Tuesday Tidbits

No Surprises Act

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Govexec lays out what appears to be an unnecessarily complicated path to a continuing resolution funding the federal government for 10 weeks into the new federal fiscal year beginning October 1. The Senate majority leadership crafted the rocky path that stems from the compromise which lead to Congressional passage of the budget reconciliation act earlier this summer.

From the No Surprises Act front, the American Medical Association informs us

The AHA and American Medical Association today moved to dismiss their challenge to the federal government’s September 2021 interim final rule governing the No Surprises Act’s independent dispute resolution process.

The groups challenged the rule in a District of Columbia court last December, but the lawsuit became moot when the Administration released a revised final rule on Aug. 26. However, the AHA and AMA remain concerned that the final rule continues to favor insurers and does not line up with what Congress intended when it passed the law.

In a joint statement the AHA and AMA said, “No patient should fear receiving a surprise medical bill. That is why the AHA and AMA strongly supported the No Surprises Act to protect patients from unexpected medical bills and keep them out of the middle of any billing disputes between providers and commercial health insurance companies. Congress enacted the law with a balanced, patient-friendly approach, and it should be implemented that way. We have serious concerns that the August 2022 final rule departs from Congressional intent just as the September 2021 interim final rule did. Hospitals and doctors intend to make our voices heard in the courts very soon about these continued problems.”

The AHA and AMA’s suit did not seek to prevent the law’s core patient protections from moving forward. It sought only to force the Administration to bring the regulations in line with the law before the dispute negotiations begin.

The AHA / AMA lawsuit is consolidated with a suit filed by an air ambulance association which may explain why these two large provider associations are dismissing its case rather than amending their complaint. The FEHBlog does not understand why the provider associations refuse to give the new rule a chance before bringing another expensive lawsuit.

From the U.S. healthcare business front —

Fierce Healthcare reports

Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.

Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.

The transaction is expected to be completed by the end of the year. * * *

As a specialty pharmacy, Shields offers medications with unique handling, administration and monitoring requirements. Specialty drugs are used to treat complex or rare conditions such as cancer, hepatitis and transplants. Shields currently names 30 health systems as partners, including 1,000 hospitals.

and

Employer health startup Transcarent is making its next move with the launch of its new pharmacy program.

Transcarent’s Pharmacy Care offering is designed to be fully transparent and integrate with its other platforms. The goal, executives said, is to break through the noise for members and make it easier for them to understand their pharmacy benefits while offering employers full control over formulary, benefit design and data.

The platform is available to self-funded employers as well as health systems, Transcarent said in an announcement. Snezana Mahon, Transcarent’s chief operating officer, told Fierce Healthcare that the company’s employer clients have felt the market changes and are seeking a way to “coexist” in a world where there are traditional pharmacy benefits, cash pay and coupon cards all working together.

From the healthcare quality front, Beckers Hospital Review calls attention to

A new data visualizer shows the 10 most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists like those from U.S. News & World Report.

SimilarityIndex | Hospitals comes from Trilliant Health Labs, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 

Users can compare hospitals to find peers in either quality alone or aggregate — the latter reflects an equally weighted combination of measurements in the categories of hospital quality (including 30-day mortality and readmission rates), outpatient service line, financial (including operating margin and average inpatient service costs), patient mix and market share.

Nifty.

From the public health front —

The US Preventive Services Task Force (USPSTF) today posted for public comment draft recommendations on screening for anxiety, depression, and suicide risk in adults.

For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety — including pregnant and postpartum women.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.

The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.

The public comment deadline is October 17.

  • The Wall Street Journal offers advice on timing the annual flu shot and the upcoming flu season in general.
  • The CDC released a vital signs report warning that rates of screening and treatment of children with sickle cell anemia for life-threatening problems are far too low.

Two recommended healthcare measures to prevent complications in children with sickle cell anemia are:

* Transcranial doppler (TCD) ultrasound screening, which identifies children with increased risk for stroke.

* Hydroxyurea therapy, which reduces the occurrence of several complications, including severe acute pain episodes and acute chest syndrome, which can result in lung injury and trouble breathing.

Far too few patients are receiving these potentially lifesaving prevention measures, recommended by an expert panel in 2014. 

  • The CDC also called attention to its website about gestational diabetes.

From the Rx coverage front, Bio Pharma Dive relates

The Food and Drug Administration on Friday [September 16] granted accelerated approval to a personalized gene therapy for an ultra-rare childhood brain disease, called cerebral adrenoleukodystrophy or CALD.

Built from a patient’s own stem cells, the therapy is the first medicine to be made available in the U.S. for CALD, which affects young boys and typically results in severe disability or death. It was developed by the biotechnology company Bluebird bio and will be sold as Skysona.

Its approval is Bluebird’s second in four weeks, following an Aug. 17 FDA decision on another gene therapy from the company for the blood disorder beta thalassemia. * * *

In the U.S., an estimated 50 boys are born each year who will go on to develop CALD. Bluebird expects to treat about 10 annually.

Meant to be a one-time infusion, Skysona will cost $3 million. The price tag makes the therapy one of the most expensive ever launched on a single-use basis, exceeding the $2.8 million cost of Bluebird’s other gene therapy. * * *

Bluebird expects Skysona to be available by the end of the year, and is planning to work with a “limited number” of centers that are experienced in treating CALD and in stem cell transplantation, including Boston Children’s Hospital and CHOP [Children’s Hospital of Philadelphia].

[Due to the small number of patients, t]he company is not putting in place “outcomes-based” coverage agreements with insurers for Skysona as it did with its other gene therapy, for which it’s offering to reimburse part of the cost if patients don’t continue to benefit.

From the surveys department —

A majority of healthcare executives think value-based-care has replaced fee-for-service billing, a new survey found. 

Of 160 C-suite executives and other high-level staff surveyed, just 4 percent said they think payers use traditional fee-for-service billing with no connection to quality and value. The majority of executives think payers use FFS models with connections to the quality and value of care taken into account. 

The survey, conducted by business intelligence firm Morning Consult and health tech company Innovaccer, found just 1 percent of executives think FFS billing with no connection to value will be in use in 2025. 

According to a Sept.14 news release, payers report that FFS billing with no account for value makes up more than 10 percent of billing, higher than providers estimated. 

“So, providers think the transition to value has substantially occurred, when in fact we’re only at the very beginning,” Brian Silverstein, MD, Innovaccer’s chief population health officer, said in the release. “The amount of financial risk providers have is going to increase significantly in the next few years.”

  • Beckers Hospital Review tells us “Patients who are publicly insured or uninsured are more likely to be treated unfairly in healthcare settings compared to patients with private insurance, according to a report from the Urban Institute with support from the Robert Wood Johnson Foundation.”

In closing Federal News Network shares the list of deserving federal employees receiving the 2022 Partnership for Public Service’s Samuel J. Heyman Service to America Medals — affectionately known as the Sammies. These awards “often dubbed the “Oscars” of federal service” will be presented at a gala tonight. Hearty congratulations to the award winners and the other nominees.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, No Surprises Act, Telehealth–

From Capitol Hill, Healthcare Dive reports

A group of 375 organizations sent a letter to the Senate on Tuesday urging lawmakers to act to pass legislation extending COVID-19-era telehealth flexibilities for another two years.

The letter was led by health IT and telehealth lobbies, but also joined by a number of health systems including Ascension and Cleveland Clinic, physician groups including the American Medical Association, tech companies including Amazon and Google and large employers including Walmart.

Without action, the policies — which threw open the doors to telehealth and led to skyrocketing utilization in the early days of the pandemic — will expire 151 days after the end of the COVID-19 public health emergency.

Health Payer Intelligence adds that according to a recently conducted survey on consumers enrolled in employer-sponsored health plans commissioned by AHIP:

First, most consumers across the political spectrum agreed that providers should not be permitted to charge unnecessary administrative fees and medical services mark-ups. Nearly eight out of ten respondents said that they supported this statement (78 percent), with three-quarters or more in each political party reporting this response.

Second, there was also strong bipartisan support for protections against hospital monopolies. Over three-quarters of consumers supported preventing hospitals from consolidation, mergers, and acquisitions that involved bringing other medical practices into one hospital system (76 percent). Consumers also indicated support for protections against site-based cost increases (75 percent).

Respondents wanted more transparency about healthcare deals. Slightly more than seven in ten consumers supported improving transparency around private-equity firms’ healthcare acquisitions.

Third, the researchers also found bipartisan alignment around telehealth. Slightly more than two-thirds of respondents agreed that the government should eliminate regulatory barriers to telehealth utilization (67 percent).

“Consumers value choice and flexibility in how they access health care. Telehealth proved to be an essential resource for consumers throughout the COVID-19 pandemic and should continue to play a role in the future of health care,” the survey stated.

To provide context, Beckers Hospital CFO Report informs us

HHS is set to extend the COVID-19 public health emergency [PHE] by its standing deadline of Oct. 13. 

HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days’ notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days’ notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.

If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023. * * *

For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.

In No Surprises Act news yesterday, the NSA regulators issued a request for information (RFI) from stakeholders and the general public. The RFI concerns the law’s requirement that health plans provide an advance explanation of benefits (AEOB) in response to a good faith estimate (GFE) of healthcare costs requested by the patient to their healthcare provider. The provider would submit the GFE request to the health plan. HIPAA governs many similar claims transactions involving providers and payers. Surprisingly, Congress did not add these claim transactions to HIPAA, which would have made perfect sense. The FEHBlog does not understand why the regulators have not asked Congress to take this necessary step. At first glance, the contemplated process strikes the FEHBlog as unnecessarily complicated if the object is to avoid patient surprises. Nevertheless, at least the regulators are seeking public input.

From the Omicron and siblings front, the National Institutes of Health announced

A research team funded by the National Institutes of Health has shown that commercially available rapid antigen tests can detect past and present variants of concern and has identified potential mutations that may impact test performance in the future. As new variants of the SARS-CoV-2 virus continue to emerge, concerns have been raised about the performance of rapid antigen tests.

The team, which was funded by NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, developed a method to evaluate how mutations to SARS-CoV-2 can affect recognition by antibodies used in rapid antigen tests. Since most rapid antigen tests detect the SARS-CoV-2 nucleocapsid protein, or N protein, the team directly measured how mutations to the N protein impacted diagnostic antibodies’ ability to recognize their target.

“Rapid antigen tests remain an important COVID-19 mitigation tool, and it is essential to ensure that these tests can detect the SARS-CoV-2 virus as it continues to evolve,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for the RADx Tech program at the NIH. “Considering the endless cycle of new variants, the data from this study will be useful for years to come.”

From the healthcare technology front, Fierce Healthcare informs us

[Cigna’s] Evernorth is expanding its digital health formulary yet again, adding five new solutions to the platform.

The formulary will now include Big Health’s Sleepio for insomnia and the tech company’s Daylight tool for anxiety. In addition, Evernorth said it will expand inclusion of Quit Genius’ tools to its platforms for alcohol use disorder and opioid use disorder.

Lastly, Evernorth will now include HealthBeacon’s Injectable Care Management System for inflammatory conditions, which is meant to assist patients in managing injectable medications. Glen Stettin, M.D., chief innovation officer at Evernorth, told Fierce Healthcare that all of the new tools fit key concerns for employers and plan sponsors, such as mental health and high-cost inflammatory conditions.

“Our clients care about areas where either lots of people need help and treatment or where they’re spending lots of money,” Stettin said.

From the federal employee benefits front, benefits expert Tammy Flanagan writing in Govexec discusses how federal employees should time their retirement.

Tuesday’s Tibits

David Ermer–ACA, CMS, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare points out four legislative items that providers should be tracking for the remainder of this year.

From the Omicron and siblings front, the Washington Post reports

Cold weather favors the coronavirus. But as summer gives way to fall, infectious-disease experts are guardedly optimistic that the spread of covid-19 this autumn and winter won’t be as brutal as in the previous two years of the pandemic.

Coronavirus scenarios from multiple research teams, shared in recent weeks with federal officials, foresee stable or declining hospitalizations in early fall. The scenarios show the possibility of a late-fall surge. A new variant remains the biggest wild card. But several factors — including the approval this week of reformulated boosters and the buildup of immunity against the latest strain of the virus — could suppress some of the cold-season spread, experts say.

In related news, the Wall Street Journal informs us

U.S. health authorities plan to recommend that people get Covid-19 boosters once a year, starting with the new shots now rolling out, a shift from their current practice of issuing new advice every several months.

The annual cadence would be similar to that of flu shots, White House officials said Tuesday, though elderly people and those with weakened immune systems may need more frequent inoculations. 

A shift to annual Covid-19 boosters would be a departure from current practice and comes after many people in the U.S. have ignored calls to get a first or second booster, partly due to fatigue with repeat inoculations. 

“Barring any new variant curveball,” said White House coronavirus coordinator Ashish Jha, “for a large majority of Americans, we are moving to a point where a single annual Covid shot should provide a high degree of protection all year.”

A very sensible approach, indeed!

From the healthcare business front, Healthcare Dive tells us

Amazon and One Medical said Friday that antitrust regulators want more information about the online retailer’s proposed $3.9 billion acquisition of the primary care group. 

The Federal Trade Commission sent a second request for information on Friday, One Medical said in a filing with the U.S. Securities and Exchange Commission.

A second request from the FTC means the two cannot move forward with the deal “until the companies have substantially complied with the additional investigatory request,” according to the FTC.

Amazon and One Medical will “promptly respond” to the second request, the primary care group said in the SEC filing.

In July, Amazon agreed to purchase One Medical for $3.9 billion in an all-cash deal.

From the tidbits department

  • Drug Channels surveys the upcoming Humira price war as biosimilar competitors take the field.
  • CMS posted new information about available group health plan defenses to CMS contractor assertions that the GHP has failed to properly coordinate its benefits with Medicare.
  • Beckers Payer Issues offers expert opinions on the impact of the transparency in coverage rule on consumerism now that the three machine-readable files of health plan pricing data have been posted for two months. For example, “Neil Mayle is the founder and president of Visible Charges, a Cambridge, Mass.-based company that provides clients with curated datasets of both payer- and provider-negotiated service prices. * * * ‘I think we’ve gone from nothing to a lot,’ Mr. Mayle said. ‘We haven’t gone to perfect.'” Of course, it was only the first of three stages in transparency in coverage rule disclosures.
  • The FEHBlog noticed today these CMS and DOL fact sheets on the No Surprises Act which are worth a gander.

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Monday Round-up

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 testing, Electronic health records, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

Yesterday, the FEHBlog discussed a U.S. Court of Appeals for the 11th Circuit opinion issued last Friday narrowing the scope of a nationwide injunction that a federal district court had imposed on the Biden Administration’s federal government contractor mandate.

Govexec adds today that

The executive order is still enjoined in Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Carolina, South Dakota, Tennessee, Utah, West Virginia and Wyoming as a result of the Friday opinion and the injunctions in the other cases, members of the law firm McGuireWoods noted in a post. 

A spokesperson for the Office of Management and Budget told Government Executive on Monday morning the Justice Department is currently reviewing the decision. “At this time, the nationwide injunction remains in effect, and thus agencies should continue not to take any steps to enforce Executive Order 14042.” 

The nationwide injunction remains in effect at least until the appellate court issues its mandate to the lower court which typically happens in two weeks.

Also from the Omicron and siblings front, the Wall Street Journal discusses best practices for Covid testing while NPR tells us

The federal government is putting a pause on sending free COVID-19 testing kits to Americans starting in September, due to a lack of funding. 

“Ordering through this program will be suspended on Friday, September 2 because Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” the ordering website says. 

However, the program is still accepting orders before [next Saturday] Sep. 2. 

From the No Surprises Act front, Mercer Consulting announced

A new prescription drug reporting mandate, adopted as part of the 2021 Consolidated Appropriations Act (CAA) (Pub. L. No. 116-260), requires group health plans and health insurers to report detailed data about prescription drug pricing (including rebates) and healthcare spending. The first reports are due by Dec. 27, 2022, and annually thereafter. The departments of Labor, Treasury, and Health and Human Services will use the information to prepare a biannual, publicly available report. The departments have issued interim final rules (IFR) detailing the data to report and recently updated submission instructions describing the mechanics of the reporting process. The updated instructions provide important information about reporting wellness services, prescription drug expenses that are covered by the pharmacy benefit manager and more.

Download PDF of this article

Click here

Download the 21-page print-friendly article for details on the prescription drug reporting rules and the compliance challenges facing group health plans. This GRIST has been updated to reflect the updated submission instructions.

OPM added FEHB plans to the list of reporting plans and insurers. The initial report on the 2020 plan year is due no later than December 27, 2022.

From the FEHB plan design front, Federal News Network reports

Democratic lawmakers are urging the Office of Personnel Management to follow through on its plans to expand federal employees’ medical coverage to cover infertility diagnoses and treatments.

Sen. Tammy Duckworth (D-Ill.) and Government Operations Subcommittee Chairman Gerry Connolly (D-Va.) urged OPM on Monday to ensure all Federal Employee Health Benefits (FEHB) program carriers provide coverage for assistive reproductive technology (ART), which includes in vitro fertilization (IVF), starting in 2023.

The legislators’ demand strikes the FEHBlog as a day late and a dollar short because FEHB carriers and OPM closed their benefit and rate negotiations earlier this month. OPM did ask carriers in the agency’s 2023 call letter to plan on expanding ART coverage or offering a discounted ART network, among other options.

From the maternal health front, the Department of Health and Human Services announced “investments of over $20 million to improve maternal and infant health and implement the White House Blueprint for Addressing the Maternal Health Crisis – PDF. Funding aims to help reduce disparities in maternal and birth outcomes, expand and diversify the workforce caring for pregnant and postpartum individuals, increase access to obstetrics care in rural communities, and support states in tackling inequities in maternal and infant health.”

From the mental healthcare front, Health Payer Intelligence delves into the resources that AHIP has made available.

Seven strategic themes emerged from the list of ways that payers have helped members manage their mental health needs:

* Helping members find the right providers

* Creating opportunities for care through telehealth, online platforms

* Designing new payment models

* Expanding and educating the mental healthcare workforce

* Offering population-based services

* Supporting caregivers

* Expanding research and awareness

The article expounds on each of these themes.

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

Months of inching performance gains were upended in July as the nation’s hospitals logged “some of the worst margins since the beginning of the COVID-19 pandemic,” Kaufman Hall wrote in its latest industry report. * * *

What’s more, seven straight months of negative margins “reversed any gains hospitals saw this year” and has the advisory group forecasting a brutal year for the industry.

“July was a disappointing month for hospitals and put 2022 on pace to be the worst financial year hospitals have experienced in a long time,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a statement. “Over the past few years, hospitals and health systems have been able to offset some financial hardship with federal support, but those funding sources have dried up, and hospitals’ bottom lines remain in the red.” * * *

The silver lining in Kaufman Hall’s report were total expenses that, although up 7.6% from July 2021, saw a modest 0.4% decline since June. Those savings came squarely among supply and drug expenses as total labor costs and labor expense per adjusted discharge still grew 0.8% and 3.5%, respectively, since June. Increases in full-time employees per adjusted occupied bed “possibly” suggest increased hiring, the group wrote in the report.

From the electronic health record interoperability front, Becker’s Health IT informs us

Judy Faulkner, CEO of Epic, discussed the company’s vision to build a nationwide health IT infrastructure last week at the annual Users Group Meeting while dressed as Amelia Earhart, according to The Cap Times. 

Ms. Faulkner has a history of dressing as characters and historical figures for her highly anticipated keynote address at the meeting every year, and this year she chose Ms. Earhart, the iconic female pilot, as a nod to the meeting’s theme: A Night at the Museum. She talked about new technologies and expectations for Epic and its data platform, Cosmos. * * *

“We are building a nationwide health IT infrastructure to connect the different parts of healthcare,” Ms. Faulkner told the crowd.

Epic’s largest competitor in the hospital market, Oracle Cerner, is also on a mission to digitally connect the U.S. healthcare system. Larry Ellison, chair, co-founder and chief technology officer of Oracle, revealed in June the company’s plans to build a unified national healthcare database after acquiring Cerner earlier this year for $28.4 billion. His vision of a national healthcare database includes anonymized data from hospitals, clinics and providers to give real-time information about patients’ health as well as public health statistics.

Tuesday Tidbits

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, No Surprises Act, OPM, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

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

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.

The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.

Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots. 

Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.

Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.

From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.

Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.

From the medical research front, BioPharma Dive reports

Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.

At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.

If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.

The article provides an overview of these RNA drug development efforts.

From the tidbits department —

  • MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
  • Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
  • The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
  • The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
  • The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.

Monday Roundup

David Ermer–CDC, COVID-19, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and unusual viruses front —

STAT News reports

Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots.

Notably, in the same press release, the companies said that a clinical study investigating the safety, tolerability, and immunogenicity of the vaccine, which also includes the original Covid strain, is expected to start this month, meaning data would not be available for the FDA to consider.

The application to authorize the vaccine without new clinical trial data is part of a bold and potentially controversial gambit by the U.S. and its advisers to try and get ahead of the fast-mutating coronavirus, SARS-CoV-2. But it’s one that could also have a big payoff.

The Pharmacy Times tells us

Officials with the FDA have granted an expanded Emergency Use Authorization (EUA) to Novavax for its COVID-19 vaccine, adjuvanted for adolescents 12 through 17 years of age, according to a press release. The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.

The expanded EUA allows for a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents. Doses are now available and primary series immunizations for adolescents can begin once the CDC releases a policy recommendation.

Will the next Novovax approval from the FDA be for a booster?

Medpage Today points to a study suggesting a connection between myocarditis in children and long Covid.

The Wall Street Journal adds

Officials in New York are urging pediatricians and parents to bring patients up to date on polio shots, as evidence suggests the infectious and potentially debilitating poliovirus was present in the state as early as April. 

Health officials said they have sent alerts to healthcare providers, hung fliers in houses of worship, grocery stores and summer camps, and talked with community leaders to boost polio vaccination rates in the greater New York City area. Some places including Rockland and Orange counties have polio vaccination rates around 60% among eligible children, compared with a national rate of around 93%, according to federal data. 

Polio is particularly insidious, health officials and other public-health experts said, because the majority of cases occur in people who never develop symptoms but can still spread the virus. That silent spread can cause meningitis or paralysis in someone unvaccinated against the disease. 

In other public health news, STAT News informs us

Anthony Fauci, the top U.S. infectious diseases official for decades and a leading researcher on crises from HIV to Covid-19, announced Monday that he would be stepping down from his positions in December.

Fauci, 81, has led the National Institute of Allergy and Infectious Diseases for 38 years, serving a line of presidents from both parties since the Reagan administration. He has also served as President Biden’s chief medical adviser since Biden took office. While Fauci has telegraphed that he was planning on leaving those roles in a matter of months, Monday’s announcement makes it official.

But Fauci, known as a tireless workhorse, said he would not be retiring. “After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field,” he said. “I want to use what I have learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.”

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

Signify Health Inc. soared the most since its shares started trading last year as UnitedHealth Group Inc., Amazon.com Inc., CVS Health Corp. and Option Care Health Inc. competed to acquire the home-health technology and services provider, according to people familiar with the matter. 

UnitedHealth has submitted the highest bid in excess of $30 a share, while Amazon’s offer is close behind, the people said, asking not to be identified as the discussions are private. Signify is holding a board meeting Monday to discuss the bids, the people said. * * *

Final bids are expected Sept. 6, but a deal could come earlier if any of the parties preempt the sales process, the people said.  * * *

Through its software and services, Signify aims to help clients — payers like health plans, government programs and employers — shift to value-based payment plans. It’s backed by private equity firm New Mountain Capital, which formed the company in 2017, according to the firm’s website. 

That is quite a big business rumble.

From the No Surprises Act front, Prof. Katie Keith and her colleagues wrote two articles on last Friday’s “final, final” independent dispute resolution rule — one concerns its impact on IDR arbitrations and the other on miscellaneous topics.

From the mental healthcare front, Health Payer Intelligence lets us know that “Payers are working toward achieving broader access to mental healthcare and behavioral healthcare services by reimbursing at higher rates and supporting primary care” according to a recent AHIP survey.

Nearly eight in ten health plans had boosted behavioral healthcare workers’ reimbursement rates (78 percent). Additionally, 83 percent of payers had attracted and retained a diverse population of behavioral healthcare providers.

Substance abuse care is becoming more accessible, the survey found. Specifically, more providers have become eligible to offer medication-assisted therapy (MAT). This population has expended 114 percent over the course of three years.

Nearly three-quarters of health plans (72 percent) support behavioral healthcare training for primary care providers. The same share supported primary care providers by helping them find behavioral healthcare specialist referral partners.

Payers have also offered primary care providers the opportunity to call behavioral healthcare specialists via telehealth or telephone in order to consult them on a patient’s condition. More than half of the health plans (56 percent) provide this option. This method has been used in pediatric psychiatry to solve members’ challenges in connecting with specialists.

Health plans reported a couple of main ways that they try to connect members with mental healthcare services. Many plans do this by supporting patient navigation (83 percent). For example, health plans might connect members with community-based organizations that can address their social determinants of health needs. 

Additionally, more than eight in ten health plans said they help members secure behavioral healthcare visits. Follow-up on inpatient care and emergency room visits is often part of health plans’ efforts to connect members with mental health services as well. Seventy-eight percent of the plans leveraged specialized case managers to perform this function.

From the medical research and development front —

Biopharma Dive informs us

Gilead’s long-acting HIV shot Sunlenca is now cleared for sale in Europe, marking the first marketing authorization for a treatment the California biotechnology company hopes can be used broadly as a standard therapy and preventive regimen.

The decision by the European Commission, announced Monday, authorizes Sunlenca for patients whose current treatment regimen can no longer keep their infection at bay. Sunlenca, previously called lenacapavir, will be added to other antiviral drugs to boost patients’ immune response and reduce levels of virus in the body.

Gilead is still waiting on a regulatory decision in the U.S., where it has been delayed by manufacturing issues. An approval by the Food and Drug Administration’s December deadline could put the drug on track to reach sales that RBC Capital Markets analysts estimate will climb as high as $4 billion a year.

The Wall Street Journal reports

Zapping the brain with weak electrical currents that mimic normal neural activity can boost memory in healthy older adults, at least over the short term, researchers said in a study published Monday in the journal Nature Neuroscience.

Electrical stimulation of the brain as a potential tool for enhancing memory is a growing field of research, with experiments showing that the ability to recall memories depends upon synchronized activity between different brain regions.

The new research, conducted on people over age 65, “adds to the growing evidence that noninvasive stimulation mimicking the rhythmic brain activity that supports cognition can improve memory” in this population, said Joel Voss, a University of Chicago professor of neurology who wasn’t involved in the research.

Weekend update

David Ermer–Congress, COVID-19, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Congress is on a State / District work break again this week.

The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.

Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.

Here’s a link to a Fierce Healthcare article on the new rules.

From the omicron and unusual viruses front —

The Wall Street Journal reports

The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.

But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.

As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S. 

This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.

The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce. 

The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.

Fingers crossed.

On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.

NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes

Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.

A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.

The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox. 

The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.

The Wall Street Journal offers articles on “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York” and “Am I Protected Against Polio? Here’s What to Know About the Vaccine.”

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.

The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.

Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.

Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.

STAT News adds

Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.

Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.

Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.

CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.

There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.

From the miscellany front

  • Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization.  The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
  • Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”

Friday Stats and More

David Ermer–COVID-19, No Surprises Act–

Based on the Centers for Disease Control’s (“CDC”) Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases for 2022.

Omicron reigned from before Week 1 through Week 15. Its siblings began to take over in week 15 and still reign.

The CDC’s weekly review of its Covid statistics adds

As of August 17, 2022, the current 7-day moving average of daily new cases (95,652) decreased 9.9% compared with the previous 7-day moving average (106,116).

CDC Nowcast projections* for the week ending August 20, 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 88.9% (95% PI 87.6-90.1%).

Here’s the CDC’s latest daily trends chart of new Covid admissions

The CDC’s weekly review adds, “The current 7-day daily average for August 10–16, 2022, was 5,690. This is a 6.1% decrease from the prior 7-day average (6,059) from August 3–9, 2022.”

Here is the FEHBlog’s weekly chart of new Covid deaths, which like new Covid cases, has plateaued for months but is trending down somewhat.

The CDC’s weekly review adds, “The current 7-day moving average of new deaths (394) has decreased 10.7% compared with the previous 7-day moving average (442).”

Here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered over the Covid vaccination era, which began in the 51st week of 2022.

The CDC’s weekly review adds,

As of August 17, 2022, 607.6 million vaccine doses have been administered in the United States. Overall, about 262.3 million people, or 79.0% of the total U.S. population, have received at least one dose of vaccine. About 223.7 million people, or 67.4% of the total U.S. population, have been fully vaccinated.

The CDC’s weekly chart includes this charts on the administration of the first and second boosters:

Medpage Today offers Physicians Address Parents’ Concerns on COVID Vaccines in Young Kids, and the New York Times provides expert medical opinions on whether to delay the fourth dose of vaccine for the bivalent vaccine in the fall.

To sum up, the CDC’s weekly review leads off with a discussion of how to stay safe from Covid in school and reminds us the check the Communities tracker, which honestly has not turned out to be that informative in the aggregate:

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.

Friday’s big, late-breaking news is the Affordable Care Act’s regulators’ release of the final No Surprises Act Independent Dispute Resolution rule following provider and court objections to the interim final rule with comments.

The departments continue to work to implement and put into effect the Jan. 1, 2022, consumer protection law to help curb surprise billing for medical care. Today’s final rules will make certain medical claims payment processes more transparent for providers and clarify the process for providers and health insurance companies to resolve their disputes. * * *

In addition to issuing the final rules, the departments are issuing [28 pages of Frequently Asked Questions Part 55 with guidance on implementing the requirements of the No Surprises Act, including those related to surprise billing protections, open negotiation and the federal IDR process.

Also available:

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, NIH, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Federal News Network identifies five federal workforce items on Congress’s to-do list.

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

The Biden administration is planning for an end to its practice of paying for Covid-19 shots and treatments, shifting more control of pricing and coverage to the healthcare industry in ways that could generate sales for companies—and costs for consumers—for years to come. * * *

Shifting payments for Covid-19 drugs and vaccines to the commercial market is expected to take months, an HHS spokesman said.  * * *

Switching vaccine purchasing to the commercial market would mean that each insurer and pharmacy benefit manager would be negotiating with drug manufacturers and prices would likely be higher than what the federal government has paid, said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. Insurers would have to start paying for the vaccines, he said, likely raising premiums.

MedPage Today informs us

More than 2 years after patients started reporting long-lasting symptoms after acute SARS-CoV-2 infection, the U.S. announced its national long COVID plan.

The National Research Action Plan on Long COVID aims to improve prevention, diagnosis, and treatment for long COVID, which currently affects up to 23 million people in the U.S., about 1 million of whom may be out of the workforce at any given time because of the condition, according to Admiral Rachel Levine, MD, HHS assistant secretary for health. * * *

Long COVID advocates expressed mixed opinions. Hannah Davis, co-founder of the Patient-Led Research Collaborative, noted the fact that “there’s going to be an [Office of Long COVID Research and Practice] is pretty amazing.”

But Davis voiced concerns about the scarcity of prevention efforts addressed by the plan. “I think there’s still a feeling like we can get through this without minimizing cases, but we really need to be focused on prevention as well,” she said.

Diana Berrent, founder of Survivor Corps, told MedPage Today that the administration “nailed the institutional challenge of long COVID” but also thought the plan was insufficient.

“Millions of Americans, young and old, are suffering the aftermath of COVID and need immediate relief from their pain,” Berrent said. “An established office in HHS is a welcome step but nothing short of actual treatments and therapeutics will do the trick.”

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of monkeypox cases, and MedPage Today reports

The Biden administration is making an additional 1.8 million doses of the Jynneos monkeypox vaccine available beginning Monday, and will be targeting certain large events — such as gay pride marches that attract many LGBTQIA participants — as sites for monkeypox vaccination and outreach, administration officials said Thursday.

From the healthcare costs front, Healthcare Dive reports

U.S. employers will pay 6.5% more on average for employee healthcare coverage in 2023 compared to this year, according to an Aon report out Thursday.

The latest predicted rise, while a jump from the 3.7% growth in employer costs between 2021 and 2022, is still far below the 9.1% Consumer Price Index, a figure reflecting inflation. 

Inflation typically hits healthcare costs later than other goods and services due to the multi-year nature of contracts between providers and insurers, but impacts will become more prevalent over the year, according to the report.

Speaking of higher costs, Fierce Healthcare discusses Moody’s report on how an economic downturn would impact health plans.

From the post-Dobbs front, the FEHBlog ran across this Congressional Research Service FAQs on Federal Resources for Reproductive Health.

From the No Surprises Act front, the American Hospital Association informs us “The Centers for Medicare & Medicaid Services has launched a new webpage with resources and guidance related to the dispute resolution process under the No Surprises Act, including guidance for disputing parties and a walkthrough of the federal portal. CMS also has added functionality to the portal for initiating disputes, including a button to upload supporting documents at initiation.”

From the miscellany department —

  • Fierce Healthcare discusses J.D. Powers’ annual study of Medicare Advantage plans. “[T]he analysts found members’ general satisfaction is up from 2021 and is higher than satisfaction reported by people in employer-sponsored plans. However, while members said they’re happy with access to preventive and routine care, coverage of mental health and substance abuse treatment is lacking.”
  • STAT News calls our attention to “a new Pew-funded report, by researchers at George Washington University, the federal government can expand methadone access without approval from Congress.” According to the article, “When it comes to fighting opioid addiction, there’s no tool more effective than methadone. Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose.”

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.