Thursday Miscellany

Thursday Miscellany

U.S. Supreme Court building

Let’s start today with news from the litigation front —

The Wall Street Journal reports that in advance of the February 27 deadline,

The Justice Department filed an antitrust lawsuit Thursday challenging UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc., arguing the tie-up would unlawfully reduce competition in markets for commercial insurance and the processing of claims.

The deal, announced in January 2021, sought to bring a major provider of healthcare clinical and financial services, including the handling of claims, under UnitedHealth’s Optum health-services arm.

The Justice Department filed its lawsuit in federal court in Washington, saying Change provided key industry technologies that are relied upon by UnitedHealth’s health-insurance rivals, making it a hub for competitively sensitive information. If the deal were allowed, UnitedHealth would have access to data that it could potentially use for its own benefit, at the expense of other insurers, the department alleged. The department also argued the deal would reduce head-to-head competition in the businesses of insurance claims transmission and review, because UnitedHealth competes with Change in those areas.

Healthcare Dive reports

A federal judge in Texas struck down a narrow part of the surprise billing rule that outlines how to resolve payment disputes between payers and providers over out-of-network claims. Wednesday’s ruling is a win for providers who were opposed to the dispute resolution process spelled out by CMS in an interim rule, arguing it favored insurers.

The judge’s ruling essentially tosses out a part of the dispute resolution process that instructs arbiters to begin with the presumption that the qualifying payment amount, or median in-network rate, is the appropriate payment amount for providers.

This is not the final word because the decision, which resulted in a final judgment is appealable to the U.S. Court of Appeals for the Fifth Circuit. A case raising the same issue is currently pending oral argument in the U.S. District Court for the District of Columbia.

The Hill adds

Katie Keith, a health law expert at Georgetown University, said the ruling is evidence of how hard doctors groups will fight even relatively modest efforts by Congress to cut health care costs.  

The surprise billing action was “one of the few things Congress has tried to do on cost containment,” she said.   

Amen to that.

From the Omicron front, Medpage Today provides background on a Centers for Disease Control decision permitting

Extended dosing intervals for Pfizer or Moderna vaccines * * * for certain individuals ages 12 to 64 years, not only to lower the risk of vaccine-associated myocarditis, but to potentially improve vaccine effectiveness, CDC staff said on Thursday.

According to the agency’s new interim guidance, young people ages 12 to 39 may especially benefit from a second mRNA dose 8 weeks after their first dose.

However, the regular 3-week interval for Pfizer and 4-week interval for Moderna is appropriate for patients who are moderately to severely immunocompromised, adults ages 65 and up, those who need rapid protection (such as “during high levels of community transmission”), and children ages 5 to 11.

From the social determinants of health front, HR Dive tells us

Though employers have invested increasingly in a variety of healthcare and healthcare-adjacent benefits, few of these efforts effectively address social determinants of health that can negatively affect patient outcomes, according to a report published this month by the Northeast Business Group on Health.

Social determinants of health include factors such as education access and quality; healthcare access and quality; economic stability; neighborhood and built environment; and social and community factors. Differences in these areas lead to disparities not only in terms of health outcomes, but also in cost management and general employee health and well-being, NEBGH said.

Employers can start addressing social determinants by collecting survey data on employees’ needs and risk factors, per the report. From there, NEBGH recommended that benefits design focus on equitable benefits access, such as evaluating what percentage of pay their health plans comprise at different pay levels. Other strategies cited include improving health literacy, taking advantage of partnerships and improving organizational culture around health and well-being, among others.

From the Rx coverage front, Fierce Healthcare discusses CVS Health’s annual Drug Trend Report.

CVS Caremark kept overall drug trend for clients to 2.4% over the first three quarters of 2021, marking multiple years of single-digit trend in drug price growth.

The pharmacy benefit management arm of CVS Health also kept its specialty drug trend to single digits through the third quarter, at an industry-low 5.8%, according to the company’s annual Drug Trend Report released Thursday. Caremark found that 35.9% of its clients saw negative specialty trend in 2021.

In addition, 65.3% saw specialty trend under 10%, according to the report.

The article explains how CVS Health accomplished this feat.

From the Medicare front, CMS announced a redesign of its Accountable Care Organization model

that better reflects the agency’s vision of creating a health system that achieves equitable outcomes through high quality, affordable, person-centered care. The ACO Realizing Equity, Access, and Community Health (REACH) Model, a redesign of the Global and Professional Direct Contracting (GPDC) Model, addresses stakeholder feedback, participant experience, and Administration priorities, including CMS’ commitment to advancing health equity. 

In addition to transitioning the GPDC Model to the ACO REACH Model, CMS is canceling the Geographic Direct Contracting Model (also known as the “Geo Model”) effective immediately. The Geographic Direct Contracting Model, which was announced in December 2020, was paused in March 2021 in response to stakeholder concerns.

Good luck, CMS, with this new model.

Happy Washington’s Birthday

The

The National Archives informs us

George Washington was born in Virginia on February 11, 1731, according to the then-used Julian calendar. In 1752, however, Britain and all its colonies adopted the Gregorian calendar which moved Washington’s birthday a year and 11 days to February 22, 1732.

Americans celebrated Washington’s Birthday long before Congress declared it a federal holiday. The centennial of his birth prompted festivities nationally and Congress established a Joint Committee to arrange for the occasion.

Washington’s Birthday was celebrated [as a federal holiday] on February 22nd [from 1879] until well into the 20th Century. However, in 1968 Congress passed the Monday Holiday Law to “provide uniform annual observances of certain legal public holidays on Mondays.” By creating more 3-day weekends, Congress hoped to “bring substantial benefits to both the spiritual and economic life of the Nation.”

One of the provisions of this act changed the observance of Washington’s Birthday from February 22nd to the third Monday in February. Ironically, this guaranteed that the holiday would never be celebrated on Washington’s actual birthday, as the third Monday in February cannot fall any later than February 21.

Contrary to popular belief, neither Congress nor the President has ever stipulated that the name of the holiday observed as Washington’s Birthday be changed to “President’s Day.”

From the Omicron front, Medscape reports

Average daily COVID-19 cases and hospitalizations are continuing to fall in the U.S., providing a signal that the Omicron variant is receding across the country.

* * *

Deaths are also beginning to decline, with an average of about 2,100 daily, according to the data tracker from The New York Times. More than 2,500 daily deaths were being reported in early February.

Medpage Today adds

The Omicron sublineage BA.2, which raised alarms because of its transmission advantage, accounts for just 4% of cases in the U.S., and experts suggested it’s not likely to reverse the current downward trend of cases overall.

BA.2 has certainly increased in prevalence, but its been a slow trajectory, according to CDC data. BA.1.1, another Omicron sublineage, actually became the dominant strain in the U.S. in mid-January, the agency reported, with the original lineage, B.1.1.529, currently accounting for about 23% of U.S. cases.

“The BA.2 Omicron variant is increasing in prevalence slowly in both CDC and private data,” tweeted Scott Gottlieb, MD, former FDA commissioner and current Pfizer board member. “While it may become a dominant strain in time, it appears increasingly unlikely that it will cause a significant change in the downward trajectory of the current epidemic wave.”

That has certainly been the case for South Africa, where BA.2 accounts for nearly 100% of cases, according to Tulio de Oliveira, PhD, of the Centre for Epidemic Response & Innovation in Stellenbosch.

“This comes on a background of decreasing infections,” de Oliveira tweeted. The country now has a 7-day average of about 2,500 daily infections, down from a peak of about 23,000 in mid-December.

“At present, the Omicron BA.2 is not of great concern in South Africa,” he tweeted. “But our network is following very close and is alerted to its emergence.”

From the Covid vaccination mandate front, the Society for Human Resource Management reports that the U.S. Court of Appeals for the Fifth Circuit ordered the lower court to reconsider whether United Airlines vaccination mandate offered sufficient protection under Tittle VII to religious objectors.

From the No Surprises Act front, the American Hospital Association tells us

The Centers for Medicare & Medicaid Services will host a conference call for health care providers Feb. 23 at 2 p.m. ET on the No Surprises Act’s continuity of care, provider directory and public disclosure requirements. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov. A recording will be available after the call through Feb. 25 by dialing 866-373-4993.

The slide deck is quite detailed.

Healthcare Dive adds

The cost of being transported by ground ambulance has increased steadily over the past five years, according to a new report from nonprofit Fair Health, threatening patients with few protections from balance billing in disputes between insurers and ambulance providers.

More ambulance trips are billing payers for advanced life support ( ALS), denoting a higher level of care (and reimbursement) than basic life support (BLS) services. Private insurers’ average payments for those trips increased 56% between 2017 and 2020, from $486 to $758, according to the analysis. Before accounting for discounts negotiated with payers, the rate that ambulance operators charged for trips jumped 23% in the same time period and now average almost $1,300.

However, the average reimbursement for advanced life support ambulance rides climbed by 5% for patients covered by Medicare, from $441 to $463, suggesting the government program is keeping a lid on rising costs.

Although at this point only air ambulance charges are subject to the No Surprises Act, this type of report could lead Congress to expand the law to include ground ambulance charges.

From the medical research front, Biopharma Dive informs us

Eli Lilly is again upping its investment in genetic medicine, announcing Tuesday plans to establish a Boston research center that will use RNA- and DNA-based technologies to develop new drugs.

The Lilly Institute for Genetic Medicine will take up 334,000 square feet in Boston’s Seaport neighborhood, with occupancy slated to begin in 2024. Lilly, which has earmarked around $700 million for the project, expects the institute to grow from 120 employees to 250 within five years. Roles will include data scientists, chemists and research biologists with expertise in genetic medicine.

Alongside drug development, the institute will take a page from another Lilly venture — Lilly Gateway Labs — and offer shared lab and office space to support biotechnology startups in the area. Use of the shared space, Lilly said, could create as many as 150 additional new jobs once it’s fully occupied.

The National Institutes of Health announced

Women who had ever experienced sexual violence in their lifetime — including sexual assault and workplace sexual harassment — were more likely to develop high blood pressure over a seven-year follow-up period, according to findings from a large, longitudinal study of women in the United States. The research, funded by the National Institutes of Health and published in the Journal of the American Heart Association, indicated that sexual violence was a common experience, affecting more than 20% of the women in the sample.

“Our results showed that women who reported experiencing both sexual assault and workplace sexual harassment had the highest risk of hypertension, suggesting potential compounding effects of multiple sexual violence exposures on women’s cardiovascular health,” said Rebecca B. Lawn, Ph.D.(link is external), of the Harvard T. H. Chan School of Public Health, Boston, lead author on the study.

From the healthcare initiative front, the Centers for Disease Control detailed its Million Hearts 2027 initiative.

From the virtual care front, Healthcare IT News tells us

The American Medical Association, in conjunction with Manatt Health, published a report this week exploring the ways that virtual care and other digital tools can accelerate the adoption of the integrated delivery of behavioral and physical healthcare.  

In the report, the organizations note that behavioral health integration is essential for solving the country’s dire need for access to services.  

“The demand for behavioral health services is significant and rising, but so is the potential for digital technology to support the integrated delivery of physical and behavioral health services,” said AMA President Dr. Gerald Harmon in a statement.  

Moreover, in Health Affairs, the National Coordinator for Health Information Technology Micky Tripathi discusses delivering on the promise of health information technology in 2022.

From the healthcare business front, Healthcare Finance reports

The Department of Justice has until Saturday, February 27 to block the merger between UnitedHealth Group and Change Healthcare, according to a Securities and Exchange Commission filing on February 17.

The filing, by Change, was done in accordance with a timing agreement made with the DOJ. In November 2021, the two companies agreed not to consummate their merger before February 22. 

The timing agreement provides the DOJ with 10 days’ notice to sue to block the deal. 

“Effective February 17, 2022, UnitedHealth Group and the Company provided such notice to the DOJ,” Change said in the filing. “Accordingly, the DOJ now has until February 27, 2022 to initiate litigation to block the consummation of the merger.”

The DOJ is preparing the lawsuit to block UnitedHealth from purchasing Change, according to Seeking Alpha.

From the awards front

  • STAT News released its inaugural STATUS List which “recongizes standout individuals in health, medicine, and science. And although there are countless contenders to choose from, we’ve selected just 46 — an homage to the number of chromosomes in human DNA.”
  • OPM “announced a call for nominations for the 2022 Presidential Rank Awards (PRAs). A Presidential Rank Award is one of the most prestigious awards in the federal career civil service, and these awards are critical to recognizing the hard work and important contributions of dedicated civil servants in the American federal workforce. The awards – which recognize exceptional performance by members of the career Senior Executive Service (SES) and Senior Career Employees – reflect the Biden-Harris Administration’s commitment to supporting the federal workforce and recognizing federal employees who serve with distinction.” The nomination deadline is March 25, 2022.  

Thrsday Miscellany

Photo by Juliane Liebermann on Unsplash

From the Postal Reform front, health benefits expert Robert Moffitt, whose work the FEHBlog admires, wrote a column titled “It’s a bad idea to use the Medicare to bail out the Postal Service.” On this occasion, the FEHBlog finds himself in disagreement with Mr. Moffitt.

  1. Medicare is not bailing out the Postal Service. Since 1984, the Postal Service and its employees has paid and continues to pay Medicare taxes for its employees until they retire. At that point, Medicare becomes primary to FEHB and other group health coverage by law.
  2. Every other business in America that provides health benefits coverage to its retirees essentially follows the same approach as the Postal Service will be authorized to do by this bill.
  3. The Postal reform bill is unique in that it creates a special Part B enrollment period for current annuitants as of January 1, 2024, who have Part A but declined to enroll for Part B, an option which OPM encourages. Under the bill that that House passed this week, the Postal Service will bear the cost of the late enrollment penalties associated with this special enrollment period.
  4. Mr. Moffitt suggests that Postal Service Health Benefit Program (PSHBP) Medicare annuitants may find it necessary to purchase Medicare supplement insurance. However, we know from experience that PSHBP plans will follow the practice of existing FEHB plans and wrap their benefits around Medicare to fill those Medicare gaps. The PSHBP coverage is the Medicare supplemental coverage available to Medicare annuitants in FEHB and the PSHBP, and more tightly integrating PSHBP and Medicare coverage will result in lower premiums for all PSHBP enrollees.

Bear in mind that studies have shown the group health plans subsidize Medicare by making payments to healthcare providers that substantially exceed Medicare’s low reimbursements.

From the No Surprises Act (“NSA”) front —

  • CMS issued more FAQs on the federal independent dispute resolution (“IDR”) process today.
  • Consumer Reports identifies five healthcare scenarios which fall outside the scope of the No Surprises Act.
  • Fierce Healthcare brings us up to date on the healthcare provider association lawsuits challenging the federal government’s decision to treat the NSA’s qualifying payment amount as the lodestar in federal IDR arbitrations.

From the Omicron front, Medscape reports that “The U.S. government is planning to roll out COVID-19 shots for children under the age of 5 as soon as Feb. 21, according to a document from the U.S. Centers for Disease Control and Prevention. * * * Young children [beginning at six months] will receive a lower dose of the vaccine, if it is authorized. Pfizer/BioNTech tested a 3-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older.”

Also, the Department of Health and Human Services announced that “the federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge.”

From the COVID vaccine mandate front, Govexec tells us

A federal appeals court has denied the Biden administration’s request to undo the pause on its COVID-19 vaccine mandate for federal employees, leaving in place a ban on agencies enforcing the requirement. The U.S. Court of Appeals for the Fifth Circuit opted not to weigh in on the Justice Department’s petition for immediate relief, meaning the mandate will likely remain enjoined for at least several months. The only path for quicker resolution would be for the administration to appeal further tNBo the Supreme Court, an option it has not yet said it will explore. A Justice spokeswoman declined to comment. 

From the miscellany department

  • NIH News discusses advances in breast cancer screening and treatment.

The clipboard of paper forms that for decades has been a standard part of Americans’ doctor visits may soon be a thing of the past. 

Federal authorities who oversee health technology have set a deadline for December for the health care industry to support smartphone apps, like Apple Health, that store records electronically. 

Their goal is to have patients use their phones to electronically share records with a doctor’s office or hospital — without a pen and paper, if they choose. 

“Patients ought to be able to use the app of their choice,” said Micky Tripathi, who’s helping to put the federal rules in place as the Biden administration’s national coordinator for health information technology. 

“Every patient has the deep frustration of going to a hospital and they give you a clipboard and you have to fill out all the information, and then you go to another part of the same hospital and they give you the clipboard again,” Tripathi said. 

The FEHBlog has been reading articles about the demise of the clipboard throughout this century. However, he thinks that this worthy idea may soon come to fruition.

Thursday Miscellany

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

Photo by Patrick Fore on Unsplash

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

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

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

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

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

From the Covid vaccine front —

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

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

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

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

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

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

From the healthcare cost front, Healthcare Dive reports that

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

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

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

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

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

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

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

From the healthcare business front, Fierce Healthcare tells us that

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

The deal was first announced in September.

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

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

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

Thursday Miscellany

From the Omicron front, MedPage Today reports that

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

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

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

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

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

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

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

* * *

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

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

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

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

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

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

From the No Suprises front

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

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

The announcement reads in pertinent part that

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

And there you are, dear readers.

From the healthcare business front, Healthcare Dive informs us that

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

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

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

Fierce Healthcare adds

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

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

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

From the telehealth front, Fierce Healthcare reports that

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

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

* * *

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

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

Monday Roundup

Photo by Sven Read on Unsplash

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

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

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

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

Check it out.

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

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

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

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

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

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

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

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

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

From the free OTC tests front, Govexec.com asks

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

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

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

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

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

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

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

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

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

The CMS slides are helpful.

From the telehealth front, Fierce Healthcare tells us that

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

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

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

Thursday Miscellany

The American Hospital Association released its latest COVID Snapshot today.

Bloomberg adds that

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

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

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

From the Covid treatment front —

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

From the COVID testing front —

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

From the COVID vaccine mandate front, FedWeek reports that

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

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

From the Rx coverage front —

  • Drug Store News reports that

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

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

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

  • Fierce Healthcare tells us that

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

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

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

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

Monday Roundup

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

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.”