Midweek Update

Congress

Midweek Update

David Ermer–Congress, COVID-19 vaccine, No Surprises Act, U.S. Healthcare–

From Washington D.C., Roll Call tells us

The federal government will run out of cash to pay all its bills sometime between July and September unless the statutory debt limit is lifted, the Congressional Budget Office [CBO] warned Wednesday.

The report by the nonpartisan budget scorekeeper could put pressure on a divided Congress to reach a deal to increase, or at least suspend, the debt limit before adjourning for the annual August recess.

[A] separate CBO report issued Wednesday underscores the challenges for both parties in making the math add up. Deficits over the next decade are now projected to grow by $3.1 trillion, or 20 percent, during the next decade from the agency’s forecast last May. 

STAT News “sat down with AMA President Jack Resneck on the sidelines of the [AMA’s Washington., D.C.] conference to talk about legislative reforms, physician burnout, and where the doctors’ lobby goes from here.” The Q&A made the FEHBlog crack up

What is the AMA stance on implementation of the law to end surprise medical bills for patients?

There’s a lot about the way those [HHS] rules were first written that went way outside of congressional intent. They put major thumbs on the scale of basically moving towards the insurers’ notion of what that value should be.

There’s so many things about those rules that basically would encourage insurers to either just say “Oh, I can pay so much less through this arbitration system that I’m just going to purposely not contract with any physicians” … or just unilaterally, dramatically lower payment rates in a way that threatens practices.

What nonsense!

Medical Economics shares a letter to Congress from a group of medical associations on the topic of value-based care.

The National Academies issued a report on “Achieving Whole Health.”

Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. Whole health care is an interprofessional, team-based approach anchored in trusted relationships to promote well-being, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose. It shifts the focus from a reactive disease-oriented medical care system to one that prioritizes disease prevention, health, and well-being. It changes the health care conversation from “What’s wrong with you?” to “What matters to you?”

The Office of Personnel Management released

its inaugural report: Government-wide DEIA: Our Progress and Path Forward to Building a Better Workforce for the American People. This report highlights accomplishments aligned with the Government-wide Strategic Plan to Advance DEIA in the Federal Workforce and preview priorities for 2023 consistent with Executive Order (EO) 14035.

“Whether you want to cure diseases, protect and preserve our national parks, combat climate change, or embark on missions to discover new galaxies, the Federal government is full of opportunity for the best and brightest to serve our country,” said OPM Director Kiran Ahuja. “In order to recruit and sustain the best talent, we must ensure every service-minded individual feels welcome and supported in contributing their talents to the Federal workforce. This inaugural report highlights progress made to advance diversity, equity, inclusion, and accessibility in the workplace, and we look forward to continuing the work to break down barriers to serve and help build a Federal government that draws from the strength and diversity of its people.”

Tomorrow, February 16, at 10 am ET, the Senate Commerce, Science, and Transportation Committee will hold a hearing titled “Bringing Transparency and Accountability to Pharmacy Benefit  Managers.”

This hearing will address how the “Pharmacy Benefit Manager Transparency Act” will bring transparency into PBM business practices and prohibit unfair or deceptive PBM conduct that drives up costs for consumers. The bipartisan S. 127, Pharmacy Benefit Manager Transparency Act of 2023, was introduced by Chair Cantwell and Sen. Chuck Grassley (R-Iowa), on January 27, 2023.

From the Omicron and siblings front —

STAT News reports

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution.

The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage. For those lacking sufficient insurance, the company will tap a patient assistance program. “Everyone in the U.S. will have access to Moderna’s Covid-19 vaccine regardless of their ability to pay,” the company said.

The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of “corporate greed” and scheduled a hearing next month to examine the initial decision to charge Americans for its Covid-19 shot. Moderna Chief Executive Officer Stéphane Bancel is among those expected to testify. * * *

A spokesman for America’s Health Insurance Plans, an industry trade group, suggested that health insurers will still get a bill. He sent a note saying the Advisory Committee on Immunization Practices (which advises the CDC) recently updated its list of recommended Covid vaccines and that, while beneficiaries pay nothing in cost sharing after commercialization, health plans are picking up the full cost.

No doubt about the validity of AHIP’s point.

Medscape notes, “The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.”

From the public health front —

  • The White House announced
    • “the Consumer Financial Protection Bureau (CFPB) released a new report that shows that the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. Today’s report is consistent with a recent report from the Centers for Disease Control and Prevention (CDC) that found that the number of Americans who are part of families having trouble paying their medical bills declined by 5.5 million between 2020 and 2021. One driver of these declines is the significant increase in the number of insured Americans over this period, a result of the President’s strategy of protecting and strengthening the Affordable Care Act (ACA) and lowering health care costs. The decline also reflects continued actions by the CFPB to highlight problems with inaccurate reporting of debt in collections and put the industry on notice to correct their behavior.”
  • The Wall Street Journal reports “More older women with low-risk breast cancer could forgo radiation after surgery to avoid further side effects and costs, research showed, as some doctors work to limit tough treatments without hurting survival.” STAT News also offers an article on this topic.
  • The National Cancer Institute posts on a variety of cancer topics. For example
    • “The Food and Drug Administration (FDA) approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drugs.”

In other health care cost news —

Beckers Payer Issues relates

Employer-sponsored plans pay much higher rates for physician-administered drugs than Medicare, a research letter published Feb. 10 in JAMA Health Forum found. 

Researchers at the Healthcare Cost Institute compared per-unit prices for the 10 most expensive and 10 most common physician-administered drugs from 2016 to 2020. 

For the most commonly used drugs, employer-sponsored plans paid prices up to 3,350 percent higher than Medicare. For midazolam, employer-sponsored plans paid 30 times more than Medicare for the same drug, and they paid 20 times more for ondansetron. 

For the most expensive drugs, employer-sponsored plans did not pay as extreme markups, the researchers found. Markups were  54 percent more than Medicare at the high end, and employer-sponsored plans paid similar prices to Medicare rates for some drugs. 

Read the full study here. 

Thank heavens OPM is allowing FEHB plans to offer Medicare Part D EGWPs for the Medicare prime members next year.

Health Payer Intelligence informs us “Out-of-pocket costs for buprenorphine prescriptions for opioid use disorder treatment decreased between 2015 and 2020, but costs varied by payer, according to a study published in JAMA Network Open.”

From the U.S. healthcare business front

Beckers Payers Issues advises

The nation’s largest payers have filed their fourth quarter earnings reports, revealing which have the most U.S. commercial members.
Commercial includes fully- and self-insured members

Commercial enrollment rankings in 2022:

  1. Elevance Health: 31.4 million
  2. UnitedHealth Group: 26.7 million
  3. Cigna: 22 million
  4. CVS Health (Aetna): 17 million
  5. Centene: 2.5 million
  6. Humana: 986,000

Healthcare Dive reports

  • After more than two decades together, CommonSpirit Health and AdventHealth are dissolving their joint venturemanaging hospital operations in Colorado and western Kansas. 
  • The management company, Centura, operates one of the largest hospital networks in the region, with 20 hospitals and a network of outpatient practices.
  • In a release on Tuesday, the systems said the partnership had reached its “natural maturity.” CommonSpirit and AdventHealth didn’t lay out a timeline for the transition.

and

Elevance has closed its deal to acquire specialty pharmacy BioPlus, the insurer announced Wednesday, after first announcing the buy in November 2022.

The acquisition builds off the Indianapolis-based insurer’s promise to acquire companies around its health services business, with Elevance CEO Gail Boudreaux announcing at a November industry conference that the insurer planned to grow “very aggressively” into adjacent care services.

Beckers Hospital Review tells us

Walgreens has agreed to buy the assets of defunct digital pharmacy Medly for $19.35 million, according to a bankruptcy court filing.

Medly declared bankruptcy in December, months after its founder stepped down and it laid off more than half its staff. A judge approved the acquisition of Medly’s assets, including its files, inventory and intellectual property, Feb. 7 in U.S. Bankruptcy Court for the District of Delaware.

Medly raised $100 million in 2020, positioning itself as a digital competitor to retail pharmacies such as Walgreens and CVS.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Telehealth, Wellness–
Photo by Josh Mills on Unsplash

From Capitol Hill, STAT News reports

The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms.

It’s unclear when the bills might advance in either chamber. 

The Congressional Research Service released an analysis of healthcare coverage spending in 2021.

Meanwhile, the Health Affairs Council on Healthcare Spending and Value updates us on the recommendations proposed in its 2018 Road Map for Action.

From the Omicron and siblings front —

The Department of Health and Human Services (HHS) announced that its Secretary Xavier Becerra had given the States 90 days advance notice of the end of the Covid public health emergency on May 11, 2023.

To help you and your communities in your preparations for the end of the COVID-19 PHE, I have attached a fact sheet to this letter that includes information on what will and will not be impacted by the end of the COVID-19 PHE.2 In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE. I will share that resource with your team when available.

MedPage Today informs us,

Early treatment with a single dose of pegylated interferon lambda in a highly vaccinated population of COVID-19 outpatients decreased the risk for hospitalization and emergency department (ED) visits lasting more than 6 hours, the phase III TOGETHER trial found.

Among nearly 2,000 participants with acute COVID symptoms and a risk factor for severe illness, 2.7% of those who received pegylated interferon lambda within a week of symptoms required hospitalization or ED visits, as compared with 5.6% of those given placebo (relative risk [RR] 0.49, 95% Bayesian credible interval [CrI] 0.30-0.76), reported Gilmar Reis, MD, PhD, of McMaster University in Hamilton, Ontario, and colleagues.

Results were similar regardless of vaccination status (over 80% were vaccinated), and the treatment effect with the long-acting form of interferon lambda-1 was more pronounced in those who received the subcutaneous injection with 3 days of their symptoms.

From the miscellany department —

HHS released initial guidance for Medicare’s Prescription Drug Inflation Rebate Program created by last year’s Inflation Reduction Act.

Under the Medicare Prescription Drug Inflation Rebate Program, drug companies who raise prices faster than the rate of inflation will be required to pay rebates to the Medicare Trust Fund. Below is a timeline of key dates for implementing the Medicare Prescription Drug Inflation Rebate Program:

  • October 1, 2022: Began the first 12-month period for which drug companies will be required to pay rebates to Medicare for raising prices that outpace inflation on certain Part D drugs.
  • January 1, 2023: Began the first quarterly period for which drug companies will be required to pay rebates for raising prices that outpace inflation on certain Part B drugs.
  • April 1, 2023: People with Traditional Medicare and Medicare Advantage may pay a lower coinsurance for certain Part B drugs with price increases higher than inflation.
  • 2025: CMS intends to send the first invoices to drug companies for the rebates.

The law has a circular aspect because the government needs a much lower general inflation index to get the full bang for the buck from this program. The notice also poses issues for public input.

The International Foundation of Employee Benefit Plans tells us,

The International Foundation has been tracking fertility and family-forming benefits over the past seven years. According to Employee Benefits Survey: 2022 Results, 40% of U.S. organizations currently offer fertility benefits (an increase from 30% in 2020).
Overall:

  • 28% cover fertility medications (8% covered in 2016, 14% in 2018, 24% in 2020)
  • 30% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018, 24% in 2020)
  • 16% cover genetic testing to determine infertility issues (11% in 2018, 12% in 2020)
  • 17% cover non-IVF fertility treatments (6% in 2016, 11% in 2018, 11% in 2020).

In 2016, only 2% of organizations covered egg harvesting/freezing services. That jumped to 6% in 2018, 10% in 2020 and even higher in 2022, with 14% reporting that they cover the benefit.

Healthcare Dives points out, “National telehealth utilization increased 1.9% month-over-month among the privately insured population in November 2022, following one month of decline, according to a new analysis from Fair Health’s monthly tracker.” The bump is attributable to the tripledemic.

Fierce Healthcare relates, “UnitedHealthcare is rolling out a new wearables-based rewards program for members and their spouses. In UnitedHealthcare Rewards, eligible members can earn up to $1,000 per year by using wearable devices to complete health goals and activities, the insurance giant announced Wednesday.”

Health Payer Intelligence notes that “High deductible health plan (HDHP) enrollment hit a record high in 2021, with nearly six out of ten employer-sponsored health plan members enrolled in a high deductible health plan, according to a ValuePenguin survey.”

Benefits consultant Tammy Flanagan writing in Govexec, explains how federal employees can get the full advantage out of the Thrift Savings Plan, which is part of the Federal Employees Retirement System.

Monday Roundup

David Ermer–ACA, Congress, COVID-19, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call offers the House Speaker’s perspective on the debt ceiling negotiation, and the Washington Post does the same for the Senate Majority Leader. The FEHBlog is becoming more optimistic that the debt negotiations will be successful.

From the Omicron and siblings front, the FEHBlog was pleasantly surprised to see that his favorite Covid columnist David Leonhardt of the New York Times, has returned from his four-month long book leave. In his return column, he lists seven surprises that happened during his leave. Here is the Covid surprise.

A milder Covid winter. In each of the past two winters, the country endured a terrible surge of severe Covid illnesses, but not this winter.

His column includes this chart of COVID hospitalizations.

New York Times February 6, 2023

Mr. Leonhardt explains —

It’s a sign that the virus has become endemic, with immunity from vaccinations and previous infections making the average Covid case less severe. If anything, the best-known Covid statistics on hospitalizations and deaths probably exaggerate its toll, because they count people who had incidental cases. Still, Covid is causing more damage than is necessary — both because many Americans remain unvaccinated and because Covid treatments are being underused, as German Lopez has explained.

Mr. Leonhart’s comment should come as no surprise to FEHBlog readers. Nevertheless, it’s encouraging to read it in the New York Times.

It’s worth noting that the first high peak from the left is Alpha which the Covid vaccines (released in December 2020) helped stem. The middle high point was Delta, and the highest point is Omicron which Paxlovid (released in December 2021) and other treatments helped stem. The public health authorities back in the day discussed a three-legged stool to deter Covid — one leg was immunity, the other was prevention (vaccines, etc.) and the third was treatments, which we did not broadly have until December 2021. What’s more the Omicron siblings have defeated some antiviral treatments but not Paxlovid.

On a related note of interest to care providers, CMS yesterday called attention to its regularly update Current Emergencies website which a chock-a-block full of helpful information.

From the Affordable Care Act and ERISA fronts

  • Fierce Healthcare discusses provider and payer reactions to the ACA’s regulators’ recently closed request for public input on the apprpropriate scope of the ACA’s essential health benefits requirement.
  • The Miller & Chevalier law firm discusses an important 9th Circuit U.S. Court of Appeals decision on remedies available in ERISA claim disputes. The decision favored the ERISA plans and their thir party administrators as well as the objective of health plan cost control.

From the executive personnel front —

  • Fierce Healthcare invites us to meet Express Script’s new president Adam Kautzner.
  • Healthcare Dive introduces us to CVS Health’s senior vice president and chief diversity, equity and inclusion officer Shari Slate.

From the broader U.S. healthcare business front —

The Wall Street Journal reports

CVS Health Corp. is close to an agreement to acquire Oak Street Health Inc.for about $10.5 billion including debt, a deal that would rapidly expand the big healthcare company’s footprint of primary-care doctors with a large network of senior-focused clinics, according to people with knowledge of the matter.

The companies are discussing a price of about $39 a share, the people said. The deal, if it goes through, could be announced as soon as this week, they said. CVS is scheduled to report earnings on Wednesday.

The Journal adds that “Oak Street, which has more than 160 centers across 21 states, focuses on the care of patients enrolled in Medicare” and that the deal would push CVS Health “far deeper” into direct provision of healthcare.

Beckers Payer Issues informs us

Alphabet, the parent company of Google, saw its medical stop-loss insurance business grow “nearly sixfold” last year, tech news site The Verge reported Feb. 2. The business, called Granular, provides medical stop-loss coverage to employers and is a subsidiary of Verily, Alphabet’s life sciences business.

Healthcare Dive tells us

  • Looking at 2,000 U.S. hospitals’ websites, only about a quarter were in full compliance with federal price transparency rules, according to a new analysis from PatientRightsAdvocate.org.
  • The majority of hospitals have some required files posted, but most are incomplete, illegible or do not clearly identify prices both associated with payer and plan, according to the report. Some 6% of the hospitals posted no usable pricing files.
  • This latest report calls out both major for-profit and nonprofit chains across the country for not following the rules, including HCA Healthcare, Tenet, Providence and UPMC, which lacked any compliant hospitals.

From the Rx coverage / drug research front —

BioPharma Dive reports

  • Gilead has secured an expanded U.S. approval for its breast cancer medicine Trodelvy, announcing Friday the Food and Drug Administration cleared the antibody treatment for the most commonly occurring form of the tumor type. 
  • Previously approved only for rarer, “triple-negative” breast tumors, Trodelvy can now be used to treat patients with metastatic breast cancer that’s hormone receptor, or HR, positive, but negative for a protein called HER2. This type of breast cancer accounts for an estimated 70% of all new cases, according to Gilead. 
  • The FDA’s decision is a win for Gilead, which gained Trodelvy when it paid $21 billion to acquire Immunomedics in 2020. But clinical trial results showed the drug’s benefit was modest, and Gilead will face competition from a rival drug sold by AstraZeneca and Daiichi.

The Raleigh NC News and Observer discusses a late stage breast cancer injectable drug that Duke University researchers have converted into an FDA approved pill. “[Duke researcher Donald] McDonnell expects elacestrant, which will be marketed as Orserdu, to completely replace the injectable treatment regimen. Not only is the pill less taxing for patients, clinical trials also found it to be more effective.”

STAT News reports

Japanese drugmaker Eisai reported Monday the first U.S. sales of Leqembi, its treatment for Alzheimer’s disease, although exact numbers were not provided and people taking the drug appear to be paying out of pocket because insurance coverage has not yet been established. * * *

The Food and Drug Administration approved Leqembi on Jan. 6. It costs $26,500 per year and is administered by infusion every two weeks. 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 slow commercial rollout.

“Engagements with payers is steadily ongoing towards insurance coverage,” Eisai said Monday, although no new details about its communications with Medicare were provided. “Several” private insurers were “advancing their formulary discussions” about Leqembi reimbursement, Eisai also said, although specific coverage decisions, if any, were not disclosed Monday.

Weekend Update

David Ermer–Congress, COVID-19, U.S. Healthcare–

The House of Representatives and the Senate are holding Committee business and floor voting this week. The President will give the State of the Union address tomorrow at 9 pm.

Following up on the May 11 end of the Covid public health emergency decision, CNBC informs us that the federal government’s free vaccine supply with be exhausted in “early fall,” likely October.

Vaccine pricing in the early fall 

Moderna CEO Stephane Bancel told CNBC last month that the company is preparing to sell the vaccines on the private market as early as this fall. Pfizer CEO Albert Bourla told investors during the company’s earnings call this week that he is preparing for the vaccines to go commercial in the second half of the year.

Pfizer and Moderna have said they are considering hiking the price of the vaccines to somewhere around $110 to $130 per dose once the U.S. government pulls out of the vaccine program.

Paxlovid pricing and available supply

Pfizer has not announced how much the antiviral will cost once it goes commercial. The federal government is paying about $530 for a five-day treatment course. It’s unclear how much patients will have to pay out of pocket and how much of the price insurance will cover.

Dawn O’Connell, who heads the federal office responsible for the U.S. stockpile, said last August that the Health and Human Services Department expected to run out of Paxlovid by mid-2023.

[Dr. Ashish] Jha [the Omicron czar] said on Tuesday that there are still millions of doses of Paxlovid and omicron boosters in the U.S. stockpile. “They will continue to be available for free to all Americans who need them,” Jha said of the remaining federal supply.

From the public health front —

  • NPR Shots reflects on the end of the 2021-2022 tripledemic. The FEHBlog was pleasantly surprised that the Omicron X.BB surge was manageable even after the flu and RSV surges faded. In the FEHBlog’s layman’s view as a grandfather, the RSV surge was an unavoidable one-time event. The silver lining in that particular cloud is that a single-shot vaccine against RSV for infants appears on the horizon. The flu, like Omicron, will be with us for the foreseeable future.
  • The New York Times Magazine featured a thought-provoking article on menopause.
  • Fortune Well discusses available and future cancer vaccines.

Happy Groundhog Day

David Ermer–ACA, Congress, Federal employment benefits, Medicare, OPM, Telehealth, U.S. Healthcare–

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 Dive informs us.

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.

Midweek update

David Ermer–ACA, CDC, CMS, Congress, COVID treatment, FDA, Medicare, NIH, No Surprises Act, U.S. Healthcare–

From our Nation’s capital, HHS Secretary Xavier Becerra made a statement honoring Black History Month which began today.

The Wall Street Journal reports

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.

The Hill tells us

  • 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.

In that regard, Health Payer Intelligence notes

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.

Tuesday’s Tidbits

David Ermer–CMS, Congress, COVID treatment, COVID-19, HSA, Mental health care, NIH, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

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.

This isn’t very encouraging.

From the U.S. healthcare business front —

Beckers Hospital Review reports

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.”

Weekend Update

David Ermer–Congress, COVID-19, Mental health care, No Surprises Act–
Photo by JOSHUA COLEMAN on Unsplash

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.

Friday Factoids

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Rx coverage, U.S. Healthcare, Wellness–
Photo by Sincerely Media on Unsplash

From Capitol Hill, Fierce Healthcare tells us

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.

From the public health front

  • 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.
  • Fierce Healthcare points out that

“A new report from the Georgetown University Center for Children and Families seeks to make several reforms to the Transparency in Coverage rule to ensure the data are more usable and accessible by researchers. The goal is to ensure that the data can be used to help regulators and lawmakers target policies that can boost coverage affordability. 

“’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.

Busy Thursday

David Ermer–CDC, Congress, COVID-19, Electronic health records, FDA, Federal employment benefits, HSA, OPM, Patient safety, Rx coverage–
Photo by Manasvita S on Unsplash

From Capitol Hill Roll Call reports

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.

STAT News adds

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.”

From the NIH research front, NIH calls attention to its research studies on the role of the placebo effect in healthcare treatments and the link between hydration and better aging.

From the miscellany department —

  • 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.