DCMedical News: Thursday, April 2, 2020
DCMedical News-DCMN
Washington, D.C.
Thursday, April 2, 2020
DCMedical News is published every day both the House and the Senate are in session. The Senate is in recess until April 20, the House until an indefinite date.
THE BIG STORY IN HEALTH CARE
Coronavirus
Public Health Resource Pages (alphabetical):
AMA resource page for physicians here. American Public Health Association information here. CDC information page here. CMS (Centers for Medicare & Medicaid Services) Current Emergencies website, here. JAMA Network’s COVID-19 resource center here. Library of Congress Coronavirus Research Guide, (here) from the In Custodia Legis blog of the Library of Congress (LoC), with links to Congressional Research Service (CRS) reports. NIH information page here. National Library of Medicine Coronavirus page here, New England Journal of Medicine update here, New England Journal of Medicine Journal Watch here. The Lancet COVID-19 Resource Centre here. State actions, Kaiser Family Foundation, here. The White House open research dataset (CORD-19) here. World Health Organization COVID-19 page here.
News, Medical: The CDC’s Morbidity and Mortality Weekly Report (here) says “Investigation of all 243 cases of COVID-19 reported in Singapore during January 23–March 16 identified seven clusters of cases in which presymptomatic transmission is the most likely explanation for the occurrence of secondary cases.” Are BiPAP machines a new source of ventilators for COVID-19 patients? A “Northwell Health physician, a respiratory therapist, and a 3D printing bioengineer have successfully designed the protocol to turn the more common bi-level positive airway pressure (BiPAP) machine into a functional invasive mechanical ventilator, through a 3D printed adaptor they also designed to aid in the conversion.” Northwell published the plans, here. Vice President Pence told CNN that “"We think Italy may be the most comparable area to the United States at this point."
DOCTORS, NURSES AND OTHER HEALTH PROFESSIONALS
PCI v. CABG, Follow Up
A commentary (here) and original investigation (here) in JAMA Network notes changes in PCI and CABG volume and outcomes, 2003 – 2016. During this time period annual PCI volume decreased from 366 to 180 per 100,000 U.S. adults, annual CABG volume from 159 to 82 per 100,000 adults. “Risk-adjusted mortality decreased significantly after CABG but not after PCI across all clinical indications.”
Follow Up on Physical Therapy vs. Meniscectomy in Osteoarthritis Patients with Meniscal Tears
This is a five-year follow up (here) on the “METEOR” study in 2013 of patients with meniscal tears and mild-to-moderate osteoarthritis (OA). Physical function and pain improved equally in the two groups at six and twelve months, but 30% of the PT only patients had gone to surgery by six months, and another 5% at twelve months. Total knee replacement was more likely to take place in those who received meniscectomy than those who receive PT alone, suggesting partial meniscectomy may predispose patients to OA progression. “This 5-year follow-up reinforces the initial 1-year message –- outcomes with PT alone and meniscectomy were the same at 60 months…PT should be the initial option for OA patients with meniscal tears, and surgery should be considered only if PT fails.”
Bullying by Surgeons? Who Knew?
A survey of workplace bullying by academic surgeons, on an equal opportunity basis, reported in JAMA Surgery, here.
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
New TAVR Volume Requirements will Challenge Smaller Hospitals, but Double the Total Number Eligible
A report in JAMA Cardiology (here) says “Medicare recently revised its national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR). The revised NCD outlines new hospital surgical volume requirements to begin a TAVR program, including at least 50 open-heart procedures during the previous year and 20 aortic valve procedures in the previous 2 years.” The number of cardiac surgery hospitals providing TAVR could double under the new surgical volume requirements (495 offer the procedure currently, an additional 448 are candidates), but with potentially limited access in rural and safety net areas. Adding the number of current TAVR hospitals to the number of likely candidate hospitals would produce 310 total hospitals performing TAVR in the East, 244 in the Midwest, 187 in the South and 212 in the West.
DRUGS AND DEVICES
Coronavirus and the Pharmaceutical Industry
Drug Channels (by Adam Fein, Ph.D., Chief Executive of the Drug Channels Institute) provides a three-part series (here, here and here) on the impact of coronavirus on the pharmaceutical industry. The first part looks at patients, pharmacies and wholesalers, and is based on nearly 700 responses to a Drug Channels survey. In sum, patients are likely to increase their use of mail order pharmacies, coinciding with a boom in telehealth and remote counseling; patients are expected to increase their use of retail clinics; pharmaceutical wholesalers are expected to maintain high inventory levels; and the coronavirus is unlikely to improve the profit prospects for retail pharmacies. The second installment looks at manufacturers and payers, concluding that drug price control legislation is off the table; new drug approvals will slow; drug manufacturing will shift back to the U.S.; and third-party payment for prescription drugs will be unchanged. The third installment looks at public perceptions and concludes that pharmacies will get the biggest reputational boost, but pharmaceutical manufacturer reputations will also improve; hospitals face significant reputation risks, but not as great as the risks faced by insurance companies and PBMs.
Secret Results
An article in Science (here) indicates that many clinical trial sponsors are failing to comply with mandatory reporting requirements, and are breaking the law in the process. Clinical trial reports are supposed to be available and accessible to the public at clinicialtrials.gov, so that providers and patients alike can determine whether new treatments are for them. The study reviewed 4,700 clinical trials “whose sponsors should have posted results by the reporting deadline, which is one year of completing the trial.” Thirty organizations “never met a single deadline,” failing to report entirely in two-thirds of their trials, and many others were late. “Habitual violators” included Harvard, Boston Children’s Hospital and the Baylor College of Medicine, as well as the top four NIH institute sponsors. The 20 largest pharmaceutical companies met all reporting requirements.
Rushing Premarket Approval a Bad Idea?:
A study in JAMA Internal Medicine (here) by Rita Redberg and colleagues (of UCSF and NYU) compared the premarket approval process and “priority review” for high-risk (class III) medical devices. Review times were longer for priority review and devices with priority review were more likely to be recalled than those with standard review. After a median follow-up period of seven years, there was “no difference in the number of adverse events reported for devices approved by either pathway.” Remedies for the higher recall rates might include strengthening post-market surveillance and availability and transparency of adverse event reports.
READINGS AND REFERENCES
Link to Harvard Global Health Institute’s prediction of hospital beds needed in different Covid-19 infection scenarios, here.
A Financial Times “Big Read” on “The hunt for a drug to treat coronavirus,” here.
U.S. House of Representatives:
Members at https://www.house.gov/representatives
Committees and Members at https://www.house.gov/committees
U. S. Senate:
Committees and Members at https://www.senate.gov/committees
CQ 2020 Calendar of Regularly Scheduled Sessions, here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
April 3, 20, 21, 22, 27, 28, 29, 30
May 12, 13, 14, 15, 18, 19, 20, 21
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.