Friday Stats and More

ACA

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 4th week of 2022.

The Omicron surge clearly has peaked. However, the weekly new Covid deaths chart continues to rise as deaths are a lagging indicator.

Here’s the FEHBlog’s chart of Covid vacciniations, including boosters, distributed and administered from the 51st week of 2020 through the 4th week of 2022.

The CDC’s Covid Data Tracker Weekly Review sums it up as follows:

COVID-19 cases and hospitalizations are starting to decline across the United States. However, deaths are still rising, and community transmission is still high nationwide. As of January 27, 2022, more than 211 million people in the United States have received a primary series of a COVID-19 vaccine and are considered fully vaccinated. More than 86 million people are up to date with their COVID-19 vaccines, which means they have received all recommended COVID-19 vaccine doses, including boosters.

Two new CDC reports show that people who are up to date with their COVID-19 vaccines have the highest amount of protection against both the Delta and Omicron variants.

STAT News adds that


New data show that vaccines still protect against a spinoff of the Omicron variant, a welcome sign as the world keeps a close eye on the latest coronavirus iteration.

BA.2, as the sublineage is known, is part of the broader Omicron umbrella. Scientists are paying more attention to it as it begins to eat into the dominance of the more common Omicron strain, which is technically called BA.1.

Here’s a link to the CDC’s latest Fluview whose key update is as follows:

The percent of specimens testing positive for influenza remains stable, indicating that influenza virus circulation has remained at similar levels during the past two weeks, even while overall levels of respiratory illness have declined.

WIRED Magazine informs us that the goverment’ covidtests.com has been working smoothly to distribute sixty million rapid antigen tests to American thanks to sound planning from the U.S. Digital Service supported by the U.S. Postal Service.

At one time, a presidential announcement like that would have caused a mad scramble in the agencies involved. But hard and bloody experience has changed the way the executive branch works. This time, even before Biden made his public promise, the people charged with actually building the site had, as Hsiang says, “a seat at the table” and were able to shape expectations from the beginning. “We did a bunch of work to make sure that it was technically feasible before we decided how we were going to implement it,” says Natalie Kates, who is the Covid lead for USDS.

They decided that the project should be sited and built at the United States Postal Service, which not only had the national database of valid addresses, but would ultimately deliver the packages. When the Postal Service’s CIO, Pritha Mehra, learned about the project in December, she was given estimates that demand might peak at a million users an hour. Mehra, a 31-year veteran of the service, concluded that was a lowball prediction and multiplied the number by 20, striving for a fail-safe capability. “Think about it—free Covid tests,” she says. “Look at the numbers of people that are trying to buy them. And so we read 20 times the demand that had been projected, and I told my team that’s what we’re going to build to.” She had no problem recruiting that team. “This is a technologist’s dream, to be able to do this,” she says.

Mehra knew it would be a challenge to the service’s architecture, which involved a combination of its own data centers and outside cloud providers. Her team set up a system with triple redundancy, beefing up the architecture, separating the customer experience process from the order fulfillment, and caching data multiple times in the process. And doing endless load testing. “Believe me, there was a lot of work behind what seemed like a very simple site,” she says.

Mazaal tov.

Health Payer Intelligence reviews insurer association comments on the HHS proposed 2023 Notice of Benefit and Payment Parameters which principally focuses on the ACA marketplace.

The proposed rule addressed a broad range of issues on the individual health insurance marketplace, from medical loss ratios to health equity data. 

AHIP and the Alliance for Community Affiliated Plans (ACAP) have both responded to the proposed rule with mixed reactions. Some elements they strongly applauded, such as the return to pre-2020 language around discrimination, web-broker display requirements, standards of conduct for brokers and agents, special enrollment period verification, and quality improvement strategy (QIS).

AHIP and ACAP highlighted a couple of key areas of the proposed rule that they would like to see changed in the finalized version [including risk adjustment, offering standardized plans, network adequacy, and medical loss ratio.

On the hand, the American Hospital Association also submitted comments on the proposed Notice.

The AHA yesterday voiced support for many of the policies proposed in the Centers for Medicare & Medicaid Services’ Notice of Benefit and Payment Parameters for 2023, including clarifications to the Medical Loss Ratio calculations, reestablishment of standardized health plan option requirements, changes to the essential health benefit nondiscrimination policy, and new requirements and standards of conduct for agents, brokers and web-brokers.

“In particular, we commend CMS on the proposed updates to the network adequacy standards, which are critical to ensuring that patients have access to the care they need,” AHA wrote. “We also strongly support CMS’ attention to advancing health equity throughout the proposed polices.”

Read the detailed comments here.

Finally and considering its the beginning of the weekend, here is a link to the American Medical Association’s What Doctors Wish Their Patients Knew about sodium consumption.

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.

Tuesday’s Tidbits

David Ermer–ACA, CDC, CMS, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Centers for Medicare and Medicaid Services (CMS) announced its proposed national coverage decision for Biogen’s Alzheimers Disease FDA-approved treatment, Aduhelm, today.

The proposed National Coverage Determination would cover Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. The proposed National Coverage Determination is open to public comment for 30 days.

STAT News sums it up as follows:

Normally, Medicare covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without a guarantee that patients actually will see slower cognitive decline. The process that led to the drug’s approval is the subject of multiple investigations, following STAT’s reporting that Biogen had an extensive back-channel relationship with the FDA. * * *

Medicare officials don’t require participation in clinical studies for beneficiaries very often — there are only about two dozen other health care products with a similar designation, called a Coverage with Evidence Development (CED), listed on Medicare’s website. Most are for medical devices or diagnostic imaging, and are less restrictive than the policy Medicare announced Tuesday. * * *

Sean Tunis, a principal at Rubix Health who helped develop the CED process during his tenure at the Centers for Medicare and Medicaid Services, said the proposal is almost as restrictive as if Medicare had decided not to cover the drug at all. Medicare, he estimated, would pay for drug costs for perhaps a few thousand patients that enroll in randomized trials over the next three to five years.

The CMS national coverage decision if finalized would help the FEHB Program dodge a bullet because it has many annuitant enrollees without Medicare Part B and for whom the FEHB plan would be the primary Aduhelm payer.

Following up on yesterday’s post about Affordable Care Act FAQ 51 implementing the President’s mandate on health plans to cover over the counter COVID tests, the FEHBlog noticed the fourth FAQ in this section of FAQ 51 which reads as follows:

Q4: When providing coverage of OTC COVID-19 tests, are plans and issuers permitted to address suspected fraud and abuse?

Yes. As stated in FAQs Part 44, Q2, although the FFCRA prohibits medical management of coverage of COVID-19 diagnostic testing, plans and issuers may act to prevent, detect, and address fraud and abuse. Examples of permissible activities include the following:

  • A plan or issuer may take reasonable steps to ensure that an OTC COVID-19 test for which a covered individual seeks coverage under the plan or coverage was purchased for the individual’s own personal use (or use by another participant, beneficiary, or enrollee who is covered under the plan or coverage as a member of the individual’s family), provided that such steps do not create significant barriers for participants, beneficiaries, and enrollees to obtain these tests. For example, a plan or issuer could require an attestation, such as a signature on a brief attestation document, that the OTC COVID-19 test was purchased by the participant, beneficiary, or enrollee for personal use, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale. In contrast, the Departments are of the view that fraud and abuse programs that require an individual to submit multiple documents or involve numerous steps that unduly delay a participant’s, beneficiary’s, or enrollee’s access to, or reimbursement for, OTC COVID-19 tests are not reasonable.
  • A plan or issuer may require reasonable documentation of proof of purchase with a claim for reimbursement for the cost of an OTC COVID-19 test. Examples of such documentation could include the UPC code for the OTC COVID-19 test to verify that the item is one for which coverage is required under section 6001 of FFCRA, and/or a receipt from the seller of the test, documenting the date of purchase and the price of the OTC COVID-19 test.

It occurred to the FEHBlog that FSAFeds the flexible spending account program for federal employees must be reimbursing participants for OTC Covid test kits. In fact the FSAFeds does offer reimbursement for OTC test kits on the condition that the participant furnishes a detailed receipt. For OTC products, FSAFeds generally requires a receipt including Vendor name, Date of purchase, Product name, and Cost. This should be a reasonable documentation standard for FEHB plans to adopt.

Also from the testing front, the Wall Street Journal looks into the reliability of rapid antigen COVID tests sold OTC.

Rapid antigen tests are a useful tool if we are smart about how we use them.

Because the data suggest that rapid tests may be yielding more false negatives at the beginning of an Omicron infection, you’ll have a better chance of getting an accurate result if you wait a day or two after developing symptoms to test, says Katelyn Jetelina, assistant professor of epidemiology at the University of Texas Health Science Center at Houston. If your test is negative, take a second test a day or two later, or get a PCR test if you can. (Easier said than done these days.)

Understand the limitations of rapid tests if you’re considering using them to screen people before gatherings. Rapid tests before a wedding or other large indoor gathering could miss early infections that could be contagious, Dr. [Blythe] Adamson says.

If you have a positive rapid test, you almost definitely have Covid-19, Dr. [Gigi] Gronvall says. False positives are rare, especially when case rates are as high as they are now. You likely don’t need to confirm a positive rapid-test result with a follow-up PCR test, unless an employer or other institution requires it.

In other Omicron news —

  • The Journal also tells us that “U.S. officials on Tuesday ordered 600,000 doses of Covid-19 treatment sotrovimab, the only monoclonal antibody therapy thought to work against the Omicron variant, as a record number of cases puts hospitals under increasing pressure in parts of the U.S. and Europe.  Sotrovimab, made by GlaxoSmithKline PLC and Vir Biotechnology Inc., is now the only Covid-19 monoclonal antibody available for patients in the U.S.”

ACA FAQ 51 also includes reminders to health plans about the wide scope of the ACA’s contraceptive mandate.

From the federal employee COVID vaccination front Federal News Network reports that

The first update by the Safer Federal Workforce task force in more than a month is addressing the challenge of testing employees and contractors who work on-site or with the public on a regular basis for COVID-19, the types of tests that are permitted and who is responsible for paying for said tests.

The crux of the updated and new frequently ask questions is agencies have until Feb. 15 to set up a testing program “for employees who are not fully vaccinated, including due to a pending or approved request for exception or extension from the COVID-19 vaccination requirement for federal employees.”

The task force said the testing program is only for employees who work on-site or interact with the public like safety inspectors, and not for those who work remotely.

Fedweek adds that “A period of waiting is continuing on two major federal workplace issues on which action was expected around now—enforcement of the Coronavirus vaccine mandate and the “reentry” from telework to regular worksites by more employees and for more often.”

From the preventive services department, the Department of Health and Human Services announced today that

Today, the U.S. Department of Health & Human Services (HHS) announced that the Health Resources and Services Administration (HRSA) has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents. Under the Affordable Care Act (ACA), certain group health plans and insurance issuers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines. Among a number of updates, for the first time the guidelines will require such group health plans and insurance plans to provide coverage without a co-pay or deductible for double electric breast pumps.

Fierce Healthcare reports news from the second day of the JPMorgan Healthcare Conference.

From the tidbits department —

  • Last week, the Office of National Coordinator for Health Information Technology announced “the release of the Project US@ (“Project USA”) Technical Specification Final Version 1.0 and thereby completed our one year goal to coordinate the creation of a health care specification that could be used across the industry for representing patient addresses (mailing, physical, billing, etc.). This new “tech spec” will advance the health care industry’s proficiency in recording and managing accurate and consistently formatted patient addresses and support more efficient patient matching and record linkage. As a reminder, among the many data elements that are used in patient matching, research has shown patient address to be one of the most sensitive to standardization and therefore impactful on patient matching, especially at scale. However, patient addresses change frequently, are often entered incorrectly or imprecisely.”

Friday Stats and More

David Ermer–ACA, CMS, COVID vaccine mandate, COVID-19, COVID-19 vaccine, SCOTUS, U.S. Healthcare–

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 chart of weekly new COVID cases for the end of June 2021 through the first week of 2022:

Omicron has produced a staggering number of new COVID cases while the number of weekly new COVID deaths has remained with a stable range for several months.

The Wall Street Journal offers an lab test based explanation for Omicron’s mild nature:

The threat posed by the Omicron variant has now come into sharper focus, with recent clinical data and laboratory studies lending support to early reports suggesting that it is milder but more transmissible than other variants of the new coronavirus.

“It spreads very, very fast, but it doesn’t appear to have the virulence or machismo to really pack as much of a wallop as the Alpha or Delta variants,” James Musser, chairman of Houston Methodist Hospital’s pathology and genomic medicine department and the leader of a new study of Omicron infections, said of the variant.

Recent laboratory studies suggest that Omicron’s lower virulence may reflect its apparent tendency to thrive in cells in the upper respiratory tract rather than in the lungs, where Covid-19 infections can cause potentially fatal breathing problems.

That’s a reassuring tidbit.

Here’s the FEHBlog’s weekly chart of COVID vaccinations from the 51st week of 2020 through the 1st week of 2022:

Throughout the holiday period the number of administered vaccinations averaged six million which is impressive. Nearly two thirds of Americans aged five years and older are fully vaccinated and half of Americans aged 50 and older also have received a booster.

Here are a link to the CDC’s interpretation of its COVID statistics and a link to the CDC’s Fluview.

From the Supreme Court front, the Wall Street Journal reports that

A majority of Supreme Court justices expressed skepticism Friday of the Biden administration’s Covid-19 vaccine-or-testing plan for large employers but somewhat less concern about a vaccination mandate for healthcare workers, in a special [four hour long] session that examined the scope of the federal government’s powers during a fast-moving pandemic.

The Court focused its attention whether the issuing agency has necessary authority to issue its broad mandate. The Court should issue a decision within a month. The Wall Street Journal adds

The Supreme Court took up the vaccine lawsuits with alacrity, acting shortly before Christmas to add a rare Friday argument to its docket, ahead of the year’s first scheduled cases. Some parts of the OSHA rules begin to take effect next week, though the agency is waiting until next month to enforce Covid-19 testing requirements. Several justices signaled the court would seek to rule quickly—and potentially could put the requirements for private employers on hold temporarily for at least a few days to give themselves time to digest the case.

From the Medicare front, the Centers for Medicare and Medicaid Services released a proposed rule with 2023 updates to the Medicare Advantage and Medicare Part D programs. Here are links to the CMS fact sheet and a Fierce Healthcare article on this development. Of note, Fierce Healthcare tells us that

The proposal takes a major aim at price concessions that Part D plans extract from drug makers, but does not affect rebates negotiated between drug makers and insurers. Under the concessions, the plan pays less money to a pharmacy if it doesn’t meet several metrics. CMS is concerned, however, that the end-user doesn’t know about the arrangement and the lower prices are not passed on at the point-of-sale.

The proposed rule also said that the negotiated prices “typically do not reflect any performance-based pharmacy price concessions that lower the price a sponsor ultimately pays for the drug.”

The proposed rule wants to require all Part D plans to apply the concessions at the pharmacy counter.

Fierce Healthcare also calls attention to the November 2020 Kaufmann Hall report on hospital service utilization.

Hospital volumes softened in November overall as operating margins remain depressed, signaling that once again consumers could be delaying or avoiding care due to the pandemic, a new report from consulting firm Kaufman Hall found.

The firm released Tuesday its latest hospital flash report detailing revenues and volumes for November before the omicron-fueled surge of COVID-19 took hold. The report found hospitals are still facing major pressures from rising expenses and labor shortages. * * *

Kaufman found that hospital volumes softened in November, with discharges dropping nearly 5% and adjusted discharges by 3.9% compared to the month before. Discharges were also down 6.1% compared with pre-pandemic levels.

Meanwhile, the average length of stay at hospitals increased by 0.8% compared to October and 8.6% compared with November 2019.

The report estimates consumers could be postponing non-COVID-19 care.  

“The potential impact of the omicron variant in future months may influence this trend further,” Kaufman’s analysis said.

Tuesday’s Tidbits

David Ermer–ACA, CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Lots of updates from the Centers for Disease Control (“CDC”) today

  • “Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine.  This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series.  The booster interval recommendation for people who received the J&J vaccine (2 months) or the Moderna vaccine (6 months), has not changed.”
  • The CDC released a study of over 40,000 COVID- vaccinated pregnant women.

In a retrospective cohort of >40,000 pregnant women, COVID-19 vaccination during pregnancy was not associated with preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women.

These data support the safety of COVID-19 vaccination during pregnancy. CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant, who are trying to become pregnant now, or who might become pregnant in the future.

  • As expected, the CDC revised and lengthened its revised COVID quarantine and isolation policy by, e.g., adding “at home testing when available,” right at the time that at home COVID test are hard to purchase. What’s more, the Wall Street Journal reports the prices for those tests are jumping at Walmart and Kroger because the White House curiously let a price support program lapse. Govexex informs about how government agencies had been struggling to implement this CDC guidance even before today’s changes.

Also from the Omicron front, Medscape tells us about a British study finding that

Protection against hospitalization from COVID-19 vaccines is “good” against the Omicron variant of SARS-CoV-2, an analysis has found.

The risk for adults of being admitted to hospital with Omicron was approximately one third (Hazard Ratio 0.33, 95% CI 0.30 to 0.37) of that for the Delta variant, the UK Health Security Agency (UKHSA) said in a technical briefing.

The analysis also found that the risk of presentation to emergency care, or being admitted to hospital, with Omicron – whether testing for symptomatic or asymptomatic infection – was approximately half of that for Delta (Hazard Ratio 0.53, 95% CI 0.50 to 0.57).

From the Affordable Care Act front – –

  • The International Foundation of Employee Benefit Plans announced that “The Centers for Medicare and Medicaid Services (CMS) issued the proposed 2023 actuarial value (AV) calculator and methodology.” This should be useful when preparing FEHB 2023 benefit and rate proposals.
  • The Labor Department’s Employee Benefit Security Administration announced that it is seeking speakers to talk at an ACA listening session about the ACA’s provider non-discrimination provision, known as Section 2706. In Division BB of the Consolidated Appropriations Act of 2021, Congress tasked the ACA regulators with adopting a rule interpreting Section 2706. The listening session bears on that effort.

From the healthcare business front

  • Fierce Healthcare tells us that “Centene Corporation has completed its acquisition of Magellan Health, the insurer announced Tuesday. The $2.2 billion deal closes exactly one year after its announcement on Jan. 4, 2021. The combination will create one of the country’s largest behavioral health platforms, including 41 million unique members. * * * In addition to its behavioral health platform, Magellan will add 5.5 million members to Centene’s government program, 16 million pharmacy members and 2 million pharmacy benefit management members.”
  • Healthcare Dive reports that “HCA Healthcare has purchased the largest urgent care chain in Florida, MD Now Urgent Care, the health system said Tuesday. The deal closed at the end of 2021 for an undisclosed sum. The deal gives HCA 59 urgent care centers in a state where it already has a significant presence, with 47 hospitals.” 

From the tidbits department

  • STAT News interviews Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “[2022] will have to be a year where we transition to working alongside the pandemic, as opposed to being dominated by the pandemic,” Dr. Marks told STAT in a wide-ranging interview. Let’s hope so.
  • Medpage Today brings us up to date on Biogen’s Aduhelm saga and considers 2022 biggest hurdles for heathcare in the U.S.
  • The new acting National Institutes of Health director Dr. Larry Tabak is continuing the tradition of writing a weekly director’s blog. This week’s issue concerns science’s 2021 breakthroughs, e.g., the COVID pills.

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.”

Midweek update

David Ermer–ACA, CDC, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, U.S. Healthcare–

From the Omicron front, the Washington Post reports that breakthrough Omicron cases are becoming the new normal in the U.S.

Long-anticipated holiday plans fell apart as people — young and old, vaccinated and unvaccinated — tested positive right and left. Those with negative tests worried it was only a matter of time.

They are likely right, according to Robert Frenck, professor of pediatrics and director of the Vaccine Research Center at the Cincinnati Children’s Hospital. “You know what? You’re probably going to get covid,” he said, but if you have been vaccinated you are unlikely to become seriously ill.

Oddly, in the FEHBlog’s view, the article does not mention the additional natural immunity gained from a mild case of Omicron.

STAT News raises three “big” questions about the Biden administration’s Covid response in 2022 —

1. Will the government broaden its focus beyond vaccines? STAT News explains that

Even before there were Covid-19 vaccines, there were commonsense tools used to prevent the disease from spreading: Wearing masks, and avoiding indoor gatherings with large numbers of other people.

But two years into the pandemic, the U.S. is still laser-focused on vaccines, and has largely ignored other factors. In particular, federal regulators haven’t done much to incentivize Americans to wear higher-quality face coverings, or to maintain better filtration and cleaner air in indoor spaces.

On the bright side, the FDA approved two new rapid over the counter COVID tests today on an emergency use basis. The more the merrier.

2. Will people who feel sick have better options for tests and treatments? STAT News explains rapid COVID tests are short in supply and pricey and the Biden Administration’s government solutions won’t be implemented for weeks. Similarly we have two exciting COVID pills which won’t be widely available for months.

3. Forget a third vaccine dose — will Americans need a fourth, too? To the FEHBlog that seems like a foregone conclusion.

From our other epidemic front, MedPage Today reports that

The volume of opioids dispensed from retail pharmacies fell by about 21% from 2008-2009 to 2017-2018, but cuts were not uniform, national prescription records showed.

Changes in opioid prescribing varied substantially by county, patient, and prescriber, reported Bradley Stein, MD, PhD, of the RAND Corporation in Pittsburgh, and co-authors in Annals of Internal Medicine. * * *

Per-capita morphine milligram equivalents (MMEs) fell by 22.6% in metropolitan counties and by 34.6% in counties with the highest rates of fatal opioid overdoses, the researchers found. In multiple counties, opioid prescribing increased over time. Some states had counties with both increases and substantial decreases, and these counties often were next to each other.

People 18 to 25 years old experienced the sharpest decrease in prescription opioids (66.6%) per capita, followed by those 26 to 35 (57%). Patients 56 to 65 had essentially no change (0.1% decline), while those 66 and older had a 12% drop.

People covered by commercial insurance had a 41.5% decline per capita. Those with Medicaid had a 27.7% reduction, and those with Medicare had a 17.5% drop.

MMEs plummeted by 70.5% among emergency physicians, even though these doctors are likely to prescribe opioids predominantly to people with acute pain, the researchers noted. The top two opioid prescribers, primary care physicians and pain specialists, also saw reductions in MMEs of 40% and 15.4%, respectively. MMEs fell by 49.3% among surgeons and by 59.5% among oncologists.

From the COVID vaccine mandate front, the Eleventh Circuit U.S. Court of Appeals which is hearing a challenge to a nationwide stay of the government contractor mandate (Case No.  21-14269), decided yesterday not to hear the case before the entire court rather than a three judge panel and today to decline the government’s request to accelerate the briefing and argument calendar. Consequently the stay will remain in effect at least through January 2022.

From the Federal Register front, the Department of Health and Human Services finalized its rescission of the Trump Administration’s most favored nation drug pricing rule. Smart move.

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.

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.