In an Associated Press interview, Jha said Americans’ immune protection from the virus is waning, the virus is adapting to be more contagious and booster doses for most people will be necessary — with the potential for enhanced protection from a new generation of shots.
Epidemiologist David Dowdy of Johns Hopkins’ Bloomberg School of Public Health said that, despite the case increases, hospitalization and death rates overall remain relatively low compared with earlier periods in the pandemic — a reflection of how much immunity there is in the population.
“In some ways, this is encouraging, in that we’re starting to see a divergence between the number of cases and the number of hospitalizations and deaths,” Dowdy said. “But it’s also a little bit discouraging that we’ve been through all this and we’re still seeing a flat line and an uptick in the number of people getting admitted to the hospital and in people dying.”
In the FEHBlog’s view, the coordinator should stop fighting the Delta pandemic by focusing attention on better government distribution of Pfizer’s Paxlovid, which can cure the Omicron if taken timely. Kaiser Health News discusses this continuing and vexing distribution problem.
Unquestionably a need to focus attention on vaccinations and boosters remains essential. Govexec and Kaiser Health News ask why one-third of Americans over 65 have not received the first booster. Nearly all Americans over 65 are fully vaccinated. The article explains
People 65 and older account for about 75% of U.S. covid deaths. And some risk persists, even for seniors who have completed an initial two-dose series of the Moderna or Pfizer vaccine or gotten one dose of the Johnson & Johnson vaccine. Among older people who died of covid in January, 31% had completed a first vaccination round but had not been boosted, according to a KFF analysis of CDC data
FEHB plans are well-positioned to help with this effort, given their demographics.
In other virus news, the American Hospital Association tells us
The Centers for Disease Control and Prevention yesterday updated its testing guidance for clinicians treating children with hepatitis of unknown cause. The agency is investigating 109 potential hepatitis cases of unknown cause in U.S. children since last October, including five deaths. More than 90% of the patients were hospitalized, 14% received liver transplants and more than half had a confirmed adenovirus infection, but officials still don’t know the actual cause of their hepatitis and cautioned that it may take time to assess the evidence and learn more. Potential cases also have been reported in the United Kingdom and other countries.
Following up on last night’s hospital system merger news, Healthcare Dive reports
The Advocate Aurora Health and Atrium Health merger is likely to get a close review from the Federal Trade Commission as the Biden administration has taken a tougher stance on healthcare consolidation, antitrust and legal experts say. * * *
“I don’t think anything of this size in a healthcare transaction today is going to get rubber stamped,” said Bill Horton, a partner at Jones Walker who focuses on healthcare transactions. * * *
“Historically, the FTC concern in hospital and healthcare institution mergers has been the geographic overlap,” Horton said.
Advocate Aurora and Atrium do not have any geographic market overlap. The systems span six separate states through the Midwest and South.
“It doesn’t raise the same red flags, but it doesn’t mean that it gets waved through,” said Leemore Dafny, a Harvard Business School professor and former deputy director of healthcare and antitrust at the FTC.
The FTC is likely to examine whether the two systems negotiate with the same insurers even if they’re in different geographic locations, Dafny said.
From the interoperability front, Health Data Management offers an interesting take on government efforts to meet lofty public health goals for Data Modernization Initiative.
From the mental health care front, and to end on a high note, Health Payer Intelligence informs us
Consumers reported having positive experiences with their employer-sponsored mental and behavioral healthcare coverage during the coronavirus pandemic, a survey conducted on behalf of AHIP discovered.
“Health insurance providers are working every day to support Americans by helping them find the mental health support and counseling they need at a price they can afford,” Matt Eyles, president and chief executive officer of AHIP, said in a press release.
From the FEHB front, the Office of Personnel Management released the 2023 call letter for benefit and rate proposals and the related technical guidance letter.
OPM is to be congratulated for releasing the two letters simultaneously. Historically, OPM has released the call letter weeks or months before the technical guidance letter. As a result, carriers cannot start preparing their benefit and rate proposals, due May 31, until they receive both letters.
From the Omicron (and sibling) front, the American Medical Association informs us
The New York Times (3/15, Mandavilli) reports about “17 million Americans received the Johnson & Johnson Covid vaccine, only to be told later that it was the least protective of the options available in the United States.” However, “new data suggest that the vaccine is now preventing infections, hospitalizations and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.” The reasons are unclear, “and not all experts are convinced that the vaccine has vindicated itself.” Still, “the accumulating data nonetheless offer considerable reassurance to recipients of the vaccine and, if confirmed, have broad implications for its deployment in parts of the world.”
From the mental health care front, the American Hospital Association tells us
The Substance Abuse and Mental Health Services Administration yesterday released a toolkit to help health care providers and others prepare for the July 16 launch of 988, the new phone number for anyone experiencing suicidal thoughts or a mental health or substance use crisis to speak, text or chat with a trained crisis counselor. Authorized by the National Suicide Hotline Designation Act of 2020, the three-digit number will operate through the National Suicide Prevention Lifeline’s network of over 200 crisis centers.
“In the longer term, our vision is to build a robust crisis care response system across the country that links callers to community-based providers who can deliver a full range of crisis care services, if needed (like mobile crisis teams or stabilization centers),” SAMHSA notes.
To access the toolkit and other suicide prevention resources, visit SAMHSA’s new 988 website.
From the U.S. healthcare front, Healthcare Dive reports
The long-term shift from hospital-based care toward more treatment delivered in the home and ambulatory centers picked up pace during the COVID-19 pandemic and is expected to continue to gain momentum, pressuring revenue growth and margins in the hospital sector, according to new research from Moody’s Investors Service.
Reimbursement changes, risk-sharing, investment in outpatient services including ambulatory surgery centers, advances in drugs and medical devices and greater use of at-home acute care services are among the forces driving the movement away from more expensive hospital inpatient care.
Medicare telehealth visits increased 63-fold during 2020, Moody’s said, citing HHS data. Although hospitals are reporting that telehealth use is receding as more patients return to in-person physician visits, it will likely remain above pre-COVID levels, the ratings agency said.
Kaiser Health News looks at the No Surprises Act from the patient’s perspective. It’s an important article because health plans should help their members keep the new law’s billing protections in perspective.
From the provider of the future front, mHealth Intelligence reports
Though a majority (63 percent) of clinicians worldwide expect most of their consultations to be remote within the next decade, 51 percent believe that telehealth will negatively impact their ability to demonstrate empathy with their patients, a new report revealed.
Developed by Elsevier Health and Ipsos, the Clinician of the Future report includes a quantitative survey, qualitative interviews, and roundtable discussions with nearly 3,000 practicing physicians and nurses worldwide. Of the total number of respondents, 434 were from the US. * * *
Empathy from physicians is becoming increasingly important for patients. A vast majority of clinicians (82 percent) surveyed said that soft skills like listening and displaying empathy have become more critical in the last decade. In the US, 76 percent of clinicians agreed with this statement.
Though the importance of soft skills has grown, the report notes that technical skills will be key in the future.
From the HIMSS Conference in Orlando, Florida, Healthcare Dive holds an interview concerning the FEHBlog leading interoperability innovation of 2022, TEFCA:
Healthcare Dive caught up with Mariann Yeager to talk TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is CEO of the Sequoia Project, a nonprofit that was selected in 2019 to serve as the recognized coordinating entity (RCE) charged with developing, updating and maintaining the common agreement and overseeing QHINs.
Yeager shared more details on the timeline of TEFCA implementation, why organizations should join the voluntary framework and how the Sequoia Project and the Office of the National Coordinator for Health IT are at the beginning of a long process of monitoring and modernizing a living document that, given uptake, could shape the future of health data exchange for decades into the future.
“We’re really proud of the work that we’ve done,” Yeager said.
Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s updated weekly chart of new Covid cases:
Not quite as low as we were in early July but very much moving in the right direction. So is the FEHBlog’s updated weekly chart of new Covid deaths, which is considered a lagging indicator.
The epidemiologists have a keen eye out for new worrisome variants. For example, for other troubling variants, Becker’s Hospital News tells us about a relatively new combination of Delta and Omicron known as Deltacron.
The recombinant variant appears unlikely to spread as easily as delta or omicron, William Lee, PhD, vice president of science at Helix, told USA Today. “We have not seen any change in the epidemiology with this recombinant,” WHO COVID-19 technical lead Maria Van Kerkhove, PhD, said of deltacron during a March 9 media briefing. “We haven’t seen any change in severity. But there are many studies that are underway.”
Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the start of the Covid vaccination era in late 2020 until the week ended this past Wednesday.
It is noteworthy that this week, the percentage of Americans aged 18 and older who are fully vaccinated (two doses of mRNA vaccine) cracked 75%. The same cadre is closing in on being 50% boostered. The most at risk, over age 65 cadre is 89% fully vaccinated and 66.7% boostered.
In a study of 1,364 children aged 5-15, two doses of the Pfizer COVID-19 vaccine reduced the risk of omicron infection by 31% in those under 12 and 59% in older children, the Centers for Disease Control and Prevention reported today. CDC said the study reinforces the importance of vaccination to keep children and teens protected from severe disease, noting that another recent study found the vaccine 92%-94% effective against COVID-19 hospitalization in adolescents during the delta surge and 74% effective against hospitalization in younger children during omicron.
Here’s a link to the CDC’s weekly review of its Covid statistics. This week’s issue focuses on protecting folks at high risk for Covid, such as the immunocompromised.
Who is most likely to become very sick or die from COVID-19? Your chances increase with age and underlying medical conditions like cancer, diabetes, heart conditions, dementia, and obesity, particularly if you’re not up to date on vaccinations. People with weakened immune systems,* some disabilities, some mental health conditions, and some chronic diseases are also at higher risk. A lot of people might not know they’re at risk for severe illness—review the list to find out if you could be.
Here’s a link to the CDC’s weekly Fluview report, which states that flu activity is increasing in “most of the country.” In this regard, the American Medical Association inform us
Healio (3/10, Downey, Gallagher) reports “interim estimates published Thursday in” the CDC’s Morbidity and Mortality Weekly Report “indicate that this season’s influenza vaccine has not been effective.” Based on the data “from more than 3,600 children and adults,” researchers “estimated that the vaccine has been 16% effective against mild or moderate influenza caused by the predominant circulating virus, influenza A(H3N2), with a 95% confidence interval…that suggests vaccination ‘did not significantly reduce the risk of outpatient medically attended illness’ caused by H3N2.”
From Capitol Hill and closing the loop on Thursday’s post, the Senate did pass the fiscal year 2022 omnibus appropriations act Thursday night. Roll Call reports
On a 68-31 vote, the Senate passed the 2,700-page, $1.5 trillion omnibus containing all 12 fiscal 2022 spending bills, $13.6 billion in supplemental appropriations to address the crisis in Ukraine and a lengthy list of unrelated measures fortunate enough to ride on the must-pass vehicle.
From the No Surprises Act front, the FEHBlog had been concerned that the federal regulators were giving up on using the Qualified Payment Amount as a rebuttable presumption in NSA arbitrations which would help tremendously to control out of network benefit and plan legal costs. The FEHBlog therefore was encouraged to find that the federal government has filed a brief with the federal district court for the District of Columbia defending that position in a case raising the same issue. An oral argument on this issue will be heard by District Judge Richard Leon on March 21, 2022, at 3 pm. The FEHBlog will keep an eye on this and the other federal cases raising this issue.
From the electronic health record front, MedCity News interviews the CEO of Epic Systems at the Vive conference. The interview covers interoperability, artificial intelligence and other timely topics.
From the opioid epidemic front, STAT News reports
It was in the mid-2010s, the researchers heard, when “tranq dope” — opioids that contained the veterinary tranquilizer xylazine — took off in Philadelphia. But now, in some places across the U.S., it was appearing in 1 in 5 overdose deaths. A recent study also found the powerful synthetic opioid fentanyl in nearly every xylazine-involved death as well, indicating it wasn’t just the tranquilizer causing these overdoses. Experts are still trying to understand the risks of xylazine, but they’re worried because the drug is not an opioid but acts as a sedative, which can increase the risk of a fatal overdose. It might also make it harder to reverse those overdoses with naloxone, which is designed to work on opioids. STAT’s Andrew Joseph has more on how adulterated — and in turn, increasingly dangerous — the U.S. drug supply has become.
Let’s start today with news from the litigation front —
The Wall Street Journal reports that in advance of the February 27 deadline,
The Justice Department filed an antitrust lawsuit Thursday challenging UnitedHealth Group Inc.’s$13 billion acquisition of health-technology firm Change Healthcare Inc., arguing the tie-up would unlawfully reduce competition in markets for commercial insurance and the processing of claims.
The deal, announced in January 2021, sought to bring a major provider of healthcare clinical and financial services, including the handling of claims, under UnitedHealth’s Optum health-services arm.
The Justice Department filed its lawsuit in federal court in Washington, saying Change provided key industry technologies that are relied upon by UnitedHealth’s health-insurance rivals, making it a hub for competitively sensitive information. If the deal were allowed, UnitedHealth would have access to data that it could potentially use for its own benefit, at the expense of other insurers, the department alleged. The department also argued the deal would reduce head-to-head competition in the businesses of insurance claims transmission and review, because UnitedHealth competes with Change in those areas.
A federal judge in Texas struck down a narrow part of the surprise billing rule that outlines how to resolve payment disputes between payers and providers over out-of-network claims. Wednesday’s ruling is a win for providers who were opposed to the dispute resolution process spelled out by CMS in an interim rule, arguing it favored insurers.
The judge’s ruling essentially tosses out a part of the dispute resolution process that instructs arbiters to begin with the presumption that the qualifying payment amount, or median in-network rate, is the appropriate payment amount for providers.
This is not the final word because the decision, which resulted in a final judgment is appealable to the U.S. Court of Appeals for the Fifth Circuit. A case raising the same issue is currently pending oral argument in the U.S. District Court for the District of Columbia.
Katie Keith, a health law expert at Georgetown University, said the ruling is evidence of how hard doctors groups will fight even relatively modest efforts by Congress to cut health care costs.
The surprise billing action was “one of the few things Congress has tried to do on cost containment,” she said.
Amen to that.
From the Omicron front, Medpage Today provides background on a Centers for Disease Control decision permitting
Extended dosing intervals for Pfizer or Moderna vaccines * * * for certain individuals ages 12 to 64 years, not only to lower the risk of vaccine-associated myocarditis, but to potentially improve vaccine effectiveness, CDC staff said on Thursday.
According to the agency’s new interim guidance, young people ages 12 to 39 may especially benefit from a second mRNA dose 8 weeks after their first dose.
However, the regular 3-week interval for Pfizer and 4-week interval for Moderna is appropriate for patients who are moderately to severely immunocompromised, adults ages 65 and up, those who need rapid protection (such as “during high levels of community transmission”), and children ages 5 to 11.
From the social determinants of health front, HR Dive tells us
Though employers have invested increasingly in a variety of healthcare and healthcare-adjacent benefits, few of these efforts effectively address social determinants of health that can negatively affect patient outcomes, according to a report published this month by the Northeast Business Group on Health.
Social determinants of health include factors such as education access and quality; healthcare access and quality; economic stability; neighborhood and built environment; and social and community factors. Differences in these areas lead to disparities not only in terms of health outcomes, but also in cost management and general employee health and well-being, NEBGH said.
Employers can start addressing social determinants by collecting survey data on employees’ needs and risk factors, per the report. From there, NEBGH recommended that benefits design focus on equitable benefits access, such as evaluating what percentage of pay their health plans comprise at different pay levels. Other strategies cited include improving health literacy, taking advantage of partnerships and improving organizational culture around health and well-being, among others.
From the Rx coverage front, Fierce Healthcare discusses CVS Health’s annual Drug Trend Report.
CVS Caremark kept overall drug trend for clients to 2.4% over the first three quarters of 2021, marking multiple years of single-digit trend in drug price growth.
The pharmacy benefit management arm of CVS Health also kept its specialty drug trend to single digits through the third quarter, at an industry-low 5.8%, according to the company’s annual Drug Trend Report released Thursday. Caremark found that 35.9% of its clients saw negative specialty trend in 2021.
In addition, 65.3% saw specialty trend under 10%, according to the report.
The article explains how CVS Health accomplished this feat.
From the Medicare front, CMS announced a redesign of its Accountable Care Organization model
that better reflects the agency’s vision of creating a health system that achieves equitable outcomes through high quality, affordable, person-centered care. The ACO Realizing Equity, Access, and Community Health (REACH) Model, a redesign of the Global and Professional Direct Contracting (GPDC) Model, addresses stakeholder feedback, participant experience, and Administration priorities, including CMS’ commitment to advancing health equity.
In addition to transitioning the GPDC Model to the ACO REACH Model, CMS is canceling the Geographic Direct Contracting Model (also known as the “Geo Model”) effective immediately. The Geographic Direct Contracting Model, which was announced in December 2020, was paused in March 2021 in response to stakeholder concerns.
George Washington was born in Virginia on February 11, 1731, according to the then-used Julian calendar. In 1752, however, Britain and all its colonies adopted the Gregorian calendar which moved Washington’s birthday a year and 11 days to February 22, 1732.
Americans celebrated Washington’s Birthday long before Congress declared it a federal holiday. The centennial of his birth prompted festivities nationally and Congress established a Joint Committee to arrange for the occasion.
Washington’s Birthday was celebrated [as a federal holiday] on February 22nd [from 1879] until well into the 20th Century. However, in 1968 Congress passed the Monday Holiday Law to “provide uniform annual observances of certain legal public holidays on Mondays.” By creating more 3-day weekends, Congress hoped to “bring substantial benefits to both the spiritual and economic life of the Nation.”
One of the provisions of this act changed the observance of Washington’s Birthday from February 22nd to the third Monday in February. Ironically, this guaranteed that the holiday would never be celebrated on Washington’s actual birthday, as the third Monday in February cannot fall any later than February 21.
Contrary to popular belief, neither Congress nor the President has ever stipulated that the name of the holiday observed as Washington’s Birthday be changed to “President’s Day.”
Average daily COVID-19 cases and hospitalizations are continuing to fall in the U.S., providing a signal that the Omicron variant is receding across the country.
* * *
Deaths are also beginning to decline, with an average of about 2,100 daily, according to the data tracker from The New York Times. More than 2,500 daily deaths were being reported in early February.
The Omicron sublineage BA.2, which raised alarms because of its transmission advantage, accounts for just 4% of cases in the U.S., and experts suggested it’s not likely to reverse the current downward trend of cases overall.
BA.2 has certainly increased in prevalence, but its been a slow trajectory, according to CDC data. BA.1.1, another Omicron sublineage, actually became the dominant strain in the U.S. in mid-January, the agency reported, with the original lineage, B.1.1.529, currently accounting for about 23% of U.S. cases.
“The BA.2 Omicron variant is increasing in prevalence slowly in both CDC and private data,” tweeted Scott Gottlieb, MD, former FDA commissioner and current Pfizer board member. “While it may become a dominant strain in time, it appears increasingly unlikely that it will cause a significant change in the downward trajectory of the current epidemic wave.”
That has certainly been the case for South Africa, where BA.2 accounts for nearly 100% of cases, according to Tulio de Oliveira, PhD, of the Centre for Epidemic Response & Innovation in Stellenbosch.
“This comes on a background of decreasing infections,” de Oliveira tweeted. The country now has a 7-day average of about 2,500 daily infections, down from a peak of about 23,000 in mid-December.
“At present, the Omicron BA.2 is not of great concern in South Africa,” he tweeted. “But our network is following very close and is alerted to its emergence.”
From the Covid vaccination mandate front, the Society for Human Resource Management reports that the U.S. Court of Appeals for the Fifth Circuit ordered the lower court to reconsider whether United Airlines vaccination mandate offered sufficient protection under Tittle VII to religious objectors.
From the No Surprises Act front, the American Hospital Association tells us
The Centers for Medicare & Medicaid Services will host a conference call for health care providers Feb. 23 at 2 p.m. ET on the No Surprises Act’s continuity of care, provider directory and public disclosure requirements. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov. A recording will be available after the call through Feb. 25 by dialing 866-373-4993.
The cost of being transported by ground ambulance has increased steadily over the past five years, according to a new report from nonprofit Fair Health, threatening patients with few protections from balance billing in disputes between insurers and ambulance providers.
More ambulance trips are billing payers for advanced life support ( ALS), denoting a higher level of care (and reimbursement) than basic life support (BLS) services. Private insurers’ average payments for those trips increased 56% between 2017 and 2020, from $486 to $758, according to the analysis. Before accounting for discounts negotiated with payers, the rate that ambulance operators charged for trips jumped 23% in the same time period and now average almost $1,300.
However, the average reimbursement for advanced life support ambulance rides climbed by 5% for patients covered by Medicare, from $441 to $463, suggesting the government program is keeping a lid on rising costs.
Although at this point only air ambulance charges are subject to the No Surprises Act, this type of report could lead Congress to expand the law to include ground ambulance charges.
From the medical research front, Biopharma Dive informs us
Eli Lilly is again upping its investment in genetic medicine, announcing Tuesday plans to establish a Boston research center that will use RNA- and DNA-based technologies to develop new drugs.
The Lilly Institute for Genetic Medicine will take up 334,000 square feet in Boston’s Seaport neighborhood, with occupancy slated to begin in 2024. Lilly, which has earmarked around $700 million for the project, expects the institute to grow from 120 employees to 250 within five years. Roles will include data scientists, chemists and research biologists with expertise in genetic medicine.
Alongside drug development, the institute will take a page from another Lilly venture — Lilly Gateway Labs — and offer shared lab and office space to support biotechnology startups in the area. Use of the shared space, Lilly said, could create as many as 150 additional new jobs once it’s fully occupied.
Women who had ever experienced sexual violence in their lifetime — including sexual assault and workplace sexual harassment — were more likely to develop high blood pressure over a seven-year follow-up period, according to findings from a large, longitudinal study of women in the United States. The research, funded by the National Institutes of Health and published in the Journal of the American Heart Association, indicated that sexual violence was a common experience, affecting more than 20% of the women in the sample.
“Our results showed that women who reported experiencing both sexual assault and workplace sexual harassment had the highest risk of hypertension, suggesting potential compounding effects of multiple sexual violence exposures on women’s cardiovascular health,” said Rebecca B. Lawn, Ph.D.(link is external), of the Harvard T. H. Chan School of Public Health, Boston, lead author on the study.
From the healthcare initiative front, the Centers for Disease Control detailed its Million Hearts 2027 initiative.
From the virtual care front, Healthcare IT News tells us
The American Medical Association, in conjunction with Manatt Health, published a report this week exploring the ways that virtual care and other digital tools can accelerate the adoption of the integrated delivery of behavioral and physical healthcare.
In the report, the organizations note that behavioral health integration is essential for solving the country’s dire need for access to services.
“The demand for behavioral health services is significant and rising, but so is the potential for digital technology to support the integrated delivery of physical and behavioral health services,” said AMA President Dr. Gerald Harmon in a statement.
Moreover, in Health Affairs, the National Coordinator for Health Information Technology Micky Tripathi discusses delivering on the promise of health information technology in 2022.
From the healthcare business front, Healthcare Finance reports
The Department of Justice has until Saturday, February 27 to block the merger between UnitedHealth Group and Change Healthcare, according to a Securities and Exchange Commission filing on February 17.
The filing, by Change, was done in accordance with a timing agreement made with the DOJ. In November 2021, the two companies agreed not to consummate their merger before February 22.
The timing agreement provides the DOJ with 10 days’ notice to sue to block the deal.
“Effective February 17, 2022, UnitedHealth Group and the Company provided such notice to the DOJ,” Change said in the filing. “Accordingly, the DOJ now has until February 27, 2022 to initiate litigation to block the consummation of the merger.”
The DOJ is preparing the lawsuit to block UnitedHealth from purchasing Change, according to Seeking Alpha.
From the awards front
STAT News released its inaugural STATUS List which “recongizes standout individuals in health, medicine, and science. And although there are countless contenders to choose from, we’ve selected just 46 — an homage to the number of chromosomes in human DNA.”
OPM “announceda call for nominations for the 2022 Presidential Rank Awards (PRAs). A Presidential Rank Award is one of the most prestigious awards in the federal career civil service, and these awards are critical to recognizing the hard work and important contributions of dedicated civil servants in the American federal workforce. The awards – which recognize exceptional performance by members of the career Senior Executive Service (SES) and Senior Career Employees – reflect the Biden-Harris Administration’s commitment to supporting the federal workforce and recognizing federal employees who serve with distinction.” The nomination deadline is March 25, 2022.
Sen. Marsha Blackburn lifted a hold on a stopgap bill needed to avoid a partial government shutdown this weekend after she won a commitment from the Biden administration that it wouldn’t fund pipes for smoking illicit substances through a substance-abuse program. * * *
[Senate Minority Leader Sen. Mitch] McConnell said Tuesday that he expected there to be some amendment votes in conjunction with the vote on the so-called continuing resolution. “I think it will all be worked out,” he said. “There’s no danger of a government shutdown.”
The House of Representatives held a pro forma, the four-minute-long session this morning at which
[The] Clerk notified the House that she had received the following message from the Secretary of the Senate on February 14, 2022, at 6:30 p.m.: That the Senate agreed to return the papers to the House of Representatives at their request for H.R. 3076 [the Postal Reform Act of 2022] * * *.
The House is not scheduled to resume floor voting until February 28 and the Senate will be on a State work period next week so Congressional passage of this bill may not occur until next month.
The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.
Califf’s confirmation means the Biden administration has a permanent FDA commissioner during the COVID-19 pandemic after 13 months with longtime agency official Janet Woodcock acting as its leader.
Califf needed bipartisan support to cross the finish line. Retiring Sens. Patrick J. Toomeyof Pennsylvania and Roy Blunt of Missouri joined four Republicans who sit on the Health, Education, Labor and Pensions Committee to confirm Califf.
From the Omicron front, the Wall Street Journal offers interesting commentary from Dr. Marc Siegal about the Novovax vaccine which is the subject of an emergency use authorization at the Food and Drug Administration.
The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.
There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective.
From the health equity front, Health Payer Intelligence discusses a Northeast Business Group on Health report on strategies for making progress on resolving inequities created by social determinants of health. Check it out.
In a similar vein, the Agency of Healthcare Research and Quality blog post on integrating patient-generated health data into electronic health records.
The 63-year-old patient has hypertension. With encouragement from his family, he checks his blood pressure daily using a digital blood pressure monitor. And thanks to advances in digital technology, he saves each reading on a mobile application whether he’s at home, at work, or on vacation.
What is the reward for his persistence? With his health data easily integrated into his electronic health record, his primary care doctor has a fuller picture of his health—one that is not limited to the traditional snapshot taken in an exam room. Using that data, he and his physician can have more informed conversations about treatment options and next steps.
While this scenario accurately recognizes that today’s patients can easily collect their own health data outside of the clinical setting, many ambulatory care practices lack the technical infrastructure, functional workflows, workforce capacity, and training to support the intake and use of patient-generated health data (PGHD).
With those challenges in mind, AHRQ has released a new guide on increasing the use of PGHD, one that provides practical tools for ambulatory care practices to implement PGHD programs and improve patient outcomes. It includes tips, ideas, and learning activities to let users tailor solutions to their needs. To our knowledge, this is the first practical guide that includes detailed considerations and steps for implementing a PGHD program.
The AHRQ guide may be helpful to health plan case managers, too.
From the tidbits department
Roll Call and Fierce Healthcare offer different takes on the public comments submitted on the Centers for Medicare Services controversial proposed national coverage deterimination on Biogen’s Alzheimers Disease drug Aduhelm. A final decision is expected in April.
The CDC encourages people with pre-diabetes to become heart health role models.
The platform is now available to all Evernorth clients and to Cigna members in employer plans or Affordable Care Act marketplace plans in 20 states.
Monument offers an evidence-based, virtual treatment program for alcohol use disorder. Evernorth said in the announcement that alcohol use has been on the rise for the past several decades, and that some 60% of people have reported higher alcohol intake under the pandemic.
Both Houses of Congress will be engaged in Committee business and floor voting this week as we are now less than one month away from the expiration of the current continuing resolution funding the federal government. That resolution runs through February 18.
From the Omnicron front, the New York Times reports that ‘
New coronavirus cases have started to fall nationally, signaling that the Omicron-fueled spike that has infected tens of millions of Americans, packed hospitals and shattered records has finally begun to relent.
More and more states have passed a peak in new cases in recent days, as glimmers of progress have spread from a handful of eastern cities to much of the country. Through Friday, the country was averaging about 720,000 new cases a day, down from about 807,000 last week. New coronavirus hospital admissions have leveled off.
Even as hopeful data points emerge, the threat has by no means passed. The United States continues to identify far more infections a day than in any prior surge, and some states in the West, South and Great Plains are still seeing sharp increases. Many hospitals are full. And deaths continue to mount, with more than 2,100 announced most days.
But following a month of extraordinary rates of case growth, blocklong lines at testing centers and military deployments to bolster understaffed I.C.U.s, the declining new-case tallies offered a sense of relief to virus-weary Americans, especially in the Northeast and parts of the Upper Midwest, where the trends were most encouraging. After another round of masking up or hunkering down, some were considering what life might look like if conditions continued to improve.
The omicron variant spreads so rapidly that sometimes it feels as if resistance is futile. It’s disheartening to hear of omicron infecting people who are up-to-date on their shots and wear an N95 mask every time they leave home. Even some well-known public-health experts are getting infected. But that doesn’t mean everyone is going to get it.
What it does mean is that life is profoundly unfair. In some of us, the Covid-19 vaccines work quite robustly, even against omicron. In others, the vaccines’ effect is weaker. Chalk this up to the spectacular diversity of the human immune system, which is partly regulated by some of the most varied genes in the human body.
A recent study led by Harvard and MIT showed that about 20% of people get much poorer protection from their vaccines against omicron. They’re still better off than completely unvaccinated people, but this variability could account for some of the fully vaccinated people who’ve been hospitalized in the omicron wave.
According to the American Medical Association (AMA), here’s what physicians want their patients to know about Omicron. “The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).”
From the Rx coverage front, the New York Times offers an interview with CVS Health’s CEO Karen Lynch. For example,
What do you see as the most effective ways that we could reduce health care costs for everyday Americans? And what’s your company’s role in doing that?
There’s a couple of things. One is there’s the site of care. Our role is offering an alternative site of care, either in our retail locations, or in the home with virtual connections. We’re entering into the primary care space because we believe that primary care has real significant influence over the cost of health care.
And I’m pretty passionate about the fact that the head is attached to the body, and most people experience behavioral health issues when they are experiencing physical health issues. We only deal with the physical health. We don’t deal with the behavioral health part, and I think there’s more we can do.
Healthcare Dive provides us with industry perspective on last week’s launch of TEFCA which is intended to vastly improve interoperability by linking together regional health information exchanges.
The goal of TEFCA is to get rid of individual legal agreements between health information networks, health plans, providers and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back on administrative burden. The framework standardizes the operational side of data exchange, while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure. * * *
Getting a nationwide network of groups of organizations that agree to the same data-sharing infrastructure could significantly streamline patient care across different geographies.
For example, if a patient from Virginia takes a vacation to California and ends up in an emergency room, doctors currently do the best they can to treat them without their medical record, which can contain valuable information about preexisting conditions, allergies and other health factors. But with a nationwide QHIN infrastructure, clinicians can query all participating networks for that patient’s data and use it to inform their clinical choices, Barrett said.
That budding future all centers on buy-in. * * *
Many, including ONC, are optimistic on TEFCA adoption, citing the competitive disadvantages to nonparticipation.
The hope is that the more networks use it, the more its value proposition will be proved. Patients will inquire why their provider doesn’t have their data from other facilities, and the provider will then wonder why the exchanges it’s a participant in aren’t qualified to work with other networks, Lee Barrett, CEO of EHR standards development organization EHNAC said.
Back in President George W. Bush’s first term, health information professionals were talking about the linking budding health information exchanges with a “national backbone.” That backbone was finally unveiled today and it has been named TEFCA. Hopefully TEFCA will be the answer to nationwide FEHB plan prayers for interoperability.
An Office of National Coordination press release explains,
The Trusted Exchange Framework and Common Agreement is now available. Within the health information technology (health IT) world, few things have been as elusive as a governance framework for nationwide health information exchange. When ONC was formed in 2004, the concept of a nationwide health information network—where your information could be located across the country in a click—was a big picture vision that drove the federal government’s early health IT infrastructure, standards, policy actions, and investments.
What’s followed as a result of two laws (HITECH Act and 21st Century Cures Act) and remarkable continuity across four administrations has been steady growth, maturity, and investment from both the public and private sectors. Most health care providers use electronic health records.1,2,3 Many are connected to and engage in at least one form of electronic health information exchange.4,5,6 And health information networks are now dotted across the US map supporting communities with a wide range of services.7
Today’s milestone marks the beginning of a new era of electronic health information exchange in the US. That world we wanted to see back in 2004—it’s here—and now it’s time to put what we’ve built to use.
Our goals for the Trusted Exchange Framework and Common Agreement (TEFCA) are:
Goal 1: Establish a universal policy and technical floor for nationwide interoperability.
Goal 2: Simplify connectivity for organizations to securely exchange information to improve patient care, enhance the welfare of populations, and generate health care value.
Goal 3: Enable individuals to gather their health care information.
The Trusted Exchange Framework is a set of non-binding principles to facilitate data-sharing among health information networks. The Common Agreement will operationalize simplified electronic health information exchange for many across the US and will provide easier ways for individuals and organizations to securely connect. Most notably, the Common Agreement sets a new baseline for the exchange purposes that need to be supported—a common source of friction across networks today. The Common Agreement includes support for treatment, payment, health care operations, individual access services, public health, and government benefits determination.
The Common Agreement is a new legal contract that ONC’s Recognized Coordinating Entity (RCE), The Sequoia Project, will sign with each Qualified Health Information Network (QHIN). QHINs will then execute certain corresponding policies within their own networks. Published in tandem is the QHIN Technical Framework, which sets the functional and technical requirements that QHINs need to support to make this new connectivity come online. While road-tested production standards are being used at the start, we are also actively working with the RCE to develop a TEFCA Health Level Seven (HL7®) Fast Healthcare Interoperability Resource (FHIR®) Roadmap (TEFCA FHIR Roadmap) to outline how FHIR will also become an established part of TEFCA-based exchange over time.
The FEHBlog is happy that the Biden Administration hit the regulatory accelerator to launch TEFCA in the Administration’s first year in office. Here’s a link to the Sequoia Projects’ TEFCA website which offers a wealth of resources.
From the Omicron front, the Wall Street Journal reports that
Pfizer Inc.’snew Covid-19 pill, Paxlovid, was effective against the Omicron variant in laboratory tests, an encouraging early sign the drug will be an important tool while the strain spreads.
Pfizer said Tuesday the drug’s main component, nirmatrelvir, worked in three separate laboratory studies. Patients take two tablets of nirmatrelvir with one tablet of another antiviral called ritonavir twice a day for five days.
The company issued the results by news release. The research hasn’t been published in a peer-reviewed medical journal.
PBS recently posted this helpful article on U.S. distribution plans for the Merck and Pfizer COVID pills. The pills are helping some folks already, but access to the medication seems serendipitous just like access to the COVID vaccines seemed a year ago.
From the OTC testing front, the Federal Government launched its COVIDTest.gov website today. The site appears to be user friendly. Let’s hope it’s holds up better than healthcare.gov did in 2014 when stress tested by the public.
The COVIDtests.gov reminds users that health plans will reimburse the costs of OTC Covid tests, and by golly Blue Cross FEP has an OTC tests coverage page on its website and so does GEHA.
The Senate remains in session for Committee and floor business while the House of Representatives remains on its District work break. Politico reports from the Senate floor that
The bipartisan infrastructure deal embraced by President Joe Biden and shaped by a gang of 10 senators is inching closer to clearing the chamber, with one more filibuster to clear on Sunday before the bill can pass later this week and land in the the House. * * *
[House Speaker] Pelosi and Senate Majority Leader] Schumer have devised a two-track process to enact as much of Biden’s domestic agenda as possible, pledging that the bipartisan infrastructure bill will only advance if it is married to the party-line legislation that will spend as much as $3.5 trillion on climate change action, paid leave policies and health care expansion.
The Senate will immediately proceed to a budget setting up that massive bill on filibuster-proof ground after it completes its work on the bipartisan infrastructure bill. Schumer is also considering forcing votes on more elections legislation after Democrats’ sweeping overhaul plan failed in June.
From the Delta variant front
The CDC’s COVID Data Tracker informs us today that just over two thirds of Americans over age 12 and 90% of Americans over 65 have received at least one dose of a COVID-19 vaccine. The data tracker consistently has shown a 10% difference between one dose and fully vaccinated Americans which indicates to the FEHBlog that people follow through a get the second dose.
However, the Wall Street Journal reports about how neighbor deaths from unvaccinated neighbors has caused an Arkansas town to reconsider their reluctance to receive the COVID-19 vaccine. Another Journal article adds that “Top U.S. public-health officials on Sunday [August 8] voiced support for Covid-19 vaccination mandates imposed at the local level, while the head of a national teachers union also backed such a move in schools.”
Speaking of mandates, the FEHBlog found a link to the Safer Federal Workers Task Force FAQs on the Biden Administration’s vaccine screening program for federal employees, federal office visitors and on-site contractors that were released last Friday August 6. Interestingly, an FAQ indicates that
Q: Do agencies need to ask employees on maximum telework or remote workers about their vaccination status?
Five intriguing panels at this week’s in-person HIMSS conference in Las Vegas.
A new survey conducted by Social Sciences Research Solutions for the Bipartisan Policy Center [that] concludes that telehealth is likely an ongoing viable option for consumers even after the COVID-19 pandemic winds down.
An overview of second quarter financial reports from health insurers.
The Biden Administration to its credit has proposed a rule rescinding the Trump Administration’s rule to establish a most favored nation pricing approach for Medicare Part B covered drugs.
Govexec reports on a recent Postal Service Board of Governors meeting attended by the three recently confirmed members whom President Biden had nominated. “The tenure of the U.S. Postal Service’s newest board members got off to a tense start on Friday as President Biden’s appointees voiced their displeasure with the agency’s direction and USPS’ leader stated he will still move forward with reforms.”
Fierce Healthcare tells us that “Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel [,the Advisory Committee on Immunization Practices] decided [today]. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA.”
Fedweek reports that “Federal employees, their unions and members of Congress continue to watch for details of federal agency ‘reentry’ and ‘post-reentry’ operational plans, with the deadline having passed on Monday (July 19) for agencies to submit those plans to OMB but with changes to telework and other workplace policies likely still weeks or months away.”
Senators Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) on Tuesday [July 20] requested updates from both the Federal Trade Commission (FTC) and the Department of Justice (DOJ) on their recent efforts to combat anticompetitive conduct in the health insurance industry. The two senators recently served as chief cosponsors of the bipartisan Competitive Health Insurance Reform Act (CHIRA), which protects consumers by repealing a long-outdated antitrust exemption for the health insurance industry. Decades of consolidation by health insurance brokers has primed the industry for abuse, allowing insurers to exert market power in order to raise premiums, restrict competition, and deny consumers choice.
Since the CHIRA’s passage in January of this year, neither the FTC nor the DOJ has announced major steps to exercise their expanded antitrust enforcement authority under the new law. In their letter, the senators called on the agencies to provide information on any enforcement actions, guidelines, rulemaking, or other actions taken to extend antitrust enforcement to the health insurance industry since then.
Following up on Mondays’ ACA FAQ 47, HHS today announced “the launch of The HIV Challenge, a national competition to engage communities to reduce HIV-related stigma and increase prevention and treatment among racial and ethnic minority people. Through this challenge, HHS is seeking innovative and effective approaches to increase the use of pre-exposure prophylaxis medication (PrEP) and antiretroviral therapy (ART) among people who are at increased risk for HIV or are people with HIV. The HIV Challenge is open to the public, and HHS will award a total of $760,000 to 15 winners over three phases. Phase 1 submissions are open from July 26, 2021, through September 23, 2021.”
Kaiser Health News explains how the Centers for Medicare and Medicaid Services is reevaluating its wellness program for pre-diabetic Medicare beneficiaries.
Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).
Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.
Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.
Leveraging Food and Drug Administration regulations loosened during the pandemic, Happify Health, which is best known for its consumer wellness app, will launch new prescription-only software to treat depression.
Happify, founded in 2012, recently announced it had raised $73 million to bolster its efforts in digital therapeutics, a space that is rapidly growing as well-funded companies make the case to regulators, insurers, and clinicians that software can be used to treat disease.
The new product, called Ensemble, is designed to treat both major depressive disorder and generalized anxiety disorder. The software, accessible on both computers and smartphones, guides patients through 10 weeks of cognitive behavioral therapy, or CBT, and other related techniques aimed at changing behavior patterns and teaching coping skills.
The FEHBlog likes the company’s name.
The American Medical Association wants the Food and Drug Administration to loosen up on its opioid prescribing rules which conflict with patient care. Perhaps the FEHBlog is oversimplifying this issue, but haven’t we been down this road to perdition before?
Large tech giants are jumping into a growing interoperability solutions market as new federal regulations spur the healthcare industry to open up and share medical records data.
Google Cloud rolled out a new tool called the healthcare data engine, currently in private preview, that helps healthcare and life sciences organizations harmonize data from multiple sources, including medical records, claims, clinical trials and research data.
It gives organizations a holistic view of patient longitudinal records, and enables advanced analytics and AI in a secure and compliant cloud environment, according to Google Cloud executives.
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