Monday Roundup

COVID-19 vaccine

Monday Roundup

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

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

David Ermer–CDC, COVID-19 testing, COVID-19 vaccine–

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

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

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

David Ermer–ACA, COVID-19 vaccine, SCOTUS–

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 identity.onc@hhs.gov 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

David Ermer–ACA, COVID-19, COVID-19 vaccine, Rx coverage–

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

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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.

Thursday Miscellany

David Ermer–ACA, CDC, COVID-19 vaccine, Federal employment benefits, OPM, SCOTUS–

The Supreme Court wrapped up its October 2019 term today. Because it relates to the Affordable Care Act, the FEHBlog calls attention to the ever reliable and prodigious Katie Keith’s Health Affair’s blog post about yesterday’s Little Sisters of the Poor v. Pennsylvania decision. As Ms. Keith explains, this decision “was the third time in six years that the Supreme Court has ruled on the scope of the contraceptive mandate. This post recounts the history of the litigation, summarizes the decision, and discusses the impact of the ruling.” This decision has no impact on the FEHBP coverage of contraceptives. Enjoy your time off, Justices.

Also on the ACA front, Fierce Healthcare reports that

The Affordable Care Act’s insurance exchanges could add more than 1 million new members because of the COVID-19 pandemic.

The analysis released Thursday by Avalere attributes the spike to special enrollment due to massive job losses caused by COVID-19. The boost in customers could cause more insurers to return to a market they have left after financial losses over the past few years.

“With unemployment rates at or near 10% in almost all states, many consumers have been separated from their previous employer-sponsored plans,” the analysis said. “The economics of Medicaid eligibility in many states and the recent boost to unemployment assistance indicate that many are turning to the exchanges for coverage.”

On the COVID-19 vaccine development front,

At Fortune Brainstorm Health this week, there was lots of talk about the 200-plus efforts to find a COVID vaccine, and the extraordinary collaboration among companies and governments to get vaccines tested, manufactured and distributed—far faster than ever before. “We are taking what normally takes five to seven years, and doing it in five to seven months,” said Johnson & Johnson CEO Alex Gorsky. But Gorsky—whose company is one of the leaders in the vaccine race—also issued a strong warning to the group not to think of a vaccine as a silver bullet.

However, an effective vaccine certainly would be better than a poke in the eye with a sharp stick. Must everyone feel the need to dampen expectations?

  • In the same vein, Fierce Pharma discusses an internal CDC debate over what would be an effective COVID-19 vaccine.

One of public health’s greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we’ll need a vaccine that’s 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said Wednesday.

That’s a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.

  • It’s worth noting that the smallpox eradication effort began in the 1790s and that pharma is on course for more than one vaccine concoction for COVID-19 which should lead to broader efficacy, right?

On the OPM front,

  • Federal News Network informs us OPM will be proposing to anoint greater Des Moine, IA as the latest metropolitan area in which federal employees will receive locality pay. Congrats Hawkeyes. “OPM will also propose an expansion of the existing Los Angeles/Long Beach, California, locality pay area to include Imperial County, California.” The changes if (when?) finalized would be effective January 1, 2021, and
  • Fedweek reports on a recent OPM Inspector General report on OPM’s federal employee retirement services. The Inspector General compliments OPM for its process improvements.

Weekend update

David Ermer–Congress, COVID-19 vaccine, SCOTUS–

The House of Representatives is engaged in Committee work this week. The Senate is on a State work period for the next two weeks. Meanwhile, according to Fierce Healthcare,

a collection of unions, business groups and policy institutes wrote to congressional leaders Wednesday asking for a provision on surprise medical bills to be included in the next coronavirus stimulus package. “We urge you to end surprise medical billing for all patients through the implementation of fair, market-based payments for out-of-network charges,” the letter said. The American Benefits Council, the AFL-CIO, the Business Group on Health and the American Health Policy Institute were among the groups that signed on to the letter.

That resolution is also the FEHBlog’s preference while provider groups often call for arbitration of some sort.

The U.S. Supreme Court has eight more cases to decide before its summer break. All of these cases were argued virtually in May 2020, and include one PPACA case involving the scope of the contraception mandate. Tomorrow is another decision day. This will be the first time in 24 years that the Supreme Court has released decisions in July. The most famous Supreme Court decision issued in July in the FEHBlog’s memory was the U.S. v. Nixon case decided July 24, 1974, which lead to the President’s resignation early the following month.

The Wall Street Journal brings us up to date on the state of COVID-19 vaccine development. Several candidates are headed into large scale final/phase 3 testing this month.

The U.S. federal government is planning to fund three 30,000-person trials starting this summer: Moderna Inc.’s vaccine starting this month, followed in August by a vaccine co-developed by University of Oxford and AstraZeneca PLC, and in September, a vaccine developed by Johnson & Johnson. Oxford’s vaccine recently began late-stage testing outside the U.S.

The scale is so large it means trials are effectively competing with each other for recruits. “One volunteer cannot be in two different studies. It’s a zero-sum game in that regard,” said Dr. Joseph Kim, chief executive of Inovio Pharmaceuticals Inc., which last week announced positive results in a small study and is preparing for a larger study. PRA Health Sciences Inc., which helps recruit trial patients, is mining busy Covid-19 testing locations, including public-health departments, testing labs and pharmacies, to find healthy volunteers, said Kent Thoelke, PRA’s chief scientific officer.

Fingers remain crossed.

On Friday, the FEHBlog suggested that readers check out last Monday’s Econtalk interview about healthcare reform. The discussion of Iora Health. Iora Health is a multi-state group practice which holds a Medicare Advantage plan contract and is looking to expand to employer groups. Their model is centered on the use of health coaches.

Midweek update

David Ermer–Congress, COVID-19 vaccine, OPM–

On the bright side, OPM has taken advantage of a recent IRS ruling. In Benefit Administration Letter 20-803

This BAL is issued pursuant to Internal Revenue Service (IRS) Notice 2020-29. As the Plan Administrator of FedFlex, OPM is permitting FSAFEDS Program participants to make certain mid-year changes for a limited period. OPM is not authorizing a new opportunity to enroll or make changes in enrollments under the Federal Employees Health Benefits (FEHB) Program or Federal Employees Dental and Vision Insurance Program (FEDVIP).
Under this BAL, participants who made an election to a DCFSA in the plan year ending December 31, 2019, can now use any 2019 funds remaining in their DCFSA account until December 31, 2020. The extended claim period is automatic for qualified participants.
Pursuant to BAL IRS Notice 2020-33, BAL 20-803 also allows an increase in the carryover amounts for HCFSA and LEX HCFSA from $500 to $550, beginning with funds remaining at the end of 2020 and carried over into 2021.Finally, OPM is extending the operational flexibilities discussed in BAL 20-201 past June 30, 2020, as necessary, depending on an agency’s operating status.

The FEHBlog heartily agrees with OPM’s decision not to create a special Open Season for FEHBP or FEDVIP because federal employees whose eligible family members have lost their employer sponsored coverage due to the COVID-19 emergency have the right under OPM’s regulations to switch their existing coverage to self plus one or self and family as necessary when a family member loses their employer sponsored coverage.

On the not so bright side, the Office of Federal Contractor Compliance Programs issued a final rule today that would subject FEHB network health care providers to federal contractor affirmative action requirements. It’s worth noting that these providers generally are subject to federal and state non-discrimination laws. The OFFCP affirmative action provisions call for time and employee consuming projects. Since the inception of the FEHB Acquisition Regulation in 1986, healthcare providers have been exempt from these requirements. Now OFFCP has overridden OPM’s approach which has allowed FEHB networks to blossom. So much for deregulation. Hopefully OFCCP eventually will come to it senses as suggested on page 25 of the final rule.

On the COVID-19 vaccine front, Fierce Pharma reports

With the eyes of the world turned on the global COVID-19 vaccine race, Pfizer and its partner BioNTech posted early positive data from one of their four candidates. With this first win—and other data yet to come—the partners are prepping for a late-stage test that could begin as early as this month.

In a phase 1/2 trial, all participants who received 10 micrograms (mcg) or 30 mcg of the mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections.

Importantly, this was a small, early-stage test with just 45 participants, and the vaccine has not yet proven it can prevent COVID-19. To win a full regulatory approval, the partners will have to run a large efficacy study in thousands of participants to demonstrate whether the vaccine prevents disease.

Hope springs eternal.

Healthcare IT News reports that “CMS [had create[d a] new Office of Burden Reduction and Health Informatics In addition to reducing the hours and costs clinicians and providers incur for CMS-mandated compliance, the office will also focus on how health data can be harnessed for more efficient healthcare and improved patient experience.” Bravo.

On the COVID-19 emergency relief front, according to the Wall Street Journal the House today joined the Senate in passing by unanimous consent legislation (S. 4116) extending the Paycheck Protection Program loan application period through Aug. 8. The PPP loan deadline expired last Tuesday. The President is expect to sign the bill into law.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Medicare–

Today the Centers for Medicare and Medicaid Services posted COVID-19 statistics from 88% of U.S. licensed nursing homes on its nursing home compare website. “These [nursing home] facilities reported over 95,000 confirmed COVID-19 cases and almost 32,000 deaths.” That is an extremely high case fatality rate and indeed the nursing home deaths represent roughly 30% of the total COVID-19 deaths in our country.

This statistic demonstrates the importance of not allowing people, particularly at risk people, to be placed in super spreader situations. The FEHBlog recalls from reading the Great Influenza book that the Spanish flu simply swept through crowded Army barracks and troopships in the fall of 1917 and 2018. The Wall Street Journal reports this evening that

The coronavirus pandemic dealt a crushing blow to nursing homes across the U.S., driving down their occupancy by nearly 100,000 residents between the end of 2019 and late May, according to new federal data. * * * The sharp decline in nursing home occupancy—about 10% of the nursing home population as of Dec. 31—reflects many factors including virus-related deaths, deaths from other causes and a steep drop in new admissions.

The silver lining in this particular COVID-19 cloud may be that the occupancy drop will allow the facilities to better socially distance the patients.

Healthcare Dive discusses how the complications associated with accepting federal grant money is discouraging “some” healthcare providers from accepting the grant money created by the CARES Act.

Of the five experts Healthcare Dive consulted, four said they had some provider clients opting to return the funds due to either a fear or unwillingness to accept the terms and conditions or worries over potential risks that come with accepting the money. “The lack of certainty has been a big pain point,” Mara McDermott, vice president of McDermott + Consulting told Healthcare Dive.

Perhaps a chunk of these opt-out provider pivoted to the Payroll Protection Program or one of the other general CARES Act offerings to small businesses.

Reuters reports that the Trump Administration “

has selected five companies, including Moderna Inc, AstraZeneca Plc and Pfizer Inc, as the most likely candidates to produce a vaccine for the novel coronavirus, the New York Times reported on Wednesday, citing senior officials. The other companies are Johnson & Johnson and Merck & Co Inc, according to the paper here The selected companies will get access to additional government funds, help in running clinical trials, and financial and logistical support, the paper reported.

The official White House announcement is expected later this month. The Wall Street Journal adds that

The U.S. government has reached a $1.2 billion deal with AstraZeneca to secure the supply of a potential coronavirus vaccine that could be ready as early as October. The government will bankroll a 30,000-person vaccine trial in the U.S. starting in the summer, plus the ramp-up of manufacturing capacity to make at least 300 million doses.

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, HIPAA Privacy and Security Rules–

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.