Weekend update

COVID-19

Weekend update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–
Mount Rushmore

From the Capitol Hill front, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Roll Call reports

A bipartisan group of senators announced an agreement Sunday on significant updates to the nation’s gun laws, and the Senate majority leader said it ​​would be put on the floor once legislative text is ready.

The agreement, announced by 10 Republicans and 10 Democratic caucus members, certainly will not go as far as many Democrats would have hoped, but the scale of the GOP support suggests it could get the all-important 60 votes to overcome the filibuster rule that kept derailing the last bipartisan attempt to change gun laws, in 2013.

The agreement, which is not yet in legislative language, is the product of discussions led by Sens. Christopher S. Murphy, D-Conn., and John Cornyn, R-Texas, in the wake of recent mass shootings, including at an elementary school in Uvalde, Texas.

“Our plan increases needed mental health resources, improves school safety and support for students, and helps ensure dangerous criminals and those who are adjudicated as mentally ill can’t purchase weapons,” the 20 senators said in a statement. “Most importantly, our plan saves lives while also protecting the constitutional rights of law-abiding Americans.”

From the Omicron and siblings front —

MedPage Today discusses the latest Omicron siblings — BA.4 and BA.5. “Generally, BA.4 and BA.5 variants cause mild disease but spread in large numbers potentially because, unlike the Wuhan strain, which settles in the lungs, these newer strains seem to attach to the more benign upper nasal passages.”

Bloomberg Prognosis answers a reader’s question about whether to get a fourth Covid booster now.

Moderna said just this week that a new version of its Covid vaccine led to a better antibody response against omicron compared with its current mRNA shot. It plans to submit data to the US Food and Drug Administration in the coming weeks and hopes the shot will be available as soon as late summer. That shot is what’s called a bivalent vaccine, meaning it contains mRNA coding for the spike protein of both the original strain of the virus and omicron. 

Pfizer should also have updated mRNA vaccines available as soon as the fall, says Monica Gandhi, an infectious disease expert at the University of California, San Francisco. The FDA will hold an advisory committee meeting later this month to address whether fall shots should be modified, and if so what strains they should include.

But while currently available boosters are less effective against omicron, Gandhi points out, they still do offer some protection. So, she says, that answer to whether to get boosted now depends on a few factors. 

”I would advise — depending on case rates in your area and your age— getting the fourth dose now,” she says. “And then deciding what to get in the fall.”

MedPage Today also explains why “the [Novovax Covid] technology is quite innovative and has potential to enhance protection against” the disease.

From the healthcare business front, the Wall Street Journal reports on a

A philanthropic organization founded by the ex-energy trader [John Arnold] and his wife Laura is providing financial backing to three lawsuits against giant hospital systems in Wisconsin, Connecticut and North Carolina, alleging the systems used their market power to squash competition and illegally inflate prices. The systems say the lawsuits from employers and consumers are baseless. * * *

The financing from Arnold Ventures is supporting the work of Fairmark Partners LLP, the law firm behind the lawsuits. Fairmark secured its funding from the philanthropy after filing its first lawsuit, one of the founders said. The firm’s founders say the backing is key to a targeted effort to reshape hospital markets through the courts, and that it received money from other philanthropies it declined to identify. 

While the FEHBlog is not a fan of litigation, this strikes him as a worthy effort.

From the medical research front —

  • Kaiser Health News summarizes recent drug research developments.
  • NPR Shots reports on efforts to connect human nerve systems to prosthetic devices.
  • Fierce Healthcare tells us

Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients. The studies, released at the American Society of Clinical Oncology’s meeting earlier this month, build on a similar analysis among lung cancer patients.

In both studies, the researchers found that using NCCN guidelines drove significant declines in total cost of care.

“Evidence-based medicine does result in improvement in quality of life,” Shirisha Reddy, M.D., senior medical director at CVS Health and an author on both studies, told Fierce Healthcare. “There’s a lot of external data that supports that.”

The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.

In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.

This included notable decreases in administered chemotherapy spend as well as outpatient care between Jan. 1, 2019, and Dec. 31, 2020.

Friday Stats and More

David Ermer–CDC, COVID-19, Electronic health records–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 23rd week of 2022.

The CDC’s weekly review of its Covid statistics observes “As of June 8, 2022, the current 7-day moving average of daily new cases (109,032) increased 8.0% compared with the previous 7-day moving average (100,916).”

Here’s is the CDC’s latest weekly report of new Covid hospitalizations:

The CDC’s weekly review notes “The current 7-day daily average for June 1–7, 2022, was 4,127. This is an 8.0% increase from the prior 7-day average (3,820) from May 25–31, 2022.”

Here’s the FEHBlog’s weekly chart of new Covid deaths over the same period as new cases:

The CDC’s weekly review adds “The current 7-day moving average of new deaths (306) has increased 18.6% compared with the previous 7-day moving average (258).” Over 2/3s of the U.S. population is now fully vaccinated.

Here’s the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era at the 51st week of 2020 through the 23rd week of 2022:

The CDC’s weekly review states “As of June 8, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 290,078, a 15.6% decrease from the previous week.”

The American Hospital Administration adds

An initial 10 million doses of COVID-19 vaccine are available for children under age 5 if the Food and Drug Administration authorizes and the Centers for Disease Control and Prevention recommends the Pfizer and Moderna vaccines for children in this age group, Assistant Secretary for Preparedness and Response Dawn O’Connell said yesterday during a White House briefing.

FDA’s vaccine advisory committee will meet June 14-15 and the CDC’s advisory committee June 17-18 to consider whether to authorize and recommend the vaccines for this age group, after which the agencies will issue their respective decisions.

“It will take some time to position these vaccines across the country, and vaccinations can’t begin until CDC has made its decision,” O’Connell said. “But we also know that many parents have been waiting for a long time, so we will be working 24/7 until every dose is shipped and delivered.”

The Administration last week opened pre-ordering of doses for states, tribes, territories and other partners, and estimates that 85% of children under 5 live within 5 miles of a potential vaccination site, she said.

The CDC’s weekly review sums things up as follows:

As of June 9, 2022, there are 314 (9.75%) counties, districts, or territories with a high COVID-19 Community Level, 1,052 (32.67%) counties with a medium Community Level, and 1,854 (57.58%) counties with a low Community Level. This represents a small (+2.20 percentage points) increase in the number of high-level counties, a moderate (+9.57 percentage points) increase in the number of medium-level counties, and a corresponding (−11.77 percentage points) decrease in the number of low-level counties. Fifty-two (100%) of 52 jurisdictions* had high- or medium-level counties this week.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

From the unusual viruses front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today reported over 1,300 monkeypox cases globally, including 45 in the United States. While no deaths have been reported and the overall risk to the U.S. public remains low, officials encouraged clinicians to review the CDC’s latest guidance and individuals to talk with their health care provider if they develop symptoms or need to get tested.

According to CDC, monkeypox spreads through direct contact with an infected person’s body fluids, sores or materials that have touched them, such as clothing or linens. It may also spread through respiratory secretions when people have close, face-to-face contact.

Smallpox vaccines are effective at protecting people against monkeypox when given before exposure and may also help prevent the disease or make it less severe. According to CDC, the Strategic National Stockpile currently holds about 72,000 doses of JYNNEOS smallpox vaccine and will soon receive an additional 300,000 doses from the manufacturer. The U.S. also has ordered another 500,000 doses for delivery later this year. In addition, the SNS holds over 100 million doses of an older smallpox vaccine (ACAM2000). 

From the electronic health record front, Beckers Hospital News reports

Oracle’s primary mission is improving the complex healthcare system with technology, according to Larry Ellison.

The chair, co-founder and chief technology officer of Oracle said in a June 9 virtual public presentation the company plans to vastly improve care delivery, outcomes and public health policy while also lowering costs. Oracle acquired Cerner in a $28.4 billion transaction earlier this week and has plans to modernize the platform, taking it from a documentation and billing system to a complete source of information about an individual’s healthcare. The EHR would also have virtual care capabilities, be interoperable and expand clinical trial accessibility.

“Together, Cerner and Oracle have all the technology required to build a revolutionary new health management information system in the cloud,” Mr. Ellison said. “That system will deliver much better information to healthcare professionals. Better information will fundamentally transform healthcare.”

Oracle aims to build a unified database for patient information, similar to the unified financial database with credit information, accessible to healthcare providers and public health officials. The database would have anonymized data from hospitals, clinics and providers across the U.S. and provide up-to-the-minute information about patients’ personal health as well as public health statistics, such as the number of people hospitalized with COVID-19 or available hospital beds in a particular state.

“We’re building a system where the health records, all American citizens’ health records, not only exist at the hospital level, but they are all in a unified national healthcare database,” Mr. Ellison said. “The national database solves the data electronic health record fragmentation problem.”

Aim high. Assuming security and privacy challenges can be addressed, such a database could be a public health game changer.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From our Nation’s capital, the New York Times reports,

White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.

Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.

Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out

Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.

The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look. 

From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”

From the maternal health front, the American Hospital Association informs us

The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.

From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.

Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.

From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.

From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.

Midweek Update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–

From Capitol Hill, Roll Call reports that FY 2023 appropriations work is gearing up.

From the Omicron and siblings front

The Wall Street Journal reports the following good news

Moderna Inc. said a modified [mRNA based] Covid-19 booster shot provided a stronger immune response than the company’s original vaccine against the Omicron variant in a new study. 

The Cambridge, Mass., company said Wednesday it will submit preliminary data from the study to U.S. health regulators in the coming weeks with the hope of making the modified booster shot available in late summer.

Researchers found that the levels of neutralizing antibodies against Omicron among people getting the modified shot were 1.75 times higher than in people who received a booster shot of the original vaccine, Moderna said.

and

AstraZeneca PLC said a study found its Covid-19 antibody treatment cut the risk of severe disease when given soon after symptoms develop, paving the way for its broader use.

The development comes at a time when the use of antibody treatments—once a mainstay for patients at high risk of developing severe Covid-19—has been complicated by the rise of the Omicron family of variants, which are less susceptible to some of the treatments. The treatments also face fierce competition from the more-convenient antiviral pills.

AstraZeneca’s antibody drug, called Evusheld, was found in its latest clinical trial to ward off severe disease in people who had already developed symptoms, according to results published late Tuesday in the Lancet Respiratory Medicine. The trial was conducted prior to the rise of the Omicron variant, but AstraZeneca has said that laboratory testing shows the antibody continues to work against the highly infectious strain.

The Food and Drug Administration released a revised checklist for prescribing the Pfizer Covid pill Paxlovid. While the checklist is intended for healthcare provider reference, it could be helpful to patients and health plans as well.

From the unusual virus front, STAT News offers an interesting article on how the hard lessons of the AIDS virus is shaping the U.S. response to monkeypox. The article notes

  • “[T]he monkeypox strain now in circulation is infinitesimally milder than HIV — zero fatalities have been reported out of the more than 1,000 cases so far.”
  • “Monkeypox isn’t transmitted sexually but by close contact with the disease’s hallmark pustules.”

From the Rx coverage front, Medpage Today informs us

The combination GIP and GLP-1 receptor agonist tirzepatide (Mounjaro [manufactured by Eli Lilly]) could soon be the next new treatment option for people with overweight or obesity, researchers reported.

In the 72-week, phase III SURMOUNT-1 clinical trial, people with obesity, but without diabetes, on 15 mg of the once-weekly injectable had a mean percentage change in weight of -20.9% (95% CI -21.8 to -19.9%) versus -3.1% (95% CI -4.3 to -1.9) with placebo, according to Ania M. Jastreboff, MD, PhD, of the Yale University School of Medicine in New Haven, and colleagues.

and

An open-source automated insulin delivery (AID) system — also known as a do-it-yourself system — was both safe and effective for patients with type 1 diabetes, according to the CREATE trial.

Over 24 weeks, users of the AID system spent more time in target glucose range (70 to 180 mg/dL) — an average of 14% longer — than those who were using sensor augmented pump therapy without automation, reported Martin de Bock, PhD, of the University of Otago in Christchurch, New Zealand, during a presentation at the American Diabetes Association (ADA) annual meeting.

The open-source AID system consists of the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone, paired with the DANA-i insulin pump and Dexcom G6 continuous glucose monitor. The researchers previously published additional information on the ins and outs of the algorithm in the Journal of Diabetes & Metabolic Disorders.

“Open-source AID, despite not being [FDA] regulated … is safe and efficacious in children and adults with type 1 diabetes compared to sensor augmented pump therapy,” de Bock noted. 

The American Diabetes Association offers more details on this significant development here.

From the transparency front, the Wall Street Journal tells us

Two Georgia hospitals on Wednesday were hit with federal financial penalties for failing to disclose their prices, marking the first such enforcement action taken under federal rules that have met with uneven compliance since taking effect in January 2021.

The Centers for Medicare and Medicaid Services (CMS), which is responsible for enforcing the rules, levied fines on Northside Hospital Atlanta and Northside Hospital Cherokee. The two hospitals, which are owned by Northside Hospital, together face penalties totaling roughly $1.1 million.

Perfect timing; right before the enforcement period for the transparency in coverage rule applicable to health plans begins on July 1.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on UnsplashFr

From the Omicron and siblings front, the Wall Street Journal reports

Omicron Covid-19 variants BA.4 and BA.5 are on the rise in the U.S., adding two more highly contagious versions of the virus to the mix that has fueled a springtime surge in cases.

The closely related subvariants represented a combined 13% of U.S. cases for the week ended June 4, according to estimates the Centers for Disease Control and Prevention released on Tuesday. Evidence suggests the variants are yet-more contagious versions of Omicron, public-health experts said, that may be able to evade some of the immune protections people built up from infections triggered by another version of Omicron during the winter.

The spread of the subvariants could at least prolong the time it takes to emerge from the current wave fueled by other versions of Omicron, some health experts said.

The Journal adds

This case wave hasn’t translated to a significant surge in severe illness. Hospitalizations, while up, remain far below earlier peaks, and reported Covid-19 deaths have recently hovered near historically low levels.  * * * Epidemiologists believe built-up immunity from vaccines and prior infections have bolstered defenses against severe illness, even though many people are falling ill from both breakthrough and repeat infections.

AHIP informs us

Today the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant emergency use authorization (EUA) for the Novavax COVID-19 vaccine in adults by a vote of 21-0.

The Committee reviewed data from Novavax showing that the benefits of the two-dose primary series outweigh the potential risks. The Committee noted the importance of making a vaccine available that has an alternative method of action, different from the mRNA vaccines currently available in the U.S., in the hope that a more traditional vaccine may appeal to those currently unvaccinated and those who may have an allergy to the components of the mRNA vaccines.

Committee members agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation, though the company has argued there’s not yet enough evidence to establish a definitive link. The FDA is expected to make a decision on granting Novavax an EUA soon, whereby the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to determine when and how the vaccine should be administered.

BioPharma Dive tells us

Pfizer on Monday announced plans to invest $120 million in a drug manufacturing facility located in Kalamazoo, Michigan, which will lead to the creation of over 250 jobs.

The investment is aimed at accelerating production of Pfizer’s COVID-19 pill Paxlovid, demand for which has risen after Pfizer’s initial struggles to make sufficient quantities following the drug’s clearance in December. To date, Pfizer has delivered 12 million courses of the drug across 37 countries, 5 million of which have been shipped to the U.S.

The Kalamazoo plant, one of Pfizer’s largest drugmaking sites, will make the starting materials and active ingredient contained within Paxlovid. The new investment expands the site’s capacity, making it one of the world’s largest producers of pharmaceutical ingredients, according to Pfizer.

From the Rx coverage front, the Federal Trade Commission announced

The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. * * *

The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:

** fees and clawbacks charged to unaffiliated pharmacies;

** methods to steer patients towards pharmacy benefit manager-owned pharmacies;

** potentially unfair audits of independent pharmacies;

** complicated and opaque methods to determine pharmacy reimbursement;

the prevalence of prior authorizations and other administrative restrictions;

** the use of specialty drug lists and surrounding specialty drug policies;

** the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

The Commisioners voted 5-0 to commence the investigation. Responses from the PBMs to the FTC’s compulsory orders are due in 90 days.

From the Pride Month front, Health Payer Intelligence reports “Members of the LGBTQ+ community reported varying experiences of discrimination in the health insurance industry but indicated that payer health equity may be improving, according to a survey from Healthcare.com.” Survey details are available in the article and the survey.

From the miscellany department

  • The American Medical Association offers expert guidance on understanding blood pressure readings.
  • The Centers for Disease Control explains the connection between diabetes and the brain.

Anthem has partnered with Happify Health to offer a slate of new digital tools for women’s health.

Happify’s platform is based on “sequences,” or digital experiences that it uses to support specific medical conditions. These sequences combine evidence-based digital therapeutics, online communities, coaching and tailored local resources in one unified platform.

Happify’s sequences are able to integrate with existing systems and solutions for ease of navigation, according to the announcement.

Everyone deserves access to mental health support that is effective and affordable. With more Americans than ever seeking help for mental health concerns, AHIP conducted a nationwide survey to understand people’s experience accessing care, whether their treatment was covered by insurance, and if insured patients were satisfied with the results. The findings reveal that nearly all respondents who sought mental health care for themselves or someone within their household over the past 2 years received treatment, and 3 in 4 insured Americans (73%) found it easy to get the care they needed. More than two-thirds of respondents were able to find an appointment with a provider in less than a month. In addition, 9 in 10 reported being satisfied with the mental health support they received, including half who say they were very satisfied.

Monday Roundup

David Ermer–Congress, COVID vaccine mandate, COVID-19, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Medpage Today suggests that prior authorization practices are under Congress’s spotlight.

From the Omicron and siblings front–

  • The Wall Street Journal offers an interesting report on the ups and downs of Omicron and its siblings.
  • Govexec tells us about recent Safer Federal Workforce changes to “its COVID-19 protocols to draw more distinctions between the policies for vaccinated and unvaccinated workers, including those related to travel and paid leave.”

From the federal employment front, the Society for Human Resource Management explains how the federal government is “struggling mightily to recruit, retain and develop the talent it needs to succeed and earn the reputation of being a “model employer.” Agencies and their HR leaders are working to upgrade antiquated systems and processes. The new-hire process currently takes an average of 100 days to complete, double that of the private sector.” Good luck.

From the Rx coverage front, Prime Therapeutics announced last week

Leading pharmacy benefit manager (PBM) Prime Therapeutics LLC (Prime) analyzed its real-world data to assess clinical outcomes and drug waste differences between medically integrated dispensing (MID) and central specialty pharmacy dispensing of oral cancer therapies. This study of a Prime pilot program showed a potential average savings opportunity of $1,800 per medication dose change at a MID pharmacy compared to a central fill specialty pharmacy. Results reinforced Prime’s position of the advantages of the MID model, on which its IntegratedRx™ program is based.

With the MID model, care providers – including doctors and pharmacists – have access to prescribing history, test results and other important patient information in the EMR. This coordination informs the care team earlier than the traditional model. This early look has potential to help lower the number of 30-day prescriptions going to waste.

Prime’s MID pilot program was implemented in early 2021 within three oncology practices and across three Blue Plans’ commercially insured lives to prove the potential care and cost advantages with this distinct model compared to a centralized specialty pharmacy model. Study participants were prescribed oral drugs that did not require dispensing and shipment from a payer-directed specialty pharmacy to the oncologist (aka white bagging).

From the studies department —

  • Health Payer Intelligence informs us “More consumers reported that their health plans are offering transparency tools and overall consumer awareness about the availability of transparency tools has grown, according to a study conducted on behalf of HealthSparq.”
  • MedPage Today discusses a study finding that weight loss, even when achieved by bariatric surgery, will reduce the risk of obesity-related cancer. The FEHBlog wonders if weight loss produced by the current, effective weight loss drugs would have a similar health impact.
  • mHealth Intelligence notes that “To reduce the amount of time spent in a virtual waiting room, researchers from the University of California San Diego conducted a pilot that used text messaging to provide patients with a meeting link when their provider was ready to see them, finding it to be a successful alternative.”
  • The New York Times reports on a GlaxoSmithKline “checkpoint inhibitor” drug trial conducted on eighteen rectal cancer patients. The drug wiped out the cancer in all of those patients. Quite amazing. According to the Times experts indicate that the trial needs to be replicated.
  • BioPharma Dive reports “Twenty-four years ago, a drug called Herceptin changed how doctors treat breast cancer. Its approval in 1998 made it possible to target the aggressive breast tumors tied to a gene called HER2. Other drugs quickly followed Herceptin and, over the years since, have substantially improved survival for people with the disease. A quarter of a century later, another shift in treatment could be on the horizon. At the American Society of Clinical Oncology meeting, AstraZeneca and Daiichi Sankyo are presenting results proving that, for the first time, a targeted medicine can help metastatic breast cancer patients whose tumors express only low levels of HER2. Clinical trial data revealed at ASCO and published in The New England Journal of Medicine Sunday show the drug, Enhertu, halved the risk of cancer progression compared to chemotherapy and reduced the risk of death by 36%.”
  • The Guardian tells us “Taller people have an increased risk of peripheral neuropathy, as well as skin and bone infections, but a lower risk of heart disease, high blood pressure and high cholesterol, according to the world’s largest study of height and disease. A person’s height raises and reduces their risk of a variety of diseases, according to the research led by Sridharan Raghavan of the Rocky Mountain Regional VA Medical Center in the US. The findings are published in the journal PLOS Genetics.”

From the potpourri department, check out this NIH Newsletter for June 2022.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, SCOTUS, Telehealth, U.S. Healthcare–

Congress is back on Capitol Hill this week for floor voting and Committee business. Roll Call notes

Lawmakers return next week for a busy June, with Senate Republicans tested by politically wrought gun talks and President Joe Biden dealing with a spate of crises and headaches.

The Hill identifies the five “looming disputes” out of 33 pending disputes that the Supreme Court is expected to decide this month which typically is the last month of its October 2021 Term. Although not found among the Hill’s cases, here’s a Medicare secondary payer act case that has not been decided yet and could impact FEHBP.

Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., No. 20-1641 [Arg: 03.1.2022 Trans./Aud.] 

Issue(s): (1) Whether a group health plan that provides uniform reimbursement of all dialysis treatments observe the prohibition provided by the Medicare Secondary Payer Act that group health plans may not “take into account” the fact that a plan participant with end stage renal disease is eligible for Medicare benefits; (2) whether a plan that provides the same dialysis benefits to all plan participants, and reimburses dialysis providers uniformly regardless of whether the patient has end stage renal disease, observe the prohibition under the Medicare Secondary Payer Act that a group health plan also may not “differentiate” between individuals with end stage renal disease and others “in the benefits it provides”; and (3) whether the Medicare Secondary Payer Act is a coordination-of-benefits measure designed to protect Medicare, not an antidiscrimination law designed to protect certain providers from alleged disparate impact of uniform treatment.

From the Omicron and siblings front —

The Wall Street Journal reports

The latest Covid-19 wave in the U.S. has shifted westward, hitting places like the San Francisco area, while pressure eases in recent Northeast hot spots.

The Western U.S. region, which includes mountain and coastal states, has recently eclipsed the Northeast to have the nation’s highest rate of known cases per 100,000 people, a Wall Street Journal analysis of CDC data shows. Recent increases in parts of the West come amid declines in the Northeast.

NPR Shots provides more background on the Novovax Covid vaccine that the FDA advisory committee will consider for emergency use authorization this Tuesday. NPR Shots adds

The federal government is trying to decide what kind of booster people should get in the fall to try to blunt the severity of a possible new wave of infections next winter. The panel of FDA advisers will meet late this month to consider which strains of the coronavirus should be targeted by updated vaccines.

From the mental health coverage front, the American Hospital Association released a TrendWatch about the pandemic’s adverse impact on mental health. Also, Healthcare Dive informs us that while telehealth use dropped in February and March 2022, according to a Fair Health study,

Teletherapy continued to remain robust, snagging the top procedure spot for telehealth visits in March and representing 26% of virtual claim lines, the report noted. Mental health conditions claimed 65% of diagnoses across all regions. Likewise, social workers remained the most popular specialty in telehealth claims for the second month in a row.

From the value-based care front, Health Payer Intelligence discusses how payers can move providers away from fee-for-service contracts to value-based contracts. It’s worth a read.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the month, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 22nd week of 2022:

The CDC’s weekly review of its Covid statistics explains “As of June 1, 2022, the current 7-day moving average of daily new cases (100,684) decreased 8.5% compared with the previous 7-day moving average (110,081).”

Here’s the CDC’s current chart of new Covid hospitalizations:

The CDC’s weekly statistical review notes that “The current 7-day daily average [of new Covid hospitalizations] for May 25–31, 2022, was 3,789. This is a 4.7% increase from the prior 7-day average (3,619) from May 18–24, 2022.

Here’s the FEHBlog’s weekly chart of new Covid deaths from the 27th week of 2021 through the 22nd week of 2022:

The CDC’s weekly statistical review adds “The current 7-day moving average of new deaths (244) has decreased 23.1% compared with the previous 7-day moving average (318).” 

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in December 2020 through the 22nd week of 2022.

According to the CDC’s weekly statistical review,

Overall, about 258.7 million people, about 221.4 million people, or 66.7% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 103.5 million people have received a booster dose,** but 49.0% of the total booster-eligible population has not yet received a booster dose. As of June 1, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 343,662, a 9.5% decrease from the previous week.

To wrap up the statistic review, the CDC’s weekly statistical review tells us

As of June 2, 2022, there are 240 (7.45%) counties, districts, or territories with a high COVID-19 Community Level, 733 (22.76%) counties with a medium Community Level, and 2,247 (69.78%) counties with a low Community Level. This represents a slight (−0.53 percentage points) decrease in the number of high-level counties, a small (+1.37 percentage points) increase in the number of medium-level counties, and a corresponding (−0.84 percentage points) decrease in the number of low-level counties. Fifty-one (98.1%) of 52 jurisdictions had high- or medium-level counties this week.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

In other Covid news

The Wall Street Journal reports

Novavax Inc.’s vaccine was 90% effective at preventing Covid-19 in its pivotal trial, but the performance came before the emergence of the Omicron variant that has eluded vaccines more than earlier strains, U.S. health regulators said.

The Food and Drug Administration also expressed concern Friday that six people developed heart-inflammation conditions known as myocarditis and pericarditis, out of about 40,000 people who had taken Novavax’s vaccine during various studies. 

The agency released its evaluation of Novavax’s Covid-19 vaccine ahead of a meeting of outside advisers who are scheduled to discuss next week whether the agency should recommend authorization of the shot.

The FDA staff’s appraisal suggests the vaccine could face a tough round of questioning from advisers weighing the shot’s uncertain efficacy against Omicron with potential heart risks.

This suggests an unfortunate outcome. The Novovax vaccine was developed using a traditional approach may be acceptable to the vaccine inquisitive.

In healthcare business news

  • Health Leaders Media informs us “Health insurers are not holding up their end of the bargain on mutually accepted prior authorization reforms, according to a new physician survey by the AMA.” The FEHBlog is growing concerned that the AMA is winning the prior authorization war.
  • Fierce Healthcare tells us “Optum has invested heavily in building out its provider enterprise. But executives at UnitedHealth Group say it’s still early days for the endeavor.”
  • Healthcare Dive reports “The Federal Trade Commission is suing to block two separate hospital mergers, the agency said Thursday. The FTC has sued to block HCA Healthcare’s acquisition of Steward Health Care System, alleging that the deal would reduce competition in Utah and ultimately raise prices. In another suit, the FTC is moving to block RWJBarnabas Health from acquiring Saint Peter’s Healthcare in New Jersey, alleging ‘overwhelming evidence’ that the deal would harm patients in the form of less choice and higher prices.”
  • The Healthcare Dive article adds

The FTC has now challenged numerous hospital deals this year following its latest action.

Rhode Island’s two largest health systems abandoned plans to merge in February about a week after the FTC sued to block the deal.

New Jersey’s largest health system, Hackensack Meridian Health, lost its appeal challenging the FTC’s move to prevent a tie-up with Englewood Hospital, one of the last independent hospitals in the area.

Bristol Myers Squibb is buying biotech Turning Point Therapeutics, announcing Friday a $4.1 billion deal that will give the pharmaceutical company an experimental drug that targets mutations found in lung cancer and other solid tumors.

The deal values Turning Point at $76 a share, more than double the $34.16 at which shares closed on Thursday and four times the biotech’s $18 initial public offering price in 2019. Yet the buyout price is well below the company’s peak of $133 a share in February 2021, which gave it a market value of $6.6 billion.

The company’s lead drug, called repotrectinib, has advanced through Phase 2 testing in lung cancer patients whose tumors harbor a mutation called ROS1. Repotrectinib would compete against Roche’s Rozlytrek, if approved. Bristol Myers expects to gain Food and Drug Administration clearance in the second half of 2023.

That’s a lot of money.

From the studies department

Fierce Healthcare points out

As the industry puts a focus on mental health coming out of COVID-19, a new study suggests that loneliness may be a key place to start.

Research from Cigna and Morning Consult finds that more than half (58%) of U.S. adults would be considered lonely. This is on par with pre-pandemic research, which found that 61% of adults are lonely, and made for a seven percentage point increase from 2018.

Loneliness and mental health issues are closely linked, according to the study. Adults with mental health concerns were twice as likely to feel lonely compared to those with strong mental health. The study also found that minorities and younger people were also more likely to be dealing with loneliness.

Three-quarters (75%) of Hispanic adults and 68% of Black adults are classified as lonely, according to the study, figures both substantially higher than the rate of loneliness in the general population. Seventy-nine percent of adults aged 18 to 24 said they feel lonely, compared to 41% of seniors aged 66 and over.

The FEHBlog wishes his readers a weekend full of family and friendship.

Thursday Miscellany

David Ermer–COVID-19, Federal employment benefits, Medicare, Rx coverage, Telehealth–

From Washington, D.C., and “Following a meeting of the Social Security and Medicare Boards of Trustees, the U.S. Department of the Treasury—joined by Departments of Health and Human Services and Labor, the Centers for Medicare & Medicaid Services, and the Social Security Administration—released the annual Social Security and Medicare Trustees Reports.” Here is a link to the government’s fact sheet on those reports.

The American Hospital Association explains

The Medicare Hospital Insurance Trust Fund will have sufficient funds to pay full benefits until 2028, according to the latest annual report released today by the Medicare Board of Trustees.

That’s two years later than last year’s report. The HI Fund, known as Medicare Part A, helps pay for inpatient hospital services, hospice care, and skilled nursing facility and home health services following hospital stays.

HI income is projected to be higher than last year’s estimates because both the number of covered workers and average wages are projected to be higher, according to the report. In addition, HI expenditures are projected to be lower than last year’s estimates in the beginning of the short-range period mainly due to the pandemic but are projected to become larger after 2023 due to higher projected provider payment updates.

“There is substantial uncertainty in the economic, demographic, and health care projection factors for HI trust fund expenditures and revenues,” the report notes. “Accordingly, the date of HI trust fund depletion could differ substantially in either direction from the 2028 intermediate estimate.”

From the Omicron and siblings front

Bloomberg Prognosis reports

More than two-thirds of the world’s population probably have significant levels of Covid-19 antibodies, meaning they have either been infected or were vaccinated, the World Health Organization said. 

So-called seroprevalence rates surged to 67% in October from 16% in February of 2021, the WHO said, in a summary of studies from around the globe. Given the emergence of the fast-spreading omicron variant, the figure is probably even higher now.

The National Institutes of Health (NIH) announced

A large randomized, placebo-controlled clinical trial led by the National Institutes of Health shows that treating adults hospitalized with COVID-19 with infliximab or abatacept – drugs widely used to treat certain autoimmune diseases – did not significantly shorten time to recovery but did substantially improve clinical status and reduce deaths.

That’s a good trade-off.

From the federal employee benefits front

  • OPM released a proposed Federal Long Term Care Insurance Program rule today. The rule indicates that OPM is planning a suspension of enrollments in this Program. “For example, it may be appropriate to suspend applications to allow a period of time for revisions to underwriting processes or for premium repricing after a review of actuarial assumptions, in order to ensure that premium rates reasonably and equitably reflect the cost of the benefits provided as required by the statute and to ensure that OPM can provide eligible individuals with the information needed to enable them to fully evaluate the advantages and disadvantages of obtaining LTCI under FLTCIP.” (pp. 4-5). The public comment deadline is expected to be July 2, 2022.
  • Benefits consultant Tammy Flanagan responds in Govexec to reader questions about “about choosing when to retire in order to maximize the impact of both the annual cost-of-living adjustment to retirement benefits and the yearly federal employee pay increase.” Check it out.

From the transparency front

Roll Call discusses the progress of the hospital industry in achieving compliance with the federal government’s pricing transparency rule which became enforceable eighteen months ago.

While most hospitals have been willing to follow parts of the rule — namely, a requirement that they post user-friendly lists or tools to help patients shop for services — they have been less compliant with a requirement that they post “machine readable” files of standard charges — data that experts say would be far more useful in driving down costs.

That’s an intriguing factoid because the federal government’s health plan transparency rule’s similar requirement to post three “machine readable” files of claim payments data becomes enforceable on July 1, 2022.

From the Rx coverage front, Healthcare Dive informs us

* Rite Aid is the latest pharmacy giant to step into clinical care delivery through a new partnership with rural home care startup Homeward.

* Under the deal announced Tuesday, Rite Aid pharmacists will direct eligible customers to Homeward’s clinical services, including annual wellness visits, health screenings, diagnostic testing, virtual visits and in-home care. Homeward will also be able to park its mobile clinician units at Rite Aid’s rural locations, with the goal of allowing senior customers to see a provider and pick up their prescriptions in one visit.

* Homeward will provide in-network services, including specialty care beginning with cardiology, in the third quarter this year for patients covered by Medicare and Medicare Advantage plans. The companies are starting the partnership in Michigan, with the opportunity to expand to Rite Aid’s 700 rural locations across the U.S. over time.

From the telehealth front, Healio tells us

Telemedicine could be as effective as in-person medicine in evaluating pediatric genetic disorders, according to a study published in Pediatrics.

The study is the latest in a string of investigations examining clinicians’ and patients’ experiences in telemedicine following its widespread implementation during the COVID-19 pandemic. Evidence has suggested that telemedicine could significantly reduce costs for certain patients, but also that patients and practitioners may prefer in-person visits.

Midweek update

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

From Capitol Hill, A bipartisan PBM transparency bill was introduced by Senators Maria Cantwell (D Wash) and Charles Grassley (R Iowa) last week.

Sens. Chuck Grassley (R-Iowa), ranking member of the Judiciary Committee, and Maria Cantwell (D-Wash.), chair of the Committee on Commerce, Science and Transportation, have introduced legislation that would empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.

The Pharmacy Benefit Manager Transparency Act of 2022 would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.

Healthcare Dive reports on a recent study supporting the goals of this bill.

From the Omicron and siblings front

Bloomberg Prognosis informs us

Turns out a third dose of messenger RNA vaccine provides a key boost to immunity against Covid regardless of the original shot.

That’s what scientists from the Chinese University of Hong Kong found after scouring 53 studies that contained at least 24 different vaccine regimens. 

Three mRNA doses offered the best protection against infection, the researchers found, though just one of those shots as a booster after other types of Covid-19 vaccines worked almost as well. 

The Wall Street Journal tells us

Pfizer Inc. and partner BioNTech SE asked U.S. health regulators to authorize three doses of their vaccine for children under 5 years.

The request Wednesday to the Food and Drug Administration comes after the companies said last month that three doses of the shot were 80% effective at preventing symptomatic Covid-19 and generated a robust immune response in children ages 6 months to 5 years old.

The Pfizer-BioNTech vaccine was also found to be safe and well-tolerated among the children in studies, according to the companies.

FDA clearance could come before the end of the month. If the Centers for Disease Control and Prevention signs off, the last remaining group of people in the U.S.—roughly 19 million young children—would get access to shots at doctors’ offices, pharmacies and other locations.

The FDA is scheduled to consider the Pfizer and Moderna emergency authorization requests for mRNA Covid vaccinations for children aged six months to five years.

The National Institutes of Health reveals

A National Institutes of Health-funded study has found that people with food allergies are less likely to become infected with SARS-CoV-2, the virus that causes COVID-19, than people without them. In addition, while previous research identified obesity as a risk factor for severe COVID-19, the new study has identified obesity and high body mass index (BMI) as associated with increased risk for SARS-CoV-2 infection. In contrast, the study determined that asthma does not increase risk for SARS-CoV-2 infection.

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) study also found that children ages 12 years or younger are just as likely to become infected with the virus as teenagers and adults, but 75% of infections in children are asymptomatic. In addition, the study confirmed that SARS-CoV-2 transmission within households with children is high. These findings were published today in the Journal of Allergy and Clinical Immunology.

From the healthcare business front

Fierce Healthcare reports

Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday.

Sources told the news outlet that the purchase from Webster Equity Partners would earn HCAT a $300 million enterprise value and earnings before interest, taxes, depreciation and amortization in the high teens. UnitedHealth Group, Optum’s parent company, has made overtures to purchase HCAT in the past, according to the report.

HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.

Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.

N.B. The FEHBlog is in Dallas today!

Fierce Biotech tells us

GSK is betting big to reenergize its fight for a share of the pneumococcal vaccine market, agreeing to pay $2.1 billion upfront to acquire Affinivax for a challenger to Pfizer’s blockbuster Prevnar franchise.

The British Big Pharma already has an approved pneumococcal vaccine, Synflorix, but has failed to turn it into a true rival to Pfizer’s incumbent. Sales of Synflorix fell (PDF) to 357 million pounds sterling ($450 million) last year, while the Prevnar range of vaccines still topped (PDF) $5 billion in the face of COVID-related headwinds and the timing of government purchases. Last year’s approval of Merck & Co.’s Vaxneuvance further intensified competition. 

From the studies department

  • Forbes informs us “The U.S. spends twice as much on cancer care than average for high-income countries but mortality rates are only slightly better than average for these countries, according to a new study.”
  • Fierce Healthcare reports on a Kaiser Family News projection of 2022 insurer rebates required by the Affordable Care Act.

Kaiser’s analysis—which is based on data reported by insurers to state regulators—predicts that individual market insurers will have to pay out $603 million in rebates for 2022, with small group markets sending out $275.5 million and $168.1 million for large group plans. The final rates will be released later this year.

The $603 million for individual market plans, which includes the ACA’s exchanges, is far below the $1.3 billion in rebates for 2021 and $1.7 billion for 2020.