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

Telehealth

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

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

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

The IDR process timeline is as follows:

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

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

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

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

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

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

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

From Capitol Hill, Roll Call reports that

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

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

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

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

From the telehealth front

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

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

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

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

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

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

As it is Thursday from the miscellany department

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

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

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

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

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

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

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

  • In support of this optimism, Reuters reports that

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

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

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

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

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

Midweek Update

David Ermer–ACA, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Yesterday was the deadline for submitting public comments on the first No Surprises Act (“NSA”) interim final rule. The first IFC concerns the surprise billing protections afforded to consumers in emergency case, out of network care at in-network facilities and air ambulance care.

Here is potpourri of pertinent articles from Becker’s Payer Issues (about AHIP’s comments), the American Hospital Association, and Health Leaders Media (MGMA’s comments). When the same tri-agencies issued interim final rules implementing the Affordable Care Act (“ACA”) in 2011, those agencies did not issue “final final” rules until four or five years later.

While the NSA law is narrower in scope than the ACA, it poses much more complicated administration issues than those ACA provisions. Consequently the final final NSA rules may be accelerated. Sensibly, AHIP suggests that the tri-agencies create a good faith safe harbor for health plans and insurers during 2022 and 2023 to allow them to come into full compliance with this complex law.

In other healthcare news

  • A friend of the FEHBlog called his attention to the September 2021 issue of NIH in the News which may provide useful article for health plan newsletters to members.
  • The Journal of AHIMA breaks down the ICD-10 diagnosis code changes that will take effect on October 1, 2021, under the HIPAA transactions and code sets rule.
  • NCQA has made available a kidney health toolkit.
  • Fierce Healthcare reports that “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members. The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system’s 3,500 physicians. Anthem will initially make these consults available to its large employer clients, with the potential to expand to other employers and other insurance programs, according to the announcement.”
  • Health Payer Intelligence tells us that “In 2020, the prevalence of employer-sponsored health plan coverage fell during the coronavirus pandemic even as employment rebounded, according to a recent study published in the JAMA Health Forum. * * * In 2021, the data forms a clearer picture. Employer-sponsored healthcare coverage declined even as employment levels recovered, potentially indicating a shift to Affordable Care Act marketplace or Medicaid plans.” That is hardly surprising given the enormous funding that Congress has provided to the ACA marketplace.

Finally, the Wall Street Journal’s the Future of Everything series today discusses how

Researchers around the world are trying to turn the humble cough into an inexpensive tool to diagnose and stop respiratory-disease killers like tuberculosis and Covid-19. They’re collecting recordings of millions of the explosive sounds from patients and consumers on smartphones and other devices. And they’re training artificial intelligence to find patterns to try to identify the type and severity of disease from the cough itself. 

“We call it acoustic epidemiology,” says Peter Small, a tuberculosis expert and chief medical officer of Hyfe Inc., a Delaware-based company with two free smartphone apps—one for consumers, another for researchers—that use AI to detect and track how often someone coughs.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the Delta variant front and acccording to the CDC’s COVID Data Tracker, the United States reached two data points today — the number of COVID cases now exceeds 40 million and the percentage of Americans aged 18 and over who have received at least one dose of a COVID-19 vaccine reached 75%.

At the end of 2020, the number of cases according to the CDC stood at 20 million. In his blog, National Institutes of Health Director Francis Collins discusses a recent Nature study estimating that “the true number of [COVID] infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of pandemic.” It also suggests to the FEHBlog that we may to closer to effective herd immunity in some areas of the U.S. than generally thought.

Also David Leonhardt in today’s New York Times tells us about another way to look at the situation.

The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.

The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.

In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.

How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community. * * *

I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not grind to a halt over the flu.

In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.

“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.

Well put, Mr. Leonhardt, as usual.

From the federal employee benefits front, OPM posted on the Federal Register website today a notice of changes to Federal Group Life Insurance premium rates for “Employee Basic Insurance, Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after October 1, 2021.”

From the tidbits department

  • Federal News Network reports that “The White House is proposing billions of dollars in supplemental funding for disaster relief and other programs, which it’s asking Congress to attach to a short-term continuing resolution that will be critical toward avoiding a government shutdown at the end of the month. ‘With the end of the fiscal year rapidly approaching, it’s clear that Congress will need to pass a short term continuing resolution to provide more time for the fiscal 2022 process to unfold,’ Shalanda Young, the Office of Management and Budget’s acting director, said Tuesday in a blog post.” 
  • Fierce Healthcare informs us that “The American Medical Association [“AMA”] released updates to its medical codes for 2022 with many tied to new technology services and the administration of COVID-19 vaccines. The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. ” The CPT is recognized as a HIPAA electronic transaction code set.
  • AP News reports that “Four companies in the drug industry said Saturday that enough states had agreed to a settlement of lawsuits over the opioid crisis for them to move ahead with the $26 billion deal. An announcement from the three largest U.S. drug distribution companies and a confirmation from drugmaker Johnson & Johnson, which had previously announced that it would move ahead, came Saturday. That was the deadline for the companies to decide whether there was enough buy-in to continue the settlement plan. * * * Together, the settlements are likely to represent the biggest piece of a string of settlements between companies in the drug industry and state and local governments over the addiction and overdose epidemic in the U.S.”
  • Healthcare Dive tells us that “The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.”
  • The AMA discusses “what doctors wish patients knew about a prediabetes diagnosis,” which of course is a fairly common diagnosis in our country.
  • The Wall Street Journal continues its series on the Future of Everything in healthcare with an article about sensor studded smart clothes. “From a prescription bra that signals cardiac arrest to a mosquito-proof textile, startups and scientists are developing garments for healthier living.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Patient safety, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Delta variant front —

Medscape reports on yesterday’s CDC Advisory Committee on Immunization Practices meeting:

“Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness,” Sara Oliver, MD, the CDC scientist who presented the information [about the mRNA vaccines], told the committee.

In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.

Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.

Healthcare Dive tells us that

The U.S. government will resume distribution of Eli Lilly’s COVID-19 antibody drug combination in a number of states, HHS said Friday, as cases and hospitalizations in the U.S. are driven higher by the spread of the delta variant.The decision comes roughly two months after administration of Lilly’s therapy was halted by U.S. officials due to concerns of reduced efficacy against coronavirus infections stemming from the beta and gamma variants. Those are now much less prevalent compared with delta, which laboratory testing has shown remains susceptible to treatment with the dual-antibody therapy, HHS said.

Fierce Pharma reports that

Last week’s FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people.

A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.

Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.

From the telehealth front, Kaiser Health News discusses re-emerging state law barriers to telehealth. “’The whole challenge is to ensure maximum access to health while assuring quality,’said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.” The article provides an overview of options available to doctors and state boards.

From the miscellany front

  • Beckers Hospital Review unveils six big ideas in health innovation. For example, Jason Joseph. Senior Vice President and Chief Digital and Information Officer at Spectrum Health (Grand Rapids, Mich.). As we innovate, we are forcing hidden barriers into the light via experimentation. We saw so many of these barriers uncovered within health care, such as lack of connectivity, digital competency, and the need for comprehensive managed workflow. We have shined a spotlight on how much of healthcare relies on people and inconsistent manual processes to get through the system. That needs to change, and that also requires changing a leader’s traditional mindset.
  • The Agency for Healthcare Quality and Research is offering a toolkit to help healthcare providers and possible health plans get patients and members engaged with the diagnosis process.

The toolkit contains two strategies, Be The Expert On You and 60 Seconds To Improve Diagnostic Safety. When paired together, these strategies enhance communication and information sharing within the patient-provider encounter to improve diagnostic safety. Each strategy contains practical materials to support adoption of the strategy within office-based practices.

Be The Expert On You is a patient-facing strategy that prepares patients and their families to tell their personal health stories in a clear, concise way. Research suggests that 79 percent of diagnostic errors are related to the patient-clinician encounter and up to 56 percent of these errors are related to miscommunication during the encounter. Environmental scan findings show that inviting patients to share their entire health story, uninterrupted, and in a way that gives clinicians the information they need can reduce diagnostic errors.

60 Seconds To Improve Diagnostic Safety prepares providers to practice deep and reflective listening for one minute at the start of a patient-encounter. Research suggests that patients are interrupted by their providers in the first 11 to 18 seconds of telling their diagnostic story. Diagnostic safety can be improved when a provider allows a patient to tell his or her health story without interruption for one minute, and then asks questions to deepen understanding.

  • Not every innovative idea makes sense to implement though. The President and Democrat leadership in Congress want the Centers for Medicare Services to “negotiate” drug prices for Medicare Part D plans. Regulatory Focus informs us that “A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.”

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth–
Photo by Sven Read on Unsplash

From the Delta variant front, the CDC’s Advisory Committee on Immunization Practices met today. It turns out that the principal topic at the meeting was reviewing the Food and Drug Administration’s final marketing approval for the Pfizer-BioNTech COVID-19 vaccine. ACIP ratified that decision, which was a foregone conclusion.

The Wall Street Journal adds

Health experts advising the U.S. government on vaccines expressed initial support for giving booster shots to people vaccinated against Covid-19, starting with healthcare workers, nursing-home residents and others immunized earliest.

Members of the Advisory Committee on Immunization Practices, or ACIP, on Monday indicated their agreement with the Biden administration’s plans to offer the extra doses. Yet they said the priority should remain increasing vaccinations of unvaccinated people, and that boosters shouldn’t distract or impede from doing that.

When giving boosters, some panel members added, the priority should be preventing severe disease in people at highest risk of becoming sick with Covid-19, as opposed to preventing infections.

For more information, here’s a link to the presentation slides for today’s ACIP meeting.

OPM helpfully sent FEHB plan carriers the following standard guidance to FEHB carriers today about Hurricane Ida:

Due to Hurricane Ida impacting the Gulf Coast and connecting states, we remind you that under Section 2.2 BENEFITS PROVIDED, you are authorized, “To pay for or provide a health service or supply in an individual case which does not come within the specific benefits provisions of the contract, if the Carrier determines the benefit is within the intent of the contract, and the Carrier determines that the provision of such benefit is in the best interest of the Federal Employees Health Benefits Program.”

If you decide to apply Section 2.2, we ask that you demonstrate maximum flexibility, including the following:

·         Relax certain provisions such as pre-certification requirements that the plan must be notified within 2 business days of an emergency admission.

·         Relax requirements about notification and levels of benefit payment if victims are taken to non-plan and/or non-PPO hospitals or other treatment centers.

·         Allow certain FEHB members to get additional supplies of medications as backup, if necessary.

·         Though charges for work-related injuries sustained by Federal workers are payable by the Office of Workers’ Compensation Programs (OWCP), we are encouraging FEHB plans to provide immediate payment and seek subsequent reimbursement from OWCP.

Today, the Department of Health and Human Services announced the establishment an Office of Climate Change and Health Equity. The Wall Street Journal notes that “The new office is likely to spur initiatives touching on many aspects of healthcare, HHS officials announced Monday. It is expected to offer protections for populations most at risk—including the elderly, minorities, rural communities and children, and the office could eventually compel hospitals and other care facilities to reduce carbon emissions.”

STAT News identifies three trends divined from research on telehealth utilization by Medicare beneficiaries during the COVID-19 pandemic. The FEHBlog’s attention was drawn to this trend:

Telemedicine use has not varied substantially by race and ethnicity. Many commenters * * * have expressed concern that telemedicine will widen disparities of care. Surprisingly, this has not by borne out by the data. Through the end of 2020, we observed no substantive differences in the proportion of beneficiaries using telemedicine by race and ethnicity: 51% of non-Latino white beneficiaries, 55% of Black beneficiaries, and 56% for both Latino and Asian beneficiaries.

This pattern may in part reflect the fact that people of color are more likely to live in urban areas, where the use of telemedicine is higher. Beneficiaries living in large metropolitan counties were substantially more likely to use telemedicine than those living in rural areas.

STAT News also offers a fascinating peak inside Pfizer’s Pearl River (NY) Research Center where a “team of “variant hunters,” as they call themselves, race to track changes in the fast-mutating SARS-CoV-2. A “virus farmer” grows the latest variants so researchers can test how they fare against the vaccine. And a colleague known as the “graphing unicorn” converts the data into intelligible results overnight.” Extraordinary.

Monday Roundup

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

From Capitol Hill, Roll Call reports that

Speaker Nancy Pelosi floated a compromise to moderate holdouts Monday that would advance the budget resolution needed to unlock a $3.5 trillion package of aid to families, students and clean energy subsidies in exchange for a guaranteed vote on a separate, $550 billion infrastructure package.

The plan would “deem” the fiscal 2022 budget resolution adopted when the chamber adopts the combined rule for floor debate on the Senate-passed infrastructure bill and voting rights legislation. Pelosi, D-Calif., also committed to a floor vote on the infrastructure bill before Oct. 1, when current surface transportation program authorizations lapse.

The House of Representatives convened at 5 pm ET this evening and went into a recess at 5:30 pm ET for a Democrat member caucus. The House resumed its session with routine business at 6 pm ET and the House recessed again at 8 pm likely for another Democrat member caucus. [Follow-up — Early Tuesday morning the Wall Street Journal reports that “Plans to hold that vote Monday night were [later] abandoned, though, and Mrs. Pelosi said the chamber would vote on the measure on Tuesday as she left the Capitol after midnight.”

From the Delta variant front, Mondays have tended to be a good day for COVID-19 vaccine news. This morning the Food and Drug Administration “approved [for marketing] the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.” This action occurred two weeks before the Labor Day.

The Wall Street Journal reports that

The Food and Drug Administration’s approval was seen by public health officials as a key step to convince hesitant individuals to get the shot and to encourage employers to mandate it. 

“Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions more people,” President Biden said. “I call on you to do that—require it.” * * *

The vaccine is now eligible for off-label prescriptions—or use beyond the approved populations. That could include booster doses, according to the FDA. Prescribing the vaccine off label for children wouldn’t be appropriate as there is no data on proper dosing or safety in youth, said acting FDA Commissioner Janet Woodcock. * * *

Pfizer * * * is now permitted to market the vaccine to doctors, healthcare providers and the general public as it does with other approved products. Pfizer declined to share its marketing and advertising plans but said it seeks to take a thoughtful approach with such communications in hopes of increasing vaccine confidence. 

Pfizer made its FDA marketing approval application last May and Moderna, which produces the other mRNA vaccine, applied for FDA marketing approval in June so Moderna now moves from the on deck circle to at bat.

Federal News Network informs us that “The Pentagon said Monday that it will require service members to receive the COVID-19 vaccine now that the Pfizer vaccine has received full approval. Pentagon spokesman John Kirby said Defense Secretary Lloyd Austin is making good on his vow earlier this month to require the shots once the Food and Drug Administration approved the vaccine. He said guidance is being developed and a timeline will be provided in the coming days.”

Govexec tells us that

During the White House’s daily press briefing, Press Secretary Jen Psaki said that some agencies may roll out requirements that subsets of the federal workforce must be vaccinated, similar to those announced for health care workers at the Veterans Affairs and Health and Human Services departments. Across the federal government, agencies are working to implement President Biden’s requirement that all federal workers and contractors either attest that they have been vaccinated against COVID-19 or submit to a stringent regimen of wearing masks and being tested regularly for the virus.

“I expect there will be more . . . we certainly expect there will be more mandates for factions of federal employees,” Psaki said. “I think you’re looking more at agency-to-agency, or different factions of the government at this point, but expect there will be more on that front.”

In the meantime, federal employee unions have already begun engaging with management at various agencies to negotiate how the Biden administration’s vaccine mandate will be implemented. Matt Biggs, president of the International Federation of Professional and Technical Employees, said that although his union publicly announced its support for the vaccine mandate, it is working to ensure workers’ rights are protected, regardless of whether they elect to be vaccinated.

In other vaccine news, the UPI reports

Most teens and young adults want to get vaccinated against COVID-19, a survey published Friday by JAMA Health Forum found.

About 75% of people ages 14 to 24 years in the United States who responded to the survey, conducted by the University of Michigan’s Institute for Healthcare Policy and Innovation, said they would get the shot, the data showed.

Most agreed with the statement that vaccination was important to “help stop the spread [of the virus], as well as get back to normal as soon as possible,” the researchers said.

Still, about 42% of respondents said they were concerned about COVID-19 vaccine side effects and 12% indicated they worried about the shot’s effectiveness, according to the researchers.

From the health savings account front, Benefits Pro informs us that

“Devenir has given another peek into the current state of HSAs with its demographic survey. Among its key findings:

  • As of December 31, 2020, the study estimates there were over 30 million HSAs covering 63 million people in the United States.
  • Nearly 1 in 5 Americans in their 30s had a health savings account by the end of the year.
  • HSAs are just as popular with older Americans: Account holders over 50 years of age held more than $44 billion in their accounts, with an average balance of just over $4300.

The study also found that HSAs are being used in every state in the country, with some states reporting nearly 77% of the privately insured populations being covered by an HSA. See our slideshow above for the states with the highest and lowest numbers of people covered by HSAs, and click here for the full study.” Here’s a link to another interesting Benefits Pro article on HSAs.

From the telehealth front, mHealth Intelligence reports that

The pandemic has proven the value of telehealth to parents, according to a recent survey by Nemours Children’s Health. But it has also highlighted the need to continue emphasizing the value of virtual visits to overcome barriers to care and improve health and wellness.

A survey of more than 2,000 adults conducted earlier this year in conjunction with Amwell found that while 35 percent of parents used telehealth prior to the COVID-19 crisis (based on a 2017 survey), that percentage jumped to 77 percent during the pandemic. In addition, almost 80 percent have accessed pediatric telehealth services, compared to 35 percent before the pandemic.

Overall, the survey reports, more than 60 percent of parents want to continue using connected health services after the pandemic – including almost 30 percent of parents who hadn’t used any telehealth in the past.

“While one might expect that factors such as income or access to technology are barriers to telehealth, this survey underscores how telehealth proved to be a viable solution to expanding access and reducing disparities in providing timely care during COVID-19,” R. Lawrence Moss, MD, president and CEO of Nemours Children’s Health System, said in a press release. “Regulations that were eased during the pandemic need to become permanent to support telehealth access for the long-term. Telehealth can be part of building health equity among people experiencing social, economic and family challenges.”

From the research front, the National Institutes of Health announced the results of a study of pregnant women:

Drinking alcohol and smoking tobacco cigarettes throughout the first trimester of pregnancy is associated with nearly three times the risk of late stillbirth (at 28 or more weeks), compared to women who neither drink or smoke during pregnancy or quit both before the end of the first trimester, according to a study funded by the National Institutes of Health. Although prenatal smoking is known to increase stillbirth risk, the researchers conducted the study to examine how smoking combined with alcohol use might influence the risk. The researchers also confirmed the higher stillbirth risk from alcohol alone, which has been suggested by earlier, less comprehensive studies.

In healthcare business news, Healthcare Dive tells us that

  • “Google is dissolving its health division, Google Health, after three years as the head of the unit, David Feinberg, departs to become CEO of health IT vendor Cerner.
  • “Google is splitting its health projects and teams across several other divisions of the company, according to an Aug. 19 internal memo to employees from Jeff Dean, the head of Google’s research division, obtained by Insider.
  • Alphabet’s Google created the Google Health division in 2018 to bring its health initiatives under a single umbrella. The Mountain View, California-based company remains committed to healthcare and will continue to invest in the space, but the goal of the reshuffling is to put its teams in the areas that make the most sense for its projects, a​ Google spokesperson told Healthcare Dive.”

Finally, the American Medical Association President Gerald E. Harmon, MD, opines on the actions that the medical community needs to take into order for American life expectancy to resume its upward track:

The AMA is committed to vigorous advocacy and broad-based collaboration to help people everywhere live longer, healthier lives. Our longstanding efforts targeting heart disease and type 2 diabetes—two of our country’s most common and most devastating chronic diseases—bring physicians in multiple practice settings and specialties together with patients, community groups, and both public- and private-sector organizations to better treat those struggling with these conditions, and also to prevent at-risk individuals from developing them.

The AMA Opioid Task Force and our Pain Care Task Force work with lawmakers and policymakers to guide their decision-making, to shift the perspective from responding to overdoses to preventing them, and to develop clinical best practices to reverse and eventually end the epidemic of fatal overdoses that worsened once the pandemic began.

Additional AMA efforts target: (1) behavioral health integration and suicide prevention;(2)firearm safety; (3) reducing maternal mortality; (4) eliminating racial and ethnic disparities in health care; (5) ensuring that digital health technology improves patient care and health outcomes, and (6) transforming medical education to ensure physicians are prepared to meet patient needs today and tomorrow.

Midweek Update

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–

From the Delta variant front –

  • In a joint statement, a group of high ranking HHS public health experts explained today that

“We have developed a plan to begin offering [COVID-19 vaccination] booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

The FEHBlog will be in line for his third dose of the Pfizer vaccine when the time comes.

  • The Wall Street Journal reports that “Early data from Israel suggests a booster shot of Pfizer Inc.’s Covid-19 vaccine can significantly improve immunity in those aged 60 and above, as the U.S. and other countries plan additional doses to increase protection against the highly infectious Delta variant.”
  • Health Affairs reports on a study suggest”[ing] that the early COVID-19 vaccination campaign was associated with reductions in COVID-19 deaths. As of May 9, 2021, reductions in COVID-19 deaths associated with vaccines had translated to value of statistical life benefit ranging between $625 billion and $1.4 trillion.” The smartest move that the government made was to prioritize the elderly who suffered the most deaths during the pre-vaccination era of COVID-19.

From the federal employee vaccination screening program front, the Safer Federal Workforce task force issued a set of FAQs on COVID-19 testing employees, contractors and visitors who cannot attest to receiving a COVID-19 vaccination. The FEHBlog was pleased to read that the FAQs impose the testing cost on the agencies, not on the FEHB Program, which is the proper legal outcome under the federal CARES Act (unnumbered FAQ 3). Federal News Network makes its own observations on the Testing FAQs here.

In healthcare utilization news, Healthcare Dive reports that

  • More than one in 10 adults ages 16 to 64 said they delayed or went without needed healthcare services due to virus fears in the past 30 days, an April survey from the Urban Institute funded by the Robert Wood Johnson Foundation found. 
  • One in 10 parents delayed seeking care for their children for that reason, according to the report published Wednesday.
  • Hispanic and Black adults, along with adults with lower incomes, reported delaying care at higher rates than other groups. Adults with chronic health problems were also more likely than those without such conditions to say they went without needed care.

It’s worth noting that this survey was conducted during the month that vaccinations became widely available and before the Delta variant broke out.

In other healthcare news

  • Govexec reports that “Officials at the Centers for Disease Control and Prevention announced on Wednesday that the agency is launching a new organization to focus on disease forecasting.  The Center for Forecasting and Outbreak Analytics will be a hub for research and innovation aimed at mitigating the effects of future disease threats. Its launch comes as the federal government continues to fight the coronavirus pandemic and now the rapidly spreading Delta variant. It will build on current modeling efforts at the agency. * * * The center’s initial funding will come from the $1.9 trillion American Rescue Plan enacted in March for coronavirus relief.”
  • The NCQA Blog discusses the hospital at home movement in the U.S. “Humana Home Solutions​ Vice President Dr. Amal Agarwal estimated that up to 35% of Medicare Advantage spending might be addressable at home. As Mayo Clinic Platform President John Halamka explained, hospital at home also “brings the family back into wellness.” This matters because family involvement affects patient satisfaction.” Interestingly the experts explained that hospital at home care is best suited for mid-level acuity patients, not folks who need the ICU or folks who don’t require hospitalization.

Dr. Halamka used an accessible and memorable analogy to outline the long-term possibilities for hospital at home.

He explained that the tractor manufacturing company John Deere transformed itself into a data company by covering its tractors with sensors. The sensors report back information about the weight and volume of crops that customers harvest—soybeans, for example. The predictive value of the information reported to John Deere is so high that the data are now used to forecast soybean prices.

Likewise, Americans are filling their homes and strapping to their bodies millions of behavioral and biometric sensors.

“We are instrumenting homes with sensors to gather patient data that we can use to understand not only that patient’s progression, but aggregating and analyzing that data [to] understand the progression of similar patients,” said Halamka.

Well put, Doctor.

  • In support of extending initiatives like this to rural areas of the country, the Department of Health and Human Services announced today “key investments that will strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nationwide. These investments—totaling over $19 million—are being distributed to 36 award recipients,” such as “Telehealth Centers of Excellence (COE) program: $6.5 million is being awarded to 2 organizations to assess telehealth strategies and services to improve health care in rural medically underserved areas that have high chronic disease prevalence and high poverty rates. The Telehealth COEs will be located in academic medical centers and will serve as telehealth incubators to pilot new telehealth services, track outcomes, and publish telehealth research. The COEs will establish an evidence-base for telehealth programs and a framework for future telehealth programs.’

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • Govexec tells us that last Friday August 13, the Department of Justice issued its internal guidance on employee, on-site contractor, and visitor COVID-19 vaccine attestation program required by the White House. ‘Federal employees, regardless if they are working in person or teleworking, must complete a Certification of Vaccination Form and update it if there is a change in their vaccination status. ‘Employees who are not fully vaccinated will be required to obtain and provide to their supervisor (or component designee) a negative COVID-19 test result, from a test taken within the past three days, each time they enter a department facility or participate in an official meeting or function in another location other than the telework location,’ said the memo. ‘The department is developing a program to facilitate testing for employees.’”
  • The American Medical Association informs us about the reasons why moderately and severely immuno-compromised Americans who compose 2.7% of the population should get an mRNA vaccine booster. “[Food and Drug Administration] Approval of a third dose comes amid growing evidence that people with weakened immune systems do not get adequate protection from the normal two-dose regimen of Pfizer and Moderna COVID-19 vaccines. This makes immunocompromised people especially susceptible to breakthrough COVID-19 infections.”
  • The Wall Street Journal reports that Pfizer and BioNTech are starting to share clinical evidence of the value of a third booster vaccination for a broader swath of the U.S. population administered six months to a year following the first two doses. “Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA. The FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.”

With regard to the other public health emergency, the American Hospital Association points us to it web resources for the addressing opioid epidemic.

In healthcare business news

  • Labcorp has announced the acquisition of “Ovia Health, a digital health platform used by millions of women seeking information and support with family planning, pregnancy and parenting.”
  • CareMax, a “technology-enabled provider of value-based care to seniors, announced [on August 13] it has signed a collaboration agreement with Anthem, a national health benefits company. Through this collaboration, CareMax plans to build medical centers in areas where Anthem will offer a value-based care model to improve patient outcomes. * * * Through this collaboration agreement, CareMax plans to open approximately 50 medical centers with a focus on Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut, and Virginia, among others.”

From the studies front

  • The University of Michigan’s Institute for Healthcare Policy and Innovation has released an eye opening study on telehealth. The FEHBlog commends it to his readership.
  • Benefits Pro tells us that “Interest in health savings accounts is on the rise, but there is still a gap in understanding about how HSAs work and how they can be used as a retirement savings tool. According to the Plan Sponsor Council of America’s (PSCA) 2021 HSA Survey, education about HSAs remains a key goal for plan sponsors. * * * The study pointed to a potential missed opportunity for employers to solicit HSA rollovers for newly hired employees, with less than 20 percent indicating they do so.”
  • The National Institutes of Health informs us that “A single two-hour session of a pain management skills class could offer as much benefit as eight sessions of cognitive behavioral therapy (CBT) for patients experiencing chronic low-back pain (CLBP), suggests a study published in JAMA Network Open(link is external). Supported by the National Center for Complementary and Integrative Health (NCCIH) and the National Institute on Drug Abuse, both part of the National Institutes of Health, the study explored whether a compressed intervention could lead to the same benefits as a longer-course of CBT.”
  • STAT News reports that the National Institute for Mental Health’s “Director Joshua Gordon told STAT the agency recognizes that new treatments for depression are needed and that it is funding research to explore the underlying biology beyond the monoamine hypothesis. When it comes to understanding depression, “there are fewer and fewer questions of importance with regard to the monoamine systems,” he said. He noted that in addition to federal funding, many startups and small companies are pursuing new treatments for depression. Currently, almost all patients with depression are first treated with medications called selective serotonin reuptake inhibitors, a class of drugs that includes both Zoloft and Prozac. They increase the amount of the neurotransmitter serotonin in the brain, which controls mood, emotions, and cognition. Serotonin and two other neurotransmitters targeted by some antidepressants, norepinephrine and dopamine, are called monoamines because they contain one chemical group called an amine.” The article also discusses those new treatments, including .

Friday Stats and More

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

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 32nd week of this year (beginning April 2, 2020, and ending August 11, 2021); using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (April 2, 2020, through August 11, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 11, 2021, which also uses Thursday as the first day of the week:

Here is a link to the Centers for Disease Control’s (“CDC”) latest weekly review for the COVID data tracker upon which the FEHBlog relies. The review is aptly titled: “Put on Your Masks and Thinking Caps.”

The American Hospital Association has released on You Tube a two minute long presentation on the value of COVID-19 vaccines. It’s called Eight Things to Know About the COVID-19 Vaccine. Its message should be widely distributed.

The Federal Times reports that Kaiser Permanente which is the third largest carrier in the FEHB Program announced a COVID-19 vaccine incentive for its FEHB plan membership today.

The CDC also issued 2021-22 Flu Season FAQs today. Among thing the FEHBlog learned that “All flu vaccines will be quadrivalent (four component), meaning designed to protect against four different flu viruses. For more information: Quadrivalent Influenza Vaccine | CDC.”

In an ironic twist, check out this quote from Fierce Healthcare

“The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,” said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.

“With mask mandates quickly returning and also acknowledging other trends we are observing within visit mix and volumes, we need to account for these other dynamics and a likely weaker cold and flu season due to these variant-related protective measures,” he said, also noting the company does not expect extra COVID-related demand.

“Consequently, we are adjusting down our visit forecast for the remainder of the year to account for these factors,” he said.

As the French say, “quelle domage”.

But seriously folks, Revcycle Intelligence informs us that

The percentage of telehealth claim lines has stabilized at about 5 percent of medical claim lines, indicating a new balance of virtual and in-person care.

The analysis conducted by FAIR Health as part of its Monthly Telehealth Regional Tracker included data representing the privately insured population, including Medicare Advantage, and excluded Medicare fee-for-service and Medicaid claims data.

The data revealed that the percentage telehealth claim lines increased slightly to 5 percent in May 2021, from 4.9 percent the previous month. The slight increase suggests a stabilization of telehealth utilization since telehealth claim lines had declined each month from February to April of this year.

And what’s more —

  • Healthcare Dive has a helpful wrap up article on the HIMSS conference. Take a look.
  • Federal News Network reports that the General Services Administration released federal employee travel per diems for the fiscal year beginning October 1, 2021. The combined per diems provide a cap of the federal contractor travel expenses that can be charged against an experience rated FEHB contract.
  • From Capitol Hill, Roll Call reports that nine centrist House Democrats have told Speaker Pelosi in writing that “We will not consider voting for a budget resolution until the bipartisan Infrastructure Investment and Jobs Act passes the House and is signed into law.” Roll Call adds that “Together, they’ve got more than enough support to stall the budget in the narrowly divided House where Democrats can lose no more than three members on party-line votes. No Republicans are expected to vote for the budget resolution, which is needed to begin the process on a $3.5 trillion reconciliation package chock full of Democratic priorities.”

Thursday Miscellany

David Ermer–COVID-19, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Govexec reports that

The Veterans Affairs Department will more than triple the number of employees who must receive the vaccine, bringing the total to 360,000. VA originally required just its frontline health care staff—those hired under Title 38 of the U.S. Code—to be inoculated, which amounted to about 115,000 workers. 

The mandate will now include Title Five employees within the Veterans Health Administration—such as housekeepers, engineers and administrative staff—and health care providers such as psychologists, pharmacists, physical therapists, nursing assistants and others in “Hybrid Title 38” positions. 

“We’re now including most VHA employees and volunteers and contractors in the vaccine mandate because it remains the best way to keep veterans safe, especially as the Delta variant spreads across the country,” Secretary Denis McDonough said. “This pandemic is not over and VA must do everything in our power to protect veterans from COVID-19. With this expanded mandate, we can once again make—and keep—that fundamental promise.”

Employees impacted by the new mandate will have eight weeks to get the vaccine or prove they already have.

In the same vein, the Department of Health and Human Services (“HHS”) announced today that

[HHS] will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19.

Staff at the Indian Health Service (IHS) and National Institutes of Health (NIH) who serve in federally-operated health care and clinical research facilities and interact with, or have the potential to come into contact with, patients will be required to receive the COVID-19 vaccine. This includes employees, contractors, trainees, and volunteers whose duties put them in contact or potential contact with patients at an HHS medical or clinical research facility.

Additionally, U.S. Surgeon General Dr. Vivek Murthy will immediately require members of the U.S. Public Health Service Commissioned Corps to be vaccinated against COVID-19 as part of medical readiness procedures to prepare for any potential deployment need as emergency responders

Those two mandates apply to about 20% of the federal workforce. In contrast, the general approach is a vaccine screening requirement — either attest to receiving the vaccine or wear a facemask and receive regular COVID-19 testing.

Furthermore, the Wall Street Journal reports that

The U.S. Food and Drug Administration authorized booster shots for certain people with weakened immune systems, likely the launch of broader efforts to better protect against evasive variants like Delta.

The agency on Thursday cleared giving a third dose of a messenger RNA Covid-19 vaccine from Pfizer Inc. PFE 2.01% and its partner BioNTech SE BNTX 4.13% or from Moderna Inc. MRNA 1.58% to immunocompromised people who had received a solid organ transplant or individuals who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

From the health equity front, the National Institutes of Health released a disturbing study on maternal mortality:

Racial and ethnic disparities in maternal mortality — deaths related to pregnancy or childbirth — in the United States may be larger than previously reported, suggests a study funded by the National Institutes of Health. By re-examining information on death certificates from 2016 and 2017, researchers found that the maternal mortality rate among non-Hispanic Black women was 3.5 times higher than among non-Hispanic white women. Previously, standard analyses had indicated a 2.5-times-higher death rate for Black women.

The new analysis also revealed that these disparities were concentrated among a few causes of death. Postpartum cardiomyopathy (disease of the heart muscle) and the blood pressure disorders preeclampsia and eclampsia were leading causes of maternal death for Black women, with mortality rates five times higher than those for white women. Pregnant and postpartum Black women were two to three times more likely than white women to die of hemorrhage (severe bleeding) or embolisms (blood vessel blockages).

The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and led by Marian MacDorman, Ph.D., of the Maryland Population Research Center at the University of Maryland. It appears in the American Journal of Public Health.

Healthcare Dive reports on HIMSS conference presentations on this important topic of achieving health equity.

Healthcare executives do say equity is a top priority for their organizations, with half of the CEOs surveyed by Deliotte early this year saying its among their top three organizational priorities this year, according to a recent report from the consultancy.

However, companies are at different stages of actually implementing equity and inclusion programs, with some reporting they’ve been focused on addressing disparities for years, and others just beginning to define what it means to their organization.

Of the 20 chief executives surveyed by Deliotte, 17 said they had a dedicated team or budget for health equity initiatives.

That top-level buy-in is important, but addressing health inequities needs to be a whole-enterprise mission, [Ronald] Copeland[, the chief equity, inclusion and diversity officer for integrated health giant Kaiser Permanente] said, integrated into every facet of payer and provider goals. One strategy to achieve this could be to make health equity a formal dimension of quality improvement, a policy that’s even recently been considered in federal payer programs under the Biden administration.

In other HIMSS conference news —

  • Fierce Healthcare informs about HIMSS conference discussion on rationalizing patient and provider experiences with multiple front end apps.
  • Healthcare Dive interviews Teladoc’s president of hospitals and health systems, Joe DeVivo about the state of the telehealth market and the company’s ambitions.

STAT News informed us today that 19,000 people attended the HIMSS conference in person and 5,000 attended virtually. 700 exhibitors attended. Both of those totals are about half of the normal in person attendance at HIMSS.

From the drug costs front, the White House released the President’s ideas on how to reduce prescription drug costs. The President leads off with encouraging Congress to allow CMS to negotiate Medicare Part D drug contracts. That change may save money for the federal government but it shift those savings to the commercial sector including the FEHB.

Also the HHS Inspector General released a report on opioid use among Medicare beneficiaries in 2020. “More than 43,000 Medicare Part D beneficiaries suffered an opioid overdose—from prescription opioids, illicit opioids, or both—in 2020.” The Inspector General also noticed a drop in prescriptions for opioid treatments which the OIG found concerning. “A May 2020 OIG data brief recommended that CMS educate Part D beneficiaries and providers about access to MAT drugs and naloxone. We continue to encourage CMS to take these steps. It is also critical for CMS to closely monitor the number of beneficiaries receiving MAT drugs and naloxone and take action, if needed. OIG is also committed to continuing our work on opioid use and access to treatment.”

In litigation news, the prescription benefit manager trade association, PCMA, has filed a lawsuit against HHS in the District of Columbia’s federal court challenging the legality of certain aspects of the payer transparency rule scheduled to start phasing in on January 1, 2022.

PCMA is not challenging the portions of the rule that direct plans to provide useful information directly to patients. But we are challenging the portions of the rule that do not meet those important objectives and will not produce information that patients and physicians can use.

These parts of the Trump administration’s transparency rule will drive prescription drug costs higher. By requiring disclosure of “historical” net prices, which are essentially current year net prescription drug prices, the rule will directly provide drug manufacturers access to their competitors’ negotiated rebates, discounts, and price concessions. This in turn will allow drug manufacturers to discount less deeply as they realize their price concessions went beyond those of competitors.

In addition, outside entities will not be able to develop reported information into a useful and understandable format for patients. Unlike health plans and PBMs, third-party application developers will not know patients’ existing insurance enrollment and eligibility or their current benefits and whether they have met a deductible or reached an out-of-pocket limit, and so the third-party applications are likely to cause widespread confusion among patients. Net prices are generally not useful information to patients because their deductible and coinsurance payments are calculated based on negotiated rates, not net prices.

PBMs and health plans already have real-time benefits tools for patients and prescribers, which they can use at the point of prescribing to check on cost-sharing for every patient based on their individual situation and health plan.

Coincidentally, the U.S. Chamber of Commerce has filed a substantially similar lawsuit in the federal court for the Eastern District of Texas. That case challenges the legality of the “historical net prices” provision and the “three machine readable tapes” provision of the HHS rule on the ground that they have no utility to consumers. Good luck.

Finally, the Census Bureau released a lot more 2020 census data today. The Wall Street Journal observes that “The nation’s population grew just 7.4% during the decade, the second slowest on record for a decennial census. Only the 1930s—the era of the Great Depression—saw slower growth.”