Thursday Miscellany

Mental health care

Thursday Miscellany

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, U.S. Healthcare–

Happy National Women’s Equality Day! Health and Human Services Department leaders offered their views on this occasion.

From the Delta variant front

  • Becker’s Hospital Review tells us that “The FDA has extended the shelf life of Pfizer’s COVID-19 vaccine from six months to nine months, the agency said Aug. 24.  The shot can now be stored at temperatures up to minus-76 degrees Fahrenheit, up from minus-130 degrees Fahrenheit, for up to nine months, up from six months.  The agency said the updated shelf life applies to batches that expired before the extension, as long as they were stored at proper temperatures.” The
  • The Wall Street Journal offers an FAQ article on COVID 19 vaccination boosters.
  • The Society for Human Resource Management discusses employer policies, similar to the federal government’s, which require routine COVID-19 testing for unvaccinated employees.
  • Bloomberg reports that COVID-19 testing has regained popularity to such an extent that “CVS Health Corp. is limiting customers’ purchases of rapid, over-the-counter Covid-19 tests, with a maximum of six packages available online and four in its pharmacies, as the spread of the delta variant spurs demand.  Put in place this week, the limits apply to Abbott Laboratories’s BinaxNOW along with a test from the startup Ellume, according to an email from a CVS spokesperson. Both tests are available without a prescription.” According to the article, Abbott is ramping up its production of these tests.

In employment news, Govexec reports that “the U.S. Postal Service is planning to hire 100,000 employees in 2021, looking to fill vacancies that have contributed to logjams in the mailing agency’s network and widespread delivery delays. * * * The Postal Service is currently seeking drivers, letter carrier assistants, mail handlers, processing clerks and others.”

Health Payer Intelligence informs that

Employers are anticipating that the coronavirus pandemic will continue to have a long-term impact in 2022, particularly in the areas of mental health and chronic disease needs, according to Business Group on Health’s recent 2022 Large Employers’ Health Care Strategy and Plan Design survey. The researchers surveyed 136 large employers in June 2021. These employers provided healthcare coverage for a total of more than 8 million employees and dependents.

That roughly matches the FEHB’s enrollment.

Speaking of mental healthcare

  • Fierce Healthcare tells us about “a recent study by CertaPet, a telehealth company, which analyzed the 50 most populous U.S. cities to find the best and worst places to live for mental health treatment.” According to this survey Denver sits at the top and Dallas rests on the bottom.
  • Healthcare Dive reports that “Meditation and mindfulness startup Headspace and on-demand mental healthcare app Ginger have announced plans to merge into a single company, called Headspace Health, valued at $3 billion, the two companies said Wednesday. The two startups focused on mental health and wellness have each raised more than $200 million in venture funding from investors. As Headspace Health, the two companies will offer support for mental health symptoms from anxiety to depression to more complex diagnoses, selling direct to consumer and to employers and health plans.”

Finally the FEHBlog was surprised to read in the Wall Street Journal that

The U.S. Chamber of Commerce and a Texas affiliate withdrew a suitfiled to block parts of a federal rule requiring insurers and employers to disclose prices they pay for healthcare services and drugs. The withdrawal, in a filing late Wednesday, came after the Biden administration delayed enforcement of provisions of the rule that were the focus of the suit. * * *Daryl Joseffer, senior vice president at the U.S. Chamber Litigation Center, said in a statement that the Biden administration decision “was a positive and constructive response to our lawsuit.” There are still “significant issues” with the rule, he said, and “we’ll continue to monitor the developments, and that includes evaluating whether in the future the Chamber will bring a new lawsuit.” An email sent Friday by the Tyler Area Chamber of Commerce to the U.S. Chamber, viewed by The Wall Street Journal, said it wanted to withdraw from the suit “based on feedback from community leadership.”

PCMA, the prescription benefit manager trade association, continue to pursue its similar lawsuit pending in the D.C. federal court (No. 1:21-cv-02161).

Midweek update

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Mental health care, OPM, U.S. Healthcare–

From the Delta variant front, the Safer Federal Workforce group issued updated guidance for federal employees receiving a COVID-19 vaccine. In short, federal agencies should

  • Allow employees to take up to 4 hours of administrative leave to get any COVID-19 dose.
  • Allow employees to take up to 2 days of administrative leave for adverse reactions to any COVID-19 vaccination dose.

Federal News Network informs us that

Nearly one month after the Biden administration first announced plans to adopt a vaccine and testing policy for federal employees and contractors, managers — presumably the ones charged with implementing and enforcing the new program on the ground level — say they’re still looking for answers about how it’ll work. * * *

Guidance has been “minimal” and the planning to date has been “stressful” for managers and supervisors, said Craig Carter, national president of the Federal Managers Association.

Professional associations don’t have exact data and they’re relying on anecdotal conversations with their members about the vaccine. But considering a little more than half of all Americans are fully inoculated against COVID-19 — and the federal workforce is in many ways a representative subset of the American public — they assume roughly 50% of the nation’s 2.1 million federal employees are unvaccinated.

That means agencies may potentially need to test about 1 million federal workers once or twice a week, the associations said.

Few things drive the FEHBlog crazier than the use of the full U.S. population as a COVID-19 vaccination benchmark because people under age 12 cannot be vaccinated at this point. 62.7% of Americans over 18 and 81.3% of Americans over 65 are fully vaccinated according to the CDC website. The FEHBlog therefore expects that at least two thirds of federal employees are fully vaccinated. The percentage should skew higher because as the FEHBlog has noted about 20% of the federl workforce is under a COVID vaccination mandate as opposed to attestation. Nevertheless, testing about 600,000 federal employees once or twice a week is no picnic for federal managers.

The Wall Street Journal reports that

  • “U.S. Covid-19 hospitalizations have surpassed 100,000 for the first time since January, nearly doubling since the start of August. While the figure remains below the country’s winter peak, hospitals in some parts of the U.S. are straining under the load, and officials in states including Georgia, Kentucky, Tennessee and Idaho have requested extra personnel and resources.
  • “Federal regulators are likely to approve a Covid-19 booster shot for vaccinated adults starting at least six months after the previous dose rather than the eight-month gap they previously announced, a person familiar with the plans said, as the Biden administration steps up preparations for delivering boosters to the public.”

The Journal also offers its perspective on the lay of the land for COVID-19 tests.

Employee Benefits News tells us that

According to the most recent Mental Health Index by Total Brain and the National Alliance of Healthcare Purchaser Coalitions, feelings of anxiety increased 94% from June to July, and incidences of PTSD have spiked 83% over the past six months.

While employees of all ages are struggling to maintain good mental health, workers aged 40-59 saw the highest increases in stress, anxiety and feelings of negativity, compared to July’s data. These workers cited return to work and back to school plans as the main drivers of their fears.

The average age of a federal employee is close to 50 years old.

From the federal employee benefits front, Reg Jones discusses the pluses and minuses of deferred annuities.

It’s a fact of life that many people work for a number of years in a job and, for one reason or another, leave before they are eligible to retire. What’s different for those who work for the federal government is that during their working time there, deductions have been taken from their pay toward a civil service annuity.

While many who resign from the government ask for a refund of those contributions, some do not (often because they were not even aware that they could). Those who leave their contributions in the fund – especially those who weren’t even aware that they could get a refund – are the people I want to talk to today, as well as any of you who are thinking about resigning from the government before retirement eligibility.

Here’s why: If you leave your contributions in the retirement fund, you will be entitled to a deferred annuity if you meet some fairly minimal requirements [as explained in the article].

In healthcare business news

  • Fierce Healthcare reports that “Hospitals and health systems’ economic recovery hit the brakes in July with mounting COVID-19 admissions, escalating expenses and early evidence that consumers are again postponing elective and outpatient care. Per the latest monthly report from Kaufman Hall, countrywide margins and volumes remained below pre-pandemic numbers but dipped most severely in the South and Midwest, where COVID-19 has had the greatest impact. The firm said it expects these trends to continue in the coming months.”
  • Healthcare Dive tells us that “GuideWell, the parent company of Blue Cross and Blue Shield of Florida, is set to acquire Triple S Management, the Blue Cross Blue Shield Plan and largest insurance carrier in Puerto Rico. The $900 million cash deal will add another company to GuideWell’s portfolio of health-focused subsidiaries. After the deal is complete, Triple S will become a wholly owned subsidiary of GuideWell and will continue to operate under the same brand name and management team, the two companies said Tuesday. The deal is expected to close in the first half of next year and is subject to regulatory approvals.”
  • Fierce Healthcare also reports that “Carbon Health, a primary care provider combining brick-and-mortar clinics with virtual services, bought two separate clinic chains to expand its national primary care footprint. The company bought Southern Arizona Urgent Care’s nine clinics in Tucson, Arizona, and Med7 Urgent Care’s four clinics in Sacramento, California, bringing its total to 83 clinics across 12 states. This acquisition underscores the company’s goal of becoming the largest national healthcare provider, fueled by its recent $350 million funding news.

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • Govexec tells us that last Friday August 13, the Department of Justice issued its internal guidance on employee, on-site contractor, and visitor COVID-19 vaccine attestation program required by the White House. ‘Federal employees, regardless if they are working in person or teleworking, must complete a Certification of Vaccination Form and update it if there is a change in their vaccination status. ‘Employees who are not fully vaccinated will be required to obtain and provide to their supervisor (or component designee) a negative COVID-19 test result, from a test taken within the past three days, each time they enter a department facility or participate in an official meeting or function in another location other than the telework location,’ said the memo. ‘The department is developing a program to facilitate testing for employees.’”
  • The American Medical Association informs us about the reasons why moderately and severely immuno-compromised Americans who compose 2.7% of the population should get an mRNA vaccine booster. “[Food and Drug Administration] Approval of a third dose comes amid growing evidence that people with weakened immune systems do not get adequate protection from the normal two-dose regimen of Pfizer and Moderna COVID-19 vaccines. This makes immunocompromised people especially susceptible to breakthrough COVID-19 infections.”
  • The Wall Street Journal reports that Pfizer and BioNTech are starting to share clinical evidence of the value of a third booster vaccination for a broader swath of the U.S. population administered six months to a year following the first two doses. “Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA. The FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.”

With regard to the other public health emergency, the American Hospital Association points us to it web resources for the addressing opioid epidemic.

In healthcare business news

  • Labcorp has announced the acquisition of “Ovia Health, a digital health platform used by millions of women seeking information and support with family planning, pregnancy and parenting.”
  • CareMax, a “technology-enabled provider of value-based care to seniors, announced [on August 13] it has signed a collaboration agreement with Anthem, a national health benefits company. Through this collaboration, CareMax plans to build medical centers in areas where Anthem will offer a value-based care model to improve patient outcomes. * * * Through this collaboration agreement, CareMax plans to open approximately 50 medical centers with a focus on Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut, and Virginia, among others.”

From the studies front

  • The University of Michigan’s Institute for Healthcare Policy and Innovation has released an eye opening study on telehealth. The FEHBlog commends it to his readership.
  • Benefits Pro tells us that “Interest in health savings accounts is on the rise, but there is still a gap in understanding about how HSAs work and how they can be used as a retirement savings tool. According to the Plan Sponsor Council of America’s (PSCA) 2021 HSA Survey, education about HSAs remains a key goal for plan sponsors. * * * The study pointed to a potential missed opportunity for employers to solicit HSA rollovers for newly hired employees, with less than 20 percent indicating they do so.”
  • The National Institutes of Health informs us that “A single two-hour session of a pain management skills class could offer as much benefit as eight sessions of cognitive behavioral therapy (CBT) for patients experiencing chronic low-back pain (CLBP), suggests a study published in JAMA Network Open(link is external). Supported by the National Center for Complementary and Integrative Health (NCCIH) and the National Institute on Drug Abuse, both part of the National Institutes of Health, the study explored whether a compressed intervention could lead to the same benefits as a longer-course of CBT.”
  • STAT News reports that the National Institute for Mental Health’s “Director Joshua Gordon told STAT the agency recognizes that new treatments for depression are needed and that it is funding research to explore the underlying biology beyond the monoamine hypothesis. When it comes to understanding depression, “there are fewer and fewer questions of importance with regard to the monoamine systems,” he said. He noted that in addition to federal funding, many startups and small companies are pursuing new treatments for depression. Currently, almost all patients with depression are first treated with medications called selective serotonin reuptake inhibitors, a class of drugs that includes both Zoloft and Prozac. They increase the amount of the neurotransmitter serotonin in the brain, which controls mood, emotions, and cognition. Serotonin and two other neurotransmitters targeted by some antidepressants, norepinephrine and dopamine, are called monoamines because they contain one chemical group called an amine.” The article also discusses those new treatments, including .

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Electronic health records, Medicare, Mental health care, OPM, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Fierce Healthcare tells us that “Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel [,the Advisory Committee on Immunization Practices] decided [today]. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA.”

Fedweek reports that “Federal employees, their unions and members of Congress continue to watch for details of federal agency ‘reentry’ and ‘post-reentry’ operational plans, with the deadline having passed on Monday (July 19) for agencies to submit those plans to OMB but with changes to telework and other workplace policies likely still weeks or months away.”

According to a press release,

Senators Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) on Tuesday [July 20] requested updates from both the Federal Trade Commission (FTC) and the Department of Justice (DOJ) on their recent efforts to combat anticompetitive conduct in the health insurance industry.  The two senators recently served as chief cosponsors of the bipartisan Competitive Health Insurance Reform Act (CHIRA), which protects consumers by repealing a long-outdated antitrust exemption for the health insurance industry.  Decades of consolidation by health insurance brokers has primed the industry for abuse, allowing insurers to exert market power in order to raise premiums, restrict competition, and deny consumers choice. 

Since the CHIRA’s passage in January of this year, neither the FTC nor the DOJ has announced major steps to exercise their expanded antitrust enforcement authority under the new law.  In their letter, the senators called on the agencies to provide information on any enforcement actions, guidelines, rulemaking, or other actions taken to extend antitrust enforcement to the health insurance industry since then.

Following up on Mondays’ ACA FAQ 47, HHS today announced “the launch of The HIV Challenge, a national competition to engage communities to reduce HIV-related stigma and increase prevention and treatment among racial and ethnic minority people. Through this challenge, HHS is seeking innovative and effective approaches to increase the use of pre-exposure prophylaxis medication (PrEP) and antiretroviral therapy (ART) among people who are at increased risk for HIV or are people with HIV. The HIV Challenge is open to the public, and HHS will award a total of $760,000 to 15 winners over three phases. Phase 1 submissions are open from July 26, 2021, through September 23, 2021.”

Kaiser Health News explains how the Centers for Medicare and Medicaid Services is reevaluating its wellness program for pre-diabetic Medicare beneficiaries.

Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).

Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.

Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.

STAT News reports that

Leveraging Food and Drug Administration regulations loosened during the pandemic, Happify Health, which is best known for its consumer wellness app, will launch new prescription-only software to treat depression.

Happify, founded in 2012, recently announced it had raised $73 million to bolster its efforts in digital therapeutics, a space that is rapidly growing as well-funded companies make the case to regulators, insurers, and clinicians that software can be used to treat disease.

The new product, called Ensemble, is designed to treat both major depressive disorder and generalized anxiety disorder. The software, accessible on both computers and smartphones, guides patients through 10 weeks of cognitive behavioral therapy, or CBT, and other related techniques aimed at changing behavior patterns and teaching coping skills.

The FEHBlog likes the company’s name.

The American Medical Association wants the Food and Drug Administration to loosen up on its opioid prescribing rules which conflict with patient care. Perhaps the FEHBlog is oversimplifying this issue, but haven’t we been down this road to perdition before?

In closing, Fierce Healthcare notes that

Large tech giants are jumping into a growing interoperability solutions market as new federal regulations spur the healthcare industry to open up and share medical records data.

Google Cloud rolled out a new tool called the healthcare data engine, currently in private preview, that helps healthcare and life sciences organizations harmonize data from multiple sources, including medical records, claims, clinical trials and research data.

It gives organizations a holistic view of patient longitudinal records, and enables advanced analytics and AI in a secure and compliant cloud environment, according to Google Cloud executives.

Tuesday Tidbits

David Ermer–CMS, COVID-19, Medicare, Mental health care–
Photo by Patrick Fore on Unsplash

Today, the FEHBlog virtually attended the NCQA Digital Quality Summit. A highlight was a VA healthcare speaker who pointed out the VA’s access to care website which is nifty. The site, for example, includes comprehensive comparisons of VA care versus outside care. The site should be useful to FEHB carriers because the FEHB Program covers a large cadre of veterans.

The Centers for Medicare Services released its proposed calendar year 2022 Medicare Part B physician payment rule. According to the fee schedule fact sheet

With the proposed budget neutrality adjustment to account for changes in RVUs (required by law), and expiration of the 3.75 percent payment increase provided for CY 2021 by the Consolidated Appropriations Act, 2021 (CAA), the proposed CY 2022 PFS conversion factor is $33.58, a decrease of $1.31 from the CY 2021 PFS conversion factor of $34.89. The PFS conversion factor reflects the statutory update of 0.00 percent and the adjustment necessary to account for changes in relative value units and expenditures that would result from our proposed policies.

That would cause a cost shift to commercial carriers.

From the tidbit front —

  • The first interim final rule implementing the No Surprises Act was published in the Federal Register today. It turns out that the public comment deadline is Tuesday, September 7, 2021.
  • The NIH Director Dr. Francis Collins relates that

Many people, including me, have experienced a sense of gratitude and relief after receiving the new COVID-19 mRNA vaccines. But all of us are also wondering how long the vaccines will remain protective against SARS-CoV-2, the coronavirus responsible for COVID-19.

Earlier this year, clinical trials of the Moderna and Pfizer-BioNTech vaccines indicated that both immunizations appeared to protect for at least six months. Now, a study in the journal Nature provides some hopeful news that these mRNA vaccines may be protective even longer [1].

In the new study, researchers monitored key immune cells in the lymph nodes of a group of people who received both doses of the Pfizer-BioNTech mRNA vaccine. The work consistently found hallmarks of a strong, persistent immune response against SARS-CoV-2 that could be protective for years to come.

Though more research is needed, the findings add evidence that people who received mRNA COVID-19 vaccines may not need an additional “booster” shot for quite some time, unless SARS-CoV-2 evolves into new forms, or variants, that can evade this vaccine-induced immunity. That’s why it remains so critical that more Americans get vaccinated not only to protect themselves and their loved ones, but to help stop the virus’s spread in their communities and thereby reduce its ability to mutate.

  • In other NIH news, NIH researchers report a conundrum:

Medications to treat alcohol use disorder, although effective, are only being used to treat 1.6% of people with the disorder, according to a new study.

The findings show that medications for alcohol use disorder are rarely prescribed, even though approved drugs are available.

  • In an article that may be helpful for FEHB plans to share with members, the Centers for Disease Control discusses the causes for type 2 diabetes.
  • Health Payer Intelligence reports that employers are shifting the focus of their wellness programs from physical health to mental health. “Over nine in ten employers said that they were increasing their mental health and wellness programming in 2021, including pediatric mental health programs, according to a survey from Fidelity and Business Group on Health. Almost 75 percent reported that they were extending work-life balance support.and nearly 70 percent were expanding their paid leave policies.”

Thursday Miscellany

David Ermer–ACA, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the COVID-19 front

  • Fierce Healthcare reports that “The quick rollout of the COVID-19 vaccine in the U.S. saved an estimated 279,000 lives and prevented 1.25 million hospitalizations, a new study finds. The study, released Wednesday, warns, however, that surges of new cases due to the highly transmissible delta variant could reverse these gains. “Until a greater majority of Americans are vaccinated, many more people could still die from this virus,” said Alison Galvani, Ph.D., director of the Yale Center for Infectious Disease Modeling and Analysis, which conducted the study alongside the Commonwealth Fund.”
  • The Wall Street Journal reports that “Children are at extremely slim risk of dying from Covid-19, according to some of the most comprehensive studies to date, which indicate the threat might be even lower than previously thought. Some 99.995% of the 469,982 children in England who were infected during the year examined by researchers survived, one study found. In fact, there were fewer deaths among children due to the virus than initially suspected. Among the 61 child deaths linked to a positive Covid-19 test in England, 25 were actually caused by the illness, the study found.”
  • The Journal also informs us that “Pfizer Inc. will seek clearance from U.S. regulators in coming weeks to distribute a booster shot of its Covid-19 vaccine to heighten protection against infections as new virus strains rise.  The company said also it plans to start clinical trials in August of an updated version of its vaccine that would better protect against the Delta variant.” While the FEHBlog looks forward to lining up for the booster, Axios reports that “People who are fully vaccinated against the coronavirus do not need a booster shot at this time, the Food and Drug Administration and the Centers for Disease Control and Prevention said in a joint statement released Thursday evening.” Axios adds

One dose of the Pfizer-BioNTech or AstraZeneca coronavirus vaccine “barely” protects against the Delta variant of the virus, because of mutations the variant has developed, a new study published in the journal Nature Thursday found. 

But two doses of those vaccines generated a neutralizing response to the variant in 95% of people, highlighting the importance of full vaccination against COVID-19, Axios’ Jacob Knutson writes. 

  • Bloomberg discusses the idea of offering COVID-19 vaccines at Dollar General stores. “The researchers found that in the most vulnerable decile, the number of retail pharmacies that are eligible to provide vaccines through the Federal Retail Pharmacy Program is the lowest. But these vulnerable regions are also where Dollar General and other discount stores like it tend to cluster.” It’s worth a shot?

The National Institutes of Health released its annual joint report on cancer mortality. “The report shows a decrease in death rates for 11 of the 19 most common cancers among men, and for 14 of the 20 most common cancers among women, over the most recent period (2014-2018). Although declining trends in death rates accelerated for lung cancer and melanoma over this period, previous declining trends for colorectal and female breast cancer death rates slowed and those for prostate cancer leveled off. Death rates increased for a few cancers like brain and other nervous system and pancreas in both sexes, oral cavity and pharynx in males, and liver and uterus in females.” STAT News points out

Accelerating declines in lung cancer deaths may account for much of the overall progress seen in recent years, the authors of the report said. Over the past two decades, the death rate for lung cancer has declined even faster than the rate at which patients are diagnosed with the disease. And while part of the early success in preventing lung cancer can be attributed to the massive drop in smoking rates, the authors note the most recent downward trends seem to correspond with the approval of new treatments for non-small cell lung cancer that improved the likelihood of survival.

Death rates from melanoma also saw an accelerated decline in the past decade, despite a growing number of diagnoses. Like in lung cancer, authors point to the introduction of novel treatments around the same time as the turnaround on the death rate. New targeted and immune checkpoint inhibitors were approved by the Food and Drug Administration in 2011, one year before major declines in death rates were seen in women and two years before they were seen in men.

On the prescription drug front

  • The New York Times reports that “Under fire for approving a questionable drug for all Alzheimer’s patients, the Food and Drug Administration on Thursday greatly narrowed its previous recommendation and is now suggesting that only those with mild memory or thinking problems should receive it. The reversal, highly unusual for a drug that has been available for only a few weeks, is likely to reduce the approximate number of Americans who are eligible for the treatment to 1.5 million from six million.”
  • GoodRX points out and discusses the fifteen most addictive prescription drugs and resource available to help the addicted. The National Institute on Drug Abuse has an outreach website for teenagers, for example.

In other healthcare news

Health Affairs blog bangs the drum for Congress to fund a universal patient identifier. For the reasons explained in the article, this step called for in the HIPAA statute of 1996 is long overdue.

Healthcare Dive reports that “Telehealth claim lines as a percentage of all medical claims dropped 13% in April, marking the third straight month of declines, according to new data from nonprofit Fair Health. The dip was greater than the drop of 5.1% in March, but not as large as the decrease of almost 16% in February. However, overall utilization remains significantly higher than pre-COVID-19 levels. The decline appears to be driven by a rebound in in-person services, researchers said. Mental health conditions bucked the trend, however, as the percentage of telehealth claim lines associated with mental conditions — the No. 1 telehealth diagnosis — continued to rise nationally and in every U.S. region.” The FEHBlog considers that to be good news because telehealth at least currently is best suited for mental health care and out of schedule healthcare situations.

In closing, the FEHBlog wants to emphasize an important aspect of last Thursday’s No Surprise Billing rule. As explained in the government’s model consumer notice for use by health plans,

When you get services from an in-network hospital or ambulatory surgical center, certain providers there may be out-of-network. In these cases, the most those providers may bill you is your plan’s in-network cost-sharing amount. This applies to emergency medicine, anesthesia, pathology, radiology, laboratory, neonatology, assistant surgeon, hospitalist, or intensivist services. These providers can’t balance bill you and may not ask you to give up your protections not to be balance billed.

If you get other services at these in-network facilities, out-of-network providers can’t balance bill you, unless you give written consent and give up your protections.”

The vast majority of surprise bills stem from out-of-network service provided by emergency rooms, air ambulance, and the types of providers listed above, all of whom are locked into using negotiation and baseball arbitration with the health plan. The only doctors who can approach the patient for a balancing billing waiver are the surgeon or oncologist in a non-emergency setting who meets with the patient well before the surgery. That makes sense.

This approach, however, will promote use of the independent dispute resolution system which the tri-agencies will unveil October 1. Three months is more than ample time for the FEHBlog’s fellow lawyer to prepare for this new business opportunity. Health plans should make sure that their out of network pricing negotiators are adequately staffed.

Weekend update

David Ermer–Congress, COVID-19, Federal employment benefits, Mental health care, SCOTUS–

The Senate has left town for a two week long State work break while the House of Representatives will continue Committee business and floor voting through Thursday July 1. The House Appropriations Committee will mark up that fiscal year 2022 financial services and general government appropriations bill on Tuesday morning, June 29. The Federal Times reports on that process here.

The U.S. Supreme Court is expected to wrap up its October 2020 term this week.

Last Friday, President Biden issued an executive order on “Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce.” Here’s a link to the accompanying fact sheet. The new OPM Director will play a key role in implementing this executive order which makes one specific mention of the FEHB Program:

Sec. 11 (c) To ensure that LGBTQ+ employees (including their beneficiaries and their eligible dependents), as well as LGBTQ+ beneficiaries and LGBTQ+ eligible dependents of all Federal employees, have equitable access to healthcare and health insurance coverage:
(i) the Director of OPM shall take actions to promote equitable healthcare coverage and services for enrolled LGBTQ+ employees (including their beneficiaries and their eligible dependents), LGBTQ+ beneficiaries, and LGBTQ+ eligible dependents, including coverage of comprehensive gender-affirming care, through the Federal Employees Health Benefits Program; * * *

The 2022 OPM technical guidance for benefit and rate proposals clearly anticipated this directive.

On the COVID-19 front

  • The Hill informs us that public health experts are wondering when the Food and Drug Administration will give full approval to the mRNA COVID-19 vaccines, given the fact that a sizable cadre of unvaccinated folks have expressed concern about emergency use authorization status of those vaccine.
  • The Wall Street Journal reports that “In the coronavirus pandemic, a wave of mental-health crises has grown into a tsunami, flooding an already taxed system of care. As the country appears to be emerging from the worst of the Covid-19 crisis, emergency departments say they are overwhelmed by patients who deferred or couldn’t access outpatient treatment, or whose symptoms intensified or went undiagnosed during the lockdowns.”

On the new Alzheimer’s drug / Aduhelm front, STAT News offers

  • a calculator to estimate the cost of Aduhelm to Medicare depending upon utilization. “Estimates of how many seniors on Medicare will actually take Aduhelm, which has a list price of $56,000 [annually], vary wildly. Some experts have guessed at relatively low patient interest, around 500,000 people. Biogen, the company behind the drug, has put its target population far higher, around 1 million to 2 million people. But technically, since the FDA approved the drug for every Alzheimer’s patient, not just those with early-onset disease, the number could skyrocket toward 5.8 million, the number of adults over 65 with Alzheimer’s.”
  • a report that “The top House Democrats on two powerful committees on Friday announced an investigation into the approval and pricing of Biogen’s controversial Alzheimer’s drug, Aduhelm. Both Biogen and the Food and Drug Administration will be under the microscope, House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.) said. “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit,” the chairs said in a joint statement.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, U.S. Healthcare–
Photo by Manasvita S on Unsplash

In anticipation of tomorrow morning’s markup session, the House Appropriations Committee today released the draft Fiscal Year 2022 financial services and general government appropriations bill. Of note,

  • Office of Personnel Management (OPM) – The bill includes $372 million, an increase of $42 million above the FY 2021 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • [The bill] eliminates provisions preventing the FEHBP from covering abortion services [subject to limited exceptions, e.g. life of the mother is endangered by continuing the pregnancy].

Govexec.com adds that “the bill makes no mention of a pay raise for federal employees, effectively endorsing [President] Biden’s plan to give feds an average 2.7% pay raise next year. It remains unclear how the White House would divvy up the 2.7% between an across-the-board increase to basic pay and an average increase in locality pay, although traditionally 0.5% has been reserved for locality pay increases.

From the COVID-19 front, the American Hospital Association informs us

The AHA today joined the Department of Health and Human Services, Centers for Disease Control and Prevention, and other national health care and public health organizations in encouraging COVID-19 vaccination for everyone age 12 and older who is eligible. “Today, the CDC Advisory Committee on Immunization Practices (ACIP) met to discuss the latest data on reports of mild cases of inflammation of the heart muscle and surrounding tissue called myocarditis and pericarditis following COVID-19 vaccination among younger people,” the statement notes. “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.” 

Separately, the Food and Drug Administration today told ACIP that it was moving quickly to adjust the language on its emergency use authorization fact sheets for the Pfizer and Moderna COVID-19 vaccines to note a likely association in rare cases of myocarditis and pericarditis in vaccine recipients.

Bloomberg reports in this regard that

CDC Director Rochelle Walensky said Wednesday that mRNA vaccines have been successful in preventing severe illness and death among young people. For every million second doses of an mRNA vaccine administered to those 18-to-24-year-olds, the CDC projects 26,000 cases of Covid and 1,657 hospitalizations are prevented, while only 49 to 61 cases of myocarditis may develop. Speaking at the Milken Institute Future of Health Summit, Walensky added that the data presented at the advisory committee meeting still “overwhelmingly demonstrate that the benefits of vaccination far outweigh the risks.”

The Society for Human Resource Management offers advice on confronting COVID-19 vaccination misinformation in the workplace.

From the prescription drug front, Fierce Healthcare reports that employer groups are asking Congress to look into Biogen’s pricing of its new Alzheimer’s drug at $56,000 per course of treatment and the CVS Health continues to remove hyperinflationary drugs from its formularies in order to control drug spending.

Posaconazole, an antifungal medication, is priced at $4,500 for a 30-day supply—while an alternative, fluconazole, costs less than $14. This is an example of a growing trend: medications, including many generics, with “hyperinflated” prices, experts at CVS Caremark say. The pharmacy benefit manager giant culled 72 such drugs from its formulary in 2020 alone, leading to savings of $1.2 billion compared to 2018.

From the price transparency world, RevCycle Intelligence tells us that “The majority of the top 100 hospitals by gross revenue are using a price estimator tool to comply with a landmark hospital price transparency rule from HHS, according to a recent study.”

Finally, CIGNA has added a telemental service called Brightside to its behavioral health network. According to the provider’s press release,

Brightside, a mental health telemedicine platform that offers access to high-quality anxiety and depression care from anywhere, today announced that it has joined the national behavioral health network for Cigna Corporation, a global health service company. Cigna’s 14 million behavioral health customers can now access Brightside’s evidence-based and data-driven approach to treating anxiety and depression through their commercial health care plans.” * * * “The pandemic has shined a light on the need for broader, more convenient access to mental health care. Cigna is committed to providing our customers with the behavioral health care they need, when and where they need it – and that is what Brightside will help us offer,” said Dr. Doug Nemecek, Cigna’s chief medical officer for behavioral health. “By increasing access through virtual care, customers can talk to a psychiatrist or therapist from the comfort and privacy of their homes. This is another demonstration of our commitment to provide timely and convenient access to depression and anxiety care for Cigna members.

The FEHBlog appreciates such services because in contrast to in person care where the mental health providers are typically out of network, telemental providers in a spoke and hub arrangement like this one are always in-network, thereby creating savings for the plan and the member.

Monday Roundup

David Ermer–Congress, COVID-19, Mental health care, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

The International Foundation of Employee Benefit Plans informs us that

The Department of Labor’s (DOL) Employee Benefits Security Administration along with the Office of Personnel Management, Internal Revenue Service, Department of the Treasury, Centers for Medicare & Medicaid Services, and Department of Health and Human Services (collectively, The Departments) issued an information collection related to certain reporting requirements under section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage.​

In addition, the Departments and OPM are also seeking input about whether the requirements apply to Federal Employees Health Benefits carriers, including whether or not they are also health insurance issuers.

Here’s the FEHBlog’s input on that last point. Congress extended specific provisions of Division BB of the Consolidated Appropriations Act, 2021 to the FEHB Program when it created a new Section 8902(p) of the FEHB Act. Today’s notice concedes that Section 204 was not among those provisions in Section 8902(p). Regulations are intended to implement and interpret statutory law, and in the case of the FEHBP there is no statute to implement here. What’s more carriers already are obligated to report aggregated prescription benefit data to OPM. In other words, the regulatory field is occupied as far as the FEHB Program is concerned. The public comment deadline on this information collection notice is July 23, 2021.

The American Hospital Association gleefully reports

Nearly 100 bipartisan House members led by Reps. Thomas Suozzi, D-N.Y., and Brad Wenstrup, R-Ohio, urge the departments of Health and Human Services, Labor and the Treasury [in a June 17, 2021 letter] to ensure their rulemaking for the No Surprises Act reflects congressional intent for a balanced process to settle payment disputes between health plans and providers. The lawmakers also emphasized the need to provide sufficient time for public comments and evaluation through proposed notice and comment rulemaking. 

The FEHBlog wonders what caused Congress to fire this shot across the regulator’s bow. The statutory deadline for these rules is October 1, 2021, thereby creating an all too brief three month long implementation period for providers, payers, lawyers and arbitrators. This should be interesting.

To show that the FEHBlog is not entirely cranky as he writes this post, CVS Health announced today

Over the last year, Aetna, a CVS Health® company, has been implementing a comprehensive strategy to reduce suicide attempts 20 percent among Aetna members by the year 2025. With the right intervention and support, resources and management of suicidal thoughts, suicide is known to be preventable. In fact, 90 percent of people who die by suicide have a potentially treatable mental health condition.

This month, Aetna is launching its latest initiative — the development of a specialty provider network with a sole focus on suicide prevention in collaboration with Psych Hub, the world’s most comprehensive platform for mental health education. The joint effort will further arm Aetna practitioners with no-cost, evidence-based instruction, tools, and resources to identify and treat those at risk of suicide.

Well done and best of luck.

Also from the COVID-19 front Bloomberg informs us

After more than a year of obsessively tracking Covid-19 case numbers, epidemiologists are starting to shift focus to other measures as the next stage of the pandemic emerges.

With rich countries vaccinating growing proportions of their vulnerable populations, the link between infection numbers and deaths appears to be diminishing. Now, in some places the focus is on learning to live with the virus — and on the data that matter most to avoid fresh lockdowns.

“It’s possible we’ll get to a stage of only monitoring hospitalizations,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins University’s Coronavirus Resource Center, which has built one of the most comprehensive platforms to track the virus and its impact.

The Wall Street Journal provides an overview of the COVID-19 variant called Delta.

The latest data from The Centers for Disease Control and Prevention estimates the Delta variant makes up 9.9% of reported U.S. Covid-19 cases, while Alpha stands at 65.5%. * * *

Scientists are still studying the virus and their early conclusions aren’t definitive. But British scientists, who have probably done the most work on the variant, estimate it is from 40% to as much as 80% more infectious than the so-called Alpha variant, or B.1.1.7, which was first identified in England last year, is now prevalent in the U.S. and is itself more contagious than the version of the virus that emerged in China in 2019.

An analysis of more than 14,000 Delta cases by England’s public-health agency found a double dose of the shot developed by Pfizer Inc. and BioNTech SE reduces the risk of hospitalization after infection with Delta by 96%. Two doses of the vaccine developed by the University of Oxford and AstraZeneca reduce the risk by 92%, Public Health England said.

Very few of those hospitalized in the U.K. have been fully vaccinated, with the new cases mostly among younger people who aren’t yet vaccinated. There is no evidence that young adults and children are more at risk proportionately from this variant than other age groups, and the increased transmission mostly reflects the fact that they haven’t been immunized, scientists say.

In other news that caught the FEHBlog’s eye this Monday —

  • The FEHBlog enjoys following the healthcare efforts of business giants like Amazon, Apple, and Walmart. ZdNet reports on Microsoft’s new healthcare strategy.
  • Louisville KY television station WDRB tells us

Brentwood, Tenn.-based LifePoint Health [a large regional health system that owns over 80 hospitals] will acquire Louisville-based Kindred Healthcare LLC, a specialty hospital company, for undisclosed terms, according to a news release Monday. The deal is scheduled to close by the end of the year. The announcement comes weeks after Louisville-based Humana Inc. said it would absorb the remainder of the former Kindred’s home health and hospice business. In the news release, LifePoint said it plans to continue Kindred’s strategy of growing by establishing joint ventures and partnerships with hospitals. * * * LifePoint said it plans to invest $1.5 billion in its business following the deal.

At the time of wrapping up this post on Monday evening, the Senate had not yet taken up Kiran Ahuja’s nomination to be OPM Director. The FEHBlog will keep an eye on this matter. [Tuesday morning supplement — The Senate Press Gallery Calendar informs us that

The Senate on Tuesday morning at 11:45 am will hold two votes:

  1. Confirmation of the Fonzone nomination.
  2. Motion to invoke cloture on Kiran Ahuja to be Director of the Office of Personnel Management.

The Senate will recess following the cloture vote on the Ahuja nomination until 2:15 p.m. 

At 2:30 p.m. vote:

  1. Confirmation of the Ahuja nomination.

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The Senate took no action on Kiran Ahuja’s nomination to be OPM Director today as Senators Booker and Peters remain out of pocket due to family illnesses.

On the hospital front —

  • The Advisory Board informs us about U.S. News and World Reports most recent rankings of children’s hospitals.
  • Axios reports that “Some of the hospitals with the highest revenue in the country also have some of the highest prices, charging an average of 10 times more than the actual cost of the care they deliver, according to new research by Johns Hopkins University provided exclusively to Axios.”

On the mental healthcare front, we have two articles on start- up companies from Katie Jennings in Forbes. One concerns Burlingame, Calif.-based Lyra Health and the other concerns “Lifestance Health Group, one of the nation’s largest outpatient mental health providers.” Check them out.

On the prescription drug front —

  • Healthcare Dive reports that “Anthem, one of the biggest U.S. payers, has joined an initiative to create low-cost generic drugs for hospital and retail pharmacies. The initiative CivicaScript, a subsidiary of hospital-owned nonprofit drugmaker Civica Rx, plans to initially develop and manufacture six to 10 common but pricey generic medicines that don’t have enough market competition to drive down cost, officials said Wednesday. The first generics could be available as early as 2022.”
  • Fierce Pharma informs us that “Antibody treatments have shown little success in helping COVID-19 patients with  severe disease. But a large [UK] study of hospitalized patients reveals that Regeneron’s antibody cocktail can reduce the chance of death in patients who haven’t produced their own antibody responses to the disease.”
  • STAT News interviews the Alzheimer Association’s CEO about the newly approved drug Aduhelm.

In miscellaneous news

  • The Wall Street Journal reports “Apple Inc. Chief Executive Tim Cook has said the company’s greatest contribution to mankind will be in health. So far, some Apple initiatives aimed at broadly disrupting the healthcare sector have struggled to gain traction, according to people familiar with them and documents reviewed by The Wall Street Journal.”
  • Healthcare Dive tells us that “A University of Pennsylvania study that tracked Medicare claims for about 1.35 million beneficiaries who had joint replacement surgery found that hospitals participating in bundled payment programs spent less on the hip and knee joint procedures than hospitals receiving traditional fee-for-service payments. Spending, however, did not differ between hospitals that voluntarily joined bundling programs and those whose involvement was mandatory, according to the findings, which were published in a JAMA research letter. The results failed to validate assumptions that voluntary participants tend to achieve greater savings because they choose programs for the opportunity to reduce spending. The findings come as the head of the Center for Medicare and Medicaid Innovation, Elizabeth Fowler, suggested the agency would look to shift away from voluntary arrangements in favor of more mandatory models.”
  • Fierce Healthcare informs us that “The Centers for Disease Control and Prevention (CDC) released new interim guidance late Monday for healthcare providers treating patients with post-COVID conditions—an umbrella term the agency is using to capture a wide range of physical and mental health issues that sometimes persist four or more weeks after an individual’s COVID-19 infection. Sometimes referred to as “long COVID,” the conditions can present among COVID-19 patients regardless of whether they were symptomatic during their acute infection, the agency wrote in the guidance.”