Monday Roundup

Mental health care

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the federal policy front, Fierce Health tells us about four healthcare policy changes beyond government negotiation of a subset of Medicare-covered drugs and extension of ACA subsidies found in the budget reconciliation bill that Congress approved last week. The President is scheduled to sign the bill into law tomorrow.

Here are four other health policy changes to look for in the bill:

  • First, expands eligibility for the full amount of low-income Part D subsidies from 135% of the federal poverty line to 150% of the FPL.
  • Gets rid of the cost-sharing for adult vaccines for Medicare Part D. The FEHBlog has personal experience with this one. In 2020 he received the new Shingrix vaccine under Medicare Part D. The vaccine was eligible for no cost sharing when administered in-network under the Affordable Care Act. However, under Part D, the FEHBlog was charged $200 for each of the two doses. This big bowl of wrong will be remedied in 2023.
  • Delays the controversial Part D rebate rule, again. “The Trump-era rule would eliminate the safe harbor for Part D rebates, leaving them open to prosecution under federal anti-kickback laws. The rule passed at the tail end of Trump’s term but has never gone into effect. The law would delay the rule from going into effect again into 2032.”
  • Limits the premium growth on Medicare Part D to no more than six percent a year from 2024 through 2029. “The cap on premium growth is intended to mitigate the impact of other changes to Part D, said Ryan Urgo, managing director of the policy practice at consulting firm Avalere Health. The legislation includes a $2,000 out-of-pocket cost cap on Part D drugs, spread out in installments for the beneficiary over a calendar year. Part D plans will also have to pick up more of the costs for spending in the catastrophic coverage phase, which a beneficiary reaches when their drug costs reach a certain level.”

From the Omicron and siblings front, BioPharma Dive informs us

British drug regulators on Monday approved a two-pronged vaccine from Moderna that’s designed to fight both the original version of the coronavirus and the omicron variant.

The decision makes the U.K. the first country to clear a COVID-19 booster that’s been specifically tailored to a newer form of the virus. While the original shots, like Moderna’s Spikevax, remain strongly effective at preventing hospitalization and death, they’ve had a harder time warding off infections from omicron and its subvariants. * * *

Speaking to a [U.S.] advisory committee in June, executives from Moderna and Pfizer said dual-acting boosters with a BA.4 or BA.5 could be available in large volumes in October and November, although they would first need to undergo regulatory review before they could be administered.

Separately, Novavax on Monday asked the FDA to authorize its COVID-19 vaccine as a booster shot in people 18 and older. The shot is only available as a primary series to those who haven’t yet been vaccinated.

The Centers for Disease Control released updated guidance on what to do if exposed to Covid.

The Wall Street Journal reports on assessing Covid-19 risks after easing CDC guidelines, which began last week. The headline notes, “More decision-making is shifting to individuals, and here is what doctors recommend.”

From the monkeypox front, the Journal discusses “What to Know About Symptoms, Vaccines and How It Spreads,” and Beckers Hospital Review offers five monkeypox updates, including a complete explanation of how the World Health Organization is going about changing the disease’s name.

From the mental healthcare front, about ten years ago, the FEHB Program under OPM’s leadership was the first large employer-sponsored program to cover a form of autism therapy called “applied behavior analysis” (ABA). A STAT News investigation discloses

ABA has long been viewed as the gold standard for kids with autism, so much so that every state mandates insurance coverage. For some families, it is the only option that insurance will cover at all. 

But like other pockets of the health care industry, this one has been transformed over the past decade by a flood of investments from private equity firms, drawn by the promise of insurance reimbursement and the rising rate of autism in children across the U.S., now estimated at 1 in 44 kids. 

Families and clinicians who once believed fully in the promise of ABA say the financial investors’ fixation on profit has degraded the quality of services kids receive, turning it into the equivalent of fast food therapy. They’ve grown disillusioned with the industry, they told STAT.

The HHS Inspector General is auditing Medicaid claims for ABA. The final audit report is expected later this year.

From the Rx coverage front, the Drug Channel blog discloses

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type. 

The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion—an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart. Hospitals accounted for 87% of these skyrocketing 340B purchases.

What’s more, the difference between list prices and discounted 340B purchases also grew, to $49.7 billion (+$7.0 billion). This figure approximates the money collected by 340B covered entities.

340B advocates have been screaming that “drug companies are cutting 340B,” but the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut. 

From the U.S. healthcare business front, Beckers Payer Issues provides an interview with “Kyu Rhee, MD, a senior vice president at CVS Health and chief medical officer at Aetna. He sat down with Becker’s to discuss ongoing trends across the healthcare industry and how he is working to create a “values-based” care system through opportunities offered by a global pandemic.”

Weekend update

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Congress is on a State / District work break until after Labor Day.

The Change Healthcare antitrust trial is ongoing. The judge Hon. Carl J. Nichols will be deciding the case without a jury. He was heard evidence for ten days already. The case is U.S. v UnitedHealth Group et al., 22-cv-481, U.S. District Court for the District of Columbia.

From the Omicron and siblings front, Bloomberg Prognosis informs us

Scientists fear that the omicron shots coming this fall won’t be all that much better at keeping people from getting Covid than the shots we already have. That’s pushing drugmakers to start working on next-generation vaccines that don’t have to be updated that often, if at all, writes Bloomberg’s Madison Muller, Riley Griffin and Fiona Rutherford. 

“Even with the highly flexible platform of mRNA, which is more flexible than virtually anything we’ve had before, it’s going to be very difficult to keep up with the pace of newly evolving variants,” Anthony Fauci, President Joe Biden’s chief medical adviser told Bloomberg. “Which gets us to the question: What about a pan-coronavirus vaccine?”

Aim high.

From the monkeypox front, the World Health Organization has renamed the disease that is quite bland.

Consensus was reached to now refer to the former Congo Basin (Central African) clade as Clade one (I) and the former West African clade as Clade two (II). Additionally, it was agreed that the Clade II consists of two subclades. 

A clade means “a group of organisms believed to have evolved from a common ancestor, according to the principles of cladistics, e.g., “the great ape and human clade.” How will WHO distinguish between the monkeypox clade and the chickenpox clade? Time will tell.

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

Humana will acquire a Wisconsin managed care plan in a bid to bulk up its Medicaid services, the insurer announced Friday.

Inclusa, Inc. offers long-term care coverage as well as supporting 16,600 older adults and adults with disabilities in Wisconsin’s Family Care program. The managed care organization has worked with local providers and community resources for more than 20 years to connect members with necessary support and services.

Inclusa partners with more than 6,000 service providers across about 40 service categories, as well as contracts with the state to provide family care services in 68 of Wisconsin’s 72 counties, according to the announcement.

The Wall Street Journal offers two expert interviews on mental health issues:

Check them out.

Speaking of eating, Forbes offers the five best diets for people with diabetes in 2022.

NPR reports on initial experience with the 988 lifelines.

The 988 hotline is the nation’s most comprehensive mental health crisis service and can provide crucial help to those in emotional distress. If you’re thinking about suicide but not taking steps to act on it, 988 is unlikely to call law enforcement without your consent. Instead, 988 counselors can provide resources, referrals and a kind ear. However, if you’re at imminent risk and could act on a plan to kill yourself, police may be called, and you could be taken to a hospital involuntarily.

Sonyia Richardson, a licensed clinical social worker who owns a counseling agency that serves mostly Black and brown clients in Charlotte, N.C., said she didn’t immediately tell her clients about 988 when it launched. Even though she’s a member of her state’s 988 planning committee, she said she needed time to develop trust in the service herself. When she learned at a recent committee meeting that fewer than 5% of 988 calls in North Carolina led to a law enforcement response, she felt reassured.


Thursday Miscellany

David Ermer–Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

The Senate is expected to begin consideration of Democrats’ climate, tax and health care package on Saturday, leaving about two days for the party to shore up support for the bill.

Senate Majority Leader Charles E. Schumer said Thursday that he’s expecting a vote on the motion to proceed Saturday afternoon, which would follow a nomination vote he scheduled for 12:30 p.m.

The motion to proceed is a simple majority threshold; no Republicans are expected to back it. 

If Democrats can secure the votes to move forward, it would trigger up to 20 hours of debate before a “vote-a-rama,” when senators can offer unlimited amendments and motions to delay the process. The debate time is equally divided between the parties and senators on either side can choose to yield back time in order to get to the vote-a-rama quicker. 

It remained unclear Thursday afternoon whether party leaders had secured crucial backing from Sen. Kyrsten Sinema. * * *

Democrats are also working to wrap up the “Byrd bath,” in which the Senate parliamentarian hears arguments from both parties and issues opinions on whether provisions meet conditions of the budget reconciliation rules. Reconciliation allows the bill to avoid a filibuster and pass with only Democrats’ votes in the 50-50 Senate. * * * [Sen.] Sinema is expected to wait for the process to play out before making her position on the package known.

While the FEHBlog was writing this post, Politico reports

Sen. Kyrsten Sinema announced on Thursday night that she’s signed off on Democrats’ climate, tax and health care legislation after securing a handful of changes. 

The Arizona Democrat was not consulted during July’s dealmaking between Senate Majority Leader Chuck Schumer and Sen. Joe Manchin, but after changes to several tax provisions she okayed the agreement on Thursday. “We have agreed to remove the carried interest tax provision, protect advanced manufacturing, and boost our clean energy economy in the Senate’s budget reconciliation legislation. Subject to the Parliamentarian’s review, I’ll move forward,” Sinema said.

From the Omicron and siblings front

The New York Times explores the question “Is This What Endemicity Looks Like?” The article points out “The basic footprint of the disease has been consistent for a few months.”

We’ve been at roughly the same number of hospitalizations and deaths in the country since the end of the initial Omicron wave in the winter. And because so much of that has to do with how much better our immune systems are working against Covid than in the past, there’s probably no reason to think that those dynamics are going to dramatically change unless there’s an out-of-left-field new variant like the original Omicron.

And I think that fits the layperson’s understanding of what an endemic disease is: It’s circulating, but it’s sort of in the background, and while there are some little peaks and some little valleys, they aren’t so dramatic that they threaten to really upend life at a community level, let alone at a national level. That’s a pretty fair description of where we are right now.

While Omicron remains a dangerous virus, particularly for the elderly, which of course is where we started, we now have vaccines against severe illness and treatments for the virus.

It’s worth reading the article.

MedPage Today tells us

Most patients with smell or taste dysfunction related to COVID-19 reported complete recovery of their senses at 2 years, according to a cross-sectional survey conducted in Italy.

Among 119 patients with smell or taste dysfunction within 4 weeks of COVID onset, 88.2% reported complete resolution at 2 years, 9.2% reported a decline in symptom severity, and 2.5% reported unchanged or worsening symptoms, said Paolo Boscolo-Rizzo, MD, of the University of Trieste, and colleagues.

MedPage also offers us some Omicron miscellany

The CDC may relax guidance for COVID-19 control, including for schools, possibly as early as this week. (CNN)

And Los Angeles schools plan on updating COVID-19 protocols for the upcoming school year by dropping “overly aggressive” testing, masking, and vaccination requirements. (KTLA).

From the monkeypox front,

NPR reports

The White House today declared monkeypox a public health emergency. 

“We are prepared to take our response to the next level in addressing this virus and we urge every American to take monkeypox seriously,” Health and Human Services Secretary Xavier Becerra said to reporters during a briefing on Thursday. 

A public health emergency can trigger grant funding and open up more resources for various aspects of a federal response. It also allows the Secretary to enter into contracts for treatments and other necessary medical supplies and equipment, as well as support emergency hospital services, among other things. Public health emergencies last for 90 days but can be extended by the Secretary.

CDC Director Rochelle Walensky, said the declaration will provide resources and increase access to care. She also said it will expand the CDC’s ability to share data.

STAT News adds

Also Thursday, FDA Commissioner Robert Califf announced the agency was considering allowing Bavarian Nordic’s Jynneos, the only vaccine licensed in the United States to prevent monkeypox, to be given in two doses that are one-fifth the size of the licensed doses, via intradermal administration. Doing so could allow five times as many people to be vaccinated with existing supplies than if the licensed dosage was employed.

The vaccine is licensed as a two-dose product, with the doses administered via intramuscular injection 28 days apart.

“We believe this could be a promising approach,” Califf said.

In other public health news, the Department of Health and Human Services announced

Our nation’s blood and plasma supply dropped to historic lows during the COVID-19 pandemic. While some areas of the country have seen improvement, other areas are still struggling to meet the demand. Blood and plasma are needed on an ongoing basis to treat a variety of life-threatening conditions, which is why the U.S. Department of Health and Human Services (HHS), is launching a new campaign, Giving = Living. * * *

Visit hhs.gov/givingequalsliving to learn more about the importance of donation and make an appointment at a donation location near you.

From the U.S. healthcare business front —

Healthcare Dive tells us

Cigna reported net income increased 6% year over year to $1.6 billion during the second quarter as fewer people were admitted to the hospital, had fewer surgeries and visited the emergency room less. 

The Connecticut-based insurer said medical costs for both COVID-19 and non-COVID-19 care were lower than projected. The insurer’s medical loss ratio, an important measure of how much is spent on medical care, fell to 80.7% for the second quarter. Analysts said price hikes helped the MLR, too. 

As a result of the quarterly performance, Cigna raised financial targets for the year for revenue and income from operations. 

Fierce Healthcare informs us

Telehealth company Amwell is working with CVS Health to roll out the retail drugstore giant’s new virtual primary care service.

CVS announced at the end of May plans to launch a virtual care service that gives consumers access to primary care, on-demand care, chronic condition management and mental health services. Eligible Aetna and CVS Caremark members will be able to use the virtual primary care service to access healthcare services on demand, whether at home or in a retail or community-based setting, the drug store company said.

CVS’ virtual care platform is a “consumer-centric offering designed to bring together the many elements of CVS Health ecosystem services into a single integrated experience with a unified digital front door,” Dr. Ido Schoenberg, chairman and co-chief executive officer of Amwell, said during the company’s second-quarter earnings call Thursday.

and

Elevance Health is betting big on primary care with a new nationwide partnership with Aledade.

The team-up will focus on assisting primary care practices in transitioning to value-based care, to boost health outcomes and lower costs. Independent primary care practices that are within the insurer’s network will be able to access Aledade’s suite of technology and local, in-person services.

Aledade’s platform provides the tools, support and resources that PCPs need to roll out value-based care, the companies said.

Bloomberg reports

Pfizer Inc. will spend $470 million to expand its vaccine research facilities 25 miles northwest of New York City, where the company hopes to maintain its edge in the booming field of messenger RNA, the technology behind its blockbuster Covid-19 shot. 

The drugmaker will construct a new building and renovate existing facilities on its campus in Pearl River, New York, which has been the nexus of laboratory research driving its vaccine programs, including the one for Covid in partnership with BioNTech SE.

From the substance use disorder front, NPR explains

Music festivals once frowned upon naloxone, and some banned it. But even though what’s known as harm reduction — the concept of minimizing the negative effects of illicit drug use without trying to stop it altogether — has gained acceptance, it’s far from embraced. Less accepted than naloxone among concert promoters is helping people test their drugs for fentanyl. Companies don’t want to be seen as condoning drug use. They’re also navigating a legal gray area and battling public perceptions. * * *

Overdose deaths continue to climb in the U.S. Drug fatalities topped 100,000nationwide in 2021, with two-thirds caused by synthetic opioids. This has prompted federal and state governments to try to think of new ways to combat the crisis, with the Biden administration giving $30 million to support programs that have often operated in the shadows. In the past few years, the Substance Abuse and Mental Health Services Administration also has fully embraced fentanyl test kits.

Still, many communities far beyond music festival grounds are resistant to harm-reduction strategies, especially fentanyl-testing tools. Dr. Yngvild Olsen, director of SAMHSA’s Center for Substance Abuse Treatment, said harm reduction requires an evolution in thinking, and she encourages organizations to consider harm reduction a lifesaving tool — especially when mass overdoses are possible.

From the telehealth front, Health Payer Intelligence reports

Telehealth flexibilities during the coronavirus pandemic contributed to a 26 percent spike in overall utilization of in-network outpatient behavioral health, according to a report from UnitedHealth Group.

“Prior to the COVID pandemic, telehealth was broadly viewed as a potential strategy for improving access to behavioral health care,” the report explained. 

“During the pandemic—which saw increased rates of depression, anxiety, and substance use disorder—federal and state policymakers and commercial health plans established temporary flexibilities to increase access to care, and patients and providers increased their use of virtual visits as an alternative to in-person office-based care.”

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.

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–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare informs us

House Rep. Lloyd Doggett, D-Texas, introduced the Assuring Medicare’s Promise Act on Monday aimed at redirecting income tax revenue as a solution to Medicare’s hospital fund that will run out of money in 2028. * * *

The legislation aims to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. * * *

If the bill is implemented, Doggett expects Medicare Trust Fund solvency to be extended through 2040.

The legislation comes as Congress is taking a sharper eye at ways to shore up Medicare’s finances. The Senate, for instance, is eyeing closing similar loopholes for NIIT and would extend Medicare solvency for another three years, according to a CNN report.

Senate Democrats are working on a deal to give Medicare the power to negotiate lower drug prices, and the tax provisions could be included. 

From the Omicron and siblings front, we have mixed bag Covid news from the Wall Street Journal.

Covid-19 is circulating widely as the BA.5 Omicron subvariant elevates the risk of reinfections and rising case counts, spoiling chances for a summer reprieve from the pandemic across much of the U.S.

Covid-19 levels are high in a fifth of U.S. counties, according to the Centers for Disease Control and Prevention’s metric based on case and hospital data, a share that has been mostly rising since mid-April. BA.5 is estimated to represent nearly two in three recent U.S. cases that are averaging just more than 100,000 a day, CDC data show. The true number of infections may be roughly six times as high, some virus experts said, in part because so many people are using at-home tests that state health departments largely don’t track.  * * *

The pace of hospital admissions for Covid-19-positive patients has recently sped up, federal data indicate. The seven-day moving average for confirmed Covid-19 patients in hospitals has topped 34,000, federal data show, up from a low near 10,000 in April but far below January’s record peak topping 150,000.

Many of the hospitalizations are cases where patients test positive after being admitted for other reasons. Deaths are hovering around 300 to 350 a day, Dr. Jha said Tuesday. This is much closer to historic lows than highs, though he called the current level unacceptable.

The reduced threat is one reason a pandemic-fatigued populace is less likely to change behavior when cases are high, said Robert Wachter, chairman of the department of medicine at the University of California, San Francisco. * * * “Part of what motivated people to be super careful for a long time was the fear that I’m going to die of this thing,” Dr. Wachter said. “I think people have less fear of that, and that’s not inappropriate.”

From the U.S. healthcare business front

  • MedPage Today identifies the heavy hitters in Healthcare who topped the recently announced Fortune 500.
  • Insurance News Net reports that “Commercial health insurers suffered a 90% decrease in underwriting income last year as fewer people signed onto group health and instead moved into individual coverage on an exchange or a Medicaid program, and COVID care requirements far exceeded expectations. * * * Large, diversified carriers fared best, according to Antonietta Iachetta, AM Best senior financial analyst. “Smaller carriers with concentrations in the commercial business found themselves in an especially difficult position — more than half of insurers with capital and surplus under $50 million posted underwriting losses in 2021, the highest share of companies with losses for that group since 2012,” Iachetta said.”
  • Beckers Payer Issues reviews the history of Mark Cuban’s PBM Cost Plus Drug Co. to identity barriers to competing in that market.
  • Fierce Healthcare tells us, “Optum has quietly teamed with Red Ventures on a new joint venture focused on consumer health. The venture, called RVO Health, covers a mix of assets from both parties, including Optum’s Store and Perks and Red Ventures’ Healthline Media and Healthgrades. Virtual coaching platforms Real Appeal, Wellness Coaching and QuitForLife, news first reported by Axios. Through these elements, RVO includes a slew of consumer offerings, including doctor ratings through Healthgrades, medical information and communications from Healthline, Optum Perks’ prescription savings card and home delivery of health and wellness products through Optum Store.”

From the U.S. healthcare front

The American Hospital Association reports

After declining in recent years, antimicrobial-resistant infections starting during hospitalization grew 15% from 2019 to 2020, the Centers for Disease Control and Prevention reported today, based on limited data for 2020.

“During the pandemic, hospitals experienced personal protective equipment supply challenges, staffing shortages, and longer patient stays,” the agency notes. “Hospitals also treated sicker patients who required more frequent and longer use of medical devices like catheters and ventilators. The impact of the pandemic likely resulted in an increase of healthcare-associated, antimicrobial-resistant infections.”

More than 90% of U.S. hospitals in 2020 had an antibiotic stewardship program aligned with CDC’s Core Elements of Hospital Antibiotic Stewardship, CDC said. The AHA released an antibiotic stewardship toolkit in 2014 to help hospitals and health systems enhance their antimicrobial stewardship programs based on the CDC’s core elements, and in 2017 partnered with CDC on guidance to help small and critical access hospitals implement programs to improve antibiotic prescribing and use and reduce the threat of antibiotic-resistant infections. For more AHA resources to promote the appropriate use of medical resources, click here.

The CDC’s July 2022 Diabetes Insider called attention to its Diabetes and Your Skin website.

From the mental healthcare front, an expert contributor to HR Morning expresses his views on what employees want in mental health coverage from their employer-sponsored health plans.

From the artificial intelligence front, the Journal of AHIMA looks at the administrative cost savings potential of artificial intelligence.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, SDOH–
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.

Friday Stats and More

David Ermer–CDC, COVID-19, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week are the FEHBlog’s weekly charts of new Covid cases for 2022:

The CDC’s Weekly Review of its Covid Statistics observes “As of July 6, 2022, the current 7-day moving average of daily new cases (106,549) decreased 3.9% compared with the previous 7-day moving average (110,875).”

Here is the CDC’s weekly chart of new Covid hospital admissions

The CDC’s Weekly Review comments “The current 7-day daily average for June 29–July 5, 2022, was 5,080. This is a 3.1% increase from the prior 7-day average (4,930) from June 22–28, 2022.”

Here is the FEHBlog’s weekly chart of new Covid deaths for 2022

The CDC’s Weekly review observes “The current 7-day moving average of new deaths (273) has decreased 20.9% compared with the previous 7-day moving average (345).”

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in the 51st week of 2020 through the 27th week of 2022.

The CDC’s weekly review explains

Overall, about 260.3 million people, or 78.4% of the total U.S. population, have received at least one dose of vaccine. About 222.5 million people, or 67.0% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 106.6 million people have received a booster dose,** but 50.1% of the total booster-eligible population has not yet received a booster dose.

The American Hospital Association adds

The Food and Drug Administration today granted full approval of Pfizer’s COVID-19 vaccine for young teens, covering the age group spanning 12 to 15 years old. FDA said the vaccine, which has been administered in two-dose regimens to nearly 9 million Americans, earned full approval following its “rigorous analysis and evaluation of the safety and effectiveness data.” The approval does not apply to booster doses for that age group.

The CDC’s Weekly Review also provides the following Communities news:

As of July 7, 2022, there are 666 (20.7%) counties, districts, or territories with a high COVID-19 Community Level, 1,218 (37.8%) counties with a medium Community Level, and 1,331 (41.3%) counties with a low Community Level. Compared to last week, this represents an increase (+1.3 percentage points) in the number of high-level counties, an increase (+2.4 percentage points) in the number of medium-level counties, and a corresponding decrease (−3.7 percentage points) in the number of low-level counties. 49 out of 52 jurisdictions* had high- or medium-level counties this week. Rhode Island, New Hampshire, and Washington, D.C., are the only jurisdictions to have all counties at low Community Levels.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

From the Medicare front, Becker’s Hospital Review points out seven things to know about the CMS 2023 Medicare Part B physician payment rule issued yesterday. The lead item has grabbed the medical community’s attention.

The proposed physician fee schedule conversion factor for 2023 is $33.08, down from $34.61 in 2022. The proposal considers a statutory requirement that the conversion factor for 2023 remain flat as well, due to the expiration of the 3 percent increase in physician fee schedule reimbursement payments in 2022 that was required in the Protecting Medicare and American Farmers From Sequester Cuts Act.

For FEHB patients with primary Medicare Part B coverage, this reduction will amount to a cost shift from Medicare to FEHB if implemented by the final rule.

From the No Surprises Act front, Morning Consult offers the results of a survey finding that

One in 5 U.S. adults say they have received an unexpected medical bill this year, according to a new Morning Consult survey that underscores the prevalence of sticker shock in health care — even after federal efforts to combat it.”

The Morning Consult’s survey needs to be taken with a grain of salt because 22% of the surveyed adults are Medicare age (see Survey, p. 131), and the No Surprises Act does not apply to Medicare.

From the Rx coverage front, the PBM’s lobby PCMA compliments the Biden Administration for

taking real action to reduce prescription drug costs. Drug manufacturer pricing strategies that include patent thickets on certain brand drugs unfairly protect those drugs and biologics from generic and biosimilar competition.

The United States Patent and Trademark Office’s and the Food and Drug Administration’s enhanced review power for applications for drug patents that simply don’t deserve an intellectual property extension is a positive step toward eliminating patent thickets and bringing more competition to the marketplace.

That is thoughtful action by the PTO and FDA.

From the Dobbs front, the White House outlines an executive order the President plans to sign in response to the Supreme Court decision.

From the mental health front, Health Payer Intelligence discusses an initiative by “CVS Health and its payer arm, Aetna, [to]  expand its existing program with Psych Hub, advancing its efforts around adolescent suicide prevention.” Bravo.

From the artificial intelligence front, the Wall Street Journal reports “Using advanced analytics and AI, health insurers are building targeted medical advice for customers. Now comes the hard part: Getting them to respond. ‘There’s an art to that data communication,’ one doctor says.” Fascinating read.

Midweek Update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, Telehealth, U.S. Healthcare–

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.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on UnsplashFr

From the Omicron and siblings front, the Wall Street Journal reports

Omicron Covid-19 variants BA.4 and BA.5 are on the rise in the U.S., adding two more highly contagious versions of the virus to the mix that has fueled a springtime surge in cases.

The closely related subvariants represented a combined 13% of U.S. cases for the week ended June 4, according to estimates the Centers for Disease Control and Prevention released on Tuesday. Evidence suggests the variants are yet-more contagious versions of Omicron, public-health experts said, that may be able to evade some of the immune protections people built up from infections triggered by another version of Omicron during the winter.

The spread of the subvariants could at least prolong the time it takes to emerge from the current wave fueled by other versions of Omicron, some health experts said.

The Journal adds

This case wave hasn’t translated to a significant surge in severe illness. Hospitalizations, while up, remain far below earlier peaks, and reported Covid-19 deaths have recently hovered near historically low levels.  * * * Epidemiologists believe built-up immunity from vaccines and prior infections have bolstered defenses against severe illness, even though many people are falling ill from both breakthrough and repeat infections.

AHIP informs us

Today the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant emergency use authorization (EUA) for the Novavax COVID-19 vaccine in adults by a vote of 21-0.

The Committee reviewed data from Novavax showing that the benefits of the two-dose primary series outweigh the potential risks. The Committee noted the importance of making a vaccine available that has an alternative method of action, different from the mRNA vaccines currently available in the U.S., in the hope that a more traditional vaccine may appeal to those currently unvaccinated and those who may have an allergy to the components of the mRNA vaccines.

Committee members agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation, though the company has argued there’s not yet enough evidence to establish a definitive link. The FDA is expected to make a decision on granting Novavax an EUA soon, whereby the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to determine when and how the vaccine should be administered.

BioPharma Dive tells us

Pfizer on Monday announced plans to invest $120 million in a drug manufacturing facility located in Kalamazoo, Michigan, which will lead to the creation of over 250 jobs.

The investment is aimed at accelerating production of Pfizer’s COVID-19 pill Paxlovid, demand for which has risen after Pfizer’s initial struggles to make sufficient quantities following the drug’s clearance in December. To date, Pfizer has delivered 12 million courses of the drug across 37 countries, 5 million of which have been shipped to the U.S.

The Kalamazoo plant, one of Pfizer’s largest drugmaking sites, will make the starting materials and active ingredient contained within Paxlovid. The new investment expands the site’s capacity, making it one of the world’s largest producers of pharmaceutical ingredients, according to Pfizer.

From the Rx coverage front, the Federal Trade Commission announced

The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. * * *

The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:

** fees and clawbacks charged to unaffiliated pharmacies;

** methods to steer patients towards pharmacy benefit manager-owned pharmacies;

** potentially unfair audits of independent pharmacies;

** complicated and opaque methods to determine pharmacy reimbursement;

the prevalence of prior authorizations and other administrative restrictions;

** the use of specialty drug lists and surrounding specialty drug policies;

** the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

The Commisioners voted 5-0 to commence the investigation. Responses from the PBMs to the FTC’s compulsory orders are due in 90 days.

From the Pride Month front, Health Payer Intelligence reports “Members of the LGBTQ+ community reported varying experiences of discrimination in the health insurance industry but indicated that payer health equity may be improving, according to a survey from Healthcare.com.” Survey details are available in the article and the survey.

From the miscellany department

  • The American Medical Association offers expert guidance on understanding blood pressure readings.
  • The Centers for Disease Control explains the connection between diabetes and the brain.

Anthem has partnered with Happify Health to offer a slate of new digital tools for women’s health.

Happify’s platform is based on “sequences,” or digital experiences that it uses to support specific medical conditions. These sequences combine evidence-based digital therapeutics, online communities, coaching and tailored local resources in one unified platform.

Happify’s sequences are able to integrate with existing systems and solutions for ease of navigation, according to the announcement.

Everyone deserves access to mental health support that is effective and affordable. With more Americans than ever seeking help for mental health concerns, AHIP conducted a nationwide survey to understand people’s experience accessing care, whether their treatment was covered by insurance, and if insured patients were satisfied with the results. The findings reveal that nearly all respondents who sought mental health care for themselves or someone within their household over the past 2 years received treatment, and 3 in 4 insured Americans (73%) found it easy to get the care they needed. More than two-thirds of respondents were able to find an appointment with a provider in less than a month. In addition, 9 in 10 reported being satisfied with the mental health support they received, including half who say they were very satisfied.