Tuesday Tidbits

Tuesday Tidbits

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

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

On the COVID-19 front —

  • Federal News Network informs us that

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

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

In other news —

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

Monday Roundup

The Wall Street Journal reports that

Two of the most advanced experimental coronavirus vaccines entered the pivotal phase of their studies on Monday, with the first subjects receiving doses of vaccines developed by Moderna Inc. and Pfizer Inc.

Researchers evaluating the vaccines plan to enroll 30,000 people in separate last-stage, or phase 3 trials, results of which will determine whether the vaccines protect against symptomatic Covid-19, and whether they should be cleared for widespread use.

Let’s go.

Also on the vaccine front, Healio informs us that the “Influenza vaccination was significantly associated with reduced risks for all-cause death, cardiovascular death, and death from acute myocardial infarction or stroke among adults with diabetes, according to an analysis of registry data.”

The FEHBlog recommends that you listen to, or read the transcript of, this week’s Econtalk podcast in which the host economist Russ Roberts discussed the COVID-19 emergency with Nissam Nicholas Taleb, who is a noted author on the topic of probability. Enlightening.

The American Hospital Association reminds us the July is Minority Mental Health Awareness month by offering a website full of resources. The FEHBlog attended an NCQA Digital Quality Summit breakout session track on racial and ethnic disparities in healthcare last week. Some of the health plan participants spoke up about the difficulty of identifying the racial and ethnic characteristics of their members. That is an important prerequisite to conducting investigations that will lead to solutions. It occurred to the FEHBlog that racial and ethnic characteristics could be added to the ICD-10 code set which would allow coders to spread this information via healthcare claims.

MedPage Today offers a variety of telehealth updates such as the following:

A program that integrated a dedicated team of 24/7 telemedicine clinicians with automated text message check-ins was able to monitor COVID-19 patients at home and quickly support those whose symptoms grew worse, a case study in NEJM Catalyst showed.

Outcomes from the first 3,000 patients invited to participate in the University of Pennsylvania Health System COVID Watch program showed that 83% of confirmed or suspected COVID-19 patients were managed by the automated program; only 17% escalated to needing clinical care, reported Anna Morgan, MD, MSc, of the Perelman School of Medicine at the University of Pennsylvania, and colleagues.

Finally, the Society for Human Resource Management summarizes recent U.S. Labor Department workplace guidance on COVID-19 issues.

Tuesday Tidbits

At today’s House Energy and Commerce Committee hearing on the COVID-19 emergency, Dr. Fauci, according to the Wall Street Journal, remarked that “he is ‘cautiously optimistic’ that a successful vaccine could be produced around the end of 2020. ‘I believe it will be when and not if,’ he said.” Amen to that. Here’s a link to today’s Senate Health Education Labor and Pension Committee’s hearing on the same topic.

The Labor Department’s Employee Benefit Security Administration issued a wide-ranging set of frequently asked questions on the health plan related provisions of the Families First Coronavirus Response Act and the CARES Act. Check it out.

Reuters reports on a sobering CMS study of the COVID-19 emergency on Medicare beneficiaries. ““The disparities in the data reflect longstanding challenges facing minority communities and low income older adults,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS).”

MedCity News informs us that “Clinical development will soon begin for an inhaled version of a [Gilead] antiviral drug {remdesivir} used to treat Covid-19 that is currently available only to hospitalized patients in intravenous form.” That’s a pro move.

Drug Channels offers its annual study of 2019 PBM drug spending reports.

The PBMs’ data highlight key trends about drug spending:
— For 2019, CVS and Express Scripts reported overall changes in drug spending that were in the low single digits. Prime reported mid-single-digit growth in overall drug spending.
— Spending growth on traditional drugs declined by mid-single digits for the third consecutive year. This decline came from deeper commercial rebates on brand-name drugs, ongoing deflation in generic drugs, and a small increase in the generic dispensing rates.
— The results for CVS and Express Scripts were comparable. For CVS Caremark’s commercial clients, net drug prices for traditional drugs declined by -6.3%, while utilization grew by 1.5%. For Express Scripts’ commercial clients, net drug prices for traditional drugs declined by -6.4%, while utilization grew by 1.4%.

In legal news

  • It was no surprise to learn from Politico that LGBTQ advocates already have brought a lawsuit against the Department of Health and Human Services (“HHS”) “over its rollback of LGBTQ patient protections, arguing that last week’s Supreme Court decision extending workplace legal protections to gay and transgender employees invalidates the new rules.” That should be a rollover win for the plaintiffs.
  • It was a pleasant surprise to learn that the U.S. District Court for the District of Columbia today ruled in favor of an HHS rule requiring hospital to disclose real prices, e.g, negotiated prices with health plans, for their services just like retail stores. The FEHBlog expects that this rule will lead to more and better (e.g., quality based) competition among hospitals. But first the decision will need to be affirmed by the Court of Appeals.

Monday Roundup

It turns out the Senate Homeland Security and Governmental Affairs Committee will be considering the President’s nomination of Craig Leen to be OPM Inspector General at its June 10 business meeting which begins at 10 am ET. The FEHBlog expect him to receive Senate confirmation later this month.

On Friday June 5 the Centers for Medicare and Medicaid Services summarized all of the COVID-19 mandates applied and flexibilities offers to non-federal governmental health plans. It’s nevertheless a useful summary for FEHB plans too.

Today the Internal Revenue Service released the PCORI fee around for plan years beginning not earlier than October 1, 2019 or later than September 30, 2020. In other words this notice applies to the current FEHB contract / plan year which aligns with the calendar year. The amount is $2.54 per belly button up nine cents from last year. The payment deadline is July 31.

Finally, Health Payer Intelligence posted a hopeful story about cooperation between the State of Washington and a community health plan in a successful effort to improve the social determinants of health data available to the plan.

Organizations may find it overwhelming to tackle every social determinant of health at once, especially when they see how expansive the social services network can be. So [Jennifer] Polello], MHPA, PCMH-CCE, director of clinical data integration and social determinants of health at Community Health Plan of Washington] recommended beginning with one social determinant of health, maybe the most prevalent.

“Create workflows and workflow aids and education around just one social issue to start the ball rolling,” she said.

Regardless of the strategy employed, building this network of community resources to address social determinants of health is important now more than ever.

Well put.

Midweek update

Yesterday, the FEHBlog noted a study from late March to early April showing a big drop in non-COVID healthcare. (After all it is a lawyer’s job to belabor the obvious.) Today, Fierce Healthcare reports on a Commonwealth Fund study finding a “slight” pick up in that care later in April. “The rebound occurred across all specialties, although the decline in visits remains largest among surgical and procedural specialties alongside pediatrics, the study said.”

The Wall Street Journal reports that

A study published this week found that banning mass gatherings had the biggest contribution to bringing the epidemic under control in Germany.

Superspreading events could even reignite the epidemic when the situation appears under control, said Prof. Cristopher Moore, a physicist with the Santa Fe Institute.

Dr. Streeck, the German virologist, agrees. While most experts expect a deadly second wave of coronavirus infections in the fall, he thinks a sharper focus on preventing superspreading events and vigilant monitoring could help avoid such a scenario.

The FEHBlog would gladly take a ban on mass gatherings over the great hunkering down. Add fake crowd noise to sporting events with fans just like TV shows add canned laughter.

In the same vein, Healthcare Dive informs us that

Apple and Google have launched software allowing public health agencies to create contact tracing apps that will notify users if they’ve been close to a person who has tested positive for COVID-19. The infrastructure, dubbed Exposure Notification, uses the Bluetooth radios within iOS and Android systems for contact tracing apps and will be part of a software update the companies are pushing out Wednesday. Amid privacy concerns, Apple and Google say the apps will be fully opt-in and have other built-in consumer protections.

22 countries and several U.S. states have requested and been given access to the technology so far.

Beckers Hospital Review unfortunately lets us know that U.S. births hit a 35 year low in 2019. No bueno.

Weekend update

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.

Midweek update

As you know, the FEHBlog tracks the daily COVID-19 cases in the U.S. posted by the Centers for Disease Control. Here are the statistics for this week so far:

COVID 19 Statistics4/54/64/74/8
Cases304,826330,891374,329395,011
Deaths7,6168,91012,06412,754
Deaths over Cases2.50%2.69%3.22%3.23%

We tragically have experienced more COVID-19 deaths so far this week than the approximately 3,000 Americans who died at Pearl Harbor (or on September 11). However, the relatively high death rate (particularly compared to the flu) was flat for the past two days. We will see on Friday whether this encouraging trend continues.

The flattening occurred because the number of deaths stopped increasing proportionally faster than the number of cases. The more rapidly increasing number of COVID-19 cases must be due at least in part to the expansion of COVID-19 testing as discussed in this Healthcare Dive article and this HHS announcement that licensed pharmacists now are authorized to order COVID-19 tests.

Fierce Healthcare reports on the development of a new COVID-19 portal called “The National Response Portal that will provide vital information to healthcare providers, policymakers and the general public as a ‘one-stop-shop’ for all health data related to COVID-19, which is caused by the novel coronavirus, according to the organizations.” The new portal is gathering information now and is expected to go live next week.

Tuesday’s Tidbits

The Wall Street Journal reports today that “U.S. public-health authorities are reviewing recommendations for wearing face masks and a wave of European governments have ordered citizens to use them outside the home, signaling a shift among Western governments on a contentious issue in the coronavirus pandemic.” The social distancing requirement is intended to serve the same purpose as masking. The FEHBlog does not know where this change would lead.

FiercePharma discusses the ongoing COVID-19 vaccine studies. “In all, about 50 vaccines are in early development across the biopharma landscape, and researchers are exploring about 10 different vaccine approaches, said Jim Mayne, vice president of science and regulatory advocacy at PhRMA.” The FEHBlog is pleased to read that there are a lot of irons in this critically important fire.

The FEHBlog ran across this interesting U.S. Health Weather Map created by Kinsa and Oregon State University.

The U.S. Health Weather Map is a visualization of seasonal illness linked to fever – specifically influenza-like illness. The aggregate, anonymized data visualized here is a product of Kinsa’s network of Smart Thermometers and accompanying mobile applications, and Kinsa is providing this map and associated charts as a public service.

This appears to be the type of health surveillance tool that public health experts are encouraging.

CARES Act Update

The Hill reports that “[House of Representatives] Speaker Nancy Pelosi (D-Calif.) said Thursday that the House will move quickly on Friday to approve the Senate’s massive, $2 trillion coronavirus relief package [the CARES Act, H.R. 748] through the lower chamber and on to President Trump, who has vowed to sign it immediately.” NPR has provided a link to the text of the bill that the Senate passed unanimously at 11:17 pm last night.

CARES Act Update

The President and the entire Senate leadership have agreed on a third COVID-19 relief bill known as the CARES Act (H.R. 748). Senator Charles Grassley, the Senate Finance Committee Chair, has released a summary of the bill’s taxation and unemployment insurance provisions and summary of its health provisions. The key health provisions affecting federal employees benefits are the following:

Sec. 3701. Health Savings Accounts for Telehealth Services
This section would allow a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services prior to a patient reaching the deductible, increasing access for patients who may have the COVID-19 virus and protecting other patients from potential exposure.

Sec. 3702. Over-the-Counter Medical Products without Prescription
This section would allow patients to use funds in HSAs and Flexible Spending Accounts for the purchase of over-the-counter medical products, including those needed in quarantine and social distancing, without a prescription from a physician.

The FEHBlog mistakenly stated on Sunday that that the House of Representatives would be back on Capitol Hill yesterday. In fact, as the Wall Street Journal explains, House members remain on recess this week. Should the Senate as anticipated pass the CARES Act today, the House leadership is expected to seek approval by a unanimous consent motion. A single member of Congress can block such a motion so a lot rides on entire House leadership support for the bill. According to the Wall Street Journal, House Speaker Nancy Pelosi wants the unanimous consent to clear the House. This motion could be brought to the House floor on tomorrow or Friday. The Journal further reports that the President is ready to sign the bill into law.

The FEHBlog has found a link to a COVID-19 statistics site, The COVID-19 Tracking Project, that displays aggregated lab results from COVID-19 testing, U.S. state by state, where available.