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.

Thursday Miscellany

The Wall Street Journal reports that

White House chief of staff Mark Meadows and Treasury Secretary Steven Mnuchin said Wednesday that if they don’t reach a deal by Friday with Mrs. Pelosi and Senate Minority Leader Chuck Schumer (D., N.Y.), they saw little point in continuing the daily negotiating sessions they have been conducting for nearly two weeks.

The quartet was expected to meet again early Thursday evening.

Democrats said Thursday that the slow pace of progress in the talks stems from a central clash over how much assistance the federal government should provide.

The President has stated that he plans to issue executive orders providing COVID-19 emergency relief if a compromise is reached.

Today the President signed an executive order directing administrative action to “reduce our dependence on foreign manufacturers for Essential Medicines, Medical Countermeasures, and Critical Inputs to ensure sufficient and reliable long-term domestic production of these products, to minimize potential shortages, and to mobilize our Nation’s Public Health Industrial Base to respond to these threats.” That seems sensible. Here’s a link to a Wall Street Journal article on the executive order. The Journal explains that “The order seeks to reverse the practice in recent decades of moving drug manufacturing outside of the U.S. That shift is partly because of more favorable tax rates, cheaper labor and friendlier environmental regulations, industry officials say.”

On the miscellany front —

  • The Federal Times reports that the U.S. Office of Personnel Management is poised to publish an interim final rule implementing the new paid parental leave program for federal employees. The program takes effect on October 1, 2020, and the interim final rule will be published in the Federal Register on August 10, 2020.

The act enables federal employees to substitute 12 weeks of paid leave for the same amount of time of unpaid leave authorized under the Family and Medical Leave Act of 1993.

But not all of the circumstances covered by unpaid leave apply to the new paid leave provisions.

Federal employees covered by the act may only take paid parental leave after the birth or placement of a child and may only do so within a 12-month window of that birth or placement.

  • Health Payer Intelligence reports on a Blue Cross study discussing payer strategies to improve sagging colorectal cancer screening rates in our country. OPM scores FEHB plans on the NCQA’s HEDIS measure for this preventive care measure. The article explains

“A major barrier to preventative screening is attitudinal – stemming from misperceptions surrounding discomfort, lack of risk awareness, and general fear of negative results,” [BCBSA Vice President Reed] Melton said. “Payers can start by working to change those perceptions and provide accurate, accessible resources to better inform the public.”

Payers can act on the information that this report unveiled by making colorectal cancer information—including screening information and other data—available to members online. This is a strategy that many Blue Cross and Blue Shield companies are already implementing.

  • Last week the FEHBlog called attention to successful COVID-19 vaccine tests performed on monkeys. One group of monkeys was given the experimental vaccine and the other group wasn’t. However, both groups were exposed to COVID-19 which increases the reliability of the testing. A friend of the FEHBlog shared a link to the 1 Day Sooner site. 1 Day Sooner proposes that human volunteers engage in the same type of testing which are known as challenge trials. ” Human challenge trials deliberately expose participants to infection, in order to study diseases and test vaccines or treatments. They have been used for influenza, malaria, typhoid, dengue fever, and cholera. Researchers are exploring whether human challenge trials could speed up the development of a vaccine for COVID-19, saving thousands or even millions of lives.” Who knew? Certainly gutsy. In any event, the FEHBlog shares a monkey’s picture today in gratitude to their efforts to protect fellow primates.

Midweek Update

The Wall Street Journal reports this evening that “White House and Democratic negotiators emerged frustrated from their [latest COVID-19 relief bill} meeting Wednesday. White House officials said Democrats were dragging their feet on talks, and Democrats countered that Republicans were thinking too small.” “Absent an agreement [by this Friday, [Treasury Secretary Steven] Mnuchin said, “We’ll have to look at the president taking actions under his executive authority.”

On the vaccine front —

  • Kaiser Health News reports that obese people are less responsive to vaccines than other folks. ” Dr. Timothy Garvey, an endocrinologist and director of diabetes research at the University of Alabama, was among those who stressed that, despite the lingering questions, it’s still safer for obese people to get vaccinated than not. “The influenza vaccine still works in patients with obesity, but just not as well,” Garvey said. “We still want them to get vaccinated.” FEHBP plans typically offer effective coaching problems to help plan members with weight reduction.
  • On the brighter side, the Wall Street Journal reports that “Researchers and companies developing Covid-19 vaccines are taking new steps to tackle a longtime challenge: Those who need the vaccines most urgently, including Black and Latino people, are least likely to participate in clinical trials to determine whether they work safely.” Health plans may be able to offer support here to researchers.

Publicly traded healthcare companies have been report second quarter results recently. Healthcare Dive reports that “All of the nation’s largest insurers, Anthem, Centene, Cigna, Molina, UnitedHealth Group (which operates UnitedHealthcare) and CVS (which owns Aetna), all reported a surge in second quarter profits due to lower medical usage among members.” To the extent that these profits stem from health insurance premiums, the ACA’s requirement that health insurers rebate premium income when they fall below the minimum medical loss ratio threshold (80% for individual coverage and 85% for group coverage) is designed to prevent excess profits.

  • For more details on second quarter results CVS Health and Humana reported today. Becker’s Hospital Review inform us about other major insurer results here.

Forbes advises us that according to a recent study, deferral of care during the great hunkering down in March and April caused a concerning drop in new cancer diagnoses. “This report demonstrates that our initial response to the pandemic of limiting so-called elective screening and diagnostic tests has consequences,” said Craig Bunnell, MD, Dana-Farber Cancer Institute Chief Medical Officer. “The true incidence of these cancers did not drop. The decline clearly represents a delay in making the diagnoses, and delays matter with cancer,” Bunnell added. But physicians are keen to stress that for symptoms that cannot wait such as anything which might indicate cancer, people must not hesitate to seek medical care, despite the pandemic. “We need to safely perform these diagnostic tests and the public needs to not think of them as optional. Their lives could depend on them,” said Bunnell.

How true. Becker’s Hospital Review provides additional perspective on this issue by publishing a Census Bureau ranking of the states by the estimated percentage of deferred care due to the COVID-19 emergency.

Nationwide, 40 percent of Americans are still delaying care, according to a survey from the U.S. Census Bureau. The agency launched its Household Pulse Survey April 23, polling roughly 1 million Americans weekly on how the pandemic is affecting their household. Over the past 12 weeks, the percentage of U.S. adults delaying care has hovered around 40 percent with little fluctuation.

Finally, there was a big healthcare industry transaction announced today. STAT reports that “telemedicine provider Teladoc Health has reached an agreement to buy the diabetes coaching company Livongo in an $18.5 billion deal.” Both companies are publicly traded. The Wall Street Journal explains that

Under the deal, each share of Livongo will be exchanged for 0.5920 shares of Teladoc, plus cash consideration of $11.33 for each Livongo share. Upon completion of the merger, existing Teladoc shareholders will own 58% of the combined company, and existing Livongo shareholders will own 42%. The transaction is expected to close by the end of this year.

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.

Tuesday Tidbits

Following up on last Friday’s and Sunday’s posts on the President’s executive orders on drug pricing, here for greater perspective is a link to a Fierce Healthcare article offering the positions of the health insurance and PBM industry trade associations’ positions on the orders. Essential Hospitals lets us know that the text of the fourth international pricing index executive order has not yet been made public.

The Wall Street Journal reports that “Eastman Kodak Co. has won a $765 million government loan under the Defense Production Act, the first of its kind. The purpose: to help expedite domestic production of drugs that can treat a variety of medical conditions and loosen the U.S. reliance on foreign sources. * * * Kodak’s loan has terms similar to a commercial loan and must be repaid over 25 years, [Kodak CEO Jim] Continenza said. He said Kodak will produce “starter materials” and “active pharmaceutical ingredients” used to produce generic medicines. “We have a long, long history in chemical and advanced materials—well over 100 years,” Mr. Continenza said. He added that Kodak’s existing infrastructure allows the company “to get up and running quickly.”

On the COVID-19 front —

  • Federal News Network informs us that

About 4,000 federal employees have filed workers’ compensation claims with the Labor Department due to COVID-19. 60 people have filed death claims. Labor projects COVID-19 claims among federal employees may reach 6,000 in the coming weeks. The department’s inspector general says the division that handles federal employee claims is anticipating a strain in resources due to demand and social distancing mandates. It has alternative staffing plans if COVID-19 compensation claims continue to surge. Labor says it’s accepted over 1,600 federal employees claims so far. Over 2,300 are unadjudicated.

  • The Society for Human Resource Management brings us up to date on the Senate majority’s new $1 trillion COVID-19 relief bill, the HEALS Act.
  • The Center for Medicare and Medicaid Services released “an early snapshot of the impact of the coronavirus disease 2019 (COVID-19) pandemic on the Medicare population. The data shows that older Americans and those with chronic health conditions are at the highest risk for COVID-19 and confirms long-understood disparities in health outcomes for racial and ethnic minority groups and among low-income populations.” A large cadre of the Medicare population of course is also enrolled in the FEHBP so this data is worth a gander.
  • The National Institutes of Health announced the successful results of a double blind study of the Moderna / NIAID COVID-19 vaccine on non-human primates / rhesus macaques. As noted yesterday that vaccine entered phase 3 human trials this week.

In other news —

  • Becker’s Hospital Review identifies the highest ranking hospital in each State as found in U.S. News and World Report.
  • NPR discusses two new studies suggesting that the risk of Alzheimer’s disease can be reduced by taking flu and pneumonia vaccines.
  • HHS’s Office for Civil Rights (“OCR”) which enforces the HIPAA Privacy and Security Rules announced that “Lifespan Health System Affiliated Covered Entity, a non-profit health system based in Rhode Island, has agreed to pay $1,040,000 to the OCR and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to the theft of an unencrypted laptop [thereby evidently allowing access to protected health information on over 20,000 patients in 2017].

Monday Roundup

In federal personnel news —

  • Politico reports that earlier today the Senate confirmed acting Office of Management and Budget Director Russell Vought to be permanent OMB Director.
  • Federal News Radio reports that the President intends to nominate John Gibbs to be permanent Director of the Office of Personnel Management. Mr. Gibbs “currently serves as the acting assistant secretary for community planning and development at the U.S. Department of Housing and Urban Development.

It’s worth noting that the Presidential inauguration will occur six months from today.

On the COVID-19 front —

  • The Wall Street Journal reports that “The prospects of successfully developing a coronavirus vaccine as soon as this year were buoyed Monday when three of the world’s leading candidates reported positive early trial data. Vaccines being developed by University of Oxford researchers and AstraZeneca PLC; PfizerInc. and German partner BioNTech BNTX 3.46% SE; and China’s CanSino Biologics all reported fresh updates showing their shots generated immune responses and were safe to use.
  • Fierce Biotech reports that a double blind human patient study of U.K. manufacturer Synairgen’s inhaled COVID-19 treatment against a placebo produced encouraging results. “The [preliminary] data showed those who were given SNG001 [a nebulizer interferon beta protein] had a 79% lower risk of developing severe disease compared to placebo * * * with patients who got that drug also more than twice as likely to recover from COVID-19 than those on a dummy med.” Synairgen’s press release advises that “‘Further analysis will be conducted over the coming weeks and reported in due course.”

Fingers remain crossed for the vaccines and the new treatment.

Health IT Analytics discusses how “geographic data has helped leaders better understand where to allocate population health resources during the COVID-19 pandemic.” Given the mantra that all healthcare is local, it only makes sense that geographic data should be helpful for this purpose. For example,

To better understand where to direct resources, researchers at NYU Grossman School of Medicine recently developed a city-oriented COVID Local Risk Index. The tool calculates COVID-19 risk down to the hyperlocal, neighborhood level by relying on key health, economic, and social data at the census tract level. The index also allows for comparison of COVID-19 risk across other cities and between neighborhoods.

Well done.

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.

Midweek update

There have been many ups and downs during the COVID-19 emergency. The one effort consistently making sure but steady progress is the COVID-19 vaccine development process. In today’s news from Fierce Healthcare

  • “AstraZeneca and the University of Oxford are set to share “positive news” on their COVID-19 vaccine soon, according to a leading U.K. journalist. The update, which could come as soon as tomorrow, may shed light on how the front-runner vaccine fared in early clinical trials.”
  • “Moderna and its partners in the federal government are just now gearing up for a late-stage COVID-19 vaccine trial set to launch later this month, but at the same time, the mRNA biotech is prepping a supply of doses for quick shipment if the shot gets an FDA go-ahead.”

In this regard, the FEHBlog has noted his addiction to the Econtalk podcast. This week the host Stanford economics professor Russ Roberts dropped this pearl of wisdom in the course of his conversation with a gaming company CEO:

It’s taken me a long time, Josh, but I’ve finally figured out that sometimes something that people are really excited about doesn’t happen. Driverless cars. Four years ago I thought , ‘By 2020 they’re going to be here for sure. AI [Artificial Intelligence], ‘Yeah, soon they won’t even–,’ you fill in the blank. A lot of these things turn out to be harder than they were thought to be. And of course, part of the reason for that is that the people who’ve spent the money to take the chances on it have an incentive to overstate the hype. It’s just part of the natural human experience.

And of course there are also the lawyers telling the entrepreneurs to tone it down. Hopefully the COVID-19 vaccine for which we are all excited will be a near term success. Knock on wood.

In telemedicine news —

  • The Health Affairs Blog features a detailed CMS Administrator Seema Verma article on the topic. She concludes “During these unprecedented times, telemedicine has proven to be a lifeline for health care providers and patients. The rapid adoption of telemedicine among providers and patients has shown that telehealth is here to stay. CMS remains committed to ensuring that the government supports innovation in telehealth that leverages modern technology to enhance patient experience, providing more accessible care.”
  • Health Payer Intelligence reports that

As payers lean more heavily on remote care, consumers stressed the need for greater convenience in care delivery and prefer to turn to telehealth and digital solutions, in part, as the answer, according to a recent CVS Health study. CVS Health fielded the survey in March 2020 and garnered 1,000 respondents. It drew particularly from twelve major cities and targeted African American and Hispanic participants. An additional survey covered 400 providers.

What a happy coincidence!

Finally, Healthcare Dive informs us about UnitedHealth Groups’s second quarter 2020 earnings report.

Payer arm UnitedHealthcare, the largest commercial health insurer in the U.S., brought in $49.1 million in revenue, up just 1% year over year. But its medical loss ratio, a marker of how much an insurer spends on patient care, plummeted to 70.2% in the quarter ended June 30, compared to 83.1% same time last year, due to temporary deferral of care amid the pandemic.

The question of course is when will the bounce back occur?

Tuesday Tidbits

Good news! STAT News reports that “Moderna’s Covid-19 vaccine led patients to produce antibodies that can neutralize the novel coronavirus that causes the disease, though it caused minor side effects in many patients, according to the first published data from an early-stage trial of the experimental shot.” The FEHBlog will take it. What’s more, “The [Moderna] data roughly mirror the results from a similar vaccine being produced by Pfizer and BioNTech, which were released July 1.” Fingers remain crossed.

Healthcare Dive informs us about a FairHealth analysis which concludes that

The median charge for hospitalized COVID-19 patients aged 23-30 was about $35,000, while those aged 51-60 had median charges of about $46,000.
The most common other illness found in those patients is chronic kidney disease or kidney failure. Nationally, those patients accounted for 13% of all hospitalized COVID-19 patients during the study period from January to May. The second most common comorbidity in all but one region is Type 2 diabetes, according to the study that looked at private healthcare claims. The exception, the South, had hypertension in that rank.
The report also found the most common venue for an initial COVID-19 diagnosis nationally was a traditional doctor's office. About 33% of COVID-19 patients sought help from an office, while 23% went to an inpatient facility, such as an emergency room. In the Northeast, about 7% of COVID-19 diagnoses in that region came via telehealth appointments, versus 6.2% from ER visits.

The Health Affairs Blog provides details on how the COVID-19 virus impacts people differently when viewed from a racial or ethnic perspective. These disparities deserve the attention of the healthcare industry.

We used data from the Medical Expenditure Panel Survey to explore potential explanations for racial-ethnic disparities in coronavirus disease 2019 (COVID-19) hospitalizations and mortality. Black adults in every age group were more likely than whites to have health risks associated with severe COVID-19 illness. However, whites were older on average than blacks. Thus, when all factors were considered, whites tended to be at higher overall risk compared to blacks, with Asians and Hispanics having much lower overall levels of risk compared to either whites or blacks. We explored additional explanations for COVID-19 disparities, namely differences in job characteristics and how they interact with household composition. Blacks at high risk of severe illness were 1.6 times as likely as whites to live in households containing health-sector workers. Among Hispanic adults at high risk of severe illness, 64.5 percent lived in households with at least one worker who was unable to work at home, versus 56.5 percent among blacks and only 46.6 percent among whites.

FYI, HealthIT.gov reports that at the request of Congress the federal government “is investigating strategies to improve patient identity and matching. Stakeholder input and insight into existing challenges and promising innovations in patient identity and matching will inform [Office of the National Coordinator of Health Information’s] ONC’s report to Congress on technical and operational methods that improve patient identity and matching. We invite all stakeholders to submit comments to [email protected] by September 18, 2020.”

Supreme Court journalist Amy Howe reports that the U.S. Supreme Court has announced its oral argument calendar for October 2020. The calendar does not include the ACA constitutionality case, Texas v. California. The FEHBlog is willing to bet the ranch that the Supreme Court will uphold the ACA’s constitutionality (although it may remove the individual mandate from the statute which is what Congress intended when it zeroed out the individual mandate penalty).

In other litigation news, the FEHBlog discovered today that on August 3, 2020, at 2 pm, the U.S. District Court for the District of Columbia will hear oral argument on the Whitman-Walker Clinic’s motion to preliminarily enjoin enforcement of the recent HHS revised ACA Section 1557 rule. Section 1557 is the ACA’s individual non-discrimination provision. The FEHBlog is keeping an eye on this case.

Regrettably , Federal News Network reports that OPM has decided not to award any Presidential Rank award this year due to the disruptions created by the COVID0-19 emergency. The FEHBlog was honored ten years ago to participate in judging these awards. The FEHBlog was and remains very impressed by the work of the federal employees wh0 are nominated for these awards. Hopefully the awards which also were suspended for 2013 will return next year.

Friday Stats and More

This week’s chart of new COVID-19 cases (and deaths) is startling. Week 27 ended on July 9.


What strikes the FEHBlog is that the number of COVID-19 related deaths has remained stable over this time period. If the number of new cases is a leading indicator of deaths, then the number of deaths should have steadily increased following week 20. That hasn’t happened. Why you ask? In the FEHBlog’s opinion, the at risk folks have been taking effective protective measures, and the doctors have learned better approaches to treating the disease.

On the COVID-19 vaccine front —

  • Medcity News reports that Moderna is making progress with its vaccine studies. If the studies prove successful, “The company said that it is on track to provide about 500 million and potentially up to 1 billion doses of the vaccine annually starting next year.”
  • Fierce Pharma reports that “In separate interviews this week, Pfizer CEO Albert Bourla and BioNTech CEO Ugur Sahin said their mRNA vaccine candidate could be ready to submit to regulators in the fall or winter, respectively, pending success in a massive pivotal study yet to kick off.”

Fingers crossed.

Pharma Catalyst informs us that “more than 20 leading biopharmaceutical companies are launching the AMR Action Fund, a ground-breaking partnership to invest nearly $1 billion to ensure a robust and diverse pipeline of new medicines to treat drug-resistant infections.” That’s important too.

The Affordable Care Act created “grandfathered plan” status for electing employer sponsored plans. Grandfather status exempts the plan from many of the ACA mandates. The Obama Administration used its regulatory authority to minimize the availability of this exemption. The Kaiser Family Foundation reported last year that 13% of employees were covered under a grandfathered plan. Most of the grandfathering occurs in the midwest. That’s more than the FEHBlog expected to find. In any event, today the Trump Administration’s ACA regulators issued a proposed rule to create two new flexibilities that would help employers preserve grandfather plan status. Here’s a link to the FAQ on the proposed rule.

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.