of-pocket payments from COVID patients whose bill exceeded “what the patients otherwise would have been required to pay” for in-network care. This audit will be based on the various federal Covid relief acts, not the No Surprises Act
From the Affordable Care Act front, the FEHBlog diligently has been on the lookout for the HHS announcement of 2023 out-of pocket cost-sharing limits for in-network care. The 2023 ACA Notice of Benefit and Payment Parameters released December 28, 2021, advised that the announcement would be released in January. The regulators must have meant that future announcements would be released beginning in January 2024 because the FEHBlog discovered yesterday that the 2023 announcement was released on December 28, 2021.
The announcement reads in pertinent part that
Under 45 CFR 156.130(a)(2), for the 2023 calendar year, cost-sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2023. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage for 2023 of 1.4408219719, and the 2014 maximum annual limitation on cost-sharing of $6,350 for self-only coverage, which was published by the Internal Revenue Service on May 2, 2013, the 2023 maximum annual limitation on cost-sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 4.6 percent increase above the 2022 parameters of $8,700 for self-only coverage and $17,400 for other than self-only coverage.
And there you are, dear readers.
From the healthcare business front, Healthcare Dive informs us that
— HCA [Healthcare] announced plans to build five new hospitals in Texas in response to the growing population there, executives said Thursday during a call with investors.
— The hospitals will serve as primary- and secondary-type hospitals with basic inpatient and outpatient services that will refer patients needing higher-acuity services to HCA’s other campuses. These new hospitals will be smaller facilities with about 50 to 75 beds, executives said Thursday.
— The new hospitals will be located in the areas of Dallas Fort-Worth, Houston, San Antonio, and Austin.
Nashville, Tenn.-based HCA Healthcare saw its revenue and profit grow year over year in the fourth quarter of 2021.
The 182-hospital system reported revenue of $15.1 billion in the fourth quarter of last year, up from $14.3 billion in the same period of 2020. The for-profit hospital operator said same-facility admissions, emergency room visits and outpatient surgeries increased year over year, while inpatient surgeries declined.
After factoring in expenses and nonoperating items, HCA’s net income in the fourth quarter of 2021 totaled $1.8 billion, up from $1.4 billion in the same quarter a year earlier.
From the telehealth front, Fierce Healthcare reports that
As telehealth companies increasingly turn to chronic care management, Cigna’s MDLive is launching its own remote patient monitoring program.
The digital-first program will allow patients with chronic conditions to track biometrics like blood pressure and glucose levels, recording daily health information that they can review with MDLive providers during their visits.
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Cigna expanded access to MDLive’s network of virtual primary care providers to all members of the insurer’s employer plans beginning January 2022.
The new patient health monitoring program will be available to all health plan clients of MDLive.
The Centers for Medicare and Medicaid Services (CMS) announced its proposed national coverage decision for Biogen’s Alzheimers Disease FDA-approved treatment, Aduhelm, today.
The proposed National Coverage Determination would cover Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. The proposed National Coverage Determination is open to public comment for 30 days.
Normally, Medicare covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without a guarantee that patients actually will see slower cognitive decline. The process that led to the drug’s approval is the subject of multiple investigations, following STAT’s reporting that Biogen had an extensive back-channel relationship with the FDA. * * *
Medicare officials don’t require participation in clinical studies for beneficiaries very often — there are only about two dozen other health care products with a similar designation, called a Coverage with Evidence Development (CED), listed on Medicare’s website. Most are for medical devices or diagnostic imaging, and are less restrictive than the policy Medicare announced Tuesday. * * *
Sean Tunis, a principal at Rubix Health who helped develop the CED process during his tenure at the Centers for Medicare and Medicaid Services, said the proposal is almost as restrictive as if Medicare had decided not to cover the drug at all. Medicare, he estimated, would pay for drug costs for perhaps a few thousand patients that enroll in randomized trials over the next three to five years.
The CMS national coverage decision if finalized would help the FEHB Program dodge a bullet because it has many annuitant enrollees without Medicare Part B and for whom the FEHB plan would be the primary Aduhelm payer.
Following up on yesterday’s post about Affordable Care Act FAQ 51 implementing the President’s mandate on health plans to cover over the counter COVID tests, the FEHBlog noticed the fourth FAQ in this section of FAQ 51 which reads as follows:
Q4: When providing coverage of OTC COVID-19 tests, are plans and issuers permitted to address suspected fraud and abuse?
Yes. As stated in FAQs Part 44, Q2, although the FFCRA prohibits medical management of coverage of COVID-19 diagnostic testing, plans and issuers may act to prevent, detect, and address fraud and abuse. Examples of permissible activities include the following:
A plan or issuer may take reasonable steps to ensure that an OTC COVID-19 test for which a covered individual seeks coverage under the plan or coverage was purchased for the individual’s own personal use (or use by another participant, beneficiary, or enrollee who is covered under the plan or coverage as a member of the individual’s family), provided that such steps do not create significant barriers for participants, beneficiaries, and enrollees to obtain these tests. For example, a plan or issuer could require an attestation, such as a signature on a brief attestation document, that the OTC COVID-19 test was purchased by the participant, beneficiary, or enrollee for personal use, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale. In contrast, the Departments are of the view that fraud and abuse programs that require an individual to submit multiple documents or involve numerous steps that unduly delay a participant’s, beneficiary’s, or enrollee’s access to, or reimbursement for, OTC COVID-19 tests are not reasonable.
A plan or issuer may require reasonable documentation of proof of purchase with a claim for reimbursement for the cost of an OTC COVID-19 test. Examples of such documentation could include the UPC code for the OTC COVID-19 test to verify that the item is one for which coverage is required under section 6001 of FFCRA, and/or a receipt from the seller of the test, documenting the date of purchase and the price of the OTC COVID-19 test.
It occurred to the FEHBlog that FSAFeds the flexible spending account program for federal employees must be reimbursing participants for OTC Covid test kits. In fact the FSAFeds does offer reimbursement for OTC test kits on the condition that the participant furnishes a detailed receipt. For OTC products, FSAFeds generally requires a receipt including Vendor name, Date of purchase, Product name, and Cost. This should be a reasonable documentation standard for FEHB plans to adopt.
Also from the testing front, the Wall Street Journal looks into the reliability of rapid antigen COVID tests sold OTC.
Rapid antigen tests are a useful tool if we are smart about how we use them.
Because the data suggest that rapid tests may be yielding more false negatives at the beginning of an Omicron infection, you’ll have a better chance of getting an accurate result if you wait a day or two after developing symptoms to test, says Katelyn Jetelina, assistant professor of epidemiology at the University of Texas Health Science Center at Houston. If your test is negative, take a second test a day or two later, or get a PCR test if you can. (Easier said than done these days.)
Understand the limitations of rapid tests if you’re considering using them to screen people before gatherings. Rapid tests before a wedding or other large indoor gathering could miss early infections that could be contagious, Dr. [Blythe] Adamson says.
If you have a positive rapid test, you almost definitely have Covid-19, Dr. [Gigi] Gronvall says. False positives are rare, especially when case rates are as high as they are now. You likely don’t need to confirm a positive rapid-test result with a follow-up PCR test, unless an employer or other institution requires it.
The Journal also tells us that “U.S. officials on Tuesday ordered 600,000 doses of Covid-19 treatment sotrovimab, the only monoclonal antibody therapy thought to work against the Omicron variant, as a record number of cases puts hospitals under increasing pressure in parts of the U.S. and Europe. Sotrovimab, made by GlaxoSmithKline PLC and Vir Biotechnology Inc., is now the only Covid-19 monoclonal antibody available for patients in the U.S.”
ACA FAQ 51 also includes reminders to health plans about the wide scope of the ACA’s contraceptive mandate.
From the federal employee COVID vaccination front Federal News Network reports that
The first update by the Safer Federal Workforce task force in more than a month is addressing the challenge of testing employees and contractors who work on-site or with the public on a regular basis for COVID-19, the types of tests that are permitted and who is responsible for paying for said tests.
The crux of the updated and new frequently ask questions is agencies have until Feb. 15 to set up a testing program “for employees who are not fully vaccinated, including due to a pending or approved request for exception or extension from the COVID-19 vaccination requirement for federal employees.”
The task force said the testing program is only for employees who work on-site or interact with the public like safety inspectors, and not for those who work remotely.
Fedweek adds that “A period of waiting is continuing on two major federal workplace issues on which action was expected around now—enforcement of the Coronavirus vaccine mandate and the “reentry” from telework to regular worksites by more employees and for more often.”
From the preventive services department, the Department of Health and Human Services announced today that
Today, the U.S. Department of Health & Human Services (HHS) announced that the Health Resources and Services Administration (HRSA) has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents. Under the Affordable Care Act (ACA), certain group health plans and insurance issuers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines. Among a number of updates, for the first time the guidelines will require such group health plans and insurance plans to provide coverage without a co-pay or deductible for double electric breast pumps.
Fierce Healthcare reports news from the second day of the JPMorgan Healthcare Conference.
From the tidbits department —
Last week, the Office of National Coordinator for Health Information Technology announced “the release of the Project US@ (“Project USA”) Technical Specification Final Version 1.0 and thereby completed our one year goal to coordinate the creation of a health care specification that could be used across the industry for representing patient addresses (mailing, physical, billing, etc.). This new “tech spec” will advance the health care industry’s proficiency in recording and managing accurate and consistently formatted patient addresses and support more efficient patient matching and record linkage. As a reminder, among the many data elements that are used in patient matching, research has shown patient address to be one of the most sensitive to standardization and therefore impactful on patient matching, especially at scale. However, patient addresses change frequently, are often entered incorrectly or imprecisely.”