Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Omicron and siblings front —

MedPage Today brings us up to date on the whereabouts of Omicron BA 2.12.1.

“What we’re seeing right now is a version of the virus that is much more transmissible than previous versions of the virus, perhaps, but also less likely to cause severe disease,” Perry Halkitis, PhD, MPH, dean of the Rutgers School of Public Health, told MedPage Today.

The FEHBlog heard a fascinating talk about the Long Covid or PASC on the second and final day of the 2022 OPM AHIP Carrier Conference. Dr. Micheal Brode explained that PASC usually is evidenced by fatigue, brain fog, or exertional fatigue more than 12 weeks after the first symptoms of Covid. People afflicted by PASC typically, but not always, were hospitalized when Covid was in its acute opening phase. Covid vaccinations reduce the risk of contracting PASC by at least 50%, but they don’t prevent PASC. Although it’s premature for evidenced-based treatment guidelines to exist, Dr. Brode complimented the work of the PASC Collaborative to get to that point expeditiously. Most PASC patients recover slowly with medical care, although some PASC patients have permanent disabilities. Dr. Brode reminded the audience that Covid is a multi-system disease, not only a lung disease. PASC’s recently added ICD-10 code is U09.9.

The American Hospital Association adds, “Moderna today asked the Food and Drug Administration to authorize for emergency use its COVID-19 vaccine in children aged six months through 5 years, citing previously released data estimating the vaccine’s efficacy against the omicron variant in this age group was similar to that in adults, with a favorable safety profile.”

From the Affordable Care Act front, the ACA regulators released the final 2023 notice of benefit and payment parameters and the Final 2023 Actuarial Value Calculator and Methodology. Fierce Healthcare highlights the significant changes facing ACA qualified health plans in 2023.

From the healthcare business front —

Humana has released its 1st Quarter 2022 earnings. Fierce Healthcare provides background on the favorable report.

Fierce Healthcare informs us, “Walmart’s telehealth provider, MeMD, is rolling out the virtual diabetes program as a standalone service or as part of a comprehensive medical and behavioral telehealth program for enterprise customers and health plans. The retail giant collaborated with the American Diabetes Association on the virtual program, which was developed to help employees and members close gaps in diabetes management through early intervention, Walmart Health executives said.”

From the drug research front, BioPharma Dive tells us

Eli Lilly’s experimental diabetes shot tirzepatide helped obese people who have an underlying medical condition lose more than 15% of their body weight in a late-stage clinical trial. At the highest dose tested, patients receiving the weekly injection lost, on average, 21% of their body weight, Lilly said in a press release Thursday.

The data suggests tirzepatide could challenge similar drugs marketed by Danish drugmaker Novo Nordisk, which earned about $1.2 billion when prescribed for obesity in 2021. Novo’s weekly weight-loss shot Wegovy helped patients with medical complications lose an average of 15% of their body weight in clinical testing.

Wall Street analysts forecast swift growth for obesity drugs in coming years as patients, doctors and insurers acknowledge the effectiveness of newer agents like Wegovy and tirzepatide. Wegovy sales alone are expected to reach $5.5 billion in 2026, according to consensus estimates highlighted by Cantor Fitzgerald analyst Louise Chen in January.

From the federal employment front —

The U.S. Office of Personnel Management (OPM) released government-wide results of the 2021 OPM Federal Employee Viewpoint Survey (OPM FEVS). Federal News Network summarizes the results as follows:

Change is the biggest constant for the federal workforce after two years in a pandemic that capsized government operations. Despite the upheaval, employee engagement remained relatively steady over the last year, dropping just one point between 2020 and 2021, from 72% down to 71%.

But other factors, like employees’ job and pay satisfaction, declined in 2021 compared to 2020. The overall index points for global satisfaction dropped as well, from 69% down to 64%.

Govexec notes

As part of his fiscal 2023 budget proposal, [President] Biden proposed an average pay increase of 4.6% for civilian federal workers and members of the military, which, if implemented, would mark the biggest raise the federal workforce has seen in 20 years. Although it is unclear how that raise would be broken up between across-the-board increases to basic pay and an average boost to locality pay, traditionally, 0.5% of the pay raise has been set aside for locality pay increases.

In a letter, [62] House Democrats led by Rep. Gerry Connolly, D-Va., pressed the leadership of the House Appropriations Committee to go further than the president and endorse a 5.1% average pay increase for feds, reflecting legislation introduced by Connolly and Sen. Brian Schatz, D-Hawaii, that would grant federal employees a 4.1% across-the-board boost to basic pay and a 1.0% average increase in locality pay.

And don’t forget that this Saturday, April 30, is National Prescription Drug Take-Back Day.

Monday Roundup

Photo by Sven Read on Unsplash

From the No Surprises Act front, the FEHBlog nearly fell off his chair when he noticed this Healthcare Dive article:

The Department of Justice intends to appeal a federal judge’s ruling that sided with providers over a challenge to the surprise billing rule, according to a Friday filing from the DOJ in the Eastern District of Texas.  

The Texas Medical Association sued the federal government over its interpretation of the No Surprises Act, arguing the rule leans too heavily on one factor arbiters are supposed to consider when resolving payment disputes between payers and providers.      

Federal Judge Jeremy Kernodle’s February ruling said nothing in the bill passed by Congress instructs arbiters to “weigh any one factor … more heavily than the others,” indicating the rule conflicts with the bill.

The Justice Department noticed an appeal to the Fifth Circuit in the referenced Friday, April 22, filing with the District Court. That notice effectuates the appeal. The FEHBlog will keep an eye on the dockets to learn whether the Justice Department will seek a stay of the February ruling while the case is on appeal.

From the Omicron and siblings front —

  • Bloomberg’s Prognosis reviews progress being made in the development of Covid vaccines administered nasally. Nasal vaccines have a better shot at preventing COVID than injected vaccines.
  • The American Hospital Association reports “The Food and Drug Administration today expanded its approval for remdesivir (Veklury) to include pediatric patients under age 12 who test positive for SARS-CoV-2 and are hospitalized or at high risk of progressing to severe COVID-19. The patient must be at least 28 days old and weigh at least 3 kilograms (about 7 pounds). FDA said the approval is supported by a clinical study of 53 pediatric patients as well as trials in adults, given the similar course of disease in adult and pediatric patients.”
  • Medical Dialogues informs us the World Health Organization has recommended Pfizer’s Paxlovid Covid pill over remdesvir, Merck’s pill and monoclonal antibodies for patients with milder forms of Covid and nevertheless at high risk of hospitalization from the disease, e.g. the elderly, the immunocompromised, and the unvaccinated.
  • WebMD News tells us “COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the CDC said Friday. * * * The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.”

The WebMD article offers other interesting public health nuggets. For example,

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the U.S. last year. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of .7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

From the healthcare business front, Fierce Healthcare reports

Change Healthcare has found a buyer for its payment integrity arm, ClaimsXten, though the sale is contingent on the closure of its merger with UnitedHealth Group.

According to a filing submitted Monday to the Securities and Exchange Commission, ClaimsXten will be sold off to an affiliate of TPG Capital for a base purchase price equal to $2.2 billion in cash. UnitedHealth is listed as the seller.

From the reports department —

  • The National Bureau of Economic Research offers a working paper titled “Pharmacy Benefit Managers and Vertical Relationships in Drug Supply: State of Current Research.”
  • Per HR Morning, “Employer support [of their workforces] is happening in the areas of increased prioritizing employee assistance programs (EAPs), expanded wellness benefits and greater attention to work/life balance. That’s according to Ragan’s 2022 Communications Benchmark Report that surveyed close to 1,000 communicators across industries on opportunities and changes.”
  • Per Health Payer Intelligence, Humana has produced an issue brief that provides “an overview of the policymaking landscape surrounding social determinants of health data collection.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

Today is Earth Day. AHRQ offers “A new AHRQ Views blog post in recognition of Earth Day 2022 highlights the Agency’s emerging efforts to reduce the impacts of climate change.”

From the FEHB front, Fedweek warns federal employees to think hard before rejecting FEHB coverage late in a career. As explained in the article you can lose out on one of the best fringe benefits for federal and postal employees — continuing their FEHB coverage into retirement with the full government contribution.

From the Omicron and siblings front —

STAT News informs us

Experts who advise the CDC met yesterday to discuss a thorny issue: Covid vaccine boosters, specifically the new policy to allow people 50 and older and people who are immunocompromised to get a second booster. By the end of the meeting — during which members of the Advisory Committee on Immunization Practices expressed frustration with the lack of clarity about the goal of the U.S. booster policy — it wasn’t entirely clear why people are being offered a second booster at this time. Data presented by CDC experts suggested the protection that immune-competent people have received from their primary series and first booster is holding up and the expected benefits from the fourth shots are modest at best. ACIP member Beth Bell raised concerns about “booster fatigue” and said offering another dose now could undercut confidence in vaccines that are working well at protecting people from severe Covid. The policy to offer the fourth doses was made without consulting ACIP.

What’s more,

Among the many views expressed around vaccine mandates, one theme persists: the idea that Covid-19 infection protects unvaccinated people against reinfection. While CDC says “getting a Covid-19 vaccination is a safer and more dependable way to build immunity to Covid-19 than getting sick with Covid-19,” a research letter in JAMA Network Open tested the concept of natural immunity by analyzing data from more than 121,000 patients receiving health care in the western U.S. from October 2020 through November 2021, before the Omicron variant took hold. Unvaccinated people who’d been sick with Covid had an 85% lower risk of acquiring Covid again compared to unvaccinated individuals without prior Covid. That level is similar to what mRNA vaccines deliver. Previous infection conferred 88% protection against hospitalization after reinfection and 83% protection against reinfection that did not require hospitalization. The authors conclude natural immunity works as well against both mild and severe illness. One difference: Natural immunity didn’t wane, but mRNA vaccines’ protection did. “This study may have important implications for vaccine policy and public health,” they write.

It is illogical to downplay natural immunity when the worst flu epidemic in U.S. history, the 2018 pandemic, was resolved by a combination of deaths and natural immunity. This is not intended to downplay vaccines. In the FEHBlog’s view, the CDC should be paying more attention to natural immunity from Covid.

From the Covid anti-fraud front, Healthcare Dive reports

The Department of Justice has charged 21 people across the U.S. for pandemic-related healthcare fraud, federal prosecutors said Wednesday.

Defendants — including doctors, medical business executives and fake vaccination card manufacturers — caused nearly $150 million in false billing to federal programs, the DOJ alleged.

The prosecution effort involves some of the “largest and most wide-ranging pandemic-related frauds detected to date,” said Kevin Chambers, the DOJ’s director for COVID-19 fraud enforcement.

From the Food and Drug Administration front —

The American Hospital Association tells us

The Food and Drug Administration seeks comments through June 21 on a potential change that would require outpatient settings to dispense opioid pain medications with prepaid mail-back envelopes and pharmacists to provide patient education on safe disposal of opioids.

“This potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would provide a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events,” the agency said.

Good idea. Also

Health care providers should not use non-invasive prenatal screening tests alone to diagnose genetic abnormalities due to the potential for false results, the Food and Drug Administration warned last week. Also known as cell-free DNA tests or non-invasive prenatal tests, these laboratory developed tests in most cases are not reviewed by the FDA.

“Patients and health care providers should be aware of the risks and limitations of using these genetic prenatal screening tests and that they should not be used alone to diagnose chromosomal (genetic) abnormalities,” FDA said, citing reports that some patients and providers have made critical health care decisions based on the results without additional confirmatory testing. 

From the Rx coverage front, STAT News reports

Thanks to Covid-19 vaccines and therapies, U.S. spending on pharmaceuticals rose 12% in 2021 as use reached record levels and new prescriptions for acute and chronic care largely recovered from the slowdown seen during the pandemic, according to a new analysis.

Meanwhile, out-of-pocket costs paid by patients hit $79 billion, a $4 billion rise from the year before and the same level seen in 2018 after two years of declining costs. Overall, these costs were relatively low — less than $20 per prescription — but about 1% of all prescriptions filled, or 64 million, ran patients $125, underscoring ongoing barriers to affordability. In fact, 81 million prescriptions were not filled last year.

“We’re not in a very different situation from where we were five years ago except for the intensified, competitive market dynamics. But there are no major changes from a major legislative or policy perspective,” said Murray Aitken, senior vice president and executive director of the IQVIA Institute for Human Data Science, which conducted the analysis.

He also noted that the overall use of health services has returned to pre-pandemic levels, but has not yet made up for the backlog in missed patient visits, screenings and diagnostics, elective procedures, and new prescription starts — which IQVIA called a “concerning gap in preventive and treatment services.”

From the opioid epidemic front, the White House announced today

President Biden sent his Administration’s inaugural National Drug Control Strategy to Congress at a time when drug overdoses have taken a heartbreaking toll, claiming 106,854 lives in the most recent 12-month period. The Strategy delivers on the call to action in President Biden’s Unity Agenda through a whole-of-government approach to beat the overdose epidemic.

The Strategy focuses on two critical drivers of the epidemic: untreated addiction and drug trafficking. It instructs federal agencies to prioritize actions that will save lives, get people the care they need, go after drug traffickers’ profits, and make better use of data to guide all these efforts.

Here is a link to the full report

Midweek Update

From the Centers for Disease Control front —

Roll Call informs us

The Centers for Disease Control and Prevention on Wednesday asked the Justice Department to appeal a federal judge’s ruling overturning the federal mask mandate for airlines and other forms of public transportation, setting up a legal battle that could permanently impact the CDC’s ability to weigh in on public health issues.

The Wall Street Journal adds

The judge’s ruling was the latest in a series of court decisions that have left the Biden administration with dwindling legal options for mandates to combat Covid-19. And it came amid a shift away from mask mandates in the U.S., even in Democratic-controlled states along the East and West coasts. An appeal gives the Biden administration the opportunity to persuade a higher court to wipe the Florida ruling off the books, which could prove useful to the White House if it chooses to pursue a mask mandate in the future.

The AP reports

A new U.S. government center [residing within the CDC] aims to become the National Weather Service for infectious diseases — an early warning system to help guide the response to COVID-19 and future pandemics.

The new Center for Forecasting and Outbreak Analytics launched Tuesday. Its leaders say predicting the course of the COVID-19 pandemic in the U.S. has been hampered by data-collection problems.

In contrast, the United Kingdom uses regular population sampling with swab tests and blood draws to get a clearer picture of who’s been infected, said Marc Lipsitch, the new center’s science director. He said similar sampling should be considered in the U.S.

And the Centers for Disease Control and Prevention needs to have better access to data from state governments and hospitals, said Caitlin Rivers, the center’s associate director.

From the Omicron front, STAT News discusses six Covid mysteries that scientists are beginning to unravel.

1. How will the virus evolve next?

2. What will future waves look like?

3. If you’ve never had Covid, how worried should you be right now?

4. How, exactly, does the virus transmit from person to person?

5. Will we get a new, better generation of vaccines, therapeutics, and tests?

6. How long before we understand long Covid?

“The eventual answers will determine our relationship with Covid and how we’ll fight a future pandemic.”

Reuters reports

Hospitalization rates for unvaccinated children ages 5 to 11 were twice as high as among those who were vaccinated during the record COVID-19 surge caused by the Omicron variant, according to a U.S. study released on Tuesday.

For every 100,000 unvaccinated children in the age group, 19.1 per were hospitalized with COVID-19 between mid-December and late February, compared with 9.2 per 100,000 vaccinated kids, the U.S. Centers for Disease Control and Prevention reported.

From the Social Determinants of Health front,

The Center for Medicare Services “outlined an action plan that demonstrates the Biden-Harris Administration’s ongoing efforts to provide high-quality, affordable health care for all people, regardless of their background, and to drive health equity across the Department of Health and Human Services (HHS).”

 “The goals of CMS’ action plan include:

  • Promoting culturally and linguistically appropriate services in organizations;
  • Enrolling more people in Medicare, Medicaid, the Children’s Health Insurance Program and Health Insurance Marketplace; and
  • Incorporating screening for and promoting broader access to health-related social needs.”

“For more information, please visit: www.cms.gov/sites/default/files/2022-04/Health%20Equity%20Pillar%20Fact%20Sheet_1.pdf

The CDC’s Division of Diabetes Translation called attention to its new website on improving health equity

From the No Surprises Act front, the American Medical Association offers an article on how doctors can use the NSA to resolve billing disputes. It’s always helpful to take a peek at the other sides’s strategies.

Cigna announced

Beginning in August, Kaiser Permanente commercial HMO and exclusive provider organization (EPO) members who need urgent care when they are traveling outside of areas served by Kaiser Permanente will have access to Cigna’s national PPO network of more than one million physicians and other providers. This will significantly expand Kaiser Permanente’s ability to provide more affordable and convenient access to valuable, high-quality health care and services for current and future members.

This is a smart move by KP to reduce its exposure to NSA emergency department billing disputes.

From the healthcare business front —

Cigna’s press release adds

In the area of specialty pharmacy services, the agreement seeks to deliver overall value and savings to Kaiser Permanente and its commercial plan members. Accredo, Evernorth’s specialty pharmacy, will become Kaiser Permanente’s preferred external pharmacy for limited distribution drugs, and Evernorth’s CuraScript SD will be a preferred distributor for purchasing certain other specialty products.

The broad agreement between Evernorth and Kaiser Permanente is effective immediately.

Forbes reports

Anthem’s first-quarter profits reached $1.8 billion thanks to strong enrollment in its Medicaid and Medicare Advantage plans. 

Anthem, which operates an array of government and commercial health insurance including Blue Cross and Blue Shield plans in 14 states, Wednesday reported first-quarter profits rose 8.4% to $1.8 billion, or $7.39 per share, compared to $1.67 billion, or $6.71 per share, in the year-ago quarter. Revenue rose nearly 17.6% to $38 billion compared to $32,4 billion a year ago.

Anthem’s membership grew by 3.3 million, or 7.5%, to 46.8 million as of March 31, 2022, compared to a year ago.

Beckers Payer Issues offers 11 takeaways from Anthem’s first-quarter 2022 earnings report.

The American Hospital Association reports

The Department of Health and Human Services today released a report and public data on 2016-2022 ownership changes for hospitals and nursing homes enrolled in Medicare.

According to the report, only 4.6% of hospitals were sold over the period. Small hospitals with 26-64 beds were more likely to be acquired than larger hospitals, and hospitals with the greatest negative margins were over twice as likely as those with the highest positive margins to be acquired (8.6% versus 3.0%). Only one critical access hospital was acquired during the study period, and urban hospitals were more likely to be acquired than rural hospitals (5.6% versus 3.3%). Long-term care hospitals were the most likely to be acquired, while psychiatric and “other” hospitals were the least likely.

The agency plans to update the data on a quarterly basis. 

In telehealth news, mHealth Intelligence tells us

When comparing the use of telehealth among different pediatric subspecialties, a JAMA Network Open study found that pediatric telehealth use was inconsistent across subspecialties, with genetics and behavioral health subspecialists using the care modality the most.

The study included 549,306 patients, representing a total of 1.8 million visits from eight pediatric medical groups from the Children’s Specialty Care Coalition (CSCC). There were 11 different subspecialties, including cardiology, orthopedics, urology, nephrology, dermatology, genetics, behavioral health, pulmonology, endocrinology, gastroenterology, and neurology. The study period began Jan. 1, 2019, and ended Dec. 31, 2021.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omnicron and siblings front

The Centers for Disease Control today posted updated websites for the following topics that include updated or new tools:

AHIP informs us

The White House and the U.S. Department of Health and Human Services (HHS) are hosting an upcoming meeting entitled, Conversations on Encouraging COVID-19 Vaccinations, a virtual program that is part of the “We Can Do This” COVID-19 public education campaign.

The virtual Summit will feature conversations among leading doctors, medical professionals, parents, and community leaders about COVID-19 vaccines and how the broader medical community can encourage vaccination among pregnant people, children, teens, and young adults.

The event will be held on Friday, April 22 at 12:00 PM – 2:30 PM ET.  You can join the meeting here.

Speaking of AHIP, the FEHBlog noticed today that the OPM AHIP FEHB carrier conference website is fully built out. The virtual conference will be held on April 27 and 28.

Speaking of OPM, OPM announced today “the Combined Federal Campaign (CFC) will conduct a special solicitation that will allow the federal community to support charities serving and affected by the war in Ukraine and the resulting humanitarian and refugee crisis. This special solicitation will run through June 30, 2022.”  Thoughtful step on OPM’s part.

Roll Call reports

The Biden administration Monday said it would not enforce the mask mandate for airplanes and transit after a federal judge in Florida struck it down.

In a 59-page order, U.S. District Judge Kathryn Kimball Mizelle said the Centers for Disease Control and Prevention overstepped its authority by requiring passengers to wear masks on public transportation, saying the mandate ”exceeds the CDC’s statutory authority and violates the procedures required for agency rulemaking.”

The Biden administration responded late Monday with a statement saying that the agencies are reviewing the decision and assessing possible next steps. * * *

The CDC recommended that people continue to wear masks in indoor public transportation settings.

USA Today adds

United, American, Southwest, Delta and Alaska and other airlines late Monday said they were dropping their face mask requirement effective immediately given a federal judge’s ruling in Florida and the White House response to it.

From the Medicare front, the Centers for Medicare Services announced

a proposed rule for inpatient and long-term hospitals that builds on the Biden-Harris Administration’s key priorities to advance health equity and improve maternal health outcomes. In addition to annual policies that promote Medicare payment accuracy and hospital stability, the FY 2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) rule includes measures that will encourage hospitals to build health equity into their core functions, thereby improving care for people and communities who are disadvantaged and/or underserved by the healthcare system. The rule includes three health equity-focused measures in hospital quality programs, seeks stakeholder input related to documenting social determinants of health in inpatient claims data, and proposes a “Birthing-Friendly” hospital designation.

For acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users, the proposed increase in operating payment rates is projected to be 3.2%. This reflects a FY 2023 projected hospital market basket update of 3.1% reduced by a projected 0.4 percentage point productivity adjustment and increased by a 0.5 percentage point adjustment required by statute. Under the LTCH PPS, CMS expects payments to increase by approximately 0.8% or $25 million. * * *

For a fact sheet on the proposed payment rule visit: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospitals-ltch-pps

For a fact sheet specific to the maternal health and health equity measures included in the proposed payment rule visit: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospitals-ltch-pps-0

The American Hospital Association’s statement on the proposed rule may be found here. The regulatory battle has been joined.

From the medical research front

  • Medpage Today offers access to “a video [in which], Scott Weiner, MD, MPH, director of the Brigham Comprehensive Opioid Response and Education (B-CORE) Program at Brigham and Women’s Hospital in Boston, discusses his recent study on the risks of chronic use and overdose with hydrocodone versus oxycodone and how providers can keep their patients safe when prescribing these medications.” A transcript of the video also is provided.

Higher levels of “good” cholesterol in the fluid surrounding your brain and spinal cord may help protect you from Alzheimer’s disease, a new study suggests.

“This study represents the first time that small HDL particles in the brain have been counted,” said study co-author Dr. Hussein Yassine. He is an associate professor of medicine and neurology at the University of Southern California’s Keck School of Medicine in Los Angeles.

For the study, Yassine and his colleagues analyzed concentrations of high-density lipoproteins (HDL) — often referred to as “good cholesterol” — in the cerebrospinal fluid of 180 healthy volunteers with an average age of nearly 77.

The study linked a higher number of small HDL particles in cerebrospinal fluid with two key indicators that they might protect against Alzheimer’s. * * *

The results suggest that small HDL particles may point the way to treatments for early Alzheimer’s, long before mental decline occurs.

From the Rx coverage front, STAT News reports

The nation’s preeminent cancer hospitals are charging commercial health insurers anywhere from double to seven times their costs of acquiring cancer drugs, a new study shows.

Most top cancer institutions also are keeping their drug prices secret in direct violation of federal law, potentially exposing themselves to fines.

The findings reinforce how cancer care, especially the drugs, generates significant revenue for hospitals, and how markups on drugs potentially put insured cancer patients in financially perilous situations. * * *

Ultimately, researchers found the amount of money that a hospital gets from an insurance company, just for the cancer therapy, often is more than what the drug company receives.

So it’s not just insulin. No bueno.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the month, here are the FEHBlog’s weekly charts of new Covid cases and deaths

Here is a link to the CDC’s weekly review of COVID statistics. Among those statistics are the following:

New Hospital Admissions

The current 7-day daily average for April 6–April 12, 2022, was 1,446. This is a 1.3% increase from the prior 7-day average (1,427) from March 29–April 4, 2022.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era to the latest week ending last Wednesday, April 13.

For the second week in a row, Covid vaccines distributed and administered have increased materially.

The CDC’s principal point in this week’s Covid statistical review is the following:

Throughout the COVID-19 pandemic, many people have delayed or avoided medical care, including routine, urgent, and emergency care. If it’s something you’ve neglected, it’s time to jump back in—consider putting “get a checkup” on top of your to-do list, especially if you’re at risk for heart disease. Regular checkups provide the opportunity to prevent, screen for, and manage chronic conditions, and to get routine vaccinations.

The FEHBlog agrees that the best step a person can make on the road to a healthy life is to establish a relationship with a primary care doctor.

In other Omicron and siblings news —

MedPage Today informs us

The FDA granted an emergency use authorization (EUA) to the first COVID-19 test that can detect the virus in breath samples, the agency announced on Thursday.

Dubbed the InspectIR COVID-19 Breathalyzer, the test uses gas chromatography-mass spectrometry to rapidly detect volatile organic compounds associated with SARS-CoV-2. Patients breathe into a disposable straw on the device — which is about the size of a piece of carry-on luggage, according to the agency — and results are returned in less than 3 minutes. The test is intended for healthcare settings where samples can be collected and analyzed, such as mobile testing sites, doctor’s offices, and hospitals.

Cool.

Kaiser Health News tells us

The federal “test-to-treat” program, announced in March, is meant to reduce covid hospitalizations and deaths by quickly getting antiviral pills to people who test positive. But even as cases rise again, many Americans don’t have access to the program.

The program allows people with covid symptoms to get tested, be prescribed antiviral pills, and fill the prescription all in one visit. The federal government and many state and local health departments direct residents to an online national map where people can find test-to-treat sites and other pharmacies where they can fill prescriptions.

But large swaths of the country had no test-to-treat pharmacies or health centers listed as of April 14. * * *

Even people who regularly see a doctor may be unable to get a prescription in time, and that’s where the program comes in. Before the pandemic, 28% of Americans didn’t have a regular source of medical care, with rates even higher for Black and Hispanic Americans. 

See above re PCPS and no bueno.

The article adds

Truepill, a company that provides telehealth and pharmacy technology, offers online covid assessments through its website findcovidcare.com * * *. The company has filled more than 10 million prescriptions in the past five years.

The service, available in all 50 states and Washington, D.C., costs $25 to $55. Though insurance isn’t accepted, the cost is comparable to insurance copays for in-person doctor appointments. Prescriptions can be sent to a local pharmacy for no additional charge or shipped to a home overnight via FedEx for a $20 fee.

It’s always good to have a Plan B.

From the FEHB front, OPM issued a final, final rule concerning a Consolidated Appropriations Act 2021 provision extending the opportunity for tribal employers to enroll employees at certain tribal schools to join the FEHB Program.

From the Social Determinants of Health Front, Fierce Healthcare calls to our attention

a Northeast Business Group on Health guide for employers looking to tackle obesity and diabetes through a racial lens. “Obesity, Diabetes and Health Equity: What Employers Can Do” lays out a step-by-step approach. Key among them is embedding health outcomes within other diversity, equity and inclusion efforts. Another big recommendation is to build benefits to address obesity and diabetes that are based in clinical best practices.

In the FEHBlog’s view, OPM’s 2023 call letter asks carriers to address member obesity issues in this manner.

From the Rx coverage front, the Wall Street Journal reports

After Covid-19, vaccine makers’ next big target is a respiratory virus that kills up to 500 children a year nationwide and has been among the leading causes of U.S. hospitalizations for decades.

The respiratory syncytial virus, or RSV, infects nearly everyone at some point, causing mild, cold-like symptoms for most people. But it can lead to serious health problems such as difficulty breathing and pneumonia for infants and older adults.

Now several drugmakers including Pfizer Inc., Johnson & JohnsonModerna Inc. and GlaxoSmithKline PLC are testing shots that infectious-disease specialists say show promise at safely preventing RSV disease. Initial development of most of these vaccines predated the current pandemic, but the rapid success in finding effective Covid-19 vaccines has energized the RSV effort, according to analysts.

Good luck.

From the federal government front

  • Meritalk provides a Who’s Who in implementing the President’s Management Agenda. The article explains “As the Office of Management and Budget’s (OMB) effort to transform the President’s Management Agenda from a list of goals into actionable policy steps gathers steam, OMB is fleshing out its list of Federal agency officials who are taking on leadership roles not only for the three major PMA pushes but for numerous strategic goals within each of them.” The OPM Director Kiran Ajuha is one of three senior federal executives in charge of the PMA’s workforce issues.
  • Federal News Network offers an interview with the Postmaster General Louis Dejoy.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Omnicron and siblings front, the Wall Street Journal reports encouraging news.

The Omicron BA.2 variant has dominated new infections in the U.S. for weeks without setting off a major surge so far, raising hopes among some public-health experts that the nation might dodge a more significant hit.

BA.2 is in particular affecting the Northeast, where virus concentrations in wastewater are rising alongside reported infections in such places as New York, Washington, D.C., and Philadelphia. Concern about BA.2 prompted Philadelphia to restore an indoor-mask requirement and U.S. authorities to extend mask mandates for airplanes and other forms of transportation.

Still, BA.2 hasn’t yet caused the rise in hospitalizations some doctors said they would have anticipated. Disease experts say some combination of immunity from Covid-19 vaccinations and a severe wintertime surge, aided by springtime weather drawing people outdoors, might be keeping the virus at bay.

MedPage Today informs us

A booster dose of the Pfizer-BioNTech COVID-19 vaccine was safe and produced an immune response in kids ages 5 to 11, including against the Omicron variant, the companies said on Thursday.

These data came from two sources: the phase II/III clinical trial on 140 children ages 5 to 11 who received a booster dose at least 6 months after their two-dose primary series, and a subgroup of 30 kids in whom response against Omicron was studied specifically. In this subgroup analysis, there was a 36-fold increase in neutralizing antibody titers compared with levels seen after the two-dose primary series, the companies reported.

The companies plan to submit a request to the FDA for an emergency use authorization (EUA) for a third dose for this age group “in the coming days.” The agency previously authorized a two-dose primary series of the 10 μg formula for this age group in October 2021.

Health IT Analytics tells us, “When comparing groups that experienced the worst effects of COVID-19, a study published in Public Health Nursing found that the pandemic had a significant impact on those who exhibit high social vulnerability, leading them to have the highest mortality levels.” This finding illustrates the importance of resolving health disparities.

On a related note, Govexec reports

More than 90 federal agencies released their first-ever equity action plans on Thursday, laying out more than 300 strategies to better help underserved communities. This follows an executive order President Biden issued on day one of his administration, which directed agencies to conduct equity assessments of their top three to five high-impact services for Americans to determine where there were systematic barriers. These findings helped agencies develop their plans.

“Taken together these 300 actions demonstrate what it means to take a whole-of-government approach to advancing equity,” said a senior administration official on a background briefing call. “For the first time Americans will see a full picture of what it looks like for the entire federal government to advance equity at once.”

For example, Health and Human Services Department plans to better help individuals with limited English proficiency access federal health programs; the General Services Administration seeks to assess the impact on communities of its vast real estate portfolio; and the Office of Personnel Management looks to invest in data to look at potential barriers in the federal hiring process.

In a significant development from the No Surprises Act front, the Affordable Care Act regulators issued helpful Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties and Certified IDR Entities. The new guidance no longer treats the Qualifying Payment Amount as a rebuttable presumption. This action strongly suggests that the QPA’s rebuttable presumption status will be removed from the “final, final” version of the IDR rule. That regulation is due out next month. However, the rule does not yet appear on the OMB Office of Information and Regulatory Affairs’ list of rules currently being subjected to their oversight.

In other regulatory news, the International Foundation of Employee Benefits Plans alerts us, ​

The Department of Justice (DOJ) released guidance including frequently asked questions (FAQs) on how the Americans with Disabilities Act (ADA) protects individuals from discrimination when they are being treated for and recovering from opioid use disorder (OUD).

From Capitol Hill, EndPoint News reports

A group of 30 bipartisan lawmakers sent letters to 7 naloxone manufacturers, calling on them to apply for over-the-counter status for their opioid overdose antidotes and open up supplies further as the opioid crisis continues in the US with record levels of overdoses and deaths.

Citing a Massachusetts study that found substantially increased access to naloxone reduced opioid overdose mortality rates by 46%, the senators and representatives called on Pfizer, Teva Pharmaceuticals, Adamis Pharmaceuticals, Akorn, Amphastar Pharmaceuticals, Emergent BioSolutions, and Hikma Pharmaceuticals to “submit applications to make naloxone available over the counter without delay.”

Currently, there are three FDA-approved forms of naloxone — injectable, auto-injector and nasal spray — and all three currently require a prescription, but in most states and the District of Columbia pharmacists are allowed to dispense naloxone under a standing order, meaning they don’t actually need individual prescriptions. Some states also have given pharmacists direct authority to prescribe and sell naloxone to consumers.

Good idea. The HHS Secretary Xavier Becerra extended the opioid epidemic public health emergency for another 90 days earlier this month.

From the healthcare business front, Healthcare Dive reports on UnitedHealth Group’s 1st Quarter 2022 financial results.

UnitedHealth is bullish on completing its controversial acquisition of data analytics firm Change Healthcare, despite legal action from the Department of Justice to block the deal.

UnitedHealth’s extended agreement with Change “reflects our firm belief in the potential benefits of this combination to improve healthcare and in our ability to successfully overcome the challenge to this merger,” Chief Operating Officer Dirk McMahon told investors on a Thursday morning call regarding first-quarter financial results.

The Minnetonka, Minnesota-based healthcare behemoth beat Wall Street expectations for earnings and revenue in the quarter, with a topline of $80.1 billion, up 14% year over year due to double-digit growth at health services arm Optum and payer business UnitedHealthcare. Net earnings were $5.1 billion, up 3% year over year. UnitedHealth raised its full-year guidance following the results.

STAT News adds

The Omicron surge didn’t lead to an explosion of medical claims at UnitedHealth Group, which contributed to higher-than-expect profits. UnitedHealth ended the first three months of the year with more than $5 billion of profit on $80.1 billion of revenue. The company’s medical loss ratio, which shows the percentage of insurance premiums that were spent on medical claims, was 82% — higher than 80.9% in the first quarter of 2021, but less than what Wall Street expected.

From the miscellany department

  • The ICD 10 Monitor discusses “two extremely encouraging studies in terms of the content coverage and feasibility of replacing ICD-10-CM with ICD-11.”
  • BioPharma Dive reports “AbbVie and Genmab said treatment with their dual-acting antibody epcoritamab led to responses in nearly two-thirds of patients with lymphoma, announcing on Wednesday that their clinical trialsurpassed its benchmark for success. The partners will now take the data to the Food and Drug Administration and other regulators to determine whether it’s good enough to formally submit for approval.”
  • Health Data Management offers useful insights into the ongoing TEFCA launch.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front

Beckers Hospital Review informs us

The World Health Organization on April 11 said it is monitoring two new “sister variants” of the original omicron strain dubbed BA.4 and BA.5, according to global news network WION.

Whither BA.3?

A lot of news sources are offering reports on Stealth Omicron. We learn from the AP that Stealth Omicron is another sibling of BA.2.

It was given the “stealth” nickname because it looks like the earlier delta variant on certain PCR tests, says Kristen Coleman at the University of Maryland School of Public Health. The original omicron, by contrast, is easy to differentiate from delta because of a genetic quirk.

BA.2 is “now the dominant coronavirus version in the U.S. and more than five dozen other countries.”

From the Health and Human Services Department, we find an account of “Secretary Becerra and HHS Leaders Celebrating Black Maternal Health Week 2022.”

From the Centers for Disease Control department

  • The CDC explains how diabetics can keep eating the cultural foods to which they are accustomed by taking a few preparation twists.
  • Neisseria gonorrhoeae (gonorrhea), a common sexually transmitted infection (STI) that can result in life-threatening ectopic pregnancy and infertility, leads to more than an estimated half a million drug-resistant infections in the United States each year.
  • With health departments in two states, CDC is expanding drug resistant-gonorrhea surveillance beyond traditional STI clinics and into emergency departments, where more people are seeking STI care.
  • From 2018 through 2019, nearly one-third (29%) of patients with positive tests from the North Carolina site were diagnosed at emergency departments, and drug resistance testing uncovered eight cases of gonorrhea less likely to be successfully treated by one of two drugs in the recommended first line treatment at that time.
  • Bloomberg adds “After sexually transmitted diseases fell during the early months of pandemic lockdowns and social distancing, the U.S. saw a resurgence of some of the most common infections through the end of 2020, according to a report.”

From the U.S. Preventive Services Task Force front, the Wall Street Journal tells us

All children should be screened for anxiety starting as young as 8 years old, government-backed experts recommended, providing fresh guidance as doctors and parents warn of a worsening mental-health crisis among young people in the pandemic’s wake.

The draft guidance marks the first time the U.S. Preventive Services Task Force has made a recommendation on screening children and adolescents for anxiety. The task force, a panel of independent, volunteer experts that makes recommendations on matters such as screening for diabetes and cancer, also reiterated on Tuesday its 2016 guidance that children between ages 12 and 18 years old should be screened for major depressive disorder. 

“What the pandemic has done is, it exacerbated a pre-existing issue,” said Nasuh Malas, director of pediatric consultation and liaison psychiatry services at C.S. Mott Children’s Hospital in Ann Arbor, Mich., who isn’t on the task force. “These guidelines are a preliminary step to many, many steps that we need to take nationally as a community of people who are concerned about our youth.”

STAT News adds

After staying flat for a decade, the overdose death rate among U.S. adolescents nearly doubled from 2019 to 2020 — an alarming climb that continued into 2021, a study in JAMA shows. It’s not a surge of 14- to 18-year-olds using drugs, researchers said. If anything, survey data indicate that fewer teens experimented with drugs during the pandemic. Rather, a main factor is the supply of increasingly deadly drugs, one that has driven overall overdose deaths to more than 100,000 per year and has now trickled down to adolescents. What teens may think is an opioid painkiller or Xanax diverted from the legal supply is now more likely to be a counterfeit tablet containing fentanyl or similar synthetic opioids. “Drug use is becoming more dangerous, not more common” among adolescents, study co-author Joseph Friedman told STAT’s Andrew Joseph. Read more.

From the antibiotic overuse front, the American Journal of Preventive Medicine informs us “Unnecessary prescription of antibiotic prophylaxis by dentists continues to be common. Antimicrobial stewardship strategies are needed to improve prescribing by dentists.” No bueno.

Also in the no bueno department, Healthcare Dive calls our attention to a Lown Institute report

— U.S. nonprofit hospitals often get tax breaks worth far more than they spend on charity care and community investment, according to a new report from the Lown Institute. Prominent systems such as Providence, Trinity Health, Mass General Brigham and the Cleveland Clinic had some of the largest of these “fair share deficits,” the healthcare think tank said.

— The Lown Institute found 227 of the 275 hospital systems it studied spent less on charity care and community investment than the value of their tax exemptions. The fair share deficits of all hospital systems studied totaled $18.4 billion, which the institute argues could have been used to address health equity, housing, food insecurity and other local needs.

— Many of the hospital systems also received hundreds of millions of dollars in grant funding through the Coronavirus Aid, Relief, and Economic Security Act in 2020. The 275 systems examined operate more than 1,800 hospitals nationwide.

From the Rx coverage department. Drug Channel assesses the recent CMS Office of Actuaries report projecting U.S. healthcare spending.

The econowonks at the Centers for Medicare & Medicaid Services (CMS) recently released the latest projections for U.S. spending on healthcare. (See links below.) These data provide our first official look at post-pandemic U.S. healthcare spending. 

As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. healthcare spending. What’s more, taxpayers—via Medicare and Medicaid—will continue to crowd out the private insurance market. One bright spot: consumers will account for an ever-smaller share of drug spending. 

Thus, the government actuaries expect that pharmaceuticals will not be the key driver of U.S. healthcare spending growth. Will someone tell our elected officials?

Here are tidbits that also follow up from stories in recent FEHBlog posts

  • Fierce Healthcare reports that the bipartisan bill to control the price of insulin to consumers will “ensure that plans and PBMs ‘cannot collect rebates, which drive up drug costs at the point of sale, on insulins that roll prices back to 2006 or equivalent levels,’ the release said.” 
  • Healthcare Dive reports that part of the Administration’s efforts to control medical debt includes the following

The Biden administration laid out a four-point plan to reduce America’s medical debt on Monday, including having the HHS dig into how providers’ billing practices impact care access and affordability.

Under the plan announced by Vice President Kamala Harris, the HHS will request data from 2,000 providers on their bill collection practices, lawsuits against patients, financial assistance offerings, debt buying practices and more. The HHS will use this information in grant determinations, and to shape data and policy recommendations to the public.

The department will also share potential violations with enforcement agencies.The White House is also guiding federal agencies to stop using medical debt as an underwriting factor in credit programs where possible

  • Health Payer Intelligence discusses AHIP’s comments on the CDC’s draft, revised opioid prescription guidelines.

Finally here are some OPM and USPS tidbits

  • Govexec offers an interview with the Postmaster General Louis DeJoy.
  • Federal News Network tells us

The Office of Personnel Management issued a second round of guidance to agencies on Tuesday, outlining several ways agencies should make employees more aware of their collective bargaining rights.

OPM’s guidance also directs agencies to quickly process requests to pay union dues through payroll deductions, and train managers and supervisors on how to remain neutral during union organizing campaigns.

OPM Director Kiran Ahuja, in a blog post, said the guidance is part of the administration’s focus on making the federal government a model employer in a competitive labor market.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill —

Roll Call informs us

The House Appropriations Committee is tentatively planning to take up its fiscal 2023 spending bills in June, teeing up potential floor votes in July, according to people familiar with the schedule.

Subcommittees would mark up their 12 annual bills from June 13 to June 22. The full committee would hold its markups from June 22 through June 30.

The top four appropriators in the House and Senate, known as the “four corners,” are expected to meet shortly after the two-week recess this month to begin discussions aimed at reaching a bipartisan agreement on overall discretionary spending levels for the fiscal year that begins Oct. 1.

STAT News tells us

A bipartisan group of four key lawmakers unveiled a long-shot policy that aims to alleviate one of the American health care industry’s most embarrassing problems: mind-bogglingly high prices for insulin, a drug millions of Americans need to survive.

The policy outline released Monday is a reboot of a three-year-old bill introduced by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine). It would dangle a carrot for drugmakers to lower their list prices. Insurers and middlemen wouldn’t get to keep fees for diabetes drugs — but only if drugmakers lower list prices for drugs back to 2006 levels. It would also make sure patients with Medicare or private insurance don’t pay more than $35 per month for their insulin, though it would not offer the same protection to the uninsured.

Federal News Radio follows up on last week’s Senate confirmation of Kristin Boyd to be the first Senate-confirmed OPM Inspector General in over six years.

From the Omicron and siblings front —

Fierce Healthcare calls attention to a Commonwealth Fund report on the efficacy of Covid vaccines

COVID-19 vaccinations have blunted the worst waves of the pandemic, preventing millions of deaths, limiting strain on the U.S. healthcare system and producing “substantial cost savings” in healthcare spending, according to new estimates published Friday by the Commonwealth Fund.

From the first authorizations in December 2020 through March 2022, COVID-19 vaccination was estimated to have averted roughly 2.3 million deaths and 66.2 million additional infections, per the analysis.

Further, the push for shots in arms was found to have prevented 17 million hospitalizations in the U.S. and saved the country’s healthcare system just shy of $900 million in total spending, notwithstanding the country’s savings related to workplace absences and deaths.

The Wall Street Journal reports

The risk of developing inflammatory heart conditions after Covid-19 vaccination is relatively low, two large studies found, especially when compared with the heart-related risks from Covid-19 disease itself and from vaccines against other diseases [such as the flu].

“The overall message is that you can never consider risk in isolation,” said Jason Perry Block, an associate professor at Harvard Medical School and a co-author of the CDC’s analysis.

Concerns over potential side effects from Covid-19 vaccines are one reason some eligible adults in the U.S. say they haven’t gotten the shots, according to public-opinion surveys. About 70% of eligible Americans have been fully vaccinated against Covid-19, according to the CDC.

In considering the cardiac risks associated with Covid-19 vaccines, Dr. Block said people “also have to consider the risk on the other hand. If you don’t get vaccinated and do get infected, the risk is higher of cardiac complications.”

From the Covid vaccine mandate front —

A federal district court in Georgia preliminarily enjoined the federal government’s vaccine mandate on its contractors. The federal government appealed to the U.S. Court of Appeals for the 11th Circuit. The appeal was argued before a panel of three judges last Friday. Federal News Network adds

A three-judge panel from the U.S. Court of Appeals for the 11th Circuit says it remains unclear whether the Biden administration has the authority to impose a COVID-19 vaccine mandate on federal contractor employees.

The administration told the court last Friday that federal contracting law gives the president broad authority to set the terms of the federal government’s contracts, including making sure contractors have enough healthy employees to complete their contracts with agencies on time.

The judges,  however, repeatedly said during oral arguments that the federal government has a high bar to clear, in order for the court to overturn a lower court’s injunction barring the administration from enforcing the mandate.

The 11th Circuit likely will issue its opinion next month.

The Hill reports on the latest developments in the federal government’s vaccine mandate on its workforce.

The Biden administration on Monday asked a federal appeals court to clear a procedural hurdle that remained after a key legal victory last week and allow the administration to quickly resume enforcement of its COVID-19 vaccine mandate for federal employees.  

The request to the U.S. Court of Appeals for the 5th Circuit, if granted, would effectively reinstate the public health policy after it was put on hold across the country in January by a federal judge in Texas.

* * *

The administration’s request Monday would move up the timeline for the panel’s judgment to take effect, which is currently not set to occur until May 31. 

From the SDOH front, Health Payer Intelligence informs us

UnitedHealthcare announced that it will expand a program to advance maternal health equity in for minority communities in North Carolina.

“Access to quality maternal health care will help close the gap on health inequity in our state,” said Anita Bachmann, chief executive officer of UnitedHealthcare Community Plan of North Carolina. “We are honored to partner with Mountain Area Health Education Center and SistasCaring4Sistas of North Carolina to address disparities and outcomes with the expanded doula program.”

The payer partnered with the community-based organization SistasCaring4Sistas to expand access to the organization’s program, Doulas for Social Justice.

From the Aduhelm front, Fierce Healthcare reports on payers’ cheerful reaction to last week’s CMS Medicare coverage decision of that expensive drug only at the clinical trial level. “We appreciate that when these treatments receive an accelerated FDA approval, Medicare will cover for patients in [Food and Drug Administration] or [National Institutes of Health] approved trials,” according to a statement from insurance lobbying group AHIP.”

From the miscellany department

  • The Wall Street Journal reports about “New apps and telehealth services [that] are providing women in middle age more access to health expertise, education and support to help them during menopause [such as MenoLife].”
  • The Department of Health and Human Services shares Secretary Becerra’s remarks at the White House Medical Debt Event with Vice President Harris. Here is a link to the Administration’s fact sheet describing new actions to lessen the burden of medical debt and increase consumer protection. According to the fact sheet,

These actions will help:

Hold medical providers and debt collectors accountable for harmful practices;

Reduce the role that medical debt plays in determining whether Americans can access credit – which will open up new opportunities for people with medical debt to buy a home or get a small business loan;

Help over half a million of low-income American veterans get their medical debt forgiven; and,

Inform consumers of their rights.

  • Medpage offers an interesting account of how a doctor is trying to make sure that his patients get the medical screening tests that they need.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021, a low points of cases and death, and the 14th week of 2022, another lull but not quite as low.

The CDC’s Weekly Review of its COVID statistics issued today notes “The current 7-day daily average for March 30–April 5, 2022, was 1,406. This is a 10.3% decrease from the prior 7-day average (1,567) from March 23–29, 2022.”

Here’s the FEHBlog’s weekly chart of Covid vaccinations administered and distributed since the beginning of the Covid vaccination era through this week, again using Thursday as the first day of the week.

The administration of Covid vaccines popped us this week. Over 75% of the U.S. population aged 18 and older are fully vaccinated. Nearly half (48.6%) of that cadre is boostered. The Weekly Review’s commentary discusses the importance of vaccinating children.

COVID-19 vaccines have undergone—and continue to undergo—the most intensive safety monitoring in U.S. history, and adverse events are rare. Vaccinating children is the single best way to protect them from severe illness associated with COVID-19. 

From Capitol Hill, the Wall Street Journal reports

Senators had also hoped to move forward on the coronavirus vaccines and treatments package, but progress quickly bogged down over Republican efforts to amend the bill to extend a pandemic-era immigration policy called Title 42—which allows Border Patrol agents to quickly turn away migrants at the southern border—with some Democrats siding with the GOP. Senators said they ran out of time, and the break could help end the logjam, even if it means the aid will need to wait at least several weeks.

“We’ll see where the discussions go, but my assumption is during the course of the break they’ll be some conversations between people who are interested in advancing it and see if we can make any headway on coming up with a process,” said Sen. John Thune (R., S.D.) on the Covid aid.

“I don’t think we’re leaving anything hanging up in the air that we’re not going to be able to continue to work with afterwards,” said Sen. Angus King (I., Maine), who caucuses with Democrats.

Congress is on State / District work periods for the next two weeks.

From the Rx coverage front, Health Affairs offers a fascinating article leading with an HHS Inspector General report on biosimilar drug use in the Medicare Part D program. The article blossoms into a broader look at biosimilar use in America. For example,

Last fall, two academics from the USC Schaeffer Center for Health Policy & Economics and the University of Chicago Harris School of Public Policy analyzed the available biosimiliars and found these were, on average, 30% less expensive than the underlying brand-name biologics. This represented a savings of about $665 off the average price.

Perhaps the biggest boost, though, will occur when biosimilar versions of Humira begin entering the U.S. market next year. This is expected to kick-start a wave of increased biosimilar usage between now and 2027, by which time the worldwide market should roughly double to $20 billion, according to Bernstein analyst Ronny Gal.

“The savings we identified with increased biosimilar use, while modest, could be significant once biosimiliar versions of Humira come on the market,” said [Melissa] Baker [from the HHS Office of Inspector Genera]. “Part D spending for Humira is in the billions of dollars.” The HHS OIG report noted that Humira and Enbrel accounted for more than $5 billion in Part D spending and nearly half of Part D spending on biologics in 2019.

From the Aduhelm front, Fierce Healthcare tells us

Leaders of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) sought to present a united front a day after CMS approved narrow Medicare coverage of the Alzheimer’s disease drug Aduhelm.

FDA Commissioner Robert Califf, M.D., and CMS Administrator Chiquita Brooks-LaSure issued a joint statement Friday to address criticism of CMS’ decision that Medicare only cover Aduhelm and similar products for beneficiaries in a qualifying clinical trial. Critics have charged CMS is trying to undermine the FDA’s approval decisions as the agency cleared the drug last year via accelerated approval.

“The work of both of our agencies is critical to ensure that medical products are available to people across the country,” the agency leaders said in a statement.

From the mental healthcare front, Health Payer Intelligence informs us

CVS Health and its payer arm, Aetna, aimed to make strides in the healthcare industry in 2021 by delivering affordable healthcare services to members, increasing access to virtual and mental healthcare, and implementing initiatives to advance health equity, according to the payer’s 2021 Environmental, Social, and Governance (ESG) report. The report reflects data from January 1 to December 31, 2021.

Well done.

Finally, the FEHBlog ran across this helpful Kaiser Family Foundation preventive services tracker website.

The Affordable Care Act (ACA) requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. For adults, the required services are recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Institute of Medicine Committee on Women’s Clinical Preventive Services.  As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date.

This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.

For more information, see the fact sheet Preventive Services Covered by Private Health Plans under the Affordable Care Act.

This tracker also applies to FEHB plans. Thanks, KFF.