Thursday Miscellany

COVID-19

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.

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. 

Friday Stats and More

David Ermer–CDC, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s (CDC) Covid Data Tracker website and using Thursday as the first day of the week, here are the FEHBlog’s charts of weekly new Covid cases and deaths from the 27th week of 2021 through the 8th week of 2022, both of which are plummeting

Here’s the FEHBlog chart of weekly Covid vaccinations distributed and administered from the 51st week of 2020 through the 8th week of 2022iew

Here are links to the CDC’s weekly review of its Covid statistics and its weekly Fluview. The Covid news is significant

CDC is updating the way it monitors COVID-19’s impact on our communities. Widespread availability of vaccines and testing, advances in treatments, and increasing levels of immunity in the population through vaccination or previous infection have moved the COVID-19 pandemic to a new phase. While we can’t prevent all cases of COVID-19, we can continue to limit the spread and protect those who are most at risk of severe illness.

Given this new phase of the pandemic, CDC is launching a new tool to monitor COVID-19 Community Levels. Each county’s COVID-19 Community Level is ranked as low, medium, or high (find your county’s level). The COVID-19 Community Level map where you can find your county’s level will be updated regularly with new data.

Medscape adds

As of now, most counties in the country fall into either low-risk or medium-risk categories, said Greta Massetti, PhD, of the COVID-19 Response Incident Management Team.

Those counties, “representing 70 percent of Americans, are in low to medium community levels,” she said. “We continue to see indicators improve in many counties.”

A total of 23% of U.S. counties fall into the low-risk group, and 39% are medium-risk, Massetti said.

But, Walensky said, these guidelines could change at any time if numbers begin moving in the wrong direction.

Also, from the policy front

Medscape tells us and as evidenced by the new CDC approach

The White House has begun a sweeping overhaul of its COVID-19 strategy as the U.S. moves out of pandemic crisis mode and into a more manageable phase, according to ABC News.

The new strategy is expected to acknowledge that the coronavirus is becoming a less urgent threat to Americans overall due to access to vaccines, testing, and therapeutics.

Insurance News Net informs us about AHIP’s 2022 priorities as identified by its President Matt Eyles:

  1. Affordable coverage, improved access. Addressing the underlying cost drivers of care. Ending pharma monopolies. Addressing hospital and physician group consolidation. Pushing back on restrictions on medical management.
  2. Improving health equity. Ensuring everyone has an equal opportunity to thrive and achieve their best possible health. Expanding initiatives to provide health care opportunities to underserved areas and populations. Providing COVID-19 vaccine outreach to at-risk older Americans. Providing outreach in a culturally competent manner to various ethnic groups.
  3. Post-pandemic health care. AHIP will develop a post-pandemic road map to improve health care. AHIP is working to maintain coverage for those who were eligible for coverage under Medicaid or the Affordable Care Act during the public health emergency so that they will continue to have coverage when the emergency ends.
  4. Improving competition and choice. Maintain a competitive private health insurance market.

Worthy priorities, indeed.

Fierce Healthcare tells us about the American Medical Association’s President’s speech on the AMA priorities for improving U.S. healthcare and readiness for future pandemics.

From the avoiding low-value care front, Medscape reports

Low-value healthcare services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association (AHA) says in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors note.

Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States, they note.

The statement was published online February 22 in Circulation: Cardiovascular Quality and Outcomes.

From the mental healthcare front, Health Affairs Forefront discusses how

This July, the US model for responding to individuals experiencing a mental health crisis is scheduled for a much-needed change. The 988 number is a three-digit, national mental health crisis hotline that was mandated by the federal government in October 2020 with an official nationwide start date on July 16, 2022. * * *

The 988 hotline holds incredible promise toward decriminalizing the response to mental health emergencies. Currently, if an individual is experiencing a mental health crisis, they, their caregivers, and bystanders have few options beyond calling 911. As a result, roughly one in 10 individuals with mental health disorders have interacted with law enforcement prior to receiving psychiatric care, and 10 percent of police calls are for mental health emergencies. * * *

Ideally, the new 988 number would activate an entirely different cascade of events. An individual in crisis, their family member, or even a bystander will be able to immediately reach a trained crisis counselor who can provide phone-based triage, support, and local resources. If needed, the counselor can activate a mobile mental health crisis team that will arrive on site to de-escalate; provide brief therapeutic interventions; either refer for close outpatient follow up or transport the individual for further psychiatric evaluation; and even offer food, drink, and hygiene supplies.

That’s an interesting perspective. Health plans should plan to publicize the 988 number this summer.

From the chronic disease front, Health Payer Intelligence uses a recent CMS report on healthcare spending to identify the ten most expenses chronic diseases in our country.

From the Rx coverage front, Healthcare Dive reports

The Federal Trade Commission is calling on the public to submit feedback on how pharmacy benefit managers’ business practices are affecting patients, pharmacies and employers.

The agency is seeking to gather a wide range of information and comments on pharmacy benefit managers, including how they affect drug prices, access, contract terms, rebates, fees, steering methods, conflicts of interest and consolidation, according to the request for information released Thursday.

Members of the public can comment through April 25. The information the FTC collects will enable the agency to “study a wide array of PBM business practices and issues and will help inform the agency’s policy and enforcement work,” the regulator said in a statement.

Finally in litigation news, the Wall Street Journal informs us

Pharmaceutical company Johnson & Johnson and three of the nation’s biggest drug distributors have agreed to move forward with a landmark settlement with a majority of states, bringing thousands of lawsuits over the opioid epidemic closer to the finish line. 

Drug distributors AmerisourceBergen Corp. , Cardinal Health Inc. and McKesson Corp. would pay a total of $19.5 billion to 46 states over 18 years, according to the companies. Johnson & Johnson said it would pay $5 billion to 45 states. 

The global settlement was first announced last summer. It was given final approval by the companies after a threshold number of state and local governments agreed to participate and currently amounts to roughly $25 billion.

The settlement is the largest to date from more than 3,000 lawsuits brought by states, local governments, Native American tribes, hospital groups and others alleging that companies from pharmaceutical manufacturers to distributors and pharmacies flooded areas with pills and created the opioid epidemic, ultimately forcing communities to spend millions of dollars responding to the crisis. 

Let’s hope that the settlement funds are used to end our other national epidemic, substance use disorder.

Thursday Miscellany

David Ermer–CDC, CMS, COVID-19, Electronic health records, No Surprises Act, Rx coverage, U.S. Healthcare–
U.S. Supreme Court building

Let’s start today with news from the litigation front —

The Wall Street Journal reports that in advance of the February 27 deadline,

The Justice Department filed an antitrust lawsuit Thursday challenging UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc., arguing the tie-up would unlawfully reduce competition in markets for commercial insurance and the processing of claims.

The deal, announced in January 2021, sought to bring a major provider of healthcare clinical and financial services, including the handling of claims, under UnitedHealth’s Optum health-services arm.

The Justice Department filed its lawsuit in federal court in Washington, saying Change provided key industry technologies that are relied upon by UnitedHealth’s health-insurance rivals, making it a hub for competitively sensitive information. If the deal were allowed, UnitedHealth would have access to data that it could potentially use for its own benefit, at the expense of other insurers, the department alleged. The department also argued the deal would reduce head-to-head competition in the businesses of insurance claims transmission and review, because UnitedHealth competes with Change in those areas.

Healthcare Dive reports

A federal judge in Texas struck down a narrow part of the surprise billing rule that outlines how to resolve payment disputes between payers and providers over out-of-network claims. Wednesday’s ruling is a win for providers who were opposed to the dispute resolution process spelled out by CMS in an interim rule, arguing it favored insurers.

The judge’s ruling essentially tosses out a part of the dispute resolution process that instructs arbiters to begin with the presumption that the qualifying payment amount, or median in-network rate, is the appropriate payment amount for providers.

This is not the final word because the decision, which resulted in a final judgment is appealable to the U.S. Court of Appeals for the Fifth Circuit. A case raising the same issue is currently pending oral argument in the U.S. District Court for the District of Columbia.

The Hill adds

Katie Keith, a health law expert at Georgetown University, said the ruling is evidence of how hard doctors groups will fight even relatively modest efforts by Congress to cut health care costs.  

The surprise billing action was “one of the few things Congress has tried to do on cost containment,” she said.   

Amen to that.

From the Omicron front, Medpage Today provides background on a Centers for Disease Control decision permitting

Extended dosing intervals for Pfizer or Moderna vaccines * * * for certain individuals ages 12 to 64 years, not only to lower the risk of vaccine-associated myocarditis, but to potentially improve vaccine effectiveness, CDC staff said on Thursday.

According to the agency’s new interim guidance, young people ages 12 to 39 may especially benefit from a second mRNA dose 8 weeks after their first dose.

However, the regular 3-week interval for Pfizer and 4-week interval for Moderna is appropriate for patients who are moderately to severely immunocompromised, adults ages 65 and up, those who need rapid protection (such as “during high levels of community transmission”), and children ages 5 to 11.

From the social determinants of health front, HR Dive tells us

Though employers have invested increasingly in a variety of healthcare and healthcare-adjacent benefits, few of these efforts effectively address social determinants of health that can negatively affect patient outcomes, according to a report published this month by the Northeast Business Group on Health.

Social determinants of health include factors such as education access and quality; healthcare access and quality; economic stability; neighborhood and built environment; and social and community factors. Differences in these areas lead to disparities not only in terms of health outcomes, but also in cost management and general employee health and well-being, NEBGH said.

Employers can start addressing social determinants by collecting survey data on employees’ needs and risk factors, per the report. From there, NEBGH recommended that benefits design focus on equitable benefits access, such as evaluating what percentage of pay their health plans comprise at different pay levels. Other strategies cited include improving health literacy, taking advantage of partnerships and improving organizational culture around health and well-being, among others.

From the Rx coverage front, Fierce Healthcare discusses CVS Health’s annual Drug Trend Report.

CVS Caremark kept overall drug trend for clients to 2.4% over the first three quarters of 2021, marking multiple years of single-digit trend in drug price growth.

The pharmacy benefit management arm of CVS Health also kept its specialty drug trend to single digits through the third quarter, at an industry-low 5.8%, according to the company’s annual Drug Trend Report released Thursday. Caremark found that 35.9% of its clients saw negative specialty trend in 2021.

In addition, 65.3% saw specialty trend under 10%, according to the report.

The article explains how CVS Health accomplished this feat.

From the Medicare front, CMS announced a redesign of its Accountable Care Organization model

that better reflects the agency’s vision of creating a health system that achieves equitable outcomes through high quality, affordable, person-centered care. The ACO Realizing Equity, Access, and Community Health (REACH) Model, a redesign of the Global and Professional Direct Contracting (GPDC) Model, addresses stakeholder feedback, participant experience, and Administration priorities, including CMS’ commitment to advancing health equity. 

In addition to transitioning the GPDC Model to the ACO REACH Model, CMS is canceling the Geographic Direct Contracting Model (also known as the “Geo Model”) effective immediately. The Geographic Direct Contracting Model, which was announced in December 2020, was paused in March 2021 in response to stakeholder concerns.

Good luck, CMS, with this new model.

Midweek update

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

From the Omicron front —

MedCity News reports

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

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

The American Hospital Association informs us

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

Fierce Healthcare adds

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

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

From the health equity front —

The American Hospital Association tells us

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

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

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

Beckers Payer Issues adds from the mental health perspective

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

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

Six insights:

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

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

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

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

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

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

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

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

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

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

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

From the healthcare business front —

Healthcare Dive informs us

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

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

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

Managed Healthcare Executive tells us

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

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

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

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

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

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

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

Happy Washington’s Birthday

David Ermer–CDC, COVID vaccine mandate, COVID-19, Electronic health records, No Surprises Act, Telehealth, U.S. Healthcare–
The

The National Archives informs us

George Washington was born in Virginia on February 11, 1731, according to the then-used Julian calendar. In 1752, however, Britain and all its colonies adopted the Gregorian calendar which moved Washington’s birthday a year and 11 days to February 22, 1732.

Americans celebrated Washington’s Birthday long before Congress declared it a federal holiday. The centennial of his birth prompted festivities nationally and Congress established a Joint Committee to arrange for the occasion.

Washington’s Birthday was celebrated [as a federal holiday] on February 22nd [from 1879] until well into the 20th Century. However, in 1968 Congress passed the Monday Holiday Law to “provide uniform annual observances of certain legal public holidays on Mondays.” By creating more 3-day weekends, Congress hoped to “bring substantial benefits to both the spiritual and economic life of the Nation.”

One of the provisions of this act changed the observance of Washington’s Birthday from February 22nd to the third Monday in February. Ironically, this guaranteed that the holiday would never be celebrated on Washington’s actual birthday, as the third Monday in February cannot fall any later than February 21.

Contrary to popular belief, neither Congress nor the President has ever stipulated that the name of the holiday observed as Washington’s Birthday be changed to “President’s Day.”

From the Omicron front, Medscape reports

Average daily COVID-19 cases and hospitalizations are continuing to fall in the U.S., providing a signal that the Omicron variant is receding across the country.

* * *

Deaths are also beginning to decline, with an average of about 2,100 daily, according to the data tracker from The New York Times. More than 2,500 daily deaths were being reported in early February.

Medpage Today adds

The Omicron sublineage BA.2, which raised alarms because of its transmission advantage, accounts for just 4% of cases in the U.S., and experts suggested it’s not likely to reverse the current downward trend of cases overall.

BA.2 has certainly increased in prevalence, but its been a slow trajectory, according to CDC data. BA.1.1, another Omicron sublineage, actually became the dominant strain in the U.S. in mid-January, the agency reported, with the original lineage, B.1.1.529, currently accounting for about 23% of U.S. cases.

“The BA.2 Omicron variant is increasing in prevalence slowly in both CDC and private data,” tweeted Scott Gottlieb, MD, former FDA commissioner and current Pfizer board member. “While it may become a dominant strain in time, it appears increasingly unlikely that it will cause a significant change in the downward trajectory of the current epidemic wave.”

That has certainly been the case for South Africa, where BA.2 accounts for nearly 100% of cases, according to Tulio de Oliveira, PhD, of the Centre for Epidemic Response & Innovation in Stellenbosch.

“This comes on a background of decreasing infections,” de Oliveira tweeted. The country now has a 7-day average of about 2,500 daily infections, down from a peak of about 23,000 in mid-December.

“At present, the Omicron BA.2 is not of great concern in South Africa,” he tweeted. “But our network is following very close and is alerted to its emergence.”

From the Covid vaccination mandate front, the Society for Human Resource Management reports that the U.S. Court of Appeals for the Fifth Circuit ordered the lower court to reconsider whether United Airlines vaccination mandate offered sufficient protection under Tittle VII to religious objectors.

From the No Surprises Act front, the American Hospital Association tells us

The Centers for Medicare & Medicaid Services will host a conference call for health care providers Feb. 23 at 2 p.m. ET on the No Surprises Act’s continuity of care, provider directory and public disclosure requirements. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov. A recording will be available after the call through Feb. 25 by dialing 866-373-4993.

The slide deck is quite detailed.

Healthcare Dive adds

The cost of being transported by ground ambulance has increased steadily over the past five years, according to a new report from nonprofit Fair Health, threatening patients with few protections from balance billing in disputes between insurers and ambulance providers.

More ambulance trips are billing payers for advanced life support ( ALS), denoting a higher level of care (and reimbursement) than basic life support (BLS) services. Private insurers’ average payments for those trips increased 56% between 2017 and 2020, from $486 to $758, according to the analysis. Before accounting for discounts negotiated with payers, the rate that ambulance operators charged for trips jumped 23% in the same time period and now average almost $1,300.

However, the average reimbursement for advanced life support ambulance rides climbed by 5% for patients covered by Medicare, from $441 to $463, suggesting the government program is keeping a lid on rising costs.

Although at this point only air ambulance charges are subject to the No Surprises Act, this type of report could lead Congress to expand the law to include ground ambulance charges.

From the medical research front, Biopharma Dive informs us

Eli Lilly is again upping its investment in genetic medicine, announcing Tuesday plans to establish a Boston research center that will use RNA- and DNA-based technologies to develop new drugs.

The Lilly Institute for Genetic Medicine will take up 334,000 square feet in Boston’s Seaport neighborhood, with occupancy slated to begin in 2024. Lilly, which has earmarked around $700 million for the project, expects the institute to grow from 120 employees to 250 within five years. Roles will include data scientists, chemists and research biologists with expertise in genetic medicine.

Alongside drug development, the institute will take a page from another Lilly venture — Lilly Gateway Labs — and offer shared lab and office space to support biotechnology startups in the area. Use of the shared space, Lilly said, could create as many as 150 additional new jobs once it’s fully occupied.

The National Institutes of Health announced

Women who had ever experienced sexual violence in their lifetime — including sexual assault and workplace sexual harassment — were more likely to develop high blood pressure over a seven-year follow-up period, according to findings from a large, longitudinal study of women in the United States. The research, funded by the National Institutes of Health and published in the Journal of the American Heart Association, indicated that sexual violence was a common experience, affecting more than 20% of the women in the sample.

“Our results showed that women who reported experiencing both sexual assault and workplace sexual harassment had the highest risk of hypertension, suggesting potential compounding effects of multiple sexual violence exposures on women’s cardiovascular health,” said Rebecca B. Lawn, Ph.D.(link is external), of the Harvard T. H. Chan School of Public Health, Boston, lead author on the study.

From the healthcare initiative front, the Centers for Disease Control detailed its Million Hearts 2027 initiative.

From the virtual care front, Healthcare IT News tells us

The American Medical Association, in conjunction with Manatt Health, published a report this week exploring the ways that virtual care and other digital tools can accelerate the adoption of the integrated delivery of behavioral and physical healthcare.  

In the report, the organizations note that behavioral health integration is essential for solving the country’s dire need for access to services.  

“The demand for behavioral health services is significant and rising, but so is the potential for digital technology to support the integrated delivery of physical and behavioral health services,” said AMA President Dr. Gerald Harmon in a statement.  

Moreover, in Health Affairs, the National Coordinator for Health Information Technology Micky Tripathi discusses delivering on the promise of health information technology in 2022.

From the healthcare business front, Healthcare Finance reports

The Department of Justice has until Saturday, February 27 to block the merger between UnitedHealth Group and Change Healthcare, according to a Securities and Exchange Commission filing on February 17.

The filing, by Change, was done in accordance with a timing agreement made with the DOJ. In November 2021, the two companies agreed not to consummate their merger before February 22. 

The timing agreement provides the DOJ with 10 days’ notice to sue to block the deal. 

“Effective February 17, 2022, UnitedHealth Group and the Company provided such notice to the DOJ,” Change said in the filing. “Accordingly, the DOJ now has until February 27, 2022 to initiate litigation to block the consummation of the merger.”

The DOJ is preparing the lawsuit to block UnitedHealth from purchasing Change, according to Seeking Alpha.

From the awards front

  • STAT News released its inaugural STATUS List which “recongizes standout individuals in health, medicine, and science. And although there are countless contenders to choose from, we’ve selected just 46 — an homage to the number of chromosomes in human DNA.”
  • OPM “announced a call for nominations for the 2022 Presidential Rank Awards (PRAs). A Presidential Rank Award is one of the most prestigious awards in the federal career civil service, and these awards are critical to recognizing the hard work and important contributions of dedicated civil servants in the American federal workforce. The awards – which recognize exceptional performance by members of the career Senior Executive Service (SES) and Senior Career Employees – reflect the Biden-Harris Administration’s commitment to supporting the federal workforce and recognizing federal employees who serve with distinction.” The nomination deadline is March 25, 2022.  

Happy Presidents’ Day

David Ermer–COVID-19, U.S. Healthcare–

The Wall Street Journal offered a fascinating article about the story behind this famous photograph of President Abraham Lincoln. The article’s author observes

[H]ere is President Lincoln as he surely looked to contemporaries, his expression mysterious yet mesmerizing: gray eyes sunken within dark hollows; brow creased; sallow cheeks mottled by scars and moles; huge ears akimbo; nose large but blunt; and the head, he noted in his only personal description, crowned “with coarse black hair.” A great sufferer, perhaps, but firmly in control and command.

As Union officer and future U.S. Rep. Theodore Lyman III once recalled of Lincoln—as if viewing this very pose: “He has the look of sense and wonderful shrewdness, while the heavy eyelids give him a mark almost of genius”—a genius desperately needed in Lincoln’s time, and fully reflected in this timeless image.

In Omicron news —

  • NPR Shots brings us to to date on the Omicron subvariant.

As the omicron surge continues to decline in the U.S., infectious disease experts are keeping a close eye on an even more contagious version of the variant that could once again foil the nation’s hopes of getting back to normal.

The virus, known as BA.2, is a strain of the highly contagious omicron variant that appears to spread even more easily — about 30% more easily. * * *

“A lot of us were assuming that it was going to quickly take off in the United States just like it was doing in Europe and become the new dominant variant,” says Nathan Grubaugh, an associate professor of epidemiology at the Yale School of Public Health.

So far that hasn’t happened. Instead, BA.2 has slowly, but steadily spread even as the omicron surge continued to dissipate. The fear is that spread may be on track to rapidly accelerate in the near future.

* * *

Some experts think it’s unlikely BA.2 will trigger a massive new surge because so many people have immunity from prior infections and vaccination at this point.

“The most likely thing that’s going to happen is that it might extend our tail, meaning it might slow down the decrease in cases. But it’s probably not going to lead to a new wave of cases,” says Grubaugh.

  • The Wall Street Journal explains the science behind why children fare better with Covid. In short in this case, it’s better to have an immature immune system.

In other healthcare news

  • A friend of the FEHBlog called his attention to the final column of New York Times personal health columnist Jane E. Brody. Ms Brody has been writing this column continuously since 1976. She joined the New York Times in 1965. If Ms. Brody doesn’t deserve a gold watch upon retirement, no one does.
  • Two well known experts write in MedPage today about how large employers are collaborating to revamp U.S. healthcare.

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?