From our Nation’s capital, the New York Times reports,
White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.
Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.
Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out
Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.
The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look.
From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”
From the maternal health front, the American Hospital Association informs us
The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.
From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.
Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.
From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.
From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.
From the Omicron and siblings front, the Wall Street Journal reports
Omicron Covid-19 variants BA.4 and BA.5 are on the rise in the U.S., adding two more highly contagious versions of the virus to the mix that has fueled a springtime surge in cases.
The closely related subvariants represented a combined 13% of U.S. cases for the week ended June 4, according to estimates the Centers for Disease Control and Prevention released on Tuesday. Evidence suggests the variants are yet-more contagious versions of Omicron, public-health experts said, that may be able to evade some of the immune protections people built up from infections triggered by another version of Omicron during the winter.
The spread of the subvariants could at least prolong the time it takes to emerge from the current wave fueled by other versions of Omicron, some health experts said.
This case wave hasn’t translated to a significant surge in severe illness. Hospitalizations, while up, remain far below earlier peaks, and reported Covid-19 deaths have recently hovered near historically low levels. * * * Epidemiologists believe built-up immunity from vaccines and prior infections have bolstered defenses against severe illness, even though many people are falling ill from both breakthrough and repeat infections.
AHIP informs us
Today the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant emergency use authorization (EUA) for the Novavax COVID-19 vaccine in adults by a vote of 21-0.
The Committee reviewed data from Novavax showing that the benefits of the two-dose primary series outweigh the potential risks. The Committee noted the importance of making a vaccine available that has an alternative method of action, different from the mRNA vaccines currently available in the U.S., in the hope that a more traditional vaccine may appeal to those currently unvaccinated and those who may have an allergy to the components of the mRNA vaccines.
Committee members agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation, though the company has argued there’s not yet enough evidence to establish a definitive link. The FDA is expected to make a decision on granting Novavax an EUA soon, whereby the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to determine when and how the vaccine should be administered.
Pfizer on Monday announced plans to invest $120 million in a drug manufacturing facility located in Kalamazoo, Michigan, which will lead to the creation of over 250 jobs.
The investment is aimed at accelerating production of Pfizer’s COVID-19 pill Paxlovid, demand for which has risen after Pfizer’s initial struggles to make sufficient quantities following the drug’s clearance in December. To date, Pfizer has delivered 12 million courses of the drug across 37 countries, 5 million of which have been shipped to the U.S.
The Kalamazoo plant, one of Pfizer’s largest drugmaking sites, will make the starting materials and active ingredient contained within Paxlovid. The new investment expands the site’s capacity, making it one of the world’s largest producers of pharmaceutical ingredients, according to Pfizer.
From the Rx coverage front, the Federal Trade Commission announced
The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. * * *
The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:
** fees and clawbacks charged to unaffiliated pharmacies;
** methods to steer patients towards pharmacy benefit manager-owned pharmacies;
** potentially unfair audits of independent pharmacies;
** complicated and opaque methods to determine pharmacy reimbursement;
the prevalence of prior authorizations and other administrative restrictions;
** the use of specialty drug lists and surrounding specialty drug policies;
** the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.
The Commisioners voted 5-0 to commence the investigation. Responses from the PBMs to the FTC’s compulsory orders are due in 90 days.
From the Pride Month front, Health Payer Intelligence reports “Members of the LGBTQ+ community reported varying experiences of discrimination in the health insurance industry but indicated that payer health equity may be improving, according to a survey from Healthcare.com.” Survey details are available in the article and the survey.
From the miscellany department
The American Medical Association offers expert guidance on understanding blood pressure readings.
The Centers for Disease Control explains the connection between diabetes and the brain.
Anthem has partnered with Happify Health to offer a slate of new digital tools for women’s health.
Happify’s platform is based on “sequences,” or digital experiences that it uses to support specific medical conditions. These sequences combine evidence-based digital therapeutics, online communities, coaching and tailored local resources in one unified platform.
Happify’s sequences are able to integrate with existing systems and solutions for ease of navigation, according to the announcement.
Everyone deserves access to mental health support that is effective and affordable. With more Americans than ever seeking help for mental health concerns, AHIP conducted a nationwide survey to understand people’s experience accessing care, whether their treatment was covered by insurance, and if insured patients were satisfied with the results. The findings reveal that nearly all respondents who sought mental health care for themselves or someone within their household over the past 2 years received treatment, and 3 in 4 insured Americans (73%) found it easy to get the care they needed. More than two-thirds of respondents were able to find an appointment with a provider in less than a month. In addition, 9 in 10 reported being satisfied with the mental health support they received, including half who say they were very satisfied.
Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the month, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 22nd week of 2022:
The CDC’s weekly review of its Covid statistics explains “As of June 1, 2022, the current 7-day moving average of daily new cases (100,684) decreased 8.5% compared with the previous 7-day moving average (110,081).”
Here’s the CDC’s current chart of new Covid hospitalizations:
The CDC’s weekly statistical review notes that “The current 7-day daily average [of new Covid hospitalizations] for May 25–31, 2022, was 3,789. This is a 4.7% increase from the prior 7-day average (3,619) from May 18–24, 2022.
Here’s the FEHBlog’s weekly chart of new Covid deaths from the 27th week of 2021 through the 22nd week of 2022:
The CDC’s weekly statistical review adds “The current 7-day moving average of new deaths (244) has decreased 23.1% compared with the previous 7-day moving average (318).”
Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in December 2020 through the 22nd week of 2022.
Overall, about 258.7 million people, about 221.4 million people, or 66.7% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 103.5 million people have received a booster dose,** but 49.0% of the total booster-eligible population has not yet received a booster dose. As of June 1, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 343,662, a 9.5% decrease from the previous week.
As of June 2, 2022, there are 240 (7.45%) counties, districts, or territories with a high COVID-19 Community Level, 733 (22.76%) counties with a medium Community Level, and 2,247 (69.78%) counties with a low Community Level. This represents a slight (−0.53 percentage points) decrease in the number of high-level counties, a small (+1.37 percentage points) increase in the number of medium-level counties, and a corresponding (−0.84 percentage points) decrease in the number of low-level counties. Fifty-one (98.1%) of 52 jurisdictions had high- or medium-level counties this week.
Novavax Inc.’s vaccine was 90% effective at preventing Covid-19 in its pivotal trial, but the performance came before the emergence of the Omicron variant that has eluded vaccines more than earlier strains, U.S. health regulators said.
The Food and Drug Administration also expressed concern Friday that six people developed heart-inflammation conditions known as myocarditis and pericarditis, out of about 40,000 people who had taken Novavax’s vaccine during various studies.
The agency released its evaluation of Novavax’s Covid-19 vaccine ahead of a meeting of outside advisers who are scheduled to discuss next week whether the agency should recommend authorization of the shot.
The FDA staff’s appraisal suggests the vaccine could face a tough round of questioning from advisers weighing the shot’s uncertain efficacy against Omicron with potential heart risks.
This suggests an unfortunate outcome. The Novovax vaccine was developed using a traditional approach may be acceptable to the vaccine inquisitive.
In healthcare business news
Health Leaders Media informs us “Health insurers are not holding up their end of the bargain on mutually accepted prior authorization reforms, according to a new physician survey by the AMA.” The FEHBlog is growing concerned that the AMA is winning the prior authorization war.
Fierce Healthcare tells us “Optum has invested heavily in building out its provider enterprise. But executives at UnitedHealth Group say it’s still early days for the endeavor.”
Healthcare Dive reports “The Federal Trade Commission is suing to block two separate hospital mergers, the agency said Thursday. The FTC has sued to block HCA Healthcare’s acquisition of Steward Health Care System, alleging that the deal would reduce competition in Utah and ultimately raise prices. In another suit, the FTC is moving to block RWJBarnabas Health from acquiring Saint Peter’s Healthcare in New Jersey, alleging ‘overwhelming evidence’ that the deal would harm patients in the form of less choice and higher prices.”
The Healthcare Dive article adds
The FTC has now challenged numerous hospital deals this year following its latest action.
Rhode Island’s two largest health systems abandoned plans to merge in February about a week after the FTC sued to block the deal.
New Jersey’s largest health system, Hackensack Meridian Health, lost its appeal challenging the FTC’s move to prevent a tie-up with Englewood Hospital, one of the last independent hospitals in the area.
Bristol Myers Squibb is buying biotech Turning Point Therapeutics, announcing Friday a $4.1 billion deal that will give the pharmaceutical company an experimental drug that targets mutations found in lung cancer and other solid tumors.
The deal values Turning Point at $76 a share, more than double the $34.16 at which shares closed on Thursday and four times the biotech’s $18 initial public offering price in 2019. Yet the buyout price is well below the company’s peak of $133 a share in February 2021, which gave it a market value of $6.6 billion.
The company’s lead drug, called repotrectinib, has advanced through Phase 2 testing in lung cancer patients whose tumors harbor a mutation called ROS1. Repotrectinib would compete against Roche’s Rozlytrek, if approved. Bristol Myers expects to gain Food and Drug Administration clearance in the second half of 2023.
As the industry puts a focus on mental health coming out of COVID-19, a new study suggests that loneliness may be a key place to start.
Research from Cigna and Morning Consult finds that more than half (58%) of U.S. adults would be considered lonely. This is on par with pre-pandemic research, which found that 61% of adults are lonely, and made for a seven percentage point increase from 2018.
Loneliness and mental health issues are closely linked, according to the study. Adults with mental health concerns were twice as likely to feel lonely compared to those with strong mental health. The study also found that minorities and younger people were also more likely to be dealing with loneliness.
Three-quarters (75%) of Hispanic adults and 68% of Black adults are classified as lonely, according to the study, figures both substantially higher than the rate of loneliness in the general population. Seventy-nine percent of adults aged 18 to 24 said they feel lonely, compared to 41% of seniors aged 66 and over.
The FEHBlog wishes his readers a weekend full of family and friendship.
The Senate and the House of Representatives are holding a State / District work period this week. Insurance News Net adds that the House Oversight and Reform Committee has “requested information regarding insurers’ and PBMs’ compliance with the ACA and CMS guidance [on contraceptive coverage] by June 8, 2022.
Pfizer’s antiviral drug, called Paxlovid, totaled more than 412,000 prescriptions through May 6, compared with about 110,000 prescriptions of molnupiravir, an antiviral from Merck & Co. and Ridgeback Biotherapeutics LP [called Lagevrio], according to drug-data firm Iqvia Holdings Inc. * * *
“Now that Paxlovid has become much easier to obtain, by and large relative to where it was before, Paxlovid is mine and the majority of my colleagues’ first choice,” said Ali Khan, chief medical officer of value-based strategy at Oak Street Health Inc., which has more than 140 primary-care clinics in 20 states across the U.S. * * *
“Doctors have become more comfortable with Paxlovid and more regularly prescribing the more effective drug,” said Zenobia Brown, medical director of health solutions at Northwell Health, a major New York healthcare provider.
Paxlovid, like Lagevrio, has been shown through lab studies to remain effective against Omicron and its subvariants. That has allowed doctors to prescribe it and reserve antibody treatments for other people who can’t take Paxlovid because of the potentially harmful drug interactions.
The White House earlier this month announced that households can now order a third round of free COVID-19 rapid tests on COVIDTest.gov.
Households can now receive eight new tests, double what households could order in the previous two rounds. USPS has delivered at least 380 million free tests through the program so far.
Bravo, USPS.
From the unusual viruses front —
STAT News updates us on monkeypox. “The ongoing monkeypox outbreak currently poses a moderate risk to global public health, the World Health Organization said Sunday in a statement that nevertheless raised the specter of the virus becoming entrenched as a pathogen that spreads from person to person. * * * To date most of the [257 confirmed] cases have been diagnosed in Europe and North America. The United States had detected 12 cases as of Friday. “Currently, the overall public health risk at [a] global level is assessed as moderate considering this is the first time that monkeyp ox cases and clusters are reported concurrently in widely disparate WHO geographical areas,” the global health agency said.”
The World Health Organization updates us on “Six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children [that] have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The majority of reported cases (n=374; 58%) are from the WHO European Region (22 countries), with 222 (34%) cases from the United Kingdom of Great Britiain and Northern Ireland alone. Probable cases and cases pending classification have also been reported from the Region of the Americas (n=240, including 216 cases in the United States of America) * * *.
From the miscellany department
The American Medical Association offers an article about what doctors wish their patients knew about living with migraines.
MedPage Today informs us “Using artificial intelligence (AI) during screening colonoscopy could be a cost-savings strategy that also could boost the prevention of colorectal cancer (CRC) incidence and mortality, a researcher reported.”
MedPage also tells us “Physical therapy-based rehabilitation frequently leads to better outcomes using fewer resources for patients with MSK pain when compared to operative procedures. But physical therapy must be a part of the treatment conversation early on, while surgery should be positioned as a last resort with the patient made well aware of surgery’s risks and complications. This is currently not the case in many patient-provider interactions.”
Based on the CDC’s Covid Data Tracker, and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 21st week of 2022:
Reliable estimates of case counts are particularly relevant with the U.S. in the midst of yet another Covid-19 wave. By official case counts, it is a modest wave, at roughly 110,000 infections a day, according to the CDC. That is smaller than the 165,000 daily cases reported during the Delta wave, or the 250,000 a day during the 2020-21 winter.
But estimates of the true number of infections, correcting for undercounting, suggest the U.S. might be experiencing the second-largest wave of Covid-19 infections since the pandemic began.
Here’s the CDC’s weekly chart of new Covid hospitalizations.
Hospitalization numbers also aren’t a perfect gauge. Someone can break a leg and test positive in the emergency room for a mild case of Covid-19. That case becomes a confirmed coronavirus hospitalization—and a strain on the hospital’s bed counts and personal-protective-equipment supplies—but not necessarily a severe case.
In Massachusetts, hospitals have begun reporting whether Covid-19 is the primary reason someone is in the hospital—and in January about 50% of cases were. It is hard to pinpoint how similar Massachusetts would be to other states, but it offers a further example of how better counting could improve assessment of the pandemic.
Here’s the FEHBlog weekly chart of new Covid deaths again from the 27th week of 2021 through the 21st week of 2022:
Covid-19 deaths in the U.S. are hovering near the lowest levels since the pandemic hit, showing how a population with built-up immune protection is less at risk of severe outcomes even as another wave of infections flows through the country.
The nearly 300 deaths reported daily are again more concentrated among older people, underscoring hazards for the more vulnerable while the overall population appears less at risk.
Particularly vulnerable people, such as those who are older and immunocompromised, will likely always have some risk of death from a Covid-19 infection, doctors and public-health experts said. Increasing booster rates and access to treatments, in addition to taking certain precautions, can help lower the threat presented by the virus, they said.
White House officials said on Thursday that they were introducing new models for distributing Paxlovid, the Covid-19 oral medication made by Pfizer, in an effort to get the treatment to more people and keep coronavirus death rates relatively low even as cases increase.
The federal government will start reimbursing a clinic in Providence, R.I., for evaluating patients who test positive and immediately prescribing Paxlovid to those eligible for it — the first of what the White House said would be a series of federally supported sites, with others set to open in New York and Illinois. Federal workers are also being sent to state-run testing sites in Minnesota, transforming them into “test-to-treat” locations, the White House said.
“Fundamentally, what we’re trying to do is get to a point where Covid deaths are largely preventable, and I think we’re pretty close to there,” Dr. Ashish K. Jha, the White House Covid-19 response coordinator, said in an interview Wednesday evening. “Deaths from this disease really should become increasingly rare.”
STAT News offers an interesting look into how scientists assess the level of Covid resistance to Paxlovid.
Resistance is the hobgoblin of antiviral medicine, even with antivirals as effective as Paxlovid. After doctors deployed nearly every new virus-killing infusion or pill in history, strains popped up — either immediately or eventually — with machinery warped in just the right way to evade the threat.
Exactly how much of a problem resistance will be for Paxlovid is complicated. In some patients, the coronavirus will inevitably find ways to evade the pill, as it did prior Covid-19 drugs.
“If there is anything we know about viruses and antiviral drugs is that eventually we will see some sort of resistance,” Andrew Pavia, chief of pediatric infectious diseases at University of Utah Health, said in an email.
What’s less clear, Pavia and other experts say, is whether any resistant variants will spread widely. The coronavirus may have particular difficulty getting around Paxlovid compared to other drugs because patients take it for only five days and because it targets a protein the virus can’t easily change. Any mutation or modification the virus makes may impair its ability to replicate or survive.
Here’s the FEHBlog weekly chart of Covid vaccinations distributed and administered
The CDC’s weekly review of its Covid statistic tells us
People who are up to date on vaccines have much lower risk of serious illness and death from COVID-19 compared with people who are unvaccinated. CDC’s COVID Data Tracker shows that in March 2022, adults ages 18 years and older who were unvaccinated were about 5 times more likely to be hospitalized with COVID-19 than those who were up to date. In the same month, people ages 12 years and older and unvaccinated were 17 timesmore likely to die of COVID-19 than those who were up to date.
COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and even dying—especially people who are boosted. As with other diseases, you are protected best from COVID-19 when you stay up to date with recommended vaccines. Find a vaccine provider near you.
As of May 19, 2022, there are 301 (9.35%) counties, districts, or territories with a high COVID-19 Community Level, 477 (14.81%) counties with a medium Community Level, and 2,442 (75.84%) counties with a low Community Level. This represents a moderate (+5.10 percentage points) increase in the number of high-level counties, a slight (−0.74 percentage points) decrease in the number of medium-level counties, and a corresponding (−5.84 percentage points) decrease in the number of low-level counties. Five (9.62%) of 52 jurisdictions had no high- or medium-level counties this week.
the Centers for Medicare & Medicaid Services (CMS) released a report that recommends cost savings from lower-than-expected Medicare Part B spending be passed along to people with Medicare Part B coverage in the calculation of the 2023 Part B premium. Earlier this year, Department of Health and Human Services (HHS) Secretary Xavier Becerra instructed CMS to reassess the 2022 Part B premium amount in response to a price reduction for Aduhelm™, a monoclonal antibody directed against amyloid for use in treating Alzheimer’s disease. Given the information available today, it is expected that the 2023 premium will be lower than 2022. The final determination will be made later this fall.
This CMS decision is quite sensible, in the FEHBlog’s view.
On a related FEHB note, FedSmith discusses the pros and cons of enrolling in Medicare Part B when you are a federal or Postal annuitant with FEHB coverage in retirement as well.
From the telehealth front, mHealth Intelligence reports
Called CVS Health Virtual Primary Care, the digital care platform will provide healthcare consumers with an array of care services, including primary care, on-demand care, chronic condition management, and mental health services. Consumers will also be able to choose their healthcare setting from various retail, community-based, virtual, and at-home care options.
“We’re meeting people where they are on their healthcare journey and providing care that is more convenient and easier to access,” said Creagh Milford, DO, vice president, enterprise virtual care at CVS Health, in the news release.
The new benefit will launch on January 1, 2023.
From the Rx coverage front, Formulary Watch reveals that
The Institute for Clinical and Economic Review (ICER) has released the protocol for its second annual review of insurance company policies to assess fair access to prescription drugs. ICER will evaluate whether 15 large U.S. commercial payers, the two largest state health exchange plans, and the Department of Veterans Affairs have formularies and procedures that provide appropriate access to the prescription drugs reviewed by ICER in 2020. These drugs include those that treat patients with cystic fibrosis, hemophilia A, migraine, sickle cell disease, and ulcerative colitis.
The analysis is expected to be completed in November 2022.
From the studies front, the Centers for Disease Control issued its 2021 Diabetes Report Card this week. Here are the highlights
* After almost 2 decades of continual increases, the incidence of newly diagnosed cases of diabetes in the United States decreased from 9.3 per 1,000 adults in 2009 to 5.9 per 1,000 adults in 2019.
* Prevalence of prediabetes among US adults remained steady from 2005–2008 to 2017–2020. However, notification of prediabetes status nearly tripled (from 6.5% to 17.4%).
* American Indian or Alaska Native, non-Hispanic Black, Hispanic, and non-Hispanic Asian people are more likely to be diagnosed with diabetes than non-Hispanic White people (14.5%, 12.1%, 11.8%, 9.5%, and 7.4%, respectively).
* During the COVID-19 pandemic, diabetes emerged as an underlying condition that increases the chance of severe illness. Nearly 4 in 10 adults who died from COVID-19 in the United States also had diabetes.
Lawmakers are facing increased pressure to pass a comprehensive mental health and substance use package but are unlikely to make an initial goal of advancing legislation before the implementation of a three-digit suicide hotline in July.
At least four congressional committees have committed to advancing a swath of bipartisan mental health bills under their jurisdiction, but lawmakers have not yet unlocked the puzzle of how to incorporate a growing laundry list of programs to authorize and establish existing and new programs dedicated to treatment, prevention, education, crisis care, drug interdiction and the workforce.
One of those four committees is the Senate Finance Committee which announced today
Senate Finance Committee Chair Ron Wyden (D-Ore.), Ranking Member Mike Crapo (R-Idaho), Senator Ben Cardin (D-Md.) and Senator John Thune (R-S.D.) today released a discussion draft for telehealth policies as a part of the committee’s ongoing work to improve mental health care across the nation, which has included a public call for comments and three hearings to help develop these initiatives. * * *
The discussion draft includes policies that would:
* Remove Medicare’s in-person visit requirement for tele-mental health services.
* Establish benefit transparency for mental health care services delivered via telehealth to inform Americans with Medicare how and when they can access telehealth.
* Preserve access to audio-only mental health coverage in Medicare when necessary and appropriate.
* Direct Medicare and Medicaid to promote and support provider use of telehealth.
* Incentivize states to use their CHIP programs to establish local solutions to serve behavioral health needs in schools, including through telehealth.
A highly contagious sublineage of the BA.2 omicron subvariant is now the nation’s dominant strain, according to the CDC’s latest variant proportion estimates.
The sublineage, BA.2.12.1, accounted for 57.9 percent of all U.S. COVID-19 cases in the week ending May 21, CDC data shows. BA.2, which became the nation’s dominant strain in mid-March, now accounts for an estimated 39.1 percent of all cases.
BA.2.12.1 is estimated to have a 25 percent growth advantage over BA.2, which is already more transmissible than the original omicron strain. The newer omicron sublineage has been gaining traction in the U.S. over the last month. In the week ending April 23, BA.2.12.1 accounted for just 24.1 percent of U.S. COVID-19 cases.
Health officials are also monitoring another omicron subvariant — BA.1.1.529 — which currently accounts for an estimated 2.8 percent of cases.
“Epidemiologically, it doesn’t appear as if we’re seeing more severe disease in places that are having more cases,” CDC Director Rochelle Walensky said of the sublineages during an April 26 news conference. “So we are not anticipating more severe disease from some of these subvariants, but we are actively studying it.”
As many as one in four seniors and one in five adults under 65 experienced “long COVID” or “post-COVID” symptoms after surviving a coronavirus infection, a new study from the Centers for Disease Control and Prevention reported Tuesday.
The study — published in the CDC’s Morbidity and Mortality Weekly Report — is the latest to try and quantify how many of the millions of Americans who have now tested positive for the virus are facing long-term issues caused by their infection.
By comparing electronic health records in a large national database of patients, the study’s authors found 38.2% of COVID-19 survivors “experienced at least one incident condition” — a list that includes heart, lung, kidney and gastrointestinal problems, pain, fatigue, loss of smell or taste, mental health issues, and more — in the months after their infection. By contrast, just 16% of other people were diagnosed with such conditions.
Vaccination reduces your risk of developing long Covid, but not by much on average, new research suggests.
A Veterans Affairs study out Wednesday found that vaccinated people with breakthrough Covid-19 infections had a 15% reduction in experiencing persistent or new symptoms and health conditions up tosix months after infection compared with those who were unvaccinated and got Covid.
Most of the vaccinated people had received two doses of the Pfizer or Moderna vaccine, while 8% received one dose of the Johnson & Johnson vaccine.The study didn’t look at people who had received boosters.
Bloomberg discusses the risks of contracting Covid while pregnant.
Canada’s first dual specialist in infectious diseases and obstetrics/gynecology, Deborah Money, MD comments “For the most part, women in communities even with Covid circulating do well,” she says. “The majority of babies are fine.”
But that’s just part of the story. Their analysis of data from 6,012 people in six Canadian provinces who tested positive for the virus during their pregnancy found a substantial increase in hospitalizations and ICU admissions compared with reproductive-age, non-pregnant females infected with the coronavirus. Their study in the May 2 issue of the JAMA medical journal also found that 11.1% of Covid–affected pregnancies resulted in preterm birth, compared with 6.8% among all unaffected Canadian pregnancies. * * *
Money says it underscores the need for obstetricians to carefully monitor their pregnant patients who become infected with SARS-CoV-2, and for expecting moms to get vaccinated and boosted.
“That’s the biggest thing they can do,” she says. “It really does look like vaccine is preventative for the serious outcomes.”
From the studies front —
The Medical Group Management Association informs us “Despite multiple waves of disruption in 2021, medical practices navigated through the “new normal” of COVID-19 to restore a sense of normalcy in productivity and compensation last year.”
Milliman released its 2022 Medical Index (MMI). “In 2022, the cost of healthcare for a hypothetical American family of four covered by an average employer sponsored PPO plan is $30,260,” 4.6% above 2021.
HR Dive tells us “[a] 2019 IRS notice expanded the list of medications and health services Health Savings Account-eligible health plans may cover prior to meeting a patient’s deductible. Employers that take advantage of the expansion could cover these treatments with little to no increases in patient premiums, according to an Employee Benefits Research Institute report published May 19.”
Commercial insurance members’ satisfaction with their plans stayed flat between 2021 and 2022, according to a new survey from J.D. Power.
Satisfaction was on a steady climb over the past five years, the survey found, but plateaued in the past year amid declines in how well members’ expectations for customer service were met and dissatisfaction with their plan designs and network providers.
Health plans that were perceived by members as responsive enjoyed higher scores than those that were not, J.D. Power found. The Kaiser Foundation Health Plan and regional Blues insurers were consistently ranked as the highest scoring in the study’s 22 geographic regions.
From the mental healthcare front, the International Foundation of Employee Benefit Plans notes
The U.S. Department of Labor (DOL) published new guidance on obtaining job protected leave under the Family and Medical Leave Act (FMLA) for workers seeking mental health support. The guidance clarifies that eligible employees are able to take FMLA leave for their own serious health condition or to care for a spouse, child or parent because of their serious health condition, and that a serious health condition can include a mental health condition.
From the federal employee benefits front, benefits consultant Tammy Flanagan writes in Govexec about Federal Employee Group Life Insurance Program options for federal and postal annuitants. What’s more, Fedweek explains how FEHBP fills Medicare coverage gaps for those fine folks.
New bipartisan legislation introduced in the Senate aims to empower the Federal Trade Commission (FTC) to crack down on pharmacy benefit manager practices such as spread pricing.
The legislation, introduced Tuesday, comes as the PBM industry faces other areas of reform, including a proposed rule to get rid of clawback fees PBMs can charge pharmacies after the drug is dispensed.
Lawmakers said federal agencies need more power, though, to rein in PBM practices.
From the No Surprises Act (“NSA”) front, AHIP and the Blue Cross Association inform us
A recent survey and analysis conducted by AHIP and the Blue Cross Blue Shield Association (BCBSA) found that in the first two months of 2022, the NSA prevented more than 2,000,000 potential surprise medical bills across all commercially insured patients. If only a fraction of these claims are ultimately disputed through IDR, it would still far exceed the government’s estimate. Should the trend hold, more than 12,000,000 surprise bills will be avoided in 2022 due to the NSA.
The law is working to protect millions of consumers from costly surprise bills and yet several hospital and provider organizations have filed lawsuits challenging the NSA regulations and legislation in order to increase their own profits at patients’ expense. Recent polling conducted by Morning Consult on behalf of the Coalition Against Surprise Medical Billing found that 8 in 10 voters, after learning about the NSA, are concerned that lawsuits from physician and hospital organizations could delay or overturn the patient protections in the Act.
The findings of the AHIP-BCBSA survey are important to demonstrate how many consumers have already benefitted from the NSA and to underscore the extent of total claims that could be impacted if the IDR process is not a predictable process with payment amounts that trend towards market rates.
That’s great news.
In public health news, the American Hospital Association tells us ‘
U.S. births rose 1% in 2021 to about 3.7 million, the first increase since 2014, according to preliminary data released today by the Centers for Disease Control and Prevention. Birth rates declined for women aged 15-24 and rose for women aged 25-49. The cesarean delivery rate rose 0.3 percentage point to 32.1%, while the preterm birth rate rose 4% to 10.48%, the highest rate since 2007, CDC said.
From the Omicron and siblings front
Reuters reports “The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc’s emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc’s vaccine for those aged 6 months through 4 years.”
Precision Vaccines tells us “The U.S. Centers for Disease Control and Prevention (CDC) issued today Health Alert Network Health Advisory CDCHAN-00467 to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 Rebound.” COVID-19 Rebound cases have been reported to occur between two and 8 days after initial recovery. They are characterized by a recurrence of COVID-19 symptoms or a new positive viral test after testing negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the beta coronavirus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.” STAT News offers a more detailed article on this topic for those interested.
Officials for the Centers for Disease Control and Prevention (CDC) on Monday said the agency is releasing doses of a smallpox vaccine in response to the few recent cases of monkeypox that have been detected in the U.S. Jennifer McQuiston, the deputy director for the CDC’s Division of High Consequence Pathogens and Pathology, said during a press briefing that more than a thousand doses of the Jynneos smallpox vaccine are currently available in the U.S., with more doses expected to become available as production ramps up. * * * The vaccines will be designated for people who are most likely to benefit from them, McQuiston said, including those who are known to have had close contact with monkeypox patients, health care workers and people who would be at high risk of developing a severe case of the disease.
From the healthcare business front, Beckers Hospital News identifies Walmart’s 18 Centers of Excellence in the U.S.
Fortune reports “The U.S. is experiencing a sixth wave of COVID, with over 90,000 confirmed new cases a day and a 20% increase in hospitalizations over the past two weeks. The actual number of new cases per day likely sits at a half-million or more, “far greater than any of the U.S. prior waves, except Omicron,” writes Dr. Eric Topol, the executive vice president of Scripps Research and a professor of molecular medicine, in a recent blog post on the maps.” It’s hard to argue against this point.
Bloomberg Prognosis offers a useful Q&A on when you can back to life after a case of Omicron. Here is a link to the CDC’s guidelines on isolation and quarantine due to Omicron.
The FEHBlog noticed that 75% of the American population age 12 and older is fully vaccinated against Covid.
The American Medical Association discusses how Covid telemonitoring sets the model for other acute conditions.
From the Aduhelm front, the Wall Street Journal reports
The commercial failure of Biogen Inc.’s drug Aduhelm is putting new focus on the state of research into the causes of Alzheimer’s disease.
“If you cut the brain open and amyloid plaque is absent, Alzheimer’s was not the cause of disease,” said Jeffrey Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas.
But research into the benefits of targeting amyloid in Alzheimer’s patients has been mixed. There are more questions than answers about the role amyloid plays in the development of the disease, neurologists say.
“Alzheimer’s is a complex disease. It’s unlikely that a single mechanism is contributing to it,” said Maria Carillo, the Alzheimer’s Association’s chief science officer. * * *
More than 140 drugs are in the pipeline as potential Alzheimer’s treatments, including drugs that target tau and microglia function, according to a survey of registered clinical trials in the U.S. Three other amyloid-targeting monoclonal antibodies, which are in the same class as Aduhelm, are in development. One, called lecanemab, was submitted this month by co-developers Biogen and Japan-based Eisai Co. to the Food and Drug Administration for potential approval.
Time will tell.
From the preventive care wellness front —
Medscape reports an “alarming increase in esophageal cancers in middle-aged adults. The study’s author, Bashar Qumseya, MD, MPH, recommends that people with multiple risk factors for these cancers, i.e., obesity, diet, and gastroesophageal reflux disease, should undergo an endoscopy at the time of their first colonoscopy at age 45.
The American Medical Association identifies steps that patients can follow to reverse pre-diabetes.
The FEHBlog just discovered that the Weekend Update did not go out on Monday morning. So here are Monday’s items that normally would have been posted in the Monday Roundup —
Three doses of Pfizer and BioNTech’s COVID-19 vaccine met the Food and Drug Administration’s bar for success in a trial studying the shot in children younger than 5 years old, the companies said Monday. The FDA has tentatively scheduled a meeting of outside advisers to review the data in three weeks.
The agency delayed review of the vaccine in the youngest children earlier this year after a December review of data indicated a two-shot series didn’t spur an immune response that was likely to protect against disease. When Pfizer and BioNTech disclosed that data, they announced plans to test immune response and efficacy after three shots.
The announcement comes days after U.S. officials warned of a new surge of COVID-19 cases as mask mandates have been lifted and while immunity from vaccination and previous infections wanes. The FDA has granted emergency use authorization for as many as four shots of Pfizer and BioNTech’s vaccine — an initial two-dose series followed by two periodic boosters — for adults at least 50 years old.
Reuters adds U.S. “Health officials are considering extending the eligibility for a second COVID-19 vaccine booster dose to people under 50 amid a steady rise in cases, with the United States seeing a threefold increase over the past month.”
Bloomberg Prognosis recommends carrying around a portable carbon dioxide monitor to help prevent Covid or at least remind you to mask up and / or move along:
Carbon-dioxide monitors can assess how Covid-risky a space is because they help tell you whether you’re breathing in clean air. They measure the concentration of carbon dioxide, which people exhale when they breathe, along with other things like, potentially, virus particles. The more well-ventilated a space, the lower the reading on my monitor’s screen — meaning not only less carbon dioxide but also less of the stuff like Covid that might make people sick.
One place I didn’t expect this to be an issue was airplanes, because you hear so much about their top-of-the-line air quality systems. But in fact, some of the highest carbon dioxide readings on my travels were taken on flights, specifically during the boarding process.
It turns out that during boarding and deplaning, air systems aren’t typically running. Those periods are risky because people are mingling more than they do during a flight, says Joe Allen, an associate professor at the Harvard T.H. Chan School of Public Health who carries around his own CO2 monitor.
“We’ve been warning about this,” Allen says.
Fresh air is important for our health in ways that go well beyond Covid, but it’s also largely invisible. Carbon-dioxide monitors can change that.
What will they think of next?
The FEHBlog confesses that he took his eye off the flu virus this year. Beckers Hospital Review informs us “The CDC estimates there have been at least 6.7 million flu illnesses, 69,000 hospitalizations and 4,200 flu-related deaths so far this season.”
In other virus news, Reuters reports “Infection with adenovirus, a common childhood virus, is the leading hypothesis for recent cases of severe hepatitis of unknown origin in children that have led to at least six deaths, U.S. health officials said on Friday [May 20]. Furthermore,
The Centers for Disease Control and Prevention (CDC) said it is continuing to investigate whether 180 cases identified in 36 states and territories since last October represent an increase in the rate of pediatric hepatitis or whether an existing pattern has been revealed though improved detection.
From the mental healthcare front, Fierce Healthcare tells us
Mental health concerns are on the rise among teens, and the impact on parents and families is an unmet need employers could address, new data from Cigna’s Evernorth show.
The pandemic has significantly worsened mental health among teens and young adults, with 25% experiencing depressive symptoms and 20% experiencing anxiety symptoms, a JAMA study shows. About 80% of the 1,000 parents included in Cigna’s survey said their children are struggling with their mental health.
Nearly one-fifth (18%) of parents say their child’s needs are negatively impacting their job performance and productivity, according to the survey. In addition, 55% said they do not have enough support from their employer, and 1 in 7 said they were forced to leave or stay out of the workforce to manage their teenager’s needs.
“I think there’s going to be a long tail for these kids and also their family members,” Stuart Lustig, M.D., national medical executive for behavioral health at Evernorth, told Fierce Healthcare. “I think we’re in this for the long haul.”
A growing number of Senate Democrats say they’re ready to take a tough vote on an amendment to keep the Title 42 health order in place at the U.S.-Mexico border if that’s what’s needed to move a stalled COVID-19 relief package.
Senate Majority Leader Charles Schumer (D-N.Y.) has held the bill from the floor because Republicans are insisting on voting on a bipartisan amendment to overrule the Biden administration’s decision to lift Title 42, a pandemic order that has stopped thousands of immigrants from entering the country on asylum claims. * * *
Without giving in to the Republicans’ demand for a vote on the hot-button issue of securing the border, COVID-19 relief could be stalled until after the November election.
The amendment is expected to fail but it’s a tough vote for vulnerable Senate Democrats.
More likely, in the FEHBlog’s view, the Majority Leader is waiting until the Title 42 health order is lifted later this month to see what happens.
Following the recommendation Thursday, many of the nation’s doctors, pharmacies and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children in the age group.
The shots are to be given five months after the second dose. The extra dose is one-third the amount that those 12 years old and above receive.
Also Thursday, the CDC said it was strengthening its recommendation that people 12 years and older who are immunocompromised, or who are 50 and older, should receive a second booster dose at least four months after their first.
This means that health plans must start covering the booster with no member cost-sharing pursuant to ACA FAQ 50.
“We are ready from a manufacturing standpoint,” Moderna Chief Executive Stéphane Bancel said during a virtual appearance Thursday at The Wall Street Journal’s Future of Everything Festival.
The FDA/CDC decision is expected next month.
In other virus news, STAT News interviewed a top CDC expert on monkeypox. From the FEHBlog’s standpoint, the key takeaway is that monkeypox is not Covid.
I think we can take away a lot from what we know about monkeypox in Congo Basin and in West Africa. Even if human-to-human transmission is documented, it is generally documented among very close contacts. So family members, people taking care of ill patients. Or health care providers.
In funding news, the Department of Health and Human Services announced today a $1.5 billion funding opportunity under the State Opioid Response
SOR grant program provides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs.
From the miscellany department
Today “the U.S. Office of Personnel Management (OPM) released guidance regarding the implementation of EO 13932; Modernizing and Reforming the Assessment and Hiring of Federal Job Candidates. OPM’s guidance represents a major step towards the federal government’s adoption of skills-based hiring practices and is an important innovation in federal hiring, which has historically relied on education and candidate self-assessments as a proxy for a candidate’s ability to perform in a job. This new approach helps hiring managers recognize and value skills regardless of where they were acquired, whether in a formal degree program, on the job, or on one’s own.”
Employee Benefit News identifies the ten most popular mental health and wellness apps.
Benefits consultant Tammy Flanagan discusses federal employee life insurance benefits in Govexec.
Health Payer Intelligence reports that CMS has updated the Medicare.gov website “to include new features such as highlighting pages that answer popular questions and spotlighting key steps that consumers should take related to Medicare coverage.”
The seven-day moving average of new Covid-19 cases recently topped 94,000 a day, Centers for Disease Control and Prevention data show, nearly four times lows reached in late March. The true number of new cases is likely significantly higher, epidemiologists say, because so many people are self-testing at home or not testing at all.
The rise in cases hasn’t translated thus far into major surges in severe illness. The seven-day average of confirmed cases in hospitalized patients reached about 18,550 on Wednesday, up from lows near 10,000 in mid-April, but far below a record peak above 150,000 in January. The numbers include people who test positive on routine screening after getting hospitalized for other reasons. The daily average of reported deaths has slipped under 300 a day, the lowest point since last summer.
But * * * the more an outbreak spreads, the more likely it will reach the most vulnerable including elderly people and others with compromised immune systems, the experts say, and the more likely the virus will continue to mutate.
As Covid-19 again surges across the US, many people are going without time-sensitive therapeutics like Paxlovid because doctors worried about shortages are reluctant to prescribe the drugs. But the situation has changed and supplies are now abundant.
The Food and Drug Administration has issued emergency-use authorizations for the drug to treat mild to moderate Covid-19 in people who are at high risk. The Centers for Disease Control and Prevention defines those as individuals ages 50 years or older, unvaccinated, or with certain medical conditions like kidney, liver, lung and heart disease, diabetes, cancer and HIV. It also recommends the drug for people who are immunocompromised, pregnant, obese, cigarette smokers or suffering from mood disorders.
You can find the one stop test to treat locations “by using the Department of Health and Human Services’ Test to Treat Locator or by calling 1-800-232-0233.”
Kaiser Health News recommends “improving ventilation and filtration of the air. ‘Ventilation matters a lot,’ said Dr. Amy Barczak, an assistant professor of medicine at Harvard Medical School. ‘If you’re taking care of someone at home, it’s really important to maximize all the interventions that work.’”
Viral particles float through the air like invisible secondhand smoke, diffusing as they travel. Outside the home, viruses are quickly dispersed by the wind. Inside, germs can build up, like clouds of thick cigarette smoke, increasing the risk of inhaling the virus.
The best strategy for avoiding the virus is to make your indoor environment as much like the outdoors as possible.
In related viral news, Beckers Hospital Review tells us
More than 400 children worldwide have developed unusual cases of acute hepatitis, and researchers are still searching for the cause of the outbreak, the World Health Organization said May 17.
As of May 15, the WHO reported 429 probable cases in 22 countries, up from 348 cases a week prior, according to Philippa Easterbrook, MD, a senior scientist in the global hepatitis program at the WHO. Another 40 cases are still under investigation, and 75 percent of all affected children are under age 5.
Twelve countries are reporting more than five cases, double the amount from last week. Of these 12 countries, nine are in Europe. In total, six children have died in the outbreak and 26 have required liver transplants, according to Dr. Easterbrook.
As of May 17, researchers were still investigating the cause of the hepatitis outbreak. The leading hypothesis is that an adenovirus and SARS-CoV-2, the virus that causes COVID-19, may be causing hepatitis in children. Scientists are exploring “how these two infections may be working together as co-factors either by enhancing susceptibility or creating an abnormal response,” Dr. Easterbrook said.
From the healthcare policy front, AHIP today launched
Healthier People through Healthier Markets, a new policy roadmap and set of solutions to improve health care affordability and access for every American. The effort is focused on boosting competition in health care markets and reining in harmful practices that hurt American families. With the launch of this policy roadmap, AHIP sent letters to President Biden and the leadership of Congress that lay out a detailed set of legislative and regulatory enforcement actions to increase competition in health care, drive down costs, and improve health care access for patients.
The Office of Personnel Management on Wednesday urged federal agencies to ensure their employees are aware and can access the mental health benefits provided to federal workers, in light of May being Mental Health Awareness Month.
In a memo to agency heads, OPM Director Kiran Ahuja noted that promoting the federal workforce’s wellbeing, including mental health, is a priority in President Biden’s management agenda.
“We want to make sure that all federal employees understand the supports available to them and underscore that there should be no shame or stigma for taking care of their mental health,” Ahuja wrote. “[As] a reminder, employee assistance programs and Federal Employees Health Benefits health plans offer mental health services to employees and their family members. We encourage agencies to proactively communicate to their workforces about their options and encourage employees to contact their agency benefits officers or EAP coordinator to learn more.”
The FEHBlog encourages OPM to better coordinate mental health care services among FEHB plans, EAPs and wellness programs.
mHealth Intelligence informs us “In the second half of 2020, only 14.1 percent of children used telehealth due to the pandemic, but use was higher among those with asthma, a developmental condition, or a disability, the Centers for Disease Control and Prevention (CDC) found.”
From the survey department, Beckers Payer Issues advises that “Castlight Health analyzed more than 160 million commercial medical claims nationwide to reveal insights about healthcare utilization patterns from 2018 to 2021.” Castlights report ranks the fifty States and DC based on average medical spending per member in 2021.
From the miscellany department —
Beckers Payer Issues reports “Anthem shareholders voted at their annual meeting May 18 to change the company’s name to Elevance Health.”
Federal News Network discusses the Postmaster General’s plans to close and consolidate Postal facilities across the delivery network. “The network transformation initiative will impact nearly 500 network mail processing locations, 1,000 transfer hubs and 100,000 carrier routes. It will also impact 10,000 delivery units, which USPS defines as post offices, stations, branches or carrier annexes that handle mail delivery functions.”
FedSmith tells us “Starting May 26, 2022, federal retirees will notice a new process for signing into the OPM Retirement Services Online website. The login process will now be managed through the federal government’s Login.gov website and will require you to create a new username and password at login.gov if you do not currently have one.”
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