About Covid-19
Americans are afraid their vaccine passports could be hacked: ”A new Harris Poll reveals that 80% of Americans are worried that getting a COVID-19 digital passport could put their personal data at risk.
Among the majority of Americans who have cybersecurity concerns about the new digital vaccine credentials, the survey found that slightly more than half were uneasy about the potential for identity theft. On top of that, less than half of Americans believe that either businesses or the government are prepared to defend passport apps against a potential cyber attack.”
U.S. FDA allows Lilly's COVID-19 drug to be taken without remdesivir: “The U.S. health regulator expanded the emergency use authorization for Eli Lilly’s COVID-19 drug baricitinib, saying it could now be used without taking Gilead’s drug remdesivir along with it, Lilly said on Thursday.
In November, the U.S. Food and Drug Administration (FDA) approved Lilly and Incyte’s arthritis drug, baricitinib, in combination with remdesivir, to treat COVID-19 patients.”
‘The war has changed’: Internal CDC document urges new messaging, warns delta infections likely more severe: The Washington Post obtained this internal CDC document. “The data and studies cited in the document played a key role in revamped recommendations that call for everyone — vaccinated or not — to wear masks indoors in public settings in certain circumstances, a federal health official said. That official told The Post that the data will be published in full on Friday. CDC Director Rochelle Walensky privately briefed members of Congress on Thursday, drawing on much of the material in the document.”
CDC study shows three-fourths of people infected in Massachusetts covid-19 outbreak were vaccinated: “Critically, the study found that vaccinated individuals carried as much virus in their noses as unvaccinated individuals, and that vaccinated people could spread the virus to each other. The CDC was criticized this week for changing its mask guidance without citing unpublished data. The report released Friday contains that data.”
Physicians who post COVID-19 vaccine misinformation may lose license, medical panel says: “The Federation of State Medical Boards warned July 29 that physicians and other healthcare professionals could be at risk of losing their medical licenses if they spread COVID-19 vaccine misinformation on social media, online and in the media.
FSMB, a nonprofit that represents all U.S. state medical boards, said any clinicians who create or spread vaccine misinformation or disinformation risk disciplinary action by state medical boards, including suspension or revocation of their medical license.”
Marshfield Clinic lab plays vital role in CDC’s COVID-19 effort: “History books written about the COVID-19 pandemic won’t be complete unless they mention the pivotal role played by the Marshfield Clinic Research Institute, which is part of Wisconsin’s Marshfield Clinic Health System. The institute’s scientists test and process some 10,000 swabs a week, helping the Centers for Disease Control and Prevention (CDC) both track the progression of the disease and prove the effectiveness of the mRNA vaccines…
The lab has built a national reputation as a leader in respiratory infectious disease research through its participation in the flu vaccine effectiveness network and its collaboration with the CDC during the H1N1 flu pandemic of 2009—which some describe as the ‘dress rehearsal’ for the COVID-19 pandemic…”
About health insurance
Insurers push back on CMS' proposals to extend ACA open enrollment, bring back standardized plans: “Insurers pushed back at the Biden administration’s efforts to extend the Affordable Care Act’s open enrollment period by another month and require them to post standardized plan options.
Several insurers and advocacy groups commented on the proposals outlined in the Centers for Medicare & Medicaid Services’ Notice of Benefit and Payment Parameters, which outlines ACA marketplace exchange regulations for the 2022 coverage year. Insurers worried that extending the open enrollment period could lead to adverse selection and raise premiums for consumers.”
CMS: Part D premiums projected to increase nearly 5% in 2022 to $33: “The average Part D premium is projected to increase by nearly 5% from $31.47 to $33 in 2022.
Thursday’s announcement comes as Congress and the Centers for Medicare & Medicaid Services are making moves to address drug prices on Part D, the program’s prescription drug benefit.”
CMS releases 4 final payment rules: 16 things to know: “CMS on July 29 released its annual final payment rules for hospices, inpatient psychiatric facilities, inpatient rehabilitation facilities and skilled nursing facilities.” This article is a good summary. Here is the CMS statement.
Medicare Advantage:Beneficiary Disenrollments to Fee-for-Service in Last Year of Life Increase Medicare Spending: From the GAO: “We found that Medicare Advantage beneficiaries in the last year of life disproportionately disenrolled to enroll in fee-for-service, indicating possible issues with their care. Shifting end-of-life costs to fee-for-service increased Medicare spending by hundreds of millions of dollars.
We recommended monitoring end-of-life Medicare Advantage disenrollments to identify and address potential quality of care concerns.”
New bill aims to boost Medicare access to chronic care services: ”New legislation aims to eliminate the cost-sharing requirement for Medicare beneficiaries to get chronic care management services and reimburse providers for 100% of the payment.
The legislation, reintroduced Thursday, intends to boost access among seniors to chronic care management services that include creating a care plan and medication reconciliation and adherence.”
About pharma
Kaiser health plan files 'pay for delay' suit against Merck over cholesterol drugs: “Kaiser Foundation Health Plan's suit claims that the insurer paid hundreds of millions more for cholesterol drugs Zetia and Vytorin because the companies agreed to delay the launch of generic competitors…
The lawsuit is the latest challenge to so-call ‘pay for delay’ arrangements, which allow drugmakers to extend the length of their patent monopolies on certain pharmaceuticals. Pharma companies argue these arrangements are critical to allowing them to recoup research and development costs.” And in a related story:
Senate takes aim at pharma's patent schemes, pay-for-delay deals in renewed drug pricing crackdown: On Thursday the Senate Judiciary Committee “voted unanimously to advance four pieces of legislation which would help rein in the cost of prescription drugs.
The new laws take particular aim at the tactics used by drug companies to extend patent protections and stifle competition from cheaper generic and biosimilar drugs. The legislation, which would enhance the Federal Trade Commission's ability to initiate enforcement actions against drug companies, now moves to the Senate floor for a vote.”
AbbVie posts new data on drug that could replace glasses or contacts for age-related far-sightedness: “AbbVie has shared full results from a phase 3 trial it is hoping will persuade the FDA to approve a medicine solution for age-related far-sightedness, which is typically treated with contacts or glasses.
The study of AGN-190584, or pilocarpine formulation, showed significant improvements in the vision of patients with age-related far-sightedness after 30 days of dosing.”
This article provides a great case study for marketing a new therapeutic alternative. What about people who like to make a “fashion statement” with their glasses?
Prothena rolls out preclinical data for anti-amyloid Alzheimer's candidate to rival Biogen's Aduhelm: “In preclinical data presented Monday, Prothena said its fully humanized antibody targeting the N-terminus of amyloid-beta achieved greater avidity, or binding, than Aduhelm. The preclinical data showed the antibody could clear two main types of amyloid-beta plaque in the brain…
With its stronger binding potential, PRX012 may be able to be delivered at a lower dose and be administered subcutaneously [compared to Aduhelm which is given intravenously]…
Pricing information was not supplied.
Creditors Show Support for Purdue Pharma’s Bankruptcy Plan: “If preliminary voting sticks, Purdue Pharma’s controversial bankruptcy plan that settles with thousands of cities and states over the company’s role in the opioid epidemic will be accepted when the final tally is made public Aug. 2.
More than 95 percent of the 120,000-plus votes submitted are in favor of the bankruptcy proposal and nearly 97 percent of almost 5,000 state and local governmental creditors voted to accept the plan, the company said.”
AstraZeneca ups annual forecast following Alexion purchase: Details are in the article.
About healthcare devices
FDA dishes out Class I label to Philips' recall of faulty CPAP machines and other ventilators: “A recall of Philips’ ventilators for at-home and clinical use was given the FDA’s most serious classification after the devices were found to put users at risk of inhaling or swallowing dangerous pieces of debris.
The FDA handed down its Class I label several weeks after Philips initiated the recall in mid-June. Patients and healthcare providers using the company’s continuous and non-continuous ventilators—including CPAP and BiPAP machines to treat sleep apnea—are urged to stop using the devices immediately and contact Philips to replace the component.
At the root of the issue is the polyester-based polyurethane foam built into Philips’ ventilators to help reduce sound and vibrations. Over time the foam can potentially break down, sending specks of black debris and dangerous chemicals into the air pathway.”
Prescient Imaging Gains 510(k) Clearance for Portable PET Scanner: A real point-of-care breakthrough: “Hawthorne, Calif.-based Prescient Imaging has received 510(k) clearance from the FDA for its portable positron emission tomography (PET) scanner BBX-PET.
The device, which can be wheeled to the point of care, is cleared for obtaining PET images of parts of the human body, including the head. Potential uses include scans in neurology, geriatric psychiatry and radiation oncology centers.”
About healthcare IT
447,000 patients exposed after phishing attack on Florida practice: “Orlando (Fla.) Family Physicians began notifying 447,426 patients that it was the victim of a phishing attack on its employee email accounts…
Exposed data may include names, health insurance information, Social Security numbers, passport numbers and medical-related information.”
The attack targeted email accounts of several employees.
IU Health launches 'hack' lab to test medical device security: At Indiana University a “new lab is testing the cybersecurity of about 15 devices, including anesthesia and electrocardiogram machines, infusion pumps and patient monitors. The security team is essentially trying to hack the devices…“