About Covid-19
Pfizer, BioNTech ask FDA to allow Comirnaty boosters in kids 5 through 11 “Pfizer and BioNTech said Tuesday that they asked the FDA to allow a third 10µg dose of their COVID-19 vaccine Comirnaty to be given to children ages 5 through 11 under an emergency-use authorisation (EUA). The companies also plan to seek authorisations to permit Comirnaty boosters in this group "in the coming weeks" from the European Medicines Agency and other global regulatory bodies.”
Vice President Harris tests positive for the coronavirus “Vice President Harris has tested positive for the coronavirus, the White House said Tuesday, becoming the most senior Biden administration official to contract a virus that has afflicted millions of Americans.
Harris tested positive on both rapid and PCR tests but has exhibited no symptoms, said Harris’s press secretary, Kirsten Allen.”
She had been vaccinated and “boosted.” The VP will be isolated and has started on Paxlovid.
Cerner, Epic collaborate with White House on COVID-19 therapeutics “The White House announced in an April 26 press release that it is calling on EHR vendors to incorporate information about oral antivirals directly into their health records interface.
Cerner and Epic reinforced their commitment to connecting clinicians and patients with correct information about COVID-19 treatments and is rolling out enhancements to its systems to support the White House's efforts.”
Read the article for specifics of EHR enhancements.
Longer intervals between COVID-19 vaccine doses produce higher antibody levels “A longer period between doses also was associated with higher antibody levels — up to nine times higher [2 to 4 weeks = 1,268.72 (95% CI, 1,043.25-1,542.91); more than 10 weeks = 11,479.73 (95% CI, 10,742-12,267.24)].”
About health insurance
CMS Plans to Reweight 2021 MIPS Cost Performance Category “CMS will reweight the cost performance category under the Merit-Based Incentive Payment System (MIPS) for the 2021 performance period due to the COVID-19 pandemic’s impact on clinicians and cost measures…
The cost performance category weight will change from 20 percent to 0 percent. The 20 percent will be redistributed to other performance categories, including the quality performance category, improvement activities performance category, and promoting interoperability performance category.”
Humana's Q1 profit jumps 12% year over year to $930M “Humana reported $930 million in profit for the first quarter of 2022, up 12.3% year over year from an $828 million haul in the first quarter of 2021.
Revenues were also up by double digits from the prior-year quarter, hitting $24 billion, the company reported Wednesday. That's a 16% hike from the first quarter of 2021, when the insurer earned $20.7 billion in revenue.”
Pharmacist Sentenced for $180 Million Health Care Fraud Scheme “A former Mississippi pharmacist was sentenced today to 10 years in the Southern District of Mississippi for a multimillion-dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary prescriptions. The conduct resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal health care programs.
According to court documents, Mitchell ‘Chad’ Barrett, 55, now of Gulf Breeze, Florida, and formerly of Mississippi, participated in a scheme to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications.”
About pharma
Arizona Passes Goldwater Institute’s Right to Try Law “Arizona has become the 41st state to enact a ‘right-to-try’ law that allows patients to access drugs that are still in clinical trials without asking the FDA for permission under the agency’s expanded access program.”
The exact terms of these laws vary by state. For example, in Illinois one of the qualifying criteria is that a patient “has a terminal illness.”
About the public’s health
1 death, 17 liver transplants in multi-country outbreak of hepatitis in children, WHO says “At least 169 cases of acute hepatitis in children aged one month to 16 years old have been identified in an outbreak that now involves 11 countries, the World Health Organization (WHO) said on Saturday.
Among the cases of acute hepatitis, at least one child has died and 17 children have required liver transplants, the WHO said in a news release…
’While adenovirus is a possible hypothesis, investigations are ongoing for the causative agent.’”
FDA Issues Marketing Decisions on NJOY Ace E-Cigarette Products “On April 26, the FDA issued decisions on multiple NJOY Ace e-cigarette products, including the authorization of four new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods, specifically:
NJOY Ace Device
NJOY Ace Pod Classic Tobacco 2.4%
NJOY Ace Pod Classic Tobacco 5%
NJOY Ace Pod Rich Tobacco 5%
This authorization allows these products to be legally marketed in the U.S. While this action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they ‘FDA approved.’ All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.”
About healthcare IT
FBI chief says espionage threat posed by China ‘unprecedented in history’ “‘The biggest threat we face as a country from a counterintelligence perspective is from the People’s Republic of China and especially the Chinese Communist Party,’ Wray said during an interview on CBS News’s ‘60 Minutes.’
‘They are targeting our innovation, our trade secrets, our intellectual property, on a scale that’s unprecedented in history,’ he added, noting that China’s hacking program is larger ‘than that of every other major nation combined.’”
Fiscal Considerations for the Future of Telehealth “When thinking about the long-term direction for telehealth authorities, we suggest attention to the following challenges related to the federal budget, and to national health expenditures.
Utilization – telehealth services should ideally help reduce over-utilization of care, but could end up substantially increasing patient utilization of health care services.
Provider incentives – telehealth services should ideally help providers reduce the cost of care, but payment incentives might lead to more costly care – especially if telehealth services continue to be reimbursed at parity with in-person care.
Fraud and abuse – telehealth services are at particular risk for fraudulent billing.”
For example: “Since telehealth's entrance into the health care market, overall recoveries in health care fraud have doubled from $2.6 billion in FY 2019 to over $5 billion in FY 2021.”
Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort “In this cohort study of 40.7 million commercially insured adults, telehealth accounted for a large share of ambulatory encounters at the peak of the pandemic and remained prevalent after infection rates subsided. Telehealth encounters for chronic conditions had similar rates of follow-up to in-person encounters for these conditions, whereas telehealth encounters for acute conditions seemed to be more likely than in-person encounters to require follow-up. These findings suggest a direction for future work and are relevant to policy makers, payers, and practitioners as they manage the use of telehealth during the COVID-19 pandemic and afterward.”
The study examined what happened once patients had a telehealth visit. It did not measure how many extra visits may have occurred because of easier access.
About health technology
Mount Sinai spinout developed algorithm that accurately diagnoses early-stage Parkinson's, per new study “The research, in a collaboration with the Michael J. Fox Foundation for Parkinson’s Research, used technology developed by a Mount Sinai spinout focused on cancer diagnostics. The study leveraged PreciseDx’s algorithms to detect a protein in salivary glands, which is linked to the disease. It was able to detect Parkinson’s with 99% sensitivity and 99% specificity and was more accurate than human pathologists in predicting the disease.”
FDA: Medtronic Issues Recall of Harmony Delivery Catheter “Medtronic is recalling the Harmony Delivery Catheter because it is possible that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the TPV [Transcatheter Pulmonary Valve System].”
Boston Scientific surges 10% in Q1 amid slew of FDA nods, company reorganization “The medtech's net sales jumped 10% over its performance during the same period last year. The total reached just past the $3 billion threshold, compared to the $2.75 billion it earned in the first three months of 2021.
The jump came even though its earnings sheet for the quarter was short one division compared to the previous year’s. The disparity comes from the sale of Boston Scientific’s BTG specialty pharmaceuticals division, which was completed in March 2021. Until that point, BTG added $13 million that quarter that wasn’t present this time around.”
About healthcare finance
Biofourmis banks $300M megaround to fuel its growth in remote care, potential M&A deal “Three years ago, technology startup Biofourmis had raised $10 million in total funding. This week, the virtual care and digital medicine-focused company announced a massive $300 million cash injection to fuel its growth.
The funding round has boosted Biofourmis' valuation to more than $1 billion, according to executives…
The Boston-based digital therapeutics company combines AI-based data analytics and biosensors to monitor the progress of medical treatment.”