Thrsday Miscellany

Congress

Thrsday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, No Surprises Act, U.S. Healthcare, Uncategorized–
Photo by Juliane Liebermann on Unsplash

From the Postal Reform front, health benefits expert Robert Moffitt, whose work the FEHBlog admires, wrote a column titled “It’s a bad idea to use the Medicare to bail out the Postal Service.” On this occasion, the FEHBlog finds himself in disagreement with Mr. Moffitt.

  1. Medicare is not bailing out the Postal Service. Since 1984, the Postal Service and its employees has paid and continues to pay Medicare taxes for its employees until they retire. At that point, Medicare becomes primary to FEHB and other group health coverage by law.
  2. Every other business in America that provides health benefits coverage to its retirees essentially follows the same approach as the Postal Service will be authorized to do by this bill.
  3. The Postal reform bill is unique in that it creates a special Part B enrollment period for current annuitants as of January 1, 2024, who have Part A but declined to enroll for Part B, an option which OPM encourages. Under the bill that that House passed this week, the Postal Service will bear the cost of the late enrollment penalties associated with this special enrollment period.
  4. Mr. Moffitt suggests that Postal Service Health Benefit Program (PSHBP) Medicare annuitants may find it necessary to purchase Medicare supplement insurance. However, we know from experience that PSHBP plans will follow the practice of existing FEHB plans and wrap their benefits around Medicare to fill those Medicare gaps. The PSHBP coverage is the Medicare supplemental coverage available to Medicare annuitants in FEHB and the PSHBP, and more tightly integrating PSHBP and Medicare coverage will result in lower premiums for all PSHBP enrollees.

Bear in mind that studies have shown the group health plans subsidize Medicare by making payments to healthcare providers that substantially exceed Medicare’s low reimbursements.

From the No Surprises Act (“NSA”) front —

  • CMS issued more FAQs on the federal independent dispute resolution (“IDR”) process today.
  • Consumer Reports identifies five healthcare scenarios which fall outside the scope of the No Surprises Act.
  • Fierce Healthcare brings us up to date on the healthcare provider association lawsuits challenging the federal government’s decision to treat the NSA’s qualifying payment amount as the lodestar in federal IDR arbitrations.

From the Omicron front, Medscape reports that “The U.S. government is planning to roll out COVID-19 shots for children under the age of 5 as soon as Feb. 21, according to a document from the U.S. Centers for Disease Control and Prevention. * * * Young children [beginning at six months] will receive a lower dose of the vaccine, if it is authorized. Pfizer/BioNTech tested a 3-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older.”

Also, the Department of Health and Human Services announced that “the federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge.”

From the COVID vaccine mandate front, Govexec tells us

A federal appeals court has denied the Biden administration’s request to undo the pause on its COVID-19 vaccine mandate for federal employees, leaving in place a ban on agencies enforcing the requirement. The U.S. Court of Appeals for the Fifth Circuit opted not to weigh in on the Justice Department’s petition for immediate relief, meaning the mandate will likely remain enjoined for at least several months. The only path for quicker resolution would be for the administration to appeal further tNBo the Supreme Court, an option it has not yet said it will explore. A Justice spokeswoman declined to comment. 

From the miscellany department

  • NIH News discusses advances in breast cancer screening and treatment.

The clipboard of paper forms that for decades has been a standard part of Americans’ doctor visits may soon be a thing of the past. 

Federal authorities who oversee health technology have set a deadline for December for the health care industry to support smartphone apps, like Apple Health, that store records electronically. 

Their goal is to have patients use their phones to electronically share records with a doctor’s office or hospital — without a pen and paper, if they choose. 

“Patients ought to be able to use the app of their choice,” said Micky Tripathi, who’s helping to put the federal rules in place as the Biden administration’s national coordinator for health information technology. 

“Every patient has the deep frustration of going to a hospital and they give you a clipboard and you have to fill out all the information, and then you go to another part of the same hospital and they give you the clipboard again,” Tripathi said. 

The FEHBlog has been reading articles about the demise of the clipboard throughout this century. However, he thinks that this worthy idea may soon come to fruition.

Midweek Update

David Ermer–Congress, COVID-19, OPM, Telehealth, U.S. Healthcare–

From Capitol Hill, Roll Call informs us

House and Senate Appropriations Committee leaders said Wednesday they have a deal on a “framework” that will allow them to start writing compromise spending bills for the fiscal year that began Oct. 1.

Senate Appropriations Chairman Patrick J. Leahy, D-Vt., and House Appropriations Chair Rosa DeLauro, D-Conn., put out statements Wednesday afternoon announcing the pact. A spokeswoman for Senate Appropriations ranking member Richard C. Shelby confirmed Republicans also view what the Alabama senator described earlier in the day as “an understanding” as an official agreement. 

Neither side revealed any details of what the framework entails.

A source familiar with the negotiations said the agreement is to have “parity,” or equal increases for defense and nondefense spending, and to start further negotiations leaving current law policy riders in place. All four committee leaders would have to agree to remove or add any other riders, the source said.

That means the longstanding Hyde amendment barring federal funding for abortion in most cases will likely be in the final package, since Republicans would object to removing it as Democrats have proposed.

From the Omicron front, the Wall Street Journal reports

Hospitalizations continued tracking downward in the U.S., with the seven-day average of patients with confirmed or suspected Covid-19 falling to about 111,000, down 30% from a peak in January, according to data from the Department of Health and Human Services. * * *

U.S. deaths are holding steady, with the seven-day average standing at 2,531 on Monday, according to data from Johns Hopkins University. Though there is growing evidence that the Omicron variant is less likely to cause severe illness than earlier strains of the virus, particularly among people who have been fully vaccinated, the number of infections means that deaths—a lagging indicator—remain high, public-health experts say. Omicron’s rapid spread means it is reaching people with other illnesses, and Covid-19 wasn’t the cause of death in some of these cases.

From the plan design front —

  • Banner Health and Aetna announced that its joint venture

Banner|Aetna [has created] a strategic relationship with type 2 diabetes reversal leader Virta Health. The collaboration brings Virta’s innovative diabetes care approach to the insurer’s eligible members of fully insured and Administrative Services Only groups. Virta’s first-of-its-kind diabetes treatment helps people actually reverse their condition: combining personalized nutrition and virtual care, patients can achieve normal blood sugar without medications.

  • Fierce Healthcare tells us

Anthem will make virtual primary care available to eligible members of its commercial health plans in 11 states, the insurer announced Tuesday.

The expansion will roll out the offering to fully insured plans and select large group administrative services clients in Colorado, Connecticut, Georgia, Indiana, Kentucky, Missouri, Nevada, New York, Ohio, Virginia and Wisconsin, the company said. Eligible members can access a virtual care team that will conduct an initial health check-in and then craft a personalized care plan.

The insurer is expecting a significant number of its administrative services clients to adopt the platform over the course of this year.

From the healthcare business front, Healthcare Dive reports

Lower COVID-19 costs in CVS’s payer business coupled with a sharp increase in vaccine administration from booster shots that benefited its drugstores drove the Rhode Island-based healthcare behemoth to revenue of $76.6 billion in the fourth quarter, up more than 10% year over year. That helped drive CVS, which beat Wall Street expectations on both earnings and revenue in the quarter, to a profit of $1.3 billion, up 33% compared to the fourth quarter of last year.

and

Dallas-based hospital operator Tenet will continue its strategy of acquiring ambulatory surgery centers to drive long-term growth and plans to buy 30 more facilities from SurgCenter Development this year, the company said Tuesday. That’s in addition to 16 it has purchased so far this year, executives said on an earnings call Tuesday. Tenet and its subsidiary United Surgical Partners International last year completed a $1.1 billion acquisition of SCD, giving it an ownership stake in 86 surgery centers and related support services. That deal also gave USPI exclusivity on developing a minimum of 50 new centers with SCD during a five-year period.

From the federal employment front, OPM announced

The White House Task Force on Worker Organizing and Empowerment yesterday publicly released its report detailing nearly 70 recommendations, approved by President Biden, that promote worker organizing and collective bargaining for public and private sector employees. The U.S. Office of Personnel Management is leading several of these recommendations, which focus on improving the ability of federal employees to exercise their right to organize and activate their labor rights.

Tuesday’s Tidbits

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

From Capitol Hill —

Govexec reports that earlier today the House of Representatives passed the Postal Reform bill (HR 3706) by a bipartisan 342 to 92 vote. The bill now heads over the the Senate. Govexec adds “Sen. Gary Peters, D-Mich., who chairs the Homeland Security and Governmental Affairs Committee and authored the companion legislation in the Senate, sounded an optimistic note for the bill’s fate in his chamber. ”

The bill would create a Postal Service Health Benefits Program within the FEHB Program beginning in 2025. The PSHBP would feature tightly integrated coverage with Medicare for its annuitants over age 65.

Roll Call informs us that

The House passed a stopgap appropriations bill Tuesday evening to extend current federal agency funding rates through March 11 as Democrats and Republicans continue to trade offers on topline spending levels for the fiscal year that began Oct. 1.

Both sides claim they’re “close” to a framework deal on the fiscal 2022 omnibus and predict this latest continuing resolution, the third one this fiscal year, will be the last stopgap. The previous CR is set to expire Feb. 18. 

Senate Majority Leader Charles E. Schumer said in floor remarks Tuesday morning that his chamber will take up the stopgap measure “quickly” after House passage, “in time before the Feb. 18 deadline.” The House vote was 272-162, indicating likely bipartisan support in the Senate as well.

Fierce Healthcare tells us

A bipartisan group of senators is crafting a package that tackles several barriers to mental health access, with a major emphasis on pay parity between behavioral and physical health and furthering telehealth use.

The Senate Finance Committee Chairman Ron Wyden, D-Oregon, announced the contours of the mental health legislative package during a hearing Tuesday on youth mental health. Wyden said the goal is to get together a bipartisan bill by the summer.

The anticipated bill would be a gold mine for lawyers unless Congress also simplifies the existing parity standards.

From the Omicron front —

The Wall Street Journal advises

You’ve been exposed to Covid-19 more times than you can count. And yet somehow you’ve never tested positive. Could all these close encounters with Covid-19 be enhancing your immune response to it? The answer isn’t clear-cut, scientists say.

Your immune system probably benefits only if you get infected, many scientists say, because a near miss probably won’t have put enough virus in your body to meaningfully rev up your defenses. You can benefit from an asymptomatic infection that you didn’t realize you had, or a case that was too low-level to show up on a rapid test.

The only safe way to build immunity is vaccination, as any exposure to Covid-19 comes with a risk of serious illness, hospitalization or death. Avoiding infection is still important, but if you are exposed, there are circumstances where you might benefit if you already have antibodies, some scientists say.

Medscape reports

People who have had COVID-19 have an increased risk for and 12-month burden of cardiovascular disease (CVD) that is substantial and spans an array of cardiovascular disorders, a deep dive into federal data suggests.

“I went into this thinking that this is most likely happening in people to start with who have a higher risk of cardiovascular disorders, smokers, people with high BMI, diabetes, but what we found is something different,” Ziyad Al-Aly, MD, told theheart.org | Medscape Cardiology. “It’s evident in people at high risk, but it was also as clear as the sun even in people who have no cardiovascular risk whatsoever.”

Rates were increased in younger adults, never smokers, White and Black people, males and females, he said. “So the risk confirmed by the SARS-CoV-2 virus seems to spare almost no one.”

Ruh roh.

From the synthetic opioid epidemic front, AP reports

The U.S. needs a nimble, multipronged strategy and Cabinet-level leadership to counter its festering overdose epidemic, a bipartisan congressional commission advises.

With vastly powerful synthetic drugs like fentanyl driving record overdose deaths, the scourge of opioids awaits after the COVID-19 pandemic finally recedes, a shift that public health experts expect in the months ahead.

“This is one of our most pressing national security, law enforcement and public health challenges, and we must do more as a nation and a government to protect our most precious resource — American lives,” the Commission on Combating Synthetic Opioid Trafficking said in a 70-page report released Tuesday.

The report envisions a dynamic strategy. It would rely on law enforcement and diplomacy to shut down sources of chemicals used to make synthetic opioids. It would offer treatment and support for people who become addicted, creating pathways that can lead back to productive lives. And it would invest in research to better understand addiction’s grip on the human brain and to develop treatments for opioid use disorder.

From the telehealth front —

According to mHealth Intelligence

Most [77%] infectious disease (ID) patients were open to using virtual care after they were informed about the toll in-person care took in terms of time, money, and travel, according to a survey conducted by Washington University and published in Open Forum Infectious Diseases.

Although patients are typically accustomed to the setting in which they receive care, information provided about virtual care can change their perspective, the new research shows.

The survey polled patients 18 years old and older who reside 25 or more miles away from their ID clinic. The goal was to acquire information regarding travel distance and time, money spent, and carbon dioxide emissions.

Beckers Hospital Review adds “Amazon Care’s virtual health services are now available nationwide, and its in-person services will be rolled out in more than 20 new cities in 2022, Amazon said Feb. 8 in a post on its website.” Amazon Care also offers in-person care in “Seattle, Baltimore, Boston, Dallas, Los Angeles, Washington, D.C, Austin, Texas, and Arlington, Virginia. This year, the company plans to bring in-person care services to more than 20 additional cities including New York City, Chicago, Miami and San Francisco, according to the post.”

From the healthcare business front

  • Biopharma Dive reports on Pfizer’s zesty 4th quarter 2021 financial report
  • Becker’s Payer Issues reports on health insurer Centene’s positive 4th quarter 2021 results.

From the rankings department, Beckers Hospital Review notes

“Healthgrades has recognized 250 hospitals nationwide for exceptional care via its America’s Best Hospitals awards released Feb. 8. Three lists feature America’s 50, 100 and 250 best hospitals, which represent the top 1 percent, 2 percent and 5 percent of hospitals in the nation, respectively.”

and

Three companies dominate the pharmacy benefit manager market, accounting for 79 percent of all prescription claims in 2020, according to data from Health Industries Research Companies, an independent, non-partisan market research firm. A breakdown of PBM market share, by total adjusted prescription claims managed in 2020:

1. CVS Caremark: 34 percent

2. Express Scripts: 24 percent

3. OptumRx (UnitedHealth): 21 percent

4. Humana Pharmacy Solutions: 8 percent

5. Prime Therapeutics: 6 percent

6. MedImpact Healthcare Systems: 5 percent

7. All other PBMs: 3 percent

Finally, from the good news department, the Wall Street Journal reports

The [CDC’s] new births data, released Monday along with final data for 2020, show the pandemic has had a more muted impact on childbearing than expected. The economists Melissa Kearney and Phillip Levine in December released calculations showing the pandemic led to 60,000 missing births from October 2020 through February 2021. Earlier in the pandemic, they predicted the health crisis and economic uncertainty would lead to 300,000 to a half million fewer births last year.

Monday Roundup

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

From Capitol Hill —

Roll Call reports that

House Democrats introduced a government funding stopgap Monday that would extend current spending levels through March 11 as appropriators continue to negotiate topline spending levels for a fiscal 2022 omnibus bill. 

The move would buy Congress an extra three weeks to complete work on an overdue omnibus package for the fiscal year that began last October. The government is currently operating on a continuing resolution that expires on Feb. 18.

Per the Roll Call article, Congress expects to meet the March 11 deadline with a consolidated appropriations bill for the current government fiscal year.

Reuters reports that the House also will vote on the Postal Reform bill (HR 3706) tomorrow. Here is a link to the House Rules Committee website describing the actions that the Rules Committee took on HR 3706 today to line up a vote for tomorrow.

From the Omicron front —

According to the CDC’s COVID Data Tracker, as of today, 90 million out of 213 fully vaccinated Americans (42%) have received a Covid booster. In his New York Times column this morning, David Leonhardt writes that the relatively slow adoption of boosters is not a function purely of skepticism. Rather

The vaccinated-but-unboosted more closely resemble the country as a whole. Millions of Americans who have already received two vaccine shots — eagerly, in many cases — have not yet received a follow-up. The unboosted include many Republicans, Democrats and independents and span racial groups. * * *

The most urgent problem involves the unboosted elderly. (About 14 percent of Americans over 65 eligible for a booster had not received one as of mid-January, according to Kaiser.) But some younger adults are also getting sick as their vaccine immunity wears off.

A recent study from Israel, published in The New England Journal of Medicine, was clarifying. For both the elderly and people between 40 and 59, severe illness and death were notably lower among the boosted than the merely vaccinated. For adults younger than 40, serious illness was rare in both groups — but even rarer among the boosted: Of the almost two million vaccinated people ages 16 to 39 in the study, 26 of the unboosted got severely ill, compared with only one boosted person.

“Boosters reduce hospitalization across all ages,” Dr. Eric Topol of Scripps Research has said. As Dr. Leana Wen wrote in The Washington Post, “The evidence is clear that it is at least a three-dose vaccine

Mr. Leonhardt places responsibility for the booster gap on the fragmented U.S. health system and the failure of government experts to make themselves understood to the American people. Health plans may want to lend a hand here.

The National Institutes of Health informed us

Pregnant women with COVID-19 appear to be at greater risk for common pregnancy complications — in addition to health risks from the virus — than pregnant women without COVID-19, suggests a study funded by the National Institutes of Health.

The study, which included nearly 2,400 pregnant women infected with SARS-CoV-2, found that those with moderate to severe infection were more likely to have a cesarean delivery, to deliver preterm, to die around the time of birth, or to experience serious illness from hypertensive disorders of pregnancy, postpartum hemorrhage, or from infection other than SARS-CoV-2. They were also more likely to lose the pregnancy or to have an infant die during the newborn period. Mild or asymptomatic infection was not associated with increased pregnancy risks.

“The findings underscore the need for women of child-bearing age and pregnant individuals to be vaccinated and to take other precautions against becoming infected with SARS-CoV-2,” said Diana Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study. “This is the best way to protect pregnant women and their babies.”

The American Hospital Association offers six tips for health care leaders looking to build vaccine confidence among pregnant women.

The Wall Street Journal reports today

Drugmaker Shionogi & Co. said it plans to seek approval this month to sell its Covid-19 treatment pill in Japan after the company found that in human trials the pill had strong virus-fighting ability compared with Pfizer Inc.’s Paxlovid. 

Shionogi acknowledged that studies of its drug are much smaller than Pfizer’s and have yet to prove effectiveness in preventing serious Covid-19 cases. Pfizer said its final-stage trial, which included more than 2,000 patients, showed Paxlovid cut the risk of hospitalization or death by 89% if patients took the pill within three days of diagnosis. 

Still, Shionogi said it believed its trials to date, covering about 400 mostly Japanese patients, would offer sufficient evidence to seek approval in Japan, where the Pfizer drug is expected to be approved shortly, but is likely to be in limited supply. Shionogi said its trial found the pill, code-named S-217622, neutralized the virus quickly and didn’t cause serious or lasting side effects. 

The more, the merrier.

In other news, Fierce Healthcare tells us

CVS Health is teaming up with Medable to access and engage around clinical trials at select MinuteClinics, the healthcare giant announced Monday.

CVS Health Clinical Trial Services, a new arm at the company launched last May, will harness Medable’s software platform to deliver clinical trials with a focus on accessibility and retention to enhance the effectiveness of research, according to the announcement.

The companies note that while clinical trials are crucially important to test the efficacy of innovative pharmaceuticals, less than 4% of Americans actually participate in them. In addition, 30% of participants drop out before trials are completed, and 80% of studies are unable to make enrollment deadlines.

Tony Clapsis, general manager and senior vice president of CVS Health Clinical Trial Services, said in a statement that CVS has the ability to make a significant impact on outreach about trials to underrepresented people as more than 40% of vulnerable populations live within five miles of one of its pharmacies.

Smart move.

STAT News reports

  • “Some of the nation’s most influential doctors and public health groups are orchestrating a mad-dash effort to convince senators to confirm Robert Califf, President Biden’s pick to lead the Food and Drug Administration. * * * The pressure campaign comes amid growing signs that Califf’s nomination is in serious trouble. Five Democrats in the Senate have already expressed serious concerns with Califf’s nomination and at least 10 more are still undecided about his candidacy. Quite a few Republicans in the chamber also have concerns. ‘It’s … the ‘break glass in case of emergency’ moment,’ said one patient advocate, who noted that many advocacy groups had, until recently, thought Califf would sail through his confirmation process easily.”

and

  • “When President Biden tapped Eric Lander as White House science adviser in January 2021, he tasked the renowned genomics researcher with “reinvigorating” American science. Following Lander’s stunning resignation on Monday evening, however, the question is no longer whether he’ll reinvigorate the U.S. scientific enterprise. It’s whether he’s derailed it. Lander resigned after an all-staff apology for abusive workplace behavior, which Politico first reported. In an email, Lander admitted speaking in a “disrespectful and demeaning way,” acknowledging he had failed to set a “respectful tone” for the office and that his actions reflected poorly on the administration.”

Let’s hope Lander didn’t derail efforts like the Cancer Moonshot.

Weekend Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, OPM, SCOTUS–
Photo by JOSHUA COLEMAN on Unsplash

Both the House and the Senate will be in session this week for Committee business and floor voting. The FEHBlog will be keeping an eye on the House Rules Committee hearing on the Postal Reform Act (HR 3706) scheduled for tomorrow at 2 pm ET.

Roll Call reports

The House could take up a three-week stopgap funding extension through March 11 as soon as Tuesday to buy more time for appropriators to write final fiscal 2022 spending bills, according to sources who spoke on condition of anonymity because details haven’t been made public.

The temporary spending bill under discussion would only move to the floor if an agreement on topline funding allocations for defense and nondefense programs is reached first. But there was enough apparent progress behind the scenes to warrant talk of a short-term extension rather than a longer continuing resolution that could delay needed funds for the Pentagon, infrastructure programs and more. * * *

It wasn’t immediately clear whether the Senate would be on board with a three-week extension, and the length was still under discussion, according to sources. During the weekly House floor colloquy on the chamber’s schedule, [House] Majority Whip James E. Clyburn, D-S.C., wouldn’t comment on timing or specifics but said he hopes it will be a “short, short-term CR” if negotiators can’t write an omnibus before Feb. 18.

From the COVID vaccine front, the Wall Street Journal’s excellent Saturday Essay concerns efforts to extend mRNa vaccines beyond Covid. The FEHBlog just finished reading Wall Street Journal reporter Gregory Zuckerman’s book “A Shot to Save the World” which offers an inside look at the development of the various COVID vaccines. Moderna and BioNTech among other drug manufacturers were working on mRNA vaccines for many years before Covid struck. Their preparation led them to rapidly develop mRNA vaccines against Covid. The BioNTech and Moderna mRNA vaccines against Covid were the first mRNA vaccines approved by the Food and Drug Administration. Researchers in those companies and others now are continuing their work on the development of mRNA vaccines for the flu, cancer, HIV, among other diseases. Hope springs eternal.

The Wall Street Journal also provides an overview of the cases in which federal courts are considering the legality of the Biden administration’s Covid vaccination mandates for federal employees and federal government contractor employees in the wake of two recent U.S. Supreme Court rulings on other vaccine mandates.

Sean Marotta, a partner with law firm Hogan Lovells, said the rulings, taken together, send a message about the federal government’s power: “A vaccine mandate that targets problems specific to a federal regulatory program will likely be upheld. A mandate that is simply an attempt to get as many people vaccinated as possible, or is a workaround for the government not having a general power of vaccination, will probably be struck down

Well put, sir.

From the federal employment front, Federal News Network tells us

The Biden administration wants to give federal employees their largest pay raise in 15 years.

Federal News Network has learned that the White House will propose a 4.6% pay increase for federal employees as part of its fiscal 2023 budget request. The budget request is expected to go to Congress after the State of the Union, which is on March 1,  Shalanda Young, the nominee to be director of the Office of Management and Budget, told the Senate Budget Committee on Feb. 1.

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.

Weekend update

David Ermer–Congress, COVID treatment, COVID-19–

Both Houses of Congress are in session this week for Committee business and floor voting.

The FEHBlog notes that the President’s nominee for Office of Management and Budget, acting Director Shalonda Young, and her designated replacement to serve as Deputy OMB Director, Nani Coloretti, will be attending their Senate confirmation hearings this week.

The current continuing resolution funding the federal goverment expires on February 18, 2022. The Hill reports that

Congressional negotiators are in danger of missing the Feb. 18 deadline for passing an omnibus package of the annual appropriations for fiscal 2022.

A shutdown is unlikely, but members of the Senate Appropriations Committee from both parties warn that if negotiators blow through the mid-February deadline, it increases the likelihood that Biden will have to settle for a yearlong stopgap funding measure to keep the government open.

At this point the budget ball is in the Senate’s hands. The Hill further states

Spokespeople for the two senior negotiators [at the Senate] declined to comment in detail on the talks.  

“The negotiations are ongoing, and it remains the chairman’s goal to complete those negotiations by Feb. 18,” said Jay Tilton, a spokesman for Leahy.  

Blair Taylor, a spokeswoman for Shelby, said, “We are working diligently to create a product that is palatable to everyone — bills that can advance through Congress and be signed into law by the president.”  

From the Omicron front, the Wall Street Journal reports that

The Omicron variant spreads so quickly and generally causes such a mild form of illness among vaccinated populations that countries are tolerating greater Covid-19 outbreaks, willingly letting infections balloon to levels that not long ago would have been treated as public-health crises.

From different starting points, authorities in North America, Europe, and the Asia-Pacific are moving in the same direction, offering a glimpse into a future in which Covid-19 becomes accepted as a fact of everyday life, like seasonal flu.

Health officials everywhere, many for the first time, are forgoing some of the sharpest tools they have to combat Omicron—even as infections soar. They are accepting the virus-like never before to minimize disruptions to economies, education, and everyday life.

At the moment, deaths and hospitalizations are at highs in many countries, and in some, hospitals are overwhelmed. But they are a much lower percentage of total cases than earlier waves. Vaccines have made the disease less deadly, and treatments hold a greater promise of recovery for those who are infected and get seriously ill.

That improving outlook, coupled with the reality that the measures taken to contain earlier surges of the virus don’t work as well against the more-contagious Omicron, is informing the decision by policymakers to abandon restrictive steps aimed at containment amid growing public fatigue over restrictions.

On a related note, Bloomberg tells us that

The omicron subvariant, BA.2, appears to be more contagious but data so far doesn’t show it’s more dangerous or that it evades protection from vaccines, said Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration. 

At worst, the strain could slow down the decline in omicron infections in the U.S., Gottlieb, a Pfizer Inc. board member, said on CBS’s “Face the Nation.” The subvariant has been found in small numbers in about half of U.S. states. 

“I don’t think it really changes the narrative,” he said. “I don’t think this is going to create a huge wave of infection.”

From the Covid pill front, ABC News informs us that “Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access.”

[Due to manufacturing issues,] [t]he current plan calls for 265,000 courses of treatment in January, gradually ramping up to 10 million by the end of June and 20 million by the end of September.

[However, s]carcity isn’t the only problem. Doctors and pharmacists told ABC News the process of obtaining the drug is opaque, even arbitrary.

In Nevada, for example, Paxlovid primarily goes to long-term care facilities like nursing homes. But in neighboring California, state officials use a complex formula that factors in rising case numbers with other risk factors. In the District of Columbia, a few Safeway grocery stores are the primary distributors, although city health officials have asked doctors to give priority to high-risk individuals.

Bloomberg adds that

New York City will provide free antiviral pills, home-delivered, to people who test positive and are at higher risk from Covid-19, Mayor Eric Adams announced on Sunday.  * * * Both oral anti-viral medications approved by the U.S. Food and Drug Administration — paxlovid from Pfizer Inc. and molnupiravir from Merck Inc. — will be available though in limited quantities, according the a City Hall press release. They will be delivered in partnership with Alto Pharmacy. 

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–

Both Houses of Congress will be engaged in Committee business and floor voting this week as we are now less than one month away from the expiration of the current continuing resolution funding the federal government. That resolution runs through February 18.

From the Omnicron front, the New York Times reports that ‘

New coronavirus cases have started to fall nationally, signaling that the Omicron-fueled spike that has infected tens of millions of Americans, packed hospitals and shattered records has finally begun to relent.

More and more states have passed a peak in new cases in recent days, as glimmers of progress have spread from a handful of eastern cities to much of the country. Through Friday, the country was averaging about 720,000 new cases a day, down from about 807,000 last week. New coronavirus hospital admissions have leveled off.

Even as hopeful data points emerge, the threat has by no means passed. The United States continues to identify far more infections a day than in any prior surge, and some states in the West, South and Great Plains are still seeing sharp increases. Many hospitals are full. And deaths continue to mount, with more than 2,100 announced most days.

But following a month of extraordinary rates of case growth, blocklong lines at testing centers and military deployments to bolster understaffed I.C.U.s, the declining new-case tallies offered a sense of relief to virus-weary Americans, especially in the Northeast and parts of the Upper Midwest, where the trends were most encouraging. After another round of masking up or hunkering down, some were considering what life might look like if conditions continued to improve. 

Bloomberg adds

The omicron variant spreads so rapidly that sometimes it feels as if resistance is futile. It’s disheartening to hear of omicron infecting people who are up-to-date on their shots and wear an N95 mask every time they leave home. Even some well-known public-health experts are getting infected. But that doesn’t mean everyone is going to get it. 

What it does mean is that life is profoundly unfair. In some of us, the Covid-19 vaccines work quite robustly, even against omicron. In others, the vaccines’ effect is weaker. Chalk this up to the spectacular diversity of the human immune system, which is partly regulated by some of the most varied genes in the human body. 

A recent study led by Harvard and MIT showed that about 20% of people get much poorer protection from their vaccines against omicron. They’re still better off than completely unvaccinated people, but this variability could account for some of the fully vaccinated people who’ve been hospitalized in the omicron wave.

According to the American Medical Association (AMA), here’s what physicians want their patients to know about Omicron. “The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).”

From the Rx coverage front, the New York Times offers an interview with CVS Health’s CEO Karen Lynch. For example,

What do you see as the most effective ways that we could reduce health care costs for everyday Americans? And what’s your company’s role in doing that?

There’s a couple of things. One is there’s the site of care. Our role is offering an alternative site of care, either in our retail locations, or in the home with virtual connections. We’re entering into the primary care space because we believe that primary care has real significant influence over the cost of health care.

And I’m pretty passionate about the fact that the head is attached to the body, and most people experience behavioral health issues when they are experiencing physical health issues. We only deal with the physical health. We don’t deal with the behavioral health part, and I think there’s more we can do.

Healthcare Dive provides us with industry perspective on last week’s launch of TEFCA which is intended to vastly improve interoperability by linking together regional health information exchanges.

The goal of TEFCA is to get rid of individual legal agreements between health information networks, health plans, providers and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back on administrative burden. The framework standardizes the operational side of data exchange, while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure. * * *

Getting a nationwide network of groups of organizations that agree to the same data-sharing infrastructure could significantly streamline patient care across different geographies.

For example, if a patient from Virginia takes a vacation to California and ends up in an emergency room, doctors currently do the best they can to treat them without their medical record, which can contain valuable information about preexisting conditions, allergies and other health factors. But with a nationwide QHIN infrastructure, clinicians can query all participating networks for that patient’s data and use it to inform their clinical choices, Barrett said.

That budding future all centers on buy-in. * * *

Many, including ONC, are optimistic on TEFCA adoption, citing the competitive disadvantages to nonparticipation.

The hope is that the more networks use it, the more its value proposition will be proved. Patients will inquire why their provider doesn’t have their data from other facilities, and the provider will then wonder why the exchanges it’s a participant in aren’t qualified to work with other networks, Lee Barrett, CEO of EHR standards development organization EHNAC said.