Monday Roundup

CDC

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, HSA, OPM, Rx coverage, U.S. Healthcare–
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

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM–
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.

Friday Stats and More

David Ermer–CDC, COVID-19, Rx coverage, U.S. Healthcare–

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

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
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

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–

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

David Ermer–CDC, Congress, COVID-19 vaccine, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
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.

Midweek Update

David Ermer–ACA, CDC, CMS, COVID-19, Federal employment benefits, U.S. Healthcare–
Photo by Manasvita S on Unsplash

Bloomberg reports today that

The B.1.1.7 variant of the coronavirus, first found in the U.K., has overtaken the initial form of the virus in the U.S. and is now the country’s most common strain, the head of the Centers for Disease Control and Prevention said Wednesday. CDC Director Rochelle Walensky said at a briefing that the version had overtaken other mutations that have emerged, as well as the initial version of the virus in the U.S.

The Centers for Disease control has identified the B.1.1.7 variant as a “variant of concern” which means

A variant for which there is evidence of an increase in transmissibility, more severe disease (increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.

Here is the CDC’s breakdown on the B.1.1.7. variant:

Name
(Pango lineage)		Spike Protein SubstitutionsName
(Nextstraina)		First DetectedBEI Reference IsolatebKnown Attributes
B.1.1.7Δ69/70
Δ144Y
(E484K*)
(S494P*)
N501Y
A570D
D614G
P681H		20I/501Y.V1United KingdomNR-54000external icon~50% increased transmission 5

Likely increased severity based on hospitalizations and case fatality rates 6
Minimal impact on neutralization by EUA monoclonal antibody therapeutics 7, 14
Minimal impact on neutralization by convalescent and post-vaccination sera 8,9,10,11,12,13,19

WebMD adds that “Of the three “variants of concern” recognized by the World Health Organization and the CDC, studies have shown that the mRNA vaccines created by Pfizer/BioNTech and Moderna, as well as the Novavax vaccine, remain highly effective against the B.1.1.7 variant, which was first recognized in the United Kingdom. * * * Johnson & Johnson, Moderna, and Pfizer are all exploring options to make their vaccines more effective against the variants [of concern].”

The Wall Street Journal offers a helpful tip — “Pharmacies and health officials are making a plea to Americans who received their Covid-19 vaccines: Cancel the other shots you booked.” That is sensible advice.

The Department of Health and Human Service reports today that “more than half a million consumers have already signed up for health insurance through HealthCare.gov as a result of the Biden Administration’s Special Enrollment Period (SEP) for the COVID-19 Public Health Emergency. * * * Today’s report from the Centers for Medicare & Medicaid Services (CMS), which covers plan selections from February 15 to March 31, also shows gains in enrollment among historically uninsured communities, including Black consumers and Americans near the poverty level. Of applicants who identified a race, 17% identified as Black – compared to about 11% in both 2020 and 2019 during the same time period. Among consumers requesting financial assistance, 41% report being at or slightly above the federal poverty level, compared to 38% in 2020 and 33% in 2019.” The SEP continues until August 15, 2021. Will / can HHS make the open enrollment permanent?

In other heathcare / healthcare business news:

  • Healthcare Dive reports “UnitedHealth Group has named longtime executive Brian Thompson as the new chief executive officer of its health benefits business, UnitedHealthcare, the biggest private payer in the U.S.”
  • The CDC discusses the “Surprising Link Between Chronic Kidney Disease, Diabetes, and Heart Disease.”

Risk factors for each condition are similar and include high blood sugar, high blood pressure, family history, obesity, unhealthy diet, and physical inactivity.

High blood sugar can slowly damage the kidneys, and, over time, they can stop filtering blood as well as they should, leading to CKD. Approximately 1 in 3 adults with diabetes has CKD.

When the kidneys don’t work well, more stress is put on the heart. When someone has CKD, their heart needs to pump harder to get blood to the kidneys. This can lead to heart disease, the leading cause of death in the United States. Change in blood pressure is also a CKD complication that can lead to heart disease. Luckily, preventing or managing one condition can help you prevent and manage the others and lower the risk for more complications [as explained in the article].

  • The Labor Department today issued FAQs and model forms to help ERISA governed plans implement the free COBRA continuation coverage available from April 1 through September 30, 2021, for COBRA-eligible folks who lost their ERISA coverage due to an involuntary termination or reduction in hours. This offer does not extend to FEHB enrollees who are covered under a different continuation of coverage program colloquially known as TCC>
  • Fedweek offers Reg Jone’s column on benefits available on the death of a current federal employee. These are very valuable rights that protect the employee’s family.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Bloomberg reports that “President Joe Biden said [today] he wants all American adults eligible for a coronavirus vaccine by April 19, two weeks earlier than his previous goal. All but two states are already set to meet that goal, with Oregon and Hawaii having planned to open up vaccines to all non-minors on May 1.”

Yesterday, the Centers for Disease Control (“CDC”) released a report finding that “The principal mode by which people are infected with SARS-CoV-2 (the virus that causes COVID-19) is through exposure to respiratory droplets carrying infectious virus. It is possible for people to be infected through contact with contaminated surfaces or objects (fomites), but the risk is generally considered to be low.” As this BBC News article illustrates, last Spring we were quite worried about contracting COVID-19 from contaminated surfaces. In any event, thank heavens that we have the vaccines.

Federal News Network reports that front line federal employee access to the COVID-19 vaccine depends upon their employing agency.

If you are a federal employee working in the field, like Food and Drug Administration inspectors, Forest Service rangers or Custom and Border Protection officers, getting a COVID-19 vaccine from your agency isn’t a sure thing.

The Department of Homeland Security is making an all-out effort to vaccinate all 300,000 employees.

Other agencies like the Agriculture Department or the IRS are asking employees to take a path through their state and local governments.

This inconsistent application of agency support for “frontline” workers to receive one of the three inoculations has the potential to create a have and have nots among agencies.

Hopefully as the COVID-19 vaccine supply continues to expand and access restrictions are removed, these unfortunate quirks in the process will be ironed out quickly.

In other healthcare related tidbits

  • On April 12, the CDC will be sponsoring its decennial meeting on healthcare associated infections.
  • The Food and Drug Administration released a COVID-19 update today. The FEHBlog wonders when the FDA will take up granting full marketing approval for the Pfizer and Moderna vaccines and when AstraZeneca will file an emergency use authorization with the FDA for its COVID-19 vaccine. Those steps take us closer to ironing out the process quirks.
  • MedPage Today reports that

A personalized, hands-on care strategy for patients struggling with addiction was effective at reducing hospital readmission, a randomized trial found. In a comparison of hospitalized adults with substance use disorder involving opioids, cocaine, or alcohol, those who received Navigation Services to Avoid Rehospitalization (NavSTAR) care saw far better outcomes than those who simply received treatment as usual, according to Jan Gryczynski, PhD, of the Friends Research Institute in Baltimore, and colleagues.

  • Health Payer Intelligence informs us that

A digital therapeutic weight loss program led to major medical cost savings, according to a Rally Health Inc. study that points to wellness programs as cost-effective strategies to tackle the obesity epidemic. The study published in Obesity examined program data over a three-year period to analyze medical cost trends for those participating in Rally Health’s Real Appeal weight loss intervention program.

Researchers compared medical costs for a group of participants in the digital therapeutic wellness program with costs for a control group of non-participants. The control group was selected to match the intervention group in terms of health risk, baseline medical costs, age, gender, geographic region, and chronic conditions.

The study found that the wellness programming resulted in significant weight loss. There was an average weight loss of 3 percent for 4,790 program participants who attended at least one session over a 52-week period. In addition to providing positive member outcomes, the wellness program lowered medical expenditures significantly. Costs for the intervention cohort were 12 percent less than costs for the control group. What’s more, the savings of the wellness program cohort were 2.3 times more than program costs, marking significant return on investment.

  • Adam Fein reports in his Drug Channels blog that

The drug channel is consolidating, both vertically and horizontally. For evidence, look no further than Drug Channels Institute’s estimates of pharmacy benefit manager (PBM) market share, which are shown in the chart below. For 2020, DCI estimates that the three biggest PBMs [CVS Health (including Caremark and Aetna), the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group] accounted for more than three-quarters of total equivalent prescription claims. * * * This concentration helps plan sponsors and payers, which can maximize their negotiating leverage by combining their prescription volumes within a small number of PBMs. 

Weekend update

David Ermer–ACA, CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM–
Photo by Michele Orallo on Unsplash

Happy Easter!

Congress remains on State/district work breaks for the coming week.

As of the beginning of this week, according the CDC’s website, 75.4% of the U.S population over age 65 and 40.2% of the U.S. population over age 18 has received at least one dose of the COVID-19 vaccine. 54.5% of the over age 65 population and 23.2% of the over 18 age population have been fully vaccinated.

That’s progress. Here are a couple of interesting angles on the vaccine distribution process:

  • The Wall Street Journal reports that “Johnson & Johnson’s Covid-19 vaccine has found a niche among organizations that work with the homeless, who say the one-dose shot is better-suited for a population that can be difficult to reach twice.”

[H]ealthcare workers say they have been surprised to find many homeless people specifically requesting the J&J vaccine, which is branded as Janssen, a unit of J&J. Some of them point out that the shot was still effective even though it was tested after Covid-19 variants entered the mix. Others say they are worried about getting a vaccine once, let alone twice, given the potential side effects.

“If you’re in a shelter, or don’t have a home, those side effects are different than if you can stay at home,” said Bobby Watts, chief executive of the National Health Care for the Homeless Council, which supports hundreds of providers that cater to the homeless.

  • Health Payer Intelligence informs us that “To ensure COVID-19 vaccine access for homebound individuals, the Commonwealth of Massachusetts has partnered with the Commonwealth Care Alliance (CCA), a health plan that says it has proven best practices for vaccinating this population.” “The Commonwealth defines a “homebound” individual as anyone who needs assistance from two or more people to leave home. In Massachusetts, there are about 20,000 individuals who meet this definition.”

As one of the first healthcare organizations in the country to vaccinate homebound individuals, CCA has also been part of the national discussion around strategies to ensure COVID-19 vaccine access for this population. Last month, CCA joined AHIP in briefing the White House, promoting the prioritization of homebound individuals in COVID-19 vaccine delivery efforts and underlining CCA’s best practices in this endeavor.

Speaking of AHIP, the organization on Friday announced

AHIP’s new SEP landing page also features other important resources to help guide consumers through the SEP, including fast facts, an educational blog, a link to a Get Covered Connector tool offered by Young Invincibles, and a link to a Health Insurance Marketplace Calculator provided by the Kaiser Family Foundation.

“Health insurance coverage is an important way to protect your health and financial stability, especially during the COVID-19 pandemic,” said Matt Eyles, president and CEO of AHIP.  “Health insurance available through the individual marketplaces cover products and services such as COVID-19 care and vaccines, mental health care and support, $0 copay preventive care, regular doctor visits and prescription medications to keep you healthy, and much more.”

In other COVID-19 news, Kaiser Health News provides details on over-the-counter COVID-19 testing kits.

Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. * * *

[M]any experts support the widespread distribution of cheap, rapid tests, even if they aren’t as sensitive as lab-run alternatives, and see a demand. In Germany, the supermarket chain Aldi began selling rapid tests in early March, roughly $30 for a five-pack, and sold out within hours. One recent study found that if a pack of tests was mailed to every household in the U.S. — even assuming that up to 75% would go into the garbage — they would save thousands of lives and avert millions of infections. “Don’t let perfect be the enemy of good,” said study co-author and Yale University professor A. David Paltiel. “This doesn’t have to work perfectly to make a huge difference.”

The Federal News Network shares opinions that it obtained from former OPM officials on the recent National Academy of Public Administration report on the agency.

Janice Lachance, the Clinton-era OPM director, sees the budget as a good starting point for the Biden administration and the new director. The president nominated Kiran Ahuja, a former chief of staff for the agency, for the role.

“The new director has a tremendous opportunity to go in there, do a very effective assessment of the situation and make a reasonable request that covers all of the things that need to be done — and that we want to do,” said Lachance, who currently serves as an executive vice president for the American Geophysical Union. “The NAPA report is very aspirational. What is it going to take to get OPM from where it is today to this desired state that’s articulated in the NAPA report over how many years?”

The new director, Lachance added, will need to make the case why an empowered OPM will help resolve the federal government’s talent problems.

Friday Stats and More

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

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 13th week of this year (beginning April 2, 2020, and ending March 31, 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 one year period (April 2, 2020 through March 31, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through March 31, 2021, which also uses Thursday as the first day of the week:

Bloomberg reported this afternoon that

More than 101 million people in the U.S. have received a first dose of a Covid-19 vaccine, or about 31% of the population.

Less than four months into the U.S. vaccination effort, coverage is best in people 65 years or older, with 74% of the group getting at least one dose and 54% completing vaccination, according to figures published by the Centers for Disease Control and Prevention and compiled by the Bloomberg Vaccine Tracker.

On Friday, the U.S. set a one-day record for vaccine doses reported administered, adding almost 4 million. On average, the U.S. is administering close to 3 million shots a day as of Friday’s update, also a record.

In other COVID-19 vaccination news

  • Fierce Pharm reports that Johnson & Johnson which offers a one dose vaccine has joined the two dose vaccine manufacturers Pfizer and Moderna in its vaccine on adolescents aged 12-17.
  • The Society for Human Resource Management informs us that

The following measures may increase vaccine acceptance in the workforce, according to the CDC:

1. Train interested staff to become COVID-19 vaccination ambassadors who will speak confidently and honestly, relaying personal stories about the vaccine to fellow co-workers and addressing any of their concerns.

2. Employ all available communication tools when promoting the COVID-19 vaccine to staff, including social media, internal communication channels, and posters or signs around the workplace.

3. Hold a virtual town hall where leadership, respected local medical experts and staff share their COVID-19 vaccine experiences and other vaccine facts and answer audience questions. Use experts to communicate to staff when talking about the COVID-19 vaccine. Ensure the experts present facts about the vaccine, including the risks.

4. Consider giving employees paid time off to get the vaccine and offering paid sick leave for employees who have adverse reactions.

5. Have workplace leadership take the COVID-19 vaccine, capture their experience using video or photo, and share the experience with staff.

  • In this regard, Govexec.com reports that

Next week, the Health and Human Services Department plans to open a vaccination site for federal employees in the National Capital Region.

A source familiar with the plans told Government Executive on Friday that the site will be in Gaithersburg, Maryland. “The site will provide COVID vaccinations to federal, essential, critical infrastructure workers,” said the source. Federal agencies will determine eligibility based on “job duties and [the Cybersecurity and Infrastructure Security Agency’s] guidance on the essential, critical infrastructure workforce,” which includes 24 agencies.  

The source was unsure at the moment on how many vaccine doses will be available or how many employees will be able to receive them. Employees will be notified starting Friday, April 2, the source said.

In health benefits news —

  • The Labor Department’s Employee Benefits Security Administration released ACA FAQ 45 today. FAQ 45 provides compliance guidance on Section 203 of Division BB of the Consolidated Appropriates Act 2021. Section 203 requires health plans, including FEHB plans, to prepare and keep current written analyses demonstrating compliance with the non-quantitative treatment limitations requirements of the federal mental health parity law and implementing regulations.
  • Fierce Healthcare explains how Optumcare successfully expanded the use of at home colon cancer screenings during the pandemic.

OptumCare used data analytics to flag the patients at risk for colon cancer and then reached out to them about the home test kits. While the kits included an information letter to describe the process, the clinical team also followed up four times by phone to check in with them.

If the testing results were positive or abnormal, the patient’s physician or care team would reach out directly to explain what the results meant and schedule them for future appointments to ensure care was coordinated throughout the process.

Frank said OptumCare saw a 5% higher return rate under the expanded program than in previous years, and the increased engagement drove interest in expanding other home health options such as home testing for blood glucose among diabetic patients.

  • Fierce Healthcare also informs us that

The American Medical Association innovation subsidiary Health2047 has spun off a company that uses personalized medicine to fight obesity. Phenomix Sciences is a phenotype testing company that carries out the AMA’s mission to confront chronic diseases such as obesity.

Phenomix uses a blood test called MyPhenome that it has licensed from the Mayo Clinic to allow doctors to prescribe individualized therapies. MyPhenome measures DNA as well as a person’s metabolites and hormones. These biomarkers make up a person’s phenotype, according to Phenomix.

The company’s blood-based test uses phenotype-driven multi-omics technology to predict responses to obesity interventions that the Food and Drug Administration (FDA) has approved. A multi-omics test is important because testing for obesity involves multiple factors, including genetics, metabolomics and environmental aspects, according to Phenomix CEO Mark Bagnall.

Because patients respond differently to obesity treatment, the Phenomix founders turned to AI to personalize this treatment. AI can personalize a multi-omics obesity test and analyze single-nucleotide polymorphisms, metabolites and hormones that correspond with a certain obesity phenotype, according to Bagnall.

AI can help identify a specific obesity phenotype so patients can receive the right treatment.

“[We] demonstrated in several clinical studies that knowing a patient’s phenotype doubles the likelihood of weight loss and doubles the amount of weight lost,” Bagnall said.