Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From Capitol Hill, Roll Call reports that Congress is not making much progress toward replacing the current continuing resolution funding the federal government with an omnibus bill resolving FY 2022 appropriations. The deadline for Congressional action is February 18. It is starting to look like Congress is headed toward passing another short-term continuing resolution according to the article. Time will tell.

From the Covid testing front, the Biden administration announced today that Medicare will begin direct coverage of over-the-counter Covid tests in the early Spring of this year.

Health Payer Intelligence informs us that America’s Health Insurance Plans wrote a statement to Congress describing the numerous administrative problems created by the “free” Covid test coverage mandates that started nearly two years ago with the CARES Act.

MedPage Today tells us about a human challenge study of the Covid incubation period conducted in London which found that the Covid incubation is only two rather than five days after exposure. Instead the symptoms tend to peak at five days and the virus remains detectable 10 days after exposure.

The Institute for Clinical and Economical Review released a draft assessment of outpatient treatments for Covid including the Pfizer and Merck pills, an intravenously administered recombinant monoclonal antibody (Sotrovimab), and an off-label use of an obsessive-compulsive SSRI drug (Fluvoxamine) for which researchers are seeking an emergency use authorization for Covid. The draft conclusion is that

Our analyses suggest that each outpatient intervention produces improved clinical outcomes. At their current prices, each intervention is estimated to meet standard cost-effectiveness levels in the US health care system, even under a scenario with a lower hospitalization risk that may reflect the current Omicron wave. The cost-effectiveness findings are primarily driven by a treatment’s ability to reduce hospitalization and the baseline probability of hospitalization.

From the No Surprises Act front, the Labor Department helpfully released a transcript of the January 19, 2022, listening session regarding provider nondiscrimination under Section 2706(a) of the Public Health Service Act. The NSA requires the ACA regulators to issue implementing rules for this law which has been in force since 2014.

Also, Kaiser Health News discusses mental health therapist concerns about the good faith pricing estimate for healthcare services that the NSA applies across the board. The law also requires health plans to issue advance explanations of benefits in response to a good faith estimate from a provider. The FEHBlog will never understand why Congress failed to direct HHS to create HIPAA standard transactions for the GFE and the AEOB. In any event, providers and health plans await implementing rules from the ACA regulators.

From the Rx coverage front, Biopharma Dive provide us with two insights

  1. “Biogen recorded $1 million in revenue from its new treatment for Alzheimer’s disease in the last quarter of 2021, offering the latest evidence that the drug, which came to market with multi-billion dollar sales expectations, continues to struggle commercially.”
  2. “AbbVie may soon face competition for its top-selling eye drug Restasis after the Food and Drug Administration on Wednesday approved a generic version.”

From the healthcare business front, Fierce Healthcare fills us in on Cigna’s fourth quarter 2021 financial report.

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.

Weekend update

David Ermer–Congress, COVID treatment, COVID-19–

Both Houses of Congress are in session this week for Committee business and floor voting.

The FEHBlog notes that the President’s nominee for Office of Management and Budget, acting Director Shalonda Young, and her designated replacement to serve as Deputy OMB Director, Nani Coloretti, will be attending their Senate confirmation hearings this week.

The current continuing resolution funding the federal goverment expires on February 18, 2022. The Hill reports that

Congressional negotiators are in danger of missing the Feb. 18 deadline for passing an omnibus package of the annual appropriations for fiscal 2022.

A shutdown is unlikely, but members of the Senate Appropriations Committee from both parties warn that if negotiators blow through the mid-February deadline, it increases the likelihood that Biden will have to settle for a yearlong stopgap funding measure to keep the government open.

At this point the budget ball is in the Senate’s hands. The Hill further states

Spokespeople for the two senior negotiators [at the Senate] declined to comment in detail on the talks.  

“The negotiations are ongoing, and it remains the chairman’s goal to complete those negotiations by Feb. 18,” said Jay Tilton, a spokesman for Leahy.  

Blair Taylor, a spokeswoman for Shelby, said, “We are working diligently to create a product that is palatable to everyone — bills that can advance through Congress and be signed into law by the president.”  

From the Omicron front, the Wall Street Journal reports that

The Omicron variant spreads so quickly and generally causes such a mild form of illness among vaccinated populations that countries are tolerating greater Covid-19 outbreaks, willingly letting infections balloon to levels that not long ago would have been treated as public-health crises.

From different starting points, authorities in North America, Europe, and the Asia-Pacific are moving in the same direction, offering a glimpse into a future in which Covid-19 becomes accepted as a fact of everyday life, like seasonal flu.

Health officials everywhere, many for the first time, are forgoing some of the sharpest tools they have to combat Omicron—even as infections soar. They are accepting the virus-like never before to minimize disruptions to economies, education, and everyday life.

At the moment, deaths and hospitalizations are at highs in many countries, and in some, hospitals are overwhelmed. But they are a much lower percentage of total cases than earlier waves. Vaccines have made the disease less deadly, and treatments hold a greater promise of recovery for those who are infected and get seriously ill.

That improving outlook, coupled with the reality that the measures taken to contain earlier surges of the virus don’t work as well against the more-contagious Omicron, is informing the decision by policymakers to abandon restrictive steps aimed at containment amid growing public fatigue over restrictions.

On a related note, Bloomberg tells us that

The omicron subvariant, BA.2, appears to be more contagious but data so far doesn’t show it’s more dangerous or that it evades protection from vaccines, said Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration. 

At worst, the strain could slow down the decline in omicron infections in the U.S., Gottlieb, a Pfizer Inc. board member, said on CBS’s “Face the Nation.” The subvariant has been found in small numbers in about half of U.S. states. 

“I don’t think it really changes the narrative,” he said. “I don’t think this is going to create a huge wave of infection.”

From the Covid pill front, ABC News informs us that “Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access.”

[Due to manufacturing issues,] [t]he current plan calls for 265,000 courses of treatment in January, gradually ramping up to 10 million by the end of June and 20 million by the end of September.

[However, s]carcity isn’t the only problem. Doctors and pharmacists told ABC News the process of obtaining the drug is opaque, even arbitrary.

In Nevada, for example, Paxlovid primarily goes to long-term care facilities like nursing homes. But in neighboring California, state officials use a complex formula that factors in rising case numbers with other risk factors. In the District of Columbia, a few Safeway grocery stores are the primary distributors, although city health officials have asked doctors to give priority to high-risk individuals.

Bloomberg adds that

New York City will provide free antiviral pills, home-delivered, to people who test positive and are at higher risk from Covid-19, Mayor Eric Adams announced on Sunday.  * * * Both oral anti-viral medications approved by the U.S. Food and Drug Administration — paxlovid from Pfizer Inc. and molnupiravir from Merck Inc. — will be available though in limited quantities, according the a City Hall press release. They will be delivered in partnership with Alto Pharmacy. 

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–

Both Houses of Congress will be engaged in Committee business and floor voting this week as we are now less than one month away from the expiration of the current continuing resolution funding the federal government. That resolution runs through February 18.

From the Omnicron front, the New York Times reports that ‘

New coronavirus cases have started to fall nationally, signaling that the Omicron-fueled spike that has infected tens of millions of Americans, packed hospitals and shattered records has finally begun to relent.

More and more states have passed a peak in new cases in recent days, as glimmers of progress have spread from a handful of eastern cities to much of the country. Through Friday, the country was averaging about 720,000 new cases a day, down from about 807,000 last week. New coronavirus hospital admissions have leveled off.

Even as hopeful data points emerge, the threat has by no means passed. The United States continues to identify far more infections a day than in any prior surge, and some states in the West, South and Great Plains are still seeing sharp increases. Many hospitals are full. And deaths continue to mount, with more than 2,100 announced most days.

But following a month of extraordinary rates of case growth, blocklong lines at testing centers and military deployments to bolster understaffed I.C.U.s, the declining new-case tallies offered a sense of relief to virus-weary Americans, especially in the Northeast and parts of the Upper Midwest, where the trends were most encouraging. After another round of masking up or hunkering down, some were considering what life might look like if conditions continued to improve. 

Bloomberg adds

The omicron variant spreads so rapidly that sometimes it feels as if resistance is futile. It’s disheartening to hear of omicron infecting people who are up-to-date on their shots and wear an N95 mask every time they leave home. Even some well-known public-health experts are getting infected. But that doesn’t mean everyone is going to get it. 

What it does mean is that life is profoundly unfair. In some of us, the Covid-19 vaccines work quite robustly, even against omicron. In others, the vaccines’ effect is weaker. Chalk this up to the spectacular diversity of the human immune system, which is partly regulated by some of the most varied genes in the human body. 

A recent study led by Harvard and MIT showed that about 20% of people get much poorer protection from their vaccines against omicron. They’re still better off than completely unvaccinated people, but this variability could account for some of the fully vaccinated people who’ve been hospitalized in the omicron wave.

According to the American Medical Association (AMA), here’s what physicians want their patients to know about Omicron. “The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).”

From the Rx coverage front, the New York Times offers an interview with CVS Health’s CEO Karen Lynch. For example,

What do you see as the most effective ways that we could reduce health care costs for everyday Americans? And what’s your company’s role in doing that?

There’s a couple of things. One is there’s the site of care. Our role is offering an alternative site of care, either in our retail locations, or in the home with virtual connections. We’re entering into the primary care space because we believe that primary care has real significant influence over the cost of health care.

And I’m pretty passionate about the fact that the head is attached to the body, and most people experience behavioral health issues when they are experiencing physical health issues. We only deal with the physical health. We don’t deal with the behavioral health part, and I think there’s more we can do.

Healthcare Dive provides us with industry perspective on last week’s launch of TEFCA which is intended to vastly improve interoperability by linking together regional health information exchanges.

The goal of TEFCA is to get rid of individual legal agreements between health information networks, health plans, providers and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back on administrative burden. The framework standardizes the operational side of data exchange, while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure. * * *

Getting a nationwide network of groups of organizations that agree to the same data-sharing infrastructure could significantly streamline patient care across different geographies.

For example, if a patient from Virginia takes a vacation to California and ends up in an emergency room, doctors currently do the best they can to treat them without their medical record, which can contain valuable information about preexisting conditions, allergies and other health factors. But with a nationwide QHIN infrastructure, clinicians can query all participating networks for that patient’s data and use it to inform their clinical choices, Barrett said.

That budding future all centers on buy-in. * * *

Many, including ONC, are optimistic on TEFCA adoption, citing the competitive disadvantages to nonparticipation.

The hope is that the more networks use it, the more its value proposition will be proved. Patients will inquire why their provider doesn’t have their data from other facilities, and the provider will then wonder why the exchanges it’s a participant in aren’t qualified to work with other networks, Lee Barrett, CEO of EHR standards development organization EHNAC said.

Holiday weekend update

David Ermer–CDC, Congress, Federal employment benefits, Medicare, Mental health care, U.S. Healthcare–

Happy King Day! Here is a link to the NPR website that includes a video and a transcript of his “I Have a Dream” speech given August 28, 1963. Dr. King proves that you don’t have to be President to lead the country. He accomplished so much in his tragically shortened life for which we all should be grateful.

From the Congress front, the House of Representatives remains in session this week for Committee business and floor voting while the Senate is on State work period. Govexec lets us know that last Thursday

Lawmakers sounded a rare note of optimism about reaching a spending agreement for the remainder of fiscal 2022 as they look to avoid yet another stopgap measure.  Leaders in both parties called a bicameral, bipartisan meeting “constructive,” saying they shared the goal of setting full-year appropriations by their Feb. 18 deadline. 

From the Omicron front, STAT News informs us that

As the coronavirus continues to wreak havoc, an expert panel at the World Economic Forum delivered a mix of good news and bad news on Monday: More variants will emerge, but vaccine production is accelerating and research is progressing toward a combined shot that may be able to attack these different variants.

On one hand, the world needs to prepare for newer strains that could be more vexing, or the “worst case scenario,” said Annelies Wilder-Smith, a professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. “Omicron will not be the last variant. There’s a high probability we will have another variant coming up. The question is when and will it be less dangerous?”

Wall Street Journal columnist Alyssia Finley offers a column on the benefits of natural immunity created by Omicron breakthrough infections.

A study last month by the Oregon Health and Science University found that vaccinated people who experienced breakthrough infections produced higher levels of antibodies that were up to 1,000% more effective than those generated two weeks after a second dose of the Pfizer vaccine. The researchers described this as superimmunity. 

“I think this speaks to an eventual end game,” said co-author Marcel Curlin. “It doesn’t mean we’re at the end of the pandemic, but it points to where we’re likely to land: Once you’re vaccinated and then exposed to the virus, you’re probably going to be reasonably well-protected from future variants.” Dr. Curlin added: “Our study implies that the long-term outcome is going to be a tapering off of the severity of the worldwide epidemic.” * * *

All of this suggests that infection with Omicron is likely to stimulate potent and durable protection against Covid-19—and potentially other coronaviruses—even if it mutates to become more virulent. As Omicron rapidly spreads, people who have been vaccinated or previously infected will develop superimmunity. Covid-19 will become a virus that causes cold- and sometimes flulike symptoms—annoying but rarely deadly or disruptive.

One caveat is that older people generate weaker T-cell responses and memories to infections and vaccines. They’re likely to need annual booster shots. Omicron will end the pandemic by making Covid-19 endemic.

The Journal also offers masking advice which help the FEHBlog finally understand the difference between N-95 and KN-95 masks. “If you can’t get an N95 [which is certified in the US], doctors suggest KN95, KF94 and FFP2 masks, which are certified in China, South Korea and Europe, respectively.”

The Journal also reports that

One year into her tenure as director of the Centers for Disease Control and Prevention, Rochelle Walensky acknowledges that she should have communicated certain things better to the American public.

She says the pandemic threw curveballs that she should have anticipated. She thinks she should have made it clearer to the public that new rules and guidelines were subject to change if the nature of the fight against Covid-19 shifted again.

“I think what I have not conveyed is the uncertainty in a lot of these situations,” Dr. Walensky said in an interview with The Wall Street Journal.

Dr. Walensky deserves credit for making these remarks.

From the FEHB and TRICARE fronts, benefits consultant Tammy Flanagan discusses the merits of enrolling in Medicare Part B when you retire from federal employment at or over age 65.

From the healthcare business front, Revcycle Intelligence calls to our attention the fact that “2021 did not set any records for the number of hospital mergers and acquisitions, but data shows a shift to larger deals between well-established organizations”

The report identified eight “mega-mergers” in which the seller or smaller partner by revenue had over $1 billion in annual revenue. Out of all the announced transactions, that is the largest percentage of announced mega-mergers in the last six years at 16.3 percent. It was also nearly double the percentage of mega-mergers announced in 2020.

The average size of the smaller party in hospital merger and acquisition deals was also up significantly compared to previous years, according to the report. The average size by annual receive increased to $619 million from $388 million in 2020.

The data may point to a new trend in healthcare consolidation.

From the benefit design front, Health Payer Intelligence reports that

Although acupuncture utilization has grown in recent years, only half of acupuncture visits had any form of coverage in 2019, according to a research letter published in JAMA Network Open.

The researchers analyzed acupuncturist visits in Medical Expenditure Panel Survey (MEPS) data from 2010 to 2019. Their aim was to uncover the total cost of the visit, the annual out-of-pocket healthcare spending for these visits, the portion of these visits that were covered under the patients’ insurance plans, and the percent of out-of-pocket costs.

The majority of the participants were female and nearly six in ten were White individuals.

Finally MedPage Today gives us a community-oriented story written by “a physician [Avik Chatterjee, MD, MPH] in a shelter-based clinic in Boston, near the intersection of Massachusetts Avenue and Melnea Cass Boulevard, where a large encampment of people experiencing homelessness has emerged. Injection drug use in this area has picked up recently, and overdoses are not uncommon. When people need help, outreach workers and shelter staff run in and call for us.” And clinic doctors and nurses respond to the calls.” His story concludes as follows:

The skills, knowledge, and compassion necessary to address the overdose crisis exist in the community of people who use drugs. Historically, this group of people has been particularly marginalized by healthcare institutions. But people who use drugs are finally starting to demand a seat at the table where decisions are made around research and treatment of substance use disorders. Researchers, clinicians, and policymakers need to come up with creative ways to partner with this community to meaningfully incorporate lived and living experience in designing research and clinical programs.

In the face of one of the biggest health crises of our generation, it’s time to realize that “we’re all family here.”

And the post comes full circle.

Friday Stats and More

David Ermer–CDC, CMS, Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, 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 FEHBlog’s weekly chart of new COVID cases from the 27th week of 2021 through the second week of this year:

Four million new cases of COVID in a week. Wow. The Delta surge is the long hill that starts at the left of the chart. Omicron is Mount Everest by comparison.

Here’s the FEHBlog’s weekly chart of new COVID deaths for the same time span.

Weekly COVID deaths haven’t crossed 10,000 since the Delta surge peaked. Of course deaths are a lagging indicator.

The FEHBlog does think based on his reading that we are close to turning another corner but it’s not showing in these charts yet. We remain in the soup.

Here’s the FEHBlog’s chart of weekly Covid vaccinations distributed and administered since COVID shots were made available to the public in December 2020.

For the first time since before the holidays the number of administered vaccines, including boosters, exceeded 10 million last week. We are closing on 75% of the U.S. population aged 18 and older being fully vaccinated and over 65% of the U.S. population aged 65 and older being boostered.

Here are links the the CDC’s interpretation of its recent Covid and Flu statistics. The American Hospital Association informs us that

As urged by the AHA, the Department of Health and Human Services today renewed the COVID-19 public health emergency declaration for another 90 days effective Jan. 16. The extension will help hospitals and health systems combat COVID-19 in their communities.

In the wake of the Supreme Court lifting the stay on the CMS healthcare worker stay mandate, the American Hospital Association explains

The Centers for Medicare & Medicaid Services today released updated interpretive guidance on its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule for states affected by yesterday’s Supreme Court’s decision  on the rule. The guidance does not apply to Texas, where the Interim Final Rule is still subject to a preliminary injunction in a separate legal action that was not before the Supreme Court. Under the guidance, the first dose compliance date for those states is Feb. 14, 2022, with full compliance expected from providers by March 15, 2022. For states not impacted by the Supreme Court decision, the previously announced compliance dates of Jan. 28 and Feb. 27 remain in effect. For both groups, the underlying interpretive guidance released on Dec. 28 applies and all members can still refer to the previously released Frequently Asked Questions for additional information. 

Tomorrow is the implementation date for the President’s mandate that health plans cover over-the-counter COVID tests. It’s worth noting that health plans generally don’t cover any products sold over-the-counter so needless to say plans needed many more than the four days that federal govenment gave them to implement. The New York Times delves into the details.

The Wall Street Journal reports that

The U.S. public can begin ordering free at-home rapid Covid-19 tests through a new government website on Jan. 19, senior Biden administration officials said.

Initially, orders will be limited to four tests per residential address. Tests will ship via mail within 7-12 days of ordering, the officials said. The administration expects that timeline to shorten as the program ramps up, one of the officials said.

The public will be able to order tests at covidtests.gov. Those without access to the internet can place orders via phone, and the administration will work with community groups to help people request tests, the officials said. The government will give priority to orders from areas that have been hard-hit by the pandemic and low-income parts of the country.

Here’s a link to the White House’s fact sheet on these programs. Govexec discusses the Postal Service’s important role in distributing the tests ordered over the government website.

From the masking front, STAT News reports that

U.S. health officials on Friday encouraged more Americans to wear the kind of N95 or KN95 masks used by health-care workers to slow the spread of the coronavirus.

Those kinds of masks are considered better at filtering the air. But they were in short supply previously, and Centers for Disease Control and Prevention officials had said they should be prioritized for health care workers.Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson

In updated guidance posted late Friday afternoon, CDC officials removed concerns related to supply shortages and more clearly said that properly fitted N95 and KN95 masks offer the most protection.

However, agency officials noted some masks are harder to tolerate than others, and urged people to choose good-fitting masks that they will wear consistently.

“Our main message continues to be that any mask is better than no mask,” Kristen Nordlund, a CDC spokeswoman, said in a statement.

In other news —

  • Regulatory News informs us that “The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).”

Researchers at Weill Cornell Medicine and the University of Oxford announced on January 10, 2022, their new study shows that common vaccines could help reduce the health burden of the COVID-19 pandemic. 

A peer-reviewed study published in the Proceedings of the National Academy of Sciences crystallizes decades of evidence suggesting that the generalized immune-boosting properties of many vaccines can cross-protect people against multiple pathogens.

While these researchers did not specify particular vaccines, they chose values for cross-protection consistent with data from earlier studies on measles, influenza, tuberculosis, and other immunizations.

  • Fierce Healthcare tells us that “A top Medicare advisory board [MEDPAC] did not recommend any new payment hikes for acute care hospitals or doctors for 2023, stating that targeted relief funding has helped blunt the impact of the COVID-19 pandemic.” We shall see.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, U.S. Healthcare–
Photo by Cristina Gottardi on Unsplash

The House of Representatives convenes tomorrow for its second session of the 117th Congress. Both House and the Senate expect to engage in Committee business and floor votes this week.

The Wall Street Journal reports that the President has accepted the House Speaker’s invitation to give his State of the Union address on March 1. The date of the address was push back to March to avoid conflicting with the 2022 Winter Olympics, which will be held from February 4 to 24. Roll Call adds that the Administration plans to release the President’s Fiscal Year 2023 budget proposal following the State of the Union address.

From the Omicron front, NPR informs us that

Scientists at Case Western Reserve University have preliminary evidence that the risk of being admitted to the hospital or the intensive care unit during the omicron surge in the U.S. is about half of the risk observed during the delta surge. And this reflects what doctors across the country are now seeing firsthand with their patients. * * *

[A]s with any variant of SARS-CoV-2, your absolute risk depends on many factors, including whether you’re vaccinated and boosted, your age, your overall health and your economic situation.

“In the older age group, it’s still a nasty disease, even if it’s less [nasty] than the delta variant,” says Dr. Pamela Davis, who’s a pulmonologist at Case Western Reserve University and a senior author on the new study. “You don’t get off scot-free just because you happen to be infected in the time of omicron.”

As with previous variants, the vast majority of people infected with omicron have a mix of symptoms that resolve relatively quickly and don’t require hospital care. * * *

And doctors are finding many of these cases tend to look like an ordinary upper respiratory infection. In other words, what you think of as the common cold.

“It’s mostly that runny nose, sore throat and nasal congestion,” says Dr. John Vanchiere, the associate director of the Center for Emerging Viral Threats at LSU Health Shreveport. “The cough is milder [than previous variants], if there’s any cough at all, and fever seems to be a little less common.”

The New York Times discusses an increase in Omicron-related hospitalizations of children aged 4 and younger.

The number of hospitalized young children infected with the coronavirus rose precipitously last week to the highest levels since the beginning of the pandemic, according to data released on Friday by the Centers for Disease Control and Prevention.

The increase was observed in children who were 4 and younger, who are not eligible for vaccination, and the data included children who were admitted to hospitals for reasons other than Covid.

The rise may be partly explained by the surge of Omicron cases, which affects all populations, and the spread of other respiratory infections.

But the data do not show a similar steep rise in coronavirus infections among hospitalized children of other ages, and federal health officials were considering the possibility that Omicron may not be as mild in young children as it is older children.

According to the article the youngest among us are most at risk for upper respiratory infections such as Omicron.

“They’re smaller, their airways are smaller,” Dr. Kristin Oliver, a pediatrician at Mount Sinai Hospital in New York, said of young children.

“It does seem reasonable in a disease that if it looks like it’s affecting the upper airway more, that they would be more impacted,” she added. “They are more at risk for that — for longer, prolonged cases, as well as the hospitalization that can come along with a more severe case.”

That may explain why more hospitalized children aged 4 and younger have tested positive for the coronavirus throughout the pandemic than those 5 and older. It’s also why young children are more vulnerable to other pathogens, like respiratory syncytial virus, and to having the seal-like cough associated with croup.

Healthline summarizes the situation as follows:

A record number of children have recently been hospitalized with COVID-19. Still, health officials say many of these kids are not in the hospital because of COVID-19 but instead incidentally tested positive when admitted for other health issues. Still, due to the sheer volume of pediatric COVID-19 cases right now, children’s hospitals across the country are seeing an increase in kids being hospitalized for COVID-19. Severe illness in kids remains rare, and even hospitalized kids tend to recover well. Still, others require intravenous fluids, steroids, and antivirals. Doctors recommend that families mask up, avoid crowded spaces, and get all eligible kids vaccinated.

From the COVID testing front, PBS reports that

Starting Jan. 15, private insurers will be required to cover the cost of at-home testing, the same way they cover the cost of PCR lab tests. People will have the option of buying tests at a store or online, then seeking reimbursement from their health insurance provider. Those with public health insurance through Medicare or Medicaid, or without insurance, will be directed to the forthcoming website to order tests or to community health centers in their area offering free testing.

However, the FEHBlog sees this program as making a change to current testing coverage rules. According to ACA FAQ 44, a healthcare provider acting within the scope of his or her license must provide an individualized clinical assessment regarding COVID-19 diagnostic testing in order to obtain health plan coverage. The provision of such assessment can be demonstrated by the provider conducting the PCR test or referring the patient to a testing facility.

That individualized clinical assessment does not occur when a consumer decides on his or her own initiative to purchase a rapid at home antigen test kit. Indeed in ACA FAQ 44, the regulators stated that

Plans and issuers are not required to provide coverage of testing such as for public health surveillance or employment purposes. But there is also no prohibition or limitation on plans and issuers providing coverage for such tests.

Thus the new at home test coverage guidance expected this week may involve a material change to the current COVID testing coverage rule. In that event, you can expect a lawsuit challenging the mandate.

The FEHBlog also expected the guidance by January 15, not implementation by that date. The regulators have to allow an opportunity for insurer feedback and then implementing this new program. We shall see.

Happy New Year!

David Ermer–Congress, Federal employment benefits, SCOTUS–
Happy New Year 2022 from unsplash.com.

Welcome 2022!!

  • Federal Benefits Open Season changes took effect yesterday for annuitants and today for employees.
  • The Senate reconvenes for the second session of the 117th Congress tomorrow. The Wall Street Journal reminds us that “The Senate returns for a new session on Monday with Democrats focused on trying to change the chamber’s rules to muscle through elections legislation over Republican opposition, as lawmakers also hope to revive President Biden’s stalled economic and climate agenda.” The Senate also will hold some Committee business this week.
  • The House of Representatives reconvenes on January 10, a week from tomorrow.
  • The Supreme Court will hear oral argument on Friday January 7 about whether or not to stay the OSHA ETS creating a COVID vaccination or testing program for business with 100 or more employees and the CMS vaccination mandate for most healthcare workers.
  • From the Omicron front, David Leonhardt writing in the New York Times illustrates with charts why we have reason to hope that the pandemic will become endemic / a part of life rather than gripping our lives in 2022.

[W]hen the current surge begins receding, it will likely have left a couple of silver linings: Omicron is so contagious that it will have infected a meaningful share of the population, increasing the amount of Covid immunity and helping defang the virus. Omicron has also helped focus Americans on the importance of booster shots, further increasing immunity.

As important, the world has more powerful weapons to fight Covid than it did only a few weeks ago: two new post-infection treatments, one from Merck and a more powerful one from Pfizer, that lower the risk of hospitalization and death. With Pfizer’s treatment, the reduction is by almost 90 percent, according to early research trials.

All of which suggests that the U.S. could emerge from the Omicron wave significantly closer to the only plausible long-term future for Covid — one in which it becomes an endemic disease and a more normal part of daily life. It will still cause illness and death; a typical flu season kills more than 30,000 Americans, most of them elderly. For the foreseeable future, battling Covid — through vaccination, treatment and research — will remain important.

The FEHBlog heartily agrees with these sentiments.

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).

Weekend update

David Ermer–ACA, CMS, Congress, COVID vaccine mandate, COVID-19, Federal employment benefits, OPM, SCOTUS, U.S. Healthcare–
Photo by Jessica Delp on Unsplash

Congress has lowered the curtain on the first session of the current two year long Congress, the 117th in our Nation’s history.

Roll Call reports that

Sen. Joe Manchin III said on Sunday that he can’t support the sweeping social safety net and climate change package that President Joe Biden and Democratic leaders have made their top legislative priority.

The West Virginia Democrat’s opposition is likely the final nail in the massive $2 trillion-plus “Build Back Better” legislation given the Senate’s 50-50 split, unless extensive changes are made that would result in key provisions being scuttled.

“I can’t vote for it and I cannot vote to continue with this piece of legislation,” Manchin told “Fox News Sunday.” “I just can’t. I’ve tried everything humanly possible.  I can’t get there … This is a ‘no.’ “

Of course, the legislative struggle over the BBB bill is not over but at least we should enjoy a peaceful holiday period.

From the Omicron front, Bloomberg reports that

Lockdowns in the U.S. will likely not be necessary even as Covid-19 cases increase, according to President Joe Biden’s top medical adviser, Anthony Fauci. Even so, many hospitals may be strained as the omicron variant spreads, especially in regions with lower levels of vaccination, he said. 

New York City Mayor Bill de Blasio called on the federal government to step up supplies of tests and treatments to the city amid a spike in infections caused by the omicron variant. New York state broke a record for new infections for the third consecutive day.

From the COVID mandate challenge front —

Since last Wednesday

  • The Fifth Circuit U.S. Court of Appeals lifted the nationwide stay on the CMS healthcare provider COVID vaccine mandate, but left the stay in place for 24 states which had obtained their own stays. The federal government has asked the U.S. Supreme Court to lift the stays applicable to those 24 states. The Supreme Court has allowed the respondent states until December 30, 2021, to respond to the federal government’s motion.
  • The American Hospital Association (“AHA”) reports in the wake of the Court action that “CMS’s website states that CMS “has suspended activities related to the implementation and enforcement of [the mandate] pending future developments in the litigation.” AHA has confirmed with CMS that this statement applies nationwide and remains accurate even after the Fifth Circuit’s order staying the nationwide effect of the Louisiana district court’s preliminary injunction. 
  • The Sixth Circuit U.S. Court of Appeals lifted the nationwide stay on the OSHA ETS COVID vaccination screening program. The State of Georgia has asked the U.S. Supreme Court to reinstate the stay.
  • The American Hospital Association reports again in the wake of the Court action that “OSHA has announced that it is ‘exercising enforcement discretion with respect to the compliance dates of the’ mandate. OSHA states that ‘it will not issue citations for noncompliance with any requirements of the [mandate] before January 10 and will not issue citations for noncompliance with the [mandate’s] testing requirements before February 9, so long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard.’ OSHA has also promised to ‘work closely with the regulated community to provide compliance assistance.’”
  • The Eleventh Circuit U.S. Court of Appeals upheld the nationwide stay on the government contractor mandate. The federal government is expected to ask the Supreme Court to lift this stay tomorrow.
  • It certainly appears that all three mandate issues will be presented to the Supreme Court simultaneously. 

In Affordable Care Act news, CMS announced on Friday that

Health insurers have provided approximately $2 billion in rebates for the 2020 reporting year to an estimated 9.8 million consumers, the Centers for Medicare & Medicaid Services (CMS) is announcing today. Insurers were generally required to provide such rebates and notice of any rebates owed to consumers no later than September 30, 2021. Rebate payments can be provided in the form of a premium credit, lump-sum check, or, if a consumer paid the premium using a credit card or direct debit, by lump-sum reimbursement to the account used to pay the premium.

CMS released a list today of all insurers owing Medical Ratio Loss (MLR) rebates for the 2020 reporting year, with total amounts by state and market. The CMS market breakdown estimate includes approximately 4.8 million consumers in the individual market and 5 million employees in the group market (this represents 2.6 million employees in the small group market, and 2.4 million employees in the large group market). 

Today’s release also includes the Public Use Files (PUFs) containing the data from all health insurers’ final MLR filings for the 2020 reporting year. 

For more information visit: https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Medical-Loss-Ratio

Link to PUFs here: https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr

If federal employee compensation news, Govexec tells us that

[Last] week, the President’s Pay Agent, which is made up of Labor Secretary Marty Walsh, Acting Office of Management and Budget Director Shalanda Young and Office of Personnel Management Director Kiran Ahuja, issued its annual report ahead of President Biden’s executive order finalizing an average 2.7% pay raise in 2022. The pay agent declined to issue waivers based on a locality’s number of authorized positions, but approved Carroll County’s addition to the Davenport, Iowa, locality pay area due to the fact that it recently has met the 2,500 employee threshold.