Tuesday Tidbits

COVID-19

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, Medicare, U.S. Healthcare, Uncategorized–

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

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

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.

Friday Stats and More

David Ermer–COVID-19, Rx coverage, U.S. Healthcare–
This chart is based on the Centers for Disease Control’s Cases in the U.S. website for the week ending May 20th through the week ending July 23, which was a doozy in terms of new cases.

Here’s the CDC’s COVID-19 Hospitalizations Chart, which has been fairly stable since May:

The Wall Street Journal reports that

President Trump signed executive orders Friday aimed at reducing drug prices. The moves revived a signature part of his health-policy agenda before the 2020 election after his earlier efforts to combat rising prescription costs stalled.

One of the executive orders focuses on pegging the cost of drugs in the U.S. to lower drug prices overseas, and another concerns speeding imports of drugs from Canada. The pharmaceutical industry and some Republicans have criticized the first order, saying it amounts to price controls, while opponents of the second initiative say it raises questions about product safety.

Another would require community health centers to pass on negotiated discounts on insulin and epinephrine-injector devices to consumers. And a fourth would attempt to undercut “middlemen” whom Mr. Trump described as profiting from deals with drugmakers and don’t pass along discounts to consumers.

The moves are unlikely to result in immediate changes. The White House said they represent the administration’s policy and begin a rule-making process. That process can be arduous and face legal challenges.

The links inside the quote are to the Executive Orders themselves (The text of the first referenced Order on the use of international price indexing is not on whitehouse.gov yet).

Health Payer Intelligence informs us that “Over half of the public rate filings from payers on the individual and small group health insurance market are proposing 2021 premium rates changes between a two percent decrease and a six percent increase, according to Kaiser Family Foundation.” For more details, check out the KFF report.

Thursday Miscellany

David Ermer–COVID-19, HIPAA Privacy and Security Rules, U.S. Healthcare–

Modern Healthcare reports this evening that Health and Human Services (“HHS”) Secretary Alex Azar has signed a 90 day extension of the COVID-19 national health emergency. The current emergency period was otherwise set to expire on Saturday July 25. Modern Healthcare explains that

The renewal gives the healthcare industry certainty through the fall on several key policies to assist with the COVID-19 response. Some notable policies tied to the public health emergency are the 20% Medicare inpatient add-on payment for COVID-19 patients, increased federal Medicaid matching funds for states, a mandate that insurers cover medically necessary COVID-19 tests without cost-sharing, relaxed telehealth restrictions, and Section 1135 waivers that give providers additional flexibility to respond to COVID-19.

In other news,

  • Aetna is rolling out two new benefit design offerings for employer sponsored health plans per Fierce Healthcare.

The new designs, called Upfront Advantage and Flexible Five, offer members coverage for some preventive services before they meet their deductibles. In Upfront Advantage, members will have access to services worth up to $500 for an individual and $1,000 for a family for free before their deductible is met. In Flexible Five, members will instead be offered five coupons per person for these services; a family of four, for example, would receive 20 coupons that can be applied to services such as primary care visits, behavioral health visits, urgent care, lab tests or x-rays conducted during those visits and generic drugs.

  • Health Payer Intelligence informs us that Humana “has committed to mail out over a million preventive care packages that members can use in their homes. The in-home preventive care packages are designed to support chronic disease prevention for members with diabetes or colon cancer. Members can take the test in their homes to detect diabetes or colon cancer developments as early as possible.” That’s quite an investment.
  • HHS’s Office for Civil Rights announced a HIPAA Privacy Rule breach settlement with a North Carolina based healthcare provider today. It’s noteworthy that the settlement resolved issues that were touched off by a data breach in 2011.

Midweek update

David Ermer–COVID-19, Rx coverage–

Another rainy evening in Bethesda MD.

Get a load of this — public health benefits from the great hunkering down:

  • From the Wall Street Journal — “From Argentina to South Africa to New Zealand, countries in the Southern Hemisphere [where it is winter] are reporting far lower numbers of influenza and other seasonal respiratory viral infections this year. In some countries, the flu seems to have all but disappeared, a surprise silver lining that health experts attribute to measures to corral the coronavirus, like mask use and restrictions on air travel.”
  • and from the New York Times (thanks to a friend of the FEHBlog) — “This spring, as countries around the world told people to stay home to slow the spread of the coronavirus, doctors in neonatal intensive care units were noticing something strange: Premature births were falling, in some cases drastically.”

The Wall Street Journal also reports that “[t]he U.S. has agreed to pay Pfizer Inc. PFE 5.10% and BioNTech SE nearly $2 billion to secure 100 million doses of their experimental Covid-19 vaccine to provide to Americans free of charge, the latest sign the government is readying plans to make vaccines available if proved to work safely.” Here is the HHS press release on this welcome purchase. The story reminded me of when the FEHBlog as a youngster was standing in a long line of his peers to receive the second polio vaccine.

On an unrelated note, Fierce Healthcare informs us that health “insurers are worried a raft of proposed changes to the Medicaid Drug Rebate Program could lead to drug manufacturers gaming the system to charge higher prices.” The FEHBlog continue to believe that the upside opportunities from this change are greater than the downside, but he appreciates the skepticism.

Monday Roundup

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

In federal personnel news —

  • Politico reports that earlier today the Senate confirmed acting Office of Management and Budget Director Russell Vought to be permanent OMB Director.
  • Federal News Radio reports that the President intends to nominate John Gibbs to be permanent Director of the Office of Personnel Management. Mr. Gibbs “currently serves as the acting assistant secretary for community planning and development at the U.S. Department of Housing and Urban Development.

It’s worth noting that the Presidential inauguration will occur six months from today.

On the COVID-19 front —

  • The Wall Street Journal reports that “The prospects of successfully developing a coronavirus vaccine as soon as this year were buoyed Monday when three of the world’s leading candidates reported positive early trial data. Vaccines being developed by University of Oxford researchers and AstraZeneca PLC; PfizerInc. and German partner BioNTech BNTX 3.46% SE; and China’s CanSino Biologics all reported fresh updates showing their shots generated immune responses and were safe to use.
  • Fierce Biotech reports that a double blind human patient study of U.K. manufacturer Synairgen’s inhaled COVID-19 treatment against a placebo produced encouraging results. “The [preliminary] data showed those who were given SNG001 [a nebulizer interferon beta protein] had a 79% lower risk of developing severe disease compared to placebo * * * with patients who got that drug also more than twice as likely to recover from COVID-19 than those on a dummy med.” Synairgen’s press release advises that “‘Further analysis will be conducted over the coming weeks and reported in due course.”

Fingers remain crossed for the vaccines and the new treatment.

Health IT Analytics discusses how “geographic data has helped leaders better understand where to allocate population health resources during the COVID-19 pandemic.” Given the mantra that all healthcare is local, it only makes sense that geographic data should be helpful for this purpose. For example,

To better understand where to direct resources, researchers at NYU Grossman School of Medicine recently developed a city-oriented COVID Local Risk Index. The tool calculates COVID-19 risk down to the hyperlocal, neighborhood level by relying on key health, economic, and social data at the census tract level. The index also allows for comparison of COVID-19 risk across other cities and between neighborhoods.

Well done.

Weekend update

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

The House and the Senate will be in session on Capitol Hill for the next two weeks. The House will begin a district work break at the end of July while the Senate will continue in session until August 5. Congress will be out of session for the remainder of August for the political conventions. It will be interesting to see whether another COVID-19 relief bill emerges over the next three week legislative period.

Speaking of COVID-19, Govexec.com estimates that 19,000 federal employees and 20,000 members of the U.S. military have tested positive for COVID-19. That’s roughly 1% of the total number of federal employees and military members and 1% of the total number of COVID-19 cases in the U.S. That’s encouraging given the fact that many federal employees, e.g., the Postal Service, law enforcement, as well as military members have not been hunkered down during the emergency. Thanks to all of you for your service.

The FEHBlog subscribes to the Washington Post’s Optimist email and today’s lead article caught his attention — “Need some good news about covid-19? Here are six reasons for optimism.” The writer who directs the Health Buildings Program at Harvard’s public health schools discusses six trends that the FEHBlog has been following to one extent of another. It’s helpful to read them summarized here.

The FEHBlog looks forward to virtually attending the National Committee for Quality Assurance’s Digital Quality Summit this coming Wednesday and Thursday. The FEHBlog will share a few tidbits with his readership.

In last Friday’s post, the FEHBlog mentioned the key roles that hospitals and other healthcare providers including “pharma” and the prescription benefit managers plus the government play in responding to the COVID-19 emergency. It occurred to the FEHBlog over the weekend that his readers may wonder where health plans fit into this mix.

Health plans need to keep on keeping on, as they have done, by paying claims and helping members navigate the healthcare system, among other things. That’s an important responsibility. In my experience, FEHB plans have not missed a beat during the emergency, and the FEHBlog is proud to serve many of them.

Friday Stats and More

David Ermer–COVID-19, Federal employment benefits, OPM, U.S. Healthcare–

For the third week in a row, new COVID-19 cases have topped 300,000 (nearly 1 million in total) while the number of new deaths remains relatively low and stable (12,000 in sum over the past three weeks) according to the CDC’s cases in the U.S. website which the FEHBlog tracks.

Axios echos the FEHBlog’s sentiment that the medical profession to its credit has learned how to treat COVID-19. That is what you would expect in 2020. Hopefully the government is doing a good job providing healthcare resources to hot spot areas in order to facilitate treatment. In that regard, HHS announced today that “it will begin distributing $10 billion in a second round of high impact COVID-19 area funding to hospitals starting next week.”

In our FEHBP world —

  • Federal News Network reports that OPM has issued new proposed rules to address enrollment problems that arose during the long government shutdown in the winter of 2018-19. Hopefully we won’t encounter another one of those unfortunate events again, but it is better to be safe than sorry. Several of the new flexibilities are already law thanks to a law that Congress passed in 2019.
  • OPM also released today a revised SF 2809 FEHB enrollment form. The form is a handy reference for FEHB enrollment rules. It’s not used as often as it was pre-internet and smart phones.

Finally, the Trump Administration enjoyed two victories in the U.S. Court of Appeals for the D.C. Circuit today. As Healthcare Dive reports

  • The Court of Appeals affirmed a lower court decision upholding the Administration’s short term duration health plan rule. The FEHBlog sees no harm in giving consumers greater choice of health care coverage after Congress zeroed out the individual mandate.
  • The Court of Appeals reversed a lower court decision and thereby upheld the Administration’s Medicare “site neutrality” rule that “reduced some payments to off-campus hospital outpatient departments to make them consistent with other outpatient payments.” The court reasoned that

“Reducing the payment rate for a particular OPPS service readily qualifies, in common parlance, as a ‘method for controlling unnecessary increases in the volume’ of that service,” according to the opinion. “The lower the reimbursement rate for a service, the less the incentive to provide it, all else being equal. Reducing the reimbursement rate thus is naturally suited to addressing unnecessary increases in the overall volume of a service provided by hospitals.”

Makes perfect sense to the FEHBlog.

Thursday Miscellany

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

On the COVID-19 front —

  • The Wall Street Journal reports that in the course of reporting its second quarter 2020 financial results, Johnson & Johnson (“J&J”) announced that “it plans to begin the first human studies of its experimental coronavirus vaccine next week, as it races to make the shot available starting early next year. * * * J&J could get an answer about whether the vaccine safely prevents Covid-19 by the end of the year, Dr. Stoffels said. If successful, the company expects the shot to become available in early 2021, and J&J plans to manufacture up to one billion doses by the end of next year.
  • Fierce Healthcare provides an update on the state of COVID-19 testing in our country. “Admiral Brett Giroir, M.D., Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS) said 45 million COVID-19 tests had been performed in the U.S. so far, or about 700,000 a day. “We see early indicators that in the hot areas, the red zones, we’re seeing the positivity rate start to go down or plateau. That’s an early sign that we’re getting control of this outbreak,” he said. “This is no victory lap, but it does show that our efforts are starting to make an impact,” he said. “In Arizona, the positivity rate has dropped dramatically.” Giroir said basic, simple measures will help to curb the pandemic, namely, closing bars and indoor dining at restaurants and individuals adhering to guidance to wear masks in public, practice social distancing and avoid large groups.” Good message.

Regrettably, the Wall Street Journal also reports that

U.S. fatal drug overdoses rose last year, new federal data show, reversing a one-year-decline and indicating that another public-health crisis was worsening as the coronavirus pandemic was poised to begin.

Provisional data from the Centers for Disease Control and Prevention include 70,980 fatal overdoses in 2019 with about 1,000 more deaths likely to be added, marking a 4.8% increase from the year before. The data indicate the U.S. last year likely eclipsed the prior record high of 70,237 overdose deaths set in 2017, said Robert Anderson, chief of the mortality-statistics branch at the CDC’s National Center for Health Statistics.

[P]roblems with synthetic drugs like methamphetamines and bootleg versions of the opioid fentanyl have challenged the nation’s ability to build on improvements. Overdose deaths in drug categories including meth and fentanyl continued to rise last year, the CDC data show, while deaths from cocaine, another stimulant, also rose.

Jim Hall, an epidemiologist in Florida who has studied the drug crisis, said the rising availability of the overdose-reversal drug naloxone helped tamp down the number of fatal overdoses in 2018. But the toxicity of fentanyl and the mixture among many users of both fentanyl and stimulants remain potentially deadly problems, he added.

For more details here’s a link to the CDC report.

The CDC also released a public health report today about the use of prescription opioids by pregnant women.

Among respondents reporting opioid use during pregnancy, most indicated receiving prescription opioids from a health care provider and using for pain reasons; however, answers from one in five women indicated misuse. Improved screening for opioid misuse and treatment of opioid use disorder in pregnant patients might prevent adverse outcomes. Implementation of public health strategies (e.g., improving state prescription drug monitoring program use and enhancing provider training) can support delivery of evidence-based care for pregnant women.

Midweek update

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

There have been many ups and downs during the COVID-19 emergency. The one effort consistently making sure but steady progress is the COVID-19 vaccine development process. In today’s news from Fierce Healthcare

  • “AstraZeneca and the University of Oxford are set to share “positive news” on their COVID-19 vaccine soon, according to a leading U.K. journalist. The update, which could come as soon as tomorrow, may shed light on how the front-runner vaccine fared in early clinical trials.”
  • “Moderna and its partners in the federal government are just now gearing up for a late-stage COVID-19 vaccine trial set to launch later this month, but at the same time, the mRNA biotech is prepping a supply of doses for quick shipment if the shot gets an FDA go-ahead.”

In this regard, the FEHBlog has noted his addiction to the Econtalk podcast. This week the host Stanford economics professor Russ Roberts dropped this pearl of wisdom in the course of his conversation with a gaming company CEO:

It’s taken me a long time, Josh, but I’ve finally figured out that sometimes something that people are really excited about doesn’t happen. Driverless cars. Four years ago I thought , ‘By 2020 they’re going to be here for sure. AI [Artificial Intelligence], ‘Yeah, soon they won’t even–,’ you fill in the blank. A lot of these things turn out to be harder than they were thought to be. And of course, part of the reason for that is that the people who’ve spent the money to take the chances on it have an incentive to overstate the hype. It’s just part of the natural human experience.

And of course there are also the lawyers telling the entrepreneurs to tone it down. Hopefully the COVID-19 vaccine for which we are all excited will be a near term success. Knock on wood.

In telemedicine news —

  • The Health Affairs Blog features a detailed CMS Administrator Seema Verma article on the topic. She concludes “During these unprecedented times, telemedicine has proven to be a lifeline for health care providers and patients. The rapid adoption of telemedicine among providers and patients has shown that telehealth is here to stay. CMS remains committed to ensuring that the government supports innovation in telehealth that leverages modern technology to enhance patient experience, providing more accessible care.”
  • Health Payer Intelligence reports that

As payers lean more heavily on remote care, consumers stressed the need for greater convenience in care delivery and prefer to turn to telehealth and digital solutions, in part, as the answer, according to a recent CVS Health study. CVS Health fielded the survey in March 2020 and garnered 1,000 respondents. It drew particularly from twelve major cities and targeted African American and Hispanic participants. An additional survey covered 400 providers.

What a happy coincidence!

Finally, Healthcare Dive informs us about UnitedHealth Groups’s second quarter 2020 earnings report.

Payer arm UnitedHealthcare, the largest commercial health insurer in the U.S., brought in $49.1 million in revenue, up just 1% year over year. But its medical loss ratio, a marker of how much an insurer spends on patient care, plummeted to 70.2% in the quarter ended June 30, compared to 83.1% same time last year, due to temporary deferral of care amid the pandemic.

The question of course is when will the bounce back occur?