The Senate returns to Capitol Hill for committee business and floor voting tomorrow. The Wall Street Journal adds “Between now and Election Day, senators are scheduled to be back in Washington for four weeks, then gone a week, and then back for two weeks in October.” The House of Representatives will be engaged in committee business but not floor voting this week. The House resumes floor voting next week.
The White House is asking Congress for $47.1 billion in emergency funding for Covid-19 and monkeypox and to back Ukraine in its war with Russia, as well as spending for natural disasters, according to administration officials.
Congress must vote on a spending bill by the end of September to avoid a partial government shutdown. Lawmakers are expected to use a stopgap funding measure that will maintain funding levels for the short term.
The White House is asking Congress to add the emergency funding on top of that, with about $22.4 billion for Covid-19 vaccines, testing programs, clinical trials and research; $4.5 billion to bolster efforts to fight monkeypox; and $6.5 billion to help areas of the country prepare for and recover from natural disasters. * * *
The emergency funds wouldn’t be paid for with new or shifted revenue, and would be new money that hasn’t been previously appropriated.
[As of last Friday, September 2] Senate Republican leadership didn’t immediately respond to a request for comment about the White House’s request for emergency funding. Spending bills require 60 votes, and in the 50-50 Senate at least 10 Republicans would need to back any bill that contained the administration’s request.
[President] Biden intends to nominate Richard Revesz, the AnBryce Professor of Law and Dean Emeritus at the New York University School of Law, to be administrator of the Office of Information and Regulatory Affairs, which is housed within the White House Office of Management and Budget. Biden has not had a permanent OIRA head since taking office.
From the U.S. healthcare business front, the Wall Street Journal reports this afternoon that CVS Health has struck a deal to purchase Signify Health:
The drugstore giant’s deal to acquire home-healthcare company Signify Health Inc., announced Monday, will add 10,000 contracted doctors and clinicians and give CVS a hand in coordinating medical care for millions of Americans.
CVS, the nation’s biggest healthcare company by revenue, said that it agreed to acquire Signify for $30.50 per share in an all-cash deal, confirming earlier Wall Street Journal reports. CVS said it expects the deal, finalized over the weekend after a sales process that drew interest from companies from Amazon.com Inc. to UnitedHealth Group Inc., to close in the first half of 2023.
CVS for years has worked to transform itself from a pharmacy chain to an integrated provider of medical services, with the biggest step being its 2018 acquisition of insurer Aetna. Initially, CVS envisioned a model centered on pharmacists, in-store clinics and a giant insurance business.
But Karen Lynch, who took over as CVS CEO last year, determined that the company needs doctors on its payroll to fulfill those ambitions. She also set out to expand CVS’s presence in home healthcare, demand for which has been rising as the U.S. population has aged.
Signify’s model is based on an analytics-and-technology platform, used by doctors that go into homes equipped with connected iPads, that allows the clinicians to assess patient needs and connect them with follow-up services.
The clinicians “operate much like Uber drivers,” said Kyle Armbrester, Signify Health chief executive. “We’re in a gig economy and this is a flexible model.”
The deal is the latest for a home-health company. Rival Walgreens Boots Alliance Inc. last week finalized a deal to purchase a majority stake in CareCentrix, Inc., another home-healthcare platform.
This spring, UnitedHealth agreed to buy LHC Group Inc., one of the country’s largest home-health firms, for about $5.4 billion. Last year, Humana Inc. agreed to take full control of home-health provider Kindred at Home. Both LHC and Kindred provide continuous home-healthcare services.
Signify has grown to serving more than 2.5 million homes from around 300,000 five years ago, said Mr. Armbrester, who is set to remain CEO of Signify Health after the acquisition.
From the public health front, NPR Shots discusses the new Covid boosters and Precision Vaccinations discusses flu shots. The FEHBlog checked chain pharmacies in his locality in Dripping Springs, TX. Flu shots are already available, and the new Covid boosters will be available mid-week.
The Centers for Disease Control and Prevention loosened Covid-19 guidelines on Thursday, freeing schools and businesses from the onus of requiring unvaccinated people exposed to the virus to quarantine at home.
The changes are a sharp move away from measures such as social distancing requirements and quarantining, which had polarized much of the country, and effectively acknowledge the way many Americans have been navigating the pandemic for some time. The agency’s action comes as children across the country return to school and many offices have reopened.
“We know that Covid-19 is here to stay,” Greta Massetti, a C.D.C. epidemiologist, said at a news briefing on Thursday. “High levels of population immunity due to vaccination and previous infection, and the many tools that we have available to protect people from severe illness and death, have put us in a different place.” * * *
Instead of focusing on slowing transmission of the virus, the recommendations prioritize preventing severe illness. They emphasize the importance of vaccination and other prevention measures, including antiviral treatments and ventilation.
The Wall Street Journal looks into why Omicron continues to become more contagious over time, and MedPage Today discusses what the future holds for Covid vaccines.
From the unusual viruses front, Beckers Hospital Review tells us
“The manufacturer of the Jynneos monkeypox vaccine, Bavarian Nordic, voiced concerns to federal health officials about efforts to expand vaccine supplies by allowing the administration of fractional doses, The Washington Post reported Aug. 10.
“Confirmed U.S. [monkey pox] cases have surpassed 10,000, according to CDC data updated Aug. 10. About a month ago, there were less than 1,000 reported cases nationwide,” and
The CDC may offer some New Yorkers an extra dose of the polio vaccine amid concerns that the virus is silently spreading through a community where the nation’s first polio case in nearly a decade was detected July 21, CNN reported. * * * “We’re looking into all aspects of how to deal with this. At this point, we don’t have a definitive answer,” José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, told CNN. The case, which was identified in an unvaccinated man, may be “just the very, very tip of the iceberg” and a sign that there “must be several hundred cases in the community circulating,” Dr. Romero said.
From the pricing transparency front, Fierce Healthcare brings us up to date on hospital compliance with its federal pricing transparency law and a new Colorado law that will hit the pocketbooks of non-compliant hospitals in that State.
A New York federal judge on Wednesday dismissed a surgeon’s legal challenge that sought to roll back key pieces of a federal law that protects patients from surprise out-of-network bills.
Judge Ann Donnelly ruled against the surgeon, finding that the law is constitutional, and dismissed the case for lack of standing and dismissed the surgeon’s request for a preliminary injunction.
Katie Keith, a lawyer and health policy expert at Georgetown University who tracks surprise billing litigation, called the ruling good news for consumers.
The lawsuit threatened to once again expose millions of patients to surprise out-of-network bills, Keith previously said in a Health Affairs report on the litigation.
The FEHBlog heartily agrees with Prof. Keith.
From the U.S. healthcare business front, Fierce Healthcare tells us
Blue Cross Blue Shield of Michigan will roll out a new family building and maternity support program head of open enrollment.
The insurer said Wednesday that the platform, launched in partnership with Maven Clinic, will allow members to access a personalized app that guides them through the family planning process, including pregnancy, postpartum and pediatrics. Users can follow multiple paths to parenthood based on their needs.
From the miscellany department
Today, the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) announced a new prize competition from the Kidney Innovation Accelerator (KidneyX) that seeks to further the development of a fully functional bioartificial kidney. * * * Up to $10.5 million in funding will be split among up to nine (9) prize winners, including up to three (3) winners from Track One each receiving $1.5 million and up to six (6) winners from Track Two each receiving $1 million. For the full rules and eligibility requirements, as well as a list of resources available to applicants, visit kidneyx.org/akp.”
MedPage Today reports “Colorectal cancer (CRC) screening was cost-effective in obese individuals as well as in those of normal weight and might even have a leg up at younger ages for obese men, a modeling study found. Having a colonoscopy every 10 years starting at age 45 or a fecal immunochemical test (FIT) at age 40 was cost-effective at a $100,000/quality-adjusted life-years (QALY) gained threshold across sexes and BMI ranges. As BMI increased, the cost-effectiveness of having colonoscopy every 10 years starting at age 45 versus 50 became even more favorable, reported Uri Ladabaum, MD, MS, of Stanford University School of Medicine in Redwood City, California; and co-authors in a paper in Clinical Gastroenterology and Hepatology.”
Healio informs us that “Salt substitutes consistently improved blood pressure and lowered risk for mortality, cardiovascular mortality and CV events, according to a meta-analysis published in Heart. ‘These findings are unlikely to reflect the play of chance and support the adoption of salt substitutes in clinical practice and public health policy as a strategy to reduce dietary sodium intake, increase dietary potassium intake, lower blood pressure and prevent major cardiovascular events,’ the researchers wrote.” Consumer Reports advises discussing salt substitutes with your PCP before starting to use them
More than 3.5 million veterans who were exposed to toxic substances on overseas deployments will gain easier access to health and disability benefits under a bill that cleared the Senate Tuesday.
President Joe Biden is certain to sign the bill into law in the coming days.
The bill would make servicemembers who contracted any of 23 conditions — from brain cancer to hypertension — after being deployed to Iraq, Afghanistan and other combat zones automatically eligible for VA benefits. The measure is expected to cost nearly $280 billion over a decade, according to the Congressional Budget Office.
This law should save the FEHB Program money as the federal workforce has a large cadre of veterans who use veterans’ healthcare. VA facilities charge the FEHB and private sector plans for non-service connected health care. This law confirms that toxic substances treatment to service-connected care for which the VA is liable.
The [VA] bill [also] authorizes leases for 31 new medical facilities at VA to help accommodate the expected surge in patients, which is expected to cost nearly $1 billion. The Congressional Budget Office found the slew of pay and other human resources changes would come with a $5.7 billion price tag over the next decade.
The bill will authorize the department to buy out the contract of health care professionals to recruit them to VA, so long as they make a four-year commitment to the department. VA will have $40 million per year for the buyouts. VA’s health care employees will be eligible for pay boosts worth 50% of their base salaries, up from the current cap of 30%. Overall pay would be capped at level two of the Executive Service pay scale, which is currently $203,000 per year. McDonough has called lifting the pay caps essential for VA’s recruiting and retention efforts and has aggressively pushed Congress to pass the reform.
With regard to the Schumer-Manchin reconciliation bill, the Hill reports that Senators Manchin and Simema are exchanging text on the bill.
From the Omicron and siblings front,
McKinsey and Company offer their assessment of when the Covid pandemic will end.
In this update, we discuss the outlook, the current and potential future use of boosters and therapeutics, and the shifts in response strategies to the COVID-19 crisis around the world. We also introduce the McKinsey COVID-19 Immunity Index—a tool for understanding a community’s current level of risk from the disease.
A group of physicians provides their observations in MedPage Today on how best to investigate the Paxolovid rebound issue.
The debate about “COVID-19 rebound” after nirmatrelvir/ritonavir (Paxlovid) treatment is one of these timely areas warranting further investigation. Continuing down the current path of uncertainty has consequences for how and by whom this antiviral should be used. However, by applying lessons learned from the early days of the pandemic — including acknowledging the importance of randomized controlled trials (RCTs) — we can avoid repeating the same mistakes. To do this, it is necessary to start by defining the question, identifying current knowledge gaps, and only then can one propose scientific solutions to bring a rapid resolution to the COVID-19 rebound controversy.
Paxlovid consists of two drugs: nirmatrelvir, which inhibits a SARS-CoV-2 protease inhibiting viral replication, and ritonavir, which slows the inactivation and breakdown of nirmatrelvir. Per a CDC health advisory released in May, COVID-19 rebound is defined as a return of symptoms or a “new positive viral test after having tested negative” occurring “2 to 8 days after initial recovery.” We just saw this over the weekend in the case of President Biden.
This definition of rebound is challenging and prone to inflating the incidence of rebound. It is possible some individuals identified as having “Paxlovid rebound” may have been experiencing a waxing and waning of COVID-19 symptoms while some unknown number of other reported rebound cases could be due to the known limitations of COVID-19 testing.
Precision Vaccinations tells us that in the near future the federal government will make the Omicron antibody based treatment known as Evusheld available through local pharmacies including “Albertsons, Acme, Jewel-Osco, Pavilions, Randalls, Safeway, Star Market, Vons, CPESN, Amber Specialty Pharmacy, Managed Healthcare Associates, and Thrifty White.”
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK, and TACKLE principal investigator, commented in a press release, “Despite the success of vaccines, many individuals such as older adults, individuals with co-morbidities, and those who are immunocompromised, remain at risk for poor outcomes from severe COVID-19.”
“Additional options are needed to prevent disease progression and reduce the burden on healthcare systems, especially with the continued emergence of new variants.”
“The TACKLE (study) results show that one intramuscular dose of Evusheld can prevent these individuals from progressing to severe COVID-19, with earlier treatment leading to even better results.”
From the moneypox front, Fierce Healthcare reports
The White House has named Robert Fenton to serve as the response coordinator for the monkeypox outbreak, as calls for a larger federal role intensify.
Fenton previously helped to coordinate COVID-19 vaccine distribution while working at the Federal Emergency Management Agency. He will work alongside Demetre Daskalakis, M.D., who will be the deputy coordinator.
The coordinators will lead the administration’s efforts on “strategy and operations to combat the current monkeypox outbreak, including equitably increasing the availability of tests, vaccinations and treatments.”
From the Affordable Care Act front, the International Foundation of Employee Benefit Plans informs us
The Internal Revenue Service (IRS) has issued Revenue Procedure 2022-34 providing the indexing adjustment for the required contribution percentage. For plan years beginning in 2023, the required contribution percentage is 9.12%, down from 9.61% in 2022.
The affordability calculation can determine whether an individual can afford employer-sponsored health coverage and affect whether the individual would be eligible for a premium tax credit on the health insurance exchanges. This could affect employers that do not use a safe harbor method to determine whether the coverage they offer is affordable to employees.
For plan years beginning in 2023, employer-provided coverage is considered affordable for an employee if the employee required contribution is no more than 9.12% of that employee’s household income. Because applicable large employers generally do not know their employees’ household incomes, there are three safe harbor methods for calculating affordability.
In the FEHB Program, OPM must assure itself that the lowest premium nationwide FEHB plan premium for the self only option does not cost more than 9.12% of the lowest paygrade federal employee eligible to participate in FEHBP.
From the FEHB front, Fedweek columnist Reg Jones wraps up his series of federal employee and annuitant survivor benefits.
From the Medicare front, Healthcare Dive reports on provider reaction to yesterday’s final CMS rule on Medicare Part A payments to inpatient hospitals beginning October 1, 2022.
Organizations like The American Hospital Association said it was “pleased” by the payment update, a 4.3% bump up from the proposed 3.2%, but added it “still falls short of what hospitals and health systems need to continue to overcome the many challenges that threaten their ability to care for patients and provide essential services for their communities.”
Group purchasing organization Premier agreed, saying the payment update “falls woefully short” of what is needed for health systems. “Coupled with record high inflation, this inadequate payment bump will only exacerbate the intense financial pressure on American hospitals,” SVP of Government Affairs Soumi Saha said in a statement.
Beckers Hospital review offers six takeaways from the final rule.
High operating expenses took their toll on hospitals and physician groups in June, producing negative year-over-year margins for a sixth consecutive month, a new report from Kaufman Hall found. Month-to-month increases in patient volumes were not enough to offset the growing cost of care, the advisory firm said Monday.
Compared with May, operating margins improved, contract labor costs fell as demand slowed, and expenses cooled slightly in the latest month. But the industry has yet to turn the corner on an “enormously difficult year,” the report said.
“Although hospitals are seeing improved volumes and reduced expenses month-over-month, they will likely end up with historically low margins for the remainder of the year,” Kaufman Hall predicted.
Louisiana-based Ochsner Health has officially merged with Rush Health Systems, giving the merged system seven hospitals and more than 30 clinics in the east Mississippi and west Alabama region, according to a Monday release.
New names and branding are being rolled out at regional hospitals under the new brand, Ochsner Rush Health, the release said. Ochsner Rush Health will have 250 staff and contracted physicians and 95 advanced practice providers.
Ochsner Rush Health is also boosting its minimum wage to $12 an hour, impacting more than 400 employees and representing a $1.5 million investment, according to the release.
From the public health front,
Healio offers a bleak outlook for chronic disease in the US over the next forty years “likely stressing an already burdened health care system.”
The Center for Disease Control points to its revamped diabetes website “for people with diabetes or who are at risk for diabetes, and their families and friends.”
From the judicial front,
STAT News tells us
In a significant victory for AbbVie, a U.S. appeals court panel declined to revive a lawsuit that accused the company of using a so-called patent thicket to forestall competition for its Humira medication, a franchise product that generates billions of dollars in sales each year.
The opinion shot down arguments by unions, insurers, and the city of Baltimore, which alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar competition” by filing dozens of patents for the drug. Some of the 132 U.S. patents that the company holds on its medicine extend to 2034, although the basic patent expired in 2016.
The case has been closely tracked over concerns that the use of numerous patents — some of which may offer only marginal improvements or changes to a medicine — are exploited by pharmaceutical companies to protect monopolies at the expense of consumers. This has prompted the Food and Drug Administration and Patent and Trademark Office to jointly examine the issue.
Congress can change the patent system applicable to prescription drugs.
The American Hospital Association reports
The Department of Justice today filed a lawsuit challenging an Idaho law restricting abortion. The complaint seeks a declaratory judgment that the law conflicts with and is preempted by the Emergency Medical Treatment and Labor Act in situations where an abortion is necessary stabilizing treatment for an emergency medical condition. It also seeks an order permanently enjoining the law to the extent it conflicts with EMTALA, which requires hospitals that receive federal Medicare funds to provide necessary stabilizing treatment to patients who arrive at their emergency departments while experiencing a medical emergency.
The FEHBlog hopes that the federal court hearing the case seeks a decision from the Idaho Supreme Court on the scope of Idaho’s abortion law before proceeding with the case. The FEHBlog finds it hard to believe that any U.S. court would interpret its state’s abortion law as overriding obligations created by EMTALA and for that matter the Hippocratic Oath.
From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.
A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.
Both articles discuss the flies remain in the reconciliation ointment.
The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.
Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.
From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.
The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.
Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.
From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.
If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity. * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.
From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.
From the monkeypox front, Reuters makes two reports
The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.
The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.
From the U.S. healthcare business front —
The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.
Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.
But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.
Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.
“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.
Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.
Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”
Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.
Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.
MedPage Today reports “Second COVID booster shot boosted antibodies in Seniors — but small Israeli study did not determine how quickly response will wane.”
At least 18 cases of the newest omicron subvariant BA.2.75 have been confirmed in seven U.S. states as of July 20, early disease surveillance data shows.
Globally, researchers have identified 201 cases in more than a dozen countries as of July 12, according to data from outbreak.info, a platform that tracks data on coronavirus variants and is supported by the CDC and other national research groups.
The subvariant has a large number of mutations that may make it more adept than BA.5 — the nation’s current dominant strain — at spreading quickly and evading immune protection. Experts say it’s still unclear whether BA.2.75 will compete against BA.5 or cause more severe illness, according to CNN.
This leads us to the Wall Street Journal’s editorial board comments
The President’s [Omicron] infection [disclosed today] demonstrates how hard it is to avoid the new and highly transmissible Covid variants. The White House has gone to great lengths to protect Mr. Biden, but there’s only so much staff can do if the President is going to do his job.
Despite continuing pleas from the White House and public-health elite, vaccination by now provides little protection against transmission. * * * The evidence is that the vaccines do reduce the chances of getting serious Covid and being hospitalized, though many elderly patients who have been vaccinated are still dying from the virus.
While this quote is an opinion, not a news report, it struck a chord with the FEHBlog. The FEHBlog wishes the President a speedy recovery.
From the unusual viruses front, the Department of Health and Human Services offers a fact sheet on its response to the monkeypox outbreak.
In mergers and acquisitions news, Healthcare Dive informs us
Amazon has agreed to acquire primary care network One Medical for $18 a share, valuing the company at $3.9 billion.
The all-cash deal for San Francisco-based One Medical comes after months of speculation about a potential acquisition, reportedly drawing interest from companies including CVS Health, according to Bloomberg.
Analysts said a potential buyout for One Medical, which has grown rapidly since it was founded in 2007, could come at a significant premium. Amazon’s price of $18 a share represents a premium of 43% over its closing price of $10.18 a share on Wednesday.
STAT News explains why Amazon pursued adding One Medical to its healthcare portfolio.
With One Medical, Amazon is also tapping deeper into the vein of health care’s payment system. One Medical gets paid through two main avenues: commercial health insurers and Medicare. The Medicare side came from Iora, which One Medical bought for $1.4 billion last year.
Commercially insured patients, or those who get coverage through their jobs, are by far the most profitable within health care and overlap with a large chunk of Amazon’s subscription base. Even though One Medical focuses on less expensive primary care, there’s evidence One Medical charges some of the highest rates for those routine office visits and services, and that’s largely assisted by One Medical’s hospital partners.
Hospitals pay fixed sums to One Medical to care for patients, but they also “extend their health insurance contracts” to One Medical, the company said when it went public in 2020. The result: Hospitals that ink deals with One Medical get the most profitable patients in their market referred to them for more intensive services, and One Medical gets to piggyback off the lucrative payments that those dominant hospitals wring out of insurers.
Amazon’s success — and how disruptive it might prove to be to telehealth competitors — will depend in part on how well it integrates One Medical into its existing in-person and virtual offerings through Amazon Care. Analysts said that will become clear over the next year.
Whether it does draw patients away from traditional health care providers depends on their partnership with payers and their fees, said Aaron Neinstein, vice president of digital health for UCSF Health. “There’s no question that the One Medical annual fee is out of reach for most people in the U.S. Might Amazon change that or bundle it with Prime? Who knows.”F
Health Leaders Media reports that, notwithstanding the Federal Trade Commission’s nascent efforts,
Hospital and health system mergers and acquisitions in Q2 of 2022 have returned to trendlines that Kaufman Hall has been following since the beginning of the pandemic, the consulting firm said in its recently released M&A quarterly report.
During the second quarter of 2022, there were 13 hospital and health system M&A transactions, on-trend and only one transaction less than the 14 transactions reached in Q2 of 2021 and 2020. However, the total transacted revenue in the second quarter reached a “historic high” of $19.2 billion, more than doubling the $8.5 billion transacted revenue in the same quarter in 2021.
From the reports department and via Axios, the FEHBlog ran across this comprehensive McKinsey and Company report on the future of U.S. healthcare: what’s next for the industry post-Covid. Check it out.
From the Rx coverage front, DrugChannels calls our attention to this Amgen preview of 2022 trends in the biosimilars market. Adam Fein observes
As I predicted two years ago, the biosimilar boom is finally here. Prices are dropping while adoption accelerates. Prices are now declining by 9% to 22% annually. For therapeutic areas with biosimilars launched in the last three years, biosimilars’ market share averages 74%. See Amgen slides 8 and 9.
Fierce Healthcare discusses a recent Fitch report on non-profit hospitals.
Labor, supply and capital cost increases have been rampant across the industry this year thanks to broader inflation pressures and other pandemic factors, the ratings agency wrote.
Reversing the margin trends will likely require nonprofit hospitals to take on a combination of rate hikes in the short term, “relentless” cost-cutting and productivity initiatives for the medium term and “transformational changes to the business model” for the long term, Fitch wrote.
Fortunately for those hospitals, many organizations already have the means to weather the storm as they overhaul their operations.
“The vast majority of our rated credits have strong balance sheets that will offset lower margins for a period of time and allow for operational improvements,” Fitch wrote. “Without more substantial changes to the current business model, or with additional coronavirus surges this fall or winter, this balance sheet cushion could eventually erode.”
Rate negotiations with payers will likely be an upward battle, the group wrote.
Healthcare Forefront points out the value of underutilized fentanyl test strips
Fentanyl test strips (FTS) are a simple, inexpensive, and evidence-based method of averting drug overdose. FTS are small strips of paper that can detect the presence of fentanyl in any drug batch—pills, powder, or injectables. This tool might be lifesaving for the teenager experimenting for the first time, the individual in the throes of a severe opioid use disorder, the concert-goer looking for a trip, the person using a preferred substance obtained from a new source, or the individual years into recovery. FTS also support the dignity and well-being of people who use drugs (PWUD), enabling them to make educated decisions about their safety.
And yet after yearsofpress and discussions of the strips’ utility, FTS aren’t as widely available as one would expect them to be. It is time to take a more critical look at the importance of destigmatizing this tool and increasing its distribution and availability, while highlighting the grave risks in not doing so.
U.S. hospitals became much safer places for patients over the past decade, with medical errors and adverse events declining significantly across the nation, federal government data show.
Between 2010 and 2019, patient safety dramatically improved among the four types of conditions for which people are most often hospitalized: heart attacks, heart failure, pneumonia and major surgical procedures.
“There has been a precipitous, very important drop in the number of these events, which to me validates the idea that these were preventable,” said senior researcher Dr. Harlan Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Education in New Haven, Conn. “The status quo wasn’t written in stone. We have been able to actually make hospitals safer for those conditions.”
The new study relied on data gathered by the Medicare Patient Safety Monitoring Program, an effort created in the wake of a landmark 1999 Institute of Medicine report that drew national attention to patient safety in hospitals, the study authors said in background notes.
Fedweek reviews the steps that federal employees should take to position themselves for retirement.
Democratic lawmakers are continuing to call on federal agencies to increase data privacy protection for patients seeking abortions, following the Supreme Court’s decision ending the constitutional right to the procedure.
Seventy-two Democratic members of Congress sent a letter Wednesday to Lina Khan, chair of the Federal Trade Commission, urging her to use the “full power” of her office to enact safeguards against data brokers collecting and selling data that could be used to prosecute pregnancy-related crimes.
The letter to the FTC follows one sent Friday by Democrat senators to HHS urging the department to update the HIPAA privacy law to limit when covered entities can share information about abortion services.
From the cyber breaches front, Cybersecurity Dive tells us
Marriott International last month suffered its third publicly acknowledged data breach in four years. The hotel chain disclosed the incident after DataBreaches.net reported an unnamed threat actor claimed to have stolen 20 gigabytes of sensitive data. * * *
Marriott claims the incident was quickly contained and potential exposure was limited to about 400 individuals. * * *
In the latest incident, a threat actor “used social engineering to trick one associate at a single Marriott hotel into providing access to the associate’s computer,” a Marriott spokesperson said via email. “The threat actor did not gain access to Marriott’s core network.”
Following an investigation, the company said it determined the information that was accessed primarily contained non-sensitive internal business files regarding the property’s operations.
The hotel chain said it identified the breach and was investigating the incident before the threat actor contacted the company in an extortion attempt. Marriott did not pay the threat actor, according to the company spokesperson.
From the cyber vulnerabilities front, CISA announced last Wednesday
The Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the U.S. Department of the Treasury (Treasury) today released a joint Cybersecurity Advisory (CSA) that provides information on Maui ransomware, which has been used by North Korean state-sponsored cyber actors since at least May 2021 to target Healthcare and Public Health (HPH) Sector organizations.
The CSA titled, “North Korean State-Sponsored Cyber Actors Use Maui Ransomware to Target the Healthcare and Public Health Sector,” provides technical details and indicators of compromise (IOC) observed during multiple FBI incident response activities over a period of more than a year and obtained from industry analysis of Maui samples. North Korean state-sponsored actors were observed using Maui ransomware to encrypt HPH servers responsible for providing healthcare services. In some cases, the malicious activity disrupted the services provided by the victim for prolonged periods.
The HPH Sector, as well as other critical infrastructure organizations, are urged to review this joint CSA and apply the recommended mitigations to reduce the likelihood of compromise from ransomware operations. The FBI, CISA, and Treasury assess that North Korean state-sponsored actors are likely to continue targeting HPH Sector organizations, because of the assumption that these organizations are willing to pay ransoms to avoid disruption of the critical life and health services they provide. For more information on state-sponsored North Korean malicious cyber activity, see CISA’s North Korea Cyber Threat Overview and Advisories webpage.
The FBI, CISA, and Treasury strongly discourage paying ransoms as doing so does not guarantee files and records will be recovered and may pose sanctions risks. In September 2021, Treasury issued an advisory highlighting the sanctions risk associated with ransomware payments and providing steps that can be taken by companies to mitigate the risk of being a victim of ransomware.
All organizations should share information on cybersecurity incidents and anomalous activity to CISA 24/7 Operations Center at report@cisa.gov or (888) 282-0870 and/or to the FBI via your local FBI field office or the FBI’s 24/7 CyWatch at (855) 292-3937 or CyWatch@fbi.gov.
Healthcare IT News offers a report on this announcement here.
The group behind Hive ransomware completed a full code migration and overhaul to use a more complex encryption method for its ransomware as a service payload, researchers from Microsoft Threat Intelligence Center found.
Microsoft describes Hive, which was first observed in June 2021, as one of the most prevalent ransomware payloads and one of the fastest evolving ransomware families.
By migrating code from Go to Rust, Hive can string encryption that boosts its ability to evade discovery, deepen control over the code and heighten protection against reverse engineering.
Of course, here’s a link to the current Week in Ransomware from Bleeping Computer. Check it out.
From the cyber defenses front —
Cybersecurity Dive identifies CISO priorities for the second half of this year.
In a similar vein, ZDNet discusses “the cybersecurity threats of tomorrow that you should be thinking about today. The rise of quantum computing, deepfakes, the Internet of Things and more are among the things that could create very real challenges for cybersecurity going forwards.”
Speaking of quantum computing, CISA announced this week “the establishment of a Post-Quantum Cryptography Initiative to unify and drive agency efforts to address threats posed by quantum computing.” HHS’s HC3 timely released a PowerPoint presentation on Quantum Cryptogtaphy and the Health Care Sector.
An ISACA expert promotes “The Case for Outcome-Based Cybersecurity: A Data-Focused Shift in Cybersecurity Management.”
Cybersecurity Dive brings us current on 5G network security issues. “The most prevailing security challenge in 5G infrastructure is the significant expansion of the attack surface in relation to pre-5G networks,” Ron Westfall, senior analyst and research director at Futurum Research, said.
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 Centers for Disease Control’s Advisory Committee on Immunization Practice meets Thursday to vote on recommending the Moderna Covid vaccine for younger folks aged 6 through 17. This drug would be an alternative Pfizer’s Covid vaccine for that age group. Assuming the ACIP votes in favor of the Moderna vaccine, then CDC Director must approve their recommendation for the health plan coverage with no cost-sharing mandate to kick in.
Electronic messages and postcards with primary care physicians’ (PCP) names got Black and Latino patients in the door for their COVID-19 vaccines.
Although the effects were “relatively modest,” if applied on a larger scale, an additional 238,000 Black and Latino older adults may have been vaccinated across the United States, according to a new study.
Kaiser Permanente Northern California’s Division of Research examined the effectiveness of standard and culturally tailored electronic messages and mailings from patients’ own PCPs encouraging COVID-19 vaccines from March 29 to May 20, 2021. The results were published in an original investigation, “Effect of Electronic and Mail Outreach from Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial,” in the journal JAMA Network Open.
The study involved 8,287 patients aged 65 years and older, around the California Central Valley, Fresno, South Sacramento and San Jose, divided into three groups.
This study again illustrates the value of health plans teaming with primary care providers.
From the nicotine front, the Wall Street Journal devined from the federal government’s Spring 2022 regulatory agenda, posted Tuesday, that
The Biden administration is moving forward on a plan to mandate the elimination of nearly all nicotine in cigarettes, a policy that would upend the $95 billion U.S. cigarette industry and, health officials say, prompt millions of people to quit smoking.
The plan, unveiled Tuesday as part of the administration’s agenda of regulatory actions, likely wouldn’t take effect for several years. The Food and Drug Administration plans to publish a proposed rule in May 2023, though the agency cautioned that date could change. Then the agency would invite public comments before publishing a final rule. Tobacco companies could then sue, which could further delay the policy’s implementation.
The Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, according to people familiar with the matter.
The FDA could announce its decision as early as this week, the people said. The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.
Uncertainty has clouded Juul since it landed in the FDA’s sights four years ago, when its fruity flavors and hip marketing were blamed for fueling a surge of underage vaping. The company since then has been trying to regain the trust of regulators and the public. It limited its marketing and in 2019 stopped selling sweet and fruity flavors.
The company’s legal actions likely are in development now.
From the Rx coverage front —
Fierce Healthcare calls to our attention expert opinions rendered on better controlling prescription drug costs at an AHIP conference. The experts agreed that all of the stakeholders need to be at the negotiating table.
Scott Gottlieb, M.D., former Food and Drug Administration commissioner, on a panel at AHIP’s 2022 conference * * * said the challenge for regulators looking to address drug prices is the fact that a one-size-fits-all solution will not work in this market. He said instead that policymakers should consider pharmaceuticals in three buckets: drugs that are in an active market with significant rebate activity; drugs that currently monopolize the market but will lose that monopoly in the near future; and drugs that are likely to monopolize a market in the long term.
“I think we need to think about the market as those three segments and think about different policy solutions for each of them,” [and attention should be focused on the third category] Gottlieb said.
The FEHBlog agrees with the experts about the importance of engaging all of the stakeholders. There are no bad guys here at least in the FEHBlog’s view.
From the preventive services front, Medscape reports
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the United States Preventive Services Task Force (USPSTF) concludes.
However, there are two vitamins — vitamin E and beta-carotene — that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos, it notes.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer.
Medscape adds that this USPSTF decision aligns with a 2014 recommendation on the same topic.
From the lab test coverage front, Fierce Healthcare reports
Optum is launching a new health plan solution that aims to reduce unnecessary testing and ensure that patients are receiving the screenings that are best for them.
The laboratory benefit management tool will assist insurers in aligning lab tests with clinical guidance and will automate large parts of lab benefit administration, Optum said in an announcement provided first to Fierce Healthcare.
The company estimates that insurers could save between $12 to $36 per member per year, or about $3 billion.
Tests that lack clinical indications can lead to unneeded sample collection form patients as well as a higher risk of false positive results, which can compound unnecessary healthcare costs. There is a dearth of industry standards and efficacy data around lab tests, making it common for results to be misinterpreted or tests to be misused.
Fierce Healthcare adds that Optum is selling this tool to all health plans.
From the U.S. healthcare front, U.S. News and World Report offers 2022 rankings on the healthiest counties in the U.S. The FEHBlog recently moved from Montgomery County Maryland to Hays County Texas. Both counties score about 55 out of 100 in the rankings.
Cybersecurity Dive provides five takeaways from the RSA conference held in San Francisco from June 6 through 9.
From the cyber breach front, MeriTalk provides more details on the settlement of the lawsuit against OPM over the massive 2015 data breach.
The lead counsel in the class action said that individual victims are in line for minimum payments of $700 each under the terms of the settlement, which still needs to be finalized. * * *
The preliminary settlement agreement will be subject to further consideration at a fairness hearing set for Oct. 14.
From the cyber vulnerabilities front,
Here is a link to CISA’s known exploited vulnerabilities catalog. Bookmark that one.
Becker’s Hospital Review explains why “Cybersecurity experts say that the two biggest threats to healthcare cybersecurity are insider threats and ransomware.”
Security Week reports “Microsoft has fixed roughly 50 vulnerabilities with its June 2022 Patch Tuesday updates, including the actively exploited flaw known as Follina and CVE-2022-30190.”
From the ransomware front
Cybersecurity Dive discusses how ransomware groups are shifting tactics and objectives.
Here is a link to Bleeping Computer’s The Week in Ransomware.
From the cyber defense front
HHS’s Healthcare Cybersecurity Coordination Center (HC3) offers a presentation about strengthening cyber posture in the health sector.
Health IT Security discusses the HC3 presentation.
From the Omicron and siblings front, MedPage Today reports
A committee of independent vaccine experts recommended that the FDA grant an emergency use authorization (EUA) for the two-dose Moderna COVID-19 vaccine for kids ages 6 to 17 years.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22-0, agreeing unanimously that the benefits of vaccination outweigh the risks in two age groups: kids ages 6 to 11 years and teens ages 12 to 17. They recommended two 50-mcg doses for the younger kids and two 100-mcg doses for teens.
The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older. * * * An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.
Only a very small number of high-risk patients with COVID-19 experienced “rebound symptoms” after being treated with nirmatrelvir/ritonavir (Paxlovid), a retrospective study found.
Among nearly 500 patients, 93% of whom were fully vaccinated, two patients were hospitalized due to symptoms that were not directly related to “rebounding” within a month and required care in the intensive care unit (ICU), and four experienced rebound symptoms at a median of 9 days (interquartile range [IQR] 7-14.5), reported Nischal Ranganath, MD, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.
All rebound symptoms were resolved with symptom-directed treatment, and no deaths were reported in any patients after 30 days following their initial COVID-19 diagnosis, the group noted in Clinical Infectious Diseases.
“We found that rebound phenomenon was uncommon in this group of patients,” said co-author Aditya Shah, MBBS, also of the Mayo Clinic, in a statement. “The four individuals who experienced rebound represent only 0.8% of the group, and all of them recovered quickly without additional COVID-directed therapy.”
That’s certainly good news to read.
From the Rx coverage front, the Drug Channels blog tears apart a recent JAMA study concluding that the pricing of recently launched drugs has skyrocketed in recent years.
[T]he study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations.
Most notably, the authors discount the fact that the most expensive new drugs treat ultra-rare conditions affecting extraordinarily small patient populations. Their policy recommendations would therefore have a devastating impact on these patients and their hope for treatments and cures.
As Nobel prize winner Ronald Coase observed: “If you torture the data long enough, it will confess to anything.”
And the Dr. Fein can back up his conclusion.
From general healthcare front, Kaiser Health News offers thought provoking articles about
waiving cost sharing on all diagnostic tests for cancer, not just the first one.
The first article draws an important distinction between medical care and SDOH. Unfortunately, the second article reminds us that no good deed goes unpunished. If the government simply had relied on personal responsibility (outside of Medicaid), we would not find ourselves in this pickle.
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