The Wall Street Journal reports, “Weight-loss drugmakers are lobbying Congress to grant them access to a monster payday for their blockbuster treatments: Medicare coverage.” At last Thursday’s carrier conference, OPM pointed out a related advantage of the Medicare Part D EGWPs that the FEHBP will offer next year. Although the weight loss drugs may not be on the Medicare formulary, those drugs would be made available to FEHB annuitants via the Plan’s formulary, which can gap-fill the Medicare formulary.
CMS announced that the updated MMSE Section 111 GHP User Guide version 6.8 has been posted to the GHP User Guide page on CMS.gov. Refer to Chapter 1 for a summary of updates.”
Per Health Payer Intelligence, AHIP launched a marketing campaign targeting Pharma’s prescription drug pricing. “The payer organization stated that prescription drug pricing is out of control and explained health insurance’s role in reducing the impact.”
The Department of Health and Human Services proposed a rule to extend ACA marketplace, Basic Health Program, Medicaid, and CHIP coverages to 580,000 DACA recipients.
From the healthcare spending and plan design fronts
“About a year ago, Elevance Health launched a pilot program to offer digital concierge care to members who were recovering from COVID-19 infections.
“Since then, the insurer has expanded that initiative to offer concierge care management to members with a number of chronic conditions, including Crohn’s disease, cancer and diabetes. Anthony Nguyen, M.D., the chief clinical officer at Elevance, told Fierce Healthcare that the program was born from a desire to be “more engaging with our members.”
“The challenge for not only the programs that we have, the traditional ones, as well as others in the market, is that it’s not personalized,” Nguyen said. “It is not tailored to an ‘n’ of one.”
“Greater personalization was built into the foundation of the program, he said. For example, concierge care deploys a nurse matching tool that connects members with a clinician who is likely to connect and resonate well with them, improving the care journey.”
“Healthcare spending declined dramatically in 2020 thanks to the COVID-19 pandemic, but expenditures rebounded the following year, according to new data from the Health Care Cost Institute.
“The group released its annual look at cost and utilization trends last week, which found the average health spending for people with employer-sponsored coverage reached $6,457, up 15% from the 2020 average of $5,630. Spending declined by 4% in 2020 as utilization decreased, the researchers said.
“John Hargraves, director of data strategy at HCCI, told Fierce Healthcare that the 2020 data are an aberration in the long-term spending trends, which had grown steadily prior to the pandemic.
“It’s almost like 2020 is a missing data point in the long-term growth in the healthcare spending and use patterns that we’ve noted,” Hargraves said.”
From the telehealth and fraud waste and abuse fronts, the HHS Inspector General made available a “toolkit intended to assist public and private sector partners—such as Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units, and other Federal health care agencies—in analyzing their own telehealth claims data to assess program integrity risks in their programs.”
Hospital and health system merger and acquisition activity remained consistent in the first quarter of 2023 with 15 healthcare industry transactions, a slight drop from 17 in the fourth quarter of 2022, according to a new report from hospital consultancy Kaufman Hall. The 15 transactions comprised $12.4 billion in total transacted revenue, down from the high of $12.7 billion in 2018.
Mergers and acquisitions are trending toward cross-regional partnerships, and the size of the smaller party in mergers is increasing to between $250 million and $750 million in annual revenue, according to the report.
Realignment of for-profit health system portfolios continued in the first quarter of 2023, particularly for high financial and operational performing health systems.
AHIP issued a report finding that hospital markups on specialty drugs cost patients thousands of dollars.
Beckers Hospital CFO Reports identifies 22 US hospitals that are cutting care.
UnitedHealthcare’s plans to implement a gold-card program in 2024 might cut another 10 percent of its prior authorization volumes on top of a 20 percent reduction that will roll out this summer, UnitedHealthcare CEO Brian Thompson said during UnitedHealth Group’s April 14 earnings call, which was transcribed by Seeking Alpha.
The payer plans to implement the national gold-card program in early 2024 for care provider groups that meet eligibility requirements, according to a March 29 company news release. The gold-card status applies for most UnitedHealthcare members across commercial, Medicare Advantage and Medicaid.
Qualifying care provider groups “will follow a simple notification process for most procedure codes rather than the prior authorization process,” according to the release.
From the public health front, Medpage Today reports
Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.
During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.
Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Report.
From the Rx coverage front, the Institute for Clincical and Economic Research released a Final Evidence Report on Lecanemab for Alzheimer’s Disease.
— Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —
— Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
— Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes
Lecanemab is an FDA approved drug that the CDC is considering for Medicare coverage beyond clinical testing. The VA has agreed to cover FDA marketing label uses for the drug in its patient population which overlaps with FEHBP.
From the medical research front, a National Institutes of Health study outlines “opportunities to achieve President Biden’s Cancer Moonshot goal of reducing cancer death rates in the United States. Accelerated progress is needed to achieve Cancer Moonshot goal of cutting the age-adjusted cancer death rate by at least 50% over 25 years, NIH study says.”
The study was conducted by researchers in NCI’s Division of Cancer Epidemiology and Genetics, the Center for Cancer Research, and their collaborators, using data from NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention’s National Center for Health Statistics. The researchers examined trends in age-standardized cancer incidence, survival, and mortality rates from 2000 to 2019 for all cancers combined, as well as for the six cancers that together account for 57% of cancer deaths: lung, colorectal, pancreatic, breast, prostate, and liver. They then projected the overall cancer death rate in 2047 based on the assumption that current trends would continue.
According to their analysis, because of decreasing cancer incidence and improvements in survival, age-adjusted death rates from all cancers combined declined by 1.4% per year from 2000 to 2015 and by 2.3% per year from 2016 to 2019. These declines reflect substantial reductions in deaths from lung cancer (-4.7% per year during 2014–2019), as well as colorectal cancer (-2.0% per year during 2010–2019) and breast cancer (-1.2% per year during 2013–2019).
Trends in prostate, pancreatic, and liver cancer death rates have been less promising. Death rates from prostate cancer had declined strongly (-3.4% per year during 2000–2013), but the decline has slowed (to -0.6% per year during 2013–2019). Death rates from pancreatic cancer have been increasing (0.2% per year during 2006–2019). Death rates from liver cancer, which had been increasing for decades, recently began to decline (-0.5% per year during 2016–2019). Death rates from all other cancer types combined have declined (-1.7% per year during 2016–2019).
Today is National Employee Benefits Day, a celebration created by the International Foundation of Employee Benefit Plans.
From inside the Capital Beltway —
OPM issued a press release on its interim final rule concerning Postal Service Health Benefits Program implementation. That IFR was published in the Federal Register today.
Federal News Network reports that members of Congress are pressuring OPM to fix the consistent delays in processing federal employee retirement applications. The straightest path to solving the delay problem is reconfiguring or replacing the current Federal Employee Retirement System that replaced an even more complex Civil Service Retirement System prospectively in the mid-1980s. That is Congress’s responsibility.
Govexec tells us that “The Internal Revenue Service will bring on about 30,000 employees over the next two years as it begins spending the $80 billion in new funds Congress provided last year, the Biden administration said in an operational plan it unveiled on Thursday.”
On Thursday, President Biden signed an executive order to improve the effectiveness of the regulatory review process and regulatory analysis, which implements his Day One memo.
“Parts of the federal regulatory review process haven’t been updated since the 1990s, and since then, we’ve seen substantial advances in scientific and economic knowledge,” wrote Richard Revesz, administrator of the Office of Information and Regulatory Affairs, in a blog post. “These new steps will produce a more efficient, effective regulatory review process that will help improve people’s lives—from protecting children from harmful toxins and lowering everyday costs for families to improving rail safety and growing our economy from the middle out and bottom up.”
Health and Human Services’ highly publicized list of the first Medicare Part B prescription drugs hit with rebates under the Inflation Reduction Act discreetly dropped from 27 to 20, prompting critiques from the pharma lobby over the Biden administration’s swift implementation of the legislation’s drug controls.
As spotted by Endpoints, the press release and accompanying guidelines released by HHS were updated on March 30 with the removal of several previously listed drugs: Gilead’s Yescarta and Tecartus, Bausch + Lomb’s Xipere, Acrotech Biopharma’s Folotyn, Shionogi’s Fetroja, Kamada’s WinRho and Stemline Therapeutics’ Elzonris.
Abbott has initiated a recall for [4.2 million] reader [devices] for its FreeStyle Libre glucose monitoring systems, which are at risk of catching fire if improperly stored or charged, according to the Food and Drug Administration.
The agency categorized the recall as Class I, the most serious category of problems with medical devices, which can cause serious injury or death. Abbott noted that users do not need to send the devices back to the company but can continue to use them as long as they use chargers and cables supplied by Abbott with the device. * * *
The company has set up a special website with more information for people who use the FreeStyle glucose readers.
Abbott said that users can replace the reader with a smartphone app.
The FDA withdrew its approval of Makena, the only preterm birth drug greenlit by the agency, on April 6 after research showed the treatment did not work better than a placebo.
The repealed approval follows an FDA advisory panel voting in favor of removing Makena and the drugmaker announcing it would halt sales.
Mark Cuban Cost Plus Drug Co. now sells more brand-name drugs.
After breaking into the brand-name market in March — over a year since launching its online wholesaler company — Cost Plus Drugs offers three brand-name products made by Janssen, a Johnson & Johnson business. Cost Plus Drugs sells about 1,000 generics and four brand-name drugs.
The three products are Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl), according to a Cost Plus Drugs tweet.
One of them, Invokana, is a Type 2 diabetes drug that typically costs more than $675, according to Cost Plus Drugs’ website. Mr. Cuban’s company’s price is $243.90.
In the first year of the COVID-19 pandemic, 2 US studies suggested that people hospitalized for COVID-19 had nearly 5 times the risk of 30-day mortality compared with those hospitalized for seasonal influenza.1,2 Since then, much has changed, including SARS-CoV-2 itself, clinical care, and population-level immunity; mortality from influenza may have also changed. This study assessed whether COVID-19 remains associated with higher risk of death compared with seasonal influenza in fall-winter 2022-2023.
[Based on an examination of Veterans Administration electronic health records] there were 8996 hospitalizations (538 deaths [5.98%] within 30 days) for COVID-19 and 2403 hospitalizations (76 deaths [3.16%]) for seasonal influenza (Table). After propensity score weighting, the 2 groups were well balanced (mean age, 73 years; 95% male).
The death rate at 30 days was 5.97% for COVID-19 and 3.75% for influenza, with an excess death rate of 2.23% (95% CI, 1.32%-3.13%) (Figure). Compared with hospitalization for influenza, hospitalization for COVID-19 was associated with a higher risk of death (hazard ratio, 1.61 [95% CI, 1.29-2.02]).
The risk of death decreased with the number of COVID-19 vaccinations (P = .009 for interaction between unvaccinated and vaccinated; P < .001 for interaction between unvaccinated and boosted). No statistically significant interactions were observed across other subgroups
The U.S. Preventive Services Task Force released its final research plan for “Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults: Preventive Medication.”
Community-Dwelling means “Community and primary care–relevant settings, including assisted and independent living facilities,” but not inpatient, SNF, or rehabilitation settings.
The average out-of-pocket spending per non-birth-related pediatric hospitalization was $1,313 for privately insured children, but spending varied depending on the time of the year, chronic condition prevalence, and plan generosity, a study published in JAMA Pediatrics found.
Non-birth-related pediatric hospitalizations occur 2.5 million times per year and can lead to high medical costs for privately insured families.
Researchers used claims data from 2017 to 2019 from the IBM MarketScan Commercial Database to assess out-of-pocket spending for these hospitalizations and which factors influence this spending.
findings showing more U.S. employers are looking to steer employees to affordable, quality care options as a way to combat rising medical costs and improve health outcomes.
Aon’s 2022 Health Care Survey outlines employer priorities in health and benefits strategies and shows how they are responding to looming health care inflation, which Aon forecasts to rise 6.5% this year to more than $13,800 per employee on average.
Data show employers are eager to steer participants toward high-quality, cost-effective hospitals and physicians using a combination of narrow network strategies, plan design, provider guidance services and financial incentives. Thirty-seven percent of employers said they were interested in using plan design to steer members to optimal providers, while 35% already have these plan design features in place.
Fierce Healthcare interviews a WTW expert about ways employers can control rising healthcare costs.
Last June, the major tracker of inflation—the Consumer Price Index—hit 9.1% but has been receding ever since. Employers should be aware that the healthcare industry will not see a similar reduction in prices and, in fact, should expect costs to rise substantially, according to an expert at Willis Towers Watson.
Tim Stawicki, a WTW senior health and benefits consultant, said in a recent blog post that a different dynamic will function in the healthcare industry because contracts lock in negotiated prices, usually for one to three years.
When those contracts end, providers will want to make up for profits they may feel that they missed out on, and that’s especially the case in the wake of the COVID-19 pandemic. * * *
Stawicki advised employers that they can avoid the worst of this fallout through better management of utilization and reviewing physician networks to make sure that they coincide with an employer’s coverage area that may have changed because of COVID-19. In addition, employers should try to improve the employee experience and implement more cost-effective points of care by steering individuals to urgent care centers or making it easier to use virtual care and choose provider networks based on their geographic footprint.
Govexec and the Federal Times report about yesterday’s release of OPM’s Postal Service Health Benefits Program interim final rule.
Fedweek offers interesting observations on the federal workforce demographics:
“For years, [federal agencies] focused on the “retirement wave”—or still more sweeping, the “retirement tsunami”—when the Baby Boom population hit retirement eligibility. That view continues today, with the constant repetition of statistics such as that 15 percent of the federal workforce is already eligible to retire, and that in five years 30 percent of current employees will be eligible.
“That wave never happened and there is no reason to believe it will.
“What has actually happened is that federal retirements have been a fairly steady flow at around 60,000 to 70,000 each year from agencies apart from the Postal Service (which accounts for about 40,000 more on average). That’s around 3 percent per year, so when it’s five years later, 15 percent or so already have retired and there’s still only 15 percent who are eligible.
“Since those first soundings about a retirement wave, the workforce actually has been increasing in age. The average is now 47—five years older than the overall U.S. workforce—with about 28.7 percent age 55 or above, up by a half-point just in the last six years. The percentage aged 60 and older—which more or less equates to retirement eligibility—rose from 9.4 to 14.5 percent over the last 15 years.”
This is the demographic challenge facing the FEHB Program which is ameliorated by the coordination of benefits with Medicare beginning at age 65. OPM improved the opportunities for coordination of benefits with Medicare by allowing carriers to integrate Medicare Part D prescription drug plans for 2024.
From the public health front —
Dana Farber Cancer Institute offers insights into which States have the highest cancer rates.
The Department of Human Services announced making progress in the “whole of government” response to long Covid.
STAT News tells us about the debate over universal infant screening for cytomegalovirus (CMV).
“[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, butnot for CMV. And testing for the infection in newborns isn’t widespread.”[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, butnot for CMV. And testing for the infection in newborns isn’t widespread.
“Through my entire career, it’s been so clear that this field is really lacking in progress,” said Laura Gibson, an infectious diseases physician at UMass Memorial Health. “It’s just been frustrating to all of us in the field over decades.”
“That is starting to change, as state public health committees and legislatures begin to debate whether to mandate doing more robust screening for CMV. In 2019, Ontario became the first region in the world to test every baby for CMV. This year, Minnesota followed suit.”
“Obesity and diabetes in mothers have traditionally been considered risk factors for the child to also develop obesity. But a new study suggests that more narrow measures of health during pregnancy could help better assess that risk.
“Researchers grouped pregnant women based on specific metabolic traits and found that insulin resistance was associated with the highest risk, compared with other traits such as high cholesterol and triglycerides, according to a study published in JAMA Network Open on Tuesday.
“The risk linked to insulin resistance was even higher than that associated with prepregnancy obesity, defined as a body mass index over 30, and with diabetes diagnosed in gestation, the study said.”
From the Rx coverage front —
AHIP offers a new resource that “highlights how biosimilars offer an effective, lower-cost alternative to a brand name biologic product. In the last 10 years, for example, $36 billion of biosimilar medication spending was associated with $56 billion in savings. And savings from biosimilars are expected to exceed $180 billion over the next 5 years — a more than 4-fold increase from the last 5 years.”
STAT News reports on cancer drug shortages that have plagued our country for years.
From the telehealth front, mhealth intelligence informs us that “According to the FAIR Health Monthly Telehealth Regional tracker, telehealth use increased [7.3%] across the country in January, with rates rising at the national level and in all US Census regions.” My word, telehealth use increased in the winter?!?
Finally, in Medicare Advantage and Part D News, CMS lowered the boom on Medicare Advantage and Part D plans with a new final rule to “strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care.” This action follows a payment policy and risk adjustment rule compromise last week.
This afternoon, OPM’s Postal Service Health Benefits Program Interim Final Rule was timely posted on the Federal Register’s website. The FEHBlog estimates that deadline for public comment on the rule is Monday June 5, 2023.
From the Omicron and siblings front, Becker’s Hospital Review tells us
“The FDA is planning to make another COVID-19 booster that targets omicron available for high-risk individuals, The Washington Post reported April 3.
“Under the authorization, people 65 and older and those with weakened immune systems would be eligible to receive a booster dose four months after their last bivalent shot.
“The policy will be “permissive,” meaning the agency will allow people to get another booster but will not definitively recommend it, sources familiar with the matter told the Post.
“The FDA is expected to announce the plan within several weeks, and the CDC is expected to quickly endorse it, sources said. “
From the anomalies front, Fierce Healthcare informs us
“Cash prices for certain hospital services were lower than the average insurance rate in nearly half of the facilities examined in a new study, which could influence rate negotiations between payers and providers.
“The study was published Monday in the journal Health Affairs and makes use of cash price data hospitals are required to disclose for 70 shoppable services. The findings suggest that some self-insured employers pay prices higher than the cash price, which could influence future negotiations with insurers or direct talks with providers.
“Researchers looked at the cash prices, commercial negotiated rates and chargemaster prices disclosed by 2,379 hospitals as of Sept. 9, 2022, per a federal rule that went into effect in 2021.
“The average and the median cash price made up 64% and 65% of the chargemaster rate.
“About 12% of the cash prices were set the same as chargemaster rates, and other cash prices were predominantly priced in increments of 5% off the chargemaster rates (64% of the time),” the study said.
“The study found that the cash prices were lower than the median commercial rates in 47% of cases, most often at hospitals with government or nonprofit ownership, located outside of metropolitan areas or located in counties with relatively high uninsurance rates or low median household incomes.
“Researchers also discovered that evaluation and management services were the most likely to have a lower cash price with 55% compared with medicine and surgery at 48%.”
From the Medicare Advantage front, Healthcare Finance confirms
“Health insurers and stakeholders have expressed support for the Centers for Medicare and Medicaid Services’ plan to phase in changes to the risk adjustment model over three years, in the 2024 Medicare Advantage Program and Part D Payment Policies released Friday.
“The model changes will begin in 2024, with the full brunt of phased-in risk adjustment to take effect in 2026, according to Susan Dentzer, president and CEO of America’s Physician Groups.
“We’re satisfied with this,” said Ms. Dentzer. “They mostly listened.”
“Insurers also voiced their support for the payment increase in the 2024 Medicare Advantage and Part D Rate Announcement.
“CMS anticipates a payment increase for Medicare Advantage plans of 3.32% from 2023 to 2024 as a result of various changes, including in risk adjustment.
“This compares to the 1.03% increase in revenue proposed in the 2024 Advance Notice released in February.”
“We appreciate that CMS recognized the serious concerns with several proposed policies in the Advance Rate Notice that would affect MA enrollees in 2024, including by phasing in changes over a period of three years,” said Matt Eyles, president and CEO of AHIP.
The various Covid-19 pandemic-related mandates are tied to the end of the public health emergency and the end of the national emergency. The Administration has told us to expect the end of both emergencies on May 11.
Congress has passed a bill (House Joint Resolution 7) which the President has agreed to sign ending the national emergency upon signing. Mercer Consulting explains:
During the NE, group health plans have been required to extend certain participant deadlines that would have expired during the “Outbreak Period,” which began March 1, 2020, and will end 60 days after the end of the NE. These deadlines related to:
Special enrollment rights under HIPAA
COBRA elections, payments and notifications
Benefit claims, appeals and external reviews
Employers will have less time to prepare for the end of the Outbreak Period relief if, as the pending legislation would require, the NE ends before May 11, 2023. Other COVID-19 relief measures, described in this post, are tied to the PHE and are not impacted by the pending legislation.
This week, regulators provided FAQs and a blog to assist employers preparing for the NE and PHE to end. The FAQs provide many helpful examples illustrating how the extended deadlines available during the Outbreak Period will wind down. However, the FAQs assume that the NE will end on May 11 and the Outbreak Period 60 days later, on July 10. Assuming President Biden signs the legislation ending the NE earlier than May 11, the dates in the FAQs will need to be adjusted.
Any deadline adjustments for these three mandates impact employers directly and group health plans indirectly. The three mandates had have had limited FEHBP impact.
Following up on Thursday’s post, MedPage Today offers a broader perspective on Thursday’s Senate Finance Committee PBM hearing. The hearing’s theme was “transparency.” For over ten years, OPM has required FEHB carriers covering most enrollees to use a strict drug pricing transparency system. This has allowed the FEHB to avoid certain practices criticized at the hearing, such a spread pricing, and it facilitates OPM Inspector General audits of the PBMs. However, it takes Congress to address the key economic concern about rebates inflating drug prices discussed at the hearing:
Karen Van Nuys, PhD, of the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California in Los Angeles, highlighted her 2021 JAMA Internal Medicine research letter that found that Medicare would have saved $2.6 billion in 2018 on 184 drugs if patients had purchased them without insurance at Costco.
CMS finalized its Medicare Advantage and Medicare Part D payment policies for 2024 today. Of note, Fierce Healthcare reports,
The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed.
The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year.
CMS also offered a fact sheet on the final actions.
From the SDOH front, Health Payer Intelligence informs us
OMB’s 1997 Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (Directive No. 15). The directive regulates consistency in federal data-sharing and the 1997 iteration emphasized that data gathering practices should seek to mirror the nation’s diversity.
OMB’s directive requires that data collection include two category options for ethnicity (Hispanic or Latino and Not Hispanic or Latino) and five for race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, and white). In contrast, the Centers for Disease Control and Prevention (CDC) includes over 900 categories for these two designations.
The directive does not include any requirement to indicate sexual orientation and gender identity (SOGI) data. Very few regulations or standardizing entities do.
OMB will release changes to Directive No. 15 in 2024.
Several associations, including AHIP and BCBSA, have commented on the importance of OMB including changes to Directive No. 15 that facilitate health insurer efforts to reduce social determinants of health-related health disparities.
The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state. The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana. The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.
The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:
October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.
Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.
The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.
I also located the CDC’s website on keeping new mothers alive.
This evening the Journal discussed why our country’s maternal mortality rate is so high.
Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.
Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.
More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.
The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.
Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.
In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.
What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”
The FEHBlog’s goal is to provide perspective on this vital issue.
From the Omicron and siblings front, MedPage Today informs us
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.
By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.
“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.
The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.
Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants.
We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will not make any change when the PHE ends: 22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost. Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.
Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.
From the Rx coverage front
STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.
For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.
Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.
In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.
From the No Surprises Act front, Fierce Healthcare reports
An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.
Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.
“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C.
The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider.
These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said.
The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.
The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.
The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.
The FEHBlog doubts that this MedPAC report made anyone happy.
From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.
From the federal employment front, Govexec tells us
The Biden administration is looking to add 82,000 employees in fiscal 2024, a 3.6% increase that would bring civilian federal rolls to their highest levels since World War II.
Nearly every federal agency would receive a funding boost in President Biden’s fiscal 2024 budget, and all but one major agency is anticipating adding staff as a result. Some of the hiring is still aimed at making up for losses sustained during Obama-era budget caps and Trump-era targeted reductions, though much of it is for implementing major new initiatives Biden has ushered into law like the Inflation Reduction Act and the bipartisan infrastructure measure Congress approved in 2021.
“As we release the President’s FY 2024 Budget, we are proud of the mission-driven investments it makes in the federal government’s most important asset—our people,” Office of Management and Budget Deputy Director for Management Jason Miller and Office of Personnel Management Director Kiran Ahuja said in a [Performance.gov] blog post Monday.
From the end of the public health emergency front, Health Payer Intelligence reports
NORC used the Urban Institute’s public health emergency Medicaid coverage loss estimates and historic data from the Current Population Survey (CPS) Annual Social and Economic Supplement (ASEC).
The researchers recategorized the data, taking into account respondents’ coverage type in year one and year two of the transition, supplementing data for smaller states, and applying a hierarchy of coverage types to distribute respondents with multiple coverage sources. When respondents had multiple coverage types, the researchers prioritized first employer-sponsored coverage, then uninsurance, CHIP, nongroup coverage, and other public coverage, respectively.
When the researchers blended these two data sources, the study found that individuals who lose their Medicaid coverage after the end of the public health emergency will transition into employer-sponsored health plans in most states.
More than half of the beneficiaries who lose Medicaid coverage will transition to employer-sponsored health plan coverage in every state except for Georgia (48.9 percent), according to the dashboard associated with the report. The state with the highest share of beneficiaries going into employer-sponsored health plans after the public health emergency was Delaware (57.1 percent).
Because FEHB-eligible annuitants and family members must be on Medicaid, OPM may want to consider sharing information with federal agencies about how this cohort can shift from Medicaid to FEHB and when to apply.
From the Medicare front —
CMS today trumpeted that Medicare Part D members can receive vaccinations without cost sharing. CMS doesn’t mention that commercial plans, including FEHB plans, have offered this opportunity under the Affordable Care Act since 2011. For example, the FEHBlog received a shingles vaccination with no-sharing (in-network) before he went on Medicare (because his company has under 20 employees). He got hit with a $400 Medicare Part D copay when he received the updated shingles shots in 2019. Better late than never because the FEHBlog needs a TDap booster next year.
While Congress emptied this bowl of wrong, Medicare beneficiaries still face a pre-existing condition limitation (except in certain states) if they try to enroll in a Medicare supplement plan after the first opportunity.
CMS announced “27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. Thanks to President Biden’s new law to lower prescription drug costs, some people with Medicare who take these drugs may save between $2 and $390 per average dose starting April 1, depending on their individual coverage.” One CMS fact sheet explains how this program works, and another CMS fact sheet lists the 27 drugs, which include Humira. This will reduce FEHB Program spending as a secondary payer for annuitant and eligible family members with primary Part B. In the FEHBlog’s opinion, this program will not generate a dollar-for-dollar cost shift from Medicare to the FEHB cohort without primary Part B due to how the new program is structured.
Looking forward, CMS released its “Initial Guidance for Historic Medicare Drug Price Negotiation Program for Price Applicability Year 2026.” Thanks to OPM’s decision to allow FEHB plans to offer Part D EGWPs in 2024, the FEHB will be advantaged by the Part D savings.
From the public health front, the Alzheimers Association issued
Alzheimer’s Disease Facts and Figures, an annual report released by the Alzheimer’s Association, reveals the burden of Alzheimer’s and dementia on individuals, caregivers, government and the nation’s health care system.
The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available.
From the miscellany department –
Forbes informs us that “the U.S. government is suing Rite Aid — accusing the drugstore chain of “knowingly” filling unlawful prescriptions for controlled substances — only adds to the financial and operational woes of the embattled drugstore chain.”
AHIP has added details to the March 29-30 OPM AHIP FEHB Carrier Conference agenda.
The Wall Street Journal reports on yesterday’s abortion pill hearing before a federal judge in Amarillo, Texas. “A federal judge on Wednesday questioned the government about its approval of a medication used in more than half of the abortions in the U.S. but also asked whether there was any precedent for a court blocking sales of a drug long after it had been allowed on the market.” The FEHBlog expects the Court to rule in the federal government’s favor because no such precedent exists.
A ChatGPT update released March 14 has been stunning physicians with its ability to deliver sound medical advice, The New York Times reported.
Anil Gehi, MD, a cardiologist and associate professor of medicine at Chapel Hill, N.C.-based UNC Health, described the health history of a patient, using advanced medical terminology, to the artificial intelligence chatbot and asked it how he should treat the person, according to the March 14 story.
“That is exactly how we treated the patient,” he said of ChatGPT’s answer.
Experts told the newspaper the new GPT-4 technology is more precise, accurate and descriptive than its predecessor, which OpenAI released in November. However, the chatbot is still prone to “hallucination” and making things up.
In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives.
Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects.
Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
“A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Instituteof MIT and Harvard, a biomedical researchcenter in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
“Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.
The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.
From the Rx coverage front —
Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024.
In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.
The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
What is already known about this topic?
The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
What is added by this report?
By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
What are the implications for public health practice?
To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.
Beckers Hospital Review tells us that drug shortages in U.S. emergency departments are increasing. “Standard antibiotics such as amoxicillin continue to be in short supply, as do dextrose 50, dextrose 25, dexamethasone and betamethasone. Even over-the-counter medications such as Tylenol and Motrin are short in some areas due to increased demand, according to Southern Standard.”
In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights
Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards.
The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals.
From the medical research front,
NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
“The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
“This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.”
Thanks, research mice.
From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”
The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.
Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.
Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”
Additional findings from Nomi Health’s Trends in Spend Tracker research include:
Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.
This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year
From the post-Dobbs front, Healthcare Dive relates
Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.
On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.
From our Nation’s capital, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:
Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection.
By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.
Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.
The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”
Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year.
Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.
An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.
STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds
The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.
The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.
Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.
From the end of the public health emergency front —
The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.
The American Hospital Association points out
The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests.
Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.
The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.
Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.
Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.
The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.
The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.
In recognition of Patient Safety Awareness Week
The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13.
The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
Here are the 10 patient safety concerns for 2023, according to the report:
1. The pediatric mental health crisis
2. Physical and verbal violence against healthcare staff
3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
4. Impact on clinicians expected to work outside their scope of practice and competencies
5. Delayed identification and treatment of sepsis
6. Consequences of poor care coordination for patients with complex medical conditions
7. Risks of not looking beyond the “five rights” to achieve medication safety
8. Medication errors resulting from inaccurate patient medication lists
9. Accidental administration of neuromuscular blocking agents
10. Preventable harm due to omitted care or treatment
The U.S. Department of Labor announced on March 10
The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
Healthexec calls attention to FDA recalls of certain eyedrops.
From the value-based care front, Health Payer Intelligence notes
CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.
Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.
From the medical debt front, Healthcare Dive reports
Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.
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