Tuesday’s Tidbits

No Surprises Act

Tuesday’s Tidbits

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog nearly fell off his office chair when he noticed a Govexec headline this afternoon reading “The House finally plans to vote on Postal reform [HR 3706] next week. The long sought after bill could make it to the President’s desk by the end of the month.” This Postal reform saga has been going on for over a decade.

The Postal reform act (HR 3706) would relieve the Postal Service of the obligation to prefund the cost of FEHB coverage in retirement for its employees. The bill also would create a Postal Service Health Benefits Program (“PSHBP”) within the FEHB Program. The PSHBP would tightly integrate Medicare annuitant coverage with primary Medicare A, B, and D. Medicare Part A (hospital care) is premium free while Medicare Part B (medical care) and Part D (prescription drugs) charge premiums.

OPM encourages Medicare age annuitants to pick up Part B but it prohibits FEHB carriers from using integrated Part D arrangements knowsn as EGWPs even though every other U.S. employer that provides drug coverage to its retirees uses a Part D EGWP or takes the retiree drug subsidy. What’s more Congress in the Medicare Modernization Act of 2003 expressly authorized FEHB plans to use Medicare EGWPs. Go figure.

In any event, all enrollee costs are included in FEHB risk pools which is an important feature of the FEHB Plan and its constituent PSHBP. The cost of Medicare Prime annuitants in the PSHBP will be much lower than those in legacy FEHB, and Medicare Prime annuitants are a signficant cadre of enrollment, PSHBP premiums will be noticeably lower than legacy FEHB premiums.

The CBO has projected that 3/5s of the Medicare integration savings for the PSHBP will come from the Part D EGWPs. The FEHBlog looks forward to the day later this decade when OPM finally permits legacy FEHB carriers to offer Medicare Part D EGWPs.

From the Covid vaccine front —

  • Pfizer and BioNTech have a submitted an emergency use authorization request for an mRNA Covid vaccine for little children aged six months through four years. The FDA and CDC are likely to approve the application by the end of February according to Medscape.

Novavax announced Monday that it has formally submitted a request to the FDA for emergency use authorization of its COVID-19 vaccine for ages 18 and older.

The request includes results from two large clinical trials that showed an overall efficacy of about 90% and a “reassuring safety profile,” the company said.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, the president and CEO of Novavax, said in the statement.

From the COVID treatment front, the Wall Street Journal reports that providers are having difficulty obtaining the drugs need to treat Omicron because the treatments typically are available under emergency use authorizations and each State makes its own decison on how to distribute EUA treatments. On the brighter side,

Antiviral-pill manufacturers are ramping up production to meet demand. Supplies of Pfizer Inc.’s Paxlovid are expected to increase in the spring, according to Pfizer and state officials. Merck & Co., which manufactures molnupiravir with partner Ridgeback Biotherapeutics LP, said it has delivered two million courses to the U.S. and will deliver the rest of the 3.1 million courses under its contract by the end of this week.

From the healthcare cost front, Healthcare Dive reports that

The omicron variant walloped hospitals in the final month of 2021, driving up both adjusted patient volumes and expenses as the number of COVID-19 cases surged to new highs for the pandemic, according to Kaufman Hall’s latest flash report.

Patient days rose nearly 4% in December compared to November, while emergency department visits jumped more than 7% as patients came in with COVID-19 symptoms. Omicron’s rapid spread drove a 98% jump in COVID-19 hospitalizations over the course of the month, Kaufman Hall said, citing Centers for Disease Control and Prevention data.

The second full year of the pandemic was marked by an increase in severely ill patients requiring longer hospital stays compared to the first year, the report also found.

From the No Surprises Act front, Healthcare Dive examines healthcare provider association legal challenges to the federal regulators’ use as the qualifying payment amount in NSA arbitrations. The FEHBlog has described those cases now pending in federal district courts in Texas and Washington DC as exercises in futility. For example,

Since the qualifying payment amount represents the median in-network rate, it by definition means that half of providers are below the QPA and half are above, according to Chris Garmon, a professor at University of Missouri – Kansas City, who has studied surprise billing. Not all providers are set to see payments decline and some may even see them increase if the QPA is used, he said.

The good professor overlooks the fact that in 2021 out of network doctors caring for patient at in-network facilities were reimbursed at out-of-network rates typically two or perhaps three times the Medicare RBRVS reimbursement. For that reason, the FEHBlog expects that in most cases the QPA will be noticeably higher than pre-NSA reimbursements. Time will tell, but the regulators’ approach is reasonable, and patient advocacy groups have been supporting the regulators in these cases.

From the mental health parity front, Health Payer Intelligence compares provider and payer reactions to the government’s recent report to Congress on payer compliance with complex federal health parity act rules.

From the healthcare business front, Fierce Healthcare tells us that

GuideWell, the parent company of Blue Cross and Blue Shield of Florida, has closed its acquisition of Triple-S Management Corporation, a Puerto Rico-based health services company.

The deal was first announced in September.

GuideWell acquired all shares of Triple-S at $36 per share in cash, according to an announcement from the company. Triple-S will now operate under its existing branding as a wholly owned subsidiary of GuideWell.

From the FDA front, check out this FDA news roundup.

From Capitol Hill, Govexec reports on OMB acting director’s Shalonda Young’s confirmation hearings to be the Presidentially nominated OMB director. Ms. Young appears on her way to confirmation.

Thursday Miscellany

David Ermer–ACA, COVID treatment, COVID-19 testing, No Surprises Act, Telehealth, U.S. Healthcare–

From the Omicron front, MedPage Today reports that

While a large meta-analysis of studies on convalescent plasma use early in the pandemic turned up no survival advantage for the typical patient hospitalized for COVID-19, researchers have mined the dataset to predict who may benefit.

Eva Petkova, PhD, of NYU Grossman School of Medicine in New York City, and colleagues devised a simple and freely available tool called the Convalescent Plasma Benefit Index Calculator that allows doctors to input certain patient criteria to determine if their patient may benefit from convalescent plasma (age, oxygen need, blood type, and history of either diabetes, heart disease, or pulmonary disease).

Note: The FEHBlog has been intrigued by convalescent plasma treatments since reading John Barry’s The Great Influenza in early 2020. The FEHBlog currently is reading Gregory Zuckerman’s A Shot to Save the World which is equally fascinating.

The Wall Street Journal’s personal technology reporter Joanna Stern reviews the latest in at home Covid testing.

It’s Friday and you’ve got a scratchy throat and a mild headache. Time to play “Cold? Covid? Or Just Crazy?”—the only game more popular than Wordle. 

Or you could open up your medicine cabinet and power-on a small white box. Swab your nose with a Lego-like stick, then slide that into the illuminated gadget. About 20 minutes later, your iPhone buzzes: “COVID-19 Positive.”

The future? Nope, it’s already here. For the past few weeks, I’ve been testing the Cue Health Monitoring system and the Detect Covid-19 Test, two systems from health-tech startups that put lab-like molecular testing right on your bathroom counter. No driving to the testing center. No waiting in line. No anticipating the results for days.

* * *

Molecular tests’ biggest benefit: They can spot Covid earlier—anywhere from 6 hours to two days, depending on the variant and other factors. Dr. Mina, who previously served as an adviser to Detect, said they’re good “if you’re really symptomatic and you definitely want to know, ‘Is this Covid?’ ”

However, if you’re using a test to determine whether you can safely go out into the world—back to work, back to school—the cheaper rapid antigen test would be best. “The problem with a molecular test is that it’s so sensitive that it may detect dead fragments and not live virus,” said Peter Chin-Hong, an infectious-disease specialist at the University of California, San Francisco.

Ms. Stern also explains in the article that the molecular test cost singificantly more than the rapid antigen tests.

Bloomberg released its latest Covid resilence ranking for 53 countries around the world.

The Covid Resilience Ranking is a monthly snapshot of where the virus is being handled the most effectively with the least social and economic upheaval. Drawing on 12 data indicators spanning virus containment, quality of healthcare, vaccination coverage, overall mortality and progress toward restarting travel, it captures how the world’s biggest 53 economies are responding to the same once-in-a-generation threat.

The United Arab Emirates and Saudi Arabia rank one and two. The U.S. ranks 23 down 11 ranks since last month. The FEHBlog recalls that last Spring before Delta hit us, the U.S. ranked number 1 in this index. How the mighty have fallen.

From the No Suprises front

  • The Affordable Care Act regulators today released 37 pages of helpful guidance about the No Suprises Act’s new federal independent dispute resolution process.
  • Healthcare Leaders tells us that “The U.S. Department of Health and Human Services (HHS), Office of Inspector General, plans to conduct a nationwide audit to determine whether hospitals that received Provider Relief Funding complied with the billing requirements for COVID patients. This requirement stipulates that those hospitals must not pursue out-of-pocket payments from COVID patients whose bill exceeded “what the patients otherwise would have been required to pay” for in-network care. This audit will be based on the various federal Covid relief acts, not the No Surprises Act

From the Affordable Care Act front, the FEHBlog diligently has been on the lookout for the HHS announcement of 2023 out-of pocket cost-sharing limits for in-network care. The 2023 ACA Notice of Benefit and Payment Parameters released December 28, 2021, advised that the announcement would be released in January. The regulators must have meant that future announcements would be released beginning in January 2024 because the FEHBlog discovered yesterday that the 2023 announcement was released on December 28, 2021.

The announcement reads in pertinent part that

Under 45 CFR 156.130(a)(2), for the 2023 calendar year, cost-sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2023. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage for 2023 of 1.4408219719, and the 2014 maximum annual limitation on cost-sharing of $6,350 for self-only coverage, which was published by the Internal Revenue Service on May 2, 2013, the 2023 maximum annual limitation on cost-sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 4.6 percent increase above the 2022 parameters of $8,700 for self-only coverage and $17,400 for other than self-only coverage.

And there you are, dear readers.

From the healthcare business front, Healthcare Dive informs us that

— HCA [Healthcare] announced plans to build five new hospitals in Texas in response to the growing population there, executives said Thursday during a call with investors.   

— The hospitals will serve as primary- and secondary-type hospitals with basic inpatient and outpatient services that will refer patients needing higher-acuity services to HCA’s other campuses. These new hospitals will be smaller facilities with about 50 to 75 beds, executives said Thursday.

— The new hospitals will be located in the areas of Dallas Fort-Worth, Houston, San Antonio, and Austin.

Fierce Healthcare adds

Nashville, Tenn.-based HCA Healthcare saw its revenue and profit grow year over year in the fourth quarter of 2021. 

The 182-hospital system reported revenue of $15.1 billion in the fourth quarter of last year, up from $14.3 billion in the same period of 2020. The for-profit hospital operator said same-facility admissions, emergency room visits and outpatient surgeries increased year over year, while inpatient surgeries declined. 

After factoring in expenses and nonoperating items, HCA’s net income in the fourth quarter of 2021 totaled $1.8 billion, up from $1.4 billion in the same quarter a year earlier. 

From the telehealth front, Fierce Healthcare reports that

As telehealth companies increasingly turn to chronic care management, Cigna’s MDLive is launching its own remote patient monitoring program.

The digital-first program will allow patients with chronic conditions to track biometrics like blood pressure and glucose levels, recording daily health information that they can review with MDLive providers during their visits.

* * *

Cigna expanded access to MDLive’s network of virtual primary care providers to all members of the insurer’s employer plans beginning January 2022.

The new patient health monitoring program will be available to all health plan clients of MDLive.

Monday Roundup

David Ermer–COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare, No Surprises Act, Telehealth–
Photo by Sven Read on Unsplash

From the COVID vaccination front, the CDC’s COVID Data Tracker indicates that over two-thirds of the U.S. population over five years old in fully vaccinated.

The American Medical Association’s column about “What Doctors Wish Patient Knew” explains

A Kaiser Family Foundation poll found that one-third of parents say they planned to get their children vaccinated right away. Yet other parents are taking a wait-and-see approach to COVID-19 vaccination for kids. But with the Delta-Omicron variant tag team, widespread vaccination is an essential tool for preventing COVID-19 deaths, hospitalizations and illnesses.

To help parents move from that “wait-and-see” mentality and calm their fears, two physicians shared what to know about COVID-19 vaccine safety for children.

Check it out.

From the Omicron treatment front, the Food and Drug Administration announced today that the agency has

revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) [which are made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc.] – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. 

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today. * * *

Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should consult the NIH panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.

From the COVID vaccination mandate front, Federal News Network reports that

Last week’s court injunction that blocked the Biden Administration’s vaccine requirement for federal employees will put a temporary halt to disciplinary actions in federal agencies. But it won’t be of much help to feds who’d already been disciplined or fired for refusing the vaccine prior to last Friday.

That’s according to new guidance the administration’s Safer Federal Workforce Task Force issued Monday. The four-page document answers some basic questions on exactly how agencies should deal with the federal employee mandate now that a Texas judge has temporarily barred its implementation and enforcement.

Among the nuances: workers who’ve been suspended for failing to comply need to have their suspensions lifted, and new proposals to fire or suspend employees need to be “held in abeyance” for as long as the injunction is in place, the task force said. But agencies don’t need to reverse other disciplinary procedures that have already taken full effect.

From the free OTC tests front, Govexec.com asks

What group is especially vulnerable to the ravages of COVID-19 even if fully vaccinated and boosted? Seniors. And who will have an especially tough time getting free at-home COVID tests under the Biden administration’s plan? Yes, seniors.

As of Jan. 15, private insurers will cover the cost of eight at-home rapid COVID tests each month for their members — for as long as the public health emergency lasts.

Finding the tests will be hard enough, but Medicare beneficiaries face an even bigger hurdle: The administration’s new rule doesn’t apply to them.

It turns out that the laws governing traditional Medicare don’t provide for coverage of self-administered diagnostic tests, which is precisely what the rapid antigen tests are and why they are an important tool for containing the pandemic. * * *

The Medicare program does cover rapid antigen or PCR testing done by a lab without charging beneficiaries, but there’s a hitch: It’s limited to one test per year unless someone has a doctor’s order.

Because the article describes orignal Medicare as exempt, one must assume that Medicare Advantage plans also are offering reimbursement for OTC COVID tests. The original Medicare exemption is a weak cup of tea because no commercial health plans covered OTC testing before the mandate.

From the No Suprises Act front, The American Hospital Association informs us that

The Centers for Medicare & Medicaid Services will host a conference call for health care providers Jan. 26 at 1 p.m. ET on the balance billing provisions of the No Surprises Act. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. P

Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov, noting “Questions for 1/26 Open Door Forum” in the subject line. A replay will be available after the call through Jan. 28 by dialing 800-308-7855 and entering the passcode.

The CMS slides are helpful.

From the telehealth front, Fierce Healthcare tells us that

Integrating virtual care can save the healthcare system significant amounts of money, as well as avoid unnecessary visits to the emergency department or urgent care center, according to a new study from Cigna.

The study, conducted alongside its telehealth arm MDLive, found that patients who saw virtual providers also saw 19% fewer visits to the ER or urgent care. In addition, virtual urgent care visits reduced duplication of care by 16% compared to other virtual primary care providers or specialists.

Cigna notes that these reductions in unneeded visits are especially crucial as hospitals face down the current COVID-19 surge, caused by the highly infectious omicron variant. 

Thursday Miscellany

David Ermer–COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, No Surprises Act, Rx coverage–

The American Hospital Association released its latest COVID Snapshot today.

Bloomberg adds that

The U.S. hospital-staffing shortage exacerbated by the latest Covid-19 wave is showing signs of easing, but many West Coast and rural states are still seeing the worst of it.

Over the past seven days, about 16.7% of U.S. hospitals have reported critical staffing shortages, down from a recent peak of 18.7% on Jan. 9, according to data from the Department of Health and Human Services. Fewer facilities are reporting shortages in populous New York, Florida and Illinois. 

The numbers are still concerning to state leaders, but are at least returning to the levels seen in October and November, before the omicron spike.

From the Covid treatment front —

The niftiest COVID news that the FEHBlog ran across today is this GoodRx website that provides “Live Updates on How to Find Paxlovid and Molnupiravir,” respectively the Pfizer and Merck Covid pills. Bookmark it.

From the COVID testing front —

SHRM brings us up to date on the unnecessarily rushed rollout of the federal government mandate that health plans cover over the counter Covid tests. Most plans did not have time to create in-network coverage because health plans do not cover OTC drugstor items except when mandated to do so.

From the COVID vaccine mandate front, FedWeek reports that

The impact of the Coronavirus vaccine mandate in terms of turnover in the federal workforce—either voluntary or not—remains largely anecdotal, although the largest agency, DoD has said there have been “no terminations yet.”

“We are still finalizing the guidance to the civilian force in that regard,” a Pentagon spokesman said late last week in a comment that seems to characterize the state of affairs in general.

From the Rx coverage front —

  • Drug Store News reports that

CVS Health is embarking on a collaboration with Uber Health, Uber’s healthcare arm, to provide critical transportation support at no cost to people who need it most when seeking access to medical care, work or educational programs.

The relationship is part of Health Zones, CVS Health’s new initiative that provides concentrated local investments designed to reduce health disparities and advance health equity in high-risk communities across the country. Health Zones is an integrated approach to addressing six key social determinants of health: housing, education, access to food, labor, transportation, and health care access. 

The Health Zones initiative is now active in five markets nationwide: Atlanta, Ga.; Columbus, Ohio; Fresno, Calif.; Hartford, Conn.; and Phoenix, Ariz. with plans to expand into more cities later this year. Working with trusted national and local partners, CVS Health is addressing community health care needs, ensuring at-risk communities have access to resources and opportunities that can help them thrive.

  • Fierce Healthcare tells us that

Mark Cuban Cost Plus Drug Company (MCCPDC) has launched its online pharmacy as part of an ongoing effort to provide consumers with low drug prices. 

The pharmacy claims to offer significant savings, with several prescription drugs reportedly at more than half the cost of the next most affordable option. For instance, leukemia treatment imatinib has a retail price of $9,657 a month, according to MCCPDC, compared to $120 with a common voucher. Its price through the new company, however, is just $47 per month.

The pharmacy’s initial inventory launch consists of 100 generic drugs. 

From the No Suprises Act front, Health Payer Intelligence discusses how the new law is likely to spur collaboration between providers and payers to improve the accuracy of provider directories. The FEHBlog has always thought the providers should post the a notice about the networks in which they participate at their offices and on their websites.

Monday Roundup

David Ermer–ACA, COVID-19, COVID-19 testing, COVID-19 vaccine, No Surprises Act, Rx coverage–
Photo by Sven Read on Unsplash

From the Omicron front, the Wall Street Journal reports that

The seven-day average of daily reported Covid-19 cases in the U.S. reached a pandemic record 403,385 on Sunday, according to a Wall Street Journal analysis of Johns Hopkins University data. The fresh peak arrived even as most states paused reporting during the New Year’s holiday weekend. Reporting delays will likely lead to spikes in reports of cases this week as states catch up. While Covid-19 tests remain in short supply in much of the U.S., Covid-19 testing was less robust last year, complicating comparisons between pandemic surges.

Hospitalizations for confirmed or suspected Covid-19 reached a seven-day average of 97,855 on Monday, according to data posted by the U.S. Department of Health & Human Services. That is up 41% in the past two weeks but below both the pandemic peak of 137,510 on Jan. 10, 2021, and the smaller peak of 102,967 on Sept. 4, 2021, during the Delta surge.

Bloomberg adds that

While omicron may be good at evading the attacks of antibodies, recent studies have also shown that it has far less success avoiding the second-line defenses of vaccines and prior infections: T-cells and B-cells.

T-cells are responsible for attacking a virus once it makes its way into the body’s cells if antibodies fail to prevent infection in the first place. In a recent study by Burgers and colleagues, scientists used white blood cells from Covid patients to show that about 70-80% of the T-cell response is preserved compared with previous strains of the virus. That means that for those who are either vaccinated or had a Covid infection in the past 6 months, it is likely their T-cells can recognize omicron and fight it off relatively quickly. 

This latest research will need to be followed up with further study. If it holds up to additional scrutiny, it just might explain why current infections appear to be more mild than in previous waves of the virus.

Yet, AP reports that

As the COVID-19 omicron variant surges across the United States, top federal health officials are looking to add a negative test along with its five-day isolation restrictions for asymptomatic Americans who catch the coronavirus, the White House’s top medical adviser said Sunday.

Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant “pushback” on its updated recommendations last week.

Adding to current mandatory testing is not going to push the COVID ball further toward endemic status particularly when people who actually may be infected soon will need a test to gain access to a COVID pill. It is time for the government to rethink its testing strategy. As a physician explained in a thought provoking Atlantic article

I will admit to being as self-interested as any other human. Despite recognizing the need for vaccine and test equity, I received three Pfizer shots as soon as I was eligible, and I’ve kept a stash of rapid-detection kits in my closet. But my own cognitive dissonance, and that of other privileged people, has become untenable in the face of Omicron’s case surge. Given the reality of our testing shortages, it’s time we started cutting back, where and when we can.

From the COVID vaccine front, AHIP tells us that

“Today the Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to expand the use of a single booster dose of the vaccine to include its use in individuals as young as 12 years of age.

“The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series. The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.

“The amended EUA additionally:

  • Decreases the time between the completion of primary vaccination of the Pfizer COVID-19 Vaccine and a booster dose to at least five months.
  • Allows for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

“Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.

“Children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but the FDA will continue to review information and communicate with the public if data emerges suggesting booster doses are needed for this pediatric population.”

From the Health and Human Services Department front —

  • Prof. Katie Keith has published in the Health Affairs Forefront the third installment of her review of the proposed 2023 Notice of Benefit and Payment Parameters. This one focuses on the Affordable Care Act’s risk adjustment provisions.
  • The Department issued today its own upbeat discussion of the recently implemented consumer billing protections provided by the No Surprises Act.
  • While the ACA risk adjustment provisions don’t apply the FEHB, the consumer billing protections do. Indeed the consumer billing protections wisely apply to both insured and uninsured folks. All consumers should become familiar with these protections.

From the prescription drug front, STAT News informs us that

As 2022 gets under way, pharmaceutical companies have so far raised wholesale prices by a median of 4.9% on more than 450 prescription medicines, an overall annual increase that is comparable to the price hikes seen over the past three years, according to a new analysis.

The numbers are preliminary, though, because still more price increases are expected to be disclosed by drug makers later this month, since not every company has reported their latest prices to industry databases. Nonetheless, the early indication is that many drug makers are keeping price hikes in check due to ongoing bad publicity that has sparked sustained political pressure.

Analyzing pharmaceutical price hikes has become a ritual each January as drug makers boost prices to meet financial goals. But as poll after poll finds more Americans are complaining about the cost of prescription medicines, these companies have gradually shied away from mid-year increases and also generally limited price hikes below double digits in hopes of avoiding still more negative headlines.

Drug Channels adds

Reality has again failed to cooperate with the politically motivated cries of “skyrocketing drug prices” or anecdotes about companies “jacking up prices” 

Brand-name drug prices continue to decline, while the prices of other healthcare products and services continue to rise. For 2021, brand-name drugs’ net prices dropped for the fourth consecutive year. Meanwhile, brand-name drug list prices grew more slowly than overall inflation. What’s more, we project that the gross-to-net bubble for patent-protected brand-name drugs will exceed $200 billion in 2021. See our updated analysis [that may be found in the linked article]. 

The factors that drive declining brand-name drug prices remain for 2022, suggesting that these trends will continue. 

Thursday Stats and More

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, No Surprises Act–

Based on the CDC’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s final weekly calendar for 2021 and it’s a stunner:

STAT News features a timely article captioned “Beyond Case Counts: What Omicron is teaching us.”

Brace yourself: Case counts are going to reach astounding heights. Already, reported infections have doubled in just a few weeks. The average daily number of infections is greater than 300,000. (It’s likely that our case counts will become increasingly less reliable as well, given both the shortcomings of our testing infrastructure and the growing use of at-home tests.)  

But, in large part because the immunological landscape today is far different than what it was two years ago, cases are less likely to result in severe disease than was the case at the start of the pandemic. 

Back then, a rise in cases inevitably led to an increase in hospitalizations and deaths. When vaccines went into wide use, those metrics started to become decoupled; cases could rise sharply but hospitalizations and deaths occurred at a lower level than before. In the current phase of the pandemic, the distance between those metrics is growing even greater. * * *

[A] key question relates to how long we’ll be in Omicron’s grasp. South Africa’s bellwether wave soared to extraordinary heights — then quickly began to ebb. Data from several European countries also suggest that Omicron waves may be short, sharp shocks compared to the waves that have preceded it. But too little is yet known to predict with any confidence whether the experience of a country with a relatively young population, such as South Africa, will hold true in a country with an older population, such as the United States. 

Here’s a link to the FEHBlog’s final weekly chart of new COVID deaths:

As cases have skyrocketed, deaths have ranged between 5,000 and 10,000 per week for over four months.

Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020, when the vaccinations became available to the public, and the 52nd week of 2021:

The number of administered COVID vaccines has dropped during the holidays. Currently, 72.8% of Americans aged 18 and older are fully vaccinated and 36.3% of that cadre are boostered. Nearly 50% of Americans aged 50 and older are boostered.

Also from the COVID vaccine front, the Hill reports that

The Food and Drug Administration (FDA) is expected to approve booster shots of Pfizer and BioNTech’s COVID-19 vaccine for 12- to 15-year-olds on Monday, people familiar with the agency’s plan told The New York Times.

In addition to that broadened policy, the FDA also intends to announce that both children and adults could seek their booster shot five months after their second dose, instead of the previously advised six months. Immunocompromised children ages 5 to 11 are also expected to be allowed boosters, according to the Times.

The Times reported that the vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) is set to meet next week to vote on approving the FDA’s policy changes, which CDC Director Rochelle Walensky is expected to endorse. 

From the No Surprises Act front, CMS has released a handy, comprehensive overview of the federal independent review process. Check it out.

From the Affordable Care Act front, Prof. Katie Keith writing in Health Affairs Forefront has released two of three articles on the ACA 2023 Notice of Benefit and Payment Parameters released earlier this week — link to Part 1 and link to Part 2. Part 1 includes a discussion of proposed changes to the medical loss ratio calculation and Part 2 discusses the standardized benefit requirements that the FEHB mentioned earlier this week.

From the health disparity front, the Agency for Healthcare Research and Quality issued its 2021 report on national healthcare qualities and disparities, the nineteen report in this series. Here’s a link to the report’s executive summary.

From the New Year’s Eve front, the New York Times made available this guidance:

“Many public health experts agree that you can celebrate with your favorite people as long as you’re taking precautions.
“To help you make a decision and gauge the level of risk, The Times has this quiz.”

Tuesday Tidbits

David Ermer–ACA, CDC, COVID treatment, COVID-19, No Surprises Act, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron front, the Wall Street Journal reports that

The Centers for Disease Control and Prevention added to research suggesting the Omicron variant can lead to reinfections that are often accompanied by mild Covid-19 symptoms, as new cases soared across the U.S.

States reported 512,553 cases on Monday—the most for a single day since the start of the pandemic—as states caught up after pausing for the Christmas holiday, according to a Wall Street Journal analysis of data from Johns Hopkins University. The tally lifted the seven-day average of reported cases to 237,061, 15,000 less than the pandemic high recorded about a year ago.

The report for Monday didn’t include North Carolina, South Carolina and Rhode Island, which remained on pause. That gap and more blackouts in reporting during the New Year weekend are expected to muddy the tracking of the full extent of the pandemic’s trajectory until January, when reporting catches up. 

Covid-19 testing was also less prevalent earlier in the pandemic, complicating case-rate comparisons from one surge to another. As with earlier variants, tracking Omicron’s spread in the U.S. has been a challenge for public-health officials. The CDC on Tuesday estimated that Omicron was responsible for 59% of new infections for the week through Dec. 25 and 23% for the week through Dec. 18. Last week, the CDC had estimated Omicron drove some 73% of infections in the week through Dec. 18. The CDC said Tuesday that the latest figures fell within the bounds of its statistical model and that the trend of Omicron’s increasing prevalence among U.S. cases is clear. 

Bloomberg adds

The omicron-fueled U.S. surge in Covid-19 cases appears to be triggering a lower rate of hospitalizations than earlier waves, more evidence that the highly transmissible variant leads to milder symptoms than other strains. 

The seven-day average of new cases hit 206,577 on Sunday, roughly 18% lower than the all-time high recorded on Jan. 11, according to data from the Centers for Disease Control and Prevention. Meanwhile, hospitalizations rose to a seven-day average of 8,964, only half their earlier peak recorded in January. * * *

Even when patients do end up in the hospital with omicron, they appear to spend less time there. However, the increasing numbers of breakthrough infections among vaccinated people may skew hospitalization data, said Jeffrey Morris, professor and director of the biostatistics division at the University of Pennsylvania’s Perelman School of Medicine.

“It appears there is less risk of hospitalized disease across the board, but we have to be a little bit careful about interpreting that,” he said in a phone interview. The rate of hospitalizations and deaths may appear artificially lower because breakthrough cases tend often turn out to be mild, Morris said.

From the Affordable Care Act front, the Department of Health and Human Services issued the first round of 2023 Benefit and Payment Parameter rules today. Here’s a link to the CMS fact sheet which describes big, disruptive proposed changes to the federal and state marketplaces. For example

CMS proposes to require issuers in the FFMs and State-based Marketplaces on the Federal Platform (SBM-FPs) to offer standardized plan options at every product network type, metal level, and throughout every service area that they offer non-standardized options in plan year (PY) 2023. For example, if an issuer offers a non-standardized gold plan in a particular service area, that issuer must also offer a standardized gold plan in that same service area. CMS is not proposing to require issuers to offer standardized plan options at product network types, metal levels, and throughout services areas in which they do not offer non-standardized options. CMS has designed two sets of standardized plan options at each of the bronze, expanded bronze, silver, silver cost-sharing reduction (CSR) variations, gold, and platinum metal levels of coverage, with each set being tailored to the unique cost-sharing laws in different sets of states. CMS also proposes to display these standardized options differentially on HealthCare.gov and to resume enforcement of the existing standardized plan option differential display requirements for web brokers and QHP issuers utilizing a Classic Direct Enrollment or Enhanced Direct Enrollment pathway.

The key aspect of these rules applicable to the FEHB Program is the disclosure of the 2023 limits on in-network cost sharing. The fact sheet explains that

CMS will issue the 2023 benefit year premium adjustment percentage, the maximum annual limitation on cost sharing, reduced maximum annual limitation on cost sharing, and the required contribution percentage (payment parameters) in guidance by January 2022, consistent with policy finalized in the 2022 Payment Notice (86 FR 24140). 

These rules also routine tweak the medical loss ratio rules under which FEHB community rated plans generally operate.

From the No Surprises Act front, the Internal Revenue Service released Rev. Proc. 2022-11. This Rev. Proc. explains that

For an item or service furnished during 2022, the group health plan or group or individual health insurance issuer must calculate the qualifying payment amount by increasing the median contracted rate (as determined in accordance with § 54.9816-6T(b), 29 CFR 2590.716-6(b), and 45 CFR 149.140(b))8 for the same or similar item or service under such plan or coverage, on January 31, 2019, by the combined percentage increase as published by the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) to reflect the percentage increase in the consumer price index for all urban consumers (U.S. city average) (CPI-U) over 2019, such percentage increase over 2020, and such percentage increase over 2021. * * *

This Rev. Proc. provides that combined (2019-2021) CPI-U adjustment for next year which of course begins on Saturday:

For items and services provided on or after January 1, 2022, and before January 1, 2023, the combined percentage increase to adjust the median contracted rate is 1.0648523983.10 Pursuant to this revenue procedure, group health plans and group and individual health insurance issuers may round any resulting qualifying payment amount to the nearest dollar.

Example. A group health plan sponsor calculates a median contracted rate for a service with service code X; the service is not an anesthesia service or air ambulance service. The median contracted rate for service code X is $12,480 as of January 31, 2019. For a service with service code X furnished during 2022, increasing the median contracted rate by the combined percentage increase of 1.0648523983 results in $13,289.36; rounding to the nearest dollar results in a qualifying payment amount of $13,289.

From the upcoming new year department —

  • Fedweek offers advice to federal employees on paycheck changes to expect / confirm in the first paycheck of 2022 which, “[d]epending on the payroll provider, employees typically receive a pay distribution late in the week following the end of a pay period [here January 15] or early in the week subsequent to that.”
  • STAT News again peers into its crystal ball and predicts / discusses three challenges facing hospitals next year: Staffing, federal assistance, and patient capacity. On that last challenge

The bright spot is that the health care system could have another tool in its arsenal to fight Covid-19 in 2022 — antivirals that could reduce hospitalizations even if people become infected. There are some logistical challenges around deploying the pills, as they have to be taken early in the course of the Covid-19 infection. If the United States can capitalize on their potential, the treatments have the potential to relieve the worst of the pressure that 2022 could bring to bear on weary hospitals.

Holiday Weekend Update

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

The FEHBlog trusts that his readers had a Merry Christmas.

Congress is on a break until next week when the second session of the 117th Congress kicks off.

On Saturday, January 1, 2022, the surprise billing protections of the federal No Surprises Act take effect.

From the Omicron front, Bloomberg’s Prognosis informs us that

The coronavirus that causes Covid-19 can spread within days from the airways to the heart, brain and almost every organ system in the body, where it may persist for months, a study found.

In what they describe as the most comprehensive analysis to date of the SARS-CoV-2 virus’s distribution and persistence in the body and brain, scientists at the U.S. National Institutes of Health said they found the pathogen is capable of replicating in human cells well beyond the respiratory tract.

The results, released online Saturday in a manuscript under review for publication in the journal Nature, point to delayed viral clearance as a potential contributor to the persistent symptoms wracking so-called long Covid sufferers. Understanding the mechanisms by which the virus persists, along with the body’s response to any viral reservoir, promises to help improve care for those afflicted, the authors said.

An opinion piece in STAT News discusses a trend in COVID weekly new death statistics in the U.S. that the FEHBlog noticed in last Thursday’s post:

Several colleagues and I [Duane Schulthess] at Vital Transformation began closely following the data on Covid-19 early in the pandemic.

Since that time, we’ve kept a keen eye on the relationship between cases and deaths, particularly during the recent waves, which have been influenced by improved treatments and vaccines, as well as by new variants. There are legitimate concerns about the trajectory of the newest variant, Omicron, and public health experts are paying close attention to the exponentially mounting cases, particularly in the United Kingdom, which in the past has functioned as a canary in the Covid-19 coal mine for the U.S.

While early reports from South Africa suggested that Omicron might cause less-severe Covid-19, the rapidly mounting case numbers and overall transmissibility have been alarming, particularly in the U.K. According to a Dec. 10 government technical briefing(see page 17), Omicron cases were expanding by 35% per day.

But there’s something else different this time around, at least in the U.K.: the statistical relationship between Covid-19 cases and deaths appears to have broken down with Omicron.

Looking at daily death rates in the U.K. from May 15 — essentially from the point at which the Delta wave began — to Sept. 15, there is a highly statistically significant relationship between daily new cases and deaths. In short, case rates accurately predict death rates. But beginning the analysis on Sept. 15, coinciding with flattening of the Delta curve and the onset of Omicron, shows no statistical relationship between Covid-19 case rates and deaths. * * *

It’s still, of course, early days. While it is possible that death rates due to Omicron may rise later, at the moment in the U.K., Covid-19 daily cases no longer meaningfully link to deaths. So, according to the math, Omicron cases rising no longer automatically means impending doom and gloom

In healthcare M&A news, Healthcare Dive tells us that

— Tenet and its subsidiary USPI completed a $1.1 billion acquisition of SurgCenter Development, giving the ambulatory surgery unit an ownership stake in 86 more surgery centers and related support services.

— Tenet said it’s willing to buy additional interests of up to $250 million from physician owners. This process is expected to continue over the coming months, Tenet said Wednesday.

— As part of the deal, USPI will have exclusivity on developing new centers — at minimum 50 — with SCD during a five-year period.

Fierce Healthcare peers into its crystal ball to let us know about

From the FDA new drug approval front, MedCity News reports that

The FDA has approved a new cholesterol-lowering drug from Novartis that addresses the same target as two commercialized medicines from Amgen and Regeneron, but with a different approach and a key dosing advantage—just two injections per year.

The drug, inclisiran, is part of a relatively new class of genetic medicines that work by stopping production of a problem protein. In the case of the Novartis drug, which will be marketed under the name Leqvio, the target is PCSK9, a liver protein that in high amounts, impedes the body’s ability to clear low-density lipoprotein cholesterol, the “bad” form of cholesterol. Leqvio is comprised of small-interfering RNA that harnesses a cellular mechanism called RNA interference to stop a gene from producing PCSK9.

The way that Leqvio and other RNAi drugs work is sometimes referred to as gene silencing. It’s a different approach than PCSK9 inhibitors, antibody drugs that bind to this protein to block it. The FDA approved two of these drugs, Amgen’s  Repatha and Regeneron’s Praluent, in 2015. They’re both given as subcutaneous injections every two weeks or monthly. However, their high price tags made them a tough sell to payers, and revenue fell short of initial expectations. In 2018, Amgen slashed Repatha’s price by nearly 60%, making the drug available at list price of $5,850 per year. Months later, Regeneron matched the pricing move for its PCSK9-blocking drug.

The benefits of competition do apply to prescription drug development.

Last week, the U.S. Census Bureau released its “Vintage 2021 national and state population estimates and components of change.” In sum,

Since April 1, 2020 (Census Day), the nation’s population increased from 331,449,281 to 331,893,745, a gain of 444,464, or 0.13%.

Between July 1, 2020, and July 1, 2021, the nation’s growth was due to natural increase (148,043), which is the number of excess births over deaths, and net international migration (244,622). This is the first time that net international migration (the difference between the number of people moving into the country and out of the country) has exceeded natural increase for a given year.

The voting-age resident population, adults age 18 and over, grew to 258.3 million, comprising 77.8% of the population in 2021.

The South, with a population of 127,225,329, was the most populous of the four regions (encompassing 38.3% of the total national population) and was the only region that had positive net domestic migration of 657,682 (the movement of people from one area to another within the United States) between 2020 and 2021. The Northeast region, the least populous of the four regions with a population of 57,159,838 in 2021, experienced a population decrease of -365,795 residents due to natural decrease (-31,052) and negative net domestic migration (-389,638).

The West saw a gain in population (35,868) despite losing residents via negative net domestic migration (-144,941). Growth in the West was due to natural increase (143,082) and positive net international migration (38,347).

Thursday Stats and More

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, No Surprises Act–

Happy Festivus, dear readers. Because the FEHBlog won’t be posting on Christmas Eve or Christmas Day, he has moved up the COVID Stats report to today’s post. Therefore, the FEHBlog also wishes you a Merry Christmas

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new COVID cases for 2021:

Bloomberg notes that

The omicron variant’s case rate has now exceeded the worst days of the first delta-fueled wave, and more cities and countries are imposing precautions. But there’s more research showing it to be less severe than previous mutations. That said, two doses and a booster of the vaccine most widely used around the world isn’t enough to fight off omicron. China’s Sinovac shot didn’t produce sufficient levels of neutralizing antibodies, research found. Another study however showed a third dose of AstraZeneca’s vaccine, like that of Moderna and Pfizer-BioNTech, significantly boosts protection against the variant. 

Here’s the FEHBlog’s weekly chart of new COVID deaths which has operated within the same range for the past three months:

Finally, here’s the FEHBlog’s weekly chart of new COVID vaccinations distributed and administered from the 51st week of 2020 through the 51st week of 2021:

The number of COVID vaccines, including boosters, topped 500,000,000 today according to the CDC. 71% of Americans aged 12 and older are fully vaccinated and over one third of Americans aged 18 and older are boostered.

David Leonhardt in his New York Times’ Morning column offers an array of convincing statistics showing the importance of being fully vaccinated and boostered against COVID.

STAT News reports that

The Food and Drug Administration on Thursday granted emergency authorization to Merck’s molnupiravir, an antiviral pill shown to reduce hospitalization and death in cases of Covid-19, but only in cases where other FDA-authorized Covid treatments are not accessible or clinically appropriate.

The approval comes a day after the FDA authorized an antiviral pill from Pfizer for much broader use in patients as young as 12. 

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

A Merck spokesperson said Merck is ready to ship hundreds of thousands of courses of treatment within days of authorization and 1 million courses over the next few weeks in the U.S. Ten million courses are ready to be packaged and distributed worldwide.

Bloomberg adds its perspective on the FDA’s EUAs of COVID pills yesterday and today.

The U.S. has cleared its first two Covid-19 treatment pills. Now comes the hard part: deciding who should get one. Merck’s molnupiravir was authorized Thursday by the Food and Drug Administration for use in some infected adults at high risk of severe illness. The U.S. will soon have 3 million courses of it available. Meanwhile, Pfizer’s Paxlovid, authorized earlier this week, showed stronger clinical trial data. But it will only be available in limited quantities at first, as Pfizer takes months to ramp up manufacturing. Regulators are signaling they prefer Pfizer’s pill, but concede Merck’s drug is better than nothing. Regardless, availability may depend on which state you live in. —David E. Rovella

In the linked article Bloomberg explains that

Just like Covid-19 testing sites and vaccines, Covid-19 treatment pills will be in short supply for months until production can increase.

The federal distribution to states will be based on population, and it will likely be up to doctors to prescribe Pfizer Inc.’s Paxlovid. The National Institutes of Health said it will release recommendations on how to allocate treatments.* * *

“Product will be limited at first and ramp up significantly in the coming months,” the department [of Health and Human Services] said. “An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December.”

The U.S. will have 265,000 Pfizer courses by the end of January and 10 million courses by July. It will also have 3 million of Merck & Co.’s Covid pill, developed with partner Ridgeback Biotherapeutics LP, by the end of January.

Doctors will be looking for the Merck and Pfizer pills to fill a gap for high-risk patients, who until now have been treated with monoclonal antibody therapies to keep them from needing hospital care.

Some of the most widely used antibody treatments from Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. appear far less effective against omicron than earlier variants because they target regions on the virus’s spike protein that have changed during its evolution.

In No Surprises Act (“NSA”) news —

  • The Centers for Medicare and Medicaid Services released FAQS for out-of-network providers who may be impacted by the NSA which takes effect on January 1, 2022.
  • The FEHBlog has been looking more deeply into the federal independent dispute resolution (“IDR”) process under this law. The IDR process allows an out-of-network provider with claims subject to the NSA to negotiate its payment with the health plan and if unsatisfied bring the payment issue to baseball arbitration using a CMS approved arbitrator. CMS has posted a list of the five currently approved organizations certified to conduct IDR arbitrations. The FEHBlog checked out a couple of these organizations and found out that at least two of them also are CMS approved independent review organizations (“IRO”) which decide health plan claim disputes under the Affordable Care Act. (In the FEHBP OPM acts as the IRO.)
  • The FEHBlog also learned that out-of-network providers who obtain patient consent to waive their NSA rights cannot access the IDR process on that consenting patient’s claims. Health plans will need to be on the lookout for the provider’s notice that the NSA rights waiver has been accepted by the patient / plan member. Here is a link to the consent form. In these cases which the FEHBlog expects to be relative few in number, the plan would pay the out-of-network provider using the ACA emergency care rules or the plan allowance for non-emergency services.
  • Generally only providers, e.g., primary surgeon, lead oncologist, who manage the patient’s care can seek patient consent to waive NSA rights. Ancillary providers, e.g., anesthesiologists, radiologist, pathologists, hospitalists, are locked into using the IDR process. This was a sound decision by the ACA regulators. Kaiser Family Foundation offers a useful compendium of these rules.
  • What’s more, Thompson Reuters reports that

HHS has released instructions for reporting data under a transparency provision included in the Consolidated Appropriations Act, 2021 (CAA , Division BB, Section 204), which requires group health plans and insurers to annually report prescription drug and health care spending, premiums, and enrollment information to the government

OPM has required FEHB carriers to comply with this reporting requirement via OPM’s reporting authority under the FEHB Act, 5 U.S.C. Sec. 8910. This strikes the FEHBlog as a bit of a stretch as Congress did not apply NSA Section 204 to the FEHBP in the NSA law and Section 8910 contemplates carriers providing reports to OPM. When FEHB carriers find themselves obligated to submit reports to HHS, a separate law outside the FEHB Act vests that authority in the other agency, e.g., Section 111 Medicare eligibility reporting to CMS. In any event, the enforcement deadline for the 2020 and 2021 reference year reporting under Section 204 is December 27, 2022.

Monday Roundup

David Ermer–ACA, Congress, COVID treatment, COVID-19, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the political front, Politico reports that

[Senator] Joe Manchin (D WV) remains at the negotiating table [with his party’s leadership], despite deep concerns about President Joe Biden’s climate and social spending bill [a/k/a the Build Back Better Act]. 

After speaking with Biden on Monday afternoon, Manchin said he was still “engaged” in discussions. And as he left the Capitol, the key Democratic senator made clear he wasn’t ready to commit to voting for or against a bill that is still coming together behind closed doors.

From the White House, the President issued an executive order on improving customer service performed by government agencies. Federal News Network explains that

Jason Miller, the Office of Management and Budget’s deputy director for management, said the EO also directs agencies to coordinate work on services that reflect common life experiences, including turning 65 and planning retirement, having a child or applying for a small business loan. * * *

The executive order gives senior administration officials 90 days to select a limited number of these customer life experiences to prioritize across government. It requires Miller and other members of the President’s Management Council to update [Presidential senior advisor Neera] Tanden and White House Chief of Staff Ron Klain on progress made improving these customer life experiences every six months.

The EO also gives the General Services Administration six months to develop a roadmap of shared services that agencies can use to improve customer experience.

The administration specifically names Login.gov and the U.S. Web Design System, a set of templates meant to create a common look and feel for agency websites, as tools that all agencies should use to improve federal customer experience.

Here is a link to the White House’s press release on the Executive Order as found on performance.gov.

From the Affordable Care Act front, the Internal Revenue Services has released the final Affordable Care Act coverage reporting forms, 1095-B and 1095-C, along with the final instructions for those forms.

From the Office of Information and Regulatory Affairs’ website, we find that the federal government’s Fall 2021 regulatory agenda has been published. Here is a link to OPM’s Fall 2021 agency rule list. A chill went up the FEHBlog’s spine when he noticed that the ACA provider non-discrimination proposed rule mandated by the No Surprises Act will be published this month due to a statutory requirement. Cost curve up?

From the employer sponsored care front, Healthcare Dive reports that

— The average per-employee cost of employer-sponsored health insurance jumped 6.3% in 2021, as employees and their families resumed care delayed last year due to the pandemic, according to a new survey of employers from Mercer.

— That’s the highest annual increase since 2010. Health benefit costs outpaced growth in inflation and worker compensation through September, the employee healthcare and investment consultancy said.

— The findings raise questions of whether employers are experiencing a temporary correction to the cost trend following a minimal year-over-year increase of just 3.4% in 2020, or if they’re staring down the barrel of a new period of higher cost growth.

No doubt those questions can keep actuaries awake at night.

From the good COVID news department (yes it exists), STAT News informs us that

Paxlovid, Pfizer’s oral treatment for Covid-19, led to an 89% reduction in hospitalization and death in final data from a pivotal trial, the company said today, confirming the results of an earlier analysis.

The news should allay concerns that the efficacy of Pfizer’s pill would wane over time. Molnupiravir, a Covid-19 antiviral from Merck, appeared 50% effective in an interim trial analysis but fell to about 30% in the final tally. Both studies enrolled unvaccinated patients who were recently diagnosed with Covid-19 and had at least one risk factor for severe disease.

The next step for Pfizer is submitting the results to the FDA, which the company expects to do this month, and applying for an emergency-use authorization. The agency is yet to disclose whether it will convene a panel of expert advisers before deciding on Paxlovid.

Based on the President’s winter is coming plan, the FEHBlog’s bet is on the FDA approving the Pfizer drug without delay.