About Covid-19
HHS withdraws Trump administration policy that limited FDA review of certain Covid-19 tests: “The Biden administration is withdrawing a policy established under the Trump administration that limited the US Food and Drug Administration's review process of certain lab tests, including some Covid-19 tests. The US Department of Health and Human Services announced the withdrawal on Monday.
Last year, the Trump administration determined that the FDA would no longer require premarket review of laboratory-developed tests, known as LDTs. Prior to that determination, laboratories were required to submit applications to develop and use their own Covid-19 tests. But the move to limit that process meant that makers of Covid-19 tests developed by certain labs -- such as Quest Diagnostics, LabCorp or those at academic medical centers -- could distribute their tests without the need to first submit documentation for review by the FDA before they were marketed.”
Biden administration to announce purchase of 10 million courses of Pfizer anti-covid pill: “The Biden administration is expected to announce this week that it is purchasing 10 million courses of treatment Pfizer’s covid pill, a multibillion-dollar investment in a medication that officials hope will help change the trajectory of the pandemic by staving off many hospitalizations and deaths, according to two people with knowledge of the transaction.
U.S. officials see this antiviral pill, and another by Merck and Ridgeback Biotherapeutics, as potential game-changers to help restore a broader sense of normalcy and are eager to add them to a small arsenal of treatments for Americans who contract the coronavirus.”
In a related story: Pfizer seeks emergency authorization for its coronavirus-fighting pill regimen: Pfizer’s submission came shortly after the company announced that the clinical trial testing the drug regimen had been halted early due to overwhelming evidence that it worked. When Paxlovid was given to people at high risk of severe illness within three days of symptom onset, it reduced the rate of death and hospitalization by 89 percent compared with people given a placebo.”
12 more states challenge healthcare worker vaccination mandate: “A coalition of 12 states sued the federal government Nov. 15 to block a CMS mandate requiring COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs.
The 12 states, led by Montana, are arguing that the mandate is at odds with the Social Security Act's focus on providing access to patient care, according to the lawsuit. They also argue that implementing the mandate exceeds the statutory authority of CMS and that the mandate violates multiple federal laws, the spending clause, the anti-commandeering doctrine, and the 10th Amendment to the U.S. Constitution…”
Disparities in COVID-19 Outcomes by Race, Ethnicity, and Socioeconomic Status: A Systematic-Review and Meta-analysis: “In this systematic review and meta-analysis of 4.3 million patients from 68 studies, African American, Hispanic, and Asian American individuals had a higher risk of COVID-19 positivity and ICU admission but lower mortality rates than White individuals. Socioeconomic disparity and clinical care quality were associated with COVID-19 mortality and incidence in racial and ethnic minority groups.”
About health insurance
Automatic MIPS Participation Exemption for Individual Eligible Clinicians: “CMS is exempting all individual eligible clinicians from Merit-Based Incentive Payment System (MIPS) participation in the 2021 performance year (PY). The eligible clinicians will receive an automatic neutral payment adjustment for the 2023 MIPS payment year, the agency recently announced via email.
The email sent to the CMS Quality Payment Program listserv said CMS is applying the automatic extreme and uncontrollable circumstances (EUC) policy because of the ongoing COVID-19 pandemic. CMS also applied the EUC policy last year to individually eligible clinicians participating in MIPS during PY 2020. The clinicians will also receive a neutral payment adjustment in the 2022 MIPS payment year.”
Amazon Care has a new customer: Hilton : “Hilton's U.S. employees who are enrolled in a corporate health plan will have access to Amazon Care in 2022, an Amazon…
Hilton employees will have free access to text chats with Amazon Care, while video or home visits with providers will carry a small fee…”
Payers earn Dow Jones sustainability recognition: “In 2021, five payers — Cigna, CVS Health, Anthem, Humana and UnitedHealth Group — made the international yearbook for their sustainability efforts. Cigna earned a top Global Gold Class honor while CVS Health earned both Global Silver Class and Global Industry Movers honors.”
Biden-Harris Administration Announces Medicare Fee-For-Service Estimated Improper Payments Decline by Over $20 Billion Since 2014 “Improper payments are payments that do not meet CMS program requirements. Improper payments can be overpayments or underpayments, or payments where insufficient information was provided to determine whether a payment is proper or not. Most improper payments involve situations where a state or provider missed an administrative step. While fraud and abuse may lead to improper payments, it is important to note that the vast majority of improper payments do not constitute fraud, and improper payment estimates are not fraud rate estimates.”
However, the improper payment rate is still about 7% or about $25B per year!
About hospitals and health systems
Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities (Revised): From CMS:“Hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services.
All co-located hospitals must demonstrate independent compliance with the hospital CoPs. This guidance clarifies how hospitals may organize shared spaces, services, personnel, and emergency services to meet regulatory requirements. When hospitals choose to co-locate, they should consider the risk to compliance through any shared space or shared service arrangements.”
Viewing 312 systems ranked by Cost Efficiency: From the Lown Insitute. See this site for a ranked list and search engine.
About healthcare IT
8 reasons patients are resistant to telehealth: “During August and September, GoodRx surveyed 1,042 patients about their telehealth experiences. Among the patients who had never used telehealth, here are…
[the top 3] reasons they cited:
1. No health issues that have required a telehealth visit: 62 percent
2. Preference for face-to-face visits: 36 percent
3. Lack of familiarity with telehealth: 25 percent”
The effectiveness of digital interventions for increasing physical activity in individuals of low socioeconomic status: a systematic review and meta-analysis: “Digital interventions targeting PA [physical activity] do not show equivalent efficacy for people of low and high SES. For people of low SES, there is no evidence that digital PA interventions are effective, irrespective of the behaviour change techniques used. In contrast, the same interventions in high SES participants do indicate effectiveness. To reduce inequalities and improve effectiveness, future development of digital interventions aimed at improving PA must make more effort to meet the needs of low SES people within the target population.”
About healthcare professionals
Surgicalists: Why Aren’t They In Your Hospital? Yet another way to fragment care or more akin to other full-time, hospital-based physicians (like pathology, radiology and anesthesiology)?
”Surgicalists are providers who are dedicated to a single hospital. They do not float between facilities like locum tenens. They serve on committees, engage with the community at large, and work side-by-side with hospital employees as a true team. Surgicalists are assigned regular shifts and are paid on a per diem basis as independent contractors.”
About the public’s health
The 'threat multiplier' healthcare leaders can't afford to ignore: “Research suggests the United States is the highest contributor to the global healthcare climate footprint. The healthcare industry accounts for 8.5 percent of all greenhouse gas emissions in the U.S.. Worldwide, the healthcare industry is responsible for 4.4 percent of net emissions, which is the equivalent of 514 coal-fired power plants, according to a 2019 report from Arup and Health Care Without Harm…
The medical supply chain accounts for 71 percent of healthcare's carbon footprint. Excess waste is created from plastic gloves, surgical supplies, medicine containers and gowns, among other materials. If the American healthcare sector were its own country, it would be the 13th largest source of greenhouse gas emissions in the world…”
Health at a Glance 2021: The OECD just published its updated health statistics. It is the single best source for this international data.
Multivitamins, but Not Cocoa, Tied to Slowed Brain Aging: “Taking a daily multivitamin for 3 years is associated with a 60% slowing of cognitive aging, with the effects especially pronounced in patients with cardiovascular (CVD) disease, new research suggests.
In addition to testing the effect of a daily multivitamin on cognition the COSMOS-Mind study also examined the effect of cocoa flavanols, but showed no beneficial effect.”
About healthcare devices
TecTraum’s pro2cool Concussion Treatment Designated a Breakthrough Device: “The noninvasive hypothermic therapy device is designed to reduce the severity of concussion symptoms and allow patients to recover more quickly.
The device provides localized cooling for the head and neck to lower blood temperature before it enters the brain. Research has shown that cooling the brain within days of a concussion significantly improves clinical outcomes, the company said.”
About pharma
AbbVie's 'unsupported' price hikes on Humira drove $1.4B in extra U.S. drug spending, ICER says: Over the years, the Institute for Clinical and Economic Review (ICER) has emerged as a champion in the fight against high U.S. drug costs. In its third report on unsupported price increases (UPI), the Institute is taking aim at seven meds that it argues have gone up in price without justification from new data.
Among the group, AbbVie's prolific rheumatoid arthritis med Humira drove the largest increase in U.S. drug spending, according to a report released Tuesday. Novartis' Promacta and Biogen's Tysabri clinched the no. 2 and no. 3 spots, respectively. Elsewhere, drugs from Bausch Health, Supernus Pharmaceuticals and Horizon Pharmaceuticals made the list. In addition, another AbbVie med ranked near the bottom of the list.