About Covid-19
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations: Yesterday the “U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:
individuals 65 years of age and older;
individuals 18 through 64 years of age at high risk of severe COVID-19; and
individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”
Today, in a related story: A CDC Panel Backs Booster Shots For Older Adults, A Step Toward Making Them Available: “Advisers to the Centers for Disease Control and Prevention have recommended a third dose of Pfizer's COVID-19 vaccine for people 65 and older, as well as others at a high risk of severe illness.”
At Covid Summit, Biden Sets Ambitious Goals for Vaccinating the World: “President Biden, declaring the coronavirus an ‘all-hands-on-deck crisis,’ set out ambitious goals on Wednesday for ending the pandemic and urged world leaders, drug companies, philanthropies and nonprofit groups to embrace a target of vaccinating 70 percent of the world by next year…
Mr. Biden announced a series of actions, including the purchase of an additional 500 million doses of Pfizer’s vaccine at a not-for-profit price to donate overseas and $370 million to administer the shots. Vice President Kamala Harris announced that the United States would donate $250 million to a new global fund that aims to raise $10 billion to prevent future pandemics.”
Public Health Law after Covid-19: This article is an excellent summary of the recent rulings on the legality of governments’ public health actions.
Is The Worst Over? Modelers Predict A Steady Decline In COVID Cases Through March: “The delta surge appears to be peaking nationally, and cases and deaths will likely decline steadily now through the spring without a significant winter surge, according to a new analysis shared with NPR by a consortium of researchers advising the Centers for Disease Control and Prevention.”
Florida Students Are No Longer Required To Quarantine After Being Exposed To COVID: “A day after assuming his job, Florida's newly appointed surgeon general on Wednesday signed new protocols allowing parents to decide whether their children should quarantine or stay in school if they are asymptomatic after being exposed to someone who has tested positive for COVID-19.
The new guidelines signed by Dr. Joseph Ladapo also tweaked the state's prohibition against school mask mandates, prompting an administrative law judge to dismiss a lawsuit against the old rule that had been filed by various school boards.”
Effectiveness of mRNA Covid-19 Vaccine among U.S. Health Care Personnel: An update published yesterday: “Vaccine effectiveness for partial vaccination was 77.6% (95% confidence interval [CI], 70.9 to 82.7) with the BNT162b2 vaccine (Pfizer–BioNTech) and 88.9% (95% CI, 78.7 to 94.2) with the mRNA-1273 vaccine (Moderna); for complete vaccination, vaccine effectiveness was 88.8% (95% CI, 84.6 to 91.8) and 96.3% (95% CI, 91.3 to 98.4), respectively. Vaccine effectiveness was similar in subgroups defined according to age (<50 years or ≥50 years), race and ethnic group, presence of underlying conditions, and level of patient contact.”
Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial: “Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19.”
Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19: “Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In the study, no deaths were observed in either arm by Day 28.”
About hospitals and health systems
Prime-UnitedHealthcare Alignment Shows Price Transparency Data Will Impact Contract Negotiations: Price transparency is supposed to lower prices, however, many saw this result coming.
”Demanding more money from insurance giant UnitedHealthcare, Prime Healthcare hospitals in New Jersey have armed themselves with a new negotiating tool: price transparency data.
Effective January 1, federal rule requires hospitals to publicly disclose the prices they charge for medical care, including rates agreed with insurers. While compliance has been grim, Prime said it still sees itself being paid far less than many of its local counterparts. This has led to a scuffle that threatens network outreach to thousands of patients.”
In a related article: Parent Preferences for Transparency of Their Child’s Hospitalization Costs: “In this cross-sectional survey study of 526 parents of hospitalized children, 398 (76%) believed it was important to know the costs of their child’s care, and 397 (75%) wanted a hospital employee to discuss these costs. However, only 36 parents (7%) reported having a cost discussion during admission.
Meaning: These findings suggest that most families desire cost transparency in the care of their hospitalized child, but cost conversations rarely happen in the inpatient setting.”
World's Best Specialized Hospitals 2022: FYI, from Newsweek.
About healthcare IT
The State of Digital Patient Access: “Kyruus assessed the top 20 US News and World Report ranked hospitals, evaluating them across four key categories representing the main stages of the digital patient access journey: Engage, Search, Match and Book” Read the report for results across these dimensions.
California woman sold Medicare tool that gave improper access to 500,000 patients' data, feds say: “ A California woman was sentenced Sept. 21 to three years of probation for her role in a multimillion-dollar Medicare fraud scheme that exposed the private data of more than 500,000 patients, according to the Justice Department.
Stefanie Hirsch, 51, of Los Angeles, pleaded guilty Feb. 24 to violating HIPAA. Ms. Hirsch, who owned Medicare-enrolled wheelchair and scooter repair company El Medical, sold access to a Medicare eligibility tool that let Juan Perez Buitrago and Nathan LaParl improperly access patients' personal, medical and insurance information, the Justice Department said.”
In a related article: The Increasing Use of HIPAA Subpoenas in Federal Health Care Investigations: “Health Insurance Portability and Accountability Act (HIPAA) subpoenas are administrative subpoenas which, pursuant to 18 U.S.C. § 3486, allow DOJ prosecutors to compel the production of documents in any investigation involving a federal health care offense. And while compelling the production of documents can be similarly achieved with the issuance of a federal grand jury subpoena, the HIPAA subpoena provides federal prosecutors with the ability to do something that the grand jury subpoena cannot: share the gathered information with civil DOJ attorneys pursuing a parallel civil investigation. By opening the door to greater intra-departmental cooperation, the HIPAA subpoena is becoming the investigative tool of choice of certain US Attorney's Offices in health care investigations.”
About pharma
Garuda thinks it has cracked the code to off-the-shelf stem cell transplants—and investors are betting $72M to find out: “We know blood stem cell transplants are potential cures for serious diseases. The problem is, patients need cells from immune-compatible donors, creating a supply bottleneck that constrains use in some areas and blocks expansion into new diseases. Garuda Therapeutics thinks it may have come up with a fix for that problem—and has persuaded investors to bet $72 million on its vision.
Massachusetts-based Garuda landed the investment on the strength of its platform for generating off-the-shelf, self-renewing blood stem cells. Equipped with the platform, Garuda wants to eliminate the need for healthcare providers to find matched donor materials or use a patient’s own cells.”
HRSA intends to fine 6 drugmakers over 340B contract pharmacy violations: “Eli Lilly, Sanofi, AstraZeneca, Novartis, Novo Nordisk, and United Therapeutics all received letters dated Wednesday outlining the update. The six drugmakers were warned back in May by the HRSA that moves to restrict sales to contract pharmacies violated the 340B statute.”
About health insurance
Pain Doctor Convicted of Over $100 Million Health Care Fraud Scheme: “According to court documents and evidence presented at trial, Francisco Patino, 66, of Wayne County, excessively prescribed highly addictive opioids to his patients at his medical clinic in Livonia. In exchange for opioids, these patients would receive (or be billed as if they had received) facet joint or nerve block injections, both lucrative spinal injections. Although these spinal injections were purportedly intended to treat chronic pain, evidence at trial demonstrated that Patino injected patients without regard to medical necessity. Evidence also revealed that if patients refused to accept the injections, Patino would withhold their prescriptions for opioids. From January 2012 through July 2017, Patino billed Medicare for more of these injections than any provider in the country…
Patino also developed illegal kickback relationships with at least one diagnostic laboratory, under which he was paid in exchange for referring his patients’ samples to that lab.”