Weekend update

COVID-19 testing

Weekend update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Mental health care, Telehealth–

The House of Representatives and the Senate will be in session this week for limited Committee business and floor voting.

The Wall Street Journal explains

Lawmakers will return to the Capitol this week with a singular focus of passing a sweeping bipartisan spending bill to avert a shutdown and fund the government through September, despite opposition from many House Republicans.

The massive bill is expected to total around $1.7 trillion and could be released as early as Monday. It would fund government agencies and programs and allow those agencies to distribute grants and contracts to the private sector. 

Because it is the last piece of legislation that Congress will pass in this session, lawmakers have spent weeks lobbying to attach other bills, including funding for Ukraine, changes to tax policy and a measure to update how Congress deals with disputes over certifying presidential-election results. * * *

The Senate is expected to vote on the bill first. Senate Minority Leader Mitch McConnell (R., Ky.) has been part of the negotiations and set a deadline of Thursday to reach a deal—a day before the money runs out—but he said his patience was limited and that he wouldn’t allow talks to stretch past Christmas. 

From the Omicron and siblings front, NPR Shots provides insights on Paxlovid.

The Centers for Disease Control and Prevention recommends treatment for patients at risk of severe disease, hospitalization and death, which includes anyone who’s 50 and older (risk increases with age), people who are unvaccinated and people with certain medical conditions, such as obesity, chronic lung disease, heart disease or a weakened immune system.

But exceptions can be made. A colleague who is under 50 told her doctor she was feeling worse each day after her positive COVID test and had a history of pneumonia. The doctor wrote a Paxlovid prescription. * * *

[In addition to you doctor or pharmacist, t]he federal government has a “Test to Treat” locator to see where you can be tested for free and, if you test positive and are eligible, leave with the drug. Spots include community health centers and some pharmacies. 

Pharmacies may also send the pills to your home for prescriptions the doctor calls in. Walgreens just announced free Paxlovid delivery via Door Dash and UberEATS; CVS will send it the same day for a fee. * * *

Since Paxlovid has to be taken within five days of symptoms starting to work, you might contact your doctor’s office to find out what steps to take if you test positive and think you need the drug. * * *

Paxlovid is the best option for reducing the risk of severe disease. The last monoclonal antibody treatment for COVID-19 lost its FDA authorization last month because it is ineffective against currently circulating variants. That leaves Paxlovid; remdesivir, which requires an outpatient infusion over three days at a hospital or treatment center; and molnupiravir [the other pill], which studies put at only 30% effective in treating the virus. In addition, some doctors are treating immunocompromised patients with convalescent plasma.

Bloomberg Prognosis discusses expiration dates on at-home Covid tests.

The Food and Drug Administration has extended the shelf-lives of 14 brands of tests. Consumers can look up their specific brand and even the lot number to see the correct expiration dates. Brands including iHealth, from a subsidiary of Andon Health in China, Abbott Laboratories’ BinaxNow and ACON Labs Inc.’s Flowfex now last up to 12  months, 15 months and 21 months, respectively. The FDA advises against using at-home Covid tests past their expiration date.

Health plans and Medicare continue to provide at-home Covid tests at no cost, and the federal government resumes mailing out free at-home Covid tests tomorrow.

From the telehealth front —

mHealth Intelligence tells us

Implementing a telehealth navigator program helped improve video visit attendance, providing clinics with a positive financial return, according to a new study published in JAMA Network Open.

The COVID-19 pandemic dramatically drove up the use of telehealth. Like many other healthcare provider organizations, Boston-based Beth Israel Deaconess Medical Center implemented and scaled telehealth visits. But they found that technical issues could hamper video visits, prompting some video visits to be converted into audio-only visits via the telephone, according to the study authors.

The medical center implemented a patient navigator pilot program to reduce barriers to video visit attendance. Through the program, a patient navigator contacted patients one day before their video visit appointment to provide technical support. The navigator went through the steps required for the patient to connect to their visit and addressed frequently asked questions.

The Wall Street Journal reports

Remote treatment of mental-health problems surged in the pandemic, as in-person treatment became difficult while pandemic-driven isolation increased anxiety and depression.

Digital mental-health companies plunged in, promising to provide millions with access to high-quality care by video, phone, and messaging.

Many of the businesses, however, put a premium on growth. Investor-backed, they deployed classic Silicon Valley tactics such as spending heavily on advertising and expansion while often using contractors instead of employees to control costs. A strategy designed for mundane businesses such as food delivery, the formula can be badly suited to the sensitive activity of treating mental-health problems.

No bueno. The article is focused on stand-alone telemental health services.

In the spirit of the Season, Bloomberg Prognosis tackles the question of “Eggnog Made With Raw Eggs Safe.”

“Eggnog may be safely made at home by using egg substitutes, whole, liquid or pasteurized eggs,” Darin Detwiler, a food-safety expert at Northeastern University, says. “These products need no further cooking to kill harmful bacteria.”

Pasteurized eggs are gently heated in their shells to a high-enough temperature to kill any bacteria without cooking the egg. They are pretty widely available, though the texture isn’t always exactly the same as an unpasteurized egg.  

If you are making eggnog the old-fashioned way, Detwiler has some advice for that, too.

“Cook the egg mixture to 160℉ and refrigerate it quickly in several small containers,” he says. “Then it will cool quickly.”

Jingle bells, all.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 testing, FDA, NIH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

The Senate passed an $858 billion defense-policy bill [National Defense Authorization Act] on Thursday that authorizes U.S. military leaders to purchase new weapons and would increase pay for service members, checking a major item off Congress’s year-end to-do list.

The House passed the legislation last week with 350 votes in favor and 80 votes against. It now goes to President Biden’s desk for his signature.

The Journal also provides information on the NDAA’s key provisions.

The Washington Post adds,

The Senate late Thursday approved a measure to fund the government through Dec. 23, securing a one-week deadline extension that gives Democrats and Republicans one final opportunity to work out a longer-term spending deal.

The 71-19 vote — coming a day after the House adopted it — sends the stopgap to President Biden and staves off a federal government shutdown that otherwise would have occurred after midnight this Friday.

From the Omicron and siblings front, the American Hospital Association informs us,

The Department of Health and Human Services today recommended governors take certain actions to prepare for a potential further increase in COVID-19 cases and hospitalizations this winter, and has pre-positioned N-95 masks, gloves, gowns and ventilators at strategic locations should states need them, the Biden Administration announced.

The Administration also announced that all U.S. households can now order four more free at-home COVID-19 tests, which will begin shipping the week of Dec. 19.

From the public health front, AP reports

The number of U.S. deaths dropped this year, but there are still more than there were before the coronavirus hit.

Preliminary data — through the first 11 months of the year — indicates 2022 will see fewer deaths than the previous two COVID-19 pandemic years. Current reports suggest deaths may be down about 3% from 2020 and about 7% vs. 2021.

The National Institutes of Health announced

The percentage of adolescents reporting substance use in 2022 largely held steady after significantly declining in 2021, according to the latest results(link is external) from the Monitoring the Future survey(link is external) of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States. Reported use for almost all substances decreased dramatically from 2020 to 2021 after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, reported use of any illicit drug within the past year remained at or significantly below pre-pandemic levels for all grades, with 11% of eighth graders, 21.5% of 10th graders, and 32.6% of 12th graders reporting any illicit drug use in the past year.

The Monitoring the Future survey is conducted each year by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

From the Rx coverage front –

BioPharma Dive takes a “deep dive” reporting on a recently approved drug called to treat ALS or Lou Gehrig’s disease. “Amylyx Pharmaceuticals’ Relyvrio is in high demand in clinics across the U.S. Though some patients are already getting it, insurance and out-of-pocket costs remain a source of anxiety. * * * In the clinical trial that led to its approval, Relyvrio appeared to slow the functional decline associated with ALS. The trial also found patients treated with the drug lived a median of five months longer than those given a placebo. While Relyvrio’s benefits have been called modest, the drug has become a vital source of hope for many ALS patients.”

BioPharma Dive also lets us know that

  • Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.
  • The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company won’t launch Idacio in the U.S. until July.
  • Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.

Health Affairs Forefront offers Parts 1 and 2 of its insights on drug pricing reform enacted this past summer’s federal budget reconciliation act.

From the regulatory front

  • The FEHBlog noticed that the HHS press release concerning the 2024 Medicare Part D proposed rule (posted yesterday) lacked links to the proposed rule and the fact sheets. So here are the missing links:

The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/2022-26956/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program. Comments on the proposed rule are due by February 13, 2023.

View the fact sheet on the proposed rule here.

  • Health Affair’s Forefront’s second article on Monday’s proposed 2024 ACA benefit and payments parameter rule is here. This article concerns risk adjustment.

From the telehealth front, Health Payer Intelligence relates that

  • Most patients who had a telehealth visit didn’t need an in-person follow-up appointment in the next three months, according to new research from Epic. The trend was reflected in almost every specialty included in the study.
  • For specialties that required follow-ups, the additional visits were likely due to patients needing additional, not duplicative, care, Epic researchers said. That’s because high follow-up rates were only present in specialties that require regular hands-on care, such as obstetrics and surgery.
  • The study is the latest addressing whether telehealth results in duplicative care, instead of replacing an in-person encounter. The question is being debated by lawmakers as they consider how much telehealth flexibility should be allowed once the COVID-19 public health emergency expires.

In innovation news, Fierce Healthcare discusses

ElliQ, [which is] a voice-operated care companion for the elderly, is getting an update with 2.0 hardware and software including a companion app for family members and caregivers.

The robot, called the first proactive AI care companion and a Time Best Invention of 2022, was developed to address the loneliness epidemic in older adults and has shown the ability to decrease loneliness by 80%, according to the company. * * *

Interventions like the ones ElliQ performs are shown to improve the quality of life for seniors living alone by 80% through increasing fitness and facilitating social connections, according to a recent McKinsey report.

The first ElliQ impact studies have shown that 80% of users report a reduction in loneliness, 82% experienced better mental health and 90% feel overall better since using the robot.

Thanksgiving Weekend Update

David Ermer–Congress, COVID-19, COVID-19 testing, Federal employment benefits, Government Contracting, No Surprises Act, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

The House of Representatives and the Senate return to Capitol Hill for Committee business and floor voting this week.

The Wall Street Journal adds

Lawmakers return to work this week with a to-do list that includes passing a critical government-funding bill, solidifying access to same-sex marriage and setting priorities for the U.S. military before the start of the new Congress next year.

Other issues emphasized by Democrats, including passing a ban on the sale of assault-style weapons, are a long-shot given their narrow majority in the Senate. Most legislation requires 60 votes to advance in the Senate. In addition, lawmakers are discussing raising the federal debt ceiling, which limits how much the government can borrow.

Congress faces a Dec. 16 deadline to pass legislation that would continue funding the federal government; failure to do so could result in a partial shutdown. Lawmakers must decide whether to approve a short-term bill or reach a deal on more-detailed legislation that would fund the government for the full fiscal year.

The Senate also will be considering the National Defense Authorization Act, which typically includes government procurement law changes.

Tomorrow, the Federal Employee Benefits Open Season will reach its clubhouse turn with two weeks left to go. Although not a part of the Open Season, Federal News Network reports an important development concerning the Federal Employees Long Term Care Insurance Program (FLTCIP.

Those looking to enroll in the FLTCIP will soon have to wait a couple of years before applying.

The Office of Personnel Management said it will suspend all new applications to the program starting on Dec. 19. The suspension will last for the next two years, but those who apply ahead of the start date may still see their applications go through. During that time, current FLTCIP enrollees cannot apply to increase their coverage. The suspension will otherwise not affect the coverage of current enrollees.

* * *

The contract for the insurance program, with John Hancock Life and Health Insurance Company, typically lasts seven years before getting a renewal. The program normally gets a premium hike each time the contract turns over. During the open period for new contract proposals earlier this year, only the current underwriter John Hancock submitted a bid. The current FLTCIP contract will expire on April 30, 2023.

The upcoming suspension on applications will allow OPM “to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency said in a Nov. 18 notice. OPM added that it will only suspend applications when it is in the best interest of the program.

Many are eligible to apply for FLTCIP coverage, including federal employees, U.S. Postal Service employees and annuitants, as well as active and retired members of the uniformed services, and qualified relatives of feds. John Hancock has historically sponsored the program, and Long Term Care Partners, LLC, has administered it.

From the Omnicron and siblings front, the National Institutes of Health announced

Reporting a positive or negative test result just became easier through a new website from the National Institutes of Health. MakeMyTestCount.org, developed through NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, allows users to anonymously report the results of any brand of at-home COVID-19 test.

COVID-19 testing remains an essential tool as the United States heads into the holiday season and people navigate respiratory viruses. While taking a rapid COVID-19 test has become commonplace, test results are not often reported. COVID-19 test results provide valuable data that public health departments can use to assess the needs and modify the responses in the local community, the state or the nation.

Lab tests have a well-established technology system for sharing test results. RADx Tech has been working on a system to standardize test reporting for at-home tests in a secure manner. The MakeMyTestCount.org website is built on this system for logging test results.

The Wall Street Journal tells us

U.S. life insurers paid a record $100 billion in 2021 in death benefits, fueled by another year of Covid-19 deaths, an industry trade group said.

Payouts rose 11% in 2021 to $100.19 billion, most likely due to the pandemic, according to the American Council of Life Insurers. The increase was on the heels of a 15% year-over-year rise in 2020, when death-benefit payments totaled $90.43 billion.

The ACLI compiles data from annual filings by insurers to state insurance departments. Given limitations in the filings, the group can’t break down causes of death, but it is reasonable to attribute the bulk of the increases to the pandemic, said Andrew Melnyk, ACLI vice president of research and chief economist.

The year-over-year increases are among the largest since the 1918 flu pandemic, when payments surged 41%. They are far above the 4.9% average from 2011 to 2021, the ACLI said.

From the No Surprises Act front, Healthcare Dive reports

House lawmakers expressed their discontent with a final rule on surprise billing and urged federal regulators to make changes.

House Ways and Means Committee Chairman Richard Neal, D-Ma., and ranking member Kevin Brady, R-Texas, sent a letter to HHS Secretary Xavier Becerra and other department heads again expressing disappointment with a much-contested section of the surprise billing ban.

The lawmakers “are severely disappointed to find that the August 2022 final rule violates the No Surprises Act in the same ways as before,” Neal and Brady said in a letter last week.

For Heaven’s sake, Congress should give the revised rule a chance before joining the medical associations in condemning it.

From the public health front, Health Payer Intelligence tells us

The number of Americans with a usual source of care has dropped 10 percent in the last 18 years, with only about three-quarters of people saying they have a regular primary care provider or at least a facility where they know they can access care, according to the Primary Care Collaborative (PCC) and AAFP Graham Center.

The analysis also revealed some health disparities, with folks who are Hispanic, have less than a high school education, are uninsured, and are younger being less likely to have a usual source of care than their counterparts. * * *

“Employers have a very important role to play to ensure that all their employees and their families have ready, convenient access to a usual source of affordable primary care,” said Asaf Bitton, MD, the executive director of Ariadne Labs – Harvard T.H. Chan School of Public Health.

“We applaud those employers who are providing highly accessible virtual and in-person primary care options, and working with preferred provider organizations and health systems to support patients in establishing and maintaining these crucial primary care relationships.”

Amen to that sentiment.

STAT New reports

Cardiovascular disease is responsible for about one in five deaths in women in the U.S., more than any other cause — including all forms of cancer combined. Black women like Shields are particularly vulnerable: In the U.S., Black adults are substantially more likely to die from heart disease than their white, Hispanic, or Asian or Pacific Islander counterparts.

To try to reduce deaths from heart disease, health professionals typically use basic risk calculators, which take about a dozen standard data points to predict a person’s likelihood of having a major event, such as a heart attack or stroke, in the next 10 years.

Regardless of their other risk factors, for the most part, patients who are young and female have a very low chance of having a cardiovascular event in the next 10 years, so they are unlikely to get recommendations for serious lifestyle interventions or medication. But they may still be heading down a path to a fatal event later in life.

Some 10 to 15% of pregnancies have at least one complication that is linked to later heart disease. In addition to preeclampsia, these include other forms of gestational hypertension; gestational diabetes; preterm delivery; low birth weight; and placental abruption. People who experience miscarriages and stillbirths are also at greater risk of heart disease. Additional reproductive health conditions — including the early arrival of periods, polycystic ovary syndrome, infertility, and early menopause — have also been linked to increased risk.

These data, however, are all missing from standard cardiovascular disease risk calculators. Some pregnancy complications are listed as part of the comprehensive American Heart Association screening guidelines. But a large national 2014 survey revealed that only 16% of primary care physicians and 22% of cardiologists were using these full guidelines. The failure of health-care providers to screen for these sorts of early warning signs is in keeping with the long-standing pattern in which women’s risk for heart disease is chronically underestimated by medical professionals — as well as by women themselves.

That’s a big bowl of wrong.

From the plan design front, Beckers Payer Issues relates

Providers using EHRs that aren’t enabled for electronic prior authorization and the cost to upgrade to those EHRs are the main barriers preventing automated PA, according to a Nov. 14 America’s Health Insurance Plans survey. 

The health insurance trade group conducted an industrywide survey on “prior authorization practices and gold carding experience of commercial plans” between February and April, according to the report. AHIP received responses from 26 plans, covering a total of 122 million commercial enrollees.

Top barriers to automated prior authorization:

  1. Provider does not use EHR enabled for electronic PA: 71 percent
  2. Costly/burdensome for providers to buy/upgrade EHR for electronic PA: 71 percent
  3. Lack of interoperability between EHR vendors: 62 percent
  4. Costly for payers to enable PA rules and information to be delivered electronically: 43 percent
  5. Lack of electronic PA solutions on market: 19 percent

This is a surprising outcome considering how vociferously providers object to prior authorization.

Monday Round-up

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 testing, Electronic health records, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

Yesterday, the FEHBlog discussed a U.S. Court of Appeals for the 11th Circuit opinion issued last Friday narrowing the scope of a nationwide injunction that a federal district court had imposed on the Biden Administration’s federal government contractor mandate.

Govexec adds today that

The executive order is still enjoined in Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Carolina, South Dakota, Tennessee, Utah, West Virginia and Wyoming as a result of the Friday opinion and the injunctions in the other cases, members of the law firm McGuireWoods noted in a post. 

A spokesperson for the Office of Management and Budget told Government Executive on Monday morning the Justice Department is currently reviewing the decision. “At this time, the nationwide injunction remains in effect, and thus agencies should continue not to take any steps to enforce Executive Order 14042.” 

The nationwide injunction remains in effect at least until the appellate court issues its mandate to the lower court which typically happens in two weeks.

Also from the Omicron and siblings front, the Wall Street Journal discusses best practices for Covid testing while NPR tells us

The federal government is putting a pause on sending free COVID-19 testing kits to Americans starting in September, due to a lack of funding. 

“Ordering through this program will be suspended on Friday, September 2 because Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” the ordering website says. 

However, the program is still accepting orders before [next Saturday] Sep. 2. 

From the No Surprises Act front, Mercer Consulting announced

A new prescription drug reporting mandate, adopted as part of the 2021 Consolidated Appropriations Act (CAA) (Pub. L. No. 116-260), requires group health plans and health insurers to report detailed data about prescription drug pricing (including rebates) and healthcare spending. The first reports are due by Dec. 27, 2022, and annually thereafter. The departments of Labor, Treasury, and Health and Human Services will use the information to prepare a biannual, publicly available report. The departments have issued interim final rules (IFR) detailing the data to report and recently updated submission instructions describing the mechanics of the reporting process. The updated instructions provide important information about reporting wellness services, prescription drug expenses that are covered by the pharmacy benefit manager and more.

Download PDF of this article

Click here

Download the 21-page print-friendly article for details on the prescription drug reporting rules and the compliance challenges facing group health plans. This GRIST has been updated to reflect the updated submission instructions.

OPM added FEHB plans to the list of reporting plans and insurers. The initial report on the 2020 plan year is due no later than December 27, 2022.

From the FEHB plan design front, Federal News Network reports

Democratic lawmakers are urging the Office of Personnel Management to follow through on its plans to expand federal employees’ medical coverage to cover infertility diagnoses and treatments.

Sen. Tammy Duckworth (D-Ill.) and Government Operations Subcommittee Chairman Gerry Connolly (D-Va.) urged OPM on Monday to ensure all Federal Employee Health Benefits (FEHB) program carriers provide coverage for assistive reproductive technology (ART), which includes in vitro fertilization (IVF), starting in 2023.

The legislators’ demand strikes the FEHBlog as a day late and a dollar short because FEHB carriers and OPM closed their benefit and rate negotiations earlier this month. OPM did ask carriers in the agency’s 2023 call letter to plan on expanding ART coverage or offering a discounted ART network, among other options.

From the maternal health front, the Department of Health and Human Services announced “investments of over $20 million to improve maternal and infant health and implement the White House Blueprint for Addressing the Maternal Health Crisis – PDF. Funding aims to help reduce disparities in maternal and birth outcomes, expand and diversify the workforce caring for pregnant and postpartum individuals, increase access to obstetrics care in rural communities, and support states in tackling inequities in maternal and infant health.”

From the mental healthcare front, Health Payer Intelligence delves into the resources that AHIP has made available.

Seven strategic themes emerged from the list of ways that payers have helped members manage their mental health needs:

* Helping members find the right providers

* Creating opportunities for care through telehealth, online platforms

* Designing new payment models

* Expanding and educating the mental healthcare workforce

* Offering population-based services

* Supporting caregivers

* Expanding research and awareness

The article expounds on each of these themes.

From the U.S. healthcare business front, Fierce Healthcare reports

Months of inching performance gains were upended in July as the nation’s hospitals logged “some of the worst margins since the beginning of the COVID-19 pandemic,” Kaufman Hall wrote in its latest industry report. * * *

What’s more, seven straight months of negative margins “reversed any gains hospitals saw this year” and has the advisory group forecasting a brutal year for the industry.

“July was a disappointing month for hospitals and put 2022 on pace to be the worst financial year hospitals have experienced in a long time,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a statement. “Over the past few years, hospitals and health systems have been able to offset some financial hardship with federal support, but those funding sources have dried up, and hospitals’ bottom lines remain in the red.” * * *

The silver lining in Kaufman Hall’s report were total expenses that, although up 7.6% from July 2021, saw a modest 0.4% decline since June. Those savings came squarely among supply and drug expenses as total labor costs and labor expense per adjusted discharge still grew 0.8% and 3.5%, respectively, since June. Increases in full-time employees per adjusted occupied bed “possibly” suggest increased hiring, the group wrote in the report.

From the electronic health record interoperability front, Becker’s Health IT informs us

Judy Faulkner, CEO of Epic, discussed the company’s vision to build a nationwide health IT infrastructure last week at the annual Users Group Meeting while dressed as Amelia Earhart, according to The Cap Times. 

Ms. Faulkner has a history of dressing as characters and historical figures for her highly anticipated keynote address at the meeting every year, and this year she chose Ms. Earhart, the iconic female pilot, as a nod to the meeting’s theme: A Night at the Museum. She talked about new technologies and expectations for Epic and its data platform, Cosmos. * * *

“We are building a nationwide health IT infrastructure to connect the different parts of healthcare,” Ms. Faulkner told the crowd.

Epic’s largest competitor in the hospital market, Oracle Cerner, is also on a mission to digitally connect the U.S. healthcare system. Larry Ellison, chair, co-founder and chief technology officer of Oracle, revealed in June the company’s plans to build a unified national healthcare database after acquiring Cerner earlier this year for $28.4 billion. His vision of a national healthcare database includes anonymized data from hospitals, clinics and providers to give real-time information about patients’ health as well as public health statistics.

Midweek update

David Ermer–Congress, COVID-19, COVID-19 testing, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Capitol Hill front, Health Affairs Forefront offers articles from

  • Prof. Katie Keith on the Affordable Care Act provisions in the budget reconciliation bill (H.R. 5376) that the House of Representatives will take up on Friday, and
  • Prof. Rachel Sachs on the Democrats’ drug pricing proposal in that bill.

The FEHBlog found information in Prof. Sachs’ article about the proposed $35 cap on insulin copayments.

[T]he IRA was drafted to include a $35 out-of-pocket cap on insulin not only for Medicare beneficiaries, but also for privately insured patients. The parliamentarian ruled that the application of this out-of-pocket cap to privately insured patients did not comply with the reconciliation rules. Rather than unilaterally remove this provision (as the Democrats did with the inflationary rebate provision), Democrats chose to advance the bill with the provision included. Republican Senators then chose to challenge its inclusion, and 43 Republicans voted to strip the $35 out-of-pocket cap for privately insured patients from the bill, enough to result in its removal. (Although seven Republicans voted with all 50 Democrats to keep the cap, the provision needed 60 votes to remain in the bill.)

The Hill adds “Senate Majority Leader Charles Schumer (D-N.Y.) said Monday night that he is going to bring a $35 cap on [non-Medicare] patients’ insulin costs back up for a vote this fall after Republicans blocked it over the weekend.”

Roll Call discusses the cost shifting between Medicare and other insurance programs, including the FEHBP, once the law is enacted and takes effect. Medicare does not negotiate prices with providers; it sets them.

Govexec informs us

President Biden announced on Wednesday his intent to appoint a prominent surgeon and professor who has been at the vanguard of advances in cancer treatment to lead the federal government’s main agency for cancer research and training. 

The president will appoint Dr. Monica Bertagnolli to be director of the National Cancer Institute, part of the National Institutes of Health, which has about 4,300 employees and had a $6.35 billion budget in fiscal 2021. She is currently the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber Cancer Institute, a top cancer hospital. Bertagnolli will be the first woman to hold this position.

“Throughout her career, Dr. Bertagnolli has been at the forefront of the field of clinical oncology, advancing, in particular, current understanding of the gene that promotes gastrointestinal cancer development,” said an announcement from the White House. “As a physician-scientist, she led gastrointestinal science initiatives from 1994 to 2011 within the [National Cancer Institute]-funded Cancer Cooperative Groups.” She also served as the chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center from 2007 to 2018. 

Good luck, Dr. Bertagnolli.

From the omicron and siblings front, Forbes reports

Pfizer and BioNTech have completed clinical trials for vaccines that include specific protection against the original omicron variant. Now the two companies have begun testing for vaccines specific to the BA.4 and BA.5 Omicron subvariants, which are the fastest spreading variants of Covid-19 in the United States. Manufacturing for the new vaccines has already begun, and could be rolled out as early as October pending regulatory approvals. That’s good news as we approach the fall and winter, which have been the times of year where Covid spread is at its highest. Competitor Moderna has also begun testing an omicron-specific booster, but the FDA has not yet authorized any Omicron-specific vaccines.   

and

Researchers have identified monkey antibodies that are effective against numerous Covid variants and other coronaviruses, a discovery that could help scientists develop better vaccines and prepare for future pandemics as pharma firms race to update their shots.

If the monkey antibodies research is successful, then the WHO definitely should change monkeypox’s name.

From the medical research front, STAT News tells us

With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month.

By the end of September, the world will learn whether lecanemab, another treatment aimed at toxic brain plaques called amyloid, can significantly slow the cognitive decline that characterizes Alzheimer’s.

The outcome is vitally important for millions of patients awaiting a medicine that can meaningfully impact the disease, and success could spell a massive financial windfall for Biogen and Eisai. Failure would damage — though not destroy — the idea that targeting amyloid might ever make for an efficacious treatment.

Fingers crossed for a successful outcome.

From the U.S. healthcare business front, Fierce Healthcare reports

Amazon Care, which currently offers virtual health visits, in-person primary care visits at patients’ homes or offices and prescription delivery, is adding behavioral health care to its slate of services.

Amazon’s health service business plans to team up with teletherapy startup Ginger as an optional add-on to Amazon Care. Through the partnership, Amazon Care users will be connected to Ginger’s on-demand mental health services including behavioral health coaches, licensed therapists and psychiatrists, according to a live website about the service. * * *

The new service hasn’t launched yet, according to people familiar with the matter, Business Insider reported.

As an aside, Smart Brief discusses telemedicine in pediatrics.

Fierce Health also tells us

A company with a long history of providing medical supplies for chronic conditions is expanding its business into monitoring and coaching services for diabetes patients.

CCS, which now includes CCS Medical and CCS Health, aims to provide a more integrated experience for chronic care management, Tony Vahedian, CEO of CCS, said in an interview. * * *

“We believe we’re in the appropriate position to really take that fragmented experience and make it an integrated, seamless experience because not only can we deliver the products at the time, but we also can coach them and provide that clinical care,” the CEO noted. CCS can combine its home-delivered medical supplies business with accredited clinicians supported by proprietary data and technology to simplify the patient experience, he added. 

The company supports more than 200,000 patients living with chronic conditions in the U.S. and delivers more than 1.2 million shipments of medical supplies to patients in their own homes.

From the nudging front, Health Payer Intelligence shares another survey illustrating that participants in employer-sponsored health plans need more help with health plan literacy.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, HIPAA Privacy and Security Rules, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The House of Representatives and the Senate are in session this week for Committee business and floor voting. This is the House’s last week of scheduled floor voting before the August recess.

The Wall Street Journal reported last Friday evening

President Biden signaled he was prepared to support a narrow bill that lowered prescription drug costs and extended Affordable Care Act subsidies but left out climate provisions, as Senate Democrats grappled with whether to abandon their broader economic agenda after intraparty talks hit an impasse.

Mr. Biden said that if the Senate didn’t move forward with climate legislation, he would turn to executive action, calling clean energy and combating climate change urgent matters. On the prescription drug portion of the agenda, he said the Senate “should move forward, pass it before the August recess, and get it to my desk so I can sign it,” characterizing it as a major victory for American households.

The statement came a day after talks between Sen. Joe Manchin (D., W.Va.) and Senate Majority Leader Chuck Schumer (D., N.Y.) broke down. Mr. Manchin told Mr. Schumer that he would back a prescription-drug proposal but couldn’t yet commit to backing tax increases or climate provisions, citing inflation worries.

From the Omicron and siblings front, NPR tells us

The BA.5 omicron subvariant, which is now the most prevalent coronavirus strain in the United States, is four times more resistant to COVID-19 vaccines, according to a new study.

The strain, which is considered “hypercontagious,” according to the Mayo Clinic, is more defiant against messenger RNA vaccines, which include Pfizer and Moderna.

The BA.5 strain represented 65% of cases from July 3 to 9, according to data from the Centers of Disease Control and Prevention. 

It is contributing to increases in COVID-19 hospitalizations and admissions to intensive care units across the country. 

But vaccines still provide much better protection than going without the safeguards.

Bloomberg Prognosis adds

Bertha Hidalgo, a University of Alabama epidemiologist, was faked out by a variant that never truly got off the launchpad.

“A few weeks ago, I thought BA2.12.1 would drive the summer wave and it would be a small wave, with not too many infections, to be followed by a BA.5 wave when schools reopened,” she says.

Instead, the BA.5 omicron variant decided that the summer of 2022 was its time to shine. The variant is now dominant in the US, according to the Centers for Disease Control and Prevention. Combined with BA.4, it is also powering a surge of the virus in Europe. 

This week, World Health Organization chief Tedros Adhanom Ghebreyesus warned that “new waves of the virus demonstrate again that Covid-19 is nowhere near over.”

The good news is that we now know much more about what strategies are effective for reducing spread of the virus as we go about our lives in these very odd times.

Hidalgo shared her list of best practices:

* Get vaccinated and get all available boosters

* Wear a mask indoors (and outdoors if in crowded spaces)

* Make sure to get a good quality, good fitting mask, like a KN95 

* Use rapid tests before gathering with others, or at the sign of any questionable symptoms

* If gathering indoors, consider improving ventilation through measures like opening windows or running a central HVAC system

“All of these are layers of protection we can take advantage of that are preventive and can help reduce chances of infection and transmission,” she says.

Quite honestly, the FEHBlog relies on vaccines, including boosters, and rapid tests along with common sense.

HR Dive informs us

Employers must now justify mandatory coronavirus testing for workers, the U.S. Equal Employment Opportunity Commission said in a July 12 update to its technical assistance manual.

Until now, the commission took the position that the Americans with Disabilities Act standard for medical examinations always permitted employer worksite COVID-19 testing. 

Going forward, employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify testing to prevent workplace transmission, the agency said. Specifically, an employer must show that testing is job-related and consistent with business necessity, as defined by the ADA.

From the unusual viruses front, Govexec brings us a CDC update on monkeypox. Here are links to

From the U.S. healthcare business front, Fierce Healthcare offers 21st Century advice on improving health plan call centers.

From the mental healthcare front, NPR takes a deep dive into the new 988 suicide and mental health crisis number.

From the HIPAA privacy and security rule enforcement front, HHS’s Office for Civil Rights announced “the resolution of eleven investigations in its Health Insurance Portability and Accountability Act (HIPAA) Right of Access Initiative, bringing the total number of these enforcement actions to thirty-eight since the initiative began.  OCR created this initiative to support individuals’ right to timely access their health records at a reasonable cost under the HIPAA Privacy Rule.” All of the chastised parties were healthcare providers.

This morning the FEHBlog was doing his weekly quality review of the FEHBlog. He noticed that last Thursday, he mentioned a new Kaiser Family Foundation report without providing a topic or a link for his readers. Lo siento. Here is the missing information:

Pregnancy is one of the most common reasons for a hospitalization among non-elderly people. In addition to the cost of the birth itself, pregnancy care also involves costs associated with prenatal visits and often includes care to treat psychological and medical conditions associated with pregnancy, birth, and the post-partum period.

This analysis examines the health costs associated with pregnancy, childbirth, and post-partum care using a subset of claims from the IBM MarketScan Encounter Database from 2018 through 2020 for enrollees in large employer private health plans. It finds that health costs associated with pregnancy, childbirth, and post-partum care average a total of $18,865 and the average out-of-pocket payments total $2,854. The analysis also examine how pregnancy, childbirth, and post-partum health spending among large group enrollees varies by the type of delivery.

The analysis can be found on the Peterson-KFF Health System Tracker, an information hub dedicated to monitoring and assessing the performance of the U.S. health system.

Childbirth also is one of the required out-of-pocket cost requirements for a health plan’s ACA summary of benefits and coverage template.

Friday Stats and More

David Ermer–COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, Rx coverage, SDOH–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the month, here are the FEHBlog’s weekly charts of new Covid cases and deaths

Here is a link to the CDC’s weekly review of COVID statistics. Among those statistics are the following:

New Hospital Admissions

The current 7-day daily average for April 6–April 12, 2022, was 1,446. This is a 1.3% increase from the prior 7-day average (1,427) from March 29–April 4, 2022.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era to the latest week ending last Wednesday, April 13.

For the second week in a row, Covid vaccines distributed and administered have increased materially.

The CDC’s principal point in this week’s Covid statistical review is the following:

Throughout the COVID-19 pandemic, many people have delayed or avoided medical care, including routine, urgent, and emergency care. If it’s something you’ve neglected, it’s time to jump back in—consider putting “get a checkup” on top of your to-do list, especially if you’re at risk for heart disease. Regular checkups provide the opportunity to prevent, screen for, and manage chronic conditions, and to get routine vaccinations.

The FEHBlog agrees that the best step a person can make on the road to a healthy life is to establish a relationship with a primary care doctor.

In other Omicron and siblings news —

MedPage Today informs us

The FDA granted an emergency use authorization (EUA) to the first COVID-19 test that can detect the virus in breath samples, the agency announced on Thursday.

Dubbed the InspectIR COVID-19 Breathalyzer, the test uses gas chromatography-mass spectrometry to rapidly detect volatile organic compounds associated with SARS-CoV-2. Patients breathe into a disposable straw on the device — which is about the size of a piece of carry-on luggage, according to the agency — and results are returned in less than 3 minutes. The test is intended for healthcare settings where samples can be collected and analyzed, such as mobile testing sites, doctor’s offices, and hospitals.

Cool.

Kaiser Health News tells us

The federal “test-to-treat” program, announced in March, is meant to reduce covid hospitalizations and deaths by quickly getting antiviral pills to people who test positive. But even as cases rise again, many Americans don’t have access to the program.

The program allows people with covid symptoms to get tested, be prescribed antiviral pills, and fill the prescription all in one visit. The federal government and many state and local health departments direct residents to an online national map where people can find test-to-treat sites and other pharmacies where they can fill prescriptions.

But large swaths of the country had no test-to-treat pharmacies or health centers listed as of April 14. * * *

Even people who regularly see a doctor may be unable to get a prescription in time, and that’s where the program comes in. Before the pandemic, 28% of Americans didn’t have a regular source of medical care, with rates even higher for Black and Hispanic Americans. 

See above re PCPS and no bueno.

The article adds

Truepill, a company that provides telehealth and pharmacy technology, offers online covid assessments through its website findcovidcare.com * * *. The company has filled more than 10 million prescriptions in the past five years.

The service, available in all 50 states and Washington, D.C., costs $25 to $55. Though insurance isn’t accepted, the cost is comparable to insurance copays for in-person doctor appointments. Prescriptions can be sent to a local pharmacy for no additional charge or shipped to a home overnight via FedEx for a $20 fee.

It’s always good to have a Plan B.

From the FEHB front, OPM issued a final, final rule concerning a Consolidated Appropriations Act 2021 provision extending the opportunity for tribal employers to enroll employees at certain tribal schools to join the FEHB Program.

From the Social Determinants of Health Front, Fierce Healthcare calls to our attention

a Northeast Business Group on Health guide for employers looking to tackle obesity and diabetes through a racial lens. “Obesity, Diabetes and Health Equity: What Employers Can Do” lays out a step-by-step approach. Key among them is embedding health outcomes within other diversity, equity and inclusion efforts. Another big recommendation is to build benefits to address obesity and diabetes that are based in clinical best practices.

In the FEHBlog’s view, OPM’s 2023 call letter asks carriers to address member obesity issues in this manner.

From the Rx coverage front, the Wall Street Journal reports

After Covid-19, vaccine makers’ next big target is a respiratory virus that kills up to 500 children a year nationwide and has been among the leading causes of U.S. hospitalizations for decades.

The respiratory syncytial virus, or RSV, infects nearly everyone at some point, causing mild, cold-like symptoms for most people. But it can lead to serious health problems such as difficulty breathing and pneumonia for infants and older adults.

Now several drugmakers including Pfizer Inc., Johnson & Johnson, Moderna Inc. and GlaxoSmithKline PLC are testing shots that infectious-disease specialists say show promise at safely preventing RSV disease. Initial development of most of these vaccines predated the current pandemic, but the rapid success in finding effective Covid-19 vaccines has energized the RSV effort, according to analysts.

Good luck.

From the federal government front

  • Meritalk provides a Who’s Who in implementing the President’s Management Agenda. The article explains “As the Office of Management and Budget’s (OMB) effort to transform the President’s Management Agenda from a list of goals into actionable policy steps gathers steam, OMB is fleshing out its list of Federal agency officials who are taking on leadership roles not only for the three major PMA pushes but for numerous strategic goals within each of them.” The OPM Director Kiran Ajuha is one of three senior federal executives in charge of the PMA’s workforce issues.
  • Federal News Network offers an interview with the Postmaster General Louis Dejoy.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Federal employment benefits, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call reports

Senate negotiators have reached agreement on a $10 billion pandemic relief package that includes funding for domestic needs but not international aid, according to two Senate aides who were not authorized to speak publicly.

The deal crystallizes an informal “agreement in principle” the parties reached last week to provide $10 billion for near-term pandemic needs by repurposing unspent funds from prior relief laws.

The Wall Street Journal adds

The White House backed the deal and urged Congress to pass the bill promptly, while noting it was less than the $22.5 billion the administration had requested for vaccines, boosters, treatments and testing.

“We will continue to work with Congress to fund our remaining domestic needs,” said Press Secretary Jen Psaki in a statement. She added that the White House would continue to press for funding global vaccination efforts.

The FEHBlog noticed that the Senate Homeland Security and Governmental Affairs Committee held a business meeting last Wednesday. The Committee favorably reported the President’s nomination of Kristin Boyd to be OPM Inspector General by voice vote (with Sen. Hawley (R Mo.) voting no). The next step for Ms. Boyd’s nomination is the Senate floor.

Last week, the House of Representatives passed a Secure 2.0 bill applicable to private sector defined contribution plans. The Senate is likely to approve the bill too. The Society for Human Resource Management has reviewed the bill’s provisions.

From the Omicron and siblings front —

  • Becker’s Hospital Review informs us “The World Health Organization is monitoring a new omicron variant — dubbed XE — that’s a hybrid of BA.1, the original omicron strain, and BA.2, a highly transmissible subvariant.” The hybrid is estimated to be 10% more contagious that BA.2.
  • American Hospital Association tells us “Beginning today through the end of the public health emergency, Medicare Part B beneficiaries may obtain up to eight free over-the-counter COVID-19 tests per month through eligible health care providers and pharmacies, the Centers for Medicare & Medicaid Services announced.” Medicare Part B beneficiaries can obtain the free tests by showing their Medicare identification card.
  • The American Medical Association discusses “How we will know when COVID-19 has become endemic.” The FEHBlog tends to think that we are there.
  • The Centers for Disease Control announced

The new nationwide Test to Treat initiative provides quick access to free treatment for COVID-19. Through this program, people can get tested and – if they are positive and treatments are appropriate for them – receive a prescription from a health care provider, and have their prescription filled all at one location. 
These “One-Stop Test to Treat” sites are available at hundreds of locations nationwide, including pharmacy-based clinics, federally qualified health centers, and long-term care facilities. 
People can continue to be tested and treated by their own health care providers who can appropriately prescribe these oral antivirals at locations where the medicines are distributed. 
A call center 1-800-232-0233 is available every day from 8:00 am to midnight ET to get help in more than 150 other languages.
The Disability Information and Access Line is available to help people with disabilities access services. Call 1-888-677-1199, Monday-Friday from 9:00 am to 8:00 pm ET or email DIAL@usaginganddisability.org.

From the CMS front, the agency announced that “the updated MMSEA Section 111 GHP User Guide version 6.5 has been posted to the GHP User Guide page on CMS.gov. Refer to Chapter 1 for a summary of updates.” Section 111 is a system that has been in place for about 12 years. Section 111 helps CMS keep tabs on Medicare beneficiaries and beneficiaries using data group health plans, including FEHB plans, automobile and liability insurers, and attorneys for injured Medicare beneficiaries.

CMS also released “the Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Rate Announcement).”

From the healthcare conference front, Fierce Healthcare tells us about the 2022 Health Datapalooza and National Health Policy Conference being held today and tomorrow in Arlington, VA.

From the federal employment front, Govexec reports

Federal employees can hold elected partisan office while also working at their agencies, a key panel found in a ruling setting a new precedent for civil servants. 

Rodney Cowan did not have to give up his role as a county commissioner in Tennessee or be removed from his job with the U.S. Postal Service, the recently reconstituted central body of the Merit Systems Protection Board said in a decision last week. It was one of the first decisions of MSPB’s central board as it addresses its backlog of more than 3,500 cases that have piled up during its five years without a quorum. 

The FEHBlog doubts that we have heard the last word on this issue.

Thursday Miscellany

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

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

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

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

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

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

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

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

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

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

Speaking of testing, the Wall Street Journal reports that

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

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

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

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

Mobihealth News reported last June

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

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

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

Two cool innovations.

From the healthcare policy front —

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

From the diabetes front —

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

From the litigation front, Reuters reports

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

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

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

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

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

From the Rx coverage front, Biopharma Dive reports

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

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

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

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

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

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

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

Tuesday’s Tidbits

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

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

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

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

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

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

From the Omicron masking and testing front —

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

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

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

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

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

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

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

From the tidbits department —

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

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

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

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

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

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

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

Good luck, OPM.