The FEHBlog

OPM IG Confirmation Hearing

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

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

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

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

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

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.

Tuesday Tidbits

While the FEHBlog has been discussing the progress of convalescent plasma to treat COVID-19, its time to turn to the Gilead drug remdesivir Fierce Pharma discusses today a recently released peer reviewed study that shows that the drug works well with patients suffering from moderate severity COVID-19.

The 1,063-patient study showed remdesivir’s benefits appear greatest for hospitalized patients in the middle of the disease-severity spectrum. For those who required oxygen supplementation but were not mechanically ventilated, remdesivir cut the time to recovery by 47% compared with placebo. But remdesivir didn’t much help patients with mild or moderate disease, and outcomes for patients on invasive ventilation or extracorporeal membrane oxygenation were nearly the same in both arms of the study.

According to the article, studies are continuing on the efficacy of the drug for patients with mild severity COVID-19.

The Wall Street Journal reports today that physicians are concerned over fact that anti-anxiety and anti-depression prescriptions have spiked during the great hunkering down. “Many physicians have a low threshold for prescribing them. It’s very problematic,” says Bruce J. Schwartz, deputy chair and professor of psychiatry and behavioral sciences at Montefiore Medical Center in New York. “Many people do develop a dependency on these medications.” The article offers alternate approaches, and FEHB plans now usually offer coaching services to help with the problems.

Speaking of healthcare coaching programs, CNBC reports that the great hunkering down has been good for companies that provide coaching or telehealth / digital health programs.

The Centers for Medicare and Medicaid Services announced that their 2021 pilot program to lower insulin costs for Medicare beneficiaries is bearing fruit.

Based on CMS’s estimates, beneficiaries who use insulin and join a plan participating in the model could see average out-of-pocket savings of $446, or 66 percent, for their insulins, funded in part by manufacturers paying an estimated additional $250 million of discounts over the five years of the model. With a robust voluntary response from Part D sponsors, CMS anticipates beneficiaries will have Part D plan options in all 50 states, the District of Columbia, and Puerto Rico, through either a standalone prescription drug plan (PDP) or a Medicare Advantage plan with prescription drug coverage. Beneficiaries will be able to enroll during Medicare open enrollment, which is from October 15, 2020 through December 7, 2020, for Part D coverage that begins on January 1, 2021.

Well done. Hopefully the Medicare approach will be translatable to employer sponsored coverage like the FEHBP.

Memorial Day Weekend Update

Congress was scheduled to be out of town this week for State / District work periods. The House however has decided to be in town for votes and a few Committee hearings on Wednesday and Thursday. Congress is considering making some adjustments to the CARES Act’s Payroll Protection Program.

This is a big week for FEHBP carriers because their 2021 benefit and rate proposals are due at OPM by May 31. (Yes, next Sunday.) It is an complicated proposal year because the COVID-19 emergency has disrupted the normal claim payment rhythm.

The Wall Street Journal reports that on a randomized study of hospitalized COVID-19 patients in New York City finding the convalescent plasma (which includes the antibodies created by people who recovered from COVID-19) produced better outcomes. “In the study, the plasma recipients were more likely to remain stable or show improvement in their requirements for supplemental oxygen. They also had improved survival when compared to the control patients.”

The Wall Street Journal also reports tonight about “early signs the U.S. economy is, ever so slowly, creeping back to life.” “If this is the only wave [of coronavirus], it looks like we’ve bottomed out and the normalization process has begun,” said Beth Ann Bovino, U.S. chief economist at S&P Global Ratings.” Much greater testing, improved treatments, and controls on potentially super spreading events hopefully will place our medical system in a position to handle another wave without another great hunkering down.

Friday Stats and More

The CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, added age demographic information this week. The basic infection mortality rate stabilized then dropped slightly then stabilized again over the past two weeks. That has to be good news. The CDC’s weekly COVIDview supports the FEHBlog’s layman analysis.

MedPage Today offers an interesting story about the downswing of the illness from the perspective of New York City clinicians who have been on the front line.

The Centers for Medicare and Medicaid Services finalized today a subset of proposed Medicare Advantage and Part D changes that the agency proposed earlier this year. CMS is releasing the final rule in two installments so that Medicare Advantage and Part D plans are not overwhelmed. That’s considerate.

OPM released additional COVID-19 guidance for federal agencies today. The guidance concerns the Families First Coronavirus Response Act’s paid leave program for employees affected by COVID-19.

Thursday Miscellany

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

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

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

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

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

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

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

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

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

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

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

Our firm is closely monitoring the impacts of COVID-19. Effective 3/16/20, Ermer & Suter has implemented telework for all of our staff to encourage social distancing and help contain the virus. We remain fully operational and are readily available from our telework locations with no change in telephone numbers or email addresses.