The U.S. House of Representatives and the Senate again will be engaged in Committee business and floor voting this week. According to the Hill, the House leadership is aiming to vote on the massive social spending / budget reconciliation bill next Sunday October 31. “We have 90 percent of the bill agreed to and written. We just have some of the last decisions to be made,” [Speaker Nancy] Pelosi said on CNN’s “State of the Union.”
From the Delta variant front —
Bloomberg reports that “Top U.S. health officials signaled confidence that children ages 5 to 11 will begin getting Covid-19 vaccines by early November. The Pfizer vaccines will likely be given at pediatricians’ offices rather than at pharmacies or large sites.”
Medpage Today informs us that “The CDC has begun to provide weekly data on COVID-19 cases and deaths by vaccination status, illustrating the stark differences between those who have received the shots and those who haven’t — and even revealing some differences [among] vaccines.”
Precision Vaccinations discusses the likely evolution of the fully vaccinated against COVID definition in our country.
From the healthcare business front —
Healthcare Dive tells us that Lyft named Buck Poropatich as its new head of healthcare, according to an email statement sent Friday. Poropatich joined the company in 2019 and previously served as the director of healthcare strategy. * * * The ride-hailing giant wants to continue capitalizing on non-emergency medical transportation, and Poropatich has been instrumental in that expansion, along with finding new use cases in the sector, Lyft said.”
Fierce Healthcare reports that “Consumer genetic testing company 23andMe plans to buy Lemonaid Health, a virtual care and pharmacy provider, to integrate its personalized genetics service more deeply into primary care. 23andMe, which went public in June via a merger with Richard Branson’s blank check company, will pay $400 million for Lemonaid Health, with 25% of the purchase price in cash and the rest in shares of 23andMe. The acquisition is expected to close by the end of 2021. The acquisition adds Lemonaid Health’s telemedicine and prescription drug delivery services to 23andMe’s consumer business.”
Health Dive also lets us know that “Oak Street Health, a value-based primary care network for seniors, has acquired virtual specialty provider RubiconMD for $130 million, integrating specialty care into its existing care model. New-York based RubiconMD offers a platform providing access to medical specialists across 230 specialties, including cardiology, nephrology and pulmonology. The deal, announced Thursday, comes as major U.S. clinical networks increasingly build out their suite of services to jockey for employer and payer clients in the increasingly competitive space.”
Mobihealth News reports that “Virtual addiction treatment Workit Health raised $118 million in Series C funding led by Insight Partners. Other investors participating in the round include CVS Health Ventures, FirstMark Capital, BCBS Venture Fund, and 3L Capital. ‘Workit is at the forefront of massive acceleration in telemedicine adoption, which is key to solving the overdose crisis that was exacerbated by COVID-19. The risk factors associated with substance use have dramatically increased,’ Lisa McLaughlin, Workit Health’s co-CEO, said in a statement. ‘This latest funding round helps us grow our relationship-based, telehealth-first, value-based approach into new regions that are in desperate need of simple and trusted solutions like Workit.’
Last Friday, the FEHBlog spoke with a group of federal annuitants at a client’s membership conference. Suffice it to say the FEHBlog thinks it is important for plans to promote OPM’s FEHB Fast Facts on FEHB and Medicare on their websites.
Last Thursday, the FEHBlog post about an OPM edit to Section 3 of the 2022 FEHB Significant Events Changes benefit administration letter. The FEHBlog noticed that he unintentionally cut off the copy of the edited section of the BAL. For that reason, here is a link to a complete copy of the revised BAL. Lo siento readers.
From the Delta variant front, Health Magazine informs us that “Former FDA Chief Scott Gottlieb, MD, calls for research into UK Surge of New Delta Plus Variant, AY.4.2 While not yet singled out as a concern in the US, the new Delta subtype prompted a reminder that the world needs ‘robust systems’ to identify up-and-coming threats.” Ruh roh?
The Food and Drug Administration [FDA] is moving to soon allow people to receive booster shots that are different from their first Covid-19 vaccine doses, people familiar with the matter said.
The FDA won’t recommend any booster over the others but will permit people to get a booster shot that is different from the shot they first received, one of the people familiar with the matter said.
The FDA is seeking to authorize mixing and matching as soon as this week, the people familiar with the matter said. The FDA is also expected to approve Moderna Inc. and Johnson & Johnson boosters this week, according to a person familiar with the matter.
If you find the last sentence somewhat confusing, at this point, only the FDA’s vaccine advisory committee has approved the Moderna and Johnson & Johnson boosters. The acting FDA commissioner Janet Woodcock has to act on that guidance. Once Dr. Woodcock acts then her decision moves to the Centers for Disease Control for its decision.
The FEHBlog noticed today that the Office of Management and Budget’s Office of Information and Regulatory Affairs has held twenty five stakeholder listening sessions so far on the OSHA vaccination screening program rule that will apply to businesses with 100 or more employees. The rule arrived at OIRA last Tuesday October 12. The large number of listening sessions suggests to the FEHBlog that OIRA wants to wrap up its work expeditiously. The OIRA approved rule will be published in the Federal Register.
From the federal employee benefits front, Federal News Network informs us that
The Office of Personnel Management has proposed expanding eligibility for the Federal Employees Dental and Vision Insurance Program (FEDVIP) to include certain temporary and seasonal workers, among others.
OPM will publish a draft rule Tuesday in the Federal Register, which will describe several recommended FEDVIP changes, including new clarifications and provisions designed to make it easier for certain employees to alter their enrollment with the program outside of the traditional open season window.
Federal employees on temporary, seasonal or intermittent schedules — specifically those who work 130 hours a month for at least 90 days — [plus seasonal firefighters] would become eligible to enroll in FEDVIP under OPM’s draft policy.
OPM expanded eligibility for the Federal Employees Health Benefits Program (FEHBP) to this group back in 2014, and the agency’s proposed rule would simply allow temporary and seasonal workers to enroll in FEDVIP as well.
[T]o give [the 86,000] federal and USPS workers on temporary, seasonal and intermittent schedules a chance to enroll for the first time in FEDVIP, OPM envisions giving newly eligible employees a 60-day window after the date that it finalizes this new policy.
The preamble to the proposed rule notes that “As of August 3, 2021, FEDVIP has 5.4 million enrollees with approximately 7.3 million covered individuals.” The FEHB Program’s enrollment is evenly split between 2 million employed enrollees and 2 million retired enrollees plus 4 million eligible family members for a grand total of eight million. The FEHBlog understands why they are more enrollees in FEDVIP because Congress recently added certain TRICARE eligible folks to the FEDVIP program. But why does FEDVIP have the only half the number of eligible family members found in the FEHB Program? Does the FEHB Program offer adequate dental coverage for children? The FEHBlog has never explored that angle.
OPM has bulked up the family member status information and documentation found on its FEHB eligibility website.
From the Rx coverage front, the FDA today approved for marketing “the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses.” Humira is a blockbuster drug which suggests big health system savings from this action. However, STAT News adds that those savings will not be realizable until June 2023 due to a Humira patent settlement. Furthermore
The FDA approved a biosimilar version that will only be available in low-dose concentrations. But three years ago, AbbVie began shifting patients to high-dose concentrations of Humira, which contain fewer excipients that often cause burning and discomfort when the medicine is injected. In fact, high-dose concentrations now account for 80% of the market, according to Bernstein analyst Ronny Gal.
The situation “is not so straightforward,” Evercore ISI analyst Josh Schimmer wrote in an investor note.
In its view, however, Boehringer Ingelheim believes Cyltezo should be considered to have the same “strength” as the corresponding original concentration and high-concentration versions of Humira, because they contain the same total drug content per container.
Nothing is simple when it comes to specialty drugs.
From the benefit design front, STAT News tells us that
The pandemic prompted a mad dash to figure out how to deliver health care virtually. As the dust settles, UnitedHealthcare, the country’s largest insurer, is laying the foundation for the future with a health plan built primarily around telemedicine services designed to be more affordable and accessible.
Called NavigateNOW, the new virtual-first plan will offer care for common services without a copay, including both in-person and virtual primary and behavioral health care, virtual urgent care, and most generic medications. UnitedHealthcare said plan premiums will be about 15% cheaper. The new offering, announced Monday, comes as both legacy insurers and startups are beginning to offer new flavors of health plans that combine conventional and digital services to offer a hybrid kind of care.
NavigateNOW enrollees will have 24-hour access to a virtual health team that includes primary, behavioral, and urgent care through UnitedHealth Group subsidiary Optum, which will also provide in-person care when necessary. Unlike some competitors, United will use its homegrown technology infrastructure to deliver the virtual care.
Seven months after announcing plans to merge, virtual care company Doctor on Demand and clinical navigator Grand Rounds are launching a new brand for their combined company: Included Health.
The name is meant to stress how the entity offers mental and behavioral healthcare, primary care, chronic care, specialty care, care for LGBTQ individuals and patient navigation tools all under the same roof, Included President Robin Glass and Chief Medical Officer Ian Tong told Healthcare Dive.
The inspiration for the rebrand came from Included Health, a care navigation platform for the LGBTQ community, which Doctor on Demand and Grand Rounds acquired in May in a bid to strengthen their offerings for the underserved population. Included, which covers just under 100 million members, declined to share how much it is investing in the rebrand.
Both the U.S. House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week.
From the telehealth front —
Fierce Healthcare discusses the state of the telehealth marketplace.
“Ten years ago, Doctor On Demand, MDLive and Amwell had the market onto themselves. Largely, in part, due to pandemic, but also with reimbursement policy changes and innovation and an emerging tech side of the market, this has all driven new entrants to what you think of as the classic telehealth space,” Jeff Becker, principal healthcare analyst at CB Insights, told Fierce Healthcare.
The competition is “coming from everywhere,” Becker said, noting that the incumbent telehealth players traditionally generated revenue from one-off urgent care, low-acuity care and primary care visits handled virtually.
“Now you have Heal and DispatchHealth sending clinicians to your house or workplace to compete for that same urgent care book of business. You have Forward and One Medical with direct primary care and they, with a lot of venture backing, are competing for that one-off primary care, urgent care telehealth book of business,” he said.
There are also startups providing remote patient monitoring and virtual chronic disease management with a focus on specialty conditions, such as Monogram Health for chronic kidney disease patients and Hinge Health, which focuses on musculoskeletal pain. And there are digital health companies like Hims & Hers and Ro that offer prescription drug delivery and telehealth visits.
What’s more, on Friday October 15, Walmart, which also is engaged in the telehealth market, and Transcarent, which sells in the digital marketplace,
announced they would be working together as go-to-market partners for self-insured employers across the country. The agreement allows Transcarent, which offers employees and their dependents a new, different, and better health and care experience, to share Walmart’s everyday low-cost on pharmaceuticals and other services with self-insured employers and their employees for the first time.
The collaboration makes it easier for millions of employees and the families of self-insured employers to access high-value care – no matter where they live – at affordable prices. This new offering will allow employers of all sizes to leverage Walmart’s healthcare size and scale to more easily provide their employees convenient care and cost-effective health and wellness options.
Several large health systems have formed a coalition to support strategies that use telehealth and remote patient monitoring to provide acute care for patients at home.
The Advanced Care at Home Coalition builds on both the surge in remote patient monitoring [RPM] programs during the pandemic and the Acute Hospital at Home Program, launched in late 2020 by the Centers for Medicare & Medicaid Services. That program, which now involves more than 100 hospitals and health systems across the country, offers CMS waivers for a home-based care management plan to treat patients who would otherwise require hospitalizations for a broad range of acute conditions, including asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD). Treatment plans combine RPM and telehealth with in-person care.
The coalition was launched by the Mayo Clinic, Medically Home and Kaiser Permanente, and includes Adventist Health, ChristianaCare, Geisinger Health, Integris, Johns Hopkins Medicine, Michigan Medicine (the University of Michigan), Novant Health, ProMedica, the Sharp Rees-Stealy Medical Group, UNC Health and UnityPoint Health.
From the Rx coverage front, this coming Saturday October 23 is the latest Drug Enforcement Administration National Rx Take Back Day allowing consumers to conveniently and safely dispose of unused prescription and over the counter drugs.
From the medical research front, Health Payer Intelligence tells us that
Using predictive analytics, University of Chicago researchers have developed a method to determine an eventual diagnosis of autism spectrum disorder (ASD) in young children. The new computational approach gathers data using diagnostic codes from previous doctor’s visits, eliminating the need for blood work or procedures to make a diagnosis.
According to researchers, this method reportedly reduced the number of false-positive ASD diagnoses produced by traditional screening methods by half. ASD can be diagnosed as early as two years old. However, false positives flagged by the initial screens commonly used today can delay confirming a true diagnosis.
With the importance of early intervention and the limited number of trained professionals, tools that can potentially reduce the number of patients required to undergo the lengthy, multistep process to receive an official positive diagnosis can significantly impact patient care.
A federal retirement COLA of 5.9 percent will be paid in January to those retired under CSRS and 4.9 percent to those retired under FERS who are eligible for COLAs, increases that have been neared in recent decades only twice.
The announcement follows completion of the count toward that adjustment with release of the September inflation figure on Wednesday (October 13), which was up 0.4 percent. * * *
A 5.9 increase also will be paid on Social Security benefits. That’s primarily of interest to FERS retirees, for whom Social Security is a basic part of the retirement benefit, but also of interest to CSRS Offset retirees who have Social Security coverage as part of their benefit. Also, some “pure” CSRS retirees qualify for Social Security through from military service or earnings covered under that system before, after—and in some cases from outside earnings during—their CSRS working years. In many cases those benefits are reduced by the “windfall elimination provision” however. * * *
Congress appears to be on track to accept a raise payout by default of President Biden’s recommendation for a 2.7 percent average raise, with 2.2 percentage points to be paid across the board and the funds for the remainder divided up as locality pay.
From the Delta variant front, MedPage Today offers an interesting article on the efforts of primary care providers to convince their reluctant patients to receive a COVID vaccine.
[Australian social psychologist Matthew] Hornsey [observed] that in a world where the institutional memory of pandemics has been lost, only the perception of vaccine risk remains. With adverse effects making headlines daily, even in mainstream outlets, it’s hard to promote a message of safety.
David M. Oshinsky, PhD, a Pulitzer Prize-winning author and professor of medicine at NYU Grossman School of Medicine in New York City, noted the sense of euphoria with the polio vaccine, dubbed at the time as “the peoples’ vaccine.”
Well put.
Also, the Food and Drug Administration (FDA) staff today released their vaccination advisory committee briefing book on the one dose Johnson & Johnson vaccine. According to the Wall Street Journal’s report
A booster of Johnson & Johnson’sCovid-19 vaccine showed signs of significantly bolstering the immune defenses of study subjects, federal health regulators said Wednesday. The regulators cautioned, however, that data was limited and that they had to rely on J&J’s own analysis for some of the study findings, rather than conducting their own.
The committee will take up the Modern booster tomorrow and the Johnson & Johnson vaccine as well as the topic of mixing and matching different COVID boosters on Friday.
From the telehealth front, Employee Benefit News reports that
Telehealth providers have found that their platforms are uniquely suited to address gaps in pediatric behavioral healthcare and are expanding their services to adolescents. Brightline, launched just before the pandemic, offers an “on-ramp” to behavioral health services, Allen says. The platform does an intake assessment and then provides education and 30-minute coaching services for parents and their children.
“Kids are actually more resilient using technology than we expected, and now there’s a strong preference for virtual first behavioral healthcare, because of the privacy and the comfort of delivering care in your home,” Allen says. “If Brightline hired every single pediatric therapist in the entire United States, we would still have a national shortage, so we instead use these tools to figure out what’s an appropriate care pathway and measure whether they’re working.”
From the Rx coverage front, STAT News informs us that Pfizer is backing up one of its expensive lung cancer drugs Xalkori with a insurance company backed warranty.
“In reality, this is for Medicare patients,” said Susan Raiola, president of Real Endpoints, an advisory and analytics firm that tracks reimbursement issues. Why? Medicare co-pays are used toward the so-called donut hole, the term used to describe a temporary limit on what Medicare will pay to cover a drug. The co-pays can add up, though, making refunds more desirable. * * *
To what extent warranties may become commonplace remains to be seen. But the concept may find takers among drug makers marketing high-priced treatments that cost $1 million or more, because winning reimbursement is challenging, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.
“So far, no one else has done this,” Samad said of the Pfizer program. “But where warranties will really come into play will be with high-cost treatments, such as gene and cell therapies. These companies will have to change commercial paths with these $1 million to $3 million drugs. They need tools – such as even more innovative warranty structures – so that payers can get comfortable with the varied outcomes potentially transformative therapies could have.”
From the medical devices front, Healthcare Dive informs us that the “FDA has awarded the latest crop of breakthrough device designations, granting regulatory privileges to investigational products including liquid biopsy tests for Alzheimer’s disease and bladder cancer. Check out the list.
From the medical research front, the National Institutes of Health announced that “A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug.” Fingers crossed.
The U.S. House of Representatives is engaged in Committee business this week following Columbus Day and the Senate is on State work break / recess. The House also is expected to vote this week on the temporary debt limit increase.
From the Federal Benefits Open Season front, Federal News Network discusses the No Surprises Act (“NSA”) which takes effect on January 1, 2022. The NSA addresses three types of surprising billing — out of network emergency care; out of network care at in-network facilities and out-of-network air ambulance services. It does not address situations where the patient chooses out of network medical or mental health care or ground ambulance services. The article appropriately concludes
Of course, these [NSA] changes shouldn’t mean federal employees toss the basic rules of choosing an appropriate health insurance plan.
[Walt] Francis suggests FEHB participants check with their doctors each year to ensure they’re planning to stay within their preferred network — and then do some research about what new benefits are coming to your current plan and the others.
The plans change every year, and nearly all insurance providers add new benefits or perks to compete with others and respond to OPM’s priorities for the FEHBP.
From the mental healthcare front, the Wall Street Journal reported last week that “Finding a therapist who takes insurance was tough before the pandemic. Now, therapists and patients say, an increase in the need for mental-health care is making the search even harder.”
Especially in big cities such as Los Angeles, New York and Washington, D.C., demand for mental-health care is so strong that many experienced therapists don’t accept any insurance plans, they say. They can easily fill their practices with patients who would pay out of pocket, they add. Therapists who do take insurance are often booked up. And in many smaller towns and rural areas, there are few mental-health professionals at all. Finding a provider who takes insurance, or lowering your rates in other ways, is possible but often takes legwork that can be draining when you are already grappling with mental-health issues.
[Among other approaches] Telehealth can provide access to a broader pool of providers, including therapists who are farther away from you. [Health plan sponsored telehealth providers are always in network.]
Insurance companies say they are trying to increase access to therapists. Anthem Inc. says it added about 2,000 additional providers to its telehealth platform during the early days of the pandemic to handle increased demand. UnitedHealth Group Inc. says it has grown its network of mental-health-care providers by 50% in the past five years to more than 260,000 nationwide.
As for therapists’ complaints of low reimbursement rates, Anthem health plans “routinely review reimbursements to ensure that providers receive market rates,” the company said in a statement. Margaret-Mary Wilson, UnitedHealth Group’s associate chief medical officer, says the company uses data on how patients are improving to financially “reward providers for delivering care with better outcomes.”
Fortune offers a fascinating article about Aetna’s preventive approach to mental health care. Among other tools the authors point out
Employee Assistance Programs (EAPs) are also valuable modes of preventing escalated mental health concerns, as they provide 24/7 life assistance across a wide range of issues that can lower risks of feeling overwhelmed, anxious or depressed. In fact, one study found that companies with EAPs see a 24% improvement in life satisfaction and a 10% reduction in workplace distress among their workers. But we need to better inform people that EAPs are more than a workplace productivity tool. Aetna’s Resources for Living, which provides EAP services,is one example of a resource that supports those facing stress and anxiety, family conflict, legal and financial issues, grief and loss and even loneliness among our Medicare members.
Federal agencies and the Postal Service offer robust employee assistance programs to their employees independent of the FEHB Program and the FEHBlog’s view OPM should put more emphasis on coordinating such related services.
The Senate passed a temporary debt limit increase along party lines Thursday evening, a move that would give the Treasury Department at least a couple of months before it once again bumps up against its legal borrowing cap.
The 50-48 vote sent the bill to the House, where that chamber will need to clear the measure before it heads to President Joe Biden. That vote, likely next week, could be tricky given GOP opposition to the short-term patch and Democrats in that chamber barely backing a longer suspension of the debt limit late last month.
Karine Jean-Pierre, the White House’s principal deputy press secretary, said Biden “looks forward to signing” the debt limit measure after it clears.
The Senate amended the House bill, which passed 219-212, replacing a longer debt ceiling suspension with a $480 billion increase in Treasury’s borrowing cap designed to last into early December, though it may go a little longer.
The current continuing appropriations resolution is set to expire relatively contemporaneously on December 3, 2021.
From the Federal Benefits Open Season front, federal benefits consultant Tammy Flanagan has posted her first GovExec column on this year’s Open Season while GEHA, the second largest plan in the FEHB, has posted information on its 2022 benefits.
From the Delta variant front, Healthcare Dive informs us that
Pfizer and BioNTech have officially asked U.S. regulators for emergency clearance of their coronavirus vaccine in children between 5 and 11 years old, making the developers the first to seek authorization for younger kids.
Thursday’s announcement, which Pfizer made on Twitter, comes nine days after the companies said they had started submitting data to the Food and Drug Administration in support of their application, which, if authorized, could make more than 28 million children in the U.S. eligible for vaccination.
The FDA has already scheduled an Oct. 26 advisory panel to discuss the vaccine’s potential authorization in children, more and more of whom have been infected and hospitalized as the delta variant spread and the school year began. Clearance is reportedly expected in November, though the evaluation could be complicated by turnover within the agency’s vaccine review office.
Total revenue of hospital M&A so far this year dipped only slightly from last year despite the number of deals being nearly cut in half, according to a Wednesday report from Kaufman Hall.
Hospitals are increasing looking outside traditional care delivery methods to diversify business models by pursuing stakes in home health, virtual care and post-acute services. They are also identifying strategic partnership with payers, physicians groups and other adjacent sectors, Kaufman Hall said.
United Healthcare’s subsidiary Optum announced a collaboration with SSM Health, a Catholic health system in the Midwest.
Together, the organizations will work to improve the overall well-being of individuals and communities – while addressing the complex social and economic factors affecting each person’s health.
SSM Health and Optum will partner across certain functions – including inpatient care management, digital transformation and revenue cycle management – to improve health outcomes and patients’ health care experiences. The organizations also will collaborate to redefine the consumer health care journey through the design and development of a seamless digital experience to simplify patient access to the care and services they need.
“Creating a new ecosystem of care requires bringing together the best and the brightest to collaborate for the common good,” said Laura S. Kaiser, FACHE, president and chief executive officer, SSM Health. “The commitment of UnitedHealth Group and Optum to improving health care experiences and outcomes for everyone aligns well with SSM Health’s Mission to ensure all people have access to high-quality, compassionate and affordable care. We are excited to partner with them to achieve our vision of transforming health care in America – and address the health equity gap for the most vulnerable in society.”
To help advance health equity, UnitedHealth Group and SSM Health will jointly invest in vital community health programs to ensure the disadvantaged and vulnerable have equal access to quality health care services. These efforts will focus on closing the health equity gap and critical health priorities in the communities SSM Health serves throughout the Midwest.
Primary and urgent care provider Carbon Health is expanding its service offerings with a new acquisition.
The San Francisco-based company has bought Alertive Healthcare, a remote patient monitoring provider, for an undisclosed sum. Alertive Healthcare provides a suite of RPM tools across a range of specialties, including primary care, cardiology, neurology and nephrology. * * *
As of August, Carbon Health operated 83 clinics across 12 states following its acquisition of Tucson, Arizona-based Southern Arizona Urgent Care and Sacramento, California-based Med7 Urgent Care.
From the telehealth front, Healthcare Dive reports that
Teladoc Health on Wednesday announced it is making its virtual primary care pilot broadly available to commercial health plans, employers and other benefits sponsors nationwide.
The Primary360 service, which the New York-based telemedicine giant has been piloting for the past few years, is currently being used by several large companies, and will be available through CVS Health-owned payer Aetna early next year, Teladoc said in a release.
The vendor hopes Primary360 will serve as an access point to the primary care system while enticing patients to its other services like specialty care and mental health to boost business.
From the miscellany department, Healthcare Dive interviewed the CEO of Morgan Health.
The mission of J.P. Morgan’s new healthcare venture is to innovate employer-sponsored healthcare, not just for the investment bank’s massive employee base but eventually for all 150 million Americans receiving coverage through their job. But it’s a lofty goal for the small business unit, called Morgan Health, launched late May, and there are many skeptics of efforts from major employers looking to disrupt the deep-rooted and complex healthcare industry.
The New York Time reports that “Johnson & Johnson on Tuesday morning asked federal regulators to authorize a booster shot for adults, becoming the third coronavirus vaccine manufacturer to do so.”
AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S.
Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people who are unlikely to respond well to vaccines, bouncing back from an earlier failure to report a 77% reduction in the risk of symptomatic coronavirus infection. With all three cases of severe COVID-19 happening in the placebo cohort, AstraZeneca emerged from the study with evidence that it can protect some of the most vulnerable people from the coronavirus.
“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Mene Pangalos, executive vice president for biopharmaceuticals R&D at AstraZeneca, said in a statement.
In his final National Institutes of Health Director’s blog today. Dr. Francis Collins optimistically supports his opinion that most COVID vaccine hesitant people are willing to change their minds. “Over the course of this pandemic, hesitancy has decreased, and many who initially said no are now getting their shots. Many others who remain unvaccinated lean toward making an appointment. The findings come from Aaron Siegler and colleagues, Emory University, Atlanta.”
Dr. Collins today submitted his resignation from his position as NIH Director following over 12 years in that role. His statement reads in part “It has been an incredible privilege to lead this great agency for more than a decade,” said Dr. Collins. “I love this agency and its people so deeply that the decision to step down was a difficult one, done in close counsel with my wife, Diane Baker, and my family. I am proud of all we’ve accomplished. I fundamentally believe, however, that no single person should serve in the position too long, and that it’s time to bring in a new scientist to lead the NIH into the future. I’m most grateful and proud of the NIH staff and the scientific community, whose extraordinary commitment to lifesaving research delivers hope to the American people and the world every day.” Good luck, Dr. Collins, who will continue working in his genetics laboratory.
From the COVID vaccine mandate front, the Safer Federal Workforce Taskforce released more FAQs on the vaccine mandate for federal employees yesterday. Federal News Network summarizes those FAQs here:
Employees have a few more details about what they should expect if they’re planning to declare a medical or religious exception to the Biden administration’s recent federal vaccine mandate.
Employees who have previously had COVID-19 must receive the vaccine, the Safer Federal Workforce Task Force clarified Monday night in another round of frequently asked questions. The task force had previously made such a statement in guidance to contractors, not federal employees.
The Biden administration didn’t detail exactly what kinds of medical or religious reasons might grant an employee an exception to the federal vaccine mandate, but it did offer more hints about what employees might expect if they pursue that route.
More significantly in the FEHBlog’s view, Federal News Network reports that the Defense Department has “issued its guidance for civilian employees on Monday, giving workers [until November 22] to get inoculated.” In order to achieve this goal an employee must have received the Johnson & Johnson one dose vaccine or both doses of the Pfizer or Moderna by November 8 because the full vaccination status accrues two weeks are being fully vaccinated.
From the mergers and acquisitions front, Becker’s Hospital Review tells us that “More than three years after signing a letter of intent to merge [and overcoming regulatory challenges], Jefferson Health and Einstein Healthcare Network have finalized the deal. The combination of the Philadelphia-based organizations brings together two academic medical centers and creates an integrated 18-hospital system with more than 50 outpatient and urgent care locations.”
Allowed in-network charges for fixed-wing air ambulances rose 76% between 2017 and 2020, and now top $15,000, a new study by Fair Health found. The average charge rose 27.6% during the same time period, to more than $24,500 from little more than $19,200. For helicopter transports, the average allowed charge rose 60.8%, from just over $11,600 to more than $18,600.
Meanwhile, the average Medicare reimbursement rose much less dramatically between 2017 and last year, and represents just a fraction of what commercial insurers are charged for air ambulance transports.
Demand may be part of the equation. Fair concluded that air ambulance claims rose 30% between 2016 and 2020. The leading reasons for such transports are digestive issues, heart attacks and bone breaks or fractures. The states with the largest volumes of fixed-wing air transports are rural: Alaska, Wyoming, South Dakota, Montana and New Mexico. For helicopters, it’s Idaho, South Dakota, New Mexico, West Virginia and Wyoming.
Health Payer Intelligences delved into the American Medical Association’s annual report on health insurer competition. Kaiser Permanente joined UnitedHealthcare, Anthem, Aetna, and Cigna in the top five.
A new study finds that while telehealth has surged during the pandemic, providers haven’t solved many of the issues that kept adoption low prior to COVID-19.
J.D. Power’s 2021 US Telehealth Satisfaction Survey, released this week, saw a surge in telehealth use from 7 percent in 2019 and 9 percent in 2020 to 36 percent in 2021, reflecting the shift to virtual care as the nation grappled with COVID-19. But the consumer advisory company’s third annual survey also saw a decrease in patient satisfaction, driven by complains over limited services (24 percent), lack of awareness on costs, confusing technology requirements and lack of information about care providers (all at 15 percent).
It’s one of the biggest market failures in modern medicine. The lack of a widely shared data language is effectively blocking adoption of innumerable software applications designed to make health care cheaper, more effective, and personal.
On Tuesday, three large health systems formed a new nonprofit company to fill that gap. The venture, dubbed Graphite Health, is seeking to build an App-Store-like marketplace where digital health entrepreneurs can sell their software tools, and hospitals and consumers can more easily buy and implement them.
Its founders, including Intermountain Healthcare of Utah, previously launched CivicaRX, another hospital-led nonprofit built to create a cheaper, more reliable supply of generic medicines. If it gains the same level of uptake, Graphite could essentially eliminate the long and costly process of vetting and customizing software that hospitals use to do everything from selecting the best treatments for patients to managing their beds and operating rooms. It will also offer a range of apps for patients.
Today, the Departments of Health and Human Services, Labor, and Health and Human Services, and OPM issued the second interim final rule on No Surprises Act (“NSA”) implementation. This rule concerns the independent dispute resolution (“IDR”) process. The process is intended to resolve disputes that arise when an out-of-network provider is dissatisfied with the qualifying payment amount (“QPA”) from the health plan pursuant to the NSA.
The IDR process timeline is as follows:
Independent Dispute Resolution Action
Timeline
Initiate 30-business-day open negotiation period
30 business days, starting on the day of initial payment or notice of denial of payment
Initiate independent dispute resolution process following failed open negotiation
4 business days, starting the business day after the open negotiation period ends
Mutual agreement on certified independent dispute resolution entity selection
3 business days after the independent dispute resolution initiation date
Departments select certified independent dispute resolution entity in the case of no conflict-free selection by parties
6 business days after the independent dispute resolution initiation date
Submit payment offers and additional information to certified independent dispute resolution entity
10 business days after the date of certified independent dispute resolution entity selection
Payment determination made
30 business days after the date of certified independent dispute resolution entity selection
Payment submitted to the applicable party
30 business days after the payment determination
The NSA IDR process uses the so-called baseball arbitration approach under which the decision maker selects one of the parties proposals rather than craft an independent approach as judges do. The requirements description accompanying the final rule explains
Basically this instructs the health plan to make a proposal close to, if not equal to, the QPA. Then the burden of proof for a higher amount is necessarily placed on the provider. The FEHBlog’s hunch is supported by the following American Hospital Association (“AHA”) statement from the provider side:
AHA Executive Vice President Stacey Hughes said, “The No Surprises Act was an important step forward in protecting patients from surprise medical bills. Hospitals and health systems strongly support these protections and the balanced approach Congress chose to resolve disputes. Disappointingly, the Administration’s rule has moved away from Congressional intent and brought new life to harmful proposals that Congress deliberately rejected. Today’s rule is a windfall for insurers. The rule unfairly favors insurers to the detriment of hospitals and physicians who actually care for patients. These consumer protections need to be implemented in the right way, and this misses the mark.”
AHA staff are reviewing the rule. Watch for a Special Bulletin tomorrow with additional details.
On the bright side for providers, it appears that the IDR process allows the health plan no opportunity to make a low ball proposal to the decision maker. However, it’s the FEHBlog’s view that the devil remains in the details of this lengthy rule and no one should underestimate the ingenuity of lawyers on either side in these novel legal situations. Finally, the apparently simple approach that the regulators took will facilitate implementing the principal feature of the No Surprises Act on January 1, 2022.
President Joe Biden signed a stopgap funding measure Thursday with hours to spare before federal agencies would otherwise have to start shutting down.
The continuing resolution gives lawmakers and the White House nine more weeks to reach agreement on spending levels and negotiate a dozen fiscal 2022 appropriations bills. * * *
The stopgap bill extends federal agencies’ current spending rates, with some exceptions known as “anomalies,” through Dec. 3, as well as certain expiring program authorizations like the National Flood Insurance Program’s ability to sell new policies and renew existing ones.
The measure provides $28.6 billion to address natural disasters like Hurricane Ida which slammed into the Gulf Coast earlier this month, and $6.3 billion to provide resettlement assistance for Afghan refugees fleeing the Taliban. Another $2.5 billion goes toward care and shelter for undocumented migrant children who crossed the border alone while the government reviews their status.
Telehealth usage was four timeshigherthan a year ago, but the industry and patients are still grappling with growing pains including service limitations, difficulty accessing appointments and inconsistent care, a survey from J.D. Power found.
From 2020 to 2021, overall satisfaction with both direct-to-consumer and payer-sponsored telehealth services declined, according to the survey. Patients frequently cited limited services, lack of awareness of costs and confusing technology requirements.
Among direct-to-consumer brands, Teladoc ranked highest for telehealth satisfaction, followed by MDLive. Among payer-sponsored telehealth services, UnitedHealthcare ranked the highest, followed by Humana and Kaiser Foundation Health Plan, both in a tie for second, the survey found.
Despite the wide-ranging expansion of telehealth in the past year, there is still a broad swath of the U.S. population it has largely failed to reach: the 57 million people in rural parts of the country.
Even now, as employers rush to add virtual care to their benefits, many telehealth companies have avoided rural areas. Several acknowledged to STAT that most of their users remain in urban and suburban areas, and they’ve made far less progress than they’d like to in reaching rural patients. The companies recognize they face an uphill battle. Beyond the foundational barrier of broadband access, providers must contend with questions about reimbursement rates, strict rules on interstate licensing, and a hazy road map without clear inroads for reaching rural patients and providers.
“Honestly, as much as our mission statement fits well with rural health care, we haven’t really made enough progress to date around this work,” Brad Younggren, the chief medical officer of telehealth company 98point6, told STAT.
As it is Thursday from the miscellany department
Recycle Intelligence discusses “Lessons learned from Aetna, Cleveland Clinic’s Joint ACO Mode / Leaders from Aetna and Cleveland Clinic reflect on the first year of their joint ACO and health plan and share how others can deliver value-based care to their local markets.” Check it out.
Scientists have unveiled new maps of the protein networks underlying different types of cancer, offering a potentially clearer way to see what’s driving the disease and to find therapeutic targets.
Sequencing the genetic information of tumors can provide a trove of data about the mutations contained in those cancer cells. Some of those mutations help doctors figure out the best way to treat a patient, but others remain more of a mystery than a clear instruction manual. Many are exceedingly rare, or there are so many mutations it’s not clear what’s fueling the cancer.
In a quest to come up with more practical and actionable tools, experts have been looking beyond the genes. Instead, they’re mapping out the proteins the genes encode and the interactions among those proteins in hopes of getting a clearer view of cancer-propelling pathways. And in a series of paperspublished Thursday in the journal Science, a team of researchers outlined those “protein-protein interaction” maps for certain cancers and explain how charting those landscapes and others like them could reveal insights about patients’ prognoses, point to drugs to try for particular patients, and perhaps identify targets for new therapies.
STAT News also seeks to predict what will become of the COVID pandemic this coming winter. The article hopefully concludes
Barney Graham, who led the vaccine design work that laid the foundation for many of the current Covid vaccines, is hopeful, though, that in Delta the virus has hit a sweet spot that will eventually undermine it.
“I’m hoping the virus has gotten itself to a point where it’s basically trapped now,” said Graham, who was deputy director of the NIH’s Vaccine Research Center until his retirement at the end of August. “That it can’t get any better at transmission, and any adaptation it makes in the immune response is going to make it less transmissible.”
Laboratory studies show that Merck & Co’s (MRK.N) experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective against known variants of the coronavirus, including the dominant, highly transmissible Delta, the company said on Wednesday.
Since molnupiravir does not target the spike protein of the virus – the target of all current COVID-19 vaccines – which defines the differences between the variants, the drug should be equally effective as the virus continues to evolve, said Jay Grobler, head of infectious disease and vaccines at Merck.
Molnupiravir instead targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus.
Data shows that the drug is most effective when given early in the course of infection, Merck said.
What’s more, the Merck drug is administered in pill form.
Yesterday was the deadline for submitting public comments on the first No Surprises Act (“NSA”) interim final rule. The first IFC concerns the surprise billing protections afforded to consumers in emergency case, out of network care at in-network facilities and air ambulance care.
Here is potpourri of pertinent articles from Becker’s Payer Issues (about AHIP’s comments), the American Hospital Association, and Health Leaders Media (MGMA’s comments). When the same tri-agencies issued interim final rules implementing the Affordable Care Act (“ACA”) in 2011, those agencies did not issue “final final” rules until four or five years later.
While the NSA law is narrower in scope than the ACA, it poses much more complicated administration issues than those ACA provisions. Consequently the final final NSA rules may be accelerated. Sensibly, AHIP suggests that the tri-agencies create a good faith safe harbor for health plans and insurers during 2022 and 2023 to allow them to come into full compliance with this complex law.
In other healthcare news
A friend of the FEHBlog called his attention to the September 2021 issue of NIH in the News which may provide useful article for health plan newsletters to members.
The Journal of AHIMA breaks down the ICD-10 diagnosis code changes that will take effect on October 1, 2021, under the HIPAA transactions and code sets rule.
Fierce Healthcare reports that “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members. The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system’s 3,500 physicians. Anthem will initially make these consults available to its large employer clients, with the potential to expand to other employers and other insurance programs, according to the announcement.”
Health Payer Intelligence tells us that “In 2020, the prevalence of employer-sponsored health plan coverage fell during the coronavirus pandemic even as employment rebounded, according to a recent study published in the JAMA Health Forum. * * * In 2021, the data forms a clearer picture. Employer-sponsored healthcare coverage declined even as employment levels recovered, potentially indicating a shift to Affordable Care Act marketplace or Medicaid plans.” That is hardly surprising given the enormous funding that Congress has provided to the ACA marketplace.
Finally, the Wall Street Journal’s the Future of Everything series today discusses how
Researchers around the world are trying to turn the humble cough into an inexpensive tool to diagnose and stop respiratory-disease killers like tuberculosis and Covid-19. They’re collecting recordings of millions of the explosive sounds from patients and consumers on smartphones and other devices. And they’re training artificial intelligence to find patterns to try to identify the type and severity of disease from the cough itself.
“We call it acoustic epidemiology,” says Peter Small, a tuberculosis expert and chief medical officer of Hyfe Inc., a Delaware-based company with two free smartphone apps—one for consumers, another for researchers—that use AI to detect and track how often someone coughs.
On the Delta variant front and acccording to the CDC’s COVID Data Tracker, the United States reached two data points today — the number of COVID cases now exceeds 40 million and the percentage of Americans aged 18 and over who have received at least one dose of a COVID-19 vaccine reached 75%.
At the end of 2020, the number of cases according to the CDC stood at 20 million. In his blog, National Institutes of Health Director Francis Collins discusses a recent Nature study estimating that “the true number of [COVID] infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of pandemic.” It also suggests to the FEHBlog that we may to closer to effective herd immunity in some areas of the U.S. than generally thought.
Also David Leonhardt in today’s New York Times tells us about another way to look at the situation.
The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.
The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.
In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.
How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community. * * *
I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not grind to a halt over the flu.
In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.
“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.
Well put, Mr. Leonhardt, as usual.
From the federal employee benefits front, OPM posted on the Federal Register website today a notice of changes to Federal Group Life Insurance premium rates for “Employee Basic Insurance, Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after October 1, 2021.”
From the tidbits department
Federal News Network reports that “The White House is proposing billions of dollars in supplemental funding for disaster relief and other programs, which it’s asking Congress to attach to a short-term continuing resolution that will be critical toward avoiding a government shutdown at the end of the month. ‘With the end of the fiscal year rapidly approaching, it’s clear that Congress will need to pass a short term continuing resolution to provide more time for the fiscal 2022 process to unfold,’ Shalanda Young, the Office of Management and Budget’s acting director, said Tuesday in a blog post.”
Fierce Healthcare informs us that “The American Medical Association [“AMA”] released updates to its medical codes for 2022 with many tied to new technology services and the administration of COVID-19 vaccines. The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. ” The CPT is recognized as a HIPAA electronic transaction code set.
AP News reports that “Four companies in the drug industry said Saturday that enough states had agreed to a settlement of lawsuits over the opioid crisis for them to move ahead with the $26 billion deal. An announcement from the three largest U.S. drug distribution companies and a confirmation from drugmaker Johnson & Johnson, which had previously announced that it would move ahead, came Saturday. That was the deadline for the companies to decide whether there was enough buy-in to continue the settlement plan. * * * Together, the settlements are likely to represent the biggest piece of a string of settlements between companies in the drug industry and state and local governments over the addiction and overdose epidemic in the U.S.”
Healthcare Dive tells us that “The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.”
The AMA discusses “what doctors wish patients knew about a prediabetes diagnosis,” which of course is a fairly common diagnosis in our country.
The Wall Street Journal continues its series on the Future of Everything in healthcare with an article about sensor studded smart clothes. “From a prescription bra that signals cardiac arrest to a mosquito-proof textile, startups and scientists are developing garments for healthier living.”
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