Monday Roundup

Monday Roundup

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From our Nation’s capital, Federal News Network informs us

The Office of Management and Budget filled a key personnel and performance leadership role with a familiar name.

Federal News Networks has confirmed that Loren DeJonge Schulman is starting as the new associate director for performance and personnel management today.

She replaces Pam Coleman, who left in August after 20 months in that role.

DeJonge Schulman joins OMB from the Partnership for Public Service where she was vice president of research, evaluation and modernizing government for the last two-plus years. In that role, she helped lead the Best Places to Work in Government rankings and focused on issues around improving federal workforce management.

The U.S. Office of Personnel Management announced

The U.S. Office of Personnel Management (OPM) has announced the Finalists for this year’s Presidential Management Fellows (PMF) Program. Of the more than 10,000 individuals from around the world who applied for the program, 850 Finalists were chosen. The large number of applications to this competitive program marks a record number of applications over the past ten years.  

“Presidential Management Fellows are the next generation of government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2023 PMF finalists. We cannot wait to see what you will accomplish in public service.”  * * *

PMFs are appointed to a two-year, full-time Federal position with salary and benefits, where they apply their skills while engaging in leadership development training that includes experiential learning, cohort-based interactive training, and optional rotational experiences. 

In Omicron and siblings news, BioPharma Dive informs us

The U.S. has agreed to buy 1.5 million additional doses of Novavax’s COVID-19 vaccine as part of preparations for the government’s planned transition from bulk purchases to private market sales.

The agreement, announced Monday by Novavax, will support development of an updated version of the company’s shot in line with the Food and Drug Administration’s plan to annually match COVID vaccines to the most prevalent virus variants. It will also aid the company in developing smaller dose vials, which are less logistically challenging.

Novavax did not disclose the cost of the purchases, which are funded under an existing $1.6 billion contract with the government. Its shot uses a vaccine technology that has long been a mainstay and that the company claims remains an important option for those who cannot or will not take the messenger RNA-based shots from Pfizer and Moderna.

From the public health front —

  • The Washington Post discusses a horrifying CDC report on the mental health of high school students.
    • “Teen girls across the United States are ‘engulfed in a growing wave of violence and trauma,’ according to federal researchers who released data Monday showing increases in rape and sexual violence, as well as record levels of feeling sad or hopeless.”
    • In its report, the CDC steered attention to the nation’s schools, saying activities there can make a profound difference in the lives of teens. It recommended improved access to mental health services, more classroom management training for teachers, school clubs that foster gay-straight alliances, high-quality health education and enforcement of anti-harassment policies. Ideally, schools would take on multiple initiatives.”
  • NBC News reports “A handful of factors, such as education, income and job type, may increase the likelihood that people in their mid-50s will still be mentally sharp, a new study finds.”

From the No Surprises Act front, Healthcare Dive adds

One in five Americans still report receiving surprise bills, despite the ban. That’s in part because the law has notable exceptions — for example, ground ambulances were excluded from the ban, though they’re a frequent source of the bills.

In January, the HHS said it’s received significantly more requests to resolve payment disputes than the department expected.

STAT News delves into the ground ambulance billing issue today. It’s worth noting at the risk of belaboring the obvious that air ambulances are considerably more expensive than ground ambulances.

The FEHBlog was surprised to read about the number of arbitration requests in January given the Texas Medical Association’s contention that the new $350 per party arbitration fee would suppress the numbers of arbitrations. In the FEHBlog’s view, providers should place more focus on the open negotiation phase of the process.

From the electronic health records front, HealthITBuzz alerts us

A little over a year ago, we announced the completion of a critical 21st Century Cures Act requirement by publishing the Trusted Exchange Framework and Common Agreement (TEFCA). This milestone established a clear infrastructure model and governing approach for nationwide health information exchange.

Today, we marked the next major milestone during an event at the U.S. Department of Health and Human Services (HHS) headquarters, which recognized the first set of networks to be approved to implement TEFCA as prospective Qualified Health Information Networks (QHINs). Once fully onboarded, the organizations will officially be “designated” as QHINs. At this event, HHS Secretary Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA for their willingness to voluntarily step up and meet the rigorous TEFCA eligibility requirements, terms and conditions of TEFCA participation, and commitment to a 12-month go-live timeline. Collectively, the QHIN applicants have networks that cover most U.S. hospitals, tens of thousands of providers, and process billions of annual transactions across all fifty states.

Bravissimo.

From the U.S. healthcare business front —

Cigna announced a rebranding of its businesses: The Cigna Group, the global health company; Cigna Healthcare, the health benefits provider; and Evernorth Health Services, the pharmacy, care and benefits solutions provider.

Politico, upon examining whether a new CMS policy can save rural hospitals, offers us a mixed bag:

The Rural Emergency Hospital designation, aimed at sustaining emergency rooms, outpatient care and clinics, will be a major consideration for a significant number of hospitals, according to a new report from Chartis, a health care consulting group.

The policy changes are among the largest made to the rural health system in years. Through Medicare, hospitals that agree to the program requirements are guaranteed a set amount of money for facilities and a boosted Medicare reimbursement rate.

About 400 hospitals are “most likely” to consider conversion, according to the analysis, with about 80 of those “ideal” candidates for the change — often facilities on the brink of closing without growing revenues.

Several dozen hospitals are expected to move toward the new designation in the next 12 to 18 months “because they’re right on the ropes,” Michael Topchik, national leader of the Chartis Center for Rural Health, told Pulse.

Another group will wait and see how the first group does under the new rules, he said.

Stillmost of the nearly 1,600 rural hospitals aren’t interested. The designation requires giving up inpatient care, a key part of many hospitals’ business and a handful of financial incentives offered through other rural health programs.

That doesn’t mean rural hospitals are thriving, though. Closures slowed significantly during the pandemic, likely because of the government’s infusion of resources through the pandemic, but are again ticking up.

Fierce Healthcare reports

Sanford Health and Fairview Health Services have agreed to push back their planned megamerger by two months.

The health systems said in a statement that they jointly determined they should “voluntarily” move the expected closure date for the deal to May 31, according to a report in MPR News. The merger was originally set to close March 31, but Minnesota Attorney General Keith Ellison asked the two providers to delay.

The deal includes 58 hospitals, and, if the two systems are joined, they would employ more than 80,000 people.

Friday Factoids

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Based on the CDC’s Covid Data Tracker, the CDC’s weekly review tells us

New Cases – As of February 8, 2023, the current 7-day average of weekly new cases (40,404) decreased 1.0% compared with the previous 7-day average (40,815). 

New Hospitalizations — The current 7-day daily average for February 1–7, 2023, was 3,665. This is an 6.2% decrease from the prior 7-day average (3,907) from January 25–31, 2023.

New Deaths — The current 7-day average of new deaths (453) decreased 9.7% compared with the previous 7-day average (502).

Vaccinations — As of February 8, 2023, 670.3 million vaccine doses have been administered in the United States. Overall, about 229.8 million people, or 69.2% of the total U.S. population, have completed a primary series. About 52.5 million people, or 15.8% of the U.S. population, have received an updated booster dose.

Communities Levels — As of February 9, 2023, there are 91 (2.8%) counties, districts, or territories with a high COVID-19 Community Level, 715 (22.2%) with a medium Community Level, and 2,407 (74.8%) with a low Community Level. Compared with last week, the number of counties, districts, or territories in the high level decreased by 1.2%, in the medium level decreased by 3.2%, and in the low level increased by 4.3%. 

The weekly report explains why immunocompromised folks with weakened immune systems should create a Covid action plan.

The CDC’s weekly flu report informs us “Seasonal influenza activity is low nationally.” Nevertheless the CDC adds

CDC reported 9 new flu-related pediatric deaths this week, bringing the total for the season to 106, the highest number of flu deaths in children since the start of the COVID-19 pandemic. Most of these children were not vaccinated. This tragic milestone underscores the importance of vaccinating children against flu. Flu vaccination uptake in children is lower by about 6 percentage points than it was prior to the COVID-19 pandemic. While flu activity has returned to low levels this season, CDC continues to recommend flu vaccination as long as flu viruses are spreading.

During the most recent 10 flu seasons, the number of pediatric flu deaths in a season has ranged from 1 (2020-2021) to 199 (2019-2020). Prior to the pandemic, the record low for pediatric deaths was 37, which was during the 2011-2012 season.

AHIP reports,

The Centers for Disease Control and Prevention (CDC) has added COVID-19 vaccinations for children, adolescents, and adults to its immunization schedule.  Adding these vaccines to the schedule formalizes guidance for health care providers and schools.

  • CDC recommends that healthy children 6 months to 4 years old receive a primary series of two doses of the Moderna or Pfizer-BioNTech monovalent COVID-19 vaccine followed by a third dose of a bivalent vaccine.
  • CDC recommends that children aged 5 to 12 years receive two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine followed by a bivalent shot.
  • CDC recommends children ages 12 and older should get either two doses of the Moderna, Pfizer-BioNTech, or Novavax vaccine, followed by a bivalent booster.
  • Immunocompromised children should receive three doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine as a primary series instead of two shots, and should receive a bivalent booster.
  • CDC recommends healthy adults receive a primary COVID-19 vaccination of two doses of the Moderna, Pfizer-BioNTech or Novavax vaccine and a bivalent booster, similar to children.  Some adults may choose to receive a Novavax booster instead if they would not like the Moderna or Pfizer-BioNTech shot, or if those boosters are not available. 
  • CDC recommends immunocompromised adults receive either two doses of the Novavax vaccine, or three doses of the Pfizer-BioNTech or Moderna vaccine and a bivalent booster.

CDC also recommends that adults who received the one-dose Johnson & Johnson vaccine receive one booster dose, followed by a bivalent booster.

MedPage Today offers a report on

The topic [of] highlights from ACIP’s new adult schedule for 2023published in the Annals of Internal Medicine, and why this new schedule may be a collector’s item.

It’s a new year, which means a new ACIP adult immunization schedule — a valuable resource collating ACIP’s most up-to-date vaccination recommendations.

Here are this year’s five most important changes:

  • COVID vaccines now front and center
  • New emphasis on polio vaccination
  • Inclusion of some nonvaccine products (such as monoclonal antibody products)
  • Pharmacists group has approved the schedule for the first time
  • New shared clinical decision-making option for pneumococcal vaccines

From the No Surprises Act front, the American Hospital Association relates

Following a Feb. 6 court decision that vacated nationwide the federal government’s revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act, the Centers for Medicare & Medicaid Services today instructed certified IDR entities to hold all payment determinations until the departments of Health and Human Services, Labor, and the Treasury issue further guidance. Certified IDR entities have also been instructed to recall any payment determinations issued after Feb. 6, 2023. 

“The Departments are currently reviewing the court’s decision and evaluating current IDR processes, guidance, templates, and systems for updates that will be necessary to comply with the court’s order,” CMS said. “The Departments will provide specific directions to certified IDR entities for resuming the issuance of payment determinations that are consistent with the court’s judgment and order. Certified IDR entities should continue working through other parts of the IDR process, including eligibility determinations, as they wait for additional direction from the Departments.”

The FEHBlog notes that while the court ordered changes to the IDR rule which favor the plaintiffs, the court did not vacate the IDR rule. The FEHBlog does not otherwise doubt the veracity of this report.

From the Rx coverage and research front —

  • BioPharma Dive reports “Pfizer and partner BioNTech on Friday started the first human trial of a messenger RNA-based vaccine for shingles, believing their shot can be easier to take, and more efficiently produced, than the one available for use [Shingrix]. 
  • Medscape alerts us that a new vibrating, drug-free pill to relieve constipation is on the market.

From the healthcare quality front, NCQA puts us on notice that

This year’s HEDIS public comment is open Monday, February 13–Monday, March 13.

We’re seeking advice on:

  • Revisions to diabetes measures.
  • Expansion of race and ethnicity stratifications in select HEDIS measures.
  • Advancing gender-inclusion measurement in two HEDIS measures.
  • Retirement of several measures.

This year’s public comment will go live at Monday, February 13, 9:00 AM ET.

We’ll post the link and more details here, so check back.

To hear NCQA leaders discuss HEDIS public comment, attend our Tuesday, February 28 Future of HEDIS webinar.

From the U.S. healthcare business front —

Kaiser Permanente released its 2022 financial results

Total operating revenues for 2022 were $95.4 billion compared to $93.1 billion in 2021. Total operating expenses were $96.7 billion compared to $92.5 billion in the prior year. There was an operating loss of $1.3 billion for the year compared to operating income of $611 million in 2021. * * *

Strong economic headwinds in the financial markets drove a loss in total other income and expense of $3.2 billion in 2022 compared to a gain of $7.5 billion in 2021. For 2022, there was a net loss of $4.5 billion compared to net income of $8.1 billion in 2021.

Capital spending totaled $3.5 billion, consistent with the $3.5 billion spent the prior year. During 2022, Kaiser Permanente opened 4 new medical offices. Kaiser Permanente now has 737 medical offices, 39 owned hospitals, and 43 retail and employee clinics.

“Clinical staff shortages, COVID-19 care and testing, higher costs of goods and services, and deferred care drove Kaiser Permanente’s expenses beyond revenue,” said chair and chief executive officer Greg A. Adams. “Rather than pull back amid financial pressures, we made the decision to continue our long-term and strategic investments in care and service improvements while carefully managing resources. Our staff and physicians worked hard to meet our members’ needs and I am grateful for their outstanding contributions.”

Fierce Healthcare reports

Major for-profit hospital chain Tenet Healthcare is projecting growth in 2023 thanks to less reliance on contract labor and growth in its surgery subsidiary.

The chain announced in its earnings release that it generated $102 million in profits with $4.9 billion in net revenue for the fourth quarter of 2022. It also released the full year financial guidance for 2023, projecting adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) to be $3.16 to $3.36 billion.

“Our momentum going into 2023 positions us for continued growth as we remain focused on expanding our industry-leading ambulatory business and investing in technology, innovation and talent,” said CEO Saum Sutaria in a statement.

Beckers Hospital Review identifies six considerations related to the fact that 43% of rural hospitals are in the red.

Reuters reports “AstraZeneca (AZN.L) on Thursday said it was poised to grow in 2023 and beyond, banking on its burgeoning line-up of cancer, metabolic and rare disease drugs to pick up the pace from dwindling COVID product sales.”

Thursday Miscellany

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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.

Tuesday’s Tidbits

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From Washington, DC, the Society for Human Resource Management tells us that Labor Secretary Marty Walsh will be leaving his position to become head of the National Hockey League (NHL) Players’ Association, according to news reports. 

In other regulatory news, Health Payer Intelligence reports

The Alliance of Community Health Plans (ACHP) was among around 50 organizations—including AHIP and Blue Cross Blue Shield Association—to sign a letter to HHS that supported fully aligning the substance use disorder patient data requirements in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) with the Health Insurance Portability and Accountability Act (HIPAA).

The group noted that the proposed rule falls short of this goal.

Also, the Office of National Coordinator of Health IT announced that “On Monday, February 13, HHS will recognize the first set of applicant organizations that are approved for onboarding as Qualified Health Information Networks (QHINs) under TEFCA.” The ongoing launch of TEFCA, which will serve as a backbone for the country’s electronic health record systems, is exciting.  

From the Omicron and siblings front —

  • The Kaiser Family Foundation’s Covid Vaccine Monitor informs us “nearly four in ten households (38%) were affected by this winter’s” tripledemic. The flu affected the largest share of households (27%), followed by Covid (15%) and RSV (10%). “At the same time, almost three years into the COVID-19 pandemic, most of the public says they are “not too” or “not at all” worried about getting seriously ill from the virus (69%), though 31% still say they are worried.”
  • The Food and Drug Administration offers step-by-step guidance on reporting Covid test results to public health authorities.

From the public health front,

  • Health Affairs discusses an interesting study finding: “A high prevalence of mental health diagnoses in adults alongside ongoing shortages of mental health specialists and expansion of the patient-centered medical home has increased the involvement of primary care clinicians in treating mental health concerns.” 
  • McKinsey and Company offer the following interview: “McKinsey Global Publishing’s Eleni Kostopoulos chats with Alex Jadad and Tamen Jadad-Garcia about their new book, Healthy No Matter What: How Humans Are Hardwired to Adapt (Penguin Random House, January 2023). Dr. Jadad created the widely popular Jadad scale for assessing clinical trials. Now, he’s combining his medical expertise with his daughter’s health entrepreneurship to explore what it truly means to be ‘healthy’.”

From the No Surprises Act front, Becker’s Payer Issues reports on a February 6, 2023, opinion from the Eastern District of Texas striking down certain provisions of the latest independent dispute resolution rule. Judge Kernodle considers those stricken provisions to conflict with the statute by placing too much emphasis on one of six factors that the law allows the arbitrator to consider: the health plan’s qualified payment amount. The FEHBlog doubts that this decision will immediately impact the IDR process, which continues to be quite bogged down. Providers should emphasize resolving billing disputes during the initial open negotiation period. Regardless, the plaintiff Texas Medical Association has two more NSA issues pending before the good Judge.

From the fraud, waste, and abuse front, the Justice Department announced that False Claims Act settlements and judgments exceeded $2 billion in fiscal year 2022. “[H]ealth care fraud remained a leading source of False Claims Act settlements and judgments.”

From the U.S. healthcare business front

  • Fierce Healthcare tells us that Health insurer Centene announced its fourth-quarter 2022 financial results today.
  • Medcity Today relates, “The U.S. healthcare system spent $60 billion on administrative tasks last year, which is about $18 billion more than it spent in 2021, according to a new report from the Council for Affordable Quality Healthcare (CAQH).” The report attributed the increase to a labor shortage and greater utilization of healthcare services in 2022.
  • The Drug Channels blog assesses biosimilar challenges to Humira.

Monday Roundup

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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

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.

Friday Factoids

Photo by Sincerely Media on Unsplash

From the Centers for Disease Control front —

  • According to the CDC’s Weekly Interpretative Report on its Covid Data Tracker, Omicron cases, hospitalizations, and deaths continued to trend down last week while community-level statistics improved. The CDC report leads with an analysis of Omicron variants. Only 4% of U.S. counties have a high level of Covid infections based on the CDC’s Communities approach.
  • The CDC’s weekly Fluview continues its string of reports that “Seasonal influenza activity continues to decline across the country.”
  • MedPage Today reports
    • “The CDC warned of a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa linked to various brands of artificial tear drops.
    • “An investigation identified artificial tears as a common exposure for many patients. Patients reported using over 10 different brands of artificial tears; EzriCare Artificial Tears, an over-the-counter product, was most common.
    • “Pending additional guidance from the CDC and FDA, “patients and healthcare providers should immediately discontinue using EzriCare Artificial Tears,” the CDC said in an advisory to its Health Alert Network.”

From the health plan design front, the FEHBlog has run across helpful articles from the Kaiser Family Foundation, the Advisory Board, and Forbes on the impact of the May 11, 2023, end of the Covid national and public health emergency. From a health plan standpoint, the biggest considerations are the end of (a) out-of-network testing and vaccine mandates and (b) the mandate to provide free rapid covid tests. Sometime in 2023, the federal government’s funding for Covid vaccines and Paxlovid will be exhausted, and health plans will need to pick up the slack.

From the FEHB front Govexec tells us

The Office of Personnel Management’s own Federal Employee Benefits Surveys, cumulatively covering hundreds of thousands of feds, have consistently reinforced this point—showing around 80% or more of feds identify strong benefits programs (led by federal retirement annuities, the Thrift Savings Plan and Federal Employees Health Benefits insurance programs) as a major part of why they stick with their jobs.  

The Employee Benefit Research Institute recently published a new report exploring such issues—one zeroing in on what makes a job “sticky” for employees, covering data and anecdotal evidence on private- and public-sector employment over the last 40 years.  

Craig Copeland, EBRI’s director of Wealth Benefits Research parsed these findings for Government Executive and affirmed that attractive federal benefits remain crucial in helping agencies retain feds. 

“Yes, it is still clear that public sector employees—including feds—are more likely to stay at their job longer than other sectors, at least up until recent years,” Copeland told Government Executive. “The defined benefits plans that public sector jobs usually provide typically are an important part of the reason that public sector employees stay longer—as well as because of the overall typically better benefits offered to public sector employees when compared with the average private sector employee.” 

However, Copeland said that it’s hard to say if these long-term trends—the popularity of strong benefits and the stickiness of the public-sector jobs that offer them—persist among the growing younger slice of feds. 

Ruh roh.

From the U.S. healthcare business front

  • The American Health Association (AHA) went bananas over the Justice Department’s unexpected withdrawal of aging antitrust guidance that favors the healthcare industry. Fierce Healthcare also discusses DOJ’s action
  • Also, from the AHA
    • Alabama hospitals lost $1.5 billion since the beginning of the pandemic, despite receiving federal COVID-19 relief funds. At the same time, costs increased $2.6 billion, leaving over half of the state’s hospitals currently operating in the red, Kaufman Hall reports. 
    • Indiana hospitals have lost $1.2 billion since 2019, with expenses for labor, medical supplies, drugs and other purchased services up by $3.2 billion, leaving many of the state’s hospitals with negative operating margins, according to a Kaufman Hall analysis.
  • The American Hospital Association’s 2023 legislative strategy is unveiled in a Politico article.

Midweek update

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

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.”

Monday Roundup

    Photo by Sven Read on Unsplash

    Today was another busy day.

    The biggest surprise is that OPM begun refreshing its website and has revealed its logo.

    U.S. Office of Personnel Management logo
    New OPM Logo

      From the public health front —

      • The Hill reports that the President plans to end the national and public health emergencies for the Covid pandemic on May 11, 2023. Congress took steps to arrange for a soft landing in the Consolidated Appropriations Act 2023, which likely is a factor in reaching this executive decision.
      • Health IT Analytics tells us, “Researchers from New York University (NYU) Grossman School of Medicine and the Robert Wood Johnson Foundation (RWJF) unveiled the Congressional District Health Dashboard (CDHD), an online data tool that provides health data for all 435 US congressional districts and the District of Columbia.” Interesting.
      • The New York Times informs us, “A new report [on maternal health in the U.S.] highlighted the dangers faced by Native American women, who face the greatest risks during and after pregnancy. Native American women were 3.5 times as likely to die during this critical period, compared with white women, the study found.” This rang a bell with the FEHBlog because the FEHB Program included Native American employers who have contracted with OPM for FEHB coverage for their employees. “During and after pregnancy, Black women also faced heightened odds of death that were almost double those of white women, along with a risk of dying specifically from pregnancy complications that was 2.8 times that of white women.” No child should be deprived of a mother due to inadequate healthcare.
      • Yale New Haven Hospital offers insights on heart disease for lay people/patients.
      • Medpage Today discusses recently extended and updated Body Mass Indices (BMIs0 for children and adolescents.
      • LifeSciences Intelligence reports that “In a recent news release, the Emergency Care Research Institute (ECRI) highlighted gaps in communication regarding medical device recalls, noting that these gaps could be a significant threat to patient safety. This commentary was a part of the organization’s Top 10 Health Technology Hazards report.”

      From the Affordable Care Act front, the ACA regulators today promulgated a proposed rule that would create

      a new independent pathway through which individuals enrolled in plans or coverage sponsored or arranged by objecting entities that have not opted for the existing accommodation (including those enrolled in individual health insurance coverage issued by such an objecting entity) could access contraceptive services at no cost. Specifically, these proposed rules would create a mechanism, independent from the employer, group health plan, plan sponsor, institution of higher education, or issuer, through which individuals could obtain contraceptive services at no cost from a willing provider of contraceptive services. This individual contraceptive arrangement would be available to the participant, beneficiary, or enrollee without the objecting entity having to take any action facilitating the coverage to which it objects. Simply put, the action is undertaken by the individual, on behalf of the individual. * * *

      These proposed rules, if finalized, would rescind the moral exemption to covering contraceptive services without cost sharing, while keeping intact the religious exemption and without narrowing its scope or the types of entities or individuals that may claim the religious exemption. These proposed rules would also maintain the optional accommodation for sponsors of group health plans and institutions of higher education arranging student health insurance coverage that qualify for the religious exemption. 

      Here’s a link to the regulator’s fact sheet. This strikes the FEHBlog has a wise solution to this knotty problem.

      From the healthcare business front —

      The American Hospital Association relates

      Last year was the worst financial year for U.S. hospitals and health systems since the start of the COVID-19 pandemic, as growth in expenses outpaced growth in revenues and volumes, according to the latest report on hospital finances from Kaufman Hall. 

      “The increases were driven in part by a competitive labor market, as well as hospitals needing to rely on more expensive contract labor to meet staffing demands,” the report notes. “Increased lengths of stay due to a decline in discharges also negatively affected hospital margins.” 

      Hospitals experienced negative operating margins for most of the year, with approximately half of the nation’s hospitals ending the year in the red. According to the report, hospitals’ expense pressures “are unlikely to recede in 2023.”

      STAT News discusses business focused on improving human longevity.

      Health Payer Intelligence reports

      The US Department of Health and Human Services (HHS) has released a final rule that aims to introduce more oversight into the Medicare Advantage risk adjustment data validation and payment process. * * * Under the finalized rule, CMS will not extrapolate audit findings for payment years 2011 through 2017, the CMS fact sheet stated. CMS will collect non-extrapolated overpayments for plan years 2011 through 2017. Extrapolation will begin with the plan year 2018 risk adjustment data validation audit using any extrapolation technique that is statistically valid. The audits will center on high-risk plans.

      The Wall Street Journal adds “A Centers for Medicare and Medicaid Services official, Deputy Administrator and Center for Program Integrity Director Dara Corrigan, said the estimated recoveries for 2018 would be around $479 million, and the agency projected a total of about $4.7 billion over a decade. The large recoveries wouldn’t actually occur until 2025 and after, however.”

      Will this regulation drive companies out of Medicare Advantage? Time will tell. In the meantime here is a link to HHS’s fact sheet.