DCMedical News: Tuesday, September 30, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY
Booster Shot Safety and Side Effects—the Same as the Second Dose
The CDC has reported (here) that “During August 12–September 19, 2021, among 12,591 v-safe registrants who completed a health check-in survey after all 3 doses of an mRNA COVID-19 vaccine, 79.4% and 74.1% reported local or systemic reactions, respectively, after the third dose; 77.6% and 76.5% reported local or systemic reactions after the second dose, respectively . . [there were] no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine.”
DOCTORS, NURSES AND OTHER HEALTH CARE PROFESSIONALS
Intermountain to Compete With Outpatient Radiology Practices
Twenty-five hospital system Intermountain announced (here) that it will create a subsidiary to open and operate stand-alone outpatient imaging centers, “offering non-invasive magnetic resonance imaging (MRI) and computed tomography (CT) services at three Utah locations—Ogden, West Valley City, and Orem—beginning in late 2021. Up to five additional locations are being planned for 2022, with more to come in subsequent years.” All of the locations will offer “flat-rate prices that fall below the costs in typical hospital-based imaging settings.”
HOSPITALS AND OTHER HEALTH CARE FACILITIES
New York Prepares for Significant Health Personnel Gaps, Which, However, Do Not Take Place
New York Governor Kathy Hochul signed an executive order (Department of Health announcement here, order here) to expand the health care workforce in the face of vocal opposition to mandatory vaccination for health workers. Two days into the mandate, most hospitals report that they have retained sufficient numbers in their workforce to provide patient care, this according to Crain’s Health Pulse.
The thirty-day executive order “Expands the number of physicians, nurses and other clinicians who can practice in the state by relaxing licensing and other requirements,” according to a report in Healthcare Finance (here). “The order allows physicians and nurses and physician assistants in Canada or any other country approved by the Department of Health to practice medicine in New York State, even if they're not registered in the state. This also includes radiologic technologists, respiratory therapists, midwives, social workers and other clinicians not registered in the state to practice. It also allows physicians who will graduate in 2021 or 2022 to practice without a medical license, supervised by a licensed physician. This also applies to graduates of nursing programs. Emergency Medical Technicians and Advanced EMTs can provide emergency and non-emergency services beyond current settings. Certified emergency medical technician-paramedics may administer vaccines against the flu and COVID-19. Non-nursing staff can take nasal swabs and other specimens to test for COVID-19 or the flu.”
Reported Crain’s, “There was no indication Tuesday that facilities in the New York metropolitan area had to avail themselves of the newly available contingencies, although the city's public hospital system brought in 500 nurses to fill in for about the same number of unvaccinated nurses put on leave.”
Crain’s noted, “The mandate was issued Aug. 16, giving unvaccinated health care workers six weeks' lead-up time to get at least one dose of a vaccine to secure their continued employment. As of Monday evening, 92% of employees at hospitals, 92% of nursing home workers and 89% of adult-care facility staff had received at least one dose, according to preliminary data provided by Hochul's office.”
Volume and Efficiency in the Emergency Department
Three studies printed or re-printed in the American Journal of Emergency Medicine speak to strategies for managing the flow of patients in the Emergency Department. The first study (here) reports on the impact of placing an intensive care unit (“emergency critical care unit," EC3) in the ED: “The proportion of CCMU [critical care medicine unit] admissions from the ED decreased. The EC3 may be most effective at reducing the admission of lower-acuity patients with GI bleeding and possibly sepsis. The EC3 may be associated with improved survival in ED patients.”
The second study (here) sought to “Identify predictors of 30-day emergency department (ED) return visits in patients age 65–79 years and age ≥ 80 years,” and found that “Age alone was not an independent predictor of return visits. Prior hospitalization, dementia and CHF [congestive health failure] were predictors of 30-day ED return. The identification of predictors of return visits may help to optimize care transition in the ED.”
The third study (here) examined this proposition: “Integration of walk-in clinics into the hospital might reduce ED-visits. Over a longer period, however, the additional service of a walk-in clinic might attract even more patients, nullifying an initial decrease in patients for the ED.” The results showed “After the introduction of the walk-in clinic, ED-visits declined significantly. This remained stable over a two-year period. Reduction in ED-visits was mainly due to low-acuity patients not requiring admission to the hospital.”
MEDICARE, MEDICAID AND COMMERCIAL HEALTH INSURANCE
Medicare Advantage Plans Disadvantage Low-Income Medicare Beneficiaries
Bloomberg reports (here) that “Low-income Medicare beneficiaries and ‘dual eligibles,’ who also qualify for Medicaid, appear to receive sub-optimal care through their private Medicare Advantage plans, a new government report [here] has found. Dual eligibles, or DE, who have complex medical needs, and Medicare beneficiaries eligible for the program’s low-income subsidy (LIS) to help purchase prescription drugs ‘often received worse clinical care than’ other beneficiaries, the report found . . . The disparities were largest in the areas of follow-up after hospitalization for mental illness, and in avoiding potentially harmful drug-disease interactions in elderly dementia patients with a history of falls, the study found.” The report was funded by CMS and conducted by RAND.
Regulator Measurement of “Quality” Is Not Necessarily “Quality” to Patients
A Dutch study in the Journal of Patient Safety (here) finds “The predominant clinical approach taken by regulators does not match the patients’ perspective of what is relevant for healthcare quality. In addition, patients seem to be more tolerant of what they perceive to be clinical or management errors than of perceived relational deficiencies in care providers. If regulators want to give patients a voice, they should expand their horizon beyond the medical framework.”
DRUGS & DEVICES
Mischief in the FDA’s Approval of Alzheimer Drugs: Amyloid Marker v. Clinical Improvement, and Now Safety Concerns
STAT+ reports (here) that Biogen and Eisai are seeking accelerated approval for another Alzheimer’s drug, relying on the “relaxed” standard the FDA used in approving Biogen’s Aduhelm. “The application will request accelerated approval . . . based on its ability to reduce levels of toxic amyloid plaques in the brain, and not its effect on slowing the cognitive decline that marks Alzheimer’s. The FDA’s decision to approve Biogen’s Aduhelm based on the same, less-decisive criteria has sparked intense criticism of the agency from Alzheimer’s experts, scrutiny from members of Congress, and an investigation by the Department of Health and Human Services’ Office of Inspector General.”
The Boston Globe (here) reported that Mass General Brigham will join the Cleveland Clinic, Mount Sinai in New York and the Providence system in the Northwest in not using the drug. Aside from the $56,000 per year price for monthly infusions of Aduhelm, the Mass General committee indicated concerns with safety. “Biogen’s medicine was associated with ‘microhemorrhages,’ or small amounts of bleeding, in the brains of some patients in the studies, but usually didn’t cause serious problems.” The FDA’s revised and more limited guidelines for Aduhelm issued July 8 “didn’t mention that it wasn’t tested on patients taking blood thinners. That omission alarmed some prominent US doctors who say such patients could be at risk for more serious bleeding.”
READINGS & REFERENCES
Select Coronavirus Public Health Resources and References may be found here.
2021 CQ Congressional Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
October 1, 19, 20, 21, 22, 25, 26, 27, 28
November 1, 2, 3, 4, 5, 15, 16, 17, 18, 30
December 1, 2, 3, 6, 7, 8, 9, 10
Notes to Fred Hyde, MD, JD, MBA, news@dcmedicalnews.org