FEHBlog

Happy First Day of Summer 2022

David Ermer–AHRQ, CDC, Congress, COVID-19, Electronic health records, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here. 

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

Holiday Monday Roundup

David Ermer–CDC, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

Happy Juneteenth (observed)! Here are a few items that came to the FEHBlog’s attention today

From the Omicron and siblings front —

The New York Times informs us that “Despite Another Covid Surge, Deaths Stay Near Lows. Most Americans now carry some immune protection, experts said, whether from vaccines, infection or both.” Amen to that.

While the Food and Drug Administration has given emergency use authorization to Moderna’s vaccine for ages 6 to 17, the Centers for Disease Control has not yet ratified that decision so Pfizer’s vaccine remains the only vaccine available to that age group for now.

From the unusual viruses front, STAT News reports

When previously healthy little kids started showing up in hospitals with failing livers last fall and this spring, startled doctors and public health authorities didn’t know what was behind what they were seeing. They also didn’t know if what they were seeing was new. * * *

Now scientists at the Centers for Disease Control and Prevention have come up with some estimates for the normal rate of this condition, at least in the United States. Their findings, published earlier this week in the online journal Morbidity and Mortality Weekly Report, may come as a surprise.

Their research suggests there has not been an increase in cases of pediatric hepatitis of unknown origin, at least in the United States. Nor has there been a rise in the number of pediatric liver transplants, which a portion of these children have needed. Likewise, the rate of detections of infections caused by adenovirus 41 — a stomach bug virus that has been implicated as a potential trigger of these hepatitis cases — has not changed over time, the CDC scientists reported. * * *

With rates unchanged since before the Covid-19 pandemic, a theory espoused by scientists from Israel — that this is some sort of post-Covid condition — becomes harder to argue.

“It doesn’t mean that Covid still can’t have some collateral role with all of this. But I think these kind of data helps support that that’s probably not the cause,” explained veteran epidemiologist Michael Osterholm, who was not involved in the CDC work.

That’s encouraging news.

The Society for Human Resource Management tells us about its 2022 Employee Benefits Survey.

“Employer rankings of the importance of benefits shifted drastically in 2020 as they made pandemic-inspired adjustments, but these rankings have returned to an order like that seen pre-pandemic as businesses regain a semblance of normal operations,” said Daniel Stunes, senior researcher at SHRM.

Significantly, however, “all benefit types were rated by employers as more important to offer today than before the COVID-19 pandemic,” Stunes said, reflecting an increased appreciation for the role benefits play in fostering employee well-being and in attracting and keeping talent in a tight labor market.

Weekend update

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

Happy Juneteenth and Fathers’ Day!

Following the observance of Juneteenth tomorrow, the Senate and the House of Representatives will be in session for floor voting and Committee business this week.

The Washington Post reports “A congressional deal for billions of dollars in additional coronavirus funding appeared all but dead Thursday [June 16] after Senate Republicans accused the White House of being dishonest about the nation’s pandemic funding needs.” The FEHBlog expects we have not heard the end of this issue.

From the Omnicron and siblings front —

The Wall Street Journal reports

The Centers for Disease Control and Prevention recommended that children as young as 6 months receive newly authorized Covid-19 shots, the final step to making the vaccines available.

The CDC said Saturday that the young children should receive either the two-dose series from Moderna Inc. or the three-dose series made by Pfizer Inc. and partner BioNTech SE.

As soon as Monday, children under 5 years, who haven’t been able to get vaccinated during the pandemic, could start getting inoculated.

The Journal also offers articles about what parents with younger kids should know about the new Covid vaccines and — what everybody wants to know — whether researchers can develop a Covid vaccine that “lasts.” On the latter point, “New variants have weakened the protection of the current shots, which require unpopular boosters. Scientists and the White House are exploring options for more durable protection, but success could take years.”

On a related note, Precision Vaccinations tells us

The U.S. Centers for Disease Control and Prevention (CDC) reported today the number of pneumonia-related fatalities continues to outpace both COVID-19 and Influenza. * * *

In the USA, common causes of viral pneumonia are influenza, respiratory syncytial virus, and SARS-CoV-2 viruses. A common cause of bacterial pneumonia is Streptococcus pneumoniae.

The good news is pneumonia is a vaccine-preventable disease, and the U.S. FDA has approved two types of pneumococcal vaccines, PCV13, and PPSV23. * * *

Unfortunately, the CDC’s data shows that in 2020, the percentage of adults who received a pneumococcal vaccination was just 25.5%.

FEHB plans may want to focus on this issue given the Program’s demographics.

From the U.S. healthcare front, the American Medical Association provides background on its freshly inaugurated President, Dr. Jack Resneck, Jr., and gives an account of Dr. Resneck’s inaugural address. Good luck, Dr. Resneck.

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

Cybersecurity Dive provides five takeaways from the RSA conference held in San Francisco from June 6 through 9.

From the cyber breach front, MeriTalk provides more details on the settlement of the lawsuit against OPM over the massive 2015 data breach.

The lead counsel in the class action said that individual victims are in line for minimum payments of $700 each under the terms of the settlement, which still needs to be finalized. * * *

The preliminary settlement agreement will be subject to further consideration at a fairness hearing set for Oct. 14.

From the cyber vulnerabilities front,

  • Here is a link to CISA’s known exploited vulnerabilities catalog. Bookmark that one.
  • Becker’s Hospital Review explains why “Cybersecurity experts say that the two biggest threats to healthcare cybersecurity are insider threats and ransomware.”
  • Security Week reports “Microsoft has fixed roughly 50 vulnerabilities with its June 2022 Patch Tuesday updates, including the actively exploited flaw known as Follina and CVE-2022-30190.”

From the ransomware front

  • Cybersecurity Dive discusses how ransomware groups are shifting tactics and objectives.
  • Here is a link to Bleeping Computer’s The Week in Ransomware.

From the cyber defense front

  • HHS’s Healthcare Cybersecurity Coordination Center (HC3) offers a presentation about strengthening cyber posture in the health sector.
  • TechRepublic reports that half of IT leaders want to implement more robust alternatives to passwords, and it describes options.
  • ISACA Journal offers an article on how businesses can reduce cybersecurity exposures to and from third parties.

Friday Stats and More

David Ermer–CDC, COVID-19, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–

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 weekly chart of new Covid cases from the 27th week of 2021 through the 24th week of 2022:

While the CDC did not publish its weekly Covid statistical review this week, the FEHBlog can tell you that the daily new Covid hospitalization average is 4,321 for the week ended June 15, 2022. That average is 4.7% higher than the previous week.

Here’s the FEHBlog’s weekly chart of new Covid deaths for the same period as new cases:

New cases and deaths are both stable. MedPage Today adds

About 4.5% of people who became infected with SARS-CoV-2 when Omicron was the dominant strain experienced long COVID symptoms, compared with 10.8% who became infected during the Delta period, reported Claire Steves, PhD, of King’s College London in England, and co-authors.

Overall odds of long COVID were about 20% to 50% less during the Omicron era — defined as December 2021 to February 2022 in this study — depending on age and time since vaccination, the researchers wrote in a letter to The Lancet.

For more information, Science discusses clues to long Covid.

Here’s the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020, when the Covid vaccination era began and the current 24th week of 2022.

Over 100,000 people aged 12 and older have received at least one booster.

The Wall Street Journal adds.

Vaccine advisers to the Centers for Disease Control and Prevention discussed Friday the merits of Covid-19 shots now authorized for children as young as 6 months. * * *

The committee is scheduled to discuss further the case for recommending giving the Pfizer-BioNTech and Moderna shots to young children, and then vote on the matter Saturday.

The Biden administration has said the shots could be made available as soon as Monday, should regulators give their assent.

The federal government has begun shipping millions of doses to doctor’s offices, children’s hospitals and pharmacies, President Biden said after the FDA’s authorizations.

From the Rx coverage front, STAT News and Medical Economics update us on the federal government’s investigation of prescription benefit managers. Notably, STAT News reports

Amid intensifying scrutiny of pharmacy benefit managers, a group of House Republicans is urging the U.S. Government Accountability Office [via a June 17 letter] to investigate the role these controversial middlemen play in the opaque pharmaceutical pricing system.

From the Federal Trade Commission front, Healthcare Dive tells us that the FTC has obtained several victories over the past week in its legal challenges to hospital system mergers in New Jersey, Rhode Island, and Utah.

From the No Surprises Act front, reginfo.gov informs us that on June 15, the Office of Information and Regulatory Affairs received for review the NSA regulators’ final rule on the independent dispute resolution process. OIRA review is the last step before the rule is published in the Federal Register. The healthcare provider associations mounted a successful legal challenge to the interim final rule’s treatment of the qualifying payment amount as a rebuttable presumption at the arbitration stage.

From the HIPAA standard transactions front, a Health and Human Services workgroup has issued guidance on how payers can help providers associate electronic explanations of benefits with electronic payments.

From the U.S. healthcare front, Kaiser Health News and a WTW study delve into the widespread related problems of medical debt and deferred care. On the bright side, the National Institutes of Health reports that flexible work schedules and paid sick leave improves employee access to healthcare.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

The Senate on Thursday took a major step toward broadening America’s commitment to take care of sick veterans, passing a bill to offer new health care and tax-free disability benefits to as many as 3.5 million veterans on an 84-14 vote.

Under the legislation written by Veterans’ Affairs Chairman Jon Tester, D-Mont., and ranking member Jerry Moran, R-Kan., the Department of Veterans Affairs would consider a veteran with any of 23 conditions, ranging from brain cancer to hypertension, who was deployed to a combat zone during the wars in Iraq or in Afghanistan automatically eligible for care at government cost, based on the presumption that exposure to toxic chemicals in the war zone caused the ailments.

The House must now pass the revised bill before President Joe Biden can sign it, which seems likely. The legislation largely mirrors, and slightly expands on, a House bill by Veterans’ Affairs Chairman Mark Takano, D-Calif., that passed 256-174 in March. Biden issued a statement at the time saying he supported the measure.

Under current law, veterans who believe toxic exposure during their service caused them to develop a disease can have trouble proving it, even when the linkage is known. So it’s likely that many veterans are denied care and disability benefits they deserve, advocates say. The new law, at a projected cost of $278.5 billion over 10 years, shifts the calculus, meaning the government will now pay for the care of veterans whose sickness is tied to their service, as well as others whose ailments might not be.

Because the federal government employs many veterans, this bill will reduce benefits costs for the FEHB Program once it becomes law.

From the Omicron and siblings front, the Wall Street Journal informs us

Many people are embarking on a summer of vacations, concerts and weddings put off during the height of the pandemic. Covid-19 is still finding ways to disrupt some of those plans.

Covid-19 isn’t causing acute illness and death on the scale it once did, thanks in part to protection built up by vaccines and prior infections.  * * *

The U.S. is logging some 100,000 known cases a day, and many more are being detected via at-home tests health departments don’t track. This is a stark difference from a year ago, when U.S. cases sank below 12,000 a day, the lowest level since the first surge, as vaccinations rose and many hoped the virus was in retreat.

The era of 12,000 cases a day was over when Delta and then Omicron arrived and will remain around until Omicron departs.

From the Rx coverage front —

STAT News tells us

In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines.

The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices.

“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan in a statement. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”

While the end of Omicron is not in the offing, the end of prescription drug rebates appears to be getting closer. However, the federal government should not put the kibosh on rebates unless the drug manufacturers agree to maintain the economic equities by offering price reductions equivalent to the rebates.

In other FTC news, BioPharma Dive reports

Drugmaker acquisitions of all sizes could receive closer scrutiny in the future if the Federal Trade Commission follows the advice of experts who spoke at a two-day agency meeting on market concentration and anticompetitive conduct.

The experts, mostly economists and other antitrust regulators, warned that some drugmakers have gained unfair market power due to the breadth of their product portfolios, allowing them to negotiate for preferred or even exclusive status on insurers’ coverage lists and thereby squeeze out competitors.

Taken together with the FTC’s plans to investigate the practices of pharmacy benefit managers, the meeting signals the Biden administration may take a tougher line on monopolistic practices in an effort to spark competition and target drug pricing.

From the Food and Drug Administration front, BioPharma Dive notes that

An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that affects millions of people.

The drug’s developer, Roche, along with Banner Alzheimer’s Institute, the Phoenix-based organization helping lead the study, announced the negative results Thursday. After years following a family believed to be genetically predisposed to the disease, researchers found no significant difference in cognition or the ability to store and retrieve new memories between participants who received the drug and those who got placebo.

The failure is an upset not only to Roche, which hopes to follow its rival Biogen in getting an Alzheimer’s therapy approved for market, but also to the wider Alzheimer’s research field. For years, a protein called beta amyloid has been at the center of efforts to treat the disease. But every drug designed to block this protein, including Biogen’s, has faced setbacks. Roche’s announcement may therefore add to concerns that this protein isn’t the best research target.

In other drug research news, Walgreens announced “the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreen’s flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.”

In U.S healthcare news, the American Medical Association completed its annual meeting. The AMA offers highlights from the session here.

Also, the Commonwealth Fund released its 2022 Scorecard on State Health System Performance.

Hawaii and Massachusetts top the 2022 State Scorecard rankings, based on overall performance across 56 measures of health care access and quality, service use and cost, health disparities, and health outcomes during the COVID-19 pandemic in 2020. The lowest-performing states were Mississippi, Oklahoma, and West Virginia.

The National Institutes of Health disclosed

From 2000-2019 overall life expectancy in the United States increased by 2.3 years, but the increase was not consistent among racial and ethnic groups and by geographic area. In addition, most of these gains were prior to 2010. This is according to a new study funded by the National Institutes of Health that examined trends in life expectancy at the county level. The study was led by researchers at the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, Seattle, in collaboration with researchers from NIH and published on June 16th in The Lancet.

MedCity News reports “Online healthcare marketplace Sesame closed a $27 million Series B funding round on Tuesday, bringing its total funding to $75 million. David Goldhill, CEO of the New York City-based startup, said the company is ‘an Expedia for medical care’ because patients can buy the care they want directly online, without the middleman of an insurance company.”

From the federal employee benefits front, Govexec delves into the impact of cost of living adjustments on federal employee retirement benefits.

Midweek update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, HSA, SCOTUS, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Capitol Hill, Medtech Dive reports

The Senate Committee on Health, Education, Labor and Pensions voted Tuesday to send a bill to the Senate that would reauthorize the Food and Drug Administration to collect user fees from device- and drug-makers for the next five years. 

A provision would require the FDA to finalize guidance that would create a category of over-the-counter hearing aids within a month of the bill’s passage. The FDA last issued a proposed guidance in October.

Committee Ranking Member Sen. Richard Burr, R-N.C., questioned on Tuesday whether the FDA should have that expanded authority, despite co-sponsoring legislation that would change how diagnostic tests are regulated, including laboratory-developed tests.

Fierce Healthcare adds

The American Hospital Association (AHA) penned a last-ditch letter to congressional leaders pleading for Medicare sequester cuts slated to take effect July 1 to be halted in light of the financial strain many of the nation’s hospitals are expected to face throughout 2022.

Congress had initially paused the 2% payment cut as part of the CARES Act when the COVID-19 pandemic began to threaten providers’ bottom lines. Sequestration cuts were continually punted downfield until last December, when a bill was signed to resume a 1% cut in April and the full 2% in July.

With half a month to go, AHA Executive Vice President Stacey Hughes warned majority and minority leaders Tuesday that financial relief from the pending cut is necessary for hospitals “to maintain access to care for the patients and communities they serve.”

From the Supreme Court, the American Hospital Association gleefully informs us

The U.S. Supreme Court today ruled unanimously in favor of the AHA and others, reversing a 2020 [U.S.] court of appeals decision upholding the authority of the Department of Health and Human Services to significantly cut payments to certain hospitals that participate in the 340B Drug Pricing Program, and thereby threatening access to care for patients.

The Supreme Court held that “HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were contrary to the statute and unlawful.” Noting that “340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support,” the Supreme Court observed that “this case has immense economic consequences, about $1.6 billion annually.”

Despite those serious practical impacts, the Supreme Court concluded that “[u]nder the text and structure of the statute,” the case is “straightforward” as a matter of law: “Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.”

From the Omicron and siblings front —

The Wall Street Journal reports

Health experts advising U.S. health regulators backed giving Covid-19 vaccines from Pfizer Inc. and BioNTech SE and from Moderna Inc. to children as young as 6 months old. 

The panel voted 21 to 0 in a pair of votes on Wednesday in support of expanding access to the vaccines.

The positive recommendations will likely lead soon to expanding the U.S. Covid-19 vaccination campaign to the 19.6 million children from 6 months to under 5 years of age, one of the last groups of people in the U.S. waiting for shots.

The Food and Drug Administration, which doesn’t have to follow the panel’s recommendations but usually does, is expected to authorize the shots within days. Vaccinations could begin as early as June 21, according to the Biden administration.

and

Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date.

The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September.

BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months.

STAT News adds

Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations.

Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid.

The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid. But the results, published in a press release, are likely to take time for experts to digest and understand.

From the unusual viruses front, the American Hospital Association explains

The Centers for Disease Control and Prevention yesterday [June 14] updated its guidance to help clinicians evaluate and test patients with relevant history, signs and symptoms for monkeypox. Over 1,800 monkeypox or orthopoxvirus cases have been reported globally this year, including 72 in the United States. According to CDC, the virus does not spread easily between people without close contact, so the risk to the general population remains low.

The World Health Organization plans to change monkeypox’s name next week.

From the healthcare business front

Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it’s also launching new brands for two of its subsidiaries.

The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word “care” with the suffix “lon,” which means full or complete, representing the company’s ambition to offer an end-to-end care experience.

Carelon will include Anthem’s in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.

and

Humana is moving its pharmacy brands under the CenterWell umbrella.

Humana Pharmacy and Humana Specialty Pharmacy will now operate as CenterWell Pharmacy and CenterWell Specialty Pharmacy, respectively, the insurer announced. Enclara Pharmacia and Humana Pharmacy Solutions, the company’s pharmacy benefit management arm, will maintain their original branding.

“The CenterWell brand symbolizes our ongoing and strong commitment to keeping members, customers and patients at the center of everything we do,” said Scott Greenwell, Humana Pharmacy Solutions president, in a statement.

  • Morning Consult discusses how CVS Health and Walgreens retained “high customer trust” in 2021.

From the benefit design front, Employee Benefits News offers the case for health savings accounts. The FEHBlog is already sold.

Tuesday’s Tidbits

David Ermer–COVID treatment, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, Uncategorized–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, MedPage Today reports

A committee of independent vaccine experts recommended that the FDA grant an emergency use authorization (EUA) for the two-dose Moderna COVID-19 vaccine for kids ages 6 to 17 years.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22-0, agreeing unanimously that the benefits of vaccination outweigh the risks in two age groups: kids ages 6 to 11 years and teens ages 12 to 17. They recommended two 50-mcg doses for the younger kids and two 100-mcg doses for teens.

The Wall Street Journal adds

The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older. * * * An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Medpage Today also informs us

Only a very small number of high-risk patients with COVID-19 experienced “rebound symptoms” after being treated with nirmatrelvir/ritonavir (Paxlovid), a retrospective study found.

Among nearly 500 patients, 93% of whom were fully vaccinated, two patients were hospitalized due to symptoms that were not directly related to “rebounding” within a month and required care in the intensive care unit (ICU), and four experienced rebound symptoms at a median of 9 days (interquartile range [IQR] 7-14.5), reported Nischal Ranganath, MD, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.

All rebound symptoms were resolved with symptom-directed treatment, and no deaths were reported in any patients after 30 days following their initial COVID-19 diagnosis, the group noted in Clinical Infectious Diseases.

“We found that rebound phenomenon was uncommon in this group of patients,” said co-author Aditya Shah, MBBS, also of the Mayo Clinic, in a statement. “The four individuals who experienced rebound represent only 0.8% of the group, and all of them recovered quickly without additional COVID-directed therapy.”

That’s certainly good news to read.

From the Rx coverage front, the Drug Channels blog tears apart a recent JAMA study concluding that the pricing of recently launched drugs has skyrocketed in recent years.

[T]he study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations. 

Most notably, the authors discount the fact that the most expensive new drugs treat ultra-rare conditions affecting extraordinarily small patient populations. Their policy recommendations would therefore have a devastating impact on these patients and their hope for treatments and cures. 

As Nobel prize winner Ronald Coase observed: “If you torture the data long enough, it will confess to anything.”

And the Dr. Fein can back up his conclusion.

From general healthcare front, Kaiser Health News offers thought provoking articles about

The first article draws an important distinction between medical care and SDOH. Unfortunately, the second article reminds us that no good deed goes unpunished. If the government simply had relied on personal responsibility (outside of Medicaid), we would not find ourselves in this pickle.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found.

The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots.

What’s more, according to the Journal

A panel of advisers to the Food and Drug Administration is set to meet Tuesday [June 14] to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.

The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older.

An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Moderna’s vaccine has been authorized for use in adults 18 years and older since late 2020, while use of the other leading Covid-19 vaccine, from Pfizer Inc. and BioNTech SE, was expanded to anyone 5 and older last year.

From the FTC investigation front, FierceHealthcare updates us on the recently launched FTC investigation of the six largest PBMs. In other FTC news, Healthcare Dive tells us

** UnitedHealth and LHC Group have been hit by a request for additional information on their acquisition from the Federal Trade Commission, as regulators take an increasingly active role in overseeing healthcare M&A.

** The second request extends the waiting period the FTC has to challenge the deal. UnitedHealth agreed to acquire home health and hospice provider LHC for $5.4 billion in March.

** https://www.healthcaredive.com/news/regulators-unitedhealth-lhc-request-merger/625343/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-06-13%20Healthcare%20Dive%20%5Bissue:42394%5D&utm_term=Healthcare%20DiveIn a filing with the SEC on Friday, the companies said they have been complying with regulators and will continue to do so.

Speaking of home health care, Home Health News discusses Aetna’s interest in the topic.

Aman Gill, Aetna’s director of product strategy and innovation, told Home Health Care News last month that a home health acquisition was “on the table” for the company. 

This past week, at HHCN’s VALUE event, Aetna CMO Dr. Kyu Rhee reiterated the company’s commitment to the home as a setting of care. He also explained how care delivery has changed over the course of the last few years.

“We’ve been committed to home health and virtual care during the pandemic,” Rhee said. “And in our Medicare program, we’ve delivered tens of thousands of healthy at-home visits as well. … So my challenge to us as we think about the opportunity we have now and the next stage of this pandemic is: Are we going to persist in those values and make sure that the system delivers on those values, that hopefully we’ve learned over the last couple of years?”

From the Rx coverage front, the Food and Drug Administration announced

the [agency approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

The drug initially was FDA-approved for the treatment of rheumatoid arthritis in 2018.

From the HIPAA Privacy Rule front, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), announced

issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth – PDF is no longer in effect. * * *

The Guidance on How the HIPAA Rules Permit Health Plans and Covered Health Care Providers to Use Remote Communication Technologies for Audio-Only Telehealth may be found at: https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html.

Weekend update

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

From the Capitol Hill front, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Roll Call reports

A bipartisan group of senators announced an agreement Sunday on significant updates to the nation’s gun laws, and the Senate majority leader said it ​​would be put on the floor once legislative text is ready.

The agreement, announced by 10 Republicans and 10 Democratic caucus members, certainly will not go as far as many Democrats would have hoped, but the scale of the GOP support suggests it could get the all-important 60 votes to overcome the filibuster rule that kept derailing the last bipartisan attempt to change gun laws, in 2013.

The agreement, which is not yet in legislative language, is the product of discussions led by Sens. Christopher S. Murphy, D-Conn., and John Cornyn, R-Texas, in the wake of recent mass shootings, including at an elementary school in Uvalde, Texas.

“Our plan increases needed mental health resources, improves school safety and support for students, and helps ensure dangerous criminals and those who are adjudicated as mentally ill can’t purchase weapons,” the 20 senators said in a statement. “Most importantly, our plan saves lives while also protecting the constitutional rights of law-abiding Americans.”

From the Omicron and siblings front —

MedPage Today discusses the latest Omicron siblings — BA.4 and BA.5. “Generally, BA.4 and BA.5 variants cause mild disease but spread in large numbers potentially because, unlike the Wuhan strain, which settles in the lungs, these newer strains seem to attach to the more benign upper nasal passages.”

Bloomberg Prognosis answers a reader’s question about whether to get a fourth Covid booster now.

Moderna said just this week that a new version of its Covid vaccine led to a better antibody response against omicron compared with its current mRNA shot. It plans to submit data to the US Food and Drug Administration in the coming weeks and hopes the shot will be available as soon as late summer. That shot is what’s called a bivalent vaccine, meaning it contains mRNA coding for the spike protein of both the original strain of the virus and omicron. 

Pfizer should also have updated mRNA vaccines available as soon as the fall, says Monica Gandhi, an infectious disease expert at the University of California, San Francisco. The FDA will hold an advisory committee meeting later this month to address whether fall shots should be modified, and if so what strains they should include.

But while currently available boosters are less effective against omicron, Gandhi points out, they still do offer some protection. So, she says, that answer to whether to get boosted now depends on a few factors. 

”I would advise — depending on case rates in your area and your age— getting the fourth dose now,” she says. “And then deciding what to get in the fall.”

MedPage Today also explains why “the [Novovax Covid] technology is quite innovative and has potential to enhance protection against” the disease.

From the healthcare business front, the Wall Street Journal reports on a

A philanthropic organization founded by the ex-energy trader [John Arnold] and his wife Laura is providing financial backing to three lawsuits against giant hospital systems in Wisconsin, Connecticut and North Carolina, alleging the systems used their market power to squash competition and illegally inflate prices. The systems say the lawsuits from employers and consumers are baseless. * * *

The financing from Arnold Ventures is supporting the work of Fairmark Partners LLP, the law firm behind the lawsuits. Fairmark secured its funding from the philanthropy after filing its first lawsuit, one of the founders said. The firm’s founders say the backing is key to a targeted effort to reshape hospital markets through the courts, and that it received money from other philanthropies it declined to identify. 

While the FEHBlog is not a fan of litigation, this strikes him as a worthy effort.

From the medical research front —

  • Kaiser Health News summarizes recent drug research developments.
  • NPR Shots reports on efforts to connect human nerve systems to prosthetic devices.
  • Fierce Healthcare tells us

Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients. The studies, released at the American Society of Clinical Oncology’s meeting earlier this month, build on a similar analysis among lung cancer patients.

In both studies, the researchers found that using NCCN guidelines drove significant declines in total cost of care.

“Evidence-based medicine does result in improvement in quality of life,” Shirisha Reddy, M.D., senior medical director at CVS Health and an author on both studies, told Fierce Healthcare. “There’s a lot of external data that supports that.”

The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.

In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.

This included notable decreases in administered chemotherapy spend as well as outpatient care between Jan. 1, 2019, and Dec. 31, 2020.