FEHBlog

Monday Roundup

Photo by Sven Read on Unsplash

Mondays have tended to be good news days for COVID-19 vaccines. As of today, over 50% of Americans over age 18 have received at least one dose of a COVID-19 vaccine.

Fierce Healthcare reports that

“CVS Pharmacy has begun stocking its virtual and in-store shelves nationwide with rapid tests for COVID-19—which can be purchased without a prescription and used by anyone regardless of whether or not they are showing symptoms—including three FDA-authorized diagnostics and sample collection kits produced by LabCorp, Ellume and Abbott.”

“Even as vaccines become more widely available, COVID-19 testing remains a critical tool to keep our communities safe,” Walgreens President John Standley said in a statement. Walgreens currently offers on-site testing at more than 5,500 of its pharmacies and plans to expand to 6,000 drive-thru sites by May, using Abbott’s ID NOW portable testing machines.

In addition, earlier this month CVS began offering COVID-19 antibody testing for $38 at 1,100 in-house clinics, using fingerstick blood samples to determine previous infections.

The U.S. Office of Personnel Management announced today that the agency

will allow [FSAFEDS] flexibilities permitted under the Consolidated Appropriations Act 2021 and the American Rescue Plan Act including allowing full carryover for a health care flexible spending account (HCFSA) and Limited Expense FSA (LEX FSA); extending the grace period for a dependent care flexible spending account (DCFSA); and permitting care for dependents through age 14 for 2020 and 2021 under a DCFSA. In addition, OPM is working with our FSAFEDS contractor, Health Equity, to offer a Special Enrollment/Election Period (SEP) in the near future.  This SEP will allow participants to increase or decrease their current elections for their DCFSA and/or their HCFSA.  In addition, the SEP will allow those who did not re-enroll for 2021 during Open Season in the Fall, the opportunity to enroll in a DCFSA and/or HCFSA for 2021.  Finally, OPM will allow DCFSA participants to increase their election during the Special Election Period to the new IRS maximum of $10,500 for 2021. 

All good news.

What’s more, the Wall Street Journal reported in its Saturday essay about the U.S. airline safety revolution.

Over the past 12 years, U.S. airlines have accomplished an astonishing feat: carrying more than eight billion passengers without a fatal crash.

Such numbers were once unimaginable, even among the most optimistic safety experts. But now, pilots for domestic carriers can expect to go through an entire career without experiencing a single engine malfunction or failure. Official statistics show that in recent years, the riskiest part of any airline trip in the U.S. is when aircraft wheels are on the ground, on runways or taxiways.

The achievements stem from a sweeping safety reassessment—a virtual revolution in thinking—sparked by a small band of senior federal regulators, top industry executives and pilots-union leaders after a series of high-profile fatal crashes in the mid-1990s. To combat common industry hazards, they teamed up to launch voluntary incident reporting programs with carriers sharing data and no punishment for airlines or aviators when mistakes were uncovered.

One wonders whether this successful strategy may be transferable to other pressing safety issues, such as patient safety. In this regard, a friend of the FEHBlog suggested check this Washington Post opinion piece written by a group of psychologists titled “We instinctively add on new features and fixes. Why don’t we subtract instead?
‘Less is more’ is a hard insight to act on, it turns out.” How true.

In other healthcare news —

  • The Kaiser Family Foundation informs us that

a relatively small number and share of drugs accounted for a disproportionate share of Medicare Part B and Part D prescription drug spending in 2019 (Figure 1).

— The 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition (7% of all Part D covered drugs) accounted for 60% of net total Part D spending.

— The top 50 drugs covered under Medicare Part B (8.5% of all Part B covered drugs) accounted for 80% of total Part B drug spending.

Some recent proposals to lower prescription drug prices have limited the number of drugs subject to price negotiation and international reference pricing. This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors. Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources . . . .

  • Employee Benefits News tells us

New research from Voya shows employees have a bias against HDHPs and the reason for that is as simple as marketing.

“One of the really interesting findings that we saw from the research about why there is that bias comes down to branding, pure and simple,” says Nate Black, vice president of consumer driven health for Voya Financial. “When we replaced the high deductible health plan name and called it something more generic, the share of people choosing high deductible health plans doubled. So just the name itself can have a really significant impact on how people think about what plan they should choose.”

Sixty-three percent of the people surveyed by Voya said they would choose the plan with the lowest deductible. As part of the study Voya designed an experiment asking participants to choose between a PPO and an HDHP. The experiment was set up in a way that the HDHP was always the optimal financial choice, despite this, 65% of those surveyed still chose the PPO plan.

Communicating the long term value of plans connected with health savings accounts is quite important.

  • Here’s a link to the CDC’s website on the Johnson & Johnson vaccine pause which explains

If you received the vaccine more than three weeks ago, the risk of developing a blood clot is likely very low at this time.

If you received the vaccine within the last three weeks, your risk of developing a blood clot is also very low and that risk will decrease over time.

Contact your healthcare provider and seek medical treatment urgently if you develop any of the following symptoms: severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin (petechiae), or new or easy bruising.

If you experience any adverse events after vaccination, report them to v-safe and the Vaccine Adverse Event Reporting System

The FEHBlog enrolled in v-safe after his first Pfizer vaccination and the CDC has continued to inobtrusively check in weekly. The FEHBlog is happy to help out.

Weekend update

Photo by Tomasz Filipek on Unsplash

Both Houses of Congress are working on floor and committee business this week. Here are links to the House floor schedule, the Senate floor schedule and the Committee business schedule. Nothing particularly interesting from an FEHBP standpoint.

In contrast, this week from Tuesday through Thursday, the U.S. Office of Personnel Management and America’s Health Insurance Plans will hold the annual FEHB carrier conference. This will be the longest conference in the FEHBlog’s memory.

In that regard, “The Alliance for Fertility Preservation (AFP) commends the U.S. Office of Personnel Management (OPM) for including coverage for fertility preservation in its annual call for benefit and rate proposals from Federal Employee Health Benefit (FEHB) Program carriers. This coverage would allow for fertility preservation services related to infertility caused by medical treatment (iatrogenic infertility).”

The AFP estimates that in the United States, approximately 160,000 people between ages 0-44 are diagnosed with cancer each year. Most of these patients will face treatments including chemotherapy, radiation, and/or surgery that can damage reproductive cells (eggs and sperm), reproductive organs, or impact the ability to carry a pregnancy. Because this damage treatment-based, it can affect patients with any type of cancer. Patients with other conditions requiring similar therapies are also at risk.

Fertility preservation is now considered part of the standard of care for age-eligible patients. Guidelines supporting fertility preservation have been issued by the relevant medical associations, including the American Society of Clinical Oncology (ASCO), the American Society for Reproductive Medicine (ASRM), and the American Medical Association (AMA).

This new benefit for 2022 is a carrier conference topic on Tuesday.

From the COVID-19 front, the FEHBlog and his wife attended the socially distanced and fan-masked Washington Nationals game this afternoon. Walking from the parking lot to Nationals Park, we walked by a CVS pharmacy which had a sign reading COVID-19 vaccinations available here. We went into the pharmacy, and the FEHBlog noticed a staff member at a table waiting to sign up people for the vaccine. The FEHBlog was so happy.

Health Payer Intelligence discusses how the Blue Cross Blue Shield plans are “aiming to be a community resource to ensure shots are administered. Reed Melton, vice president of clinical operations at the Blue Cross Blue Shield Association (BCBSA), told Fierce Healthcare that the group’s member plans are partnering with regional and community organizations to tackle vaccine hesitancy and support administration efforts. “We have a full-court press from Honolulu to San Juan,” Melton said.  At the national level, BCBSA has partnered with Feeding America to offer educational materials on COVID-19 vaccines to people at 200 food banks, which can reach 40 million Americans.”

Last week the Centers for Disease Control reported to providers of care about so-called vaccine breakthrough cases of COVID-19.

Vaccine breakthrough cases occur in only a small percentage of vaccinated persons. To date, no unexpected patterns have been identified in the case demographics or vaccine characteristics among people with reported vaccine breakthrough infections.COVID-19 vaccines are effective. CDC recommends that all eligible people get a COVID-19 vaccine as soon as one is available to them.

The Wall Street Journal reports today that

President Biden’s chief medical adviser said he expects Johnson & Johnson’s Covid-19 vaccine to return to use in the U.S. by Friday, after a pause because of concerns about blood clots in several patients. “I would be very surprised…if we don’t have a resumption in some form by Friday,” Dr. Anthony Fauci told CBS’s “Face the Nation,” echoing remarks he made on other networks Sunday.

The American Medical Association has shared information about what physicians should know about this blood clot issue.

Cybersecurity Saturday

Before it’s too late, here is the Cybersecurity and Infrastructure Agency’s Week 2 website for National Supply Chain Integrity month. Week 2 focuses on Assessing ICT Trustworthiness. The website offers new resources. Check it out.

The Labor Department’s Employee Benefits Security Administration which regulates employer sponsored benefit plans governed by ERISA has created a lengthy, yet helpful, list of cybersecurity best practices for ERISA plans which no doubt could be used by FEHB plans too.

Bleeping Computer informs us today that “Microsoft has fixed a bug that could allow a threat actor to create specially crafted downloads that crash Windows 10 simply by opening the folder where they are downloaded. “BleepingComputer strongly recommends that all Windows users install the latest Patch Tuesday security updates. Not only for this vulnerability but the 107 other vulnerabilities fixed this month.”

The AP discusses Microsoft’s cybersecurity woes.

Many security experts believe Microsoft’s single sign-on model, emphasizing user convenience over security, is ripe for retooling to reflect a world where state-backed hackers now routinely run roughshod over U.S. networks.

Alex Weinert, Microsoft’s director of identity security, said it offers various ways for customers to strictly limit users’ access to what they need to do their jobs. But getting customers to go along can be difficult because it often means abandoning three decades of IT habit and disrupting business. Customers tend to configure too many accounts with the broad global administrative privileges that allowed the SolarWinds campaign abuses, he said. “It’s not the only way they can do it, that’s for sure.”

In 2014-2015, lax restrictions on access helped Chinese spies steal sensitive personal data on more than 21 million current, former and prospective federal employees from the Office of Personnel Management.

Curtis Dukes was the National Security Agency’s head of information assurance at the time.

The OPM shared data across multiple agencies using Microsoft’s authentication architecture, granting access to more users than it safely should have, said Dukes, now the managing director for the nonprofit Center for Internet Security.

“People took their eye off the ball.”

Interesting.

Last Wednesday, the Senate Intelligence Committee held an open hearing on worldwide threats and of course the SolarWinds hack was a topic. Here is Cyberscoop’s take on that hearing. The following day per the Wall Street Journal, “President Biden announced retaliatory measures against Russia over election interference, the SolarWinds cyberattack and other malign activity, saying he isn’t seeking to kick off “a cycle of escalation” but would take more drastic action if necessary.” The Journal adds that

The U.S. has punished Russia for election interference in the past, notably after its multipronged operations during the 2016 election. But previous administrations typically refrained from retaliating for cyber intrusions they classified as political espionage—no matter how broad or successful—in part because the U.S. and its allies regularly engage in similar conduct, current and former officials said.

Subsequently, again per the Journal, “Russia said it would expel 10 U.S. diplomats and bar a number of senior U.S. officials from entering the country in response to measures against Moscow.”

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 15th week of this year (beginning April 2, 2020, and ending April 14, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through April 14, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through April 14, 2021 which also uses Thursday as the first day of the week:

It’s looking reasonably good. According to the CDC, as of today, 49.6% of the U.S. population over age 18, and 80.4% of the U.S. population over age 65, have had at least one dose of the vaccines. 31.1% of the over age 18 population and 64.6% of the over age 65 population are fully vaccinated. Over 200 million doses of the vaccines have been administered in the U.S.

The CDC has announced that “a virtual emergency meeting will be held to discuss Janssen (Johnson & Johnson) COVID-19 vaccine on [Friday] April 23, 2021, 11:00 a.m. to 5:00 p.m. ET” to discuss the ongoing FDA/CDC recommended pause in administration of that vaccine in the U.S. The Wall Street Journal reports that

Johnson & Johnson said Friday there wasn’t enough evidence to establish that the company’s Covid-19 vaccine causes the rare blood-clotting condition that prompted U.S. health officials this week to recommend a pause in its use.

The New England Journal of Medicine published online a letter from three J&J employees involved in vaccine development and epidemiology saying, “At this time, evidence is insufficient to establish a causal relationship between these events” and J&J’s vaccine.

And now for more —

  • Beckers ASC Review informs us that Optum “announced plans to add 10,000 physicians in 2021 earlier this year, and Wyatt Decker, CEO of OptumHealth, said Optum is on track to exceed that number [this week]. Optum now has 56,000 affiliated, contracted and employed physicians.” Wow.
  • The Food and Drug Administration announced its marketing approval for “Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. ‘Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,’ said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. ‘The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.’”
  • Fierce Healthcare reports that “Despite the challenges in 2020, physicians’ salaries have rebounded, along with hours working and with only a slight dip in patient volume, according to the Medscape Physician Compensation Report 2021. Based on responses from more than 18,000 U.S. physicians across 29 specialties, the survey—conducted Oct. 6, 2020, to Feb. 11, 2021—found that average salaries for primary care physicians held steady at $242,000 from $243,000 the previous year. Similarly, specialists’ average salaries dropped $2,000 to $344,000.”
  • Fierce Healthcare also reports

Ride-sharing company Lyft is letting patients schedule nonemergency medical transport (NEMT) on health organization’s dime with the launch of Lyft Pass for Healthcare. The latest healthcare offering falls in line with the initial Lyft Pass service launched in July 2020, which allows business organizations to monitor and cover the cost of employees’ transportation. Now, the company is extending those capabilities to healthcare organizations—commercial health plans as well as Medicare or Medicaid—and their members.

Through the app, users who need a ride to their medical appointments, vaccinations, prescription pickups or other destinations request a ride. This process is similar to ordering a pickup as a consumer, except that patients will need to select an in-app branded Lyft Pass provided via phone number, access code or a direct link. Healthcare organizations sponsoring the pass, meanwhile, are able to customize the program’s budgets, approved locations and scheduling windows. The organizations are able to monitor usage and manage spend while allowing members to be more autonomous with their NEMT scheduling.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

From Capitol Hill, Govexec reports that yesterday, “a Senate panel advanced President Biden’s pick [Jason Miller] to be deputy director for management for the Office of Management and Budget to the full chamber. Today, Fierce Healthcare reports Chiquita Brooks-LaSure’s confirmation hearing to be Centers for Medicare Service administrator before the Senate Finance Committee. “The hearing didn’t highlight any major opposition from Republicans to her nomination, likely signaling her confirmation as the head of CMS.”

From the Johnson & Johnson vaccine pause front, Healthcare Dive discusses “What Happens Next, A call by regulators to stop J&J vaccinations won’t dramatically disrupt U.S. supply. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.” The Wall Street Journal adds that

A study by the University of Oxford found the risk of rare but sometimes-deadly blood clotting is roughly eight to 10 times greater in Covid-19 sufferers than among people who have received any of the first three Western-developed vaccines widely available. The study, involving vaccinations from Pfizer Inc. and BioNTech SE, another from Moderna Inc. and one from AstraZeneca PLC, adds to competing evidence related to blood clotting that regulators and governments may need to take into account as they weigh continued deployment of vaccines

While the Johnson & Johnson vaccine was not included in this study, the Astra-Zeneca vaccine uses the same adenovirus technology as the Johnson & Johnson vaccine.

In other COVID-19 vaccine news, the HHS Office of Inspector General issued a warning that provider must not charge patients for the COVID-19 vaccine.


OIG is aware of complaints by patients about charges by providers when getting their COVID-19 vaccines. Providers that charge impermissible fees must refund them and ensure that individuals are not charged fees for the COVID-19 vaccine or vaccine administration in the future. Consistent with the CDC Vaccination Program, providers are permitted to bill third-party payers (such as Medicare, Medicaid, the HRSA COVID-19 Uninsured Program, or a private insurer) for an administration fee, in accordance with the payer’s applicable billing rules.

In FEHB news, today the Office of Personnel Management issued a benefit administration letter to employing agencies and a letter to FEHB carriers instructing them to tighten up on the process of adding family members to an FEHBP enrollment. For the employing offices —

An employing office must require proof of family member eligibility for coverage through the FEHB Program for: 

• new employees during their initial opportunity to enroll (IOE) 

• employees requesting FEHB changes due to all other QLEs2 

Due to the large volume of transactions during the annual Federal Benefits Open Season, employing offices may, but are not required to, verify family member eligibility. 

When reviewing a new family member’s eligibility, employing offices may take this opportunity to verify the eligibility of family members currently enrolled who have not previously been verified. 

For the carriers — “Before adding a family member to an existing Self and Family enrollment, an FEHB Carrier must require that the enrollee provide proof of that family member’s eligibility for coverage through the FEHB Program.” In the middle of the last decade, OPM considered but never implemented an audit of family member eligibility records.

From the Centers for Disease Control reports front

  • Health Day informs us that “Emergency department visits were lower during December 2020 to January 2021 compared with prepandemic levels one year earlier, according to research published in the April 16 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. * * * The researchers found that after an initial decrease during March to April 2020, there was an increase in emergency department visits through July 2020, but at levels below those during 2019; during December 2020 to January 2021, there was a decrease of 25 percent in visits compared with prepandemic levels.”
  • The New York Times reports that

More than 87,000 Americans died of drug overdoses over the 12-month period that ended in September, according to preliminary federal data, eclipsing the toll from any year since the opioid epidemic began in the 1990s.

The surge represents an increasingly urgent public health crisis, one that has drawn less attention and fewer resources while the nation has battled the coronavirus pandemic. Deaths from overdoses started rising again in the months leading up to the coronavirus pandemic — after dropping slightly in 2018 for the first time in decades — and it is hard to gauge just how closely the two phenomena are linked. But the pandemic unquestionably exacerbated the trend, which grew much worse last spring: The biggest jump in overdose deaths took place in April and May, when fear and stress were rampant, job losses were multiplying and the strictest lockdown measures were in effect

That’s quite sad.

In other news —

  • Becker’s Hospital Review informs us that “UnitedHealth Group posted nearly $5 billion in profit for the first quarter of 2021 as its UnitedHealthcare and Optum businesses continue to grow.”
  • STAT News offers an interesting report on the burgeoning market for increasingly inexpensive continuous glucose monitors for folks with Diabetes I.

Glucose monitors are becoming the backbone of a new movement in consumer tech — one that so far is outpacing the evidence. “You kind of have this dichotomy with the perceived value of CGM,” said Susan Schembre, a researcher at the University of Arizona who has studied the use of CGMs in healthy people. “We have the consumers really driving the market on one end, and then the science kind of resisting it on the other.”

Eventually, the devices and the evidence will converge. Already, clinical CGMs have expanded from their initial patient population: Doctors regularly prescribe them to people who manage their type 2 diabetes with insulin, and sometimes to help type 2 patients tweak their habits and avoid going on medication. Manufacturers are planning for a future in which patients use the devices to both treat and prevent metabolic issues — dramatically increasing their market share. Consumer tech companies are looking for their slice of the pie.

Midweek Update

Bloomberg reports that

A Centers for Disease Control and Prevention panel ended discussion about the Johnson & Johnson vaccine without taking a vote, leaving it unclear how long the distribution of the shot will remain paused in the U.S. Some panel members advocated for a monthlong pause, while others were concerned about the effects of not having the J&J vaccine available, especially to the communities it was being targeted toward. As a result, distribution of the vaccine will remain halted at least until the panel meets next, perhaps in a week to 10 days.

The Wall Street Journal adds

The six cases [which resulted in the pause] exceed the background rate for the rare brain blood-clotting condition alone in women of this age group, said Tom Shimabukuro, a vaccine safety expert at the CDC who presented data on the cases. The illness the six women developed—cerebral venous sinus thrombosis, or CVST, combined with a low-platelet count—is even more rare, he said. 

The CDC issued an alert to healthcare providers Tuesday warning them to screen for the blood-clotting condition among patients who recently received the J&J vaccine and have severe headache or abdominal pain, shortness of breath, backache, leg swelling, new neurological symptoms or new or easy bruising. The condition requires a unique treatment, and healthcare providers shouldn’t give these patients the standard treatment, which involves using the anticoagulant heparin, the agency also warned. 

Notwithstanding yesterday’s supply disruption, 2.5 doses of the COVID-19 vaccines were administered yesterday according to the CDC. 47.6% of the U.S. population over age 18, and 79.6% of the U.S. population over age 65, have had at least one dose of the vaccines. 29.6% of the over age 18 population and 63% of the over 65 population are fully vaccinated.

On the artificial intelligence front, STAT News informs us that

Mayo Clinic [along with business partners] is forming a pair of companies to collect and analyze data from remote monitoring devices and diagnostic tools, a move that comes as part of a broader bid to harness patient data to deliver continuous care guided by artificial intelligence. The ultimate goal of the companies is to deliver more precise physiological information to patients and doctors around the clock, allowing them to make faster decisions to head off disease and deliver care without the usual morass of extra office visits and trips to the pharmacy.

Here’s hoping plus a link to the Mayo Clinic’s press release.

In other healthcare news, the Mayo Clinic also reminds us that “One in 5 Americans has a sexually transmitted infection,according to the Centers for Disease Control and Prevention (CDC). During Sexually Transmitted Diseases Awareness Week, April 12–17, the CDC encourages discussion, testing and help to remove the stigma surrounding sexually transmitted infections and diseases.”

The International Foundation of Employee Benefit Plans lets us know that

The number of organizations offering fertility benefits has increased over the past five years. According to the International Foundation of Employee Benefit Plans (Employee Benefits Survey: 2020 Results), 30% of U.S. organizations offer fertility benefits. Overall,

  • 24% cover fertility medications (8% covered in 2016, 14% in 2018)
  • 24% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018)
  • 14% cover visits with counselors (e.g., geneticists, surrogacy, etc.) (4% in 2016, 8% in 2018)
  • 12% cover genetic testing to determine infertility issues (up slightly from 11% in 2018)
  • 11% cover non-IVF fertility treatments (6% in 2016, 11% in 2018).

In 2016, only 2% of organizations covered egg harvesting/freezing services. That jumped to 6% in 2018 and even higher in 2020, with 10% reporting that they cover the benefit.

Fierce Healthcare reports

As growing numbers of specialty drugs come through the development pipeline, employers are finding new strategies to manage the associated costs, a new report from Willis Towers Watson shows. Katie Asch, senior director and U.S. consulting pharmacy practice lead at WTW, told Fierce Healthcare that two-thirds of new drug approvals are for specialty drug products. In addition, these products are gaining approval for additional indications, Asch said. * * *

The WTW analysis groups potential solutions in financial and clinical responses, with financial options focusing on costs directly and clinical solutions focusing on utilization. For instance, utilization management tools like prior authorization can ensure patients are taking drugs appropriately, while copay assistance programs can manage individual costs.

In addition, according to the report, employers are finding ways to deploy multiple solutions in tandem. The insurer may offer a stop-loss program that can work well in tandem with advanced strategies for chronic care management, for example. “We’re seeing plans focus a bit more attention there if they have already pulled all the levers,” she said.

The report also highlights some drug products that are expected to get the Food and Drug Administration’s OK in the coming months. Ponesimod, a therapy for multiple sclerosis, is expected to be approved around March 18 and would cost between $60,000 and $80,000 per year.

The Pause plus Tuesday Tidbits

Photo by Patrick Fore on Unsplash

Here is a link to the joint Food and Drug Administration / Centers for Disease Control statement on the recommended pause in administration of the Johnson and Johnson single dose COVID-19 vaccine that the agencies issued this morning. Becker’s Hospital Review reports that pharmacies and State governments administering the vaccine have implemented this recommendation.

Next steps —

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these [six] cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

STAT News adds

Experts applauded the decision as the right thing to do.

“The pause is a prudent step to take, because when very serious adverse events occur that are also very rare, what matters most is ‘very serious,’” said John Moore, an immunologist at Weill Cornell Medicine. “Not only are individual members of the public at some risk, but so is the wider confidence in the Covid-19 vaccines.”

“It’s a reasonable but unproven assumption that the J&J and AstraZeneca vaccine safety concerns are linked by being related to an immune response against an adenovirus component,” he said. “So, FDA and scientists need time to better understand what is going on, which means a pause is the right course of action.”

And now for the tidbits

  • Modern Healthcare reports that the House today joined the Senate in delaying otherwise required 2% cuts in Medicare payments for the remainder of 2021. The means that CMS will be giving the Medicare Administrative Contracts its approval to resume paying Medicare claims once the President signs the bill into law.
  • Healthcare Dive reports that “Salt Lake City-based Intermountain [which sponsors an FEHB HMO] is acquiring air ambulance company Classic Air Medical in a bid to better coordinate virtual and physical care for rural patients. Snapping up Classic, which operates aircraft in eight western states and has a significant overlap with Intermountain’s telehealth footprint, is meant to make it easier to transport high-need patients to the closest medical facility equipped for their needs, the nonprofit system said in a Monday statement.”
  • The Department of Health and Human Services “have published several new resources to help states, vaccination providers, and others leading COVID-19 response activities improve access to vaccines for people with disabilities and older adults. These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them – to ensure accessibility.”
  • FedSmith explains “the Difference Between Postponed and Deferred FERS Retirement While postponed and deferred retirement sound similar, there are big differences for FERS federal employees who retire early with these options.” You only receive lifetime FEHB coverage in retirement with a postponed FERS retirement.
  • The trade association of prescription drug manufacturers Phrma has launched a new public relations campaign about its patient centered agenda while the Campaign for Sustainable Rx Prices “launched [its own] campaign Tuesday encouraging policymakers to act on campaign promises to hold Big Pharma accountable and lower prescription drug prices.” And so it goes.

Monday Roundup

Photo by Sven Read on Unsplash

Bloomberg reports that

The Covid-19 variant that’s become the dominant strain in the U.S isn’t as deadly as earlier research indicated, although it’s confirmed to be faster-spreading than other versions, according to a study.

Among 339 patients with the coronavirus, 36% of those infected with the B.1.1.7 strain that arose in the U.K. became severely ill or died, according to research published Monday in the Lancet Infectious Diseases journal, compared with 38% of those who had non-B.1.1.7 infections.

“We’re not saying it’s nothing, but it’s not worse in terms of outcome in our study, in our setting,” said Eleni Nastouli, a co-author of the study and an associate professor at University College London. She noted that the study differed from some earlier research, looking at patients in hospitals, rather than in the community, and making precise identifications of variants with whole-genome sequencing.

Earlier data released by a U.K. advisory group and cited by the U.S. Centers for Disease Control and Prevention indicated that B.1.1.7 might be as much as a third more deadly than other variants of the virus. 

FLASH: Bloomberg reports Tuesday morning that

U.S. health officials recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine on concerns about rare and severe blood clotting side effects. A type of brain blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets in six women between the ages of 18 and 48, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration said Tuesday in a joint statement. As of April 12, more than 6.8 million doses of the vaccine have been administered, the agencies said.

If you had to pause one of the vaccines this would be the week to pause the Johnson & Johnson vaccine due to the manufacturing / distribution problems. Fingers crossed for a short pause.

The Department of Health and Human Services today

marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventative care in rural areas to improve maternal health outcomes. HHS Secretary Xavier Becerra announced that Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery. A new data brief shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months post-partum and disruptions in Medicaid coverage often lead to periods of uninsurance, delayed care, and less preventive care. The American Rescue Plan provides an easier pathway for states to extend Medicaid postpartum coverage from 60 days to 12 months.

Secretary Becerra also announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population. For the first time, applicants are required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

For more information on the fourth Black Maternal Health Week, check out the Black Mamas Matter Alliance’s website.

From the prescription drug front —

  • Cigna’s Evernorth unit, which includes the Express Scripts PBM, has released its 2020 Drug Trends report. The report’s by the numbers webpage is quite illuminating.
  • STAT News informs us that

Patrizia Cavazzoni has been named the permanent leader of the Food and Drug Administration’s Center for Drug Evaluation and Research, the agency’s acting commissioner, Janet Woodcock, announced Monday morning. The position of CDER director is one of the most influential at the sprawling agency. Cavazzoni, who is in her late 50s, was handpicked by Woodcock to join the agency in 2018 and has been leading the drug center in an acting role since last spring. Cavazzoni is known as a problem-solver who has taken on some of the FDA’s most pressing problems, former top FDA officials told STAT last year.

From the healthcare technology front —

Healthcare Dive lets us know that

Microsoft is acquiring clinical documentation and artificial intelligence company Nuance Communications for $19.7 billion, two years after first inking an R&D partnership with the speech-to-text market leader. The Redmond, Washington-based tech giant said Monday it has entered into a definitive agreement to acquire Nuance for $56 a share — a hefty price tag, representing a 23% premium on the closing price on Friday. Nuance develops conversational artificial intelligence and cloud-based ambient clinical intelligence for doctor’s offices and hospitals.

Jingle bells to Nuance Communications. Healthcare AI is obviously a big deal.

  • Becker’s Hospital Review reports that “Google is in the early stages of a new project that aims to explore and develop a new consumer-facing health records tool for Android users, according to an April 9 STAT report. * * * The project could support the development of a medical records tool similar to Apple’s Health Records app, according to the report.”

Finally here’s an interesting smoking cessation twist from Healio:

A parental smoking intervention was effective and “inexpensive” to implement in pediatric primary care practices, with costs per quit that were comparable to other interventions, according to researchers. * * * “The impetus for screening parents for tobacco use in the pediatric setting is to protect children from exposure to secondhand smoke,” Douglas E. Levy, PhD, MPH, associate professor of medicine at Harvard Medical School and associate investigator at the Mongan Institute Health Policy Center at Massachusetts General Hospital, told Healio Primary Care. “Parents may be more receptive to smoking cessation messages when the recommendation comes from pediatric health care providers because the benefits are framed in terms of protecting their child’s health.”

Weekend update

Congress returns to committee work and floor voting this week. On Wednesday, the Senate Homeland Security and Governmental Affairs Committee will hold a business meeting concerning the nomination of Jason S. Miller, of Maryland, to be Deputy Director for Management, Office of Management and Budget. On Thursday, the Senate Finance Committee with hold a confirmation hearing for Andrea J. Palm, of Wisconsin, to be Deputy Secretary, and Chiquita Brooks-LaSure, of Virginia, to be Administrator of the Centers for Medicare and Medicaid Service, both of the Department of Health and Human Services.

On the COVID-19 front —

  • The Center for Disease Control announced that 4.6 million COVID-19 vaccinations were administered on April 10. As of Saturday, 46% of the U.S. population over age 18 has received at least one dose of the COVID-19 vaccine and 28% of that population are fully vaccination. 78.5% of the U.S. population over age 65 have received at least one dose and 61% of that population are fully vaccinated. A Bloomberg columnist adds that

Consider one of the most at-risk populations, people over 65. As of March, they accounted for most Covid-19 deaths — about 430,000, compared with just 104,000 for people under 65. Now, though, about 55% of older folks are vaccinated, and 75% have received at least one dose — which suggests that about 65% are probably protected from death by Covid. So if the past year of cases were replayed, the U.S. would see 65% — or 280,000 — fewer deaths among the elderly, and the total death count would be cut by more than half.

New cases will probably be even less deadly. For one, the vaccination campaign has targeted the most vulnerable among the elderly — people in nursing homes and other group living arrangements — so the distribution of those who get sick will also be skewed younger and healthier now. Also, younger people — and particularly those with underlying health conditions — have been taking up the vaccine more and more. Given these trends, the mortality rate per confirmed case is likely to be a lot less than half of what it used to be.

Bravo.

There’s a late entrant into the COVID-19 vaccine race: The United States Army. And it hopes its own variety of COVID shot can protect against emerging variant strains of coronavirus, a threat which may loom large going forward and is feeding a resurgence of cases in certain regions.

On Tuesday, Army doctors began human clinical trials of the somewhat complicatedly dubbed the spike ferritin nanoparticle (SpFN) COVID vaccine candidate at the Walter Reed Army Institute of Research (WRAIR), which is housed under the Army’s medical research arm. 

Officials said that the technology behind this particular vaccine could be more effective at protecting against new strains of coronavirus, although existing COVID vaccines such as Pfizer/BioNTech’s have demonstrated efficacy against certain newer strains.

Fingers crossed.

What’s wrong with offering more good news? The AP reports that

The number of U.S. suicides fell nearly 6% last year amid the coronavirus pandemic — the largest annual decline in at least four decades, according to preliminary government data. Death certificates are still coming in and the count could rise. But officials expect a substantial decline will endure, despite worries that COVID-19 could lead to more suicides.

The number of suicides dropped by 1% in 2019 so this will be the second year in a row. The FEHBlog hope this drop is attributable to greater acceptance of mental illness, e.g., no more stigmatizing, and the major uptick in virtual mental healthcare stemming from the pandemic. Nevertheless, health plans and healthcare providers should promote the national suicide prevention lifeline. tel:1-800-273-8255.

If you have access to STAT News check out this article by Bryan Vartabedian, MD, about the portrait in the header of this post.

I couldn’t escape the painting’s draw, though I couldn’t put my finger on what I found so compelling about the image this time around.

Then it hit me. It was the intensity of the doctor’s gaze and his posture. What caught me this time was his presence. This doctor was all in.

Presence is the mindfulness that one individual brings to an encounter with another. It’s a defining element of human connection. In medicine, it’s what happens when a clinician’s connection is untrammeled by a screen or other competing inputs. It’s the focus of mind, spirit, and intent around a moment in time that’s about another person and his or her most pressing problem. Presence, be it in a clinic exam room or with a friend over coffee, is a uniquely human gift.

The good doctor suggests that the use of artificial intelligence will enable doctors to return to applying this human gift to patients. Hope springs eternally.

Cybersecurity Saturday

Cyberscoop reports

The White House on Friday [April 9, 2021] asked Congress for $110 million in additional funding in [fiscal year] 2022 to help the Department of Homeland Security shore up federal and state defenses in the wake of high-profile hacking operations. The money would allow DHS’s Cybersecurity and Infrastructure Security Agency to improve its defensive tools, hire more experts and “obtain support services to protect and defend federal information technology systems,” Shalanda Young, the acting director of the Office of Management and Budget, wrote in an April 9 letter to congressional appropriators. It would add to a recent $650 million funding boost for CISA that was part of the coronavirus relief package cleared by Congress.

A Security Week columnist ponders what cybersecurity policy changes to expect from the Biden Administration.

As the U.S. transitions to a new presidential administration, which can be expected to differ largely from the last, it is hard not to speculate how President Biden’s Administration will reduce the risk of a major cyberattack against the U.S. or her interests. The recent SolarWinds attack, widely attributed to Russian actors, further amplifies the need for improved security and deterrence. Despite my best efforts to come up with a brilliant “thought leadership” piece on what I think the Biden Administration should do, the best answer has already been written and published in March of 2020 as the 2020 Cyberspace Solarium Commission Report.

Co-chaired by Senator Angus King (I-ME) and Representative Mike Gallagher (R – WI), the bipartisan Cyberspace Solarium Commission proactively scrutinized U.S. cybersecurity in much the same way the 2004 9/11 Commission Report reactively assessed failings within the U.S. Intelligence Community (IC) and offered recommendations for sweeping changes. The Cyberspace Solarium Commission, just as the 9/11 Commission before it, made bold recommendations for significant changes that I believe President Biden will likely use as the blueprint for restructuring how America operates in cyberspace.

The columnist focuses on the Solarium Commission’s recommendations to update the national cybersecurity policy, seat a national cybersecurity director, and improve the pipeline of cybersecurity talent.

Per the FBI, its “Internet Crime Complaint Center (IC3) has released its annual report [for 2020], which includes information from 791,790 complaints of suspected Internet crime—an increase of more than 300,000 complaints from 2019—and reported losses exceeding $4.2 billion. Notably, 2020 saw the emergence of scams exploiting the COVID-19 pandemic. The IC3 received over 28,500 complaints related to COVID-19, with fraudsters targeting both businesses and individuals.”

The Wall Street Journal reported last Wednesday that

Data from a 2019 hack of Facebook Inc. was made public in recent days, revealing the phone numbers and personal information of more than a half-billion people. While the data came from a vulnerability of Facebook platforms that the company says it has since fixed, security experts say that scammers could use the information for nefarious purposes like spam email and robocalling.

The hackers began selling the data online to bidders soon after it was accessed. Alon Gol, chief technology officer of the Israeli cybersecurity firm Hudson Rock, said it was initially sold for tens of thousands of dollars, and the price kept dropping until it was recently made available for free on sites like raidforums.com. Hackers often release data for free once it has been circulated long enough, said Zack Allen, senior director of threat intelligence at ZeroFOX, a Baltimore-based cybersecurity company.

[S]ome cybersecurity experts have created sites that allow people to see if their information was contained in data leaks. One such site is haveibeenpwned.com, where you can enter your phone number or email address and see the result. The website, which allows people to check if their information was swept up in different data breaches, was created by Australian web-security consultant Troy Hunt.

The FEHBlog checked his gmail address on this site and he discovered that his email address “pwned” in 14 different breaches since 2012. The FEHBlog has gone the double authentication route with that address. By the way pwn means “especially in video gaming) utterly defeat (an opponent or rival); completely get the better of. “I can’t wait to pwn some noobs in this game.”