Thursday Miscellany

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

The Wall Street Journal reports that the entire Senate Republican caucus, with the exception of Sen. Rand Paul, voted for the scaled down $500 billion (is that an oxymoron?) COVID-19 relief bill, but the bill failed to receive the 60 votes necessary for cloture because the Democratic caucus lined up in opposition. So we have another political issue for the election.

Thankfully, the Congress and the White House have agreed on a continuing resolution to fund the federal government into the new federal fiscal year. The House will be holding votes next week so the FEHBlog expects that the House will pass the continuing resolution and then peace out for the campaign trail. The Senate will hang around as long as it can to approve more nominations. Following the election Congress will hold a lame duck session at which point another COVID-19 relief bill is likely to be enacted.

In healthcare news —

  • The National Academies of Sciences has a detailed web page about social determinants of health that is worth a look.
  • Humana has launched value based hearth surgery and shoulder replacement programs. “””The value-based care models are part of a portfolio of payment bundles created by Humana including a Maternity Episode-of-care Model and an Oncology Model of Care. Humana also offers a Hospital Incentive Program for acute care inpatient admissions. About 2.4 million MA members and 115,000 commercial members are enrolled in value-based models, Humana has said.”
  • Fierce Biotech reports that quick, inexpensive saliva based COVID-19 tests are being piloted at Heathrow Airport in London, England. Send the tests over here.
  • The Wall Street Journal informs us that “health experts say it’s increasingly likely that several [COVID-19] vaccines could pass muster in clinical trials and become available in phases over a period of weeks and months.”

The Centers for Disease Control and Prevention sent documents last week to state officials that lay out various scenarios, including availability of a limited number of doses of two vaccines by the end of October with more doses by the end of the year. The CDC document doesn’t name the two vaccines that could become available but describes characteristics that match those of the vaccines from Pfizer and Moderna.

Experts say multiple vaccines will be needed because no single company can make enough for the whole world. Several companies have signed contracts with the federal government to supply at least 100 million doses of each vaccine in the U.S., and are planning to produce larger global supplies.

Progress.

Happy Labor Day!

Photo by Karl Magnuson on Unsplash

The FEHBlog drove from New Haven, CT, to Bethesda, MD, today with a stop in Long Island. Traffic was quite cooperative. This trip allowed the FEHBlog to listen to this week’s Econtalk episode in which Econtalk host Russ Roberts interviewed leadership expert Margaret Heffernan about her new book “Uncharted — How to Navigate the Future.” “The central thesis of her book is that while the future may be unpredictable, that doesn’t mean you can’t prepare for it. And smart organizations and people can learn how to do it.” Here’s a valuable nub from the conversation:

I remember–oh, I don’t know, probably 2010 to 2012–having a number of arguments with my husband about when the next banking crash would be. And it suddenly struck me, this was just a stupid argument. Right? Because neither of us knew. No little economic fairy had sprinkled gold dust on us.

And, I said, ‘Okay, let’s ask a different question. Let’s ask the question: If there is another banking crash, or when there is another banking crash, what will we wish we had been doing right now?’ And, we thought through that in some pretty gritty detail about where we would want our investments to be, where we would want to be, what resources we would want to have. And so we slightly changed some of the things we were doing. We accelerated some things. We put other things on hold. And, what it did is it left us feeling, ‘Okay, we don’t know what the future is, but we think we’ve placed ourselves in a reasonably robust context.’ And actually that’s pretty much all we can do.

Accordingly, time would be better spent on thinking about how to restructure healthcare in the post pandemic world or how to better deal with a similar pandemic in the future and not on trying to figure out when this particular pandemic will end. Of course, everyone should work together toward the end of the current pandemic as it eventually will end.

The FEHBlog noticed for example that the benefit consulting firm Willis Towers Watson is holding a virtual conference later this month on resetting health and other employee benefits for the post-pandemic world. The conference website links to already available articles on this important topic.

What’s more with respect to getting current job done, the Wall Street Journal reports this weekend,

FDA [r]egulators authorized [last week] a new test developed by Fluidigm that uses saliva rather than a nasal swab. The clinical study associated with Fluidigm’s submission to the FDA demonstrated 100% agreement between the saliva results and paired nasopharyngeal samples. Fluidigm’s test returns results in several hours. Meanwhile, OraSure Technologies is developing a nasal-swab test that is potentially suitable for at-home use and could be ready this fall. * * * Thanks to health care innovation, a return to normalcy for the United States might just be in the cards in the months ahead.

Amen to that.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Healthcare Dive informs us about the American Hospital Association’s reaction to yesterday’s final FY 2020 inpatient prospective payment system rule.

The American Hospital Association quickly criticized the price transparency element of the final rule Wednesday night.

“By continuing to focus on negotiated rates rather than expanding access to a patient’s out-of-pocket costs, the Administration fails to meet the goal it set for itself — assisting consumers in becoming more prudent purchasers of health care,” the group said in a statement. “We once again urge the agency to focus on what is really important to patients — ready access to their out-of-pocket costs.”

Evidently, the hospitals seek to dump the entire transparency burden on the health plans. The FEHBlog thinks that consumers would better informed by requiring hospitals and all providers to publicly announce the health plan network(s) in which they participate, an analog to the summary of benefits and coverage that health plans must distribute to members.

Speaking of comparison tools, the Centers for Medicare and Medicaid Services today launched

Care Compare, a streamlined redesign of eight existing CMS healthcare compare tools available on Medicare.gov. Care Compare provides a single user-friendly interface that patients and caregivers can use to make informed decisions about healthcare based on cost, quality of care, volume of services, and other data. With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools.

CMS notes that “Although the tool was created for people with Medicare in mind, many of the measures shown here apply to people who may not have Medicare. Information on this site isn’t an endorsement or advertisement for any provider type.”

Speaking of FY 2020, the Hill reports

Treasury Secretary Steven Mnuchin and Speaker Nancy Pelosi (D-Calif.) have informally agreed to pursue a clean, short-term stopgap measure to avert a government shutdown at the end of the month, sources in both parties confirmed Thursday. That means the continuing resolution (CR) needed to keep the government open past Sept. 30 would be free of controversial policy riders that have bogged down previous funding bills, significantly lowering the odds of a shutdown leading up to the crucial Nov. 3 elections.

That my friends is good news for the country.

In other news —

  • The Wall Street Journal brings us up to date on the cost, accuracy, and turnaround times for popular (?) COVID-19 testing methods.
  • The Department of Human Services released an action plan for improving rural healthcare in the United States.
  • Beckers Hospital Review reports that Walmart will be bringing Oak Health primary care centers into their super centers located in Arlington, Benbrook and Carrollton, Texas, later this year.
  • HR Dive discusses recent back to school guidance from the Labor Department regard the federal relief acts COVID-19 paid leave program. It’s complicated just like COVID-19.

Thursday Miscellany

The Wall Street Journal reports “The Trump administration unveiled Thursday a $750 million deal to buy 150 million rapid Covid-19 tests from Abbott Laboratories, a move that would substantially expand the nation’s capacity for rapid testing.” As noted in yesterday’s post, this $5 antigen test, which received Food and Drug Administration emergency use authorization on Wednesday, ” is roughly the size of a credit card. The test could be administered in a doctor’s or school nurse’s office and uses technology similar to home pregnancy tests. It returns results in about 15 minutes.”

While on the subject of COVID-19 testing, Fierce Healthcare informs us that

Out-of-network costs for COVID-19 testing far outpace the costs for in-network tests, according to a new report from America’s Health Insurance Plans. The results suggest that price gouging is a significant problem under the pandemic, the group argues. The AHIP analysis finds that a test for the novel coronavirus costs on average $130 for commercial insurers. However, out-of-network providers charged more than $185 for 40% of diagnostic test and 25% of antibody tests, the lobby organization found.

Shameful. Congress should step in on this one.

In encouraging developments,

Fierce Biotech lets us know that

As the world scrambles to develop diagnostics, treatments and vaccines for COVID-19, one big question looms: How will we face the next pandemic? Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) are teaming up once again to answer that.

Through a joint effort dubbed Blue Knight, the duo aims to boost innovation and “amplify” scientific and technological advancements to prepare for potential health threats—starting with COVID-19. They’ve picked seven startups from J&J’s global JLABS network to participate. The startups will receive up to $500,000 in support, as well as mentorship from BARDA and J&J to help them navigate R&D challenges and regulatory pathways and get medicines and tools to patients and healthcare workers as soon as possible.

and Healthcare Dive reports that

Aetna is partnering with WellBe Senior Medical, a relative newcomer, to deliver primary care services to about 10,000 high-risk seniors in their homes, according to WellBe CEO Jeff Kang, who is also a physician. The program launched in Atlanta last month and is now available for certain seniors in the Chicagoland area. For eligible seniors, this means access to at-home care 24 hours, seven days a week, lessening the burden of getting a ride to an appointment or venturing to a medical facility amid the pandemic. Even COVID-19 testing can be done in their homes. Aetna assigns eligible high-risk patients to WellBe, which is then responsible for managing their care and receives capitated payments from Aetna. Those eligible are typically seniors in their 80s with multiple chronic conditions, including diabetes, heart failure, osteoarthritis and dementia, Kang said in an interview with Healthcare Dive.

There are plenty of elderly annuitants in the FEHBP although most of them have primary Medicare coverage.

Finally in Office of Personnel Management new:

Office of Personnel Management acting Director Michael Rigas [considerately] has issued a new memorandum to agency heads Aug. 27 informing them that [under a new regulation] employees will no longer have to pre-schedule their annual leave prior to the third pay period before the end of the year, so that the agency can then cancel and restore it. [A]ny leave that is forfeited at the end of the year due to a national emergency where the employee was deemed essential and not able to take leave would automatically be considered “scheduled in advance” and restored into a separate leave account for later employee use.

and Govexec.com updates us on the upcoming Combined Federal Campaign. This annual charity drive for federal employees runs from Sept. 21 through Jan. 15, 2021.

Midweek update

On the COVID-19 healthcare front –

  • The Wall Street Journal reports this evening that

The U.S. Food and Drug Administration has granted emergency-use authorization to Abbott Laboratories for a $5 rapid-response Covid-19 antigen test that is roughly the size of a credit card. The low-cost, rapid-response test could be administered in a doctor’s or school nurse’s office and uses technology similar to home pregnancy tests. It returns results in about 15 minutes. * * *Abbott’s new test, called the BinaxNOW COVID-19 Ag Card, searches for virus proteins and is intended to be used for patients within seven days of feeling coronavirus symptoms. It involves a nasal swab administered by a health-care professional such as a doctor, school nurse or pharmacist. The swab is inserted into the card-like test.

  • Beckers Hospital Review reports that to the consternation of outside experts, the Centers of Disease Control (CDC) has advised that “people without symptoms don’t always need to be tested. The original guidelines recommended testing for all close contacts of known COVID-19 patients. The updated version says known contacts “do not necessarily need a test” if they don’t have symptoms. Exceptions can be made for vulnerable individuals and if clinicians or public health officials recommend testing.”
  • MedPage Today informs us that “Patients with COVID-19 should delay getting their influenza vaccine, not because of any evidence about how the virus affects vaccination, but in order to ensure others in the healthcare setting are not exposed unnecessarily, CDC officials said on a call with clinicians on Thursday [August 20].”
  • National Committee for Quality Assurance leaders discuss in the Health Affairs blog how the NCQA’s new digital quality measures are responsive to the COVID-19 public health emergency. In the FEHBlog’s view these digital changes which tie in with electronic health record interoperability advances, e..g., HL7’s FHIR API, will lead to health care quality improvements generally.

The Abbott Labs test is an important development from the FEHBlog’s perspective.

In COVID-19 developments outside of healthcare —

  • Bloomberg Government notes, as the FEHBlog expected, that “Representatives of Rite Aid Corp, Walgreens Pharmacy, OptumRx Inc., and Express Scripts Inc., all major pharmacy and pharmaceutical benefit manager chains, said they aren’t seeing major disruptions to order times for prescriptions this year.”
  • HR Dive discusses three COVID-19 workplace trends that are likely here to stay — expanded paid leave access, increased attention to employee and customer safety, and telework as an accommodation.
  • The Society for Human Resource Management summarizes new Labor Department guidance on tracking hours worked by teleworking employees who are subject to the Fair Labor Standards Act.

In other news —

  • The FEHBlog registered this evening for the FREE Health Payment Action and Learning Network’s virtual summit scheduled for October 13. You can register here. The FEHBlog has been attending this interesting event for a few years.
  • Healio reports that according to a new CDC report on teen vaccination rates in our country, “HPV and meningococcal vaccination coverage among adolescents aged 13 to 17 years in the United States continues to improve, although geographical disparities persist, according to findings published in MMWR. Researchers found that adolescents at or above the poverty line who lived outside a metropolitan statistical area (MSA) were less likely to have received an HPV or meningococcal vaccine than adolescents living in MSA principal cities.”
  • Health Payer Intelligence reports that “To further discover trends in COVID-19 mortality and the spread of the virus, researchers are increasingly leveraging geographic and population data for new insights on how the disease operates.” Investigations of all wide spread health problems can benefit from this geographic approach because after all healthcare is local.

Weekend update

Because Congress is out of town until after Labor Day. let’s lead with the story that caused the FEHBlog to levitate out of his easy chair yesterday. The Yale News headline says it all — “Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorization.”

A couple weeks ago the FEHBlog mentioned a USA Today story about an Xprize competition to find a quick and inexpensive COVID-19 test that would facilitate going back to work, school, etc. The Xprize competition’s first round closes next week and we already have one winner.

Check this out:

Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said [Yale Assistant Professor of Public Health Nathan] Grubaugh.

One of the team’s goals was to eliminate the expensive saliva collection tubes that other companies use to preserve the virus for detection. In a separate study led by Wyllie and the team at the Yale School of Public Health, and recently published on medRxiv, they found that SARS-CoV-2 is stable in saliva for prolonged periods at warm temperatures, and that preservatives or specialized tubes are not necessary for collection of saliva.

The Yale researchers validated their test with the cooperation of the National Basketball Association. It was interesting to watch this season’s opening Hard Knocks show on HBO which showed how NFL teams similarly are focused both on the team’s schedule and COVID-19.

In litigation news —

  • Last Friday, as Healthcare Dive reports, the U.S. Court of Appeals for the Federal Circuit handed health insurers participating in the ACA’s marketplace another win against the federal government. This time the unpaid amounts involve reimbursable cost sharing reductions for low income marketplace participants.
  • On Tuesday, August 18, the Health and Human Services Department’s revised rule on the ACA’s individual non-discrimination provision, Section 1557, takes effect. The federal government, as requested by the Court, filed a sur-reply on the standing issue last Monday, and one of the plaintiff’s advised the Court on Wednesday that the U.S. Court of Appeals for the Fifth Circuit has revived the dormant Franciscan Alliance case which is the granddaddy of challenges to the 1557 rule (although it was filed in an effort to challenge the Obama Administration’s versions of the rule.)

In other news, Health Payer Intelligence reports that

Payers can play a significant role in decreasing the expense and complexity of serious illness care for patients through whole person care and palliative care, a study from America’s Health Insurance Plans (AHIP) found.

“Recognizing the difficulties of serious illness, health insurance providers have set out to help, support, and ease the journey for patients, caregivers and loved ones,” the AHIP study stated.

“Ensuring access to tools, education, and services for patients and their loved ones during a difficult time can provide the opportunity to plan, allow patients to maintain their dignity and choice, and support loved ones to know their role and how best they can help.”

Check it out.

Finally, the Federal News Network informs us that the General Services Administration made no changes to the current standard per diem rates for hotels, meals, and incidental expenses of federal employee business travel within the contiguous United States effective for the next federal fiscal year beginning October 1, 2020. What’s more,

There are, however 319 non-standard areas (NSAs), which have higher per diem rates than the standard CONUS allowance. GSA added one area, Albuquerque, New Mexico, as a new NSA location this year. Four locations came off the NSA list from 2020 and will now receive the standard per diem rate: Gainesville, FL; Atlantic City, NJ; College Station, NJ, and Abingdon, VA.

These rates also apply to government contracts such as experience rated FEHB carriers that are subject to the Federal Acquisition Regulation’s Cost Principle. The GSA assumes, of course, that business travel will resume next year, and in view of the low cost saliva test, it just might.

Thursday Miscellany

The FEHBlog generally writes his posts at home in the evening, and he has been noting when it has been raining in Bethesda as it has been quite a rainy summer. This evening features blue skies (although it did rain this morning.)

On the COVID-19 front, the Department of Health and Human Services announced today

combined investments of $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional SARS-CoV-2 per month. SARS-CoV-2 is the virus that causes COVID-19. The investments in Aegis Sciences Corporation and in Sonic Healthcare USA will provide critical laboratory equipment supplied by Beckman Coulter Life Sciences and Thermo Fisher Scientific and increase staffing and infrastructure to allow the U.S. to perform an additional 1 million tests each week by early October.

The American Hospital Association, the American College of Surgeons, and other major provider organizations have updated their roadmap for performing essential surgeries during the COVID-19 emergency. This may be helpful to health plan utilization review units.

A Wall Street Journal op-ed piece points out that

More than 500 clinical trials are under way world-wide in the race to find an effective treatment for Covid-19. Everybody wants it; nobody has it—yet. But one of the most promising therapies for Covid-19 patients uses “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body.

In preliminary studies, these cells cut the death rate significantly, particularly in the sickest patients. With a powerful 1-2-3 punch, these cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue—a combination offered by no other drug. This type of regenerative medicine could be as revolutionary as Jonas Salk’s polio vaccine.

Here’s a link to a STAT News report on newly released information on a study of convalescent plasma to treat COVID-19. Something has to pay off soon, right?

In general prescription drug news, GoodRx lists the twenty most expensive medicines in the U.S. The list identifies the manufacturer assistance program associated with each drug.

In other healthcare news —

  • Becker’s Hospital Review reports that UnitedHealthcare is resuming its COVID-19 delay effort to stop sending paper benefit checks to network providers. UHC plans to rely entirely on electronic payments. Smart move.
  • The Affordable Care Act provided government funding to create new CO-OP health plans. The FEHBlog criticized the decision as unnecessary. At on point there were 23 CO-OP plans and OPM was enlisting them for their ACA create Multi-State Program (“MSP”). ThinkAdvisor informs us that the New Mexico Co-op plan is shutting down at the end of this year which will leave three Co-ops operating in Maine and the Midwest. The MSP similarly failed because it was over-complicated and unnecessary.

Midweek Update

It’s another rainy night in Bethesda.

Fierce Pharma reports that “the U.S. has ordered 800 million doses [of various COVID-19 vaccines currently in phase 3 testing] for a country with a population of about 330 million, likely under the assumption that some vaccines won’t make it through clinical testing. The government is “assembling a broad portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS secretary Alex Azar said in a statement.”

The Wall Street Journal informs us that

Doctors, nursing homes and federal officials are scrambling to get rapid-response Covid-19 antigen testing supplies from the two companies that secured emergency approval to produce them, as cases continue to rise in the U.S.

Rapid-response antigen tests make up a small but growing area of Covid-19 testing in the U.S. and are seen as helpful in tamping down outbreaks because they offer faster results than many molecular tests that must be sent to labs for processing. The tests search for virus proteins while other tests look for the virus’s genetic material.

Quidel Corp. QDEL 4.36% and Becton Dickinson & Co., the only companies that so far have federal emergency authorization to supply such diagnostic tests, also make machines that process them. The boxlike test-analyzers, which before the pandemic processed tests for ailments such as the flu, are found in doctors’ offices and nursing homes, allowing facilities to avoid shipping samples to commercial labs for processing. They can deliver results in about 15 minutes and process dozens of samples an hour.

Quidel is struggling to produce enough analyzers to meet demand, while Becton Dickinson’s challenge is making enough tests, the companies say. * * *

Public health officials have raised some concerns that rapid antigen tests deliver false-negative results at a higher rate than other tests. But federal officials have said that, as these tests become more widespread, they appear equal in sensitivity to the more broadly used polymerase chain reaction diagnostic tests.

Perhaps Kodak can help (FEHBlog humor).

Fierce Healthcare lets us know that “According to the J.D. Power 2020 U.S. Pharmacy study, the expansion of pharmacy companies into the primary care realm has driven ‘significant increases in both satisfaction and consumer spending.'” On a related note, Forbes reports that “CVS Health is back on track with the rollout its new health hub concept to 1,500 stores across the U.S. within the next two years despite the continuing spread of the coronavirus strain Covid-19. CVS Health currently has 205 HealthHubs opened in 22 states. “CVS HealthHubs dedicate more than 20% of the store to health services that include new durable medical equipment, supplies and various new product and service combinations. CVS is adding thousands of new personal care items as well as additional services at its MinuteClinics in the HealthHub stores.”

The Centers for Medicare and Medicaid Services announced today its proposed national coverage decision that would allow local Medicare administrative contractors to make the initial decision on whether to cover an artificial heart or a ventricular assist device for Medicare beneficiaries with end stage heart disease. Currently the devices are treated as experimental treatments that CMS can cover on an exception basis. The CMS announcement explains that 6.5 million Americans “are living with heart failure.” A CMS decision whether or not to finalize the proposal will be made within 60 days following the end of the 30 day public comment period which began today.

Earlier this week the Centers for Disease Control announced their “Hear Her” campaign to reduce maternal mortality.

Over 700 women die each year in this country from problems related to pregnancy or delivery complications. Every death is a tragedy, especially when we know that two thirds of pregnancy-related deaths could be prevented. As many as 50,000 women experience severe, unexpected health problems related to pregnancy that may have long-term health consequences.

CDC’s Division of Reproductive Health is committed to healthy pregnancies and deliveries for every woman. The Hear Her campaign supports CDC’s efforts to prevent pregnancy-related deaths by sharing potentially life-saving messages about urgent warning signs.

Women know their own bodies better than anyone and can often tell when something does not feel right. The campaign seeks to encourage partners, friends, family, coworkers, and providers—anyone who supports pregnant and postpartum women—to really listen when she tells you something doesn’t feel right. Acting quickly could help save her life.

How true. This campaign deserves support from health plans as well as healthcare providers.

Friday Stats and More

Here you friends. This chart is based on the CDC’s cases in the US statistics running on a Thursday to Wednesday weekly basis from May 14 through July 30:

As of today there have been 4,473,974 COVID-19 cases and 151,499 deaths in our country. Purely for context, in winter’s flu season there were 39 million cases of the flu and 24,000 related deaths again according to the CDC.

Here’s is the latest chart of weekly rates of COVID-19 hospitalizations:

A friend of the FEHBlog shared with him these interesting National Institutes of Health statements on new types of COVID-19 testing and the state of COVID-19 treatments. Also here’s a related HHS update on COVID-19 testing.

Have a good weekend.

Thursday Miscellany

Fierce Biotech reports on other successful double blind studies of COVID-19 vaccines on non-human primates / monkeys. It’s interesting and encouraging that the manufacturers are taking varied approaches to COVID-19 vaccine development. Thanks monkeys.

The Department of Health and Human Services has launched a public service advertising campaign asking COVID-19 survivors to donate plasma for the convalescent plasma treatment nearing FDA emergency authorization. That may be a good initiative for health plans and providers to promote as well.

Bear in mind this Wall Street Journal article reminding COVID-19 survivors that the length of time that the body’s antibodies protects survivors from COVID-19 reinfection is as yet unknown.

USA Today offers a hopeful article about the ongoing development of rapid, inexpensive at-home COVID-19 testing. What’s more, “The XPRIZE, a nonprofit that designs and hosts public competitions, announced Tuesday that it would split a $5 million prize among five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15.”

HR Dive discusses the impact of recent CDC changes its COVID-19 self quarantine guidelines for non-hospitalized COVID-19 patients on employer return to work policies. As with most COVID-19 personnel issues, it’s complicated.