Weekend Update

Weekend Update

Photo by Tomasz Filipek on Unsplash

Today has been the first day of Spring. But, it is the first day of Fall for my youngest son, who is studying medicine at Queensland University in Brisbane, Australia.

The House of Representatives is on a district work break this week. Meanwhile, the Senate will be engaged in committee business and floor voting on Capitol Hill.

Fedweek discusses the highlights of the call letter for 2023 benefit and rate proposal letters that OPM released last week.

OPM has told FEHB carriers to continue with increased levels of telehealth and other services related to the pandemic in the 2023 plan year, while also either ordering or encouraging them to expand benefits for certain other conditions.

While Fedweek gets the facts right, its article overlooks that OPM’s orders diminish FEHB competition which Congress relies upon to control premiums.

From the cost management front, Fierce Healthcare tells us

While prior authorization is a key tool in an insurer’s arsenal as it thinks about managing costs, the process remains a key source of friction with physicians.

Amid a nationwide conversation around addressing physician burnout and stress, plans are seeking ways to grow automated and virtual prior auth technologies to ease those barriers. At eviCore Healthcare, the benefit management arm of Cigna’s Evernorth subsidiary, the team has found one of the keys to success in this endeavor is bringing physicians into the conversation early on.

Eric Gratias, M.D., eviCore’s chief medical officer, told Fierce Healthcare that prior authorization programs are often built by people who, while well-intentioned, lack first-hand knowledge of what a clinical encounter is like.

The company’s own prior authorization technology, intelliPath, is built on collaboration with physicians who are actively practicing, he said.

“That partnership with our provider clients is absolutely critical for our success,” Gratias said.

Good point.

From the Rx coverage front

  • NPR Shots points out significant problems with the distribution of Covid treatments.

[D]ata on COVID treatment utilization, shared with NPR by the U.S. Department of Health and Human Services, indicates that millions of COVID treatments are sitting on shelves unused. 

“We are still in a public health emergency,” said Dr. Derek Eisnor, who leads the government’s distribution of COVID drugs, on a call with national health organizations on March 16. He urged health leaders to try to get the drugs to communities that have a demand for them, rather than let them go to waste. 

“There’s an assumption that there’s not enough of [these drugs] around but it does seem when you look at the numbers that there is a lot around — it’s just not being used,” says Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They clearly are not getting to people at high enough rates to have their maximum impact.” * * *

It can be hard to know which pharmacies have the pills in stock or which infusion clinics have appointments available. A patient needs to be able to quickly find a clinician, get a diagnosis and prescription, and be able to access the treatment, all within a few days. 

“It’s multifactorial why these drugs are underutilized,” Adalja says. “It’s likely all of those things are playing some role in the discrepancies between what’s been ordered and and what’s actually been administered.”

The Biden administration launched the Test to Treat initiative this month to address these gaps. “We know the challenges that are involved with patients obtaining therapeutics,” said Dr. Meg Sullivan, acting chief medical officer for HHS’ Office of the Assistant Secretary for Preparedness and Response, in a call with clinicians on March 12. The program aims to improve access to rapid testing and to bolster public and provider awareness of available COVID treatments and how to get them.

Here is a link to the HHS website that offers a U.S map that “displays public locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority. The long-acting antibody combination, Evusheld; monoclonal antibody treatments, bebtelovimab and sotrovimab; as well as the oral antiviral therapies, Paxlovid and molnupiravir are products authorized by the FDA for either prevention (Evusheld) or treatment (Paxlovid, sotrovimab, bebtelovimab, and molnupiravir) of COVID-19.   The locations displayed in the locator have reported available courses within the last seven days.”

The test to treat program’s website is not online yet as far as the FEHBlog can tell.

On March 30, the Food and Drug Administration is bringing together outside experts in neurology to review an experimental drug from Amylyx for the treatment of amyotrophic lateral sclerosis, or ALS. The hearing is expected to be closely watched by ALS patients and their advocates, given the significant need for new treatments for the disease.

But the hearing is likely to garner extra attention because it’s the first meeting of the FDA advisory group since it met in November 2020 and voted unanimously against the approval of Aduhelm, Biogen’s drug for Alzheimer’s disease. The FDA later ignored that recommendation and approved the medication, leading to the resignation of three members of the panel and an uproar over whether the agency had compromised its standards.

Sixteen months removed from all the Aduhelm drama, the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee, restocked with new members, is back to tackle another high-stakes review of a drug targeting a progressive, fatal nervous system disease. The Amylyx treatment — called AMX0035 — isn’t likely to generate the same acrimony as Aduhelm, but it could similarly force the FDA to bend its standards.

Here’s what you need to know about AMX0035, the data from its single clinical trial, and the issues that are likely to take center stage at the FDA advisory panel meeting.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly charts of new Covid cases and deaths (a lagging indicator):

The CDC observes in its weekly review of its Covid statistics

COVID-19 caseshospitalizations, and deaths all continue to decrease in the United States. According to CDC’s COVID Data Tracker, as of March 16, 2022, 76.7% of the total U.S. population has received at least one dose of a COVID-19 vaccine, and 65.3% has completed their primary series. However, only about half of the booster-eligible population has received a booster dose and is considered up to date on their COVID-19 vaccines.

Two new studies show the effectiveness of COVID-19 vaccines and boosters across periods of three variants of concern (Alpha, Delta, and Omicron). CDC released a study today showing that, among adults hospitalized with COVID-19 during the Delta and Omicron waves, those who received two or three doses of the Pfizer-BioNTech or Moderna vaccine had 90–95% less risk of dying or needing a ventilator compared with adults who were not vaccinated. Protection was highest in adults who received a third COVID-19 vaccine dose. A study published in the British Medical Journalexternal icon found that vaccines gave a high level of protection against hospitalization for all variants, but not as much for Omicron among adults who received only a primary series. However, boosters increased protection against Omicron. The study also showed that hospital patients who were vaccinated had much lower disease severity than patients who were not vaccinated.

These studies emphasize the importance of staying up to date with vaccinations—they are our best protection against severe COVID-19 illness. Vaccination is also the safest way to reduce the chance that new variants will emerge. Find a vaccine provider and get your booster dose as soon as you can.

In that regard, here is the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in late 2020:

Here’s a link to the Food and Drug Administration’s March 18 round of its Covid related activities.

While the bulk of Covid care spending goes to hospitals, Becker’s Hospital Review reports that a “sizable minority” have a significant amount out-of-pocket spending for this care, according to a study published in the American Journal of Managed Care March 16.”

It’s worth adding that the Wall Street Journal reports that

The biggest credit-reporting firms will strip tens of billions of dollars in medical debt from consumers’ credit reports, erasing a black mark that makes it harder for millions of Americans to borrow.

Equifax Inc.,  Experian  PLC and TransUnion are making broad changes to how they report medical debt beginning this summer. The changes, which have been in the works for several months, will remove nearly 70% of medical debt in collections accounts from credit reports.

Beginning in July, the companies will remove medical debt that was paid after it was sent to collections. These debts can stick around on a consumer’s credit report for up to seven years, even if they are paid off. New unpaid medical debts won’t get added to credit reports for a full year after being sent to collections.

The firms are also planning to remove unpaid medical debts of less than $500 in the first half of next year. That threshold could rise, according to people familiar with the matter.

From the compliance front —

  • The Internal Revenue Services issued a notice on how to calculate the No Surprises Act’s Qualified Payment Amount when the health plan does not have enough data to calculate a January 2019 median.
  • The Department of Labor is offering a webinar on March 30 at 11 am that “will help employers, service providers, and benefit professionals understand how the provisions of [the federal mental health partity act] apply to employer-sponsored group health plans and provide information on how to avoid common problems. The webinar runs about 45 minutes to an hour and is limited to 200 participants.

From this week’s healthcare conferences front

  • Fierce Healthcare discusses the electronic medical records interoperability theme of the HIMSS conference.
  • Fierce Healthcare also offers a wrap report on “the most interesting innovations at SXSW 2022: From holograms to the future of psychedelics.”

From the telehealth front

  • Becker’s Payer Issues reports that most consumer driven plans have taken advantage of the IRS offered flexibility to cover telehealth before the “high” annnual deductible.
  • Forbes informs us “Telehealth Accounts For One In Three Mental Health Visits Two Years Into Pandemic.” Whoopee.

From the good works department, the American Medical Association tells us about a North Carolina physician who is talking the diabetes problem.

Dr. [Brian] Klausner is the medical director of WakeMed’s Community Population Health program in Raleigh. He also is a physician champion for DiabetesFreeNC. That is the statewide initiative where AMA partnered with the North Carolina Medical Society and others to support collaborative efforts to end type 2 diabetes in the Tar Heel State.  

Rather than think of the pandemic as having “derailed” diabetes prevention or other population health efforts, Dr. Klausner said that “COVID-19 expedited new perspective in how we can do a better job addressing historic roadblocks to community health initiatives, including those related to diabetes and prevention.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

Happy Ides of March. The President signed the Consolidated Appropriations Act 2022 into law today. The Postal Reform Act of 2022 continues to await the President’s signature.

From the Omicron front, David Leonhardt reports on COVID surges in China and Europe. He concludes

Even if [Covid] cases rise [in the U.S. again], as seems likely, there are good reasons not to panic. Vaccination tends to turn Covid into a mild illness, especially for people who have received a booster. For the unvaccinated and unboosted, BA.2 is another reason to get a shot.

It’s also a reason for the federal government and states to expand access to both Evusheld — a drug that can help protect the immunocompromised — and Paxlovid — a post-infection treatment. Finding either is often difficult today. (If you’re looking for one of them, click on this link for Evusheld and this one for Paxlovid.)

The bottom line: Covid isn’t going away, but vaccination and other treatments can keep future increases manageable. The biggest problem remains the millions of people who remain unvaccinated, many of them by choice. That’s the case in the U.S., in Hong Kong and across much of EuropeAfrica and the rest of the world.

Inducing more people to get shots — through persuasion or mandates — would probably save more lives than any other Covid policy.

What is the FDA’s hold up in reviewing the standard Covid vaccines for which emergency use authorizations have been filed? As previously noted, the traditional vaccines may be appealing to those resistant to the state-of-the-art mRNA vaccines.

The Wall Street Journal reports

Pfizer Inc. and partner BioNTech SE have asked U.S. health regulators to authorize a second booster dose of its Covid-19 vaccine for people 65 years and older.

The companies said Tuesday that they had filed the application. The Food and Drug Administration is expected to make a decision in time for the Biden administration to begin a potential fall vaccine campaign.

The FDA has been reviewing data and looking at potentially authorizing a fourth dose of the shot for use in the fall, The Wall Street Journal reported last month.

From the Rx coverage front —

STAT News informs us

The prices pharmacy benefit managers and insurers pay for Sanofi medicines have decreased for a sixth consecutive year, yet patient out-of-pocket costs are rising. Once again, there is further evidence that focusing solely on lowering the list price of medicines doesn’t guarantee lower costs for patients. Sanofi pulls back the curtain on the impact of list and net prices and more in its annual pricing report.

and

Back in 2019, when the Senate Finance Committee called seven drug industry CEOs to testify, it seemed like proof that Washington was within striking distance of actually reining in the industry’s high prices. “It’s past time to get beyond the excuses and make prescription drugs affordable,” Sen. Ron Wyden, the top Democrat on the committee, told drugmakers that day. Tomorrow, almost exactly three years later, Wyden will chair another hearing on prescription drug pricing. He’s billing the hearing as “an opportunity for members to discuss how high drug prices have impacted seniors and families in their states and identify solutions” — even though lawmakers have had more than a dozen such hearings to “discuss” high drug prices over the past three years. STAT’s Nicholas Florko tallies what’s at stake in STAT+.

In FDA News, the agency reports approving today “the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.”

From the opioid epidemic front, “the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced two grant programs totaling $25.6 million that will expand access to medication-assisted treatment for opioid use disorder and prevent the misuse of prescription drugs. By reducing barriers to accessing the most effective, evidence-based treatments, this funding reflects the priorities of HHS’ Overdose Prevention Strategy, as well as its new initiative to strengthen the nation’s mental health and crisis care systems.”

From the patient front, HHS’s Agency for Healthcare Research and Quality announced the agency’s

Support for Patient Safety Awareness Week. Ongoing investments in safety research, the development of safety toolkits and training resources, and a growing emphasis on improving diagnostic safety are all part of a mission to make healthcare safe for all Americans. Access more information about AHRQ’s support of Patient Safety Awareness Week, including a special introductory video from Jeff Brady, M.D., director of the Center for Quality Improvement and Patient Safety; information about how to get involved in Patient Safety Awareness Week activities; and recent patient and diagnostic safety resources, including:

Diagnostic Safety Supplemental Items for the Surveys on Patient Safety Culture (SOPS) Medical Office Survey

Safer Together: A National Action Plan to Advance Patient Safety

Making Healthcare Safer III: A Critical Analysis of Existing and Emerging Patient Safety Practices

— AHRQ QuestionBuilder App (also available in Spanish

From the HIMSS conference in Orlando, Healthcare Dive tells us

The Biden administration has been working on additional rulemaking to address issues with the payer-to-payer data exchange requirements set out in sweeping interoperability rules finalized in early 2020, and “we look forward to sharing this rule with you soon,” CMS administrator Chiquita Brooks-LaSure told attendees at the HIMSS annual conference in Orlando on Tuesday.

CMS decided not to enforce those provisions when they kicked in this year, after health insurers raised concerns about operational challenges and risks to data quality given a lack of specificity in the rule.

The new rule will incorporate extensive public comment to try to address stakeholder concerns, and will standardize how payers exchange data through application programming interfaces, Brooks-LaSure said.

and

An online tool that allows patients in markets across the country to compare prices for hundreds of hospital services before getting treatment has launched in its beta development stage.

Turquoise Health’s platform uses cost data from machine-readable files made public by hospitals as part of compliance with a federal price transparency rule that went into effect in January 2021.

The San Diego-based startup’s platform includes a scorecard that lets users assess price transparency compliance with the CMS requirements for nearly 6,000 hospitals, Turquoise Health said Monday. Hospitals receive a score based on an algorithm-driven five-star rating system.

Fierce Healthcare reports from the SXSW Conference in Austin, TX.

Samsung and Best Buy executives shared why they place big bets on tech to help elderly Americans age at home.

Experts are laying out the business case to invest in care for underserved communities.

Leaders in women’s health say empowering female patients is key to addressing gender biases in healthcare.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omicron front

Medpage Today offers an interesting discussion of the test to treat program.

The Wall Street Journal informs us

A new Covid-19 pill from Merck & Co. and Ridgeback Biotherapeutics LP has been more widely used than expected since rolling out late last year, though regulators and many doctors consider it a last resort. 

Many doctors and health officials anticipated a rival pill, Pfizer Inc.’s Paxlovid, would be the Covid-19 drug of choice. Paxlovid was found to be far more effective than Merck-Ridgeback’s molnupiravir in clinical trials, and regulators and guidelines recommended using Paxlovid if possible.

Prescriptions for the two antivirals have been running about equal since their authorization in December, however. The larger-than-expected use is a sign of the high demand for easy-to-use coronavirus treatments that can be taken at home, especially during surges like the recent Omicron wave.

Govexec tells us

Federal agencies are not restricted on the size of events they host, unless under certain conditions, according to new guidelines. 

The Biden administration’s Safer Federal Workforce Task Force issued updated and new guidance on March 11, most of which reflects the Centers for Disease Control and Prevention’s new framework released in late February. That framework “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,” as CDC Director Dr. Rochelle Walensky said on a briefing call. 

There are no “restrictions on the size of agency-hosted in-person meetings, events, or conferences,” said one of the new “frequently asked question” prompts. “Should an agency intend to host a meeting, conference, or event that will be attended in-person by more than 50 participants at a facility in a county where the COVID-19 Community Level is HIGH, the agency should first seek the approval of its agency head or official to which this responsibility has been delegated, in consultation with the agency’s COVID-19 coordination team.” 

From the Rx coverage front –

BioPharma Dive reports good news

The Food and Drug Administration has approved AstraZeneca and Merck & Co.’s drug Lynparza for people with a genetic form of early breast cancer, a decision that could spur greater use of DNA testing in diagnosing and treating the disease.

Lynparza is already used to treat metastatic breast cancer in patients with so-called BRCA gene mutations. The new approval makes Lynparza available earlier in their disease, after surgery to remove a tumor and standard drugs like chemotherapy and radiation. People with cancers that are “HER2-negative” and at a high risk of relapsing are eligible for treatment.

The decision is based on the results of a large study published last year in The New England Journal of Medicine last year. In it, Lynparza reduced the risk of disease progression or death by 42% versus placebo after a median of 2.5 years of follow-up. Updated results show the drug cut the risk of death by about a third, a finding the companies will detail at a medical meeting on Wednesday.

The National Institutes of Health announced launching “a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines.” mRNA developers were working on HIV vaccines before the pandemic struck. Fingers crossed.

Healthcare Dive reports from Capitol Hill

Sen. Chuck Grassley (R Iowa) is urging the Federal Trade Commission to “find consensus” and vote again to launch a study into the business practices of pharmacy benefit managers, according to a letter he sent to FTC Chairwoman Lina Khan dated March 9.

“PBMs operate with little to no transparency, making it very difficult if not impossible to understand the flow of money in the prescription drug marketplace,” the Republican senator from Iowa said in his letter, nodding to the bipartisan consensus for such an examination.

Grassley urged the commissioners to come up with a more targeted focus for the study and suggested narrowing a review to the impact on consumers and their out of pocket costs.

From the patient safety front, Beckers Hospital Review explains

Staffing shortages are the top threat to patient safety in 2022, according an annual report on patient safety concerns from ECRI, an organization that conducts independent medical device evaluations, published March 14. 

Researchers identified the top threats to patient safety by analyzing a wide range of data, including scientific literature, patient safety events or concerns reported to or investigated by ECRI. 

Ten top patient safety concerns this year: 

1. Staffing shortages

2. COVID-19 effects on healthcare workers’ mental health

3. Bias and racism in addressing patient safety 

4. Vaccine coverage gaps and errors

5. Cognitive biases and diagnostic error

6. Nonventilator healthcare-associated pneumonia 

7. Human factors in operationalizing telehealth

8. International supply chain disruptions

9. Products subject to emergency use authorization

10. Telemetry monitoring 

From the mental healthcare front, the Department of Health and Human Services announced

A new U.S. Department of Health and Human Services (HHS) study published in the American Medical Association’s journal JAMA Pediatrics  reports significant increases in the number of children diagnosed with mental health conditions. The study, conducted by the Health Resources and Services Administration (HRSA), finds that between 2016 and 2020, the number of children ages 3-17 years diagnosed with anxiety grew by 29 percent and those with depression by 27 percent. The findings also suggest concerning changes in child and family well-being after the onset of the COVID-19 pandemic.

No bueno.

Midweek Update

Photo by Josh Mills on Unsplash

From Capitol Hill, overnight, the FY 2022 onmnibus appropriations bill language was released. The bill is over twenty one hundred pages long. The American Hospital Association has taken the time to summarize the bill’s healthcare provisions. Federal News Network discusses the bill’s federal workforce provisions. The Wall Street Journal notes

Democratic House leaders said they would remove a contentious $15.6 billion Covid-19 aid provision from the omnibus spending bill to try to get it over the finish line, after angry rank-and-file members rejected clawing back states’ unused coronavirus money to fund the proposal.

The decision to drop the Covid-19 aid was a dramatic setback for both House Speaker Nancy Pelosi (D., Calif.), who negotiated the plan, and President Biden, whose administration originally asked for $22.5 billion for Covid-19 aid and now will get nothing from the bill.

The House of Representative currently is considering the bill and a fourth continuing resolution that would last the four days beyond March 11 that the Senate needs to pass the bill. The House is expected to vote on the bill around 9:15 pm ET. Passage of the bill and the brief continuing resolution is expected.

From the Rx coverage front, Fierce Healthcare informs us

Amazon Pharmacy is partnering with Blue Plans in five states and Prime Therapeutics to tackle the affordability of prescription medications.

The online retail giant’s pharmacy arm is rolling out a prescription discount savings card that’s available to some Blue Plans members.

Integrating this discount card pricing into the shopping experience lets eligible customers compare their co-pay or discount price upfront and then apply purchases for eligible medications to the out-of-pocket maximums and deductibles associated with their insurance plan, according to Nworah Ayogu, M.D., chief medical officer for Amazon Pharmacy. * * *

Eligible plans now include Horizon Blue Cross Blue Shield of New Jersey, Blue Cross Blue Shield of Nebraska, Blue Cross Blue Shield of Alabama, Florida Blue and Blue Cross and Blue Shield of Kansas. 

From the miscellany department —

  • The National Committee for Quality Assurance has created a health equity website.
  • America’s Health Insurance Plans celebrated International Womens’ Day yesterday with remarks from healthcare leaders on how health plans can improve healthcare for women.
  • The Centers for Medicare and Medicaid Services issued new guidance for group health plans on submitting a valid documented defense to Medicare overpayment recovery demands.

Thursday Miscellany

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

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.  

Friday Stats and More

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

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

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.