Weekend update

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, Telehealth–

The Senate is engaged in legislative and committee business this week. Last week the Senate passed by unanimous consent a bill (S. 279) to amend the FEHB and FEGLI Acts for the purpose of extending coverage to employees of Indian tribal grant schools. This bill would close a gap created by the Affordable Care Act which generally extended coverage under these programs to Indian tribal employees. There are 128 tribal grant schools in the U.S.

The House of Representatives is engaged in committee business this week. That body is next scheduled to hold votes over the period June 30 through July 2.

The Supreme Court continues this week to release the remaining opinions from its October 2019 term. The Hill includes an article discussing the seven opinions that are expected to be politically controversial.

In other news Fierce Healthcare reports

  • “A top Department of Health and Human Services (HHS) official acknowledged [last week] that telehealth is here to stay after an explosion of use due to COVID-19 but hedged on whether new regulatory flexibility on reimbursement is going to stick around.” The permanent flexibility depends largely on Congress and state regulators, and
  • “OptumRx researchers are highlighting three more drug products that payers should be keeping an eye on in 2020″ — Roche’s Risdiplam, NS Pharma’s Viltolarsen, and Immunomedic’s Trodelvy.

Friday Stats and More

David Ermer–Congress, COVID-19–

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, over the past four weeks the numbers of new cases and deaths have taken a downward path

Week ending5/155/225/296/5
New Cases297,581159,546148,210142,829
New Deaths8956816075616353

The basic infection mortality rate (as calculated by the FEHBlog) continues to drop since its peak on May 15.

The Miami Herald features a fascinating article on disease super spreaders — both people and events.

“It’s not just that superspreading events are happening with SARS-CoV-2; they appear to be driving much of the pandemic,” The University of Hong Kong epidemiologists Dillon Adam and Benjamin Cowling wrote in the New York Times.

“This fact is alarming and reassuring at the same time … because it suggests a virus swift and efficient, and so seemingly unstoppable,” and “it also suggests a way to stop SARS-CoV-2 that is both less onerous and more effective than many of the strategies that have been pursued so far.”

”Forget about maintaining … sweeping measures designed to stem the virus’s spread in all forms. Just focus on stopping the superspreading,” the epidemiologists proposed in the newspaper.

In other words, restricting large gatherings could lower transmission rates, but in the U.S., it hasn’t been that easy.

It’s probably not easy anywhere, but it needs to be done in the FEHBlog’s humble opinion.

The International Foundation of Employee Benefit Plans offers a very thoughtful article on steps that health plans should take this year and next in response to the great hunkering down. For example, health plans should

  • Communicate the safety measures that have been put in place at hospitals and clinics. The Centers for Disease Control and Prevention have issued safety guidelines, including limiting visitors and screening patients and employees for the virus.
  • Communicate the importance of seeking urgent and preventive care. “We really want to encourage people to go and seek care that is needed when it is needed,” Baker said. “If we can just share the importance of preventive care from a high-level standpoint, without getting into the employees’ personal business, that may be something really beneficial in order to help manage plan costs,” she said.
  • Tweak wellness programs. Some employees may not have been able to qualify for wellness program incentives, so employers may want to change the guidelines to allow them to qualify.
  • Steps that plans take now could flatten the cost curve for the 2020 plan year. “Just a simple communication may be beneficial as things reopen,” [Dana] Baker [from the Mayo Clinic] said.

In closing, the Wall Street Journal reports that today’s surprisingly strong May employment report “boosted hopes that the economy has moved beyond the worst fallout from the pandemic and may recover more quickly than expected.” Also the President today signed the Payroll Protection Program flexibility act into law today. Here’s a summary of the new 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.

Midweek update

David Ermer–Congress, Rx coverage, Telehealth–

NBC News reports that Wednesday evening, the Senate passed by unanimous consent a House passed bill to improve the Payment Protection Program that the CARES Act created to help small businesses with liquidity issues created by the great hunkering down.

UPI provides helpful context around the new Medicare program to control Medicare beneficiary out of pocket costs for insulin.

“Among commercially insured patients, high insulin prices do not necessarily translate to high out-of-pocket costs,” study co-author Dr. Amir Meiri, a research fellow with the Harvard Medical School Department of Population Medicine and a practicing internist, told UPI.

For these patients, “insulin out-of-pocket costs are generally lower than expected and declining, except among patients in high-deductible health plans with health savings accounts, who must pay for the full cost of medications — including insulin — until they reach their deductible,” Meiri said.

The time period for the study was 2007-16. Last year, the Internal Revenue Service pursuant to an executive order issued a ruling permitting coverage of insulin before the high deductible.

A friend of the FEHBlog called to his attention this 21st century, FDA approved digital stethoscope that could revolutionize care at home. Fierce Healthcare quotes Cambia Health’s chief medical officer who notes ““Telehealth as always been a benefit,” she said. “I think physicians now know that their patients want to use telehealth.”

OPM IG Confirmation Hearing

David Ermer–Congress, OPM–

This afternoon, the Senate Homeland Security and Government Affairs Committee held a virtual confirmation hearing for the President’s nominee for OPM Inspector General, Craig E. Leen, who currently is the Director of the Labor Department’s Office of Federal Contractor Compliance Programs (“OFCCP”). The FEHBlog caught a good chunk of the hearing online. The Senators’s attention principally was on the other nominee Russell Vought who is the acting Director of the Office of Management and Budget and hopes to be made the permanent director.

Mr. Leen was in no sense ignored though. Each Senator asked him a question or two. His opening testimony is available here. Of note, Mr. Leen stated that

As Inspector General, I would focus on the following immediate priorities:
 Closing open IG recommendations and establishing a public dashboard to track my office’s progress;
 Addressing improper payments and seeking to eliminate them;
 Evaluating OPM’s guidance related to COVID-19 and learn from what went well and what could be improved;
 Increasing the amount of evaluations done by OPM Office of the Inspector General (OIG), and
 Ensuring equal employment opportunity for all protected classes, including ensuring inclusion and accommodations of individuals with disabilities (the federal government should follow the same guidance it gives federal contractors in how to ensure equal employment opportunity)

I would like to take a moment to focus on the first and last priorities. The OPM OIG has over 300 open recommendations going back many years. This is a common issue for IGs. I am concerned about what open IG recommendations does to public trust in government; a problem has been specifically identified, but not corrected. I would make closing these open recommendations a primary focus as Inspector General.

Mr. Leen mentioned during the Q&As that the OPM Inspector General historically has performed one evaluation annually. The next step will be a Committee business meeting to consider sending Mr. Leen’s nomination to the Senate floor.

Monday Roundup

David Ermer–CDC, COVID-19–

Let’s begin with a story that surprised as well as interested the FEHBlog. The Society for Human Resource Management reports that the U.S. Occupational Health and Safety Administration is requiring health plans, insurers, and other low hazard employers to report to OSHA “work-related coronavirus illnesses that result in a fatality or an employee’s in-patient hospitalization, an amputation or the loss of an eye.” Other employers have broader recording and reporting obligations.

A friend of the FEHBlog called to his attention this Newsweek interview with Dr. Anthony Fauci about whether we may encounter a second wave of COVID-19. While Dr. Fauci expects COVID-19 infections to continue at least through 2020, Dr. “Fauci says whether or not these ongoing new cases will become a wave will depend on whether ‘we prepare ourselves from now through June, July, August and September. We have four months to make sure we have in place the system, the test, the capability, the manpower to do the kind of identification, isolation and contact tracing as cases begin to reappear in the fall, because they will reappear.'”

STATNews also also features an interview with Dr. Fauci which focuses on vaccine development.

Today, prescription drug manufacturer Eli Lilly announced

[hospital] patients have been dosed in the world’s first study of a potential antibody treatment designed to fight COVID-19.

This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2, the virus that causes COVID-19.

The FEHBlog heard a discussion of the investigational new drug on television this morning. The Eli Lilly representative explained that this drug focuses on one antibody while convalescent plasma relies on an array of antibodies. The investigation. The Wall Street Journal explains that

Researchers at AbCellera Biologics Inc., a Canadian company that partnered with Lilly in March, and the U.S. National Institute of Allergy and Infectious Diseases identified an antibody with virus-fighting potential in a blood sample taken from one of the first U.S. patients who recovered from Covid-19.

Lilly’s scientists then essentially cloned the antibody to make the new therapy [which is administered intravenously]. Its goal is to block the virus from attaching to and entering human cells, thus neutralizing it.

This first random study uses hospitalized patients and if successful the next random study will use non-hospitalized patients. “Lilly said it is starting large-scale manufacturing of the therapy, so that if studies prove successful, it will have several hundred thousand doses available by the end of the year.” Let’s go.

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, OPM, Rx coverage, SCOTUS–

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.”

Friday Stats and More

David Ermer–COVID-19, OPM, Telehealth–

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, the number of COVID-19 deaths topped 100,000 this week. Due to greatly increased testing rate, the number of confirmed COVID-19 cases is now greatly outpacing the number of COVID-19 deaths. For example, over the past week the number of confirmed cases has increased by nearly 150,000 to 1,719,827 while the number of deaths increased by 7,561 to 101,711. The basic infection mortality rate (as calculated by the FEHBlog) has dropped over the past week. That is good news. Also check out Avik Roy’s Forbes column analyzing COVID-19 deaths.

In last Monday’s post, the FEHBlog gently ribbed OPM for not extending the 2021 benefit and rate submission deadline from Sunday May 31 to Monday June 1. To the delight of the FEHBlog and those FEHB carriers bumping up against the May 31 deadline, the FEHBlog learned today that OPM has granted this grace period. Muchos gracias.

Here’s a link to an interesting Healio report on patient deferral of wellness and chronic care visits to their primary care doctors during the great hunkering down. It is easy to register for Healio.

Results of a survey conducted by the Primary Care Collaborative and the Larry A. Green Center showed that 81% of 736 primary care clinicians reported that they have limited their wellness and chronic care visits, and 70% reported that the patients themselves postponed these visits.

The survey also revealed that preventive services are down among primary care practices, with just 5% reporting cancer screenings, 10% reporting adult vaccinations, 12% monitoring cancer survivors, 14% reporting childhood vaccinations and 25% screening for violence and neglect.

On a related note Healthcare Dive reports

  • Virtual care use grew 1.6 times since the summer of 2019, according to the Blue Cross Blue Shield Association’s COVID-19 National Pulse Survey. More than half of that growth has occurred since the onset of the COVID-19 crisis.
  • Generation Z (35%) uses telemedicine the most, with millennials (30%), Gen Xers (21%) and baby boomers (15%) behind them.
  • The pandemic has changed several behaviors, the survey found. Alcohol consumption is up 23%, and smoking, vaping and non-medical drug use rose by 19%, 15% and 13%, respectively.

Finally, Becker’s Hospital Review brings us up to date on a, HL7 / FHIR healthcare data sharing collaborative known as the Gravity Project “that aims to standardize medical data used to identify social determinants of health.” Cool.

Thursday Miscellany

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, Medicare–

Earlier this month, the National Center for Health Statistics released a report on 2019 births in our country. Here are some notable snippets from that report:

  • The provisional number of births for the United States in 2019 was 3,745,540, down 1% from the number in 2018 (3,791,712). This is the fifth year that the number of births has declined after the increase in 2014, down an average of 1% per year, and the lowest number of births since 1985.
  • The birth rate for teenagers in 2019 was 16.6 births per 1,000 females aged 15–19, down 5% from 2018 (17.4), reaching another record low for this age group. The rate has declined by 60% since 2007 (41.5), the most recent period of continued decline, and 73% since 1991, the most recent peak.
  • The low-risk cesarean delivery rate, or cesarean delivery among nulliparous (first birth), term (37 or more completed weeks based on the obstetric estimate), singleton (one fetus), vertex (head-first) births, also decreased to 25.6% of births in 2019 from 25.9% in 2018.
  • The percentage of infants born preterm (births at less than 37 completed weeks of gestation) fell 8% from 2007 (the most recent year for which national data are available based on the obstetric estimate of gestation) to 2014, but has risen 7% from 2014 (9.57%) to 2019.

Healthcare Dive reports that

The number of Medicare beneficiaries using telehealth skyrocketed in the early weeks of the pandemic as the Trump administration relaxed regulations to virtual care.

The looser regulations are only in place for the extent of the national public health emergency, but myriad groups have called on HHS to permanently relax the barriers. Top administration health officials have said they’re exploring the possibility.

Here’s hoping.

Health IT Security informs us about Verizon’s latest data breach investigations report.

For healthcare, there were 798 security incidents and 521 confirmed data breaches in 2019, compared to 304 incidents in the previous year. While miscellaneous insider errors, privilege misuse, and web applications were the leading causes 2018 healthcare data breaches, external threats outpaced insiders in this year’s report.

In fact, 51 percent of healthcare data breaches were caused by external actors, and insider-related breaches fell to 48 percent. Despite the slight increase in external-related breaches, healthcare does remain the leading industry for internal bad actors.

It’s not always a good thing to be in first place.

Let’s wrap it up with a story about responsible corporate citizenship. Becker’s Hospital CFO Report informs us that

CMS automatically sent out the first slice of federal funding under the Coronavirus Aid, Relief and Economic Security Act based on historical Medicare fee-for-service reimbursement. Now, several companies are returning the relief aid.

[Healthcare companies] Cigna, CVS Health, DaVita, Encompass and Walmart are among the companies sending back federal grants they received under the CARES Act, which are meant to reimburse healthcare providers for expenses or lost revenues tied to the COVID-19 pandemic, according to Business Insider. The companies are returning a total of nearly $574 million.

The common reason for returning these large amounts of money was aptly stated by CVS Health:

“We have made the decision to return the funds and forgo participation in subsequent disbursements,” CVS Health President and CEO Larry Merlo wrote in a May 19 letter to HHS Secretary Alex Azar. “In doing so, we hope to help HHS provide additional support to other providers who are facing significant financial challenges as a result of the pandemic.”

Bravo.

Midweek Update

David Ermer–COVID-19, OPM, Wellness–

Health Payer Intelligence discusses a Kaiser Family Foundation survey on deferred healthcare due to the COVID-19 emergency. “Almost 50 percent of American adults deferred care themselves or have a household member who deferred care due to the coronavirus, but more than two-thirds of those who deferred (32 percent of the total adult population) plan to get care in the next couple of months” Wow. Bear in mind that this backlog developed over the past three months. The FEHBlog therefore expects that providers will have the capacity to provide all of this deferred care quickly. But no doubt they will try to do so safely.

Speaking of patient safety, the Choosing Wisely program explains a successful program to improve patient care while reducing costs.

Choosing Wisely serves as the foundational underpinning for all of our discussions with clinicians regarding how we can deliver the highest value care to our patients,” said Alistair Aaronson, MD, MHA, FACP, who joined St. Jude (part of Providence St. Joseph Health System) in 2017 as its Executive Medical Director for Operations and High-Value Care.

Under Dr. Aaronson’s leadership, the 320-bed hospital launched a series of “bite-size projects” to reduce overutilization. Clinicians would pick a topic where there was anecdotal evidence of overutilization and then select a Choosing Wisely recommendation related to that topic. They would then compare their practice patterns against the recommendation; if the results were not positive, they would develop a project to address the overuse.

That’s a sensible solution that can be applied to other nagging problems that face us.

The FEHBlog took note of this Wall Street Journal article on progress being made in the convalescent plasma program to treat COVID-19. The article explains how proponents of this treatment are recruiting COVID-19 survivors to donate plasma in order produce the treatment.

Finding qualified plasma is more complicated than it might seem. Potential donors must meet the requirements of all blood donors, such as weight, age, and underlying health. Some don’t show up for their appointments; others find they are unable to give a sufficient amount.

“These are all challenges we have to recognize along the way in getting a donation from someone to an actual product,” said Dr. Pampee Young, chief medical officer of biomedical services at the American Red Cross. “We are building the plane as we fly it.”

The Red Cross has collected plasma from 4,000 recovered Covid-19 donors to date through its website RedCrossBlood.org/plasma4covid, according to a spokeswoman. She said the organization supports the efforts of the coalition but didn’t join it. “At this time, the Red Cross is fortunate to be able to meet the needs of our hospital partners,” she said. “We also have the capacity to ramp up our supply if necessary.”

[Moreover,] for-profit companies in the coalition [such as Microsoft] also continue to look for donors on their own through digital advertising and other online outreach, according to industry experts.

Surprisingly, one dose of the treatment may require donations from more than one survivor. The developers are fine tuning this issue now as studies continue.

UPI reports that “Workplace wellness programs designed to encourage employees to engage in activities and monitor their health might have negligible benefits, according to a study published Tuesday by JAMA Internal Medicine.”

[The researchers] compared healthcare outcomes and attitudes among [3,300] employees enrolled in the [generous wellness program] to those of 1,584 staff members not included in the initiative. [The study was conducted over a two year period.]

Overall, they found that participants in the wellness program were 5 percent more likely to have a regular primary care physician and more likely to have a positive attitude about their own health, compared to employees who did not participate in wellness-related initiatives.

The FEHBlog cannot understand why increased adoption of primary care physicians did not produce

significant effects on participants’ height, weight, waist circumference, body mass index, blood pressure, cholesterol or blood-sugar levels.

In addition, the risk for high blood pressure, diabetes or obesity was roughly the same for participants and non-participants after one and two years, researchers said.

Similarly, there were no differences between the two groups in terms of doctors’ office visits, hospital visits or emergency department visits.

That is one sobering study.

In other news, OPM today posted a “Fact Sheet: The Use of Flexible Work Schedules in Response to Coronavirus Disease 2019 (COVID-19)” and Govexec.com reports that the Postal Service like many other businesses is struggling with the COVID-19 emergency. But to their credit the mail continues to be delivered.