Midweek Update

Midweek Update

It’s another rainy night in Bethesda.

Fierce Pharma reports that “the U.S. has ordered 800 million doses [of various COVID-19 vaccines currently in phase 3 testing] for a country with a population of about 330 million, likely under the assumption that some vaccines won’t make it through clinical testing. The government is “assembling a broad portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS secretary Alex Azar said in a statement.”

The Wall Street Journal informs us that

Doctors, nursing homes and federal officials are scrambling to get rapid-response Covid-19 antigen testing supplies from the two companies that secured emergency approval to produce them, as cases continue to rise in the U.S.

Rapid-response antigen tests make up a small but growing area of Covid-19 testing in the U.S. and are seen as helpful in tamping down outbreaks because they offer faster results than many molecular tests that must be sent to labs for processing. The tests search for virus proteins while other tests look for the virus’s genetic material.

Quidel Corp. QDEL 4.36% and Becton Dickinson & Co., the only companies that so far have federal emergency authorization to supply such diagnostic tests, also make machines that process them. The boxlike test-analyzers, which before the pandemic processed tests for ailments such as the flu, are found in doctors’ offices and nursing homes, allowing facilities to avoid shipping samples to commercial labs for processing. They can deliver results in about 15 minutes and process dozens of samples an hour.

Quidel is struggling to produce enough analyzers to meet demand, while Becton Dickinson’s challenge is making enough tests, the companies say. * * *

Public health officials have raised some concerns that rapid antigen tests deliver false-negative results at a higher rate than other tests. But federal officials have said that, as these tests become more widespread, they appear equal in sensitivity to the more broadly used polymerase chain reaction diagnostic tests.

Perhaps Kodak can help (FEHBlog humor).

Fierce Healthcare lets us know that “According to the J.D. Power 2020 U.S. Pharmacy study, the expansion of pharmacy companies into the primary care realm has driven ‘significant increases in both satisfaction and consumer spending.'” On a related note, Forbes reports that “CVS Health is back on track with the rollout its new health hub concept to 1,500 stores across the U.S. within the next two years despite the continuing spread of the coronavirus strain Covid-19. CVS Health currently has 205 HealthHubs opened in 22 states. “CVS HealthHubs dedicate more than 20% of the store to health services that include new durable medical equipment, supplies and various new product and service combinations. CVS is adding thousands of new personal care items as well as additional services at its MinuteClinics in the HealthHub stores.”

The Centers for Medicare and Medicaid Services announced today its proposed national coverage decision that would allow local Medicare administrative contractors to make the initial decision on whether to cover an artificial heart or a ventricular assist device for Medicare beneficiaries with end stage heart disease. Currently the devices are treated as experimental treatments that CMS can cover on an exception basis. The CMS announcement explains that 6.5 million Americans “are living with heart failure.” A CMS decision whether or not to finalize the proposal will be made within 60 days following the end of the 30 day public comment period which began today.

Earlier this week the Centers for Disease Control announced their “Hear Her” campaign to reduce maternal mortality.

Over 700 women die each year in this country from problems related to pregnancy or delivery complications. Every death is a tragedy, especially when we know that two thirds of pregnancy-related deaths could be prevented. As many as 50,000 women experience severe, unexpected health problems related to pregnancy that may have long-term health consequences.

CDC’s Division of Reproductive Health is committed to healthy pregnancies and deliveries for every woman. The Hear Her campaign supports CDC’s efforts to prevent pregnancy-related deaths by sharing potentially life-saving messages about urgent warning signs.

Women know their own bodies better than anyone and can often tell when something does not feel right. The campaign seeks to encourage partners, friends, family, coworkers, and providers—anyone who supports pregnant and postpartum women—to really listen when she tells you something doesn’t feel right. Acting quickly could help save her life.

How true. This campaign deserves support from health plans as well as healthcare providers.

Friday Stats and More

Here you friends. This chart is based on the CDC’s cases in the US statistics running on a Thursday to Wednesday weekly basis from May 14 through July 30:

As of today there have been 4,473,974 COVID-19 cases and 151,499 deaths in our country. Purely for context, in winter’s flu season there were 39 million cases of the flu and 24,000 related deaths again according to the CDC.

Here’s is the latest chart of weekly rates of COVID-19 hospitalizations:

A friend of the FEHBlog shared with him these interesting National Institutes of Health statements on new types of COVID-19 testing and the state of COVID-19 treatments. Also here’s a related HHS update on COVID-19 testing.

Have a good weekend.

Thursday Miscellany

Fierce Biotech reports on other successful double blind studies of COVID-19 vaccines on non-human primates / monkeys. It’s interesting and encouraging that the manufacturers are taking varied approaches to COVID-19 vaccine development. Thanks monkeys.

The Department of Health and Human Services has launched a public service advertising campaign asking COVID-19 survivors to donate plasma for the convalescent plasma treatment nearing FDA emergency authorization. That may be a good initiative for health plans and providers to promote as well.

Bear in mind this Wall Street Journal article reminding COVID-19 survivors that the length of time that the body’s antibodies protects survivors from COVID-19 reinfection is as yet unknown.

USA Today offers a hopeful article about the ongoing development of rapid, inexpensive at-home COVID-19 testing. What’s more, “The XPRIZE, a nonprofit that designs and hosts public competitions, announced Tuesday that it would split a $5 million prize among five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15.”

HR Dive discusses the impact of recent CDC changes its COVID-19 self quarantine guidelines for non-hospitalized COVID-19 patients on employer return to work policies. As with most COVID-19 personnel issues, it’s complicated.

Thursday Miscellany

On the COVID-19 front —

  • The Wall Street Journal reports that in the course of reporting its second quarter 2020 financial results, Johnson & Johnson (“J&J”) announced that “it plans to begin the first human studies of its experimental coronavirus vaccine next week, as it races to make the shot available starting early next year. * * * J&J could get an answer about whether the vaccine safely prevents Covid-19 by the end of the year, Dr. Stoffels said. If successful, the company expects the shot to become available in early 2021, and J&J plans to manufacture up to one billion doses by the end of next year.
  • Fierce Healthcare provides an update on the state of COVID-19 testing in our country. “Admiral Brett Giroir, M.D., Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS) said 45 million COVID-19 tests had been performed in the U.S. so far, or about 700,000 a day. “We see early indicators that in the hot areas, the red zones, we’re seeing the positivity rate start to go down or plateau. That’s an early sign that we’re getting control of this outbreak,” he said. “This is no victory lap, but it does show that our efforts are starting to make an impact,” he said. “In Arizona, the positivity rate has dropped dramatically.” Giroir said basic, simple measures will help to curb the pandemic, namely, closing bars and indoor dining at restaurants and individuals adhering to guidance to wear masks in public, practice social distancing and avoid large groups.” Good message.

Regrettably, the Wall Street Journal also reports that

U.S. fatal drug overdoses rose last year, new federal data show, reversing a one-year-decline and indicating that another public-health crisis was worsening as the coronavirus pandemic was poised to begin.

Provisional data from the Centers for Disease Control and Prevention include 70,980 fatal overdoses in 2019 with about 1,000 more deaths likely to be added, marking a 4.8% increase from the year before. The data indicate the U.S. last year likely eclipsed the prior record high of 70,237 overdose deaths set in 2017, said Robert Anderson, chief of the mortality-statistics branch at the CDC’s National Center for Health Statistics.

[P]roblems with synthetic drugs like methamphetamines and bootleg versions of the opioid fentanyl have challenged the nation’s ability to build on improvements. Overdose deaths in drug categories including meth and fentanyl continued to rise last year, the CDC data show, while deaths from cocaine, another stimulant, also rose.

Jim Hall, an epidemiologist in Florida who has studied the drug crisis, said the rising availability of the overdose-reversal drug naloxone helped tamp down the number of fatal overdoses in 2018. But the toxicity of fentanyl and the mixture among many users of both fentanyl and stimulants remain potentially deadly problems, he added.

For more details here’s a link to the CDC report.

The CDC also released a public health report today about the use of prescription opioids by pregnant women.

Among respondents reporting opioid use during pregnancy, most indicated receiving prescription opioids from a health care provider and using for pain reasons; however, answers from one in five women indicated misuse. Improved screening for opioid misuse and treatment of opioid use disorder in pregnant patients might prevent adverse outcomes. Implementation of public health strategies (e.g., improving state prescription drug monitoring program use and enhancing provider training) can support delivery of evidence-based care for pregnant women.

Tuesday Tidbits

The Senate Health Education Labor and Pensions Committee held a hearing this morning on progress made in reopening schools and businesses from the great hunkering down. Fierce Healthcare reports on the hearing here.

The Department of Health and Human Services announced today the extension of “its partnership with national pharmacy and grocery retail chains CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and eTrueNorth (through services at Kroger, Health Mart, and Walmart) so they may continue to seamlessly provide Americans convenient access to COVID-19 testing. The partnership, which is part of the Community-Based Testing Program, has scaled up to more than 600 COVID-19 testing sites in 48 states and the District of Columbia. Approximately 70% of these testing sites are located in communities with moderate-to-high social vulnerability, as evidenced by their racial, and ethnic composition, and their housing, economic, language barrier, and similar considerations.” “The [partnership] contract utilizes a federal bundled payment program paid directly to retailers that receive a flat fee for each test administered, with participating retailers responsible for coordinating the full end-to-end testing.” So far the collaborative program has tested 750,000 Americans. That makes sense.

The Office of Management and Budget’s Office of Information and Regulatory Affairs issued its anxiously awaited Spring 2020 regulatory agenda. The regulatory agenda tells you what’s baking in each agency’s regulatory oven but you can rely on the oven timers’ shown in the reports. Here’s a link to OPM’s “rule list.” Nothing earth shaking to report.

The FEHBlog’s favorite healthcare quality consulting firm, Discern Health, notes the release of the National Health Quality Roadmap by the Department of Health and Human Services. “The National Health Quality Roadmap highlights not only many of the challenges that have been faced by health care stakeholders across the quality environment, but also a plan for addressing them,” Discern Health Vice President Donna Dugan said. “It will be important for stakeholders across the continuum to participate where possible in order to facilitate this transformation and aid in the realization of quality goals.”

Becker’s Hospital Review reports on a class action settlement of a phishing attack related lawsuit against UnityPoint Health which is based in Iowa. ‘The class action lawsuit alleges the health system didn’t notify [over 16,000] patients of the breach in a timely manner and told patients Social Security numbers weren’t compromised, but they were.’ The settlement is valued at $2.8 million.

For what it’s worth, Forbes reports an IRS announcement that that “the 2019 tax filing deadline remains July 15, 2020.” Forbes considers and the FEHBlog agrees that this will be the IRS’s final work on the topic. Also the Labor Department yesterday added q&a 93 to its list of frequently asked questions on the Families First Coronavirus Response Act’s paid leave program

Weekend update

The House of Representatives and the Senate both will be in session on Capitol Hill this coming week, Of note from an FEHBP perspective is that Senate Homeland Security and Governmental Affairs Committee has scheduled a confirmation hearing for the President’s nominee for OPM Inspection General, Craig E. Leen, for Tuesday June 2 at 2:30 pm. Mr. Leen currently is Director of the Office of Federal Contract Compliance Programs (OFCCP) at the U.S. Department of Labor. The FEHBlog plans to tune in.

The Supreme Court heads into the home stretch of its October 2019 term tomorrow. The Court has 25 decisions left to issue before adjourning for the summer according to the Scotusblog.

OPM released more COVID-19 guidance last Friday. This guidance concerns preparedness for returning to OPM facilities.

Fierce Healthcare brings us up to date on COVID-19 testing at home options. The latest product receiving FDA approval is offered by Quest Diagnostics a/k/a Quest Labs.

The FEHBlog ran across on Twitter today this May 24 column from Reason senior editor Jacob Sillum.

According to the Centers for Disease Control and Prevention (CDC), the current “best estimate” for the fatality rate among Americans with COVID-19 symptoms is 0.4 percent. The CDC also estimates that 35 percent of people infected by the COVID-19 virus never develop symptoms. Those numbers imply that the virus kills less than 0.3 percent of people infected by it.

The FEHBlog also found this reassuring (at least to the FEHBlog) Science News article on COVID-19 mutations.

[C]oronavirus mutations are guaranteed to pop up over the coming months — and experts will continue to track them. “The data will tell us whether we need to worry, and in what way we need to worry,” [Louise] Moncla[, an evolutionary epidemiologist at the Fred Hutchinson Cancer Research Center in Seattle] says. “Everyone should take a deep breath and realize that this is exactly what we’ve always expected to happen, and we don’t necessarily need to be concerned.”

Thursday Miscellany

In accordance with law, the Internal Revenue Service released today 2021 inflation adjustments to health savings account contribution limits and minimum deductibles for related high deductible health plans as described in Section 223 of the Internal Revenue Code. Only high deductible benefit plan participants may contribute to health savings accounts.

According to Fierce Healthcare, CVS Health today announced a major expansion of their drive up COVID0-19 testing sites.

Starting Friday, the retail and pharmacy giant will open nearly 300 additional test sites across 14 states for a total of nearly 350 available test sites in Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts, New Jersey, New York, Pennsylvania and Texas.The company said it plans to establish up to 1,000 locations across the country by the end of May with the goal of processing up to 1.5 million tests per month.

Finally, there will be a drive up testing site located in Montgomery County, MD, where the FEHBlog lives.

Healthcare Dive wrote a follow up report on the Commonwealth Fund study mentioned in yesterday’s post.

Telehealth visits that exploded in recent months are starting to plateau and in some cases decline in popularity as doctor’s offices reschedule backlogged patients for more in-person appointments, according new data from The Commonwealth Fund. Telemedicine visits accounted for about 14% of all total visits the week of April 19, according to the report, but that number dropped to 13% the next week and 12% the week after that. Telehealth visits held at 12% for the first two weeks of May.

In this regard, a Health Affairs Blog article discusses how primary care can be rejuvenated in the wake of the COVID-19 emergency. The number one suggestion is

Ending the hegemony of the face-to-face visit and rebalancing the appointment template toward 50 percent distance visits are likely to improve patient access while reducing work and burnout.

Studies are mixed but suggest that e-visits and phone visits reduce the number of face-to-face visits and take less time for clinicians and staff. When the Kaiser Permanente system in Hawaii massively changed its primary care model in 2004—with e-visits and phone visits increasing sixfold and eightfold, respectively—office visits decreased 26.2 percent.

Multiple studies demonstrate that these visits can provide high-quality care for a large number of medical conditions. 

It should be easier for the physician community to redirect patient care in this manner.

Monday Roundup

Fierce Biotech reports on today’s positive but not definitive results from Moderna’s early COVID-19 vaccine testing. “With eyes on a phase 3 study this summer, Moderna posted promising early data for its COVID-19 vaccine. The jab prompted an immune response similar to those seen in patients who have recovered from the disease.” Fingers crossed.

CVS Health, Walgreen’s and Rite Aid / Verily continue to expand their drive up COVID-19 testing capabilities. Healthcare Dive reports that the Food and Drug Administration (“FDA”) last Friday “authorized multiple laboratories to test for coronavirus in nasal samples collected by consumers using an at-home kit” produced by Everlywell. This is the second FDA approved at home kit.

What’s more, Fierce Biotech reports that Verily’s Project Baseline “has launched a new clinical research effort focused on COVID-19 antibody testing and exploring the body’s immune response to the novel coronavirus.” Fierce Healthcare adds that the American Medical Association is offering guidance on COVID-19 antibody testing for physicians. “Although many are using these tests to determine whether an individual had COVID-19, we encourage physicians to only use antibody tests authorized by the FDA and only for the purposes of population-level studies [like the Project Baseline study], evaluating recovered individuals for convalescent plasma donations, or along with other clinical information as part of a well-defined testing plan for groups or individuals.”

A friend of the FEHBlog called his attention to this federal government list of top ten routinely exploited cybersecurity vulnerabilities and mitigations over the period 2016 through 2019 and this year.

Weekend update

The House of Representatives returned to Capitol Hill on Friday to pass a resolution (H.R. Res. No. 965) permitting remote Committee hearings and proxy voting during a federal declared emergency like the COVID-19 pandemic. The House also passed a wide-ranging, $3 trillion COVID-19 relief bill known as the HEROES Act (H.R. 6888) by a narrow 208-199 vote. The House thereby laid down its wishlist before the Senate and the President in the looming negotiations over what would be the fourth COVID-19 relief bill.

The FEHBlog’s favorite podcast Econtalk featured a special edition in which the host Stanford economist Russ Roberts interviewed Nobel in Economics laureate Paul Romer about the COVID-19 pandemic. Mr. Romer supports much less hunkering down and a lot more testing. It’s worth the hour or so to listen to the interview.

In other news:

  • The Washington Post reports that “Four months into the U.S. coronavirus epidemic, tests for the virus finally are becoming widely available, a crucial step toward lifting stay-at-home orders and safely returning to normal life. But while many states no longer report crippling supply shortages, a new problem has emerged: too few people lining up to get tested.” This word needs to get out.
  • Healthcare Dive discusses health insurer and tech company efforts to help their employer plan sponsors to safely reopen their businesses.
  • The Wall Street Journal reports on the state of the race to develop a safe and effective COVID-19 vaccine. Eight investigational versions have begun human testing trials. “Testing of early vaccines could show the way for subsequent shots by giving researchers a better idea of the level of immune response needed to provide protection against the virus, Emory’s Dr. Orenstein said.”
  • Fierce Healthcare discusses J.D. Powers 2020 analysis of consumer attitudes toward commercial health plans. “Consumers want a coordinated, integrated experience that their health plan may be unwilling or unable to provide, [James Breen from J.D. Power] said. “Health plan members have an expectation that health insurance companies do that, but I’m not certain whether or not health insurance companies feel that’s part of their major role, so there’s a disconnect there,” Beem said.
Our firm is closely monitoring the impacts of COVID-19. Effective 6/08/20, Ermer & Suter has reopened its physical offices for business, however for the continued safety of our staff, in-office capacity will not exceed 40%. We remain fully operational and are readily available from both our office and telework locations.