Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Weekend Update

Congress returns to committee work and floor action this coming week for an expected two more weeks of the its lame duck session.

Top House and Senate appropriators on Tuesday [November 24] clinched a deal on a bipartisan set of funding levels, paving the way for a $1.4 trillion spending package to avert a government shutdown next month. The agreement on the funding allocations, confirmed by a House Democratic aide, establishes overall totals for 12 appropriations measures that will be rolled into one massive omnibus bill that would boost federal budgets for the rest of the fiscal year. Negotiators plan to keep the numbers — known as 302(b)s — under wraps until a bipartisan, bicameral omnibus is finalized, the aide said.

This means that Congress remains on track to pass an FY 2021 omnibus spending bill before the current continuing resolution funding the federal government expires on December 12.

Negotiations on another Covid-19 relief bill are at an impasse. Some measures may get attached to a spending package that must pass by Dec. 11 to avert a government shutdown. Another weekly boost to unemployment benefits would most likely be part of the mix, according to unemployment and policy experts.  The subsidy would probably fall between $250 and $600 a week and be retroactive to early September, they said.

  • The Wall Street Journal reports that “President Trump’s decision to defer payroll taxes until the end of the year is leaving challenges for lawmakers to manage after he leaves office in January, and they haven’t figured out what—if anything—to do. * * * [P]ayroll processor Paychex Inc. said take-up has been very low. The one big exception—which could create pressure for Congress to act—is the federal workforce, including many members of the military. Mr. Trump required executive-branch employees to participate. Lawmakers, particularly those from the Washington [D.C.] area, support legislation to let employees decide whether their taxes can be deferred. As the weeks tick by toward the year’s end, that becomes less feasible.

Late Wednesday, the Department of Health and Human Services released the proposed ACA Notice of Benefit and Payment Parameters for 2022. Of note, to community rated FEHB plan carriers HHS proposes to make the following changes to the medical loss ratio (“MLR”) calculation:

We propose to amend the MLR regulation to establish the definition of prescription drug rebates and other price concessions that issuers must deduct from incurred claims for medical loss ratio (MLR) reporting and rebate calculation purposes beginning with the 2022 MLR reporting year (MLR reports filed in 2023). We additionally propose to explicitly allow issuers the option to prepay a portion or all of the estimated MLR rebate for a given MLR reporting year in advance of the deadlines set forth in §§ 158.240(e) and 158.241(a)(2) and the filing of the MLR Annual Reporting Form. We also propose to establish a safe harbor allowing such issuers, under certain conditions, to defer the payment of any remaining rebates owed after prepayment until the following MLR reporting year beginning with the 2020 MLR reporting year (MLR reports filed in 2021). In addition, we propose to allow issuers to provide MLR rebates in the form of a premium credit prior to the date that the rules currently provide and beginning with the 2020 MLR reporting year (MLR reports filed in 2021). Lastly, we propose to clarify MLR reporting and rebate requirements for issuers that choose to offer temporary premium credits during a public health emergency declared by the Secretary of HHSfor future benefit years, beginning with the 2021 MLR reporting year (MLR reports filed in 2022). 

Of note to all FEHB plan carriers, HHS proposes to make the following changes to the out of pocket (“OOP”) cost sharing ceilings for in-network care:

The proposed 2022 maximum annual limitation on cost sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 6.4 percent increase above the 2021 parameters of $8,550 for self-only coverage and $17,100 for other than self-only coverage. Similar to the proposal for the premium adjustment percentage index, for the 2023 benefit year and beyond, we propose to release the maximum annual limitation on cost sharing in guidance by January of the year preceding the applicable benefit year. 

For more details on the Notice check out Katie Keith’s columns on the Health Affairs Blog.

The Biden Administration’s HHS will finalize the Notice next year. HHS has a good deal of statutory discretion over the MLR calculation but very little discretion over (“OOP”) cost sharing ceiling calculations in the FEHBlog’s opinion.

The FEHBlog has learned that a two step process exists for approval a COVID-19 vaccine for individual and group health plan coverage.

  • First, as discussed in the FEHBlog, the FDA must give emergency use authorization to the vaccine. The relevant FDA advisory committee is meeting December 10 to consider the Pfizer – BioNTech vaccine. The Committee’s recommendation goes to the FDA Commissioner for final approval.
  • Once FDA approval has been given, the CDC’s relevant advisory committee the Advisory Committee on Immunization Practices (ACIP) must add its approval.
  • Fifteen days after ACIP approval is given, individual and group health plans, including FEHB plans will become obligated to cover the administration of the approved vaccine in and out of network without member cost sharing. That effective date will be in late December at the earliest. 
  • An emergency use authorization can only trigger plan health plan coverage of a vaccine during a related public health emergency. The current COVID-19 public health emergency period expires on January 20, 2021, unless as expected HHS extends that period for another 90 days before then,

Happy Thanksgiving

Even in this difficult year, we Americans can still enjoy our great holiday Thanksgiving. The Wall Street Journal discusses a study of how to cope with the COVID-19 great hunkering down — the results tie in with traditional Thanksgiving activities

“[M]usic [parades], exercise [touch football] and entertainment [NFL football and movies] were the most potent stress relievers for the greatest number of people. But of those three activities, music—singing, dancing, playing an instrument, or just listening to a favorite playlist—was the only one that led to a reduction of depression symptoms. A fifth of all the participants reported it as the most effective way to reduce their pandemic-induced blues. Music’s palliative effects were particularly potent for people who were highly sensitive to rewards.  * * * [Needless to say] Cooking, baking and eating also helped tamp down the blues. 

Health Payer Intelligence reports, and the FEHBlog could not agree more strongly that

Employers are gravitating toward integrated health care benefits to improve member engagement and patient experience as well as lower healthcare spending, according to a report commissioned by Anthem.

Integrated health care interweaves pharmacy, ancillary, supplemental health, and other benefits data into the employer’s health plan to facilitate smoother communication between employees’ providers.

Provider collaboration is key to this strategy. Three key methods for facilitating provider collaboration included connecting all providers through an [electronic medical record] EMR, establishing automatic reminders about extra dental cleanings, and sending health-related reminders to employees. Employers also leveraged AI and apps to connect employees to their benefits.

That’s a very interesting use of EMRs to help close gaps in care.

The Internal Revenue Service has announced that the Affordable Care Act’s Patient Centered Outcomes Research Institute (“PCORI”) fee “for policy years and plan years that end on or after October 1, 2020, and before October 1, 2021, is $2.66” per covered health plan life (/ bellybutton). The PCORI fee payment is due at the end of July. The adjusted fee is 12 cents higher than the fee paid in July 2020.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

The Boston Globe reports today that

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday that as many as 20 million people could get coronavirus vaccinations around the end of the year.

He said that by that time there could be as many as 25 million doses of vaccine available from Pfizer and 15 million doses available from Moderna. The vaccination takes two shots so that would mean 20 million people could get protection.

He said it could happen by the end of December, or early January if the timeline slips a bit. “That’s what we’re anticipating and hoping,” he said in an interview at the 2020 STAT Summit.

The Wall Street Journal adds that

The strong early results for two leading Covid-19 vaccines have implications that go far beyond the current pandemic: They suggest the time has come for a gene-based technology that could provide new treatments for cancer, heart disease and other infectious diseases.

The [previously] unproven technology, named messenger RNA after the molecular couriers that deliver genetic instructions, has long eluded researchers. An mRNA vaccine has never been cleared by regulators. It is now the basis for Covid-19 vaccines from Moderna Inc.  and Pfizer Inc. and its partner BioNTech SE. * * *

The mRNA vaccines’ early success [with COVID-19] “gives us some encouragement for the technology for other vaccine targets in the future,” said Dr. Mark Mulligan, director of the Vaccine Center at NYU Langone Health. 

One of the advantages of mRNA vaccines, [Biotech co-founder] Dr. [Ugur] Sahin said, is that they can be quickly adjusted so vaccines can better respond to an eventual decline in immunity or virus mutations, which could render other vaccines less effective. Dr. Sahin said that regulator authorization [of the Pfizer and Moderna COVID-19 vaccines] could potentially lead to a “whole new category of medicines.”

Hope springs eternal.

Healthcare Dive informs us that “After years of speculation, Amazon finally announced Tuesday that it will sell and deliver prescription drugs on its online platform, Amazon Pharmacy.” Moreover —

Here’s a key distinction in how Amazon Pharmacy will operate: “Before checking out customers can compare their insurance co-pay, the price without insurance, or the available savings with the new Prime prescription savings benefit to choose their lowest price option,” Amazon said.

A previously vexing problem for patients was that sometimes prescription drugs would be cheaper using cash, or without using insurance coverage. But pharmacists were sometimes barred from alerting patients to the discrepancy due to “gag clauses.” In 2018, Congress passed a bill to ban gag clauses in certain plans.

Amazon Pharmacy shoppers will be able to input their insurance information and their clinicians will be able to send prescription information directly to the Amazon Pharmacy.

Speaking of market disruption, Plan Sponsor advises us about the growing popularity of “individual coverage health reimbursement arrangements (ICHRAs) to provide their workers with tax-preferred funds to pay for the cost of health insurance coverage that workers purchase in the individual market [/ the ACA marketplace].” This is the one major Trump Administration reform to the Affordable Care Act that did not attract opposition, in court or elsewhere, because it unquestionably strengthened the ACA marketplace.

On the healthcare studies front –

  • The National Library of Medicine informs us about the susbtantial patient safety benefits of including the patient’s photograph in the top line of their electronic health record when used at healthcare facilities, particularly emergency rooms
  • The National Institutes of Health announced $21 million of funding into research examining racial and ethnic disparities in pregnancy-related complications and deaths.

According to the Centers for Disease Control and Prevention, approximately 700 women die each year in the United States from pregnancy-related complications.

Research will include original, innovative, and multidisciplinary efforts to advance the understanding, prevention, and reduction of pregnancy-related complications and deaths among disproportionately affected women. This includes women from racial and ethnic minority groups, women with underprivileged socioeconomic status, and those living in underserved rural settings.

The racial disparities in pregnancy-related mortality are stark: respectively, African American and American Indian/Alaska Native women are 3.2 and 2.3 times more likely to die from pregnancy-related causes than are white women. In the case of African American women, the disparity increases with age. Black women under 20 are 1.5 times more likely to die from pregnancy-related causes than are white women in the same age group, but black women ages 30-34 are 4.3 times more likely to die from pregnancy-related causes than are white women ages 30-34. Approximately two thirds of pregnancy-related deaths are preventable, underscoring the need for more research to improve the maternal health outcomes for women before, during, and after delivery.

In addition to maternal deaths, over 25,000 women each year experience severe maternal morbidity(link is external) (SMM), requiring unexpected short- or long-term life-saving healthcare interventions. Like maternal mortality, SMM has a high rate of preventability. All racial and ethnic minority populations have higher rates of SMM than do white women.

Monday Roundup

Photo by Sven Read on Unsplash

Perhaps at last we are beginning to see the light at the end of the COVID-19 tunnel. Pfizer announced positive initial results from the phase three trial of its two dose COVID-19 vaccine.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The Wall Street Journal explains (in part) that ‘

“When will the Pfizer vaccine be ready for [emergency use] authorization?

“It will be several more weeks at the earliest, because researchers and regulators still need to make sure the shot is safe. The U.S. Food and Drug Administration has said it wants to see two months’ worth of safety outcomes after vaccination for at least half of the people participating in any large, final-stage clinical trial before it considers authorizing a Covid-19 vaccine. The FDA says this will allow identification of any side effects, such as neurological or heart conditions, that weren’t apparent immediately after vaccination. So far, no serious safety issues have been found, Pfizer says. It expects the two months of safety data later this month, and can ask the FDA to authorize the vaccine soon thereafter. It isn’t yet clear how long the FDA will take to make a decision.

“When will people start getting vaccinated?

“Shots from Pfizer and BioNTech could start becoming available before the end of the year, as production has already begun, but initial supplies will be limited. Pfizer says it expects to produce up to 50 million doses globally in 2020—enough for 25 million people because the vaccine is given in two doses—and up to 1.3 billion doses in 2021. This means only the highest risk groups, such as front-line health care workers, could be inoculated this year. Many more doses would be needed to cover the U.S. and global population. Other Covid-19 vaccines in development will likely be needed for everyone to get vaccinated. Their makers have projected they could produce billions of doses next year if their vaccines are successful in clinical testing.”

The Centers for Disease Control released a study of hospital readmissions of COVID-19 patients from March through July 2021.

Among 126,137 unique patients with an index COVID-19 admission during March–July 2020, 15% died during the index hospitalization. Among the 106,543 (85%) surviving patients, 9% (9,504) were readmitted to the same hospital within 2 months of discharge through August 2020. More than a single readmission occurred among 1.6% of patients discharged after the index hospitalization.

The CDC also offered us guidance on avoiding COVID-19 during the Thanksgiving holidays.

The Centers for Medicare and Medicaid Services (“CMS”) released Affordable Care Act medical loss ratio rebate data from the latest health insurer reports for the three year period ending in 2019. The medical loss ratio data is broken out into three cohorts — individual insurance (minimum MLR 80%), small group insurance (minimum MLR 80%), and large group insurance (minimum MLR 85%). Each cohort then is further broken down state by state which no doubt increase the rebates. FEHB plan insurer rebates sensibly are paid to the the carrier’s contingency reserve, which is FEHB lingo for a premium stabilization fund.

Katie Keith in the Health Affairs blog offers her insights into tomorrow’s California v. Texas oral argument before the U.S. Supreme Court. C-SPAN will play the audio live on radio and the internet.

“The main issues to listen for are:

  • “Do the challengers—a coalition of states led by Texas and two individuals—have standing to challenge the ACA?
  • “Is the individual mandate, with a $0 penalty, unconstitutional?
  • “If the mandate is unconstitutional, is it severable from the rest of the ACA? If not, which other ACA provisions should be struck down alongside the mandate?”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Not without cause, Katie Keith in the Health Affairs blog provides her thoughts on how Biden’s election will impact the Affordable Care Act “in what otherwise appears to be a status quo election.” Compare your thoughts with hers. Remember that the ACA puts a lot authority in the hands of the Secretary of Health and Human Services often together with the Labor and Treasury Secretaries.

On the COVID-19 front, Healthcare Dive reminds us, not surprisingly, that

Patients overwhelmingly turned to telehealth visits early in the COVID-19 pandemic but skipped out on diagnostic procedures and other preventive and elective care that can only be done in-person, according to a study published Thursday [today] in JAMA Network Open. The number of mammograms and colonoscopies performed in March and April dropped more than 65% compared to the year prior, according to the analysis of more than 5 million commercially insured patients. Overall, healthcare utilization dropped 23% in March and 52% in April. * * *

Researchers looked at insurance claims data from 2018 to 2020 from about 200 employers. Beyond major declines for mammograms and colonoscopies, they found other procedures like musculoskeletal surgery, cataract surgery and MRIs all dropped by 45% or more.

In-person visits to manage chronic conditions dropped too, including blood sugar tests for patients with diabetes, which fell more than 50% in March and April. Chemotherapy treatments dropped 4%. And among children under 2 years old, vaccinations dropped 22%.

Utilization did increase in the third quarter. Fierce Healthcare reports that

Major insurer Cigna reported a rebound in healthcare utilization in the third quarter from massive declines in the second quarter due to COVID-19. Cigna, which posted a $1.39 billion profit in the third quarter, said that healthcare use remains slightly below average when not taking into account costs for COVID-19. The insurer’s performance in the quarter was bolstered by its newly rebranded Evernorth subsidiary.  Cigna executives said that utilization was 95% below normal levels without factoring COVID-19 costs. 

Nevertheless, given the current upswing in COVID-19 cases, it’s unlikely that a lot of catch up preventive care will happen this year. It is incumbent on health plans to help members catch up, in the FEHBlog’s opinion.

In sobering news, the Robert Wood Johnson Foundation helps us look at the impact of COVID-19 on households across our country.

Finally, FedWeek offers upcoming Open Season advice to federal employees and annuitants

Tuesday Tidbits

Thanks to Aaron Burden for sharing their work on Unsplash.

Happy Election Day!

The FEHBlog enjoyed reading this American Medical Association article about the five things that doctors should tell their patients about the COVID-19 vaccines currently under development. This could be good information for health plans to share with their members.

Fierce Healthcare reports that

Nearly half the nation’s hospitals, many of which are still wrestling with the financial fallout of the unexpected coronavirus, will get lower payments for all Medicare patients because of their history of readmitting patients, federal records show.

The penalties are the ninth annual round of the Hospital Readmissions Reduction Program created as part of the Affordable Care Act’s broader effort to improve quality and lower costs. The latest penalties are calculated using each hospital case history between July 2016 and June 2019, so the flood of coronavirus patients who have swamped hospitals this year were not included.

The number and severity of penalties were comparable to those of recent years, although the number of hospitals receiving the maximum penalty of 3% dropped from 56 to 39.

Beckers Hospital Review provides a list of those 39 hospitals here.

Healthcare Dive informs us that

Humana bested Wall Street expectations as it gained more members during the third quarter, generated higher revenue and beat earnings estimates, according to its quarterly results released Tuesday morning.

The payer’s medical utilization continued to trend slightly below pre-COVID levels during the third quarter, though still well above the severe dip in March and April. The lower levels of utilization were partially offset by higher COVID-19 testing and treatment costs as cases began to tick back up.

Executives warned during Tuesday’s call with investors that they expect a loss in the fourth quarter due to a number of issues, including COVID-19 testing and treatment and rebounding utilization.

It’s the last bullet that caught the FEHBlog’s attention.

Finally, Kaiser Health News offers a nice story about seniors forming friendship pods to ward off the loneliness of the great hunkering down.

Weekend update

In view of the impending national election on Tuesday, Congress is out of session for the next two weeks except for one Committee hearing on November 10.

On the COVID-19 front –

  • The Wall Street Journal reports about research and medical efforts to address the health problems of so-called COVID-19 long haulers.

Nearly a year into the global coronavirus pandemic, scientists, doctors and patients are beginning to unlock a puzzling phenomenon: For many patients, including young ones who never required hospitalization, Covid-19 has a devastating second act.

Many are dealing with symptoms weeks or months after they were expected to recover, often with puzzling new complications that can affect the entire body—severe fatigue, cognitive issues and memory lapses, digestive problems, erratic heart rates, headaches, dizziness, fluctuating blood pressure, even hair loss.

What is surprising to doctors is that many such cases involve people whose original cases weren’t the most serious, undermining the assumption that patients with mild Covid-19 recover within two weeks. Doctors call the condition “post-acute Covid” or “chronic Covid,” and sufferers often refer to themselves as “long haulers” or “long-Covid” patients.

According to the article, the estimated numbers of long haulers varies “widely.” Nevertheless, [w]ith more than 46 million cases world-wide, even the lower estimates would translate into millions living with long-term, sometimes disabling conditions, increasing the urgency to study this patient population, researchers said. What they find could have implications for how clinicians define recovery and what therapies they prescribe, doctors said.” What’s more, “[o]ther viral outbreaks, including the original SARS, MERS, Ebola, H1N1 and the Spanish flu, have been associated with long-term symptoms.”

  • Last Friday, ” the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) jointly announced a $12.7 million contract with InBios International Inc., of Seattle, to expand domestic production capacity for two rapid point-of-care tests for SARS-CoV-2, the virus that causes COVID-19. The first, called the SCoV-2 Ag Detect Kit, detects current infections by identifying antigens – genetic material – of the virus in a nose swab sample. The second test, called the SCoV-2 Detect IgM/IgG Kit, detects antibodies for the virus in a finger prick of blood, indicating whether the person had a previous COVID-19 infection. The contract enables InBios to ramp up production of either or both tests to 400,000 units per week – 20 times the facility’s current output – by May 2021, significantly expanding the nation’s testing capacity.

Fierce Healthcare informs us

According to UnitedHealth Group’s fifth annual UnitedHealthcare Consumer Sentiment Survey, which examines Americans’ opinions about multiple areas of healthcare, a survey-record 56% said it is likely they would use virtual care for medical services.  More than a quarter of respondents (26%) said they would prefer a virtual relationship with a primary care physician, the survey found. And when comparison shopping for care, 55% of respondents said they had used the internet or mobile apps to comparison shop for healthcare during the past year, with 1 in 4 patients saying that online or mobile resources were their first option for evaluating health issues.

Follow up on a couple of stories that the FEHBlog has been following:

  • Health Payer Intelligence discusses various angles on the payer transparency rule that the ACA regulators issued last week. That rule is applicable to the FEHBP.
  • A friend of the FEHBlog related that the federal government has noticed an appeal to the D.C. Circuit of District Judge James Boasberg’s September 2, 2020, decision preliminarily enjoining certain provisions of the Trump Administration’s revised ACA Section 1557 rule that adversely affected transgendered people. The government’s 60 day period to notice such an interlocutory appeal would have expired tomorrow.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Today’s big news is that the ACA regulators (the Departments of Health and Human Services (“HHS”), Labor, and Treasury) finalized a lengthy pricing transparency rule for payers, including ERISA and FEHBP group health plans (see footnote 233). The related fact sheet explains

This final rule includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping.

First, most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. For the first time, most consumers will be able to get real-time and accurate estimates of their cost-sharing liability for health care items and services from different providers in real time, allowing them to both understand how costs for covered health care items and services are determined by their plan, and also shop and compare health care costs before receiving care. An initial list of 500 shoppable services as determined by the Departments will be required to be available via the internet based self-service tool for plan years that begin on or after January 1, 2023. The remainder of all items and services will be required for these self-service tools for plan years that begin on or after January 1, 2024.

Second, most non-grandfathered group health plans or health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to the public, including stakeholders such as consumers, researchers, employers, and third-party developers, three separate machine-readable files that include detailed pricing information.
The first file will show negotiated rates for all covered items and services between the plan or issuer and in-network providers.
The second file will show both the historical payments to, and billed charges from, out-of-network providers. Historical payments must have a minimum of twenty entries in order to protect consumer privacy.
And finally, the third file will detail the in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level.
Plans and issuers will display these data files in a standardized format and will provide monthly updates. This data will provide opportunities for detailed research studies, data analysis, and offer third party developers and innovators the ability to create private sector solutions to help drive additional price comparison and consumerism in the health care market. These files are required to be made public for plan years that begin on or after January 1, 2022.

The final rule also provides some medical loss ratio relief to compliant health insurance issuers as explained in the fact sheet. Here is AHIP’s reaction to the final rule.

Also today HHS issued an interim final rule with a comment period that “extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements. Released to the public on March 9, 2020, ONC’s Cures Act Final Rule established exceptions to the 21st Century Cures Act’s information blocking provision and adopted new health information technology (health IT) certification requirements to enhance patients’ smartphone access to their health information at no cost through the use of application programming interfaces (APIs).” The rule had been scheduled to take effect beginning next week.

Fierce Healthcare reports that “Regeneron’s anti-SARS-CoV-2 antibody cocktail has significantly reduced medical visits in ambulatory COVID-19 patients. The phase 2/3 clinical trial linked REGN-COV2 to a 57% decline in medical visits associated with COVID-19 in the 29 days after treatment.”

HealthPartners, a Minneapolis health insurer that participates in the FEHBP, offers a helpful, complete explanation of the benefits of wearing masks to prevent COVID-19. “At its core, wearing a mask is an act of kindness and neighborliness. It’s one of the simplest good deeds you can do these days, and a great way to be a force of positivity for the people in your life.”

Fierce Healthcare reports

The financial crisis for hospitals and physician practices caused by the COVID pandemic is a “clarion call” for the healthcare industry to move from a fee-for-service payment model to value, said Kevin Mahoney, chief executive officer of the University of Pennsylvania Health System (Penn Medicine).

“The hospital sector has taken a giant hit. We keep hearing about ‘the new normal.’ The lesson that we learned is that there is nothing new or normal about a pandemic, there’s just been an acceleration of trends,” Mahoney said during a recent virtual event hosted by the University of Pennsylvania. “It has laid bare how dependent hospitals are on commercially-insured, elective procedures, and without them, we don’t make money.”

The FEHBlog’s youngest son is a research coordinator for Penn Medicine. The FEHBlog seconds his boss’s sentiments.

The Surgeon General issued a timely

Call to Action to Control Hypertension (Call to Action) seeks to avert the negative health effects of hypertension by identifying evidence-based interventions that can be implemented, adapted, and expanded in diverse settings across the United States.

The Call to Action outlines three goals to improve hypertension control across the United States, and each goal is supported by strategies to achieve success:

Goal 1. Make hypertension control a national priority.
Goal 2. Ensure that the places where people live, learn, work, and play support hypertension control.
Goal 3. Optimize patient care for hypertension.

Following up on yesterday’s post about mandatory of coverage of COVID-19 vaccines with no member cost sharing once available, the FEHBlog wants to add that the same rule applies to Medicare. CMS “estimates the overall cost of providing the vaccine to every senior on Medicare would be around $2.6 billion, which would be covered by the federal government. CMS will also cover the vaccine for any uninsured individuals by using money from a $175 billion provider relief fund passed as part of the CARES Act.” It appears however that the vaccine would be administered through the Part D program. That would not be much help to FEHB plans as most FEHB members with primary Medicare coverage does not carry Medicare Part D.

Nextgov reports that

The Health and Human Services Department, the Cybersecurity and Infrastructure Security Agency and the FBI warn hospitals face an imminent threat from cybercriminals that encrypt and hold their data hostage—and some health care facilities are already dealing with the fallout.

The agencies collectively issued an advisory Wednesday detailing the tactics, techniques and procedures reportedly used against at least five hospitals already this week. The advisory includes recommendations for mitigating what observers are referring to as the most serious cyber threat the U.S. has seen to date, being perpetrated by an especially ruthless group of criminals.  

“CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers,” reads the advisory.

Midweek Update

Photo by Manasvita S on Unsplash

The Affordable Care Act regulators (the Departments of Health and Human Services, Labor and Treasury) issued an interim final rule with an opportunity to comment (“IFC”) on coverage of COVID-19 preventive services. This rule focuses on coverage of COVID-19 vaccinations. The fact sheet explains with respect to private plans, including FEHB plans, that

the Departments [have] amend[ed] existing regulations to implement the unique requirements related to rapid coverage of qualifying coronavirus preventive services. This coverage is required to be provided within 15 business days after the date on which the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) makes an applicable recommendation relating to a qualifying coronavirus preventive service.

Specifically, plans and issuers must cover COVID-19 immunizations that have in effect a recommendation of ACIP with respect to the individual involved, even if not listed for routine use on the Immunization Schedules of the CDC. This IFC also provides that during the public health emergency for COVID-19, plans and issuers must cover without cost sharing qualifying coronavirus preventive services, regardless of whether an in-network or out-of-network provider delivers such services. The IFC also affirms that plans and issuers subject to section 2713 of the Public Health Service Act must cover without cost sharing items and services that are integral to the furnishing of recommended preventive services, including the administration of COVID-19 immunizations.

In related news, Route Fifty reports that

When the coronavirus vaccine arrives on the market, demand will far exceed supply. During those first few months, state and county public health officials will face tough questions about who should be first in line to get one of the limited vaccine doses. The Vaccine Allocation Planner for Covid-19, a new tool released Wednesday, aims to help make those decisions with data.

Jointly developed by Ariadne Labs, a project run out of Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, and the Surgo Foundation, a nonprofit at the intersection of behavioral and data science, the tool allows policymakers to look at region-specific data. They can estimate the size of high-risk populations, consider factors like particular community’s vulnerabilities, and run scenarios based on an estimated number of vaccine doses available.

The New York Times maintains a COVID-19 vaccine tracker here

In other healthcare news —

Anthem beat Wall Street’s third-quarter expectations on earnings and reported revenue of $31.2 billion, up 16.8% from the year prior, in results released Wednesday morning. Expenses, however, were up more than 22% year over year, leaving profit to plummet roughly 80%.
Total medical membership jumped 4%, attributed to increases in Medicare and Medicaid rolls. Anthem CEO Gail Boudreaux said on the earnings call the overall membership trends are outpacing internal expectations.
The payer also reported a $594 million payment in Q3 toward a federal antitrust settlement reached with Blue Cross Blue Shield plans that is still awaiting approval by a judge. Other terms include nixing the “best efforts” rule that required member plans to generate at least two-thirds of their annual revenue from Blues brands and allowing employers to request a second bid from a non-local Blues plan, Boudreaux said, adding “we don’t see this changing our strategy.”

There is a clear overlap between specialties that are using telemedicine the most, and those specialties that manage chronic illnesses, such as endocrinology and rheumatology. Treating long-term chronic conditions like diabetes and arthritis require frequent patient visits, but they don’t always need to be in-person. For patients that require long-term care, telemedicine tools can reduce taxing trips to hospitals or clinics.

Doximity is a professional network for physicians.

  • Medpage Today lets us know that

Screening for colorectal cancer (CRC) should begin at age 45 for all average-risk adults in the United States, the U.S. Preventive Services Task Force (USPSTF) recommends in a guideline draft. Screening should continue at recommended intervals until age 75, the draft states. For patients ages 76 to 85, the decision to continue screening should be based on an individualized assessment of the benefits and harms associated with screening.

Currently FEHB plans are required to cover CRC screening with no member cost sharing for members beginning at age 50. If this guideline is finalized in 2020, the no cost sharing coverage requirement would drop to age 45 on January 1, 2022 pursuant to the Affordable Care Act’s requirements.

Here is a list of all of the USPSTF Grade A and B preventive service for adults recommendations which are eligible for cost free coverage starting in the plan year that begins on or after exactly one year from the issue date. FEHB plan years follow the calendar year, but not all health plans do.