“The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
“A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit.
“The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
“Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”
“The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
“The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
“The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”
Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.
From the Rx coverage front, the Wall Street Journal points out
“Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country.
“The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
“The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July.
“The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”
The cost curve is pointing down.
From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.
From the healthcare quality front, NCQA informs us
“The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
Improving data collection of race and ethnicity data is vital to improving health equity.
“The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
“Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
From the federal employment front, the Office of Personnel Management announced
released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.
“These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.”
From Capitol Hill, the Wall Street Journal reports that “Sen. Joe Manchin, who has been a crucial vote in shaping major pieces of President Biden’s agenda, urged Democratic colleagues to hold talks with Republicans on cutting federal spending, ahead of a summer deadline to reach a deal on raising the country’s debt ceiling.”
A larger share of people are being diagnosed with colorectal cancer at a younger age and at a more dangerous stage of the disease, a report showed. Doctors aren’t sure why.
The American Cancer Society said Wednesday that about 20% of new colorectal cancer diagnoses were in patients under 55 in 2019, compared with 11% in 1995. Some 60% of new colorectal cancers in 2019 were diagnosed at advanced stages, the research and advocacy group said, compared with 52% in the mid-2000s and 57% in 1995, before screening was widespread.
Cases and death rates for colorectal cancer have continued a decadeslong decline overall thanks to screening, better treatments and reductions in risk factors such as smoking, the ACS report’s authors said. But the shift of the burden toward younger people and diagnoses at more advanced stages has oncologists on alert.
“The improvements have slowed, and they’ve slowed because of this opposite trend we’re seeing in young people,” said Kimmie Ng, director of the Young-Onset Colorectal Cancer Center at Dana-Farber Cancer Institute in Boston. “More and more are getting diagnosed with cancer that might not be curable.”
The U.S. Preventive Serves Task Force is routinely reevaluating its 2018 grade A recommendation to screen pregnant women/persons for syphilis.
The number of remote patient monitoring (RPM) reimbursement claims hit a new high in 2022, according to a report by Definitive Healthcare.
By November, the volume of claims across the 10 Centers for Medicare & Medicaid Services’ codes for RPM was already 27% above the total for all of 2021, adding to the growth seen since the start of 2019.
Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.
Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services.
The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note. * * *
In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people withnon-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.
From the Rx coverage front, the Congressional Research Service issued an “In Focus” report about “Selected Issues in Pharmaceutical Drug Pricing.”
From the healthcare quality front, NCQA posted slides and a recording from its latest Future of HEDIS webinar on February 28.
The Cleveland Clinic reported a $1.2 billion net loss for 2022 as expenses climbed from the prior year. Expenses ticked up in every key category in 2022, including salaries and wages, supplies and pharmaceuticals, Cleveland Clinic’s latest financial report shows.
Cleveland Clinic grew 2022 revenue roughly 5% to $13 billion from the prior year, but didn’t outpace expenses as costs increased nearly 14% to $12.4 billion before interest, depreciation and amortization.
Investment income helped pull the Midwest provider into the red as non-operating losses totaled $1 billion.
Oak Street Health’s losses grew in 2022 to almost $510 million as the value-based primary care company, which is pending an acquisition by CVS Health, continued to aggressively pursue growth.
In comparison, Oak Street, which operates a network of clinics for seniors on Medicare, reported a loss of $415 million in 2021.
The company opened 40 new centers over 2022 and ended the year with 169 facilities in 21 states, serving some 224,000 patients.
In what may well be the latest fad in hospital consolidation, two not-for-profit health systems located across the country from one another are seeking to link up — this time, to create a system with roughly $11 billion in revenue.
UnityPoint Health and Presbyterian Healthcare Services announced Thursday they’ve inked a letter of intent to explore a merger. Hospital mergers often involve partners in the same region so they can gain leverage with insurers, but in this case, UnityPoint is in the Midwest, whereas all nine of Presbyterian’s hospitals are several states away in New Mexico.
The deal illustrates not only health systems’ insatiable desire to get bigger in a tough operating environment, but their evolving strategy for doing so. Antitrust regulators have sunk deals involving partners they said would command too much market share in a given region, so hospitals are doing the next-best thing: seeking partners in far-flung states.
Walmart plans to expand its network of medical centers in 2024, including a launch into two new states, as retail health giants race to build out their primary care footprints.
The company announced Thursday it plans to open 28 new Walmart Health centers in 2024, bringing its number of total locations to more than 75.
Walmart Health will open clinics in Missouri and Arizona for the first time, while deepening its presence in Texas by expanding in the Dallas area and growing into Houston, according to the announcement.
From the Omicron and siblings front, HealthDay tells us
Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows
The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it
Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1
From the public health front —
Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.
“A new study found that extreme temperatures may raise the risk of death from heart disease. * * * To protect your heart on hot days, stay hydrated, seek shade, and wear light clothes. On cold days, hydrate and avoid too much strenuous outdoor activity.”
From the healthcare quality front
Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.
From the Medicare front —
The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
“Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
“Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
“Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness.
In hospital pricing transparency news —
Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.
From the HR department
The Society for Human Resource Management tells us
“Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
“All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act?
HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”
From the tidbits department
Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”
From Capitol Hill, the Wall Street Journal reports
Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.
The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.
With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.
“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,
Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.
Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.
In other HLTH 2022 conference news,
Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”
From the federal employee benefits front,
Govexec collected all of its current Open Season articles for convenient access.
Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.
From the Affordable Care Act front —
The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”
From the public health front —
Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”
From the miscellany department —
Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”
Moderna Inc said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months.
Omicron-tailored shots by Pfizer Inc and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron.
The New York Times provides an update on the new Omicron variants, including this critical point
Fortunately, Paxlovid works against these new variants. The mutations that make them spread so quickly are changes to the surface of the virus where it locks onto cells and where antibodies attach to it. Paxlovid attacks the virus in a different way. It detects the virus after it’s inside the cell and is replicating, and these new subvariants seem to be just as vulnerable to Paxlovid as the earlier variants.
Federal funding was crucial in enhancing access to coronavirus resources during the initial phases of the pandemic, but questions remain about what will occur when the public health emergency ends and how it will impact consumer healthcare spending, according to a Kaiser Family Foundation brief.
The end of the public health emergency is still undetermined. However, experts have projected that it will end in 2023. The scheduled termination has been pushed back multiple times. Its final termination will signal the end of various flexibilities and protections that have been tied to the declaration.
Additional Covid funding is likely to occur in the Congressional lame-duck session following the November 8 election, in the FEHBlog’s opinion.
Patient volumes continue to remain below pre-pandemic levels for hospitals and health systems this year as COVID-19 likely accelerated a shift to outpatient settings, a new report finds.
Consulting firm Kaufman Hall released its “2022 Healthcare Performance Improvement” report (PDF), which outlines the barriers hospitals and health systems face in a rough year financially. Another key obstacle continues to be workforce shortages, as more and more facilities shift resources to retain staff.
“Healthcare leaders must navigate short-term challenges that continue to pressure revenue and expenses, while also adapting organizational strategy to match larger transformations in the way care is delivered,” said Kaufman Hall Managing Director Lance Robinson in a statement on the report.
and offers a discussion of an expert-touted hybrid approach to compensating primary care providers. In the FEHBlog’s view, adequately paying PCPs is critically important to resolving SDOH and mental health issues adversely impacting our country.
In the regard
A National Institutes of Health study uncovered racial disparities in advanced cardiac care.
When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes.
Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility treatments than among children who were conceived “spontaneously.”
One key finding: while neonatal mortality rates were twice as high among spontaneously conceived children of Black women versus white women, they were four times as high among infants of Black women conceived through technologies like IVF, according to the researchers’ study, which was published in the journal Pediatrics.
The National Committee for Quality Assurance gives us an update on their efforts to stratify HEDIS measures results by racial and ethnic categories.
In other U.S. healthcare business news, Healthcare Dive reports
As the U.S. heads toward a possible recession, Elevance Health CEO Gail Boudreaux said the insurer is preparing for a possible economic decline.
“Certainly we’re mindful of an economic downturn. We’re planning for it in our businesses,” Boudreaux said on a Wednesday call with investors to discuss third-quarter earnings.
Elevance’s profit climbed to $1.6 billion for the third quarter, a 7% increase compared with the prior-year period on a bigger membership base of 47.3 million members.
Despite little growth in the cost of medical services over the last year, inflation has finally caught up with healthcare.
As of September, medical services costs have risen 6.5 percent year over year, according to a Bureau of Labor Statistics report released Oct. 13.
Analysts like Fitch have said the rise in costs will lead to payers raising insurance premiums across the board because of the growing cost pressures on providers, including workforce disruptions.
Studies have already confirmed employers are preparing for higher healthcare expenditures next year because of inflation. Aon analysts said Aug. 18 that U.S. employers’ healthcare costs are expected to rise by an average of 6.5 percent, or $13,800 per employee, in 2023.
“The only 100 percent sure way to keep within budget as the medical industry (especially hospitals) demand more and more is to raise premiums, increase deductibles, higher copays and coinsurance,” James Gelfand, president of the ERISA Industry Committee, told The Washington Post Oct. 14. “Employers hate to do this, but the medical-industrial complex demands an ever-increasing share of workers’ wages.”
The rise in insurance costs could begin to appear when employees sign up for employer-sponsored coverage during their next enrollment period, a trend that could continue through at least 2024, according to the Post.
A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.
Pittsburgh-based Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” which paves the way for the health insurer to be the first to cover the category for a population of millions of members.
The policy indicates Highmark’s intention to pay for claims only for prescription digital therapeutics cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. Highmark is currently negotiating with product developers about how much it will pay for individual treatments and over details such as what constitutes an “episode of care,” said Matt Fickie, a senior director at Highmark, which has 6 million members in Pennsylvania, Delaware, West Virginia, and New York. “That’s the part that is sticky and that requires additional work,” he told STAT.
After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.
The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.
The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena [on an accelerated basis] in 2011, failed to show the expected benefit. For its part, Clovis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.
The sentiment among most panelists was reflected in remarks by Susan Ellenberg, a professor emeritus of biostatistics, medical ethics, and health policy at the Perelman School of Medicine at the University of Pennsylvania, who said “unmet need is not a basis for keeping a drug available when you don’t know if it works.”
The FDA Commissioner, Robert Califf, MD, is the final decision maker.
The NCQA has created
A new website adds two key resources in the fight against antibiotic resistance:
* A How-To Toolkit: Webinars and written summaries outline best practices, emerging trends and lessons from the field about savvy stewardship of antibiotics.
* An “Honor Roll”: Learn which health plans’ management of antibiotics leads the industry.
From the No Surprises Act front, CMS today issued updated guidance on how to initiate an NSA arbitration. The new guidance reflects the revised final independent dispute resolution rule published this past summer.
Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.
Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.
This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.
That’s not the case in the FEHB Program. Moreover,
The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.
That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.
The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.
Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *
So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”
The American Hospital Association informs us
The Centers for Disease Control and Prevention today recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the Food and Drug Administration authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults. The boosters protect against the most recently circulating omicron variants as well as the original virus strain.
MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”
In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is
Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus.
Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.
Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.
It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.
The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.
This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.
Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.
Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.
Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.
From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”
From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.
From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:
Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021
Based on the Centers for Disease Control’s (CDC) Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s 2022 weekly chart of new Covid cases:
The bulge on the left is the first strain of Omicron.
As of September 14, 2022, the current 7-day moving average of daily new cases (59,856) decreased 15.9% compared with the previous 7-day moving average (71,190).
CDC Nowcast projections* for the week ending September 17, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five lineages designated as Omicron: BA.5, BA.4.6, BA.4, BF.7, and BA.2.75. UPDATE: BF.7 has been separated from BA.5 and BA.2.75 sublineage is separated from BA.2 due to their positive growth rate. Until last week, these were aggregated with BA.5 and BA.2, respectively. The predominant Omicron lineage is BA.5, projected at 84.8% (95% PI 83.2-86.3%).
Here is the CDC’s chart of daily trends in new Covid hospitalizations:
The CDC’s weekly interpretative summary adds “The current 7-day daily average for September 7–12, 2022, was 4,371. This is a 6.1% decrease from the prior 7-day average (4,657) from August 31–September 6, 2022.”
Here’s the FEHBlog 2022 weekly chart of new Covid deaths
The CDC’s weekly interpretative summary adds, “The current 7-day moving average of new deaths (358) increased 3.9% compared with the previous 7-day moving average (344).”
The American Hospital Association points out that
In-hospital mortality among patients hospitalized primarily for COVID-19 fell from 15.1% during the delta period to 4.9% this April through June, the Centers for Disease Control and Prevention reported this week.
“In-hospital mortality risk was substantially lower during the later Omicron period overall and for older adults, persons with disabilities, and persons with multiple underlying medical conditions, who accounted for a larger proportion of hospitalizations in this period than they did during previous periods and remained at highest risk for death,” the authors said.
Here’s the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 37th week of 2022. In the 37th week of this year, you will note a noticeable jump in distributions and administrations due to the release of bivalent mRNA booster.
As of September 14, 2022, 612.8 million vaccine doses have been administered in the United States. Overall, about 263.4 million people, or 79.3% of the total U.S. population, have received at least one dose of vaccine. About 224.6 million people, or 67.7% of the total U.S. population, have been fully vaccinated.
Of those fully vaccinated, about 109.2 million people have received a booster dose,* but 50.0% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.
The CDC’s Communities Levels experienced “Compared with last week, * * * a moderate decrease (−3.9 percentage points) in the number of high-level counties, a moderate decrease (-3.8 percentage points) in the number of medium-level counties, and a large increase (+7.4 percentage points) in the number of low-level counties.”
From the unusual viruses front —
The AP reports that the CDC warns providers against giving the only monkeypox treatment Tpoxx “to otherwise healthy adults who are not suffering severe symptoms. ‘For most patients with healthy immune systems, supportive care and pain control may be enough,’ agency officials said in a statement.”
The New York Times offers information on what parents should know about “the Latest Enterovirus Spike; The C.D.C. has issued an alert [to providers] about enterovirus D68, which has been linked to rare, polio-like paralysis.” In addition, the Times article advises soap and water handwashing and respiratory etiquette.
From the U.S. healthcare business front, we have two articles from Healthcare Dive.
“Hospitals are likely to lose “billions of dollars” due to continued depressed margins and heightened labor costs, according to a report Thursday prepared for the American Hospital Association by Kaufman Hall. Even in the report’s optimistic model, more than half of all hospitals could end the year with negative margins, driven by an expected $135 billion increase in expenses this year and an $86 billion rise in labor costs alone.” Here’s a link to the article.
From the medical research front, we have two articles from STAT News:
“CAR-T therapy isn’t exclusive to oncology: A half-dozen people with severe lupus, an autoimmune condition, have gone into remission after receiving an infusion of CAR-T cells, STAT’s Isabella Cueto reports. In lupus, B cells create antibodies against a person’s body, resulting in a vicious cycle of inflammation and immune attacks that lead to pain, fatigue, and organ damage. * * * Although the treatment has only been tested in six patients thus far, experts agree it is tantalizing.”
“There hasn’t been much in the pharmaceutical arsenal to help people who abuse methamphetamines. But STAT’s Lev Facher reports that researchers are now studying a new monoclonal antibody, which binds to meth molecules and helps prevent them from entering the brain. The antibody is showing early promise in the smattering of emergency rooms involved in the study. One Phase 2 study is testing if the monoclonal antibody can treat meth overdose, and another is measuring its efficacy in helping long-term recovery. Ideally, the drug could be used for both purposes. The drug’s development is overseen by the University of Arkansas for Medical Sciences and the biotech InterveXion.”
From the miscellany front
WTW released a study on how large employers are “doubling down on controlling healthcare costs and enhancing affordability.
The National Committee for Quality Assurance released its Measurement Year 2021 health plan ratings.
RevCycle Intelligence offers an interesting angle on a Health Affairs study of the efficacy of State No Surprise Billing laws in controlling out-of-network spending.
The seven-day moving average of new Covid-19 cases recently topped 94,000 a day, Centers for Disease Control and Prevention data show, nearly four times lows reached in late March. The true number of new cases is likely significantly higher, epidemiologists say, because so many people are self-testing at home or not testing at all.
The rise in cases hasn’t translated thus far into major surges in severe illness. The seven-day average of confirmed cases in hospitalized patients reached about 18,550 on Wednesday, up from lows near 10,000 in mid-April, but far below a record peak above 150,000 in January. The numbers include people who test positive on routine screening after getting hospitalized for other reasons. The daily average of reported deaths has slipped under 300 a day, the lowest point since last summer.
But * * * the more an outbreak spreads, the more likely it will reach the most vulnerable including elderly people and others with compromised immune systems, the experts say, and the more likely the virus will continue to mutate.
As Covid-19 again surges across the US, many people are going without time-sensitive therapeutics like Paxlovid because doctors worried about shortages are reluctant to prescribe the drugs. But the situation has changed and supplies are now abundant.
The Food and Drug Administration has issued emergency-use authorizations for the drug to treat mild to moderate Covid-19 in people who are at high risk. The Centers for Disease Control and Prevention defines those as individuals ages 50 years or older, unvaccinated, or with certain medical conditions like kidney, liver, lung and heart disease, diabetes, cancer and HIV. It also recommends the drug for people who are immunocompromised, pregnant, obese, cigarette smokers or suffering from mood disorders.
You can find the one stop test to treat locations “by using the Department of Health and Human Services’ Test to Treat Locator or by calling 1-800-232-0233.”
Kaiser Health News recommends “improving ventilation and filtration of the air. ‘Ventilation matters a lot,’ said Dr. Amy Barczak, an assistant professor of medicine at Harvard Medical School. ‘If you’re taking care of someone at home, it’s really important to maximize all the interventions that work.’”
Viral particles float through the air like invisible secondhand smoke, diffusing as they travel. Outside the home, viruses are quickly dispersed by the wind. Inside, germs can build up, like clouds of thick cigarette smoke, increasing the risk of inhaling the virus.
The best strategy for avoiding the virus is to make your indoor environment as much like the outdoors as possible.
In related viral news, Beckers Hospital Review tells us
More than 400 children worldwide have developed unusual cases of acute hepatitis, and researchers are still searching for the cause of the outbreak, the World Health Organization said May 17.
As of May 15, the WHO reported 429 probable cases in 22 countries, up from 348 cases a week prior, according to Philippa Easterbrook, MD, a senior scientist in the global hepatitis program at the WHO. Another 40 cases are still under investigation, and 75 percent of all affected children are under age 5.
Twelve countries are reporting more than five cases, double the amount from last week. Of these 12 countries, nine are in Europe. In total, six children have died in the outbreak and 26 have required liver transplants, according to Dr. Easterbrook.
As of May 17, researchers were still investigating the cause of the hepatitis outbreak. The leading hypothesis is that an adenovirus and SARS-CoV-2, the virus that causes COVID-19, may be causing hepatitis in children. Scientists are exploring “how these two infections may be working together as co-factors either by enhancing susceptibility or creating an abnormal response,” Dr. Easterbrook said.
From the healthcare policy front, AHIP today launched
Healthier People through Healthier Markets, a new policy roadmap and set of solutions to improve health care affordability and access for every American. The effort is focused on boosting competition in health care markets and reining in harmful practices that hurt American families. With the launch of this policy roadmap, AHIP sent letters to President Biden and the leadership of Congress that lay out a detailed set of legislative and regulatory enforcement actions to increase competition in health care, drive down costs, and improve health care access for patients.
The Office of Personnel Management on Wednesday urged federal agencies to ensure their employees are aware and can access the mental health benefits provided to federal workers, in light of May being Mental Health Awareness Month.
In a memo to agency heads, OPM Director Kiran Ahuja noted that promoting the federal workforce’s wellbeing, including mental health, is a priority in President Biden’s management agenda.
“We want to make sure that all federal employees understand the supports available to them and underscore that there should be no shame or stigma for taking care of their mental health,” Ahuja wrote. “[As] a reminder, employee assistance programs and Federal Employees Health Benefits health plans offer mental health services to employees and their family members. We encourage agencies to proactively communicate to their workforces about their options and encourage employees to contact their agency benefits officers or EAP coordinator to learn more.”
The FEHBlog encourages OPM to better coordinate mental health care services among FEHB plans, EAPs and wellness programs.
mHealth Intelligence informs us “In the second half of 2020, only 14.1 percent of children used telehealth due to the pandemic, but use was higher among those with asthma, a developmental condition, or a disability, the Centers for Disease Control and Prevention (CDC) found.”
From the survey department, Beckers Payer Issues advises that “Castlight Health analyzed more than 160 million commercial medical claims nationwide to reveal insights about healthcare utilization patterns from 2018 to 2021.” Castlights report ranks the fifty States and DC based on average medical spending per member in 2021.
From the miscellany department —
Beckers Payer Issues reports “Anthem shareholders voted at their annual meeting May 18 to change the company’s name to Elevance Health.”
Federal News Network discusses the Postmaster General’s plans to close and consolidate Postal facilities across the delivery network. “The network transformation initiative will impact nearly 500 network mail processing locations, 1,000 transfer hubs and 100,000 carrier routes. It will also impact 10,000 delivery units, which USPS defines as post offices, stations, branches or carrier annexes that handle mail delivery functions.”
FedSmith tells us “Starting May 26, 2022, federal retirees will notice a new process for signing into the OPM Retirement Services Online website. The login process will now be managed through the federal government’s Login.gov website and will require you to create a new username and password at login.gov if you do not currently have one.”
COVID-19 vaccinations prevented an estimated 107,000 Medicare hospitalizations between January and May 2021, resulting in $2.6 billion in savings for Medicare and Medicare Advantage plans, according to a new report by the Department of Health and Human Services. The report estimates the impact of COVID-19 vaccination during a five-month period shortly after the first vaccine was authorized and recommended for health care workers and elderly people in long-term care facilities. Future analyses will examine hospitalizations prevented by vaccination during the delta and omicron waves, HHS said.
“Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said in an interview. “Then your body is supposed to do the job.” But for unknown reasons, the CEO said, some patients aren’t able to clear the virus with the first course of treatment.
In cases where virus levels do rebound, Bourla said, “then you give a second course, like you do with antibiotics, and that’s it.”
As noted in the article, the fly in the ointment is that the FDA emergency use authorization does not expressly approve a second course of the medication.
From the Rx coverage front
MedCity News reports on Bristol Myers Squibb’s (BMS) NEX-T program to improve CAR-T treatments.
The company has described NEX-T as changes to manufacturing driven by the translational insights it has gleaned from treating thousands of patients with its CAR T therapies. In addition to a faster turnaround time, the strategy is intended to reduce the costs of the overall process.
One of the key goals for the next-generation of cell therapies is treating solid tumors.
Another strategy that BMS is pursuing is going after two targets with a single therapy, reducing the risk that a tumor escapes from the treatment
Looking at the flip side of this coin, Forbes reports
Health plans and pharmacy benefit managers (PBMs) that manage drug costs speaking at this year’s Asembia Specialty Pharmacy Summit in Las Vegas say specialty drugs now account for 50% or greater of the total prescription spending they manage. In some cases, employer clients are seeing specialty costs account for 60% or even greater of their total drug spending.
“It really is frightening for our clients,” Lucille Accetta, senior vice president of pharmacy benefit management and specialty product development at CVS Health told hundreds of attendees at the Asembia event, which runs through Thursday and drew more than 5,000 people from the healthcare industry. “We have to be the best purchaser for our clients.” * * *
To reign in the costs of prescription drugs while maintaining access to life-saving treatments, health plans and pharmacies say they are more closely monitoring patients as soon as they are on the drug, said Rina Shah, group vice president of pharmacy operations and services at Walgreens.
The Forbes article adds
Abarca Health [is] an independent PBM that manages more than $5 billion in drug costs annually for more than four million Americans has executives at this week’s Asembia meeting talking up its efforts to better manage specialty pharmacy costs.
The company’s Assura solution launched earlier this year “guarantees the net cost of drugs, including specialty medications, by offering an annual fixed per script cost for a health plan’s entire population,” Abarca said in announcing the new pricing solution earlier this year. The guarantee, Abarca CEO Jason Borschow says, is adjusted each year based on drug benefit coverage changes.
Even as COVID-19’s benefit waned, new plan members across multiple product lines helped drive CVS to $2.3 billion in profit in the first quarter, slightly higher than the $2.2 billion brought in at the same time last year.
In results published Wednesday, the company beat Wall Street expectations on earnings and revenue, with a topline of $76.8 billion, up 11% year over year.
Fierce Healthcare explains how CVS has shifted from a retail to a digital marketing focus.
Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.
The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RN
Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.
The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax. * * *
From the health risks front, MedPage Today explains that
Seven risk factors, some modifiable and some not, accounted for the vast majority of risk for first-time acute myocardial infarction (MI) in young adults, according to a case-control study.
The seven factors — diabetes, depression, hypertension, smoking, family history of premature MI, low household income, and hypercholesterolemia — were responsible for 83.9% of the total acute MI risk in young women and 85.1% of the risk in young men, reported Harlan Krumholz, MD, SM, of Yale New Haven Hospital in New Haven, Connecticut, and colleagues.
Older adults who obtain a flu shot are less likely to suffer a heart attack or stroke and are at lower risk for death from heart-related health events in the year after getting vaccinated, an analysis published Friday found.
Just under 4% of older adults vaccinated against the seasonal virus experienced a “cardiovascular event” within the next year compared to just over 5% of those who did not receive the shot, data published Friday by JAMA Network Open showed.
From the meetings department,
HHS provides a readout of a high-level meeting among Labor Department, health insurance and business executives “to discuss compliance with the Mental Health Parity and Addiction Equity Act, adequacy of in-network providers and mental health and substance use disorder treatment during the pandemic, as the nation observes Mental Health Awareness Month.”
The National Committee for Quality Assurance reviews the presentations at last week’s Quality Talks conference.
From the federal employee benefits front, FedWeek discusses OPM’s planned improvement to processing retirement applications as unveiled in the Fiscal Year 2023 budget document. Processing federal retirement benefits will be a heavy lift for OPM until Congress simplifies the pension calculation.
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