Thursday Miscellany

Congress

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.

Midweek Update

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

From Capitol Hill, the Senate press gallery informs us “The Senate will convene Thursday at 10:00 am and resume the postal reform bill, which ML Schumer filed cloture on this evening.” It’s worth noting that yesterday “Amendment SA 4955 [was] proposed by Senator Schumer for Senator Peters. (consideration: CR S872; text: CR S872) To modify the deadline for the initial report on the operations and financial condition of the United States Postal Service.” The FEHBlog did not expect any amendments to be offered. Nevertheless, the bill appears on track to passage soon.

From the State of the Union address department

  • Healthcare Dive discusses the President’s healthcare policy proposals.
  • The Society for Human Resources Management discusses the President’s employment policy proposals.

From the Omicron front, the Administration announced a new Covid strategy today. Beckers Hospital Review lists eight highlights from the new strategy. The Wall Street Journal adds

The plan underscores the administration’s shifting focus from responding to the pandemic crisis to a new normal that focuses on managing the disease. But the road map, the result of weeks of work with advisers, state leaders and public health experts, relies heavily on Congress approving billions of dollars in new Covid-19 relief funding.

In other healthcare policy news

  • EHR Intelligence tells us

The Sequoia Project’s Emergency Preparedness Information Workgroup (EPIW) has published a free whitepaper that outlines public health recommendations based on lessons learned from COVID-19 response efforts.

The workgroup of public health, emergency preparedness, and response experts met over several months to create the Pandemic Response Insights and Recommendations whitepaper.

EPIW members created a SWOT (strengths, weaknesses, opportunities, threats) analysis of the COVID-19 response. They then consolidated this data into 17 recommendations to help local, state, and federal stakeholders prepare for a more coordinated national response to the next public health emergency.

  • The Food and Drug Administration issued “three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care.”
  • The HHS Office for Civil Rights published guidance on gender-affirming care, civil rights, and patient privacy. The underlying policy as explained in the guidance is as follows:

The Department of Health & Human Services (HHS) stands with transgender and gender nonconforming youth and their families—and the significant majority of expert medical associations—in unequivocally stating that gender affirming care for minors, when medically appropriate and necessary, improves their physical and mental health. Attempts to restrict, challenge, or falsely characterize this potentially lifesaving care as abuse is dangerous. Such attempts block parents from making critical health care decisions for their children, create a chilling effect on health care providers who are necessary to provide care for these youth, and ultimately negatively impact the health and well-being of transgender and gender nonconforming youth.

On the Rx coverage front, Beckers Hospital Review informs us “Annual spending on pharmaceutical products has skyrocketed since 2010, though out-of-pocket costs have fallen, according to a Feb. 28 report from ValuePenguin.”

From the truth is stranger than fiction department, Govexec reports

The panel tasked with enforcing [federal] civil service protections has regained a governing quorum after the Senate approved two of President Biden’s three nominees on Tuesday, putting an end to five years of dysfunction. 

Both Tristan Leavitt and Raymond Limon won unanimous support in Senate voice votes, giving the Merit Systems Protection Board confirmed members of its central panel for the first time since 2019. The board needs at least two of its three slots filled to have a quorum and hear appeals, which has not occurred since January 2017. Cathy Harris, Biden’s third and final nominee for the board, is still awaiting a vote in the Senate. 

The quasi-judicial agency has a backlog of more than 3,500 cases pending before its central board, which the nominees have pledged to quickly address through an expedited process. Regional administrative judges at MSPB have continued to hear cases of alleged violations of prohibited personnel practices by federal agencies, but agencies or individuals that have sought further appeal to the board’s presidentially appointed, Senate-confirmed central panel have seen their causes languish—in some instances, for years.  

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.

Monday Roundup

David Ermer–Congress, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

To the FEHBlog’s dismay, the Labor Department’s Employee Benefits Security Administration announced this evening that the federal government is accepting, at least for the time being, Judge Kernodle’s interpretation of the No Surprises Act discussed in yesterday’s Weekend Update post.

The Departments [/ the ACA regulators] are reviewing the court’s decision and considering next steps. This announcement serves as a notification to health care providers, emergency facilities, providers of air ambulance services, group health plans, health insurance issuers, Federal Employees Health Benefits (FEHB) Carriers (“Disputing Parties”), and certified IDR entities of steps the Departments are taking to conform to the court’s order. Specifically, the Departments will:

— Effective immediately, withdraw guidance documents that are based on, or that refer to, the portions of the Rule that the court invalidated. Once these documents have been updated to conform with the court’s order, we will promptly repost the updated documents

— Provide training on the revised guidance for certified IDR entities and Disputing Parties. This training will be offered through webinars and roundtable discussions, and will occur after the above-referenced documents are updated.

— Open the IDR process for submissions through the IDR Portal. For disputes for which the open negotiation period has expired, the Departments will permit submission of a notice of initiation of the IDR process within 15 business days following the opening of the IDR Portal.

The Departments had the option of filing a notice of appeal and asking the court to stay the case pending the appeal’s outcome. The Departments thought this favorable outcome is unlikely. But, in the timeless words of Kenny Rogers, you have to know when to hold them and when to fold them.

The Senate Press Gallery reports this evening the Senate voted 74-20 to invoke cloture on the Postal Reform Act of 2022, H.R. 3076, which means that the bill will be called up on the Senate floor later this week for a final vote. That vote requires a simple majority for passage.

Earlier in the day, the Congressional Budget Office released a supplemental letter on HR 3076 in which

CBO addresses the following questions concerning the agency’s assessment of the budgetary effects of H.R. 3076, the Postal Service Reform Act of 2022, which CBO transmitted on February 4, 2022.

— What are the budgetary effects and costs to the Medicare program of H.R. 3076 over the next 20 years?

— What is the effect of the legislation on the Medicare Hospital Insurance Trust Fund?

— What is the effect on Medicare premiums in Part B and Part D?

In health equity news, Kaiser Permanente announced

Colorectal cancer disparities between Black and white adults were eliminated among Kaiser Permanente members in Northern California after the health care organization instituted a regionwide, structured colorectal cancer screening program, new research shows.

“Our study found that organized screening works to improve colorectal cancer outcomes for all of our members,” said the study’s senior author Theodore R. Levin, MD, a research scientist at the Kaiser Permanente Division of Research and a gastroenterologist with The Permanente Medical Group. “I knew our program had helped to reduce disparities, but I was surprised by the magnitude and the rate of improvement. It exceeded my expectations.”

The article provides details on a structured program. Bravo KP.

From the telehealth front, Healthcare IT News reports

Teladoc Health announced this week that it was partnering with Amazon to launch voice-activated virtual care on Alexa-supported Echo devices.  

According to the companies, U.S. customers around the country can connect with a Teladoc provider via audio at any time for general medical needs.  

“By introducing and integrating our virtual-first care experience with Echo devices, we are providing an innovative and convenient way for users to connect with a doctor,” Donna Boyer, chief product officer at Teladoc Health, said in a statement.

“We are meeting consumers where they are, to continue to deliver value and high-quality care to members,” Boyer said.   

From the looking forward department, ICD 10 Monitor tells us

On Feb. 11, the World Health Organization (WHO) released ICD-11 2022. This is the official version of the 11th revision of the International Classification of Diseases (ICD) coding set that WHO member countries will be implementing worldwide. In fact, according to the WHO release announcement, 35 countries are already using ICD-11.

In addressing implementation timeframes, the WHO anticipates that * * * countries with highly sophisticated information systems, where earlier versions of ICD are already in use [such as the U.S.], may require 4 -5 years to transition to ICD-11. * * *

So, when will the U.S. replace ICD-10-CM and begin using a version of ICD-11 for reporting on healthcare claims? Well, we don’t know yet. But this release of the official ICD-11 is sure to spur activity in this respect.

In September 2021, the National Committee on Vital and Health Statistics (NCVHS) issued recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) advising on a research agenda to evaluate the use of ICD-11 in the U.S. This release of the official ICD-11 2022 version from the WHO is sure to increase research activity.

So, while the timeline for a U.S. transition to ICD-11 is still uncertain, it’s clear that planning for the transition to ICD-11 is underway.

The FEHBlog, whose crystal ball is not the clearest, predicts 2029 as the over/under year for ICD-11 implementation.

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. 

Weekend update

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

In commemoration of the President’s Day holiday tomorrow, Congress is on a local work break this week and will be back in session on February 28.

From the Omicron front, the New York Times offers an interactive article seeking to uncover the mysteries of “Long Covid.”

The accuracy of Bloomberg’s welcome report on the growing availability of Pfizer’s Paxlovid and Merck’s molnupiravir Covid pills is evidenced by the Wall Street Journal’s report that pharmacists are demanding more money to dispense those pills. Why?

Pharmacists say Paxlovid and molnupiravir prescriptions typically take more than 30 minutes to fill, longer than other drugs. They say they must often gather the medical history of new customers and then make sure they aren’t taking any other drugs that the Covid-19 pills can’t be used with safely.

Pharmacists also say they have to spend substantial time counseling patients on taking the pills.

Here’s where it stands.

The National Community Pharmacists Association trade group has urged the Centers for Medicare and Medicaid Services to recommend a fee similar to the $40 that Medicare pays pharmacies administering Covid-19 vaccines.

The National Association of Chain Drug Stores, which represents pharmacies including Kroger Co. and Walgreens Boots Alliance Inc., also supports a CMS recommendation, though it isn’t specifying an amount. The figure could help pressure all commercial and government health plans to increase how much they are paying, said Sara Roszak, senior vice president for health and wellness strategy and policy for the industry group.

Benefit managers will likely revise fees, but are looking for the government to provide more direction on what the fees should be, said JC Scott, chief executive of the Pharmaceutical Care Management Association, the trade group for pharmacy-benefit managers.

The Wall Street Journal also reports

U.S. health regulators are looking at potentially authorizing a fourth dose of a Covid-19 vaccine in the fall, according to people familiar with the matter. 

The planning is still in early stages, and authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster and reduce their risk of symptomatic and severe disease, the people said.

The Food and Drug Administration, however, has begun reviewing data so it can make a decision, the people said.

The thinking among regulators is that the agency would look at authorizing a second booster dose of the messenger RNA vaccines from Pfizer Inc. and partner BioNTech SE and from Moderna Inc., one of the people said.

Among the issues that need to be resolved, the person said, are whether the second booster should be authorized for all adults or particular age groups, and whether it should target the Omicron variant or be formulated differently. Whether the fourth booster could ultimately be the start of an annual Covid-19 vaccination is also under consideration.

It strikes the FEHBlog that this would be a good occasion for the Centers for Disease Control to position this evaluation as part of their effort to refocus Covid from pandemic to endemic status. An epidemiologist writing in STAT News explains

I’m not confident about how the pandemic endgame will play out. While I do think the most likely future scenario for SARS-CoV-2 is that it will become endemic, the other more worrisome scenarios I describe here are within the realm of possibility: a mutant that produces a different disease, a new recombinant virus, or a variant that exploits immunity. And these scenarios are not mutually exclusive. A new SARS-CoV-2 recombinant virus containing animal coronavirus genes might well cause altered disease.

After two years, why not position the country for the most likely scenario?

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From Capitol Hill, Govexec reports that “The Senate on Thursday cleared 65-27 a three-week stopgap bill to avoid a government shutdown, sending the measure to President Biden with just one day before the deadline.”

From the Omicron front, the American Hospital Association provides us with its most recent Covid snapshot

From the Covid treatment front, The American Medical Association reports

Efforts to boost production of [Covid] therapeutics are underway, a Food and Drug Administration (FDA) official said during an episode of the AMA-sponsored webinar series, “COVID-19: What Physicians Need to Know.” 

Recommended usage in therapeutics is an important step in counseling patients and providing the most timely and relevant information about defeating this virus, said AMA President Gerald E. Harmon, MD, who moderated the webinar. Physicians facing supply issues of hard-to-get antivirals such as Paxlovid (PDF) also want to know about the timeline of any new antivirals or antibody treatments, he said.

For doctors and other health professionals, “it’s been a very difficult winter and it’s not over yet,” acknowledged John Farley, MD, MPH, director of FDA’s Office of Infectious Diseases in the Center for Drug Evaluation and Research’s Office of New Drugs. Monitoring the situation with these drugs is a complex process that involves FDA, the Centers for Disease Control and Prevention and several branches of government, he added.

Distribution of therapeutics should improve over time. However, at least for the combination of antiviral nirmatrelvir and ritonavir tablets marketed as Paxlovid, “we have a period of continued short supply ahead,” said Dr. Farley, who joined two other FDA experts to discuss the efficacy of the treatments.

In the FEHBlog’s view, Pfizer’s Paxlovid appears to offer the best opportunity for lowering Covid hospital admissions which have been a major cost for health plans over the past year which has seen three major Covid surges.

Speaking of innovations, Cleveland.com tells us

The next generation of mRNA vaccines, as well as treatments for type 2 diabetes and postpartum depression are among the innovations that earned spots on the Cleveland Clinic’s Top 10 Medical Innovations for 2022.

The list of breakthrough technologies, chosen by a committee of Clinic experts, was announced Wednesday.

These medical advancements have the potential to transform healthcare in the coming year, the Clinic said. The committee considered technologies developed by the Clinic as well as other research centers.

From the Federal Trade Commission front, Healthcare Dive reports

The Federal Trade Commission will not launch a study into pharmacy benefit managers’ pricing and contractual practices after a 2-2 vote at a Thursday meeting. The measure needed a simple majority to commence the investigation, which would have compelled large PBMs to turn over information and documents to the agency.

The two commissioners appointed by former President Donald Trump, Noah Phillips and Christine Wilson, voted against the study after raising concerns about its design and whether the current draft asks the proper questions for the answers the agency is seeking. Phillips also complained about receiving a “substantially revised” draft from staff “just hours” before the meeting.

FTC Chair Lina Khan said she was disappointed with Thursday’s vote, and said this is an area the agency has “a real moral imperative” to act upon.

From the Rx coverage front, Fierce Healthcare informs us

Optum has launched a new solution for specialty drugs that aims to lower costs and improve care management for people with complex conditions.

Specialty Fusion arms payers and providers with real-time insights into which specialty therapies are the most effective for the patient at the lowest cost. The platform leads to quicker treatment approvals for patients as well as a similar experience for providers at the point of care, Optum said in an announcement.

Internal analysis of the solution suggests it can drive cost savings of 17%.

From the healthcare business front, Healthcare Dive notes

Pharmacy giant Walgreens and value-based medical network VillageMD are on pace to open more than 200 co-branded primary care practices by the end of the year.

On Wednesday, the companies opened their first clinic in a new Florida market, Jacksonville, bringing their total markets in the state up to three, including Orlando and Tampa. Walgreens and VillageMD plan to open five new Village Medical at Walgreens primary care practices in total in the Jacksonville area through this summer.

With the Jacksonville openings, Walgreens and VillageMD have now opened more than 80 primary care practices across 12 markets in Arizona, Florida, Texas, Kentucky and Indiana.

Last but not least FedWeek explains how to guard against losing FEHB coverage in retirement.

Midweek Update

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

From Capitol Hill —

Today, the Senate invoked cloture on the resolution to continue funding the federal government until March 11 by unanimous consent. Consequently, the new resolution should be approved by Congress tomorrow, which is the day before funding expires under the current resolution.

The House of Representatives has returned the correct version of the Postal Reform Act, H.R. 3076, to the Senate, and the Senate has had the correct version read twice. We will have to wait and see if anything happens with the bill tomorrow.

In the meantime, check out the Congressional Research Service’s February 11, 2022, report on the Postal Reform bill approved by the House, H.R. 3076. In the FEHBlog’s view, a unique feature of the House version compared to earlier versions is that the bill destined to become law creates a transitional Open Season. The Transitional Open Season will auto-enroll those Postal employees and annuitants who failed to transfer over to the PSHBP in the 2024 Open Season for the 2025 plan year. The receiving PSHBP plan will be the lowest premium nationwide PSHBP plan that is not a high deductible plan and does not require dues payments. Also, the House version makes the Postal Service financially responsible for the late Medicare Part B enrollment fees otherwise owed by the Postal annuitants with Part A only who take advantage of a special Part B enrollment period in 2024.

Following up on Robert Califf’s second confirmation as Food and Drug Administrator yesterday, STAT News identified the six major drug approval decisions awaiting him, including Pfizer’s toddler COVID vaccine, the Novovax Covid vaccine, and Alzheimer’s Disease treatments. Good luck, Mr. Califf.

Also among those drug approval decisions awaiting Mr. Califf is a Covid treatment discussed in Bloomberg

After omicron weakened some of the defenses that doctors have against Covid, an experimental treatment being developed by Novartis and a small Swiss biotech partner holds some promise as a new therapy.

Last week, Novartis sought emergency approval from the U.S. Food and Drug Administration for an intravenous drug, called ensovibep, that’s similar in some ways to monoclonal antibody treatments. However, the way it works is significantly different, which might allow it to succeed where antibody therapies fail against omicron.

The compound uses tiny proteins to attack the coronavirus’s spike protein in not just one, but multiple places. That appears to give it a leg up in fighting the virus even as it mutates.

In other federal leadership changes, STAT News adds

President Joe Biden is replacing a top science adviser who resigned under a cloud with two individuals who will split his duties on an interim basis.

Biden is tapping [Alondra Nelson, ]a deputy in the White House science and technology office along with [Dr. Francis Collins] the recently retired director of the National Institutes of Health, according to a personal familiar with the president’s plans.

From the Omicron front, Beckers Hospital Review tells us

The COVID-19 omicron subvariant BA.2, dubbed “stealth omicron,” has spread to at least 74 countries and 47 states across the U.S., according to data from outbreak.info.

Four more updates: 

1. BA.2 is most prevalent in HHS’ region 3, which includes Pennsylvania, West Virginia, Virginia, Delaware and Maryland, according to CDC data.

2. Region 7, which includes Iowa, Kansas, Missouri and Nebraska, had the lowest percentage of BA.2 cases last week, according to CDC data. 

3. BA.2 currently accounts for 3.9 percent of total COVID-19 cases in the U.S., with omicron subvariant BA.1.1 accounting for 73.2 percent of cases, CDC data shows. 

4. A South African study analyzing nearly 100,000 COVID-19 cases found that BA.2 doesn’t cause significantly more severe illness than the original omicron variant, Bloomberg reported Feb. 16.

From the Covid vaccine front, The American Medical Association reports

The New York Times (2/15, Anthes) reports infants born to mothers who “received two doses of an mRNA coronavirus vaccine during pregnancy are less likely to be admitted to the hospital for COVID-19 in the first six months of life, according to a new study from the Centers for Disease Control and Prevention.” The study found that “overall, maternal vaccination was 61% effective at preventing infant hospitalization.”

Reuters (2/15, Mishra, Steenhuysen) reports, “That protection rose to 80% when the mothers were vaccinated 21 weeks through 14 days before delivery.” Meanwhile, the “effectiveness fell to 32% for the babies whose mothers were inoculated earlier during pregnancy.”

The Hill (2/15, Sullivan) reports the study used data “from 20 pediatric hospitals in 17 states, from July 2021 to January 2022.”

From the Covid front, Fierce Healthcare reports

Anthem has launched a new pilot that aims to offer a digital concierge care experience to members recovering from COVID-19.

Through COVID Concierge Care, eligible members can access an app and fill out a questionnaire that tracks their symptoms on a daily basis. They can connect with a clinician via secure, two-way text-based messages in the app or via text or email.

In addition, based on their reported symptoms, members can access evidence-based educational tools and wellness content to help them self-manage their conditions. For example, members can connect with breathing exercise guides to manage stress or health articles about their symptoms.

From the Covid vaccine mandate front, Federal News Network tells us

The Postal Service is laying the groundwork to track the vaccination and testing status of its workforce amid the COVID-19 pandemic, or any future public health emergency.

USPS, however, says it’s only giving notice as it prepares for “potential future contingencies,” and is not, at this time, updating its COVID-19 vaccine or testing requirements, nor is it seeking to collect data on the vaccination status of its workforce.

In healthcare business news, Healthcare Dive informs us

The Department of Justice is preparing a lawsuit to block UnitedHealth from purchasing Change Healthcare, according to a new report, as regulators take a more aggressive stance on checking consolidation in the healthcare industry.

According to Dealreporter, which cited sources familiar with the matter, UnitedHealth and Change are expected to meet with the DOJ soon for a “last rites” meeting on the proposed deal, first announced early last year. Despite UnitedHealth and Change exploring divestitures to assuage antitrust concerns, the DOJ has not found any that would make the deal acceptable, according to Dealreporter’s sourcing.

From the health savings account front, Health Payer Intelligence offers nine best practices for high deductible health plan design based on a recent report from the National Pharmaceutical Council (NPC) and Gallagher.

From the antibiotic overutilization front, AHIP lets us know

A study published in the CDC’s Morbidity and Mortality Weekly Report found 41% of antibiotic prescriptions for Medicare Part D beneficiaries in 2019 were written by just 10% of prescribers. Researchers found nearly half of these high-volume prescribers practiced in southern states, and they had a median antibiotic prescribing rate of 680 per 1,000 beneficiaries, compared with 426 per 1,000 beneficiaries among low-volume prescribers. 

Tuesday’s Tidbits

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

From the Capitol Hill front —

The Wall Street Journal reports

Sen. Marsha Blackburn lifted a hold on a stopgap bill needed to avoid a partial government shutdown this weekend after she won a commitment from the Biden administration that it wouldn’t fund pipes for smoking illicit substances through a substance-abuse program. * * *

[Senate Minority Leader Sen. Mitch] McConnell said Tuesday that he expected there to be some amendment votes in conjunction with the vote on the so-called continuing resolution. “I think it will all be worked out,” he said. “There’s no danger of a government shutdown.”

The House of Representatives held a pro forma, the four-minute-long session this morning at which

[The] Clerk notified the House that she had received the following message from the Secretary of the Senate on February 14, 2022, at 6:30 p.m.: That the Senate agreed to return the papers to the House of Representatives at their request for H.R. 3076 [the Postal Reform Act of 2022] * * *.

The House is not scheduled to resume floor voting until February 28 and the Senate will be on a State work period next week so Congressional passage of this bill may not occur until next month.

FInally Roll Call reports

The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

Califf’s confirmation means the Biden administration has a permanent FDA commissioner during the COVID-19 pandemic after 13 months with longtime agency official Janet Woodcock acting as its leader.

Califf needed bipartisan support to cross the finish line. Retiring Sens. Patrick J. Toomeyof Pennsylvania and Roy Blunt of Missouri joined four Republicans who sit on the Health, Education, Labor and Pensions Committee to confirm Califf.

From the Omicron front, the Wall Street Journal offers interesting commentary from Dr. Marc Siegal about the Novovax vaccine which is the subject of an emergency use authorization at the Food and Drug Administration.

The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.

There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective.

From the health equity front, Health Payer Intelligence discusses a Northeast Business Group on Health report on strategies for making progress on resolving inequities created by social determinants of health. Check it out.

In a similar vein, the Agency of Healthcare Research and Quality blog post on integrating patient-generated health data into electronic health records.

The 63-year-old patient has hypertension. With encouragement from his family, he checks his blood pressure daily using a digital blood pressure monitor. And thanks to advances in digital technology, he saves each reading on a mobile application whether he’s at home, at work, or on vacation.

What is the reward for his persistence? With his health data easily integrated into his electronic health record, his primary care doctor has a fuller picture of his health—one that is not limited to the traditional snapshot taken in an exam room. Using that data, he and his physician can have more informed conversations about treatment options and next steps.

While this scenario accurately recognizes that today’s patients can easily collect their own health data outside of the clinical setting, many ambulatory care practices lack the technical infrastructure, functional workflows, workforce capacity, and training to support the intake and use of patient-generated health data (PGHD).

With those challenges in mind, AHRQ has released a new guide on increasing the use of PGHD, one that provides practical tools for ambulatory care practices to implement PGHD programs and improve patient outcomes. It includes tips, ideas, and learning activities to let users tailor solutions to their needs. To our knowledge, this is the first practical guide that includes detailed considerations and steps for implementing a PGHD program.

The AHRQ guide may be helpful to health plan case managers, too.

From the tidbits department

  • Roll Call and Fierce Healthcare offer different takes on the public comments submitted on the Centers for Medicare Services controversial proposed national coverage deterimination on Biogen’s Alzheimers Disease drug Aduhelm. A final decision is expected in April.
  • The CDC encourages people with pre-diabetes to become heart health role models.

Cigna’s Evernorth is adding Monument’s virtual care services to its behavioral health network, the insurer announced Tuesday.

The platform is now available to all Evernorth clients and to Cigna members in employer plans or Affordable Care Act marketplace plans in 20 states.

Monument offers an evidence-based, virtual treatment program for alcohol use disorder. Evernorth said in the announcement that alcohol use has been on the rise for the past several decades, and that some 60% of people have reported higher alcohol intake under the pandemic.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, HSA, Telehealth–
Photo by Sven Read on Unsplash

From Capitol Hill we are presented with some surprising developments —

Govexec tells us

Sen. Rick Scott, R-Fla., blocked the Senate from moving forward with the bipartisan 2021 Postal Reform Act, which won overwhelming support last week in the House. Lawmakers in both parties have attempted for years to eliminate much of the agency’s debt and restructure some of its operations and the efforts appeared to finally reach a breakthrough with the successful vote in the lower chamber. The bill has the backing of 14 Republican senators, indicating broad support and votes that will ultimately clear the 60-member support threshold with ease. 

When the House sent the bill to the Senate last week, however, it passed along the wrong version that did not include the most up-to-date text. The House on Friday quickly corrected the error by unanimously approving a measure to send over the correct version. Senate Majority Leader Chuck Schumer, D-N.Y., had already started the process of approving the incorrect bill last week and was hoping to move the House-backed technical correction on Monday with unanimous consent, allowing the chamber to resume consideration of the full bill. 

That is when Sen. Rick Scott, R-Fla., objected, sending the process into chaos. The Senate is slated to recess on Friday and will likely not have time to pass the bill until after it returns in March.  * * *

Scott said on the floor he was concerned the measure had not gone through the committee process on the Senate side and about the funding for a potential increase in Medicare costs. The Congressional Budget Office said in a recent score the measure would save the government $1.5 billion over the next 10 years. Lawmakers have estimated it will save the Postal Service $50 billion over the same period.

The Wall Street Journal reports

Sen. Marsha Blackburn (R., Tenn.) said that she will hold up a bill to keep the government funded until the Biden administration responds to her questions about whether a program intended to help people with substance-abuse disorders could be used for pipes to smoke illicit substances.

Her position injects uncertainty into the government’s ability to avoid a partial shutdown later this week. While a single senator can’t stop legislation, he or she can slow down the process by declining to consent to cutting out procedural hurdles.

The Senate is aiming to pass a three-week government funding bill by Feb. 18, when a current funding bill expires, in order to provide breathing room for negotiators to reach a deal funding the full fiscal year. A Senate Democratic aide said that there isn’t enough time to go through each step in the process with the maximum amount of debate time and still avoid a temporary shutdown.

“All we want to know is how much money they are using for safe-smoking kits? What is in the kits? Where is this money going?” Ms. Blackburn said in an interview. “Once I get an answer, I will lift my hold. I’m just waiting for an answer.”

Roll Call informs us

The Biden administration’s nominee to lead the Food and Drug Administration, Robert Califf, survived a Senate procedural vote, 49-45, on Monday evening with the help of five Republicans.

A confirmation vote on the Senate floor is expected to take place Tuesday, and it’ll likely be a close one. Sens. Susan Collins, R-Maine; Lisa Murkowski, R-Alaska; Mitt Romney, R-Utah; Richard M. Burr, R-N.C.; and Roy Blunt, R-Mo., joined Democrats to help shut off debate on Califf’s nomination.

Califf faced controversy throughout his nomination process from both parties. The former FDA commissioner had to cut deals with multiple lawmakers ahead of the floor vote, trading policy promises for votes. Several Senate Democrats opposed Califf’s nomination, due to his past ties to the pharmaceutical industry and handling of the opioid crisis when he led the FDA during the tail end of the Obama administration.

From the Omicron front, STAT News explains why the COVID vaccines are a “freaking miracle.”

Two years into the Covid-19 pandemic, it’s easy to lament all that has come to pass. The devastating losses. The upending of what we regarded as normal ways of life. The sheer relentlessness of it all.

But let’s stop for a moment and consider something else that may have escaped you: You have witnessed — and you are a beneficiary of — a freaking miracle.

That miracle is the development, testing, manufacturing, and global distribution of Covid vaccines.

How freaking true. It’s worth a read.

From the telehealth front, STAT New also delves into what we know and don’t know about whether telehealth can cut costs. This article gives the FEHBlog an opportunity to express his opinion that hub and spoke telehealth services, like Teladoc, can save costs by offering mental healthcare therapy on a long-term basis. Teletherapy is more accessible than in person therapy and all hub and spoke teletherapists are in-network. What’s not to like?

From the consumer driven health care front, Health Payer Intelligence considers the pros and cons of CDHP products in 2022. There are lots of FEHB CDHP offerings.