Tuesday’s Tidbits

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.

Weekend update

Photo by Mark Tegethoff on Unsplash

From the Capitol Hill front, Congress is on a State / District work period for the next two weeks.

Medpage Today identifies the likely winners and losers if the Senate joins the House of Representatives in capping insulin cost-sharing at $35 per dose. There are no surprises.

From the federal employment front, Govexec tells us

The U.S. Postal Service has converted 63,000 part-time or non-permanent workers into career positions, with leadership saying it has helped stabilize the workforce after years of escalating turnover.  * * *

The Postal Service ended 2021 with nearly 517,000 career employees, its highest total since 2012. The non-career workforce has remained fairly steady in recent years at 136,000. 

This factoid is worth noting because career employees typically are eligible for FEHB coverage while part-timers and non-permanent workers are not.

From the Omicron and siblings front, the Wall Street Journal informs us about the BA.2-related numbers to watch when considering whether or not to take additional Covid precautions. For example,

Hospitalization rates are likely a more accurate indicator of transmission and reflect the severity of infections, some scientists say. A related useful metric:  the number of people visiting emergency rooms with influenza-like illnesses, which the CDC tracks and publishes nationally; New York has data, too. Scientists say BA.2 is more transmissible than the original Omicron variant but not more dangerous. * * *

UNC’s Dr. Lessler says the [CDC’s Communities] map is useful for those who aren’t at high risk for severe Covid and don’t have close contact with those who are. “It can serve as a good lower limit for how cautious to be,” he says.

The CDC’s surveillance of wastewater for Covid-19 is also telling, he says, though it is based on limited samples. Some wastewater data show readings from the Northeast, in particular, have been edging higher from low levels. * * *

Should you decide that the level of Covid-19 circulating is too high for your comfort, Dr. Varma advises putting a few measures in place:

— Make sure you’re up to date with Covid vaccinations and boosters for which you’re eligible.

— Have a supply of high-quality masks you can wear in indoor settings.

— Ensure that you have a supply of rapid antigen tests; one pack per family member is a good rule of thumb.

— Improve indoor ventilation when you have visitors over or if someone in your household gets Covid-19.

— Have the number of your local or state health department on hand so you can get antiviral pills if you qualify and fall sick.

And, if you test positive, follow the latest guidelines recommended by the CDC and your doctor. 

From the opioid epidemic front

  • NPR discusses draft CDC guidance on prescribing opioids that will replace the current guidance that was issued in 2016.
  • MedPage Today suggests that doctors should not prescribe opioids without first preparing a deprescribing plan for the patient.

A deprescribing plan involves laying out a specific path for reducing, and then eliminating, opioid use even before the first prescription is written. It is often a way for physicians to involve other resources, including mental health care, community support, and social services to assist the patient as opioid dosage gradually falls.

Importantly, the plan should not be an act of enforcement, but rather, the product of physician and patient working together. Properly structured, the plan will give the patient confidence that an opioid prescription may help relieve pain in the short run but will not lead to dependence or addiction in the long term. The goal is to produce a better outcome for the patient than is possible with continued opioid use.

From the telehealth front, mHealth Intelligence reports

MemorialCare in Fountain Valley, California, is partnering with TytoCare to enhance its telehealth services.

TytoCare provides virtual home examination and diagnosis solutions, including a hand-held tool for remotely examining the heart, lungs, skin, ears, throat, abdomen, and body temperature, and a telehealth platform for sharing exam data, conducting live video exams, and scheduling visits.

Through the new partnership, MemorialCare will expand its virtual care offerings. TytoCare’s handheld device will allow patients to perform guided medical exams with MemorialCare providers remotely. The device has received Food and Drug Administration approval.

Patients can use the TytoCare app to participate in video visits offered through MemorialCare’s Virtual Urgent Care service. Data from the remote exam is sent to MemorialCare providers through an encrypted network.

Providers can leverage exam data to diagnose and treat conditions and write a prescription if needed. The virtual visit is also downloaded into MemorialCare’s MyChart EMR system.

From the medical research department, STAT News reports

While CAR T-therapy has cured some people with blood cancers, this form of immunotherapy has so far produced lackluster results for solid tumors like lung or kidney cancer. But a new early-phase clinical trial presented on Sunday at the American Association of Cancer Research (AACR) conference suggests that CAR T-cells may be able to shrink some solid tumors — as long as it gets a boost from an mRNA vaccine from BioNTech.

The mRNA vaccine manufacturers worked on cancer cures before they pivoted to Covid in early 2020. It’s hopeful to see that BioNTech is back in cancer research.

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.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Capitol Hill front, today, the Senate took the following action

PN1166: Krista Anne Boyd, of Florida, to be Inspector General, Office of Personnel Management– Considered by Senate.– Confirmed by the Senate by Voice Vote.

And just like that, OPM has a Senate-confirmed Inspector General for the first time in over six years. The FEHBlog wishes Inspector General Boyd good luck.

The President issued a statement on World Health Day, which was celebrated today.

From the Omicron and siblings front —

  • The Centers for Medicare Services released an updated Toolkit on Covid Vaccines for health insurers and Medicare Advantage plans.

A federal appeals court has reinstated President Biden’s COVID-19 vaccine mandate for the federal workforce, overturning a lower court’s nationwide pause that had been in effect since January.

The plaintiffs who brought their suit over Biden’s executive order did not have standing in the federal circuit, a panel of the U.S Court of Appeals for the Fifth Circuit said in a 2-1 opinion Thursday evening, and instead must pursue their appeals through the Merit Systems Protection Board or Office of Special Counsel as laid out in the Civil Service Reform Act. The court vacated the injunction and instructed the district court in Texas that issued it to dismiss the case upon remand. 

From the Rx coverage front —

STAT News reports

Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.

The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.

The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.

But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients.

They would still need to collect some data, but the possible design of the studies is much more flexible — a significant win for Lilly.

Here is a link to the CMS fact sheet on this decision.

U.S. News adds “Medicare said Thursday it’s considering a cut in enrollee premiums after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.” Given Medicare’s shaky financial condition, one would expect the government to build up reserves with the additional cash and then adjust the premium for the following Medicare year, taking all considerations into account.

From the No Surprises Act front, AHIP released a new resource reflecting on the first 100 days of the NSA.

From the healthcare business front, Fierce Healthcare informs us

[Blue Cross of California and Walgreen] are launching new Health Corners in 12 Walgreens stores in the San Francisco Bay area and Los Angeles County.

At the Health Corner locations, Blue Shield members and customers will be able to connect with health advisers who can offer simple in-store care as well as assistance with preventive screenings, chronic care management and medications. The health advisers have clinical backgrounds, such as pharmacists or nurse practitioners.

The partnership seemed a natural fit, D.D. Johnice, vice president of the Health Transformation Lab at Blue Shield of California, said in an interview. * * * Some 80% of people in California live within five miles of a Walgreens store, she said, so the Health Corners could be a valuable tool for reaching people who live in healthcare deserts, or more specifically, Blue Shield network deserts.”

In sad news, the Wall Street Journal reports

Michael F. Neidorff, who as chief executive officer of Centene Corp. transformed a tiny medical insurance firm serving three counties in 1996 into a nationwide giant in government-backed health coverage, died Thursday after what his family described as a long illness. He was 79.

Mr. Neidorff recently took medical leave and had signaled last year a plan to retire in 2022 from the CEO job he held for more than 25 years. Centene announced in March the appointment of Sarah London, who had been vice chairman, to succeed him as CEO.

St. Louis-based Centene is the biggest company in managed Medicaid, contracting with states to provide coverage to people enrolled in the program for lower-income Americans.

Centene offers FEHB HMO coverage through its Health Net subsidiary. RIP.

Midweek update

The Postal Service Health Benefits Program was born today as the President signed into law the Postal Reform Act of 2022 (H.R. 3076). Here is a link to the President’s remarks made at the bill signing.

The PSHBP will become operational on January 1, 2025. OPM’s implementing rules must be finalized by April 6, 2023.

Govexec adds

The U.S. Postal Service is once again seeking to raise its rates by historically unusual amounts, announcing the increases on the same day President Biden signed into law a bipartisan bill to erase much of the agency’s debts and allow it to pursue new lines of revenue.  * * *

The new prices, which are set to go into effect July 10, would raise rates for regular, First-Class mail by 6.5% and by 8.5% for package services. A standard stamp would go from $0.58 to $0.60. The large increases were made possible under new authority the Postal Service’s regulator granted it in 2020 and which USPS employed for the first time last year. DeJoy promised as part of his 10-year business plan to use his authority to raise rates above inflation “judiciously,” but predicted USPS would generate between $35 billion and $52 billion by 2031 by raising prices.

From the Capitol Hill front, Roll Call reports “A bipartisan $10 billion COVID-19 supplemental is stuck in the Senate amid a dispute over a tangential pandemic-related border control policy, with both parties at a loss on how the impasse will be resolved.”

In other Omicron (and siblings) news

The Food and Drug Administration’s Vaccine and Biological Products Advisory Committee met today for a general discussion of Covid vaccines. The Wall Street Journal reports

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves.

Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap.

STAT News offers a play-by-play account of that meeting here.

The American Hospital Association informs us

Medicare and Medicaid will cover a second Pfizer or Moderna COVID-19 booster at no cost to eligible enrollees, the Centers for Disease Control and Prevention announced today. Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program also must provide authorized COVID-19 vaccines at no cost to recipients.

The FEHBlog discovered from reading an AHA squib that CDC Director Rochelle Wolensky approved the FDA’s March 29 second booster recommendation last week. That joint recommendation permits adults aged 50 and older to receive a second Pfizer or Moderna COVID-19 vaccine booster dose at least four months after an initial booster dose. In addition, those agencies authorized and recommended a second Moderna booster dose for certain immunocompromised adults and a second Pfizer booster dose for certain immunocompromised individuals aged 12 or older.”

What’s odd is that the ACA FAQ 50 indicates that the CDC advisory committee’s recommendation triggers the health plan to cover a particular use of a Covid vaccine with no member cost-sharing. Given that CMS has given the green light and the advisory committee reports to the CDC Director, the FEHBlog concludes that health plans also should step up to the plate and provide no cost-sharing coverage for these second boosters.

STAT Health tells us that

A new survey by STAT and The Harris Poll finds six in 10 Americans have already decided they will get another booster if it’s recommended for them.

Just under one-quarter of U.S. adults indicated they will only receive a second booster shot if a new variant arises or there is a surge in Covid-19 cases in their area, and 18% have no plans to get a booster at all, according to the survey, which polled 2,028 U.S. adults between March 25 and 27.

America has spoken.

From the No Surprises Act front, the AHA notes

The Centers for Medicare & Medicaid Services has released a new FAQ for health care providers on the No Surprises Act’s requirements and prohibitions, and the independent dispute resolution process; and a new FAQ on providing good faith estimates to uninsured and self-pay patients. CMS plans to launch next week the online portal through which uninsured and self-pay patients may initiate the dispute resolution process.

The CMS FAQs are worth reviewing by health plans because they go beyond the out-of-network bill consumer protections to address the NSA good faith estimate, continuity of care, and provider directory accuracy provisions. For example, the good faith estimate discussion on page 6 is quite informative.

From the Health Affairs front

  • Jane Zhu and a team of fellow experts wrote an article on Trends in Outpatient Mental Health Services Use before and during the pandemic. Here are excerpts from the abstract which is quite pro-telemental care.

In-person mental health encounters were reduced by half in the early months of the pandemic, with rapid recovery of service delivery attributable to telehealth uptake (accounting for 47.9 percent of average monthly encounters). We found variation in the degree to which telehealth use increased across groups: People with schizophrenia made up a lower proportion of telehealth encounters relative to in-person visits (1.7 percent versus 2.7 percent), whereas those with anxiety and fear-related disorders accounted for a higher proportion (27.5 percent versus 25.5 percent). These findings highlight the importance of broadening access to services through new modalities without supplanting necessary in-person care for certain groups.

  • Joshua Liao and Amol Navathe wrote an article in the Health Affairs Forefront describing a new Accountable Care Organization model designed to improve health equity.

From the healthcare business front —

Optum continues its buying spree and has picked up Kelsey-Seybold Clinic, a large, multi-specialty group practice based in Houston, Texas, Axios reported Monday.

With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. The organization partners with payers to offer value-based commercial health plans also owns its own Medicare Advantage plan for seniors, KelseyCare Advantage.

Intermountain Healthcare and SCL Health completed their merger, creating one of the nation’s largest nonprofit health systems, the two organizations announced Tuesday.

The new system, which will use the Intermountain name to reflect the parent entity, will operate 33 hospitals and hundreds of clinics across seven states and insure 1 million people in Utah and Idaho.

Colorado’s attorney general signed off on the merger last week after conducting a review, concluding the tie-up will not result in a material change to the charitable purposes of nonprofit SCL Health, based in Colorado, and that SCL assets will not leave the state.

  • Business Wire tells us “Millennium Trust Company, LLC (“Millennium Trust”), a leading provider of retirement and financial services for employers, institutions, advisors, and individuals, today announced it has signed a definitive agreement to acquire PayFlex Holdings, Inc. (“PayFlex”), a provider of health savings accounts (HSAs) and consumer-directed benefit administration services, from CVS Health Corporation (“CVS Health”).

In HIPAA Privacy and Security Rule News, the Department of Health and Human Services announced issuing

a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).  This RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.

* * *

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more: https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health

Please note that comments must be submitted by June 6, 2022 in order to be considered.

Interestingly, the HHS seeks public input on developing the safe harbors created by the 2021 law.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

Happy National Employee Benefits Day, an occasion created by the International Foundation of Employee Benefit Plans.

From the Capitol Hill front, Roll Call reports

The week is still young. But prospects for getting a bipartisan supplemental aid package for pandemic response efforts to President Joe Biden’s desk before a two-week recess seem increasingly remote.

Without a deal on amendments Republicans want to offer, the Senate on Tuesday rejected a procedural motion needed to begin debate on the bill, which would provide $10 billion for the Department of Health and Human Services to buy more therapeutics, vaccines and testing supplies and prepare for future virus variants.

Utah Sen. Mitt Romney, the lead GOP negotiator, said the underlying bill will have enough bipartisan support to pass if leaders can agree on an amendment process, but it’s an open question whether it will get done before the recess.

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

The Omicron BA.2 variant is increasing its share of U.S. cases and putting particular pressure on parts of the Northeast, where wastewater readings and Covid-19 cases have ticked upward again from low levels.

Recorded Covid-19 cases remain low nationally and hospitals are treating the smallest number of Covid-19 patients after any surge. Places where cases are rising, including New York, are reporting relatively small increases from recent troughs. The mixed signals are prompting officials to warn that BA.2 will likely lead to more viral transmission, but also hope among public-health experts that warming weather and built-up immunity in the population are muting the variant’s impact.

“There are certainly some big factors that are in our favor right now compared to the situation back in November and December,” said Bruce Y. Lee, professor of health policy and management at the City University of New York School of Public Health.

From the White House, the Administration announced

  • A “whole of government” effort to prevent, detect, and treat long Covid. Long Covid is a topic at the OPM AHIP FEHB carrier conference to be held virtually on April 27 and 28, 2022.
  • A regulatory fix to the so-called family glitch in the Affordable Care Act. The family glitch that this fix addresses stems from the fact that the ACA does not require employers to make contributions to family member coverage. “Should today’s proposed rule be finalized, family members of workers who are offered affordable self-only coverage but unaffordable family coverage may qualify for premium tax credits to buy ACA coverage.” In the FEHBlog’s personal experience, the unaddressed family glitch is that that small employers (generally under 50 employees) must pay for each family member’s coverage on an age rated basis instead of the plus one or plus and family rates that large employers are permitted to use. Pre-ACA, all employers could use the bucket approach to family member rating. The proposed regulation won’t fix that problem.

agencies (as described in section 3502(1) of title 44, United States Code, except for the agencies described in section 3502(5) of title 44, United States Code) with responsibilities related to Americans’ access to health coverage shall review agency actions to identify ways to continue to expand the availability of affordable health coverage, to improve the quality of coverage, to strengthen benefits, and to help more Americans enroll in quality health coverage.  As part of this review, the heads of such agencies shall examine the following:

(a)  policies or practices that make it easier for all consumers to enroll in and retain coverage, understand their coverage options, and select appropriate coverage;

(b)  policies or practices that strengthen benefits and improve access to healthcare providers;

(c)  policies or practices that improve the comprehensiveness of coverage and protect consumers from low-quality coverage;

(d)  policies or practices that expand eligibility and lower costs for coverage in the ACA Marketplaces, Medicaid, Medicare, and other programs;

(e)  policies or practices that help improve linkages between the healthcare system and other stakeholders to address health-related needs; and

(f)  policies or practices that help reduce the burden of medical debt on households.

These are interesting objectives, but FEHB typically is not considered to be a employee benefit program and not a government health program.

From the healthcare business front

  • Beckers Hospital Review tells us “Walmart Health will open five new clinics in Florida, according to an April 5 press release.” Healthcare Dive offers a deep dive into Walmart’s healthcare efforts in the Sunshine State.

UnitedHealth Group’s Optum and Change Healthcare have further extended their merger agreement to Dec. 31. The extension comes ahead of a two-week trial to determine the deal’s fate.

The Department of Justice sued to block the merger in late February, alleging that the combination could allow UnitedHealth to get a leg up on its competitors in the insurance space. The deal was first announced in January 2021 and is valued at $8 billion in cash and $5 billion in debt.

The trial is set to begin on Aug. 1.

“The extended agreement reflects our firm belief in the potential of our combination to improve healthcare and in our commitment to contesting the meritless legal challenge to this merger,” the companies said in a joint statement Tuesday.

From the tidbits department

  • Shatterproof offers alcohol awareness resources in recognition of April being Alcohol Awareness Month.
  • Per Health Day, “Significantly higher average body mass index (BMI) and obesity prevalence rates were seen among U.S. adults during the COVID-19 pandemic, according to a study published online April 4 in the American Journal of Preventive Medicine.” The complete journal article is available here.
  • The same preventive medicine journal also offers an article on mortality rates of childbearing aged women in our country. “Given the high correlation between pregnancy-related mortality and all-cause mortality at the state level, addressing the structural factors that shape mortality risks may have the greatest likelihood of improving women’s health outcomes across the life course.”
  • The HHS Inspector General has created a website on telehealth.

The Office of Personnel Management last week offered guidance to agencies on how they should implement the recently enacted benefit providing federal workers with up to two weeks of paid bereavement leave following the death of a child.

The new leave was adopted as part of the 2022 National Defense Authorization Act, signed by President Biden last December.

In a memo to agency heads, OPM Director Kiran Ahuja wrote that although each agency is responsible for its own implementation of the new benefit, her agency wants to ensure that it is provided to employees across government “in an equitable and uniform way.”

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call reports

Senate negotiators have reached agreement on a $10 billion pandemic relief package that includes funding for domestic needs but not international aid, according to two Senate aides who were not authorized to speak publicly.

The deal crystallizes an informal “agreement in principle” the parties reached last week to provide $10 billion for near-term pandemic needs by repurposing unspent funds from prior relief laws.

The Wall Street Journal adds

The White House backed the deal and urged Congress to pass the bill promptly, while noting it was less than the $22.5 billion the administration had requested for vaccines, boosters, treatments and testing.

“We will continue to work with Congress to fund our remaining domestic needs,” said Press Secretary Jen Psaki in a statement. She added that the White House would continue to press for funding global vaccination efforts.

The FEHBlog noticed that the Senate Homeland Security and Governmental Affairs Committee held a business meeting last Wednesday. The Committee favorably reported the President’s nomination of Kristin Boyd to be OPM Inspector General by voice vote (with Sen. Hawley (R Mo.) voting no). The next step for Ms. Boyd’s nomination is the Senate floor.

Last week, the House of Representatives passed a Secure 2.0 bill applicable to private sector defined contribution plans. The Senate is likely to approve the bill too. The Society for Human Resource Management has reviewed the bill’s provisions.

From the Omicron and siblings front —

  • Becker’s Hospital Review informs us “The World Health Organization is monitoring a new omicron variant — dubbed XE — that’s a hybrid of BA.1, the original omicron strain, and BA.2, a highly transmissible subvariant.” The hybrid is estimated to be 10% more contagious that BA.2.
  • American Hospital Association tells us “Beginning today through the end of the public health emergency, Medicare Part B beneficiaries may obtain up to eight free over-the-counter COVID-19 tests per month through eligible health care providers and pharmacies, the Centers for Medicare & Medicaid Services announced.” Medicare Part B beneficiaries can obtain the free tests by showing their Medicare identification card.
  • The American Medical Association discusses “How we will know when COVID-19 has become endemic.” The FEHBlog tends to think that we are there.
  • The Centers for Disease Control announced

The new nationwide Test to Treat initiative provides quick access to free treatment for COVID-19. Through this program, people can get tested and – if they are positive and treatments are appropriate for them – receive a prescription from a health care provider, and have their prescription filled all at one location. 
These “One-Stop Test to Treat” sites are available at hundreds of locations nationwide, including pharmacy-based clinics, federally qualified health centers, and long-term care facilities. 
People can continue to be tested and treated by their own health care providers who can appropriately prescribe these oral antivirals at locations where the medicines are distributed. 
A call center 1-800-232-0233 is available every day from 8:00 am to midnight ET to get help in more than 150 other languages.
The Disability Information and Access Line is available to help people with disabilities access services. Call 1-888-677-1199, Monday-Friday from 9:00 am to 8:00 pm ET or email DIAL@usaginganddisability.org.

From the CMS front, the agency announced that “the updated MMSEA Section 111 GHP User Guide version 6.5 has been posted to the GHP User Guide page on CMS.gov. Refer to Chapter 1 for a summary of updates.” Section 111 is a system that has been in place for about 12 years. Section 111 helps CMS keep tabs on Medicare beneficiaries and beneficiaries using data group health plans, including FEHB plans, automobile and liability insurers, and attorneys for injured Medicare beneficiaries.

CMS also released “the Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Rate Announcement).”

From the healthcare conference front, Fierce Healthcare tells us about the 2022 Health Datapalooza and National Health Policy Conference being held today and tomorrow in Arlington, VA.

From the federal employment front, Govexec reports

Federal employees can hold elected partisan office while also working at their agencies, a key panel found in a ruling setting a new precedent for civil servants. 

Rodney Cowan did not have to give up his role as a county commissioner in Tennessee or be removed from his job with the U.S. Postal Service, the recently reconstituted central body of the Merit Systems Protection Board said in a decision last week. It was one of the first decisions of MSPB’s central board as it addresses its backlog of more than 3,500 cases that have piled up during its five years without a quorum. 

The FEHBlog doubts that we have heard the last word on this issue.

Weekend Update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

This week, the House of Representatives and the Senate will be in session for flooring voting and Committee business. In addition, the House and the Senate will be taking District and State work breaks for two weeks beginning next Monday.

From the Omnicron and siblings front, the New York Times Well column advises on preparing now for the next surge. Of course, as we lawyers say, the Times is assuming facts not in evidence. Nevertheless, given the huge Omnicron surge last winter, an ounce of prevention may become a pound of cure.

Last week, Bloomberg updated its Covid resiliency ranking of the world’s countries. The U.S ranks 24. Norway, the United Arab Emirates, and Ireland hold the top three spots. Mainland China ranks 48, and Russia and Hong Kong have the last two spots, 52 and 53.

From the Rx coverage front, STAT News brings us up to date on the Mark Cuban Cost Plus Drug Company.

Mark Cuban’s drug company started with an ambitious premise: to circumvent middlemen to offer cheaper costs to patients.

To do so, the company has had to grapple with which parts of the supply chain to develop themselves, and which to outsource using unusually transparent contracts, Mark Cuban Cost Plus Drug Company Founder and CEO Alex Oshmyansky said Thursday at STAT’s Breakthrough Science Summit.

“We decided that the only way to really ensure that pricing for our products actually reaches the patient, the most important part at the end of the day, was to build essentially a parallel supply chain,” Oshmyansky said.

But the company’s ambitions to entirely recreate the pharmaceutical supply chain have started smaller in the process of exploring what’s possible, and what’s profitable.

For example, instead of manufacturing many drugs to sell them cheaply, the company is choosing to focus on manufacturing drugs in shortage to ensure there’s a market for them, and working directly with existing generic manufacturers to keep costs down.

“​​We basically said, ‘Hey, why don’t we, instead of going through the effort of manufacturing these products ourselves, why don’t we just purchase them and just sell them close to their actual price?’” Oshmyansky said.

A lofty plan to create their own pharmacy benefit manager has also been shelved for the moment, though Oshmyansky insisted it’s not off the table entirely. Instead of creating its own PBM, the company instead chose to whitelist PBMs that behave well for the moment.

From the health plan front —

  • OPM and AHIP will hold the annual FEHB Carrier Conference later this month. Recently AHIP posted the conference agenda. In addition, the early registration discount ends on Friday, April 8.
  • Last week, AHIP provided a lengthy list of health insurer actions to address social determinants of health. Bravo.

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 weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 13th week of 2022:

The CDC weekly review of its Covid data adds

Currently, there are 19 (0.59%) counties with a high COVID-19 Community Level, 146 (4.53%) counties with a medium Community Level, and 3,059 (94.88%) counties with a low Community Level. This represents a slight (−0.84%) decrease in the number of high-level counties, a moderate (−2.73%) decrease in the number of medium-level counties, and a corresponding (+3.57%) increase in the number of low-level counties. Twenty-seven (48.21%) of 56 jurisdictions had no high- or medium-level counties this week. To check your COVID-19 community level, visit COVID Data Tracker.

* * *

The current 7-day daily average [of new Covid hospital admissions] for March 23–29, 2022, was 1,564. This is a 15.8% decrease from the prior 7-day average (1,858) from March 16–22, 2022. * * *

The current 7-day moving average of new [Covid] deaths (627) has decreased 14.4% compared with the previous 7-day moving average (732).

Here’s a link to the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the beginning of the Covid vaccination era until last Wednesday.

The CDC’s weekly review notes

As of March 30, 2022, the 7-day average number of adhttps://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.htmlministered vaccine doses reported (by date of CDC report) to CDC per day was 214,405, a 17.8% increase from the previous week.

CDC’s COVID Data Tracker displays vaccination trends by age group, race/ethnicity, and urban/rural status. To see trends by age group and race/ethnicity, visit the Vaccination Demographic Trends tab. To see trends by urban/rural status, visit the COVID-19 Vaccination Equity tab.

The American Medical Association offers guidance to physicians concerning the FDA’s emergency authorization of a second Covid booster for Americans aged 50 and older.

HR Dive discusses what employers should take away from the Biden Administration’s updated approach to Omicron.

Here’s a link to the CDC’s weekly flu surveillance report or Fluview.

From the “and more” department —

  • HR Dive discusses what employers can do to help employees with adolescent children suffering from behavioral health issues. For example, because a shortage of child psychiatrists exists,

Telemental health programs offer convenient access (often at lower cost than in-person care) for many services—and some, like Brightline, are designed specifically for families of children with mental health needs. However, recent studies have shown that telehealth offerings are not being utilized as much for children as they are for adults, for rural populations as they are for urban ones, or for low-income communities as they are for wealthier ones. Clearly, there is an opportunity for employers to make vulnerable populations aware of the telemental health services available to them. 

  • BioPharma Dive identifies “Five FDA decisions to watch in the second quarter. Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs.”