House passes $1.7 trillion spending package: 6 healthcare takeaways: A good summary of the healthcare provisions, including “a provision to allow Medicare parts B and D to negotiate prices directly with manufacturers on certain drugs…”
About Covid-19
CDC advisers back coronavirus boosters for all adults, urge them for people 50 or older: “Advisers to the Centers for Disease Control and Prevention endorsed a coronavirus booster-shot-for-all policy Friday, voting 10-to-1 to allow all adults to get an extra shot of the Pfizer-BioNTech or Moderna vaccines. In a separate vote, they recommended the shots for all people 50 or over.”
Dozens of health groups urge businesses to voluntarily adopt Biden’s vaccine rule: “The American Medical Association and more than 60 other health care associations on Thursday called on employers to voluntarily implement President Biden’s contested vaccine-or-testing mandate, saying businesses had no time to waste ahead of the busy holiday season.”
Lower SARS-CoV-2 viral shedding following COVID-19 vaccination among healthcare workers in Los Angeles, California: “Among 880 healthcare workers with a positive SARS-CoV-2 test, 264 (30.0%) infections were identified following receipt of at least one vaccine dose. Median SARS-CoV-2 cycle threshold values were highest among individuals receiving two vaccine doses, corresponding to lower viral shedding. Vaccination might lead to lower transmissibility of SARS-CoV-2.”
Effectiveness of public health measures in reducing the incidence of covid-19, SARS-CoV-2 transmission, and covid-19 mortality: systematic review and meta-analysis: “Eight of 35 studies were included in the meta-analysis, which indicated a reduction in incidence of covid-19 associated with handwashing (relative risk 0.47, 95% confidence interval 0.19 to 1.12, I2=12%), mask wearing (0.47, 0.29 to 0.75, I2=84%), and physical distancing (0.75, 0.59 to 0.95, I2=87%). Owing to heterogeneity of the studies, meta-analysis was not possible for the outcomes of quarantine and isolation, universal lockdowns, and closures of borders, schools, and workplaces.”
Impact of Hospital Strain on Excess Deaths During the COVID-19 Pandemic — United States, July 2020–July 2021: “The conditions of hospital strain during July 2020–July 2021, which included the presence of SARS-CoV-2 B.1.617.2 (Delta) variant, predicted that intensive care unit bed use at 75% capacity is associated with an estimated additional 12,000 excess deaths 2 weeks later. As hospitals exceed 100% ICU bed capacity, 80,000 excess deaths would be expected 2 weeks later.”
UK study suggests Delta subvariant less likely to cause symptoms: “According to a coronavirus prevalence survey, a subvariant of Delta that is growing in the UK is less likely to lead to symptomatic COVID-19 infection, adding that overall cases had dropped from a peak in October, as reported by Fidelity.
The Imperial College London REACT-1 study found that the subvariant, known as AY.4.2, had grown to be nearly 12% of samples sequenced, but only a third had ‘classic’ COVID-19 symptoms, compared with nearly a half of those with the dominant Delta lineage AY.4.
The survey found that two-thirds of individuals with AY.4.2 had "any" symptom, compared with more than three-quarters with AY.4.”
Texas court says hospital can’t be forced to offer ivermectin to covid patient on ventilator: “A Texas appeals court ruled Thursday that a hospital can’t be forced to treat a covid-19 patient in its care with ivermectin, a drug normally used to eliminate parasitic worms, after the patient’s wife sued the hospital to demand the treatment.”
About pharma
Characteristics of Cost-effectiveness Studies for Oncology Drugs Approved in the United States From 2015-2020: “In this cross-sectional study of 116 drug approvals and 228 cost-effectiveness studies and 254 analyses, a drug was 40 times more likely to be deemed cost-effective when the study was funded by pharmaceutical companies compared with no funding.”
J&J previews $60B-a-year future with plans to go after viruses that have long evaded vaccine makers: “Johnson & Johnson has a lofty goal to become a $60 billion-a-year drugmaker by 2025. To reach that goal, the healthcare giant is going to take a crack at a couple of viruses [RSV and HIV] that have long eluded vaccine makers.”
In a related article: Johnson & Johnson expects 14 new blockbusters by the middle of the decade, execs say: “To get there, the company will rely on a combination of established medicines, investigational drugs, and new, innovative therapeutics such as CAR-T meds and gene therapies, Taubert [Jennifer Taubert, executive vice president, worldwide chairman of pharmaceuticals] said. The company has 14 novel medicines on the way, all of which have more than $1 billion in sales potential. Even sweeter, five of those products have the potential to reap $5 billion or more, Taubert said.
As for its established brands, J&J expects eight products to deliver double-digit revenue growth through 2025. Fourteen established J&J meds are expected to reel in more than $1 billion each by the middle of the decade, Taubert added.”
About 77% of clinical research execs expect to run decentralized trials in next 12 months: survey: “It appears the virtual or decentralized clinical trial landscape is here to stay as the growth of theses studies could outpace new traditional site-based studies in the coming year, according to Science 37.
That's based on a survey of 127 senior clinical research executives conducted during September and October. About 77% of respondents said they plan to run a hybrid trial in the next 12 months compared to 59% for the previous year. That's slightly higher than the 7 in 10 who said they plan to run traditional, site-based studies in the next 12 months.”
CBO: Democrats' package saves about $160B on drug prices: “Provisions to lower prescription drug prices in President Biden's Build Back Better package would save the government about $160 billion over a decade, according to a Congressional Budget Office (CBO) estimate released Thursday.
That includes about $80 billion in savings from allowing Medicare to negotiate lower drug prices in limited instances, and another roughly $80 billion in limiting drug price increases to the rate of inflation…
The CBO estimated that the measure would result in one fewer drug coming to market in the next decade, followed by four in the following decade and five in the decade after that. That's out of about 1,300 drugs expected to be approved in those 30 years.”
First Interchangeable Biosimilar Launched In US: “Viatris and Biocon have introduced their interchangeable Semglee insulin glargine biosimilar in the US, along with an unbranded interchangeable version, marking the first ever launch of an interchangeable biosimilar. The non-interchangeable version is expected to be phased out rapidly.”
Federal Judge Approves $345 Million EpiPen Settlement by Pfizer: “A federal judge has cleared Pfizer’s $345 million settlement resolving claims the drugmaker overcharged for its EpiPen epinephrine self-injector for treatment of severe allergic reactions.”
Insurers Balk at Paying for Biogen’s $56,000-a-Year Alzheimer’s Treatment: “None of the 25 large insurers that responded to a Bloomberg News survey judged the $56,000-a-year drug “medically necessary,” a term used to describe treatments that are needed for specific ailments and meet medical standards. Most have deemed Aduhelm experimental, while some say they’re still evaluating it.”
The Most and Least Expensive Cities for Prescription Medications: “Key takeaways:
Large coastal cities top the list for the most expensive cities for prescription medications, with New York and Los Angeles ranking in the top two. However, Little Rock, Arkansas, and Milwaukee, cities toward the middle of the country, stray from this pattern and join the top-five list at positions three and four, respectively.
Denver remains the cheapest city for prescription drugs by far, with cash prices more than 38% below the national average.
The cost of living and big-box store discounts account for much of the price variation but don’t tell the whole story.”
Pressure grows for funding to tackle ‘silent pandemic’ of antimicrobial resistance: “To remain effective for as long as possible, antibiotics should be tightly targeted: made affordable for all patients who need them, but with their administration otherwise tightly limited to avoid the excessive and improper use that can drive resistance. That requires ‘delinking’ the reward paid to drug developers from the revenues derived directly from their sales, which has encouraged excessive prescriptions. Instead, attention is turning towards a model akin to insurance, with companies paid lump sums or ‘premiums’ to compensate them for developing and stockpiling drugs in the hope they will be available but rarely used.”
About hospitals and health systems
Mayo Clinic operating income more than doubles: “Rochester, Minn.-based Mayo Clinic's revenue totaled $11.71 billion in the first three quarters of this year, up from $9.98 billion in the same period a year earlier. Net medical service revenue was up nearly 19 percent year over year…
The health system's operating expenses climbed 11.2 percent year over year to $10.7 billion in the first three quarters of 2021. Mayo Clinic saw expenses increase across several categories, including supplies and salaries and benefits.”
About the public’s health
CMS says evidence is sufficient to expand Medicare coverage for low-dose CT lung cancer screening: “Under the proposal, Medicare beneficiaries between the ages of 50 to 77 would be eligible, a drop from the previous starting age at 55. CMS also plans to reduce the threshold from 30 pack-years down to 20—meaning 20 cigarettes smoked per day for the past two decades. The new coverage guidelines align with recently updated recommendations from the U.S. Preventive Services Task force, released in March.”
Achieving Racial and Ethnic Equity in U.S. Health Care, A Scorecard of State Performance : A monograph from The Commonwealth Fund: “In this report, we evaluate health equity across race and ethnicity, both within and between states, to illuminate how state health systems perform for Black, white, Latinx/Hispanic, AIAN, and Asian American, Native Hawaiian, and Pacific Islander (AANHPI) populations. Our hope is that policymakers and health system leaders will use this tool to investigate the impact of past policies on health across racial and ethnic groups, and that they will begin to take steps to ensure an equitable, antiracist health care system for the future.”
Single-dose HPV vaccine highly effective, researchers say: “‘The single-dose vaccine was highly effective at 18 months for HPV vaccination,’ said Ruanne Barnabas, principal investigator of the trial and a professor of global health at the University of Washington School of Medicine. ‘The single-dose efficacy was the same as multiple doses.’”
About health insurance
Final 2022 Medicare Physician Payment and Quality Reporting Changes: From the MGMA.
Highlights:
”Key 2022 Medicare physician fee schedule (PFS) policies
The 2022 Medicare PFS conversion factor is 33.5893. The Anesthesia conversion factor is 20.9343. The payment penalty phase of the Appropriate Use Criteria (AUC) program is delayed at least one year. Physician assistants can directly bill and reassign payment for their services under Medicare.
CMS is providing an on-ramp for new split (or shared) E/M policies.
Key 2022 MIPS and APMs policies
The performance threshold to avoid a negative adjustment under MIPS is 75 points, and the exceptional performance threshold increased to 89 points. Under statute, the final year of the exceptional performance adjustment under MIPS is the 2022 performance year / 2024 payment year.
PY 2023 will be the first year for eligible clinicians to voluntarily report under an MVP. CMS finalized seven proposed MVPs beginning in the 2023 performance year.
CMS extended the period during which multispecialty groups can report under an MVP without forming a subgroup. Current policy will require multispecialty groups to form subgroups for voluntary MVP reporting beginning in the 2026 performance year.
Reporting via the CMS Web Interface has been extended as a quality reporting option through the 2024 performance year for Medicare Shared Savings Program participants.”
About medical devices
FDA clears Medtronic’s PillCam system for remote endoscopy procedures: “PillCam SB3 is delivered straight to a patient and, via a telehealth appointment, a provider guides the patient through the remote procedure. Over the course of the eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images securely to the cloud where they can be assessed by a GI physician to make a diagnosis. The patient returns the data recorder and sensor belt to Medtronic once the procedure is complete.
The SB3 @Home platform previously held temporary FDA approval during the National Public Health Emergency, while Medtronic’s PillCam capsule endoscopy has been in use for more than 20 years. PillCam SB is now in its third generation and only holds clearance for remote use in the U.S. and not in other geographies.”