Cardiac arrest study in young athletes raises heart screening questions

From Reuters:

Screening exams to identify young athletes at risk for cardiac arrest might not be worthwhile, a new study suggests.

Having your heart stop while playing a sport is very unusual, and fewer than 1 in 5 cases of sudden cardiac arrest among competitive amateur athletes would have been predicted by a screening examination, the authors of a study from Canada say.

“Our results indicate that sudden cardiac death during participation in competitive sports is rare, the causes are varied, and more than 80% of cases would not have been identified with the use of systematic (screening),” the research team, led by Dr. Paul Dorian at the University of Toronto, reported in The New England Journal of Medicine.

Not only do screening programs exclude people who could safely engage in sports, he told Reuters Health by phone, the money spent on them could be better used by having defibrillators handy at competition sites and training people to use them.

Navigating the Rising Risks of EHRs

From The Doctor’s Company (hat tip: Dr. Menadue):

Currently, 80 percent of physician office practices and 90 percent of hospitals have adopted electronic health records (EHRs) to help optimize productivity, workflow, and communication.

At The Doctors Company, we’ve seen the number of closed claims in which EHRs were a contributing factor increase continuously over the past 10 years. While EHRs have brought many positives, they have also created new risks and frustrations for doctors and patients.

Evaluation and Management: Emergency Department Visit, with Highly Complex Medical Decision Making

From Palmetto GBA:

Because the level of E/M service is dependent on three key components, performance and documentation of one component (for example: examination) at the highest level does not necessarily mean that the encounter in its entirety qualifies for the highest level of E/M service. To meet the guidelines for 99285 emergency CPT Code, the provider must document each of the three components at the level required, in support of medical necessity for the level of care being provided.

According to the Medicare manual any physician seeing a patient registered in the emergency department may use emergency department visit codes (for services matching the code description). It is not required that the physician be assigned to the emergency department. The emergency department codes should only be used if the patient is seen in the emergency department and the services described by the HCPCS code definition are provided. The emergency department is defined as an organized hospital-based facility for the provision of unscheduled or episodic services to patients who present for immediate medical attention.

Acute Chest Pain in the Emergency Department

From JAMA:

The authors conducted a post hoc analysis of the 118 patients in the usual care group in ROMICAT-II who underwent no noninvasive testing compared with the 882 patients who underwent testing. Those in whom noninvasive testing was omitted had shorter lengths of stay, less radiation exposure, and lower costs, yet there were no differences between the 2 groups in the rates of percutaneous coronary intervention, coronary artery bypass surgery, or major adverse cardiac events, all of which occurred in 5% or less of the patients during the 28-day follow-up period. The study was made possible by obtaining ROMICAT-II data from the Biologic Specimen and Data Repository Information Coordinating Center of the National Heart Lung and Blood Institute under a data sharing agreement.

While the findings are suggestive that testing may safely be omitted in such patients, the results are not definitive. The study was not designed or powered to address this question, and patients were not randomized to testing or no testing. The study by Reinhardt et al3 should motivate a randomized clinical trial of noninvasive testing to address this important clinical question. While awaiting a trial, clinicians may wish to consider following patients with low-risk chest pain and reserving noninvasive testing if indicated by subsequent events.

ENA Releases New Emergency Department Manager’s Survival Guide

Press Release from the ENA:

The Emergency Nurses Association released its new Emergency Department Manager’s Survival Guide, a digital reference for new and experienced ED managers. Since nearly half of U.S. medical care takes place in the ED, outstanding and informed leadership is essential to providing the best patient care.

Nurses must become accustomed to unique situations and topics while acclimating to a managerial role. The ED Manager’s Survival Guide serves as transitional tool to help them adjust to the nuances of ED management.

Topics covered include operations, human resource management, professional development, quality and safety, legal and regulatory information and finance. Authored by ENA members with extensive ED management experience, this “survival” guide was created specifically for nurse managers in emergency care.

“Like all nurses, the primary responsibility of ED managers is caring for patients,” said ENA President Karen Wiley, MSN, RN, CEN. “The ED Manager’s Survival Guide is a valuable and easily accessible resource for ED managers in their unique role, allowing them to focus on providing the best possible care in the ED.”

The 50 concise chapters of the ED Manager’s Survival Guide serve as a quick-reference resource for established managers, a go-to digital “mentor” for new managers and an educational tool for nursing students.

For nurses aspiring to ED leadership, the guide provides an introduction and path into understanding the higher responsibilities of ED management.

The ED Manager’s Survival Guide is now available in ENA’s Marketplace.

About the Emergency Nurses Association
The Emergency Nurses Association (ENA) is the premier professional nursing association dedicated to defining the future of emergency nursing through advocacy, education, research, innovation, and leadership. Founded in 1970, ENA has proven to be an indispensable resource to the global emergency nursing community. With more than 42,000 members worldwide, ENA advocates for patient safety, develops industry-leading practice standards and guidelines, and guides emergency healthcare public policy. ENA members have expertise in triage, patient care, disaster preparedness, and all aspects of emergency care. Additional information is available at www.ena.org.

FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal

Press Release from the FDA:

Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids.”

The NSS-2 Bridge device is a small electrical nerve stimulator placed behind the patient’s ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may provide relief from opioid withdrawal symptoms. Patients can use the device for up to five days during the acute physical withdrawal phase. Opioid withdrawal causes acute physical withdrawal symptoms including sweating, gastrointestinal upset, agitation, insomnia and joint pain.

To permit marketing of this device for this use, the FDA reviewed data from a single-arm clinical study of 73 patients undergoing opioid physical withdrawal. The study evaluated patients’ clinical opiate withdrawal scale (COWS) score, which is a clinical assessment conducted by a health care professional that measures opioid withdrawal symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors and anxiety. COWS scores range from 0 to more than 36 — the higher the number, the more severe the withdrawal symptoms are to a patient.

Prior to using the device, the average COWS score for all patients was 20.1. Study results showed that all patients had a reduction in COWS of at least 31 percent within 30 minutes of using the device. Overall, 64 of the 73 patients (88 percent) transitioned to medication assisted therapy after five days using the device, along with any medications needed for persistent symptoms, such as nausea and vomiting.

The FDA cleared the EAD (electro auricular device, now called Bridge Neurostimulation System) in 2014 for use in acupuncture. FDA’s granting of the current request for the NSS-2 Bridge expands the use of the device as an aid to reduce the symptoms of opioid withdrawal. It is available only by prescription. The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris.

The FDA reviewed the NSS-2 Bridge device through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

The FDA permitted marketing of the NSS-2 Bridge device to Innovative Health Solutions, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Hospitals file lawsuit to block 340B drug payment cut

From Healthcare Dive:

  • The American Hospitals Association (AHA) and other organizations have made good on their promise to sue the federal government in an effort to halt a major cut planned for the 340B Drug Pricing Program.
  • The hospitals are arguing the reimbursement change exceeds the authority of the HHS secretary and is “arbitrary and capricious.” They ask the court to force HHS to delay implementation or strike the cut entirely.
  • In addition to AHA, plaintiffs include America’s Essential Hospitals, the Association of American Medical Colleges, Eastern Maine Healthcare Systems (Brewer, Maine), Henry Ford Health System (Detroit) and Adventist Health System’s Park Ridge Health (Henderson, North Carolina).