Thursday Miscellany

No Surprises Act

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.

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

From Capitol Hill, Govexec reports

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

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

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

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

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

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

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

From the Omicron and siblings front —

The American Hospital Association informs us

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

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

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

The Wall Street Journal reports

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

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

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

From the fraud, waste and abuse front —

Fierce Healthcare tells us

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

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

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

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

The Justice Department also announced

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

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

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

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

From the U.S. healthcare business front —

Fierce Healthcare informs us

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

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

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

Healthcare Dive tells us

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

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

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

From the U.S. general healthcare front —

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

Friday Stats and More

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

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

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

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

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

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

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

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

The CDC’s weekly review explains

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

The American Hospital Association adds

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

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

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

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

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

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

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

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

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

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

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

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

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

That is thoughtful action by the PTO and FDA.

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

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

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

Friday Stats and More

David Ermer–CDC, COVID-19, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’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 from the 27th week of 2021 through the 24th week of 2022:

While the CDC did not publish its weekly Covid statistical review this week, the FEHBlog can tell you that the daily new Covid hospitalization average is 4,321 for the week ended June 15, 2022. That average is 4.7% higher than the previous week.

Here’s the FEHBlog’s weekly chart of new Covid deaths for the same period as new cases:

New cases and deaths are both stable. MedPage Today adds

About 4.5% of people who became infected with SARS-CoV-2 when Omicron was the dominant strain experienced long COVID symptoms, compared with 10.8% who became infected during the Delta period, reported Claire Steves, PhD, of King’s College London in England, and co-authors.

Overall odds of long COVID were about 20% to 50% less during the Omicron era — defined as December 2021 to February 2022 in this study — depending on age and time since vaccination, the researchers wrote in a letter to The Lancet.

For more information, Science discusses clues to long Covid.

Here’s the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020, when the Covid vaccination era began and the current 24th week of 2022.

Over 100,000 people aged 12 and older have received at least one booster.

The Wall Street Journal adds.

Vaccine advisers to the Centers for Disease Control and Prevention discussed Friday the merits of Covid-19 shots now authorized for children as young as 6 months. * * *

The committee is scheduled to discuss further the case for recommending giving the Pfizer-BioNTech and Moderna shots to young children, and then vote on the matter Saturday.

The Biden administration has said the shots could be made available as soon as Monday, should regulators give their assent.

The federal government has begun shipping millions of doses to doctor’s offices, children’s hospitals and pharmacies, President Biden said after the FDA’s authorizations.

From the Rx coverage front, STAT News and Medical Economics update us on the federal government’s investigation of prescription benefit managers. Notably, STAT News reports

Amid intensifying scrutiny of pharmacy benefit managers, a group of House Republicans is urging the U.S. Government Accountability Office [via a June 17 letter] to investigate the role these controversial middlemen play in the opaque pharmaceutical pricing system.

From the Federal Trade Commission front, Healthcare Dive tells us that the FTC has obtained several victories over the past week in its legal challenges to hospital system mergers in New Jersey, Rhode Island, and Utah.

From the No Surprises Act front, reginfo.gov informs us that on June 15, the Office of Information and Regulatory Affairs received for review the NSA regulators’ final rule on the independent dispute resolution process. OIRA review is the last step before the rule is published in the Federal Register. The healthcare provider associations mounted a successful legal challenge to the interim final rule’s treatment of the qualifying payment amount as a rebuttable presumption at the arbitration stage.

From the HIPAA standard transactions front, a Health and Human Services workgroup has issued guidance on how payers can help providers associate electronic explanations of benefits with electronic payments.

From the U.S. healthcare front, Kaiser Health News and a WTW study delve into the widespread related problems of medical debt and deferred care. On the bright side, the National Institutes of Health reports that flexible work schedules and paid sick leave improves employee access to healthcare.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, NIH, No Surprises Act, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare reports

New bipartisan legislation introduced in the Senate aims to empower the Federal Trade Commission (FTC) to crack down on pharmacy benefit manager practices such as spread pricing.

The legislation, introduced Tuesday, comes as the PBM industry faces other areas of reform, including a proposed rule to get rid of clawback fees PBMs can charge pharmacies after the drug is dispensed.

Lawmakers said federal agencies need more power, though, to rein in PBM practices. 

From the No Surprises Act (“NSA”) front, AHIP and the Blue Cross Association inform us

A recent survey and analysis conducted by AHIP and the Blue Cross Blue Shield Association (BCBSA) found that in the first two months of 2022, the NSA prevented more than 2,000,000 potential surprise medical bills across all commercially insured patients. If only a fraction of these claims are ultimately disputed through IDR, it would still far exceed the government’s estimate. Should the trend hold, more than 12,000,000 surprise bills will be avoided in 2022 due to the NSA.

The law is working to protect millions of consumers from costly surprise bills and yet several hospital and provider organizations have filed lawsuits challenging the NSA regulations and legislation in order to increase their own profits at patients’ expense. Recent polling conducted by Morning Consult on behalf of the Coalition Against Surprise Medical Billing found that 8 in 10 voters, after learning about the NSA, are concerned that lawsuits from physician and hospital organizations could delay or overturn the patient protections in the Act.

The findings of the AHIP-BCBSA survey are important to demonstrate how many consumers have already benefitted from the NSA and to underscore the extent of total claims that could be impacted if the IDR process is not a predictable process with payment amounts that trend towards market rates.

That’s great news.

In public health news, the American Hospital Association tells us ‘

U.S. births rose 1% in 2021 to about 3.7 million, the first increase since 2014, according to preliminary data released today by the Centers for Disease Control and Prevention. Birth rates declined for women aged 15-24 and rose for women aged 25-49. The cesarean delivery rate rose 0.3 percentage point to 32.1%, while the preterm birth rate rose 4% to 10.48%, the highest rate since 2007, CDC said.

From the Omicron and siblings front

  • Reuters reports “The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc’s emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc’s vaccine for those aged 6 months through 4 years.”
  • Precision Vaccines tells us “The U.S. Centers for Disease Control and Prevention (CDC) issued today Health Alert Network Health Advisory CDCHAN-00467 to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 Rebound.”  COVID-19 Rebound cases have been reported to occur between two and 8 days after initial recovery. They are characterized by a recurrence of COVID-19 symptoms or a new positive viral test after testing negative.  A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the beta coronavirus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.” STAT News offers a more detailed article on this topic for those interested.

In other virus news, the Hill informs us

Officials for the Centers for Disease Control and Prevention (CDC) on Monday said the agency is releasing doses of a smallpox vaccine in response to the few recent cases of monkeypox that have been detected in the U.S. Jennifer McQuiston, the deputy director for the CDC’s Division of High Consequence Pathogens and Pathology, said during a press briefing that more than a thousand doses of the Jynneos smallpox vaccine are currently available in the U.S., with more doses expected to become available as production ramps up. * * * The vaccines will be designated for people who are most likely to benefit from them, McQuiston said, including those who are known to have had close contact with monkeypox patients, health care workers and people who would be at high risk of developing a severe case of the disease.

From the healthcare business front, Beckers Hospital News identifies Walmart’s 18 Centers of Excellence in the U.S.

In National Institutes of Health news, NIH Reseach Matters discusses antioxidant effects on dementia risk and how the health benefits of dietary fibers depend on the fiber type, the amount, and the individual.”

Midweek update

David Ermer–CDC, Congress, COVID-19, No Surprises Act, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Capitol Hill, Roll Call reports

Third time’s a charm. Or so Democrats hope as they attempt to negotiate a third COVID-19 funding deal after their previous two bipartisan agreements — one for $15.6 billion in domestic and international aid, and a second for $10 billion in only domestic funds — stalled out. 

The House is taking the lead on the latest iteration. But it’s not yet clear whether they’ll hold out for a bipartisan, bicameral agreement or attempt to move a Democrat-led version that would provide more funding, closer to President Joe Biden’s original $22.5 billion request. 

“All the options are on the table,” House Majority Leader Steny H. Hoyer, D-Md., said Wednesday. “But it’s critical to get it done. And the fastest way to get it done is have an agreement on the four corners.” 

From the No Surprises Act front, the U.S. Court of Appeals for the Fifth Circuit has granted the federal government/appellant’s “unopposed motion to stay further proceedings in this court pending ongoing rulemaking proceedings involving provisions of the No Surprises Act, with a status report due every sixty (60) days.” It’s worth noting that the final independent dispute resolution rule has not yet appeared on the OMB’s Office of Regulatory Affairs reginfo.gov site.

From the Omicron and siblings front, Fierce Healthcare tells us

Reported cases of COVID-19 and hospitalizations for the disease are on the rise across most of the U.S., with the Centers for Disease Control and Prevention (CDC) recently shifting many counties in the Northeast to medium or high levels of community risk. * * *

COVID-19 hospitalizations—which have become the CDC and other public health experts’ preferred metric for decisionmaking—have similarly begun to tick upward over the past month.

After reaching a seven-day average low of 1,426 daily admissions in early April, national admissions have continually increased and exceeded the seven-day average of 2,400 daily hospitalizations late last week. These new admissions represented an 11% increase over the previous week’s seven-day average, according to the agency, but were still nearly 90% below the January peak of more than 21,500 average daily admissions.

From the opioid epidemic front, the Wall Street Journal reports

Drug-overdose deaths in 2021 topped 100,000 for the first time in a calendar year, federal data showed, a record high fueled by the spread of illicit forms of fentanyl throughout the country.

More than 107,000 people in the U.S. died from drug overdoses last year, preliminary Centers for Disease Control and Prevention data released Wednesday showed, roughly a 15% increase from 2020. The proliferation of the potent synthetic opioid fentanyl has been compounded by the destabilizing effects of the Covid-19 pandemic on users and people in recovery, according to health authorities and treatment providers. 

The U.S. has recorded more than one million overdose deaths since 2000, and more than half of those came in the past seven years. 

“We’ve never seen anything like this,” said Robert Anderson, chief of the mortality-statistics branch at the CDC’s National Center for Health Statistics, regarding fentanyl’s impact on the numbers.

From the telehealth front, Healthcare Dive informs us

Telehealth visits for COVID-19 diagnoses fell in February, mirroring the sharp decline in new cases of the virus reported to the Centers for Disease Control and Prevention after January’s omicron-driven peak, according to Fair Health’s monthly telehealth claims tracker.

Overall telehealth use also slowed, falling 9.3% in February across the country. Virtual visits were 4.9% of all medical claim lines, down from 5.4% in the prior month.

With declining COVID-19 cases generating fewer telehealth sessions, mental health conditions accounted for a greater share of all diagnoses conducted via virtual platforms, according to the Fair Health data released Monday. Mental health diagnoses rose to about 64% of telehealth claims, up from 60% in January.

The FEHBlog is happy that people are using telehealth for mental healthcare,e which strikes the FEHBlog as a good, productive fit.

From the healthcare business front, Healthcare Dive reports

Advocate Aurora Health and Atrium Health said Wednesday they plan to merge, creating one of the nation’s largest nonprofit health systems with $27 billion in combined revenues and 67 hospitals across six states.

Board members from both systems unanimously approved the agreement, which is subject to regulatory review. The combined entity will be led by both CEOs for the first 18 months, at which time Advocate’s CEO Jim Skogsbergh will retire, leaving Atrium’s CEO Eugene Woods as sole leader.

Advocate and Atrium will have an equal number of board seats. Atrium’s board chair Edward Brown will first serve as chair until the end of 2023, followed by a two-year term for Advocate’s chair Michele Richardson.

The health systems’ joint press release adds

The new organization will have a combined footprint across Illinois, Wisconsin, North Carolina, South Carolina, Georgia and Alabama. It will serve 5.5 million patients, operate more than 1,000 sites of care and 67 hospitals, employ more than 7,600 physicians and nearly 150,000 teammates, and have combined annual revenues of more than $27 billion.

That’s an interesting combination.

Health Payer Intelligence calls attention to

Six technology vendors [who] were highlighted for their abilities to address one of the six main points of friction between payers and providers that leading healthcare organizations strive to address, according to a KLAS report that is part of the KLAS Payer/Provider Initiative.

KLAS launched the Payer/Provider Initiative to identify points of friction between payers and providers and to highlight strong collaboration case studies.

The six payer-provider challenges that leading healthcare organizations tackled were prior authorization, value-based care, payer-provider interoperability, denials, credentialing, and patient billing.

From the OPM front, Federal News Network tells us

Agencies have to choose two out of four new focus areas to help improve their workforce over the next four years.

Deciding which options are most impactful gives agencies flexibility in how they approach new workforce objectives from the Office of Personnel Management.

Although OPM’s federal workforce priorities report, released on May 10, asks agencies to focus on only two of the four focus areas, implementing all four can help agencies resolve bigger workforce issues.

Among four primary priorities and four enabling priorities, OPM hopes agencies can implement proactive approaches to common issues, such as recruitment challenges.

From OPM’s federal workforce priorities report via Federal News Network

Tuesday’s Tidbits

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

From the Omicron and siblings front, Fortune Well explores earlier pandemics for similarities to our current one.

As U.S. COVID czar Dr. Anthony Fauci and colleagues pointed out in a 2009 New England Journal of Medicine article, “It is not generally appreciated that descendants of the H1N1 influenza A virus that caused the catastrophic and historic pandemic of 1918–1919 have persisted in humans for more than 90 [now 100] years and have continued to contribute their genes to new viruses, causing new pandemics,” including the 2009 H1N1 “swine flu.”

“We are living in a pandemic era that began around 1918,” they wrote 13 years ago—long before the advent of COVID-19.

Harald Brüssow, editor of Microbial Biotechnology, agrees with Fauci and his colleagues that “viruses do not simply disappear.”

“They change and hopefully they adapt and behave,” Brüssow said. “But there are still some escapes, and we might see a return with higher virulence. Vigilance is indicated.”

From the healthcare business front —

The Wall Street Journal reports

Pfizer Inc. expects demand for its Covid-19 antiviral drug to increase as governments return to replenish their supplies and seek to thwart surges as the pandemic virus continues to evolve.

The treatment, a pill called Paxlovid, brought in $1.5 billion in sales during Pfizer’s first quarter, while its vaccine totaled $13.2 billion, reflecting the need for tools to combat the virus despite a slowdown in cases and a growing sense of life trying to return to normal.

The company said Tuesday it is on track to deliver between $98 billion and $102 billion in revenue for the year, with $32 billion coming from its Covid-19 vaccine Comirnaty and $22 billion from Paxlovid. 

“We remain bullish on Paxlovid” said Chief Financial Officer Frank D’Amelio on a call discussing earnings with analysts. “The rhythm of that product looks very good.”

STAT New informs us

Biogen is replacing CEO Michel Vounatsos, the company said Tuesday, ending a five-year tenure in which he presided over the disastrous approval and rollout of its Alzheimer’s treatment, Aduhelm.

The company also said it is “substantially eliminating” all spending on Aduhelm just 10 months after securing U.S. approval — a concession from the struggling biotech that the drug had become a financial liability following a Medicare decision to restrict patient access and payment.

From the Affordable Care Act front, Health Affairs Forefront features the third and final part of Katie Keith’s series on the final 2023 notice of benefit and payment parameters. The third part discusses changes to the ACA marketplace’s risk adjustment program.

From the No Surprises Act, the FEHBlog had understood that the NSA regulators planned to release a final rule on the NSA’s arbitration process, replacing the interim final rule, this month. However, a Justice Department filing with the U.S. Court of Appeals for the Fifth Circuit submitted late last week states, “the Departments expect to issue a final rule early this summer that will supersede the portions of the interim final rule that Plaintiffs [in the Texas Medical Association case] challenged.” No wonder then that the final rule has not been presented yet to OMB’s Office of Information and Regulatory Affairs for its required review before publication in the Federal Register.

From the tidbits department —

  • Here is a link to the new CMS Strategic Plan.
  • Federal News Network tells us,

Agencies’ hiring efforts for the Bipartisan Infrastructure Law (IIJA) are “foot to the pedal,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

The surge includes filling 3,000 of those new positions over the first six months after President Joe Biden signed the bill into law.

Ahuja has frequently spoken about her goals to attract more early-career workers to federal service. The BIL gives OPM another chance to do just that.

  • FedSmith identifies four personal budget factors Federal retirees must anticipate. One of those factors is our beloved FEHBP.
  • The CDC offers ten tips for coping with diabetes distress.

Monday Roundup

David Ermer–COVID treatment, COVID-19, COVID-19 vaccine, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the No Surprises Act front, the FEHBlog nearly fell off his chair when he noticed this Healthcare Dive article:

The Department of Justice intends to appeal a federal judge’s ruling that sided with providers over a challenge to the surprise billing rule, according to a Friday filing from the DOJ in the Eastern District of Texas.  

The Texas Medical Association sued the federal government over its interpretation of the No Surprises Act, arguing the rule leans too heavily on one factor arbiters are supposed to consider when resolving payment disputes between payers and providers.      

Federal Judge Jeremy Kernodle’s February ruling said nothing in the bill passed by Congress instructs arbiters to “weigh any one factor … more heavily than the others,” indicating the rule conflicts with the bill.

The Justice Department noticed an appeal to the Fifth Circuit in the referenced Friday, April 22, filing with the District Court. That notice effectuates the appeal. The FEHBlog will keep an eye on the dockets to learn whether the Justice Department will seek a stay of the February ruling while the case is on appeal.

From the Omicron and siblings front —

  • Bloomberg’s Prognosis reviews progress being made in the development of Covid vaccines administered nasally. Nasal vaccines have a better shot at preventing COVID than injected vaccines.
  • The American Hospital Association reports “The Food and Drug Administration today expanded its approval for remdesivir (Veklury) to include pediatric patients under age 12 who test positive for SARS-CoV-2 and are hospitalized or at high risk of progressing to severe COVID-19. The patient must be at least 28 days old and weigh at least 3 kilograms (about 7 pounds). FDA said the approval is supported by a clinical study of 53 pediatric patients as well as trials in adults, given the similar course of disease in adult and pediatric patients.”
  • Medical Dialogues informs us the World Health Organization has recommended Pfizer’s Paxlovid Covid pill over remdesvir, Merck’s pill and monoclonal antibodies for patients with milder forms of Covid and nevertheless at high risk of hospitalization from the disease, e.g. the elderly, the immunocompromised, and the unvaccinated.
  • WebMD News tells us “COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the CDC said Friday. * * * The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.”

The WebMD article offers other interesting public health nuggets. For example,

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the U.S. last year. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of .7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

From the healthcare business front, Fierce Healthcare reports

Change Healthcare has found a buyer for its payment integrity arm, ClaimsXten, though the sale is contingent on the closure of its merger with UnitedHealth Group.

According to a filing submitted Monday to the Securities and Exchange Commission, ClaimsXten will be sold off to an affiliate of TPG Capital for a base purchase price equal to $2.2 billion in cash. UnitedHealth is listed as the seller.

From the reports department —

  • The National Bureau of Economic Research offers a working paper titled “Pharmacy Benefit Managers and Vertical Relationships in Drug Supply: State of Current Research.”
  • Per HR Morning, “Employer support [of their workforces] is happening in the areas of increased prioritizing employee assistance programs (EAPs), expanded wellness benefits and greater attention to work/life balance. That’s according to Ragan’s 2022 Communications Benchmark Report that surveyed close to 1,000 communicators across industries on opportunities and changes.”
  • Per Health Payer Intelligence, Humana has produced an issue brief that provides “an overview of the policymaking landscape surrounding social determinants of health data collection.”