Friday Stats and More

COVID-19 vaccine

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.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Uncategorized–

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.