From Capitol Hill, Federal News Network discusses two bipartisan bills affecting federal hiring practices and federal retirement annuities that are under active consideration.
From the Postal Service Health Benefits Program front, it appears to the FEHBlog that OPM has been adding to its PSHBP FAQs without giving the public an online heads-up when an addition occurs, e.g., last updated xx/xx/xxxx.
From the public health front
The U.S. Preventive Services Task Force released for public comment a draft inconclusive (“I”) recommendation “that the current evidence is insufficient to assess the balance of benefits and harms of screening for lipid disorders in children and adolescents age 20 years or younger.” This proposed action would confirm the ongoing vitality of a 2016 recommendation. The public comment deadline is February 21.
The National Institutes of Health discusses its approach to “shouldering the burden of rare diseases.” NIH notes “While individually each disease is rare, collectively rare diseases are common: More than 10,000 rare diseases affect nearly 400 million people worldwide. In the United States, the prevalence of rare diseases (over 30 million people) rivals or exceeds that of common diseases such as diabetes (37.3 million people), Alzheimer’s disease (6.5 million people), and heart failure (6.2 million people).”
STAT News discusses legal developments in the FDA’s practices of approving “orphan drugs” to treat rare diseases. “In an unexpected move, the Food and Drug Administration will continue to apply exclusive marketing rights for so-called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine.”
Fierce Healthcare reports “The White House, federal agencies and lawmakers today marked the elimination of the DATA-Waiver Program, better known as the X-Waiver requirement, with calls for providers to begin incorporating opioid use disorder treatment buprenorphine in everyday patient care. The X-Waiver requirement only permitted doctors who had received specialized training and federal permissions to prescribe the opioid partial agonist, which is a controlled substance.”
From the Rx coverage front —
Segal Consulting offers plan sponsors its analysis of weight loss drugs to treat diabetes and obesity.
Fierce Healthcare tells us about Amazon’s new RxPass program and adds that Optum Rx “launched a new tool that aims to make it easier to compare the direct-to-consumer price for generic drugs to the price with insurance.” RxPass is not available to Medicare or Medicaid beneficiaries and “is not currently available to send medications to California, Louisiana, Maryland, Minnesota, New Hampshire, Pennsylvania, Texas, and Washington.”
Congress is back in our Nation’s capitol this week. The House is considering legislative business but is not holding hearings. The Senate is holding hearings and floor votes.
A deeply divided Congress will return to work this week, pushing ahead with partisan priorities in the Senate and House while also gearing up for a fight over how lawmakers will address raising the debt ceiling before a potential default later this year.
The Senate, narrowly controlled by Democrats as it opens its new session, is expected to focus primarily on confirming President Biden’s executive and judicial nominees in the coming weeks. Immigration is emerging as one area of possible compromise after a group led by Sen. Kyrsten Sinema (I., Ariz.) and Sen. John Cornyn (R., Texas) co-hosted a bipartisan delegation of senators to the Texas and Arizona borders during the January recess.
House Republicans, back from a weeklong break, will dive into investigations focused on Mr. Biden, his family and his administration, starting with a hearing on border security early next month that will feature testimony from border patrol agents.
The American Medical Association outlines its wish list for improvements in the Medicare payment system.
From the Omicron and siblings front
The American Medical Association tells us about what doctors wish their patients knew about Covid reinfections. Oddly the article does not mention the availability of Paxlovid treatment.
Medscape informs folks over age 65 about what they need to know about taking Paxlovid.
The message from infectious disease experts and geriatricians is clear: Seek treatment with antiviral therapy, which remains effective against new covid variants.
The therapy of first choice, experts said, is Paxlovid, an antiviral treatment for people with mild to moderate covid at high risk of becoming seriously ill from the virus. All adults 65 and up fall in that category. If people can’t tolerate the medication — potential complications with other drugs need to be carefully evaluated by a medical provider — two alternatives are available.
The upshot is the older Americans and immunocompromised American should create a treatment plan in consultation with their primary care providers before Omicron shows up at the door.
NPR offers us an update on the state of rapid Covid testing
As the COVID-19 pandemic enters its fourth year, a negative result on a little plastic at-home test feels a bit less comforting than it once did.
Still, you dutifully swab your nostrils before dinner parties, wait 15 minutes for the all-clear and then text the host “negative!” before leaving your KN95 mask at home.
It feels like the right thing to do, right?
The virus has mutated and then mutated again, with the tests offering at least some sense of control as the Greek letters pile up. But some experts caution against putting too much faith in a negative result.
A so-called “super strain” of gonorrhea—against which many types of antibiotics are less effective or not effective at all—has been identified in the U.S. for the first time, health officials said Thursday, [January 19] raising further concern that a post-antibiotic era is approaching.
The case, identified in Massachusetts, was successfully treated with ceftriaxone, an antibiotic recommended to treat the disease, state health officials said in a news release. A higher-than-recommended dose wasn’t required to clear the infection, a state public health spokesperson tells Fortune, though the U.S. Centers for Disease Control and Prevention recently doubled the recommended dose.
The newly identified strain showed reduced susceptibility to three types of antibiotics and resistance to an additional three, including penicillin. It marks the first U.S. case in which all recommended drugs were less effective or completely ineffective, the state health department said in a Thursday bulletin to clinicians.
The case serves as “an important reminder that strains of gonorrhea in the U.S. are becoming less responsive to a limited arsenal of antibiotics,” health officials said in a statement.
The U.S. is experiencing “a rising epidemic of sexually transmitted disease,” Dr. Georges Benjamin, executive director of the American Public Health Association, tells Fortune, with some experts referring to the issue as a “hidden epidemic.”
No bueno.
From the mental health care front
NPR Shots discusses when patients can opt for chat therapy from a free chatbot., e.g., Wysa .
Bloomberg Prognosis calls our attention to a dementia quiz.
Most cases of dementia aren’t linked to lifestyle. But in as many as four in 10 cases, external risk factors — everything from educational level, brain injury and hearing loss to excessive drinking and smoking — may play a role, a report by The Lancet Commission found in 2020. This week, Alzheimer’s Research UK, a charity that funds science and education about dementia, launched an online quiz that draws on that study to help people zero in on what they could change in their own lives to help improve the health of their brains.
“Much of this is about helping people understand that they can be empowered to affect their risk of Alzheimer’s disease,” Paul Matthews, director of the UK Dementia Research Institute at Imperial College London, said in a briefing hosted by the Science Media Centre. “We need to give people the knowledge to make these choices.”
For what it’s worth, The FEHBlog took the quiz which is offered by the British Alzheimers Disease Association. The FEHBlog found it worthwhile.
From our Nation’s capital, the Wall Street Journal reports
The Treasury Department began taking special measures to keep paying the government’s bills on Thursday as the U.S. bumped up against its borrowing limit, kicking off a potentially lengthy and difficult debate in Congress over raising the debt ceiling.
With the federal government constrained by the roughly $31.4 trillion debt limit, the Treasury Department began deploying so-called extraordinary measures. Those accounting maneuvers, which include suspending investments for certain government accounts, will allow the Treasury to keep paying obligations to bondholders, Social Security recipients and others until at least early June, the department said last week.
That gives lawmakers on Capitol Hill and the Biden administration roughly five months to pass legislation raising or suspending the debt limit. In a letter to congressional leaders on Thursday, Treasury Secretary Janet Yellen said there was “considerable uncertainty” about how long extraordinary measures can last.
“I respectfully urge Congress to act promptly to protect the full faith and credit of the United States,” Ms. Yellen said.
From the OPM front, OPM issued “Guidance on Increasing Opportunities for Federal Internships, Fellowships, and Other Early Career Programs” and, according to MeriTalk, held a “virtual job fair organized today by Tech to Gov in partnership with the Office of Personnel Management (OPM) is targeting a wide range of Federal government technology and related positions as part of the government’s goal to restock its tech ranks amid a slowdown in hiring by the private sector.” As daily reports of layoffs at tech companies have been appearing in the news, OPM’s timing for the job fair is opportune.
Today, benefits expert Tammy Flanagan completed her three Govexec columns on federal employee and annuitant benefit changes for this year.
From the Omicron and siblings front,
MedPage Today tells us, “Real-World Data Support Bivalent COVID-19 Boosters in Older Adults — Study from Israel showa ed high level of protection in people 65 and up.” MedPage Today’s medical editor in chief Dr. Jeremy Faust comments
[T]he Israeli data really helps us understand that for 65-years-olds and over, getting a bivalent booster is going to protect against hospitalization. We don’t know how long that’s going to last, and that’s the key. If it turns out that the bivalent booster ends up having a much longer tail of effectiveness than the monovalent did, that’ll be good news, but it’ll depend upon what variants are circulating and other factors, but we are watching that.
The European Union’s drug regulator has not identified any safety signals in the region related to U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech’s updated COVID-19 shot, the agency said on Wednesday.
On Friday, the U.S. Food and Drug Administration and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data.
The FDA’s Vaccines and Related Biological Products Advisory Committee will consider this safety issue at a meeting on January 26.
Also from the FDA front, the Wall Street Journal informs us
The setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration eventually decides to approve it. * * *
Lilly had been hoping for an accelerated FDA approval of donanemab early this year. Now, a midyear filing of a standard drug application means an FDA decision could be pushed back into 2024, based on typical FDA timelines of taking six to 10 months to review new drug applications.
In an online survey last November of 1,200 U.S. adults previously vaccinated against COVID-19, 62% had not yet received a bivalent booster dose, most often because they did not know they were eligible or the booster was available, or believed they were immune against infection, the Centers for Disease Control and Prevention reported today. After viewing information about eligibility and availability, over two-thirds of them planned to get a bivalent booster and 29% reported receiving the booster in a follow-up survey in December. To help increase bivalent booster coverage, the report recommends using evidence-based strategies to inform patients about booster recommendations and waning immunity.
From the No Surprises Act front, Healthcare Dive points out
Many Americans are still exposed to the potential for a surprise medical bill from an out-of-network ambulance ride, a research report published in Health Affairs found. About 28% of emergency trips in a ground ambulance resulted in a potential surprise bill, according to the research that analyzed commercial insurance claims.
About 85% of emergency transports were deemed out of network between 2014 and 2017, researchers found. But two-thirds of those trips are paid in full by insurers, eliminating the risk of a surprise bill.
The report shows the difference in pricing by ground ambulance ownership and how that affects patients’ financial exposure. * * *
Given the high prevalence for a potential surprise bill, protections like those afforded to consumers in the No Surprises Act may be necessary for both emergency and non-emergency transports, the authors said.
The FEHBlog is puzzled by the author’s extension of NSA protection to non-emergency transports, which the consumer should have time to manage. Congress should not overload the NSA system.
From the telehealth front, Healthcare Dive reports
Private insurers paid roughly the same for telehealth and in-person visits during the early days of the COVID-19 pandemic as virtual care surged, according to new research from the Kaiser Family Foundation.
Though it’s unclear how payment rates might have changed over the past two years, the findings call into question the argument that telehealth is saving the healthcare system money, researchers said.
However, researchers said that perks of telehealth included expanded access and convenience — cost benefits of which were not factored into the study.
UnitedHealthcare is rolling out a new virtual behavioral health coaching program backed by Optum.
The offering is available as of Jan. 1 for 5 million fully insured members, and self-insured employers can purchase the program as an employer benefit. Through the program, adults with symptoms of mild depression, stress and anxiety can access support for their mental health needs through virtual modules as well as one-on-one video conferences, phone calls or messaging with coaches. * * *
Members who use virtual coaching can connect with a dedicated behavioral health coach for a 30-minute weekly audio or video call and can chat with their coach using in-app messaging between sessions.
The program lasts eight weeks, and each member will complete an assessment at the onset to identify their individual needs. Coaches use cognitive behavioral therapy techniques to assist the patient in crafting an action plan that is personalized to them.
The largest employer of physicians in the United States is not HCA, the VA, or Kaiser Permanente — it’s UnitedHealth Group’s Optum.
With at least 60,000 employed or aligned physicians across 2,000 locations in 2023, Optum has cemented itself at the forefront of the quickly changing healthcare delivery landscape. For comparison, Bloomberg reported in 2021 that Ascension employs or is affiliated with 49,000 physicians, HCA has 47,000 and Kaiser has 24,000.
Given that the Affordable Care Act limits health insurers, but not healthcare providers, profits, UHC made a smart move, in the FEHBlog’s opinion.
In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty that will cover the cost for any hospital if a specific medicine fails to work, marking only the second time a major pharmaceutical company has taken such a step.
In this instance, Sanofi designed a warranty program for its Cablivi medication, which is used to treat aTTP, a rare, life-threatening autoimmune blood disorder that is considered a medical emergency. The cost will be refunded for up to six doses for patients who fail to initially respond or up to 12 doses for patients whose condition worsens.
The move comes after Pfizer began offering warranties for two of its medicines, the first of which debuted in August 2021. At the time, the Pfizer effort was the first of its kind in the pharmaceutical industry. Unlike the Sanofi warranty, however, the Pfizer programs offer refunds to patients — not hospitals — if the medicines fail to work sufficiently.
Although the approaches vary, both companies are signaling their interest in differentiating themselves from competitors, not just responding to complaints about the rising cost of medicines, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.
How would these warranties redound to the benefit of third party payers?
From the miscellany front
Cigna offers a paper about “Digging into the Unique Drivers and Healthy Behaviors That Impact Vitality.”
The U.S. Preventive Services Task Force released a chart of its most impactful 2022 recommendations.
Fierce Healthcare reports, “The number of providers serving as [Medicare] accountable care organizations increased slightly this year thanks to the start of a new advanced model and a slew of reforms meant to reverse a slide in participation.”
Mercer Consulting digs into “must do” valued based care strategies.
The MIT Technology Review considers the prospect of gene editing for the masses using CRISPR 3.0
STAT News discusses the “hot mess” of legal issues associated with the FDA’s recent decision to make abortion drugs available at pharmacies.
From Capitol Hill, Roll Call reports that Senator Joe Manchin (D W Va) “has talked “briefly” with Speaker Kevin McCarthy about a bill he co-sponsored with Sen. Mitt Romney, R-Utah, in the last Congress to create a “rescue committee” for every endangered government trust fund, like the Social Security, Medicare and highway trust funds.
The Concord Coalition, a nonpartisan research group, named Romney and Manchin as its 2022 Economic Patriot Awards honorees because of their work on the legislation.
The bill, which they have yet to reintroduce in the 118th Congress, would allow the top four congressional leaders to appoint three members each for every rescue committee and give lawmakers on the panels 180 days to come up with policy solutions for solvency.
Any legislation the rescue committees produce would be subject to expedited procedures for floor consideration; it couldn’t be amended but would require 60 Senate votes to advance to final passage.
Moderna Inc. plans to expand its mRNA vaccine production capacity, saying shots targeting different pathogens can be made in the same facility, Chief Executive Stephane Bancel said.
“This is what gives me hope, not only for [coronavirus] variants, but also for other vaccines,” Mr. Bancel said on a panel at the World Economic Forum in Davos, Switzerland. * * *
The company was able to roll out booster shots adapted to the Omicron variant in 60 days, according to Mr. Bancel.
That would be helpful assuming the FDA and CDC are on board.
The Centers for Disease Control and Prevention yesterday released a dashboard tracking hospitalization rates for laboratory-confirmed COVID-19, flu and Respiratory Syncytial Virus by age group, sex, race/ethnicity, state and season based on data from select counties in 13 states, which the agency will update weekly. CDC also released another dashboard tracking weekly emergency department visits for COVID-19, flu and RSV by age group and percent of all ED visits based on data from the National Syndromic Surveillance Program.
In other vaccine news, the National Institutes of Health announced today
An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America. Based on the DSMB’s recommendation, the study will be discontinued. Participants are being notified of the findings, and further analyses of the study data are planned.
Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, sponsored the Mosaico study with funding support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial was conducted by the NIAID-funded HIV Vaccine Clinical Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The U.S. Army Medical Research and Development Command provided additional study support.
Keep trying.
Also from the public health front
Gallup informs us “The percentage of Americans reporting they or a family member postponed medical treatment in 2022 due to cost rose 12 points in one year, to 38%, the highest in Gallup’s 22-year trend.” The story concludes
With high inflation creating moderate to severe hardship for a majority of Americans in the second half of 2022, their reports of delaying medical care in general due to cost — as well as delaying care for a serious condition — rose sharply to new highs. Young adults, those in lower-income households and women were especially likely to say they or a family member had put off medical care.
No bueno.
From the U.S. healthcare business front, McKinsey & Co. tells us
From the Medicare front, Fierce Healthcare relates
Enrollment in Medicare Advantage (MA) has topped 30 million, according to new data from the Centers for Medicare & Medicaid Services.
This represents coverage across 776 contracts, according to the data, as of Jan. 1 payments, which reflect enrollments accepted through Dec. 2. Enrollment in standalone prescription drug plans was also about 22.7 million, bringing total enrollment across all types of private Medicare plans to nearly 50.3 million.
This represents growth of about 2 million from 2022. An analysis from the Kaiser Family Foundation found that enrollment in MA plans was about 28 million last year.
Following today’s national holiday, both Houses of Congress are on State / District work breaks until next week.
Today’s blog is focused on preventive care topics.
HR Advisor discusses the Dos and Don’ts of Employee Wellness Programs. The FEHBlog dearly wishes that OPM would create a connection between the federal agency employee wellness and assistance programs and its FEHB plans. Doing so would help employees better navigate federal employee benefits.
NPR Shots offers encouraging news on a new initiative:
The 988 Suicide and Crisis Lifeline received over 1.7 million calls, texts and chats in its first five months. That’s nearly half a million more than the old 10-digit Suicide Prevention Lifeline fielded during the same period the year before. Launched in mid-July last year, the 988 number is modeled on the 911 system and is designed to be a memorable and quick number that connects people who are suicidal or in any other mental health crisis to a trained mental health professional. Not only are more people reaching out, more are being connected to help. Federal data shows that the Lifeline responded to 154,585 more contacts – including calls, text messages and chats – in November 2022 than the same month the year before. The number of abandoned calls fell from 18% in November 2021 to 12% last November.
The American Medical Association tells us what doctors want their patients to know about preventing cervical cancer. The upshot is HPV vaccines and HPV and pap smear testing. The article discusses topics such as the timing of testing and may be worth sharing with plan members
Speaking of vaccinations, Precision Vaccination informs us
Women can give their babies protection against whooping cough (pertussis) before their little ones are even born, says the U.S. Centers for Disease Control and Prevention (CDC).
The U.S. Food and Drug Administration (FDA) recently approved a second, safe vaccine that prevents whooping cough from achieving that goal.
When these (Tdap) vaccines are given during pregnancy, it increases antibodies in the mother, which are transferred to the developing fetus.
On January 10, 2023, the FDA announced the Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed) is now approved for immunization during the third trimester of pregnancy.
As well as an active booster immunization against tetanus, diphtheria, and pertussis for use in persons 10 through 64 years of age.
Kaiser Family News explores when pregnant women with severe nausea should seek medical care. The FEHBlog expects this is why NCQA and OPM encourage a visit to the OB-GYN in the first trimester.
A Govexec contributor offers a simple exercise regimen for office workers.
From Capitol Hill, the Wall Street Journal reports
House Republicans passed a rules package Monday dictating the terms of the next session of Congress, the first test for House Speaker Kevin McCarthy (R., Calif.) in keeping his raucous conference united.
The rules package, a required step before moving on to legislation, is typically passed on the first day of a new Congress. But it was delayed by the GOP fight to elect a new speaker. Mr. McCarthy prevailed early Saturday morning on the 15th ballot over four days, after making a series of concessions to holdouts.
The package passed 220 to 213, with all Democrats and one Republican, Rep. Tony Gonzales of Texas, opposing the measure. It is customary for the minority party to oppose the legislation.
The package, which includes standard rules on decorum, also restores what is known as the motion to vacate the chair, a procedure that would allow one Republican member to ask for a vote to remove the speaker. It also outlines several Republican priorities around spending, such as banning consideration of any bill that has the net effect of increasing mandatory spending.
House Republican leaders chose Rep. Jason Smith (R., Mo.) to run the House Ways and Means Committee, giving him a prime perch to shape the party’s approach to tax, trade and health policy.
As chairman, Mr. Smith will lead a committee with broad power over economic policy and healthcare that is poised to receive an influx of new Republican members.
From the other side of Capitol Hill, Healthcare Dive informs us
Longtime Congressman Sen. Bernie Sanders, I-Vt., is expected next month to take the helm of the Senate’s Health, Education, Labor and Pensions Committee, bringing the Medicare-for-All proponent center stage in one of the nation’s most broadly influential health policy forums.
The anticipated appointment comes after the current committee chair Sen. Patty Murray, D-Wash., announced that she was stepping down to head the Senate Committee on Appropriations. Sanders has been on the Senate’s Health, Education, Labor and Pensions Committee, or HELP, since 2007, but the chance to lead the committee will give Sanders sway on some of his most prominent healthcare policy positions.
High healthcare costs — including prescription drugs like insulin —nursing education and elder care are issues Sanders anticipates focusing on, calling the national healthcare system dysfunctional, unsustainable and disgraceful in a Jan. 1 video.
From the FEHB front —
OMB’s Office of Information and Regulatory Affairs (OIRA) posted the federal government’s fall 2022 regulatory agenda on January 4. Here are the three FEHB rulemakings:
OPM proposes to modify its FEHB enrollment regulations regarding the effective date of coverage. The regulatory changes would allow, at an employing agency’s discretion, FEHB Coverage to become effective upon a new employee’s start date if their election is received before that date. The regulatory changes would promote the recruitment of new Federal employees and align with the best practices of the private sector. Publication of the proposed rule is scheduled for March 2023.
OPM and the three other No Surprises Act regulators plan to release a proposed rule on the law’s complicated good faith estimate and advance explanation of benefits provisions in August 2023.
As previously noted in the FEHBlog, OPM has passed along its interim final rule to implement the Postal Service Health Benefits Program to OIRA for final regulatory review. The statutory deadline for promulgating the rule is April 6, 2023. OPM clearly will meet that deadline.
Here is the complete list of OPM rule-makings in process or recently completed.
The Government Accountability Office released a report titled “Federal Employees Health Benefits Program: Additional Monitoring Mechanisms and Fraud Risk Assessment Needed to Better Ensure Member Eligibility.” The report summary tells us
More than 8 million federal employees and their families receive health insurance benefits under the Federal Employees Health Benefits program.
In 2021, the Office of Personnel Management began requiring some new program enrollees to verify that their family members are eligible. But OPM doesn’t have a process to identify and remove ineligible family members who are already enrolled in the program. As a result, the program may be spending almost $1 billion per year on payments for ineligible members.
We recommended that OPM take steps to remove ineligible family members and assess fraud risks associated with ineligible program members.
In the middle of the last decade, OPM added an FEHB contract provision requiring carriers to share OPM’s expenses to arrange for a family member eligibility audit, which is a common practice among employers. This struck the FEHBlog as a proven approach to identifying ineligible family members. Why not give it a go?
The Centers for Medicare and Medicaid Services released updated guidance for its Section 111 reporting program, which applies to FEHB carriers and other employer-sponsored health plans.
In contrast to previous recommendations, pediatricians and other pediatric healthcare providers are advised to provide “immediate, intensive obesity treatment to each patient” as soon as they receive a diagnosis, according to new guidance from the American Academy of Pediatrics (AAP).
The guidance, published in Pediatrics, marks the AAP’s first clinical practice guideline outlining evidence-based evaluation and treatment for children and adolescents with overweight (defined as a body mass index [BMI] at or above the 85th percentile and below the 95th percentile) or obesity (defined as a BMI at or above the 95th percentile), though the organization previously published recommendations on prevention and treatment in 2007.
“This is one of the most important messages that differentiates our current clinical practice guidelines from the prior recommendations, and that is to say 15 years of data have taught us that ‘watchful waiting’ only leads to greater increase in child BMI, accumulation of comorbidities, and more challenges in trying to reverse some of this,” author Sarah Armstrong, MD, co-director of the Duke Center for Childhood Obesity Research in Durham, North Carolina, told MedPage Today.
In a number of key action statements, the guideline authors state that pediatricians and other providers should refer children ages 6 years and older — and potentially those ages 2 to 5 years — with overweight or obesity to intensive health behavior and lifestyle treatment.
Additionally, healthcare providers should offer weight-loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment to adolescents ages 12 and older, Armstrong and colleagues noted. They should also offer referrals for evaluation for metabolic and bariatric surgery to adolescents ages 13 and older with severe obesity (BMI ≥35 or 120% of the 95th percentile for age and sex, whichever is lower).
This flu season hit earlier and harder than those of the past couple of years, doctors say. The reason is likely because of the cyclical nature of the flu and the lifting of Covid precautions such as working from home, wearing masks and having smaller social gatherings, says Robert Frenck, a pediatrician in the division of infectious diseases at Cincinnati Children’s hospital in Ohio.
We asked doctors what to expect this year if the influenza virus causes illness in your household.
Doctors are frustrated that patients are getting test results before they can explain them, POLITICO’s Ben Leonard reports.
A recently implemented federal [information blocking] rule requires HHS to ensure that patients receive test results as soon as they become available, but doctors argue that they often need to add context and support to results before patients view them — even as technology has made the results easier to share.
The disagreement, with doctors on one side and HHS and patient advocates on the other, has raised a key question: How should patients get bad news, especially in the rapidly evolving world of telehealth?
Before this rule was in effect, a member of the FEHBlog’s family received an email on a Sunday morning suggesting that she log into the patient portal. She promptly did so and was faced with confusing test results. See Seinfeld. Can’t doctors give patients a choice at the time of portal registration to get the log on email or wait to hear the results from a medical professional in non-emergency circumstances?
Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts.
The timing was not offered, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 shot. The Moderna pricing was first reported by The Wall Street Journal and confirmed by a company spokesperson.
The 41st JP Morgan healthcare conference is being held this week in San Francisco. “Fierce Healthcare will be covering the day’s biggest news as it happens. Check back here for updates, and catch Fierce Biotech’s reporting here and Fierce Pharma’s reporting here.”
The Senate is on a State work break until January 23.
The House of Representatives will be in session this week for floor business. The Wall Street Journal adds
The House will dive into its first week of substantive work with bills to cut Internal Revenue Service funding and investigate economic competition from China, after a leadership election that underscored Republican divides and the fragile position of Speaker Kevin McCarthy (R., Calif.). * * *
On Monday, the House will vote on a set of chamber rules for the 118th Congress that will enshrine some of the pledges regarding legislative procedure Mr. McCarthy made to win over holdouts in his speaker election. The rules package will also make key changes to the operations of the Office of Congressional Ethics, which conducts initial reviews of allegations of impropriety against lawmakers.
“We’ll pass the rules package tomorrow, and we’ll get moving on doing what the American people elected us to do,” said Rep. Jim Jordan (R., Ohio), the incoming Judiciary Committee chairman and a prominent McCarthy ally, in an interview Sunday on Fox News. “In a two-year time span, we have seen a border that is no longer a border. We have seen a military that can’t meet its recruitment goals. We’ve seen terrible energy policy, terrible education policy…We’re going to unite around fixing those problems.”
Democrats said they hoped to find areas of bipartisan agreement. “Clearly we are going to have strong disagreements at times, but we can agree to disagree without being disagreeable,” said House Minority Leader Hakeem Jeffries (D., N.Y.) on NBC on Sunday.
The Journal also provides greater insight into the availability of the new Alzheimer’s disease drug that the FDA approved last week.
A sweeping Medicare rule issued last year [following the Aduhlem fiasco] will keep the newly approved Alzheimer’s disease drug Leqembi out of reach of most U.S. patients for months to come.
The Food and Drug Administration on Friday approved Eisai Co. and Biogen Inc.’s Leqembi, known generically as lecanemab,for the treatment of people with early-stage Alzheimer’s disease, the vast majority of whom are insured by Medicare. However, Medicare won’t pay for the drug unless patients are enrolled in government-sanctioned clinical trials, and no such studies are ongoing or planned.
The Alzheimer’s Association patient-advocacy group asked the Centers for Medicare and Medicaid Services in December to reconsider its policy, a process that could take as long as six to nine months if it chooses to do so.
As many as 85% of patients who could benefit from Leqembi are insured by Medicare, said Ivan Cheung, Eisai’s global Alzheimer’s disease officer. Eisai projects that 100,000 patients could be using the drug by its third year on the market, assuming that Medicare officials lift coverage restrictions, Mr. Cheung said.
From the public health front, Forbes delves into Omicron XBB 1.5. As the FEHBlog noted last Friday new Covid cases and hospitalizations are up because winter has arrived. Forbes reminds us
From Dec. 21 to 27, 2022, 5,613 people were admitted with positive COVID tests, compared to 6,519 from Dec. 28 to Jan. 3. However this is still a far cry, down 69.7%, from the peak seven-day average in mid-January 2022 when 21,525 were admitted with COVID.
Last year’s Omicron alpha phase dwarfs the current surge which the FEHBlog attributes to the fact that Paxlovid did not reach the market until December 22, 2021.
Forbes also offers parents information about signs and symptoms of invasive strep cases currently afflicting children.
NPR Shots reports on the worthy efforts of various physicians to improve the care of miscarrying patients.
“Fewer abortions will mean more pregnancies, and more pregnancies will mean more miscarriages,” said Dr. Sarah Prager, a professor of obstetrics and gynecology at the University of Washington and a co-author of the guidelines on miscarriage management for the American College of Obstetricians and Gynecologists.
Around 15% of known pregnancies end in miscarriage, and the first medical professional many of those patients see will be in an emergency room. Yet, by and large, she says, “emergency medicine physicians aren’t trained in managing miscarriage and don’t see it as something they should own.”
For more than a decade, Prager has been trying to change that through her work with the TEAMM Project, the nonprofit she co-founded on the premise that “many people experience miscarriage before they’re established with an OB-GYN.” Short for Training, Education and Advocacy in Miscarriage Management, TEAMM has conducted in-person workshops for clinicians at more than 100 sites in 19 states on all aspects of miscarriage care — everything from the use of ultrasound to diagnose fetal death to the three treatment options miscarrying patients should be offered when they come in for care.
From the medical trial front, the Wall Street Journal points out a significant issue with cancer treatment trials.
After Mikhail Rubin learned his lethal blood disease had progressed, he decided that he wanted a stem-cell transplant through a clinical trial. But there was an obstacle: his age.
Mr. Rubin, who is now 72, was too old to participate. Many cancer trials cap enrollment at age 65. Even when trials for older people are available, oncologists are reluctant to enroll elderly patients because frailties might make them less resilient against side effects from toxic treatments, according to a 2020 study in an American Cancer Society journal. People over 70 represent a growing share of the cancer-patient population but are vastly underrepresentedin clinical trials, the study said.
“How can we make decisions for people over 70 if people over 70 are not included in the trials that we use to base our decision making?” said Dr. Mina Sedrak, deputy director of the Center for Cancer and Aging at City of Hope, a cancer center near Los Angeles and an author of the paper.
Fair question, Dr. Sendrak.
From the health plan consumer app front, Fierce Healthcare tells us
Elevance Health is making the latest expansion to its Sydney member app with the addition of a new Nutrition Tracker tool.
The tracker uses artificial intelligence to recognize foods in photographs taken by a member’s smartphone camera. It can log individual foods as well as entire meals using this functionality, the insurer, formerly Anthem, said.
Once the information on a meal is logged, it can quickly be added to the member’s health record and then be shared with their provider, with consent, allowing for personalized feedback from their medical team.
Anil Bhatt, global chief information officer at Elevance Health, told Fierce Healthcare that the insurer wants Sydney to be able to offer as much valuable information to the member “at their fingertips” as possible. Elevance Health regularly gathers consumer feedback on features that would most benefit them.
Finally the FEHBlog noticed that NPR Shots is offering useful advice for white collar workers.
After staring at a computer screen for hours at a time, the body often gives us a clue that it is stressed: nagging neck and back pain.
To fix the problem, you might have gotten advice to focus on posture or ergonomics, but exercise research points to another strategy as well – taking short spurts of movement throughout the day to release tension and stress in the body.
“As a society, the assumption is that we have pain because of poor posture and slouching,” says Kieran O’Sullivan, an associate professor of physiotherapy at the University of Limerick’s School of Allied Health in Ireland. “But [the issue] isn’t as neat and tidy as we thought. We have been trying all these fixes [with ergonomics] and it has arguably not fixed the problem. I think it is more about needing breaks from the working day with … movement.”
Here’s how researchers think quick hits of movement – sometimes called exercise “snacks” – may help prevent pain. When the brain senses physical or emotional stress, the body releases hormones that trigger muscles to become guarded and tight. Exercise counters that stress response by increasing blood flow to muscles, tendons and ligaments and sending nutrients to the spine’s joints and discs.
From Capitol Hill, the Wall Street Journal reports
Rep. Kevin McCarthy stepped up negotiations with Republican detractors, offering fresh concessions to win support after a third day of House speaker votes yielded no movement toward a winner in the GOP-controlled chamber.
Mr. McCarthy and some of his detractors appeared to be coalescing around a deal, stepping up the pace of discussions as the House marked its 11th round of votes with no winner, the most since just before the Civil War. While most Republicans backed Mr. McCarthy over three days of tallies, 20 continued to oppose him, and it wasn’t known if enough detractors would potentially change their votes to give Mr. McCarthy the gavel. All Democrats supported their pick, Rep. Hakeem Jeffries of New York.
Shortly after 8 p.m., lawmakers voted 219-213 to adjourn until Friday at noon, with Republicans in favor and Democrats opposed.
Voting is expected to continue into the weekend.
From the Affordable Care Act front, the FEHBlog discovered today that on December 12, 2022, the Department of Health and Human Services announced the maximum 2024 out-of-pocket limits for in-network care offered by FEHB and other group health plans.
[T]he 2024 maximum annual limitation on cost sharing is $9,450 for self-only coverage and $18,900 for other than self-only coverage. This represents an approximately 3.8 percent increase above the 2023 parameters of $9,100 for self-only coverage and $18,200 for other than self-only coverage.
The announcement also covers other ACA topics: the premium adjustment percentage, reduced maximum annual limitation on cost sharing, and required contribution percentage, which apply to marketplace plans.
From the New Year front —
Mercer offers strategic planning guidance for health plan and human resources executives.
STAT News identifies three drug pricing issues to watch this year — 1. Inflation Reduction Act implementation; 2. Medicare’s lecanemab coverage decision, and 3. Insulin cost protections.
Tammy Flanagan writes in Govexec about Federal “Employee Benefit Changes for 2023; How new pay rates, Social Security earnings limits and other factors could affect your retirement planning.”
Bloomberg Prognosis offers a January guide to weight loss.
Healio adds, “More physical activity was associated with a lower risk for type 2 diabetes regardless of age, sex, BMI or sedentary time, according to an analysis published in The Journal of Clinical Endocrinology & Metabolism.”
Teladoc Health announced on Thursday it’s launching a new app allowing users to access its full range of services in one place and under one account.
The app, which includes primary care, mental health and chronic condition management, is meant to integrate all of Teladoc’s assets in one personalized platform, making care navigation and selection easier for consumers,
Teladoc Chief Medical Officer Vidya Raman-Tangella told Healthcare Dive. The app is available to a select number of Teladoc’s existing clients this month. Teladoc plans to make the app available to the full market later this year.
Fierce Healthcare adds “Teladoc’s full suite of services will be available in the Spanish language on the mobile app and the website, marking a critical shift with more than 40 million people in the United States reporting they speak Spanish at home.”
CMS announced adding “a new telehealth indicator on clinician profile pages on Medicare Care Compare and in the Provider Data Catalog (PDC). The new indicator helps beneficiaries and caregivers more easily find clinicians who provide telehealth services.”
Two of the biggest pharmacy chains in the country are planning to seek the certification needed to dispense abortion pills in the states where it is legal, according to spokespeople for the companies.
The decisions by Walgreens and CVS are likely to provide a boost to a new Food and Drug Administration (FDA) policy announced Tuesday that will allow retail pharmacies to dispense mifepristone from a certified prescriber if they meet certain criteria.
Until 2021, mifepristone could only be dispensed in person by a physician. The FDA temporarily lifted that requirement because of the COVID-19 pandemic, and the Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.
A bloc of [twenty] Republican opponents Tuesday kept Kevin McCarthy from becoming speaker on three ballots, and the House adjourned to come back on Wednesday and try again to pick a leader.
McCarthy, R-Calif., had told his colleagues as the day began he would not back down, and his supporters said there would be repeated votes. After three votes, the last of which saw McCarthy lose one of his earlier supporters, a motion from McCarthy ally Tom Cole of Oklahoma to adjourn until noon Wednesday was adopted by voice vote.
The history-making chaos in the House drew most of the attention Tuesday, but longtime senators were making history of their own.
Sen. Patty Murray, D-Wash., was elected as the first woman to serve in the constitutional office of president pro tempore, while Senate Minority Leader Mitch McConnell eclipsed Montana Democratic Sen. Mike Mansfield’s record for length of service as a party floor leader. * * *
And not to be outdone, [Sen. Chuck] Schumer had some history of his own, becoming the longest serving senator from the state of New York.
The nation’s health agencies already have a long to-do list for 2023.
Top officials have promised reforms in the food, drug, and public health departments as frustrations mount over the federal response to Covid-19 and last year’s widespread baby formula shortages. Biden administration appointees are racing to fix pandemic-exposed cracks in the systems for mental health care, addiction treatment, and health coverage, even as millions of people are likely to be kicked out of Medicaid, the federal program serving low-income people with few resources. There’s still no one leading the National Institutes of Health.
And while Congress delivered many of the president’s requests in the end-of-year spending package last month, it also dropped several provisions that would have given federal health regulators more authority.
From the New Years predictions front, STAT News informs us
For almost three years, hospitals and health insurers have been riding the waves of the Covid-19 pandemic. Even though they can better predict what lies ahead in 2023, there remain several big unknowns. STAT’s business reporters will be paying attention to three trends in particular: the end of the public health emergency, how hospital price hikes will affect people’s paychecks, and Medicare Advantage’s explosive growth.
From the pricing transparency front, Kaiser Health News reminds us that
As of Jan. 1, health insurers and employers that offer health plans [including FEHB plans] must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs. * * *
So how will it work?
Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like “repair of knee joint,” or “MRI of abdomen.” They can also enter a hospital’s or physician’s name or the dosage amount of a drug for which they are seeking price information.
Not all drugs or services will be available in the first year of the tools’ rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.
Once the information is entered, the calculators are supposed to produce real-time estimates of a patient’s out-of-pocket cost.
Starting in 2024, the requirement on insurers expands to include all drugs and services.
This requirement was created by the 2020 Transparency in Coverage Rule issued under the 21st Century Cures Act and the 2021 No Surprises Act.
According to the recent report by the OIG investigating instances of incorrect co-surgery and assistant-at-surgery modifier usage, 69 of 100 sampled procedural services did not meet federal requirements.
An additional review of 127 corresponding services found that 49% were noncompliant with federal requirements, as well.
The OIG reviewed a randomly selected sample of 100 services rendered by Part B providers between 2017 and 2019 with certain CPT procedural codes and a Medicare Physician Fee Schedule (MPFS) co-surgery indicator of 1 or 2. The reviewed procedures included spinal fusions, knee replacements, and endovascular repairs, among others.
That’s a big bowl of wrong.
From the pricing reforms front, Fierce Healthcare relates
Physician group practices participating in the Bundled Payments for Care Improvement (BPCI) Initiative garnered cost savings for the top five conditions that require medical intervention but did not save money for the top five surgical procedures.
On the other hand, hospitals participating in the BPCI initiative saved money for both categories, according to a study in JAMA Health Forum.
Researchers at the University of Pennsylvania said their findings underscore the “suitability of hospitals to bundled payment models, specifically highlighting their relative advantage over group practices in achieving cost and potential quality outcomes for medical conditions.”
From the Rx coverage front —
Biopharma Dive offers us a look back at the FDA’s drug approvals in 2022 — “The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.” — and a look forward at ten clinical trials to watch in the first half of 2023 — “Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.”
STAT News has questions stemming from the recent Congressional investigative report on the Aduhelm fiasco.
The New York Times reports “For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication. * * * Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. A spokesman for Walgreens, Fraser Engerman, said: “We are going to review the F.D.A.’s decision.”
The Wall Street Journal adds “Most abortions in the U.S. happen via the pill, according to the Guttmacher Institute. Several organizations that mail abortion pills, sometimes to women in states with abortion bans, have seen shipments increase since the Supreme Court’s latest abortion decision. * * * Also on Tuesday, the Justice Department issued an opinion saying that abortion pills can be sent through the U.S. mail, as long as the sender doesn’t intend them to be used unlawfully. The U.S. Postal Service and the Department of Health and Human Services had asked the Justice Department to clarify an 1873 law, which had been invoked by Mississippi’s attorney general in a lawsuit last year, that prohibits mailing items that can be used to produce abortions.”
From the mental healthcare front, the American Hospital Association places a spotlight on children and adolescent care.
NPR shares its favorite articles with “actionable, evidence-based strategies for cultivating a healthy body and mind.”
Fortune Well identifies “six foods and drinks to choose in the New Year to improve mood, energy, and longevity” and discusses the differences between dry January and damp January.
The American Medical Associations tells us about what doctors wish their patients knew about effective New Years resolutions.
From Capitol Hill, the Wall Street Journal reports
A new era of divided government dawns this week as the 118th Congress begins, with Republicans looking to deploy their power with a fragile majority in the House and Democrats doing the same in the Senate.
The House of Representatives will convene on Tuesday, a date designated by the 20th Amendment of the U.S. Constitution that stipulates Congress should begin each new session at noon on Jan. 3.
The first order of business will be electing a new Speaker. The last time that the election went beyond one ballot was one hundred years ago, but the streak could be broken tomorrow as Roll Call explains.
The Senate whose leadership is not changing will hold a routine opening day tomorrow.
No Congressional Committee hearings will be held this week.
From the Omicron and siblings front, NBC News and Forbes each offer detailed looks at the latest dominant Omicron variant XBB and XBB 1.5. NBC News states
“It’s clear that there’s immune evasive properties of XBB,” said Dr. Isaach Bogoch, an infectious disease physician and epidemiologist at the University of Toronto. “That’s been demonstrated both in laboratory studies and seen clinically in cases and hospitalizations.”
Given the high level of population immunity in the U.S. — either through infection, vaccination or both — Bogoch and others hope that, even if cases start to rise significantly, there won’t be a dramatic spike in hospitalizations or deaths as seen in previous waves.
Antibody studies don’t tell the whole story. Other parts of the immune system can protect against the virus and the Covid vaccines should remain effective at preventing severe illness and death from the virus, evidence suggests.
From the FEHB front, the Postal Service’s Inspector General released a “primer” on the 2022 Postal Reform Act, which requires a new Postal Service Health Benefits Program to be launched in two years.
From the Affordable Care Act marketplace, Health Payer Intelligence informs us
Affordable Care Act (ACA) marketplace enrollment has grown 18 percent from last year, with 11.5 million people signing up for coverage as of December 15, 2022, HHS announced.
“Unprecedented investments lead to unprecedented results. Under President Biden’s leadership, we have strengthened the Affordable Care Act Marketplace with continued record affordability, robust competition, and historic outreach efforts – and today’s enrollment numbers reflect that,” HHS Secretary Xavier Becerra said in the press release. * * *
“Thanks to the Inflation Reduction Act, four out of five customers will be able to find a plan for $10 or less. As we head into the new year, there is no greater gift than the peace of mind that comes with having high-quality, affordable health care. There is still time to sign up until January 15 – visit HealthCare.gov today,” Becerra added.
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