From the omicron and siblings front, Govexec and Federal News Network recount today’s oral argument before the Fifth Circuit U.S. Court of Appeals over the legality of the Administration’s Covid vaccine mandate on federal employees.
The en banc ruling, expected in the next few weeks, could be the last step after a lengthy court battle that has played out through many fits and starts over the last year. Feds for Medical Freedom has previously said it will take its case to the Supreme Court if the Fifth Circuit rules against it, though the high court may be less inclined to weigh in on the case after it already ruled on two vaccine mandate cases in January. If the mandate is ultimately permitted to stand, individual employees could still wind up in the federal circuit if they take their cases to MSPB and appeal further after an initial decision. The mandate has not been enforced since a U.S. district judge in Texas first enjoined it in January.
In other virus news, the Wall Street Journal offers one of its helpful overview articles titled “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York.”
From the healthcare cost front, HHS’s Agency for Healthcare Quality and Research called attention to a recent agency report about the characteristic “high spenders”:
• In 2019, the top 1 percent of persons ranked by their healthcare expenditures accounted for about 21 percent of total healthcare expenditures, while the bottom 50 percent accounted for only 3 percent. • Hypertension and osteoarthritis/other non-traumatic joint disorders were the most commonly treated conditions among the top 5 percent of spenders. • Persons ages 65 and older and Whites were disproportionately represented in the top spending tiers. • Inpatient hospital care accounted for about 37 percent of spending for persons in the top 5 percent of spenders. • Over three-quarters of aggregate expenses for persons in the top 5 percent of spenders were paid for by private insurance or Medicare.
From the SDOH front, MedCity News reports about “Information as a social determinant: Three ways Google is addressing health inequity: Google announced three updates at the Google Health Equity Summit, including a new video series partnership, improved search features and an expanded program with Fitbit.”
The American Medical Association said its 2023 Current Procedural Terminology code set, released Friday, contains burden-reducing revisions to the codes and guidelines for providers.
The updates to the data-sharing terminology for medical procedures and services are intended to make coding and documentation easier and more flexible, freeing providers from time-wasting administrative tasks that are clinically irrelevant to providing high-quality care to patients, the AMA said.
The modifications follow the 2021 revisions made to the evaluation and management codes for office visit services. They extend to inpatient and observation care services, consultations, emergency department services, nursing facility services, home and residence services and prolonged services.
HHS regulations implementing HIPAA electronic transaction standards require that the CPT be used to code outpatient services.
From the Omicron and siblings front, Regulatory Focus reports
[Last week,] both Pfizer and Moderna are seeking FDA authorization for their bivalent COVID-19 vaccines containing components of both the prototype virus and Omicron BA.4/5.
“The FDA is working tirelessly to evaluate the submissions to ensure the data meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality so that these new boosters are available as soon as possible,” Califf tweeted on Thursday, noting that the agency would base its decision on “the totality of available evidence,” including clinical trial data from other bivalent mRNA vaccines, real-world evidence from current vaccines and non-clinical data on the two BA.4/5-containing vaccines.
Califf also said that the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) would not be convened to review the submissions. “FDA will not hold a VRBPAC meeting about these submissions, as the agency feels confident in the extensive discussion that was held in June. VRBPAC voted overwhelmingly to include an omicron component in COVID-19 boosters. FDA has no new questions that warrant committee input,” he wrote.
From the monkeypox front, the Wall Street Journal informs us
A person in Texas who was diagnosed with monkeypox and had a weak immune system has died, Texas state health officials said Tuesday, in what could be the first-known fatality from the virus in the U.S.
The Texas Department of State Health Services said this was the first death of a person diagnosed with monkeypox in Texas. Officials are investigating what role monkeypox played in the death. They said the patient, who was an adult and a resident of Harris County, Texas, was “severely immunocompromised” but didn’t offer additional details.
In a statement, Texas health commissioner Dr. John Hellerstedt said that “monkeypox is a serious disease, particularly for those with weakened immune systems.” He urged those who have been exposed or have symptoms to seek treatment.
Concerns over monkeypox vaccine supplies appear to be softening after federal public health agencies initially scrambled to acquire enough doses of the shot.
The Biden administration has been working to boost its supply of vaccines in recent weeks, and so far has made over 1 million vials available to jurisdictions, “which is nearly enough to reach the entire population that’s most at risk,” HHS Secretary Xavier Becerra said during a call with reporters Tuesday.
The HHS also announced on Monday that it will provide about $11 million to support the first U.S.-based productioneffort for manufacturing the Jynneos vaccine at a facility in Grand Rapids, Michigan.
The FDA authorized administering the Jynneos shot intradermally — a method that requires only one-fifth of the usual dose but is just as effective, according to the agency.
However, the vaccine’s developer, Bavarian Nordic, has raised concerns about the method, citing a lack of data and evidence related to its efficacy.
About 75% of jurisdictions that have received the vaccine are administering it intradermally now, Bob Fenton, the White House’s monkeypox response coordinator, said on Tuesday’s call.
From the public health front, CNN Health discloses
CDC Director Dr. Rochelle Walensky has tapped Mary Wakefield — an Obama administration veteran and former nurse — to helm a major revamp of the sprawling agency and its multibillion-dollar budget. Making the changes will require winning over wary career CDC scientists, combative members of Congress, and a general public that in many cases has stopped looking to the agency for guidance.
“If she can’t fix it, she’ll say, ‘It’s not fixable, here’s why, and here’s what needs to be done next,'” said Eileen Sullivan-Marx, dean of the New York University Rory Meyers College of Nursing, who’s known Wakefield professionally for decades.
Less than 20% of providers submitted claims using a type of payment code [ICD 10 Z codes] that could help identify and address health disparities that adversely affect patient outcomes, according to a new ICON Market Access report.
The results come amid a growing call for payors and pharmaceutical manufacturers to work together to better address racial and ethnic health inequalities, speakers said during the AMCP 2022 annual meeting.
Such health disparities exist in nearly all U.S. states, said Jessica Cherian, PharmD, RPh, the vice president of content and strategic services for ICON Market Access, citing a 2021 Commonwealth Report, In 2021, her company surveyed 32 payor executives for their perceptions regarding health disparities in racial and ethnic groups, with a targeted focus on medication access and utilization.
Payors typically review data from claims, case manager screenings and more, and use that information to match members to programs that meet their SDOH needs, such as access to care, housing or transportation help, Ms. Fleming said. Payors also track needs through Z codes: additional codes provided in the International Classification of Diseases, Tenth Revision to report nonmedical factors influencing health status. For example, code Z63 would indicate difficulty with a patient’s family/support, such as alcoholism or drug addiction. Approximately 71% of payors in the ICON report used Z codes to monitor SDOH; however, they said less than 20% of submitted claims included these codes.
In payor personnel news, Healthcare Dive informs us
Name: David Brailer
New title: Executive vice president and chief health officer, Cigna
Brailer will assume his new role in early September, and will be Cigna’s first chief health officer.
In his role, he will focus on bringing together Cigna products, technologies and services in new ways in an attempt to drive more value and help improve overall health, according to the release.
He will report to Cigna Chairman and CEO David Cordani and will serve on the company’s enterprise leadership team.
From the healthcare costs front, the HHS Agency for Healthcare Quality and Research released “STATISTICAL BRIEF #543: Trends in Health Insurance at Private Employers, 2008-2021.”
“Highlights
“Employment-sponsored health insurance at private-sector employers was characterized by increases in premiums and cost-sharing for covered workers in 2021.
In 2021, average health insurance premiums were $7,380 for single coverage, $14,634 for employee-plus-one coverage, and $21,381 for family coverage, representing increases of 3.2, 3.1 and 3.0 percent, respectively, from their 2020 levels.
In 2021, the average employee contribution was $1,643 for single coverage, a 7.2 percent increase from the 2020 level. Single premium contributions increased at small (12.3 percent), medium (14.1 percent), and large firms (5.6 percent).
From 2020 to 2021, average deductible levels for single coverage increased by 3.0 percent to $2,004, and family coverage deductibles increased 3.9 percent to $3,868.
“From 2020 to 2021, there were no statistically significant changes in enrollment rates or offer rates for small, medium, or large firms.
“Overall enrollment and offer rates decreased from 2020 to 2021. These decreases are due to an increase in employment among small employers, and a corresponding decrease in the proportion of employees in medium and large firms, which have higher rates for both measures.
“In 2021, overall eligibility and take-up rates were not significantly different from 2020 levels.”
Cholesterol-lowering statins are proven lifesavers, but they’ve also gained a reputation for causing muscle aches and pains in a good number of patients.
That reputation is undeserved, according to a new large-scale analysis of data from nearly two dozen clinical trials of statins.
There’s a less than 10% chance that muscle symptoms reported by patients are caused by the statin they are taking, researchers report.
“Our analysis showed that over 90% of muscle symptoms were not attributable to the statin, and those cases that were due to statins occurred mainly within the first year of treatment,” said joint lead researcher Colin Baigent, director of the Medical Research Council Population Health Research Unit at the University of Oxford, in England.
Statins have simply gotten a bad rap when it comes to muscle side effects, Baigent said.
In government contract reporting news, the Society for Human Resource Management reports
The Office of Federal Contract Compliance Programs (OFCCP) has issued a revised directive on compensation compliance, addressing concerns federal contractors had about a previous directive issued earlier this year. Some contractors were concerned that the prior version of the directive intruded upon communications protected by attorney-client privilege.
On the same day the revised directive was issued, OFCCP Director Jenny Yang wrote in a blog post that a top priority for the OFCCP is combating agency pay discrimination.
“Contractors therefore should review the directive and ensure they are engaging in compensation analyses as required by the regulations and be prepared to respond to questions regarding those analyses that are detailed in the directive,” said Guy Brenner, an attorney with Proskauer in Washington, D.C.
“Federal regulations require contractors periodically—or OFCCP interprets now as annually—[to] review their compensation systems to determine whether there are gender, race or ethnicity-based disparities in compensation,” said Sheila Willis, an attorney with Fisher Phillips in Columbia, S.C.
A federal judge approved Blue Cross Blue Shield companies’ settlement of a sweeping antitrust suit filed on behalf of their customers, with the insurers agreeing to pay $2.67 billion and change certain practices that allegedly limited competition. * * *
Under the settlement, the Blue insurers would drop a Blue Cross Blue Shield Association rule that limits the share of each company’s total national revenue that can come from business that isn’t under Blue brands.
That change could increase competition among the companies if they choose to expand their non-Blue lines of business in one another’s geographies, insurance experts said.
The settlement would also loosen a rule that had limited the Blue insurers’ ability to compete with one another for the business of large national employers. Under the changes, certain national employers would be able to also request a bid from a second Blue insurer of their choice, setting up competition between the two Blues.
However, the settlement stops short of unwinding the Blues’ licensing setup that grants exclusive geographic branding rights to companies—the main original focus of the litigation. * * *
A spokeswoman for the Blue Cross Blue Shield Association said it was pleased with the approval, and is committed to finalizing and implementing the agreement.
The settlement should be implemented beginning in 30 days. There are limited appeal rights for class members. The Journal adds, “The Blue insurers still face a second, parallel antitrust suit filed on behalf of doctors, hospitals and other healthcare providers.”
From the Omicron and siblings front, the New York Times offers advice on how to manage Omicron BA.5 symptoms, including sore throats, from home.
From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of U.S. monkeypox cases and offers physician perspectives on the monkeypox cases that they are treating. “‘The biggest misconception is that this is always a mild disease,’ Jason Zucker, MD, an infectious diseases specialist at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, said during an Aug. 5 call with reporters.”
Govexec reports that the FDA implemented its plan to significantly extend the supply of the preferred monkeypox vaccine. Bloomberg Prognosis provides more medical details on this development.
From the Rx coverage front, Fierce Healthcare discusses Optum’s latest drug development pipeline report and STAT News reports
For only the second time, Pfizer is offering a warranty for a medicine that will cover the cost for any patient or health plan if the medication fails to work, a move that expands an effort to appease concerns about high drug costs.
The newest warranty program began last month and covers Panzyga, which was approved last year in the U.S. to treat a rare neurological disorder called chronic inflammatory demyelinating polyneuropathy, or CIPD. Patients can get repaid for four treatments — up to $16,500 each, or a maximum of $50,000 — if use is discontinued for clinical reasons. And insurers can also get reimbursed for their own outlays.
Unlike the first warranty program — which Pfizer began a year ago for its Xalkori lung cancer treatment — this newest warranty is only available to patients who are covered by commercial insurance or pay cash, not government health care programs. The Xalkori program is available to patients who are covered by commercial insurance or those who pay cash but are also covered by Medicare.
And how about an Rx coverage tidbit? Bayer tells us with understandable pride
This year, acetylsalicylic acid (ASA), the active ingredient that brought Aspirin to fame, celebrates its 125th anniversary. On August 10, 1897, Dr. Felix Hoffmann discovered the ideal formula for acetylsalicylic acid when he synthesized the first chemically pure and stable form of acetylsalicylic acid. * * *
Hoffmann’s breakthrough was entered in the trademark register of the Imperial Patent Office in Berlin in 1899 and received a patent in the USA the following year, and scientists continue to conduct research even to this day on Aspirin, other potential areas of application, and dosage forms. In 1969, the round tablet made its way to the moon with the astronauts in the Apollo 11 capsule.
From the U.S. healthcare business front, MedCity News examines CVS Health’s expansion into the primary and homecare markets.
From the plan design front,
AHRQ’s Medical Expenditure Panel released a survey on trends in health insurance at private employers, 2008 – 2021.
The International Foundation of Employee Benefit Plans offers four steps for evaluating your plan’s diabetes coverage.
The Congressional Research Service updated its health savings account report.
From the telehealth and fraud, waste and abuse fronts
More patients turned to telehealth to see a doctor in May than April, in step with an increase in COVID-19 cases reported to the Centers for Disease Control and Prevention, according to Fair Health’s latest monthly tracker of private insurance claim lines.
Virtual visits rose 10.2% in May, accounting for 5.4% of all medical claim lines in the month, compared to 4.9% in April, Fair Health said Monday. It was the second straight month that telehealth’s share of claims grew.
COVID-19 made the list of top five telehealth diagnoses in every region of the country in May, holding in the No. 2 spot in the Northeast while climbing to second place in the Midwest and West and third place in the South.
STAT News delves into how telehealth fraud concerns could impact the industry’s future.
In Postal Service news, Federal News Network reports that USPS is eyeing mail price increases for January 2023.
USPS Chief Financial Officer Joe Corbett said the agency remains “in a financial hole,” and that more progress under the 10-year reform plan is needed.
“While we have accomplished a tremendous amount executing on the [Delivering for America] plan, we still have a lot of work to do. We need to continue executing the management initiatives in our Delivering for America plan to fill this hole and return to Postal Service to continuous self-sustaining financial health,” Corbett said.
[Postmaster General] DeJoy said USPS contributions to the retirement health care plan for its employees, under Postal Service Reform Act, will resume in 2026, and will grow to about $6.7 billion a year.
“We will not be able to make these payments unless we timely engage and accomplish all our initiatives, and we are trying to do just that,” DeJoy said.
The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services. * * *
Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.
Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out
Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.
The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.
The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.
Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.
So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?
Probably not, infectious disease experts say.
“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.
The American Hospital Association tells us
More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”
Speaking of hospitals, Beckers Hospital Review reports
Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience. * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience. * * * View the full list of recipients here.
From the Rx coverage front —
The Food and Drug Administration released one of its news roundups today.
Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”
From the interoperability and telehealth fronts
Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
AHRQ offers research on telehealth for women’s preventive healthcare services.
President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.
The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.
Today is Earth Day. AHRQ offers “A new AHRQ Views blog post in recognition of Earth Day 2022 highlights the Agency’s emerging efforts to reduce the impacts of climate change.”
From the FEHB front, Fedweek warns federal employees to think hard before rejecting FEHB coverage late in a career. As explained in the article you can lose out on one of the best fringe benefits for federal and postal employees — continuing their FEHB coverage into retirement with the full government contribution.
From the Omicron and siblings front —
STAT News informs us
Experts who advise the CDC met yesterday to discuss a thorny issue: Covid vaccine boosters, specifically the new policy to allow people 50 and older and people who are immunocompromised to get a second booster. By the end of the meeting — during which members of the Advisory Committee on Immunization Practices expressed frustration with the lack of clarity about the goal of the U.S. booster policy — it wasn’t entirely clear why people are being offered a second booster at this time. Data presented by CDC experts suggested the protection that immune-competent people have received from their primary series and first booster is holding up and the expected benefits from the fourth shots are modest at best. ACIP member Beth Bell raised concerns about “booster fatigue” and said offering another dose now could undercut confidence in vaccines that are working well at protecting people from severe Covid. The policy to offer the fourth doses was made without consulting ACIP.
What’s more,
Among the many views expressed around vaccine mandates, one theme persists: the idea that Covid-19 infection protects unvaccinated people against reinfection. While CDC says “getting a Covid-19 vaccination is a safer and more dependable way to build immunity to Covid-19 than getting sick with Covid-19,” a research letter in JAMA Network Open tested the concept of natural immunity by analyzing data from more than 121,000 patients receiving health care in the western U.S. from October 2020 through November 2021, before the Omicron variant took hold. Unvaccinated people who’d been sick with Covid had an 85% lower risk of acquiring Covid again compared to unvaccinated individuals without prior Covid. That level is similar to what mRNA vaccines deliver. Previous infection conferred 88% protection against hospitalization after reinfection and 83% protection against reinfection that did not require hospitalization. The authors conclude natural immunity works as well against both mild and severe illness. One difference: Natural immunity didn’t wane, but mRNA vaccines’ protection did. “This study may have important implications for vaccine policy and public health,” they write.
It is illogical to downplay natural immunity when the worst flu epidemic in U.S. history, the 2018 pandemic, was resolved by a combination of deaths and natural immunity. This is not intended to downplay vaccines. In the FEHBlog’s view, the CDC should be paying more attention to natural immunity from Covid.
From the Covid anti-fraud front, Healthcare Dive reports
The Department of Justice has charged 21 people across the U.S. for pandemic-related healthcare fraud, federal prosecutors said Wednesday.
Defendants — including doctors, medical business executives and fake vaccination card manufacturers — caused nearly $150 million in false billing to federal programs, the DOJ alleged.
The prosecution effort involves some of the “largest and most wide-ranging pandemic-related frauds detected to date,” said Kevin Chambers, the DOJ’s director for COVID-19 fraud enforcement.
From the Food and Drug Administration front —
The American Hospital Association tells us
The Food and Drug Administration seeks comments through June 21 on a potential change that would require outpatient settings to dispense opioid pain medications with prepaid mail-back envelopes and pharmacists to provide patient education on safe disposal of opioids.
“This potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would provide a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events,” the agency said.
Good idea. Also
Health care providers should not use non-invasive prenatal screening tests alone to diagnose genetic abnormalities due to the potential for false results, the Food and Drug Administration warned last week. Also known as cell-free DNA tests or non-invasive prenatal tests, these laboratory developed tests in most cases are not reviewed by the FDA.
“Patients and health care providers should be aware of the risks and limitations of using these genetic prenatal screening tests and that they should not be used alone to diagnose chromosomal (genetic) abnormalities,” FDA said, citing reports that some patients and providers have made critical health care decisions based on the results without additional confirmatory testing.
Thanks to Covid-19 vaccines and therapies, U.S. spending on pharmaceuticals rose 12% in 2021 as use reached record levels and new prescriptions for acute and chronic care largely recovered from the slowdown seen during the pandemic, according to a new analysis.
Meanwhile, out-of-pocket costs paid by patients hit $79 billion, a $4 billion rise from the year before and the same level seen in 2018 after two years of declining costs. Overall, these costs were relatively low — less than $20 per prescription — but about 1% of all prescriptions filled, or 64 million, ran patients $125, underscoring ongoing barriers to affordability. In fact, 81 million prescriptions were not filled last year.
“We’re not in a very different situation from where we were five years ago except for the intensified, competitive market dynamics. But there are no major changes from a major legislative or policy perspective,” said Murray Aitken, senior vice president and executive director of the IQVIA Institute for Human Data Science, which conducted the analysis.
He also noted that the overall use of health services has returned to pre-pandemic levels, but has not yet made up for the backlog in missed patient visits, screenings and diagnostics, elective procedures, and new prescription starts — which IQVIA called a “concerning gap in preventive and treatment services.”
From the opioid epidemic front, the White House announced today
President Biden sent his Administration’s inaugural National Drug Control Strategy to Congress at a time when drug overdoses have taken a heartbreaking toll, claiming 106,854 lives in the most recent 12-month period. The Strategy delivers on the call to action in President Biden’s Unity Agenda through a whole-of-government approach to beat the overdose epidemic.
The Strategy focuses on two critical drivers of the epidemic: untreated addiction and drug trafficking. It instructs federal agencies to prioritize actions that will save lives, get people the care they need, go after drug traffickers’ profits, and make better use of data to guide all these efforts.
Scientists around the world are discovering and tracking newer forms of the Omicron coronavirus variant, showing how even when a strain becomes globally dominant, it continues to evolve and can splinter into different lineages.
Case in point: Updated data released Tuesday showed that a burgeoning form of Omicron, called BA.2.12.1 — itself a sublineage of the BA.2 branch of Omicron — now accounts for nearly one in five infections in the United States. It’s eating into the prevalence of the ancestral BA.2, highlighting the emergent virus’s transmission advantage over its parent. BA.2 now accounts for about 74% of cases, while the remaining 6% or so are from the BA.1 branch of Omicron, the first form of the variant that took over globally and whose prevalence has been falling as BA.2 became dominant.
The menagerie can be dizzying to track, especially because all these cases technically fall under the Omicron umbrella. But even as scientists closely monitor the divergence of Omicron, early signs suggest the different lineages don’t substantially differ in terms of how virulent they are or in their ability to evade the protection generated by immunizations. While some of the newer forms of the virus might be better spreaders than others, their emergence doesn’t necessarily result in huge increases in cases.
David Leonhardt adds in his New York Times morning column today
In several places where the number of cases has risen in recent weeks, hospitalizations have stayed flat. (In past Covid waves, by contrast, hospitalizations began rising about a week after cases did.) * * *
Even if hospitalizations do rise in coming weeks, a declining share of coronavirus cases that result in serious illness would be very good news, Dr. Craig Spencer, director of global health in emergency medicine at Columbia University, has pointed out.
I haven’t seen a Covid patient in the E.R. in weeks and go to work now expecting not to,” Spencer told me, “despite a swirl of Covid in the community.”
Among other things, a decoupling of cases and severe illness would mean that hospitals were less likely to become overwhelmed during future Covid surges. When hospitals avoid getting swamped, they can provide care to every patient who needs it — which becomes another factor that reduces bad health outcomes.
For these reasons, Mr. Leonhardt plans to shift his focus from new cases to new hospitalizations.
Because mRNA-based vaccines are a relatively new class of vaccines, they do not include the traditional adjuvants. The current mRNA vaccines used in the U.S. rely on small balls of fat called lipid nanoparticles to deliver the mRNA. These lipid molecules can act as adjuvants, but how precisely these molecules affect the long-term immune response remains to be seen. And whether the current COVID-19 vaccines’ failure to trigger strong long-lived antibody response is related to the adjuvants in the existing formulations remains to be explored.
While the current vaccines are highly effective in preventing severe disease, the next phase of vaccine development will need to focus on how to trigger a long-lived antibody response that would last for at least a year, making it likely that COVID-19 vaccines will become an annual shot.
New data from Moderna offer hope that booster shots against Covid-19 could become at least somewhat more effective than they already are. But the data also point to how difficult it could be to determine exactly which Covid shots to give as annual boosters.
At a hearing of a Food and Drug Administration advisory panel earlier this month, experts fretted about exactly how governments should make decisions about the composition of annual boosters. And they were adamant that governments, not pharmaceutical companies, should be deciding the strain composition of the shots, as the World Health Organization does for influenza shots. But these data are a reminder that those decisions can be tough. What would experts do when faced with booster shots with several different compositions? Will adding new strains work similarly for different types of vaccines? There are a huge number of open questions.
There’s also the biggest problem with annual flu shots: People don’t get them. Even with the current Covid boosters, this has been true. Data presented to the FDA panel said that 217 million Americans are vaccinated about Covid. But only 90 million people have received a booster dose. How many will turn out for a new booster next year?
Look at this comparison of winter 2019-2020 flu vs. 2020-2021 Covid
2019 – 2020 Winter CDC Fluview
3/28/20
2020-2021 Winter COVID-19
10/1/2020 to 3/21/2021
Flu Deaths
24,000
COVID-19 Deaths
332,636
Flu Cases
39,000,000
COVID-19 cases
22,399,598
Deaths over total cases
0.06%
1.49%
https://www.cdc.gov/flu/weekly/index.htm
Who would look back on pre-Covid flu as the good old days? But comparatively, it is. We see millions more flu cases, but hundreds of thousands fewer flu deaths.
Kaiser Health News discusses the need for better ventilation in office buildings which could help tamp down Covid and flu cases. “The science is airtight,” said Joseph Allen, director of the Healthy Buildings program at Harvard University’s T.H. Chan School of Public Health. “The evidence is overwhelming.”
From the No Surprises Act front, Healthcare Dive reports
The online portal for resolving payment disputes between payers and providers for certain out-of-network charges is now open, the CMS said Monday. The portal initiates what’s known as the federal independent dispute resolution process, a key part of the No Surprises Act that outlaws balance bills in most cases. As a last resort, it allows payers and providers to resolve payment disputes using an arbitration style similar to the model adopted by Major League Baseball in salary negotiations.
From the transparency in coverage rule front, the Labor Department issued ACA FAQ 53 today. FAQ 53 provides guidance to health plans, including FEHB plans, on how to post three machine-readable pricing files on their website. The Labor Department will begin to enforce this requirement on July 1, 2022.
Commercial health plans pay higher prices than public payers for hospital care, which accounts for more than 5 percent of US gross domestic product. Crafting effective policy responses requires monitoring trends and identifying sources of variation. Relying on data from the Healthcare Provider Cost Reporting Information System, we describe how commercial hospital payment rates changed relative to Medicare rates during 2012–19 and how trends differed by hospital referral region (HRR). We found that average commercial-to-Medicare price ratios were relatively stable, but trends varied substantially across HRRs. Among HRRs with high price ratios in 2012, ratios increased by 38 percentage points in regions in the top quartile of growth and decreased by 38 percentage points in regions in the bottom quartile. Our findings suggest that restraining the growth rate of HRR commercial hospital price ratios to the national average during our sample period would have reduced aggregate spending by $39 billion in 2019.
Seniors save nearly $2,000 on average a year in total healthcare spending in Medicare Advantage (MA) compared to fee-for-service Medicare, a new study finds.
The study, published Tuesday, by the advocacy group Better Medicare Alliance finds that seniors spent $1,965 less including premiums and out-of-pocket costs on MA when compared to fee-for-service.
“We see particularly strong results for historically disadvantaged populations, including Black and Hispanic beneficiaries and those who are low-income,” said Allison Rizer, principal at the consulting firm ATI Advisory, which performed the study that examined 2019 Medicare Current Beneficiary Survey data.
From the healthcare business front, Fierce Healthcare tells us
UnitedHealth Group executives said Thursday that its Optum Health subsidiary, which is one of the country’s largest physician groups, is building out value-based care partnerships at a faster rate than was expected.
In its earnings report, the healthcare giant said it initially projected that 500,000 new patients would be treated in value-based arrangements. It’s upping that projection to 600,000. Wyatt Decker, M.D., CEO of Optum Health, said on the company’s earnings call that reflects Optum’s efforts to invest in technology, analytics and building networks are paying off.
“What you’re really seeing is a result of almost 10 years of building a flywheel that now has significant momentum,” Decker said. “All of that continues to yield benefits and, frankly, growth.”
The severity of multiple sclerosis (MS) was linked with geographic latitude, an observational study showed.
Among 46,000 MS patients living in temperate zones, more severe disease was seen in those who lived above 40° latitude, reported Tomas Kalincik, MD, PhD, of the University of Melbourne, Australia, and co-authors.
The association was driven mainly, but not exclusively, by ultraviolet B (UVB) radiation exposure contributing to both MS susceptibility and severity, the researchers wrote in Neurology.
AHRQ discusses a study on “Geographic Variation in Inpatient Stays for Five Leading Substance Use Disorders, 2016-2018.” There are interesting State variations.
In yesterday’s post, the FEHBlog accurately predicted that the Supreme Court would decide today whether to stay the OSHA ETS vaccination screening program and end the partial stay on the CMS healthcare worker vaccination mandate.
This afternoon, the Supreme Court issued its decision reinstating the nationwide stay of the OSHA ETS and its companion decision ending all stays on the CMS mandate. The decisions came down as many, many pundits predicted.
The Secretary of Labor who oversees OSHA commented that
“We urge all employers to require workers to get vaccinated or tested weekly to most effectively fight this deadly virus in the workplace. Employers are responsible for the safety of their workers on the job, and OSHA has comprehensive COVID-19 guidance to help them uphold their obligation.
“Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the Covid-19 National Emphasis Program and General Duty Clause.”
In the OSHA ETS decision, the Supreme Court expressed the key point of administrative law on which the two cases turned:
Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided.
The Court reasoned that Congress had granted CMS the necessary authority to issue its broad mandate but had not granted OSHA the same level of authority.
The cases now return to the courts of appeal for a decision on the merits — 6th Circuit for the OSHA ETS case and 5th Circuit for the CMS mandate case. In the meantime the Court’s decisions on the stays will remain in place.
Given how the Court handled these stay decisions, we have a pretty good idea where the Supreme Court will land should either of those merits decisions return to the Court.Such a return likely only will happen if either appellate court disagrees with the Court’s administrative law conclusion on the merits.
The Justice Department will appeal a Louisiana federal court’s ruling that blocked President Joe Biden‘s order for government-contractor workers to get the Covid-19 vaccine.
The U.S. Court of Appeals for the Fifth Circuit will be the third federal appeals court to consider a challenge to the measure. A coalition of three states—Louisiana, Mississippi, and Indiana—sought to block the mandate for companies that do business with the federal government. U.S. District Court Judge Dee Drell of the Western District of Louisiana granted a preliminary injunction in December.
The federal contractor mandate—which won’t be enforced while litigation proceeds—would apply to roughly a quarter of the U.S. workforce, and affect businesses including Lockheed Martin Corp., Microsoft Corp., Alphabet Inc.‘s Google, and General Motors Co.
Appeals are ongoing in the Eleventh and Sixth circuits, respectively, over a nationwide injunction against the measure from a Georgia federal court and a narrower one from a Kentucky federal judge for a coalition that includes Ohio and Tennessee. A Missouri federal court also blocked the executive order, but that ruling has yet to be appealed.
From the Omicron front, David Leonhardt writing in today’s New York Times cautiously senses that the Omicron surge is cresting in our country following Europe’s and South Africa’s leads. “To be clear, the current emergency is not on the verge of ending. Cases appear to be peaking only in places where Omicron arrived early, mostly in the Northeast. In much of the country, cases are still soaring.”
Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.
As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.
Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.
The low rates are “very disturbing,” said Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine. “It’s just amazing.”
Parents who hesitate “are taking an enormous risk and continuing to fuel the pandemic,” Murphy said.
From the telehealth front, STAT News informs us that
A handful of virtual care companies are inking new types of contracts that reward them for keeping patients’ cost low and penalize them for overspending — a model known as risk-sharing. It’s a departure from the traditional “fee-for-service” billing process, and a move companies hope could help them get paid for the services they offer in addition to virtual doctors’ appointments, like in-app messaging, medication reminders, and digital health coaching. They’re also betting that embracing risk could endear them to the health plans and employers they depend on for contracts.
Execs from companies like Heartbeat Health and Teladoc saythey’re in the very early stages of cementing these contracts. While there’s no clear roadmap for how to structure them, whether they take hold could clarify how virtual care will fit into the brick-and-mortar healthcare system and incentivize those companies to work with traditional providers on prevention, said Jennifer Goldsack, CEO of the Digital Medicine Society. “There is an opportunity to reimagine what health care looks like when it is around the patient,” she told Mohana. Read the full story.
From the healthcare cost front, STAT News tells us that
— Medical cost growth trailed that of other industries in 2021, though rising pressure from the omicron variant could fuel future increases in healthcare costs.
— Prices for goods and services skyrocketed at the fastest pace in four decades, rising 7% between December 2020 and December 2021, according to new data released Wednesday from the Bureau of Labor Statistics.
— By comparison, prices for healthcare services rose roughly 2.5% last year, while the cost of medical care goods rose just 0.4%. However, that slow rate of growth could accelerate as COVID-19 cases persist in 2022 and beyond.
From the miscellany department —
The Agency for Healthcare Quality and Research’s Acting Director Dr. David Meyers looks back at 2021.
Biopharma Dive considers five questions facing gene therapy in 2022.
As the healthcare system faces significant labor challenges, a new report suggests pharmacists are well positioned to fill some of the critical gaps.
The analysis, conducted by Express Scripts and the Columbia University Mailman School of Public Health, found that a majority of pharmacists see their roles transitioning to more direct patient care responsibilities over the next decade.
AARP’s Public Policy Institute examines the importance of medication literacy in the medication decision-making of older adults.
While health literacy is widely understood as a quality measure of health care decision making, another related measure calls for increased attention, particularly regarding older adults: medication literacy. Medication literacy is the degree to which individuals can obtain, comprehend, communicate, calculate, and process patient-specific information about their medications to make informed medication and health decisions in order to safely and effectively use their medications, regardless of the mode by which the content by which the content is delivered (i.e., written, oral, or visual).
Money offers a comprehensive update on the President’s mandate that health plans cover over the counter COVID tests effective on Saturday January 15.
Based on the CDC’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s final weekly calendar for 2021 and it’s a stunner:
STAT News features a timely article captioned “Beyond Case Counts: What Omicron is teaching us.”
Brace yourself: Case counts are going to reach astounding heights. Already, reported infections have doubled in just a few weeks. The average daily number of infections is greater than 300,000. (It’s likely that our case counts will become increasingly less reliable as well, given both the shortcomings of our testing infrastructure and the growing use of at-home tests.)
But, in large part because the immunological landscape today is far different than what it was two years ago, cases are less likely to result in severe disease than was the case at the start of the pandemic.
Back then, a rise in cases inevitably led to an increase in hospitalizations and deaths. When vaccines went into wide use, those metrics started to become decoupled; cases could rise sharply but hospitalizations and deaths occurred at a lower level than before. In the current phase of the pandemic, the distance between those metrics is growing even greater. * * *
[A] key question relates to how long we’ll be in Omicron’s grasp. South Africa’s bellwether wave soared to extraordinary heights — then quickly began to ebb. Data from several European countries also suggest that Omicron waves may be short, sharp shocks compared to the waves that have preceded it. But too little is yet known to predict with any confidence whether the experience of a country with a relatively young population, such as South Africa, will hold true in a country with an older population, such as the United States.
Here’s a link to the FEHBlog’s final weekly chart of new COVID deaths:
As cases have skyrocketed, deaths have ranged between 5,000 and 10,000 per week for over four months.
Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020, when the vaccinations became available to the public, and the 52nd week of 2021:
The number of administered COVID vaccines has dropped during the holidays. Currently, 72.8% of Americans aged 18 and older are fully vaccinated and 36.3% of that cadre are boostered. Nearly 50% of Americans aged 50 and older are boostered.
Also from the COVID vaccine front, the Hill reports that
The Food and Drug Administration (FDA) is expected to approve booster shots of Pfizer and BioNTech’s COVID-19 vaccine for 12- to 15-year-olds on Monday, people familiar with the agency’s plan told The New York Times.
In addition to that broadened policy, the FDA also intends to announce that both children and adults could seek their booster shot five months after their second dose, instead of the previously advised six months. Immunocompromised children ages 5 to 11 are also expected to be allowed boosters, according to the Times.
The Times reported that the vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) is set to meet next week to vote on approving the FDA’s policy changes, which CDC Director Rochelle Walensky is expected to endorse.
From the No Surprises Act front, CMS has released a handy, comprehensive overview of the federal independent review process. Check it out.
From the Affordable Care Act front, Prof. Katie Keith writing in Health Affairs Forefront has released two of three articles on the ACA 2023 Notice of Benefit and Payment Parameters released earlier this week — link to Part 1 and link to Part 2. Part 1 includes a discussion of proposed changes to the medical loss ratio calculation and Part 2 discusses the standardized benefit requirements that the FEHB mentioned earlier this week.
From the health disparity front, the Agency for Healthcare Research and Quality issued its 2021 report on national healthcare qualities and disparities, the nineteen report in this series. Here’s a link to the report’s executive summary.
From the New Year’s Eve front, the New York Times made available this guidance:
“Many public health experts agree that you can celebrate with your favorite people as long as you’re taking precautions.
The House and Senate are moving swiftly toward passing legislation introduced Tuesday that would limit Senate debate on debt limit legislation to 10 hours, creating a loophole in that chamber’s 60-vote legislative filibuster rules.in his Morning’s column in the New York Times andor a vote Tuesday night, Speaker Nancy Pelosi wrote in a letter to lawmakers, along with a revised fiscal 2022 defense policy bill that would be sent to the Senate separately.
The two legislative vehicles are unrelated bills that previously passed both chambers with amendments; using them to carry the budget and defense measures allows Senate leaders to avoid a time-consuming motion to proceed in that chamber. Instead, only one cloture vote per bill would be needed.
Senate Minority Leader Mitch McConnell, who briefed his caucus at lunch on Tuesday, blessed the arrangement in comments to reporters. He said the new debt limit measure could pass as early as Thursday, after the Senate clears the bill to create an expedited process.
“I’m confident that this particular procedure coupled with the avoidance of Medicare cuts will achieve enough Republican support to clear the 60 vote threshold,” McConnell said.
If Congress accomplishes all of these actions, it may just call it quits at the end of this week which was the original schedule. A delay in Medicare cuts is extremely important to the medical facility and provider professional associations.
On the COVID vaccine mandate front, a federal district judge in Georgia today ordered a nationwide preliminary injunction against enforcement of the federal government contractor mandate per Govexec which adds
The Biden administration’s vaccine rule for private businesses and vaccine mandate for Medicare- and Medicaid-certified providers and suppliers are also temporarily blocked by courts. So far, the vaccine mandate for federal employees has not been stopped.
This PI applies to all FEHB plan contractors and subcontractors.
From the Delta variant front, David Leonhardt who is the FEHBlog’s go-to COVID columnists recommends in his Morning column in the New York Times today
For now, vaccinated people can reasonably continue to behave as they were — but many should feel urgency about getting booster shots. Older people and others who are vulnerable, like people receiving cancer treatment, should continue to be careful and ask people around them to test frequently.
Unvaccinated people remain at substantial risk of serious illness. About 1,000 Americans have been dying each day of Covid in recent weeks, the vast majority of them unvaccinated.
From the Rx coverage front, Drug Channels released its
annual deep dive into employer-sponsored coverage for prescription drugs.
For 2021, employers backed away slightly from high-deductible health plans. However, their pharmacy benefit designs increased the use of coinsurance for specialty and fourth-tier drugs. These designs have significantly raised patients’ out-of-pocket obligations and are likely to have reduced adherence.
Manufacturers’ patient support funds help offset patients’ higher expenses. But employer plans are rapidly adopting copay accumulators, which allow payers and PBMs to absorb these funds.
From the health benefits trends front, the Society for Human Resource Management informs us that
Three-quarters of health insurers say that managing a health plan’s network of care providers is critical to controlling rising medical costs.
The finding is from consultancy Willis Towers Watson’s 2022 Global Medical Trends Survey, conducted from July through September 2021 among 209 leading insurers globally.
The plan features mostly likely to keep costs under control, insuers said, were:
— Contracting with high-quality, cost-competitive doctors and hospitals for in-network coverage (cited by 75 percent of respondents).
— Requiring preapproval for scheduled inpatient services (67 percent).
— Offering telehealth services (63 percent).
Telehealth or virtual care rose to the third spot from the fifth position last year, “a sign that more insurers see potential savings from remote options for diagnosing and treating patients,” according to the report.
Yesterday was the deadline for submitting public comments on the the second No Surprises Act interim final rule, which concerns the independent dispute resolution process. For a ying and yang take on the comments, here are links to American Hospital Association’s comments and to AHIP’s comments.
Let’s wrap it up with a bunch of HHS tidbits
HHS today announced its plan to “propose a national “Birthing-Friendly” hospital designation on the Hospital Compare section of the CMS Care Compare website, and also encourages states to provide 12 months postpartum coverage to people with Medicaid and CHIP.”
The National Institutes of Health reported that “Researchers identified brain cells that help suppress hunger and regulate food intake” and that “The findings may help lead to better treatments for excessive eating and obesity.”
NIH also announced “The winners of the National Institutes of Health’s Decoding Maternal Morbidity Data Challenge were announced today in conjunction with the White House “day of action” on maternal health. Twelve prizes were awarded to seven winners who proposed innovative solutions to identify risk factors in first-time pregnancies. Without a prior pregnancy for comparison, it is difficult to identify risks for adverse pregnancy outcomes. Early detection of these risks can help reduce pregnancy complications and prevent maternal deaths.”
The Agency for Healthcare Quality and Researched released
A final report on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ. Required by the Patient Safety Act of 2005, the report was made available for public review and comment and review by the National Academy of Medicine. It outlined several strategies to accelerate progress in improving patient safety, including using analytic approaches in patient safety research, measurement, and practice improvement to monitor risk; implementing evidence-based practices into real-world settings through clinically useful tools and infrastructure; encouraging the development of learning health systems that integrate continuous learning and improvement in day-to-day operations; and encouraging the use of patient safety strategies outlined in the National Action Plan by the National Steering Committee for Patient Safety.
The Centers for Disease Control “announced today that it has awarded $22 million to nearly 30 organizations around the world to combat antimicrobial resistance (AR) and other healthcare threats through the establishment of two new networks—the Global Action in Healthcare Network (GAIHN) and the Global AR Laboratory and Response Network (Global AR Lab & Response Network).”
Citing mounting evidence of ongoing harm, U.S. Surgeon General Vivek H. Murthy on Tuesday issued a public health advisory on the mental health challenges confronting youth, a rare warning and call to action to address what he called an emerging crisis exacerbated by pandemic hardships.
Symptoms of depression and anxiety have doubled during the pandemic, with 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms, according to Murthy’s 53-page advisory. There also appear to be increases in negative emotions or behaviors such as impulsivity and irritability — associated with conditions such as attention deficit hyperactivity disorder or ADHD.
And, in early 2021, emergency department visits in the United States for suspected suicide attempts were 51% higher for adolescent girls and 4% higher for adolescent boys compared to the same time period in early 2019, according to research cited in the advisory.
From the Delta variant vaccination and treatment front, AHIP informs us that
The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) held a meeting to discuss the safety and efficacy of the COVID-19 antiviral treatment molnupiravir, developed by Merck and Ridgeback Biotherapeutics. The oral treatment is the first COVID-19 therapy that could be taken outside a clinical setting. The Committee reviewed data by Merck and the FDA on molnupiravir’s toxicity, efficacy, and safety, and discussed concerns over treatment of pregnant persons and the potential effects of viral mutation and evolution. Initial data from Merck showed that molnupiravir reduced the hospitalization risk among high-risk patients by 48%, however data released November 26 suggests the reduction in hospitalizations may be closer to 30%.
The Committee voted 13-10 that the potential benefits of molnupiravir outweigh the known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Given concerns about the potential harmful effects on fetal development, Committee members further stressed the need for pregnancy testing prior to taking molnupiravir.
The FDA will review AMDAC’s conclusions and formally decide whether or not to grant emergency use authorization (EUA) to molnupiravir in the coming weeks.
Acting Food and Drug Commissioner Dr. Janet Woodcock announced
The [Food and Drug Administration] is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more.
Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.
The emergence of a new COVID-19 variant, named Omicron (B.1.1.529), is putting pressure on diagnostics manufacturers who test for the presence of SARS-CoV-2 to ensure its results are not impacted. Thermo Fisher Scientific, Qiagen and Lucira Health were quick to claim their tests can detect the emerging variant.
The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.
While the new variant might evade the antibodies generated in reaction to the vaccines, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.
“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Dr. Sahin said in an interview Tuesday.
In that regard, Govexec.com notes that “Pfizer/BioNTech are expected to apply for approval for their booster shots for 16 and 17 year olds and the FDA “could authorize extra shots within roughly a week,” The New York Times reported on Monday.”
In COVID vaccine mandate legal news, the FEHBlog was quite surprised to read in Govexec that
On Tuesday, a federal judge temporarily blocked the COVID-19 vaccine mandate for federal contractors in three states.
U.S. District Judge Gregory Van Tatenhove, who serves in the U.S. District Court for the Eastern District of Kentucky, issued a preliminary injunction for the vaccine mandate for federal contractors and subcontractors in all covered contracts in Kentucky, Ohio and Tennessee. Following President Biden’s issuance of the executive order on the mandate on September 9, there have been numerous legal challenges.
“This is not a case about whether vaccines are effective. They are. Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can,” wrote Van Tatenhove. “The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors? In all likelihood, the answer to that question is ‘no.’”
A federal judge issued a preliminary injunction on Tuesday to halt the start of President Biden’s national vaccine mandate for health care workers, which had been set to begin next week.
The injunction, written by Judge Terry A. Doughty, effectively expanded a separate order issued on Monday by a federal court in Missouri. The earlier one had applied only to 10 states that joined in a lawsuit against the president’s decision to require all health workers in hospitals and nursing homes to receive at least their first shot by Dec. 6 and to be fully vaccinated by Jan. 4.
“There is no question that mandating a vaccine to 10.3 million health care workers is something that should be done by Congress, not a government agency,” Judge Doughty of U.S. District Court for the Western District of Louisiana wrote. He added: “It is not clear that even an act of Congress mandating a vaccine would be constitutional.”
The plaintiffs, he added, also have an “interest in protecting its citizens from being required to submit to vaccinations” and to prevent the loss of jobs and tax revenue that may result from the mandate.
It looks like the vaccine mandates are creating more work Judicial Panel on Multidistrict Litgation.
From the HIV front —
The National Institutes of Health tells us that “Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.”
The Centers for Disease Control informs us that “Improving access to and use of HIV services for [men having sex with men] MSM, particularly Black MSM, Hispanic/Latino MSM, and younger MSM, is essential to ending the HIV epidemic in the United States.”
Here is a link to the CDC’s website on HIV treatment.
From the tidbits department —
Fierce Healthcare calls to our attention the fact that
The Business Group on Health has identified several trends in health and wellness to keep an eye on next year, which they say highlight the sense of “collective urgency” employers and their workforces feel.
For example, the organization echoed an ongoing industry trend: virtual care isn’t going away following a massive increase in use during the pandemic. However, the Business Group argues that taking full advantage of its strengths will require integration with in-person offerings.
The Society for Human Resource Management, having lost respect for the Delta variant, discusses how the Omicron variant may impact the workplace.
AHRQ tells us that “Patients with retail medications to treat opioid use disorders spent on average 3.4 times more for out-of-pocket prescriptions than the rest of the U.S. population, according to an AHRQ-study published in the Journal of Substance Abuse and Treatment.” No bueno.
Also “AHRQ has released an updated Chartbook on Rural Healthcare that shows that people in rural areas face difficulty getting timely, high-quality, affordable healthcare.
HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules now has settled in OCR’s favor 25 complaints against healthcare providers for allegedly violating HIPAA’s individual right to access medical records.
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