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.
An experimental vaccine from Moderna Inc. significantly reduced the risk of a viral respiratory disease among older adults in a large clinical trial, the latest promising sign in drugmakers’ efforts to fight the deadly RSV virus. * * *
Meanwhile, Sanofi SA and AstraZeneca PLC have co-developed an antibody-based drug to be used for the prevention of RSV in infants. They applied for FDA approval of the drug and expect a decision in the third quarter of 2023.
From the FEHB front, Reg Jones, a retired OPM FEHB contracting officer, provides an “insiders look at FEHB” in FedWeek. His first observation is
First, when the FEHB became law some 60 years ago, I think it would have been better if there had only been a single risk pool. In other words, no Self Only, Self Plus One, and Self and Family options. Because there are these distinctions, enrollees have ever since wanted to further carve up the risk pool, creating subcategories, such as employees vs. retirees or retirees with or without Medicare as their primary insurer.
While the FEHBlog fully agrees with Mr. Jones about the value of risk pooling to FEHB, the self only, self plus one, and self and family choices are enrollment choices that affect the premiums paid but not the risk pool. OPM does break out risk pools by plan option, e.g., Standard, Basic, Elevate.
Mr. Jones is concerned about the risk pool splitting occasioned by the creation of the new Postal Service Health Benefits Program. The FEHBlog has stated his belief that OPM could have avoided this outcome by allowing FEHB plans to offer Medicare Part D EGWPs back in 2005. The FEHBlog expects that once FEHB enrollees see the lower premiums in PSHBP, Medicare D EGWPs will be added to FEHB and before the PSHBP and FEHB will become one again.
Mr. Jones also presses concern about access to medically necessary benefits which coincidentally is a topic that STAT News addressed today stemming from the Institute for Clinical and Economic Research’s publication of its “Second Annual Assessment of Barriers to Fair Access Within US Commercial Insurance Prescription Drug Coverage.” Here is a summary of the ICER Assessment’s results:
The assessment found a high level of alignment between coverage policies and fair access criteria across the formularies with the highest number of covered lives of large private payers and the VHA in the United States. Across all relevant payer policies, ICER gave concordance ratings of 70% (59/84) for cost-sharing policies of drugs that ICER found to be reasonably priced, 96% (310/322) for clinical eligibility criteria, 98% (316/322) for step therapy criteria and 100% (322/322) for prescriber restrictions.
In the exploratory transparency analysis for select migraine and ulcerative colitis (UC) drugs aimed at discerning whether prospective plan members can find information about cost-sharing and clinical eligibility, payers were found to provide relatively good transparency into their formularies (16/18 payers met transparency criteria) but only 10/18 payers provided adequate transparency into their clinical coverage policies. In an exploratory analysis for documentation burden which reviewed the number of questions on prior authorization forms, prior authorization policies for UC and migraine drugs had a median number of questions from 25 to 36 and a range of questions from 22 to 71.
One of the most notable results of this effort is the change in coverage policies made by five payers for 11 drugs following receipt of draft results of the assessment. These changes all served to bring coverage into alignment with fair access criteria.
Note bene
ICER will host a public webinar at 12:00 p.m. ET on January 18, 2023 to discuss the key conclusions and policy implications of this assessment. Webinar presenters will include:
Sarah Emond, MPP, Executive Vice President and Chief Operating Officer, ICER
Mary B. Dwight, Senior Vice President and Chief Policy & Advocacy Officer, Cystic Fibrosis Foundation
Meghan Buzby, Executive Director, Coalition for Headache and Migraine Patients (CHAMP)
Fierce Healthcare reports “California has filed suit against a slew of major drugmakers and pharmacy benefit managers, alleging that they acted unlawfully to drive up the cost of insulin.”
The FDA has approved a label update for semaglutide (Rybelsus; Novo Nordisk) that allows the drug to be used in addition to diet and exercise as a first-line option to improve glycemic control in adults with type 2 diabetes.
This update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes. With its initial FDA approval in 2019, semaglutide became the first and only glucagon-like peptide-1 (GLP-1) analog in pill form.
“The removal of the limitation of use is an important step forward for people living with type 2 diabetes and provides the option for Rybelsus to be taken earlier,” said Aaron King, MD, a family medicine and diabetes specialist, in a press release. “By taking Rybelsus first, people with type 2 diabetes, in conjunction with their care teams, are now able to utilize this medicine early in their diabetes treatment journeys.”
On a related note, the Wall Street Journal tells us
Parents and doctors are looking for new strategies to help adolescents with obesity. One controversial approach drawing the interest of some families is intermittent fasting, which limits people to eating for just a part of the day or week.
Intermittent fasting has gained traction among adults who use it to try to manage weight and improve health. Doctors have largely avoided trying it with adolescents out of concern that introducing a fasting period to their schedules might result in nutritional gaps or trigger eating disorders when teens are rapidly growing and developing.
Now, a small number of doctors and researchers are evaluating types of intermittent fasting in adolescents, searching for solutions as rates of obesity and Type 2 diabetes rise. One pediatric endocrinologist in Los Angeles is launching a clinical trial looking at eating within a set time window in adolescents with obesity. Researchers in Australia are completing a separate trial, the results of which they expect to publish later this year.
Healthcare Dive and Fierce Healthcare offer tidbits from the medical technology front. Healthcare IT News considers whether telehealth can be used for preventive care.
From the U.S. healthcare front,
Beckers Hospital Review lists Healthgrades’ Top 50 Hospitals.
Insurance News Net fills us in on AHIP’s foci for 2023. “Access and affordability are the top two concerns of the health insurance industry as we move into a new year.”
You can scan Fierce Healthcare’s Fierce 15 of 2023 honorees here.
Because there is no CDC interpretative summary of Covid stats on a holiday weekend, here is a link to the CDC’s Covid data tracker, which updates on Thursday. The FEHBlog sees more of the same which would be expected when a disease reaches the endemic phase.
In other Omicron news
MedPage Today reports, “An early signal of stroke risk was detected in older adults who received Pfizer-BioNTech’s bivalent COVID-19 vaccine, the FDA and CDC announced in a joint statement late on Friday, yet the agencies found no link in further analyses and are not recommending a change in COVID-19 vaccination practice.” Agency experts will discuss this data “an already-scheduled January 26 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee.”
Because the FEHBlog is in that Pfizer cohort, he will keep an eye on this meeting. Attending the meeting is Dr. Paul Offit who explains in Medscape his expert opinion that the bivalent booster’s administration should be limited to older and immunocompromised people. It’s an interesting read for a concerned layperson.
WebMD tells us, “The evidence is piling up that physical activity can lower the risk of getting very sick from COVID. The CDC, based on a systematic review of the evidence, has reported that “physical activity is associated with a decrease in COVID-19 hospitalizations and deaths, while inactivity increases that risk.” Other research has linked regular physical activity with a lower risk of infection, hospitalization, and death from COVID. The latest such study from Kaiser Permanente suggests that exercise in almost any amount [e.g., a 10-minute weekly walk] can cut the risk of severe or fatal COVID even among high-risk patients like those with hypertension or cardiovascular disease.
Here’s the CDC’s Fluview ,which is updated for today. “Seasonal influenza activity continues but is declining in most areas.” Good news.
In OPM News
The Chair and Ranking Member of the Senate Committee that oversees OPM who requested this week’s report GAO report on family member eligibility are not happy with its conclusions.
Federal News Network reports on OPM’s long-term efforts to advance diversity, equity, inclusion and accessibility for the federal workforce.
In other agency news
Politico discusses efforts to help the CDC reform itself.
STAT News reports, “The Democrats leading the Federal Trade Commission are hoping to expand the agency’s authority to crack down on unfair business practices — and the shift could have major implications for its ongoing scrutiny of pharmacy benefit managers.”
HR Dive notes that the EEOC’s “draft Strategic Enforcement Plan (SEP) for 2023-2027 appeared in the Federal Register and stakeholders may comment through Feb. 9.”
Govexec reports, “The federal government is expecting to run up against its borrowing limit as soon as June, Treasury Department Secretary Janet Yellen told Congress on Friday, kicking off a legislative fight that could result in significant disruptions to government operations and the U.S. economy.”
In U.S. healthcare business news, Healthcare Dive informs us
Healthcare giant UnitedHealth Group beat analyst expectations for the fourth quarter of 2022 with revenue of $82.8 billion, up more than 12% year over year, according to results released premarket Friday.
Industry experts have expressed concern about potential recessionary pressures and upset care utilization patterns headed into 2023. But UnitedHealth’s earnings, which are considered a bellwether for the health insurance sector’s performance, may prove to be a positive sign for payers.
Govexec explains how federal employees can calculate their 2023 pay raises.
The Federal Times discusses how the Secure 2.0 Act, part of the Consolidated Appropriations Act 2023, affects federal employee retirement programs.
Healthcare Dive identifies key trends for payers and providers in 2023.
This year’s outlook for a large chunk of the healthcare sector remains negative as inflation and pricier labor create difficult operating conditions for nonprofit providers, Moody’s Investor Service said.
As a result, health systems and hospitals are likely to clash with insurers over desired rate increases to offset higher expenses and providers will look to increase their revenue as much as possible by bargaining for higher rates.
Becker’s Hospital CFO Report fills us in on the highlights of a Fitch Ratings webinar on healthcare
Five things to know:
There will continue to be “extremely contentious” negotiations between healthcare providers and payers, Mr. Holloran said. An “above average” exiting of contracts and networks is expected.
There will be far more labor strikes in 2023 with “very contentious” labor negotiations, Mr. Holloran said. Unions will be quick to move as healthcare systems seek to recruit and retain “on steroids.”
Regional differences will continue to emerge. The fast-growing Southern states of Florida, Texas and Georgia will see significant capital expenditure, for example, while regions with declining populations and others will seek to tighten such expenses.
There will be increased merger and acquisition activity even as the Biden administration takes a harder look at potential anti-competitive behavior. “We know everyone is talking to everyone else” about ways in which they can partner, Mr. Pascaris said. “It’s a very interesting time for M&A as increased levels of stress will likely include greater levels of M&A.”
Healthcare systems cannot spend their way out of financial difficulties because the cost of labor will remain very high. The 75/75 conundrum where most systems’ revenues are fixed at 75 percent and most have a similar 75 percent fixed expense in terms of salaries and supplies is an “unstainable” model, Mr. Holloran said.
From the public health front,
The Secretary of Health and Human Services extended the Omicron public health emergency for another 90 days today.
STAT News explores “What’s standing in the way of wastewater data becoming a more mainstream public health tool.”
Moderate-to-severe hearing loss was linked with a higher prevalence of dementia, a cross-sectional study of Medicare beneficiaries showed.
Among 2,413 older adults in the National Health and Aging Trends Study (NHATS), dementia prevalence among people with moderate-to-severe hearing loss was higher than it was among people with normal hearing (prevalence ratio 1.61, 95% CI 1.09-2.38), reported Nicholas Reed, AuD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues.
But among people with moderate-to-severe hearing loss in the study, hearing aid use was associated with a lower prevalence of dementia compared with no hearing aid use (prevalence ratio 0.68, 95% CI 0.47-1.00), they wrote in a JAMA research letter.
Given the FEHB’s demographics, FEHB plans should take a look at improving health aid coverage for 2024.
From the U.S. healthcare business front
Fierce Healthcare reports on today’s events at the J.P. Morgan Healthcare conference.
The following Fierce Healthcare report from the conference caught the FEHBlog’s eye today
Fertility benefits are becoming a major lever in the ongoing talent wars, and that’s good news for Progyny.
The eight-year-old company, which provides family building and fertility benefits for employees at large firms, launched with five clients and 110,000 covered lives. Today, Progyny has more than 370 clients with 5.4 million covered lives.
“In the past year given the current macroeconomic environment, inflationary economy an a potential looming recession, despite all that, for Progyny and its members, it’s proven to be a resilient space. People aren’t foregoing and or deferring family building, in light of all those things, and companies aren’t deferring their decisions,” Pete Anevski, Progyny’s CEO, told Fierce Healthcare on the conference sidelines.
From the telehealth front, McKinsey and Company explain how healthcare organizations can tackle the following problem:
Federal procurement contracts, including FEHB contracts, include a clause requiring contractors to support government efforts to combat human trafficking. During the human trafficking awareness month, the Government Accountability Office reports
Tens of millions of people are victims of human trafficking each year, according to one international organization’s estimate. Human trafficking victims are often held in slave-like conditions and forced to work in the commercial sex trade or other types of servitude. The U.S. government has also found forced labor overseas in various industries producing goods imported into the U.S., such as agricultural and seafood industries.
Several U.S. government entities work with international entities to combat human trafficking. Today, for National Human Trafficking Awareness Day (January 11), our blog post looks at our work reviewing these efforts and our snapshot highlighting areas where continued attention is needed.
From the FEHB front, Federal News Network provides an update on the GAO report on FEHB that was mentioned in yesterday’s post.
The Office of Personnel Management, the agency that runs the health insurance program for federal employees and retirees, does not have a clear way to identify and remove FEHB enrollees’ family members who are erroneously part of the program, according to the Government Accountability Office.
“The longer OPM delays its efforts to establish a monitoring mechanism to identify and remove ineligible members from FEHB, the more ineligible members and related improper payments in the program may continue to accrue, costing the program millions, or up to approximately one billion dollars per year, according to OPM’s own estimate,” GAO said in a Jan. 9 report.
OPM said it has received the final report and is planning to flesh out a larger response soon.
OPM’s Healthcare and Insurance Office “will be evaluating potential action items, including timelines, and will provide a comprehensive response to GAO within 180 days upon evaluation of the recommendations,” OPM spokesperson Viet Tran told Federal News Network.
From the public health front,
January is Cervical Cancer Awareness Month, and Patient Engagement HIT tells us
Nearly one in 10 women have never had a common cervical cancer screening, like a Pap test, with issues such as limited health literacy and poor access to care getting in the way, according to a Harris Poll conducted on behalf of BD (Becton, Dickinson and Company).
These trends are more common in racial minorities, with Black and Hispanic women being more likely to say they have never had a Pap test. Compared to the 6% of White women who said they’ve never had a Pap test, 12% of Hispanic women and 13% of Black women said the same. * * *
receipt of Pap tests is extremely low, the survey of 872 women ages 18 to 64. Overall, 71 percent of respondents have delayed getting a Pap test, with 15 percent saying their last OB/GYN check-up was three years ago.
Although not explicitly explored in the survey, it’s key to note that timeline aligns with the outbreak of the COVID-19 pandemic when access to primary and preventive care stalled. * * *
The good news is, around three-quarters of all respondents, regardless of race, said they have resolved to get back on track with their primary and preventive care, including Pap tests and HPV screenings, in the new year.
But doing so will require some leg work from the healthcare industry, which should note some patient health literacy and convenient care access snags getting in the way.
Even though nearly every respondent said they are knowledgeable about women’s health (91 percent), a whopping 81 percent admitted they don’t know how often they should get a Pap test and 51 percent said they were unaware of how often they should get an HPV test.
The survey also found consumer support for an at-home screening test. Kaiser Permanente and MD Anderson Center offer their views on at-home screening, and MD Anderson reminds us
The best protection for both men and women against HPV and related cancers[, i.e. cervical cancer,] is the HPV vaccine. All males and females ages 9-26 should get the HPV vaccine. It is most effective when given at ages 11-12. Unvaccinated men and women ages 27-45 should also talk to their doctor about the benefits of the vaccine.
Adhering to healthy eating patterns was associated with lower risk of total and cause-specific mortality, a prospective cohort study with up to 36 years of follow-up showed.
Among 75,230 women from the Nurses’ Health Study and 44,085 men from the Health Professionals Follow-up Study, those who scored in the highest quintile for healthy eating patterns recommended by the Dietary Guidelines for Americans (DGAs) had a 14% to 20% lower risk of total mortality versus those in the lowest quintile, reported Frank Hu, MD, PhD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Internal Medicine opens in a new tab or window.
The pooled multivariable-adjusted hazard ratios of total mortality with four healthy eating patterns were (P<0.001 for trend for all):
Healthy Eating Index 2015 (HEI-2015): HR 0.81 (95% CI 0.79-0.84)
Alternate Mediterranean Diet (AMED): HR 0.82 (95% CI 0.79-0.84)
Healthful Plant-Based Diet Index (HPDI): HR 0.86 (95% CI 0.83-0.89)
Alternate Healthy Eating Index (AHEI): HR 0.80 (95% CI 0.77-0.82)
This lower risk was consistent across all racial and ethnic groups.
NIH’s NIAAA Director provides tips for a successful dry January. Good luck to all those who made this resolution because
Taking a break from alcohol for an entire month provides one with an opportunity to assess their patterns of alcohol consumption and how it affects them physically and mentally. It gives a person a chance to cultivate alternatives for relaxing, socializing, and coping with stress. As a result, many people experience benefits such as improved sleep and waking without the fatigue, malaise, and upset stomach of a hangover. Some also find that without the extra calories due to alcohol they lose weight. Participants in Dry January also describe positive effects on their relationships. And an added bonus is saving money.
Becker’s Hospital Review provides some geographic details on the current winter’s Covid surge.
The National Institutes of Health announced “The antiviral treatment Paxlovid reduced the risk of hospitalization or death from SARS-CoV-2 Omicron variants in older adults by 44%. Wider use of Paxlovid may help temper a winter surge of COVID-19, as some other treatments are no longer effective.”
Politico reports on progress being made to end the Covid public health emergency later this year.
From the Food and Drug Administration front,
STAT News interviews the FDA Administrator Robert Califf on the Congressional investigative report concerning the Aduhelm fiasco.
The FDA announced that “In 2022, the Center for Drug Evaluation and Research approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in our annual New Drug Therapy Approvals report. We also approved drugs in new settings, such as for new uses and patient populations.”
From the Rx coverage front, Drug Channels delves into major prescription benefit manager formulary exclusions lists for 2023.
From the medical research front, the National Institutes of Health announced, “Researchers developed a blood test that could detect Alzheimer’s disease-promoting compounds in the blood long before symptoms emerged. The findings may lead to early diagnostic tests for Alzheimer’s and other neurodegenerative diseases.”
From the U.S. healthcare business front
Fierce Healthcare’s lead article on the ongoing JP Morgan healthcare conference concerns CVS’s Heath’s foray into primary care.
Healthcare Dive adds, “CVS Health is exploring an acquisition of value-based primary care chain Oak Street Health, according to a Monday Bloomberg report. The two are in ongoing talks and could reach a deal within weeks that values Oak Street at more than $10 billion including debt, according to Bloomberg, which cited sources familiar with the matter a deal.”
Healthcare Dive informs us that “Teladoc Health shared an early look at its financial results at JPMorgan’s healthcare conference on Monday, indicating between $633 million and $640 million in revenue for the fourth quarter, a little higher than consensus estimates from analysts. The virtual care giant projected total 2022 revenue between $2.4 billion and $2.41 billion, according to its regulatory filing. Teladoc’s direct-to-consumer mental health unit, BetterHelp, is expected to contribute roughly $1 billion of that topline.”
STAT News reports, “Rising labor costs have been the main financial concern for hospitals over the past year, but those costs have peaked and are now a lot lower, according to hospital system executives who presented during the J.P. Morgan Healthcare Conference.”
From the post-Dobbs front, STAT News tells us about telehealth provider reactions to the Justice Department’s announcement last week permitting abortion drugs to be sold by mail and the FDA’s opportunity for pharmacies to sell those drugs.
From the Supreme Court front, STAT News relates
The U.S. Supreme Court rejected a bid by Pfizer to use a copay-assistance program to help Medicare beneficiaries pay for an expensive heart drug. The company argued the program would not violate kickback laws, a controversial issue that forced numerous drugmakers to pay large fines. Last July, an appeals court panel upheld a lower court ruling that such programs would violate federal law, but Pfizer filed a petition to the Supreme Court that contended such interpretations are “staggeringly overbroad.” Pfizer maintained there was no “corrupt intent” in offering assistance and that Medicare beneficiaries would be denied needed medicines they would otherwise not be able to afford.
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 the Centers for Disease Control’s weekly interpretative summary of its Covid statistics:
New Cases — “As of January 4, 2023, the current 7-day average of weekly new cases (67,243) increased 16.2% compared with the previous 7-day average (57,847). A total of 101,094,670 COVID-19 cases have been reported in the United States as of January 4, 2023. * * *
The most prevalent Omicron lineages this week are BQ.1.1, projected to be 34.4% (95% PI 26.7- 43%); XBB.1.5, projected to be 27.6% (95% PI 14.0-46.5); and BQ.1, projected to be 21.4% (95% PI 16.1-27.7%). XBB, BA.5, BN.1, BF.7, and BA.2.75 are all projected to be between 1% and 5% of circulating viruses.”
New Hospitalizations — “The current 7-day daily average for December 28, 2022–January 3, 2023, was 6,519. This is a 16.1% increase from the prior 7-day average (5,613) from December 21–27, 2022.”
New Deaths — “The current 7-day average of new deaths (390) increased 8.3% compared with the previous 7-day average (360). As of January 4, 2023, a total of 1,091,184 COVID-19 deaths have been reported in the United States.”
Vaccinations — “As of January 4, 2023, 665.1 million vaccine doses have been administered in the United States. Overall, about 229.3 million people, or 69.1% of the total U.S. population, have completed a primary series. More than 48.2 million people, or 15.4% of the U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
Though Covid hospitalizations appear to be on the rise nationwide, experts don’t project this Omicron subvariant alone to cause a spike — forecasts from early data suggest they’ll remain fairly steady, Céline Gounder, an infectious disease specialist and senior fellow at the Kaiser Family Foundation, said. * * *
The prediction matches the data from Singapore, where a related subvariant recently became dominant but didn’t result in a spike in hospitalizations and deaths — though that country’s vaccination rate is higher than that of the U.S.
But some individuals — particularly people who are older or pregnant or have weakened immune systems — are at heightened risk from the virus, regardless of larger population trends.
“I’m a bit concerned with it just because it’s coupled with the extremely low booster rates of those over 65,” Katelyn Jetelina, epidemiologist and professor at the University of Texas Health Science Center, said. “Our most vulnerable aren’t as protected.”
The FEHBlog was encouraged to read this American Hospital Association post about a National Institutes for Health / HHS trial:
The Department of Health and Human Services will launch this month a COVID-19 Home Test to Treat telehealth pilot program in Berks County, Pa. Program organizers will work this year with public health departments to expand the program to 100,000 people in vulnerable communities. Telehealth services provider eMed will implement the program, and UMass Chan Medical School will analyze the impact on participating communities.
“At-home testing for COVID-19 is now widely available in the United States, as are antiviral treatments, and this program combines easy home access to both,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering, which will launch the program with HHS’ Administration for Strategic Preparedness and Response.
“What is clearer now, compared to even a year ago, is that we can really blunt the worst of [Omicron] by doing the things that we know work,” Dr. Ashish Jha, the White House coronavirus response coordinator, told NPR in an interview.
That includes getting vaccinated and boosted, especially if you’re older. Most deaths from COVID-19 are occurring in people age 65 or older.
Other precautions include avoiding crowded, poorly ventilated parties, restaurants, bars and other places; testing before gathering; and, yes, putting that mask back on in risky situations. And if you do get sick, check with your doctor about getting treatment quickly.
“It is a time not to let your guard down,” warns Dr. Tina Tan, an infectious disease specialist at Northwestern University.
The good news is the worst appears to be over from the RSV surge that has been making life miserable for many children and their parents. RSV cases have been falling steadily since the end of November, according to the Centers for Disease Control and Prevention.
At the same time, the flu — which also came roaring back this fall after mostly disappearing for the previous two years — looks like it’s finally receding in most places, according to the latest data out Friday from the CDC.
From Capitol Hill, Roll Call reports that Rep. Kevin McCarthy (R CA) has been elected House of Representatives speaker. The 118th Congress, therefore, is in session.
The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease.
The [intravenously administered] drug, called Leqembi [scientific name lecanemab], was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.
Leqembi will cost $26,500 per year for a person of average weight, Eisai said. The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it. Unless Medicare changes the way it pays for drugs like Leqembi, Eisai expects a relatively slow rollout. * * *
Eisai restricted the study of Leqembi to people with mild cognitive impairment or early stage Alzheimer’s that also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The FDA-approved label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% currently living with an Alzheimer’s diagnosis.
The label also mandates that patients undergo three additional brain scans during the first 14 weeks of treatment as a precautionary step to monitor for potentially serious brain swelling or bleeding episodes. * * *
Technically, the FDA granted accelerated approval to Leqembi, a faster path to the market based on preliminary evidence that the drug eliminates toxic amyloid. It’s the same controversial, regulatory shortcut that the FDA used to approve Aduhelm. But unlike Biogen, Eisai within days is expected to submit the cognition data from its positive, confirmatory study to the FDA, which will then consider the drug for full, or final, approval.
BioPharma Dive tells us, “The Food and Drug Administration is set to decide by April 13, 2023, whether to approve Alvotech’s biosimilar to AbbVie’s top-selling drug Humira, pending a facility inspection the company said Thursday it is trying to schedule early next year.” This keeps the drug on track to be on the market when the Humira patents are lifted on July 1, 2023.
According to a press release issued on January 5, 2023:
Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.
Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people. * * *
Synergie Medication Collective will go to market in January of 2023.
For only the second time since launching nearly two years ago, the AMR Action Fund has announced an investment in a fledgling biotech company as it tries to underwrite efforts to develop badly needed medicines for combating antibiotic resistance.
In its latest move, the fund is providing $7.5 million to BioVersys, which is developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitalized patients. The drug, which is about to enter Phase 2 testing, is targeting hospital-acquired pneumonia, pneumonia associated with ventilators, and blood stream infections that originate from pneumonia.
From the health plan design front, EBRI released a study on cost-sharing trends for medical services from 2013-2020.
VillageMD, which is majority owned by Walgreens Boots Alliance, completed its acquisition of Summit Health-CityMD Jan. 3, adding more than 2,800 providers to its ranks.
News of the deal’s completion comes roughly two months after it was announced. On Nov. 7, VillageMD said it entered a definitive agreement to acquire Summit Health-CityMD for $8.9 billion with investments from Walgreens Boots Alliance and Evernorth, the health services portfolio of Cigna.
VillageMD, established in 2013, operates standalone Village Medical practices, full-size Village Medical practices alongside Walgreens pharmacies, and primary care in the home and virtually.
The combination of Summit Health-CityMD and VillageMD creates one of the largest independent provider groups in the country, according to the companies’ news release. With the buy, VillageMD more than doubles its locations from more than 250 to more than 680 in 26 markets and grows its ranks by more than 2,800 providers. VillageMD declined to share the precise number of providers it now employs, but did say it employs more than 20,000 people.
The addition also strengthens VillageMD’s footprint in five states. Summit Health and CityMD have locations in New York, New Jersey, Connecticut, Pennsylvania and Central Oregon.
Fierce Healthcare discusses the Federal Trade Commission’s proposed rule banning post-employment non-compete clauses in employment agreements on healthcare.
Noncompete agreements have become so ubiquitous that a proposed rule published by the Federal Trade Commission (FTC) yesterday [January 5] will affect almost all industries, experts say.
Healthcare will be no exception, Carrie Amezcua, an attorney with the law firm Buchanan Ingersoll & Rooney, told Fierce Healthcare. She said healthcare industry executives should keep a close eye on the debate about the rule.
The public has 60 days to submit comments before the FTC can make it final.
“It could still change—it could still be challenged actually—because it goes too far from what the FTC has the authority to do,” said Amezcua, who usually represents employers in disputes over noncompete agreements.
Backlash to the rule has already begun. In a statement, the U.S. Chamber of Commerce called the regulation “blatantly unlawful.” * * *
Amezcua added: “Insurers are not exempt from the FTC Act. They would be subject to this rule in its final form. And right now, it is written as a complete ban on noncompete agreements, post-employment. You could still have a noncompete during your employment. But you can’t have the provision that says you can’t work for another company for two years after you leave.”
In closing, FedSmith updates us on federal retirement statistics for those interested.
From Capitol Hill, the Wall Street Journal reports
Kevin McCarthy and his allies launched a new round of talks late Wednesday with a small but stubborn band of conservative holdouts who have blocked his bid for House speaker, as Republicans sought a path forward following a second day of votes without a winner.
Mr. McCarthy didn’t reach the majority in of three votes on Wednesday, deepening doubts about whether he would ever be able to bring enough Republicans to his side and fueling talk of alternatives.
Twenty GOP lawmakers remained opposed, along with all Democrats, blocking the California Republican from getting the necessary majority of the full House. After the sixth vote, the House adjourned and reconvened at 8 p.m. [at which point the House voted 216 to 214 to call it a day and convene at noon on Thursday.]
A flurry of meetings were taking place by early evening with Republicans shuttling between offices. In one major concession, a McCarthy-aligned super PAC, the Congressional Leadership Fund, agreed to stop picking candidates in primaries where the seat is expected to stay in Republican hands.
From the Omicron and siblings front, we have a man bites dog story.
First Nature informs us that “COVID drug Paxlovid was hailed as a game-changer. What happened? Insufficient investment and fears about rebound and side effects are driving dowthe n use of a lifesaving antiviral.” The FEHBlog, who has had four Covid vaccinations, points his finger at the government for promoting vaccinations, which, while helpful for older and immunocompromised folks don’t prevent the illness yet, over Paxlovid, a treatment for virtually everyone.
A new antiviral pill for Covid was found to be as effective as Paxlovid at curbing mild to moderate illness among people at high risk of severe disease in a Phase 3 trial in China.
The results, published Wednesday in The New England Journal of Medicine, suggest that the treatment had fewer side effects than Paxlovid, the go-to antiviral for high-risk patients. Around 67% of people who took the experimental pill, called VV116, reported side effects, compared to to 77% who took Paxlovid.
The new pill was also less likely than Paxlovid to cause unexpected side effects due to reactions with other medications, such as those for insomnia, seizures or high blood pressure.
“You have a medication that looks to be just as good as Paxlovid, but less cumbersome,” said Dr. Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins Medicine in Baltimore.
VV116 is similar to the antiviral remdesivir, which the Food and Drug Administration has approved as an IV infusion. But the team behind the new drug — pharma companies Junshi Biosciences and Vigonvita Life Science — tweaked the formula so that the body can absorb it in pill form, said Dr. Peter Gulick, an associate professor of medicine at Michigan State University. Gilead Sciences, which developed remdesivir, is testing a similar oral version of its drug.
From the Rx coverage front —
STAT News reports “Walgreens plans to seek certification to begin providing abortion pills under new Food and Drug Administration rules that allow the drugs to be distributed by retail pharmacies, the company told STAT on Wednesday.” P.S. FEHB plans can only cover abortion drugs when abortion is necessary to save the life of the pregnant woman, or if the pregnancy arises from incest or rape.
For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.
The factors behind declining drug prices will remain in the coming years—and become even stronger due to forthcoming changes in Medicare and Medicaid. Employers, health plans, and PBMs will determine whether patients will share in this ongoing deflation.
Insulin costs vary based on insurance coverage type and coverage types that lead to high healthcare spending can force patients to ration their insulin supplies, a report from the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) uncovered.
Healthcare spending for individuals who have diabetes—including diabetes treatment, comorbidities, preventive care, and more—amounted to approximately $446 billion total in 2019. Drug costs, including spending on insulin, were responsible for nearly a third of that amount (32 percent).
Insulin users, who tend to be in a more severe stage of the disease, contributed 46 percent of the healthcare spending total among patients with diabetes. Average healthcare spending across the population of insulin users is 4.3 times higher than for non-institutionalized Americans. * * *
Medicare beneficiaries had the highest total out-of-pocket healthcare spending for the drug when compared to privately insured and uninsured individuals’ costs. Medicaid out-of-pocket healthcare spending on insulin was low and hard to estimate.
Most insulin users have either Medicare coverage (52 percent) or private insurance (33 percent). The remainder was covered by Medicaid or reported being uninsured.
It’s worth adding that Medicare covers insulin under Medicare Part B, not Part D.
From the U.S healthcare front —
The American Hospital Association relates “U.S. hospitals and health systems continued to experience negative operating margins through November 2022, Kaufman Hall reported today. Median operating margins were down 44% so far this year compared with 2021, as high labor and other costs continued to outpace revenues, according to data from over 900 hospitals.”
BioPharma Dive reports “Moderna said Wednesday it will pay $85 million to buy OriCiro Genomics, describing the company’s tools as “best in class” for the synthesis of plasmid DNA.”
From the telehealth front
The Agency for Healthcare Quality and Research released a report on the use of telehealth during the Covid era.
The Society for Human Resource Management reminds us “Employers [sponsoring health plans including FEHB plans] will have the option to provide pre-deductible coverage of telehealth services for people with high-deductible health plans for another two years [through December 31, 2024].
From the No Surprises Act front, Health Dive digs into the recent CMS report on first-year experience with the NSA’s arbitration process.
The report from regulators provides insight on how the arbitration system is faring so far. It helps paint a picture of how frequently the portal is being used and the types of services payers and providers found themselves fighting over. It also shows what providers have initiated the most disputes.
The vast majority of disputes originated from emergency room visits.
About 81% of disputes (excluding air ambulance services) started in the emergency room.
The entities that initiated the most [arbitrations] were mainly physician staffing and revenue cycle management firms, including TeamHealth and Envision Healthcare, private equity backed practices that staff emergency rooms around the country. As a business strategy, the two work out of network, which can lead to surprise billing if the hospital remains in network, according to a prior study from Yale researchers.
The 10 groups that submitted the most disputes accounted for 75% of all the disputes involving out-of-network emergency services and non-emergency items.
From the public health front, “the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH), which shows how people living in America reported about their experience with mental health conditions, substance use, and pursuit of treatment in 2021. The 2021 NSDUH national report includes selected estimates by race, ethnicity, and age group. It is the most comprehensive report on substance use and mental health indicators that SAMHSA has released to date.” This HHS announcement summarizes the survey’s findings.
From the OPM front, Federal News Network reports on OPM’s plans to refresh its website, which in the FEHBlog’s opinion can’t come soon enough. “Aside from overhauling its main website, OPM is also planning to make more updates to its retirement services. It’s the area of the agency that encompasses the most legacy — or outdated — technology in all of OPM, [an OPM spokesperson] said. Bravo.
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.
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Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
