About Covid-19
Covid sufferers become infectious quicker than first thought, study shows: “The UK government-funded ‘human challenge’ trial found that levels of the Sars-Cov-2 virus in the nose and throat peaked after five days, though participants remained infectious for an average of nine days and a maximum of 12 days after exposure. The researchers said their results support guidance that people should quarantine for 10 days after they first feel Covid symptoms or have a positive test result. The study took place in a special unit at the Royal Free Hospital in London. Eighteen of the 34 volunteers aged 18 to 29 became infected after receiving a low dose of the original Sars-Cov-2 strain via droplets in the nose.”
Another important finding of the study was: “No quantitative correlation was noted between VL [viral load] and symptoms, with high VLs even in asymptomatic infection…”
KFF COVID-19 Vaccine Monitor: January 2022 Parents And Kids Update: “Key Findings
In the midst of the latest surge of the omicron COVID-19 variant, the share of parents who say their child has gotten at least one shot of a COVID-19 vaccine increased between November and January. Six in ten parents of 12-17 year-olds now say their child has received at least one shot (61%, up from 49% in November), as do one-third of parents of 5-11 year-olds (33%, up from 16% in November). Three in ten parents of children under 5 say they’ll get their child vaccinated right away once a vaccine is approved for their age group, up somewhat from one in five in July.
One in five (21%) parents of vaccinated teens say their child has already received a COVID-19 booster, and around two-thirds (65%) say they will “definitely” or “probably get” one. Just one in seven parents of vaccinated 12-17 year-olds say their teen “probably” or “definitely won’t” get the booster (14%).
Half of parents report being worried about their child becoming seriously sick from the coronavirus, including substantially higher shares among parents who are Black or Hispanic and those with lower incomes.
Four in ten parents of school-age children report some type of disruption to their child’s in-person learning in the first month of the year, including needing to quarantine, schools shutting down in-person classes, or parents choosing to keep children home due to safety concerns. Most (63%) say their child’s school did not provide access to COVID-19 testing before returning to classes in January.”
Army to begin discharging soldiers who refuse coronavirus vaccination: “The U.S. Army announced Wednesday that soldiers who refuse coronavirus vaccinations will be immediately discharged.
The Army order, which applies to regular soldiers, active-duty reservists and cadets, comes in response to the Pentagon’s August order mandating vaccination for all U.S. troops… The Army’s deadline was in December.”
AMA announces CPT update for pediatric COVID-19 vaccine candidate: “For quick reference, the article has the new product and administration codes assigned to the Pfizer-BioNTech COVID-19 vaccine for children in the age range of 6 months to 5 years is:
Biden-Harris Administration Will Cover Free Over-the-Counter COVID-19 Tests Through Medicare: “As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA).”
BD doubles COVID sales forecast for 2022 even as steep testing dropoff leads to revenue loss: “In BD’s case, even though the medtech giant spent the last year introducing new devices and diagnostics and making acquisitions to break into new businesses, it still reported a drop in revenue for the first quarter of its 2022 fiscal year, attributed almost solely to a sharp dip in COVID-related earnings.
BD raked in just under $5 billion for the three-month period ending Dec. 31. That marks a 6% decline compared to the first fiscal quarter of the previous year, when it took in $5.3 billion.
Subtracting the impact of COVID-only diagnostic testing from those totals, however, tells a completely different story. Without those test sales, BD earned $4.8 billion for the quarter, which represents an increase of 8.1% over the previous year’s $4.5 billion COVID-less haul.”
At Nursing Homes, Long Waits for Results Render COVID Tests 'Useless': “The double whammy of slower turnaround times for lab-based PCR tests and a shortage of rapid antigen tests has strained facilities where quickly identifying infections is crucial for keeping a highly vulnerable population safe.
A KHN [Kaiser Health News]analysis of data from the Centers for Medicare & Medicaid Services finds that 25% of nursing homes that sent tests to a lab waited an average of three or more days for results as of Jan. 16. In early December, that number was 12%.”
Unvaccinated to Pay More Out-of-Pocket Under New Covid Policies: “People who choose not to get vaccinated can’t be denied health insurance, but they could be forced to pay more for their coverage.
The Affordable Care Act prohibits private health insurers from denying someone coverage or charging higher premiums because of a pre-existing condition or their health status, which would include whether or not they’re vaccinated.
Short-term health plans are an exception. Those plans could turn down applicants who refuse the Covid-19 vaccine because they aren’t subject to ACA regulations.
The ACA allows employer wellness programs to charge unvaccinated workers a surcharge as long as it doesn’t discriminate against people with disabilities.”
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH [CDRH] PROGRAMMATIC ACCOMPLISHMENTS EMERGENCY USE AUTHORIZATIONS: A review of its activities during the pandemic, which involve not only test reviews but also PPE approvals. In summary: “CDRH authorized 15 times more Emergency Use Authorization (EUA) requests than during all previous public health emergencies combined.” Translates to 2039 medical devices authorized (EUA and full market authorizations).
About health insurance
QUALITY PAYMENT PROGRAM [QPP] PARTICIPATION IN 2020: RESULTS AT-A-GLANCE: Good graphical presentation of latest results from the QPP. Some highlights:
For 2020:
--”89.11% were engaged in QPP in 2020
--Fewer clinicians participated in MIPS APMs than in 2019 (2020 – 398,719; 2019 – 416,201)
--25.72% received reweighting of one or more MIPS performance categories
Snapshot of 2022 Payment Adjustments for MIPS Eligible Clinicians:
--81% will receive an additional adjustment for exceptional performance
933,547 Total clinicians who will receive a MIPS payment adjustment (positive, neutral, or negative)
--10% will receive a positive payment adjustment
7% will receive a neutral adjustment (no increase of decrease)
2% will receive a negative payment adjustment
Cigna beats the Street with $1.1B in profit for Q4: “Cigna brought in $1.1 billion in earnings for the fourth quarter, down from a $4.1 billion haul in the same period in 2020.
Revenues for the quarter were $45.7 billion, up from $41.7 billion in the prior-year quarter, the company said in its earnings report released Thursday. Both figures exceeded Wall Street's expectations, according to Zacks Investment Research.
For full-year 2021, Cigna earned $5.4 billion in profit and $174.1 billion in revenue. By comparison, the insurer raked in $8.5 billion in profit for 2020 and $160.4 billion in revenue.”
CMS Releases 2023 Medicare Advantage and Part D Advance Notice: “CMS is requesting input on a potential change to the MA and Part D Star Ratings that would take into account how well each plan advances health equity. CMS is also requesting comment on including a quality measure in MA and Part D Star Ratings that would specifically assess how often plans are screening for common health-related social needs, such as food insecurity, housing insecurity, and transportation problems.”
Next big health crisis: 15M people could lose Medicaid when pandemic ends: “States expect the current federal public health emergency to expire this year, triggering a requirement that they must comb through their Medicaid rolls to see who is no longer eligible. Those audits, which have been suspended for the past two years, could lead to as many as 15 million people losing their health insurance, including 6 million children, according to an analysis from the Urban Institute.”
Medicare Advantage Plans Can Increase Income by Almost 8%: “Centers for Medicare and Medicaid Services on Wednesday proposed a 7.98% increase in Medicare Advantage payments in 2023 as they anticipate future changes to their risk adjustment model.
In a proposed fee policy for 2023, the agency solicited feedback on whether the risk adjustment model and MA star ratings could account for the impact of the social determinants of health and health equity.
Under the proposed changes, revenue for Medicare Advantage organizations could increase by nearly 8% next year compared to 2022. The proposed increase is nearly double the 4.08% salary increase planned for 2022.
This projection includes a 3.5% increase in the MA risk score trend, which is a median increase in risk scores. Risk estimates take into account a participant’s expected costs and tend to be higher when participants are sicker. The forecast also takes into account an effective growth rate of 4.75%.”
Georgia nurse practitioner convicted of health care fraud in complex telemedicine fraud scheme: “As described in court documents and testimony, Beaufils, as a nurse practitioner, facilitated orders for more than 3,000 orthotic braces that generated more than $3 million in fraudulent or excessive charges to Medicare. Co-conspirators captured the identities of senior citizens, identified through a telemarketing scheme, and bundled that information as ‘leads.’
Beaufils then signed her name to fake medical records, in which she falsely claimed she provided examinations of those patients, and then created orders for orthotic braces for patients she never met or spoke with – including a knee brace for an amputee, and a back brace for a recently deceased patient – and other durable medical equipment, in exchange for money. Beaufils’s fraudulent orders were then sold to companies that would generate reimbursement from Medicare.”
About hospitals and healthcare systems
Bottom-tier hospitals got better at infection control, but still hit with 1% Medicare pay cuts: “Hospitals with the worst rates patient infections have, on average, improved since 2018. Despite moving the needle on healthcare-associated infections, however, there will always be losers under the CMS Hospital-Acquired Condition Reduction Program. The bottom 25%—749 hospitals—are subject to 1% Medicare payment cuts in fiscal 2022. The Affordable Care Act established the penalty program as a way to put a spotlight on persistent patient safety problems. But the hospital industry questions whether the system is is fair, especially because healthcare-associated infections were declining prior to the COVID-19 pandemic.”
Union accuses HCA of widespread Medicare fraud in 45-page report: “Service Employees International Union is taking aim at Nashville, Tenn.-based HCA Healthcare, accusing the hospital operator of maximizing profits at the expense of patient care and obtaining more than $1 billion in fraudulent payments from Medicare…
The Medicare fraud allegations stem from SEIU's analysis of the average emergency department admission rate among HCA hospitals. The union found that HCA hospitals' admission rates exceeded the national average by more than 5 percent from 2014 to 2019. In some states, like Texas and California, the average HCA ED admission rate is 10 percent higher than the state average, the report found.”
Association of Emergency Department Pediatric Readiness With Mortality to 1 Year Among Injured Children Treated at Trauma Centers: “In this cohort study of 88 071 injured children from 8 states cared for in 146 EDs of trauma centers in 15 states, receiving initial care in an ED in the highest quartile of readiness was associated with 30% lower hazard of death to 1 year. The findings were consistent after removing children who died early…
Results of this study indicate high ED readiness is independently associated with long-term survival among injured children.”
Drug prices for hospitals to increase 3% in 2022, with remdesivir topping adalimumab in total spend: “Drug prices for hospitals are expected to increase by 3.09% in the coming year with newfound COVID-19 treatment remdesivir (Veklury) edging out longtime leader adalimumab (Humira) as hospitals’ top drug by total spend, according to a recent market outlook report from Vizient…
Remdesivir alone comprised 3.42%, more than $1 billion, of total Vizient member spend, according to the group’s report. It also led the way for anti-infective drugs, comprising 4% of total spend within the class and outstripping the second product, rifaximin (Xifaxan), by a factor of 10.”
About pharma
Pharma Marketing in the Era of COVID: This monograph is not about Covid, but about how the pandemic changed pharma marketing. Several trends are noteworthy.
First, obviously, is an accelerated trend to digital communication media.
Second "is personalising content for customers. While at least 77 percent of pharma marketers believe that personalisation of content is a high priority, only 25 percent have access to the right technology to do so.” Third, as “almost all in-person meetings were cancelled in 2020, and many took a hybrid approach through 2021, the importance of digital opinion leaders (DOLs) has grown. As physicians increasingly turn to social media for knowledge translation and education, DOLs – keen scientific minds with social media savvy – have become an important marketing tool. DOLs tend to be different to traditional key opinion leaders (KOLs). Academic KOLs receive their status based on their experience, seniority and roles within an institution. A DOL’s stature is based on their online influence, which is not necessarily related to their years of experience or position.10 However, some KOLs have been making the transition to DOL.”
Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: “This meta-analysis and systematic review of 31 cancer biosimilar studies of 3 reference products involving 12 310 patients found that, compared with pivotal trials of reference drugs, studies of 3 cancer drugs with biosimilars available at the time of the analysis were, on average, larger, more often a randomized clinical trial, and more often double blinded. Meta-analyses showed biosimilars to be as effective as their reference products in all disease settings…
This study suggests that studies of biosimilars for treating cancer have design elements of rigorous trials and show equivalent effectiveness to their reference products.”
See, also, the accompanying editorial: Cancer Biosimilars—A Regulatory Success So Far, but Value Still to Be Determined
Astellas maintains full-year outlook, despite drop in Q3 profit: “Astellas maintained its full fiscal-year forecast of sales totalling JPY 1.3 trillion ($11.4 billion) on profit of JPY 174 billion ($1.5 billion).”
Takeda boosts full-year outlook: “Takeda now expects mid-single-digit revenue growth in fiscal year 2021 to JPY 3.5 trillion ($30.5 billion), up from a prior estimate of JPY 3.4 trillion ($29.6 billion). Meanwhile, profit is now seen at JPY 242.5 billion ($2.1 billion), lifted from an earlier forecast of JPY 184.3 billion ($1.6 billion).”
AbbVie's blockbuster eye drug Restasis under threat as FDA approves Viatris' copycat: “The FDA has approved Viatris' generic to AbbVie's chronic dry eye treatment Restasis, which generated $1.23 billion in U.S. sales last year. Patents on the drug began expiring in 2014, Viatris' Mylan Pharmaceuticals has noted, but generics haven't been able to pass through the FDA's gate until today despite years of regulatory efforts.”
Biogen's Aduhelm call to action backfires as CMS receives many more comments in favor of restrictive coverage: analyst: “During a January Q&A call with investors, Biogen chief Michel Vounatsos pressed Aduhelm supporters to fight the Centers for Medicare & Medicaid Services’ (CMS') restrictive coverage proposal on the beleaguered Alzheimer’s drug. Turns out, however, most people think CMS made the right call—at least according to one group of analysts.
The public supports CMS’ decision, which would limit Medicare coverage for antibeta-amyloid drugs like Aduhelm to patients enrolled in approved clinical studies, according to a BofA Securities analysis of more than 1,000 comments received by CMS.
There were thrice as many comments in support of CMS’ National Coverage Determination (NCD) and questioning Aduhelm’s efficacy as there were comments asking for a proposal tweak, BofA’s Geoff Meacham wrote in a note to clients Tuesday.
But are all those comments legit? More than 500 letters posted in support of CMS’ restrictive coverage were generated through a campaign run by non-profit media outlet More Perfect Union, a Biogen spokesperson said over email.”
J&J's Janssen inks $1B biobucks pact for Mersana's ADC tech in 3 targets: “After expanding its antibody-drug conjugate (ADC) deal with Synaffix last November to the tune of $1 billion, Mersana Therapeutics is back with another major deal. This time, Johnson & Johnson's Janssen unit is doling out $40 million upfront and more than $1 billion in biobucks for ADCs spanning three targets.
The pair will work together to research target candidates during preclinical development. J&J's biotech unit will provide proprietary antibodies, and Mersana will contribute its Dolasynthen platform to help find the new ADC product candidates.”
Amgen enters hot protein degradation field with $500M biobucks deal with Plexium: “Amgen is breaking into the protein degradation space in a $500 million biobucks deal with Plexium just weeks after lining up for RNA degraders in a tie-up with Arrakis.
The California neighbors entered a multi-year research collaboration and licensing agreement for new protein degradation therapies initially focused on two programs in cancer and other serious diseases. Amgen will dish out the milestones in exchange for a commercial license to the two programs.”
About the public’s health
Appeals court restores Tennessee Down syndrome abortion ban: “A federal appeals court on Wednesday once again reinstated a Tennessee ban on abortions because of a prenatal diagnosis of Down syndrome, or because of the race or gender of the fetus.
The ban is part of a sweeping anti-abortion measure that has faced multiple legal challenges since it was enacted in 2020 by Republican Gov. Bill Lee. Notably, the law banned abortion as early as six weeks — a time frame when most women don’t know they’re pregnant — but that portion has remained blocked from going into effect.”
Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission: For those interested in an overview, read the introductory comments in the seven Domains the Commission identifies.
Development of an Open Database of Genes Included in Hereditary Cancer Genetic Testing Panels Available From Major Sources in the US: “Hereditary cancer syndromes occur when germline variants increase an individual’s risk of developing cancer. Genetic testing can identify these variants, enabling clinicians to intervene through increased screening or prophylactic surgery.”
However, databases for these genes are not synched. Among other findings, the study found: “A total of 706 genes were included in at least 1 laboratory’s panel. Only 13 genes were included by all 17 companies. Only 110 genes appeared in at least 1 clinical guideline for hereditary cancer or had a ClinGen gene-disease relationship assessment.” Hence, the need for an open database.
About healthcare IT
Deploying digital health tools within large, complex health systems: key considerations for adoption and implementation: “In this piece, we put forth nine dimensions along which clinically validated digital health tools should be examined by health systems prior to adoption, and propose strategies for selecting digital health tools and planning for implementation in this setting. By evaluating prospective tools along these dimensions, health systems can evaluate which existing digital health solutions are worthy of adoption, ensure they have sufficient resources for deployment and long-term use, and devise a strategic plan for implementation.”
This article is well worth reading. It is a thoughtful, management tool that fulfills the purpose of the headline.
“Overall during the study period, we found that one in four respondents (23.1%) reported use of telehealth services in the previous four weeks.
Telehealth use rates were similar (21.1-26.8%) among most demographic subgroups but were much lower among those who were uninsured (9.4%) and young adults ages 18 to 24 (17.6%).
The highest rates of telehealth visits were among those with Medicaid (29.3%) and Medicare (27.4%), Black individuals (26.8%), and those earning less than $25,000 (26.7%).
There were significant disparities among subgroups in terms of audio versus video telehealth use. Among telehealth users, the highest share of visits that utilized video services occurred among young adults ages 18 to 24 (72.5%), those earning at least $100,000 (68.8%), those with private insurance (65.9%),andWhiteindividuals(61.9%). Videotelehealthrateswerelowestamongthosewithouta high school diploma (38.1%), adults ages 65 and older (43.5%), and Latino (50.7%), Asian (51.3%) and Black individuals (53.6%).
Policy efforts to ensure equitable access to telehealth, in particular video-enabled telehealth, are needed to ensure that disparitiesthat emerged during the pandemic do not become permanent.”
Comment: An additional problem not mentioned in the summary is need for expansion and affordability of broadband access. See: As internet access limits telehealth’s reach, insurers are starting to cover the bill Nearly a quarter of adults in the U.S. don’t have broadband at home, network speeds are insufficient for video calls in much of rural America, and 15% struggle to pay for internet.”
Top 5 telehealth diagnoses in November 2021: “Across the U.S., mental health conditions were the No. 1 telehealth diagnosis in November 2021, according to new data from Fair Health.
Telehealth claim lines remained steady from October 2021 to November 2021, rising from 4.1 percent of all medical claim lines to 4.4 percent….
1.Mental health conditions: 62.2 percent
2.Acute respiratory disease and infections: 4.5 percent
3.Developmental disorders: 1.9 percent
4.Joint/soft tissue diseases and issues: 1.8 percent
5.COVID-19: 1.4 percent”
About healthcare personnel
Strained US hospitals seek foreign nurses amid visa windfall: “There’s an unusually high number of green cards available this year for foreign professionals, including nurses, who want to move to the United States — twice as many as just a few years ago. That’s because U.S. consulates shut down during the coronavirus pandemic weren’t issuing visas to relatives of American citizens, and, by law, these unused slots now get transferred to eligible workers.”