Tuesday’s Tidbits

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Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–

From Capitol Hill, the Senate approved a motion to proceed to a vote on the Postal Reform Act of 2022 (HR 3076) by a voice vote. This vote suggests to the FEHBlog that the Senate will approve the bill this week.

Roll Call discusses the status of the Consolidated Appropriations Act for Fiscal Year 2022. Congress has a week and half to finish cobbling together this law before it needs a fourth continuing resolution.

From the Omicron vaccine front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today released a study examining the effectiveness of the Pfizer COVID-19 vaccine at preventing emergency department and urgent care visits by children aged 5-11 and 12-17. Among children aged 5-11, effectiveness 14-67 days after dose 2 (the longest interval in this age group) was 46%, significantly lower than overall estimates for adolescents aged 12-17. However, most encounters among children aged 5-11 occurred during omicron predominance, when the vaccine’s effectiveness also significantly declined for adolescents, suggesting that the lower effectiveness for children aged 5-11 was likely driven by the predominant variant rather than differences in effectiveness across age groups, the authors said. During omicron predominance, there was no evidence 2 doses protected adolescents after 150 days; however, a booster dose restored effectiveness to 81% in this age group, the authors said.

Another study released today by the CDC looks at reactions to the Pfizer booster in adolescents aged 12-17, which were generally mild to moderate and transient. Myocarditis was less frequently reported after a booster dose than a second primary dose, the authors said.

From the Omicron masking and testing front —

Federal agencies can relax their mask and testing protocols in the wake of new public health guidance. 

The Centers for Disease Control and Prevention’s released on Friday a “new framework” that “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” Dr. Rochelle Walensky, the agency’s director, said on a call with reporters. Guidance from the Biden administration’s Safer Federal Workforce Task Force on Monday reflects this new framework. 

“This document provides federal agencies with initial implementation guidance they should follow in utilizing the CDC’s COVID-19 Community Levels to determine the appropriate mask-wearing and screening testing requirements for each federal facility at a given time,” said the guidance. 

Nearly half of the 500 million free COVID-19 tests the Biden administration recently made available to the public still have not been claimed as virus cases plummet and people feel less urgency to test.

Wild demand swings have been a subplot in the pandemic, from vaccines to hand sanitizer, along with tests. On the first day of the White House test giveaway in January, COVIDtests.gov received over 45 million orders. Now officials say fewer than 100,000 orders a day are coming in for the packages of four free rapid tests per household, delivered by the U.S. Postal Service.

It would be a good idea for the federal government to tell health plans to refer their members to the federal site if they are interested in receiving test kits.

To sum it up from the Omicron front, check out the lead article from the NIH Director’s blog titled “How Covid immunity holds up over time.”

From the tidbits department —

  • The CDC discusses the unholy connection between diabetes and chronic kidney disease.
  • Fierce Healthcare discusses telehealth provider Amwell’s fourth quarter results.
  • Beckers Payer Issues notes

UnitedHealth Group is beginning to act on its November promise to shore up its sustainability efforts by halting its mailing paper of prior authorization and clinical decisions to providers, according to a Feb. 25 post on the California Medical Association website. 

The first move — a nationwide shift to digital clinical decision letters — is effective March 4 for most UnitedHealthcare Medicare Advantage and commercial plan members. Instead of receiving a mail appeal decision, providers can view the decisions digitally immediately after they are made. 

President Joe Biden is calling for more federal employees to return to the office, saying “significant progress” fighting the COVID-19 pandemic has made it safer to do so.

Ahead of his State of the Union address, Biden issued a letter Tuesday thanking the federal workforce for its “tireless work this past year” confronting the pandemic and leading economic recovery efforts.

A return to the office, however, doesn’t necessarily mean a return to the pre-pandemic status quo.

Biden urged agencies to “build on the innovations and technologies that we put to work serving the American people throughout the pandemic, making our government more efficient, resilient, and effective.”

Good luck, OPM.

Friday Stats and More

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest chart of weekly new Covid cases from the 27th week of 2021 through the 6th week of 2022.

The chart shows a steep drop in Covid cases this year. Yet, according to the CDC, the rate of Omicron transmission remains high across our country. The CDC also reports

The current 7-day daily average for February 2–February 8, 2022, was 12,099 [new Covid hospitalizations]. This is a 25.4% decrease from the prior 7-day average (16,212) from January 26–February 1, 2022.

For the reasons explained in this Medscape article, the weekly count of Covid deaths continues to increase.

Finally, here is the FEHBlog’s chart of weekly Covid vaccinations distributed and administered.

New vaccinations, including boosters, have run under four million weekly for the past two weeks.

Here is a link to the CDC’s weekly review of its Covid statistics. The CDC’s critical observation is as follows:

COVID Data Tracker shows that as of February 10, 2022, about 213.4 million people, or 64.3% percent of the total U.S. population, have received a primary series of a COVID-19 vaccine.

However, only about half of those eligible to receive a booster dose have done so. Everyone ages 12 years and older should get a booster shot after they have completed their COVID-19 vaccine primary series. Omicron is extremely contagious, and even though overall severity is lower, the high volume of hospitalizations has strained the healthcare system. Being up to date with vaccination, in coordination with other key prevention strategies, is critical for preventing severe illness from COVID-19 and for reducing the likelihood of new variants from emerging. Find a vaccine provider and get your booster dose as soon as you can.

CDC’s Fluview adds “Sporadic influenza activity continues across the country.” The 2021 and 2002 winters have featured many Covid infections, but not that many flu infections.

The Wall Street Journal reports

U.S. drug regulators authorized the use of a new Covid-19 antibody drug from Eli Lilly & Co. that retains effectiveness against the Omicron variant of the virus, filling a void after authorities stopped distributing some older antibody drugs that lost effectiveness against the strain.

The Food and Drug Administration on Friday cleared the drug, bebtelovimab, for the treatment of mild to moderate Covid-19 in nonhospitalized individuals 12 and older who are at high risk of getting severely sick. The drug is intended for people who can’t get access to alternative Covid-19 treatments, or for whom those treatments aren’t appropriate.

Yesterday, the Biden administration announced the purchase of 600,000 courses of this drug.

From the Covid vaccine front, the Journal further reports that the Food and Drug delayed consideration of granting emergency use authorization to the Pfizer BioNTech Covid vaccine for children ages six months through four years.

The FDA had been considering a request by the companies to clear the use of two doses of the vaccine. The agency was then going to look at expanding the authorization to a third dose, should the study show it works safely.

The new move [to consider all three dose at one time] will delay the rollout of the shot for children younger than 5, the last age group without access to vaccination.

Pfizer and BioNTech said they expect results on whether three doses of the vaccine works safely in early April. Researchers are collecting more data, including from more children in the study who have become infected as more time has passed.

The FEHBlog, who has young grandchildren, honestly does not understand why the government has been pushing so hard to vaccinate this age group.

From the opioid epidemic front, the American Medical Association informs us

The New York Times (2/10, Hoffman) reports that on Thursday, the CDC “proposed new guidelines for prescribing opioid[s]…that remove its previous recommended ceilings on doses for chronic pain patients and instead encourage doctors to use their best judgment.” Although they are “still in draft form, the 12 recommendations…are the first comprehensive revisions of the agency’s opioid prescribing guidelines since 2016,” and “they walk a fine line between embracing the need for doctors to prescribe opioids to alleviate some cases of severe pain while guarding against exposing patients to the well-documented perils of opioids.”

The AP (2/10, Stobbe) reports that the proposed changes are “contained in a 229-page draft update in the Federal Register,” and “the CDC will consider comments before finalizing the updated guidance.”

The Washington Post (2/10, Bernstein) reports that in a statement, AMA Board of Trustees Chair Bobby Mukkamala, M.D., said, “for nearly six years, the AMA has urged the CDC to reconsider its problematic guideline on opioid prescriptions that proved devastating for patients with pain. The CDC’s new draft guideline – if followed by policymakers, health insurance companies and pharmacy chains – provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”

From the quality metrics front, NCQA released its proposed HEDIS and CAHPS changes for the 2023 measurement year today. NCQA is proposing to retire the CAHPS flu vaccination measure, which currently is included in OPM’s set of QCR measures used in the Plan Performance Assessment program. NCQA’s public comment period on the proposed changes closes on March 11.

From the Rx coverage front, STAT News tells us

In a move hailed by pharmacies, the U.S. Federal Trade Commission plans to vote later this month on whether to examine pharmacy benefits managers and how their controversial practices affect independent and specialty pharmacy operations.

The agency disclosed the planned Feb. 17 vote in a brief notice that specified interest in the “competitive impact of contractual provisions and reimbursement adjustments, and other practices affecting drug prices,” but did not provide any further detail. An FTC spokesperson wrote us that additional information will not be released until the upcoming meeting.

The FEHBlog will keep an eye on this vote.

From the Aduhelm front, Health Payer Intelligence discusses AHIP’s comments supporting CMS’s decision to provide very limited coverage of this drug in Medicare.

From the healthcare business front, Fierce Healthcare reports

Kaiser Permanente [the third largest carrier in the FEHB Program] reported $3 billion in net income for the second quarter of the year as membership in its health plan remains steady.

The health system and insurer posted total operating revenues of $23.7 billion against total operating expenses of $23.3 billion. The revenue was slightly above the $22.1 billion it earned in the second quarter of 2020.

Kaiser noted in its earnings statement Friday that favorable financial market conditions resulted in $3 billion in net income, compared with $4.5 billion for the second quarter of 2020.

“The COVID-19 health threat is not over, and we will continue to focus our resources on providing needed care for our patients and increasing vaccination rates to protect the health and safety of our workforce, members and the communities we serve,” said Kaiser CEO Greg Adams in a statement.

If you have time over the Super Bowl weekend, listen to or read Econtalk host Russ Robert’s discussion with macroeconomist John Taylor about inflation. Mr. Taylor created the Taylor Rule “that prescribes a value for the federal funds rate—the short-term interest rate targeted by the Federal Open Market Committee (FOMC)—based on the values of inflation and economic slack such as the output gap or unemployment gap.”

Thrsday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, No Surprises Act, U.S. Healthcare, Uncategorized–
Photo by Juliane Liebermann on Unsplash

From the Postal Reform front, health benefits expert Robert Moffitt, whose work the FEHBlog admires, wrote a column titled “It’s a bad idea to use the Medicare to bail out the Postal Service.” On this occasion, the FEHBlog finds himself in disagreement with Mr. Moffitt.

  1. Medicare is not bailing out the Postal Service. Since 1984, the Postal Service and its employees has paid and continues to pay Medicare taxes for its employees until they retire. At that point, Medicare becomes primary to FEHB and other group health coverage by law.
  2. Every other business in America that provides health benefits coverage to its retirees essentially follows the same approach as the Postal Service will be authorized to do by this bill.
  3. The Postal reform bill is unique in that it creates a special Part B enrollment period for current annuitants as of January 1, 2024, who have Part A but declined to enroll for Part B, an option which OPM encourages. Under the bill that that House passed this week, the Postal Service will bear the cost of the late enrollment penalties associated with this special enrollment period.
  4. Mr. Moffitt suggests that Postal Service Health Benefit Program (PSHBP) Medicare annuitants may find it necessary to purchase Medicare supplement insurance. However, we know from experience that PSHBP plans will follow the practice of existing FEHB plans and wrap their benefits around Medicare to fill those Medicare gaps. The PSHBP coverage is the Medicare supplemental coverage available to Medicare annuitants in FEHB and the PSHBP, and more tightly integrating PSHBP and Medicare coverage will result in lower premiums for all PSHBP enrollees.

Bear in mind that studies have shown the group health plans subsidize Medicare by making payments to healthcare providers that substantially exceed Medicare’s low reimbursements.

From the No Surprises Act (“NSA”) front —

  • CMS issued more FAQs on the federal independent dispute resolution (“IDR”) process today.
  • Consumer Reports identifies five healthcare scenarios which fall outside the scope of the No Surprises Act.
  • Fierce Healthcare brings us up to date on the healthcare provider association lawsuits challenging the federal government’s decision to treat the NSA’s qualifying payment amount as the lodestar in federal IDR arbitrations.

From the Omicron front, Medscape reports that “The U.S. government is planning to roll out COVID-19 shots for children under the age of 5 as soon as Feb. 21, according to a document from the U.S. Centers for Disease Control and Prevention. * * * Young children [beginning at six months] will receive a lower dose of the vaccine, if it is authorized. Pfizer/BioNTech tested a 3-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older.”

Also, the Department of Health and Human Services announced that “the federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge.”

From the COVID vaccine mandate front, Govexec tells us

A federal appeals court has denied the Biden administration’s request to undo the pause on its COVID-19 vaccine mandate for federal employees, leaving in place a ban on agencies enforcing the requirement. The U.S. Court of Appeals for the Fifth Circuit opted not to weigh in on the Justice Department’s petition for immediate relief, meaning the mandate will likely remain enjoined for at least several months. The only path for quicker resolution would be for the administration to appeal further tNBo the Supreme Court, an option it has not yet said it will explore. A Justice spokeswoman declined to comment. 

From the miscellany department

  • NIH News discusses advances in breast cancer screening and treatment.

The clipboard of paper forms that for decades has been a standard part of Americans’ doctor visits may soon be a thing of the past. 

Federal authorities who oversee health technology have set a deadline for December for the health care industry to support smartphone apps, like Apple Health, that store records electronically. 

Their goal is to have patients use their phones to electronically share records with a doctor’s office or hospital — without a pen and paper, if they choose. 

“Patients ought to be able to use the app of their choice,” said Micky Tripathi, who’s helping to put the federal rules in place as the Biden administration’s national coordinator for health information technology. 

“Every patient has the deep frustration of going to a hospital and they give you a clipboard and you have to fill out all the information, and then you go to another part of the same hospital and they give you the clipboard again,” Tripathi said. 

The FEHBlog has been reading articles about the demise of the clipboard throughout this century. However, he thinks that this worthy idea may soon come to fruition.

Friday Stats and More

David Ermer–CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Mental health care, Uncategorized–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s chart of weekly new Covid cases from the 27th week of 2021 through the 5th week of this year:

The Omicron surge is subsiding. The CDC’s weekly interpretation of its COVID statistics indicates that

COVID-19 cases and hospitalizations are continuing to decline across the United States. As of February 2, 2022, cases are down 53.1% from their peak on January 15. However, community transmission is still high nationwide.

Unfortunately Covid-related deaths, a lagging indicator, continue to rise:

Here’s the FEHBlog’s chart of weekly Covid vaccinations administered and distributed from the 51st week of 2020 through the 5th week of 2022.

The pace of COVID vaccinations is slowing again. 212.5 million out of 303 million Americans (net of 23.6 million children under 5 years old) are fully vaccinated and of that cadre, 89.3 million have been boostered.

The American Medical Association offers seven reasons why parents should get their kids ages 5 to 11 vaccinated against Covid.

Also today the CDC’s Advisory Committee on Vaccination Practices unanimously ratified the FDA’s decision to award full marketing approval to the Moderna mRNA vaccine Spikevax for use with adults age 18 and older.

For the hardcore Covid statistics folks check out this tidbit from the CDC’s weekly interpretative report

Wastewater (sewage) surveillance is a promising tool for tracking the spread of SARS-CoV-2, the virus that causes COVID-19. Many people with COVID-19 shed the virus in their feces, so testing wastewater can help us find COVID-19 in communities. Wastewater testing has been successfully used as a method for detection of other diseases, such as polio. Wastewater surveillance results can provide an early warning of increasing COVID-19 cases and help communities prepare.

On February 3, 2022, COVID Data Tracker released a Wastewater Surveillance tab, which tracks SARS-CoV-2 levels in sewage at more than 400 testing sites across the country. This marks the first time CDC’s wastewater surveillance data is available for download. See “A Closer Look” below for more information about this method of data collection.

From the Covid testing mandate front, the Affordable Care Act regulators issued ACA FAQ 52 late this afternoon. The regulators use this FAQ to provide helpful clarifications to the mandate. Check it out.

From the Covid treatment front, Medscape tells us that

A little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.

Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said.

“We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”

The CDC’s weekly Fluview report summarizes the flu situation as follows: “Influenza activity has decreased in recent weeks, but sporadic activity continues across the country.”

From the Postal reform front, Federal News Network reports that

The Postal Service’s best shot at a long-term legislative reform in recent years is finally moving ahead in Congress next week.

The House expects to vote on the Postal Service Reform Act next week. The House Oversight and Reform Committee approved the legislation last May.

Notably, the most recent version of the bill now has the support of the National Active and Retired Federal Employees (NARFE), which raised significant concerns about an earlier version.

NARFE, in a letter of support Friday, said an earlier version of the bill contained “onerous provisions” that could have increased health insurance premiums for all non-postal federal employees and retires.

The earlier version of the bill, the association added, would have also required current postal retirees to pay additional premiums for mostly duplicative health insurance coverage through Medicare.

Moreover, this afternoon, the Congressional Budget Office released its report on the House Rules Committee Print 117-32 for H.R. 3076, the Postal Service Reform Act of 2022. The FEHBlog does not see any showstoppers in that CBO report. The House Rules Committee has scheduled a hearing on this bill for Monday at 2 pm ET. You can read the current version of the bill here.

Finally, Healthcare Dive reports that

Congress appears poised to work on a bipartisan mental health and substance misuse package this year, following a series of hearings this week stressing the need to boost the workforce, insurer benefits and telehealth access.

Legislators also seemed to support giving federal departments more power to force health insurers to comply with parity laws, following a report in late January finding widespread inequities between mental and medical benefits in the U.S. that sent physician groups up in arms.

That, dear readers, is a big bowl of wrong because the outrage stems from the “non-quantitative treatment limit” mental health parity standard set by the Obama era regulation, not the original law. That standard, in the FEHBlog’s view, is amorphous. The FEHBlog favors mental health parity but please Congress don’t make the standard impossible to achieve consistently. Keep it simple.

Cybersecurity Saturday

David Ermer–Uncategorized–

From inside the Capital Beltway

Cyberscoop reports that cybermeasures are gaining momentum at federal agencies in response to the President’s May 2021 executive order and increased funding from Congress.

Security Week adds that

The White House on Wednesday released its federal zero trust strategy, requiring agencies to meet certain cybersecurity standards and objectives by the end of fiscal year 2024. * * *

When a zero trust model is implemented, no user, system, network or service operating inside or outside the security perimeter is trusted, and every access attempt is verified.

The latest memorandum from the Office of Management and Budget (OMB) requires agencies to achieve certain goals by the end of 2024. These goals focus on identity, devices, networks, applications and workloads, and data — these are the five pillars described by the zero trust model of the DHS’s Cybersecurity and Infrastructure Security Agency (CISA).

From the Log4j vulnerability front, ZDnet warns that the threat is not over yet.

Despite the absence of immediate mass exploitation, Sophos security’s Chester Wisniewski backs the view that it will be a target for exploitation for years to come. 

Microsoft continues to rate the Log4j vulnerabilities as a “high-risk situation” for companies across the globe and reckons there is high potential for their expanded use. But for now, Wisniewski believes an immediate crisis has been swerved.   

“[T]he immediate threat of attackers mass exploiting Log4Shell was averted because the severity of the bug united the digital and security communities and galvanised people into action. This was seen back in 2000 with the Y2K bug and it seems to have made a significant difference here,” says Wisniewski. * * *

As for the duration of Log4Shell, Wisniewski reckons internet-facing applications will be found and patched or taken offline. But that still leaves a ton of internally vulnerable systems that might never be discovered, hence Log4Shell will live on for years as a favorite target for penetration testers and state-backed threat actors. 

From the cyber-agency front —

  • HC3 released an analyst note “with updated information regarding the BlackMatter ransomware-as-a-service (RaaS) program. While HC3 previously identified multiple healthcare and public health (HPH) sector or health sector- affiliated organizations impacted by this malware, the group has not claimed a victim since October 31, 2021 and appears to have shut down operations. HC3 is reducing the threat level posed by BlackMatter to BLUE or GUARDED.”
  • NIST released version 5 of NIST 800-53A.

This publication provides a methodology and set of procedures for conducting assessments of security and privacy controls employed within systems and organizations within an effective risk management framework. The assessment procedures, executed at various phases of the system development life cycle, are consistent with the security and privacy controls in NIST Special Publication 800-53, Revision 5. The procedures are customizable and can be easily tailored to provide organizations with the needed flexibility to conduct security and privacy control assessments that support organizational risk management processes and are aligned with the stated risk tolerance of the organization. Information on building effective security and privacy assessment plans is also provided with guidance on analyzing assessment results.

From the ransomware front, Cyberscoop reports that

The REvil (Sodinokibi) ransomware cooperative’s activity has not slowed down following Russia’s recent move to arrest several alleged members of the group, according to threat intelligence company ReversingLabs.

Two weeks have passed since Russia’s law enforcement agency FSB announced the takedown of the REvil group “at the request of US authorities,” but the ransomware-as-a-service (RaaS) enterprise remains as active as before.

After long being accused of allowing cybercriminals to proliferate within its borders – as long as Russian nationals or organizations are not hurt – Russia appeared set to send a different message with the arrest of 14 members of the REvil gang, even if some saw it as a political move – amidst the increasing tensions at the Ukraine border.

However, as ReversingLabs points out, the high-profile arrests of affiliates did not put a dent in REvil operations. In fact, the group is continuing operations at the very same pace as just before the arrests.

What’s more, here’s a link to the latest edition of Bleeping Computer’s the Week in Ransomware.

This week’s biggest news is about a new ransomware operation called DeadBolt encrypted QNAP [storage] devices worldwide, illustrating how threat actors can still earn a lot of money by targeting consumers and small businesses.

The attacks started on January 25th and have since encrypted over 4,300 QNAP NAS devices where they demand 0.03 bitcoins, worth approximately $1,100, for a decryption key.

The attacks started on January 25th and have since encrypted over 4,300 QNAP NAS devices where they demand 0.03 bitcoins, worth approximately $1,100, for a decryption key.

Finally from the cyberprevention front

  • Cybersecurity Dive informs us about cybersecurity tool trends to watch this year — both from the waxing and waning standpoints.
  • ISACA writes about the important role that company culture plays in maintaining reliable cybersecurity.

Monday Roundup

David Ermer–CDC, COVID-19, Rx coverage, Uncategorized–
Photo by Sven Read on Unsplash

From the Omicron front, STAT News offers an article about forecasting the Omicron winter, and it’s cloudy.

Which immediate future plays out will be a function of a few big unknowns — some already baked into Omicron’s biology and some that can be altered based on how people behave in the coming days and weeks. Further out, the models get fuzzier still. But though they differ in the details, all of them point to SARS-CoV-2 being here to stay.

“I think we may be in for a longer road than we had hoped,” said Jeffrey Shaman, an infectious disease forecaster at Columbia University’s Mailman School of Public Health. 

In an encouraging development, the Centers for Disease Control have announced changes to their 10 day quarantine requirement for folks who contract COVID:

Given what we currently know about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation from 10 days for people with COVID-19 to 5 days, if asymptomatic, followed by 5 days of wearing a mask when around others. The change is motivated by science demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after. Therefore, people who test positive should isolate for 5 days and, if asymptomatic at that time, they may leave isolation if they can continue to mask for 5 days to minimize the risk of infecting others.

Additionally, CDC is updating the recommended quarantine period for those exposed to COVID-19. For people who are unvaccinated or are more than six months out from their second mRNA dose (or more than 2 months after the J&J vaccine) and not yet boosted, CDC now recommends quarantine for 5 days followed by strict mask use for an additional 5 days. Alternatively, if a 5-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure. Individuals who have received their booster shot do not need to quarantine following an exposure, but should wear a mask for 10 days after the exposure.  For all those exposed, best practice would also include a test for SARS-CoV-2 at day 5 after exposure. If symptoms occur, individuals should immediately quarantine until a negative test confirms symptoms are not attributable to COVID-19.

For a little holiday humor, Mary Norris in the New Yorker provides a linguistic look at Omicron. Of note,

Having reached omicron (ο), we are already more than halfway through the alphabet.

If this seems to be happening too fast, it’s partly because scientists have skipped some letters. They got to mu (μ), which is right in the middle, and then left out nu (ν), because it sounds confusingly like “new”; we can’t go around talking about a new Nu variant of interest. They also skipped the next letter, xi (ξ), not because it looks so exotic, sitting there between “N” and “O,” but because Xi is a Chinese surname and, one cannot help but notice, the surname of the guy who runs China.

In other healthcare news, the Department of Health and Human Services today

release[d] the annual update to the Department’s National Plan to Address Alzheimer’s Disease, which for the first time includes a new goal focused on work being done to promote healthy aging and reduce the risks that may contribute to the onset of Alzheimer’s disease and related dementias.

Although these diseases cannot yet be prevented, there is growing evidence that addressing certain risk factors for dementia, such as high blood pressure, physical inactivity, and chronic medical conditions such as diabetes and depression, may lower the chances of developing the disease or delay its onset. * * *

Under the plan’s new goal, the federal government will accelerate research on risk factors for Alzheimer’s disease and related dementias, and strengthen the infrastructure that is necessary to rapidly translate and disseminate information about risk factors, interventions to reduce the burden of risk factors, and related health promotion activities to health care providers, community-based providers, caregivers, and public health networks.

STAT News peered into its crystal ball to identify three pharma trends to watch next year:

  • Continued uncertainty over drug pricing
  • Intensifying debate over global access, and
  • Debate over FDA standards / Ahuhelm fallout

Holiday Weekend Update

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

The FEHBlog trusts that his readers had a Merry Christmas.

Congress is on a break until next week when the second session of the 117th Congress kicks off.

On Saturday, January 1, 2022, the surprise billing protections of the federal No Surprises Act take effect.

From the Omicron front, Bloomberg’s Prognosis informs us that

The coronavirus that causes Covid-19 can spread within days from the airways to the heart, brain and almost every organ system in the body, where it may persist for months, a study found.

In what they describe as the most comprehensive analysis to date of the SARS-CoV-2 virus’s distribution and persistence in the body and brain, scientists at the U.S. National Institutes of Health said they found the pathogen is capable of replicating in human cells well beyond the respiratory tract.

The results, released online Saturday in a manuscript under review for publication in the journal Nature, point to delayed viral clearance as a potential contributor to the persistent symptoms wracking so-called long Covid sufferers. Understanding the mechanisms by which the virus persists, along with the body’s response to any viral reservoir, promises to help improve care for those afflicted, the authors said.

An opinion piece in STAT News discusses a trend in COVID weekly new death statistics in the U.S. that the FEHBlog noticed in last Thursday’s post:

Several colleagues and I [Duane Schulthess] at Vital Transformation began closely following the data on Covid-19 early in the pandemic.

Since that time, we’ve kept a keen eye on the relationship between cases and deaths, particularly during the recent waves, which have been influenced by improved treatments and vaccines, as well as by new variants. There are legitimate concerns about the trajectory of the newest variant, Omicron, and public health experts are paying close attention to the exponentially mounting cases, particularly in the United Kingdom, which in the past has functioned as a canary in the Covid-19 coal mine for the U.S.

While early reports from South Africa suggested that Omicron might cause less-severe Covid-19, the rapidly mounting case numbers and overall transmissibility have been alarming, particularly in the U.K. According to a Dec. 10 government technical briefing(see page 17), Omicron cases were expanding by 35% per day.

But there’s something else different this time around, at least in the U.K.: the statistical relationship between Covid-19 cases and deaths appears to have broken down with Omicron.

Looking at daily death rates in the U.K. from May 15 — essentially from the point at which the Delta wave began — to Sept. 15, there is a highly statistically significant relationship between daily new cases and deaths. In short, case rates accurately predict death rates. But beginning the analysis on Sept. 15, coinciding with flattening of the Delta curve and the onset of Omicron, shows no statistical relationship between Covid-19 case rates and deaths. * * *

It’s still, of course, early days. While it is possible that death rates due to Omicron may rise later, at the moment in the U.K., Covid-19 daily cases no longer meaningfully link to deaths. So, according to the math, Omicron cases rising no longer automatically means impending doom and gloom

In healthcare M&A news, Healthcare Dive tells us that

— Tenet and its subsidiary USPI completed a $1.1 billion acquisition of SurgCenter Development, giving the ambulatory surgery unit an ownership stake in 86 more surgery centers and related support services.

— Tenet said it’s willing to buy additional interests of up to $250 million from physician owners. This process is expected to continue over the coming months, Tenet said Wednesday.

— As part of the deal, USPI will have exclusivity on developing new centers — at minimum 50 — with SCD during a five-year period.

Fierce Healthcare peers into its crystal ball to let us know about

From the FDA new drug approval front, MedCity News reports that

The FDA has approved a new cholesterol-lowering drug from Novartis that addresses the same target as two commercialized medicines from Amgen and Regeneron, but with a different approach and a key dosing advantage—just two injections per year.

The drug, inclisiran, is part of a relatively new class of genetic medicines that work by stopping production of a problem protein. In the case of the Novartis drug, which will be marketed under the name Leqvio, the target is PCSK9, a liver protein that in high amounts, impedes the body’s ability to clear low-density lipoprotein cholesterol, the “bad” form of cholesterol. Leqvio is comprised of small-interfering RNA that harnesses a cellular mechanism called RNA interference to stop a gene from producing PCSK9.

The way that Leqvio and other RNAi drugs work is sometimes referred to as gene silencing. It’s a different approach than PCSK9 inhibitors, antibody drugs that bind to this protein to block it. The FDA approved two of these drugs, Amgen’s  Repatha and Regeneron’s Praluent, in 2015. They’re both given as subcutaneous injections every two weeks or monthly. However, their high price tags made them a tough sell to payers, and revenue fell short of initial expectations. In 2018, Amgen slashed Repatha’s price by nearly 60%, making the drug available at list price of $5,850 per year. Months later, Regeneron matched the pricing move for its PCSK9-blocking drug.

The benefits of competition do apply to prescription drug development.

Last week, the U.S. Census Bureau released its “Vintage 2021 national and state population estimates and components of change.” In sum,

Since April 1, 2020 (Census Day), the nation’s population increased from 331,449,281 to 331,893,745, a gain of 444,464, or 0.13%.

Between July 1, 2020, and July 1, 2021, the nation’s growth was due to natural increase (148,043), which is the number of excess births over deaths, and net international migration (244,622). This is the first time that net international migration (the difference between the number of people moving into the country and out of the country) has exceeded natural increase for a given year.

The voting-age resident population, adults age 18 and over, grew to 258.3 million, comprising 77.8% of the population in 2021.

The South, with a population of 127,225,329, was the most populous of the four regions (encompassing 38.3% of the total national population) and was the only region that had positive net domestic migration of 657,682 (the movement of people from one area to another within the United States) between 2020 and 2021. The Northeast region, the least populous of the four regions with a population of 57,159,838 in 2021, experienced a population decrease of -365,795 residents due to natural decrease (-31,052) and negative net domestic migration (-389,638).

The West saw a gain in population (35,868) despite losing residents via negative net domestic migration (-144,941). Growth in the West was due to natural increase (143,082) and positive net international migration (38,347).

Monday Roundup

David Ermer–CDC, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the Omicron front, STAT News reports that

The Omicron variant now accounts for 73% of Covid-19 infections being diagnosed in the United States, and in some parts of the country 90% of infections are caused by viruses from the Omicron strain, the Centers for Disease Control and Prevention said late Monday.

Though it’s been clear from Omicron’s astonishing spread elsewhere that it would rapidly take over from Delta as the dominant variant in this country, the speed is nevertheless startling to witness.

“What we are watching unfold is microbial evolution. This is remarkable,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “But this is what these viruses can do.”

The Centers for Disease Control updated its Omicron website today.

This Wall Street Journal article indicates the obtaining an mRNA booster (Moderna or Pfizer) will provide protection against Omicron as well as Delta.

The Centers for Medicare and Medicare Services today updated their “vaccine toolkit designed for issuers of group and individual health insurance and Medicare Advantage health plans.”

From the COVID vaccine mandate litigation front, the American Hospital Association reports that

Over the weekend, and as of this writing, eight groups of challengers to the OSHA vaccine mandate filed emergency applications with the U.S. Supreme Court asking the high court to once again stay the mandate following the Sixth Circuit’s Dec. 17 decision to lift the Fifth Circuit’s previously entered stay.
 
Today, the Supreme Court asked the federal government for a response to the challengers’ applications by Dec. 30 by 4 p.m. If that sounds familiar, it is because Dec. 30 at 4 p.m. is also the date and time the challengers to the CMS vaccine mandate will be filing their responses to the federal government’s Supreme Court application asking the court to stay the Missouri and Louisiana preliminary injunctions enjoining the CMS mandate. Both sets of applications will be briefed at the same time and the Supreme Court will have the opportunity to rule on the fate of both the CMS and OSHA vaccine mandates at the same time, if it so chooses.

The FEHBlog can find no word about whether the government has appealed to the Supreme Court the 11th Circuit’s decision last Friday to maintain in force the stay on the federal government contractor COVID vaccine mandate. The FEHBlog will keep looking.

From the healthcare business front —

  • Fierce Healthcare informs us that “Amazon has consolidated its healthcare efforts under one central organization and tapped a former Prime executive to run the businesses. The tech giant elevated Neil Lindsay to the new role of senior vice president of health and brand within Amazon’s worldwide consumer business, an Amazon spokesperson confirmed to Fierce Healthcare.”
  • mHealth Intelligence reports that “Supermarket retailer Hy-Vee, Inc. has launched a telehealth platform that allows individuals to receive treatments and prescriptions through the mail. The new service, RedBox Rx, offers virtual health consultations through a partnership with Reliant Immune Diagnostics’ telehealth platform MDbox.”
  • Healthcare Dive tells us that

Software giant Oracle is acquiring EHR vendor Cerner for $28.3 billion, the two companies announced Monday. The deal is expected to close sometime next year.

It will be Oracle’s largest acquisition to date, with the next highest being the 2005 purchase of PeopleSoft Inc. for $10 billion. The deal further pushes Oracle into the healthcare market, where its presence is mostly in data use efficiency for payers and providers. Oracle’s areas of focus include database software and cloud systems.

Cerner will be a dedicated business unit within Oracle, according to the Monday press release. Voice-enabled user interfaces will be a key focus with a goal to “deliver zero unplanned downtime in the medical environment.”

From the too little too late front, STAT News tells us that

Biogen said Monday that it has reduced the price of its Alzheimer’s drug Aduhelm by half and is planning a series of cost-cutting measures across the company next year that aim to save $500 million.

The moves follow a disappointing commercial launch of Aduhelm, as well as anger over the drug’s high price. 

The new, lower price for Aduhelm is $28,200, or roughly half what the drug cost when it launched in June. Insurance companies balked at its original list price, averaging $56,000 a year per patient, while physicians have fervently questioned whether Biogen’s supporting evidence merited the drug’s approval by the Food and Drug Administration, let alone widespread use. * * *

Biogen is announcing the Aduhelm price cut less than one month before Medicare is expected to make an all-important decision on whether and how widely to pay for the drug. A draft ruling is expected in January, followed by a final decision in the spring.

But with Aduhelm delivering paltry revenue, Biogen is also being forced to downsize the company. On Monday, Biogen said it would implement a series of cost-cutting measures in 2022 that are expected to total approximately $500 million. Details will be announced in the first quarter. 

Monday Roundup

David Ermer–ACA, Congress, COVID treatment, COVID-19, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the political front, Politico reports that

[Senator] Joe Manchin (D WV) remains at the negotiating table [with his party’s leadership], despite deep concerns about President Joe Biden’s climate and social spending bill [a/k/a the Build Back Better Act]. 

After speaking with Biden on Monday afternoon, Manchin said he was still “engaged” in discussions. And as he left the Capitol, the key Democratic senator made clear he wasn’t ready to commit to voting for or against a bill that is still coming together behind closed doors.

From the White House, the President issued an executive order on improving customer service performed by government agencies. Federal News Network explains that

Jason Miller, the Office of Management and Budget’s deputy director for management, said the EO also directs agencies to coordinate work on services that reflect common life experiences, including turning 65 and planning retirement, having a child or applying for a small business loan. * * *

The executive order gives senior administration officials 90 days to select a limited number of these customer life experiences to prioritize across government. It requires Miller and other members of the President’s Management Council to update [Presidential senior advisor Neera] Tanden and White House Chief of Staff Ron Klain on progress made improving these customer life experiences every six months.

The EO also gives the General Services Administration six months to develop a roadmap of shared services that agencies can use to improve customer experience.

The administration specifically names Login.gov and the U.S. Web Design System, a set of templates meant to create a common look and feel for agency websites, as tools that all agencies should use to improve federal customer experience.

Here is a link to the White House’s press release on the Executive Order as found on performance.gov.

From the Affordable Care Act front, the Internal Revenue Services has released the final Affordable Care Act coverage reporting forms, 1095-B and 1095-C, along with the final instructions for those forms.

From the Office of Information and Regulatory Affairs’ website, we find that the federal government’s Fall 2021 regulatory agenda has been published. Here is a link to OPM’s Fall 2021 agency rule list. A chill went up the FEHBlog’s spine when he noticed that the ACA provider non-discrimination proposed rule mandated by the No Surprises Act will be published this month due to a statutory requirement. Cost curve up?

From the employer sponsored care front, Healthcare Dive reports that

— The average per-employee cost of employer-sponsored health insurance jumped 6.3% in 2021, as employees and their families resumed care delayed last year due to the pandemic, according to a new survey of employers from Mercer.

— That’s the highest annual increase since 2010. Health benefit costs outpaced growth in inflation and worker compensation through September, the employee healthcare and investment consultancy said.

— The findings raise questions of whether employers are experiencing a temporary correction to the cost trend following a minimal year-over-year increase of just 3.4% in 2020, or if they’re staring down the barrel of a new period of higher cost growth.

No doubt those questions can keep actuaries awake at night.

From the good COVID news department (yes it exists), STAT News informs us that

Paxlovid, Pfizer’s oral treatment for Covid-19, led to an 89% reduction in hospitalization and death in final data from a pivotal trial, the company said today, confirming the results of an earlier analysis.

The news should allay concerns that the efficacy of Pfizer’s pill would wane over time. Molnupiravir, a Covid-19 antiviral from Merck, appeared 50% effective in an interim trial analysis but fell to about 30% in the final tally. Both studies enrolled unvaccinated patients who were recently diagnosed with Covid-19 and had at least one risk factor for severe disease.

The next step for Pfizer is submitting the results to the FDA, which the company expects to do this month, and applying for an emergency-use authorization. The agency is yet to disclose whether it will convene a panel of expert advisers before deciding on Paxlovid.

Based on the President’s winter is coming plan, the FEHBlog’s bet is on the FDA approving the Pfizer drug without delay.

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare, Uncategorized–
Lincoln Memorial in the Fall

The Senate is on a State work break this week which includes the Veterans’ Day holiday on Thursday. The House of Representatives is not holding votes this week but a handful or so of Committee hearings are scheduled for Tuesday and Wednesday.

Roll Call tells us that

Buoyed, finally, by forward movement on a larger package of President Joe Biden’s domestic priorities, the House late Friday cleared a Senate-passed bipartisan infrastructure bill that pours billions of dollars into roads, bridges, water systems, transit and broadband.

The long-awaited House vote sends the bill, which passed the Senate in August, to Biden for his signature. 

The House vote was 228-206, with 13 Republicans backing it despite GOP leadership whipping against the bill. All but six Democrats voted for the measure, despite the House not voting in tandem on the larger budget reconciliation package as progressives had demanded for months. 

Instead, Democrats were forced to accept a vote to adopt the rule that sets debate parameters on the reconciliation bill as a sign of progress on that measure. 

Under that rule, the House is expected to vote on the social spending / climate budget reconciliation bill during the week of November 15. The additional week is expected to allow the Congressional Budget Office to release its report on this massive spending bill

With respect to the infrastructure bill the Wall Street Journal explains that ‘

The $1 trillion package would invest in refurbishing aging roads, bridges and ports; easing transportation bottlenecks; replacing harmful lead pipes; expanding internet access; upgrading the nation’s power grid; and boosting infrastructure resilience amid growing concerns over climate change. The spending is to be paid for with a variety of revenue streams, including more than $200 billion in repurposed funds originally intended for coronavirus relief but left unused; about $50 billion from delaying a Trump-era rule on Medicare rebates; and $50 billion from certain states returning unused unemployment insurance supplemental funds.

From the COVID vaccine mandate front, the Wall Street Journal reports that the U.S. Court of Appeals temporarily stated the OSHA vaccination screening program rule applicable to private sector employers with 100 or more employees plus the Postal Service.

A three-judge panel on the New Orleans-based Fifth U.S. Circuit Court of Appeals granted an emergency stay prohibiting enforcement of the rules for now, saying they raise “grave statutory and constitutional issues.” The Fifth Circuit said it would quickly consider whether to issue an injunction against the vaccine and testing requirements, ordering the Biden administration to file initial legal papers by late Monday afternoon.

OSHA issued this emergency rule under a law providing that challenges to such rules should be brought in the U.S. Court of Appeals rather than the lower District Courts. That’s a quicker path to Supreme Court review.

Roll Call discusses federal government contractor concerns about legal risks arising from the unclear federal vaccine mandate. The Federal Acquisition Regulation implementing the President’s executive order is still weeks away. In the meantime, contractors have to rely on the Safer Federal Workforce Task Force’s subregulatory FAQs. The Task Force typically issues new FAQs on a weekly basis.

From the Delta variant front, the American Medical Association discusses the available evidence on the utility of COVID booster mixing and matching which the Food and Drug Administration recently authorized.

In other vaccine news, Precision Vaccines reports on a Lancet study on the high value of HPV vaccine:

The Lancet published a review of the UK’s national human papillomavirus (HPV) vaccination program and its positive impact on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence.

Published on November 3, 2021, this observational study shows the use of HPV vaccines dramatically reduces cervical cancer rates by almost 90% in women in their 20s who were offered the vaccine beginning at age 12.

These researchers estimated that the HPV vaccination program prevented around 450 cervical cancers and about 17,200 cases of precancerous conditions over 11 years.

HPV vaccination was most effective when given between the ages of 11 and 13 when someone is less likely to have been exposed to HPV.

“It’s a historic moment to see the first study showing that the HPV vaccine has and will continue to protect thousands of women from developing cervical cancer,” stated Michelle Mitchell, Cancer Research UK’s chief executive, in a related press statement.

The HPV vaccine when administered to boys protects against male cancers according to the CDC’s website. “The U.S. FDA has approved different types of HPV vaccines listed on this Precision Vaccinations webpage.”

Last but not least tomorrow is the opening day for the Federal Employees Benefits Open Season for 2022. Here’s a link to today’s FedWeek report on the big day. “There will be 275 [FEHB] plan choices—down by one after a few dropouts and additions—including 18 nationwide plan choices open to all, four available only to certain groups, and the rest available regionally.” December 13 is the closing day of this Open Season.