FEHBlog

Weekend update

David Ermer–CDC, Congress, COVID treatment, COVID-19, COVID-19 vaccine–

In commemoration of the President’s Day holiday tomorrow, Congress is on a local work break this week and will be back in session on February 28.

From the Omicron front, the New York Times offers an interactive article seeking to uncover the mysteries of “Long Covid.”

The accuracy of Bloomberg’s welcome report on the growing availability of Pfizer’s Paxlovid and Merck’s molnupiravir Covid pills is evidenced by the Wall Street Journal’s report that pharmacists are demanding more money to dispense those pills. Why?

Pharmacists say Paxlovid and molnupiravir prescriptions typically take more than 30 minutes to fill, longer than other drugs. They say they must often gather the medical history of new customers and then make sure they aren’t taking any other drugs that the Covid-19 pills can’t be used with safely.

Pharmacists also say they have to spend substantial time counseling patients on taking the pills.

Here’s where it stands.

The National Community Pharmacists Association trade group has urged the Centers for Medicare and Medicaid Services to recommend a fee similar to the $40 that Medicare pays pharmacies administering Covid-19 vaccines.

The National Association of Chain Drug Stores, which represents pharmacies including Kroger Co. and Walgreens Boots Alliance Inc., also supports a CMS recommendation, though it isn’t specifying an amount. The figure could help pressure all commercial and government health plans to increase how much they are paying, said Sara Roszak, senior vice president for health and wellness strategy and policy for the industry group.

Benefit managers will likely revise fees, but are looking for the government to provide more direction on what the fees should be, said JC Scott, chief executive of the Pharmaceutical Care Management Association, the trade group for pharmacy-benefit managers.

The Wall Street Journal also reports

U.S. health regulators are looking at potentially authorizing a fourth dose of a Covid-19 vaccine in the fall, according to people familiar with the matter. 

The planning is still in early stages, and authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster and reduce their risk of symptomatic and severe disease, the people said.

The Food and Drug Administration, however, has begun reviewing data so it can make a decision, the people said.

The thinking among regulators is that the agency would look at authorizing a second booster dose of the messenger RNA vaccines from Pfizer Inc. and partner BioNTech SE and from Moderna Inc., one of the people said.

Among the issues that need to be resolved, the person said, are whether the second booster should be authorized for all adults or particular age groups, and whether it should target the Omicron variant or be formulated differently. Whether the fourth booster could ultimately be the start of an annual Covid-19 vaccination is also under consideration.

It strikes the FEHBlog that this would be a good occasion for the Centers for Disease Control to position this evaluation as part of their effort to refocus Covid from pandemic to endemic status. An epidemiologist writing in STAT News explains

I’m not confident about how the pandemic endgame will play out. While I do think the most likely future scenario for SARS-CoV-2 is that it will become endemic, the other more worrisome scenarios I describe here are within the realm of possibility: a mutant that produces a different disease, a new recombinant virus, or a variant that exploits immunity. And these scenarios are not mutually exclusive. A new SARS-CoV-2 recombinant virus containing animal coronavirus genes might well cause altered disease.

After two years, why not position the country for the most likely scenario?

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cyberthreats front, ABC News reports

A top Justice Department official issued a stark warning Thursday [February 17] to companies in the U.S. and abroad, calling on them to immediately shore up their cybersecurity defenses amid a potential Russian invasion of Ukraine.

“Given the very high tensions that we are experiencing, companies of any size and of all sizes would be foolish not to be preparing right now as we speak — to increase their defenses, to do things like patching, to heighten their alert systems, to be monitoring in real-time their cybersecurity,” deputy attorney general Lisa Monaco said in remarks at the Munich Cybersecurity Conference. “They need to be as we say, ‘shields up’ and to be really on the most heightened level of alert that they can be and taking all necessary precautions.”

Here is a link to CISA website with advice on how to place your Shields up.

Last Tuesday February 15, the FEHBlog ran across the following government announcement:

The Federal Bureau of Investigation (FBI) and the United States Secret Service (USSS) have released a joint Cybersecurity Advisory (CSA) identifying indicators of compromise associated with BlackByte ransomware. BlackByte is a Ransomware-as-a-Service group that encrypts files on compromised Windows host systems, including physical and virtual servers.

CISA encourages organizations to review the joint FBI-USSS CSA and apply the recommended mitigations.

What’s more, here is our link to Bleeping Computer’s The Week in Ransomware:

The big news this week is that the Conti ransomware gang has recruited the core developers and managers of the TrickBot group, the developers of the notorious TrickBot malware.

This recruitment drive now allows the Conti ransomware gang to focus on developing further stealthy malware, such as BazarBackdoor, while letting the TrickBot malware slowly wane away due to its easy detection by antivirus software.

With this “merger,” Conti has evolved into an actual cybercrime syndicate with different groups focusing on developing malware for each leg of a ransomware attack, ranging from initial access to encrypting.

From the cyber protection front –

  • Health IT Security offers a useful review of the HIPAA Security Rule’s technical safeguard provisions.
  • Bleeping Computer informs us about CISA’s list of free cybersecurity tools and services.
  • The FEHBlog also ran across a comprehensive HHS HC3 PowerPoint presentation on protecting electronic health records.

Friday Stats and More

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

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths beginning with the 27th week of 2021 and ending with the 7th week of 2022.

At last, both charts are headed down.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered beginning with the 51st week of 2020, when the vaccination program launched, and the 7th week of this year.

As of today, nearly 75% of Americans aged 18 and older (74.7%) are fully vaccinated, and 46.5% of Americans in that age group are boostered.

Precision Vaccines reports

More than one year after the first COVID-19 vaccine was administered in the United States, new data from a recent survey conducted online by The Harris Poll show 73% of consumers would like to see additional COVID-19 vaccines become available.

Currently, the World Health Organization has listed ten different COVID-19 vaccines based on various technologies.

But the U.S. FDA has only authorized/approved three COVID-19 vaccines.

Moreover, consumers would like to see COVID-19 vaccines developed from traditional methods, such as technologies used to produce diphtheria, mumps, chickenpox, or polio vaccines.

Novavax’s traditionally developed Covid vaccine is pending Food and Drug Administration emergency use authorization. The FDA’s Vaccines Advisory Committee will consider the EUA application first. That Committee’s next meeting will be held on March 3, 2022. The agenda is not available yet.

In great news, Bloomberg reports

[W]ith [Covid] cases plummeting thanks to the omicron decline, and government orders continuing to roll into pharmacies, doctors and health officials in New York and across the country say the supply is looking plentiful in many areas.

“You have lots of the drug and very few cases — that’s the best place you could possibly be,” says Infectious Diseases Society of America spokesman Aaron E. Glatt. The pills are broadly available, he said, though not at every corner drugstore.

The federal government tracks Paxlovid on a public-facing website that names which pharmacies have it, and a federal website for health-care providers indicates more than 130,000 courses are available.

Dare we hope that the country will be prepared for the next Covid variant if it crops up?

Here are links to the CDC’s Covid Data Tracker weekly review and its FluView. The top line of FluView reads, “Sporadic influenza activity continues across the country. In some areas, influenza activity is increasing.” The current winter continues to mirror the 2020-21 winter, with Omicron edging out the flu.

From the Covid fallout front, Health Payer Intelligence informs us

Senior members might continue to see canceled or delayed care even as coronavirus cases decline, a trend which has had significant impacts on payer revenues and spending in 2020 and 2021, a report from the University of Michigan’s National Poll on Healthy Aging found.

Nearly three out of ten adults over 50 (28 percent) delayed care due to the coronavirus pandemic in 2021.

“Whether they chose to postpone or their provider did, these patients missed opportunities for preventive care and for early detection and effective management of chronic conditions, not to mention operations and procedures to address a pressing health need,” said Jeffrey Kullgren, MD, associate director of the poll and a health care researcher and associate professor of internal medicine at Michigan Medicine in the University of Michigan’s academic medical center.

The National Poll on Healthy Aging surveyed 1,011 adults ages 50 and older in late January 2022. Seniors could complete the survey by phone or online.

Considering the FEHB’s demographics, this report should be relevant to FEHB carriers.

Speaking earlier of the FDA, here is a link to the FDA’s roundup for February 18, 2022. Moreover, Fierce Healthcare reports

Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry.

The study (PDF), released Wednesday by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products. The study was released a day before a scheduled meeting Thursday of the Federal Trade Commission on whether to probe the competitive impact of PBM contracts and how they could disadvantage independent and specialty pharmacies.

“The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” said Matt Eyles, president and CEO of AHIP, in a statement.

From the telehealth front, mHealth Intelligence notes

Though patients have previously made their preference for virtual waiting rooms over traditional ones known, new survey results show that a majority of telehealth patients would rather just be notified by a text or call when their doctor is ready to see them.

Doximity, an online networking service and telehealth platform for healthcare professionals, conducted the new survey last November, polling 2,000 US adults, of whom 1,000 identified as having a chronic illness.

As telehealth becomes integrated into care delivery, questions around patient preferences arise. The survey helps shed some light, showing that 79 percent of patients would prefer a call or text letting them know that their doctor is ready to see them versus having to wait in a virtual waiting room. Even among chronic illness patients only, an overwhelming majority (81 percent) would prefer to receive a call or text.

Patients also displayed a strong preference for familiarity with a provider. Overall, 83 percent of patients surveyed said they would wait one to three days to see their current doctor rather than seeing a new physician immediately.

If these statistics float your boat, you will find many more exciting telehealth stats in the article.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

From Capitol Hill, Govexec reports that “The Senate on Thursday cleared 65-27 a three-week stopgap bill to avoid a government shutdown, sending the measure to President Biden with just one day before the deadline.”

From the Omicron front, the American Hospital Association provides us with its most recent Covid snapshot

From the Covid treatment front, The American Medical Association reports

Efforts to boost production of [Covid] therapeutics are underway, a Food and Drug Administration (FDA) official said during an episode of the AMA-sponsored webinar series, “COVID-19: What Physicians Need to Know.” 

Recommended usage in therapeutics is an important step in counseling patients and providing the most timely and relevant information about defeating this virus, said AMA President Gerald E. Harmon, MD, who moderated the webinar. Physicians facing supply issues of hard-to-get antivirals such as Paxlovid (PDF) also want to know about the timeline of any new antivirals or antibody treatments, he said.

For doctors and other health professionals, “it’s been a very difficult winter and it’s not over yet,” acknowledged John Farley, MD, MPH, director of FDA’s Office of Infectious Diseases in the Center for Drug Evaluation and Research’s Office of New Drugs. Monitoring the situation with these drugs is a complex process that involves FDA, the Centers for Disease Control and Prevention and several branches of government, he added.

Distribution of therapeutics should improve over time. However, at least for the combination of antiviral nirmatrelvir and ritonavir tablets marketed as Paxlovid, “we have a period of continued short supply ahead,” said Dr. Farley, who joined two other FDA experts to discuss the efficacy of the treatments.

In the FEHBlog’s view, Pfizer’s Paxlovid appears to offer the best opportunity for lowering Covid hospital admissions which have been a major cost for health plans over the past year which has seen three major Covid surges.

Speaking of innovations, Cleveland.com tells us

The next generation of mRNA vaccines, as well as treatments for type 2 diabetes and postpartum depression are among the innovations that earned spots on the Cleveland Clinic’s Top 10 Medical Innovations for 2022.

The list of breakthrough technologies, chosen by a committee of Clinic experts, was announced Wednesday.

These medical advancements have the potential to transform healthcare in the coming year, the Clinic said. The committee considered technologies developed by the Clinic as well as other research centers.

From the Federal Trade Commission front, Healthcare Dive reports

The Federal Trade Commission will not launch a study into pharmacy benefit managers’ pricing and contractual practices after a 2-2 vote at a Thursday meeting. The measure needed a simple majority to commence the investigation, which would have compelled large PBMs to turn over information and documents to the agency.

The two commissioners appointed by former President Donald Trump, Noah Phillips and Christine Wilson, voted against the study after raising concerns about its design and whether the current draft asks the proper questions for the answers the agency is seeking. Phillips also complained about receiving a “substantially revised” draft from staff “just hours” before the meeting.

FTC Chair Lina Khan said she was disappointed with Thursday’s vote, and said this is an area the agency has “a real moral imperative” to act upon.

From the Rx coverage front, Fierce Healthcare informs us

Optum has launched a new solution for specialty drugs that aims to lower costs and improve care management for people with complex conditions.

Specialty Fusion arms payers and providers with real-time insights into which specialty therapies are the most effective for the patient at the lowest cost. The platform leads to quicker treatment approvals for patients as well as a similar experience for providers at the point of care, Optum said in an announcement.

Internal analysis of the solution suggests it can drive cost savings of 17%.

From the healthcare business front, Healthcare Dive notes

Pharmacy giant Walgreens and value-based medical network VillageMD are on pace to open more than 200 co-branded primary care practices by the end of the year.

On Wednesday, the companies opened their first clinic in a new Florida market, Jacksonville, bringing their total markets in the state up to three, including Orlando and Tampa. Walgreens and VillageMD plan to open five new Village Medical at Walgreens primary care practices in total in the Jacksonville area through this summer.

With the Jacksonville openings, Walgreens and VillageMD have now opened more than 80 primary care practices across 12 markets in Arizona, Florida, Texas, Kentucky and Indiana.

Last but not least FedWeek explains how to guard against losing FEHB coverage in retirement.

Midweek Update

David Ermer–CDC, Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 vaccine, HSA, Rx coverage, U.S. Healthcare–

From Capitol Hill —

Today, the Senate invoked cloture on the resolution to continue funding the federal government until March 11 by unanimous consent. Consequently, the new resolution should be approved by Congress tomorrow, which is the day before funding expires under the current resolution.

The House of Representatives has returned the correct version of the Postal Reform Act, H.R. 3076, to the Senate, and the Senate has had the correct version read twice. We will have to wait and see if anything happens with the bill tomorrow.

In the meantime, check out the Congressional Research Service’s February 11, 2022, report on the Postal Reform bill approved by the House, H.R. 3076. In the FEHBlog’s view, a unique feature of the House version compared to earlier versions is that the bill destined to become law creates a transitional Open Season. The Transitional Open Season will auto-enroll those Postal employees and annuitants who failed to transfer over to the PSHBP in the 2024 Open Season for the 2025 plan year. The receiving PSHBP plan will be the lowest premium nationwide PSHBP plan that is not a high deductible plan and does not require dues payments. Also, the House version makes the Postal Service financially responsible for the late Medicare Part B enrollment fees otherwise owed by the Postal annuitants with Part A only who take advantage of a special Part B enrollment period in 2024.

Following up on Robert Califf’s second confirmation as Food and Drug Administrator yesterday, STAT News identified the six major drug approval decisions awaiting him, including Pfizer’s toddler COVID vaccine, the Novovax Covid vaccine, and Alzheimer’s Disease treatments. Good luck, Mr. Califf.

Also among those drug approval decisions awaiting Mr. Califf is a Covid treatment discussed in Bloomberg

After omicron weakened some of the defenses that doctors have against Covid, an experimental treatment being developed by Novartis and a small Swiss biotech partner holds some promise as a new therapy.

Last week, Novartis sought emergency approval from the U.S. Food and Drug Administration for an intravenous drug, called ensovibep, that’s similar in some ways to monoclonal antibody treatments. However, the way it works is significantly different, which might allow it to succeed where antibody therapies fail against omicron.

The compound uses tiny proteins to attack the coronavirus’s spike protein in not just one, but multiple places. That appears to give it a leg up in fighting the virus even as it mutates.

In other federal leadership changes, STAT News adds

President Joe Biden is replacing a top science adviser who resigned under a cloud with two individuals who will split his duties on an interim basis.

Biden is tapping [Alondra Nelson, ]a deputy in the White House science and technology office along with [Dr. Francis Collins] the recently retired director of the National Institutes of Health, according to a personal familiar with the president’s plans.

From the Omicron front, Beckers Hospital Review tells us

The COVID-19 omicron subvariant BA.2, dubbed “stealth omicron,” has spread to at least 74 countries and 47 states across the U.S., according to data from outbreak.info.

Four more updates: 

1. BA.2 is most prevalent in HHS’ region 3, which includes Pennsylvania, West Virginia, Virginia, Delaware and Maryland, according to CDC data.

2. Region 7, which includes Iowa, Kansas, Missouri and Nebraska, had the lowest percentage of BA.2 cases last week, according to CDC data. 

3. BA.2 currently accounts for 3.9 percent of total COVID-19 cases in the U.S., with omicron subvariant BA.1.1 accounting for 73.2 percent of cases, CDC data shows. 

4. A South African study analyzing nearly 100,000 COVID-19 cases found that BA.2 doesn’t cause significantly more severe illness than the original omicron variant, Bloomberg reported Feb. 16.

From the Covid vaccine front, The American Medical Association reports

The New York Times (2/15, Anthes) reports infants born to mothers who “received two doses of an mRNA coronavirus vaccine during pregnancy are less likely to be admitted to the hospital for COVID-19 in the first six months of life, according to a new study from the Centers for Disease Control and Prevention.” The study found that “overall, maternal vaccination was 61% effective at preventing infant hospitalization.”

Reuters (2/15, Mishra, Steenhuysen) reports, “That protection rose to 80% when the mothers were vaccinated 21 weeks through 14 days before delivery.” Meanwhile, the “effectiveness fell to 32% for the babies whose mothers were inoculated earlier during pregnancy.”

The Hill (2/15, Sullivan) reports the study used data “from 20 pediatric hospitals in 17 states, from July 2021 to January 2022.”

From the Covid front, Fierce Healthcare reports

Anthem has launched a new pilot that aims to offer a digital concierge care experience to members recovering from COVID-19.

Through COVID Concierge Care, eligible members can access an app and fill out a questionnaire that tracks their symptoms on a daily basis. They can connect with a clinician via secure, two-way text-based messages in the app or via text or email.

In addition, based on their reported symptoms, members can access evidence-based educational tools and wellness content to help them self-manage their conditions. For example, members can connect with breathing exercise guides to manage stress or health articles about their symptoms.

From the Covid vaccine mandate front, Federal News Network tells us

The Postal Service is laying the groundwork to track the vaccination and testing status of its workforce amid the COVID-19 pandemic, or any future public health emergency.

USPS, however, says it’s only giving notice as it prepares for “potential future contingencies,” and is not, at this time, updating its COVID-19 vaccine or testing requirements, nor is it seeking to collect data on the vaccination status of its workforce.

In healthcare business news, Healthcare Dive informs us

The Department of Justice is preparing a lawsuit to block UnitedHealth from purchasing Change Healthcare, according to a new report, as regulators take a more aggressive stance on checking consolidation in the healthcare industry.

According to Dealreporter, which cited sources familiar with the matter, UnitedHealth and Change are expected to meet with the DOJ soon for a “last rites” meeting on the proposed deal, first announced early last year. Despite UnitedHealth and Change exploring divestitures to assuage antitrust concerns, the DOJ has not found any that would make the deal acceptable, according to Dealreporter’s sourcing.

From the health savings account front, Health Payer Intelligence offers nine best practices for high deductible health plan design based on a recent report from the National Pharmaceutical Council (NPC) and Gallagher.

From the antibiotic overutilization front, AHIP lets us know

A study published in the CDC’s Morbidity and Mortality Weekly Report found 41% of antibiotic prescriptions for Medicare Part D beneficiaries in 2019 were written by just 10% of prescribers. Researchers found nearly half of these high-volume prescribers practiced in southern states, and they had a median antibiotic prescribing rate of 680 per 1,000 beneficiaries, compared with 426 per 1,000 beneficiaries among low-volume prescribers. 

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19 vaccine, Electronic health records, Mental health care, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Capitol Hill front —

The Wall Street Journal reports

Sen. Marsha Blackburn lifted a hold on a stopgap bill needed to avoid a partial government shutdown this weekend after she won a commitment from the Biden administration that it wouldn’t fund pipes for smoking illicit substances through a substance-abuse program. * * *

[Senate Minority Leader Sen. Mitch] McConnell said Tuesday that he expected there to be some amendment votes in conjunction with the vote on the so-called continuing resolution. “I think it will all be worked out,” he said. “There’s no danger of a government shutdown.”

The House of Representatives held a pro forma, the four-minute-long session this morning at which

[The] Clerk notified the House that she had received the following message from the Secretary of the Senate on February 14, 2022, at 6:30 p.m.: That the Senate agreed to return the papers to the House of Representatives at their request for H.R. 3076 [the Postal Reform Act of 2022] * * *.

The House is not scheduled to resume floor voting until February 28 and the Senate will be on a State work period next week so Congressional passage of this bill may not occur until next month.

FInally Roll Call reports

The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

Califf’s confirmation means the Biden administration has a permanent FDA commissioner during the COVID-19 pandemic after 13 months with longtime agency official Janet Woodcock acting as its leader.

Califf needed bipartisan support to cross the finish line. Retiring Sens. Patrick J. Toomeyof Pennsylvania and Roy Blunt of Missouri joined four Republicans who sit on the Health, Education, Labor and Pensions Committee to confirm Califf.

From the Omicron front, the Wall Street Journal offers interesting commentary from Dr. Marc Siegal about the Novovax vaccine which is the subject of an emergency use authorization at the Food and Drug Administration.

The Novavax vaccine is based on tried and true technology. It involves growing the virus’s spike protein in moth cells and then combining it with an adjuvant, a chemical that amplifies the protein’s effect on the immune system. Whereas the mRNA vaccines signal human cells to make part of the protein, Novavax injects it directly as a “nanoparticle,” which induces a robust immune response (antibodies and T-cells). Side effects appear to be minimal: flulike symptoms, headache, temporary fatigue and pain at the injection site.

There are several reasons to think that Novavax may give a more powerful boost than a third or fourth mRNA shot. For one thing, the nanoparticle includes the whole spike protein, which could provoke a more complete immunity. So could the glycosylation of the spike—the addition of a sugar molecule in insect cells, which isn’t what the virus is expecting. Perhaps most important, the adjuvant (known as Matrix-M1), which comes from the inner bark of a Chilean soapbark tree, is very high in quality and has been used to make a malaria vaccine effective.

From the health equity front, Health Payer Intelligence discusses a Northeast Business Group on Health report on strategies for making progress on resolving inequities created by social determinants of health. Check it out.

In a similar vein, the Agency of Healthcare Research and Quality blog post on integrating patient-generated health data into electronic health records.

The 63-year-old patient has hypertension. With encouragement from his family, he checks his blood pressure daily using a digital blood pressure monitor. And thanks to advances in digital technology, he saves each reading on a mobile application whether he’s at home, at work, or on vacation.

What is the reward for his persistence? With his health data easily integrated into his electronic health record, his primary care doctor has a fuller picture of his health—one that is not limited to the traditional snapshot taken in an exam room. Using that data, he and his physician can have more informed conversations about treatment options and next steps.

While this scenario accurately recognizes that today’s patients can easily collect their own health data outside of the clinical setting, many ambulatory care practices lack the technical infrastructure, functional workflows, workforce capacity, and training to support the intake and use of patient-generated health data (PGHD).

With those challenges in mind, AHRQ has released a new guide on increasing the use of PGHD, one that provides practical tools for ambulatory care practices to implement PGHD programs and improve patient outcomes. It includes tips, ideas, and learning activities to let users tailor solutions to their needs. To our knowledge, this is the first practical guide that includes detailed considerations and steps for implementing a PGHD program.

The AHRQ guide may be helpful to health plan case managers, too.

From the tidbits department

  • Roll Call and Fierce Healthcare offer different takes on the public comments submitted on the Centers for Medicare Services controversial proposed national coverage deterimination on Biogen’s Alzheimers Disease drug Aduhelm. A final decision is expected in April.
  • The CDC encourages people with pre-diabetes to become heart health role models.

Cigna’s Evernorth is adding Monument’s virtual care services to its behavioral health network, the insurer announced Tuesday.

The platform is now available to all Evernorth clients and to Cigna members in employer plans or Affordable Care Act marketplace plans in 20 states.

Monument offers an evidence-based, virtual treatment program for alcohol use disorder. Evernorth said in the announcement that alcohol use has been on the rise for the past several decades, and that some 60% of people have reported higher alcohol intake under the pandemic.

Monday Roundup

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

From Capitol Hill we are presented with some surprising developments —

Govexec tells us

Sen. Rick Scott, R-Fla., blocked the Senate from moving forward with the bipartisan 2021 Postal Reform Act, which won overwhelming support last week in the House. Lawmakers in both parties have attempted for years to eliminate much of the agency’s debt and restructure some of its operations and the efforts appeared to finally reach a breakthrough with the successful vote in the lower chamber. The bill has the backing of 14 Republican senators, indicating broad support and votes that will ultimately clear the 60-member support threshold with ease. 

When the House sent the bill to the Senate last week, however, it passed along the wrong version that did not include the most up-to-date text. The House on Friday quickly corrected the error by unanimously approving a measure to send over the correct version. Senate Majority Leader Chuck Schumer, D-N.Y., had already started the process of approving the incorrect bill last week and was hoping to move the House-backed technical correction on Monday with unanimous consent, allowing the chamber to resume consideration of the full bill. 

That is when Sen. Rick Scott, R-Fla., objected, sending the process into chaos. The Senate is slated to recess on Friday and will likely not have time to pass the bill until after it returns in March.  * * *

Scott said on the floor he was concerned the measure had not gone through the committee process on the Senate side and about the funding for a potential increase in Medicare costs. The Congressional Budget Office said in a recent score the measure would save the government $1.5 billion over the next 10 years. Lawmakers have estimated it will save the Postal Service $50 billion over the same period.

The Wall Street Journal reports

Sen. Marsha Blackburn (R., Tenn.) said that she will hold up a bill to keep the government funded until the Biden administration responds to her questions about whether a program intended to help people with substance-abuse disorders could be used for pipes to smoke illicit substances.

Her position injects uncertainty into the government’s ability to avoid a partial shutdown later this week. While a single senator can’t stop legislation, he or she can slow down the process by declining to consent to cutting out procedural hurdles.

The Senate is aiming to pass a three-week government funding bill by Feb. 18, when a current funding bill expires, in order to provide breathing room for negotiators to reach a deal funding the full fiscal year. A Senate Democratic aide said that there isn’t enough time to go through each step in the process with the maximum amount of debate time and still avoid a temporary shutdown.

“All we want to know is how much money they are using for safe-smoking kits? What is in the kits? Where is this money going?” Ms. Blackburn said in an interview. “Once I get an answer, I will lift my hold. I’m just waiting for an answer.”

Roll Call informs us

The Biden administration’s nominee to lead the Food and Drug Administration, Robert Califf, survived a Senate procedural vote, 49-45, on Monday evening with the help of five Republicans.

A confirmation vote on the Senate floor is expected to take place Tuesday, and it’ll likely be a close one. Sens. Susan Collins, R-Maine; Lisa Murkowski, R-Alaska; Mitt Romney, R-Utah; Richard M. Burr, R-N.C.; and Roy Blunt, R-Mo., joined Democrats to help shut off debate on Califf’s nomination.

Califf faced controversy throughout his nomination process from both parties. The former FDA commissioner had to cut deals with multiple lawmakers ahead of the floor vote, trading policy promises for votes. Several Senate Democrats opposed Califf’s nomination, due to his past ties to the pharmaceutical industry and handling of the opioid crisis when he led the FDA during the tail end of the Obama administration.

From the Omicron front, STAT News explains why the COVID vaccines are a “freaking miracle.”

Two years into the Covid-19 pandemic, it’s easy to lament all that has come to pass. The devastating losses. The upending of what we regarded as normal ways of life. The sheer relentlessness of it all.

But let’s stop for a moment and consider something else that may have escaped you: You have witnessed — and you are a beneficiary of — a freaking miracle.

That miracle is the development, testing, manufacturing, and global distribution of Covid vaccines.

How freaking true. It’s worth a read.

From the telehealth front, STAT New also delves into what we know and don’t know about whether telehealth can cut costs. This article gives the FEHBlog an opportunity to express his opinion that hub and spoke telehealth services, like Teladoc, can save costs by offering mental healthcare therapy on a long-term basis. Teletherapy is more accessible than in person therapy and all hub and spoke teletherapists are in-network. What’s not to like?

From the consumer driven health care front, Health Payer Intelligence considers the pros and cons of CDHP products in 2022. There are lots of FEHB CDHP offerings.

Weekend update

David Ermer–CMS, Congress, COVID-19, Medicare, U.S. Healthcare–
Vince Lombardi Trophy

Happy Super Bowl Sunday!

The House of Representatives will engage in limited Committee business this week while the Senate will convene for Committee business and floor voting. Indeed, tomorrow the Senate will resumes consideration of the motion to proceed to H.R.3076, Postal Service Reform Act of 2022.

The Wall Street Journal observes that Congress has passed several bills on a bipartisan basis since the President’s Build Back Better plan stalled on Capitol Hill.

Already, bills to make the U.S. Postal Service more financially viable, boost U.S. competitiveness with China and ban mandatory arbitration in cases of sexual assault and harassment have picked up steam in Congress. Senators passed the arbitration bill by voice vote, sending it to the president’s desk without a single member of either party demanding a roll call to record yeas and nays.

Legislators also announced an agreement on a framework for legislation to fund the federal government through fiscal year 2022, and a deal to reauthorize a landmark domestic-violence bill, which lapsed in 2019.

Pretty, pretty good.

From the national health emergency front, Vox tells us the latest about the second Omicron variant, and The New York Times’ Morning column reviewed the disgraceful course of our country’s opioid epidemic. The article concludes

“The solutions are costly. A plan that President Biden released on the campaign trail, which experts praised, would total $125 billion over ten years. That’s far more than Congress has committed to the crisis. Lawmakers haven’t taken up Biden’s plan, and the White House hasn’t pushed for it, so far embracing smaller steps.
“But inaction carries a price, too. Overdose deaths cost the economy $1 trillion a year in health expenses, reduced productivity and other losses, a new  report concluded — equivalent to nearly half of America’s economic growth last year.”

While the FEHBlog has not read the President’s plan, he does believe that a solution is desperately needed.

From the healthcare business front, Fierce Healthcare reviews the fourth quarter of 2021 financial results of significant health payers. At the top of the head were United Health Group and CVS Health /Aetna. “Both healthcare giants expect to top $300 billion in revenue this year, according to their forecasts.”

From the compliance front, Healthcare Dive reports

An analysis of 1,000 U.S. hospitals found that only 14.3% were complying with federal price transparency rulesand about 38% of hospitals posted a “sufficient amount of negotiated rates” on their websites.

The PatientRightsAdvocate.org analysis follows a report in July 2021 that showed only 5.6% of 500 random hospitals were in compliance with the rules that were introduced at the start of 2021.

“The largest hospital systems are effectively ignoring the law with no consequences,” the 61-page report said, noting that only two hospitals of 361 at three of the largest hospital systems were in compliance.

The FEHBlog wonders whether compliance would be higher if the compliance deadline (January 1, 2021) had not been at the height of a COVID surge in the ongoing pandemic.

From the preventive care front, the FEHBlog noticed in Health Payer Intelligence a Medicare national coverage determination on lung cancer screening that aligned Medicare coverage with a 2021 U.S. Preventive Services Task Force B graded recommendation.

This in turn reminded the FEHBlog that FEHB plans must cover all 21 USPSTF A and B graded recommendations made in 2021 with no member cost-sharing when delivered in-network beginning January 1, 2023. The FEHBlog counted a dozen such 2021 recommendations in the USPSTF list. Standing alone, those are a lot of changes to include in the 2023 benefit and rate proposals at the end of May 2022.

From the general healthcare front, NPR explains that the surprising details of the 65-year-old actor and comedian Bob Saget disclosed last week illustrate the importance of seeking immediate medical attention if you suffer a blow to your head.

According to his family, [Mr. Saget] “accidentally hit the back of his head on something, thought nothing of it and went to sleep.” No drugs or alcohol were involved, according to a coroner’s report.

Saget had “fractures to the back of his head and around his eyes” at the time of his death, according to an autopsy report from the Orange County, Fla., medical examiner obtained by People. Saget was also COVID-19 positive at the time of his death, the autopsy noted.

While details of how exactly Saget hit his head were not released, doctors stress the importance of seeking medical care immediately if you sustain a head or brain injury.

If you are concerned that you may have a head injury, consider getting yourself checked out,” said Dr. Amit Sachdev, medical director in the department of neurology at Michigan State University.

“Unfortunately, it’s all too common and we in neurology see it quite frequently that head injuries lead to bleeding,” said Sachdev.

The FEHBlog wonders what would have happened if Mr. Saget had been wearing an Apple watch with a fall detection monitor.

Cybersecurity Saturday

David Ermer–Cybersecurity–
Photo by Library of Congress on Unsplash

Today is the 113th anniversary of the birth of President Abraham Lincoln who, in the FEHBlog’s opinion, is the best President our Nation ever had.

From the federal legislative and regulatory proposals front —

Nextgov tells us

[On February 8, 2022] Leaders of the Homeland Security and Governmental Affairs Committee introduced the Strengthening American Cybersecurity Act bundling provisions they view as crucial in the wake of vulnerabilities like one found in open-source software library log4j, but couldn’t get over the finish line in previous attempts.

“This landmark, bipartisan legislative package will provide our lead cybersecurity agency, [the Cybersecurity and Infrastructure Security Agency], with the information and tools needed to warn of potential cybersecurity threats to critical infrastructure, prepare for widespread impacts, coordinate the government’s efforts, and help victims respond to and recover from online breaches,” Committee Chairman Gary Peters, D-Mich., said in a press release Tuesday. “Our efforts will significantly bolster and modernize federal cybersecurity as new, serious software vulnerabilities continue to be discovered, such as the one in log4j. This combined bill will also ensure that agencies can procure cloud-based technology quickly, while ensuring these systems, and the information they store, are secure.” 

Health IT Security adds that also last week, “US Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduced the Health Data Use and Privacy Commission Act intending to modernize health data privacy laws to reflect the current tech landscape. * * * If passed, the act would establish a commission to review existing health data protections and assess current practices for health data use. The commission, whose members would be appointed by the Comptroller General, would also submit a report to Congress and the President six months after formation with recommendations on modernizing health data privacy.”

Evidently, in furtherance of this legislative proposal, AHIP announced  its “core guiding priorities and a detailed roadmap to further protect the privacy, confidentiality, and cybersecurity of consumer health information.”

Reginfo.gov tells us that the Office of Management and Budgets’ Office of Information and Regulatory Affairs has received for its review the following: “HIPAA Rules: Request for Information on Sharing Civil Money Penalties or Monetary Settlements With Harmed Individuals, and Recognized Security Practices Under HITECH.” As the HITECH Act of 2009 asked the Department of Health and Human Services to issue such a rule, this RFI falls into the better late than never category.

From the Apache Log4j vulnerability front, Cybersecurity Dive reports

Apache Software Foundation President David Nalley on Tuesday told the Senate Homeland Security & Government Affairs Committee it could take months, or even years, to fully eliminate the Log4j vulnerability. 

Every stakeholder in the software industry, especially the federal government and major customers, should be investing in supply chain security, Nalley said. He endorsed efforts like the software bill of materials (SBOM), but said the legislation won’t prevent vulnerabilities, only uncover them more quickly. 

Sen. Alex Padilla, D-Calif., raised questions over whether there is a “free rider” problem where large companies benefit from open source contributors, while providing very little compensation in return.

Another Cybersecurity Dive article explains

Security flaws in free and open-source software (FOSS) will be a recurring source of cyber risk, Moody’s Investors Service found. It could take organizations three to five years to fully resolve issues related to the Log4j vulnerability.

Certain industries vary in their ability to respond to vulnerabilities, according to 2021 data from BitSight, a Moody’s partner on cyber issues. The telecommunications industry trails other sectors, remediating only 29% of critical vulnerabilities within 90 days. The legal industry, with the quickest response time, remediated 68% of critical vulnerabilities in the same time frame.

The use of FOSS can save organizations considerable time and funding. But issues remain about the lack of financial support and, due to the voluntary participation of many contributors, developers experience high levels of burnout. * * *

While open source helps organizations save considerable time and effort on development, security concerns must be accounted for, said Sandy Carielli, a principal analyst at Forrester.

“However, the mistake is to assume that you can grab an open source library and then never look at it or update it again,” Carielli said via email. “Organizations need to get better about managing their open source — understanding where it is used and automating updates so that when something like Log4j happens, it’s a blip on the radar and can be remediated with practiced upgrade procedures.”

The Moody’s report follows a January report from Fitch warning about the increased cyber risk of Log4j to public finance entities, including local governments, small utilities and critical infrastructure providers. 

From the cybersecurity business front, Cyberscoop informs us

Sustained demand for cybersecurity services and continued innovation across the industry helped 2021 become a record-setting year for deals involving cyber companies, analysts say.

The funding that flowed into cyber companies increased 136% over 2020 levels, to $29.3 billion, up from $12.4 billion the previous year, according to a report published Wednesday by Momentum Cyber, which advises cyber companies on mergers and acquisitions.

Likewise, the total volume of mergers and acquisitions activity reached $77.5 billion, up 294% from calendar year 2020, according to the report.

Several trends are driving those numbers, analysts and executives say: Companies across the economy have expanded their budgets for reliable cybersecurity services, boosting revenues for the industry. In turn, big investors — including private equity groups and venture capitalists — are following that money. And as cyberthreats increase in severity and complexity, smaller firms continue to develop valuable expertise in niche areas of information security.

From the government alert front, the HHS Cybersecurity Program issued an alert last week captioned “Indicators of Compromise Associated with LockBit 2.0 Ransomware and Additional Mitigations.”

Also,

“The Cybersecurity and Infrastructure Security Agency (CISA), along with the Federal Bureau of Investigation (FBI), National Security Agency (NSA), Australian Cyber Security Centre (ACSC), and the United Kingdom’s National Cyber Security Centre (NCSC-UK) issued a joint Cybersecurity Advisory outlining the growing international threat posed by ransomware over the past year.  

“The advisory titled “2021 Trends Show Increased Globalized Threat of Ransomware” outlines top trends seen across three nations including:

  • Cybercriminals are increasingly gaining access to networks via phishing, stolen Remote Desktop Protocols (RDP) credentials or brute force, and exploiting software vulnerabilities.
  • The market for ransomware became increasingly “professional” and there has been an increase in cybercriminal services-for-hire.
  • More and more, ransomware groups are sharing victim information with each other, including access to victims’ networks.
  • Cybercriminal are diversifying their approaches extorting money.
  • Ransomware groups are having an increasing impact thanks to approaches targeting the cloud, managed service providers, industrial processes and the software supply chain.
  • Ransomware groups are increasingly targeting organizations on holidays and weekends.

“Importantly, today’s Cybersecurity Advisory also lays out mitigations to help network defenders reduce their risk of compromise, appropriate responses to ransomware attacks, and key resources from each respective cyber agency.”

Here is a link to that advisory and, of course, a link to Bleeping Computer’s The Week in Ransomware.

Happy Super Bowl weekend.

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.”