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.
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.
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.
Wishing everyone a happy end of the second quarter 2022.
From Capitol Hill, the American Hospital Association informs us
The House Appropriations Committee today voted 32-24 to approve legislation that would provide $242.1 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2023, a 13% increase over the prior fiscal year.
According to a committee summary, the bill would provide $124.2 billion for HHS, $15.6 billion more than the FY 2022 enacted level but slightly below the president’s request.
* * *
Notably, the HHS report language would urge the Centers for Medicare & Medicaid Services to evaluate several aspects of the Medicare Advantage program that are important to hospitals and health systems. Specifically, Congress would urge CMS to assess MA enrollees’ access to long-term acute care hospitals, inpatient rehabilitation facilities and substance use services, including by looking at MA plan prior authorization policies and network adequacy. In addition, the report encourages CMS to examine potential MA plan overpayments with a particular focus on risk adjustment.
The full House is expected to consider the bill in July.
Senate Democrats are vetting a new, tweaked version of a drug pricing package as they hurtle toward a September deadline to pass any major reforms.
It’s by no means certain that Congress will pass prescription drug pricing reform as part of a broader domestic policy package being hammered out between Senate Majority Leader Chuck Schumer and moderate Sen. Joe Manchin (D-W.V.), but this week, the chances are looking better than ever. * * *
The new plan looks a lot like the one Democrats settled on last fall — a sweeping overhaul of how the government pays for prescription drugs [which fell short of passage]. There are a few main differences, according to a summary obtained by STAT. The Washington Post first reported the summary. * * *
In the coming days, Senate leadership is planning to ask the Senate’s rules referee to review the policy to see whether it could be passed using a fast-track process known as reconciliation. The original drug pricing plan was never actually vetted by the referee last year, after negotiations soured between the White House and Manchin in December.
Senate Democrats are hoping to finalize tax and climate provisions and put a full bill on the floor as soon as late July, according to a source familiar with the talks. Democrats would have to advance a bill by Sept. 30 to use the reconciliation mechanism, which allows them to advance policy without Republican support.
From the Omicron and siblings front, MedPage Today tells us
“We have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19.”
If all goes according to plan, the modified vaccines could potentially be available in “early to mid-fall,” he said.
The Robert Wood Johnson Foundation calls our attention to the following resource:
The US COVID Atlas, led by University of Chicago with support from RWJF, is a near real-time visualization tool that helps you access current, validated county-level data and spatial analysis to better understand the spread in communities and to bolster planning efforts.
* Identify hotspots in real-time
* Track vaccination rates by region or county
* Locate areas that will soon be affected by the virus
* Connect social, economic, and health indicators for meaningful community context
From the rural health care front, the American Hospital Association informs us
The Centers for Medicare & Medicaid Services today released a proposed rule establishing the conditions of participation for Rural Emergency Hospitals and updating a few requirements for Critical Access Hospitals. The Consolidated Appropriations Act of 2021 established REHs to preserve an emergency presence in communities where rural hospitals could no longer be sustained. By law, REHs can provide emergency services, observation care, and additional medical and health outpatient services. CMS has proposed standards for REHs based largely on the current CAH CoPs and, where appropriate, on outpatient services’ requirements. CMS is seeking input from the rural community on specific proposed REH standards, including the ability of an REH to provide low-risk labor and delivery services and the minimum qualifications for professionals who will provide on call emergency services.
HHS adds
For today’s rule, the comment period closes on August 29, 2022.
The federal government’s latest push for more health care price transparency starts July 1, and it is focused on those who are writing the checks: Health insurance companies and employers that directly pay for their workers’ medical care will have to start posting data on what they pay hospitals, doctors, and other providers.
The law requires all health insurers and self-insured employers (also known as self-funded) to publish machine-readable files with two sets of information: the negotiated prices paid to in-network hospitals and doctors, and the allowed rates paid to out-of-network hospitals and doctors. This data — which has to be on a public website, just like hospitals’ prices — does not reflect what workers pay out-of-pocket for care, but does reflect the premiums that employers and workers pay.
The law also says insurers and employers have to disclose what they pay for prescription drugs. However, that has been punted for now while the federal government mulls “whether this requirement remains appropriate,” according to an April notice.
From the second-quarter earnings front, the Wall Street Journal reports “Walgreens Boots Alliance Inc. is bracing for a recession and life after Covid. The second-biggest U.S. drugstore chain by stores said Thursday that quarterly sales fell and earnings plunged as revenue from Covid-19 vaccinations dried up. The pharmacy chain also paid out a $683 million opioid settlement.”
From Capitol Hill, MedPage Today reports on yesterday’s House Oversight and Reform Committee hearing on the federal response to the drug overdose crisis. Both parties flogged the government agency witnesses. It’s worth reading. This epidemic merits more attention that Covid at this point in the FEHBlog’s view.
Nevertheless, from the Omnicron and siblings front
The easily spread Omicron BA.4 and BA.5 subvariants represent more than half of all U.S. Covid-19 cases, federal estimates showed, ramping up pressure as a spring surge stretches into summer.
The two variants represented a combined 52% of cases for the week ended June 25, according to estimates the Centers for Disease Control and Prevention released on Tuesday. The variants were most prevalent—an estimated 60% of cases—in a five-state region that includes Texas, Oklahoma, Louisiana, Arkansas and New Mexico.
Federal health authorities moved a step closer to authorizing modified Covid-19 booster shots that better target the Omicron variant and could be rolled out by the fall.
Vaccine advisers to the Food and Drug Administration, which includes doctors and public-health specialists, voted 19 to 2 to recommend updating Covid-19 vaccines to target the Omicron variant.
The recommendation, which the FDA doesn’t have to follow but often does, suggests the agency may go ahead and direct vaccine makers Pfizer Inc., its partner BioNTech SE and Moderna Inc. to proceed with plans to roll out modified boosters.
The vote didn’t specify whether the modified boosters should only target Omicron, or target both Omicron and the ancestral strain of the coronavirus, though several committee members said they preferred a dual-target approach.
The vote also didn’t specify whether the modified shots should target more recent subvariants of Omicron now dominant in the U.S. * * *
Many members of the committee said they thought it should target the recent subvariants of Omicron, known as BA.4 and BA.5.
After the vote, Dr. Peter Marks, who heads the FDA’s vaccines division, said he took away from the meeting support for shots that target the ancestral strain as well as BA.4 and BA.5.
The options for a fall booster shot include sticking with current vaccines or using updated, Omicron-targeted vaccines that have shown promise in clinical studies. Another option: Use boosters that target more recent Omicron subvariants, including BA.4 and BA.5, but that haven’t been tested in people.
From the hospital systems front, the American Hospital Association informs us
U.S. hospitals and health systems continued to face difficult financial and operational headwinds in May, according to the latest report by Kaufman Hall, based on data from more than 900 hospitals.
“Nearly halfway through 2022, margins are cumulatively negative,” the report notes. “While some metrics have normalized, hospitals continue to perform below pre-pandemic levels, and there is an uncertain outlook for the rest of the year.”
Hospitals continue to see higher labor costs and fewer hours worked, “a sign of inflation and an indicator that long-standing labor shortages are likely worsened by increased turnover,” the authors said.
In addition, the Lown Institute has released its 2022 rankings of socially responsible hospital systems in the U.S. According to the Institute’s press release,
Sixty-six U.S. hospitals earned the distinction of “most socially responsible” by the Lown Institute, a think tank known for its evidence-based assessments of America’s healthcare providers. To achieve this designation, hospitals earned “A” grades across measures of health equity, value, and outcomes.
Launched in 2020, the Lown Institute Hospitals Index for Social Responsibility draws attention to leading and lagging institutions nationwide, and provides benchmarks for hospitals to measure how well they serve their patients and communities.
A Phase 1 clinical trial of a novel influenza vaccine has begun inoculating healthy adult volunteers at the National Institutes of Health Clinical Center in Bethesda, Maryland. The placebo-controlled trial will test the safety of a candidate vaccine, BPL-1357, and its ability to prompt immune responses. The vaccine candidate was developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID). The single-site trial can enroll up to 100 people aged 18 to 55 years and is led by NIAID investigator Matthew J. Memoli, M.D. * * *
“With the BPL-1357 vaccine, especially when given intranasally, we are attempting to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection,” said Dr. Memoli. “This is very different than nearly all other vaccines for influenza or other respiratory viruses, which focus on inducing immunity to a single viral antigen and often do not induce mucosal immunity.”
“Our study will examine the safety of BPL-1357 and also will allow us to assess the importance of mucosal immunity against flu and whether a strategy of inducing both the cellular and antibody arms of the immune system can provide broader protection against the ever-changing influenza virus,” he added.
For additional information about the trial, visit clinicaltrials.gov and search on the trial identifier NCT05027932.
That’s the question facing orthopedic surgeons and rehab physicians as they learn to work with a new knee replacement that incorporates sensors and processors to send data about how the joint works from deep inside the patient’s body.
It’s one of a growing number of devices sending data to physicians to help them monitor their patients, including continuous glucose monitors and wearables to monitor for heart arrhythmia. With this influx of information, medtech companies are still ironing out how to make the data useful for doctors. * * *
“The talking knee is a reality,” Indiana-based Zimmer Biomet announced at the American Academy of Orthopaedic Surgeons’ conference last year. The company was presenting its new knee-implant extension with an embedded sensor just days after receiving de novo clearance from the Food and Drug Administration.
Now, Zimmer, which developed the device along with California-based Canary Medical, Inc., a company that creates sensors for medical devices, has begun selling the smart knee implant, called Persona IQ. It can measure a patient’s range of motion, step count, stride length, and walking distance from inside the human body. Still, physicians don’t yet know how to use this data to help patients [due to lack of time currently]. * * *
Eventually, sensors will detect problems with implants, help patients adjust their gait or provide data to predict patient outcomes. Meanwhile, competitors are creating systems that use wearable sensors to track patient recovery and hinting at their own plans for sensor-embedded implants.
Bill Hunter, Canary’s founder and chief executive, said in an interview that medical technology companies are already unleashing a wave of sensor-loaded devices in other sectors.
“Having this ability for the device to provide the clinician with actual feedback from inside the body has implications in most every major medical device,” he said. “So I do believe that you will see this showing up in all kinds of different ways.”
Time will tell but the FEHBlog’s money is on the sensor companies. Fascinating article.
From Capitol Hill, Federal News Network discusses the federal employee pay raise angles presented by the House financial service and general appropriations bill which cleared the House Appropriations Committee last Friday. Federal News Network indicates that the bill leaves the door open for the Senate to also accept the President’s proposed 2023 4.6% pay raise for federal employees and the military.
President Joe Biden announced two actions immediately after the ruling: one directing the Department of Health and Human Services to safeguard access to contraception and medication abortion, and another protecting travel for medical appointments.
To those ends,
Govexec tells us that OPM today confirmed that its policy allowing federal employees to apply sick time to travel out of state remains in effect after the high court struck down Roe v. Wade, and
The Department of Health and Human Services (HHS) announced that a meeting was held today between Affordable Care Act regulators, including the HHS and Labor Department Secretaries, and health plan executives to emphasize the importance of full compliance with the ACA’s contraceptive coverage with no cost-sharing mandate when delivered in-network. The ACA regulators also issued a letter to health plans making the same point.
The FEHBlog ran across this NPR Shots article which explains that the Plan B or morning-after pill is considered a contraceptive and not an abortion drug. The Wall Street Journal informs us
Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.CVS Health Corp., Walmart Inc., and Rite Aid Corp. were limiting purchases of the pills, which were in short supply or out of stock Monday morning on major retailer websites. CVS and Rite Aid were limiting purchases to three. Walmart had some pills available without limits, but only in cases where they wouldn’t ship until next month. Pills available this week were limited to four or six.
From the Omicron and siblings and monkeypox front
Govexec reports on a U.S. Court of Appeals for the Fifth Circuit decision order rehearing a federal employee vaccine mandate case which upheld the mandate on lack of plaintiffs’ standing to challenge the mandate. The mandate nevertheless has remained on hold while the case winds it way through the appellate court.
USA Today reports on when and how to access the monkeypox vaccine.
a new model aimed at improving cancer care for Medicare patients and lowering health care costs. CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) designed the Enhancing Oncology Model (EOM) to test how to improve health care providers’ ability to deliver care centered around patients, consider patients’ unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs.
From the reports and studies department —
The next issue of Health Affairs offers a bevy of articles on Type 2 diabetes and pre-diabetes which are available at this link.
The Congressional Budget Office has made available examples of the work performed by its Health Analysis Division.
HealthDay reports “More than 18 million Americans have now survived cancer, a new report shows. The American Cancer Society (ACS) and the U.S. National Cancer Institute collaborated on the report to estimate cancer prevalence and help public health officials better serve survivors.”
mHealth Intelligence calls our attention to a telehealth-oriented Healthcare Experience Report: 2022 released by Zocdoc. The FEHBlog was pleased to read “Mental health continues to hold a place of dominance in telehealth. In May of 2020, 2021, and 2022, the percentage of mental health visits that occurred virtually was 74 percent, 85 percent, and 87 percent, respectively.” Hub and spoke telehealth, e.g, Teladoc, brings mental health care in-network thereby lowering benefit costs while improving access to care.
The Senate is on a State work break for the next two weeks which encompasses Independence Day. The House of Representatives will be engaged in Committee business this week through Thursday. Then the House will be on District work break through the end of the following week.
The House Oversight and Reform Committee is holding a hearing tomorrow on an important topic: “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis.”
On Friday, the House Appropriations Committee approved
the fiscal year 2023 Financial Services and General Government bill on a 31 to 22 vote. * * *
The following amendments to the bill were adopted by the full Committee:
Rep. Quigley – The manager’s amendment makes technical and noncontroversial changes to the bill and report. The amendment was adopted by voice vote.
Rep. Stewart #3 – This amendment prohibits the government’s use of cloud computing platforms unless they prevent child exploitation images. The amendment was adopted by voice vote.
A summary of the bill is here. The text of the draft bill is here. The bill report, before the adoption of amendments in full Committee, is here.
This bill includes FEHB and OPM funding.
It occurred to the FEHBlog over the weekend that on Friday he did not explain how the Supreme Court’s Dobbs decision overruling Roe v. Wade impacts the FEHB Program. The short answer in the FEHBlog’s opinion is that it has no impact.
Under the Hyde Amendment whose requirements have been applied to the FEHB via annual appropriations bills for decades, FEHB Program coverage of abortions is limited to abortions in cases of rape, incest, or endangerment of the mother’s life. Federal courts of appeals uniformly have held that the Hyde Amendment preempts more restrictive State abortion limitations. E.g., Planned Parenthood Affiliates v. Engler, 73 F.3d 654 (6th Cir. 1996) (citing precedential authorities).
The BA.4 and BA.5 subvariants are spiking globally because they can spread faster than other circulating variants — mostly BA.2, which caused a surge in cases at the beginning of the year. But so far, the latest Omicron variants seem to be causing fewer deaths and hospitalizations than their older cousins — a sign that growing population immunity is tempering the immediate consequences of COVID-19 surges.
Nature explores what the rise of BA.4 and BA.5 means for the pandemic.
The FEHB agrees that the complete Nature article is worth reading.
A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday. * * *
The Journal adds that the Food and Drug Administration is considering whether to give emergency use authorization to the Omicron-oriented boosters for fall 2022. Based on the Nature article, it appears that Omicron will still be with us then.
Fortune identifies seven things doctors who treat long Covid want people to know.
From the Monkeypox front, Bloomberg Prognosis tells us
The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern.
The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak.
“What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.”
NPR Shots expresses concern that U.S. testing program for this disease is inadequate.
For many of the [201] confirmed cases, health officials don’t know how the person caught the virus. Those infected haven’t traveled or come into contact with another infected person. That means the virus is spreading in some communities and cities, cryptically.
“The fact that we can’t reconstruct the transmission chain means that we are likely missing a lot of links in that chain,” Jennifer Nuzzo, an epidemiologist at Brown University, says. “And that means that those infected people haven’t had the opportunity to receive medicines to help them recover faster and not develop severe symptoms.
“But it also means that they’re possibly spreading the virus without knowledge of the fact that they’re infected,” she adds.
In other words: “We have no concept of the scale of the monkeypox outbreak in the U.S.,” says biologist Joseph Osmundson at New York University. “
NPR explains that the monkeypox testing process is much too cumbersome and the CDC hopes to have the process streamlined “sometime in July.”
New influenza vaccine effectiveness data presented at the U.S. CDC’s June 22, 2022 meeting of the Advisory Committee on Immunization Practices (ACIP) show flu shots worked better during 2021 – 2022 than initially reported.
Published on June 23, 2022, this ACIP data shows flu shots reduced the risk of influenza illness by about 35% among vaccinated people.
Data from October 4, 2021, through April 30, 2022, showed that flu vaccines reduced people’s risk of mild to moderate flu illness caused by H3N2 flu viruses—the most common flu viruses this season—by about one-third overall. * * *
Also, at the meeting, ACIP voted in favor of a preferential recommendation for certain flu vaccines over others for adults 65 years and older in the United States.
The ACIP voted to preferentially recommend higher-dose flu vaccines (Fluzone High-Dose vaccine and Flublok recombinant vaccine) or adjuvanted flu vaccine (Fluad vaccine) over standard-dose unadjuvanted flu vaccines.
And if one of these vaccines is unavailable at the time of administration, people in this age group should get a standard-dose flu vaccine instead.
From the health information technology front, Health Data Management calls out attention to the following
“In a [very sensible] letter to Department of Health and Human Services Secretary Xavier Becerra, several healthcare standards organizations are calling for streamlining and making more predictable the process for submitting attachments as well as modernizing existing rules to improve patient care and reduce burdens on clinicians.”
“New legal requirements for providers to give an estimated cost of patients’ medical services will be difficult to meet, particularly when multiple organizations are involved in a patient’s care, according to WEDI, the Workgroup on Electronic Data Interchange. Meeting the requirements of the No Surprises Act, which was included as part of a Consolidated Appropriations Act passed late in 2020, will be challenging because there is no standardized process to enable the exchange of cost information among facilities, WEDI notes.”
“While healthcare organizations see the prevailing trend of increasing patient consumerism, the ability to give patients opportunities to schedule their own appointments is lagging. Many organizations have adopted some capabilities for self-scheduling, according to new research from the Center for Connected Medicine (CCM), yet the use of these tools remains low [because] scheduling solutions lack the right algorithms and that organizations lack standardized scheduling templates across appointment types.”
In particular the second bullet strikes a chord with the FEHBlog as he has pointed out that Congress made a huge mistake by failing add the provider’s good faith estimate and the health plan’s advance explanation of benefits to the list of HIPAA standard transactions.
Note — Unfortunately, Thursday’s post did not arrive on the E&S website until 9 am ET today, so it did not go out to subscribers this morning. Lo siento. Here is a link to yesterday’s post.
Onto today’s post —
Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases:
The CDC’s weekly review of its Covid statistics states “As of June 22, 2022, the current 7-day moving average of daily new cases (97,430) decreased 5.6% compared with the previous 7-day moving average (103,175).”
Here’s the CDC’s weekly chart of new Covid hospital admissions:
The CDC’s weekly review states “The current 7-day daily average for June 15–21, 2022, was 4,375. This is a 1.0% increase from the prior 7-day average (4,329) from June 8–14, 2022.”
Here is the FEHBlog’s latest weekly chart of new Covid deaths:
The CDC’s weekly review states “The current 7-day moving average of new deaths (255) has decreased 10.4% compared with the previous 7-day moving average (285).”
As of June 23, 2022, there are 391 (12.1%) counties, districts, or territories with a high COVID-19 Community Level, 996 (30.9%) counties with a medium Community Level, and 1,830 (56.8%) counties with a low Community Level. This represents an increase (+1.9 percentage points) in the number of high-level counties, a slight increase (+1.6 percentage points) in the number of medium-level counties, and a corresponding decrease (−3.6 percentage points) in the number of low-level counties. 51 jurisdictions had high- or medium-level counties this week. Rhode Island is the only jurisdiction to have all counties at low Community Level.
The weekly statistics generally are stable and moving in the right direction.
The American Hospital Association adds
The Centers for Disease Control and Prevention last night endorsed Moderna’s COVID-19 vaccine for children aged 6-17, as its advisory committee recommended, creating an alternative to Pfizer’s COVID-19 vaccine for this age group. The Food and Drug Administration authorized the Moderna vaccine for children and adolescents last week.
Before ACA FAQ 50 issued October 4, 2021, the period for covering COVID vaccines with no cost sharing began 15 days after the CDC’s action. The FEHBlog, who is not errorless, thought that FAQ 50 eliminated the 15 day waiting period, but upon further review, FAQ 50 requires immediate no cost sharing coverage of Covid vaccines filing the FDA’s approval, usually an emergency use authorization. The FEHBlog doesn’t think this makes any practical difference because the Covid vaccines aren’t distributed without CDC approval.
From the Capitol Hill, the American Hospital Association provide us with this encouraging news:
The House of Representative today voted 234-193 to pass and send to the President for his signature bipartisan legislation to help reduce gun violence in communities. Approved by the Senate last night, the AHA-supported package includes behavioral health provisions, including funding for school safety resources, school-based supportive services and expanded access to telehealth for mental and behavioral health services.
From the Supreme Court, the Court decided today that the right to an abortion is a matter controlled by state law, not the U.S. Constitution. The Wall Street Journal sums it up as follows “In upholding a Mississippi law banning the procedure after 15 weeks of pregnancy, the court’s conservative majority said the Roe decision was egregiously wrong in recognizing a constitutional right to abortion.” In response
Reproductive health care, including access to birth control and safe and legal abortion care, is an essential part of your health and well-being. While Roe v. Wade was overturned, abortion remains legal in many states, and other reproductive health care services remain protected by law. The U.S. Department of Health and Human Services (HHS) is committed to providing you with accurate and up-to-date information about access to and coverage of reproductive health care and resources. Our goal is to make sure you have appropriate information and support.
Health Payer Intelligence discusses health insurer reaction to the decision. “Payers and healthcare leaders are responding to the Supreme Court’s decision to overturn Roe v Wade, the case which protected abortion rights at the federal level, and while the repercussions remain uncertain many healthcare leaders are voicing their commitment to helping women navigate the impacts.”
The Wall Street Journal discusses employer reaction to the decision. “Businesses with health plans covering abortion now are weighing whether and how to pay for employees to travel to a state where the procedure is legal.”
From the OPM front
Federal News Network reports on OPM Director Karen Ahuja’s press conference held yesterday, the first anniversary of her swearing in as OPM Director.
FedWeek tells us that “OPM has said it is working to improve features for federal employees and annuitants to compare FEHB plans, although it does not project having those improvements in place until late next year—potentially in time for that year’s open season for selecting coverage in 2024.”
From the nicotine front, the Wall Street Journal reports
A federal appeals court on Friday granted Juul Labs Inc. a temporary stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
A panel of judges from the U.S. Court of Appeals for the D.C. Circuit on Friday afternoon granted Juul’s request to delay the FDA’s ban, according to court documents. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.
Finally, HR Dive brings us a roundup of happenings at this week’s Society for Human Resource Management conference.
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.
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