As we close out Black History Month, let’s join the Trust for American Health in celebrating notable African American in public health.
From the Covid front, the Wall Street Journal reports
The U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress.
The shift by the Energy Department, which previously was undecided on how the virus emerged, is noted in an update to a 2021 document by Director of National Intelligence Avril Haines’s office.
The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic’s origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided.
From the miscellany department —
Fortune Well provides us with insights on how to manage a life-threatening diagnosis.
Health Payer Intelligence tells us what payers can expect to find in the proposed CMS electronic prior authorization rule. The public comment deadline on the rule is March 13, 2023
Errata — In Thursday’s post, the FEHBlog’s item on the CDC action concerning Alzheimer’s Drug coverage in Medicare should say that the CDC was NOT changing its position that such coverage is limited to clinical trials.
From the No Surprises Act front, U.S. District Judge Jeremy Kernodle modified the NSA’s independent dispute resolution (IDR) arbitration rule on February 6 so it does not skew in favor of the statutory qualifying payment amount. The FEHBlog personally marked up the relevant portion of the IDR rule to show the edits. The FEHBlog, who represents health plans, does not find the edits earthshaking.
The NSA regulators sensibly told the NSA arbitration community to stop issuing arbitration awards while considering the next steps. This afternoon, the American Hospital Association tells us that an interim step was announced.
Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
“The standards governing a certified IDR entity’s consideration of information when making payment determinations in these disputes are provided in the October 2021 interim final rules, as revised by the [February 2022] opinions and orders of the U.S. District Court for the Eastern District of Texas ” CMS said. [This refers to the FEHBlog’s edited portion of the IDR rule without the Judge’s Feburary 6, 2023 edits.]
The agency said IDRs will hold issuance of payment determinations for items or services furnished on or after Oct. 25, 2022 until the departments of Health and Human Services, Labor,The and the Treasury issue further guidance.
There you go.
From the public health front, the CDC’s Covid Data Tracker new cases, hospitalizations, and deaths continue their downward trend, while the CDC’s weekly interpretative review of its Covid data notes that “As of February 23, 2023, there are 67 (2.1%) counties, districts, or territories with a high COVID-19 Community Level, 655 (20.3%) with a medium Community Level, and 2,498 (77.6%) with a low Community Level [of the disease].
Sign of the times — the CDC Weekly Review is moving to a bi-weekly schedule.
The CDC’s FluView, which will shut down at the traditional end of the flu season, reports, “Seasonal flu activity is low nationally.”
Meanwhile, the Food and Drug Administration announced issuing
an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
People with many low-risk sleep factors had reduced all-cause, CV and cancer mortality risk vs. those with one or no low-risk sleep factors, according to data slated for presentation at the American College of Cardiology Scientific Session.
“We saw a clear dose-response relationship, so the more beneficial factors someone has in terms of having higher quality of sleep, they also have a stepwise lowering of all cause and cardiovascular mortality,” Frank Qian, MD, an internal medicine resident physician at Beth Israel Deaconess Medical Center and a clinical fellow in medicine at Harvard Medical School, said in a press release. “These findings emphasize that just getting enough hours of sleep isn’t sufficient. You really have to have restful sleep and not have much trouble falling and staying asleep.”
One in five Americans will experience major depressive disorder in their lifetime, and many will not find relief from current therapies. But now researchers have identified an unexpected source of the problem: inflammation.
Inflammation in the bodymay be triggering or exacerbating depression in the brains ofsome patients. And clinical trial data suggests that targeting and treating the inflammation may be a way to provide more-precise care.
The findings have the potential to revolutionize medical care for depression, an often intractable illness that doesn’t always respond to conventional drug treatments.While current drug treatments target certain neurotransmitters, the new research suggests that in some patients, depressive behaviors may be fueled by the inflammatory process.
The Powerline Blog shares eye-catching charts on the U.S. population’s gray wave.
From the wearables front —
mHealth Intelligence relates
In 2023, about 40 percent of U.S. adults are using healthcare-related applications, and 35 percent are using wearable healthcare devices, a new survey shows.
Released by Morning Consult, the survey polled 2,201 adults between Jan. 23 and Jan. 25. The results were compared to a previous Morning Consult poll conducted in December 2018 among 2,201 adults.
The 2023 survey shows gains in health app and wearables use. While health app use jumped 6 percentage points from 2018, wearables use increased by 8 percentage points.
Health app and wearables use varied across age groups, according to the survey. Forty-seven percent and 40 percent of respondents aged 18 to 34 used health apps and wearables, respectively, compared to 30 percent and 25 percent of adults over 65.
Of those who said they used health apps and wearables, most use them daily.
Bloomberg adds that “Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch.” Completion of the moonshot project remains “years away.”
Govexec informs us that the President “doubled down Thursday on his administration’s commitment to using the federal government’s power to support underserved communities and advance racial equity. A new executive order issued by the president builds on one he signed his first day in office as well as other executive and legislative actions.”
“The U.S. Office of Personnel Management (OPM), Department of Labor, and Office of Management and Budget (OMB) have developed and launched a new portal on USAJOBS for prospective Federal interns. Located at intern.usajobs.gov, the Federal Internship Portal is a one-stop shop for prospective interns to find opportunities and apply for internships in the Federal government.”
The Senate Commerce, Science and Transportation Committee held a hearing on PBM transparency and accountability, which Fierce Healthcare describes as the hearing as “heated.”
The Senate Health, Education, Labor and Pensions Committee held a hearing on healthcare workforce shortages, which Fierce Healthcare describes as the beginning of “a major effort to shore up the healthcare workforce after lingering shortages have roiled the industry.”
The U.S. Commissioner of Food and Drugs updated the public on his agency’s efforts prevent drug overdoses and reduce deaths.
In related news from MedPage Today, “Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug. * * *While the FDA is not required to follow the recommendations of its advisory committees, it typically does.”
From the medical research front
STAT News tells us, “A team of researchers from Stanford and University of California San Francisco have built a predictive model that uses electronic health records to calculate the risk of sepsis, cerebral palsy, and other serious conditions in newborns. The team trained a deep learning model on health records from more than 30,000 mother-newborn pairs treated in the Stanford health system, building a neural network that could predict 24 different health outcomes. The researchres, who also published an interactive website for readers to explore the network’s data. said the predictions outperformed currently-used risk scores.”
Nature explains “How a pioneering diabetes drug teplizumab offers hope for preventing autoimmune disorders. Approving an antibody therapy that pauses the progression of type 1 diabetes is a first in the field, and some say, a model for other drug developers.
The National Institutes of Health disclosed that “Black and Hispanic Americans appear to experience more symptoms and health problems related to long COVID, a lay term that captures an array of symptoms and health problems, than white people, but are not as likely to be diagnosed with the condition, according to new research funded by the National Institutes of Health. The findings – from two different studies by NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative – add to a growing body of research aimed to better understand the complex symptoms and other issues associated with long COVID that millions have experienced.”
The All of Us program shared its research roundup, focusing on heart disease this month.
The Robert Wood Johnson Foundation offers an award-winning scholar’s “Lessons From the Intersection of Race, Inequality, and Health.”
The Institute for Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
From the U.S. healthcare business front —
Beckers Payer Issues identified over thirty payers who made Forbes rankings of top U.S. employers.
Beckers also reports, “A federal judge granted Cigna a temporary restraining order in its lawsuit alleging former executive Amy Bricker’s departure for rival CVS Health violated a noncompete agreement, Bloomberg Law reported Feb. 15.” A TRO is a short duration order that allows the court time to consider awarding a preliminary injunction.
CommonSpirit Health announced Wednesday that it will acquire regional health system Steward Health Care in Utah for $685 million.
The deal marks CommonSpirit’s entry into Utah, expanding the hospital operator’s footprint to a total of 22 states.
CommonSpirit will acquire five hospitals from Steward, along with more than 40 clinics and other ambulatory services, the system said. The deal is expected to close later this year. CommonSpirit’s Centura Health will manage the Utah sites.
Wednesday is the last day that LHC Group will trade on the Nasdaq, suggesting UnitedHealth will complete its acquisition of the home health business prior to market open on Thursday.
LHC’s stock will be halted aftermarket on Wednesday, according to a Nasdaq notice. As a result, the merger is tentatively scheduled to close the next morning, subject to pending regulatory approvals.
Speculation that the Federal Trade Commission will move to block the $5.4 billion deal has been rampant, but reports late last month suggest that regulators are unlikely to challenge the transaction.
Louisiana-based LHC is a major player in the home health space, with more than 960 locations in 37 states and $2.2 billion in revenue last year
The Baton Rouge Business Report discusses a foundation that would be created in the wake of the Blue Cross and Blue Shield of Louisiana sale would have more than $3 billion in assets. The Accelerate Louisiana Initiative, as the foundation would be called, would be one of the largest private foundations in the nation, says Cindy Wakefield with BCBSLA.
Fierce Healthcare reports, “EHR provider Elation Health announced its acquisition of medical billing company Lightning MD. The growth adds a piece to the Elation puzzle as it seeks to become the sector’s first all-in-one technology solution for primary care practices, the company said.”
From the miscellany department —
Health Payer Intelligence reports, “AHIP Asks CMS to Reconsider Proposed Medicare Advantage Policy Changes. The extensive policy changes included in the proposed rule will negatively impact Medicare Advantage beneficiaries and plans, AHIP said.” It’s easier to write up orders than to implement them.
CMS announced that “a new chart titled Top 10 Section 111 Group Health Plan Reporting Errors, covering the July 1 – December 31, 2022, is now available in the Download section below. Descriptions of these and all reporting errors are available for review in the GHP User Guide.”
WTW explains “What the end of the COVID-19 emergencies will mean for group health plans.”
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.
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 Washington, DC, the Society for Human Resource Management tells us that Labor Secretary Marty Walsh will be leaving his position to become head of the National Hockey League (NHL) Players’ Association, according to news reports.
In other regulatory news, Health Payer Intelligence reports
The Alliance of Community Health Plans (ACHP) was among around 50 organizations—including AHIP and Blue Cross Blue Shield Association—to sign a letter to HHS that supported fully aligning the substance use disorder patient data requirements in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) with the Health Insurance Portability and Accountability Act (HIPAA).
The group noted that the proposed rule falls short of this goal.
Also, the Office of National Coordinator of Health IT announced that “On Monday, February 13, HHS will recognize the first set of applicant organizations that are approved for onboarding as Qualified Health Information Networks (QHINs) under TEFCA.” The ongoing launch of TEFCA, which will serve as a backbone for the country’s electronic health record systems, is exciting.
From the Omicron and siblings front —
The Kaiser Family Foundation’s Covid Vaccine Monitor informs us “nearly four in ten households (38%) were affected by this winter’s” tripledemic. The flu affected the largest share of households (27%), followed by Covid (15%) and RSV (10%). “At the same time, almost three years into the COVID-19 pandemic, most of the public says they are “not too” or “not at all” worried about getting seriously ill from the virus (69%), though 31% still say they are worried.”
The Food and Drug Administration offers step-by-step guidance on reporting Covid test results to public health authorities.
Health Affairs discusses an interesting study finding: “A high prevalence of mental health diagnoses in adults alongside ongoing shortages of mental health specialists and expansion of the patient-centered medical home has increased the involvement of primary care clinicians in treating mental health concerns.”
McKinsey and Company offer the following interview: “McKinsey Global Publishing’s Eleni Kostopoulos chats with Alex Jadad and Tamen Jadad-Garcia about their new book, Healthy No Matter What: How Humans Are Hardwired to Adapt (Penguin Random House, January 2023). Dr. Jadad created the widely popular Jadad scale for assessing clinical trials. Now, he’s combining his medical expertise with his daughter’s health entrepreneurship to explore what it truly means to be ‘healthy’.”
From the No Surprises Act front, Becker’s Payer Issues reports on a February 6, 2023, opinion from the Eastern District of Texas striking down certain provisions of the latest independent dispute resolution rule. Judge Kernodle considers those stricken provisions to conflict with the statute by placing too much emphasis on one of six factors that the law allows the arbitrator to consider: the health plan’s qualified payment amount. The FEHBlog doubts that this decision will immediately impact the IDR process, which continues to be quite bogged down. Providers should emphasize resolving billing disputes during the initial open negotiation period. Regardless, the plaintiff Texas Medical Association has two more NSA issues pending before the good Judge.
From the fraud, waste, and abuse front, the Justice Department announced that False Claims Act settlements and judgments exceeded $2 billion in fiscal year 2022. “[H]ealth care fraud remained a leading source of False Claims Act settlements and judgments.”
From the U.S. healthcare business front
Fierce Healthcare tells us that Health insurer Centene announced its fourth-quarter 2022 financial results today.
Medcity Today relates, “The U.S. healthcare system spent $60 billion on administrative tasks last year, which is about $18 billion more than it spent in 2021, according to a new report from the Council for Affordable Quality Healthcare (CAQH).” The report attributed the increase to a labor shortage and greater utilization of healthcare services in 2022.
The Drug Channels blog assesses biosimilar challenges to Humira.
The biggest surprise is that OPM begun refreshing its website and has revealed its logo.
From the public health front —
The Hill reports that the President plans to end the national and public health emergencies for the Covid pandemic on May 11, 2023. Congress took steps to arrange for a soft landing in the Consolidated Appropriations Act 2023, which likely is a factor in reaching this executive decision.
Health IT Analytics tells us, “Researchers from New York University (NYU) Grossman School of Medicine and the Robert Wood Johnson Foundation (RWJF) unveiled the Congressional District Health Dashboard (CDHD), an online data tool that provides health data for all 435 US congressional districts and the District of Columbia.” Interesting.
The New York Times informs us, “A new report [on maternal health in the U.S.] highlighted the dangers faced by Native American women, who face the greatest risks during and after pregnancy. Native American women were 3.5 times as likely to die during this critical period, compared with white women, the study found.” This rang a bell with the FEHBlog because the FEHB Program included Native American employers who have contracted with OPM for FEHB coverage for their employees. “During and after pregnancy, Black women also faced heightened odds of death that were almost double those of white women, along with a risk of dying specifically from pregnancy complications that was 2.8 times that of white women.” No child should be deprived of a mother due to inadequate healthcare.
Yale New Haven Hospital offers insights on heart disease for lay people/patients.
Medpage Today discusses recently extended and updated Body Mass Indices (BMIs0 for children and adolescents.
LifeSciences Intelligence reports that “In a recent news release, the Emergency Care Research Institute (ECRI) highlighted gaps in communication regarding medical device recalls, noting that these gaps could be a significant threat to patient safety. This commentary was a part of the organization’s Top 10 Health Technology Hazards report.”
From the Affordable Care Act front, the ACA regulators today promulgated a proposed rule that would create
a new independent pathway through which individuals enrolled in plans or coverage sponsored or arranged by objecting entities that have not opted for the existing accommodation (including those enrolled in individual health insurance coverage issued by such an objecting entity) could access contraceptive services at no cost. Specifically, these proposed rules would create a mechanism, independent from the employer, group health plan, plan sponsor, institution of higher education, or issuer, through which individuals could obtain contraceptive services at no cost from a willing provider of contraceptive services. This individual contraceptive arrangement would be available to the participant, beneficiary, or enrollee without the objecting entity having to take any action facilitating the coverage to which it objects. Simply put, the action is undertaken by the individual, on behalf of the individual. * * *
These proposed rules, if finalized, would rescind the moral exemption to covering contraceptive services without cost sharing, while keeping intact the religious exemption and without narrowing its scope or the types of entities or individuals that may claim the religious exemption. These proposed rules would also maintain the optional accommodation for sponsors of group health plans and institutions of higher education arranging student health insurance coverage that qualify for the religious exemption.
Here’s a link to the regulator’s fact sheet. This strikes the FEHBlog has a wise solution to this knotty problem.
Last year was the worst financial year for U.S. hospitals and health systems since the start of the COVID-19 pandemic, as growth in expenses outpaced growth in revenues and volumes, according to the latest report on hospital finances from Kaufman Hall.
“The increases were driven in part by a competitive labor market, as well as hospitals needing to rely on more expensive contract labor to meet staffing demands,” the report notes. “Increased lengths of stay due to a decline in discharges also negatively affected hospital margins.”
Hospitals experienced negative operating margins for most of the year, with approximately half of the nation’s hospitals ending the year in the red. According to the report, hospitals’ expense pressures “are unlikely to recede in 2023.”
STAT News discusses business focused on improving human longevity.
The US Department of Health and Human Services (HHS) has released a final rule that aims to introduce more oversight into the Medicare Advantage risk adjustment data validation and payment process. * * * Under the finalized rule, CMS will not extrapolate audit findings for payment years 2011 through 2017, the CMS fact sheet stated. CMS will collect non-extrapolated overpayments for plan years 2011 through 2017. Extrapolation will begin with the plan year 2018 risk adjustment data validation audit using any extrapolation technique that is statistically valid. The audits will center on high-risk plans.
The Wall Street Journal adds “A Centers for Medicare and Medicaid Services official, Deputy Administrator and Center for Program Integrity Director Dara Corrigan, said the estimated recoveries for 2018 would be around $479 million, and the agency projected a total of about $4.7 billion over a decade. The large recoveries wouldn’t actually occur until 2025 and after, however.”
Will this regulation drive companies out of Medicare Advantage? Time will tell. In the meantime here is a link to HHS’s fact sheet.
Two top senators have reintroduced legislation that would introduce several reforms to pharmacy benefit managers, including prohibiting clawbacks of pharmacy payments.
Sens. Maria Cantwell, D-Washington, and Chuck Grassley, R-Iowa, reintroduced on late Thursday the Pharmacy Benefit Manager Transparency Act and the Prescription Pricing for the People Act. The move shows the lawmakers are not backing down from going after PBMs in the latest Congress.
Congress is a piker compared to OPM, which has been successfully “going after PBM’s” for over a decade.
All of the Omicron metrics are trending down. “As of January 25, 2023, there are 118 (3.7%) counties, districts, or territories with a high COVID-19 Community Level, 855 (26.6%) with a medium Community Level, and 2,242 (69.6%) with a low Community Level.”
Overall, about 268.9 million people or 81% of the total U.S. population, have had a single dose of Covid vaccine, “About 229.6 million people, or 69.2% of the total U.S. population, have completed a primary series.* More than 41.6 million people, or 19.9% of the eligible U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
The CDC’s Weekly FluView again headlines, “Seasonal influenza activity continues to decline across the country.”
Turning to our longest-standing public health emergency, the U.S. Drug Enforcement Administration informs us
Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.
While scientists have not conducted much research on its effects, anecdotal reports suggest that users experience symptoms similar to those encountered via opioids, namely depression of the central nervous system. More specifically, effects associated with xylazine use include dry mouth, drowsiness, hypertension, respiratory depression, and even coma. Users can develop a physical dependence to xylazine, reporting withdrawal symptoms more serious than from heroin or methadone, such as sharp chest pains and seizures.
Note: Since xylazine is not an opioid, naloxone does not reverse its effects.
The Food and Drug Administration proposed changing from “time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
Bloomberg relates, “Americans aren’t exercising enough. Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday.”
From the Rx coverage front, STAT News reports, “After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.” Time will tell.
From the electronic health records front —
MedCity News identifies five ways to inject intelligence into the prior authorization process.
“’The good news is that many of the access and usability problems stem from the technical specifications provided by the Centers for Medicare & Medicaid Services [CMS],’ the report said. ‘Most can be fixed through administrative action and better enforcement, with minimum cost burdens for the plans and issuers.’”
From the U.S. healthcare business front —
MedCity News informs us that health insurers continue to receive a C grade from Leapfrog.
Fierce Healthcare tells us, “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening. The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”
Healthcare Dive reports, “In a lawsuit filed Thursday, Cigna alleged that Amy Bricker’s appointment to chief product officer of CVS’s consumer segment places the payer’s trade secrets at risk and violates her noncompete agreement.”
The Wall Street Journal reports that CVS and Walmart pharmacies will follow Walgreen’s lead by reducing their retail pharmacy hours. “CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists.” Walmart will be closing its pharmacy at 7 pm rather than 9 pm.
House Republicans are mulling an attempt to buy time for further negotiations on federal spending and deficits by passing one or more short-term suspensions of the statutory debt ceiling this summer, including potentially lining up the deadline with the end of the fiscal year Sept. 30.
No decisions on a cutoff date have been made, and it’s not yet clear when the Treasury Department will run out of cash to meet all U.S. financial obligations. But most analysts agree Congress will need to act at some point between early June and September, and lawmakers likely won’t want to leave the matter unaddressed before the August recess.
The Senate is taking its time getting to work for 2023.
Back in Washington after a two-and-a-half week recess, the chamber adjourned Thursday afternoon without adopting an organizing resolution, meaning committees will remain in their holdover state until at least next week.
Senate Majority Leader Charles E. Schumer announced the Democratic committee assignments for the new Congress, with Michigan Democratic Sen. Gary Peters, the Democratic Senatorial Campaign Committee chair, earning a coveted seat on the Appropriations Committee.
From the Omicron and sibligns front, The American Hospital Association tells us
A Food and Drug Administration Vaccines and Related Biological Products Advisory Committee [VRBAC] unanimously voted today to recommend harmonizing the composition of all primary series and booster doses administered in the U.S. For example, the composition of all vaccines administered going forward might be bivalent.
STAT News offers a complete report on today’s meeting. For example, STAT News explains
The FDA is also asking the members of VRBPAC their thoughts on its proposal that Americans get an annual Covid shot, in the way they get a flu shot, one that is reconstituted regularly to try to target the strains in circulation at the time. In documents the FDA made public before the meeting, it proposed choosing new vaccine strains in June for a vaccine campaign that would begin in September.
Covid is clearly here to stay, so this may sound sensible. But there are concerns some of this is still based on a leap of faith rather than a data-led process. For example, the idea that everyone might need an annual Covid booster will not earn a unanimous “yea” vote out of this expert panel.
The VRBAC recommendation is subject to FDA and CDC approval.
The FDA on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to be rendered ineffective by the mutations the virus has picked up. Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems.
In other FDA news
The FDA announced, “Given the growing cannabidiol (CBD) products market, the FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
Fierce BioTech informs us “More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.”
From the obesity treatment front —
HealthDay discusses findings made by “Utah researchers who followed patients for up to 40 years after they had one of four types of weight-loss (bariatric) surgery.”
Weight-loss surgery can literally be a lifesaver, cutting death rates significantly during the course of a decades-long study
Death from all causes was 16% lower, while it was 29% lower for heart disease, 43% lower for cancer and 72% lower for diabetes
But there were some troubling findings: These patients were 83% more likely to die of liver disease and 2.4 times more likely to die by suicide, mostly seen in younger patients
STAT News provides a two minute long video explaining how the new obesity drugs work.
STAT News also describes an unusual alliance that has banded together to lobby Congress to repeal a provision in the Medicare Modernization Act of 2023 that prohibits Part D from covering obesity drugs. “Recent scientific advances, media coverage, and advocacy have helped raise the profile of the issue on Capitol Hill, said Jeanne Blankenship, the vice president for policy initiatives and advocacy at the Academy of Nutrition and Dietetics. ‘It’s becoming front and center. I think we can’t turn our backs on it any longer,’ Blankenship said.”
From the Rx coverage front, Beckers Hospital Review introduces us to the three PBMs that have partnered with the Mark Cuban Pharmacy.
From the HIPAA / electronic health records front —
MedPage Today reports, “Unique Patient Identifier Funding Once Again Barred by Congress— Biden administration working on better patient matching instead.” The FEHBlog will never understand Congress’s intransigence here.
Healthcare Dive tell us “Interoperability continues to improve among U.S. hospitals, but there’s still a ways to go, according to new government data. More than six in 10 hospitals electronically shared health information and integrated it into their electronic health records in 2021, up 51% since 2017, the Office of the National Coordinator released in a Thursday data brief. The availability and usage of electronic data received from outside sources at the point of care has also increased over the last four years, reaching 62% and 71% respectively in 2021.”
Mercer Consulting “projects the 2024 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will rise significantly from 2023 levels.”
Benefits Consultant Tammy Flanagan, writing in Govexec, discusses the categories of family members who are eligible and ineligible for FEHB coverage.
HR Dive identifies five trends that will share HR this year.
From Capitol Hill, the Wall Street Journal reports
House Republicans passed a rules package Monday dictating the terms of the next session of Congress, the first test for House Speaker Kevin McCarthy (R., Calif.) in keeping his raucous conference united.
The rules package, a required step before moving on to legislation, is typically passed on the first day of a new Congress. But it was delayed by the GOP fight to elect a new speaker. Mr. McCarthy prevailed early Saturday morning on the 15th ballot over four days, after making a series of concessions to holdouts.
The package passed 220 to 213, with all Democrats and one Republican, Rep. Tony Gonzales of Texas, opposing the measure. It is customary for the minority party to oppose the legislation.
The package, which includes standard rules on decorum, also restores what is known as the motion to vacate the chair, a procedure that would allow one Republican member to ask for a vote to remove the speaker. It also outlines several Republican priorities around spending, such as banning consideration of any bill that has the net effect of increasing mandatory spending.
House Republican leaders chose Rep. Jason Smith (R., Mo.) to run the House Ways and Means Committee, giving him a prime perch to shape the party’s approach to tax, trade and health policy.
As chairman, Mr. Smith will lead a committee with broad power over economic policy and healthcare that is poised to receive an influx of new Republican members.
From the other side of Capitol Hill, Healthcare Dive informs us
Longtime Congressman Sen. Bernie Sanders, I-Vt., is expected next month to take the helm of the Senate’s Health, Education, Labor and Pensions Committee, bringing the Medicare-for-All proponent center stage in one of the nation’s most broadly influential health policy forums.
The anticipated appointment comes after the current committee chair Sen. Patty Murray, D-Wash., announced that she was stepping down to head the Senate Committee on Appropriations. Sanders has been on the Senate’s Health, Education, Labor and Pensions Committee, or HELP, since 2007, but the chance to lead the committee will give Sanders sway on some of his most prominent healthcare policy positions.
High healthcare costs — including prescription drugs like insulin —nursing education and elder care are issues Sanders anticipates focusing on, calling the national healthcare system dysfunctional, unsustainable and disgraceful in a Jan. 1 video.
From the FEHB front —
OMB’s Office of Information and Regulatory Affairs (OIRA) posted the federal government’s fall 2022 regulatory agenda on January 4. Here are the three FEHB rulemakings:
OPM proposes to modify its FEHB enrollment regulations regarding the effective date of coverage. The regulatory changes would allow, at an employing agency’s discretion, FEHB Coverage to become effective upon a new employee’s start date if their election is received before that date. The regulatory changes would promote the recruitment of new Federal employees and align with the best practices of the private sector. Publication of the proposed rule is scheduled for March 2023.
OPM and the three other No Surprises Act regulators plan to release a proposed rule on the law’s complicated good faith estimate and advance explanation of benefits provisions in August 2023.
As previously noted in the FEHBlog, OPM has passed along its interim final rule to implement the Postal Service Health Benefits Program to OIRA for final regulatory review. The statutory deadline for promulgating the rule is April 6, 2023. OPM clearly will meet that deadline.
Here is the complete list of OPM rule-makings in process or recently completed.
The Government Accountability Office released a report titled “Federal Employees Health Benefits Program: Additional Monitoring Mechanisms and Fraud Risk Assessment Needed to Better Ensure Member Eligibility.” The report summary tells us
More than 8 million federal employees and their families receive health insurance benefits under the Federal Employees Health Benefits program.
In 2021, the Office of Personnel Management began requiring some new program enrollees to verify that their family members are eligible. But OPM doesn’t have a process to identify and remove ineligible family members who are already enrolled in the program. As a result, the program may be spending almost $1 billion per year on payments for ineligible members.
We recommended that OPM take steps to remove ineligible family members and assess fraud risks associated with ineligible program members.
In the middle of the last decade, OPM added an FEHB contract provision requiring carriers to share OPM’s expenses to arrange for a family member eligibility audit, which is a common practice among employers. This struck the FEHBlog as a proven approach to identifying ineligible family members. Why not give it a go?
The Centers for Medicare and Medicaid Services released updated guidance for its Section 111 reporting program, which applies to FEHB carriers and other employer-sponsored health plans.
In contrast to previous recommendations, pediatricians and other pediatric healthcare providers are advised to provide “immediate, intensive obesity treatment to each patient” as soon as they receive a diagnosis, according to new guidance from the American Academy of Pediatrics (AAP).
The guidance, published in Pediatrics, marks the AAP’s first clinical practice guideline outlining evidence-based evaluation and treatment for children and adolescents with overweight (defined as a body mass index [BMI] at or above the 85th percentile and below the 95th percentile) or obesity (defined as a BMI at or above the 95th percentile), though the organization previously published recommendations on prevention and treatment in 2007.
“This is one of the most important messages that differentiates our current clinical practice guidelines from the prior recommendations, and that is to say 15 years of data have taught us that ‘watchful waiting’ only leads to greater increase in child BMI, accumulation of comorbidities, and more challenges in trying to reverse some of this,” author Sarah Armstrong, MD, co-director of the Duke Center for Childhood Obesity Research in Durham, North Carolina, told MedPage Today.
In a number of key action statements, the guideline authors state that pediatricians and other providers should refer children ages 6 years and older — and potentially those ages 2 to 5 years — with overweight or obesity to intensive health behavior and lifestyle treatment.
Additionally, healthcare providers should offer weight-loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment to adolescents ages 12 and older, Armstrong and colleagues noted. They should also offer referrals for evaluation for metabolic and bariatric surgery to adolescents ages 13 and older with severe obesity (BMI ≥35 or 120% of the 95th percentile for age and sex, whichever is lower).
This flu season hit earlier and harder than those of the past couple of years, doctors say. The reason is likely because of the cyclical nature of the flu and the lifting of Covid precautions such as working from home, wearing masks and having smaller social gatherings, says Robert Frenck, a pediatrician in the division of infectious diseases at Cincinnati Children’s hospital in Ohio.
We asked doctors what to expect this year if the influenza virus causes illness in your household.
A recently implemented federal [information blocking] rule requires HHS to ensure that patients receive test results as soon as they become available, but doctors argue that they often need to add context and support to results before patients view them — even as technology has made the results easier to share.
The disagreement, with doctors on one side and HHS and patient advocates on the other, has raised a key question: How should patients get bad news, especially in the rapidly evolving world of telehealth?
Before this rule was in effect, a member of the FEHBlog’s family received an email on a Sunday morning suggesting that she log into the patient portal. She promptly did so and was faced with confusing test results. See Seinfeld. Can’t doctors give patients a choice at the time of portal registration to get the log on email or wait to hear the results from a medical professional in non-emergency circumstances?
Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts.
The timing was not offered, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 shot. The Moderna pricing was first reported by The Wall Street Journal and confirmed by a company spokesperson.
The 41st JP Morgan healthcare conference is being held this week in San Francisco. “Fierce Healthcare will be covering the day’s biggest news as it happens. Check back here for updates, and catch Fierce Biotech’s reporting here and Fierce Pharma’s reporting here.”
From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.
From the medical research and development front,
STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”
The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.
The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *
[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.
A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.
New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.
Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.
“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”
. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.
“Causality is a bit up in the air,” he said.
From the mental healthcare front, Fierce Healthcare tells us
While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.
The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.
In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.
At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.
The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.
However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.
There are now 305 mental health providers per 100,000, according to the report.
Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.
Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.
During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.
The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.
Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.
Of course, PBM formularies are designed to correct these issues.
Emergent BioSolutions Inc., maker ofNarcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.
The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market.
The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.
Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.
From the fraud, waste, and abuse front, mHealth Intelligence reports
As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.
They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.
In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.
Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.
But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.
From the plan design front, Fierce Healthcare relates
The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026.
The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.
“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement.
It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans.