Midweek update

Rx coverage

Midweek update

David Ermer–Congress, COVID-19, COVID-19 testing, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Capitol Hill front, Health Affairs Forefront offers articles from

  • Prof. Katie Keith on the Affordable Care Act provisions in the budget reconciliation bill (H.R. 5376) that the House of Representatives will take up on Friday, and
  • Prof. Rachel Sachs on the Democrats’ drug pricing proposal in that bill.

The FEHBlog found information in Prof. Sachs’ article about the proposed $35 cap on insulin copayments.

[T]he IRA was drafted to include a $35 out-of-pocket cap on insulin not only for Medicare beneficiaries, but also for privately insured patients. The parliamentarian ruled that the application of this out-of-pocket cap to privately insured patients did not comply with the reconciliation rules. Rather than unilaterally remove this provision (as the Democrats did with the inflationary rebate provision), Democrats chose to advance the bill with the provision included. Republican Senators then chose to challenge its inclusion, and 43 Republicans voted to strip the $35 out-of-pocket cap for privately insured patients from the bill, enough to result in its removal. (Although seven Republicans voted with all 50 Democrats to keep the cap, the provision needed 60 votes to remain in the bill.)

The Hill adds “Senate Majority Leader Charles Schumer (D-N.Y.) said Monday night that he is going to bring a $35 cap on [non-Medicare] patients’ insulin costs back up for a vote this fall after Republicans blocked it over the weekend.”

Roll Call discusses the cost shifting between Medicare and other insurance programs, including the FEHBP, once the law is enacted and takes effect. Medicare does not negotiate prices with providers; it sets them.

Govexec informs us

President Biden announced on Wednesday his intent to appoint a prominent surgeon and professor who has been at the vanguard of advances in cancer treatment to lead the federal government’s main agency for cancer research and training. 

The president will appoint Dr. Monica Bertagnolli to be director of the National Cancer Institute, part of the National Institutes of Health, which has about 4,300 employees and had a $6.35 billion budget in fiscal 2021. She is currently the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber Cancer Institute, a top cancer hospital. Bertagnolli will be the first woman to hold this position.

“Throughout her career, Dr. Bertagnolli has been at the forefront of the field of clinical oncology, advancing, in particular, current understanding of the gene that promotes gastrointestinal cancer development,” said an announcement from the White House. “As a physician-scientist, she led gastrointestinal science initiatives from 1994 to 2011 within the [National Cancer Institute]-funded Cancer Cooperative Groups.” She also served as the chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center from 2007 to 2018. 

Good luck, Dr. Bertagnolli.

From the omicron and siblings front, Forbes reports

Pfizer and BioNTech have completed clinical trials for vaccines that include specific protection against the original omicron variant. Now the two companies have begun testing for vaccines specific to the BA.4 and BA.5 Omicron subvariants, which are the fastest spreading variants of Covid-19 in the United States. Manufacturing for the new vaccines has already begun, and could be rolled out as early as October pending regulatory approvals. That’s good news as we approach the fall and winter, which have been the times of year where Covid spread is at its highest. Competitor Moderna has also begun testing an omicron-specific booster, but the FDA has not yet authorized any Omicron-specific vaccines.   

and

Researchers have identified monkey antibodies that are effective against numerous Covid variants and other coronaviruses, a discovery that could help scientists develop better vaccines and prepare for future pandemics as pharma firms race to update their shots.

If the monkey antibodies research is successful, then the WHO definitely should change monkeypox’s name.

From the medical research front, STAT News tells us

With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month.

By the end of September, the world will learn whether lecanemab, another treatment aimed at toxic brain plaques called amyloid, can significantly slow the cognitive decline that characterizes Alzheimer’s.

The outcome is vitally important for millions of patients awaiting a medicine that can meaningfully impact the disease, and success could spell a massive financial windfall for Biogen and Eisai. Failure would damage — though not destroy — the idea that targeting amyloid might ever make for an efficacious treatment.

Fingers crossed for a successful outcome.

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

Amazon Care, which currently offers virtual health visits, in-person primary care visits at patients’ homes or offices and prescription delivery, is adding behavioral health care to its slate of services.

Amazon’s health service business plans to team up with teletherapy startup Ginger as an optional add-on to Amazon Care. Through the partnership, Amazon Care users will be connected to Ginger’s on-demand mental health services including behavioral health coaches, licensed therapists and psychiatrists, according to a live website about the service. * * *

The new service hasn’t launched yet, according to people familiar with the matter, Business Insider reported.

As an aside, Smart Brief discusses telemedicine in pediatrics.

Fierce Health also tells us

A company with a long history of providing medical supplies for chronic conditions is expanding its business into monitoring and coaching services for diabetes patients.

CCS, which now includes CCS Medical and CCS Health, aims to provide a more integrated experience for chronic care management, Tony Vahedian, CEO of CCS, said in an interview. * * *

“We believe we’re in the appropriate position to really take that fragmented experience and make it an integrated, seamless experience because not only can we deliver the products at the time, but we also can coach them and provide that clinical care,” the CEO noted. CCS can combine its home-delivered medical supplies business with accredited clinicians supported by proprietary data and technology to simplify the patient experience, he added. 

The company supports more than 200,000 patients living with chronic conditions in the U.S. and delivers more than 1.2 million shipments of medical supplies to patients in their own homes.

From the nudging front, Health Payer Intelligence shares another survey illustrating that participants in employer-sponsored health plans need more help with health plan literacy.

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, HSA, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Wall Street Journal reports

A federal judge approved Blue Cross Blue Shield companies’ settlement of a sweeping antitrust suit filed on behalf of their customers, with the insurers agreeing to pay $2.67 billion and change certain practices that allegedly limited competition. * * *

Under the settlement, the Blue insurers would drop a Blue Cross Blue Shield Association rule that limits the share of each company’s total national revenue that can come from business that isn’t under Blue brands.

That change could increase competition among the companies if they choose to expand their non-Blue lines of business in one another’s geographies, insurance experts said.

The settlement would also loosen a rule that had limited the Blue insurers’ ability to compete with one another for the business of large national employers. Under the changes, certain national employers would be able to also request a bid from a second Blue insurer of their choice, setting up competition between the two Blues.

However, the settlement stops short of unwinding the Blues’ licensing setup that grants exclusive geographic branding rights to companies—the main original focus of the litigation. * * *

A spokeswoman for the Blue Cross Blue Shield Association said it was pleased with the approval, and is committed to finalizing and implementing the agreement.

The settlement should be implemented beginning in 30 days. There are limited appeal rights for class members. The Journal adds, “The Blue insurers still face a second, parallel antitrust suit filed on behalf of doctors, hospitals and other healthcare providers.”

From the Omicron and siblings front, the New York Times offers advice on how to manage Omicron BA.5 symptoms, including sore throats, from home.

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of U.S. monkeypox cases and offers physician perspectives on the monkeypox cases that they are treating. “‘The biggest misconception is that this is always a mild disease,’ Jason Zucker, MD, an infectious diseases specialist at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, said during an Aug. 5 call with reporters.”

Govexec reports that the FDA implemented its plan to significantly extend the supply of the preferred monkeypox vaccine. Bloomberg Prognosis provides more medical details on this development.

From the Rx coverage front, Fierce Healthcare discusses Optum’s latest drug development pipeline report and STAT News reports

For only the second time, Pfizer is offering a warranty for a medicine that will cover the cost for any patient or health plan if the medication fails to work, a move that expands an effort to appease concerns about high drug costs.

The newest warranty program began last month and covers Panzyga, which was approved last year in the U.S. to treat a rare neurological disorder called chronic inflammatory demyelinating polyneuropathy, or CIPD. Patients can get repaid for four treatments — up to $16,500 each, or a maximum of $50,000 — if use is discontinued for clinical reasons. And insurers can also get reimbursed for their own outlays.

Unlike the first warranty program — which Pfizer began a year ago for its Xalkori lung cancer treatment — this newest warranty is only available to patients who are covered by commercial insurance or pay cash, not government health care programs.  The Xalkori program is available to patients who are covered by commercial insurance or those who pay cash but are also covered by Medicare.

And how about an Rx coverage tidbit? Bayer tells us with understandable pride

This year, acetylsalicylic acid (ASA), the active ingredient that brought Aspirin to fame, celebrates its 125th anniversary. On August 10, 1897, Dr. Felix Hoffmann discovered the ideal formula for acetylsalicylic acid when he synthesized the first chemically pure and stable form of acetylsalicylic acid. * * *

Hoffmann’s breakthrough was entered in the trademark register of the Imperial Patent Office in Berlin in 1899 and received a patent in the USA the following year, and scientists continue to conduct research even to this day on Aspirin, other potential areas of application, and dosage forms. In 1969, the round tablet made its way to the moon with the astronauts in the Apollo 11 capsule.

From the U.S. healthcare business front, MedCity News examines CVS Health’s expansion into the primary and homecare markets.

From the plan design front,

  • AHRQ’s Medical Expenditure Panel released a survey on trends in health insurance at private employers, 2008 – 2021.
  • The International Foundation of Employee Benefit Plans offers four steps for evaluating your plan’s diabetes coverage.
  • The Congressional Research Service updated its health savings account report.

From the telehealth and fraud, waste and abuse fronts

Healthcare Dive informs us

More patients turned to telehealth to see a doctor in May than April, in step with an increase in COVID-19 cases reported to the Centers for Disease Control and Prevention, according to Fair Health’s latest monthly tracker of private insurance claim lines.

Virtual visits rose 10.2% in May, accounting for 5.4% of all medical claim lines in the month, compared to 4.9% in April, Fair Health said Monday. It was the second straight month that telehealth’s share of claims grew.

COVID-19 made the list of top five telehealth diagnoses in every region of the country in May, holding in the No. 2 spot in the Northeast while climbing to second place in the Midwest and West and third place in the South.

STAT News delves into how telehealth fraud concerns could impact the industry’s future.

In Postal Service news, Federal News Network reports that USPS is eyeing mail price increases for January 2023.

USPS Chief Financial Officer Joe Corbett said the agency remains “in a financial hole,” and that more progress under the 10-year reform plan is needed.

“While we have accomplished a tremendous amount executing on the [Delivering for America] plan, we still have a lot of work to do. We need to continue executing the management initiatives in our Delivering for America plan to fill this hole and return to Postal Service to continuous self-sustaining financial health,” Corbett said.

[Postmaster General] DeJoy said USPS contributions to the retirement health care plan for its employees, under Postal Service Reform Act, will resume in 2026, and will grow to about $6.7 billion a year.

“We will not be able to make these payments unless we timely engage and accomplish all our initiatives, and we are trying to do just that,” DeJoy said.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill —

The Federal Times seeks to project the timeline for implementing the new law requiring the Veterans’ Administration to cover illnesses contracted by Iraq and Afghanistan veterans who were exposed to burn pit smoke while overseas.

The Republicans on the House Ways and Means Committee offer their perspective on the budget reconciliation bill that Senate passed yesterday and the House will take up this Friday.

From the OPM front, the FEHBlog noticed today that its Office of Inspector General (OIG) has posted on its revamped website the OIG’s semi-annual report to Congress for the period ended March 31, 2022. This report is always worth a gander to those who are interested in the FEHB Program.

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

Parents are having their say about the Covid-19 vaccines for children under 5, and for most, the answer so far is no.

More than a month after the U.S. Centers for Disease Control and Prevention recommended shots for about 17.4 million children ages 6 months through 4 years, about 4% to 5% of them have received a shot, according to the most recent agency data and population estimates from the American Academy of Pediatrics. 

By contrast, the vaccination rate for children 5 to 11 years reached about 18% a month after the CDC first recommended shots last November. The rate now stands at about 38%. * * *

Uptake has varied by state, recent counts from around the U.S. show. In Massachusetts, roughly 40,541 children under 5, about 11% of the state’s population in that age group, have received one dose. In New Jersey, more than 21,000 young children, or 4.6% of the children under 5 in that state, have received one dose. 

A lawyer writing on the Society for Human Resource Management advises “employers with workers who test positive for COVID-19 should follow guidance from the Centers for Disease Control and Prevention (CDC), including its guidelines on quarantining and isolation, to minimize safety and legal risks, even though the guidance is somewhat complex.”

From the public health front, the Department of Health and Human Services announced today its Health Resources and Services Administration (HRSA) is

awarding nearly $90 million in American Rescue Plan funding to nearly 1,400 community health centers across the country to advance health equity through better data collection and reporting. On Friday, August 5, President Biden issued a proclamation on National Health Center Week to recognize the vital role health centers play in safeguarding the well-being of Americans and honor the heroic staff who keep these facilities running.

What’s more, the American Hospital Association tells us

[HRSA] today awarded $45.7 million from the American Rescue Plan Act [ARPA]to develop the public health workforce in rural and tribal communities. The grants will help train dental hygienists, medical and dental assistants, doulas and other community health workers; health information technology and telehealth technical support staff; community paramedical workers; and respiratory therapists and care coordinators for patients with long-term COVID-19 effects and chronic medical conditions.

In addition to the ARPA grants, the agency awarded $9.7 million to help hospitals and others establish new medical residency programs in rural communities; $2.9 million to improve health outcomes in rural counties; and nearly $1 million to improve access to care for rural veterans. 

From the No Surprises Act front, Healthcare Dive informs us

The Medical Group Management Association, which represents physician practices, is urging the HHS and the CMS to delay enforcing certain requirements of the No Surprises Act to allow providers time to understand and implement the mandates.

In a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks La-Sure, MGMA asked that medical group practices be given six months’ notice before enforcement of additional surprise billing requirements.

The provider group requested the enforcement delay following publication of more anticipated rulemaking including an advanced explanation of benefits, continuity of care protections and provider directory requirements. 

The FEHBlog supports the MGMA’s position because Congress goofed in the NSA by not treating the good faith estimate and advance EOB as HIPAA electronic transaction standards.

STAT News discusses the stress that providers and payers are experiencing as they wait for the Labor Department to issue its final rule (following receipt of public comments on its interim final rule) about the NSA’s independent dispute resolution process.

From the Rx coverage front, STAT News reports

Karuna Therapeutics said Monday that a novel combination pill reduced psychosis and related symptoms experienced by patients with schizophrenia, achieving the main goals of a late-stage clinical trial.

With positive study results in hand, the Boston-based biotech intends to submit a marketing application with the Food and Drug Administration by the middle of next year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.

Called KarXT, the Karuna drug targets muscarinic acetylcholine receptors in the brain to reduce psychotic symptoms. Current antipsychotics — which mostly block dopamine receptors — have become blockbuster schizophrenia medicines despite causing troubling side effects like weight gain and somnolence. Peak sales for KarXT could also reach into the billions of dollars, analysts forecast.

That’s certainly encouraging.

From the U.S. healthcare business front —

Fierce Healthcare reports

Kaiser Permanente posted a thinned operating margin and nearly $1.3 billion net loss during its second quarter “driven largely by investment market conditions,” according to topline financials for the quarter ended June 30 reported Friday evening.

The massive integrated nonprofit health system notched $23.47 billion in total operating revenues, representing a minor 0.9% dip from the second quarter of last year. Total operating expenses inched nearly 0.2% upward year over year, to $23.38 billion.

The result was an operating income of $89 million (0.4% operating margin) during the most recent quarter, down from the prior year’s $349 million (1.5% operating margin).

“Much like the entire health care industry, we continue to address deferred care while navigating COVID-19 surges and associated expenses. Kaiser Permanente’s integrated model of providing both care and coverage enables us to meet these challenges as demonstrated by our moderate increase in year-over-year operating expenses for the second quarter,” EVP and Chief Financial Officer Kathy Lancaster said in a statement accompanying the filing.

BioPharma Dive informs us

Pfizer on Monday said it has agreed to acquire Global Blood Therapeutics for $5.4 billion in a deal that will hand it a recently approved drug for sickle cell disease, as well as two other experimental medicines for the rare blood condition. Under terms of the deal, Pfizer will pay $68.50 in cash per Global Blood share * * *. * * * Pfizer and Global Blood expect the deal, which has been approved by the boards of directors at both companies, to close as early as the fourth quarter, pending the sign off regulators and Global Blood shareholders. 

Becker’s Hospital Review is running a series on health information interoperability:

Health data interoperability has long been a goal of health IT executives and policy experts. But it’s 2022 — and the healthcare system doesn’t appear all that close to getting there.

Becker’s spoke to experts from health systems, industry and academia on what it will take to create an open exchange of healthcare information in the U.S.

The first entry in the series is a Q&A with Donna Roach, CIO of University of Utah Health in Salt Lake City

Check it out.

Weekend update

David Ermer–Congress, No Surprises Act, Rx coverage, U.S. Healthcare–

The Senate passed its budget reconciliation bill (H.R. 5376) this afternoon by a 51-50 vote, with Vice President Harris casting the deciding vote. The Senate Democrats have created a one-page summary of the bill.

The Wall Street Journal reports

The deal would dedicate $64 billion to extending for three years the Affordable Care Act subsidies that first kicked in under the 2021 American Rescue Plan. Nearly all of the 13 million people who get federal subsidies under the ACA would be spared from higher health-insurance premiums they would see next year without an extension.  * * * The change would push the next expiration beyond the 2024 election.

The measure would also allow Medicare to negotiate the cost of some prescription drugs with pharmaceutical companies, a longtime goal of many Democrats that has been opposed by the drug industry, which says it would stifle innovation. That move would save the government $288 billion, according to the summary.

Here is a link to the Senate Democrat’s summary of the Medicare changes.

Bloomberg adds

[While Medicare was cleared [yesterday] to negotiate drug prices for the first time by the Senate’s top rules official, the Democrats’ proposal intended to cap price increases for prescription drugs in the commercial market was blocked. * * *

The rulings are a partial victory for drug makers, who could try to make up their lost profits in Medicare on private insurers.

Axios notes that during the amendment “vote-a-rama” preceding the vote on H.R. 5376, a provision to cap insulin copayments at $35 was stripped from H.R. 5376.

The House of Representatives will convene on Friday, August 12, to consider and, in all likelihood, pass H.R. 5376. Otherwise, both Houses of Congress are now on their August State/District work break.

In U.S. healthcare business news, the Wall Street Journal reports

CVS Health Corp. is seeking to buy Signify Health Inc., according to people familiar with the matter, as the drugstore and insurance giant looks to expand in home-health services.

Signify Health is exploring strategic alternatives including a sale, The Wall Street Journal reported this past week. Initial bids are due this coming week and CVS is planning to enter one, some of the people said. Others also are in the mix, they said, and CVS could face competition from other managed-care providers and private-equity firms.

There is no guarantee any of them will reach a deal for Signify, which has a market value of around $4.7 billion after its shares rose on the news of a potential sale.

From the Rx coverage front, BioPharma Dive informs us

A new targeted treatment for breast cancer could reshape how doctors classify and treat the disease, offering another option for people whose tumors have spread or are unable to be removed through surgery.

On Friday, the Food and Drug Administration approved Enhertu, a medicine developed by AstraZeneca and Japanese drugmaker Daiichi Sankyo, for patients with advanced breast cancer that has low levels of a protein called HER2. It’s the first targeted drug to be approved for this group of patients.

For more than two decades, HER2 status has shaped treatment of breast cancer. Named after the gene that encodes it, the protein’s presence in high levels is linked to more aggressive tumors that grow and spread faster. But the approval in 1998 of a HER2-targeting drug called Herceptin gave doctors a powerful treatment to combat breast cancers positive for the protein. Since then, several other drugs aimed at HER2 have joined Herceptin on the market.

Until now, HER2 status has been black or white — either positive or negative. However, testing showed Enhertu to be dramatically effective in treating tumors with very low levels of HER2, levels that would typically be considered negative.

The drug’s approval therefore creates a new classification on which doctors can act. About 60% of breast cancer patients who would previously be categorized as having HER2-negative tumors can be now be counted as HER2-low and potentially receive Enhertu, the FDA estimated. HER2-negative cancers are estimated to be by far the most common, accounting for between 80% to 85% of the more than 250,000 people who are diagnosed with breast cancer in the U.S. each year.

From the health information technology front, the FEHBlog picked up this tidbit from a Health Data Management email from “Fred Bazzoli, Editor-in-Chief” this morning:

Much has been changing in healthcare – for providers, payers and consumers.

With a lot of change to assimilate, it’s no wonder that the results are delayed and hard to see. A case in point is healthcare APIs that enable patients to access their medical data. Industry players spent heavily to ready systems for patients to use APIs to access their records. But at this week’s WEDI Summer Forum in Chicago, attendees reported that there was little or no activity in patients using such capabilities. Shoot, only 5 percent to 20 percent of patients are using portals for that purpose now, one payer executive at the forum estimated – so it will take time for them to learn about these apps and get used to using them. Consumers don’t want multiple sources of medical information, or services…they want simplicity, which change doesn’t always seem to provide immediately. 

Change is also hard – WEDI is compiling challenges with rules requiring providers to provide patients with good faith estimates. Seemingly simple, providing accurate estimates is wrought with difficulty and peril, as forum attendees heard (see my story next week). More time is needed, WEDI contends. 

Slowing down change to allow for consumer adjustment seems to be the right course of action now.

From the public health front, the American Medical Association shares what doctors wish their patients knew about family immunizations.

Midweek Update

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

From Capitol Hill, Roll Call reports

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

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

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

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

From the OPM front, Federal News Digest tells us

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

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

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

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

From the Omicron and siblings front —

Bloomberg informs us

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

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

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

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

From the monkeypox front

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

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

From the U.S. healthcare business front

Healthcare Dive reports

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

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

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

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

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

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

Biopharma Dive informs us

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

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

Fierce Healthcare adds

CivicaScript’s first product is hitting the market.

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

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

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

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

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

From the research front —

Benefits Pro points to

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

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

Medscape reports

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

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

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

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

Friday Stats and More

David Ermer–CDC, COVID-19, Rx coverage, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Controls Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases for 2022:

The CDC’s weekly review of its Covid statistics notes “As of July 27, 2022, the current 7-day moving average of daily new cases (126,272) decreased 0.9% compared with the previous 7-day moving average (127,478).”

Here is the CDC’s chart of daily trends in new Covid hospital admissions:

The CDC’s weekly review notes “The current 7-day daily average for July 20–26, 2022, was 6,340. This is a 1.7% increase from the prior 7-day average (6,231) from July 13–19, 2022.

Also, “CDC Nowcast projections for the week ending July 23, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 81.9% (95% PI 79.9-83.8%).”

STAT News reports

[New Yorker Janet] Handal and the roughly 200,000 other Americans to receive Evusheld have had to recalibrate their hopes. Although the Food and Drug Administration doubled the recommended dose to compensate, and the drug — when given along with the full complement of vaccines — still offers protection against severe disease, gone are hopes that the most vulnerable could ditch masks or return to their pre-Covid lives.

Although the problem is now eight months old, few other prophylactic drugs for people with compromised immune systems are on the horizon. Several companies have announced plans to bring forward new Covid-19 antibodies, but they virtually are all either still in animal studies or are being principally developed as therapeutics.

The absence is particularly notable given the potential size of the market: Although Evusheld has remained vastly underused, a fact some physicians attribute to its hazily defined efficacy, between 7 and 10 million Americans are immunocompromised — a huge market by drug industry standards.

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

The CDC’s weekly review notes “The current 7-day moving average of new deaths (364) has decreased 4.8% compared with the previous 7-day moving average (382).”

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the 50th week of 2020, when the Covid vaccination era began to the 30th week of 2022:

The CDC’s weekly review notes, “About 223.2 million people, or 67.2% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 107.9 million people have received a booster dose, but 50.1% of the total booster-eligible population has not yet received a booster dose.”

Reuters reports

The U.S. government said on Friday it agreed to a $1.74 billion deal for 66 million doses of a Moderna COVID vaccine updated for the Omicron subvariant for use in a fall and winter booster campaign ***. Combined with 105 million doses the government already agreed to buy from Pfizer Inc and partner BioNTech SE for $3.2 billion, the latest deal puts the U.S. booster dose supply at about 171 million shots. read more

In CDC Communities News

As of July 28, 2022, there are 1,474 (45.8%) counties, districts, or territories with a high COVID-19 Community Level, 1,144 (35.5%) counties with a medium Community Level, and 602 (18.7%) counties with a low Community Level. Compared with last week, this represents a moderate increase (+3.9 percentage points) in the number of high-level counties, and a small decrease (−2.11 percentage points) in the number of medium-level counties and also a small decrease (−1.74 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 the District of Columbia 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 monkeypox front, the FDA provides an update on the agency’s response to this outbreak.

From the mental healthcare front —

MedPage Today brings us encouraging news

Local outpatient mental health providers are doing fine handling the increased demand from the newly launched nationwide “988” Suicide and Crisis Lifeline, despite fears that they wouldn’t be ready, according to a senior administration official.

“The states and call centers across the country absolutely rose to the increased volume that we saw,” the official said Thursday evening during a background briefing on distribution of federal grants to shore up mental health services in schools. “We can see a 45% increase in the volume of calls that came in the week of the launch, compared to the week prior, across the country — an additional 23,000 … calls, texts, and chats that came in across the lifeline.”

Healthcare Dive reports that CVS Health has appointed its first chief psychiatric officer. “Taft Parsons, MD, who has previously worked for Molina Healthcare and Henry Ford Health System, will be tasked with focusing on mental well-being for patients and will lead the Aetna Medical Affairs Behavioral Health organization.” Good luck, Dr. Parsons.

From the medical research front —

  • HealthDay informs us  “Obesity, depression, high blood pressure, asthma: These are just a few of the chronic health conditions that are now affecting almost 40 million Americans between the ages 18 and 34, new federal data shows.”
  • Mhealth Intelligence adds “While discovering new methods of care during the COVID-19 pandemic, Stanford Medicine researchers found that a smartphone app known as SkinIO is highly resourceful when detecting skin cancer among older people.”

From the telehealth front —

  • UPI reports “Using telehealth to supplement or replace in-person maternal care services, such as postpartum depression and diabetes and hypertension monitoring during pregnancy, leads to similar — and sometimes better — clinical outcomes and patient satisfaction compared to in-person care. That’s the gist of a study whose findings were published Monday in Annals of Internal Medicine.”

Finally, Health Payer Intelligence discusses a strategy for communicating relating high health plan premium increases for next year.

There are two key factors that will influence employer-sponsored health plan premiums in 2023, Jim Winkler, chief strategy officer at the Business Group on Health, told HealthPayerIntelligence by email: 

* Market inflation on prices of healthcare services

* Utilization rate of healthcare services

“Heading into 2023, employers face uncertainty in terms of the impact of market inflation on the prices of health care services and potential increases in utilization of those services,” Winkler said. 

“This all comes at a time when employers also have a heightened focus on attracting and retaining key talent while addressing the overall health and well-being needs of the workforce and their families.” * * *

“As employers prepare to communicate with their workforce, they will see that employees tend to be focused on what any cost increase means to them, both in terms of out-of-pocket costs and paycheck deductions. Employers will therefore need to assist employees on understanding how best to manage their own costs,” Winkler recommended.

Omnichannel communication with health plan members can be particularly useful for improving member engagement in employer-sponsored health plans. With omnichannel communication, payers and employers coordinate communication across multiple channels and platforms, improving the timeliness and convenience of member interactions.

Thursday Miscellany

David Ermer–COVID-19, Federal employment benefits, Rx coverage, SDOH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From the Omicron and siblings’ front —

MedPage Today reports “Second COVID booster shot boosted antibodies in Seniors — but small Israeli study did not determine how quickly response will wane.”

Becker’s Hospital Reviews tells us

At least 18 cases of the newest omicron subvariant BA.2.75 have been confirmed in seven U.S. states as of July 20, early disease surveillance data shows. 

Globally, researchers have identified 201 cases in more than a dozen countries as of July 12, according to data from outbreak.info, a platform that tracks data on coronavirus variants and is supported by the CDC and other national research groups. 

The subvariant has a large number of mutations that may make it more adept than BA.5 — the nation’s current dominant strain — at spreading quickly and evading immune protection. Experts say it’s still unclear whether BA.2.75 will compete against BA.5 or cause more severe illness, according to CNN.

This leads us to the Wall Street Journal’s editorial board comments

The President’s [Omicron] infection [disclosed today] demonstrates how hard it is to avoid the new and highly transmissible Covid variants. The White House has gone to great lengths to protect Mr. Biden, but there’s only so much staff can do if the President is going to do his job. 

Despite continuing pleas from the White House and public-health elite, vaccination by now provides little protection against transmission. * * * The evidence is that the vaccines do reduce the chances of getting serious Covid and being hospitalized, though many elderly patients who have been vaccinated are still dying from the virus.

While this quote is an opinion, not a news report, it struck a chord with the FEHBlog. The FEHBlog wishes the President a speedy recovery.

From the unusual viruses front, the Department of Health and Human Services offers a fact sheet on its response to the monkeypox outbreak.

In mergers and acquisitions news, Healthcare Dive informs us

Amazon has agreed to acquire primary care network One Medical for $18 a share, valuing the company at $3.9 billion.

The all-cash deal for San Francisco-based One Medical comes after months of speculation about a potential acquisition, reportedly drawing interest from companies including CVS Health, according to Bloomberg.

Analysts said a potential buyout for One Medical, which has grown rapidly since it was founded in 2007, could come at a significant premium. Amazon’s price of $18 a share represents a premium of 43% over its closing price of $10.18 a share on Wednesday.

STAT News explains why Amazon pursued adding One Medical to its healthcare portfolio.

With One Medical, Amazon is also tapping deeper into the vein of health care’s payment system. One Medical gets paid through two main avenues: commercial health insurers and Medicare. The Medicare side came from Iora, which One Medical bought for $1.4 billion last year.

Commercially insured patients, or those who get coverage through their jobs, are by far the most profitable within health care and overlap with a large chunk of Amazon’s subscription base. Even though One Medical focuses on less expensive primary care, there’s evidence One Medical charges some of the highest rates for those routine office visits and services, and that’s largely assisted by One Medical’s hospital partners.

Hospitals pay fixed sums to One Medical to care for patients, but they also “extend their health insurance contracts” to One Medical, the company said when it went public in 2020. The result: Hospitals that ink deals with One Medical get the most profitable patients in their market referred to them for more intensive services, and One Medical gets to piggyback off the lucrative payments that those dominant hospitals wring out of insurers.

STAT News concludes

Amazon’s success — and how disruptive it might prove to be to telehealth competitors — will depend in part on how well it integrates One Medical into its existing in-person and virtual offerings through Amazon Care. Analysts said that will become clear over the next year.

Whether it does draw patients away from traditional health care providers depends on their partnership with payers and their fees, said Aaron Neinstein, vice president of digital health for UCSF Health. “There’s no question that the One Medical annual fee is out of reach for most people in the U.S. Might Amazon change that or bundle it with Prime? Who knows.”F

Health Leaders Media reports that, notwithstanding the Federal Trade Commission’s nascent efforts,

Hospital and health system mergers and acquisitions in Q2 of 2022 have returned to trendlines that Kaufman Hall has been following since the beginning of the pandemic, the consulting firm said in its recently released M&A quarterly report.

During the second quarter of 2022, there were 13 hospital and health system M&A transactions, on-trend and only one transaction less than the 14 transactions reached in Q2 of 2021 and 2020. However, the total transacted revenue in the second quarter reached a “historic high” of $19.2 billion, more than doubling the $8.5 billion transacted revenue in the same quarter in 2021.

From the reports department and via Axios, the FEHBlog ran across this comprehensive McKinsey and Company report on the future of U.S. healthcare: what’s next for the industry post-Covid. Check it out.

From the Rx coverage front, DrugChannels calls our attention to this Amgen preview of 2022 trends in the biosimilars market. Adam Fein observes

As I predicted two years ago, the biosimilar boom is finally here. Prices are dropping while adoption accelerates. Prices are now declining by 9% to 22% annually. For therapeutic areas with biosimilars launched in the last three years, biosimilars’ market share averages 74%.  See Amgen slides 8 and 9.

Before the boom began, Dr. Scott Gottlieb, a former FDA commissioner, argued that we shouldn’t give up on biosimilars and prematurely regulate prices. As we can now see, Dr. Gottlieb was right. #NoTowel

From the SDOH front, Health Payer Intelligence explains

Race and ethnicity data collection is complex, but there are steps that health insurers—and the healthcare industry at large—can take to improve the process, according to a report from Urban Institute funded by Elevance Health (formerly Anthem).

From the miscellany department

  • Fierce Healthcare discusses a recent Fitch report on non-profit hospitals.

Labor, supply and capital cost increases have been rampant across the industry this year thanks to broader inflation pressures and other pandemic factors, the ratings agency wrote.

Reversing the margin trends will likely require nonprofit hospitals to take on a combination of rate hikes in the short term, “relentless” cost-cutting and productivity initiatives for the medium term and “transformational changes to the business model” for the long term, Fitch wrote.

Fortunately for those hospitals, many organizations already have the means to weather the storm as they overhaul their operations.

“The vast majority of our rated credits have strong balance sheets that will offset lower margins for a period of time and allow for operational improvements,” Fitch wrote. “Without more substantial changes to the current business model, or with additional coronavirus surges this fall or winter, this balance sheet cushion could eventually erode.”

Rate negotiations with payers will likely be an upward battle, the group wrote.

  • Healthcare Forefront points out the value of underutilized fentanyl test strips

Fentanyl test strips (FTS) are a simple, inexpensive, and evidence-based method of averting drug overdose. FTS are small strips of paper that can detect the presence of fentanyl in any drug batch—pills, powder, or injectables. This tool might be lifesaving for the teenager experimenting for the first time, the individual in the throes of a severe opioid use disorder, the concert-goer looking for a trip, the person using a preferred substance obtained from a new source, or the individual years into recovery. FTS also support the dignity and well-being of people who use drugs (PWUD), enabling them to make educated decisions about their safety.

And yet after years of press and discussions of the strips’ utility, FTS aren’t as widely available as one would expect them to be. It is time to take a more critical look at the importance of destigmatizing this tool and increasing its distribution and availability, while highlighting the grave risks in not doing so.

  • HealthDay gives us some good news.

U.S. hospitals became much safer places for patients over the past decade, with medical errors and adverse events declining significantly across the nation, federal government data show.

Between 2010 and 2019, patient safety dramatically improved among the four types of conditions for which people are most often hospitalized: heart attacks, heart failure, pneumonia and major surgical procedures.

“There has been a precipitous, very important drop in the number of these events, which to me validates the idea that these were preventable,” said senior researcher Dr. Harlan Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Education in New Haven, Conn. “The status quo wasn’t written in stone. We have been able to actually make hospitals safer for those conditions.”

The new study relied on data gathered by the Medicare Patient Safety Monitoring Program, an effort created in the wake of a landmark 1999 Institute of Medicine report that drew national attention to patient safety in hospitals, the study authors said in background notes.

  • Fedweek reviews the steps that federal employees should take to position themselves for retirement.

Friday Stats and More

David Ermer–COVID-19, Rx coverage, U.S. Healthcare–

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases for this year:

The CDC’s weekly review of its Covid statistics adds

As of July 13, 2022, the current 7-day moving average of daily new cases (124,048) increased 15.7% compared with the previous 7-day moving average (107,174).

CDC Nowcast projections* for the week ending July 9, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 65.0% (95% PI 62.2-67.7%).

Here is the CDC’s chart of daily trends in new Covid hospital admissions:

The CDC’s weekly review adds “The current 7-day daily average for July 6–12, 2022, was 5,851. This is a 14.4% increase from the prior 7-day average (5,115) from June 29–July 5, 2022.”

Here’s the FEHBlog’s weekly chart of new Covid deaths for 2022: “The current 7-day moving average of new deaths (352) has increased 12.6% compared with the previous 7-day moving average (312).”

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered:

The CDC’s weekly review adds

Overall, about 260.7 million people, or 78.5% of the total U.S. population, have received at least one dose of vaccine. About 222.7 million people, or 67.1% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 107.0 million people have received a booster dose,** but 50.2% of the total booster-eligible population has not yet received a booster dose. Here’s another visual breakdown, this time from the CDC

The CDC’s weekly review summarizes the situation as follows:

As of July 14, 2022, there are 1,141 (35.4%) counties, districts, or territories with a high COVID-19 Community Level, 1,275 (39.6%) counties with a medium Community Level, and 804 (25.0%) counties with a low Community Level. Compared with last week, this represents an increase (+14.8 percentage points) in the number of high-level counties, an increase (+1.8 percentage points) in the number of medium-level counties, and a corresponding decrease (−16.4 percentage points) in the number of low-level counties. 50 out of 52 jurisdictions* had high- or medium-level counties this week. Rhode Island and Maine 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.

The American Hospital Association informs us “The Department of Health and Human Services today renewed the COVID-19 public health emergency declaration for another 90 days. The AHA and other national health care organizations have urged HHS to maintain the public health emergency until it’s clear that the global pandemic has receded and the capabilities authorized by the PHE are no longer necessary.” In that event, the Covid PHE may never end. Here’s the rub :

[T]he additional 6.2% in Federal Medical Assistance Percentage funding for the state Medicaid programs, designated in the Families First Coronavirus Relief Act, is tied to the length of the PHE and the continuous coverage requirement has been essential in helping provide health care coverage to vulnerable populations during the economic downturn.

KFF provides context “After declines in enrollment from 2017 through 2019, preliminary data for March 2022 show that total Medicaid/CHIP enrollment grew to 87.9 million, an increase of 16.7 million from enrollment in February 2020 (23.4%), right before the pandemic and when enrollment began to steadily increase.”

The FEHBlog is not suggesting cutting back Medicaid. The FEHBlog is suggested that Congress decouple these important actions from the PHE period.

From the Medicare front, the American Hospital Association informs us

The Centers for Medicare & Medicaid Services late today issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.7% in calendar year 2023 compared to 2022.

In a statement shared with the media, AHA Executive Vice President Stacey Hughes said, “We are deeply concerned about CMS’ proposed payment update of only 2.7%, given the extraordinary inflationary environment and continued labor and supply cost pressures hospitals and health systems face … A much higher update is warranted, and we will be closely analyzing CMS’ proposed market basket, as well as its proposed productivity offset.”

From the Rx coverage front, Healthcare Dive informs us

UnitedHealth plans to offer some medicines at zero cost share to eligible members in 2023, including insulin and other emergency-use drugs, in a bid to address inflationary pressures and keep patients out of the emergency room, CEO Andrew Witty announced.

The offering from the Minnetonka, Minnesota-based company, which operates the largest private payer in the U.S., applies to UnitedHealth’s standard insured group plans. But the larger cost containment of drugs must come from pharmaceutical manufacturers lowering prices, Witty told investors during UnitedHealth’s second-quarter earnings call on Friday.

UnitedHealth beat Wall Street expectations for earnings and revenue in the quarter with revenue of $80.3 billion, up 13% year over year. Profit of $5.2 billion was up 19% year over year. UnitedHealth increased its full-year earnings expectations on the results.

Fierce Healthcare adds

With new competitors closing in, UnitedHealth is bolstering its defenses by purchasing Genoa Healthcare, the fifth-largest pharmacy chain in the country with 435 locations. Genoa—which also offers telepsychiatry services and medication management for behavioral health patients—will be absorbed by UnitedHealth’s pharmacy benefit manager OptumRx. According to its website, Genoa fills more than 15 million prescriptions each year and serves more than 650,000 customers.

From the telehealth front, OPM’s chief medical officer Dr. Ron Kline issued a newsletter to FEHB carriers on the topic of telehealth.

From the transparency front, Fierce Healthcare tells us

Major health insurers have released massive reams of data detailing their in- and out-of-network rates to comply with a new rule.

Now, experts are sifting through those data to identify trends that could affect contract negotiations with providers.

“So far so good, if you will, on compliance,” said Niall Brennan, chief analytics and privacy officer for Clarify Health, a healthcare analytics software company. “I don’t have a truly overarching picture right down to the smallest plans, but so many of the nationals and [Blue Cross plans] are participating. Even if some of the smaller plans are a little slower … we are probably catching the vast majority of rates.”

Third parties are now looking into how to use the data that have been released, which is a tall order. 

“The amount of data is massive,” said Marcus Dorstel, vice president of operations at Turquoise Health, which has created a consumer website to compare prices for hospitals. 

Midweek Roundup

David Ermer–COVID-19, COVID-19 vaccine, NIH, Rx coverage, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From the Omicron and siblings front, MedPage Today informs us

As expected, the FDA has granted an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced on Wednesday.

The decision follows a near-unanimous FDA advisory committee recommendation more than a month ago, with the EUA reportedly delayed in order to allow regulators time to review recent changes to the vaccine’s manufacturing process.

Novavax’s product is a protein subunit vaccine that contains the SARS-CoV-2 spike protein plus an adjuvant to enhance the recipient’s immune response. The product is to be administered as a two-dose primary series given 3 weeks apart.

Becker’s Hospital Review discusses the White House’s latest Covid strategy.

From the No Surprises Act front, the U.S. Office of Personnel Management issued a carrier letter today on various NSA topics affecting FEHB carriers.

From the Rx coverage front

The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.

On July 26, 2022, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Medical Advisor Francesca Beaudoin, MD, PhD, MS will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.

From the Dobbs front, Healthcare Dive has created a state abortion law tracker and the Department of Human Resources announced the steps that its agencies have taken to protect reproductive rights.

From the research studies department, the National Institutes of Health announced today

The percentage of methadone-involved overdose deaths relative to all drug overdose deaths declined from January 2019 to August 2021, according to a new study. Access to methadone, a medication to treat opioid use disorder, was expanded at the start of the COVID-19 pandemic to allow more patients to take home doses, rather than visit a clinic daily. These data indicate that broader access to treatment was not associated with harms. While drug overdose deaths both with and without methadone increased in the month of March 2020, overdose deaths that did not involve methadone continued to increase in the months after the policy changes, while overdose deaths involving methadone held steady.

Published today in JAMA Psychiatry, this study was a collaborative effort led by researchers at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and the National Center for Injury Prevention and Control, part of the Centers for Disease Control and Prevention. 

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.