About Covid-19
CDC no longer recommends universal masking in health facilities “The Centers for Disease Control and Prevention no longer recommends universal masking in health care settings, unless the facilities are in areas of high COVID-19 transmission.
The agency quietly issued the updates as part of an overhaul to its infection control guidance for health workers published late Friday afternoon. It marks a major departure from the agency’s previous recommendation for universal masking.”
We wear 'black robes, not white coats': Court overturns ruling compelling UPMC to give ivermectin “A Pennsylvania appeals court on Sept. 22 overturned an injunction that required a Pittsburgh-based UPMC hospital to administer ivermectin to a COVID-19 patient, court documents show.
In January, a county court issued a preliminary injunction, directing UPMC Harrisburg (Pa.) to allow two physicians — who were not credentialed at the hospital — to give a critically ill COVID-19 patient ivermectin at the request of his power of attorney. UPMC appealed the ruling, and the patient, who was in intensive care, died in February before the issue was resolved.
In its ruling, the appeals court rebuked the lower court for the injunction, saying courts do not have the legal authority to compel a healthcare organization to administer a treatment contrary to physicians' professional judgment and outside the standard of care.”
HHS to pay for 60K doses of Eli Lilly's COVID-19 drug following its commercialization “The federal government said Sept. 23 that it will cover the cost for 60,000 doses of bebtelovimab, Eli Lilly's COVID-19 antibody drug. The news comes about a month after the drugmaker started selling the treatment commercially for $2,000 per dose.
The initiative is intended to help uninsured and underinsured patients, as health systems and hospitals that bought bebtelovimab can now have HHS replace the dose for free for eligible patients, according to the department.”
Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types “The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.”
About health insurance/insurers
Strengthen States’ Oversight of Medicaid Managed Care Plans’ Reporting of Medical Loss Ratios From the HHS OIG: “States reported that most Medicaid managed care plans submitted MLR reports as required. However, we found that 49 percent of the 495 MLR reports reviewed were incomplete. These incomplete MLR reports were missing at least one of seven numeric data elements that are essential to the MLR calculation. This missing data occurred across four of the seven MLR report data elements—non-claims costs; taxes and fees; member months; and quality-improvement activity expenses. Two-thirds of the incomplete MLR reports did not contain fields for plans to even enter amounts for at least one of these data elements.
The data element for non-claims costs, generally defined as plans’ expenses for administrative services, accounted for the majority of incomplete MLR reports.”
Read the report for proposed solutions.
Medicare Part B premiums to decrease for the first time in over a decade “The Centers for Medicare & Medicaid Services (CMS) announced that Medicare Part B premiums would be lowered by three percent, or $5.20, going from $170.10 a month to $164.90. The program’s annual deductible will also fall by $7, from $233 to $226…”
However, it is not a true decrease because:
”In 2022, Medicare Part B premiums rose by 14.5 percent, one of the largest annual increases ever seen in the program’s history. A major factor in this increase was the inclusion of Aduhelm, the first Alzheimer’s medication approved by the Food and Drug Administration in 20 years.
The drug was highly scrutinized due to questions regarding its efficacy in treating Alzheimer’s disease as well as its sky-high price. Aduhelm initially cost $56,000 before its manufacturer Biogen announced it was halving the price to $28,200.”
OIG finds fewer Medicare improper payments to acute care hospitals in latest audit “Acute care hospitals generated $39.3 million in Medicare Part B improper payments over four years but faced a steep drop after the federal government implemented new tools to root out such errors.”
Review Identifies “Noteworthy” Differences in Effects on Patients of Traditional Medicare vs Medicare Advantage Well-worth reading to understand the quality and cost differences between the plans.
About hospitals and healthcare systems
THE ECONOMIC AND SOCIAL BENEFITS OF PHYSICIAN-LED HOSPITALS A good in-depth monograph on the topic.
CommonSpirit Health weathers $1.85B net loss in fiscal 2022, eyes dual challenges of staffing and inflation “The Catholic healthcare giant said Friday it saw a nearly $1.3 billion operating loss (-3.8% operating margin) and a $1.85 billion net loss across the full year. During the previous fiscal year, it had brought in almost $1 billion in operating income (3% operating margin) and experienced a $5.45 billion net gain….
Similar to other systems, CommonSpirit’s $551 million nonoperating loss was fueled by dicey investment markets. The organization reported a $971 million net loss attributed to its investments, a contrast to the $3.4 billion it enjoyed during last year’s swelling markets.”
Additionally, CommonSpirit has received $1.6 billion in CARES Act grants as of June 30, most of which were awarded in 2020 and 2021.
About pharma
Mark Cuban's pharmacy on track to make profit in 2023 “Mark Cuban's pharmacy, Cost Plus Drugs, is expected to be profitable in 2023, Forbes reported Sept. 26.
Mr. Cuban says the company has more than a million customers with roughly a 10 percent growth rate each week. Although no official revenue reports have been released, Forbes estimates Cost Plus has made at least $25 million in sales during the first nine months.”
Experimental Alzheimer’s drug slows cognitive decline in trial, firms say “An experimental Alzheimer’s drug slowed cognitive and functional decline by 27 percent in a closely watched clinical trial, the sponsors of the medication said Tuesday, increasing the therapy’s chance for approval as soon as early next year.
Japanese drugmaker Eisai and its American partner, Biogen, in a news release said the slowing of deterioration, compared with a placebo, was “highly statistically significant.” They said the drug, called lecanemab, had met the primary and secondary goals of the 18-month late-stage study. The trial results have not undergone peer review.”
Biogen finalizes $900M deal to settle whistleblower’s long-running MS kickback suit “Biogen has finalized an agreement to pay $900 million to resolve a lawsuit in which a former employee alleged that the Massachusetts biotech paid kickbacks to doctors over a five-year span starting in 2009 to boost sales of its multiple sclerosis drugs, the Department of Justice said Monday. Biogen in July said it had reached the $900 million deal in principle.”
Association of Research and Development Investments With Treatment Costs for New Drugs Approved From 2009 to 2018 “In this cross-sectional study of 60 new therapeutic agents approved by the US Food and Drug Administration from 2009 to 2018, there was no association between estimated research and development investments and treatment costs based on list prices at the launch of the product or based on net prices a year after launch.”
About the public’s health
Opioid-Reversal Drug Access to Ease Under Relaxed FDA Rules “Harm reduction programs distributing the opioid-reversal drug naloxone are exempt from certain federal product tracing requirements in an effort to better expand supply, the FDA said Thursday.
The Food and Drug Administration said in guidance that it won’t enforce certain Drug Supply Chain Security Act requirements on programs distributing FDA-approved naloxone to underserved communities while an opioid public health emergency declaration is in place.
About healthcare IT
Comparison of Quality Performance Measures for Patients Receiving In-Person vs Telemedicine Primary Care in a Large Integrated Health System “In this cohort study of 526 874 patients, telemedicine exposure was associated with significantly better performance or no difference in 13 of 16 comparisons, mostly in testing-based and counseling-based quality measures. Patients with office-only visits had modestly better performance in 3 of 5 medication-based quality measures.”
Public Health Emergencies: Data Management Challenges Impact National Response From the GAO: “Longstanding challenges in the federal government’s management of public health data undermine the nation’s ability to quickly respond to public health emergencies like COVID-19 and monkeypox. These challenges include the lack of:
common data standards—requirements for public health entitles to collect certain data elements, such as patient characteristics (e.g., name, sex, and race) and clinical information (e.g., diagnosis and test results) in a specific way;
interoperability—the ability of data collection systems to exchange information with and process information from other systems; and
public health IT infrastructure—the computer software, hardware, networks, and policies that enable public health entities to report and retrieve data and information.”
See the report for recommendations.