U.S. Healthcare Archives - Page 53 of 111

Monday Roundup

David Ermer–Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare–December 19, 2022December 20, 2022

From Capitol Hill, STAT News reports

Leaders in Congress have reached a sweeping deal to ease Medicare pay cuts to doctors, make major changes to post-pandemic Medicaid policy, and to help prepare for future pandemics.

Lawmakers are aiming to pass a health care policy package along with legislation to fund the federal government by Friday. The details of the omnibus spending package were confirmed by two lobbyists and two congressional aides.

The bill’s text is not yet finalized, and the deal is still subject to changes.

Details may be found in the article.

Following up on last Friday’s post on emergency medical care, MedPage Today counters

The New York Times reported last week that a newly released federal government study believes that up to 250,000 people die in the U.S. annually due to misdiagnoses made in emergency rooms.

However, in a large document obtained by Inside Medicine that is not yet public, one expert contributing to an internal review of the report prior to its publication found a “fatal flaw” in the methodology behind some of the most crucial and eye-catching findings. Other major concerns were brought up by other reviewers and technical experts, which the study authors did not fully address prior to the release of the report. The technical expert concerned about the “fatal flaw” wrote that results were, “Headline grabbing, yes, but this is at best gravely misleading, given the concerns….”

Emergency medicine organizations have already pointed out major problems in the report. One thing not yet pointed out is that the magnitude of the findings fail every whiff test imaginable. If the findings of the report were somehow to be true, that would mean that 8.6% of all deaths in the U.S. — that is, 250,000 out of 2.9 million deaths (2019, the last pre-pandemic year) — are caused by mistakes and misses in ERs. That’s preposterous, on its face. * * *

This report seems unfamiliar with the idea that what we seek in medicine is net benefit. This report counts only the misses, but none of the saves ERs routinely make by following evidence-based medicine developed by emergency physicians, cardiologists, neurologists, and other experts working together. This report seems to think that abiding by the principle of balancing risks and harms is somehow synonymous with medical error. * * *

Here is the internal review and here is the link to the federal government’s report

In medical billing news, MedCity News informs us

Nearly 40% of Americans struggle to understand their medical bills, a recent survey showed. But the respondents also shared a few ways providers and insurers could step in to make bills less confusing.

The survey was released Friday by AKASA, an AI developer for healthcare operations. It was conducted online in March by YouGov and included responses from 2,026 U.S. adults. * * *

How can providers and insurers help? Survey respondents shared several ways:

About 27% said it would be beneficial to receive a call from the physician’s office or hospital staff before the medical procedure, explaining terms of payments and the payment plans available.

Another 12% said they’d like an online calculator that can show cost ranges for procedures.

About 11% said it would be helpful to receive an email from their insurer that walks through the bill after they receive care.

About 9% said they’d like the payer to call and walk them through the bill.

Another 9% said they want access to live online customer service through their health plan’s website.

Additionally, 8% want a call from the physician’s office or hospital staff that explains the bill after receiving services.

From the Rx coverage front, STAT News discusses current prescription drug shortages.

The Wall Street Journal adds

Medicines to lower fevers, clear congestion and ease aches and pains are in high demand this winter as the U.S. is experiencing a surge in pediatric cases of RSV, influenza and Covid-19. Parents and caregivers are struggling to find over-the-counter fever reducers such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil) as well as amoxicillin, an antibiotic prescribed to treat common childhood ailments such as ear or upper respiratory infections. Both CVS Health Corp. and Walgreens Boots Alliance Inc. announced they have imposed purchase limits on children’s cold and flu medicines. * * *

Manufacturers are producing at full capacity [in contrast to the baby formula shortage] and directing inventory to where it is most needed, the Consumer Healthcare Products Association, which represents producers of over-the-counter medications. “However, we understand it might be frustrating for parents to quickly locate these products from their usual pharmacy or retailer due to intermittent out-of-stocks,” the group said. A spokeswoman for Johnson & Johnson, whose brands include pain relievers Tylenol and Motrin, said that while some products might be less readily available, the company isn’t experiencing widespread shortages of children’s Tylenol or Motrin.

From the mental health care front —

The Department of Health and Human Services announced “the annual release of the Department’s National Plan to Address Alzheimer’s Disease: 2022 Update – PDF. Through the National Plan, HHS and its federal partners work to improve the trajectory of Alzheimer’s disease and related dementias (ADRD) research, support people living with dementia and their caregivers, and encourage action to reduce risk factors.”

HR Dive explains how employers can help resolve the “unspoken crisis” in men’s mental health.

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

In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury [on November 14] convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars.

The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests, according to the Department of Justice (DOJ). * * *

The convicted individual—Minal Patel, 44, of Atlanta, the owner of LabSolutions LLC—personally pocketed $27 million of the $187 million that the scheme raked in from Medicare from July 2016 through August 2019.

Patient brokers, call centers and telemedicine companies also allegedly cashed in, as Patel paid them kickbacks and bribes after the Medicare beneficiaries agreed to take the tests, DOJ said. The patient brokers allegedly obtained signed doctors’ orders recommending the tests from telemedicine companies. Patel made the patient brokers sign contracts that misleadingly stated that the brokers were performing legitimate advertising services for LabSolutions.

At last week’s ABA Health Law Section Washington Health Law Summit, the FEHBlog learned about a recent federal anti-health care fraud law called the Eliminating Kickbacks in Recovery Act (“EKRA”). The law is directed at patient brokers, laboratories etc. in situations involving, for example, opioid misuse or this one. EKRA criminalizes fraud against private sector health plans as well as the federal treasury. Here’s a law firm’s article about EKRA if you are interested.

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

Two South [New] Jersey hospitals have signed a letter of intent to merge into a system of more than 10,000 employees and over $2.2 billion in annual revenues.

Camden, New Jersey-based Cooper University Health Care and Cape May Court House, New Jersey-based Cape Regional Health System said in a Wednesday announcement they’ll be working toward a definitive merger agreement in March and then regulatory approvals that “could take until the first quarter of 2024.”

Should the agreement come to pass, the joined system would comprise 900 licensed beds across the organizations’ two flagship hospitals, six urgent care centers and over 130 ambulatory locations across eight counties.

From the federal employment front, Federal News Network relates

Leaders in the Biden administration called for “major reforms” to the federal pay system, building on a not-so-new conversation around issues with the compensation system for much of the federal workforce.

The current structure for determining pay for the 1.5 million federal employees on the General Schedule is inherently flawed, the President’s Pay Agent said in its annual report to the president.

“As has been noted in earlier pay agent reports and discussed in other venues, we believe there is a need to consider major legislative reforms of the white-collar federal pay system, which continues to utilize a process requiring a single percentage adjustment in the pay of all white-collar civilian federal employees in each locality pay area without regard to the differing labor markets for major occupational groups,” the pay agent said in the Dec. 19 report. “The current pay comparison methodology used in the locality pay program ignores the fact that non-federal pay in a local labor market may be very different between different occupational groups. As currently applied, locality payments in a local labor market may leave some mission-critical occupations significantly underpaid while overpaying others.”

The pay agent, composed of Office of Personnel Management Director Kiran Ahuja, Labor Secretary Marty Walsh and Office of Management and Budget Director Shalanda Young, issued its annual report ahead of the planned 4.6% pay raisefor the federal workforce in 2023.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 testing, FDA, NIH, Telehealth, U.S. Healthcare, Uncategorized–December 15, 2022December 15, 2022

From Capitol Hill, the Wall Street Journal reports

The Senate passed an $858 billion defense-policy bill [National Defense Authorization Act] on Thursday that authorizes U.S. military leaders to purchase new weapons and would increase pay for service members, checking a major item off Congress’s year-end to-do list.

The House passed the legislation last week with 350 votes in favor and 80 votes against. It now goes to President Biden’s desk for his signature.

The Journal also provides information on the NDAA’s key provisions.

The Washington Post adds,

The Senate late Thursday approved a measure to fund the government through Dec. 23, securing a one-week deadline extension that gives Democrats and Republicans one final opportunity to work out a longer-term spending deal.

The 71-19 vote — coming a day after the House adopted it — sends the stopgap to President Biden and staves off a federal government shutdown that otherwise would have occurred after midnight this Friday.

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

The Department of Health and Human Services today recommended governors take certain actions to prepare for a potential further increase in COVID-19 cases and hospitalizations this winter, and has pre-positioned N-95 masks, gloves, gowns and ventilators at strategic locations should states need them, the Biden Administration announced.

The Administration also announced that all U.S. households can now order four more free at-home COVID-19 tests, which will begin shipping the week of Dec. 19.

From the public health front, AP reports

The number of U.S. deaths dropped this year, but there are still more than there were before the coronavirus hit.

Preliminary data — through the first 11 months of the year — indicates 2022 will see fewer deaths than the previous two COVID-19 pandemic years. Current reports suggest deaths may be down about 3% from 2020 and about 7% vs. 2021.

The National Institutes of Health announced

The percentage of adolescents reporting substance use in 2022 largely held steady after significantly declining in 2021, according to the latest results(link is external) from the Monitoring the Future survey(link is external) of substance use behaviors and related attitudes among eighth, 10^th, and 12^th graders in the United States. Reported use for almost all substances decreased dramatically from 2020 to 2021 after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, reported use of any illicit drug within the past year remained at or significantly below pre-pandemic levels for all grades, with 11% of eighth graders, 21.5% of 10^th graders, and 32.6% of 12^th graders reporting any illicit drug use in the past year.

The Monitoring the Future survey is conducted each year by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

From the Rx coverage front –

BioPharma Dive takes a “deep dive” reporting on a recently approved drug called to treat ALS or Lou Gehrig’s disease. “Amylyx Pharmaceuticals’ Relyvrio is in high demand in clinics across the U.S. Though some patients are already getting it, insurance and out-of-pocket costs remain a source of anxiety. * * * In the clinical trial that led to its approval, Relyvrio appeared to slow the functional decline associated with ALS. The trial also found patients treated with the drug lived a median of five months longer than those given a placebo. While Relyvrio’s benefits have been called modest, the drug has become a vital source of hope for many ALS patients.”

BioPharma Dive also lets us know that

Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.

The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company won’t launch Idacio in the U.S. until July.

Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.

Health Affairs Forefront offers Parts 1 and 2 of its insights on drug pricing reform enacted this past summer’s federal budget reconciliation act.

From the regulatory front

The FEHBlog noticed that the HHS press release concerning the 2024 Medicare Part D proposed rule (posted yesterday) lacked links to the proposed rule and the fact sheets. So here are the missing links:

The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/2022-26956/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program. Comments on the proposed rule are due by February 13, 2023.

View the fact sheet on the proposed rule here.

Health Affair’s Forefront’s second article on Monday’s proposed 2024 ACA benefit and payments parameter rule is here. This article concerns risk adjustment.

From the telehealth front, Health Payer Intelligence relates that

Most patients who had a telehealth visit didn’t need an in-person follow-up appointment in the next three months, according to new research from Epic. The trend was reflected in almost every specialty included in the study.

For specialties that required follow-ups, the additional visits were likely due to patients needing additional, not duplicative, care, Epic researchers said. That’s because high follow-up rates were only present in specialties that require regular hands-on care, such as obstetrics and surgery.

The study is the latest addressing whether telehealth results in duplicative care, instead of replacing an in-person encounter. The question is being debated by lawmakers as they consider how much telehealth flexibility should be allowed once the COVID-19 public health emergency expires.

In innovation news, Fierce Healthcare discusses

ElliQ, [which is] a voice-operated care companion for the elderly, is getting an update with 2.0 hardware and software including a companion app for family members and caregivers.

The robot, called the first proactive AI care companion and a Time Best Invention of 2022, was developed to address the loneliness epidemic in older adults and has shown the ability to decrease loneliness by 80%, according to the company. * * *

Interventions like the ones ElliQ performs are shown to improve the quality of life for seniors living alone by 80% through increasing fitness and facilitating social connections, according to a recent McKinsey report.

The first ElliQ impact studies have shown that 80% of users report a reduction in loneliness, 82% experienced better mental health and 90% feel overall better since using the robot.

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, No Surprises Act, SDOH, U.S. Healthcare–December 13, 2022December 13, 2022

From Capitol Hill, Politico reports tonight

Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.

In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”

Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.

That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.

From the Omicron and siblings front, Healthcare Dive reports that

In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.

Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said.

To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.

The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.

From the CMS front —

CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.

CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”

CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”

In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.

In other HHS news —

HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.

The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.

From the drug development front —

The Wall Street Journal reports

A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.

The combination of Moderna’s personalized cancer vaccine and Merck MRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.

The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.

MedCity News reports

Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).

Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.

From the healthcare business front, Fierce Healthcare tells us

Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress.

The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *

Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said.

From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today

The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.

In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”

Monday Roundup

David Ermer–ACA, Congress, COVID-19, U.S. Healthcare–December 12, 2022December 13, 2022

From Capitol Hill, Govexec reports

Congress will vote this week on a seven-day stopgap funding bill to avoid a shutdown Friday evening and buy negotiators more time to reach a deal on full-year appropriations.

Top lawmakers voiced optimism on Monday for the first time in weeks as they inched toward an agreement on setting line-by-line funding levels across the government. The current continuing resolution is set to expire late Friday, while the new measure would push that back by one week and set the new deadline just two days before Christmas.

“Over the weekend, appropriators held positive and productive conversations, enough that both sides are moving forward in good faith to reach a deal,” Senate Majority Leader Chuck Schumer, D-N.Y., said Monday. He advised his colleagues to prepare to take “quick action” on a one-week CR “so we can give appropriators more time to finish a full funding bill before the holidays.” * * *

“We’re trading serious suggestions back and forth,” said Sen. Richard Shelby, R-Ala., who serves as ranking member on the Senate Appropriations Committee. “The main thing is, fund the government. Don’t shut it down.”

WisPolitics tells us

On Monday, U.S. Sen. Ron Johnson (R-Wis.) and U.S. Sen. Rick Scott (R-Fla.) sent a letter to Gene Dodaro, Comptroller General of the Government Accountability Office (GAO), requesting an audit of health care providers under the Federal Employees Health Benefits (FEHB) Program. Following reports on similar programs, GAO uncovered potential fraud through improper payments causing an increase in the cost of the FEHB Program.

“GAO’s previous work on similar issues in the Medicare program and the Veterans Community Care program has uncovered a number of potentially ineligible providers, flagged weaknesses in provider vetting controls, and made valuable recommendations for improving program integrity and managing the potential risk to the care of Medicare enrollees and veterans, respectively, from ineligible providers,” explained the senators.

FEHB is an employer-sponsored health benefits program with strong controls. The FEHBlog does not expect the GAO to find similar problems in FEHB.

Govexec reports that the incoming Republican Chair of the House Oversight and Reform Committee says that his Committee will return “to its primary duty to root out waste, fraud, abuse, and mismanagement in the federal government.”

From the regulatory front —

The Department of Health and Human Services issued its proposed 2024 Notice of Benefit and Payment Parameters as the Affordable Care Act (ACA) requires. Here’s the Fact Sheet.

The Internal Revenue Service finalized the rule that it first issued in December 2021 to modify Form 1095-B and 1095-C following the Tax Cuts and Jobs Act sunsetting the ACA’s individual penalty for failure to maintain essential coverage during the tax year. The final rule makes some helpful tweaks to the 2021 modifications.

Today the FEHBlog attended the first day of the American Bar Association’s Washington Health Law Summit. Of note, there was a talk about the looming end of the Covid public health emergency, which, according to Politico reporters, is likely to occur in the first half of 2023. A “soft landing” is predicted, which is the outcome the FEHBlog also expects.

Others spoke about healthcare worker burnout / the workforce problem. Two speakers noted that a noticeable increase in hospital code calls for security assistance compounds the problem. The FEHBlog had not heard of that factor.

Following up on yesterday’s healthcare business post, Healthcare Dive tells us

Amgen on Monday said it has agreed to acquire Ireland-based drugmaker Horizon Therapeutics, outlasting rival suitors Sanofi and Johnson & Johnson in takeover negotiations that were first disclosed last month.

The deal values Horizon at $27.8 billion on a fully diluted basis. In dollar terms, it’s the largest in Amgen’s four-decade history, eclipsing a 2002 acquisition of Immunex that gave the California biotechnology company rights to Enbrel, its top-selling drug and for years one of the most lucrative pharmaceutical products.

While buying Horizon is not likely to give Amgen its next Enbrel, it does hand the company a portfolio of rare and immune disease drugs that are projected to bring in sales of $3.6 billion this year.

Enbrel will lose market exclusivity at the end of this decade and Amgen, like other pharmas facing looming patent cliffs, has turned to dealmaking to hunt for new products. In August, it spent $4 billion to acquire ChemoCentryx and its inflammatory disease drug Tavneos.

Per terms of the acquisition, Amgen will pay $116.50 per Horizon share, a roughly 20% premium to their closing price Friday and 48% higher than what they were worth before Horizon disclosed it was in deal talks.

Weekend update

David Ermer–Congress, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–December 11, 2022December 12, 2022

The House of Representatives and the Senate are in session this week for Committee business and floor voting.

The Wall Street Journal adds

Congressional leaders are set to return to the Capitol on Monday under pressure to negotiate a spending bill that would fund the federal government’s operations beyond Friday.

Negotiators have days to reach a deal on a full-year spending bill or pass a short-term measure delaying the deadline to avoid a partial government shutdown. To reach a longer-term deal, they will have to break the partisan deadlock between Republicans and Democrats, who are split over $26 billion in nondefense spending in talks to craft an omnibus bill. * * *

Senate lawmakers are expected this week to pass a defense policy bill that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19.

Tomorrow is the last day of the Federal Employee Benefits Open Season. According to OPM, the official end is 11:59 pm “in the location of your electronic enrollment system”

The FEHBlog noticed on Linked In that OPM Director Kiran Ahuja spoke last week at the Milken Institute’s Future of Health Summit.

Director Ahuja spoke about eradicating stigmas surrounding mental health treatment and creating a welcoming work environment for all.

As the largest employer in the nation, the Federal government must continue to invest in policies, tools, and resources that gives every employee the high quality and accessible mental health supports they need

Hey OPM, why don’t you post the Director’s remarks on opm.gov?

From the infectious disease front, the Secretary of the Treasury has written a letter to the state governors on resources available to combat the tripledemic. The FEHBlog has read articles recommending that we must return to masking and social distancing. The FEHBlog, who is a lawyer, not a health professional, thinks that if we accept this mistaken guidance, we will be tied to masking and social distancing in the winter forever. N.B. This is not a criticism of people who choose to mask social distance. The FEHBlog’s point is that the tripledemic was unavoidable.

From the No Surprises Act (NSA) front, the FEHBlog checked out the docket sheet for the second Texas Medical Association versus the federal NSA regulators challenging the revised final rule implementing the NSA’s independent dispute resolution process without giving the revised rule a chance.

The case is at the cross-summary judgment stage. A summary judgment motion asks the Court to decide the case without a trial because the issues presented are entirely legal.

The federal government filed its motion in early November. The FEHBlog knew the AHIP and employee benefit associations subsequently had filed friends of the court/amici briefs supporting the NSA regulators. The FEHBlog was delighted to read that a group of patient/consumer organizations, including “ALS Association, CancerCare, Epilepsy Foundation, Families USA Action, Hemophilia Federation of America, Leukemia & Lymphoma Society, National Multiple Sclerosis Society, United States Public Interest Research Group, Inc., and Cancer Support Community” also filed an amicus brief supporting the NSA regulators. That is an uplifting amici lineup.

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

Amgen Inc. is in advanced talks to buy drug company Horizon Therapeutics PLC. according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.

The U.S. biotechnology company was the last of three suitors standing in an auction for Horizon, the people said, after French drugmaker Sanofi SA said Sunday it was out of the running.

A deal could be finalized by Monday assuming the talks with Amgen don’t fall apart, the people said.

Horizon develops medicines to treat rare autoimmune and severe inflammatory diseases that are currently sold mostly in the U.S. Its biggest drug, Tepezza, is used to treat thyroid eye disease, an affliction characterized by progressive inflammation and damage to tissues around the eyes.

The company is Nasdaq-listed, but based in Ireland and has operations in Dublin, Deerfield, Ill., and a new facility in Rockville, Md.

Wow-wee.

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–December 8, 2022December 8, 2022

From Capitol Hill, the Wall Street Journal reports

A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

“This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September.

The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

The Journal adds,

House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

STAT News tells us

Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

Investment News provides advice on income adjusted Medicare premium issues.

Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

In other health benefits news, Insurance News Net informs us

The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

From the Rx development and coverage front, we have three reports from STAT News —

Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”

Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”

Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

From the public health front —

The Washington Post reports

An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”

Health Payer Intelligence tells us

Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

Increased drug deaths

Increased non-medical drug use

Increased premature death

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Government Contracting, Mental health care, OPM, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–December 7, 2022December 7, 2022

From Capitol Hill, the Wall Street Journal reports

Senate Democrats celebrated their win in Georgia giving them 51 seats next year, a result that enhances their power by allowing them to more easily advance President Biden’s nominees while also providing slightly more flexibility on legislation.

Sen. Raphael Warnock’s win in a runoff election over GOP challenger Herschel Walker comes after two years in which Vice President Kamala Harris provided a tiebreaking vote in the 50-50 Senate. * * *

Since early 2021, the two parties have been operating under a power-sharing agreement with evenly divided committees, which has prevented Democrats from issuing subpoenas to witnesses without GOP support. When nominees have tied in a committee vote, Democrats have been forced to hold an extra procedural vote to finalize their nomination. The Warnock victory will give Democrats a narrow majority on each panel.

“It’ll be easier for Democrats to move forward with some of their nominees, particularly in the judiciary, and that makes it more difficult for us,” said Sen. Mitt Romney (R., Utah).

Roll Call informs us

The newly minted defense authorization bill for fiscal 2023 [NDAA], made public Tuesday night, provides a shot in the arm to the U.S. defense budget but bars the military from discharging any more troops who refuse COVID-19 vaccine shots in their arms. * * *

[This bill has been approved by a House-Senate conference committee.] The House is expected to vote on the NDAA as soon as Thursday and the Senate to soon follow suit, perhaps next week.

The bill would authorize a 4.6 percent across the board pay increase for military personnel and civilians. However, House and Senate negotiators removed a House-passed “inflation bonus” of an additional 2.4 percent for troops and Defense Department civilians making less than $45,000 a year. * * *

Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.

Govexec offers two more insights on the NDAA

Congressional negotiators on Tuesday night finally revealed a compromise version of the annual defense policy bill with the aim of passing it through both the House and Senate this week. But to some lawmakers, federal employee groups and good government experts’ chagrin, the measure did not include [Insight link] a provision aimed at blocking Republican-led efforts to strip potentially tens of thousands of federal employees of their civil service protections.

and

The authorization bill compromise text contains provisions [Insight link] that seek to increase transparency and accountability of investigations into Inspectors Generals [IG] and operations of the Council of Inspectors General on Integrity Efficiency (and its integrity committee, specifically); ensure IGs are only removed for justiciable and compelling reasons (and Congress is notified); and limit who can serve as acting IGs. There are also stipulations for notifying Congress when an agency doesn’t provide requested information or assistance to an IG and providing more training opportunities for IGs.

In an effort to address persistent watchdog job vacancies, the bill’s text states: “If the president fails to make a formal nomination for a vacant inspector general position that requires a formal nomination by the president to be filled within the period beginning on the later of the date on which the vacancy occurred or on which a nomination is rejected, withdrawn, or returned, and ending on the day that is 210 days after that date, the president shall communicate, within 30 days after the end of such period and not later than June 1 of each year thereafter, to the appropriate congressional committees.”

From the federal employee benefits front —

FedWeek gives us last minute guidance on the Federal Employee Benefits Open Season that ends next Monday December 12.

The Wall Street Journal offers ideas for use of flexible spending account dollars. The article make a point that was not on the FEHBlog’s radar screen:

This year’s December FSA spending crunch could be worse than usual. While you’re meant to empty your FSA every year, during the pandemic the government relented on this rule, allowing FSA savers to roll over what they saved in 2020 and 2021, with some accounts swelling to more than $7,000.

That special treatment is set to end in 2022, meaning if you have been accumulating money in your FSA, you may need to empty our account by Dec. 31 or you risk losing it all. “Some people might be in for a rude surprise,” says Spiegel.

Employers are permitted to give workers a little wiggle room—but not much. Some plans include a rollover provision that allows account holders to carry forward a small portion of their savings, although this amount is limited to $570 for 2022. Other plans may allow a spending grace period of up to 10 weeks.

From the infectious disease front —

The Wall Street Journal brings us up to date on Omicron treatments.

The Hill reports on the state of the flu and RSV surges. “Dr. Andrew Pekosz, a virologist and professor at Johns Hopkins Bloomberg School of Public Health, believes the U.S. is still in the “early stages” of a surge in influenza cases, he told Nexstar. * * * “With RSV we seem to be hitting a plateau,” said Pekosz. “Case numbers have not increased significantly for a couple of weeks, but they’re still at a very high level. So the burden of RSV is still great, but we may be closer to the peak there than we are with flu.”

Forbes relates, “A newly discovered immune response inside the nose could explain why respiratory illnesses like RSV, Covid, the common cold and flu thrive in winter, according to research published Tuesday in The Journal of Allergy and Clinical Immunology, a finding that challenges the conventional wisdom that infections spread because people are stuck indoors and signposts ways to develop new treatments.”

From the Rx development and coverage front

MPR informs us “The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). * * * Results showed that treatment with PH10 significantly reduced depressive symptoms as early as 1 week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared with placebo (P =.022). The intranasal spray was found to be well tolerated, with no serious adverse events reported.”

STAT News reports

Touted by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.

Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment. * *

There’s much overlap between the two conditions, said Beverly Tchang, an endocrinologist and assistant professor of clinical medicine at Weill Cornell Medicine. “Obesity can lead to diabetes, diabetes can lead to obesity,” she said. “They’re very much intertwined, and to treat one but not the other seems inequitable.” Tchang treats both types of patients and feels the drug shouldn’t be conserved for one group at the expense of the other.

From the telehealth front, mHealth Intelligence explains

FAIR Health’s Monthly Telehealth Regional tracker reported no change in telehealth usage in September compared with August and noted that COVID-19 fell in its rankings on top telehealth diagnoses lists in all regions and at the national level.

The FAIR Health Monthly Telehealth Regional tracker is a complimentary service that analyzes how telehealth activity and use change monthly by tracking various factors such as claim lines, procedure codes, and diagnostic categories. It represents the privately insured population, including Medicare Advantage but excluding Medicare Fee-for-Service and Medicaid beneficiaries.

From the public health front —

“Today, The Leapfrog Group announced the 2022 recipients of its annual Top Hospital Award and Top Ambulatory Surgery Center (ASC) Award, a national recognition widely acknowledged as one of the most competitive awards United States hospitals and ASCs can receive for patient safety and quality.”

MedPage Today informs us “Drug overdose deaths in pregnancy or the postpartum period increased sharply in the U.S. in recent years, with the rise most pronounced at the start of the COVID-19 pandemic in 2020, researchers reported. * * * Jacob S. Ballon, MD, MPH, of Stanford University in California, noted that the study authors did not provide explanations for why the overdose-related death rate rose sharper among the pregnant and postpartum group during the study period, but said it will likely be the basis for further research. “[It’s] an interesting signal,” said Ballon, who was not involved with the study. “But now what do we do with that to explain it or make some sense of it?”

Healthcare Dive tells us

Increased delays in discharging patients who require additional care after a hospital stay could slow their recovery, potentially harming health outcomes and quality of life, the American Hospital Association cautioned in a report released Tuesday.

The inability to discharge patients is putting additional strain on hospitals operating with thin workforces, and health systems are bearing the cost of care for patients who stay excess days without appropriate reimbursement, the AHA said.

The association has urged Congress to help offset the costs of care for patients’ additional days in the hospital by creating a temporary per diem Medicare payment targeted to acute, long-term care, rehabilitation and psychiatric facilities.

From the U.S. healthcare business front —

Health Payer Intelligence reports, “Health insurance prices rose faster than other medical care categories’ prices but broke from normal patterns by failing to outpace the overall price increases on all goods and services, a brief from Peterson-Kaiser Family Foundation (KFF) Health System Tracker found.”

Forbes tells us

Imagine going into your doctor’s office and facing not a staff of overworked doctors and nurses, but an inviting conversation. A talk with a healthcare professional who has plenty of time, isn’t in a hurry and is ready to listen to a recital of the different aches and pains of your life. Someone with expertise in medications dedicated to making your life easier and healthier. A professional who makes and then hands you a cup of coffee before you even start talking.

With that conversation–easy, low stress–you can begin a level of trust with your doctor’s office that you might not have had before. And the person listening may, in conjunction with the doctors and nurses, find some better paths to helping you get healthier, even if you suffer from a chronic disease.

That’s the vision that Fergus Hoban has for the American healthcare system. His company, UpStream, provides integrated services for primary care physicians, both independently and as part of networks or bigger healthcare systems. Centered around a prescribing pharmacist, a team of nurses and other professionals work with doctors to provide better care for Medicare patients while at the same time lowering costs.

Fierce Healthcare relates

LHC Group and UnitedHealth Group have extended their merger agreement as the feds take a deeper look at the deal.

The agreement was extended until March 28, 2023, and the two companies now expect the merger to close in the first quarter of 2023, according to a filing with the Securities and Exchange Commission.

That the insurance giant intended to acquire LHC, a home health provider, was announced in March, and the deal is valued at about $5.4 billion. UnitedHealth said it plans to fold LHC into its Optum subsidiary as part of its provider arm, Optum Health, which is one of the country’s largest employers of physicians.

LHC Group would add 30,000 employees who provide more than 12 million home health services annually.

Health Payer Intelligence also tells us about positive provider and payer reactions to the CMS proposed rule to promote widespread use of electronic prior authorizations. As noted here yesterday, “[t]he proposed rule would require the implementation of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interface (API) and mandates that payers have to explain the specific reason behind a prior authorization denial. Expedited prior authorizations will have to occur within 72 hours and non-urgent prior authorizations will have to be turned around in seven calendar days.”

Tuesday’s Tidbits

David Ermer–CMS, Electronic health records, FDA, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–December 6, 2022December 6, 2022

From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.

From the medical research and development front,

STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”

The National Institutes of Health announced

The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.

The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *

[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.

A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.

The Wall Street Journal reports

New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.

Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.

The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.

“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”

. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.

“Causality is a bit up in the air,” he said.

From the mental healthcare front, Fierce Healthcare tells us

While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.

The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.

In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.

At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.

The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.

However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.

There are now 305 mental health providers per 100,000, according to the report.

Health Payer Intelligence adds

Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.

Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.

From the Rx coverage front, STAT News tells us

During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.

The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.

Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.

Of course, PBM formularies are designed to correct these issues.

The Wall Street Journal adds

Emergent BioSolutions Inc., maker of Narcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.

The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market.

The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.

Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.

From the fraud, waste, and abuse front, mHealth Intelligence reports

As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.

They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.

In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.

Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.

But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.

From the plan design front, Fierce Healthcare relates

The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026.

The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.

“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement.

It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–December 5, 2022December 5, 2022

From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”

From the infectious disease front —

Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.

Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.

The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”

MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer

MedPage further reports

Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.

“Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *

This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).

The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.

It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.

Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”

For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.

2019 – 2020 Winter CDC Fluview	3/28/20
Flu Deaths	24,000
Flu Cases	39,000,000

The flu is a highly contagious, dangerous disease.

NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.

From the telehealth front, Health Leaders Media tells us

According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.

Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.

Some 36% used telehealth just once over the past year, while 53% used it between two and five times.

From the mental healthcare front, Health Payer Intelligence reports

CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.

The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.

“CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.

Kudos

From the Rx coverage front, Fierce Healthcare informs us

Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.

Specialty drugs account for just 2% of prescriptions but drive half of drug spending.

In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.

From the federal government employee benefits front, Federal News Network relates

The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.

OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.

“OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.

The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.

The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.

Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, Medicare, Mental health care, OPM, U.S. Healthcare–December 2, 2022December 2, 2022

From the Omicron and siblings front, the Centers for Disease Control’s weekly interpretative summary of its Covid statistics explains

Cases

As of November 30, 2022, the current 7-day average of weekly new cases (43,300) decreased 1.2% compared with the previous 7-day average (43,837). A total of 98,777,220 COVID-19 cases have been reported in the United States as of December 30, 2022.

Variant Proportions

CDC Nowcast projections* for the week ending December 3, 2022, estimate the proportion of lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6,and XBB. XBB is a recombinant of two BA.2 sublineages.

New Hospital Admissions

The current 7-day daily average for November 23–29, 2022, was 4,201. This is a 17.6% increase from the prior 7-day average (3,572) from November 16–22, 2022.

Vaccinations

As of November 30, 2022, 655.3 million vaccine doses have been administered in the United States. Overall, about 267.3 million people, or 80.5% of the total U.S. population, have received at least one dose of vaccine. About 228.4 million people, or 68.8% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 114.8 million people have received a booster dose,* and more than 39.7 million people have received an updated (bivalent) booster dose. But 48.3% of the total booster-eligible population has not yet received a booster dose. Learn more about who is eligible.

Deaths

The current 7-day average of new deaths (254) decreased 32.4% compared with the previous 7-day average (376). As of November 30, 2022, a total of 1,077,303 Covid-19 deaths have been reported in the United States

The CDC also released an encouraging report about Paxlovid’s efficacy.

Summary

What is already known about this topic?

Nirmatrelvir-ritonavir (Paxlovid) is an outpatient antiviral medication recommended for adults with mild-to-moderate COVID-19 who have elevated risk of severe illness.

What is added by this report?

Among U.S. adults diagnosed with COVID-19, including those with previous infection or vaccination, persons who were prescribed Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid.

What are the implications for public health practice?

Paxlovid should be offered to eligible adults irrespective of vaccination status, especially in groups with the highest risk for severe COVID-19 outcomes, such as older adults and those with multiple underlying health conditions.

Also from the public health front, the CDC’s Fluview tells us

Seasonal influenza activity is high and continues to increase across the country.

Of influenza A viruses detected and subtyped this season, 79% have been influenza A(H3N2) and 21% have been influenza A(H1N1).

Two influenza-associated pediatric deaths were reported this week, for a total of 14 pediatric flu deaths reported so far this season.

CDC estimates that, so far this season, there have been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu.

The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 47 during every previous season since 2010-2011.

The number of flu hospital admissions reported in the HHS Protect system during week 47 almost doubled compared with week 46.

The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

All viruses collected and evaluated this season have been susceptible to influenza antivirals.

An annual flu vaccine is the best way to protect against flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.

CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.

There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

The Wall Street Journal offers a helpful overview of the tripledemic situation.

From the Alzheimer’s Disease front —

STAT News reports

Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success.

This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-long cycle of disappointment.

A packed audience repeatedly burst into applause during Eisai’s lecanemab presentation on Tuesday — with onlookers clapping even when they learned that the results had been concurrently published in the New England Journal of Medicine. Supplemental figures don’t usually don’t draw cheers, but the warm reception underscored how overjoyed researchers were to have any kind of success against Alzheimer’s, even a modest one. * * *

Several researchers compared this moment in Alzheimer’s research to the early days of cancer therapy or HIV treatment — the first drugs aren’t smash hits, but they’re something for scientists and doctors to build on and learn from.

“It’s not like you’ve won the war with lecanemab,” said Eric Siemers, chief medical officer of Acumen Pharma. “We’ve got a lot of work to do. But this is an inflection point. There’s no question about it.”

In that regard, BioPharma Dive points out lessons learned from testing a Roche drug similar to lecanermab.

After one year of treatment, [the Roche drug] gantenerumab reduced amyloid burden in patients only half as well as the trials’ designers had expected based on previous research, said researcher Randall Bateman, a neurology professor at Washington University in St. Louis who helped lead the studies.

Moreover, around half as many gantenerumab patients as predicted tested negative for amyloid over the course of the trial. Almost none tested negative after one year of treatment, and only around a quarter did after more than two years, researchers revealed.

Data for lecanemab and donanemab presented at CTAD, meanwhile, showed stronger amyloid clearance, helping boost confidence in those drugs.

Bateman also pointed to a post-study analysis researchers conducted of Roche’s trials that hinted at better outcomes for trial participants who had higher reductions in amyloid, although this finding wasn’t statistically conclusive.

Taken together with data from other trials, gantenerumab’s results should help researchers as they try to optimize available therapies and develop new ones, Bateman said.

“I see this as one of the missing essential pieces of the puzzle of figuring out how to optimally treat along this pathway for amyloid removal,” he said.

Meanwhile, the New York Times tells us about “A Promising Trial Targets a Genetic Risk for Alzheimer’s
Preliminary results offer hope that gene therapy can protect people with a version of the brain disease driven by a particular gene variant.”

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

Advocate Aurora Health and Atrium Health announced Friday the two providers have closed their merger deal, becoming the nation’s fifth-largest nonprofit health system by revenue.

The new system, Advocate Health, will generate revenue of more than $27 billion and operate 67 hospitals and more than 1,000 sites of care in six states. The system expects to treat nearly 6 million patients each year. * * *

The two systems do not have any geographic overlap, an aspect that has tripped up prior hospital mergers.

Instead, economists told Healthcare Dive, the FTC is likely to examine insurer overlap in the case of Advocate Health. The combined entity operates in Illinois, Wisconsin, Georgia, North Carolina, South Carolina and Alabama.

From the federal employment front —

Govexec informs us

The Biden administration will allow agencies to hire employees in certain positions on a temporary basis for up to 10 years, more than doubling the current cap limiting the assignments for those workers.

The Office of Personnel Management issued the rule on Thursday, finalizing a proposal first put forward by the Trump administration. The rule will enable federal agencies to appoint employees in STEM jobs for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects. Previous regulations required agencies to get special permission from OPM to keep any term employee on staff for longer than four years.

Viet Tran, an OPM spokesman, said the rule showed the administration’s “commitment to STEM hiring.” He added it would allow for more federal, rather than outsourced, hiring.

“With this final rule, agencies have more flexibility and support (and less administrative burden) to hire employees—rather than contractors—for non-permanent STEM positions that agencies expect from the outset to last longer than 4 years but not more than 10 years,” Tran said. “This is another tool to help agencies better compete for talent.”

As the FEHBlog has explained, federal employees can expect a 4.6% pay raise for 2023 with 4.1% of the increase being distributed across the GS schedule and the remaining 0.5% allocated to locality pay. As it turns out, the Society for Human Resource Management tells us

Employers in the U.S. plan to boost salaries an average of 4.6 percent in 2023, up from 4.2 percent this year, according to a new study.

Employers say inflationary pressures and the ongoing challenges of finding and keeping workers are the main reasons for the higher projected increases. Indeed, 3 in 4 of the 1,550 U.S. employers in the latest Salary Budget Planning Report by consultancy WTW say they continue to experience problems attracting and retaining workers. The survey was conducted from Oct. 3 to Nov. 4, 2022.

From the plan design front, a recent Kaiser Family Foundation report explains the growing use of all sizes of employers to provide retiree health benefits through Medicare Advantage plans.

This analysis uses data from the 2022 KFF Employer Health Benefits Survey to examine the extent to which large private and non-federal public employers that offer retiree health benefits are turning to Medicare Advantage and why they are making this shift. However, the Survey does not include information about union-administered benefits. For additional information about methods, see Survey Design and Methods.

Based on the Survey, we find:

Half (50%) of large employers offering retiree health benefits to Medicare-age retirees offer coverage to at least some retirees through a contract with a Medicare Advantage plan, nearly double the share in 2017 (26%).

About 44% of large employers that offer Medicare Advantage coverage to their retirees do not give retirees a choice in coverage options.

Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most commonly cited reason they elected this option was the lower cost.

FEHB plans also are implementing integrated Medicare Advantage plans as a cost-saving measure.

From the HHS front, “Today, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra marked the one-year anniversary of HHS’s Overdose Prevention Strategy (Strategy) by announcing the progress the nation has made since the release of the Strategy, showing expanded treatment capacity, lives saved from an overdose, and commitment to long term recovery supports.” Kudos. Here is the fact sheet.

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