Thursday Miscellany

COVID-19 testing

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Senate has adjourned until Monday March 7 after setting another cloture vote on the Postal Reform Act of 2022 (HR 3076) for Monday at 5:30 pm. While the FEHBlog is not a Senate procedure expert, it appears that another cloture vote is required because a minor Senate amendment was filed after the first cloture vote. Postal reform must be getting real because the Wall Street Journal posted an account of the decade-long effort to pass this legislation today.

From the Omicron front, the FEHBlog’s favorite part of the President’s new strategy was explained by the White House Covid czar yesterday:

Pfizer’s pill {Paxlovid] is a gamechanger — 90 percent effective at keeping people out of the hospital.

We collaborated with Pfizer to accelerate development of the pill.  And we’ve ordered 20 million courses.

As the President announced last night, Pfizer worked overtime to further accelerate delivery.  This month alone — the month of March — we’ll have 1 million of these treatment courses available.  And in April, that number will more than double.

To ensure these lifesaving treatments are easily accessible, the President’s Plan launches a new “Test to Treat” initiative to provide individuals access to testing and treatment for free, all in one stop. 

Hundreds of one-stop sites will open across the country this month, located at local pharmacy clinics, community health centers, long-term care facilities, and veterans’ health centers.

Marketwatch adds today that “CVS Health Corp., the Walgreens Boots Alliance Inc., and Walmart Inc. said they will participate in the test-to-treat initiative, a new program that allows someone who has tested positive for the virus to get antiviral pills during the same visit at no cost.”

Covid treatment costs were astronomical because care principally was given in hospitals and other healthcare facilities, creating a major burden on the healthcare system. Facilitating the use of Flonase for Covid will avoid the vast majority of those hospitalizations, thereby lowering healthcare costs.

Speaking of testing, the Wall Street Journal reports that

Manufacturers are developing new types of at-home tests, including for flu and strep throat, aimed at consumers who are increasingly monitoring and managing their own health through fitness apps and smartwatches.

Boulder, Colo.-based fertility company MFB Fertility Inc. received clearance from the U.S. Food and Drug Administration in February 2020 for its Proov test, designed to help women measure their hormone levels and to know when in a given month they are most likely to become pregnant. A typical kit includes 20 testing strips, allowing a woman to test daily, which the company said would be tough to achieve through visits to a doctor’s office.

Amy Beckley, the company’s chief executive, said the rise of at-home Covid-19 tests over the past year has made it much easier for people to understand her product.

“All of a sudden, home diagnostics and home testing became a thing,” she said.

Mobihealth News reported last June

The U.S. Air Force has inked a $1.3 million deal with MFB Fertility in order to provide military members and their partners the former’s home fertility tests.

The Air Force’s AFWERX office will invest in Proov, an at-home ovulation test with FDA clearance. The test works by measuring Pregnanediol Glucuronide (PdG), the urine metabolite of progesterone, which is released by the ovary after ovulation. High levels of PdG over multiple days can confirm that successful ovulation took place.

The contract will provide free Proov kits to Air Force couples upon request and connect them to fertility specialists.

Two cool innovations.

From the healthcare policy front —

  • The White House released a fact sheet on steps underway to address the Nation’s opioid epidemic.
  • The Associated Press reports on the President’s mental healthcare policy proposals made in Tuesday’s State of the Union address. For example, under the President’s plan, “Health insurance plans would have to cover three mental health visits a year at no added cost to patients.” I suggest that the Administration consider the fact that most employers offer employee assistance plans that already offer two or three free mental health therapy visits. The overcomplicated federal mental health parity law fails to look at the big picture.

From the diabetes front —

  • The AMA offers six tips for screening patients for pre-diabetes. Many of the tips also could be applied by health plan case managers and coaches.
  • The American Diabetes Association delves into the relationship between diabetes and kidney disease.

From the litigation front, Reuters reports

The Sackler family owners of Purdue Pharma LP reached a deal with a group of attorneys general to pay up to $6 billion in cash to resolve widespread litigation alleging that they fueled the U.S. opioid epidemic, bringing the OxyContin maker closer to exiting bankruptcy.

The attorneys general for eight states and the District of Columbia, who had blocked a previous settlement that included a $4.3 billion cash payment, announced the deal after weeks of mediation with the Sacklers.

The family agreed to pay at least $5.5 billion in cash, which will be used for abating a crisis that has led to nearly 500,000 U.S. opioid overdose deaths over two decades.

The value of the deal could grow as the family members sell additional assets.

U.S. Bankruptcy Judge Robert Drain must approve the deal, which protects the Sacklers from civil lawsuits. Purdue requested a March 9 hearing for Drain to review the agreement.

From the Rx coverage front, Biopharma Dive reports

Civica is making plans to offer three versions of insulin that can be sold at dramatically lower prices than today’s alternatives, targeting a need highlighted by President Joe Biden during this week’s State of the Union Address.

The nonprofit company, created by hospital systems and philanthropies to address drug shortages, said Wednesday it will recommend pricing of no more than $30 for the vials it produces. Name-brand versions can currently cost 10 times that amount at cash prices.

Civica announced an ambitious timeline, projecting that the first product — designed to be interchangeable with Sanofi’s Lantus — would be available as soon as early 2024. The company also aims to manufacture cheaper versions of Eli Lilly’s Humalog and Novo Nordisk’s Novolog, in both vials and pre-filled pens.

Also the Institute for Clinical and Economic Review (“ICER”) announced

it will assess the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), phentermine / topiramate (Qsymia, Vivus Pharmaceuticals), liraglutide (Saxenda, Novo Nordisk), and naltrexone/bupropion (Contrave, Currax Pharma) for the treatment of obesity. 

The assessment will be publicly discussed during a meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in September 2022, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.

ICER’s website provides timelines of key posting dates and public comment periods for this assessment.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–

From Capitol Hill, the Senate approved a motion to proceed to a vote on the Postal Reform Act of 2022 (HR 3076) by a voice vote. This vote suggests to the FEHBlog that the Senate will approve the bill this week.

Roll Call discusses the status of the Consolidated Appropriations Act for Fiscal Year 2022. Congress has a week and half to finish cobbling together this law before it needs a fourth continuing resolution.

From the Omicron vaccine front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today released a study examining the effectiveness of the Pfizer COVID-19 vaccine at preventing emergency department and urgent care visits by children aged 5-11 and 12-17. Among children aged 5-11, effectiveness 14-67 days after dose 2 (the longest interval in this age group) was 46%, significantly lower than overall estimates for adolescents aged 12-17. However, most encounters among children aged 5-11 occurred during omicron predominance, when the vaccine’s effectiveness also significantly declined for adolescents, suggesting that the lower effectiveness for children aged 5-11 was likely driven by the predominant variant rather than differences in effectiveness across age groups, the authors said. During omicron predominance, there was no evidence 2 doses protected adolescents after 150 days; however, a booster dose restored effectiveness to 81% in this age group, the authors said.

Another study released today by the CDC looks at reactions to the Pfizer booster in adolescents aged 12-17, which were generally mild to moderate and transient. Myocarditis was less frequently reported after a booster dose than a second primary dose, the authors said.

From the Omicron masking and testing front —

Federal agencies can relax their mask and testing protocols in the wake of new public health guidance. 

The Centers for Disease Control and Prevention’s released on Friday a “new framework” that “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” Dr. Rochelle Walensky, the agency’s director, said on a call with reporters. Guidance from the Biden administration’s Safer Federal Workforce Task Force on Monday reflects this new framework. 

“This document provides federal agencies with initial implementation guidance they should follow in utilizing the CDC’s COVID-19 Community Levels to determine the appropriate mask-wearing and screening testing requirements for each federal facility at a given time,” said the guidance. 

Nearly half of the 500 million free COVID-19 tests the Biden administration recently made available to the public still have not been claimed as virus cases plummet and people feel less urgency to test.

Wild demand swings have been a subplot in the pandemic, from vaccines to hand sanitizer, along with tests. On the first day of the White House test giveaway in January, COVIDtests.gov received over 45 million orders. Now officials say fewer than 100,000 orders a day are coming in for the packages of four free rapid tests per household, delivered by the U.S. Postal Service.

It would be a good idea for the federal government to tell health plans to refer their members to the federal site if they are interested in receiving test kits.

To sum it up from the Omicron front, check out the lead article from the NIH Director’s blog titled “How Covid immunity holds up over time.”

From the tidbits department —

  • The CDC discusses the unholy connection between diabetes and chronic kidney disease.
  • Fierce Healthcare discusses telehealth provider Amwell’s fourth quarter results.
  • Beckers Payer Issues notes

UnitedHealth Group is beginning to act on its November promise to shore up its sustainability efforts by halting its mailing paper of prior authorization and clinical decisions to providers, according to a Feb. 25 post on the California Medical Association website. 

The first move — a nationwide shift to digital clinical decision letters — is effective March 4 for most UnitedHealthcare Medicare Advantage and commercial plan members. Instead of receiving a mail appeal decision, providers can view the decisions digitally immediately after they are made. 

President Joe Biden is calling for more federal employees to return to the office, saying “significant progress” fighting the COVID-19 pandemic has made it safer to do so.

Ahead of his State of the Union address, Biden issued a letter Tuesday thanking the federal workforce for its “tireless work this past year” confronting the pandemic and leading economic recovery efforts.

A return to the office, however, doesn’t necessarily mean a return to the pre-pandemic status quo.

Biden urged agencies to “build on the innovations and technologies that we put to work serving the American people throughout the pandemic, making our government more efficient, resilient, and effective.”

Good luck, OPM.

Weekend Update

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

Congress is back in session this week for Committee business and floor voting. The Senate calendar notes the cloture motion on the Postal Reform Act of 2022 ripens tomorrow February 28 at 5:30 pm. This means that the Senate can hold a cloture vote on the bill later that evening or the following business day. A cloture vote requires 60 votes in favor.

We are eleven days away from the end of the current continuing resolution funding the federal government. That deadline will grab Congress’s attention.

The President will give his State of the Union address on Tuesday, March 1.

From the No Surprises Act (NSA) front, Prof. Katie Keith breaks down the Texas Medical Association decision rendered last Wednesday in the federal district court for the Eastern District of Texas. At stake were the provisions in the second interim final rule implementing the NSA that the independent dispute resolution entity acting as the arbitrator to resolve payment disputes between health plans and certain out-of-network provider accept the plan’s statutory payment known as the Qualifying Payment Amount “unless a party submits credible information that clearly demonstrates that the QPA is materially different from the appropriate out-of-network rate.”

On February 23, Judge Kernodle * * * issued a decision and final judgment vacating provisions of the interim final rule related to the “rebuttable presumption.” He held that the plaintiffs had standing to challenge the rule, that the rule is inconsistent with the NSA, that the federal agencies should not have bypassed notice and comment procedures, and that the challenged provisions should be vacated and remanded to the agencies for revisions. The vacated provisions, listed here, are:

— The requirement that the IDR entity select the offer closest to the QPA unless there is credible information to demonstrate that this is not the appropriate rate;

— The requirement that “additional information” clearly demonstrate that the QPA is materially different from the out-of-network rate;

— The definition of “material difference;”

— All four examples on how IDR entities should choose between competing offers; and

— The requirement that the IDR entity explain why it chose an offer not closest to the QPA.

As you can see, this is a relatively surgical approach; these are the only provisions in the rule that have been invalidated. But these are important provisions designed to ensure a well-functioning, predictable IDR process and help hold down health care costs and premiums.

Professor Keith adds

Judge Kernodle rejected [the federal government’s] requests for limited relief. Instead, he vacated the challenged provisions on a nationwide basis with a sweeping assertion that “there is nothing the Departments can do on remand to rehabilitate or justify the challenged portions of the Rule as written. * * *

From here, DOJ will presumably appeal Judge Kernodle’s decision to the Fifth Circuit and perhaps request a stay while the case is on appeal. If a stay is not granted, the court’s decision remains in effect, meaning the IDR provisions noted above are unlawful and set aside. The IDR process will still be available and is expected to begin in earnest in March 2022. But the ruling increases the risk that some providers will try to leverage the federal IDR process to obtain higher rates than are warranted, potentially leading to higher health care costs and premiums. 

What’s more,

Federal officials have already indicated that they will issue a final IDR rule by May 2022 and will likely be reviewing Judge Kernodle’s decision with an eye towards whether the final rule can include provisions that are similar to those in the interim final rule—as well as whether to rescind or replace the challenged provisions. The final rule will likely affect the timeline of current litigation and perhaps trigger future lawsuits.

It’s not a pretty picture for health plans at this point.

From the Omicron front, the Wall Street Journal discusses the steps that government agencies and public health organizations are taking to make rapid at home Covid tests available and understandable to the most vulnerable of us, “including low-income areas, rural parts of the country and some communities of color.”

From the behavior health care front, Health Payer Intelligence tells us

AHIP called on providers and policymakers to join payers in their efforts to integrate behavioral healthcare and physical healthcare in an issue brief on the subject.

The payer organization laid out three critical strategies for integrating behavioral healthcare. 

The collaborative care model (CoCM) uses care management to facilitate patient-centered care, and many of its services are recognized and reimbursed by CMS. 

The expanded and integrated care management model uses care management to support individuals with chronic conditions, specifically behavioral healthcare conditions. The model leans on screening tools in the primary care environment to identify conditions earlier.

Finally, the value-based purchasing and alternative payment models incentivize whole-person care financially. However, outcomes-based payment is challenging to measure in behavioral healthcare.

This is straight path to federal mental health parity compliance. Thanks AHIP.

From the OPM front —

  • Fedscoop lists the important links on the OPM website for federal and Postal employees considering retirement or about to retire.
  • Govexec discusses a recent GAO report on an OPM information technology project to overhauls it financial system for managing the government’s fringe benefit programs, including the FEHB.

From the good works department, Fierce Healthcare reports

Health Care Service Corporation [a Blue Cross licensee] is teaming up with the National Fitness Campaign to open outdoor fitness centers in Illinois and Texas.

The insurer will invest $850,000 to open 35 Fitness Courts across both states, according to an announcement. Construction is set to begin this summer, with the goal of opening the first locations in the fall. 

Midweek update

David Ermer–CDC, CMS, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron front —

MedCity News reports

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster. 

This news bears similarities to the reports about the Novavax Covid vaccine already submitted to the Food and Drug Administration for emergency use authorization.

The American Hospital Association informs us

The Food and Drug Administration yesterday listed all over-the-counter COVID-19 diagnostic tests authorized for home use, including links to home use instructions for each test.

Fierce Healthcare adds

Walmart has administered tens of millions of COVID-19 vaccines to date, with 80% delivered in medically underserved communities, the retail giant announced Wednesday.

The company released a report (PDF) looking back at its progress in providing vaccines over the course of 2021. Cheryl Pegus, M.D., executive vice president of health and wellness at Walmart, told Fierce Healthcare the company has focused on connecting with people who may not otherwise have been able to get the shot.

From the health equity front —

The American Hospital Association tells us

The U.S. maternal mortality rate increased to 23.8 deaths per 100,000 live births in 2020 from 20.1 in 2019 as rates for Black and Hispanic women increased, according to data released today by the Centers for Disease Control and Prevention. The maternal mortality rate for Black women was nearly three times the rate for white women. Mortality rates increased with maternal age, with the rate for women aged 40 and over nearly eight times higher than the rate for women under 25.

The AHA’s Better Health for Mothers and Babies initiative offers resources to help hospitals and health systems eliminate maternal mortality and address health disparities for mothers and babies. 

What can be more tragic than a baby losing a mother?

Beckers Payer Issues adds from the mental health perspective

Work-sponsored health plans aren’t addressing the growth of loneliness, which leads to employees missing work and decreased productivity, according to data from Cigna’s Loneliness Index shared with Becker’s. 

The data, which is slated to be published in the Journal of Organizational Effectiveness: People and Performance, surveyed nearly 6,000 employees between July 16 and Aug. 2, 2019. 

Six insights:

1. The widespread presence of loneliness affected 3 in 5 (62 percent) adults before the COVID-19 pandemic. Feelings of loneliness play key roles both in employee health and work performance, according to the study.

2. On average, preventable, stress-related absences caused lonely employees to miss about five more work days than their counterparts who did not identify as lonely.

3. Employees who reported higher levels of loneliness were almost twice as likely to consider quitting their current job than employees who were less lonely. 

4. The study estimates that absenteeism and productivity losses tied to preventable loneliness cost employers $154 billion each year. 

5. The study said work-based factors like communication, work-life balance and social companionship play key roles in determining employee loneliness. Personal resilience and a feeling of connection outside of the workplace also play a role. 

6. Employers looking to combat employee loneliness should consider actions that hit on these factors, including flexible work hours, email “blackout” periods and forming employee resource groups.

From the Black History Month department, Everywell, an at-home testing service, celebrates ten Black pioneers who improved healthcare in our country. Bravo.

From the U.S. healthcare front, Healthcare Finance News reports

Including federal government support, national health spending grew by 3.4% in 2021, according to new data released by Altarum.

This growth in spending, the analysis found, reflected the fact that support from the federal government was strong in 2020, likely in response to the recession caused by the COVID-19 pandemic, and was lower in 2021.

Taking these support dollars out of both 2020 and 2021 estimates, spending growth from 2020 to 2021 would have been 8.4%, as the economy continued to recover.

From the healthcare business front —

Healthcare Dive informs us

Despite worries that demand for telehealth could fall as the U.S. emerges from the COVID-19 pandemic, virtual care giant Teladoc beat Wall Street expectations with its 2021 financial results, and issued strong future growth projections Tuesday.

The New York-based vendor posted revenue of more than $2 billion in 2021, 86% higher than in 2020. Total visits were up 38% to 15.4 million, and Teladoc closed out the year with 53.6 million U.S. paid members, up just slightly from the year prior.

Beckers Hospital Review identifies 92 U.S. health systems with CMS-approved “hospital at home” programs.

Managed Healthcare Executive tells us

Tired of grappling with the rising costs and poor quality of healthcare, a coalition of major healthcare purchasers is taking things into its own hands, establishing a company that is designing healthcare products to meet its members’ needs. “There’s an incredibly high frustration level among buyers of healthcare,” says Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health (PBGH) in San Francisco. 

The nonprofit PBGH represents almost 40 large private employers and public entities that together spend $100 billion each year on healthcare services for more than 15 million Americans and their families. PBGH members include Microsoft, Walmart and American Airlines.

The decision to create the company, Emsana Health, was made about two years ago, with the initial focus on “really understanding the needs on a deep level,” Mitchell says. The company officially launched in the fall, and its first venture is setting up a pharmacy benefit manager (PBM), EmsanaRx, which went started operating on Jan. 1.

Finally, in a troubling tidbit, the Wall Street Journal reports

U.S. life insurers, as expected, made a large number of Covid-19 death-benefit payouts last year. More surprisingly, many saw a jump in other death claims, too.

Industry executives and actuaries believe many of these other fatalities are tied to delays in medical care as a result of lockdowns in 2020, and then, later, people’s fears of seeking out treatment and trouble lining up appointments.

Some insurers see continued high levels of these deaths for some time, even if Covid-19 deaths decline this year.

Friday Stats and More

David Ermer–CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Mental health care, Uncategorized–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s chart of weekly new Covid cases from the 27th week of 2021 through the 5th week of this year:

The Omicron surge is subsiding. The CDC’s weekly interpretation of its COVID statistics indicates that

COVID-19 cases and hospitalizations are continuing to decline across the United States. As of February 2, 2022, cases are down 53.1% from their peak on January 15. However, community transmission is still high nationwide.

Unfortunately Covid-related deaths, a lagging indicator, continue to rise:

Here’s the FEHBlog’s chart of weekly Covid vaccinations administered and distributed from the 51st week of 2020 through the 5th week of 2022.

The pace of COVID vaccinations is slowing again. 212.5 million out of 303 million Americans (net of 23.6 million children under 5 years old) are fully vaccinated and of that cadre, 89.3 million have been boostered.

The American Medical Association offers seven reasons why parents should get their kids ages 5 to 11 vaccinated against Covid.

Also today the CDC’s Advisory Committee on Vaccination Practices unanimously ratified the FDA’s decision to award full marketing approval to the Moderna mRNA vaccine Spikevax for use with adults age 18 and older.

For the hardcore Covid statistics folks check out this tidbit from the CDC’s weekly interpretative report

Wastewater (sewage) surveillance is a promising tool for tracking the spread of SARS-CoV-2, the virus that causes COVID-19. Many people with COVID-19 shed the virus in their feces, so testing wastewater can help us find COVID-19 in communities. Wastewater testing has been successfully used as a method for detection of other diseases, such as polio. Wastewater surveillance results can provide an early warning of increasing COVID-19 cases and help communities prepare.

On February 3, 2022, COVID Data Tracker released a Wastewater Surveillance tab, which tracks SARS-CoV-2 levels in sewage at more than 400 testing sites across the country. This marks the first time CDC’s wastewater surveillance data is available for download. See “A Closer Look” below for more information about this method of data collection.

From the Covid testing mandate front, the Affordable Care Act regulators issued ACA FAQ 52 late this afternoon. The regulators use this FAQ to provide helpful clarifications to the mandate. Check it out.

From the Covid treatment front, Medscape tells us that

A little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.

Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said.

“We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”

The CDC’s weekly Fluview report summarizes the flu situation as follows: “Influenza activity has decreased in recent weeks, but sporadic activity continues across the country.”

From the Postal reform front, Federal News Network reports that

The Postal Service’s best shot at a long-term legislative reform in recent years is finally moving ahead in Congress next week.

The House expects to vote on the Postal Service Reform Act next week. The House Oversight and Reform Committee approved the legislation last May.

Notably, the most recent version of the bill now has the support of the National Active and Retired Federal Employees (NARFE), which raised significant concerns about an earlier version.

NARFE, in a letter of support Friday, said an earlier version of the bill contained “onerous provisions” that could have increased health insurance premiums for all non-postal federal employees and retires.

The earlier version of the bill, the association added, would have also required current postal retirees to pay additional premiums for mostly duplicative health insurance coverage through Medicare.

Moreover, this afternoon, the Congressional Budget Office released its report on the House Rules Committee Print 117-32 for H.R. 3076, the Postal Service Reform Act of 2022. The FEHBlog does not see any showstoppers in that CBO report. The House Rules Committee has scheduled a hearing on this bill for Monday at 2 pm ET. You can read the current version of the bill here.

Finally, Healthcare Dive reports that

Congress appears poised to work on a bipartisan mental health and substance misuse package this year, following a series of hearings this week stressing the need to boost the workforce, insurer benefits and telehealth access.

Legislators also seemed to support giving federal departments more power to force health insurers to comply with parity laws, following a report in late January finding widespread inequities between mental and medical benefits in the U.S. that sent physician groups up in arms.

That, dear readers, is a big bowl of wrong because the outrage stems from the “non-quantitative treatment limit” mental health parity standard set by the Obama era regulation, not the original law. That standard, in the FEHBlog’s view, is amorphous. The FEHBlog favors mental health parity but please Congress don’t make the standard impossible to achieve consistently. Keep it simple.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From Capitol Hill, Roll Call reports that Congress is not making much progress toward replacing the current continuing resolution funding the federal government with an omnibus bill resolving FY 2022 appropriations. The deadline for Congressional action is February 18. It is starting to look like Congress is headed toward passing another short-term continuing resolution according to the article. Time will tell.

From the Covid testing front, the Biden administration announced today that Medicare will begin direct coverage of over-the-counter Covid tests in the early Spring of this year.

Health Payer Intelligence informs us that America’s Health Insurance Plans wrote a statement to Congress describing the numerous administrative problems created by the “free” Covid test coverage mandates that started nearly two years ago with the CARES Act.

MedPage Today tells us about a human challenge study of the Covid incubation period conducted in London which found that the Covid incubation is only two rather than five days after exposure. Instead the symptoms tend to peak at five days and the virus remains detectable 10 days after exposure.

The Institute for Clinical and Economical Review released a draft assessment of outpatient treatments for Covid including the Pfizer and Merck pills, an intravenously administered recombinant monoclonal antibody (Sotrovimab), and an off-label use of an obsessive-compulsive SSRI drug (Fluvoxamine) for which researchers are seeking an emergency use authorization for Covid. The draft conclusion is that

Our analyses suggest that each outpatient intervention produces improved clinical outcomes. At their current prices, each intervention is estimated to meet standard cost-effectiveness levels in the US health care system, even under a scenario with a lower hospitalization risk that may reflect the current Omicron wave. The cost-effectiveness findings are primarily driven by a treatment’s ability to reduce hospitalization and the baseline probability of hospitalization.

From the No Surprises Act front, the Labor Department helpfully released a transcript of the January 19, 2022, listening session regarding provider nondiscrimination under Section 2706(a) of the Public Health Service Act. The NSA requires the ACA regulators to issue implementing rules for this law which has been in force since 2014.

Also, Kaiser Health News discusses mental health therapist concerns about the good faith pricing estimate for healthcare services that the NSA applies across the board. The law also requires health plans to issue advance explanations of benefits in response to a good faith estimate from a provider. The FEHBlog will never understand why Congress failed to direct HHS to create HIPAA standard transactions for the GFE and the AEOB. In any event, providers and health plans await implementing rules from the ACA regulators.

From the Rx coverage front, Biopharma Dive provide us with two insights

  1. “Biogen recorded $1 million in revenue from its new treatment for Alzheimer’s disease in the last quarter of 2021, offering the latest evidence that the drug, which came to market with multi-billion dollar sales expectations, continues to struggle commercially.”
  2. “AbbVie may soon face competition for its top-selling eye drug Restasis after the Food and Drug Administration on Wednesday approved a generic version.”

From the healthcare business front, Fierce Healthcare fills us in on Cigna’s fourth quarter 2021 financial report.

Tuesday’s Tidbits

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog nearly fell off his office chair when he noticed a Govexec headline this afternoon reading “The House finally plans to vote on Postal reform [HR 3706] next week. The long sought after bill could make it to the President’s desk by the end of the month.” This Postal reform saga has been going on for over a decade.

The Postal reform act (HR 3706) would relieve the Postal Service of the obligation to prefund the cost of FEHB coverage in retirement for its employees. The bill also would create a Postal Service Health Benefits Program (“PSHBP”) within the FEHB Program. The PSHBP would tightly integrate Medicare annuitant coverage with primary Medicare A, B, and D. Medicare Part A (hospital care) is premium free while Medicare Part B (medical care) and Part D (prescription drugs) charge premiums.

OPM encourages Medicare age annuitants to pick up Part B but it prohibits FEHB carriers from using integrated Part D arrangements knowsn as EGWPs even though every other U.S. employer that provides drug coverage to its retirees uses a Part D EGWP or takes the retiree drug subsidy. What’s more Congress in the Medicare Modernization Act of 2003 expressly authorized FEHB plans to use Medicare EGWPs. Go figure.

In any event, all enrollee costs are included in FEHB risk pools which is an important feature of the FEHB Plan and its constituent PSHBP. The cost of Medicare Prime annuitants in the PSHBP will be much lower than those in legacy FEHB, and Medicare Prime annuitants are a signficant cadre of enrollment, PSHBP premiums will be noticeably lower than legacy FEHB premiums.

The CBO has projected that 3/5s of the Medicare integration savings for the PSHBP will come from the Part D EGWPs. The FEHBlog looks forward to the day later this decade when OPM finally permits legacy FEHB carriers to offer Medicare Part D EGWPs.

From the Covid vaccine front —

  • Pfizer and BioNTech have a submitted an emergency use authorization request for an mRNA Covid vaccine for little children aged six months through four years. The FDA and CDC are likely to approve the application by the end of February according to Medscape.

Novavax announced Monday that it has formally submitted a request to the FDA for emergency use authorization of its COVID-19 vaccine for ages 18 and older.

The request includes results from two large clinical trials that showed an overall efficacy of about 90% and a “reassuring safety profile,” the company said.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, the president and CEO of Novavax, said in the statement.

From the COVID treatment front, the Wall Street Journal reports that providers are having difficulty obtaining the drugs need to treat Omicron because the treatments typically are available under emergency use authorizations and each State makes its own decison on how to distribute EUA treatments. On the brighter side,

Antiviral-pill manufacturers are ramping up production to meet demand. Supplies of Pfizer Inc.’s Paxlovid are expected to increase in the spring, according to Pfizer and state officials. Merck & Co., which manufactures molnupiravir with partner Ridgeback Biotherapeutics LP, said it has delivered two million courses to the U.S. and will deliver the rest of the 3.1 million courses under its contract by the end of this week.

From the healthcare cost front, Healthcare Dive reports that

The omicron variant walloped hospitals in the final month of 2021, driving up both adjusted patient volumes and expenses as the number of COVID-19 cases surged to new highs for the pandemic, according to Kaufman Hall’s latest flash report.

Patient days rose nearly 4% in December compared to November, while emergency department visits jumped more than 7% as patients came in with COVID-19 symptoms. Omicron’s rapid spread drove a 98% jump in COVID-19 hospitalizations over the course of the month, Kaufman Hall said, citing Centers for Disease Control and Prevention data.

The second full year of the pandemic was marked by an increase in severely ill patients requiring longer hospital stays compared to the first year, the report also found.

From the No Surprises Act front, Healthcare Dive examines healthcare provider association legal challenges to the federal regulators’ use as the qualifying payment amount in NSA arbitrations. The FEHBlog has described those cases now pending in federal district courts in Texas and Washington DC as exercises in futility. For example,

Since the qualifying payment amount represents the median in-network rate, it by definition means that half of providers are below the QPA and half are above, according to Chris Garmon, a professor at University of Missouri – Kansas City, who has studied surprise billing. Not all providers are set to see payments decline and some may even see them increase if the QPA is used, he said.

The good professor overlooks the fact that in 2021 out of network doctors caring for patient at in-network facilities were reimbursed at out-of-network rates typically two or perhaps three times the Medicare RBRVS reimbursement. For that reason, the FEHBlog expects that in most cases the QPA will be noticeably higher than pre-NSA reimbursements. Time will tell, but the regulators’ approach is reasonable, and patient advocacy groups have been supporting the regulators in these cases.

From the mental health parity front, Health Payer Intelligence compares provider and payer reactions to the government’s recent report to Congress on payer compliance with complex federal health parity act rules.

From the healthcare business front, Fierce Healthcare tells us that

GuideWell, the parent company of Blue Cross and Blue Shield of Florida, has closed its acquisition of Triple-S Management Corporation, a Puerto Rico-based health services company.

The deal was first announced in September.

GuideWell acquired all shares of Triple-S at $36 per share in cash, according to an announcement from the company. Triple-S will now operate under its existing branding as a wholly owned subsidiary of GuideWell.

From the FDA front, check out this FDA news roundup.

From Capitol Hill, Govexec reports on OMB acting director’s Shalonda Young’s confirmation hearings to be the Presidentially nominated OMB director. Ms. Young appears on her way to confirmation.

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 4th week of 2022.

The Omicron surge clearly has peaked. However, the weekly new Covid deaths chart continues to rise as deaths are a lagging indicator.

Here’s the FEHBlog’s chart of Covid vacciniations, including boosters, distributed and administered from the 51st week of 2020 through the 4th week of 2022.

The CDC’s Covid Data Tracker Weekly Review sums it up as follows:

COVID-19 cases and hospitalizations are starting to decline across the United States. However, deaths are still rising, and community transmission is still high nationwide. As of January 27, 2022, more than 211 million people in the United States have received a primary series of a COVID-19 vaccine and are considered fully vaccinated. More than 86 million people are up to date with their COVID-19 vaccines, which means they have received all recommended COVID-19 vaccine doses, including boosters.

Two new CDC reports show that people who are up to date with their COVID-19 vaccines have the highest amount of protection against both the Delta and Omicron variants.

STAT News adds that


New data show that vaccines still protect against a spinoff of the Omicron variant, a welcome sign as the world keeps a close eye on the latest coronavirus iteration.

BA.2, as the sublineage is known, is part of the broader Omicron umbrella. Scientists are paying more attention to it as it begins to eat into the dominance of the more common Omicron strain, which is technically called BA.1.

Here’s a link to the CDC’s latest Fluview whose key update is as follows:

The percent of specimens testing positive for influenza remains stable, indicating that influenza virus circulation has remained at similar levels during the past two weeks, even while overall levels of respiratory illness have declined.

WIRED Magazine informs us that the goverment’ covidtests.com has been working smoothly to distribute sixty million rapid antigen tests to American thanks to sound planning from the U.S. Digital Service supported by the U.S. Postal Service.

At one time, a presidential announcement like that would have caused a mad scramble in the agencies involved. But hard and bloody experience has changed the way the executive branch works. This time, even before Biden made his public promise, the people charged with actually building the site had, as Hsiang says, “a seat at the table” and were able to shape expectations from the beginning. “We did a bunch of work to make sure that it was technically feasible before we decided how we were going to implement it,” says Natalie Kates, who is the Covid lead for USDS.

They decided that the project should be sited and built at the United States Postal Service, which not only had the national database of valid addresses, but would ultimately deliver the packages. When the Postal Service’s CIO, Pritha Mehra, learned about the project in December, she was given estimates that demand might peak at a million users an hour. Mehra, a 31-year veteran of the service, concluded that was a lowball prediction and multiplied the number by 20, striving for a fail-safe capability. “Think about it—free Covid tests,” she says. “Look at the numbers of people that are trying to buy them. And so we read 20 times the demand that had been projected, and I told my team that’s what we’re going to build to.” She had no problem recruiting that team. “This is a technologist’s dream, to be able to do this,” she says.

Mehra knew it would be a challenge to the service’s architecture, which involved a combination of its own data centers and outside cloud providers. Her team set up a system with triple redundancy, beefing up the architecture, separating the customer experience process from the order fulfillment, and caching data multiple times in the process. And doing endless load testing. “Believe me, there was a lot of work behind what seemed like a very simple site,” she says.

Mazaal tov.

Health Payer Intelligence reviews insurer association comments on the HHS proposed 2023 Notice of Benefit and Payment Parameters which principally focuses on the ACA marketplace.

The proposed rule addressed a broad range of issues on the individual health insurance marketplace, from medical loss ratios to health equity data. 

AHIP and the Alliance for Community Affiliated Plans (ACAP) have both responded to the proposed rule with mixed reactions. Some elements they strongly applauded, such as the return to pre-2020 language around discrimination, web-broker display requirements, standards of conduct for brokers and agents, special enrollment period verification, and quality improvement strategy (QIS).

AHIP and ACAP highlighted a couple of key areas of the proposed rule that they would like to see changed in the finalized version [including risk adjustment, offering standardized plans, network adequacy, and medical loss ratio.

On the hand, the American Hospital Association also submitted comments on the proposed Notice.

The AHA yesterday voiced support for many of the policies proposed in the Centers for Medicare & Medicaid Services’ Notice of Benefit and Payment Parameters for 2023, including clarifications to the Medical Loss Ratio calculations, reestablishment of standardized health plan option requirements, changes to the essential health benefit nondiscrimination policy, and new requirements and standards of conduct for agents, brokers and web-brokers.

“In particular, we commend CMS on the proposed updates to the network adequacy standards, which are critical to ensuring that patients have access to the care they need,” AHA wrote. “We also strongly support CMS’ attention to advancing health equity throughout the proposed polices.”

Read the detailed comments here.

Finally and considering its the beginning of the weekend, here is a link to the American Medical Association’s What Doctors Wish Their Patients Knew about sodium consumption.

Thursday Miscellany

David Ermer–ACA, COVID treatment, COVID-19 testing, No Surprises Act, Telehealth, U.S. Healthcare–

From the Omicron front, MedPage Today reports that

While a large meta-analysis of studies on convalescent plasma use early in the pandemic turned up no survival advantage for the typical patient hospitalized for COVID-19, researchers have mined the dataset to predict who may benefit.

Eva Petkova, PhD, of NYU Grossman School of Medicine in New York City, and colleagues devised a simple and freely available tool called the Convalescent Plasma Benefit Index Calculator that allows doctors to input certain patient criteria to determine if their patient may benefit from convalescent plasma (age, oxygen need, blood type, and history of either diabetes, heart disease, or pulmonary disease).

Note: The FEHBlog has been intrigued by convalescent plasma treatments since reading John Barry’s The Great Influenza in early 2020. The FEHBlog currently is reading Gregory Zuckerman’s A Shot to Save the World which is equally fascinating.

The Wall Street Journal’s personal technology reporter Joanna Stern reviews the latest in at home Covid testing.

It’s Friday and you’ve got a scratchy throat and a mild headache. Time to play “Cold? Covid? Or Just Crazy?”—the only game more popular than Wordle. 

Or you could open up your medicine cabinet and power-on a small white box. Swab your nose with a Lego-like stick, then slide that into the illuminated gadget. About 20 minutes later, your iPhone buzzes: “COVID-19 Positive.”

The future? Nope, it’s already here. For the past few weeks, I’ve been testing the Cue Health Monitoring system and the Detect Covid-19 Test, two systems from health-tech startups that put lab-like molecular testing right on your bathroom counter. No driving to the testing center. No waiting in line. No anticipating the results for days.

* * *

Molecular tests’ biggest benefit: They can spot Covid earlier—anywhere from 6 hours to two days, depending on the variant and other factors. Dr. Mina, who previously served as an adviser to Detect, said they’re good “if you’re really symptomatic and you definitely want to know, ‘Is this Covid?’ ”

However, if you’re using a test to determine whether you can safely go out into the world—back to work, back to school—the cheaper rapid antigen test would be best. “The problem with a molecular test is that it’s so sensitive that it may detect dead fragments and not live virus,” said Peter Chin-Hong, an infectious-disease specialist at the University of California, San Francisco.

Ms. Stern also explains in the article that the molecular test cost singificantly more than the rapid antigen tests.

Bloomberg released its latest Covid resilence ranking for 53 countries around the world.

The Covid Resilience Ranking is a monthly snapshot of where the virus is being handled the most effectively with the least social and economic upheaval. Drawing on 12 data indicators spanning virus containment, quality of healthcare, vaccination coverage, overall mortality and progress toward restarting travel, it captures how the world’s biggest 53 economies are responding to the same once-in-a-generation threat.

The United Arab Emirates and Saudi Arabia rank one and two. The U.S. ranks 23 down 11 ranks since last month. The FEHBlog recalls that last Spring before Delta hit us, the U.S. ranked number 1 in this index. How the mighty have fallen.

From the No Suprises front

  • The Affordable Care Act regulators today released 37 pages of helpful guidance about the No Suprises Act’s new federal independent dispute resolution process.
  • Healthcare Leaders tells us that “The U.S. Department of Health and Human Services (HHS), Office of Inspector General, plans to conduct a nationwide audit to determine whether hospitals that received Provider Relief Funding complied with the billing requirements for COVID patients. This requirement stipulates that those hospitals must not pursue out-of-pocket payments from COVID patients whose bill exceeded “what the patients otherwise would have been required to pay” for in-network care. This audit will be based on the various federal Covid relief acts, not the No Surprises Act

From the Affordable Care Act front, the FEHBlog diligently has been on the lookout for the HHS announcement of 2023 out-of pocket cost-sharing limits for in-network care. The 2023 ACA Notice of Benefit and Payment Parameters released December 28, 2021, advised that the announcement would be released in January. The regulators must have meant that future announcements would be released beginning in January 2024 because the FEHBlog discovered yesterday that the 2023 announcement was released on December 28, 2021.

The announcement reads in pertinent part that

Under 45 CFR 156.130(a)(2), for the 2023 calendar year, cost-sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2023. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage for 2023 of 1.4408219719, and the 2014 maximum annual limitation on cost-sharing of $6,350 for self-only coverage, which was published by the Internal Revenue Service on May 2, 2013, the 2023 maximum annual limitation on cost-sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 4.6 percent increase above the 2022 parameters of $8,700 for self-only coverage and $17,400 for other than self-only coverage.

And there you are, dear readers.

From the healthcare business front, Healthcare Dive informs us that

— HCA [Healthcare] announced plans to build five new hospitals in Texas in response to the growing population there, executives said Thursday during a call with investors.   

— The hospitals will serve as primary- and secondary-type hospitals with basic inpatient and outpatient services that will refer patients needing higher-acuity services to HCA’s other campuses. These new hospitals will be smaller facilities with about 50 to 75 beds, executives said Thursday.

— The new hospitals will be located in the areas of Dallas Fort-Worth, Houston, San Antonio, and Austin.

Fierce Healthcare adds

Nashville, Tenn.-based HCA Healthcare saw its revenue and profit grow year over year in the fourth quarter of 2021. 

The 182-hospital system reported revenue of $15.1 billion in the fourth quarter of last year, up from $14.3 billion in the same period of 2020. The for-profit hospital operator said same-facility admissions, emergency room visits and outpatient surgeries increased year over year, while inpatient surgeries declined. 

After factoring in expenses and nonoperating items, HCA’s net income in the fourth quarter of 2021 totaled $1.8 billion, up from $1.4 billion in the same quarter a year earlier. 

From the telehealth front, Fierce Healthcare reports that

As telehealth companies increasingly turn to chronic care management, Cigna’s MDLive is launching its own remote patient monitoring program.

The digital-first program will allow patients with chronic conditions to track biometrics like blood pressure and glucose levels, recording daily health information that they can review with MDLive providers during their visits.

* * *

Cigna expanded access to MDLive’s network of virtual primary care providers to all members of the insurer’s employer plans beginning January 2022.

The new patient health monitoring program will be available to all health plan clients of MDLive.

Midweek update

David Ermer–CDC, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron front, Live Science informs us about the so-called stealth Omicron variant.

A stealthy version of the omicron variant has been detected in the U.S., but so far, it makes up a very low proportion of the overall cases in the country.

This version of the variant, called BA.2, bears some genetic mutations not seen in the original omicron lineage, and some of these mutations lie in the spike protein, according to the World Health Organization (WHO). Some preliminary data hint that BA.2 may be slightly more transmissible, but not more severe, than the original omicron, but it’s too early to interpret that data with any confidence.

In December, scientists reported that the original version of omicron had split into multiple sublineages, one of these being BA.2, Live Science previously reported. BA.2 bears a genetic quirk that makes it harder to track using PCR tests, so it’s been nicknamed “stealth omicron.” 

The New York Times tells us about a new study identifying four factors that may lead to “Long Covid“.

The researchers said they had found that there was an association between these factors and long Covid (which goes by the medical name post-acute sequelae of Covid-19, or PASC) whether the initial infection was serious or mild. They said that the findings might suggest ways to prevent or treat some cases of long Covid, including the possibility of giving people antiviral medications soon after an infection has been diagnosed. * * *

One of the four factors researchers identified is the level of coronavirus RNA in the blood early in the infection, an indicator of viral load. Another is the presence of certain autoantibodies — antibodies that mistakenly attack tissues in the body as they do in conditions like lupus and rheumatoid arthritis. A third factor is the reactivation of Epstein-Barr virus, a virus that infects most people, often when they are young, and then usually becomes dormant.

The final factor is having Type 2 diabetes, although the researchers and other experts said that in studies involving larger numbers of patients, it might turn out that diabetes is only one of several medical conditions that increase the risk of long Covid.

From the Covid booster front

The COVID-19 booster drive in the U.S. is losing steam, worrying health experts who have pleaded with Americans to get an extra shot to shore up their protection against the highly contagious omicron variant.

Just 40% of fully vaccinated Americans have received a booster dose, according to the Centers for Disease Control and Prevention. And the average number of booster shots dispensed per day in the U.S. has plummeted from a peak of 1 million in early December to about 490,000 as of last week.

Also, a new poll from The Associated Press-NORC Center for Public Affairs Research found that Americans are more likely to see the initial vaccinations — rather than a booster — as essential.

“It’s clear that the booster effort is falling short,” said Jason Schwartz, a vaccine policy expert at Yale University. * * *

As for why an estimated 86 million Americans who have been fully vaccinated and are eligible for a booster have not yet gotten one, Schwartz said public confusion is one important reason.

“I think the evidence is now overwhelming that the booster is not simply an optional supplement, but it is a foundational part of protection,” he said. “But clearly that message has been lost.”

The need for all Americans to get boosters initially was debated by scientists, and at first the government recommended only that certain groups of people, such as senior citizens, get additional doses. The arrival of omicron, and additional evidence about falling immunity, showed more clearly a widespread need for boosters.

But the message “has been lost in the sea of changing recommendations and guidance,” Schwartz said.

  • Speaking of confusion over boosters, Kaiser Health News reports that

The Centers for Disease Control and Prevention reached out to pharmacists Wednesday to reinforce the message that people with moderate to severe immune suppression are eligible for fourth covid shots.

The conference call came a day after KHN reported that immunocompromised people were being turned away by pharmacy employees unfamiliar with the latest CDC guidelines.

  • If you thought that the idea of mixing and matching Covid boosters was confusing, the National Institutes of Health reassureed us that

In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the U.S. Food and Drug Administration, an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal of Medicine. The findings served as the basis for recommendations by the FDA and the Centers for Disease Control and Prevention in late fall 2021 to permit mix-and-match COVID-19 booster vaccinations in the United States. Additional data from the ongoing Phase 1/2 trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are expected in the coming months.

From the Postal Service front, Govexec reports that

USPS, like the rest of the nation, has experienced a surge in COVID-19 cases from the omicron variant and thousands of workers are sick or quarantining each day. Still, the agency oversaw a largely successful holiday period and continues to ramp up its delivery of COVID-19 rapid tests on behalf of the administration. The Health and Human Services Department is reimbursing USPS for its costs, but the Postal Service has declined to disclose the terms of that arrangement. The mailing agency has kept on thousands of temporary staff to support the effort and is using its own facilities to stage the shipments. Tens of millions of tests have already gone out, White House Coronavirus Response Coordinator Jeff Zients said on Wednesday. 

Zients added the administration opted against using USPS to distribute 400 million N95 masks from the National Stockpile because its alternative approach—sending them to pharmacies and other locations to give to customers for free—is quicker. The masks have already reached many facilities and Americans are picking them up. 

From the hearing aid front, Roll Call reports on the state of the Food and Drug Administration’s efforts to craft a rule allowing hearing aids to be sold over the counter, a Biden Administration initiative. Suffice it to say that nothing is simple.

From the healthcare business front, Healthcare Dive tells us that

The fourth quarter results for Indianapolis-based Anthem were mixed, analysts said. The financial results released premarket Wednesday beat Wall Street expectations on earnings, but missed on operating revenue.

Higher-than-expected coronavirus-related costs driven by the omicron variant — most notably in December — were “more than offset” by lower utilization of non-COVID-19 care, CFO John Gallina told investors on a Wednesday morning call.

Anthem’s commercial business had the highest costs relative to baseline, driven by factors like children becoming eligible for COVID-19 vaccines and the omicron surge. Medicare was next in line, followed by Medicaid, which actually ended the quarter slightly below baseline, Gallina said. The CFO noted he expects that theme to continue in 2022.

The payer’s medical loss ratio, the percentage of premiums invested back into patient care, was 89.5% in the quarter, in line with analyst forecasts and up sequentially from the third quarter’s 87.7%, which was much lower than analysts had expected. The fourth quarter of the year typically has a higher MLR, even notwithstanding pandemic pressures.

What’s more Fierce Healthcare informs us that

The number of accountable care organizations participating in the Medicare Shared Savings Program (MSSP) modestly increased to 483 this year compared with 477 for 2021, sparking new worries from advocates over the future of the program.

The Centers for Medicare & Medicaid Services released new figures Wednesday that show the patient population being served by ACOs has slightly grown. The new data come as the Biden administration released a strategic refresh last year for its payment models with the intent of getting every Medicare beneficiary in an accountable care relationship by 2030. * * *

ACO advocates have been concerned about a decline in overall participation that has been occurring in the MSSP in recent years. There were 517 ACOs participating in 2020, which was up from the 519 that operated in 2019. However, that’s down significantly from the 561 that participated in 2018.

The National Association of ACOs (NAACOS) has previously called for CMS to make it easier for organizations to take on financial risk. The group criticized a Trump-era program called “Pathways to Success” that requires ACOs to take on financial risk much earlier in the process.

NAACOS has also called for greater predictability in ACO benchmarks that set the spending and quality targets ACOs must meet to qualify for shared savings as well as increases in such shared savings rates.

From the mental health parity front, Health Payer Intelligence digs into yesterday’s government report on health plan compliance with the federal mental health parity law.

EBSA conducted a review from April 16, 2021 to October 31, 2021 that assessed 156 payers on their non-quantitative treatment limitations, a parity compliance measure that often poses challenges to payers. * * *

Out of all of the comparative analyses that EBSA received, not a single payer provided all of the information that the review requested in the initial submission.

As a result, the administration sent out 80 letters to payers requesting more information. Twelve of the letters went to payers that had already received a letter from EBSA notifying them that they had submitted insufficient information and seeking the requested details.

EBSA still has not announced any final determinations. However, after this back and forth with payers, EBSA accrued enough information to find 30 health plans in non-compliance on a total of 46 NQTLs.

Three major issues stood out to EBSA as the administration assessed NQTL compliance.

First, the administration found that many health plans and issuers were not prepared for compliance. * * *

Second, the initial comparative analyses perpetuated a historic trend of providing insufficient data due to five types of errors. * * * [For example] payers did not perform a comparative analysis before designing their NQTLs, so the NQTLs were unlikely to meet EBSA’s standards.  * * *

Finally, despite lack of preparation and a range of errors that led to a fragmentary picture of the NQTLs and their applications, EBSA found that some plans could receive an initial determination even for an incomplete analysis. Hence, 30 plans have already received initial determinations of non-compliance.

As EBSA continues the determinations, the administration recommended changes to Congress that would enhance enforcement of the mental health parity compliance law, promote access to coverage, and standardize compliance regulations.

The FEHBlog recommends reading the entire article. As the FEHBlog mentioned yesterday, the mental health parity law could be made simpler and more effective but that outcome is just not in the cards at least currently.