Midweek Update

Congress

Midweek Update

David Ermer–ACA, CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare, Wellness–
Photo by Manasvita S on Unsplash

From Capitol Hill, Roll Call reports

Democrats may need to make some changes to the tax portion of their budget reconciliation package to earn the support of Arizona Sen. Kyrsten Sinema, including possible removal of a tax increase on investment fund managers and softening a new minimum tax on the biggest corporations.

The bill could also undergo other tweaks as Senate Parliamentarian Elizabeth MacDonough continues her review of the bill. Changes to the prescription drug pricing provisions are already in the works, but many pieces of the package have yet to go through the formal “Byrd bath” to determine whether the language complies with budget rules.

Despite all the work still underway, several Democratic senators said they anticipated voting on the motion to proceed to the reconciliation package as soon as Thursday and beginning the “vote-a-rama” process, in which senators can offer unlimited amendments to the measure, as soon as this weekend. 

“As soon as possible, but don’t count on going home on the weekend,” Michigan Sen. Debbie Stabenow, a member of Democratic leadership, said. “We’re probably going to be here all weekend, so get lots of sleep.

From the OPM front, Federal News Digest tells us

The Office of Personnel Management is getting a second in command.

President Joe Biden nominated Rob Shriver to be the OPM deputy director on Aug. 3. * * *

Shriver is a political appointee already, having been the associate director for employee services since January 2021.

If confirmed by the Senate, Shriver would be OPM’s first deputy director since Michael Rigas, who held the job from March 2018 to January 2021, but worked in other administration positions from March 2020 until January 2021.

From the Omicron and siblings front —

Bloomberg informs us

[Israeli] Hospital workers who got a fourth dose of Pfizer Inc.’s messenger RNA vaccine were far less likely to get Covid than triple-vaccinated peers in a study. 

The findings published Tuesday in the American Medical Association’s open access journal are the latest to confirm the benefits of a second booster against breakthrough infections caused by omicron. The study’s authors pointed to an extra dose as a tool to prevent medical staff shortages and spare health systems in times of strain.  * * *

Doctors, nurses and other health-care workers who got a fourth mRNA shot in January showed a 7% rate of breakthrough infections. Those with three doses — the third having been administered by the end of September — saw an infection rate of 20%.  

The Department of Health and Human Services released two reports on long Covid to support patients and further research.

From the monkeypox front

  • Beckers Hospital Review explains that the Centers for Disease Control have released isolation guidance “as cases near 6,000.”

The New York Times delves into various aspects of the disease, including what people can do the stay safe.

From the U.S. healthcare business front

Healthcare Dive reports

CVS Health raised its full-year guidance in its second quarter earnings report despite a $77 million decrease in adjusted operating income primarily due to declines in its retail segment.

The company’s Aetna subsidiary boosted earnings with reported gains of 922,000 covered lives compared to the second quarter of last year and growth in all product lines contributing to a nearly 11% rise in revenues year over year.

Adjusted operating income was 9.1% lower in its retail division compared to the year prior due to a decrease in coronavirus vaccinations, “continued pharmacy reimbursement pressure” and the lack of an antitrust legal settlement gain that was recorded in the second quarter last year, according to the earnings report. * * *

In its race to add more primary care services, the executive team further teased acquisition plans, with [CVS Health CEO Karen] Lynch adding that the company could take the “next step on this journey” by the end of this year.

“We can’t be in … primary care without M&A. We’ve been very clear about that,” Lynch said.

[Larry] McGrath [CVS Health senior vice president of business development and investor relations] added that the company has been active in evaluating a wide range of assets around the care delivery space. CVS also signaled that it could potentially pursue multiple acquisitions, adding that there was “no one and done asset” in the market.

Biopharma Dive informs us

Gilead’s cell therapy business outperformed Wall Street expectations during the second quarter. The unit — which currently consists of two products, Yescarta and Tecartus, used to treat various blood cancers — generated $368 million in the three-month period, an increase of 68% year over year, earnings numbers released Tuesday show.

Key to that growth was a recent, first-of-its-kind approval from the Food and Drug Administration. In April, the agency cleared Yescarta as a so-called second line therapy for large B-cell lymphoma that resists or returns within a year of initial treatment with chemoimmunotherapy. Before, Yescarta was used only when patients either relapsed after or hadn’t responded to at least two other kinds of therapies.

Fierce Healthcare adds

CivicaScript’s first product is hitting the market.

The public benefits company and sister to Civica Rx is making its first generic available: 250-mg abiraterone acetate tablets. The drug is used in combination with the steroid medication prednisone as a treatment for prostate cancer that has spread to other parts in the body.

CivicaScript will make the drug available to pharmacies at $160 per bottle of 120 tablets, a typical one-month supply. The company suggests pharmacies sell it to patients at no more than $171 for each bottle. This price is about $3,000 less per month than the average cost for people enrolled in Medicare Part D, which is the largest portion of patients with this type of cancer.

Using CivicaScript’s abiraterone will lead to significant savings for patients both in the deductible phase and in the Part D “donut hole,” where they face the highest out-of-pocket costs, the company said in an announcement (PDF). * * *

“We’re proud the first lower-cost generic drug of our partnership with CivicaScript is entering the market,” said Kim Keck, president and CEO of BCBSA. “This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication.”

From the Affordable Care front, Prof. Katie Keith takes a deep dive into last week’s ACA FAQ 54 on mandated contraceptive coverage under that law.

From the research front —

Benefits Pro points to

A survey of nearly 2,500 U.S. healthcare consumers by PYMNTS.com offered more proof that this remains a barrier to consumer trust of the healthcareThe survey revealed that many consumers continue to under budget for their health care –probably because most have little idea about the cost of various procedures and appointments. * * *

For instance, nearly 20% of those surveyed said they “experienced financial distress due to health care costs because they spent more than they could afford in the past 12 months.” A quarter of respondents who said their advance notice cost estimates were accurate said they still spent more than they could really afford. Not surprisingly, 43% of those who received inaccurate cost estimates said they spent more than they could afford. system. PYMNTS.com, a provider of data, news and insights on innovation in payments and the payment-related, conducted the survey to learn how many respondents fell into the unexpectedly high and inaccurate estimate category, and what the outcome for them was in the aftermath. * * *

Medscape reports

Regular exercise, regardless of intensity level, appears to slow cognitive decline in sedentary older adults with mild cognitive impairment (MCI), new research from the largest study of its kind suggests.

Topline results from the EXERT trial showed patients with MCI who participated regularly in either aerobic exercise or stretching/balance/range-of-motion exercises maintained stable global cognitive function over 12 months of follow-up — with no differences between the two types of exercise.

“We’re excited about these findings, because these types of exercises that we’re seeing can protect against cognitive decline are accessible to everyone and therefore scalable to the public,” study investigator Laura Baker, PhD, Wake Forest University School of Medicine, Winston-Salem, North Carolina, said at a press briefing.

The topline results were presented at the Alzheimer’s Association International Conference (AAIC) 2022.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID treatment, COVID-19, Federal employment benefits, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

Roll Call reports from Capitol Hill

More than 3.5 million veterans who were exposed to toxic substances on overseas deployments will gain easier access to health and disability benefits under a bill that cleared the Senate Tuesday.

President Joe Biden is certain to sign the bill into law in the coming days.

The bill would make servicemembers who contracted any of 23 conditions — from brain cancer to hypertension — after being deployed to Iraq, Afghanistan and other combat zones automatically eligible for VA benefits. The measure is expected to cost nearly $280 billion over a decade, according to the Congressional Budget Office.

This law should save the FEHB Program money as the federal workforce has a large cadre of veterans who use veterans’ healthcare. VA facilities charge the FEHB and private sector plans for non-service connected health care. This law confirms that toxic substances treatment to service-connected care for which the VA is liable.

Govexec adds

The [VA] bill [also] authorizes leases for 31 new medical facilities at VA to help accommodate the expected surge in patients, which is expected to cost nearly $1 billion. The Congressional Budget Office found the slew of pay and other human resources changes would come with a $5.7 billion price tag over the next decade.

The bill will authorize the department to buy out the contract of health care professionals to recruit them to VA, so long as they make a four-year commitment to the department. VA will have $40 million per year for the buyouts. VA’s health care employees will be eligible for pay boosts worth 50% of their base salaries, up from the current cap of 30%. Overall pay would be capped at level two of the Executive Service pay scale, which is currently $203,000 per year. McDonough has called lifting the pay caps essential for VA’s recruiting and retention efforts and has aggressively pushed Congress to pass the reform.

With regard to the Schumer-Manchin reconciliation bill, the Hill reports that Senators Manchin and Simema are exchanging text on the bill.

From the Omicron and siblings front,

McKinsey and Company offer their assessment of when the Covid pandemic will end.

In this update, we discuss the outlook, the current and potential future use of boosters and therapeutics, and the shifts in response strategies to the COVID-19 crisis around the world. We also introduce the McKinsey COVID-19 Immunity Index—a tool for understanding a community’s current level of risk from the disease.

A group of physicians provides their observations in MedPage Today on how best to investigate the Paxolovid rebound issue.

The debate about “COVID-19 rebound” after nirmatrelvir/ritonavir (Paxlovid) treatment is one of these timely areas warranting further investigation. Continuing down the current path of uncertainty has consequences for how and by whom this antiviral should be used. However, by applying lessons learned from the early days of the pandemic — including acknowledging the importance of randomized controlled trials (RCTs) — we can avoid repeating the same mistakes. To do this, it is necessary to start by defining the question, identifying current knowledge gaps, and only then can one propose scientific solutions to bring a rapid resolution to the COVID-19 rebound controversy.

Paxlovid consists of two drugs: nirmatrelvir, which inhibits a SARS-CoV-2 protease inhibiting viral replication, and ritonavir, which slows the inactivation and breakdown of nirmatrelvir. Per a CDC health advisory released in May, COVID-19 rebound is defined as a return of symptoms or a “new positive viral test after having tested negative” occurring “2 to 8 days after initial recovery.” We just saw this over the weekend in the case of President Biden.

This definition of rebound is challenging and prone to inflating the incidence of rebound. It is possible some individuals identified as having “Paxlovid rebound” may have been experiencing a waxing and waning of COVID-19 symptoms while some unknown number of other reported rebound cases could be due to the known limitations of COVID-19 testing.

Precision Vaccinations tells us that in the near future the federal government will make the Omicron antibody based treatment known as Evusheld available through local pharmacies including “Albertsons, Acme, Jewel-Osco, Pavilions, Randalls, Safeway, Star Market, Vons, CPESN, Amber Specialty Pharmacy, Managed Healthcare Associates, and Thrifty White.”

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK, and TACKLE principal investigator, commented in a press release, “Despite the success of vaccines, many individuals such as older adults, individuals with co-morbidities, and those who are immunocompromised, remain at risk for poor outcomes from severe COVID-19.”

“Additional options are needed to prevent disease progression and reduce the burden on healthcare systems, especially with the continued emergence of new variants.”

“The TACKLE (study) results show that one intramuscular dose of Evusheld can prevent these individuals from progressing to severe COVID-19, with earlier treatment leading to even better results.”

From the moneypox front, Fierce Healthcare reports

The White House has named Robert Fenton to serve as the response coordinator for the monkeypox outbreak, as calls for a larger federal role intensify. 

Fenton previously helped to coordinate COVID-19 vaccine distribution while working at the Federal Emergency Management Agency. He will work alongside Demetre Daskalakis, M.D., who will be the deputy coordinator. 

The coordinators will lead the administration’s efforts on “strategy and operations to combat the current monkeypox outbreak, including equitably increasing the availability of tests, vaccinations and treatments.” 

From the Affordable Care Act front, the International Foundation of Employee Benefit Plans informs us

The Internal Revenue Service (IRS) has issued Revenue Procedure 2022-34 providing the indexing adjustment for the required contribution percentage. For plan years beginning in 2023, the required contribution percentage is 9.12%, down from 9.61% in 2022. 

The affordability calculation can determine whether an individual can afford employer-sponsored health coverage and affect whether the individual would be eligible for a premium tax credit on the health insurance exchanges. This could affect employers that do not use a safe harbor method to determine whether the coverage they offer is affordable to employees.

For plan years beginning in 2023, employer-provided coverage is considered affordable for an employee if the employee required contribution is no more than 9.12% of that employee’s household income. Because applicable large employers generally do not know their employees’ household incomes, there are three safe harbor methods for calculating affordability.

In the FEHB Program, OPM must assure itself that the lowest premium nationwide FEHB plan premium for the self only option does not cost more than 9.12% of the lowest paygrade federal employee eligible to participate in FEHBP.

From the FEHB front, Fedweek columnist Reg Jones wraps up his series of federal employee and annuitant survivor benefits.

From the Medicare front, Healthcare Dive reports on provider reaction to yesterday’s final CMS rule on Medicare Part A payments to inpatient hospitals beginning October 1, 2022.

Providers remained largely unhappy early this week despite a final ruling issued by the CMS on Monday that increases inpatient payments to hospitals by more than was initially proposed.

Organizations like The American Hospital Association said it was “pleased” by the payment update, a 4.3% bump up from the proposed 3.2%, but added it “still falls short of what hospitals and health systems need to continue to overcome the many challenges that threaten their ability to care for patients and provide essential services for their communities.”

Group purchasing organization Premier agreed, saying the payment update “falls woefully short” of what is needed for health systems. “Coupled with record high inflation, this inadequate payment bump will only exacerbate the intense financial pressure on American hospitals,” SVP of Government Affairs Soumi Saha said in a statement.

Beckers Hospital review offers six takeaways from the final rule.

From the U.S. healthcare business front

Healthcare Dive reports

High operating expenses took their toll on hospitals and physician groups in June, producing negative year-over-year margins for a sixth consecutive month, a new report from Kaufman Hall found. Month-to-month increases in patient volumes were not enough to offset the growing cost of care, the advisory firm said Monday.

Compared with May, operating margins improved, contract labor costs fell as demand slowed, and expenses cooled slightly in the latest month. But the industry has yet to turn the corner on an “enormously difficult year,” the report said.

“Although hospitals are seeing improved volumes and reduced expenses month-over-month, they will likely end up with historically low margins for the remainder of the year,” Kaufman Hall predicted.

and

Louisiana-based Ochsner Health has officially merged with Rush Health Systems, giving the merged system seven hospitals and more than 30 clinics in the east Mississippi and west Alabama region, according to a Monday release.

New names and branding are being rolled out at regional hospitals under the new brand, Ochsner Rush Health, the release said. Ochsner Rush Health will have 250 staff and contracted physicians and 95 advanced practice providers.

Ochsner Rush Health is also boosting its minimum wage to $12 an hour, impacting more than 400 employees and representing a $1.5 million investment, according to the release.

From the public health front,

  • Healio offers a bleak outlook for chronic disease in the US over the next forty years “likely stressing an already burdened health care system.”
  • The Center for Disease Control points to its revamped diabetes website “for people with diabetes or who are at risk for diabetes, and their families and friends.”

From the judicial front,

STAT News tells us

In a significant victory for AbbVie, a U.S. appeals court panel declined to revive a lawsuit that accused the company of using a so-called patent thicket to forestall competition for its Humira medication, a franchise product that generates billions of dollars in sales each year.

The opinion shot down arguments by unions, insurers, and the city of Baltimore, which alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar competition” by filing dozens of patents for the drug. Some of the 132 U.S. patents that the company holds on its medicine extend to 2034, although the basic patent expired in 2016.

The case has been closely tracked over concerns that the use of numerous patents — some of which may offer only marginal improvements or changes to a medicine — are exploited by pharmaceutical companies to protect monopolies at the expense of consumers. This has prompted the Food and Drug Administration and Patent and Trademark Office to jointly examine the issue.

Congress can change the patent system applicable to prescription drugs.

The American Hospital Association reports

The Department of Justice today filed a lawsuit challenging an Idaho law restricting abortion. The complaint seeks a declaratory judgment that the law conflicts with and is preempted by the Emergency Medical Treatment and Labor Act in situations where an abortion is necessary stabilizing treatment for an emergency medical condition. It also seeks an order permanently enjoining the law to the extent it conflicts with EMTALA, which requires hospitals that receive federal Medicare funds to provide necessary stabilizing treatment to patients who arrive at their emergency departments while experiencing a medical emergency.

The FEHBlog hopes that the federal court hearing the case seeks a decision from the Idaho Supreme Court on the scope of Idaho’s abortion law before proceeding with the case. The FEHBlog finds it hard to believe that any U.S. court would interpret its state’s abortion law as overriding obligations created by EMTALA and for that matter the Hippocratic Oath.

Monday Roundup

David Ermer–CMS, Congress, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Capitol Hill front, the Hill reports

Senate Democrats are growing more anxious over maverick Sen. Kyrsten Sinema’s (D-Ariz.) five-day silence on a sweeping proposal to reform the tax code, tackle climate change and reduce the federal deficit.

Democratic lawmakers are privately worried that Sinema’s not happy about being left out of the negotiations between Senate Majority Leader Charles Schumer (D-N.Y.) and centrist Sen. Joe Manchin (D-W.Va.), which resulted in a surprise announcement last week of a major deal.   

Govexec.com reports on the Republican response to the Senate Appropriations Committee’s release of its twelve fiscal year 2023 appropriations bills last week.

From the Medicare front, Fierce Healthcare informs us

The Biden administration finalized a 4.3% bump for inpatient payments for the federal fiscal year 2023, an increase compared to the 3.2% that was originally proposed back in April. 

The Centers for Medicare and Medicaid Services released on Monday the final Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System rule that updates payments to hospitals. The rule also details health equity quality measures hospitals must now meet for participation in the Inpatient Quality Reporting program. 

Here’s a link to the CMS fact sheet on this final rule.

Revcycle Intelligence tells us that last week “CMS released FY23 final rules for hospice providers, inpatient psychiatric facilities, and inpatient rehabilitation facilities. The final rules for fiscal year 2023 include a 3.8% payment increase for hospice providers, 2.5% increase for inpatient psychiatric facilities, and 3.2% boost for inpatient rehabilitation facilities.

Also, last week, CMS released the FY 2023 final rules for skilled nursing facilities. The rule represents a 2.7% payment increase for SNFs.

Fierce Healthcare adds “CMS said Friday [July 29] that it expects the average premium to decrease to $31.50 in 2023, or about 1.8% from the 2022 rate of $32.08.

From the healthcare quality front, the National Committee for Quality Assurance released its Measurement Year 2023 HEDIS and CAHPS guidelines today. NCQA made publicly available a list of adds, drops and other significant changes for MY 2023.

From the U.S. healthcare business front, Bloomberg reports

Labcorp, a diagnostics and laboratory company, is spinning off its clinical trials division into a separate publicly traded company.

Labcorp will house the company’s existing global laboratory business while the new company will manage clinical trials for drug companies. Management said in a release Thursday [July 28] that this structure will allow each division more flexibility to grow within their individual markets.

From the post-Dobbs front, Healthcare Dive tells us

Abortion access nonprofit Just the Pill plans to build a fleet of mobile clinics offering mobile procedural abortion “for the first time in U.S. history,” the nonprofit said. * * *

The group currently operates two mobile clinics in Colorado and plans to build out its network of vans and deploy them in states where abortion is legal but surrounding states have banned the procedure, such as New Mexico, Pennsylvania and Illinois.

“Our mobile clinics will travel to parts of these states based on where the need is greatest,” Julie Amaon, medical director of Just The Pill, told Healthcare Dive. * * *

Mobile health clinics have been held up as an avenue to cut costs and expand healthcare access, especially in underserved or marginalized communities. One 2009 Boston study found that a mobile health clinic, The Family Van, had a return on investment of $36 for every $1 invested in the program. Mobile clinics can also provide primary and preventative care, an important feature given that many regions in the U.S. lack healthcare access.

Currently, there are an estimated 2,000 mobile clinics in America, providing almost 7 million visits each year.

From the wellness front, Morning Consult provides advice on offering wellness services to younger employees.

While benefits like annual raises and an employee assistance program (EAP) with appointment limits have been alluring, these perks are now expected by many Millennial and Gen Z employees, who will soon make up 75% of the U.S. workforce. 

Improving hiring and retention for the shifting workforce starts with understanding the core values that drive younger generations to join, or leave, organizations in the first place – and that’s health and mental well-being, as a whopping 83% of employees place their benefits as a main deciding factor in whether they will stay at their current job.

As a baby boomer, the FEHBlog prefers to refer to the younger crowd as Zoomers over Gen Z.

From the medical research front —

Medscape reports “A simple blood test that looks for a combination of specific RNA snippets may become a novel way to screen for early-onset colorectal cancer, suggests a new study published online in Gastroenterology.”

“The point would be to use this test as a routine part of annual healthcare, or for people in high-risk families every 6 months,” study senior author Ajay Goel, PhD, MS, chair of the Department of Molecular Diagnostics and Experimental Therapeutics at the City of Hope Comprehensive Cancer Center, Duarte, California, told Medscape Medical News.

“It’s affordable, it can be done easily from a small tube of blood, and as long as that test stays negative, you’re good,” Goel said, because even if patients miss a test, the next one, whether it’s 6 months or a year later, will catch any potential cancer.

Health IT Analytics informs us

A study published this week in Nature Communications shows that an automated clinical decision support tool for genetic disease diagnosis and treatment can provide accurate results and disease management guidance within 13.5 hours.

The tool, known as Genome-to-Treatment (GTRx), is a virtual disease management system that integrates whole genome sequencing to provide diagnostics and guidance for 500 diseases, according to a press releasediscussing the study’s findings. The study was completed in collaboration with multiple organizations, vendors, and health systems.

The study states that the 7,200 genetic disorders currently known to medical science result in high levels of morbidity and mortality in children, specifically in neonatal, pediatric, and cardiovascular patients. Approximately 140 million children worldwide suffer from rare genetic diseases, and experts estimate that 30 percent of them will not survive until their 5th birthday.

From the miscellany department, STAT News asks why monkeypox does not have a new name yet. The FEHBlog wonders if monkeypox’s name is changed, then what’s next chickenpox? swine flu?

Weekend Update

David Ermer–CDC, Congress, COVID-19, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

While the House of Representatives starts its August recess / District work break this week, the Senate will remain in session for Committee business and floor voting. The Senate will be focusing on its reconciliation bill spurred by a compromise between Senate Majority Leader Chuck Schumer (D NY) and Sen. Joe Manchin (D WV). The Senate is scheduled for to begin its August recess / State work break next week.

Bloomberg reports that tomorrow the Justice Department’s antitrust case against Optum’s proposed merger with Change Healthcare begins in federal district court in Washington, DC. The Bloomberg article notes

Testing new theories in court is part of the Biden administration’s antitrust push. “Settlements do not move the law forward,” Jonathan Kanter, the Justice Department’s antitrust chief, said in a January speech. “We need new published opinions from courts that apply the law in modern markets in order to provide clarity to businesses.”

Last Friday, the FEHBlog linked to a Health Payer Intelligence article on anticipated premium spikes for 2023.

Fierce Healthcare adds

Executives from some of the country’s largest for-profit health systems say it’s likely their organizations will be able to pass rising cost pressures along to commercial insurers during the next round of contract negotiations. * * *

Looking to the coming year’s commercial negotiations, [Sam] Hazen said HCA has already seen “some early success and recognition by the payers” and that some of its recently renegotiated contracts reflected higher price escalation than those of the past.

“I think it’s reasonable to assume that we were in 3.5% to 4% zone previously with our commercial pricing,” he told investors. “We’re in a competitive positioning as a company globally and that allows us to negotiate based upon the inflationary pressures. … I believe our relationships will allow us to get to a number that makes sense for both organizations, but I do anticipate it being somewhere around the mid-single-digits.”

Universal Health Services Chief Financial Officer Steve Filton said his company is “aggressively” looking to trim under-earning managed care contracts and seek out higher prices in the coming year.

Both its acute and behavioral care hospitals are identifying contracts that “are not even remotely” keeping pace with inflationary and labor pressure and giving those payers notice of terminations “at a pace faster than, quite frankly, I can really remember,” he told investors.

What’s more, the Wall Street Journal catalogs the large array of costly healthcare problems that “have grown in the pandemic’s shadow.”

It’s also worth calling attention to

  • An NPR article reporting on an animal sedative xylazine that is now “is showing up in illegal street drugs up and down the East Coast.” What a mess.
  • A Kaiser Family Foundation article explaining how the CDC is handling a polio case that paralyzed a man in a vaccine-resistant community in Rockland County, NY.

The chances of a major outbreak tied to the Rockland County case are slim. The virus can spread widely only where there is low vaccine coverage and poor surveillance of polio cases, said Dr. David Heymann, a professor of epidemiology at the London School of Hygiene and Tropical Medicine and former director of the world’s polio eradication effort.

Rockland County has ample experience battling vaccine-preventable outbreaks. In 2018 and 2019, the county fought a measles epidemic of 312 cases among followers of anti-vaccine Hasidic rabbis.

“Our people defeated measles, and I’m sure we’ll eliminate the latest health concern as well,” County Executive Ed Daly told a news conference July 21.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, Medicare, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.

The Hill adds that

A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.

Both articles discuss the flies remain in the reconciliation ointment.

Govexec informs us

The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.

Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.

From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.

The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.

On a related note, Healthcare Dive tells us

Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.

From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.

If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity.  * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.

From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.

From the monkeypox front, Reuters makes two reports

  • The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.
  • The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.

From the U.S. healthcare business front —

The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.

Healthcare Dive reports

Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.

But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.

STAT News chimes in

Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.

“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.

Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.

Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”

Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.

Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Telehealth, U.S. Healthcare–

From Capitol Hill —

The Wall Street Journal reports

Sen. Joe Manchin (D., W.Va.) agreed to back a package aimed at lowering carbon emissions and curbing healthcare costs while raising corporate taxes, marking a stunning revival of core pieces of President Biden’s economic and climate agenda that the West Virginia Democrat had seemingly killed earlier this month. 

The deal, negotiated privately between Messrs. Manchin and Senate Majority Leader Chuck Schumer (D., N.Y.) since the start of last week, would raise roughly $739 billion, with much of the revenue coming from a 15% corporate minimum tax and enhanced tax enforcement efforts at the Internal Revenue Service, as well as projected savings from allowing Medicare to negotiate some prescription-drug prices.

Of that new revenue, roughly $369 billion would be spent on climate and energy programs, with another $64 billion dedicated to extending healthcare subsidies for three years for some Affordable Care Act users. The bill would dedicate the rest of the new revenue toward reducing the deficit, according to a summary provided by Messrs. Schumer and Manchin. * * *

The deal will still need the support of almost every other Democrat in Congress. Passing the agreement into law will test Mr. Schumer and the ability of House Speaker Nancy Pelosi (D., Calif.) to convince an ideologically diverse group of lawmakers to accept a deal announced by one of the party’s most conservative members. 

The announcement of a deal on Wednesday appeared to catch other Democrats off guard.

The Hill informs us

The House passed a bill Wednesday to expand telehealth services that were first introduced during the COVID-19 pandemic.

The legislation, titled the Advancing Telehealth Beyond COVID–19 Act, passed in a 416-12 vote. Eleven Republicans and one Democrat objected to the measure. Two Republicans did not vote.

The measure seeks to continue a number of telehealth policies established under Medicare that were first implemented at the beginning of the COVID-19 pandemic. If passed by the Senate and signed into law, the provisions would continue through 2024.

Fierce Healthcare adds

A key House panel advanced legislation to create an electronic prior authorization process for Medicare Advantage plans and several other reforms.

The House Ways and Means Committee unanimously advanced on Wednesday the Improving Seniors Timely Access to Care Act of 2022. The legislation has more than 300 co-sponsors and wide support across the healthcare industry.

From the Omicron and siblings front, Medpage Today asks “Can I boost with Novovax?”

While the Novavax shot is not yet authorized by the FDA as a booster, several experts told MedPage Today it could be headed that way.

“Probably the best niche now for Novavax’s purified protein vaccine is as a booster strategy for mRNA vaccines,” Paul Offit, MD, of Children’s Hospital of Philadelphia, who served on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Novavax, told MedPage Today.

Robert “Chip” Schooley, MD, an infectious disease expert at the University of California San Diego who has served on VRBPAC in the past, said since there “aren’t many people left who have been neither vaccinated nor infected … it will likely be mainly used as a booster.”

NPR Shots tells us

The Biden administration may scrap plans to let more younger adults get second COVID-19 boosters this summer. Instead, officials are trying to speed up availability of the next generation of boosters in the fall, NPR has learned.

The new strategy is aimed at trying to balance protecting people this summer with keeping people safe next winter, when the country will probably get hit by yet another surge.

But the possible shift is being met with mixed reactions. The Food and Drug Administration could make a final decision by the end of the week. 

The dilemma facing the FDA is that the immunity many people have gotten from getting vaccinated or infected has been wearing off. At the same time, the most contagious version of the virus to emerge yet — the omicron subvariant BA.5 — is making people even more vulnerable.

So as COVID is starting to become more serious than a cold or flu again, most people younger than age 50 aren’t eligible for fourth shots — second boosters — to protect themselves. In response, the FDA was considering opening up eligibility for second boosters for all adults.

But letting more people get boosted with the original vaccine now could interfere with plans to boost them with updated, hopefully more protective vaccines in the fall to blunt the toll of the winter surge. 

It’s quite a conundrum for the experts.

From the monkeypox front

  • NPR provides a helpful FAQ on the disease.

The Centers for Disease Control and Prevention (CDC) has expanded access to vaccines, tests, and treatments for monkeypox, agency officials said in a webinar Tuesday.

The CDC expects to release more than 750,000 doses of the JYNNEOS vaccine from its strategic stockpile within days, said panelists at the Clinician Outreach and Communication Activity (COCA) call.

In addition, by working with commercial labs, the agency has expanded US testing capacity and streamlined requirements for administering the antiviral tecovirimat, they said.

Encouraging news from the HIV front. The Wall Street Journal reports

A 66-year-old man in Southern California and a woman in her 70s in Spain are the latest in a small group of people who appear to have beaten their HIV infections, providing researchers new clues to a possible cure at a time when Covid-19and other crises are slowing progress against the spreading virus.

Doctors caring for the man said they haven’t found any human immunodeficiency virus that can replicate in his body since he stopped antiretroviral drug therapy in March 2021 after a transplant of stem cells containing a rare genetic mutation that blocks HIV infection. He was given the transplant for leukemia, for which people with HIV are at increased risk. Details of his case were made public Wednesday and will be presented at a large international AIDS conference in Montreal that opens Friday.

“He saw many of his friends and loved ones become ill and ultimately succumb to the disease and had experienced some stigma associated with having HIV,” she said. His success “opens up the opportunity potentially for older patients to undergo this procedure and go into remission from both their blood cancer and HIV.

Also from the medical research front, STAT News informs us

[F]or several years, a small New Haven, Conn.-based startup has quietly been building technology to move the needle on suicide rates among the people at highest risk: those with a history of attempts or who have suicidal thoughts and have expressed a strong desire to die.

The company, called Oui Therapeutics, has raised roughly $26 million from high-profile investors like CVS Health Ventures and First Round Capital to develop and launch an app designed to train people how to quell their suicidal impulses. It pulls from in-person therapy methods that have shown dramatic reductions in suicide attempts — nearly 60% — in a randomized trial of soldiers at high risk. * * *

If the research bears out and the app secures buy-in from regulators, it could become a powerful tool in curbing suicide, which kills over 45,000 people in the U.S. each year. Oui is part of a broader constellation of efforts — including a new national suicide prevention hotline number and the development of prevention frameworks like Zero Suicide — in recent years that aim to address rates that have risen stubbornly high.

Fingers crossed for both worthy efforts.

From the Medicare front, Beckers Hospital Review reports

CMS updated its Overall Hospital Quality Star Ratings for 2022, giving 429 hospitals a rating of five stars.

CMS assigned star ratings to hospitals nationwide based on their performance across five quality categories. This year:

* 192 hospitals received a one-star rating

* 692 hospitals received a two-star rating

* 890 hospitals received a three-star rating

* 890 received a four-star rating

* 429 received a five-star rating

The article lists all of the five star hospitals by state.

From the U.S. healthcare business front, Healthcare Dive tells us

Humana raised its profit estimates for the full year after reporting lower than expected medical costs during the second quarter.

“The lower utilization trends and lack of COVID headwinds seen to date, give us confidence in raising our full year adjusted [earnings per share] guide,” Humana CFO Susan Diamond said Wednesday on a call with investors.

Humana’s net income increased 18% to $696 million for the second quarter as the Louisville-based insurer recorded increased revenues of $23.6 billion amid enrollment growth in both Medicare and Medicaid.

The insurer noted lower inpatient utilization among Medicare members for Q2.

But the lower-than-anticipated inpatient utilization has been partially offset by higher unit costs, Diamond said. * * *

The company’s total medical membership of 17.1 million was up 0.8% year over year.

As the company continues on its value creation plan to trim $1 billion in costs, Humana said it will restructure its organization into two distinct units as it looks to simplify the company’s overall organization.

Revcycle Intelligence reports on how healthcare spending varies by region and payer type.

There is substantial variation and low correlation in healthcare spending across Medicare, Medicaid, and private insurance plans within different US regions, a study published in JAMA Network Open found.

The US spends around $3.8 trillion per year on healthcare funded by Medicare, Medicaid, and private insurers. However, spending and healthcare utilization are rarely the same for all three payers. * * *

Healthcare spending per beneficiary varied across payers. The mean private insurance spending per beneficiary was $4,441, while the Medicare mean was $10,281, and the Medicaid mean was $6,127 per beneficiary. The overall mean for the three payers was $5,782 per beneficiary.

Medicaid had the most variation in spending per beneficiary across the [241 hospital referral regions] HRRs, with a coefficient of variation of 0.233, according to the study. Private insurance had a coefficient of variation of 0.160 and Medicare had a coefficient of variation of 0.126.

Medicaid and private insurance plans likely saw more variation in spending than Medicare because Medicare relies on regulated payments to hospitals, while Medicaid and privately insured prices are generally determined by the region’s market.

In addition to spending variation among the payers individually, there was low spending correlation within regions across all three payers.

For example, the correlation coefficient between HRR level spending was 0.020 for private insurance and Medicare, 0.213 for private insurance and Medicaid, and 0.162 for Medicare and Medicaid.

Tuesday Tidbits

David Ermer–CMS, Congress, COVID-19, U.S. Healthcare–

From Capitol Hill, EndPoints News reports

Photo by Patrick Fore on Unsplash

A bill that would cap out-of-pocket insulin costs for the insured at $35 per month remains in limbo as the Congressional Budget Office told the two Senate sponsors of the bill that it will likely increase net prices for insulin, and will increase premiums for commercial health insurance and Medicare Part D.

The comments from the CBO may spell the end for the bill, which is effectively a Band-Aid for a segment of the pharma market that has ballooned in recent years, driving many to ration their life-saving drug.

“Spending for insulin and other pharmaceutical products would increase, CBO estimates, because overall medication use would increase in response to lower cost-sharing requirements,” CBO director Phillip Swagel wrote to Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) on Friday. “Some use of insulin might also shift to newer and more expensive insulin products. Increased spending for pharmaceutical products would result in increased spending for health care overall.”

STAT News adds

Democrats are closer than ever before to finally achieving a goal they’ve been pursuing for nearly two decades — allowing Medicare to negotiate prescription drug prices. Skeptical lawmakers seem to be on board; the bill text is already under review by the Senate’s rules referee. Congressional leadership and the White House have come up with a plan to barrel toward a vote that could come as soon as next week.

Drugmakers, in turn, are intensifying their opposition efforts.

From the Omicron and siblings front

The Wall Street Journal informs us

Charley Ding spent weeks early in the pandemic intubating patients sick with Covid-19. The 42-year-old anesthesiologist in South Barrington, Ill., said he has since watched most of the doctors and nurses he works with get infected at some point.

But he has never gotten Covid-19, he said. “It’s probably a combination of being careful, maybe being blessed with a good immune system,” he said. “But also just luck.”

Dr. Ding is a member of a shrinking club of people who are pretty sure they have never been infected with SARS-CoV-2, the virus that causes Covid-19. Geneticists and immunologists are studying factors that might protect people from infection, and learning why some are predisposed to more severe Covid-19 disease.

For many, the explanation is likely that they have in fact been infected with the virus at some point without realizing it, said Susan Kline, professor of medicine at the University of Minnesota Medical School. About 40% of confirmed Covid-19 cases are asymptomatic, according to a meta-analysis published in December in the Journal of the American Medical Association.

More than two years into the pandemic, most people worldwide have likely been infected with the virus at least once, epidemiologists said. Some 58% of people in the U.S. had contracted Covid-19 through February, the Centers for Disease Control and Prevention has estimated. Since then, a persistent wave driven by offshoots of the infectious Omicron variant thas kept daily known cases in the U.S. above 100,000 for weeks. 

As someone who is a member of Dr. Ding’s shrinking club, the FEHBlog thinks that he may have had Covid at some point and in any event, it’s a matter of time before officially contracts it. Covid is gaining similarity to its cousin the common cold.

The FEHBlog has moved his residence inside the Capital Beltway to Dripping Springs, Texas. His Texas residence has a home office. He has come back to work at his DC law firm this week. When working in DC, he stays at a hotel next to his office building. All of this has cut into his commuting time when he listened to Russ Robert’s Econtalk. This evening he traveled up to have dinner with one of his sons outside Baltimore. This allowed him to listen to the July 18 episode of Econtalk during which Russ Roberts discussed Covid with Dr. Vinay Prasad of the University of California San Francisco. Their conversation is very insightful into the public health aspects of the Covid pandemic. It’s worth a listen or read the transcript on the website.

From the public health front, the Department of Health and Human Services announced

Today, the Centers for Medicare & Medicaid Services (CMS) unveiled its Maternity Care Action Plan to support the implementation of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. The action plan takes a holistic and coordinated approach across CMS to improve health outcomes and reduce inequities for people during pregnancy, childbirth, and the postpartum period. CMS’ implementation of the action plan will support the Biden-Harris Administration’s broad vision and call to action to improve maternal health.

“Strengthening maternal health is key to strengthening the health and wellbeing of communities across America,” said HHS Secretary Xavier Becerra. “At HHS, we are taking unprecedented action to advance the Biden-Harris Administration’s vision to improve maternal health and tackle disparities, and I’m proud of the bold action plan CMS has laid out to contribute to our goals. Today is just the beginning: we will tirelessly work to make sure all mothers get the care and support they need.”

Through the action plan, CMS Administrator Chiquita Brooks-LaSure also encouraged industry stakeholders – including health care facilities, insurance companies, state officials, and providers – to consider key commitments the private sector can make to improve maternal health outcomes. Industry can submit proposed commitments at http://cms.gov/maternalhealthcommitments .

From the U.S. healthcare front, Healthcare Dive tells us

The Mayo Clinic earned the No. 1 spot for a seventh straight year in U.S. News & World Report’s best hospitals ranking published Tuesday. Cedars-Sinai Medical Center, NYU Langone Hospitals and the Cleveland Clinic followed next, with Johns Hopkins Hospital and UCLA Medical Center tied in fifth place.

In the specialty rankings, University of Texas MD Anderson Cancer Center was named best in cancer, Cleveland Clinic was first in cardiology and heart surgery, and NYU Langone Hospitals led in neurology and neurosurgery.

U.S. News added three service areas of evaluation this year, for ovarian, prostate and uterine cancer surgeries. The publication also introduced “home time” as an outcome measure in certain ratings, reflecting patients’ preference for recovering at home.

Becker’s Health IT looks at the Amazon – One Medical deal from the perspective of Amazon v. Optum.

From the U.S. healthcare business front, Fierce Healthcare reports

In its latest earnings results, [health insurer Centene] posted a $172 million loss in the second quarter, still beating the Street and slimming its losses compared to the prior year’s quarter. In the second quarter of 2021, Centene reported a $535 million loss, according to its earnings report released Tuesday morning. * * *

The company added about 200,000 members in the second quarter, reaching 26.4 million in total membership. That’s up by more than one million from the second quarter of 2021, when the insurer reported 24.7 million members.

“Our strong second quarter results reflect the consistency of Centene’s product performance,” Centene CEO Sarah London said in a statement. “The second quarter reflects continued execution on our Value Creation Plan with tangible actions and results, providing an excellent foundation from which we will continue to build over the next couple of years.”

From the reports and studies (tidbits?) department —

Health Leaders Media informs us

It’s payers, not providers, that American turn to when seeking out pricing information for healthcare services, according to a survey on price transparency.

The poll, conducted by YouGov on behalf of AI for healthcare operations company AKASA, highlights the need for both insurers and providers to follow pricing regulations for the sake of the patient experience.

Of the 2,026 adults surveyed nationally in March, just 36% indicate they have researched prices for services, of which 60% say they would look to their insurance company for pricing information.

When seeking out information through a payer, 44% would look on the insurer’s website and 29% would call their insurer.

InsuranceNews Net reports

A majority of those who receive health insurance through their employer-provided plan said they are more satisfied with the coverage they receive through work than they are with the current health insurance system overall.

That was one of the key takeaways from research conducted by Locust Street Group and presented at a webinar by America’s Health Insurance Plans. The research was part of AHIP’s Coverage@Work campaign, which aims to educate policymakers and the public about the value of employer-provided coverage.

The survey showed that although 54% of the 1,000 adults surveyed said they are satisfied with the current health system overall, 67% said they were satisfied with the coverage they receive through their employer.

What makes someone satisfied with their coverage? The top three reasons given were:

* Affordability – 45%

* Comprehensive coverage – 45%

* Choice of providers – 44%

Other factors that rounded out the list of reasons for being satisfied included: free preventive services, consistency, customer service, the ability to receive care locally, wellness incentives and innovation.

Weekend update

David Ermer–ACA, Congress, COVID-19, Medicare, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Capitol Hill, The House of Representatives and the Senate will be in session for Committee business and floor voting this week. This is the last week that the House is in session before the August recess. The Senate has one more week of legislative work before it heads off on its State work period for the eighth month of the year.

The Wall Street Journal adds

Congress nears the close of a packed legislative session this week, aiming to pass legislation providing about $54 billion to boost U.S. semiconductor manufacturing while also juggling a raft of other bills ahead of the monthlong August recess.

Along with the bipartisan bill subsidizing chips, Democrats are hoping to salvage a piece of President Biden’s once-ambitious domestic agenda, looking to advance a measure aimed at lowering some drug and healthcare costs. The party is also weighing whether to hold votes related to social issues and guns that could help rally the party’s base. * * *

In the Senate, Democrats are awaiting guidance from the Senate’s parliamentarian over whether a measure aimed at lowering drug costs by giving Medicare the right to negotiate prices for a narrow set of drugs will comport with the Senate’s procedures for passing bills through a budget-related process known as reconciliation. Democrats in the 50-50 Senate are using the special process because it allows the passage of bills with only a simple majority, instead of the 60 votes required for most legislation. The procedure is only available until Sept. 30, the end of the fiscal year.

Mr. Hoyer said that if Senate Democrats are able to soon pass the drug-pricing bill, which would also extend Affordable Care Act subsidies, then the House would return from its August recess to clear the measure in time for insurance companies to factor in the subsidies when they set prices for their plans.

From the Omicron and siblings front, the New York Times informs us

People with coronavirus infections of the Omicron variant often have significantly different viral levels in their noses, throats and saliva, and testing just a single type of sample is likely to miss a large share of infections, according to two new papers, which analyzed Omicron infections over time in a small number of people.

The papers, which have not yet been published in scientific journals, suggest that coronavirus tests that analyze both nasal and throat swabs would pick up more Omicron infections than those that rely on just a nasal swab. Although these combined tests are common in other countries, including Britain, none are yet authorized in the United States.

“You could get a lot more bang for your buck if you use these mixed specimen types,” said Rustem Ismagilov, a chemist at the California Institute of Technology and the senior author of both papers. But in the United States, he said, “we are stuck with nobody doing it.”

And yet the CDC has recorded nearly 90 million cases in our country.

From the unusual viruses front

STAT News reports

The World Health Organization on Saturday declared the unprecedented monkeypox outbreak that has spread around the world a public health emergency, a decision that will empower the agency to take additional measures to try to curb the virus’s spread.

In an unusual move, WHO Director-General Tedros Adhanom Ghebreyesus made the declaration even though a committee of experts he had convened to study the issue did not advise him to do so, having failed to reach a consensus. The same committee met just one month ago and declined to declare a public health emergency of international concern, or PHEIC [pronounced fake].

Secretary of Health and Human Services expressed his support for this decision.

Bloomberg Prognosis provides a quick take on monkeypox and its spread. Among other takes

The illness is usually mild and most patients will recover within a few weeks; treatment is mainly aimed at relieving symptoms. About 10-to-15% of cases have been hospitalized, mostly for pain and bacterial infections that can occur as a result of monkeypox lesions. The CDC says smallpox vaccine, antivirals, and vaccinia immune globulin can be used to treat monkeypox as well as control it.

The Wall Street Journal adds

Unusual for an emerging disease, there are already vaccines and treatments that can be used to counter monkeypox. That is because some governments have invested in developing defenses against the accidental or deliberate reintroduction of smallpox, a closely related but much more severe virus. Some countries hold these treatments and vaccines in national stockpiles, but they aren’t readily available everywhere.

In some places, including the U.S., U.K. and parts of Canada, broad groups of men who have sex with men are being offered vaccination in an effort to slow the spread, although vaccine supplies have so far been constrained. Public-health authorities also are working to raise awareness among men who have sex with men about the spread of monkeypox.

From the Medicare front, STAT News reports

The federal government is hashing out the details on a new type of rural hospital, and new developments suggest regulators want to make it an attractive option.

So-called Rural Emergency Hospitals (REH) will run emergency rooms, but won’t offer inpatient care. On top of bumped-up Medicare reimbursement, they’ll get facility payments north of $3 million annually, which is nothing to sneeze at for small hospitals. The new details were part of the government’s proposed Medicare payment rates for hospital outpatient services in 2023, released Friday [July 15].

For their part, hospitals aren’t yet sold on the idea.

From the Affordable Care Act front, we have Section 1557 news:

On Monday, July 25, 2022, [at 2:15 pm ET] the U.S. Department of Health and Human Services will announce a proposed rule to strengthen Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, and disability in certain health programs and activities. 

In regard to sex, which includes sexual orientation and gender identity, the proposed rule would solidify protections against discrimination consistent with the U.S. Supreme Court’s holding in Bostock v. Clayton County.  

Strengthening this rule is a significant achievement for the Biden-Harris Administration and promotes gender and health equity and civil rights for communities of color, women, LGBTQI+ individuals, people with disabilities, persons with limited English proficiency (LEP), and seniors.

From the reports and studies department

  • Fortune Well tells us “While two-thirds of Alzheimer’s cases are in women, an overwhelming majority don’t know they are at an increased risk for the disease, a new survey finds. A survey conducted by the Cleveland Clinic last month found that while 71% of women respondents saw a doctor for their health in the last year, 82% of them did not know that they are at increased risk for Alzheimer’s disease and 73% percent had not talked to their doctor about their brain health.”

Early physician follow-up with a comprehensive transitional care strategy and effective chronic disease management after discharge was associated with reduced 90-day readmissions among patients with COPD and other complex conditions.

“This population-based retrospective cohort study found that early follow-up with a [primary care] physician or relevant specialist was associated with fewer readmissions for patients with [congestive heart failure] or COPD, fewer COPD-related readmissions for patients with COPD and lower mortality for patients with [congestive heart failure], all within 90 days of discharge, but that there was no demonstrable benefit at 30 days or for patients with [acute myocardial infarction],” Farah E. Saxena, MPH,researcher at the Canadian Partnership Against Cancer in Toronto, and colleagues wrote in JAMA Network Open.

  • The CDC reports “Adults who receive diabetes education follow more recommended preventive care practices, such as getting regular physical activity.” Many FEHB plans offer diabetes education services.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–
Mount Rushmore
Mt. Rushmore

From Capitol Hill, Govexec reports

The House [of Representatives on Wednesday voted 220-207 to pass the first minibus fiscal 2023 spending package, effectively endorsing President Biden’s plan to increase federal employees’ pay by an average of 4.6% next year.

The minibus contains six of the 12 annual appropriations bills, including transportation, housing and urban development; agriculture and rural development; energy and water development; military construction and veterans affairs; and financial services and general government, the last of which serves as the vehicle for provisions impacting federal employee compensation[, including the FEHBP].

In other news from our Nation’s Capital, Bloomberg tells us

The Biden administration is giving new powers to an office within the Health and Human Services Department to take a more prominent role in responding to public health crises, spanning from pandemics to natural disasters. 

HHS’s Office of the Assistant Secretary for Preparedness and Response will be renamed and enabled to “mobilize a coordinated national response more quickly and stably during future disasters and emergencies,” Dawn O’Connell, who heads the unit, said in a memo obtained by Bloomberg News. 

The office will be rebranded the Administration of Strategic Preparedness and Response and will be reclassified an operating division alongside other major health agencies like the Centers for Disease Control and Prevention and the Food and Drug Administration, according to the memo. Those agencies, along with the National Institutes of Health, have been criticized for their response and messaging since the outbreak of Covid-19 more than two years ago. 

In the memo, O’Connell wrote that the ASPR had taken on an increasingly important role during the pandemic and that the new designation would equip the unit with “greater hiring and contracting capabilities.”

From the Omicron and siblings front —

The American Hospital Association informs us

The Centers for Disease Control and Prevention last night endorsed the two-dose Novavax COVID-19 vaccine as a COVID-19 vaccine primary series for emergency use in adults, as recommended by its advisory committee. Authorized by the Food and Drug Administration last week, the protein-based vaccine offers an option to individuals who may have an allergic reaction to or prefer not to receive an mRNA vaccine.

CDC today updated its COVID-19 vaccine guidance to include the Novavax vaccine, and issued a chart summarizing the dosing schedules for all authorized or approved COVID-19 vaccines.

In other vaccine news, a new study by the National Institutes of Health comparing the effectiveness of COVID-19 vaccine boosters against the omicron variant found neutralizing antibody levels decreased substantially within three months, with the BA.4 and BA.5 sub-lineages up to 2.5 times less susceptible to neutralization. NIH said the results could help inform decisions regarding future vaccine schedule recommendations, including the need for variant vaccine boosting.

The Wall Street Journal reports

A serious inflammatory complication that strikes some children in the weeks following a Covid-19 infection has almost disappeared. A buildup of immunity and changes to the virus both likely play a part, pediatric infectious-disease doctors and researchers said.

Multisystem inflammatory syndrome is afflicting far fewer children as a proportion of known Covid-19 cases than during earlier waves of the pandemic, according to data from the Centers for Disease Control and Prevention. The condition, also known as MIS-C, is similar to Kawasaki disease, another rare pediatric inflammatory condition. Early in the pandemic, doctors believed they were seeing Kawasaki disease but soon recognized MIS-C as a distinct condition associated with an earlier Covid-19 infection.

MIS-C can cause inflammation two to six weeks after infection with Covid-19 in organ systems including the heart, lungs, kidneys and brain. Researchers haven’t determined why some children developed the condition but they have linked it to a hyperactive immune response. Treated with drugs such as intravenous immune globulin or corticosteroids, most children make a full recovery. Even so, the condition can be deadly. In the U.S., 70 children have died from MIS-C since the start of the pandemic, according to the CDC.

From the fraud, waste and abuse front —

Fierce Healthcare tells us

Federal prosecutors charged 36 defendants with committing a variety of alleged schemes to bilk Medicare using telehealth, as regulators continue to tinker with how to make the COVID-19 telehealth boom permanent.

The Department of Justice announced on Wednesday that the defendants allegedly engaged in a series of actions that led to $1.2 billion in medical fraud, with much of that coming from phony telehealth claims for advanced genetic testing and unnecessary medical equipment.

“Fraudsters and scammers take advantage of telemedicine and use it as a platform to orchestrate their criminal schemes,” said Luis Quesada, assistant director in the FBI’s Criminal Investigative Division, in a statement. “This collaborative law enforcement action shows our dedication to investigating and bringing to justice those who look to exploit our U.S. health care system at the expense of patients.”

Here’s a link to the HHS Office of Inspector General fraud alert which provides background on these telehealth schemes.

The Justice Department also announced

Inform Diagnostics, Inc., (Inform) formerly known as Miraca Life Sciences, Inc. (Inform), has agreed to pay $16 million to resolve allegations that it submitted false claims for payment to Medicare and other federal health care programs. 

Inform is a clinical laboratory headquartered in Irving, Texas, that provides anatomic pathology services to physician practices throughout the United States. On April 27, 2022, Fulgent Genetics purchased Inform, and the company is now a wholly owned subsidiary of Fulgent Genetics.

According to the settlement, Inform admits that, between 2013 and 2018, it routinely and automatically conducted additional tests on biopsy specimens prior to a pathologist’s review and without an individualized determination regarding whether additional tests were medically necessary. The United States contends that Inform’s policy of conducting routine additional tests caused Inform to perform many tests that were medically unnecessary. Inform submitted these medically unnecessary tests for payment, causing federal health care programs to pay for false claims. * * *

“Submitting claims for medically unnecessary tests threatens the integrity of the federal health care programs and wastes taxpayer dollars,” said Amy K. Parker, Special Agent in Charge of the Office of Personnel Management’s Office of Inspector General. “Today’s settlement is a reminder to all providers that the OPM OIG will not tolerate fraud against the Federal Employees Health Benefits Program.”

From the U.S. healthcare business front —

Fierce Healthcare informs us

Elevance Health subsidiary myNEXUS recently launched a post-acute care program for Medicare members in Indiana, and the insurance giant is aiming to take it nationwide over the next year.

During the company’s earnings call Wednesday morning, CEO Gail Boudreaux said it plans to take the next six to 12 months to scale up the program, which uses a capitated risk-sharing arrangement. The platform arms docs with technology tools that aim to optimize patient care post-discharge. * * *

The company reported $1.7 billion in profit for the second quarter of this year, down from $1.8 billion in the second quarter of 2021 or by 7.8%. Revenues for the quarter were up, however, increasing by 14.1% to $38.6 billion.

Healthcare Dive tells us

JPMorgan Chase’s healthcare venture arm plans to invest $30 million in Centivo, a health plan for self-funded employers. It’s Morgan Health’s third major investment in a startup looking to lower the costs of employer-sponsored healthcare in the past year.

Three-year-old health plan administrator Centivo contracts with providers on behalf of large employers with the goal of improving quality and efficiency. The startup, which ties payments to patient outcomes, says it saves employers 15% to 30% annually compared to traditional health plans.

Morgan Health has shelled out at least $85 million in the past year, including the Centivo deal. The unit invested $50 million in value-based primary care company Vera Whole Health in August and $5 million in healthcare navigation startup Embold Health in March.

From the U.S. general healthcare front —

  • Forbes offers an interesting article about health insurance literacy in our country. The No Surprises Act has spurred people to look more carefully at their healthcare provider bills, but their analyses fall short because they need help understanding those bills and health insurance coverage.
  • Yale New Haven Hospital’s July newsletter provides good advice on avoiding skin cancer and stay safe in the summer. The FEHBlog was born at the facility’s predecessor Grace New Haven Hospital.
  • STAT News reports “Gestational diabetes is on the rise, climbing 30% between 2016 and 2020, according to a new study published Tuesday by the Centers for Disease Control and Prevention. “There is a growing maternal health crisis in the United States, and gestational diabetes is an important and common complication that requires new focus,” said Sadiya Khan, an assistant professor of medicine and preventive medicine at the Northwestern University Feinberg School of Medicine, who was not involved in the new study. “That inflection point there is really striking and something that we’re going to want to follow up [on].” * * * “This issue does not resolve with the pregnancy and is really one that we need to focus on before, during, and after pregnancy for those at risk.”
  • STAT News also explores the work of various mental health crisis centers in the days following the launch of the nationwide 988 suicide / mental health crisis hotline. Here’s a link to an HHS site that refers to the hotline more appropriately as a LifeLine.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill Fierce Healthcare reports

Senate leadership said they reached a deal with centrist Sen. Joe Manchin, D-W.Va., to give Medicare narrow authority to negotiate lower drug prices and extend key Affordable Care Act subsides for another two years.

“We are excited about doing something on prescription drugs,” Schumer said during a press conference Tuesday. “This is something we have waited for.”

Centrist Sen. Joe Manchin, D-W.Va., had reached a narrow deal to give Medicare the power to negotiate for lower prices on up to 10 drugs in 2026 and up to 20 drugs starting in 2029. The package includes a host of other reforms that include a $2,000 cap on out-of-pocket drug costs.

The deal released earlier this month would also repeal a controversial Trump-era rule that stripped Part D rebates of their safe harbor from prosecution under federal anti-kickback laws. 

It now includes a two-year extension of a boost to ACA subsidies that has helped fuel record-breaking enrollment of more than 14 million people.

The Senate majority leader plans to move this legislation via the reconciliation process which means the Senate Parliamentarian must confirm that the bill meets the standards for the reconciliation approach.

STAT News adds that the Senate majority leadership has encountered problems from across the aisle in obtaining passage of the must-pass Food and Drug Administration users fee bill which helps fund the thousands of FDA experts who process drug review requests. Absent the necessary user fee funding, these folks will be furloughed.

From the Omicron and siblings front

AHIP tells us

Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommended the use of the Novavax two-dose COVID-19 vaccine as a primary vaccine series for adults 18 years and older.  The two dose series is recommended to be administered by intramuscular injection with 3-8 weeks between doses depending on the patient risk and immunocompetency status.

The Committee reviewed data showing the vaccine is approximately 90.4% effective in preventing mild, moderate or severe COVID-19 and 79% effective in a subset of people aged 65 years or older. Additionally, the vaccine had favorable safety data that showed mild side effects. Committee members noted the hope that Novavax’s traditional protein-based vaccine will help to convince the 10-13% of adults who remain unvaccinated to receive a COVID-19 vaccine.

Members also expressed concerns about vial size, potential discard waste, and lack of an expiration date on the vial or carton, with clinicians needing to go to NovavaxCovidVaccine.com to get expiration date. The committee clearly stated that the vaccine is not recommended to be used in combination with other COVID-19 vaccines for primary or booster series completion at this time.

The FDA granted the Novavax vaccine an emergency use authorization on July 14. CDC Director Walensky is expected to make an official recommendation statement on Novavax in the coming day.

The Wall Street Journal reports that natural immunity from contracting Covid, typically has lasts 90 days. However, the highly contagious and current king of Covid infections, Omicron BA.5, can bear natural immunity based on an earlier strain of Omicron. Rest assured that your natural immunity can be expected to last 90 days when you contracted Omicron BA.5.

Also from the public health front,

The New York Times reports on the difficulties that New Yorkers infected with monkeypox have encountered when they seek treatment for that disease.

“What many of us learned in medical schools is that monkeypox is a mild, self-limiting illness,” said Dr. Mary Foote, medical director of the office of emergency preparedness and response at the city’s Department of Health, speaking at a Thursday briefing hosted by the Infectious Diseases Society of America. “But the reality on the ground is that a lot of people with this infection are really suffering.”

What’s also striking, she said, about this outbreak, is “how many of these patients have had difficulty getting the care they need to treat these symptoms.”

STAT News adds

[E]ven as global health officials race to curb spread of the virus, most experts polled by STAT said they don’t believe it will be possible to contain it.

Not everyone is categorical — or pessimistic.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, and Rosamund Lewis, the World Health Organization’s technical lead on monkeypox, expressed the belief that with a lot of effort, transmission in the population of men who have sex with men can be stopped.

Walensky’s optimism in this case derives from the fact that, to date, the virus appears to be spreading mainly within a defined community — one that has mobilized to get out the word of the risk its members face.

“Within this community there was a lot of high-risk [exposures] before we were able to test enough, educate enough, both on the provider side and the patient side. And there’s a lot of that happening right now,” Walensky said.

Healio notes

In June, HHS began shipping orthopoxvirus tests to five commercial laboratory companies — Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare — to increase monkeypox testing capacity and access. As of Monday, they all have begun testing, the most recent being Sonic Healthcare. * * *

In addition to increased testing, the CDC has issued travel alerts and expanded access to vaccines in response to the outbreak. HHS also ordered an additional 2.5 million doses of Bavarian Nordic’s Jynneos vaccine to strengthen preparedness. This followed an earlier order made for 2.5 million doses that will begin arriving over the next year and will bring the federal stockpile of vaccine to treat monkeypox to nearly 7 million doses by mid-2023.

Medscape reports

Overdose deaths continued increasing in 2019-2020, especially among Black and American Indian/Alaskan Native (AI/AN) individuals, the CDC reported Tuesday.

Overdose deaths in the U.S. increased by about 30% during that period, said Mbabazi Kariisa, PhD, MPH, a health scientist in the CDC’s Division of Overdose Prevention, during a phone briefing with reporters. “We know that health disparities play a key role in overdose death rates among people in certain racial and ethnic minority groups. In just 1 year, overdose death rates increased 44% for Black people and 39% for American Indian and Alaskan Native people.”

STAT News tells us “The deaths were broadly driven by illicit fentanyl, CDC officials said, though deaths attributed to other drug types, including stimulants like methamphetamine, have also been rising in recent years.”

In advocacy news, MedPage Today discusses the American Medical Association President Jack Resneck’s campaign to tie physician burnout to prior authorization and other health insurer hassles. It’s unfortunate that the various health care professional and trade associations can’t work together to reduce healthcare spending while improving quality.

In that regard, Kaiser Health News reports

Fresh off the Federal Trade Commission’s successful challenges to four hospital mergers, the Biden administration’s new majority on the commission is primed to more aggressively combat consolidation in the health care industry than it has in past years.

Although hospital mergers were supposed to improve cost efficiency, experts agree that the creation of huge conglomerates and hospital networks has driven up U.S. medical costs, which are by far the highest in the world. Many enjoy near-monopoly pricing power. * * *

Extensive research has found that prices rise when hospital systems acquire or merge with their competitors or when they buy a significant percentage of physician practices in their market. Highly consolidated markets, such as Northern California (dominated by Sutter Health) and western Pennsylvania (dominated by UPMC) tend to have higher prices.

The FTC has a long history, under both Democratic and Republican administrations, of antitrust enforcement actions to block so-called horizontal mergers between hospitals that could stifle competition in a market.