Novavax’s product is a protein subunit vaccine that contains the SARS-CoV-2 spike protein plus an adjuvant to enhance the recipient’s immune response. The product is to be administered as a two-dose primary series given 3 weeks apart.
Becker’s Hospital Review discusses the White House’s latest Covid strategy.
From the No Surprises Act front, the U.S. Office of Personnel Management issued a carrier letter today on various NSA topics affecting FEHB carriers.
From the Rx coverage front
The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.
On July 26, 2022, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Medical Advisor Francesca Beaudoin, MD, PhD, MS will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
From the Dobbs front, Healthcare Dive has created a state abortion law tracker and the Department of Human Resources announced the steps that its agencies have taken to protect reproductive rights.
From the research studies department, the National Institutes of Health announced today
The percentage of methadone-involved overdose deaths relative to all drug overdose deaths declined from January 2019 to August 2021, according to a new study. Access to methadone, a medication to treat opioid use disorder, was expanded at the start of the COVID-19 pandemic to allow more patients to take home doses, rather than visit a clinic daily. These data indicate that broader access to treatment was not associated with harms. While drug overdose deaths both with and without methadone increased in the month of March 2020, overdose deaths that did not involve methadone continued to increase in the months after the policy changes, while overdose deaths involving methadone held steady.
Published today in JAMA Psychiatry, this study was a collaborative effort led by researchers at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and the National Center for Injury Prevention and Control, part of the Centers for Disease Control and Prevention.
House Rep. Lloyd Doggett, D-Texas, introduced the Assuring Medicare’s Promise Act on Monday aimed at redirecting income tax revenue as a solution to Medicare’s hospital fund that will run out of money in 2028. * * *
The legislation aims to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. * * *
If the bill is implemented, Doggett expects Medicare Trust Fund solvency to be extended through 2040.
The legislation comes as Congress is taking a sharper eye at ways to shore up Medicare’s finances. The Senate, for instance, is eyeing closing similar loopholes for NIIT and would extend Medicare solvency for another three years, according to a CNN report.
Senate Democrats are working on a deal to give Medicare the power to negotiate lower drug prices, and the tax provisions could be included.
From the Omicron and siblings front, we have mixed bag Covid news from the Wall Street Journal.
Covid-19 is circulating widely as the BA.5 Omicron subvariant elevates the risk of reinfections and rising case counts, spoiling chances for a summer reprieve from the pandemic across much of the U.S.
Covid-19 levels are high in a fifth of U.S. counties, according to the Centers for Disease Control and Prevention’s metric based on case and hospital data, a share that has been mostly rising since mid-April. BA.5 is estimated to represent nearly two in three recent U.S. cases that are averaging just more than 100,000 a day, CDC data show. The true number of infections may be roughly six times as high, some virus experts said, in part because so many people are using at-home tests that state health departments largely don’t track. * * *
The pace of hospital admissions for Covid-19-positive patients has recently sped up, federal data indicate. The seven-day moving average for confirmed Covid-19 patients in hospitals has topped 34,000, federal data show, up from a low near 10,000 in April but far below January’s record peak topping 150,000.
Many of the hospitalizations are cases where patients test positive after being admitted for other reasons. Deaths are hovering around 300 to 350 a day, Dr. Jha said Tuesday. This is much closer to historic lows than highs, though he called the current level unacceptable.
The reduced threat is one reason a pandemic-fatigued populace is less likely to change behavior when cases are high, said Robert Wachter, chairman of the department of medicine at the University of California, San Francisco. * * * “Part of what motivated people to be super careful for a long time was the fear that I’m going to die of this thing,” Dr. Wachter said. “I think people have less fear of that, and that’s not inappropriate.”
From the U.S. healthcare business front
MedPage Today identifies the heavy hitters in Healthcare who topped the recently announced Fortune 500.
Insurance News Net reports that “Commercial health insurers suffered a 90% decrease in underwriting income last year as fewer people signed onto group health and instead moved into individual coverage on an exchange or a Medicaid program, and COVID care requirements far exceeded expectations. * * * Large, diversified carriers fared best, according to Antonietta Iachetta, AM Best senior financial analyst. “Smaller carriers with concentrations in the commercial business found themselves in an especially difficult position — more than half of insurers with capital and surplus under $50 million posted underwriting losses in 2021, the highest share of companies with losses for that group since 2012,” Iachetta said.”
Beckers Payer Issues reviews the history of Mark Cuban’s PBM Cost Plus Drug Co. to identity barriers to competing in that market.
Fierce Healthcare tells us, “Optum has quietly teamed with Red Ventures on a new joint venture focused on consumer health. The venture, called RVO Health, covers a mix of assets from both parties, including Optum’s Store and Perks and Red Ventures’ Healthline Media and Healthgrades. Virtual coaching platforms Real Appeal, Wellness Coaching and QuitForLife, news first reported by Axios. Through these elements, RVO includes a slew of consumer offerings, including doctor ratings through Healthgrades, medical information and communications from Healthline, Optum Perks’ prescription savings card and home delivery of health and wellness products through Optum Store.”
From the U.S. healthcare front
The American Hospital Association reports
After declining in recent years, antimicrobial-resistant infections starting during hospitalization grew 15% from 2019 to 2020, the Centers for Disease Control and Prevention reported today, based on limited data for 2020.
“During the pandemic, hospitals experienced personal protective equipment supply challenges, staffing shortages, and longer patient stays,” the agency notes. “Hospitals also treated sicker patients who required more frequent and longer use of medical devices like catheters and ventilators. The impact of the pandemic likely resulted in an increase of healthcare-associated, antimicrobial-resistant infections.”
More than 90% of U.S. hospitals in 2020 had an antibiotic stewardship program aligned with CDC’s Core Elements of Hospital Antibiotic Stewardship, CDC said. The AHA released an antibiotic stewardship toolkit in 2014 to help hospitals and health systems enhance their antimicrobial stewardship programs based on the CDC’s core elements, and in 2017 partnered with CDC on guidance to help small and critical access hospitals implement programs to improve antibiotic prescribing and use and reduce the threat of antibiotic-resistant infections. For more AHA resources to promote the appropriate use of medical resources, click here.
The CDC’s July 2022 Diabetes Insider called attention to its Diabetes and Your Skin website.
From the mental healthcare front, an expert contributor to HR Morning expresses his views on what employees want in mental health coverage from their employer-sponsored health plans.
From the artificial intelligence front, the Journal of AHIMA looks at the administrative cost savings potential of artificial intelligence.
BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Timereported July 11.
Two cases were detected in California and one in Washington as of July 8, according to data from Helix, which works with the CDC on viral surveillance.
The subvariant is gaining traction in India and has also been detected in 10 other countries.
Better start looking over your shoulders Omicron subvariants BA.4 and BA.5.
Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries.
The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week.
In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.
In the U.S., however, Moderna will develop a different dual-target booster, mRNA-1273.222, which goes after both the ancestral strain and the BA.4 and BA.5 subvariants of Omicron. These subvariants, which are nearly identical to each other for the purposes of a vaccine, now account for most new cases of Covid-19 in the U.S.
What about BA.2.75?
An announcement from HHS today points to an FDA emergency use authorization of the traditionally developed Novovax in the near future.
The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.
Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.
Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.
The company has submitted an emergency use authorization request to the US Food and Drug Administration to use sabizabulin to treat COVID-19.
Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.
Benefits Pro calls to our attention health plan stop-loss insurer Sun Life’s top 10 high-cost claim conditions report.
Sun Life’s latest report saw a 354% increase in the number of COVID-19 claims from 2020 to 2021 [the Delta variant] —specifically, 107 claims to 486 claims. Total spend also rose from $30.4M to $114.0M, although the average cost for treatment went from $283.7K to $231.2K over the same period, amounting to an 18% decrease. Even so, COVID-19 landed (“somewhat ironically,” the study stated) at number 19 on Sun Life’s top 20 list of high-cost claim conditions over four years. This is significant, as every other condition on the list has amassed four years worth of claims to COVID’s two, underlining the severity of the pandemic.
Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.
HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.
HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.
At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.
FDA approval of OTC contraceptives should have been approved years ago, in the FEHBlog’s opinion.
From the SDOH front, Health Payer Intelligence informs us
The Association for Community Affiliated Plans (ACAP) has initiated a center designed to spur new ideas about how to address social determinants of health, according to a press release that HealthPayerIntelligence received by email.
“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, chief executive officer of ACAP, shared in the press release.
“Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades. This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment.”
Bravo.
The Wall Street Journal reminds us that the new three-digit 988 suicide hotline launches on Saturday, July 16.
Health officials preparing to broaden the reach of a national mental-health crisis line are working to strengthen an overstretched network of call centers that didn’t connect with about one in six callers in recent years, a Wall Street Journal data review showed.
The National Suicide Prevention Lifeline will transition on July 16 to a three-digit number for calls and texts, 988, from a 10-digit number that has operated since 2005 in coordination with local crisis centers. The line’s operators, including the Substance Abuse and Mental Health Services Administration and the nonprofit Vibrant Emotional Health, said they expect an increase in calls to the shorter and more memorable 988 number during the next year. Stress, suffering and disruption of routines during the pandemic has worsened many people’s mental health, clinicians have said.
Congress returns on Monday with Democrats aiming to revive central pieces of President Biden’s stalled economic agenda while trying to keep on track a separate, bipartisan bill targeted at boosting competitiveness with China that top Republicans are threatening to block.
House Democrats also are set to roll out legislation responding to the Supreme Court ruling ending federal abortion protections. The push could include legislation to write into law the right to an abortion before fetal viability, as well as a bill intended to block any state attempts to criminalize travel for the purpose of getting an abortion. The bills wouldn’t have enough support to pass the Senate.
The three-week work period may be the last chance lawmakers have for a legislative victory before campaigning begins in earnest for midterm election races across the country. Republicans are heavily favored to win back control of the House this fall, while the Senate is seen as a tossup.
From the Omicron and siblings front, MedTecHDive Dive informs us
A single antigen test may only be able to correctly identify the virus 60% of the time in patients who have the omicron variant and who display symptoms of the disease, Tim Stenzel, director of the Food and Drug Administration’s Office of In Vitro Diagnostics and Radiological Health, said during a [recent[ meeting on testing.
The FDA is seeing an increase in samples with the omicron variant that have a relatively low viral load, also referred to as a low positive. “Instead of seeing the usual 10% to 20% low positives in clinical studies last year, we saw a jump to 30% to 40% low positives,” Stenzel said. “When you have 40% low positives… you’re going to see a really big hit in sensitivity.”
The lower sensitivity means people testing for Covid should use multiple antigen tests to rule out a negative result, with 24 to 48 hours between tests, according to the regulator.
From the unusual viruses front, Medpage Today discusses the ties between cases of monkeypox and syphillis.
Syphilis is a known sexually transmitted infection (STI) that can manifest in lesions in the groin area and can transmit through bodily fluid. The genital sores associated with syphilis can make it easier to transmit other diseases such as HIV — and especially pressing at the current moment, genital sores or lesions are also common transmission pathways for the current B1 monkeypox outbreak. While monkeypox has not technically been categorized as an STI, there have been reports of some monkeypox patients also having STIs.
By scaling up testing and treatment for syphilis, we can better identify people who may be more likely to get and transmit monkeypox. Additionally, because the lesions in the genital region can be difficult to distinguish from those associated with syphilis, testing for both conditions is important.
The incidence of syphilis has been increasing in the U.S. In 2020 alone, there were more than 130,000 new cases of syphilis. While 43% of the new infections occur in men who have sex with men, cases have also been rising in heterosexual men and women, and over 50% of the new infections were in people ages 15 to 24.
From the U.S. healthcare front, Fierce Healthcare tells us
Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday. * * *
HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.
Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.
UnitedHealth Group [Optum’s parent] is aiming to address 600 million gaps in care for its members by 2025.
The healthcare and insurance giant released its annual Sustainability Report last week, where it outlined three strategic goals to improve health outcomes and affordability.
Alongside addressing care gaps, the company said it wants to ensure at least 85% of its members receive preventive care each year by 2030 as well as to make sure 55% of outpatient surgeries and radiology services are provided in high-quality, cost-efficient sites of care by 2030.
The CMS’ innovation center has found evidence of implicit bias in three payment models as the agency takes an harder internal look at how its policies might perpetuate health disparities.
The use of certain risk assessment and screening tools, provider processes and payment design algorithms caused some beneficiaries to be unintentionally excluded from the Kidney Care Choices Model, Comprehensive Care for Joint Replacement Model and Million Hearts Cardiovascular Risk Reduction Model, according to a new article published in Health Affairs from Center for Medicare and Medicaid Innovation researchers.
“These findings are troubling” due to limiting access to model participation and stymied efforts to evaluate the models, researchers wrote. CMMI has taken initial steps to address existing bias, and has begun developing a guide to screen and mitigate bias in existing and future models prior to launch, according to the article.
Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week are the FEHBlog’s weekly charts of new Covid cases for 2022:
The CDC’s Weekly Review of its Covid Statistics observes “As of July 6, 2022, the current 7-day moving average of daily new cases (106,549) decreased 3.9% compared with the previous 7-day moving average (110,875).”
Here is the CDC’s weekly chart of new Covid hospital admissions
The CDC’s Weekly Review comments “The current 7-day daily average for June 29–July 5, 2022, was 5,080. This is a 3.1% increase from the prior 7-day average (4,930) from June 22–28, 2022.”
Here is the FEHBlog’s weekly chart of new Covid deaths for 2022
The CDC’s Weekly review observes “The current 7-day moving average of new deaths (273) has decreased 20.9% compared with the previous 7-day moving average (345).”
Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in the 51st week of 2020 through the 27th week of 2022.
Overall, about 260.3 million people, or 78.4% of the total U.S. population, have received at least one dose of vaccine. About 222.5 million people, or 67.0% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 106.6 million people have received a booster dose,** but 50.1% of the total booster-eligible population has not yet received a booster dose.
The American Hospital Association adds
The Food and Drug Administration today granted full approval of Pfizer’s COVID-19 vaccine for young teens, covering the age group spanning 12 to 15 years old. FDA said the vaccine, which has been administered in two-dose regimens to nearly 9 million Americans, earned full approval following its “rigorous analysis and evaluation of the safety and effectiveness data.” The approval does not apply to booster doses for that age group.
The CDC’s Weekly Review also provides the following Communities news:
As of July 7, 2022, there are 666 (20.7%) counties, districts, or territories with a high COVID-19 Community Level, 1,218 (37.8%) counties with a medium Community Level, and 1,331 (41.3%) counties with a low Community Level. Compared to last week, this represents an increase (+1.3 percentage points) in the number of high-level counties, an increase (+2.4 percentage points) in the number of medium-level counties, and a corresponding decrease (−3.7 percentage points) in the number of low-level counties. 49 out of 52 jurisdictions* had high- or medium-level counties this week. Rhode Island, New Hampshire, and Washington, D.C., are the only jurisdictions to have all counties at low Community Levels.
From the Medicare front, Becker’s Hospital Review points out seven things to know about the CMS 2023 Medicare Part B physician payment rule issued yesterday. The lead item has grabbed the medical community’s attention.
The proposed physician fee schedule conversion factor for 2023 is $33.08, down from $34.61 in 2022. The proposal considers a statutory requirement that the conversion factor for 2023 remain flat as well, due to the expiration of the 3 percent increase in physician fee schedule reimbursement payments in 2022 that was required in the Protecting Medicare and American Farmers From Sequester Cuts Act.
For FEHB patients with primary Medicare Part B coverage, this reduction will amount to a cost shift from Medicare to FEHB if implemented by the final rule.
From the No Surprises Act front, Morning Consult offers the results of a survey finding that
One in 5 U.S. adults say they have received an unexpected medical bill this year, according to a new Morning Consult survey that underscores the prevalence of sticker shock in health care — even after federal efforts to combat it.”
The Morning Consult’s survey needs to be taken with a grain of salt because 22% of the surveyed adults are Medicare age (see Survey, p. 131), and the No Surprises Act does not apply to Medicare.
From the Rx coverage front, the PBM’s lobby PCMA compliments the Biden Administration for
taking real action to reduce prescription drug costs. Drug manufacturer pricing strategies that include patent thickets on certain brand drugs unfairly protect those drugs and biologics from generic and biosimilar competition.
The United States Patent and Trademark Office’s and the Food and Drug Administration’s enhanced review power for applications for drug patents that simply don’t deserve an intellectual property extension is a positive step toward eliminating patent thickets and bringing more competition to the marketplace.
That is thoughtful action by the PTO and FDA.
From the Dobbs front, the White House outlines an executive order the President plans to sign in response to the Supreme Court decision.
From the mental health front, Health Payer Intelligence discusses an initiative by “CVS Health and its payer arm, Aetna, [to] expand its existing program with Psych Hub, advancing its efforts around adolescent suicide prevention.” Bravo.
From the artificial intelligence front, the Wall Street Journal reports “Using advanced analytics and AI, health insurers are building targeted medical advice for customers. Now comes the hard part: Getting them to respond. ‘There’s an art to that data communication,’ one doctor says.” Fascinating read.
From the Capitol Hill front, STAT News provides more information on the Senate Democrats’ drug pricing proposal
The text released Wednesday is similar to a sweeping package that passed the House last year — it would allow Medicare to negotiate prices with drugmakers, it would protect seniors from especially exorbitant drug costs, and it would discourage drugmakers from raising their prices dramatically.
There are some notable changes that will affect when patients see savings, how the drug development pipeline works, how certain patients will pay for insulin, and how the new prices would affect safety-net programs and Medicaid.
The Washington Examiner emphasizes The proposal * * * lacks language included in the lower chamber’s bill that would cap insulin prices for people with diabetes at $35 a month.”
Senate Democrats are taking a gamble and removing all of the provisions that would have lowered patients’ insulin prices out of the bill, to allow a separate, bipartisan effort led by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) to advance.
Now, the HHS secretary would still be allowed to negotiate insulin prices, but only within the parameters and limits of the regular process. Shaheen and Collins’ bill relies on drugmakers voluntarily lowering their prices in exchange for banning rebates for the products.
The brand drug lobby PhRMA blasted the out-of-pocket cost changes, claiming that “Democrats weakened protections for patient costs included in previous versions, while doubling down on sweeping government price-setting policies.”
Six months after regulators issued an emergency use authorization for Paxlovid, physicians say they still have significant questions about prescribing guidelines for the leading treatment for high-risk Covid patients.
STAT spoke with providers who said they and their colleagues aren’t on the same page about when to prescribe Paxlovid or the criteria that separates those who need it from those who do not. They also said it is unclear whether they can give a second course when patients test positive again after taking Paxlovid, a phenomenon known as a rebound. And nearly all the experts who spoke with STAT said that they are clamoring for more data on rebounds, which is complicating and sometimes changing their calculus about when to give the drug.
“There is a real dearth of evidence right now out there, and obviously there’s a lot of confusion,” said Jonathan Li, a physician at Brigham and Women’s Hospital and virology researcher at Harvard Medical School who is also a member of the Covid-19 Treatment Guidelines Panel. “And even amongst people who are immersed in the literature, and who are infectious disease experts, you’ll see actually a fairly wide range in opinions.” * * *
“Pretty much everybody meets the EUA criteria. They made it very, very, very broad,” said David Smith, a professor, physician, and virology researcher at the University of California, San Diego. In a single week in May, over 160,000 Paxlovid prescriptions were filled.
Physicians generally agree that certain high-risk patients — including people who are unvaccinated or those over 65 with multiple comorbidities — should always be prescribed the drug. But the broader eligibility makes it difficult for some physicians to decide who should or should not receive Paxlovid. A child is not likely to need it, but what about a healthy 50-year-old man? A 65-year-old woman? The experts STAT spoke with didn’t agree.
According to Lawrence Kleinman, MD, MPH, of the department of pediatrics at Rutgers Robert Wood Johnson Medical School in New Jersey, we need to take our time in defining long COVID, whether it’s with a checklist, an algorithm, or an entry for the medical dictionary.
“If we defined it a certain way and we missed something in that initial definition, then there will be silence on that until someone comes around and does a postmortem on our analysis,” Kleinman, who is also the lead researcher in the Rutgers pediatric hub of the NIH’s nationwide RECOVER study, told MedPage Today. “We want to avoid that to the extent that’s possible.”
He said more research and data collection are needed before the work of defining long COVID is possible in a clinically meaningful way. At the moment, he noted, there isn’t even clear criteria for where to start.
For example, should researchers focus on setting a specific number of days a person experiences fatigue after an acute COVID infection? If so, what should those ranges look like — fatigue after 30 days? As he pointed out, there are not enough data to develop the foundational elements needed for researchers to piece together a practical definition just yet.
Nothing is simple.
From the Medicare front, the American Hospital Association reports
The Centers for Medicare & Medicaid Services today released its calendar year 2023 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor to $33.08 in CY 2023, as compared to $34.61 in CY 2022, which reflects the following: the expiration of the 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment. In addition, CMS proposes to delay for one year (until Jan. 1, 2024) the implementation of its policy to define the substantive portion of a split (or shared) visit based on the amount of time spent by the billing practitioner. Under this policy, if a non-physician practitioner performed at least half of an E/M visit and billed for it, Medicare would only pay 85% of the PFS rate.
CMS proposes numerous policy changes to the Medicare Shared Savings Program. For example, it would modify the manner in which accountable care organizations’ benchmarks are calculated to help sustain long-term participation and reduce costs. It also would provide increased flexibility for certain smaller ACOs to share in savings. The rule also proposes updates to MSSP quality-measurement policies, including a new health equity adjustment that would award bonus points to ACOs serving higher proportions of underserved or dually-eligible beneficiaries.
For the Quality Payment Program, CMS proposes five new, optional Merit-based Incentive Payment System Value Pathways that would be available beginning in 2023. These MVPs align the reporting requirements of the four MIPS performance categories around specific clinical specialties, medical conditions or episodes of care. CMS also proposes refinements to the MIPS subgroup reporting process, an increase to the quality data completeness threshold, and changes to the requirements and scoring of the Promoting Interoperability category. The proposed rule also includes requests for input on policy ideas for advancing health equity and transitioning to digital quality measurement.
The FDA suddenly reversed course this week on its efforts to ban Juul e-cigarette sales, an embarrassing about-face that calls into question the reasoning behind the agency’s initial decision, experts said.
Tuesday evening, the Food and Drug Administration announced it was giving Juul’s application for its vaping products a second look because of “scientific issues … that warrant additional review.” The move came less than two weeks after the FDA made international headlines for ordering all of the vaping giant’s products off the market, prompting praise from lawmakers and advocates alike.
The FDA previously said that Juul “did not provide [sufficient] evidence and instead left us with significant questions,” which prevented the agency from granting its application. But now, it seems, the FDA is acknowledging there is additional information in Juul’s application that regulators didn’t adequately consider.
Fertility benefits and family-building programs have become table stakes for employers looking to support their workforce, but an increasing number of providers and employees are working to offer care during the next stage of reproductive health: menopause.
Nine out of 10 working women said menopause affects their work performance, according to a survey by AARP, which estimates that companies lose $150 billion a year in lost productivity as a result. Yet, 99% of women in the U.S. don’t have access to an employer-sponsored menopause care benefit.
“This is an area that nobody has really focused on, and there isn’t much out there available for employees,” says Maya Bodinger, vice president of business development at P.volve. “The menopause transition can be anywhere from four years to 12. This is not just a year or two like how we traditionally think about reproductive health.”
Cesarean deliveries have increased in the U.S. over the last few years, driven by a rise in patients who underwent first-time C-sections, according to a CDC report.
While the rate of primary C-sections fluctuated from 2016 to 2019, it increased from 2019 to 2021 among women in all age groups, reported Michelle Osterman, MHS, of the CDC’s National Center for Health Statistics.
The repeat cesarean rate, however, which captures patients who have multiple procedures, steadily decreased by around 1% each year from 2016 to 2021 (87.6% to 85.9%), Osterman noted. Repeat cesarean delivery rates decreased specifically for women ages 25 to 39, those who identified as white or Hispanic, and those with full- or late-term pregnancies.
The increase in overall C-sections likely would have been higher if not for the decrease in repeat procedures, she said.
“Because 7 to 9 out of 10 pregnant folks with a prior cesarean will have a repeat cesarean, we can anticipate an overall climb in the overall cesarean delivery rate for the years ahead,” Kjersti Aagaard, MD, PhD, an ob/gyn at Baylor College of Medicine and Texas Children’s Hospital in Houston, told MedPage Today.
Finally, the FEHBlog notes that benefits consultant Tammy Flanagan has released the second part of her three-part story on a typical federal employee’s experience with the federal government’s retirement process. The report appears in Govexec.
Senate Democrats have narrowly reached a deal on legislation to give Medicare the power to negotiate for lower drug prices.
The Senate released text Wednesday (PDF) on the deal that also repeals the controversial Part D rebate rule and installs a cap on monthly cost-sharing payments for Part D and Medicare Advantage plans.
The legislative text shows that starting in 2026, the Department of Health and Human Services will choose 10 drugs eligible for negotiation. The next year, the number of eligible drugs will increase to 15, and in 2029 and every year after by 20.
The sole-source drugs subject to negotiation will be chosen based in part on their total spending under Medicare Parts B and D. There is an exception for small biotech drugs from 2026 through 2028 such as vaccines and excludes certain orphan drugs as well.
Roll Call adds “Congress is fast approaching its scheduled August recess, followed by peak campaign season, so Democratic lawmakers only have a few more weeks in session to push their legislative priorities before they could lose control of either chamber in November.”
From the Omicron and siblings front, the American Hospital Association tells us
The Food and Drug Administration today authorized state-licensed pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) to patients as a treatment for those at high risk of severe COVID-19. Because Paxlovid must be taken within five days of symptom onset, the change could spur expanded access and more-timely treatment of eligible patients. The change was made through an amended emergency use authorization.
This standing order approach should accelerate the continuing rollout of test to treat locations.
Governments, drugmakers and vaccination sites are discarding tens of millions of unused Covid-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce. * * *
In the U.S., about 90.6 million Covid-19 doses have been wasted, or 11.9% of the more than 762 million Covid-19 vaccine doses delivered since the shots became available in late 2020, according to the Centers for Disease Control and Prevention.
The wastage rate has accelerated recently: Some 12 million of the discarded doses have been thrown out since late May.
The disposals come during a significant drop in demand for Covid-19 vaccines, even with young children recently becoming eligible. The seven-day moving average of doses administered daily in the U.S. was about 155,000 as of June 21, down from about 1.1 million on Jan. 1 and the peak of about 3.5 million daily in April 2021.
Partly driving the wastage, health experts said, is the way the Covid-19 vaccines are packaged in multiuse vials containing from five to 20 doses. Once opened, the vials generally must be used within about 12 hours of opening or the remaining doses discarded.
From the telehealth front
Healthcare Dive reports
COVID-19 made its way back into the top five telehealth diagnoses nationally on Fair Health’s monthly tracker in April for the first time since January, according to the report out Wednesday.
Every U.S. census region except the South saw COVID-19 return to the top five diagnoses list, and the uptick is in line with rising cases reported in April by the Centers for Disease Control and Prevention.
Telehealth use overall also rose nationally and in every region after two months of decline, the report found.
Teladoc is further building out its primary care offering, Primary360, with new services that enhance care coordination and grow in-home options.
Primary360 will now provide care coordination support and health plan in-network referrals alongside free same-day medication delivery from Capsule and in-home, on-demand phlebotomy services backed by Scarlet Health, according to an announcement Wednesday from Teladoc.
The new care coordination capabilities will allow Primary360’s care team to take a “holistic” view of the patient’s coverage and make streamlined referrals to Teladoc services they can access. The care team can also then ensure a patient is referred to an in-network provider when in-person services are necessary.
mHealth Intelligence reports “The burgeoning mental health epidemic in America is widespread across age groups, but the youth have faced a particularly challenging time amid the COVID-19 pandemic. As the youth mental health crisis reaches new heights, providers are increasingly turning to telehealth to help expand access to behavioral healthcare.”
In the same spirit, Health Data Management discusses best practices for hospitals interested in providing acute care at home services.
From the U.S healthcare front, Beckers Hospital Review calls our attention to the fact that “Money, formerly Money Magazine, and Leapfrog Group collaborated for their first shared ranking of “best hospitals” to help consumers make decisions about which healthcare institutions are best for their money. The inaugural list was released July 6 and can be found in full here.” Check it out.
From the fraud, waste and abuse front, Healthcare Dive reports
The federal government won or negotiated more than $5 billion in healthcare fraud judgments and settlements in its 2021 fiscal year, the largest amount ever in the history of the HHS and Department of Justice’s fraud and abuse enforcement program.
Due to those and other efforts from previous years, the government clawed back almost $1.9 billion, according to a new report from the departments.
Of that $1.9 billion, about $1.2 billion went to the Medicare trust funds, which are on increasingly precarious financial footing due to growing stress on the insurance program. In addition, roughly $99 million in federal Medicaid money was transferred back to the CMS.
Finally, Govexec brings us up to date on projections for 2023 annual raises for federal employees.
President Biden and House appropriators seem thus far to be in agreement that federal employees should receive an average 4.6% pay raise next year, but there are still several steps officials must take before it can be implemented at the end of the year. * * *
On Capitol Hill, there are still a few opportunities for federal employee groups and some lawmakers to try to increase the raise to the average 5.1% figure they have been advocating for.
The highly contagious Omicron BA.5 subvariant has taken over as the dominant version of the virus causing new Covid-19 cases in the U.S., the latest federal data show.
BA.5 represented nearly 54% of U.S. cases in the week ended July 2, the Centers for Disease Control and Prevention estimated Tuesday. It surpassed BA.2.12.1, the version of Omicron partly responsible for a persistent springtime surge in cases, which is now estimated to represent closer to one in four cases.
Another version known as BA.4, which is closely related to BA.5, and also ramped up recently, represents nearly 17% of cases, the CDC estimates.
Virus experts believe BA.5 is particularly adept at evading immune protections built up from prior infections and vaccines, giving it an advantage as it takes over as the major subvariant. This adds to the possibility people will contract Covid-19 repeatedly while facing the risk of developing complications like long-running and sometimes debilitating symptoms.
Covid-19 reinfections can bring some new risks of serious medical problems, hospitalization and death, a new study has found.
Protection provided by vaccines and prior infection has greatly improved Covid outcomes since the pandemic’s early days, and reinfections are typically less severe than initial ones. Yet each new infection carries a risk of medical problems, including hospitalization, death and long Covid, according to preliminary data from a study of patients in the Veterans Affairs health system.
This is a timely finding, doctors say, as more-infectious Omicron subvariants BA.4 and BA.5 proliferate and are expected to make reinfections more common. * * *
One caveat of the VA study is that their patients are older and tend to have multiple comorbidities, says Amesh A. Adalja, a senior scholar at Johns Hopkins Center for Health Security, who wasn’t involved with the VA study. For instance, an otherwise healthy 18-year-old “is not likely to significantly add to their risk” in the same way as an older person with underlying health problems, says Dr. Adalja.
And VA patients who went to the doctor for a reinfection are also more likely to have had more symptoms than those who don’t seek medical care and aren’t captured in the study, Dr. Adalja notes. Still, “it’s better not to get reinfected than to be reinfected,” he says. “Reinfections are not something you want to have, even though they’re likely going to be ubiquitous.”
The National Institutes of Health informs us “COVID-19 was the third leading cause of death in the United States between March 2020 and October 2021, according to an analysis of national death certificate data by researchers at the National Cancer Institute, part of the National Institutes of Health. The study appears July 5 in JAMA Internal Medicine.”
From the unusual viruses front, Becker’s Hospital Review reports
As of July 1, 460 cases of monkeypox have been confirmed across 31 states and Washington, D.C. That’s up from 351 cases as of June 29.
California has the highest number of confirmed cases in the nation at 95, followed by New York, where 90 cases have been reported, according to the CDC. Globally, there have been more than 5,000 cases reported since May.
The article offers readers three other monkeypox updates.
From the transparency front, Beckers Payer Issues reminds us that while the first stage of the transparency in coverage rule, which applies to the FEHB Program and private sector employer-sponsored health plans, will benefit governments and businesses, the next stage which takes effect on January 1, 2023, will benefit health plan members.
In 2023, payers must start providing an internet-based price comparison tool that allows members to receive an estimate of their cost-sharing responsibility for a specific item or service from a specific provider or providers for 500 items and services. That comparison tool must be provided for all services by 2024.
Provider price disclosure rules went into effect at the start of 2021, but the majority of facilities have not complied. CMS warned 342 hospitals they were not in compliance in February and fined the first health system in June for violations.
From the U.S. healthcare front, Beckers Hospital Review tells us
Merative, formerly IBM Watson Health, on June 30 released its 2022 rankings of the top hospitals and health systems in the U.S., in partnership with Fortune.
For the rankings, 2,650 short-term, acute care, non-federal U.S. hospitals were evaluated on measures assessing inpatient outcomes, extended outcomes, processes of care, operational efficiency, financial health, and patient experience using publicly available data.
This year’s study also incorporated a community health measure, which is equally weighted with other ranked measures.
Penn Presbyterian Medical Center in Philadelphia PA is the top major teaching hospital and St. David’s Medical Center in Austin TX is the top large community hospital in the rankings.
From the research front —
BioPharma Dive discusses the top 10 biotech clinical trials to watch in the second half of 2022.
The New York Times reports “Dementia cases are climbing along with an aging world population, and yet another much-anticipated Alzheimer’s medication, crenezumab, has proved ineffective in clinical trials — the latest of many disappointments. Public health experts and researchers argue that it is past time to turn our attention to a different approach — focusing on eliminating a dozen or so already known risk factors, like untreated high blood pressure, hearing loss and smoking, rather than on an exorbitantly priced, whiz-bang new drug.”
The National Institutes of Health’s Director’s Blog informs us that “researchers have found that an approved drug for insomnia that works differently than other sleep medications could offer some needed help for the sleeplessness that affects those overcoming an opioid addiction. The drug, known as suvorexant (Belsomra ®), was provided in a study to people during and immediately after tapering off opioids, and it allowed them to sleep significantly more during this week-long period. Suvorexant also helped to reduce their opioid withdrawal and craving.”
Congress is on a State / District work break this week.
The Supreme Court ended its October 2021 Term last week by recognizing retiring Justice Stephen Breyer and Judge Ketanji Brown Jackson was sworn in as the 104th Associate Justice of the Supreme Court last Thursday, June 30.
From the Omicron and siblings front –
Bloomberg Prognosis reports on New York City’s significant improvements to its test to treat program.
New York City will start offering Pfizer Inc.’s Covid antiviral Paxlovid at “first of its kind” mobile test-to-treat sites across the city, providing immediate treatment for those who test positive for the virus.
Initially [last Thursday June 30], mobile sites will be stationed outside of pharmacies in Inwood, South Ozone Park and the East Bronx, and will expand to 30 locations by the end of July, Manhattan’s Borough President Mark Levine said on Twitter Thursday. People who test positive for Covid and qualify for Paxlovid will be able to get a prescription on-the-spot, which they can take to a nearby pharmacy to pick up the drug. By the end of the summer, officials plan to bypass pharmacies entirely, offering Paxlovid directly through the mobile sites.
“We were the epicenter of the Covid pandemic at the start, but we’re leading the way in prevention and mitigation,” [NYC Mayor Eric] Adams said during the press conference. “What we’re doing here other cities can look at to make a determination of how they want to address Covid.”
Bloomberg adds “Earlier on Thursday, Pfizer asked US regulators for full approval of Paxlovid for people at high risk of developing severe disease, bringing the drugmaker one step closer to securing a formal clearance that would allow it to sell and market the antiviral outside of the public health emergency.”
Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. According to an updated list of expiration dates, it may still be good.
The Food and Drug Administration has extended the expiration dates for some authorized at-home, over-the-counter Covid test kits in recent months, meaning some unused tests may still be viable.
Many Americans received free tests from the federal government this year. They also bought their own tests, especially at the height of the first Omicron wave that hit much of the country over the winter.
While the FDA initially marked many at-home Covid-19 kits with a fairly short shelf life, additional data gathered since then from manufacturers has given the agency more insight into how long the tests can be used accurately.
Using the CDC’s Covid Data Tracker and Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 26th week of 2022:
The CDC did not produce its weekly review of Covid statistics today as it’s the beginning of the July 4th holiday weekend. The CDC’s daily averages of new cases, new deaths and new hospitalization for the past week has been 109,944 cases, 316 deaths and 4,947 hospitalizations.
Temporary loss of smell emerged as a common indicator of COVID-19 early in the pandemic. Research into the cause and treatment of the condition, known as anosmia, is ongoing, though recent studies have brought us one step closer to answers.
Two latest findings on COVID-19-related anosmia:
1. Loss of smell and taste is becoming less common as the virus evolves, according to researchers.
2. Smell and taste hasn’t fully returned for many people who contracted COVID-19 early in the pandemic, research shows.
In retrospect, the FEHBlog is pleased that he continued theses charts from the last six months of 2021 into the first half of 2022 because doing so captured the three important surges. Now the FEHBlog has to decide what to do next Friday as the charts present a years worth of data.
Here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era (the 51st week of 2020) through this week, the 26th week of 2022.
It’s worth adding that the CDC is currenly providing weekly, not daily, vaccination stats. The CDC is now offering on a colorful, adjustable chart on “Primary Series Completion, Booster Dose Eligibility, and Booster Dose Receipt by Age, United States.
COVID-19 vaccines protected against severe disease and death in people with overweight or obesity, a large English study found.
Compared with the unvaccinated, vaccinated individuals in each BMI group experienced significantly lower likelihood of COVID-related hospitalization starting at 2 weeks from their second dose, reported Carmen Piernas, PhD, of the University of Oxford, and colleagues:
A new study provides more evidence that influenza vaccination may help protect older adults against Alzheimer’s disease (AD).
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings ― that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years ― adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, with McGovern Medical School at the UTHealth, Houston, Texas, told Medscape Medical News.
Sign me up.
Also from the public health front, Medscape tells us
About 80% of US adults have low to moderate cardiovascular (CV) health based on the American Heart Association (AHA) checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health. With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist. * * *
The AHA Presidential Advisory — Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health — was published online June 29 in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the US population is “suboptimal, and we see important differences across age and sociodemographic groups,” [Dr. Donald] Lloyd-Jones [chair of the department of preventive medicine at Northwestern University’s Feinberg School of Medicine in Chicago] said.
Medpage offers a detailed Q&A on monkeypox. Among them
Could monkeypox be spread easily from person to person, similar to COVID-19?
“Monkeypox is certainly not COVID-19,” stressed [Capt. Agam] Rao [, MD, a medical officer at the U.S. Public Health Service at the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)]. Based on prior outbreaks and the current outbreak, monkeypox appears to spread through “direct close contact. So, intimate contact that might happen during sex, but also any other close contact that might occur — for example, if you live with someone who has monkeypox and you are sleeping on the same bedding and using the same towels.”
“It really is not something that you will just pass on to someone walking down the street,” she said.
While agency researchers are “keeping an open mind” about the possibility that the virus could be more easily transmitted, “at this time, there’s no indication that it would spread the way that COVID spread and spread to as many people, [and] at this time, the risk for the worldwide population … is low,” she added.
From the prior authorization front, Healthcare Dive reports
Aetna is no longer requiring prior authorization for cataract surgeries, a controversial policy the payer adopted a year ago, according to a new provider notice.
Aetna is also rolling back prior authorization requirements for video EEGs and home infusion for some drugs. It’s adding two new-to-market drugs to the precertification list.
The payer said in a statement that it came to its decision after analyzing real-time data from the year the requirement was in place. “Going forward, we will focus on retrospective reviews of procedures and providers where questions of medical necessity exist,” Aetna said.
From the Rx coverage front, Fierce Pharma offers an article on how payers are planning to avoid cost shocks associated with gene therapy.
Kelley Miller, senior director of managed markets for the specialty pharmacy Optum Frontier Therapies, said there are three major considerations for his team during coverage talks. One is the clinical landscape, while another is the “human” element of what the patients and their families are going through. Thirdly, the team looks at the “economic impact” of the treatment.
Once Miller’s team has that information, the “conversations should come fast and furious,” he said.
Despite the biopharma industry’s advances in gene therapies, ICER president Steven Pearson, M.D., M.Sc., said it’s still a “fairly dicey business proposition” for companies in this field, especially outside the U.S. He pointed to bluebird bio’s decision to pull beta thalassemia gene therapy Zynteglo from the European market last year.
From the U.S. healthcare front, Beckers Hospital Review reports
IBM Watson Health, in partnership with Fortune, has released its top 15 health systems, which they find set an example for health systems and hospitals across the nation. With its data, the report will continue to stand as a resource for these groups to improve their quality of care and efficiency.
In its 14th year of publishing this study, IBM Watson Health found that the top 15 health systems had better survival rates, fewer patient complications, fewer healthcare-associated infections, better long-term outcomes, better 30-day mortality/revisitation rates and more. The study also found that patients revered the top 15 hospitals more than peer system hospitals.
For 2022, Allina Health of Minneapolis, MN, sits on top of the large health systems division. Cone Health of Greensboro, NC, sits on top of the medium health systems division. Asante of Medford Oregon sits on top of the small health system division.
From the Medicare Advantage front, Health Payer Intelligence discusses AHIP’s statement on the Medicare Advantage program which places various attacks against the MA program in perspective.
In addition to defending prior authorizations and spotlighting certain facets of OIG reporting, AHIP also offered evidence for Medicare Advantage plans’ efficacy overall.
The health plans have been proven to excel on quality measures and on overall efficiency, surpassing original Medicare’s quality level. They also have to ascribe to certain network adequacy standards.
Medicare Advantage plans produce savings for the Medicare program and offer higher value for members and taxpayers. In particular, Medicare Advantage plans offer strong value to members who are lower-income and underserved.
Lastly, AHIP pointed out that these plans have bipartisan support.
Finally federal employee benefits consultant Tammy Flanagan follows the retirement process of a federal employee in a three-part article in Govexec.
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