DCMedical News: Thursday, July 21, 2022
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY Thursday, July 21, 2022
COVID-WATCH
The Editor in Chief of The New England Journal of Medicine’s Journal Watch/Infectious Diseases reviews (here) recent studies of “Antibody Evasion by the Subvariants of Omicron.”
He writes, “In vitro studies suggest vaccine-induced immunity and current therapeutic monoclonal agents offer diminishing protection against the latest SARS-CoV-2 variants.” He adds, “The past 9 months have seen the spread of multiple highly transmissible SARS-CoV-2 variants causing infections in vaccinated and previously infected individuals alike. Three studies provide insights about the protective efficacy of COVID-19 vaccines and therapeutic monoclonal antibody preparations in the face of Omicron subvariants with greater ability to evade neutralizing antibodies.”
One study “Found that the BA.2.12.1 and BA.4/BA.5 Omicron subvariants (circulating in the U.S. since early 2022) strongly evaded neutralization by sera from recipients of 3-dose vaccination or those who had had prior infection with BA.1. They also found these variants were neutralized only by bebtelovimab and cilgavimab [a preventive] and not the earlier therapeutic monoclonals developed to target the original SARS-CoV-2 strain and subsequent BA.1 variants.” Researchers in another study “Used comparable methodology to assess the ability of differing SARS-CoV-2 variants to evade neutralization by therapeutic monoclonal preparations, with very similar results.”
HHS COVID-19 therapeutics “side-by-side” summary here.
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
RAND on Out-of-Hospital Cardiac Arrest and the Dismal (Current) Outcomes
RAND reports (here) on “Out-of-hospital cardiac arrest (OHCA) [which] is a common, life-threatening event that is a leading
cause of death in the United States.”
“Of the approximately 305,800 cases of OHCA treated by emergency medical services (EMS) in 2021, about 91 percent result in death . . . An estimated 24 percent of patients survive to hospital admission, and 9 percent are discharged alive. A 2015 National Academy of Medicine report highlighted substantial regional variations in successful OHCA response and treatment across the United States—specifically, survival rates between communities.”
RAND reports that “The American Heart Association (AHA) recognizes the chain of survival as an operational framework for assessing EMS response to OHCA. This framework consists of six interdependent links: • recognition of cardiac arrest and activation of emergency response • early cardiopulmonary resuscitation (CPR) • rapid defibrillation • effective advanced cardiac life support (ACLS) • integrated post-resuscitative care • recovery.”
This “National Heart, Lung, and Blood Institute (NHLBI)–funded Enhancing Pre-Hospital Outcomes for Cardiac Arrest (EPOC) study lays the foundation for future quality improvement efforts in OHCA by identifying, understanding, and validating the strategies adopted within emergency response systems to address these life-threatening events and by addressing potential barriers to implementation of these practices.”
Nursing Home Staffing: National Standard Too High, Says Industry, Even a Twenty Year old Standard
The American Health Care Association has released a report (here) which found that “increasing federal staffing minimums to meet the decades-old 4.1 hours per resident day standard would cost the sector over $10 billion and require hiring 187,000 new nurses over 94% of facilities -- a finding beneficiary advocates say is an admission by the nursing home industry of rampant understaffing as the administration works to establish a minimum staffing mandate that potentially could adopt that standard. AHCA says even meeting a less-stringent federal staffing minimum of 3.1 hours per resident day would come at a cost of $3.5 billion.”
CMS has recommended the 4.1 hour standard since 2001.
MEDICARE, MEDICAID AND COMMERCIAL HEALTH INSURANCE
Insurers Not Thriving in Market, Rate Increases Loom
Elevance Health (f/k/a/ Anthem, NYSE: ELV) led a selloff of managed care companies, as reported by Seeking Alpha, which labeled Elevance “the worst performer in the S&P 500,” and added that “Its rivals, UnitedHealth Group (UNH), Cigna Corporation (CI), Humana (HUM), CVS Health Corp (CVS), and Centene Corp (CNC), are not far behind.” This despite a year-over-year increase of 16% for revenue, 14% for earnings per share, and an increase in the medical loss ratio to 87%.
The Associated Press reports (here) that “US health insurers raise rates to match increase in usage.” The report continues, “After putting off routine health care for much of the pandemic, Americans are now returning to doctors’ offices in big numbers — a trend that’s starting to show up in higher insurance rates across the country. Health insurers in individual marketplaces across 13 states and Washington D.C. will raise rates an average of 10% next year, according to a review of rate filings by the Kaiser Family Foundation.”
The rates review included Georgia, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, New York, Oregon, Rhode Island, Texas, Vermont and Washington . . . About 155 million people get their insurance through their employer-sponsored coverage. But Kaiser said the filings for the individual plans are more detailed and publicly available . . . The rate increases come as Congress debates whether to extend financial help for consumers through the American Rescue Plan — the $1.9 trillion economic aid package Congress passed last year to combat the economic impacts of the pandemic.
“The American Rescue Plan included significant funding to keep health insurance premiums low for people who purchase coverage through state marketplaces.” If that assistance expires at the end of 2022 it is estimated that 3 million people will drop coverage, no longer affordable. Reported KFF, “Without guidance on whether Congress will extend the assistance next year, some insurers have reacted by proactively raising rates in anticipation of people dropping coverage.”
DRUGS & DEVICES
Pharma Policing 340 Discounts: 340B Hospitals, Congress Unhappy
More than 180 members of the House of Representatives are urging the Biden administration to crack down on drugmakers restricting drug discounts in the 340Bprogram,” according to a report in Healthcare Dive (here).
“The 340B program requires drugmakers to charge hospitals only the statutory ceiling prices for eligible outpatient drugs. The goal of the three-decade-old program is to have savings flow into care for low-income patients and underserved communities. But critics — notably, drugmakers and some lawmakers — argue the program doesn’t have enough oversight, as hospitals don’t need to account for what they do with any savings,” a small safety net program in 1992 having become a major source of unprogrammed income for more than half of the nation’s hospitals.
“Drug manufacturers began imposing restrictions on 340B discounts as early as summer 2020, sparking legal challenges from regulators. The HHS sent nine warning letters to pharmaceutical companies, referring seven of them to the Office of the Inspector General for investigation and potential enforcement.”
“However, eight months later, the OIG has yet to take enforcement action, the new letter from 181 House members (here) reads. The letter asks the OIG to finish its ongoing review of seven drug manufacturers for potential noncompliance with federal law on 340B discounts as soon as possible.” The law allows the OIG to impose fines up to $6,000 per drug claim on companies that intentionally overcharge 340B providers, according to the Health Resources and Services Administration, which oversees the program.
READING & REFERENCES
Select Coronavirus Public Health Resources and References may be found here.
Monkeypox resources, CDC (here), JAMA Patient Page (here).
2022 CQ Congressional Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
July 26, 27, 28, 29
August, Congress adjourned, no editions of DCMN
September 13, 14, 15, 16, 19, 20, 21, 22, 28, 29, 30
Notes to Fred Hyde, MD, JD, MBA, news@dcmedicalnews.org