Thursday Miscellany

Federal employment benefits

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.

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

Happy Halloween!

The U.S. House of Representatives and the Senate will be engaged in floor voting and Committee business this coming week. The Hill brings us up to date on Democrat Congressional leadership negotiations over the social spending budget reconciliation bill. Bloomberg adds

While the $500 billion infrastructure bill has already passed the Senate, the larger economic package will have to return there for another vote. Some Democratic Senators are signaling they may seek changes to what is passed in the House, possibly adding further delays. 

From the Open Season front, the ACA marketplace open season resumes tomorrow. The Federal Employee Benefits Open Season begins a week from tomorrow. OPM’s 2022 online FEHB Plan Comparison Tool is now available.

From the Delta variant front, the Wall Street Journal tells us that

The Food and Drug Administration is delaying a decision on Moderna Inc.’s application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said.

The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday.

The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports. 

Moderna also said it would delay asking the FDA to authorize use of a lower dose of its shot in even younger children, ages 6 to 11, while the agency continues to review its request to clear the shots in adolescents.

From the CMS front, Medicare offers coverage for those under age 65 who are afflicted with End Stage Renal Disease (“ESRD”). On Friday, CMS finalized its ESRD prospective payment rule for calendar year 2022. In its announcement CMS explained that

Through the ESRD Prospective Payment System (PPS) annual rulemaking, CMS is making changes to the ESRD Quality Incentive Program (QIP) and the ESRD Treatment Choices (ETC) Model, and updating ESRD PPS payment rates. The changes to the ETC Model policies aim to encourage dialysis facilities and health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model one of the agency’s first CMS Innovation Center models to directly address health equity.

“Today’s final rule is a decisive step to ensure people with Medicare with chronic kidney disease have easy access to quality care and convenient treatment options,” said CMS Administrator Chiquita Brooks-LaSure. “Enabling dialysis providers to offer more dialysis treatment options for Medicare patients will catalyze better health outcomes, greater autonomy and better quality of life for all patients with kidney disease.”

That makes sense to the FEHBlog.

From the healthcare network front, the Yale School of Public Health (YSPH”) informs use that “a new survey analysis from a researcher at the YSPH suggests that privately insured adults are significantly more likely to rate their mental health provider network as inadequate compared to their medical provider network.” With due respect to Yale, this finding is hardly surprising given the fact that relative few mental health therapists join a health plan network because they don’t need patient referrals. That’s why it so important for the hub and spoke telehealth services to offer ongoing mental health care over their networks.

From the OPM front, Federal News Network reports that

As agencies contemplate and continue to plan for the future of work, the Office of Personnel Management is trying to let agencies know they have some help — and some new resources — to guide them through the unknown.

The agency is preparing to release more guidance on telework and remote work “very soon,” OPM Director Kiran Ahuja said in an interview with Federal News Network.

It’s all part of an effort to help agencies establish themselves as model employers that can meet the moment — and part of OPM’s own plans to reestablish itself as a human capital resource for the rest of government. They’re priorities Ahuja set in the early days since becoming OPM director, and they’ll continue well into 2022 and beyond, she said.

The guide will offer, in some detail, advice for agencies on making the shift to remote and hybrid work.

“We want to support what’s involved in our lives around flexibilities and child care but also knowing that we can be really productive,” Ahuja said. “We have this guide coming out. We’re also pulling together trainings and information around how to manage in a hybrid work environment and how to operate well in a work environment, as well as a new website focused on future of work.”

Thursday Miscellany

David Ermer–ACA, Congress, Federal employment benefits, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The FEHBlog was particularly struck by an in-depth article in the Wall Street Journal about a lower income man in his sixties who emptied his retirement plan to pay for hospital bills for his wife who was stricken with cervical cancer. How does this happen in the Affordable Care Act world. The FEHBlog is not blaming the law. Rather the FEHBlog believes that people from the hospital, the insurance company, etc. dropped the ball when they had a chance to help this now broken man. The woman’s adult daughter, presumably the man’s step daughter, created a Go Fund Me page. Isn’t that a red flag?

The Journal also reports from Capitol Hill that the President’s Hail Mary pass to score a legislative victory with the billion dollar infrastructure bill fell short.

The Mercer consulting company is offering a report on furious state legislative efforts this year to regulate prescription benefit managers in the wake of last December’s U.S. Supreme Court decision on ERISA preemption and such laws, which was favorable to the state legislatures. The laws in the FEHBlog’s view while well intentioned mainly raise administrative costs.

Govexec in an Open Season related article discusses the No Surprises Act provisions that take effect on January 1, 2022, for enrollees with primary FEHB coverage in the United States. The FEHBlog does expect that this law will achieve its objective of getting patients out of the middle of billing disputes between out of network providers and health plans in emergency care, ancillary care at hospitals and surgicenters and air ambulances. The article notes that “The new rules don’t apply to people with coverage through programs such as Medicare, Medicaid, the Indian Health Service, the Veterans Affairs health system or TRICARE, because these programs already have other protections against high medical bills.”

From the third quarter financial reporting front / telehealth front, Healthcare Dive tells us that

  • “Teladoc plans to take on financial risk for its offerings in the future, including its virtual-first primary service, in a bid to expand revenue per member, the CEO of the New York-based virtual care giant said Wednesday.
  • The telehealth vendor made that program, called Primary360, available nationwide earlier this month, and it will be available through CVS Health-owned payer Aetna and Centene’s marketplace plans in Michigan, Mississippi, South Caroline and Texas early next year. And Teladoc is also beginning to talk with health systems about using Primary360 as a white-labeled digital front door to care for their populations, CFO Mala Murphy told investors on a call.
  • In its third quarter financial results also released Wednesday, Teladoc beat Wall Street expectations on earnings and revenue, with a topline of $522 million, up 81% year over year due to strength in multi-product sales and behavioral health, management said. The 19-year-old vendor saw 3.9 million visits in the quarter, representing 37% year-over-year growth.”

From the Affordable Care Act front, Kaiser Health News reports that

The federal government’s effort to penalize hospitals for excessive patient readmissions is ending its first decade with Medicare cutting payments to nearly half the nation’s hospitals.

In its 10th annual round of penalties, Medicare is reducing its payments to 2,499 hospitals, or 47% of all facilities. The average penalty is a 0.64% reduction in payment for each Medicare patient stay from the start of this month through September 2022. The fines can be heavy, averaging $217,000 for a hospital in 2018, according to Congress’ Medicare Payment Advisory Commission, or MedPAC. Medicare estimates the penalties over the next fiscal year will save the government $521 million. Thirty-nine hospitals received the maximum 3% reduction, and 547 hospitals had so few returning patients that they escaped any penalty.

Here is a link to KHN’s online tool to look up hospitals to find out whether the hospital was assessed a 2022 penalty.

From the reports and studies department —

  • The Kaiser Family Foundation released its COVID vaccine monitor for October 2021.
  • The American Medical Association discusses a study concluding that, notwithstanding a tremendous amount of consolidation between health systems and providers, private practices continue to play a “big part” in primary care, which the FEHBlog finds reassuring.
  • Health Payer Intelligence informs us

From the beginning, it was clear that seniors’ lives would be turned upside down as a result of the coronavirus pandemic, but Humana’s survey of over 1,000 seniors reveal the severe toll the pandemic has taken on senior mental health and social health.

“Health plans should take particular notice, since it is critical to understand all the evolving needs of seniors – health, social and behavioral – as the industry increasingly moves toward models of ‘whole health’ senior care and coverage,” said Kathy Driscoll, senior vice president and chief nursing officer at Humana.

The survey reached 1,003 Americans ages 64 and older, nationwide. Kelton Global fielded the survey from September 14 to September 21, 2021.

One of the most striking results of the survey was that, despite the rise in mental and behavioral healthcare needs and the expanded access to telemental and telebehavioral services that the pandemic brought, only three percent of seniors had accessed mental healthcare.

The results run parallel with a separate Anthem study which found that mental healthcare claims dropped even though mental healthcare demand rose during the coronavirus pandemic.

However, the low rate of telehealth utilization for these specific demands does not mean that seniors were as hesitant to use telehealth for other health-related purposes. Seniors were far more likely to use telehealth in order to access wellness programming (84 percent) and a third of seniors used telehealth to connect with their providers.

Monday Roundup

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

From the Delta variant front —

  • The Wall Street Journal reports “Federal officials said they would do more to get over-the-counter Covid-19 tests to consumers, after some manufacturers have struggled to meet demand after the Delta surge drove increased demand from individuals, schools and businesses.” Better late, etc. Here’s a link to the HHS press release.
  • The Journal also reports that “Moderna Inc.’s MRNA 7.05% Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. * * * An FDA decision on the Pfizer vaccine in children [ages 5 to 11] could come soon, following an advisory panel meeting scheduled for Tuesday. 
  • The Centers for Disease Control informs us in a newly issued study on Delta variant cases

What is already known about this topic?

The SARS-CoV-2 B.1.617.2 (Delta) variant is highly transmissible; however, whether it causes more severe disease in adults has been uncertain.

What is added by this report?

Analysis of COVID-NET data from 14 states found no significant increases in the proportion of hospitalized COVID-19 patients with severe outcomes during the Delta period. The proportion of hospitalized unvaccinated COVID-19 patients aged 18–49 years significantly increased during the Delta period.

What are the implications for public health practice?

Lower vaccination coverage in adults aged 18–49 years likely contributed to the increase in hospitalized patients during the Delta period. COVID-19 vaccination is critical for all eligible adults, including adults aged <50 years who have relatively low vaccination rates compared with older adults.

From the COVID vaccine mandate front

  • The Equal Employment Opportunity Commission released new FAQ guidance on “Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates.”
  • The Senate today confirmed the President’s nominee, Douglas Parker as Assistant Secretary of Labor in charge of the Occupational Health and Safety Administration by a 50 to 41 vote. Govexec adds that “Douglas Parker, most recently chief of California’s Division of Occupational Safety and Health, [will lead] the workplace safety agency that has about 1,800 employees. Parker previously served as deputy assistant secretary for policy in the Labor Department’s Mine Safety and Health Administration under the Obama administration and was part of the Biden transition team on worker health and safety issues.” OSHA is responsible for the pending vaccination screening program rule applicable to private sector employers with 100 or more employees.

On a related note, Federal News Network tell us that

The federal workforce used just slightly more than half of the funds Congress set aside earlier this year for a special emergency leave program.

The American Rescue Plan Act, which Congress passed into law in March, created a $570 million emergency paid leave fund that allowed federal employees to take time off for a variety of pandemic-related reasons.

Employees were each eligible for 600 hours, or 15 weeks, of paid leave to quarantine, recover from a personal infection or care for a family member sick with COVID-19. They could also use the emergency paid leave to recover from adverse symptoms after receiving the COVID-19 vaccine.

The Office of Personnel Management was responsible for administering the fund on behalf of the executive branch and U.S. Postal Service. OPM formally launched the program at the end of April.

Eligible federal employees had until Sept. 30 to request emergency paid leave, per the sunset date in the American Rescue Plan, or earlier if the funds were exhausted before that date.

From the cost and frequency of healthcare front —

  • The American Hospital Association issued a report about the cost of healthcare over the past decade / the first decade of the Affordable Care Act, particularly the cost of hospital care versus health insurance premiums.
  • Fierce Healthcare reports that “Common elective surgeries are starting to recover volume lost during COVID-19 lockdown measures, according to a new study by Epic Health Research Network. No common elective surgery is back at pre-pandemic volumes, though some are nearing it, the study found.”

From the Rx coverage front —

  • Healthcare Dive informs us that “National employer group the Purchaser Business Group on Health is starting a new company to develop healthcare products for large employers, frustrated by unmet need and rising costs. The venture, called Emsana Health, launched on Monday with its first business unit, a pharmacy benefit manager called EmsanaRx. Emsana will develop products designed with and for PBGH member organizations, which include Walmart, Costco, Microsoft, Intel and Tesla, among others, but products will be available to outside companies as well, a PBGH spokesperson confirmed.”
  • Fierce Healthcare adds that “The Mark Cuban Cost Plus Drug Company PBC also launched its own PBM this week, The Wall Street Journal reported. Cuban’s company aims to sell generic drugs at a transparent, fixed rate, and to achieve this united manufacturing, distribution and pharmacy services under one roof, according to the article. Cuban, a billionaire investor, told the WSJ he agreed to back the venture after receiving a pitch via email from its now-CEO, Alex Oshmyansky M.D., Ph.D. The PBM will begin to bid for clients next year and aims to be fully up and running by 2023, Oshmyansky told WSJ. “The supply chain for distributing pharmaceuticals to patients is so cumbersome and broken,” he told the outlet. “We decided the only way to get our drugs to the people who need them is to build a parallel supply chain where we have control of all the intermediary players and ensure the same level of transparency at every level.”
  • Health Payer Intelligence reports that “Prescription digital therapeutics (PDTs) coverage remains nascent, as the adoption rate is only at 40 percent among the minority of payers who have familiarity with PDTs, according to a survey that Avalere conducted for Pear Therapeutics. A post from the Institute for Patient Access defined PDTs most succinctly. ‘Prescription digital therapeutics are software programs that physicians prescribe as a form of treatment,’ the post explained. ‘The software captures patients’ information about symptoms or progress that can then be shared or remotely accessed by their providers. The technology has been found to help patients adhere to their treatment plans.’”

From the FEHB Open Season front, OPM today released a spreadsheet identifying those FEHB plans for which the 2022 employee contribution for self and one coverage will be more than the 2022 employee contribution for self and family coverage. In all cases the total premium for self and family coverage is more the total premium for self plus one coverage. The employee contributions become upside down due to the vagaries of the government contribution formula. It was a Congressional mistake to add the self plus one tier to FEHB given the relatively small family size in FEHB plans.

Weekend update

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

The U.S. House of Representatives and the Senate again will be engaged in Committee business and floor voting this week. According to the Hill, the House leadership is aiming to vote on the massive social spending / budget reconciliation bill next Sunday October 31. “We have 90 percent of the bill agreed to and written. We just have some of the last decisions to be made,” [Speaker Nancy] Pelosi said on CNN’s “State of the Union.”

From the Delta variant front —

  • Bloomberg reports that “Top U.S. health officials signaled confidence that children ages 5 to 11 will begin getting Covid-19 vaccines by early November. The Pfizer vaccines will likely be given at pediatricians’ offices rather than at pharmacies or large sites.”
  • Medpage Today informs us that “The CDC has begun to provide weekly data on COVID-19 cases and deaths by vaccination status, illustrating the stark differences between those who have received the shots and those who haven’t — and even revealing some differences [among] vaccines.”
  • Precision Vaccinations discusses the likely evolution of the fully vaccinated against COVID definition in our country.

From the healthcare business front —

  • Healthcare Dive tells us that Lyft named Buck Poropatich as its new head of healthcare, according to an email statement sent Friday. Poropatich joined the company in 2019 and previously served as the director of healthcare strategy. * * * The ride-hailing giant wants to continue capitalizing on non-emergency medical transportation, and Poropatich has been instrumental in that expansion, along with finding new use cases in the sector, Lyft said.”
  • Fierce Healthcare reports that “Consumer genetic testing company 23andMe plans to buy Lemonaid Health, a virtual care and pharmacy provider, to integrate its personalized genetics service more deeply into primary care. 23andMe, which went public in June via a merger with Richard Branson’s blank check company, will pay $400 million for Lemonaid Health, with 25% of the purchase price in cash and the rest in shares of 23andMe. The acquisition is expected to close by the end of 2021. The acquisition adds Lemonaid Health’s telemedicine and prescription drug delivery services to 23andMe’s consumer business.”
  • Health Dive also lets us know that “Oak Street Health, a value-based primary care network for seniors, has acquired virtual specialty provider RubiconMD for $130 million, integrating specialty care into its existing care model. New-York based RubiconMD offers a platform providing access to medical specialists across 230 specialties, including cardiology, nephrology and pulmonology. The deal, announced Thursday, comes as major U.S. clinical networks increasingly build out their suite of services to jockey for employer and payer clients in the increasingly competitive space.”
  • Mobihealth News reports that “Virtual addiction treatment Workit Health raised $118 million in Series C funding led by Insight Partners. Other investors participating in the round include CVS Health Ventures, FirstMark Capital, BCBS Venture Fund, and 3L Capital. ‘Workit is at the forefront of massive acceleration in telemedicine adoption, which is key to solving the overdose crisis that was exacerbated by COVID-19. The risk factors associated with substance use have dramatically increased,’ Lisa McLaughlin, Workit Health’s co-CEO, said in a statement.  ‘This latest funding round helps us grow our relationship-based, telehealth-first, value-based approach into new regions that are in desperate need of simple and trusted solutions like Workit.’

Last Friday, the FEHBlog spoke with a group of federal annuitants at a client’s membership conference. Suffice it to say the FEHBlog thinks it is important for plans to promote OPM’s FEHB Fast Facts on FEHB and Medicare on their websites.

Last Thursday, the FEHBlog post about an OPM edit to Section 3 of the 2022 FEHB Significant Events Changes benefit administration letter. The FEHBlog noticed that he unintentionally cut off the copy of the edited section of the BAL. For that reason, here is a link to a complete copy of the revised BAL. Lo siento readers.