Target to $26 from $20
Friday, March 4, 2022
Healthcare job gains in February far exceed recent months
- The healthcare sector added 64,000 jobs in February with gains in home health services (+20,000), physician offices (+15,000) and offices of other healthcare practitioners (+12,000), according to data out Friday from the Bureau of Labor Statistics that showed strong overall recovery for U.S. jobs.
- February's gains are higher than recent months for healthcare jobs — in January the sector gained about 17,000 jobs and in December employment in the industry remained largely unchanged.
- Healthcare employment is down about 2% from levels in February 2020.
Many of those jobs have since recovered, but recovery across the sector has been uneven.
While jobs in ambulatory care services have seen mostly consistent gains throughout the pandemic, jobs in nursing homes have fallen nearly every month.
Job gains for hospitals have fluctuated throughout the pandemic amid various coronavirus waves and staffing shortages.
In February, hospitals added 2,800 jobs, according to BLS.
Hospitals most recently have grappled with some of their most acute staffing shortages since the pandemic began as frontline workers deal with stress and burnout spurring many to consider leaving their roles.
A recent survey from USA Today and Ipsos Research of 1,170 healthcare workers found more than half reported feeling burned out, and nearly a quarter are considering quitting their jobs in the near future.
In a recent Congressional hearing, witnesses pointed to the difficult working conditions. Margaret Flinter, senior vice president and clinical director at Community Health Center, said some jobs have become untenable because they've "been understaffed for a long time, under-resourced and people are just frustrated."
Staffing shortages have been acute, also, during the omicron wave as more people called out sick with COVID-19. That's led to huge demand for traveling nurses, who can now garner much higher salaries than other nurses, as well as perks like sign-on bonuses.
Recently, hospital lobbies and members of Congress have pressed for investigations into the staffing firms that supply traveling nurses, with the American Hospital Association alleging exploitation of the ongoing staffing shortages. The staffing firms have defended their practices.
AHA has also called on Congress to alleviate the problem through policies like boosting support for nursing schools and lifting the cap on Medicare-funded physician residencies.
https://www.healthcaredive.com/news/healthcare-adds-64K-jobs-february-BLS/619846/
Senate narrowly votes to get rid of COVID-19 national emergency
The Senate narrowly passed a resolution to get rid of the COVID-19 national emergency that has given providers increased flexibility on telehealth.
The resolution that passed 48-47 Thursday garnered a veto threat from the White House and may not pass the House. However, the narrow vote underscores political pressure the Biden administration could face to unwind pandemic-related emergencies, including the public health emergency (PHE) that expires next month and is not affected by the resolution.
Sen. Roger Marshall, R-Kansas, sponsored the resolution and said on the Senate floor that the “robust powers this emergency declaration provides the federal government are no longer necessary and Congress must debate and ultimately repeal them to unwind the powers the government took hold of at the peak of the crisis.”
Last month, Biden extended the national emergency indefinitely before its March 1 expiration date. The emergency has enabled waivers to providers to expand the use of telehealth and other flexibilities for hospitals and providers.
The White House said in a statement Thursday that cutting off the national emergency abruptly would “unnecessarily and abruptly curtail the ability of the administration to respond to the COVID-19 pandemic.”
It added that the authorities are critical to continue responding to the omicron variant and “respond to potential future variants.”
Despite the White House veto threat, the resolution’s passage underscores political pressure the administration is facing to unwind pandemic emergencies.
Republicans on the House Energy and Commerce Committee wrote to the Department of Health and Human Services (HHS) calling for it to start a glidepath to unwind the PHE that gave providers more flexibility to get Medicare reimbursement for telehealth. The PHE was extended by HHS Secretary Xavier Becerra until April, but the department said it would give stakeholders a 60-day heads-up before it expires.
https://www.fiercehealthcare.com/providers/senate-narrow-votes-get-rid-covid-19-national-emergency
Medicare’s new devices
Last week Pear Therapeutics trumpeted the creation of new reimbursement codes by the Centers for Medicare and Medicaid for its three approved digital therapies, saying this was a step towards more widespread coverage of this category of medical device.
But Pear was not the only company to have its innovative devices recognised by the CMS as worthy of simplified reimbursement. Outset Medical, maker of a portable dialysis system, and the sleep apnoea specialist Signifier Medical Technologies are also beneficiaries, and could see their sales rise as a result.
CMS uses reimbursement codes to facilitate the processing of health insurance claims by Medicare and other insurers. When new devices reach the market, sometimes they are so unlike anything already available that new codes must be created. Similar devices that gain approval subsequently can then use these new codes.
In the latest list of decisions from the CMS, Signifier was awarded two new codes to describe eXciteOSA, which gained de novo FDA clearance in early 2021 for daytime treatment of mild obstructive sleep apnoea and primary snoring.
eXciteOSA is a handheld device that applies electrical stimulation to the tongue. This strengthens the upper airway muscles, Signifier says, improving endurance and preventing airway collapse during sleep. Unlike other sleep apnoea devices such as CPAP machines, which are used while patients sleep, eXciteOSA is the first commercial-stage device that is used when the patient is awake.
According to Dr Marc Benton, a pulmonologist and sleep medicine specialist, once reimbursement is established a broader population of sleep apnoea patients will be able to get hold of eXciteOSA. Like all the new codes, those covering Signifier’s device will become effective on April 1.
Rejected
Another device that works by stimulating the tongue was denied reimbursement. Helius Medical’s Pons device sends impulses to the tongue to stimulate cranial nerves and then the brain stem, to improve the gait of patients with balance disorders caused by traumatic brain injury. It gained de novo clearance last March at the second time of asking, but the CMS opted not to award it the two new codes Helius requested, saying it needed more information.
Pons is not the only device for which the CMS has declined to create a new code. For example, Smith & Nephew’s Oxinium, an alloy used in many of the company’s knee and hip implants, will not receive a new code after the CMS pointed out that the purpose of these codes was to provide a way of conveying information required for accurate payment of claims – “not necessarily to differentiate among similar devices”.
But Pear Therapeutics arguably wins the prize for the most important achievement in gaining new codes. The means of reimbursing digital therapeutics has, until now, not been well defined, and the question has dogged not just Pear but companies like Akili, Orexo, Onduo and Mahana Therapeutics.
That said, the revelation of easier reimbursement for Pear’s apps has left investors cold. The company’s stock has not risen above $5 since mid-January, meaning it has lost more than half of its value since Pear listed on Nasdaq via the Spac Thimble Point Acquisition Corp last December.
| Recipients of new reimbursement codes | ||||
| Company | Device | Description | Pathway | US approval date |
| Coopervision | MiSight 1 day | Contact lens for myopic ametropia | PMA | Nov 2019 |
| Impulse Dynamics | Optimizer patient charger | Implanted muscle stimulator for heart failure | PMA | Mar 2019 |
| Signifier Medical Technologies | eXciteOSA control unit | Tongue stimulator for sleep apnoea | De novo | Feb 2021 |
| Signifier Medical Technologies | eXciteOSA mouthpiece | Tongue stimulator for sleep apnoea | De novo | Feb 2021 |
| Pear Therapeutics | reSET | Digital therapeutic for substance use disorder | De novo | Sep 2017 |
| Koya Medical | Dayspring Lite | Compression garment for lymphoedema and venous disease | 510(k) | Sep 2021 |
| Koya Medical | Dayspring* | Compression garment for lymphoedema and venous disease | 510(k) | Apr 2021 |
| Triad Life Sciences (Convatec) | InnovaMatrix FS | Bioactive scaffold for wounds and burns | 510(k) | Apr 2021 |
| Outset Medical | Tablo | Haemodialysis system for renal disease | 510(k) | Mar 2020 |
| Pear Therapeutics | Somryst | Digital therapeutic for insomnia | 510(k) | Mar 2020 |
| Pear Therapeutics | reSET-O | Digital therapeutic for substance use disorder | 510(k) | Dec 2018 |
| Polymedics | Supra SDRM | Synthetic matrix for difficult to heal wounds | 510(k) | Jun 2017 |
| Polymedics | Suprathel | Synthetic dressing for wounds and burns | 510(k) | May 2009 |
| *Received two new reimbursement codes. Source: Evaluate Medtech, CMS & FDA. https://www.evaluate.com/vantage/articles/news/policy-and-regulation/medicares-new-devices | ||||
UK Recovery trial confirms Covid benefit for Olumiant
Huge state-funded clinical trials have been instrumental in uncovering the benefits, or otherwise, of potential Covid treatments, and results are still rolling in. This week the UK’s Recovery trial concluded that Lilly’s Olumiant did indeed reduce the risk of death in very sick patients, albeit with a smaller benefit than some previous studies had found.
And, over in the US, the NIH scrapped an arm of the Activ-2 trial that was studying SAB Biotherapeutics’ antibody, SAB-185, because too few people were getting sick enough. The agency also told the UK’s Synairgen that its agent would not progress further in the study any time soon, presumably for the same reason.
Behind these moves lie Omicron and climbing background vaccination rates, which are leading to less severe symptoms and sending fewer people to hospital. As such, it is becoming increasingly hard to tease out an agent’s potential benefits, at least without running huge clinical studies.
Activ-2, a basket study that has put seven agents through their paces, is being carried out in patients with mild-to-moderate disease at high risk of ending up in hospital. Symptom duration and rate of hospitalisations are important endpoints.
The phase 3 arm studying SAB-185 had already been upsized. But this week the National Institute of Allergy and Infectious Diseases, the NIH division running the programme, accepted that the trial would still not be large enough to generate statistically rigorous findings.
Activ-2 is still ongoing, the NIAID confirmed to Evaluate Vantage, pointing out that the SAB-185 arm was the only one recruiting during the Omicron surge.
The agency this week told Synairgen to pause preparing clinical supplies for the start of the phase 3 portion of Activ-2 that will test SNG001. The inhaled beta interferon has already completed the phase 2 stage of its cohort, results from which are still awaited.
SNG001 recently failed to show a benefit in hospitalised patients in a large company-run trial. Should the NIAID road continue to close down, the tiny biotech, which is now worth only £50m ($66m), could struggle to justify further pandemic-focused investment.
| The Activ-2 arms: NIH-funded phase 2/3 outpatient trial | |||
|---|---|---|---|
| Project | Description | Company | Outcome |
| BMS-986414 and BMS-986413 | Subcutaneous MAb combination | Bristol Myers Squibb | Ph2 data awaited |
| SNG001 | Inhaled beta interferon | Synairgen | Ph2 data awaited; plans to start Ph3 on hold |
| SAB-185 | Intravenous polyclonal antibody | SAB Biotherapeutics | Arm closed in Mar 2022 after DSMB concludes trial likely to fail owing to lack of severe disease |
| Amubarvimab and romlusevimab | Infused MAb combination | Brii Biosciences | Positive results announced Aug 2021; no news since EUA submitted Oct 2021 |
| Evushield | Intramuscular MAb combination | Astrazeneca | Arm closed, Ph2 data expected in 1H 2022. Not approved in Activ-2 setting (EUA granted for pre-exposure prophylaxis in Dec 2021) |
| Bamlanivimab | Infused MAb | Lilly/Abcellera | EUA granted in combination with etesevimab in Sep 2021, but withdrawn Jan 2022 (no activity against Omicron) |
| Regen-Cov/ | Infused MAb | Regeneron | EUA granted Nov 2020, but withdrawn Jan 2022 (no activity against Omicron) |
| Ronapreve | |||
| Camostat mesilate | Oral protease inhibitor | Sagent Pharmaceuticals | Arm closed in Jun 2021 for futility |
| Source: NIH & company statements. | |||
Omicron might be damping demand for interventions at the milder end of Covid, but for the small number of people who end up very sick in hospital there remains a need for effective options. This is where the Recovery data on Olumiant come in, showing its mortality benefit, a finding made more impressive by the fact that patients were already on other drugs known to prevent death.
The study recruited over 8,000 patients, with 95% receiving steroids and 23% Actemra – agents that have become standard thanks to previous Recovery sub-studies. The primary finding was a statistically significant (p=0.026) 13% reduction in mortality for patients given Olumiant on top of standard of care, versus those on standard of care alone.
Researchers noted that this was smaller than the 43% reduction found by a meta-analysis of eight previous studies of a Jak inhibitor; when the Recovery result was incorporated the benefit came out at 20%.
Recovery was more than three times the size, in terms of statistical information, of the eight previous trials put together, the UK researchers noted in a preprint of the data.
Olumiant is already being widely used to treat Covid in hospitals throughout the world, of course; the drug has emergency use authorisation in the US, and was recently endorsed by the World Health Organization. Lilly reported that its sales almost doubled last year, with the rise driven by use in this setting.
The Recovery result confirms Olumiant as a valuable option, despite pointing to a benefit around half as great as previously thought. This in itself underlines the importance of running sufficiently powered studies to tease out the real benefit that various therapies might play.
Newsom unveils plan for California mental health courts to help homeless
California Gov. Gavin Newsom (D) announced a new plan Thursday to help homeless people with mental health and substance abuse disorders.
The Community Assistance, Recovery and Empowerment (CARE) Court would require all California counties to provide free comprehensive treatment to homeless citizens suffering from a list of ailments.
“CARE Court is about meeting people where they are and acting with compassion to support the thousands of Californians living on our streets with severe mental health and substance use disorders,” Newsom said at a mental health treatment center in San Jose. “We are taking action to break the pattern that leaves people without hope and cycling repeatedly through homelessness and incarceration.”
The will allow community members including family members, first responders and mental health service providers to refer homeless people struggling with disorders to community-based services in an effort to treat people before they are “hospitalized or arrested.”
The plan includes local court-ordered individualized interventions and services, stabilization medication, advanced mental health directives and housing assistance, with service plans that last up to one or two years.
People referred to CARE Court will also be given a public defender and a supporter “to help individuals make self-directed care decisions.”
“It’s time we face the painful, but obvious truth: our behavioral health system in California is broken. All of us see it every day on our streets — and it’s long past time we fix it,” said San Diego Mayor Todd Gloria in response to Newsom’s plan. “Governor Newsom’s CARE Court…will provide individuals who are struggling with behavioral health issues a pathway to the housing and health services they need and give those who encounter these individuals a real way to get them the help they need.”
Newsom’s proposal is awaiting approval by the California Legislature.
Roberts's roadmap to reversing Roe v. Wade
During oral argument in Dobbs v. Jackson Women's Health Organization – about Mississippi’s 15-week abortion ban – Supreme Court Chief Justice John G. Roberts’s questions indicated that he was searching for a way to uphold Mississippi’s law while leaving Roe v. Wade intact. But Roberts has already penned the most convincing argument for overturning Roe, in his dissenting opinion in the Court’s same-sex marriage case.
In Obergefell v. Hodges, the Court held that the due process clause of the Constitution’s 14th Amendment – the same clause on which Roe relied – contains a right of same-sex marriage. Justice Roberts wrote a blistering dissent, ending with the memorable lines: “If you are among the many Americans . . . who favor expanding same-sex marriage, by all means celebrate today’s decision. . . . But do not celebrate the Constitution. It had nothing to do with it.”
The bulk of Roberts’s dissent was a primer for the Court about how its precedents structure a due process inquiry: The clause forbids deprivations of “liberty” without due process, but leaves it to the Court to name the particular liberties protected. Quoting an earlier case, Roberts cautioned his colleagues that “substantive due process” analysis is the “most sensitive category of constitutional adjudication” rendering the Court “most vulnerable and . . . nearest to illegitimacy when it deals with judge-made constitutional law having little or no cognizable roots in the language or even the design of the Constitution.” He underscored just how wrong the Court’s “own conception of liberty” had proved in the past, citing the Dred Scott decision upholding the rights of slaveholders.
Most importantly, Roberts reminded the Court that its leading substantive due process precedents require any claimed right to be “objectively, deeply rooted in this Nation’s history and tradition,” and “implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if they were sacrificed.” In short, legal history matters enormously. There can be no “right” that blatantly contradicts the laws widely embraced by states at the time the Constitution or the 14th Amendment was ratified.
But pre-Roe abortion law was a sea of state prohibitions. From the founding of the United States to 1973, when Roe was decided, state laws protected unborn human lives from the point that science could determine with certainty that they were alive. Thus, before the early 19th century, common law protected life from “quickening,” when the mother could feel movement.
After scientists discovered the ova and fertilization, abortion laws changed to meet the new scientific standard. Thus, by1868, when the 14th Amendment was ratified, 30 of 37 states had legislative protections for unborn life, with all but three protecting life from conception. Over the next 28 years, the remaining seven states also adopted laws protecting unborn life. Even when antibiotics rendered abortion much safer from about the1940s forward, state laws continued to protect unborn life in the vast majority of circumstances. Immediately before Roe, more than 150 bills attempting to allow more abortion failed. And each year since Roe, hundreds of pro-life bills have been introduced; at least 1,327 have become law.
Roberts exhorts his colleagues to resist the siren song of “delivering social change,” and to “exercise humility and restraint in deciding cases according to the Constitution and law,” no matter how long the public has debated the issue. “In our democracy” he writes, “debate about the content of the law is not an exhaustion requirement to be checked off before courts can impose their will.” In fact, he concludes, the public will grant the Court “legitimacy” only if they perceive that it has “decided cases according to the Constitution and law.”
Same-sex marriage is not an issue in Dobbs, but Roberts’s roadmap from Obergefell is a sure guide for a majority of the Court to reverse Roe on the foundations of respect for its own precedent and separation of powers. Since the foundation of our country, up to the moment the case was handed down, states protected unborn life from abortion in the vast majority of cases, and continued to try even when the Court had almost completely tied their hands. Roberts’s Obergefell dissent is right: If history is ignored, “No matter the Court’s profession of its own discipline in identifying fundamental rights, what a judge is too often ‘discovering,’ whether or not he is fully aware of it, are his own values.”
Helen Alvaré is the Robert A Levy Chair and professor of law at the Antonin Scalia Law School at George Mason University.
https://thehill.com/opinion/judiciary/596877-robertss-roadmap-to-reversing-roe-v-wade
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