Weekend update

Weekend update

Photo by Dane Deaner on Unsplash

Happy New Year. Shanah Tovah.

The House of Representatives and the Senate are scheduled to be in session this week for Committee business and floor voting. Congress is set to go on an election break on September 30, the end of the federal fiscal year. Due to the incentive to get on the campaign trail, the FEHBlog expects Congress to wrap up by the end of next weekend a continuing resolution funding the federal government through December 16. The Senate version of the continuing resolution will be released tomorrow as negotiations are ongoing.

From the Omicron and siblings front, the Department of Health and Human Services announced how the federal government supports the Covid treatment market as its funding shifts to the private sector.

From the Rx coverage front, STAT News tells us

Brand-name drugmakers increased wholesale prices by 4.9% in the second quarter this year, up slightly from 4.4% a year ago. But when accounting for inflation, wholesale prices fell by 3.7%. Inflationary pressures are likely to push wholesale prices still higher, STAT writes, citing a new analysis. At the same time, net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — dropped by 0.8%, but after considering inflation, net prices actually fell 7.9% compared with 3.8% in this year’s first quarter. This was the largest quarterly decline in real terms seen by analysts at SSR Health, which conducted the analysis.

From the litigation front, Health Affairs Forefront provides helpful background on a September 7 decision from a Texas district federal court holding the Appointments clause of the U.S. Constitution bars the federal government from treating U.S Preventive Services Task Force recommendations as binding on health plans. The lawsuit also involves a Religious Freedom Restoration Act (“RFRA”)claim. The Court has reserved a ruling on appropriate remedies. The FEHBlog expects that the Appointments clause challenge will not survive appellate review but who knows what can happen with an RFRA claim. Another remaining issue is the plaintiffs’ challenge to the contraceptive mandate.

From the maternal care front, MedCity News informs us

Racial disparities in maternal health complications grew amid Covid-19, BCBS report finds
Pregnancy-related complications increased 9% between 2018 and 2020 among all women, but the rate of change is even more significant among women of color. The disparities exist regardless of having commercial insurance or Medicaid. * * *

The fact that racial disparities exist regardless of commercial insurance or Medicaid coverage suggests that the issues are due to broader health challenges, including underlying conditions, racial inequities and biases in the healthcare system, according to the report.

To combat these disparities, BCBS listed several actions players in the healthcare industry can take. This includes adding nurse-midwives and birthing centers to provider networks, expanding coverage for postpartum care to one year after giving birth and using value-based contracts for maternal health.

BCBS doesn’t just call on healthcare leaders to act, but the government as well. In the report, the payer urges Congress to pass the Congressional Black Maternal Health Caucus’ Momnibus package, which provides steps to improve health outcomes for pregnant women and mothers of color. BCBS also asks for states to extend Medicaid coverage from 60 days to a full year postpartum, an option provided through the American Rescue Plan Act.

One’s race or ethnicity should not determine how likely you are to suffer from pregnancy-related complications. We must address deep-rooted issues like implicit bias and systemic racism that cause these disparities in the first place,” [Dr. Adam] Myers said in a news release.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omnicron and siblings front —

The Wall Street Journal and STAT News consider when the Covid pandemic will be over in the United States in response to the President’s comment to a 60 Minutes interviewer Sunday night.

STAT News also offers an interview with the President’s science advisor Francis Collins, MD. Dr. Collins “revealed his pain at seeing people spurn mRNA Covid vaccines developed with breathtaking speed and lamented that he and other health officials failed to communicate the ever-changing science behind Covid recommendations.”

The Wall Street Journal adds

More than a year-and-a-half after the first Covid-19 vaccines became available, people are trickling in every day to get their first doses. 

As health officials and physicians roll out retooled boosters targeting substrains of the Omicron variant, federal data suggest there are still thousands of people a day getting shots of the original vaccines for the first time. 

All together, the seven-day average for adults getting first shots each day ranged between roughly 15,000 and 18,000 in late August, according to a Wall Street Journal analysis of data from the U.S. Centers for Disease Control and Prevention. 

The data can overestimate first-shot recipients, because there are times where the agency can’t link follow-up shots, including boosters, to people who received an initial series. The same effect can lead to an undercount of booster shots, according to the CDC.

People who recently got the first jab cited a range of reasons. Some said they were ordered to do so, such as to start a new job or travel for a vacation. Others waited until a vaccine using a more-traditional technology, instead of the newer mRNA versions, became available. Some went ahead after getting sick with Covid-19, or after a family member vouched that the shots worked. 

Perhaps this news will reassure Dr. Collins.

Moreover, Paxlovid helps people who contract Omicron whether or not they are vaccinated. However, STAT News cautions that advances in treating the sickest Covid patients have stalled since February 2021.

From January 2020 to February 2021, researchers proved four different effective therapies for patients hospitalized with Covid-19 — a lightning pace for drug research, where progress is often measured in decades.

That picture has changed starkly. Advances in treating the sickest Covid patients have stalled. Since February 2021, no new therapies for the hospitalized have emerged as decisively effective, even as over 2,000 patients continue to die daily around the globe, including 300 to 500 in the U.S. * * *

[The stall is due to the fact that m]ost trials have been too small to generate decisive results. Breakthroughs in treating hospitalized patients have come exclusively from large coordinated studies run by governments, NGOs, or consortiums, often testing multiple therapies at once. 

As severe Covid grows rarer, those large studies become harder to do. The U.K.’s landmark Recovery trial, which early on demonstrated steroids were effective and hydroxychloroquine was not, is still ongoing and has expanded to new countries. But it hasn’t issued results since May and hasn’t shown a new therapy was effective since 2021

Quite a conundrum.

In monkeypox news, Fierce Healthcare tells us

New cases of monkeypox are down 50% since early August, the Center for Disease Control and Prevention announced in a press briefing.

The nation’s seven-day average for new cases peaked on Aug. 10, with 461 cases, and on Sept. 14 was 170, according to federal health officials. Credit for the decrease was given to education and vaccination efforts.

“We approach this news with cautious optimism,” said Rochelle Walensky, M.D., director of the CDC, at a Sept. 15 press briefing. “We continue to closely monitor data on this outbreak, those at risk, and how prevention measures are being used.”

Walensky stated that while overall growth was down, geographical pockets of the U.S. still showed an increase in cases. Over 23,000 cases of the virus have been confirmed in the U.S. as of Sept. 16.

From the maternal health front, the American Hospital Association reports

An estimated 84% of pregnancy-related deaths in 36 states between 2017 and 2019 were preventable, according to a new Centers for Disease Control and Prevention report based on data from interdisciplinary committees that review deaths during and up to one year after pregnancy.

Among deaths with information on timing, 22% occurred during pregnancy, 25% on or within seven days of delivery, and 53% seven days to one year after pregnancy. The leading underlying causes of pregnancy-related death were cardiac and coronary conditions among Black people, mental health conditions among Hispanic and white people, and hemorrhage among Asian people.

The first data released under a CDC-funded program to support these Maternal Mortality Review Committees, the report “paints a much clearer picture of pregnancy-related deaths in this country,” said Wanda Barfield, M.D., director of CDC’s Division of Reproductive Health at the National Center for Chronic Disease Prevention and Health Promotion. “The majority of pregnancy-related deaths were preventable, highlighting the need for quality improvement initiatives in states, hospitals, and communities that ensure all people who are pregnant or postpartum get the right care at the right time.”

From the healthcare costs front, Health Leaders Media discusses a Buck Consultants survey of health insurers and administrators finding rising costs in employer-sponsored plans.

In US healthcare business news –

The Wall Street Journal reports

A federal judge Monday ruled against a Justice Department antitrust challenge to UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc., rejecting government claims that the deal would unlawfully suppress competition and limit innovation in health-insurance markets.

U.S. District Judge Carl Nichols ruled for the companies in an opinion that he kept under seal for now because he said it “may contain competitively sensitive information.” The judge said he would release a redacted public version of the ruling in the coming days. In a one-page public order, he denied the Justice Department’s request to block the companies from completing the deal.

The lawsuit, filed in February, is an early blow to stepped-up antitrust enforcement by the Biden administration. The department didn’t immediately respond to a request for comment.

The decision is a triumph for UnitedHealth, which owns the largest U.S. health insurer and a healthcare operation that comprises thousands of doctors as well as clinics, surgery centers and other assets, along with a powerful conglomeration of health data.

Healthcare Dive adds

Humana expects to pay between $450 million and $550 million to acquire the first group of senior-focused primary care centers that it developed through a joint venture with Welsh, Carson, Anderson & Stowe, Chief Financial Officer Susan Diamond said Friday during the insurer’s investor day.

The agreement inked with Welsh Carson in 2020 included options for Humana to acquire the private equity firm’s interest in the joint venture in stages over the next five to 10 years. The venture was expected to open 67 clinics by early 2023. “We are planning for the full acquisition of centers built in partnership with Welsh Carson through our put and call options beginning in 2025,” Diamond said.

In mid-May, Humana and Welsh Carson announced a second joint venture that will spend up to $1.2 billion to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 under the CenterWell Senior Primary Care brand.

From the Medicare front, STAT News relates

Chronic kidney disease, already a problem affecting millions of Americans, is only expected to become more prevalent as the country ages. For those with end-stage disease, a transplant is the ideal treatment, but dialysis is their reality. Hundreds of thousands of Americans flock to clinics three times a week to have their blood filtered through — in the absence of a functioning kidney — a machine.

As a medical treatment, dialysis is a stopgap measure that fails to fix a chronic problem (average life expectancy on dialysis is five to 10 years). As an industry, dialysis has significant flaws, including a lag in home dialysis use. Critics argue dialysis clinics have for decades shirked a responsibility to help patients get on the kidney transplant waitlist and receive organs from living donors — the gold standard. 

Now federal health officials are trying to fix those problems with a big policy experiment, using one of their biggest hammers: how dialysis providers are paid. 

That should get the dialysis providers’ attention.

From the National Institutes of Health front, the NIH Center for Alzheimer’s and Related Dementias issued an update on its work and operations.

Midweek update

Photo by Manasvita S on Unsplash

From the Omicron and siblings front —

The New York Times reports

The Food and Drug Administration on Wednesday [August 31] authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.

The new formulation arrives as roughly 90,000 infections and 475 deaths are still being recorded daily around the United States, more than two years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.

With winter approaching and the BA.5 variant of Omicron still circulating widely, federal officials hope the redesigned shots will help slow the pandemic’s seemingly relentless march. Yet many Americans appear to have become indifferent to the virus and its risks, making the task tougher than ever.

The new boosters are “bivalent,” meaning they contain a combination of the original formulation and one targeting BA.5, now the dominant version of the virus, as well as a sister subvariant of Omicron. One is made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.

Here’s a link to the CDC’s 2021 U.S. life expectancy report which was released today.

Reuters adds

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Thursday [September 1] to vote on whether to recommend the use of two COVID-19 vaccine boosters tailored against the Omicron variant.

A recommendation in favor of the modified vaccines by Pfizer Inc and its German partner BioNTech SE , as well as Moderna Inc is expected to pave the way for a rollout next week.

Medpage Today offers background on tomorrow’s CDC Advisory Committee on Immunization Practices meeting.

ACIP will weigh in on newly authorized fall COVID boosters this week, in a manner unprecedented during the pandemic — without data from human clinical trials.

While most experts agree that there are no safety concerns, and many support the FDA’s attempt to keep up with viral variants, others have pointed out gray areas and open questions when it comes to Omicron-targeting bivalent vaccines.

That includes whether boosters with components targeting Omicron would offer a significant advantage in terms of efficacy — particularly, protection against infection — over boosting against the ancestral strain of the virus alone.

David Leonhardt, writing in his Morning column for the New York Times, provides his latest Covid poll which finds all Americans trending toward placing Covid in the rear view mirror.

A growing number of very liberal Americans have decided that it’s time to treat Covid as an unpleasant but manageable part of life, much as many other Americans — as well as people in other countries — decided months ago.

While the FEHBlog was pleased with the Times poll results, he thinks that Forbes hits the nail on the head with its opinion piece on how America can bring down its Covid death rate which took 383 lives yesterday.

Tragically, the vast majority of Covid-19 deaths are now preventable – if all Americans were up to date with vaccines, and if high-risk individuals got treated promptly after testing positive. If all that were to happen, Covid deaths in the U.S. would be nearly zero, as White House Covid-19 Response Team Coordinator Dr. Ashish Jha told the U.S. Chamber of Commerce Foundation recently.

What can the nation do to make that happen? Put simply, we must embrace the notion that Covid-19 deaths are largely preventable, not inevitable. Instead of trying to put those deaths out of mind, we should focus on what we can do to stop them.

Why are 400 Americans still dying each day? For starters, 15 million seniors have not received their first booster, and only 33% of Americans over 50 and 40% over 65 have received their second booster. In addition, over 20% of adults have not completed their primary vaccination series.

The health impacts of that inaction are sizable. The CDC estimates that among those 50 and older, the unvaccinated had a 29-fold increased risk of dying from Covid-19 and vaccinated people with only one booster had a 4-fold increased risk compared to those with two or more booster doses.

Meanwhile, access to the oral antiviral medication Paxlovid – which reduces the rates at which high-risk people get severe cases of Covid-19 or die from it – is the most limited in zip codes in which people were highly vulnerable to the virus. Moreover, access to and awareness of Evushield – which reduces the risk that immunocompromised people will develop symptomatic Covid-19 for up to six months – remains limited.

To keep Covid-19 and its impact in public consciousness, local health officials should publicly recognize when citizens in their communities lose their lives to the virus. For the same reason, local print and broadcast media should provide coverage of community memorials to those who have died. That should inspire citizens within communities to help each other fully access and use the tools available to all Americans, whether vaccines or treatments.

Local faith organizations, businesses, and other community leaders who have the trust of the population should redouble their efforts reminding individuals that their actions with respect to Covid-19 testing, vaccination, and treatment can make a tangible difference for their community.

Health care professionals should use every office visit, even if unrelated to Covid-19, to remind patients about the need to stay up to date with their vaccinations and have a plan to access treatment if they test positive and are eligible for treatment. The medical community’s attention to preventing and managing chronic conditions such as obesity and diabetes is now even more vital given their detrimental impact on Covid-19 outcomes.

Amen to that. Honestly, while the FEHBlog falls into the senior category, he has been delaying his second booster in order to receive the bivalent vaccine (or the Novovax booster which hasn’t been approved yet). The FEHBlog plans to make an appointment for the bivalent vaccine next week.

Finally, Healthcare Dive informs us

Americans may have to pay for their COVID-19 vaccinations as early as January as federal funding for vaccine purchase and distribution runs out and the shots shift to the commercial market, according to Dawn O’Connell, Assistant Secretary for Preparedness and Response at the HHS.

The announcement comes after the HHS hosted over 100 representatives from state and local governments, including various stakeholders, insurers and pharmaceutical companies in a planning meeting on Tuesday.

“While the federal government has been pleased to play this role, we have always known that we would not be in this business forever,” O’Connell said in a post on the ASPR site. “Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.”

Read that as health plans may have to pay for their members’ Covid vaccinations next year. Conceding that the FEHBlog is not a Hyde amendment expert, he does not understand why the Senate leadership did not ram through more Covid funding in the massive budget reconciliation act.

Moving onto the country’s fentanyl crisis

CBS News tells us

The Drug Enforcement Administration issued an advisory Tuesday about an “emerging trend” of “brightly-colored” fentanyl pills being used to lure children and young people. What is often called “rainbow fentanyl” has been seized by law enforcement agencies in 18 states just this month, the DEA said.

The drugs, made to look like candy, comes in several forms, including “pills, powder and blocks that resembles sidewalk chalk,” the DEA said.

“Rainbow fentanyl — fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes — is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” DEA Administrator Anne Milgram said in a statement.

Regulatory Focus adds

The US Food and Drug Administration (FDA) said it plans to fight the current opioid crisis by going after online drug retailers and promoting the development of non-opioid alternatives.
 
On 30 August, the agency published its FDA Overdose Prevention Framework that largely aligns with the Department of Health and Human Service’s (HHS) 2021 Overdose Prevention Strategy. The framework echoes concepts in the HHS strategy, such as supporting primary prevention, encouraging harm reduction and advancing evidence-based treatments. FDA’s framework also includes the actions to protect the public from unapproved, diverted and counterfeit drugs with overdose risk.
 
In a blog post, FDA Commissioner Robert Califf said the agency needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs and methamphetamines on the market. Cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority, he said.

In U.S. healthcare business news, Healthcare Dive reports

Walgreens Boots Alliance has completed its majority stake acquisition in at-home care technology platform CareCentrix, the retail pharmacy giant announced Wednesday.

The $330 million investment gives Walgreens a 55% ownership of CareCentrix. Walgreens has the option to acquire the remaining equity in the future.

The investment, first announced in October, expands Walgreen’s reach in the health sector, especially in the areas of primary care, specialty pharmacy, post-acute and home care, the company said in a Wednesday release.

STAT News observes

Employers, who provide health coverage to roughly half the U.S. population, are acutely aware of where health care’s current cost trajectory is headed. In a recent survey of executives at 300 of the country’s largest employers, nearly 90% said they believe the cost of providing health benefits will become unsustainable within five to 10 years.

Yet instead of finding new ways to manage costs and help sustain this critical lifeline for America’s workers, many health systems continue to increase the prices they charge commercial insurers. And they can because, in many cases, newly consolidated health systems are the only game in town.

Employers and private insurers pay, on average, 224% of what Medicare would have paid for the same service at the same facility, despite new data showing that hospitals require payments that represent just 127% of Medicare to cover their expenses.

In federal employee compensation news, Federal News Network reports

President Joe Biden has formally announced his plans to give civilian federal employees a pay raise next year, starting on Jan. 1, 2023.

Most civilian employees under the General Schedule, as anticipated, will receive an average 4.6% federal pay raise in 2023, according to the alternative pay plan Biden submitted to congressional leaders Wednesday afternoon.

The president is specifically recommending a 4.1% across-the-board pay raise for federal employees in 2023, with an additional 0.5% average locality pay adjustment — resulting in a 4.6% average pay increase.

Biden said his alternative pay plan would help federal pay stay competitive with what workers with critical skills could earn in the private sector.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the omicron and siblings front, MedPage Today provides us with good news.

Older patients treated with nirmatrelvir boosted by ritonavir (Paxlovid) for COVID-19 had lower rates of hospitalization and death compared with those not treated with the antiviral during the Omicron wave, according to an observational retrospective cohort study from Israel.

Among patients ages 65 and older, the rate of hospitalization due to COVID was 14.7 cases per 100,000 person-days for the 2,484 patients who received nirmatrelvir compared with 58.9 cases per 100,000 person-days for the 40,337 untreated patients (adjusted HR 0.27, 95% CI 0.15-0.49), reported Ronen Arbel, PhD, of Clalit Health Services in Tel Aviv, and colleagues.

Death occurred in two nirmatrelvir-treated patients and in 158 untreated patients (aHR 0.21, 95% CI 0.05-0.82), they said in the New England Journal of Medicine.

Herd safety, indeed.

From the Rx research and development front, NBC News reports

Two doses of psilocybin pills, along with psychotherapy, helped people with alcohol use disorder reduce drinking for at least eight months after their first treatments, results from the largest clinical trial of its kind show. 

During the eight-month trial, 93 men and women ages 25 to 65 were chosen to receive either two psilocybin doses or antihistamine pills, which the researchers used as a placebo. They all also participated in 12 psychotherapy sessions.

All of the volunteers were averaging seven alcoholic drinks at a time before the trial. 

More than 80% of those who were given the psychedelic treatment had drastically reduced their drinking eight months after the study started, compared to just over 50% in the antihistamine control group, according to results published Wednesday in JAMA Psychiatry. At the end of the trial, half of those who received psilocybin had quit drinking altogether, compared to about one-quarter of those who were given the antihistamine.

STAT News reports

A vaccine Pfizer is developing protected older adults against the respiratory syncytial virus, or RSV, which is a common cause of hospitalization and death in the U.S., the company said Thursday.

The experimental vaccine, known as RSVpreF, is considered a key product in Pfizer’s pipeline of experimental drugs. Right now drug companies are close to launching several different products against RSV, focused on protecting both older adults and infants.

BioPharma Dive tells us

BioMarin, a California-based biotechnology company, said Wednesday that its gene therapy for hemophilia has been cleared for market by European regulators, marking a first-of-its-kind approval.

The therapy, known as Roctavian, was given conditional marketing authorization as a treatment for certain patients with hemophilia A, the more common version of the rare bleeding disorder. Specifically, Roctavian is to be used in adults with “severe” disease — hallmarked by exceedingly low levels of a blood-clotting protein called Factor VIII — who don’t have a history of developing antibodies that attack this protein.

With approval in hand, BioMarin is now working to secure reimbursement across the European Commission’s various member states. Jeff Ajer, the company’s chief commercial officer, said on a conference call Thursday that the plan is to immediately launch Roctavian in Germany, followed by France. The company expects Roctavian’s list price in Europe to be “around” 1.5 million euros, or roughly $1.5 million, net of all discounts, he said. 

Ajer added that BioMarin expects to disclose the specific European list price in October, a number that will be in-line but lower than the comparable net price in the U.S.

From the mental healthcare front —

Fierce Healthcare tells us

Employers view long-term mental health as the key healthcare issue coming out of COVID-19, according to a new survey.

Nearly half (44%) of employers surveyed by the Business Group on Health said they have seen this trend in their workforces, and another 44% expect to see worsening mental health in the future. Most (85%) said they anticipate enhanced mental health benefits launched under the pandemic to continue.

Mental health conditions also ranked sixth on the survey’s list of conditions driving healthcare costs, with 17% of those surveyed saying it was a major driver. This is a marked increase from 9% in 2020 and 14% in 2021.

Brenna Shebel, vice president of the Business Group on Health, said during a briefing with reports Tuesday that many employers are tackling mental health challenges “at all different angles.”

Forbes adds

AHIP, which stands for America’s Health Insurance Plans, issued a statement and “advocacy vision” at a time its member health plans are looking beyond paying and coordinating just medical care but also integrating behavioral health care into benefit plans for their government, commercial and employer clients. * * * Further details of the policy proposals and commitments can be found here.

From the U.S. healthcare business front, we learn about financial results for two health systems involved with the FEHB Program.

Becker’s Hospital Review reports that ” Intermountain Healthcare [based in Utah and serves surrounding states] saw its revenues increase in the first half of this year, and its merger with SCL Health fueled a significant increase in net income, according to recently released financial documents. The financial documents are the first Intermountain has filed since completing a merger with Broomfield, Colo.-based SCL Health in April. 

Beckers Hospital CFO Report tells us, “UPMC reported higher revenue in the first half of this year than in the same period of 2021, but the Pittsburgh-based health system’s operating income declined year over year, according to financial documents released Aug. 23. * * * “Throughout 2022, the continued effect of COVID-19, along with conditions in the labor and supply markets have resulted in cost growth in employment, staffing and other operating expenses in excess of revenue growth,” UPMC management wrote in the financial filing.”

Finally STAT News delves into why so many large healthcare companies are interested in Signify Health. Quite simply,

The bidding war over Signify Health — a health technology business that could fetch multibillion-dollar offers from Amazon, CVS, and UnitedHealth Group — is not about its dazzling software or a blockbuster AI algorithm.

The crush of corporate interest, experts said, stems from something much bigger: the opportunity to move medical services back into the home. In-home care is quickly becoming the biggest battlefield in America’s biggest business, with a huge array of companies seeking to move health care outside the institutional walls that have confined it for much of the last century.

Signify Health is among those at the forefront of the quest. The Texas-based company, founded in 2017 as the result of a merger, has built its business around delivering highly detailed assessments of patients by visiting with them in their bedrooms and living rooms, creating better visibility — and clearer data — about their lives and health status.

Tuesday Tidbits

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

Photo by Sven Read on Unsplash

From Capitol Hill, the Hill provides a useful outline of scheduled Congressional activities for this week.

From the Omicron and siblings front,

Becker’s Hospital Review reports

BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Time reported July 11. 

Two cases were detected in California and one in Washington as of July 8, according to data from Helix, which works with the CDC on viral surveillance. 

The subvariant is gaining traction in India and has also been detected in 10 other countries. 

Better start looking over your shoulders Omicron subvariants BA.4 and BA.5.

The Wall Street Journal informs us

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries.

The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week.

In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.

In the U.S., however, Moderna will develop a different dual-target booster, mRNA-1273.222, which goes after both the ancestral strain and the BA.4 and BA.5 subvariants of Omicron. These subvariants, which are nearly identical to each other for the purposes of a vaccine, now account for most new cases of Covid-19 in the U.S.

What about BA.2.75?

An announcement from HHS today points to an FDA emergency use authorization of the traditionally developed Novovax in the near future.

The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.

Medscape tells us

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.

Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.

The company has submitted an emergency use authorization request to the US Food and Drug Administration to use sabizabulin to treat COVID-19.

The analysis was published online July 6 in NEJM Evidence.

Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Benefits Pro calls to our attention health plan stop-loss insurer Sun Life’s top 10 high-cost claim conditions report.

Sun Life’s latest report saw a 354% increase in the number of COVID-19 claims from 2020 to 2021 [the Delta variant] —specifically, 107 claims to 486 claims. Total spend also rose from $30.4M to $114.0M, although the average cost for treatment went from $283.7K to $231.2K over the same period, amounting to an 18% decrease. Even so, COVID-19 landed (“somewhat ironically,” the study stated) at number 19 on Sun Life’s top 20 list of high-cost claim conditions over four years. This is significant, as every other condition on the list has amassed four years worth of claims to COVID’s two, underlining the severity of the pandemic.

From the Rx coverage front, Fierce Pharma reports

Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.

HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.

HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.

At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.

FDA approval of OTC contraceptives should have been approved years ago, in the FEHBlog’s opinion.

From the SDOH front, Health Payer Intelligence informs us

The Association for Community Affiliated Plans (ACAP) has initiated a center designed to spur new ideas about how to address social determinants of health, according to a press release that HealthPayerIntelligence received by email.

“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, chief executive officer of ACAP, shared in the press release. 

“Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades. This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment.”

Bravo.

The Wall Street Journal reminds us that the new three-digit 988 suicide hotline launches on Saturday, July 16.

Health officials preparing to broaden the reach of a national mental-health crisis line are working to strengthen an overstretched network of call centers that didn’t connect with about one in six callers in recent years, a Wall Street Journal data review showed. 

The National Suicide Prevention Lifeline will transition on July 16 to a three-digit number for calls and texts, 988, from a 10-digit number that has operated since 2005 in coordination with local crisis centers. The line’s operators, including the Substance Abuse and Mental Health Services Administration and the nonprofit Vibrant Emotional Health, said they expect an increase in calls to the shorter and more memorable 988 number during the next year. Stress, suffering and disruption of routines during the pandemic has worsened many people’s mental health, clinicians have said.

Fingers crossed for this important initiative.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Capitol Hill front, STAT News provides more information on the Senate Democrats’ drug pricing proposal

The text released Wednesday is similar to a sweeping package that passed the House last year — it would allow Medicare to negotiate prices with drugmakers, it would protect seniors from especially exorbitant drug costs, and it would discourage drugmakers from raising their prices dramatically.

There are some notable changes that will affect when patients see savings, how the drug development pipeline works, how certain patients will pay for insulin, and how the new prices would affect safety-net programs and Medicaid.

The Washington Examiner emphasizes The proposal * * * lacks language included in the lower chamber’s bill that would cap insulin prices for people with diabetes at $35 a month.”

The STAT News article adds

Senate Democrats are taking a gamble and removing all of the provisions that would have lowered patients’ insulin prices out of the bill, to allow a separate, bipartisan effort led by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) to advance.

Now, the HHS secretary would still be allowed to negotiate insulin prices, but only within the parameters and limits of the regular process. Shaheen and Collins’ bill relies on drugmakers voluntarily lowering their prices in exchange for banning rebates for the products.

The brand drug lobby PhRMA blasted the out-of-pocket cost changes, claiming that “Democrats weakened protections for patient costs included in previous versions, while doubling down on sweeping government price-setting policies.”

From the Omicron and siblings’ front

STAT News reports

Six months after regulators issued an emergency use authorization for Paxlovid, physicians say they still have significant questions about prescribing guidelines for the leading treatment for high-risk Covid patients.

STAT spoke with providers who said they and their colleagues aren’t on the same page about when to prescribe Paxlovid or the criteria that separates those who need it from those who do not. They also said it is unclear whether they can give a second course when patients test positive again after taking Paxlovid, a phenomenon known as a rebound. And nearly all the experts who spoke with STAT said that they are clamoring for more data on rebounds, which is complicating and sometimes changing their calculus about when to give the drug.

“There is a real dearth of evidence right now out there, and obviously there’s a lot of confusion,” said Jonathan Li, a physician at Brigham and Women’s Hospital and virology researcher at Harvard Medical School who is also a member of the Covid-19 Treatment Guidelines Panel. “And even amongst people who are immersed in the literature, and who are infectious disease experts, you’ll see actually a fairly wide range in opinions.” * * *

“Pretty much everybody meets the EUA criteria. They made it very, very, very broad,” said David Smith, a professor, physician, and virology researcher at the University of California, San Diego. In a single week in May, over 160,000 Paxlovid prescriptions were filled.

Physicians generally agree that certain high-risk patients — including people who are unvaccinated or those over 65 with multiple comorbidities — should always be prescribed the drug. But the broader eligibility makes it difficult for some physicians to decide who should or should not receive Paxlovid. A child is not likely to need it, but what about a healthy 50-year-old man? A 65-year-old woman? The experts STAT spoke with didn’t agree.

MedPage Today informs us

According to Lawrence Kleinman, MD, MPH, of the department of pediatrics at Rutgers Robert Wood Johnson Medical School in New Jersey, we need to take our time in defining long COVID, whether it’s with a checklist, an algorithm, or an entry for the medical dictionary.

“If we defined it a certain way and we missed something in that initial definition, then there will be silence on that until someone comes around and does a postmortem on our analysis,” Kleinman, who is also the lead researcher in the Rutgers pediatric hub of the NIH’s nationwide RECOVER study, told MedPage Today. “We want to avoid that to the extent that’s possible.”

He said more research and data collection are needed before the work of defining long COVID is possible in a clinically meaningful way. At the moment, he noted, there isn’t even clear criteria for where to start.

For example, should researchers focus on setting a specific number of days a person experiences fatigue after an acute COVID infection? If so, what should those ranges look like — fatigue after 30 days? As he pointed out, there are not enough data to develop the foundational elements needed for researchers to piece together a practical definition just yet.

Nothing is simple.

From the Medicare front, the American Hospital Association reports

The Centers for Medicare & Medicaid Services today released its calendar year 2023 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor to $33.08 in CY 2023, as compared to $34.61 in CY 2022, which reflects the following: the expiration of the 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment. In addition, CMS proposes to delay for one year (until Jan. 1, 2024) the implementation of its policy to define the substantive portion of a split (or shared) visit based on the amount of time spent by the billing practitioner. Under this policy, if a non-physician practitioner performed at least half of an E/M visit and billed for it, Medicare would only pay 85% of the PFS rate.

CMS proposes numerous policy changes to the Medicare Shared Savings Program. For example, it would modify the manner in which accountable care organizations’ benchmarks are calculated to help sustain long-term participation and reduce costs. It also would provide increased flexibility for certain smaller ACOs to share in savings. The rule also proposes updates to MSSP quality-measurement policies, including a new health equity adjustment that would award bonus points to ACOs serving higher proportions of underserved or dually-eligible beneficiaries.

For the Quality Payment Program, CMS proposes five new, optional Merit-based Incentive Payment System Value Pathways that would be available beginning in 2023. These MVPs align the reporting requirements of the four MIPS performance categories around specific clinical specialties, medical conditions or episodes of care. CMS also proposes refinements to the MIPS subgroup reporting process, an increase to the quality data completeness threshold, and changes to the requirements and scoring of the Promoting Interoperability category. The proposed rule also includes requests for input on policy ideas for advancing health equity and transitioning to digital quality measurement.

Comments are due Sept. 7. 

CMS adds

For a fact sheet on the CY 2023 Physician Fee Schedule proposed rule, please visit:https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule

For a fact sheet on the CY 2023 Quality Payment Program proposed changes, please visit (clicking link downloads zip file): https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1972/2023%20Quality%20Payment%20Program%20Proposed%20Rule%20Resources.zip

For a fact sheet on the proposed Medicare Shared Savings Program changes, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule-medicare-shared-savings-program

For a CMS blog on the proposed behavioral health changes, please visit: https://www.cms.gov/blog/strengthening-behavioral-health-care-people-medicare

To view the CY 2023 Physician Fee Schedule and Quality Payment Program proposed rule, please visit: https://www.federalregister.gov/public-inspection/2022-14562/medicare-and-medicaid-programs-calendar-year-2023-payment-policies-under-the-physician-fee-schedule  

From the nicotine front, STAT News tells us

The FDA suddenly reversed course this week on its efforts to ban Juul e-cigarette sales, an embarrassing about-face that calls into question the reasoning behind the agency’s initial decision, experts said.

Tuesday evening, the Food and Drug Administration announced it was giving Juul’s application for its vaping products a second look because of “scientific issues … that warrant additional review.” The move came less than two weeks after the FDA made international headlines for ordering all of the vaping giant’s products off the market, prompting praise from lawmakers and advocates alike.

The FDA previously said that Juul “did not provide [sufficient] evidence and instead left us with significant questions,” which prevented the agency from granting its application. But now, it seems, the FDA is acknowledging there is additional information in Juul’s application that regulators didn’t adequately consider.

Ruh-roh.

From the women’s healthcare front —

Employee Benefit News reports

Fertility benefits and family-building programs have become table stakes for employers looking to support their workforce, but an increasing number of providers and employees are working to offer care during the next stage of reproductive health: menopause. 

Nine out of 10 working women said menopause affects their work performance, according to a survey by AARP, which estimates that companies lose $150 billion a year in lost productivity as a result. Yet, 99% of women in the U.S. don’t have access to an employer-sponsored menopause care benefit. 

“This is an area that nobody has really focused on, and there isn’t much out there available for employees,” says Maya Bodinger, vice president of business development at P.volve. “The menopause transition can be anywhere from four years to 12. This is not just a year or two like how we traditionally think about reproductive health.” 

MedPage reports

Cesarean deliveries have increased in the U.S. over the last few years, driven by a rise in patients who underwent first-time C-sections, according to a CDC report.

While the rate of primary C-sections fluctuated from 2016 to 2019, it increased from 2019 to 2021 among women in all age groups, reported Michelle Osterman, MHS, of the CDC’s National Center for Health Statistics.

The primary cesarean rate reached 22.4% in 2021, Osterman wrote in Vital Statistics Rapid Release.

The repeat cesarean rate, however, which captures patients who have multiple procedures, steadily decreased by around 1% each year from 2016 to 2021 (87.6% to 85.9%), Osterman noted. Repeat cesarean delivery rates decreased specifically for women ages 25 to 39, those who identified as white or Hispanic, and those with full- or late-term pregnancies.

The increase in overall C-sections likely would have been higher if not for the decrease in repeat procedures, she said.

“Because 7 to 9 out of 10 pregnant folks with a prior cesarean will have a repeat cesarean, we can anticipate an overall climb in the overall cesarean delivery rate for the years ahead,” Kjersti Aagaard, MD, PhD, an ob/gyn at Baylor College of Medicine and Texas Children’s Hospital in Houston, told MedPage Today.

Finally, the FEHBlog notes that benefits consultant Tammy Flanagan has released the second part of her three-part story on a typical federal employee’s experience with the federal government’s retirement process. The report appears in Govexec.

Midweek Update

From Capitol Hill, Fierce Healthcare reports

Senate Democrats have narrowly reached a deal on legislation to give Medicare the power to negotiate for lower drug prices.

The Senate released text Wednesday (PDF) on the deal that also repeals the controversial Part D rebate rule and installs a cap on monthly cost-sharing payments for Part D and Medicare Advantage plans. 

The legislative text shows that starting in 2026, the Department of Health and Human Services will choose 10 drugs eligible for negotiation. The next year, the number of eligible drugs will increase to 15, and in 2029 and every year after by 20. 

The sole-source drugs subject to negotiation will be chosen based in part on their total spending under Medicare Parts B and D. There is an exception for small biotech drugs from 2026 through 2028 such as vaccines and excludes certain orphan drugs as well.

Roll Call adds “Congress is fast approaching its scheduled August recess, followed by peak campaign season, so Democratic lawmakers only have a few more weeks in session to push their legislative priorities before they could lose control of either chamber in November.”

From the Omicron and siblings front, the American Hospital Association tells us

The Food and Drug Administration today authorized state-licensed pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) to patients as a treatment for those at high risk of severe COVID-19. Because Paxlovid must be taken within five days of symptom onset, the change could spur expanded access and more-timely treatment of eligible patients. The change was made through an amended emergency use authorization. 

This standing order approach should accelerate the continuing rollout of test to treat locations.

Regrettably the Wall Street Journal adds

Governments, drugmakers and vaccination sites are discarding tens of millions of unused Covid-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce. * * *

In the U.S., about 90.6 million Covid-19 doses have been wasted, or 11.9% of the more than 762 million Covid-19 vaccine doses delivered since the shots became available in late 2020, according to the Centers for Disease Control and Prevention.

The wastage rate has accelerated recently: Some 12 million of the discarded doses have been thrown out since late May.

The disposals come during a significant drop in demand for Covid-19 vaccines, even with young children recently becoming eligible. The seven-day moving average of doses administered daily in the U.S. was about 155,000 as of June 21, down from about 1.1 million on Jan. 1 and the peak of about 3.5 million daily in April 2021.

Partly driving the wastage, health experts said, is the way the Covid-19 vaccines are packaged in multiuse vials containing from five to 20 doses. Once opened, the vials generally must be used within about 12 hours of opening or the remaining doses discarded.

From the telehealth front

Healthcare Dive reports

COVID-19 made its way back into the top five telehealth diagnoses nationally on Fair Health’s monthly tracker in April for the first time since January, according to the report out Wednesday.

Every U.S. census region except the South saw COVID-19 return to the top five diagnoses list, and the uptick is in line with rising cases reported in April by the Centers for Disease Control and Prevention.

Telehealth use overall also rose nationally and in every region after two months of decline, the report found.

Fierce Healthcare informs us

Teladoc is further building out its primary care offering, Primary360, with new services that enhance care coordination and grow in-home options.

Primary360 will now provide care coordination support and health plan in-network referrals alongside free same-day medication delivery from Capsule and in-home, on-demand phlebotomy services backed by Scarlet Health, according to an announcement Wednesday from Teladoc.

The new care coordination capabilities will allow Primary360’s care team to take a “holistic” view of the patient’s coverage and make streamlined referrals to Teladoc services they can access. The care team can also then ensure a patient is referred to an in-network provider when in-person services are necessary.

mHealth Intelligence reports “The burgeoning mental health epidemic in America is widespread across age groups, but the youth have faced a particularly challenging time amid the COVID-19 pandemic. As the youth mental health crisis reaches new heights, providers are increasingly turning to telehealth to help expand access to behavioral healthcare.”

In the same spirit, Health Data Management discusses best practices for hospitals interested in providing acute care at home services.

From the U.S healthcare front, Beckers Hospital Review calls our attention to the fact that “Money, formerly Money Magazine, and Leapfrog Group collaborated for their first shared ranking of “best hospitals” to help consumers make decisions about which healthcare institutions are best for their money. The inaugural list was released July 6 and can be found in full here.” Check it out.

From the fraud, waste and abuse front, Healthcare Dive reports

The federal government won or negotiated more than $5 billion in healthcare fraud judgments and settlements in its 2021 fiscal year, the largest amount ever in the history of the HHS and Department of Justice’s fraud and abuse enforcement program.

Due to those and other efforts from previous years, the government clawed back almost $1.9 billion, according to a new report from the departments.

Of that $1.9 billion, about $1.2 billion went to the Medicare trust funds, which are on increasingly precarious financial footing due to growing stress on the insurance program. In addition, roughly $99 million in federal Medicaid money was transferred back to the CMS.

 Finally, Govexec brings us up to date on projections for 2023 annual raises for federal employees.

President Biden and House appropriators seem thus far to be in agreement that federal employees should receive an average 4.6% pay raise next year, but there are still several steps officials must take before it can be implemented at the end of the year. * * *

On Capitol Hill, there are still a few opportunities for federal employee groups and some lawmakers to try to increase the raise to the average 5.1% figure they have been advocating for.

Midweek update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.

Midweek update

Photo by Michele Orallo on Unsplash

From Capitol Hill, Medtech Dive reports

The Senate Committee on Health, Education, Labor and Pensions voted Tuesday to send a bill to the Senate that would reauthorize the Food and Drug Administration to collect user fees from device- and drug-makers for the next five years. 

A provision would require the FDA to finalize guidance that would create a category of over-the-counter hearing aids within a month of the bill’s passage. The FDA last issued a proposed guidance in October.

Committee Ranking Member Sen. Richard Burr, R-N.C., questioned on Tuesday whether the FDA should have that expanded authority, despite co-sponsoring legislation that would change how diagnostic tests are regulated, including laboratory-developed tests.

Fierce Healthcare adds

The American Hospital Association (AHA) penned a last-ditch letter to congressional leaders pleading for Medicare sequester cuts slated to take effect July 1 to be halted in light of the financial strain many of the nation’s hospitals are expected to face throughout 2022.

Congress had initially paused the 2% payment cut as part of the CARES Act when the COVID-19 pandemic began to threaten providers’ bottom lines. Sequestration cuts were continually punted downfield until last December, when a bill was signed to resume a 1% cut in April and the full 2% in July.

With half a month to go, AHA Executive Vice President Stacey Hughes warned majority and minority leaders Tuesday that financial relief from the pending cut is necessary for hospitals “to maintain access to care for the patients and communities they serve.”

From the Supreme Court, the American Hospital Association gleefully informs us

The U.S. Supreme Court today ruled unanimously in favor of the AHA and others, reversing a 2020 [U.S.] court of appeals decision upholding the authority of the Department of Health and Human Services to significantly cut payments to certain hospitals that participate in the 340B Drug Pricing Program, and thereby threatening access to care for patients.

The Supreme Court held that “HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were contrary to the statute and unlawful.” Noting that “340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support,” the Supreme Court observed that “this case has immense economic consequences, about $1.6 billion annually.”

Despite those serious practical impacts, the Supreme Court concluded that “[u]nder the text and structure of the statute,” the case is “straightforward” as a matter of law: “Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.”

From the Omicron and siblings front —

The Wall Street Journal reports

Health experts advising U.S. health regulators backed giving Covid-19 vaccines from Pfizer Inc. and BioNTech SE and from Moderna Inc. to children as young as 6 months old

The panel voted 21 to 0 in a pair of votes on Wednesday in support of expanding access to the vaccines.

The positive recommendations will likely lead soon to expanding the U.S. Covid-19 vaccination campaign to the 19.6 million children from 6 months to under 5 years of age, one of the last groups of people in the U.S. waiting for shots.

The Food and Drug Administration, which doesn’t have to follow the panel’s recommendations but usually does, is expected to authorize the shots within days. Vaccinations could begin as early as June 21, according to the Biden administration.

and

Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date.

The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September.

BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months.

STAT News adds

Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations.

Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid.

The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid. But the results, published in a press release, are likely to take time for experts to digest and understand.

From the unusual viruses front, the American Hospital Association explains

The Centers for Disease Control and Prevention yesterday [June 14] updated its guidance to help clinicians evaluate and test patients with relevant history, signs and symptoms for monkeypox. Over 1,800 monkeypox or orthopoxvirus cases have been reported globally this year, including 72 in the United States. According to CDC, the virus does not spread easily between people without close contact, so the risk to the general population remains low.

The World Health Organization plans to change monkeypox’s name next week.

From the healthcare business front

Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it’s also launching new brands for two of its subsidiaries.

The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word “care” with the suffix “lon,” which means full or complete, representing the company’s ambition to offer an end-to-end care experience.

Carelon will include Anthem’s in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.

and

Humana is moving its pharmacy brands under the CenterWell umbrella.

Humana Pharmacy and Humana Specialty Pharmacy will now operate as CenterWell Pharmacy and CenterWell Specialty Pharmacy, respectively, the insurer announced. Enclara Pharmacia and Humana Pharmacy Solutions, the company’s pharmacy benefit management arm, will maintain their original branding.

“The CenterWell brand symbolizes our ongoing and strong commitment to keeping members, customers and patients at the center of everything we do,” said Scott Greenwell, Humana Pharmacy Solutions president, in a statement.

  • Morning Consult discusses how CVS Health and Walgreens retained “high customer trust” in 2021.

From the benefit design front, Employee Benefits News offers the case for health savings accounts. The FEHBlog is already sold.