Weekend Update

Federal employment benefits

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–

Congress will remain in session for Committee business and floor voting.

The focus of attention will be the President’s Build Back Better Act. The Senate Finance Committee released the text of its portion of the Senate version of the BBB Act yesterday. The Wall Street Journal explains that

President Biden this week will lobby Sen. Joe Manchin, the centrist West Virginia Democrat, in an attempt to lock in a deal on a roughly $2 trillion social-policy and climate bill that Democrats hope to finish by Christmas.

Passage hinges largely on the support of Mr. Manchin, who hasn’t endorsed the legislation. He has repeatedly raised concerns about the cost of the bill and the potential effect of new government spending on inflation. Messrs. Biden and Manchin plan to talk early this week, a Senate aide said.

Senator Manchin’s vote is critical because the Democrat’s can’t lose one vote in the evenly divided Senate as the Republicans in the Senate all intend to vote against the bill. The Journal adds

With Democrats holding the narrowest congressional majority in decades, passing the sweeping bill is akin to threading yarn through a tiny needle. Democrats already navigated past opposition from Arizona Democratic Sen. Kyrsten Sinema on several of the tax increases they originally had proposed, making revenue-generation intended to pay for the legislation difficult.

Ms. Sinema hasn’t endorsed the House-passed bill. Democrats have also needed to write a bill that lawmakers from the party’s most progressive wing would support, along with centrists.

Because the Senate bill will not mirror the already passed House bill, the two Houses of Congress might convene a conference committee. Time will tell.

Tomorrow is the last day of the current Federal Benefits Open Season. OPM explains that

The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 13, 2021 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday December 13, 2021.

From the No Surprises Act front, the Kaiser Family Foundation offers a consumer friendly overview of the law’s provisions that take effect on January 1, 2021. Basically, FEHB plans will pay certain out-of-network (“OON”) providers (emergency care, air ambulance, and OON providers when the patient is treated at an in-network facility) a qualifying payment amount (“QPA”), net of the in-network cost sharing amount which is the member’s financial responsibility. If the provider is dissatisfied with the QPA, he or she must work out the matter with the health plan. The member therefore is held harmless against the outcome of that controversy.

These QPA provisions, however, are inapplicable to claims submitted for FEHB plan members who have primary Medicare coverage or in the case of fee for service plans have primary Medicare Part A only. Also if another payer is primary to the FEHB plan, e.g., a spouse’s plan, then the primary plan is responsible for compliance with the No Surprises Act. The FEHB plan is responsible only for making the secondary payment, which usually equals the primary plan’s deductibles and co-insurance.

From the health care business front, Medcity News informs us that

After a challenging quarter, insurance company Bright Health is raising $750 million in financing. In an unusual move, another insurance company is joining as an investor. Cigna Ventures and Bright’s largest shareholder, New Enterprise Associates, both participated in the financing.

Head of Cigna Ventures Tom Richards talked about potential opportunities to collaborate with NeueHealth, Bright’s provider enablement platform to help practices move to value-based contracts.

“We seek to be partners of choice and we look forward to exploring new ways that NeueHealth and Evernorth can potentially provide services to each other’s customers and clients,” he said in a news release.

From the Omicron front, Bloomberg reports (recall last week’s post about U.S. experts tracking the U.K.’s experience with Omicron because the United Kingdom started to experience Omicron cases before the U.S.):

Prime Minister Boris Johnson warned the U.K. is facing a “tidal wave” of omicron infections and set an end-of-year deadline for the country’s booster vaccination program. Infections in the U.K. from the new variant doubled in the last day and now make up a third of new cases in London. 

Anthony Fauci, U.S. President Joe Biden’s chief medical adviser, said omicron appears able to evade vaccines and some Covid-19 treatments but that a booster shot can increase protection. At least 30 U.S. states are reporting cases of the variant.  

CNBC adds that “Covid booster shots are “optimal care” as the deadly virus continues to mutate and spread, but the U.S. government is staying firm for the time being on the definition of fully vaccinated, top U.S. infectious disease expert Dr. Anthony Fauci said Sunday.”

Midweek Update

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, Telehealth, U.S. Healthcare–

From the Omicron front, and as a public service, the FEHBlog notes this Wall Street Journal A-hed article from yesterday explaining the proper pronunciation of Omicron:

“There isn’t one way of saying Omicron,” said Armand D’Angour, professor of classical languages and literature at the University of Oxford. “First of all, you know, we’re not there, we haven’t recorded it.”

Egbert Bakker, professor of ancient Greek at Yale University, says the letter is pronounced “AWE-mee-kron” in both modern and ancient Greek. But he is open to other forms: “Some people would say ‘oh-MIKE-ron,’ that is the Americanized way. I wouldn’t do it but I don’t think it’s completely unacceptable.”

Isn’t Egbert a perfect name for an Ivy League professor of foreign languages?

Also, the Wall Street Journal reports that

Pfizer Inc. and BioNTech SE  said that a third dose of their Covid-19 vaccine neutralized the Omicron variant in lab tests but that the two-dose regimen was significantly less effective at blocking the virus.

A third dose increased antibodies 25-fold compared with two doses against the Omicron variant, the companies said. Still, two doses may prove effective in preventing severe illness from Covid-19, they said, because immune cells are able to recognize 80% of parts of the spike protein that the vaccine targets.

The results were issued in a press release by the companies, and weren’t peer reviewed and published in a scientific journal.

As of today, just over 200 million Americans are fully vaccinated against COVID according the CDC. Next Tuesday December 14 will mark the first anniversary of COVID vaccinations outside of trials in the U.S.

From the Federal Benefits Open Season front, FedWeek reminds us that

December 13 is the last day of the current open season for electing or changing coverage in FEHB and FEDVIP for the 2022 plan (calendar) year of each program.

If current enrollees make no changes, they will retain the same coverage next year, subject to new premium rates and coverage terms. In practice, only single-digit percentages change plans, levels of coverage within plans that have more than one, or type of enrollment (between family coverage and self plus one, for example).

In contrast to the FEHB and FEDVIP programs, a new enrollment is required each year for those who want a health care flexible spending account, a dependent care account, or both in the following year. The dependent care maximum remains $5,000 while the health care maximum is rising $2,850.

OPM encourages FEHB plan enrollees to use its online FEHB and FEDVIP Plan comparison tools.

From the telehealth front —

Healthcare Dive reports that

— COVID-19 was no longer among the top five telehealth diagnoses nationwide in September, though use of virtual care rose overall, according to new data from nonprofit Fair Health.

— In August, COVID-19 was among the top five diagnoses nationally and in every U.S. census region except the Northeast. In September, the only region where the it ranked in the top five was the Midwest.

— However, national telehealth use (measured as a percentage of all medical claim lines) rose more than 2% in September for the second straight month as the delta variant gained a foothold in the U.S. following a sustained period of decline early this year.

Kaiser Health News discusses the provider push for expanded coverage of audio-telehealth services.

From the benefit design front, Health Payer Intelligence tells us that

UnitedHealthcare has launched a new employer-sponsored health plan for Arizona residents that seeks to prioritize customer support experiences and lower member premiums.

The Doctors Plan of Arizona is the result of a partnership between the payer and the accountable care organization (ACO) Banner Health Network. The plan will serve Maricopa and Pinal County residents who receive employer-sponsored health coverage.

Banner Health Network frequently partners with health plans and providers to increase access to affordable care, the press release noted. The ACO’s network includes primary and specialty care physicians.

Through the Doctors Plan of Arizona, members will gain access to Banner Health’s network of more than 5,000 physicians and 15 medical centers.

Additionally, the plan will offer members a chance to potentially save up to 15 percent on premiums compared to other traditional health plans. The plan will also offer zero-dollar copays for primary care and urgent care visits, around-the-clock access to telehealth visits, and care coordination from the member’s primary care provider.

UnitedHealthcare will work to improve the customer experience with a personalized concierge approach. The payer’s Doctors Plan of Arizona will include a customer service team that has access to patient data from the provider and the health plan, allowing for more streamlined coordination, the press release stated.

The FEHBlog’s love affair with the ACO concept has not abated.

Health Payer Intelligence also discusses nutritional benefits.

Payers face a variety of challenges in expanding nutritional benefits, particularly due to the lack of ability to measure outcomes, but there are ways to navigate this uncertainty, according to a report from McKinsey & Company (McKinsey).

Among American adults who have at least one chronic condition, 60 percent also have poor nutrition, the report noted. This social determinant of health tends to occur hand-in-hand with some of the most expensive conditions in the US such as hypertension, obesity, and diabetes.

Check out the McKinsey report and the article for nutritional benefit tips.

Finally the Internal Revenue Service today released its draft Fringe Benefits Tax Guide for 2022 which may come in handy for 2022 budgeting purposes.

Weekend Update

David Ermer–Congress, COVID-19, Federal employment benefits, OPM–
Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors

The House and the Senate will be holding Committee business and floor votes this week. Yesterday when writing up Cybersecurity Saturday, the FEHBlog could not find any fresh news on the National Defense Authorization Act (“”NDAA”) vote. The NDAA often includes federal procurement law changes and this year may include cyberbreach and cyber-ransom payment notice requirements.

The Wall Street Journal reports today that

Congress is expected to focus this week on the defense policy bill known as the National Defense Authorization Act, or NDAA, which was held up in the Senate last week over provisions regarding Russia and China. Instead of the Senate passing its own bill, a compromise bill—negotiated by leadership in the House and Senate—is expected to come to the House for a vote as early as this week.

The Journal further reports that Congressional leadership is working on the debt ceiling issue which may come to a head mid-month and hoping to bring the Build Back Better multi-trillion dollar budget reconciliation bill to a vote before Christmas.

The House of Representatives’ Postal Reform bill (H.R. 3076) would create a new Postal Service Service Health Benefits Program within the FEHB Program. The PSHBP would be tightly integrated with Medicare with respect to annuitant coverage. For that reason, the bill initially was referred to the House Oversight and Reform, Energy and Commerce, and Ways and Means Committees.

A friend of the FEHBlog called to his attention the fact that last Friday December 3, the Energy and Commerce and Ways and Means Committee were granted an extension for further consideration of the bill ending not later than Jan. 21, 2022. Of course, the Oversight and Reform Committee approved a substitute bill for House floor voting on May 13.

The ongoing Federal Employee Benefits Open Season ends on a week from tomorrow December 13, a few day following the end of Medicare Open Enrollment period which ends this week on December 7.

From the Delta variant front —

  • Today’s Washington Post has an interesting article on early analyses of the Omicron variant. The Post notes that

The omicron variant is likely to have picked up genetic material from another virus that causes the common cold in humans, according to a new preliminary study, prompting one of its authors to suggest omicron could have greater transmissibility but lower virulence than other variants of the coronavirus.FAQ: What to know about the omicron variant of the coronavirus

Researchers from Nference, a Cambridge, Mass.-based firm that analyzes biomedical information, sequenced omicron and found a snippet of genetic code that is also present in a virus that can bring about a cold. They say this particular mutation could have occurred in a host simultaneously infected by SARS-CoV-2, also known as the novel coronavirus, and the HCoV-229E coronavirus, which can cause the common cold. The shared genetic code with HCoV-229E has not been detected in other novel coronavirus variants, the scientists said.

The study is in preprint and has not been peer-reviewed.

  • National Public Radio offers conservative yet sensible guidance filled with expert opinions on how to navigate the holiday season without contracting COVID. For example,

The good news is, you don’t have to hibernate like it’s 2020. Experts note we’re in a much different place than we were last winter, with COVID-19 vaccines and boosters now widely available. There’s good hope that the current vaccines offer protectionagainst severe disease with omicron. 

That said, if this pandemic has taught us anything, it’s that when you don’t know what you’re dealing with, “we should invoke the precautionary principle,” says Dr. Abraar Karan, an infectious disease physician at Stanford University. 

In other words, don’t panic, but do be thoughtful about what risks you want to take.

In the FEHBlog’s opinion, that’s sound approach to living one’s life.

Holiday Weekend Update

David Ermer–ACA, COVID treatment, COVID-19, Federal employment benefits, U.S. Healthcare–
Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors

Congress returns from the holiday weekend tomorrow for Committee business and floor voting. The Wall Street Journal reports that

Democrats will sort through a heavy pile of to-do items when they return to Washington, including ironing out disagreements over their Build Back Better bill, keeping the government funded and boosting the debt limit before the U.S. runs out of money to pay its obligations.

The party’s $2 trillion education, healthcare and climate package, which passed the House before the Thanksgiving recess, now heads to the 50-50 Senate, where Senate Majority Leader Chuck Schumer (D., N.Y.) is hoping to approve the legislation before Christmas.

Senate Democrats need to reach unanimous agreement on the policy proposals and work through expected procedural challenges, both of which could mean changes to the package. * * *

Republicans blocked an attempt to vote on a bipartisan slate of 20 amendments to the National Defense Authorization Act, a $777.9 billion annual defense-policy bill, before leaving for Thanksgiving break. Democrats set up a procedural vote Monday at a 60-vote threshold on a substitute bill that has GOP amendments. If 60 senators agree to move forward, final passage could happen soon.

Meanwhile, funding for current government programs runs out after Friday, Dec. 3, giving lawmakers just days to pass legislation preventing a government shutdown. Some Democrats have pushed for a very short-term extension of government funding, possibly through Dec. 17, while Republicans are seeking an extension that lasts into 2022.

Some Republicans have signaled that they would accept holding funding for existing government programs flat for the fiscal year, which would preserve funding levels negotiated under the Trump administration. Democrats want to increase funding levels.

Prof. Katie Keith, writing in the Health Affairs blog, provides an overview of the healthcare provisions found in the version of the Democrat’s $2 trillion social and climate oriented budget reconciliation bill, a/k/a the Build Back Better bill which is now pending before the Senate as noted by the Wall Street Journal above. Two of the bill’s provisions would impact group health plans, presumably including FEHB plans:

“Beginning with the 2023 plan year, group health plans and insurers offering individual or group health insurance coverage would be required to cover certain insulin products on a pre-deductible basis and with limited cost sharing. Cost sharing would be capped at $35 or 25 percent of the negotiated price, whichever is lower, for a 30-day supply of insulin. Any associated out-of-pocket costs would be counted towards a consumer’s annual deductible and out-of-pocket maximum. CBO estimates that these new requirements will cost, on average, $2 billion annually. * * * The legislation would define both “insulin” and “selected insulin products” and makes clear that plans and insurers could charge higher cost sharing for products that do not meet these definitions. Higher cost sharing could also apply if a consumer receives the selected insulin products from an out-of-network provider.”

The Wall Street Journal adds that “[The Senate Majority Leader] Mr. Schumer said at a press conference in New York last weekend that the insulin cap could face procedural problems.”

The other Build Back Better bill’s provision affecting group health plans would require insurers and prescription benefit managers to semi-annually report to employers and other plan sponsors on prescription drug spending in their health plans.

The report would reflect information on dispensed drugs, utilization, costs, out-of-pocket spending, drug manufacturer copay assistance, and compensation paid to brokers and other consultants, among many other data elements laid out in the law. The law would impose civil monetary penalties for violating these requirements, and insurers and PBMs could not enter into contracts with gag clauses that prevent these disclosures.

Group health plans, insurers, and PBMs could restrict public access to cost data but would have to disclose reported information to federal officials. Federal agencies would also be required to develop separate, more limited reporting requirements. This requirement would go into effect for plan years that begin on or after January 1, 2023.

This reporting requirement seems to duplicate Section 204 of the No Surprises Act. Speaking of unnecessary complexity, health plan expert Robert Moffitt reminds us in the Hill that Congress has not yet bothered to repeal the dormant MultiState Plan Program provisions in the Affordable Care Act.

As explained in this KFF article, the Build Back Better bill also would allow the federal government authority to negotiate certain drug prices for the Medicare program, and moreover Section 8926 of the Build Back Better bill (HR 5376) would require FEHB plans to participate in this “fair price negotiation program.”

From the Delta variant front, we learned on Friday that the Delta variant has a new competition named the Omicron variant. The Wall Street Journal explains that

The WHO designated the strain a “variant of concern,” formally alerting health authorities around the world to the extra risks it appears to carry. To qualify as a variant of concern, a new virus strain has to be proved to be more contagious, lead to more serious illness or decrease the effectiveness of public-health measures, Covid-19 tests, treatments or vaccines.

Other variants of concern include the Delta variant, which is now dominant world-wide, and the Alpha variant, which drove a deadly wave of infections across Europe and the U.S. last winter and spring.

STAT News adds that

“Right now there are many studies that are underway,” Maria Van Kerkhove, the World Health Organization’s technical lead on Covid-19, said Friday. “There is a lot of work that is ongoing in South Africa and in other countries to better characterize the variant itself, in terms of transmissibility, in terms of severity, and any impact on our countermeasures, like the use of diagnostics, therapeutics, or vaccines. So far, there is little information, but those studies are underway, so we need researchers to have the time to carry them out.”

She added: “It will take days to weeks for some of these studies to be undertaken.” * * *

For now, perhaps the most pressing questions about Omicron are: Is it more transmissible than even the Delta variant, and if so, how much? And to what extent can it evade immune protection generated by earlier infections or vaccines?

On the transmissibility question, experts will watch closely to see how Omicron continues to play out in South Africa and elsewhere. * * *

With new variants, vaccines can lose a step at blocking infections — particularly if the antibodies they elicit aren’t able to recognize the virus as well — but still largely maintain their ability to guard against severe disease and death because of the broader immune response, including T cells. This has happened already to varying degrees with other variants, to the greatest extent with the Beta variant and even to some extent with Delta. It’s also possible that if there’s a greater degree of immune escape, a higher percentage of breakthrough cases will lead to serious outcomes. That wouldn’t point to complete vaccine failure — but it would point to reduction in vaccine effectiveness.

In other news —

The obesity rate among emerging adults — who researchers defined as individuals aged 18 to 25 years — increased more than 26 percentage points over a 42-year span, National Health and Nutrition Examination Survey data show. * * * *

“Emerging adulthood may be a key period for preventing and treating obesity given that habits formed during this period often persist through the remainder of the life course,” Ellison-Barnes and colleagues wrote. “There is an urgent need for research on risk factors contributing to obesity during this developmental stage to inform the design of interventions as well as policies aimed at prevention.”

  • The Federal Employee Benefits Open Season ends two weeks from tomorrow, December 13, 2021.
  • Precision Vaccinations reminds us that an FDA advisory committee will meet on Tuesday November 30 to “discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.” The New York Times adds that

In briefing documents posted to the F.D.A.’s website on Friday, agency reviewers did not take a position on whether the drug should be authorized, though they found that the clinical trial data did not show any major safety concerns and that the drug was effective in preventing severe disease. * * *

Merck’s initial estimate that the drug reduced hospitalization and death by 50 percent came from an early look at results from 775 study participants. The updated figure announced on Friday came from more than 1,400. In the final analysis, the participants who received molnupiravir had a 6.8 percent risk of being hospitalized, and one patient died. Those who received a placebo had a 9.7 percent risk of being hospitalized, and nine died.

Dr. David Boulware, an infectious disease researcher at the University of Minnesota, said he expected the drug would still receive emergency authorization. If the expert committee endorses it and the F.D.A. heeds the recommendation, the treatment could be authorized in the United States as soon as next week.

“The reduction in hospitalization is a little bit less, but there is still a big mortality benefit if you start early,” he said.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth–
OPM Headquarters a/k/a the Theodore Roosevelt Building

The FEHBlog discovered OPM’s Agency Financial Report for the 2021 fiscal year, dated November 2020, on its website tonight. The most interesting discussion of the FEHB begins at page 125, the start of OPM’s response to the Inspector General’s top management challenges paper.

From the Delta variant vaccine front, Politico reports tonight that

The Food and Drug Administration on Friday is expected to authorize Moderna’s Covid-19 booster shot for all adults — a move that would come in tandem with the clearance of Pfizer-BioNtech’s booster for widespread use, two people with knowledge of the matter told POLITICO.

The decision comes just days after Moderna officially asked the FDA to green-light its booster for Americans 18 and older, and reflects the administration’s growing unease over the recent rise in Covid-19 cases across the nation.

The FDA had previously planned to authorize Pfizer’s booster shot this week, enabling the government to roll out shots to millions more people ahead of the Thanksgiving holiday.

But after Moderna filed a similar request on Wednesday, officials began debating whether to speed that authorization along as well, the people with knowledge of the matter said.

The FDA declined to comment.

From the Open Season front, Govexec discusses how to get the biggest bang for your buck in dental benefits if you are a federal or postal employee / annuitant.

From the telehealth front, Fierce Healthcare informs us that

In a report from Quest Diagnostics released Monday, 67% of the over 500 primary care physicians surveyed said they fear they missed signs of drug abuse in their patients during the pandemic.

And nearly all of them were prescribing those often-misused drugs—a whopping 97% reported prescribing opioids within 6 months of taking the survey.

Their concerns extend beyond the pandemic into telemedicine use today. Only 50% of physicians said they were confident they could recognize signs of drug misuse during telehealth visits, a far cry from the 91% that said the same of in-person patient interactions.

From the Rx coverage front, the Wall Street Journal reports that

CVS Health Corp. said Thursday it will close 900 stores over the next three years, nearly 10% of its U.S. locations, while adding more health services at remaining locations.

The largest U.S. pharmacy chain said it would close 300 stores a year while adding primary-care offices at certain sites as well as converting more stores into so-called health hubs with offerings such as diagnostic testing, mental-health services and hearing exams.

“The company has been evaluating changes in population, consumer buying patterns and future health needs to ensure it has the right kinds of stores in the right locations for consumers and for the business,” CVS said in a statement.

A CVS spokesman said the company doesn’t yet have a list of which stores are closing, a process that will begin early next year. 

From the strategy front, Federal News Network tells us that

The Biden administration on Thursday laid out the vision for its President’s Management Agenda, detailing three broad goals and four values that will drive a multi-year, multi-faceted effort throughout the government.

The initial vision is a roadmap that explains how the administration will build capacity within government agencies to make good on the president’s broader agenda, Jason Miller, deputy director for management at the Office of Management and Budget, said.

“The how matters. This president has been clear from day one that how we do things shapes what we can do,” Miller told reporters Wednesday evening.

To that end, the Biden administration said values of equity, dignity, accountability and results would drive its PMA priorities. Each priority has multiple underlying strategies.

Those priorities are:

Strengthening and empowering the federal workforce

Delivering excellent, equitable and secure federal services and customer experiences

Managing the business of government to “build back better”

“This simple, yet powerful three-part approach builds on lessons learned across administrations, while also repairing damage done over time to the federal government, by strengthening its capacity to deliver results,” Miller said.

The administration wanted to keep the PMA simple, and it explicitly wanted to avoid setting “dozens and dozens of new initiatives,” Miller added.

Meritalk adds

The Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) are set to release their four-year strategic plan later this month, according to OPM Director Kiran Ahuja, who previewed what the Federal government can expect to see in that plan.

During an FCW event today, Ahuja said the four-year strategic plan is currently “in OMB’s hands and will be released fairly soon.” Ahuja also said the plan will focus on rebuilding the Federal workforce.

“We have an opportunity to remake it, both in the early career talent that we need to bring in, as well as the importance of professional development opportunities,” Ahuja said.

She went on to say the plan will also focus on the Federal workforce becoming “the model employer,” through both telework and remote work flexibilities, as well as “a whole range of efforts,” including providing support to the Federal workforce and leaning in to “a hybrid work environment and being an example there.”

It seems like yesterday that OPM released its last four year plan in 2018.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID treatment, COVID-19, Federal employment benefits, OPM, Rx coverage, Telehealth–
Photo by Patrick Fore on Unsplash

From Capitol Hill, we learn that “U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) today introduced their highly anticipated, bipartisan Cures 2.0 legislation that some leading health care organizations are calling a potential “game changer” in how the U.S. conducts biomedical research going forward.” Here’s a link\ to a Fierce Healthcare article on the bill.

From the Food and Drug Administration front —

  • The Wall Street Journal reports that “Pfizer said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year.  Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease.” Moreover, “Pfizer Inc. is licensing its experimental Covid-19 antiviral to a global health organization in an effort to make the pill more readily available to people in low- and middle-income countries. Under the licensing agreement, the United Nations-backed Medicines Patent Pool will work with other drugmakers to manufacture the pill for use in 95 countries, including in sub-Saharan Africa, Pfizer and the nonprofit said Tuesday.”
  • The agency announced that authorizing “marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain. “Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”

From the Delta variant vaccine mandate front, Reason informs us that

The ping-pong ball has been drawn, and the U.S. Court of Appeals for the Sixth Circuit is the winner. All of the various state, industry, and union challenges to the Occupational Safety and Health Administration’s Emergency Temporary Standard (ETS) mandating large employers to require vaccination or regular testing and masking of employees will be consolidated into a single proceeding in the Sixth Circuit.

Given that challenges had been filed in all twelve regional circuits, and there are over three-dozen parties, this will be one bear of a case. Red states and employer groups initially filed in the more conservative circuits, including the Fifth Circuit which issued a stay on Friday, arguing that OSHA’s action was unlawful. Blue states and progressive groups responded by filing challenges in more liberal circuits, alleging that OSHA’s ETS is too lax. Each side was trying to increase the chances that the case would be consolidated on favorable turf by increasing the number of favorable circuits in the lottery draw.

Today the Labor Department referred the case to the Joint Panel on Multidistrict Litigation which conducted the lottery. The Sixth Circuit’s case presenting the legality of the OSHA ETS is Kentucky v. OSHA, No 21-4031. Bloomberg adds that “Although the Fifth Circuit temporarily halted the rule before the case was transferred, the Sixth Circuit will have the authority to modify or lift that order.” The case ultimately is expected to be resolved at the Supreme Court.

From the Centers for Disease Control front

  • The CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) has created a website full of “the links to access select information from NCCDPHP on health equity and racial/ethnic disparities.”
  • The CDC also has made available a pre-diabetes risk test for consumer use along with suggestions on how to deal with this condition.

From the federal employee benefits front, Federal News Network informs us

Some same-sex spouses of deceased federal employees and retirees will have another shot at earning survivor benefits from the federal government, the Office of Personnel Management announced this week.

A new notice, scheduled for publication in the Federal Register Wednesday, describes how widows or widowers who meet a specific set of criteria can apply for federal survivor benefits that they were previously ineligible for or, in some cases, denied.

OPM also has created an online “support center” for federal retirees. Check it out.

From the prescription drug pricing front, Healthcare Dive tells us that

Price hikes taken last year by AbbVie on its anti-inflammatory drug Humira increased U.S. healthcare spending by $1.4 billion, an amount unsupported by evidence showing any new health benefits, the Institute for Clinical and Economic Review said in a new report.

Humira, which treats rheumatoid arthritis and other diseases, was one of nine high-cost drugs singled out by ICER for large price increases without corresponding data proving greater effectiveness or new clinical uses.

Humira’s net price rose 9.6% in 2020, the watchdog group said in its report. The increase in net price, which reflects what insurers pay after rebates, actually exceeded AbbVie’s hike to the drug’s list price, a reversal of what usually happens during negotiations with drugmakers.

STAT news adds that

The findings, which appear amid ongoing national turmoil over the cost of prescription drugs, mark the third time that ICER has attempted to identify price hikes on big-selling drugs for which no new clinical evidence was offered. The exercise has underscored a debate over the value of medicines and the extent to which price hikes occur beyond medical inflation, even after rebates are counted.

At the same time, however, ICER also noted that overall net prices for prescription drugs in the U.S. market declined in the past several years, and even wholesale price increases have not exceeded the broader inflation rate. This helped restrain health insurance premiums, which benefited patients, although not necessarily in relation to specific medications.

Finally an intriguing telehealth tidbit from mHealth Intelligence

The number of outpatient visits after hospital discharges remained stable during the COVID-19 pandemic but telehealth use for these visits increased, suggesting that telehealth was a substitute for in-person care rather than an addition, a study published in JAMA Health Forum revealed.

Tuesday’s Tidbits

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–

From the Open Season advice front, here are recent articles from FedSmith and Govexec .

From Capitol Hill, FedWeek reports that last Wednesday Nov. 3

The Senate Homeland Security and Governmental Affairs Committee has approved:

HR-2662, to give agency IGs authority to subpoena former federal employees; require an administration to provide a “substantive rationale, including detailed and case-specific reasons” prior to removing an IG; limit the use of administrative leave for IGs, including during the 30 days following the removal announcement; require acting IGs to be selected from among senior-level employees within the watchdog community; and require regular training to IG employees on their whistleblower rights.

The House already has passed the HR 2662. The Senate Committee amended the House bill before voting to sending the “favorable” substitute bill to the Senate floor for a vote.

From the Delta variant front Medscape informs us that

Pfizer and its European partner BioNTech have asked the US Food and Drug Administration (FDA) to expand emergency authorization of its COVID vaccine to allow everybody 18 and older to get a booster dose.

If it goes through, the broader use of Pfizer boosters would be a step toward President Joe Biden’s goal of boosters for all adults. He announced the goal last August but backed off to let the regulatory process by the FDA and the Centers for Disease Control and Prevention (CDC) play out.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to a company news release.

This would be Pfizer’s second bite at the FDA apple for this approach to its booster.

Govexec informs us from the Delta variant vaccine mandate front that

VA Secretary Denis McDonough spoke at the National Press Club in Washington, D.C. on Tuesday afternoon, which came after the October 8 deadline for health care employees to get vaccinated but before the November 22 deadline for the rest of the federal workforce. 

“We’re still getting all of our data together,” he said. As of this morning, about 91% of the health care professionals at VA “have uploaded their data,” which could be proof of vaccination or requests for one of the exemptions. This is up from about 70% about two and a half weeks ago. 

“We’re not going to question the legitimacy of anyone’s individual declaration of a religious exception,” McDonough said. However, “we may find ourselves in a situation where, for example, in an oncology department or in a spinal cord injury facility or in an intensive care unit…or community living center[s], we may have so many people who have claimed a religious exemption that we can’t safely provide care to our veterans in those vulnerable situations, in which case we reserve the right to deny religious exemptions.” 

Fedweek cautions that “Both supporters and opponents of the Coronavirus vaccine mandate expect it to increase turnover among federal employees, although it is hard to say how large that increase will be and how much of it will be involuntary versus voluntary.”

From the No Surprises Act (NSA) front, the FEHBlog noticed that the Centers for Medicare and Medicaid Services has created a public NSA website. Posted on the site is an October 25, 2021, CMS letter announcing required federal government website and contact information to be included in the consumer notice about the NSA and other NSA related documents.

Website: https://www.cms.gov/nosurprises/consumers. Note, consumer and provider functionality for complaints inquiry and triage will not be operational until January 2022.

Phone number for information and complaints: 1-800-985-3059.

We ask regulated entities not to include the above phone number in any plan documents for any plan or policy years that begin before January 1, 2022.

In other healthcare news

Per Fierce Healthcare, here are the 10 most cost-efficient hospitals in the U.S., according to the Lown Institute: 

  1. Pinnacle Hospital (Crown Point, Indiana)
  2. Saint Mary’s Regional Medical Center (Reno, Nevada)
  3. Mercy Medical Center Dubuque (Dubuque, Iowa)
  4. Encino Hospital Medical Center (Encino, California)
  5. Park Ridge Health (Hendersonville, North Carolina)
  6. Oroville Hospital (Oroville, California)
  7. Saint Michael’s Medical Center (Newark, New Jersey)
  8. UnityPoint Health – Meriter (Madison, Wisconsin)
  9. East Liverpool City Hospital (East Liverpool, Ohio)
  10. Maple Grove Hospital (Maple Grove, Minnesota)

“Overall, if all hospitals performed as well as the most cost-efficient hospitals, Medicare would save $8 billion each year.”

Healthcare Dive informs us that

Nonprofit health giant Kaiser Permanente’s operating margin continued to shrink in the third quarter as expenses grew faster than revenue, spurred by labor unrest and surging COVID-19 patients, the Oakland, California-based integrated health system said.

Kaiser reported $38 million in operating income in the quarter, on $23.2 billion in revenue. That’s a 0.2% operating margin — exceedingly low compared to a margin of 2.1% same time last year. 

The 39-hospital system’s expenses in the third quarter grew 7.5% year over year to $23.1 billion, while revenue only increased 5.5%. Kaiser said the expense growth was due to higher costs from COVID-19 patients and workforce requirements, as — like other hospital operators — Kaiser has had to pay more for travel nurses and other contract labor to meet rising patient levels during the pandemic.

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the FEHB Open Season front, consultant Tammy Flanagan reports on the new trend of FEHB plans to offer Medicare Part B premium reimbursement contingent upon joining a related Medicare Advantage plan.

From the Delta variant front, the American Hospital Association informs us that

The Food and Drug Administration Friday authorized another over-the-counter COVID-19 diagnostic test for emergency use. The iHealth COVID-19 Antigen Rapid Test delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022, FDA said.

STAT News offers an interesting snapshot of the now diminishing Delta variant surge.

Chart comparing hospitalizations by vaccine status

The chart truly speaks for itself.

In the maternal health field, the Health and Human Services Department announced that “200+ hospitals that are participating in the HHS Perinatal Improvement Collaborative, a contract with Premier, Inc. This new network is focused on improving maternal and infant health outcomes by reducing disparities. Comprised of hospitals from all 50 states, the collaborative is the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.” A list of the participating hospitals may be found at the bottom of the HHS press release.

From the Rx coverage front, STAT News tells us

Nearly a dozen of the highest-rated hospitals in the U.S. charged commercial health insurers and cash-paying patients significantly more than what Medicare has recently paid for 10 infused medicines on which the government spends the most money, according to a new analysis.

Median prices exceeded the Medicare Part B payment limit by a low of 169% at Rush University Medical Center in Chicago, while the Mayo Clinic Hospital in Phoenix exceeded the payment limit by 344%. Among cash-paying customers, the prices ranged from 149% of the Medicare payment limit at Rush to 306% at Brigham and Women’s Hospital and Massachusetts General Hospital, both based in Boston.

The Part B infused medicines for which Medicare Part B spent the most money were Rituxan, Orencia, Enbrel, Prolia, Eylea, Opdivdo, Keytruda, Avastin, Lucentis, Neulasta, and Remicade, but the list did not include biosimilar versions. These medications are variously used to treat conditions including cancer, rheumatoid arthritis, and macular degeneration.

Medicare Part B already sets Part B drug prices which tend to be injectables administered at facilities. Democrat legislators in Congress also want Medicare Part D to fix prices for certain drugs distributed by pharmacies. Government price fixing has never worked successfully in the American economy in the FEHBlog’s understanding.

Also from the healthcare pricing front, Health Payer Intelligence informs

Outcomes-based contracts continue to be popular for certain therapies as healthcare costs mount, an Avalere study found.

Avalere’s findings draw on survey responses from 51 insurers and pharmacy benefit managers. Altogether, the survey participants cover approximately 59 million members. The survey was fielded from September 27 to October 8, 2021 and it is Avalere’s fifth annual survey on the subject.

“OBCs typically include an agreement between health plans and drug or device manufacturers that ties product reimbursement to specific clinical, quality, or utilization outcomes,” Avalere researchers explained.

Let’s go.

Weekend update

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

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

Roll Call tells us that

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Midweek Update

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

From the Delta variant front, MedPage Today reports on a recent study supporting the FDA/CDC conclusion that all immunocompromised folks over the vaccine eligibility age should receive a COVID vaccine booster.

Kaiser Health News surveys the U.S. market for convenience COVID testing.

FedWeek reminds us that

Just days remaining before the deadline for federal employees to receive a Coronavirus vaccination under the mandate and disciplinary actions could soon follow, although indications are that such actions will not necessarily be immediate nor fast-moving.

Taking into account the two-week waiting period afterward that required to be considered fully vaccinated by the deadline of November 22, employees would need to receive either the single Johnson and Johnson vaccine or the second dose of the two-dose Pfizer or Moderna vaccines no later than next Monday (November 8).

In the third quarter financial results department, we find

Healthcare Dive reporting that

  • “CVS Health’s payer business Aetna reported higher-than-expected costs for COVID-19 treatment and testing in the third quarter as the highly infectious delta variant spread and deferred care returned.
  • “However, a greater volume of vaccinations and COVID-19 tests (along with pharmacy services growth) fueled a sharp jump in profit, leading the Woonsocket, Rhode Island-based company to boost its full-year outlook.
  • “CVS beat Wall Street expectations on both earnings and revenue for the quarter, with a topline of $73.8 billion, up 10% year over year, contributing to net income of $1.6 billion, up 30% year over year.”

Fierce Healthcare reporting

  • “Humana expects its individual Medicare Advantage membership to grow by 8% in 2022 as part of a more conservative financial outlook. 
  • “The insurer gave hints to its outlook for next year as part of its earnings report released Wednesday that saw Humana post a $1.5 billion profit in the third quarter but cut its financial outlook for 2021 due in part to higher-than-expected COVID-19 costs.
  • “The insurer’s third-quarter earnings report, though, released Wednesday, pointed to strong growth in its Medicare Advantage offerings and lower-than-expected healthcare use among MA beneficiaries.
  • “Humana also generated $20.7 billion in revenue for the third quarter, which fell short of Wall Street expectations.”

BioSpace reporting

  • “Pfizer reported its third-quarter 2021 financials, citing $24.1 billion in quarterly revenues, a stunning 130% operational growth. If you exclude the sales of its COVID-19 vaccine with BioNTech, revenues grew 7% operationally to $11.1 billion. The company raised its full-year guidance to range from $81 to $82 billion.
  • “’While we are proud of our third quarter financial performance, we are even more proud of what these financial results represent in terms of the positive impact we are having on human lives around the world,’ said Albert Bourla, Pfizer’s chairman and chief executive officer. ‘For example, more than 75% of the revenues we have recorded up through third-quarter 2021 for Comirnaty have come from supplying countries outside the U.S., and we remain on track to achieve our goal of delivering at least two billion doses to low- and middle-income countries by the end of 2022 — at least one billion to be delivered this year and one billion near year, with the possibility to increase those deliveries if more are placed by these countries for 2022.’”

The FEHBlog also ran across this STAT News article discussing Moderna’s unexpected approach to breaking into the CRISPR gene editing market.

Moderna, flush with cash thanks to its blockbuster Covid-19 vaccine, made waves back in August when CEO Stéphane Bancel declared the company’s next frontier to be genome editing, the nascent science of rewriting DNA to treat disease. Three months later, Moderna has picked a partner for its foray into CRISPR, and it’s not one of the field’s multibillion-dollar players.

Metagenomi, a three-year-old startup out of the University of California, Berkeley, signed a deal to help Moderna discover and develop genome-editing therapies, the companies said Tuesday. The agreement includes an up-front cash payment to Metagenomi, bonuses for meeting development milestones, and royalties on any products that arise from the collaboration. Moderna will also make an equity investment in the company. Neither side disclosed financial details.

The idea behind Metagenomi is mining nature’s infinite complexity in search of new ways to edit DNA. That means scouring the natural world for soils, sediments, and microbiomes, putting the samples through intensive genome sequencing, and sifting the results for better genome-editing mousetraps. It’s a process called metagenomics, according to company co-founder and CEO Brian Thomas, and it has already produced results.

Many genome-editing efforts rely on pairing CRISPR with an enzyme called Cas9, which functions as the molecular pair of scissors that makes cuts to DNA. By studying nature, Metagenomi has discovered newer and potentially more potent enzymes that might broaden CRISPR’s medicinal promise.

Cool.

From the Open Season front, Health Payer Intelligence directed the FEHBlog to this fascinating ValuePenguin study of consumer attitudes toward health benefit open seasons. For example, eagerness to consider changing plans steadily decreases with age which may explain the relatively low turnover rate that typically occurs in FEHB Open Seasons.

Who is planning to change their health insurance?
From the ValuePenguin study

EHR Intelligence reports that the federal government is putting its weight behind the adoption of The HL7 Gender Harmony Logical Model in U.S. electronic health record systems:

  • “Gender identity (GI): an individual’s personal sense of being a man, woman, boy, girl, or something else.
  • “Sex for clinical use: a summary sex classification element based on clinical observations like organ survey, hormone levels, and/or chromosomal analysis.
  • “Recorded sex or gender (RSG): sex values or gender values that are specified administrative documents such as identity cards or insurance cards.
  • “Name to use (NtU): the name that the patient wishes to use in healthcare interactions.
  • “Pronouns: the English language third-person personal pronoun determined by the patient for use in healthcare interactions, clinical notes, and written instructions to caregivers.”

Assuming the model works with EHR system, it would be a logical next step to extended this model to health plan claim and customer service systems.