FEHBlog

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the COVID variant front, David Leonhardt writes in the New York Times as follows:

Covid-19 is once again in retreat.

The reasons remain somewhat unclear, and there is no guarantee that the decline in caseloads will continue. But the turnaround is now large enough — and been going on long enough — to deserve attention.

These declines are consistent with a pattern that regular readers of this newsletter will recognize: Covid’s mysterious two-month cycle. Since the Covid virus began spreading in late 2019, cases have often surged for about two months — sometimes because of a variant, like Delta — and then declined for about two months. * * *

The recent declines, for example, have occurred even as millions of American children have again crowded into school buildings. * * *

I need to emphasize that these declines may not persist. Covid’s two-month cycle is not some kind of iron law of science. * * *

Eventually, immunity will become widespread enough that another wave as large and damaging as the Delta wave will not be possible. “Barring something unexpected,” Dr. Scott Gottlieb, a former F.D.A. commissioner and the author of “Uncontrolled Spread,” a new book on Covid, told me, “I’m of the opinion that this is the last major wave of infection.”

The New York Times reports that

Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection.

NBC Boston discusses where the regulators stand in terms of approving a Moderna booster. Moderna submitted its emergency use application on September 1. “Adding to the complexity of further decisions on booster shots, Moderna wants its third dose to be half of the original shots.”

The Food and Drug Administration announced

[issuing] an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers.

Today’s authorization for the ACON Laboratories Flowflex COVID-19 Home Test should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.

The manufacturer’s press release adds that

The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms. This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing.

Flowflex COVID-19 tests are already available in many countries outside the U.S., including widespread distribution in the UK through the National Health Service (NHS). The international popularity of this test has led ACON to greatly expand global production capacity at multiple manufacturing sites. This emergency use authorization will now allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.

STAT News discusses the pricing considerations for Merck’s pill under development to treat COVID at its symptomatic onset. The article notes

Last June, the U.S. government signed a $1.2 billion deal with Merck for 1.7 million doses, which works out to a $712 unit cost for a five-day treatment course, according to the contract. This assumes the U.S. Food and Drug Administration will authorize emergency use of the pill. Separately, the company has indicated there are plans to produce 10 million doses by the end of this year.

This action suggests to the FEHBlog that Merck can charge a substantially lower price for subsequently manufactured pills.

In today’s column David Leonhardt reminds us that COVID has been a national tragedy, which is unquestionably true in the FEHBlog’s opinion. In that regard, Kaiser Health News explains how COVID deaths have struck rural, black, Hispanic, and Native Americans harder than others which also happens to be the pattern of opioid pandemic deaths as the FEHBlog recalls.

From the COVID regulatory front, the federal departments that regulate the Affordable Care Act and related laws issued ACA FAQ 50. AHIP helpfully explains

The first two FAQs address the recent ACIP and CDC announcements regarding booster doses. The FAQ is intended to notify plans and issuers that the December 12, 2020 ACIP recommendation is the applicable recommendation for purposes of the definition of qualifying coronavirus preventive services under section 3203 of the CARES Act and its implementing regulations.

Plans must cover COVID-19 vaccines and their administration, without cost sharing, immediately once the particular vaccine becomes authorized or approved under an Emergency Use Authorization (EUA) or approved under a Biologics License Application (BLA). This coverage must be provided consistent with the scope of the EUA or BLA for the particular vaccine, including any EUA or BLA amendment, such as to allow for the administration of an additional dose to certain individuals, administration of booster doses, or the expansion of the age demographic for whom the vaccine is authorized or approved.

The prior Q8 in FAQs Part 44 is superseded to the extent it provides that the coverage requirement effective date is related to the vaccine-specific recommendations of ACIP.

In response to stakeholder questions around COVID-19 vaccine incentives and surcharges, the Departments released three FAQs:

Premium discounts for COVID-19 vaccinations are permitted if they comply with applicable wellness program regulations including the requirement to provide a reasonable alternative standard to qualify. The vaccine incentive program must not exceed 30 percent of the total cost of employee-only coverage and must give individuals eligible for the program the opportunity to qualify for the reward under the program at least once per year.

Plans and issuers may not discriminate in eligibility for benefits or coverage based on whether or not an individual obtains a COVID-19 vaccination.

Wellness incentives that relate to the receipt of COVID-19 vaccinations are treated as not earned for purposes of determining whether employer-sponsored health coverage is affordable. However, vaccine surcharges would not be disregarded in assessing affordability.

The FEHBlog had called attention to the 15 day deadline for plans to convert their systems to accomodate the new vaccine. The regulators have removed that grace period which likely reflects COVID reality.

Also, Becker’s Hospital Review informs us that “To clear up a lot of misinformation surrounding COVID-19 vaccines and HIPAA, HHS published guidelines Sept. 30 for employees and employers to better understand the privacy rule.”

Weekend Update

David Ermer–Congress, COVID-19, Medicare, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

This coming week, the U.S. House of Representatives will engage in Committee business and the Senate will engage in both Committee business and the Senate will engage in Committee business and floor voting. Roll Call explains that “President Joe Biden told House Democrats on Friday to hold off on his bipartisan infrastructure bill until they reach agreement on a scaled-back partisan tax and spending package funding the rest of his economic agenda.”

The U.S. Supreme Court opens its October 2021 term tomorrow. Two Affordable Care Act Section 1557 (individual non-discrimination law) cases will be argued this calendar quarter.

On the Delta variant front, the Wall Street Journal reports that

The cost of similar Covid-19 treatments can vary by tens of thousands of dollars a patient, even within the same hospital, according to a Wall Street Journal analysis of pricing data that indicates pandemic care hasn’t escaped the complex economics of the U.S. health system.

One kind of patient, with a type of severe respiratory condition that is common among those admitted with Covid-19, is an example of the wide range. The rates for these patients usually spanned from less than $11,000 to more than $43,000, the analysis found, but some prices could be far higher, depending on the severity of the case.

Federal News Network informs us that

The Office of Personnel Management on Friday offered up more details on how agencies might approach disciplinary action against employees who fail to comply with the Biden administration’s recent federal vaccine mandate.

Because employees aren’t considered fully vaccinated until two weeks after receiving a single-shot series or the second dose of a two-shot series, they must get the vaccine by Nov. 8 to comply with the federal mandate.

Therefore, agencies can begin the disciplinary process for employees who are unvaccinated by Nov. 8 on the following day, Nov. 9, OPM Director Kiran Ahuja said Friday in a new memo.

On the No Surprises Act front, Prof. Katie Keith and her colleagues delves into the details of the second interim final rule on the NSA which concerns the independent dispute resolution process.

On the newly opened Federal Benefits Open Season front, the FEHBlog notes that Blue Cross FEP and Kaiser Permanente have posted information about 2022 benefits on their respective websites. Here’s a belated link to OPM’s announcement of 2022 premiums from last Thursday.

On a related note Healthcare Dive informs us that

Average Medicare Advantage premium rates are dropping 10% to $19 a month next year as nearly 30 million people are expected to be enrolled in the program, an increase of about 2.6 million from this year, CMS said in a Thursday press release.

Cigna and UnitedHealthcare are expanding their MA footprints. Cigna is going into three new states and increasing its geographic coverage by 30%. UnitedHealthcare is entering 276 new counties, giving it access to 94% of Medicare members.

Analysts at Cowen said in a note Friday that after reviewing benefits for the three largest plans from top insurers, it saw stability to modest improvements. That indicates conservative bids among the uncertainty of the COVID-19 pandemic.

Open enrollment for Medicare runs from Oct. 15 to Dec. 7.

Cybersecurity Saturday

David Ermer–Cybersecurity–

October is National Cybersecurity Awareness Month. The FEHBlog reminds readers that

CISA will host its fourth annual National Cybersecurity Summit on Wednesdays during the month of October. The 2021 Summit will be held as a series of four virtual events bringing stakeholders together in a forum for meaningful conversation:

Oct. 6 – Assembly Required: The Pieces of the Vulnerability Management Ecosystem 

Oct. 13 – Collaborating for the Collective Defense 

Oct. 20 – Team Awesome: The Cyber Workforce 

Oct. 27 – The Cyber/Physical Convergence

Register for this free summit and read more about the presentations at CISA.gov/cybersummit2021

Security Week offers an article on ways to support this national effort.

Also yesterday, October 1, according to ZDNet,

The White House plans to convene a 30-country meeting this month to address cybersecurity, President Biden said in a statement Friday. 

The topics of the meeting, Biden said, will include combating cybercrime, improving law enforcement collaboration, stemming the illicit use of cryptocurrency, building trusted 5G technology and better securing supply chains. 

From Capitol Hill, Senator Gary Peters (D Mich.) tells us about American Rescue Plan funding totaling $1 billion that is being used to modernize federal IT systems. Here is a complete list of the unclassified Technology Modernization Funds projects.

With respect to cybersecurity practices

  • Earlier this week, CISA and the National Security Administration “released the cybersecurity information sheet Selecting and Hardening Standards-based Remote Access VPN Solutions to address the potential security risks associated with using Virtual Private Networks (VPNs). Remote-access VPN servers allow off-site users to tunnel into protected networks, making these entry points vulnerable to exploitation by malicious cyber actors.” Here is a Cyberscoop article on this development.
  • Helpnetsecurity.com offers an interesting article about the move from password verification to identity verification to secure networks against cyberattacks. “Identity verification is the most important step in an organization’s system for providing access, and authentication cannot occur until identity is established. This is known as identity-based authentication and it is the foundation of effective security measures. Once identity is established with a high level of efficacy, password-based credentials become obsolete. The end goal is not passwordless solutions – the goal is identity-based authentication, with passwordless as a means to that end.”
  • The National Institute of Standards and Technology issued its 2020 annual report (SP 800-214) last week.

As always, here is a link to Bleeping Computer’s The Week in Ransomware.

Friday Stats and More

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

Using the CDC’s COVID Data Tracker and Wednesday as the last day of the week, here is the FEHBlog’s latest weekly chart of weekly COVID cases for 2021 through the 39th week (September 29, 2021):

Here is a link to the CDC’s weekly new hospitalization chart which also is trending down:

Here is the FEHBlog’s latest weekly chart of new COVID deaths this year:

Medscape notes that “COVID-19 deaths are beginning to plateau in the US, adding another promising sign that the latest coronavirus surge has peaked. The 7-day average of daily deaths has hovered around 2000 for more than a week and dropped below 1900 on Thursday. The trend follows a 2-month climb in deaths as the Delta variant hit unvaccinated populations, particularly in Arkansas, Florida, and Louisiana. * * * COVID-19 cases began to level off nationally in early September, and hospitalizations and deaths have followed a similar trend several weeks later.”

Here is the FEHBlog’s latest weekly chart of COVID vaccinations distributed and administered in 2021:

The CDC reports that as of today 65% of the eligible U.S population (over age 12) and 84% of the U.S population over age 65 is fully vaccinated. The CDC COVID Data tracker now is displaying booster administration. For example, 6% of the fully vaccinated population over age 65 has received a booster.

Health Leaders Media reports on stakeholder reaction to the No Surprises Act interim final rule on the independent dispute resolution process. AHIP’s President Matt Eyles remarked that the final rule

“signals a strong commitment to consumer affordability and lower healthcare spending through an independent dispute resolution process that should encourage more providers to join health plan networks.”

“We are particularly encouraged to see the rules conform to the intent of the No Surprises Act and direct that arbitration awards must begin with a presumption that the appropriate out-of-network reimbursement is the qualified payment amount,” Eyles said.

“This is the right approach to encourage hospitals, health care providers, and health insurance providers to work together and negotiate in good faith. It will also ensure that arbitration does not result in unnecessary premium increases for businesses and hardworking American families.”

The FEHBlog’s take is that the interim final rule protects consumers while controlling the cost of care. After all, the surprise was not receiving out of network care; rather the suprise was the eye popping bill.

Second Interim Final Rule on NSA Implementation Released / Gov’t Shutdown Avoided

David Ermer–Congress, COVID-19, COVID-19 vaccine, OPM, Telehealth, U.S. Healthcare–
The White House

Today, the Departments of Health and Human Services, Labor, and Health and Human Services, and OPM issued the second interim final rule on No Surprises Act (“NSA”) implementation. This rule concerns the independent dispute resolution (“IDR”) process. The process is intended to resolve disputes that arise when an out-of-network provider is dissatisfied with the qualifying payment amount (“QPA”) from the health plan pursuant to the NSA.

The IDR process timeline is as follows:

Independent Dispute Resolution ActionTimeline
Initiate 30-business-day open negotiation period30 business days, starting on the day of initial payment or notice of denial of payment
Initiate independent dispute resolution process following failed open negotiation4 business days, starting the business day after the open negotiation period ends
Mutual agreement on certified independent dispute resolution entity selection3 business days after the independent dispute resolution initiation date
Departments select certified independent dispute resolution entity in the case of no conflict-free selection by parties6 business days after the independent dispute resolution initiation date
Submit payment offers and additional information to certified independent dispute resolution entity10 business days after the date of certified independent dispute resolution entity selection 
Payment determination made30 business days after the date of certified independent dispute resolution entity selection
Payment submitted to the applicable party30 business days after the payment determination

The NSA IDR process uses the so-called baseball arbitration approach under which the decision maker selects one of the parties proposals rather than craft an independent approach as judges do. The requirements description accompanying the final rule explains

When making a payment determination, certified independent dispute resolution entities must begin with the presumption that the QPA is the appropriate OON amount. If a party submits additional information that is allowed under the statute, then the certified independent dispute resolution entity must consider this information if it is credible. For the independent dispute resolution entity to deviate from the offer closest to the QPA, any information submitted must clearly demonstrate that the value of the item or service is materially different from the QPA. Without this additional information, the certified independent dispute resolution entity must select the offer closest to the QPA.

Basically this instructs the health plan to make a proposal close to, if not equal to, the QPA. Then the burden of proof for a higher amount is necessarily placed on the provider. The FEHBlog’s hunch is supported by the following American Hospital Association (“AHA”) statement from the provider side:

AHA Executive Vice President Stacey Hughes said, “The No Surprises Act was an important step forward in protecting patients from surprise medical bills. Hospitals and health systems strongly support these protections and the balanced approach Congress chose to resolve disputes. Disappointingly, the Administration’s rule has moved away from Congressional intent and brought new life to harmful proposals that Congress deliberately rejected. Today’s rule is a windfall for insurers. The rule unfairly favors insurers to the detriment of hospitals and physicians who actually care for patients. These consumer protections need to be implemented in the right way, and this misses the mark.”

AHA staff are reviewing the rule. Watch for a Special Bulletin tomorrow with additional details.

On the bright side for providers, it appears that the IDR process allows the health plan no opportunity to make a low ball proposal to the decision maker. However, it’s the FEHBlog’s view that the devil remains in the details of this lengthy rule and no one should underestimate the ingenuity of lawyers on either side in these novel legal situations. Finally, the apparently simple approach that the regulators took will facilitate implementing the principal feature of the No Surprises Act on January 1, 2022.

From Capitol Hill, Roll Call reports that

President Joe Biden signed a stopgap funding measure Thursday with hours to spare before federal agencies would otherwise have to start shutting down.

The continuing resolution gives lawmakers and the White House nine more weeks to reach agreement on spending levels and negotiate a dozen fiscal 2022 appropriations bills. * * *

The stopgap bill extends federal agencies’ current spending rates, with some exceptions known as “anomalies,” through Dec. 3, as well as certain expiring program authorizations like the National Flood Insurance Program’s ability to sell new policies and renew existing ones. 

The measure provides $28.6 billion to address natural disasters like Hurricane Ida which slammed into the Gulf Coast earlier this month, and $6.3 billion to provide resettlement assistance for Afghan refugees fleeing the Taliban. Another $2.5 billion goes toward care and shelter for undocumented migrant children who crossed the border alone while the government reviews their status.

From the telehealth front

Telehealth usage was four times higher than a year ago, but the industry and patients are still grappling with growing pains including service limitations, difficulty accessing appointments and inconsistent care, a survey from J.D. Power found.

From 2020 to 2021, overall satisfaction with both direct-to-consumer and payer-sponsored telehealth services declined, according to the survey. Patients frequently cited limited services, lack of awareness of costs and confusing technology requirements.

Among direct-to-consumer brands, Teladoc ranked highest for telehealth satisfaction, followed by MDLive. Among payer-sponsored telehealth services, UnitedHealthcare ranked the highest, followed by Humana and Kaiser Foundation Health Plan, both in a tie for second, the survey found.

Despite the wide-ranging expansion of telehealth in the past year, there is still a broad swath of the U.S. population it has largely failed to reach: the 57 million people in rural parts of the country.

Even now, as employers rush to add virtual care to their benefits, many telehealth companies have avoided rural areas. Several acknowledged to STAT that most of their users remain in urban and suburban areas, and they’ve made far less progress than they’d like to in reaching rural patients. The companies recognize they face an uphill battle. Beyond the foundational barrier of broadband access, providers must contend with questions about reimbursement rates, strict rules on interstate licensing, and a hazy road map without clear inroads for reaching rural patients and providers.

“Honestly, as much as our mission statement fits well with rural health care, we haven’t really made enough progress to date around this work,” Brad Younggren, the chief medical officer of telehealth company 98point6, told STAT.

As it is Thursday from the miscellany department

  • Recycle Intelligence discusses “Lessons learned from Aetna, Cleveland Clinic’s Joint ACO Mode / Leaders from Aetna and Cleveland Clinic reflect on the first year of their joint ACO and health plan and share how others can deliver value-based care to their local markets.” Check it out.

Scientists have unveiled new maps of the protein networks underlying different types of cancer, offering a potentially clearer way to see what’s driving the disease and to find therapeutic targets.

Sequencing the genetic information of tumors can provide a trove of data about the mutations contained in those cancer cells. Some of those mutations help doctors figure out the best way to treat a patient, but others remain more of a mystery than a clear instruction manual. Many are exceedingly rare, or there are so many mutations it’s not clear what’s fueling the cancer.

In a quest to come up with more practical and actionable tools, experts have been looking beyond the genes. Instead, they’re mapping out the proteins the genes encode and the interactions among those proteins in hopes of getting a clearer view of cancer-propelling pathways. And in a series of papers published Thursday in the journal Science, a team of researchers outlined those “protein-protein interaction” maps for certain cancers and explain how charting those landscapes and others like them could reveal insights about patients’ prognoses, point to drugs to try for particular patients, and perhaps identify targets for new therapies.

  • STAT News also seeks to predict what will become of the COVID pandemic this coming winter. The article hopefully concludes

Barney Graham, who led the vaccine design work that laid the foundation for many of the current Covid vaccines, is hopeful, though, that in Delta the virus has hit a sweet spot that will eventually undermine it.

“I’m hoping the virus has gotten itself to a point where it’s basically trapped now,” said Graham, who was deputy director of the NIH’s Vaccine Research Center until his retirement at the end of August. “That it can’t get any better at transmission, and any adaptation it makes in the immune response is going to make it less transmissible.”

  • In support of this optimism, Reuters reports that

Laboratory studies show that Merck & Co’s (MRK.N) experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective against known variants of the coronavirus, including the dominant, highly transmissible Delta, the company said on Wednesday.

Since molnupiravir does not target the spike protein of the virus – the target of all current COVID-19 vaccines – which defines the differences between the variants, the drug should be equally effective as the virus continues to evolve, said Jay Grobler, head of infectious disease and vaccines at Merck.

Molnupiravir instead targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus.

Data shows that the drug is most effective when given early in the course of infection, Merck said.

What’s more, the Merck drug is administered in pill form.

OPM Announces 2022 FEHB and FEDVIP Premiums

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

OPM, as promised, announced 2022 FEHB and FEDVIP premiums before the end of September. Here are links to the OPM website for 2022 FEHB plan premiums and its website for 2022 FEDVIP plan premiums. In addition, here are links to related articles from the Washington Post, GovExec, Federal News Network, FedWeek, and the Federal Times which offered a separate article on FEDVIP.

The Washington Post summed it up as follows: “Premiums for federal employees will rise by 3.8 percent on average in 2022, the second straight year of moderate increases despite the coronavirus pandemic, the government announced Wednesday.” That’s a credit to OPM and the carriers as well as this competitive program. Also as OPM usually explains, the average increase is shown before the Open Season results when federal and postal employees and annuitants can elect lower premium plans from Nov. 8 through Dec. 13.

From Capitol Hill, the Wall Street Journal reports this evening that

Party leaders are racing to unify Democrats around changes to a separate $3.5 trillion healthcare, education and climate package, which progressives want to see advance as a condition of supporting the infrastructure bill in the narrowly divided House. Speaker Nancy Pelosi (D., Calif.) so far has stuck to her plan to bring the infrastructure bill up for a vote Thursday, saying she was taking it “one hour at a time,” though she opened the door to further delay if talks don’t progress. * * *

The Thursday deadline for the infrastructure vote is one of several scheduling crunches Democrats face in the coming days. They are also rushing to pass a stand-alone measure extending government funding, currently set to expire on Friday at 12:01 a.m., through Dec. 3. Republicans and Democrats in the Senate were nearing an agreement to pass the spending patch Thursday before sending it to the House. 

From the Delta variant front, STAT News tells us that “People who’ve received a third dose of a Covid-19 vaccine are reporting rates of side effects similar to those after the second dose, according to data released Tuesday by the Centers for Disease Control and Prevention.”

From the No Surprises Act front, OMB’s Office of Information and Regulatory Affairs has concluded its review of the second interim final rule which concerns the independent dispute resolution process. This means that the regulators can timely release information on the rule this week, if not the entire rule itself.

From the health equity front, Fierce Healthcare reports that “CVS Caremark is expanding its health equity efforts, setting goals that specifically target diseases that disproportionately impact patients of color, such as HIV and sickle cell disease.”

In other healthcare news

  • HHS’s Agency for Healthcare Quality and Research reminds us that today is ‘World Heart Day — an observance that aims to improve how we understand, prevent, and manage the disease.” AHRQ describe its efforts to improve heart health.
  • Healthcare Dive without grinding an axe informs us that

U.S. health insurance markets have become increasingly concentrated over the past half decade, according to a new report from the American Medical Association, which argues payer M&A results in rising costs and fewer care options for patients, but largely excludes the impact of provider consolidation in driving those trends.

Almost three-fourths of metropolitan statistical areas were highly concentrated in 2020 according to federal guidelines used by the Department of Justice and Federal Trade Commission, up from 71% in 2014. Of markets that were already highly concentrated in 2014, 54% become more concentrated as of last year, while 26% of markets that were not highly concentrated become so by 2020, the AMA said.

The medical association’s study is the latest salvo in a messaging war between provider and payer lobbies as they work to shift the blame for rapidly rising medical costs in the U.S.

  • The National Institutes of Health reports on the efforts of its “Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, the Wall Street Journal reports that on Tuesday the Senate Republicans refused to give unanimous consent to the Democrat effort to solve the debt ceiling issue without Republican support. Secretary of the Treasury Yellen advised Congress yesterday that she expects that current emergency measures used since August 1 to deal with the debt ceiling problem would soon be exhausted and “the government would be unable to pay all of its bills on time starting Oct. 18 unless Congress acts.” That of course is an unprecedented situation. The FEHBlog finds it interesting that the Congressional Democrat leadership has not lead with the bipartisan crafted continuing appropriation bill instead of the debt ceiling bill because the federal fiscal year ends on Thursday.

From the Delta variant front

  • The National Institutes of Health Director summarizes where we stand on the COVID-19 booster effort in his weekly blog post. The FEHBlog who has received two doses of the Pfizer vaccine over six months ago checked a major retail pharmacy chain site to see whether the booster is readily available and he found that it is which happily is a stark difference from last winters efforts to find the initial doses.
  • The Wall Street Journal reports that

Regulatory clearance of the Pfizer Inc. and BioNTech SE vaccine for young children may not come until November, according to a person familiar with the matter, after the companies said they won’t ask for the green light for a few weeks.

The companies said Tuesday they provided U.S. health regulators with data from a recent study of their vaccine in children 5 to 11 years old. They said they would file an application asking the Food and Drug Administration to authorize use in the coming weeks, though they had previously targeted submitting the application as early as the end of September.

  • The Kaiser Family Foundation released an interesting survey on the current public response to COVID. As of today, according to the CDC, just over 75% of Americans eligible to receive the vaccine (ages 12 and older) have receive at least one dose.
  • Healthcare Dive adds that

As of Tuesday, hospitalizations in the U.S. are down 16% over the past two weeks, according to the 14-day average from data compiled by The New York Times.

The U.S. reached a turning point in this year’s summer surge earlier this month, according to the seven-day averages. The average hospitalizations reached a peak on Sept. 3, started to decline the next day and have been trending down ever since, according to data compiled by the Times.

In the tidbits department

  • The Department of Health and Human Services announced awarding “nearly $1 billion in American Rescue Plan funding to nearly 1,300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects. These awards will strengthen our primary health care infrastructure and advance health equity and health outcomes in medically underserved communities, including through projects that support COVID-19 testing, treatment, and vaccination. The awards were made through the Health Resources and Services Administration.”
  • Health Payer Intelligence discusses a Manatt Health report on episode based care.
  • HHS also announced “the appointment of Lisa J. Pino as Director of the Office for Civil Rights (“OCR”). OCR is the HHS agency which enforces the HIPAA Privacy and Security Rules among other things. As it is a small world, Ms. Pino previously was “Senior Counselor [at Homeland Security] and drove the 2015 U.S. cyber breach mitigation of 4 million federal personnel and 22 million surrogate profiles, the largest hack in federal history, by renegotiating 700 vendor procurements and establishing new cybersecurity regulatory protections.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, HSA–
Photo by Sven Read on Unsplash

From Capitol Hill, the Wall Street Journal reports that the Senate failed to override a filibuster (requiring 60 votes) on a House of Representatives bill including stop gap federal government funding from October 1, 2021, the beginning of the new federal fiscal year, and December 3, 2021.

While lawmakers in both parties negotiated the short-term government funding, Republicans voted against Monday’s procedural motion in a bid to force Democrats to address the debt limit themselves. With 48 in favor and 50 opposed, the legislation fell short of the 60 votes required to advance in the evenly split chamber. * * *

The failure of the procedural vote Monday could prompt Democrats to decouple the short-term spending measure and the debt-limit vote. House Speaker Nancy Pelosi (D., Calif.) suggested last week that Democrats would do so, saying that Congress would pass a stopgap spending measure before the end of the month to keep the government funded.

We shall see.

From the Delta variant front, the New York Times reports that

At the drugstore, a rapid Covid test usually costs less than $20.

Across the country, over a dozen testing sites owned by the start-up company GS Labs regularly bill $380.

There’s a reason they can. When Congress tried to ensure that Americans wouldn’t have to pay for coronavirus testing, it required insurers to pay certain laboratories whatever “cash price” they listed online for the tests, with no limit on what that might be.

GS Labs’s high prices and growing presence — it has performed a half-million rapid tests since the pandemic’s start, and still runs thousands daily — show how the government’s longstanding reluctance to play a role in health prices has hampered its attempt to protect consumers. As a result, Americans could ultimately pay some of the cost of expensive coronavirus tests in the form of higher insurance premiums.

Many health insurers have refused to pay GS Labs’ fees, some contending that the laboratory is price-gouging during a public health crisis. A Blue Cross plan in Missouri has sued GS Labs over its prices, seeking a ruling that would void $10.9 million in outstanding claims.

The FEHBlog disagrees with the journalist’s statement that the government is reluctant to play a role in healthcare prices, see the No Surprises Act, most recently. The FEHBlog further disagrees that the law forces carriers to pay a facially unreasonable price given the web of laws over fraud, waste, and abuse. Certainly though Congress can and should fix this problem its own.

Also Fierce Healthcare informs us that

As schools and businesses weigh their options for tracking COVID-19 cases, UnitedHealth Group’s researchers have developed an online calculator tool these organizations can use to game out potential testing programs.

The free tool allows users to simulate the financial cost as well as the likely number of false positives for several different testing options and frequencies.

For example, if a school in a low-spread area wants to model the cost associated with administering weekly polymerase chain reaction tests, they can input that information to see an estimated per person expense as well as the likely number of infections in a 100-day window.

Cool. This tool also could be useful to project the cost of the vaccination screen program planned for businesses with 100 or more employees.

From the health savings account front, HR Dive tells us that

  • The average individual contribution to health savings accounts fell between 2019 and 2020, while average annual distributions fell to an “all-time low” last year, according to an Employee Benefit Research Institute report published this month.
  • Both trends may have been driven by the pandemic in some way, EBRI said. HSA owners may have reduced contributions as unemployment increased last year, while the decline in both contributions and distributions may have been due to decreased use of healthcare services.
  • HSA owners primarily appear to use their accounts to cover current expenses instead of making contributions in preparation for retirement healthcare expenses, EBRI said. The organization also noted that the average HSA contribution was less than half the maximum allowable contribution for family coverage.

Weekend update

David Ermer–ACA, Congress, SCOTUS, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The U.S. House of Representatives and Senate continue to be engaged in Committee business and floor voting this week which should be a humdinger on Capitol Hill. The Wall Street Journal sums the situation up as follows:

Congress Heads Into Tumultuous Week Pressured by Converging Deadlines
Government shutdown, debt ceiling loom as Democratic leaders plan votes on multitrillion-dollar spending ambitions

The Supreme Court prepares for the opening of its October 2021 term on October 4. Amy Howe informs us

The Supreme Court announced on Tuesday that oral arguments will follow a slightly different plan when the justices return to the courtroom for in-person arguments next month. Instead of reverting entirely to the traditional “free for all” format for asking questions, the justices will adopt a hybrid approach that sets aside time for the justices to take turns asking questions, just as they did when hearing oral arguments by telephone during the pandemic. The change appears to increase the chances that Justice Clarence Thomas, who was rarely heard in the courtroom but was an active participant in remote arguments, will continue to participate when in-person arguments resume.

How collegial.

We also can look forward to the Departments of Health and Human Services, Labor, and Treasury as well as OPM issuing the second big No Surprises Act interim final rule this week. The statutory deadline for releasing this rule concerning the independent dispute resolution process is Friday October 1.

From the Delta variant front

  • Both CVS Health and Walgreen’s have announced that their multitude of pharmacies are offering the Pfizer booster to all eligible folks.
  • If you noticed the articles recently reporting that the number of COVID-19 deaths in America exceeds the 1918 flu pandemic, check out this Health Affairs blog article from last April debunking this apples to oranges comparison.

In any event check out this Health Payer Intelligence article on three strategies for sustaining payer innovation momentum post-pandemic. “The coronavirus pandemic resulted in accelerated payer innovation and payers can continue that momentum by identifying opportunities, involving members, and using data effectively.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the Capitol Hill front, we learn from Cyberscoop that

  • Last Monday, September 20, nine Senate Democrats wrote a letter to the Federal Trade Commission urging the agency to adopt stronger rules cracking down on privacy violations and data breaches.
  • “The Department of Homeland Security’s cyber division, a key government agency charged with helping stop and respond to cyberattacks, might be getting ready for a bigger role in the spotlight. * * * Both chambers of Congress are contemplating legislation that would make CISA the hub where vital companies would report major cybersecurity incidents, following the string of monumental cyberattacks that began with the SolarWinds breach in December.” The article also discusses a planned large infusion of federal funding to CISA.
  • “The head of the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency testified at a Senate hearing Thursday [September 23] in favor of requiring critical infrastructure owners and operators, federal contractors and agencies to report attacks to CISA within 24 hours of detection. * * * At Thursday’s hearing, Easterly further advocated for CISA and the Justice Department to decide what kinds of companies would have to meet the reporting requirements, rather than writing them specifically into the bill. She also advocated fines, rather than subpoenas, to compel companies to obey the reporting requirements. * * * National Cyber Director Chris Inglis, testifying at the same hearing, said he agreed with Easterly’s preferences.”

From the guidance front

  • On September 21, CISA laid out cybersecurity goals and objectives for critical infrastructure owners. “[W]hile all of the goals outlined in this document are foundational activities for effective risk management, they represent high-level cybersecurity best practices.”
  • On the same day, the HHS Office for Civil Rights which enforces the HIPAA Privacy and Security Rules posted a list of ransomware resources for HIPAA covered entities.
  • Security Week offers an interesting article on working securely from anywhere with Zero Trust.

From the ransomware front

  • A federal government cybersecurity alert was issued on September 22 about Conti ransomware. “CISA, FBI, and NSA encourage network defenders to examine their current cybersecurity posture and apply the recommended mitigations in the joint CSA, which include:  
  • Updating your operating system and software, 
  • Requiring multi-factor authentication, and  
  • Implementing network segmentation.
  • Last but not least here is a link to current Bleeping Computer post on the Week in Ransomware.

This week’s biggest news is the USA sanctioning a crypto exchange used by ransomware gangs to convert cryptocurrency into fiat currency. By targeting rogue exchanges, the US government is hoping to disrupt ransomware’s payment system.

This other interesting news this week is a list of vulnerabilities commonly used by ransomware gangs and how the REvil operators reportedly use their operator key to hijack negotiations from affiliates.