The Hill reflects on the history of Groundhog Day. By the way, “on Thursday, Punxsutawney Phil predicted six more weeks of winter.”
Each year on the first Friday in February, [February 3, 2023], the National Heart, Lung, and Blood Institute, The Heart Truth® and others around the country celebrate National Wear Red Day® to bring greater attention to heart disease as a leading cause of death for Americans and steps people can take to protect their heart. Promote Wear Red Day in your community with resources such as printable stickers, posters, and social media graphics, including customizable ones.
From Capitol Hill, Roll Call tells us that “Senate committees will be able to get to work next week after the Senate adopted resolutions constituting their membership for the 118th Congress before departing Thursday afternoon.”
STAT News interviews the Chair and Ranking Member of the Senate’s Health, Education, Labor and Pensions Committee, Senators Bernie Sanders and Bill Cassidy respectively.
Both senators cited addressing the national shortage of nurses as high on the bipartisan to-do list. The chairman also said he thinks expanding community health centers and improving dental coverage could get both parties’ buy-ins, while Cassidy pointed to mental health care legislation and probing the rollout of efforts to eliminate patients’ surprise medical bills.
Unsurprisingly, however, Sanders’ top priority is slashing drug costs — and he’s banking on voter polling to push GOP members, or at least put them in an uncomfortable spot with constituents.
From the Medicare front, Health Payer Intelligence provides an overview of reactions to yesterday’s CMS 2024 Medicare Advantage Advance Notice with changes for Medicare Advantage plans and Medicare Part D.
The Kaiser Family Foundation offers a detailed study of prior authorization requests for Medicare Advantage enrollees in 2021. Adverse decisions on prior authorization requests. The number of requests varied by Medicare Advantage carrier. Six percent of all prior authorizations were partially or entirely denied. 11% of prior authorization requests were appealed, and 82% of appeals were decided in the Medicare Advantage enrollee’s favor. What an interesting batch of percentages.
From the U.S. healthcare business front, BioPharma Dive reports
Sales of Eli Lilly’s new diabetes drug Mounjaro grew strongly in the final quarter of 2022, the company reported Thursday, challenging the market position of competing medicines from rival Novo Nordisk.
Fourth quarter sales totaled $279 million, bringing the total for 2022 to $483 million following the drug’s June launch. The fast sales put Mounjaro, approved to improve blood sugar control in people with Type 2 diabetes, on pace to quickly reach blockbuster status. Studies have shown the drug to have a powerful weight-loss effect as well, supporting Lilly’s current efforts to expand the drug’s approval to include obesity treatment. * * *
On an earnings call Thursday, Lilly executives said the company is having trouble keeping Mounjaro production high enough to match patient demand. More manufacturing capacity is being added, with a site in North Carolina expected to start production sometime later this year, CFO Anat Ashkenazi said on the call.
Russ Roberts spoke with Dr. Vinay Prasad on this week’s Econtalk episode. The topic is “Pharmaceuticals, the FDA, and the Death of Duty.” During the episode, Dr. Prasad identified Dr. Bernard Fisher as one of his heroes. Dr. Fisher passed away in 2019 at age 101. I had never heard of Dr. Fisher, but his story should be shared.
Healthcare consumers appear to be increasingly comfortable switching providers when their current one isn’t meeting their needs, according to a report from Accenture. About 30% of patients selected a new provider in 2021 — up from 26% in 2017, the report found. A quarter switched providers in 2021 because they were unhappy with their care — up from 18% in 2017. Switching providers is especially true among younger generations, like Gen Zers and millennials, who were six times more likely to switch providers than older people, according to the report.
From the miscellany department —
Health Affairs Forefront delves into the data produced to date by the government’s payer transparency rules.
Fierce Healthcare tells us about a recent expansion of CVS Health’s virtual primary care service.
Benefit consultant Tammy Flanagan writing in Govexec, follows the path of a federal employee’s retirement application.
President Biden and House Speaker Kevin McCarthy began face-to-face debt-ceiling discussions [today], with the latter expressing cautious optimism that they can come to a deal to avoid the first-ever default of the country’s debt.
Senate Minority Leader Mitch McConnell (R-Ky.) has pulled Sen. Rick Scott (R-Fla.), who tried to oust him as the Senate’s top Republican in a bruising leadership race, off the powerful Commerce Committee.
McConnell also removed Sen. Mike Lee (R-Utah), who supported Scott’s bid to replace McConnell as leader, from the Commerce panel, which has broad jurisdiction over a swath of federal agencies.
Speaking of federal agencies, Healthcare Dive informs us
The Federal Trade Commission is penalizing GoodRx for sharing users’ sensitive health information with advertisers, in the agency’s first enforcement action under the Health Breach Notification Rule.
The FTC filed an order with the Department of Justice on Wednesday that would prohibit GoodRx from sharing user health data with third parties for advertising purposes, among other guardrails. GoodRx has also agreed to pay a $1.5 million fine, though the company admitted no wrongdoing. The order needs to be approved by a federal court in order to go into effect.
Also, the President issued a Statement of Administration Policy objecting to Republican legislative efforts to end the national and public health emergencies for the Covid pandemic without further delay. The Statement explains why the White House has opted to end those emergencies on May 11.
CMS announced that there will be a special enrollment period on the Affordable Care Act marketplace for individuals who lose their Medicaid coverage due to the public health emergency unwinding.
“Today, CMS is announcing a Marketplace Special Enrollment Period (SEP) for qualified individuals and their families who lose Medicaid or CHIP coverage due to the end of the continuous enrollment condition, also known as ‘unwinding,’” the FAQ sheet explained.
The special enrollment period will stretch from March 31, 2023 to July 31, 2024. In order to be eligible for the special enrollment period, individuals must be eligible for Affordable Care Act marketplace coverage and must have lost their Medicaid, Children’s Health Insurance Program (CHIP), or Basic Health Program (BHP) coverage.
From the Omicron and siblings front, Beckers Hospital Review points out
The FDA altered its emergency use authorizations on Paxlovid and Lagevrio, two COVID-19 treatments, on Feb. 1 to revoke a requirement for a positive COVID-19 test before a provider can prescribe them.
“The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19,” the FDA said in an emailed statement. But, “in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their healthcare provider as having COVID-19” even if they test negative.
From the public health front —
The Commonwealth Fund issued a report titled “U.S. Health Care from a Global Perspective, 2022: Accelerating Spending, Worsening Outcomes.” The FEHBlog’s perception is quite sunny compared to this gloomy report.
The National Institutes of Health is celebrating American Heart Month.
The National Cancer Institute offers an interesting newsletter on its work.
The Wall Street considers dangerous fungi that are infecting people as a result of climate change.
From the No Surprises Act front, according to Healthcare Dive, the Texas Medical Association has filed a fourth lawsuit concerning the law. This time the TMA objects to the regulators’ entirely appropriate decision to increase the arbitration administration fee from $100 split between the parties to $700 similarly split. The arbitration or IDRE process was being bombarded with arbitration requests from providers. The fee increase will focus more provider attention on the open negotiation period that precedes the arbitration. “The suit also challenges the laws’ restrictions on batching claims, which allows arbitration processes only on claims with the same service code, requiring providers to go through a separate payment dispute process for each claim related to an individual’s care episode, according to the suit.” Quelle domage.
From the U.S. healthcare business front
Beckers Payer Issues reports, “Humana posted revenues of nearly $93 billion in 2022 and a net loss of $15 million in the most recent quarter, according to its year-end earnings report published Feb. 1. The company also appointed Steward Health Care President Sanjay Shetty, MD, to lead its healthcare services business, CenterWell, which includes pharmacy dispensing, provider and home health services. Dr. Shetty will start April 1. In addition, the company promoted its Medicare president, George Renaudin, to president of Medicare and Medicaid, effective immediately.”
Beckers Hospital Review examines whether Amazon can disrupt the pharmacy industry.
From the Medicare front, the Centers for Medicare and Medicaid Services released
the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2024 Advance Notice through Friday, March 3, 2023. CMS will carefully consider timely comments received before publishing the final Rate Announcement by April 3, 2023.
The Biden administration will send its budget for the next fiscal year up to Capitol Hill on March 9, according to a memo from top White House aides.
That’s about a month later than the statutory deadline, which is the first Monday in February, though that target is often missed and there’s no penalty for doing so.
National Econonic Council Director Brian Deese and Office of Management and Budget Director Shalanda Young laid out the timing in a memo to “interested parties” that also discussed agenda topics for Wednesday’s scheduled meeting between President Joe Biden and Speaker Kevin McCarthy, R-Calif.
The memo, first reported by ABC News, said Biden will ask McCarthy to “commit to the bedrock principle that the United States will never default on its financial obligations,” a reference to the upcoming fight over the statutory debt ceiling. Treasury Secretary Janet L. Yellen has warned that the U.S. could be in danger of missed payments by early June if Congress doesn’t act to raise or suspend the $31.4 trillion debt limit.
The memo also says Biden will urge McCarthy and House Republicans to release their own fiscal 2024 budget blueprint that spells out the spending cuts they want to attach to any debt limit deal and how their budget will balance if they plan to extend expiring tax cuts.
Senator Tina Smith (D MN) and a bipartisan group of colleagues sent several large health insurers a letter requesting answers to questions about ghost networks. It turns out the ghost networks are online provider directories with errors. The FEHBlog thinks that the Senators should be pressuring the No Surprises Act regulators to implement the provider directory accuracy provision in that law.
From the Omicron and siblings front, the New York Times explores why Paxlovid, a reliable treatment, is underprescribed by doctors.
Doctors prescribed it in about 45 percent of recorded Covid cases nationwide during the first two weeks of January, according to White House data. In some states, Paxlovid is given in less than 25 or even 20 percent of recorded cases. (Those are likely overestimates because cases are underreported.)
Why is Paxlovid still relatively untapped? Part of the answer lies in a lack of public awareness. Some Covid patients also may decide that they don’t need Paxlovid because they are already vaccinated, have had Covid before or are younger. (My colleagues explained why even mild cases often still warrant a dose of Paxlovid.) * * *
Experts have increasingly pointed to another explanation for Paxlovid’s underuse: Doctors still resist prescribing it. Today’s newsletter will focus on that cause.
Some doctors have concerns that are rooted in real issues with Paxlovid and inform their reluctance to prescribe it. But experts are unconvinced that those fears are enough to avoid prescribing Paxlovid altogether, especially to older and higher-risk patients.
“What I’m doing for a living is weighing the benefits and the risks for everything,” said Dr. Robert Wachter, the chair of the medicine department at the University of California, San Francisco. In deciding whether to prescribe Paxlovid, he said, the benefits significantly outweigh the risks.
Six years after regulators approved Amjevita, a biosimilar to the nation’s most lucrative drug, Humira, Amgen’s drug jumped on the U.S. market Jan. 31 with two list prices.
The biosimilar to AbbVie’s most profitable drug will either cost 5 percent or 55 percent less than Humira’s price, according to Amgen. Humira costs $6,922 for a month’s supply, meaning Amjevita’s price — depending on the buyer — will be $6,576 or $3,115. The higher price is designed to entice pharmacy benefit managers, and the lower one is for payers, according to Bloomberg.
As Humira’s 20-year, $114 billion, 247-patent-strong monopoly ends with the first biosimilar, more copycat versions are set to premiere in the next few months.
STAT News dives deeper into the implications of Amgen’s pricing approach.
AHIP responded yesterday to CMS’s final Medicare Advantage plan audit rule.
“Our view remains unchanged: This rule is unlawful and fatally flawed, and it should have been withdrawn instead of finalized. The rule will hurt seniors, reduce health equity, and discriminate against those who need care the most. Further, the rule would raise prices for seniors and taxpayers, reduce benefits for those who choose MA, and yield fewer plan options in the future.
“We encourage CMS to work with us, continuing our shared public-private partnership for the health and financial stability of the American people. Together, we can identify solutions that are fair, are legally sound, and ensure uninterrupted access to care and benefits for MA enrollees.”
Is the next step the courthouse?
Money Magazine offers a list of hospitals that provide bariatric surgery with Leapfrog safety grades.
From the mental healthcare front, Fierce Healthcare tells us
Parents can now be added alongside providers, health insurers and employers to the list of stakeholders with growing concerns about mental health, according to a study by the Pew Research Center.
The study found that 40% of parents call the fact that their children might be struggling with anxiety and depression their No. 1 concern—something they’re extremely or very worried about—followed by 35% of parents who put the fear that their children are being bullied into that category.
From the tidbits department —
The NY Times lists ten nutrition myths that experts wish would be forgotten.
The NIH Directors blog explains why a “New 3D Atlas of Colorectal Cancer Promises Improved Diagnosis, Treatment.”
The National Association of Plan Advisors points out that “Despite a rebound in out-of-pocket health care spending in 2021, health savings account (HSA) balances increased on average over the course of the year, the Employee Benefit Research Institute (EBRI) recently found. Its analysis of HSA balances, contributions, and distributions also found, “patients sought health care services more frequently in 2021—and spent more out of pocket, as well—than they did in 2020, yet the average end-of-year balance was higher than the average beginning-of-year balance.”
Congress will be in session this week for Committee and floor business.
The No Surprises Act’s RxDC reporting deadline is this Tuesday, January 31, for the 2020 and 2021 reporting years. RxBenefits informs us, “Optum, Caremark, and Express Scripts have finalized their submission files and confirmed that all submissions would be completed before January 31, 2023, if not already filed.”
From the public health front —
NPR Shots explains why your kids are germ vectors, albeit adorable ones.
Fortune Wells reports that “Researchers at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London have developed a blood-based test that can detect Alzheimer’s disease up to 3.5 years before a clinical diagnosis.” This test would help people decide whether they need the new Biogen/Eisai drug assuming Medicare approves it.
Fortune Well also points out how employers can reduce workplace stress.
Kaiser Family Foundation provides us with recent upbeat data on long Covid.
Two top senators have reintroduced legislation that would introduce several reforms to pharmacy benefit managers, including prohibiting clawbacks of pharmacy payments.
Sens. Maria Cantwell, D-Washington, and Chuck Grassley, R-Iowa, reintroduced on late Thursday the Pharmacy Benefit Manager Transparency Act and the Prescription Pricing for the People Act. The move shows the lawmakers are not backing down from going after PBMs in the latest Congress.
Congress is a piker compared to OPM, which has been successfully “going after PBM’s” for over a decade.
All of the Omicron metrics are trending down. “As of January 25, 2023, there are 118 (3.7%) counties, districts, or territories with a high COVID-19 Community Level, 855 (26.6%) with a medium Community Level, and 2,242 (69.6%) with a low Community Level.”
Overall, about 268.9 million people or 81% of the total U.S. population, have had a single dose of Covid vaccine, “About 229.6 million people, or 69.2% of the total U.S. population, have completed a primary series.* More than 41.6 million people, or 19.9% of the eligible U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
The CDC’s Weekly FluView again headlines, “Seasonal influenza activity continues to decline across the country.”
Turning to our longest-standing public health emergency, the U.S. Drug Enforcement Administration informs us
Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.
While scientists have not conducted much research on its effects, anecdotal reports suggest that users experience symptoms similar to those encountered via opioids, namely depression of the central nervous system. More specifically, effects associated with xylazine use include dry mouth, drowsiness, hypertension, respiratory depression, and even coma. Users can develop a physical dependence to xylazine, reporting withdrawal symptoms more serious than from heroin or methadone, such as sharp chest pains and seizures.
Note: Since xylazine is not an opioid, naloxone does not reverse its effects.
The Food and Drug Administration proposed changing from “time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
Bloomberg relates, “Americans aren’t exercising enough. Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday.”
From the Rx coverage front, STAT News reports, “After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.” Time will tell.
From the electronic health records front —
MedCity News identifies five ways to inject intelligence into the prior authorization process.
“’The good news is that many of the access and usability problems stem from the technical specifications provided by the Centers for Medicare & Medicaid Services [CMS],’ the report said. ‘Most can be fixed through administrative action and better enforcement, with minimum cost burdens for the plans and issuers.’”
From the U.S. healthcare business front —
MedCity News informs us that health insurers continue to receive a C grade from Leapfrog.
Fierce Healthcare tells us, “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening. The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”
Healthcare Dive reports, “In a lawsuit filed Thursday, Cigna alleged that Amy Bricker’s appointment to chief product officer of CVS’s consumer segment places the payer’s trade secrets at risk and violates her noncompete agreement.”
The Wall Street Journal reports that CVS and Walmart pharmacies will follow Walgreen’s lead by reducing their retail pharmacy hours. “CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists.” Walmart will be closing its pharmacy at 7 pm rather than 9 pm.
House Republicans are mulling an attempt to buy time for further negotiations on federal spending and deficits by passing one or more short-term suspensions of the statutory debt ceiling this summer, including potentially lining up the deadline with the end of the fiscal year Sept. 30.
No decisions on a cutoff date have been made, and it’s not yet clear when the Treasury Department will run out of cash to meet all U.S. financial obligations. But most analysts agree Congress will need to act at some point between early June and September, and lawmakers likely won’t want to leave the matter unaddressed before the August recess.
and
The Senate is taking its time getting to work for 2023.
Back in Washington after a two-and-a-half week recess, the chamber adjourned Thursday afternoon without adopting an organizing resolution, meaning committees will remain in their holdover state until at least next week.
Senate Majority Leader Charles E. Schumer announced the Democratic committee assignments for the new Congress, with Michigan Democratic Sen. Gary Peters, the Democratic Senatorial Campaign Committee chair, earning a coveted seat on the Appropriations Committee.
From the Omicron and sibligns front, The American Hospital Association tells us
A Food and Drug Administration Vaccines and Related Biological Products Advisory Committee [VRBAC] unanimously voted today to recommend harmonizing the composition of all primary series and booster doses administered in the U.S. For example, the composition of all vaccines administered going forward might be bivalent.
STAT News offers a complete report on today’s meeting. For example, STAT News explains
The FDA is also asking the members of VRBPAC their thoughts on its proposal that Americans get an annual Covid shot, in the way they get a flu shot, one that is reconstituted regularly to try to target the strains in circulation at the time. In documents the FDA made public before the meeting, it proposed choosing new vaccine strains in June for a vaccine campaign that would begin in September.
Covid is clearly here to stay, so this may sound sensible. But there are concerns some of this is still based on a leap of faith rather than a data-led process. For example, the idea that everyone might need an annual Covid booster will not earn a unanimous “yea” vote out of this expert panel.
The VRBAC recommendation is subject to FDA and CDC approval.
The FDA on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to be rendered ineffective by the mutations the virus has picked up. Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems.
In other FDA news
The FDA announced, “Given the growing cannabidiol (CBD) products market, the FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”
Fierce BioTech informs us “More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.”
From the obesity treatment front —
HealthDay discusses findings made by “Utah researchers who followed patients for up to 40 years after they had one of four types of weight-loss (bariatric) surgery.”
Weight-loss surgery can literally be a lifesaver, cutting death rates significantly during the course of a decades-long study
Death from all causes was 16% lower, while it was 29% lower for heart disease, 43% lower for cancer and 72% lower for diabetes
But there were some troubling findings: These patients were 83% more likely to die of liver disease and 2.4 times more likely to die by suicide, mostly seen in younger patients
STAT News provides a two minute long video explaining how the new obesity drugs work.
STAT News also describes an unusual alliance that has banded together to lobby Congress to repeal a provision in the Medicare Modernization Act of 2023 that prohibits Part D from covering obesity drugs. “Recent scientific advances, media coverage, and advocacy have helped raise the profile of the issue on Capitol Hill, said Jeanne Blankenship, the vice president for policy initiatives and advocacy at the Academy of Nutrition and Dietetics. ‘It’s becoming front and center. I think we can’t turn our backs on it any longer,’ Blankenship said.”
From the Rx coverage front, Beckers Hospital Review introduces us to the three PBMs that have partnered with the Mark Cuban Pharmacy.
From the HIPAA / electronic health records front —
MedPage Today reports, “Unique Patient Identifier Funding Once Again Barred by Congress— Biden administration working on better patient matching instead.” The FEHBlog will never understand Congress’s intransigence here.
Healthcare Dive tell us “Interoperability continues to improve among U.S. hospitals, but there’s still a ways to go, according to new government data. More than six in 10 hospitals electronically shared health information and integrated it into their electronic health records in 2021, up 51% since 2017, the Office of the National Coordinator released in a Thursday data brief. The availability and usage of electronic data received from outside sources at the point of care has also increased over the last four years, reaching 62% and 71% respectively in 2021.”
Mercer Consulting “projects the 2024 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will rise significantly from 2023 levels.”
Benefits Consultant Tammy Flanagan, writing in Govexec, discusses the categories of family members who are eligible and ineligible for FEHB coverage.
HR Dive identifies five trends that will share HR this year.
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.
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